Delivery device and method of delivery

• US 7,678,089 B2
• Filed: 11/15/2004
• Issued: 03/16/2010
• Est. Priority Date: 11/14/2003
• Status: Expired due to Fees

• Current Assignee: Medical Instill Technologies Inc.
• Original Assignee: Medical Instill Technologies Inc.
• Inventors: Atwood, Jeffrey M., Chan, Julian V., Py, Daniel
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): HOLLOWAY, IAN KNOBEL
• Application Number:
  US10/990,164
• Publication Number:
  US 20050165368A1
• Time in Patent Office: 1,947 Days
• Field of Search: 604/295, 604/294, 604/289, 604/19, 604/68, 604/9, 604/30, 604/34, 604/22, 604/35, 604/27, 604/32, 604/521, 604/119, 604/65, 604/67, 604/153, 604/167.01, 604/541, 137/484.2, 137/15.19, 137/595, 137/614.19, 137/487.5, 137/541, 222/212, 222/105, 222/129, 251/129.12, 251/129.21, 251/174
• US Class Current: 604/302
• 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 dosage chamber for holding a dosage of fluid;

a nozzle including a valve seat and a valve cover, wherein the valve cover extends about the valve seat and forms an interface therebetween, and the interface defines an inlet in fluid communication with the dosage chamber and an outlet for dispensing fluid therethrough; and

a pump in fluid communication with the reservoir and dosage chamber;

wherein 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 from the dosage chamber and into the inlet of the interface at a pressure greater than a valve opening pressure to allow the passage of pressurized fluid between the valve cover and valve seat;

wherein the dosage chamber defines a first cross-sectional area and the valve seat defines a second cross-sectional area at the inlet to the interface with the valve cover greater than the first cross-sectional area to dispense each 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 comprises a slide defining a passageway and a piston slidably received within the passageway, wherein the slide defines within the passageway a compression zone forming the dosage chamber, 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 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 second 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 first position to the second position to pressurize fluid in the compression zone and, in turn, dispense a dosage of fluid through the nozzle.

4. 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.

5. 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.

6. 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) a rest position with the piston tip located in the second portion of the slide;

(ii) to a 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.

7. The ophthalmic delivery device as defined in claim 6, 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.

8. The ophthalmic delivery device as defined in claim 7, wherein the stop surface defines a first morphology, and the piston tip defines a second morphology substantially conforming to the first morphology.

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

10. The ophthalmic delivery device as defined in claim 1, further comprising a filling valve in fluid communication with the reservoir, wherein the filling valve includes a flexible filling valve member, and a filling valve seat engagable with the flexible filling 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.

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

12. The ophthalmic delivery device as defined in claim 1, wherein the valve cover forms an interference fit with the valve seat to form the 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 delivery device.

13. The ophthalmic delivery device as defined in claim 1, further comprising manually-engageable actuator drivingly connected to the pump for moving the pump from a rest position to an actuated position.

14. The ophthalmic delivery device as defined in claim 13, 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 actuated position in response to movement of the trigger.

15. 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.

16. The ophthalmic delivery device as defined in claim 15, wherein the housing includes an eyelid depressor for engaging facial tissue adjacent to an eye and lowering the eyelid to expose an ocular cul-de-sac upon delivering a dosage thereto, and wherein the outlet of the nozzle interface is aligned with the eyelid depressor for delivering a dosage to the exposed ocular cul-de-sac.

17. The ophthalmic delivery device as defined in claim 15, 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.

18. The ophthalmic delivery device as defined in claim 15, 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.

19. The ophthalmic delivery device as defined in claim 1, wherein at least one of an interference between the valve seat and the valve cover and an axial length of the interface is dimensioned to dispense the dosage of fluid through the interface at a velocity of equal to or less than about 10 meters per second.

20. The ophthalmic delivery device as defined in claim 1, wherein at least one of an interference between the valve seat and the valve cover and an axial length of the interface is dimensioned to release the dosage of fluid in a plurality of micro-droplets.

21. The ophthalmic delivery device as defined in claim 20, wherein the energy of each micro-droplet upon exiting the delivery device is less than approximately 5 micro-joules.

22. 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.

31. The ophthalmic delivery device as defined in claim 1, wherein the dosage chamber is defined by a first radius, and the valve seat is defined by a second radius at the inlet to the interface with the valve cover that is greater than the first radius.

