Applicator for dispensing measured quantities with use of controlled suction

• US 6,331,172 B1
• Filed: 04/14/1997
• Issued: 12/18/2001
• Est. Priority Date: 04/14/1997
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Plyley, Alan, Epstein, Gordon Howard, Redmond, Russell James
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Thanh, LoAn H.
• Application Number:
  US08/838,078
• Time in Patent Office: 1,709 Days
• Field of Search: 604/82, 604/73, 604/94, 604/131, 604/135, 604/134, 604/173, 604/181, 604/187, 604/191, 604/208, 604/214, 604/218, 604/224, 604/228, 604/46, 604/49, 604/56, 424/423, 222/137, 222/327, 222/391, 239/113
• US Class Current: 604/82
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61M 1/7411 by changing the size of a vent in combination with changing the cross-section of the line A61M1/7413
• CPC Class Codes: A61M 1/7413 by changing the cross-section of the line
• CPC Class Codes: A61M 1/774 Handpieces specially adapted for providing suction as well as irrigation, either simultaneously or independently
• CPC Class Codes: A61M 5/31581 performed by rotationally moving or pivoting actuator operated by user, e.g. an injection lever or handle

Abstract

A medical fluid applicator for dispensing a fluid onto biological tissues in tissue adhesive or sealant applications includes a dispensing pathway with an audible loudness indicator that signals the cumulative amount of fluid delivered by varying the pitch or tone of audible signals emitted at discrete volumetric increments. A suction pathway is also included for applying vacuum pressure to the applicator tip contemporaneous with the fluid application. The medical fluid applicator further includes a clearing pathway for retrogradedly withdrawing coagulated mixed fluids, such as mixed two-part tissue adhesives, from the applicator tip. A valve manifold and a shuttle valve are actuated to adjust the operation of vacuum pressure in the device between the various suctioning, clearing, and venting conduits of the device. The valve manifold is also adapted to couple a vent pathway and the suction pathway simultaneously to the vacuum conduit adapted for connection to a vacuum source. The coupling of vacuum to these pathways may be selectively adjusted by use of inversely and reciprocally shaped valving apertures on the valve manifold, such that preselected levels of applied suction at the suction pathway may be achieved. The device also includes a supply device portion and an applicator portion removably coupled thereto. The supply device portion includes the proximal portions of the dispensing assembly including the audible loudness indicator and the fluid reservoirs. The applicator portion includes the suction conduit, the clearing conduit, and a mixing conduit for mixing the components of the fluid reservoirs immediately prior to fluid delivery. A filling dispenser is further provided which is keyed to engage the supply device portion of the device in a predetermined orientation such that each fluid reservoir of the supply device is coupled for filling from a specified, predetermined filling reservoir.

Claims

1. A manually operable medical fluid applicator for dispensing mixed sealant on to a work surface, the applicator comprising:

a) a fluid sealant dispensing pathway connecting with multiple sources of sealant components and including a mixing region where the sealant components can be mixed;

b) a suction pathway connectable to a suction source and with the dispensing pathway; and

c) a suction control valve operable to connect the suction pathway with the fluid dispensing pathway to apply suction to, and to remove undesired material from, the mixing region of the fluid sealant dispensing pathway.

2. A sealant applicator according to claim 1 comprising a valve to disconnect the fluid sealant dispensing pathway from the sealant component sources when the suction pathway is connected with the fluid dispensing pathway.

3. A sealant applicator according to claim 1 wherein the suction pathway comprises a suction dispensing aperture enabling suction to be applied to the work surface.

4. A sealant applicator according to claim 3 wherein the suction control valve is operable to apply suction to the suction dispensing aperture and to disconnect the suction dispensing aperture from the suction source when suction is applied to the fluid dispensing pathway.

5. A sealant applicator according to claim 1 wherein the fluid sealant dispensing pathway has a cross-sectional area which increases and does not decrease in a direction from a point of dispensing to a point of connection with the suction pathway to facilitate removal of undesired solids therefrom.

