Microblade array impact applicator

• US 9,192,749 B2
• Filed: 10/14/2005
• Issued: 11/24/2015
• Est. Priority Date: 10/13/2000
• Status: Active Grant

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Trautman, Joseph C., Keenan, Richard, Cao, Michael T.
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US11/251,488
• Publication Number:
  US 20060095061A1
• Time in Patent Office: 3,693 Days
• Field of Search: 606/167, 606/172, 606181-186, 604/22, 604/46, 604/117, 604/118, 604/135, 604/272, 604/289, 604/506
• US Class Current: 1/1
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

An applicator device (10) is provided for applying a patch (44) having an array of microprotrusions (90) to the stratum corneum. The applicator device (10) includes a device body (12) and a piston moveable within the device body (12). A cap (16) is provided on the device body (12) for activating the device (10) to impact the stratum corneum with a microprotrusion array (44, 90). The device (10) is capable of being cocked by one handed operation of the user which allows the device (10) to be used by patients having neither the strength nor the manual dexterity to cock other types of applicator devices.

Claims

1. A device which in use impacts a penetrating member against the stratum corneum comprising:

a body having a first end and a second end;

said first end adapted to receive said penetrating member;

a piston slidably disposed within said body for impacting said penetrating member against the stratum corneum, wherein said penetrating member is releasably attached to said piston;

an impact spring adapted to provide an impact force to said piston and bias said piston out of said first end of said body;

wherein said impact spring is energized when said piston is further disposed within said body;

a latching mechanism wherein said latching mechanism releasably engages said piston with said body after said piston has been sufficiently disposed within said body;

a releasing mechanism for disengaging said latching mechanism whereby said impact spring impacts said piston against said penetrating member forcing the penetrating member into said stratum corneum; and

a cap movably mounted on said body for activating said releasing mechanism when said cap is moved onto said body;

a hold down spring disposed between said body and said cap for resisting the activation of said release mechanism until said hold down spring has been sufficiently energized such that said hold down spring exerts a predetermined hold down force;

wherein said body and piston are adapted to be releasably engaged by the use of a single hand;

wherein said device comprises said penetrating member, said penetrating member comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

2. A device which in use impacts a penetrating member against the stratum corneum comprising:

a body having a first end and a second end;

said first end adapted to receive said penetrating member;

a piston slidably disposed within said body for impacting said penetrating member against the stratum corneum, wherein said penetrating member is releasably attached to said piston;

an impact spring adapted to provide an impact force to said piston and bias said piston out of said first end of said body;

wherein said impact spring is energized when said piston is further disposed within said body;

a latching mechanism wherein said latching mechanism releasably engages said piston with said body after said piston has been sufficiently disposed within said body;

wherein said latching mechanism includes inter-engaging latch members on said body and piston;

a releasing mechanism for disengaging said latching mechanism whereby said impact spring impacts said piston against said penetrating member forcing said penetrating member into said stratum corneum; and

a cap movably mounted on said for activating said releasing mechanism when said cap is moved onto said body;

a hold down spring disposed between said body and said cap for resisting the activation of said release mechanism until said hold down spring has been sufficiently energized such that said hold down spring exerts a predetermined hold down force;

wherein said body and piston are adapted to be releasably engaged by the use of a single hand;

wherein said device comprises said penetrating member, said penetrating member comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

3. A device which in use impacts a penetrating member against the stratum corneum comprising:

a body having a first end and a second end;

said first end adapted to receive said penetrating member;

a piston slidably disposed within said body for impacting said penetrating member against the stratum corneum, wherein said penetrating member is releasably attached to said piston;

an impact spring adapted to provide an impact force to said piston and bias said piston out of said first end of said body;

wherein said impact spring is energized when said piston is further disposed within said body;

a latching mechanism wherein said latching mechanism releasably engages said piston with said body after said piston has been sufficiently disposed within said body;

a releasing mechanism for disengaging said latching mechanism whereby said impact spring impacts said piston against said penetrating member forcing said penetrating member into said stratum corneum; and

a flexible finger on said body and a stop on said piston wherein said flexible finger and said stop comprise inter-engaging latch members;

a cap movably mounted on said for activating said releasing mechanism when said cap is moved onto said body;

a hold down spring disposed between said body and said cap for resisting the activation of said release mechanism until said hold down spring has been sufficiently energized such that said hold down spring exerts a predetermined hold down force;

wherein said body and piston are adapted to be releasably engaged by the use of a single hand;

wherein said device comprises said penetrating member, said penetrating member comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