32. The ophthalmic delivery device as defined in claim 31, wherein the dosage chamber defines a first diameter, and the valve seat defines a second diameter at the inlet to the interface with the valve cover that is greater than the first diameter.

33. The ophthalmic delivery device as defined in claim 1, wherein the dosage chamber is defined by a wall spaced a first radial distance about an elongated axis of the device, and the valve seat is spaced a second radial distance about the elongated axis of the device that is greater than the first radial distance.

34. The ophthalmic delivery device as defined in claim 1, further including a flow aperture in fluid communication between the dosage chamber and the inlet to the interface, wherein an inlet end of the flow aperture defines a first cross-sectional area and an outlet end of the flow aperture defines a second cross-sectional area that is greater than the first cross-sectional area.

35. The ophthalmic delivery device as defined in claim 34, wherein the outlet aperture is oriented at an oblique angle relative to an elongated axis of the device.

36. The ophthalmic delivery device as defined in claim 34, wherein the outlet aperture extends angularly throughout an arc about an elongated axis of the device.

37. The ophthalmic delivery device as defined in claim 36, wherein the device is mounted within a housing defining a facial engaging surface for engaging facial tissue adjacent to an eye, and the outlet aperture is angularly positioned within the housing such that is it aligned with an ocular cul-de-sac of an eye with the facial engaging surface engaging facial tissue adjacent to the eye.

23. An ophthalmic delivery device comprising:

first means for defining a variable-volume chamber and for storing an ophthalmic substance to be delivered to an eye;

second means for metering a dose of substance from the variable-volume chamber at a volume within the range of about 15 to about 25 micro liters and for pressurizing the metered dose above a valve opening pressure;

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 the metered dose of substance pressurized by the second means at a pressure greater than the valve opening pressure to flow therethrough; and

fourth means for delivering the metered dosage in a plurality of micro droplets at a velocity exiting the third means of less than approximately 10 meters per second.

24. The ophthalmic delivery device as defined in claim 23, further comprising:

fifth means for actuating the second means; and

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

25. The ophthalmic delivery device as defined in claim 24, wherein the sixth means engages the facial tissue substantially simultaneously with the fifth means actuating the second means.

26. The ophthalmic delivery device as defined in claim 23, wherein the fourth means delivers the pumped dosage at a velocity exiting the third means of less than approximately 6 meters per second.

27. The ophthalmic delivery device as defined in claim 23, wherein the first means is a body of the device defining therein the variable-volume chamber;

the second means is a pump;

the third means is a one-way valve; and

the fourth means is (i) at least one of an interference of a valve cover and a valve seat of the one-way valve, and an axial length of an interface between the valve cover and the valve seat, being dimensioned to dispense the dosage in a plurality of micro droplets at a velocity of less than approximately 10 meters per second, and (ii) a dosage chamber of the pump defining a first cross-sectional area and the valve seat defining a second cross-sectional area at an inlet to the interface with the valve cover greater than the first cross-sectional area.

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

(i) storing multiple doses of the substance hermetically sealed in a variable-volume chamber connectible in fluid communication with a one-way valve defining a normally closed valve opening that opens in response to the substance at an inlet to the valve opening exceeding a valve opening pressure;

(ii) metering a dose of substance from the variable-volume storage chamber at a volume within the range of about 15 micro liters to about 25 micro liters and pressurizing the metered dose above the valve opening pressure;

(iii) introducing the pressurized metered dose through the one way valve; and

(iv) delivering the metered dose from the one way valve in a plurality of micro droplets at a velocity of less than approximately 10 meters per second and into the eye.

29. A method as defined in claim 28, wherein step (iv) includes delivering the metered dose at a velocity of less than approximately 6 meters per second.

30. A method as defined in claim 28, 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 wherein step (iv) includes delivering the metered dose to the conjunctiva cul-de-sac.

38. The method as defined in claim 28, wherein step (iv) includes delivering the metered dose at an energy upon impacting the eye that is equal to or less than approximately 40 micro-joules.

39. The method as defined in claim 28, further comprising repeating steps (ii) through (iv) a plurality of times at spaced time intervals relative to each other.

40. The method as defined in claim 28, wherein step (iv) includes delivering the metered dose in a plume of micro droplets that extend through an approximately semi-circular arc that substantially conforms to the angular extent of a conjunctiva cul-de-sac.