6. A handheld sealant applicator comprising:

a) a housing with an applicator tip having a tip dispensing aperture;

b) a fluid dispensing pathway within said housing comprising;

i) at least two fluid reservoirs for two sealant components; and

ii) a dispensing conduit leading from the fluid reservoirs to the tip dispensing aperture, the dispensing conduit having a distal portion including the dispensing aperture;

c) a suction pathway connectable to a vacuum source;

d) a clearing pathway connectable to the vacuum source via the suction pathway; and

e) a control valve assembly capable of being coupled to the fluid dispensing pathway and to the clearing pathway and having a control valve having a valve member movable outside the fluid dispensing pathway from a first, dispensing position wherein the dispensing conduit is in fluid communication with the fluid reservoirs and is substantially isolated from the clearing pathway, to a second, clearing position wherein at least a distal portion of the dispensing conduit is substantially isolated from the fluid reservoirs and is in fluid communication with the clearing pathway.

7. A sealant applicator according to claim 6 comprising a manually operable dispensing actuator to dispense fluid contained in the fluid reservoirs through the dispensing conduit when the valve assembly is in the first dispensing position, wherein in the second, clearing position of the control valve assembly, the distal portion of the dispensing pathway is connectable with the vacuum source to clear the distal portion of its contents.

8. A sealant applicator according to claim 7 wherein one of said fluid reservoirs contains a first fluid, the other of said fluid reservoirs contains a second fluid and operation of the actuator causes said first and second fluids to flow distally from the fluid reservoirs and to form a mixture within the dispensing conduit.

9. A sealant applicator according to claim 8 wherein said first fluid is a fibrinogen-containing fluid and said second fluid contains an activator for coagulating said first fluid.

10. A sealant applicator according to claim 9 wherein the activator comprises thrombin.

11. A medical fluid applicator according to claim 6 wherein a biologically or pharmacologically active agent is contained in at least one of the fluid reservoirs.

12. A sealant applicator according to claim 6 wherein the dispensing conduit comprises:

i) a branched portion having two branch conduits, each branch conduit being in fluid communication with one of the fluid reservoirs; and

ii) a mixing portion having a mixing conduit which terminates distally in the tip dispensing aperture;

and wherein, when the control valve assembly is in the first dispensing position, the mixing conduit is isolated from the clearing pathway and is in fluid communication with the branch conduits so that fluid from the branch conduits is mixed in the mixing conduit prior to discharge through the tip dispensing aperture, and when the control valve assembly is in the second clearing position, the mixing conduit is in fluid communication with the clearing pathway and is isolated from the branch conduits.

13. A sealant according to claim 12 wherein the clearing pathway and the mixing conduit are coupled to form a continuously tapered bore with a distally reducing inner diameter.

14. A sealant applicator according to claim 12 wherein the valve assembly further comprises a clearing valve portion coupled to an inner lumen of the clearing pathway so that, in the first, dispensing position, the clearing valve portion substantially isolates the mixing conduit from the clearing pathway, and, in the second clearing position, the clearing valve portion couples the mixing conduit and the clearing pathway to allow for fluid communication therebetween.

15. A sealant applicator according to claim 14 wherein the control valve assembly further comprises two dispensing valve portions, each being coupled to an inner lumen of one of the branch conduits so that, in the first, dispensing position, the branch conduit is in fluid communication with the mixing conduit and, in the second, clearing position, the branch conduit is substantially isolated from the mixing conduit.

16. A sealant applicator according to claim 15

wherein each branch conduit has a slotted portion to slidably receive one of the dispensing valve portions, the clearing pathway has a slotted portion to receive the clearing valve portion and each of the dispensing valve portions and the clearing valve portion has both a flow aperture and a closed portion

wherein in the first, dispensing position, the flow aperture of each dispensing valve portion registers with the slotted portion of a branch conduit to allow flow therethrough, and the closed portion of the clearing valve portion registers with the slotted portion of the clearing pathway to substantially obstruct flow therethrough

and wherein, in the second clearing position, the closed portion of each dispensing valve portion registers with the slotted portion of a branch conduit to substantially obstruct flow therethrough, and the flow aperture of the clearing valve portion registers with the slotted portion of the clearing pathway to allow flow therethrough.

