Delivery device and method of delivery

• US 20050165368A1
• Filed: 11/15/2004
• Published: 07/28/2005
• Est. Priority Date: 11/14/2003
• Status: Active Grant

• Current Assignee: Medical Instill Technologies Inc.
• Original Assignee: Medical Instill Technologies Inc.
• Inventors: Chan, Julian V., Py, Daniel, Atwood, Jeffrey M.
• Granted Patent: US 7,678,089 B2
• Time in Patent Office: Days
• US Class Current: 604/289
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 35/003 Portable hand-held applicators having means for dispensing or spreading integral media hand-held massage devices with liquid delivery A61H7/003
• CPC Class Codes: B05B 11/0056 with an additional opening for filling or refilling
• CPC Class Codes: B05B 11/007 being opened by deformation of a sealing element made of resiliently deformable material, e.g. flaps, skirts, duck-bill valves
• CPC Class Codes: B05B 11/0072 A valve member forming part of an outlet opening
• CPC Class Codes: B05B 11/026 Membranes separating the content remaining in the container from the atmospheric air to compensate underpressure inside the container
• CPC Class Codes: B05B 11/028 Pistons separating the content remaining in the container from the atmospheric air to compensate underpressure inside the container
• CPC Class Codes: B05B 11/1004 comprising a movable cylinder and a stationary piston
• CPC Class Codes: B05B 11/1056 comprising rotatable or articulated levers B05B11/1053 takes precedence; lever actuated piston pumps B05B11/1009; lever actuated pumps with deformable chamber B05B11/1029
• CPC Class Codes: B05B 11/107 Gate valves; Sliding valves
• CPC Class Codes: B05B 11/1074 located outside pump chambers
• CPC Class Codes: B05B 11/1077 characterised by a particular shape or material B05B11/1076 takes precedence

Abstract

An ophthalmic delivery device includes a body defining a fluid reservoir and a pump in fluid communication with the reservoir. The delivery device also includes a nozzle that includes a dosage chamber for holding a dosage of fluid, a valve seat, and a valve cover. The valve cover extends about the valve seat and forms an interface therebetween and the valve seat includes an outlet aperture. The interface is in fluid communication with the outlet aperture and the dosage chamber, and at least part of the valve cover is movable between (i) a closed position with the valve cover engaging the valve seat to close the interface and form a fluid-tight seal therebetween, and (ii) an open position with at least part of the valve cover spaced away from the valve seat in response to fluid flowing through the outlet aperture at a pressure greater than a valve opening pressure to allow the passage of pressurized fluid therebetween. The valve seat and the valve cover are dimensioned to dispense the dosage of fluid through the interface at a velocity of equal to or less than 6 meters per second.

Claims

1. An ophthalmic delivery device comprising:

a body defining a fluid reservoir;

a pump in fluid communication with the reservoir; and

a nozzle including a dosage chamber for holding a dosage of fluid, a valve seat, and a valve cover, the valve cover extends about the valve seat and forms an interface therebetween, the valve seat includes an outlet aperture,

wherein the interface is in fluid communication with the outlet aperture and the dosage chamber, and at least part of the valve cover is movable between (i) a closed position with the valve cover engaging the valve seat to close the interface and form a fluid-tight seal therebetween, and (ii) at least one open position with at least part of the valve cover spaced away from the valve seat in response to fluid flowing through the outlet aperture at a pressure greater than a valve opening pressure to allow the passage of pressurized fluid therebetween,

wherein the valve seat and the valve cover are configured to dispense the dosage of fluid through the interface at a velocity of less than approximately 10 meters per second.

2. The ophthalmic delivery device as defined in claim 1, wherein the pump further comprises a slide defining a passageway and a piston slidably received within the passageway, wherein the slide defines within the passageway a compression zone, a first portion formed between the compression zone and the reservoir, and a second portion located on an opposite side of the compression zone relative to the first portion, wherein the first portion is defined by a first cross-section and the compression zone is defined by a second cross-section that is less than the first cross-section, and at least one of the piston and slide is movable relative to the other between (i) a first actuated position with a tip of the piston received within the first portion of the slide, and the compression zone coupled in fluid communication with the reservoir for receiving fluid therefrom, and (ii) a rest position with the tip of the piston received within the second portion of the slide.