4. A device which in use impacts a penetrating member against the stratum corneum comprising:

a body having a first end and a second end;

said first end adapted to receive said penetrating member;

a piston slidably disposed within said body for impacting said penetrating member against the stratum corneum, wherein said penetrating member is releasably attached to said piston;

an impact spring adapted to provide an impact force to said piston and bias said piston out of said first end of said body;

wherein said impact spring is energized when said piston is further disposed within said body;

a latching mechanism wherein said latching mechanism releasably engages said piston with said body after said piston has been sufficiently disposed within said body;

a releasing mechanism for disengaging said latching mechanism whereby said impact spring impacts said piston against said penetrating member forcing said penetrating member into said stratum corneum; and

wherein said releasing mechanism is adapted to release said piston after a force is exerted upon said releasing mechanism;

a cap movably mounted on said for activating said releasing mechanism when said cap is moved onto said body;

a hold down spring disposed between said body and said cap for resisting the activation of said release mechanism until said hold down spring has been sufficiently energized such that said hold down spring exerts a predetermined hold down force;

wherein said body and piston are adapted to be releasably engaged by the use of a single hand;

wherein said device comprises said penetrating member, said penetrating member comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

5. A device which in use impacts a penetrating member against the stratum corneum comprising:

a body having a first end and a second end;

said first end adapted to receive said penetrating member;

a piston slidably disposed within said body for impacting said penetrating member against the stratum corneum, wherein said penetrating member is releasably attached to said piston;

an impact spring adapted to provide an impact force to said piston and bias said piston out of said first end of said body;

wherein said impact spring is energized when said piston is further disposed within said body;

a latching mechanism wherein said latching mechanism releasably engages said piston with said body after said piston has been sufficiently disposed within said body;

a releasing mechanism for disengaging said latching mechanism whereby said impact spring impacts said piston against said penetrating member forcing said penetrating member into said stratum corneum; and

wherein said releasing mechanism is adapted to release said piston after a force is exerted upon said releasing mechanism;

wherein said latching mechanism and said piston releasing mechanism are adapted to allow one handed operation of each mechanism;

a cap movably mounted on said for activating said releasing mechanism when said cap is moved onto said body;

a hold down spring disposed between said body and said cap for resisting the activation of said release mechanism until said hold down spring has been sufficiently energized such that said hold down spring exerts a predetermined hold down force;

wherein said device comprises said penetrating member, said penetrating member comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

6. A device which in use impacts a penetrating member against the stratum corneum comprising:

a body having a first end and a second end;

said first end adapted to receive said penetrating member;

a piston slidably disposed within said body for impacting said penetrating member against the stratum corneum, wherein said penetrating member is releasably attached to said piston;

an impact spring adapted to provide an impact force to said piston and bias said piston out of said first end of said body;

wherein said impact spring is energized when said piston is further disposed within said body;

a latching mechanism wherein said latching mechanism releasably engages said piston with said body after said piston has been sufficiently disposed within said body;

a releasing mechanism for disengaging said latching mechanism whereby said impact spring impacts said piston against said penetrating member forcing said penetrating member into said stratum corneum; and

a cap movably mounted on said body for activating said releasing mechanism when said cap is moved onto said body;

a hold down spring disposed between said body and said cap for resisting the activation of said release mechanism until said hold down spring has been sufficiently energized such that said hold down spring exerts a predetermined hold down force;

wherein said body and piston are adapted to be releasably engaged by the use of a single hand;

wherein said releasing mechanism is adapted to release said piston after a force is exerted upon said releasing mechanism;

wherein said device comprises said penetrating member, said penetrating member comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

7. A device which in use impacts a penetrating member against the stratum corneum comprising:

a body having a first end and a second end;

said first end adapted to receive said penetrating member;

a piston slidably disposed within said body for impacting said penetrating member against the stratum corneum, wherein said penetrating member is releasably attached to said piston;

an impact spring adapted to provide an impact force to said piston and bias said piston out of said first end of said body;

wherein said impact spring is energized when said piston is further disposed within said body;

a latching mechanism wherein said latching mechanism releasably engages said piston with said body after said piston has been sufficiently disposed within said body;

a releasing mechanism for disengaging said latching mechanism whereby said impact spring impacts said piston against said penetrating member forcing said penetrating member into said stratum corneum; and

a cap movably mounted on said body for activating said releasing mechanism when said cap is moved onto said body;

wherein said releasing mechanism is adapted to release said piston after a force is exerted upon said releasing mechanism;

a hold down spring disposed between said body and said cap for resisting the activation of said release mechanism until said hold down spring has been sufficiently energized such that said hold down spring exerts a predetermined hold down force;

wherein said body and piston are adapted to be releasably engaged by the use of a single hand,

wherein said device comprises said penetrating member, said penetrating member comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