17. A sealant applicator according to claim 6 further comprising:

f) a clearing conduit coupled to at least a distal portion of the dispensing conduit and adapted to form at least in part the clearing pathway;

g) a suction conduit adjacent the dispensing conduit and terminating at the applicator tip in a tip suction aperture;

h) a vacuum conduit adapted to couple to a vacuum source; and

i) a valve manifold coupled to the clearing, suction, and vacuum conduits the valve manifold being adjustable from a first, suction position to a second, manifold clearing position;

wherein in the first, suction position the vacuum conduit is substantially isolated from the clearing conduit and is in fluid communication with the suction conduit to form a suction pathway and in the second, manifold clearing position the vacuum conduit is substantially isolated from the suction conduit and is in fluid communication with the clearing conduit to form the clearing pathway.

18. A sealant applicator according to claim 17 wherein the housing further comprises:

j) a body portion including the fluid reservoirs, the vacuum conduit, the valve manifold and a supply conduit fluidly coupling each fluid reservoir with one of two supply ports; and

k) an applicator portion including the applicator tip, the dispensing conduit, the suction conduit, the clearing conduit, and the valve assembly;

wherein the dispensing conduit has a mixed portion and two branched channels extending proximally therefrom and terminates proximally in two proximal dispensing ports, the suction conduit terminates proximally in a proximal suction port, and the clearing conduit terminates proximally in a proximal clearing port

and wherein the applicator portion is removably engageable with the body portion to bring the proximal dispensing ports into fluid communication with the supply ports and to couple the proximal suction port and the proximal clearing port with the valve manifold.

19. A sealant applicator according to claim 18 further comprising

l) a valve housing housing the valve manifold and including a vacuum aperture in communication with the vacuum conduit, a suction aperture in communication with the suction conduit, and a clearing aperture in communication with the clearing conduit;

wherein the valve manifold further comprises a valve wall defining a valve chamber, the valve chamber communicating externally of the valve wall through a valve vacuum port, a valve suction port, and a valve clearing port,

wherein, in the first suction position, the valve vacuum port and valve suction port are aligned with the vacuum and suction apertures, respectively, to form a suction pathway and the valve clearing port is out of alignment with the clearing aperture with the valve wall substantially isolating the clearing conduit from the suction pathway

and wherein, in the second manifold clearing position, the valve vacuum port and valve clearing port are aligned with the vacuum and clearing apertures, respectively, to form the clearing pathway, the suction port being out of alignment with the suction conduit with the valve wall substantially isolating the suction aperture from the clearing pathway.

20. A sealant applicator according to claim 18 comprising a valve actuator which is coupled to both the valve assembly and the valve manifold, the valve actuator being adjustable from a first actuated position, wherein the valve assembly is in the first, dispensing position and the valve manifold is in the first, suction position, to a second actuated position, wherein the valve assembly is adjusted to the second clearing position and the valve manifold is adjusted to the second manifold clearing position.

21. A fluid adhesive applicator for dispensing a two-component fluid adhesive, the applicator comprising:

a) a dispensing aperture;

b) two fluid reservoirs respectively for the two fluid adhesive components;

c) a dispensing conduit capable of being in simultaneous fluid communication with the reservoirs and the dispensing aperture, the dispensing conduit having a mixing portion for simultaneously receiving and mixing the two fluids to form a mixture and a dispensing portion extending from the mixing portion to the dispensing aperture;

d) a manually operable dispensing actuator for effecting simultaneous flow of a fluid from each reservoir into the dispensing conduit; and

e) a manually operable clearing actuator movable to apply a clearing force to clear undesired material from the dispensing conduit.

22. A fluid applicator according to claim 21 comprising a valve member movable to isolate the fluid reservoirs from the mixing portion, the valve member being operable by movement of the clearing actuator whereby the fluid reservoirs are isolated from the mixing portion when clearing of the dispensing conduit is effected.

23. A fluid applicator according to claim 21 wherein the fluid reservoirs comprise tubular chambers, each tubular chamber having a plunger slidable therein in response to manual operation of the dispensing actuator to discharge fluid in the chamber into the dispensing conduit.

24. A fluid applicator according to claim 21 comprising a clearing pathway communicable with a vacuum source wherein the clearing actuator comprises a shuttle valve to selectively couple the clearing pathway with the mixing portion of the dispensing conduit.

