Microneedel-based pen device for drug delivery and method for using same

• US 20090157041A1
• Filed: 02/12/2009
• Published: 06/18/2009
• Est. Priority Date: 09/12/2001
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Kaestner, Scott A., Martin, Frank E., Pettis, Ronald J.
• Granted Patent: US 8,900,186 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/288 by piercing without internal pressure increase A61M5/283 takes precedence
• CPC Class Codes: A61M 5/31548 Mechanically operated dose setting member
• CPC Class Codes: A61M 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: A61M 5/31593 Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/3298 Needles arranged in parallel
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A system and method is provided for an injectable substance delivery pen comprising a microneedle hub assembly removably engaged with a pen device body which includes a cartridge, a plunger, and a drive mechanism. The hub assembly includes at least one microneedle for intradermal or shallow subcutaneous injection of the contents of the cartridge. The cartridge, plunger and drive mechanism components of the pen body are fabricated of non-compliant and non-compressible materials to allow effective communication of the cartridge contents via the microneedle patient interface.

Claims

1. An injection mechanism for injecting fluid into a targeted tissue layer comprising:

a primary reservoir for storing fluid prior to injection having a first axis; and

a secondary reservoir for holding the amount of fluid to be injected having a second axis, wherein the secondary reservoir is located co-axially and in series with the primary reservoir and has a smaller cross-sectional area than the cross-sectional area of the primary reservoir.

2. The injection mechanism of claim 1, further comprising:

a needle connecting portion comprising a needle septum and a needle stop; and

a patient needle intersecting the needle septum for penetrating the skin of the patient to inject the fluid in the targeted tissue layer.

3. The injection mechanism of claim 1, wherein the fluid is at least one of a therapeutic drug, vaccine or diagnostic material.

4. The injection mechanism of claim 1, wherein the primary reservoir is adapted to receive a medicament cartridge for administering a dosage of medication.

5. The injection mechanism of claim 4, wherein a dose means is used to transfer said dosage of medication into said secondary reservoir in preparation for giving an injection.

6. The injection mechanism of claim 2, wherein the patient needle penetrates said patient skin until stopped by a needle stop, wherein said needle stop has an area larger than that of said patient needle.

7. The injection mechanism of claim 6, wherein an injection is administered by applying pressure to said primary reservoir thereby causing said fluid in said secondary reservoir to flow through said needle septum and patient needle to be injected into said intradermal tissue.

8. A method of injecting a solution into a patient comprising the steps of:

providing solution into a first reservoir;

collapsing the first reservoir to transfer the solution into a second reservoir; and

transferring the solution from the second reservoir into a targeted space.

9. The method of claim 8, wherein the collapsing the first reservoir step transfers the solution into a secondary reservoir with a smaller cross-sectional area than the first reservoir.

10. The method of claim 9, wherein the cross-sectional area of the secondary reservoir is smaller than the cross-sectional area of the first reservoir.

11. A substance delivery device, comprising:

a supply housing having an outlet;

a single cartridge in said supply housing containing a substance and having a septum at a first end and a stopper having a distal face at a second end to seal said cartridge, said stopper having a proximal face being positioned to engage a plunger having a distal face;

a hub housing having a proximate end and a distal end, said distal end having a skin contact surface and at least one microneedle extending from said skin contact surface, said proximate end removably coupled to said outlet of said supply housing and having a piercing member oriented to pierce said septum, said piercing member mounted to said hub housing so as to be removable therewith, said at least one microneedle having a length suitable for intradermal or shallow subcutaneous delivery of said substance, said microneedle being separate, and spaced, from said piercing member, said microneedle being in fluid communication with said piercing member for receiving said substance from said cartridge, a fluid flow path is defined through said hub housing, said microneedle defining the narrowmost portion of said fluid flow path; and

a drive mechanism located within said supply housing for moving said plunger and said stopper, wherein the distal face of said stopper moves a substantially equivalent distance to the distal face of said plunger toward said septum, said septum being substantially free of deflection to dispense said substance from said cartridge through said piercing member to said at least one microneedle for delivering said substance to a patient.

12. A substance delivery device as claimed in claim 11, wherein said skin contact surface further comprises a depth limiting post to support and limit a depth of insertion for said microneedle, said post formed about said microneedle and extending above said skin contact surface.

13. A substance delivery device as claimed in claim 12, wherein said depth limiting post includes an axial dimension and an outer face, and wherein said microneedle extends axially from said outer face.

14. A microneedle delivery device as claimed in claim 12, wherein said depth limiting post has a height above said skin contact surface and a width sufficient to allow substantially complete penetration of said microneedle.