8. A device which in use impacts a penetrating member against the stratum corneum comprising:

a body having a first end and a second end;

said first end adapted to receive said penetrating member;

a piston slidably disposed within said body for impacting said penetrating member against the stratum corneum, wherein said penetrating member is releasably attached to said piston;

an impact spring adapted to provide an impact force to said piston and bias said piston out of said first end of said body;

wherein said impact spring is energized when said piston is further disposed within said body;

a latching mechanism wherein said latching mechanism releasably engages said piston with said body after said piston has been sufficiently disposed within said body;

a releasing mechanism for disengaging said latching mechanism whereby said impact spring impacts said piston against said penetrating member forcing said penetrating member into said stratum corneum; and

a cap movably mounted on said body for activating said releasing mechanism when said cap is moved onto said body;

a hold down spring disposed between said body and said cap for resisting the activation of said release mechanism until said hold down spring has been sufficiently energized such that said hold down spring exerts a predetermined hold down force;

wherein said body and piston are adapted to be releasably engaged by the use of a single hand,

wherein said releasing mechanism is adapted to release said piston after a force is exerted upon said releasing mechanism;

a lock mechanism for preventing movement of said cap relative to said body whereby activation of said release mechanism is prevented;

wherein said device comprises said penetrating member, said penetrating member comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

9. A device which in use impacts a penetrating member against the stratum corneum comprising:

a body having a first end and a second end;

said first end adapted to receive said penetrating member;

a piston slidably disposed within said body for impacting said penetrating member against the stratum corneum, wherein said penetrating member is releasably attached to said piston;

an impact spring adapted to provide an impact force to said piston and bias said piston out of said first end of said body;

wherein said impact spring is energized when said piston is further disposed within said body;

a latching mechanism wherein said latching mechanism releasably engages said piston with said body after said piston has been sufficiently disposed within said body;

a releasing mechanism for disengaging said latching mechanism whereby said impact spring impacts said piston against said penetrating member forcing said penetrating member into said stratum corneum; and

a cap movably mounted on said body for activating said releasing mechanism when said cap is moved onto said body;

wherein said releasing mechanism is adapted to release said piston after a force is exerted upon said releasing mechanism;

a lock mechanism for preventing movement of said cap relative to said body whereby activation of said release mechanism is prevented;

an indicator for indicating when said cap is in said locked position;

a hold down spring disposed between said body and said cap for resisting the activation of said release mechanism until said hold down spring has been sufficiently energized such that said hold down spring exerts a predetermined hold down force; and

wherein said body and piston are adapted to be releasably engaged by the use of a single hand,

wherein said device comprises said penetrating member, said penetrating member comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

10. A device which in use impacts a penetrating member against the stratum corneum comprising:

a body having a first end and a second end;

said first end adapted to receive said penetrating member;

a piston slidably disposed within said body for impacting said penetrating member against the stratum corneum, wherein said penetrating member is releasably attached to said piston;

an impact spring adapted to provide an impact force to said piston and bias said piston out of said first end of said body;

wherein said impact spring is energized when said piston is further disposed within said body;

a latching mechanism wherein said latching mechanism releasably engages said piston with said body after said piston has been sufficiently disposed within said body;

a releasing mechanism for disengaging said latching mechanism whereby said impact spring impacts said piston against said penetrating member forcing said penetrating member into said stratum corneum; and

wherein said latching mechanism automatically locks said piston in a cocked position with respect to said body when said piston has been sufficiently disposed within said body;

a cap movably mounted on said for activating said releasing mechanism when said cap is moved onto said body;

a hold down spring disposed between said body and said cap for resisting the activation of said release mechanism until said hold down spring has been sufficiently energized such that said hold down spring exerts a predetermined hold down force;

wherein said body and piston are adapted to be releasably engaged by the use of a single hand,

wherein said device comprises said penetrating member, said penetrating member comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