25. A fluid applicator according to claim 24 wherein the fluid reservoirs comprise syringes having plungers movable to discharge the fluids from the cylinders, wherein the applicator comprises a drive mechanism to translate operation of the dispensing actuator into movement of the plungers and wherein the housing houses the syringes, the vacuum valve and the drive mechanism.

26. A fluid applicator according to claim 21 having a suction aperture located adjacent the dispensing aperture and the applicator comprises a suction adapter connectable to a vacuum source to apply suction to the suction aperture.

27. A fluid applicator according to claim 26 comprising a suction valve operable to selectively apply suction from a vacuum source either to the suction aperture or to the dispensing conduit.

28. A fluid applicator according to claim 21 combination with a filling dispenser connectable with the fluid applicator and having separate volumes to contain separate supplies of the two fluids, the combination being operable to fill each of the fluid reservoirs with a predetermined one of the two fluids.

29. A fluid applicator according to claim 21 comprising a shuttle valve movable by the clearing actuator to a position isolating the fluid reservoirs from the mixing portion and comprising a clearing pathway communicable with a vacuum source wherein the shuttle valve selectively couples the clearing pathway with the mixing portion of the dispensing conduit when the fluid reservoirs are isolated from the mixing portion.

30. A fluid applicator according to claim 21 wherein the dispensing actuator is operable to dispense fluid from the reservoirs in discrete incremental volumes.

31. A fluid applicator according to claim 21 comprising an audible indicator responsive to operation of the dispensing actuator for providing an audible signal indicative of a cumulative volume of fluid dispensed from the applicator.

32. A fluid applicator according to claim 31 wherein the audible indicator generates an audible signal incrementally variable in either pitch or loudness according to the cumulative volume dispensed over a plurality of incrementally dispensed volumes.

33. A fluid applicator according to claim 21 comprising a toothed rack disposed adjacent the reservoirs and coupled with at least one reservoir to discharge fluid from the reservoir and a reciprocating pawl to move the toothed rack, a reciprocating pawl driven by the dispensing actuator to discharge the fluids from the reservoirs.

34. A fluid applicator according to claim 21 comprising a housing housing the fluid reservoirs and a dispensing conduit wherein the housing supports the dispensing aperture, the dispensing actuator and the clearing actuator to be accessible externally of the housing.

35. A fluid applicator according to claim 21 for dispensing a fibrin adhesive, wherein the two fluids comprise a fibrinogen component and a thrombin component in combination with supplies of the two fluids.

36. A medical fluid applicator for applying a medically useful fluid to a work surface, the applicator comprising:

a) an elongated housing having a distal end and a proximal end and being receivable into one hand of the user;

b) at least two reservoirs for components of a biological sealant attached to a branched dispensing pathway to dispense the components externally of the applicator;

c) a dispensing cannula extending from the distal end of the applicator to dispense fluid from the at least two reservoirs;

d) a manual actuator operable to apply manual force from the user to discharge fluid from at least two reservoirs to the dispensing cannula;

e) a suction adapter intermediate the housing ends and projecting externally and traversely of the housing for connection with an external vacuum source;

thereby permitting the user to operate the applicator with one hand and engage the suction adapter with said hand to help orient the applicator; and

f) said branched dispensing pathway having two branches, each said pathway connected to at least one said reservoir, including the dispensing cannula, wherein a suction control valve communicates with the suction adapter downwardly through the housing between the two branches of the dispensing pathway.

37. The medical fluid adapter of claim 36 wherein the dispensing pathway is configured to mix the fluid components and discharge the mixture through the dispensing cannula when the manual actuator is operated to discharge fluid components from the reservoirs.