3. The ophthalmic delivery device as defined in claim 2, further comprising a spring drivingly connected to at least one of the body, the piston, and the slide, wherein the spring drives at least one of the body, the piston, and the slide from the loaded to the rest position to pressurize fluid in the compression zone and, in turn, dispense the dosage of fluid through the nozzle.

4. The ophthalmic delivery device as defined in claim 2, wherein the valve seat is defined at least in part by a third cross-section that is greater than the second cross-section of the compression zone.

5. The ophthalmic delivery device as defined in claim 2, wherein the tip of the piston is softer than the compression zone of the slide, and the tip and the compression zone form an interference fit to thereby form a fluid-tight seal therebetween.

6. The ophthalmic delivery device as defined in claim 2, wherein the compression zone is disposed at the dosage chamber.

7. The ophthalmic delivery device as defined in claim 2, wherein the tip defines an annular base portion that forms an interference fit with the first portion of the slide and a fluid-tight seal therebetween.

8. The ophthalmic delivery device as defined in claim 2, wherein at least one of the piston and the slide is movable relative to the other from (i) the rest position with the piston tip located in the second portion of the slide;

(ii) to the first actuated position with the piston tip located in the first portion of the slide and the compression zone coupled in fluid communication with the reservoir for receiving fluid therefrom;

(iii) to a second actuated position with the piston tip located in the compression zone, a fluid tight seal formed between the piston tip and compression zone to pressurize the fluid in the compression zone to a pressure greater than the valve opening pressure and, in turn, cause the pressurized fluid to open the valve and dispense through the valve; and

(iv) to the rest position with the piston tip located in the second portion of the slide and the outlet aperture coupled in fluid communication with the reservoir to reduce the pressure between the outlet aperture and the compression zone and allow closure of the valve.

9. The ophthalmic delivery device as defined in claim 2, wherein the nozzle defines a stop surface that contacts the piston tip in the rest position, and the surfaces of the piston tip and stop surface cooperate to define substantially zero volume within the second portion of the slide when the piston tip is in the rest position.

10. The ophthalmic delivery device as defined in claim 9, wherein the stop surface defines a first morphology, and the piston tip defines a second morphology substantially conforming to the first morphology.

11. The ophthalmic delivery device as defined in claim 1, further comprising a flexible bladder received within the body and the fluid reservoir includes a variable-volume storage chamber between the bladder and body.

12. The ophthalmic delivery device as defined in claim 1, further comprising a filling valve in fluid communication with the dosage chamber, the filling valve includes a flexible filling valve member formed integral with the bladder, and a filling valve seat engagable with the flexible valve member, wherein the flexible filling valve member is movable into a closed position in engagement with the filling valve seat to form a fluid-tight seal therebetween, and an open position spaced away from the filling valve seat and forming a filling valve opening for the passage of fluid therebetween.

13. The ophthalmic delivery device as defined in claim 1, further comprising a filling valve in fluid communication with the dosage chamber, the filling valve includes a flexible filling valve member movable between the closed and open positions, and a spring coupled to the flexible valve member and biasing the flexible filling valve member toward the closed position.

14. The ophthalmic delivery device as defined in claim 1, wherein the valve cover forms an interference fit with the valve seat to form a fluid-tight seal therebetween, and the valve cover defines a progressively decreasing wall thickness in a direction from an interior toward an exterior of the deliver device.

15. The ophthalmic delivery device as defined in claim 1, further comprising an actuator drivingly connected to the pump for moving the pump from the rest position to the first actuated position.

16. The ophthalmic delivery device as defined in claim 15, wherein the actuator includes a trigger and a lever arm drivingly connected between the trigger and the pump for moving the pump from the rest position to the first actuated position in response to movement of the trigger.

17. The ophthalmic delivery device as defined in claim 1, further comprising a housing surrounding the body, the pump, and the nozzle, wherein the housing includes an opening and the nozzle is positioned to dispense the dosage of fluid through the opening.

18. The ophthalmic delivery device as defined in claim 17, wherein the housing includes an eyelid depressor for engaging the facial tissue adjacent to an eye and lowering the eyelid to expose the ocular cul-de-sac upon delivering a metered dosage thereto, and wherein the outlet aperture of the nozzle is aligned with the eyelid depressor for accurately delivering the metered dosage to the exposed ocular cul-de-sac.