15. A substance delivery device as claimed in claim 11, wherein said skin contact surface further comprises a tensioning ring to tension patient skin during insertion of said microneedle, said ring comprising a ridge raised from said skin contact surface and concentrically located about said microneedle.

16. A substance delivery device as claimed in claim 15, wherein said tensioning ring extends from said contact surface a height of less than or equal to said height of said depth limiting post.

17. A substance delivery device as claimed in claim 11, wherein said proximate end includes an engagement opening which comprises a mechanical coupling mechanism to securely engage said supply housing, said engagement bringing said piercing member into contact with said contents of said cartridge and allowing communication of said contents to said microneedle via said fluid delivery channel.

18. A substance delivery device as claimed in claim 17, wherein said mechanical coupling is selected from the group consisting of a threaded fitting, a luer fitting and a snap fit fitting.

19. A substance delivery device as claimed in claim 11, wherein said device is further adapted to allow delivery of said contents from said cartridge to said patient at a rate substantially equivalent to delivery via a single 31 gauge needle.

20. A substance delivery device as claimed in claim 11, wherein said microneedle has an exposed length ranging from about 0.3 mm to about 5.0 mm.

21. A method for intradermal delivery of a substance, comprising:

engaging a hub assembly, having a patient contact surface with a tensioning member, a depth limiting member, a piercing member and a microneedle of a length suitable for intradermal or shallow subcutaneous penetration, said piercing member being mounted to said hub assembly, said microneedle being separate, and spaced, from said piercing member, a fluid flow path being defined through said hub housing, said microneedle defining the narrowmost portion of said fluid flow path, with a pen body housing containing a single cartridge, a plunger having a distal face and a drive mechanism;

piercing a septum of said cartridge in said pen body housing with said piercing member, said cartridge having said septum at a first end and a stopper having a distal face at a second end to seal contents within said cartridge, said piercing member engaging said contents of said cartridge;

controlling said pen body housing to insert said microneedle at an insertion site on a patient while maintaining said pen body at an angle of 90 degrees or less relative to the plane of said insertion site surface such that said patient contact surface is parallel to said insertion site surface and applying tension to said insertion site via said tensioning member; and

controlling said drive mechanism located within said pen body housing to engage said plunger and said stopper, wherein the distal face of said stopper moves a substantially equivalent distance to the distal face of said plunger causing said contents to flow from said cartridge through said hub assembly and into said insertion site.

22. A method for intradermal delivery of a substance as claimed in claim 21, wherein said applied tension is created by said tensioning member comprising a ridge raised from said patient contact surface and concentrically located about said microneedle and adapted to tension said injection site during insertion of said microneedle.

23. A method for intradermal delivery of a substance as claimed in claim 21, wherein said applied tension is created by said depth limiting member comprising a depth limiting post formed about said microneedle and extending above said patient contact surface, said post having an axial dimension and an outer face wherein said microneedle extends axially from said outer face

24. A method for intradermal delivery of a substance as claimed in claim 21, wherein said patient contact surface is formed at an angle of 90 degrees or less relative to a center line of said hub assembly.

25. A method for intradermal delivery of a substance as claimed in claim 21, wherein said microneedle has an exposed length ranging from about 0.3 mm to about 5.0 mm.

26. A method for intradermal delivery of a substance as claimed in claim 21, wherein said microneedle has an exposed length ranging from about 0.3 mm to about 2.0 mm to access intradermal tissue space.

27. A method for intradermal delivery of a substance as claimed in claim 21, wherein said microneedle has an exposed length ranging from about 0.75 mm to about 1.70 mm to access intradermal tissue space.

28. A method for intradermal delivery of a substance as claimed in claim 21, wherein said microneedle has an exposed length ranging from about 2.0 mm to about 5.0 mm to access shallow subcutaneous tissue space.

29. A method for intradermal delivery of a substance as claimed in claim 21, wherein said microneedle has an exposed length ranging from about 1.7 mm to about 5.00 mm to access shallow subcutaneous tissue space.

30. A method for intradermal delivery of a substance as claimed in claim 21, wherein said microneedle has an exposed length ranging from about 1.7 mm to about 3.0 mm to access shallow subcutaneous tissue space.

31. A method for intradermal delivery of a substance as claimed in claim 21, wherein said hub assembly comprises a plurality of said microneedles extending from said patient contact surface.

32. A method for intradermal delivery of a substance as claimed in claim 21, wherein said hub assembly comprises a plurality of said tensioning members raised from said patient contact surface.

33. A method for intradermal delivery of a substance as claimed in claim 21, wherein said hub assembly comprises a plurality of said depth limiting members extending above said patient contact surface.