38. A medical fluid applicator to apply a two-component tissue sealant to a work surface, the applicator comprising:

a) two syringes, one for each of two fluid components to be dispensed from the applicator, each syringe having a fluid reservoir and a plunger, the plunger being movable to vary the volume of the fluid reservoir;

b) a reciprocally operable manual actuator to apply manual force from the user to discharge fluids from the reservoirs; and

c) an actuator mechanism coupled with the manual actuator and the syringe plungers to translate force on the manual actuator into movement of the plungers in directions to discharge fluids from the reservoirs, wherein the actuator mechanism comprises;

i) a toothed rack supported for travel outside the volumes of the fluid reservoirs the toothed rack having a series of teeth disposed along the rack in the direction of travel and being coupled with each plunger to move the plungers concurrently in their reservoirs and remaining coupled with the plungers throughout the plungers'"'"' travel; and

ii) a rack advance mechanism to receive force from the manual actuator, and advance the rack and plungers in the fluid discharging direction, the rack advance mechanism having a reciprocally movable rack-engagement member engageable with successive ones of the teeth of the toothed rack to advance the toothed rack and plungers in a progressive manner;

where in repeated operation of the manual actuator progressively discharges both fluid reservoirs at the same time.

39. A medical fluid applicator according to claim 38 wherein the syringes are disposed in side-by-side alignment, wherein the toothed rack is disposed alongside the syringe reservoirs and wherein the actuator mechanism has a mechanical advantage effective to apply an amplified manual force to the toothed rack.

40. A medical fluid applicator according to claim 38 wherein the rack advance mechanism includes a pawl cyclically engageable with the toothed rack to drive the rack in a direction to discharge fluid from the reservoirs, the pawl being movable in the discharge direction by the manual actuator.

41. A medical fluid applicator according to claim 40 wherein the manual actuator is movable transversely of the discharge direction and the rack advance mechanism comprises a pivoted lever to translate movement of the manual actuator into movement of the pawl.

42. A medical fluid applicator according to claim 41 comprising a housing housing the syringes, the rack and the rack advance mechanism.

43. A medical fluid applicator according to claim 38 comprising a decoupling structure to decouple the rack advance mechanism from the rack and a manually grippable rack member, wherein the rack member is coupled with the syringe plungers for retraction therewith whereby the rack and syringe plungers can be manually retracted by gripping the manually grippable rack member with the rack advance mechanism decoupled from the rack.

44. A biological fluid dispensing device, comprising:

a) a support member adapted to be held in the hand of a user;

b) plural reservoirs supported with respect to the support member, the plural reservoirs each defining an internal volume for containing a quantity of one of plural biological fluids to be dispensed;

c) plural output ports defined one for each reservoir;

d) a driver mechanically coupled to each reservoir and mounted for movement during a dispensing operation, the movement being within a range of driver positions with respect to the reservoir, and the driver cooperating with the reservoir to reduce the internal volume in response to advancement of the driver through the driver positions, and to drive the biological fluid through the output port;

e) an audible indicator coupled to the driver for emitting, in response to advancement of the driver position, an audible sound with an audible characteristic indicating the position of the driver and the corresponding magnitude of a volume of biological fluid contained within the internal volume; and

f) plural conduits connecting one to each output port to deliver each fluid from a respective one of the reservoirs, wherein the conduits are configured and disposed to deliver the fluids to be mixed together.

45. A biological fluid dispensing device as claimed in claim 44, wherein the support member can be grasped by the hand of the user in a manner leaving at least one finger able to mechanically engage the driver to manually advance the driver to successive positions where the internal volume is successively reduced to drive the biological fluid through the output port.

46. A biological fluid dispensing device as claimed in claim 44, wherein the audible indicator comprises a first vibrating assembly having:

i) a striker; and

ii) a plurality of vibrators, the vibrators being positioned, configured and dimensioned to emit an audible sound when struck by the striker;

wherein the driver is coupled to either the striker or the vibrators, movement of the driver within the range of positions causing relative movement between the striker and the vibrators, the movement causing the striker to sequentially strike the vibrators and cause the vibrators to emit the audible sound, wherein the audible sound has audio characteristics varying in accordance with the position of the striker, the variation in audio characteristics varying in accordance with a pattern which indicates to the user the magnitude of the internal volume, whereby the user can determine the volume of the biological fluid remaining in the device.