11. A device which in use impacts a penetrating member against the stratum corneum comprising:

a body having a first end and a second end;

said first end adapted to receive said penetrating member;

a piston slidably disposed within said body for impacting said penetrating member against the stratum corneum, wherein said penetrating member is releasably attached to said piston;

an impact spring adapted to provide an impact force to said piston and bias said piston out of said first end of said body;

wherein said impact spring is energized when said piston is further disposed within said body;

a latching mechanism wherein said latching mechanism releasably engages said piston with said body after said piston has been sufficiently disposed within said body;

a releasing mechanism for disengaging said latching mechanism whereby said impact spring impacts said piston against said penetrating member forcing said penetrating member into said stratum corneum; and

a cap movably mounted on said for activating said releasing mechanism when said cap is moved onto said body;

a hold down spring disposed between said body and said cap for resisting the activation of said release mechanism until said hold down spring has been sufficiently energized such that said hold down spring exerts a predetermined hold down force;

wherein said body and piston are adapted to be releasably engaged by the use of a single hand,

wherein said piston includes an application surface having a shape and size which provides for an effective application of the specific patch to be impacted; and

wherein said device comprises said penetrating member, said penetrating member comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said the plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

12. A device which in use impacts a penetrating member against the stratum corneum comprising:

a body having a first end and a second end;

said first end adapted to receive said penetrating member;

a piston slidably disposed within said body for impacting said penetrating member against the stratum corneum, wherein said penetrating member is releasably attached to said piston;

an impact spring adapted to provide an impact force to said piston and bias said piston out of said first end of said body;

wherein said impact spring is energized when said piston is further disposed within said body;

a latching mechanism wherein said latching mechanism releasably engages said piston with said body after said piston has been sufficiently disposed within said body;

a releasing mechanism for disengaging said latching mechanism whereby said impact spring impacts said piston against said penetrating member forcing said penetrating member into said stratum corneum; and

a cap movably mounted on said for activating said releasing mechanism when said cap is moved onto said body;

a hold down spring disposed between said body and said cap for resisting the activation of said release mechanism until said hold down spring has been sufficiently energized such that said hold down spring exerts a predetermined hold down force;

wherein said body and piston are adapted to be releasably engaged by the use of a single hand,

wherein said piston further includes an application surface having a shape and size which provides for an effective application of the specific patch to be impacted;

wherein said application surface has a shape selected from the group consisting of a convex shape, a substantially planar shape and a shape configured to mate with a predetermined body surface site;

wherein said device comprises said penetrating member, said penetrating member comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

13. A device which in use impacts a microblade array against the stratum corneum, said device comprising:

a device body;

a piston mounted within said device body, said piston having a microblade array applying surface;

an impact spring acting between said device body and said piston to impact the stratum corneum with said microblade;

a cap movably mounted on said device body;

a hold down spring acting between said device body and said cap;

a latching mechanism for locking said piston in a cocked position with one hand by compressing said device body and piston together;

a piston release for releasing said piston from said cocked position to impact the stratum corneum with said microblade array when said hold down spring is compressed;

wherein said device comprises said microblade array, said microblade array comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a dry coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

14. A device which in use impacts a microblade array against the stratum corneum, said device comprising:

a device body;

a piston mounted within said device body, said piston having a microblade array applying surface;

an impact spring acting between said device body and piston to impact the stratum corneum with said microblade;

a cap movably mounted on said device body;

a hold down spring acting between said device body and said cap;

a latching mechanism for locking said piston in a cocked position with one hand by compressing said device body and piston together;

a piston release comprising a release finger for releasing said piston from said cocked position to impact the stratum corneum with said microblade array when said hold down spring is compressed;

wherein said device comprises said microblade array, said microblade array comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.

15. A device which in use impacts a microblade array against the stratum corneum, said device comprising:

a device body;

a piston mounted within said device body, said piston having a microblade array applying surface;

an impact spring acting between said device body and said piston to impact the stratum corneum with said microblade;

a cap movably mounted on said device body;

a hold down spring acting between said device body and said cap, said hold down spring adapted to resist the activation of said piston release until a predetermined hold down force is reached;

a latching mechanism for locking said piston in a cocked position with one hand by compressing said device body and piston together;

a piston release for releasing said piston from said cocked position to impact the stratum corneum with said microblade array when said hold down spring is compressed;

wherein said device comprises said microblade array, said microblade array comprising a plurality of microprotrusions coated with an agent, wherein said plurality of microprotrusions comprise a coating of said agent, wherein said plurality of microprotrusions extend at an angle from a sheet, wherein said sheet is incorporated in an agent delivery patch, and wherein said device is without an agent reservoir.