Insertion device

• US 9,808,574 B2
• Filed: 06/25/2008
• Issued: 11/07/2017
• Est. Priority Date: 06/25/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Neta, Avraham, Gescheit, Illai
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): WILSON, LARRY ROSS
• Application Number:
  US12/215,255
• Publication Number:
  US 20080319414A1
• Time in Patent Office: 3,422 Days
• Field of Search: 604136-138, 604156-158, 60416404, 60416406, 60416411, 60416412, 604180, 604272, 604506, 604513, 6048901
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2205/362 by gas flow
• CPC Class Codes: A61M 2205/3673 thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/422 Desensitising skin

Abstract

An insertion apparatus and a method for use with a device for delivery of a therapeutic fluid into a body of a patient and/or for sensing of a bodily analyte are disclosed. The apparatus includes a housing adapted for loading therein at least one cannula cartridge unit having a protective member. The protective member accommodates at least one penetrating cartridge having a subcutaneously insertable element and a penetrating member. The apparatus includes a displacement mechanism capable of protracting the penetrating cartridge towards the body of the patient, where protraction of the penetrating cartridge results in insertion of the subcutaneously insertable element into the body of the patient.

Claims

1. A subcutaneous insertion apparatus comprising:

a housing configured to receive at least one cartridge unit, the at least one cartridge unit comprising a protective member containing therein at least one subcutaneously insertable element and at least one penetrating member, the housing including;

a first housing opening adapted for at least loading therethrough the at least one cartridge unit into the housing; and

a second housing opening adapted for at least protracting therethrough the at least one insertable element and the at least one penetrating member; and

a displacement mechanism contained within the housing and configured to at least protract the at least one insertable element and the at least one penetrating member through the second housing opening toward the body of the patient for subcutaneous insertion of the at least one insertable element,

wherein the displacement mechanism is configured to be primed for activation prior to the housing receiving the at least one cartridge unit; and

the insertion apparatus is configured to couple to a skin-securable cradle that comprises a tubular protrusion emerging upwardly from the cradle that defines therein a well, the well comprising a plurality of penetration tunnels for directing the subcutaneous insertable element toward a plurality of angles with respect to a plane of a bottom housing opening, and the insertion apparatus is configured to align the subcutaneous insertable element with any of the plurality of penetration tunnels of the well, so as to insert the subcutaneous insertable element through the aligned tunnel.

2. The insertion apparatus according to claim 1, wherein the displacement mechanism is further configured to retract the penetrating member into the protective member subsequent to the subcutaneous insertion of the insertable element.

3. The insertion apparatus according to claim 1, wherein the displacement mechanism comprises a rod for manually forcing the at least one insertable element and the at least one penetrating member toward the body of the patient.

4. The insertion apparatus according to claim 1, wherein the displacement mechanism includes a loadable spring, wherein unloading of the spring results in protraction of the at least one insertable element and the at least one penetrating member toward the body of the patient.

5. The insertion apparatus according to claim 4, wherein the displacement mechanism further comprises a second spring, wherein unloading of the second spring results in retraction of the penetrating member into the protective member subsequent to subcutaneous insertion of the insertable element.

6. The insertion apparatus according to claim 1, further comprising a user-actuated button for actuating the displacement mechanism when the cartridge unit is loaded therein.

7. The insertion apparatus according to claim 1, further comprising a safety means for preventing inadvertent actuation of the displacement mechanism.

8. The insertion apparatus according to claim 1, wherein the displacement mechanism comprises one or more hooks configured to engage with at least a portion of the cartridge unit when the cartridge unit is loaded within the housing.

9. The insertion apparatus according to claim 1, wherein the displacement mechanism comprises:

a release button having a restraining arm;

a ratchet flywheel;

a loadable flywheel torsion spring at least a portion of which is embedded in the ratchet flywheel;

a manually rotatable loading button capable of being coupled to the ratchet flywheel for loading the flywheel torsion spring;

a ratchet crank coupled to the ratchet flywheel and rotatable by the flywheel torsion spring; and

an insertion lever provided with at least one engagement hook and displaceable by the ratchet crank, wherein;

upon coupling the loading button to the ratchet flywheel and subsequent rotation of the loading button the flywheel torsion spring is loaded,

upon actuation of the release button, the restraining arm of the release button is disengaged from the ratchet crank allowing the ratchet crank to rotate via an application of force of the loaded flywheel torsion spring, and

the ratchet crank displaces the insertion lever and the at least one engagement hook resulting in the protraction of the at least one insertable element and the at least one penetrating member toward the body of the patient and, subsequently, the retraction of the penetrating member, thereby retaining the insertable element in the body of the patient.

10. The insertion apparatus according to claim 1, wherein at least one of the first and second housing openings is further configured for unloading therethrough at least a portion of the at least one cartridge unit from the housing.

11. The insertion apparatus according to claim 1, wherein the first housing opening is further configured for unloading therethrough the protective member with at least the penetrating member contained therein from the housing.

12. The insertion apparatus according to claim 1, wherein the insertion apparatus is configured for repetitive use via subsequent loading of one or more additional cartridge units.

13. The insertion apparatus according to claim 1, wherein the housing further includes a securing mechanism configured to secure the at least one cartridge unit to the housing upon loading the at least one cartridge unit into the housing.

14. The insertion apparatus according to claim 1, wherein the first housing opening is a side opening.

15. The insertion apparatus according to claim 1, wherein the second housing opening is a bottom opening.

16. The insertion apparatus according to claim 1, wherein the second housing opening is separate from the first housing opening.

17. The insertion apparatus according to claim 1, wherein the housing further comprises one or more recesses configured to engage with one or more corresponding protrusions of the cradle for connecting the insertion apparatus to the cradle.

18. The insertion apparatus according to claim 1, further comprising a mechanism for disconnecting the insertion apparatus from the cradle unit.

19. The subcutaneous insertion apparatus of claim 1, further comprising a selection mechanism configured to set an angle of the insertable element from the plurality of angles with respect to the plane of the bottom housing opening, the selection mechanism comprising a button coupled to the cartridge unit, wherein rotation of the button rotates the cartridge unit in a corresponding direction.

20. The subcutaneous insertion apparatus of claim 1, further comprising a depth selection mechanism configured to set a depth of insertion of the at least one penetrating member.

21. A subcutaneous insertion apparatus comprising:

a housing configured to receive at least one cartridge unit, the at least one cartridge unit comprising a protective member containing therein at least one subcutaneously insertable element and at least one penetrating member, the housing including;

a side housing opening adapted for at least loading therethrough the at least one cartridge unit into the housing, and

a bottom housing opening adapted for at least protracting therethrough the at least one insertable element and the at least one penetrating member; and

a displacement mechanism contained within the housing and configured to at least protract the at least one insertable element and the at least one penetrating member through the second housing opening towards the body of the patient for subcutaneous insertion of the at least one insertable element,

wherein the displacement mechanism is configured to be primed for activation prior to the housing receiving the at least one cartridge unit; and

the insertion apparatus is configured to couple to a skin-securable cradle that comprises a tubular protrusion emerging upwardly from the cradle that defines therein a well, the well comprising a plurality of penetration tunnels for directing the subcutaneous insertable element toward a plurality of angles with respect to a plane of a bottom housing opening and configured to serve as a stopper to prevent excessive insertion of the at least one penetrating member and to hold a hub of the at least one subcutaneously insertable element upon retraction of the penetrating member, and the insertion apparatus is configured align the subcutaneous insertable element with any of the plurality of penetration tunnels of the well, so as to insert the subcutaneous insertable element through the aligned tunnel.