Reusable medication delivery device

• US 6,482,186 B1
• Filed: 09/29/2000
• Issued: 11/19/2002
• Est. Priority Date: 09/29/1999
• Status: Expired due to Fees

• Current Assignee: TecPharma Licensing AG (Ypsomed Holding AG)
• Original Assignee: Sterling Medivations, Inc. (Guided Therapeutics, Inc.)
• Inventors: Douglas, Joel, Ramirez, John, Hugo, Robert
• Primary Examiner(s): Esquivel, Denise L.
• Assistant Examiner(s): Zec, Filip
• Application Number:
  US09/672,103
• Time in Patent Office: 781 Days
• Field of Search: 604/28, 604/135, 604/155, 604/181, 604/186, 604/191, 604/208, 604/211, 604/218
• US Class Current: 604/218
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2005/3151 by friction
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/585 having magnification means, e.g. magnifying glasses
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• 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 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/31501 Means for blocking or restricting the movement of the rod or piston A61M5/5013 takes precedence
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/31535 Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/31556 Accuracy improving means
• CPC Class Codes: A61M 5/31558 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/31566 Means improving security or handling thereof
• CPC Class Codes: A61M 5/3157 Means providing feedback signals when administration is completed A61M5/20 takes precedence
• CPC Class Codes: A61M 5/31571 Means preventing accidental administration for automatic syringes A61M5/20
• CPC Class Codes: A61M 5/3158 : performed by axially moving actuator operated by user, e.g. an injection button
• CPC Class Codes: A61M 5/31591 : Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
• CPC Class Codes: A61M 5/3202 : Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001

Abstract

A medication injection or delivery system is provided for injecting fluids such as insulin within body tissue. The device includes a housing, a flexible shaft movably mounted within the housing, and a dose setting mechanism for controlling the movement of the shaft with respect to a fluid-containing cartridge removably positioned within or mounted to the housing. The flexible shaft, according to exemplary embodiments, includes a plunger and a flexible cable connected to the dose setting mechanism. The plunger and dose setting mechanism are connected together by the flexible shaft. The dose setting mechanism, in one aspect of the invention, includes a screw, a locking mechanism, and a nut assembly connected to the flexible shaft. The dose setting mechanism is used to set the dosage and prime the catheter. The plunger retracts into a recess to permit a new cartridge to be installed quickly.

Claims

1. A portable infusion device comprising:

a housing having a cavity, a first opening into the cavity, and a second opening into the cavity, the cavity having, a curved portion;

an elongate flexible member, comprising a spring on the outside of the flexible member, the flexible member being positioned at least in part in the curved portion, the flexible member being substantially axially incompressible and laterally flexible; and

a manual dosage selection mechanism,

whereby, when a medication ampule including a piston is positioned adjacent to the first opening, the flexible member can be advanced through the curved portion of the cavity to push against and move the ampule piston without substantially compressing the flexible member, and whereby the manual dosage selection mechanism controls the distance that the elongate flexible member moves with respect to the medication ampule.

2. An infusion device in accordance with claim 1, wherein the curved portion includes a U-shaped portion.

3. An infusion device in accordance with claim 1, further comprising:

an ampule holder having a cavity sized to receive an ampule therein, a first opening into the ampule holder cavity, and a second opening into the ampule holder cavity, the ampule holder second opening positioned adjacent to the housing first opening.

4. An infusion device in accordance with claim 3, further comprising:

a collar sized to receive a first portion of the ampule holder in the collar, the ampule holder first portion including the ampule holder first opening.

5. An infusion device in accordance with claim 4, wherein the collar is a split collar having an interior surface, a slot, and a groove on the interior surface, and the ampule holder includes an upstanding peg sized to be received in the groove.

6. An infusion device in accordance with claim 3, further comprising:

an ampule in the ampule holder, the ampule containing a medication.

7. An infusion device in accordance with claim 1, further comprising:

a tubular element suitable for subcutaneous insertion;

an elongate septum piercing element for piercing a septum of an ampule, the septum piercing element in fluid communication with the tubular element.

8. An infusion device in accordance with claim 7, wherein the tubular element suitable for subcutaneous insertion is a subcutaneous catheter, and further comprising a flexible tube fluidly communicating the subcutaneous catheter with the septum piercing element.

9. An infusion device in accordance with claim 7, wherein the tubular element suitable for subcutaneous insertion is a needle, and further comprising a tubular shroud surrounding the septum piercing element.

10. An infusion device in accordance with claim 1, wherein the elongate flexible member comprises:

an outer flexible member; and

an intermediate flexible member positioned inside the outer flexible member.

11. An infusion device in accordance with claim 10, wherein the outer flexible member and the intermediate flexible member are not connected to each other along substantially their entire lengths.

12. An infusion device in accordance with claim 10, wherein the outer flexible member and the intermediate flexible member each include first and second end and are attached to each other at their first and second ends, respectively.

13. An infusion device in accordance with claim 10, further comprising an inner flexible member positioned inside the intermediate flexible member, the inner flexible member being substantially axially inextensible.

14. An infusion device in accordance with claim 1, wherein the manual dosage selection mechanism further comprises:

a dosage sleeve at least partially positioned in the housing cavity and movable out of the housing second opening, the dosage sleeve including a hollow interior and an interior surface having threads;

a nut including an outer surface, a part of the nut outer surface including threads sized and configured to mate with the dosage sleeve threads, the nut attached to one end of the elongate flexible member;

whereby rotation of the sleeve relative to the nut moves the sleeve away from the elongate flexible member.