47. A biological fluid dispensing device as claimed in claim 46, wherein the audible indicator further comprises a second vibrating assembly having:

iii) a second striker; and

iv) a second plurality of second vibrators, the second vibrators being positioned, configured and dimensioned to emit an audible sound when struck by the second striker;

wherein the driver is coupled to either the second striker or the second vibrators, movement of the driver within the range of positions causing relative movement between the second striker and the second vibrators, the movement causing the second striker to sequentially strike the second vibrators and cause the second vibrators to emit the audible sound, wherein the audible sound has audio characteristics varying in accordance with the position of the second striker, the variation in audio characteristics varying in accordance with a pattern which indicates to the user the magnitude of the internal volume, whereby the user can determine the volume of the biological fluid remaining in the device, and wherein the variation in audio characteristics of the first and second vibrating assemblies being a variation in pitch, the relationship between the pitch produced by the first vibrating system with respect to the pitch of the audible sound produced by the second vibrating assembly being an indication of the volume of biological fluid remaining in the device.

48. A biological fluid dispensing device as claimed in claim 47, wherein the first and second vibrating assemblies emit a series of sounds at discrete points corresponding to particular positions of the driver, successive sounds being of one pitch, several succeeding sounds being of a lower pitch, and so forth until the vibrators corresponding to the second subrange are struck by the strikers.

49. A biological fluid dispensing device as claimed in claim 48, wherein the audible sounds produced by the first and second vibrating assemblies are of different pitch in the positions between the positions corresponding to the first and second subranges, the difference in pitch generating an audio heterodyne varying from a high pitch to a low pitch as the internal volume is reduced in volume corresponding to movement from the first subrange of positions to the second subrange of positions.

50. A biological fluid dispensing device as claimed in claim 47, wherein the audible sounds produced by the first and second vibrating assemblies are of substantially identical high pitch in a first subrange of positions including the position where the internal volume is at a maximum, and of substantially identical low pitch in a second subrange of positions including the position where when the internal volume is at a minimum.

51. A biological fluid dispensing device as claimed in claim 50, wherein the audible sounds produced by the first and second vibrating assemblies change pitch at different positions between the positions corresponding to the first and second subranges.

52. A biological fluid dispensing device as claimed in claim 44, further comprising:

f) a second reservoir supported with respect to the support member, the second reservoir defining a second internal volume for containing a quantity of second biological fluid to be dispensed;

g) a second output port defined within the second reservoir; and

h) a second audible indicator coupled to the driver for emitting in response to driver position a second audible sound with audible characteristics indicating the position of the driver and the corresponding magnitude of a volume of second biological fluid contained within the second internal volume;

wherein the first and second output ports are positioned, configured and dimensioned to communicate with a mixing chamber;

and wherein the driver is mechanically coupled to the second reservoir, the movement during the dispensing operation is within a range of driver positions with respect to the second reservoir, and the driver cooperates with the second reservoir to reduce the second internal volume in response to advancement of the driver through the driver positions, and to drive the second biological fluid through the second output port.

53. A biological fluid dispensing device as claimed in claim 44, wherein the output port is adapted to serve as an applicator nozzle for application of the biological fluid to a site to be treated with the biological fluid.

54. A biological fluid dispensing device as claimed in claim 44, wherein the output port is adapted to receive and engage an applicator nozzle for application of the biological fluid to a site to be treated with the biological fluid.

55. A biological fluid dispensing device as claimed in claim 44, wherein the audible indicator produces the audible sound in response to changes in the position of the driver.

56. A biological fluid dispensing device as claimed in claim 44, wherein the audible indicator applies acoustic energy to the support, causing the support to resonate.

57. A biological fluid dispensing device as claimed in claim 44, wherein the reservoir comprises a syringe cylinder and the driver comprises a syringe plunger.

58. A biological fluid dispensing device as claimed in claim 44, wherein the reservoir comprises a compressible bladder.

59. A handheld medical fluid applicator comprising:

a) at least two reservoirs respectively for at least two fluids to be dispensed;

b) a manual actuator to dispense the at least two fluids from the at least two reservoirs ;

c plural conduits connecting one with each reservoir to deliver each fluid from a respective one of the reservoirs, wherein the conduits are configured and disposed to deliver the fluids to be mixed together; and

c) an audible indicator providing an audible indication, as the at least two fluids are dispensed, of the cumulative volume dispensed of at least one of the fluids.