19. The ophthalmic delivery device as defined in claim 17, wherein the housing includes a support surface coupled to the body for engaging facial tissue adjacent to an eye and setting an approximate delivery distance between an anterior end of the nozzle and the eye.

20. The ophthalmic delivery device as defined in claim 17, wherein the nozzle is positioned within the housing so that a delivery distance of the dosage of fluid is within the range of approximately 3 centimeters through approximately 10 centimeters.

21. The ophthalmic delivery device as defined in claim 1, wherein the valve seat and the valve cover are dimensioned to dispense the dosage of fluid through the interface at a velocity of equal to or less than about 6 meters per second.

22. The ophthalmic delivery device as defined in claim 21, wherein the valve seat and the valve cover are dimensioned to dispense the dosage of fluid through the interface at a velocity of less than approximately 5 meters per second.

23. The ophthalmic delivery device as defined in claim 1, wherein an energy of a dosage upon impacting a user'"'"'s eye is equal to or less than approximately 40 micro-joules.

24. The ophthalmic delivery device as defined in claim 1, wherein the valve cover and valve seat cooperate to release the dosage of fluid in a plurality of micro-droplets.

25. The ophthalmic delivery device as defined in claim 24, wherein the energy of each micro-droplet upon exiting the delivery device is less than approximately 5 micro-joules.

26. The ophthalmic delivery device as defined in claim 2, wherein a linear surface area of the interface is greater than a linear surface area of the compression zone.

27. An ophthalmic delivery device comprising:

first means for defining a variable-volume chamber for storing a substance to be delivered;

second means for pumping a metered dose of substance from the variable-volume chamber;

third means in fluid communication with the second means for (i) forming a closed position defining a fluid-tight seal for preventing the passage of substance therethrough, and (ii) at least one open position for allowing a metered dose of substance pumped by the second means to flow therethrough; and

fourth means for delivering the pumped dosage at a velocity exiting the third means of less than approximately 10 meters per second.

28. The ophthalmic delivery device as defined in claim 27, further comprising:

fifth means for actuating the second means to pump a metered dose of substance; and

sixth means for engaging facial tissue adjacent to an eye for exposing at least a portion of a conjunctive cul-de-sac for delivering a metered dose of substance thereon.

29. The ophthalmic delivery device as defined in claim 28, wherein the sixth means engages the facial tissue substantially simultaneously with the fifth means actuating the second means.

30. The ophthalmic delivery device as defined in claim 27, wherein the fourth means delivers the pumped dosage at a velocity exiting the third means of less than approximately 6 meters per second.

31. The ophthalmic delivery device as defined in claim 27, wherein the first means is a body of the device defining therein the variable-volume chamber.

32. The ophthalmic delivery device as defined in claim 31, wherein the device further includes one of (i) a piston slidably received within the body, and (ii) a flexible bladder mounted within the body, for defining the variable-volume chamber therebetween.

33. The ophthalmic delivery device as defined in claim 27, wherein the second means is a piston slidably received within a compression chamber.

34. The ophthalmic delivery device as defined in claim 27, wherein the third means is a one-way valve including an axially extending valve seat, and an annular flexible valve cover overlying the valve seat.

35. The ophthalmic delivery device as defined in claim 27, wherein the fifth means is defined by a valve seat and valve cover of the fourth means configured to cause the pumped dosage to exit the third means at a velocity of less than approximately 10 meters per second.

36. A method for delivering a substance to an eye, comprising:

storing multiple doses of the substance in a variable-volume chamber;

pumping a metered dose of substance from the variable-volume chamber through a one-way valve defining a closed position forming a fluid-tight seal for preventing the passage of substance therethrough, and at least one open position for allowing a metered dose of substance pumped by the second means to flow therethrough; and

controlling the velocity of the pumped dose exiting the one-way valve to be less than approximately 10 meters per second.

37. A method as defined in claim 36, wherein the controlling step includes controlling the velocity of the pumped dose exiting the one-way valve to be less than approximately 6 meters per second.

38. A method as defined in claim 36, further comprising engaging with a tissue-engaging member facial tissue adjacent to the eye to at least partially expose the conjunctiva cul-de-sac, and delivering the substance thereon.

39. A method as defined in claim 38, further comprising substantially simultaneously pumping the metered dose and engaging the facial tissue to expose the conjunctiva cul-de-sac.