15. An infusion device in accordance with claim 14, wherein the dosage sleeve further comprises:

an exterior surface including a plurality of longitudinally extending grooves; and

wherein the housing includes at least one peg sized and positioned to engage the dosage sleeve exterior surface and produce a click when the dosage sleeve is rotated.

16. An infusion device in accordance with claim 14, wherein the dosage sleeve includes an inner end inside the cavity and an outer end, and wherein the flexible member has a length so that when the nut is adjacent to dosage sleeve outer end a second end of the flexible member is immediately adjacent to the housing first opening.

17. An infusion device in accordance with claim 14, wherein the dosage sleeve further comprises an annular shoulder positioned at the dosage sleeve inner end, wherein the housing further comprises a shoulder adjacent to the dosage sleeve, and further comprising a spring positioned between the dosage sleeve shoulder and the housing shoulder, the spring being compressed when the dosage sleeve moves out of the housing.

18. An infusion device in accordance with claim 14, wherein the dosage sleeve further comprises a friction surface, wherein the housing further comprises a friction surface bearing against the dosage sleeve friction surface, and wherein the housing friction surface is configured and arranged so that the friction generated between the housing friction surface and the dosage sleeve friction surface is not constant as the dosage sleeve moves out of the housing.

19. An infusion device in accordance with claim 14, further comprising:

a zero set sleeve positioned around a portion of the dosage sleeve, the zero set sleeve being rotatable on the dosage sleeve and including an annular ring;

a zero set spring;

wherein the dosage sleeve include an annular ring at the dosage sleeve outer end;

wherein the zero set spring is positioned between the zero set sleeve annular ring and the dosage sleeve annular ring to bias the zero set sleeve and the dosage sleeve together.

20. An infusion device in accordance with claim 19, wherein the zero set sleeve includes an outer surface and dosage indicia on the zero set sleeve outer surface;

and

further comprising a window through the housing, the zero set sleeve dosage indicia being visible through the window.

21. An infusion device in accordance with claim 14, further comprising a slot in the housing, an annular ring positioned around the dosage sleeve, an arm connected to the annular ring and extending through the slot, and a side injection actuator attached to the arm outside of the housing, wherein pushing on the side injection actuator pushes the dosage sleeve.

22. An infusion device in accordance with claim 14, wherein the dosage sleeve further comprises an inner end, an outer end, and a pair of slots extending longitudinally from the dosage sleeve inner end, the pair of slots forming a finger from a portion of the dosage sleeve;

wherein the housing cavity further comprises a recess adjacent to the housing second opening; and

further comprising a locking member rotatably positioned in the recess, the locking member having a non-uniform exterior surface including first and second portions;

whereby when the locking member is positioned with the first portion immediately adjacent to the dosage sleeve finger, the first portion prevents the finger from flexing radially outward, and when the locking member is positioned with the second portion immediately adjacent to the dosage sleeve finger, the second portion permits the finger to flex radially outward.

23. An infusion device in accordance with claim 1, further comprising a locking cam movably mounted in the housing cavity, the cam positioned adjacent to the elongate flexible member, the locking cam being movable between a first orientation in which the locking cam does not interfere with movement of the flexible member in the cavity, and a second orientation in which the locking cam presses against the flexible member an inhibits movement of the flexible member in the cavity.

26. An infusion device in accordance with claim 8, further comprising:

an ampule holder having a cavity sized to receive an ampule therein, a first opening into the ampule holder cavity, and a second opening into the ampule holder cavity, the ampule holder second opening positioned adjacent to the housing first opening.

27. An infusion device in accordance with claim 26, further comprising:

an ampule in the ampule holder, the ampule containing a medication.

24. A portable infusion device comprising:

a housing having a proximal end, a distal end, a sidewall extending longitudinally between said proximal end and said distal end, an opening formed in at least one of said sidewall, said proximal end. and said distal end, and an interior cavity;

an ampule positioned in said housing interior cavity, said ampule including a distal end having a sealed outlet, a piston in said ampule, and said ampule sized and configured to pass through said housing opening;

a catheter having a proximal end, a distal end, and at least one lumen extending between said proximal end and said distal end, said catheter proximal end being releasably attached to one of said housing distal end and said ampule distal end;

a longitudinally movable plunger, comprising a spring on the outside of the logitudinally movable plunger, positioned in said housing for engaging with and distally moving said ampule piston;

manually movable dosage selection means including;

interior portions positioned in said housing and selectively engaging said plunger;

manually movable exterior portions positioned exterior of said housing for permitting a user of said portable infusion device to select a plunger travel distance; and

a manually engageable element connected to said interior portions to move said plunger said plunger travel distance when said interior portions engage said plunger.

25. A method of injecting a medication into a patient, comprising the steps of:

providing a portable infusion device comprising;

a housing having a cavity, a first opening into the cavity, and a second opening into the cavity, the cavity having a curved portion; and

an elongate flexible member, comprising a spring on the outside of the flexible member, the flexible member being positioned at least in part in the curved portion, the flexible member being substantially axially incompressible and laterally flexible;

positioning a medication ampule including a piston adjacent to the first opening;

positioning a tube in fluid communication with the medication ampule and subcutaneously in a patient;

advancing the flexible member through the curved portion of the cavity, wherein the distance the elongate flexible member is advanced through the cavity is controlled by the manual dosage selection mechanism;

pushing against and moving the ampule piston without substantially compressing the flexible member to dispense medication from the ampule, through the tube, and into the patient.