Medicine Delivery Device Having Detachable Pressure Sensing Unit

• US 20150367066A1
• Filed: 05/21/2015
• Published: 12/24/2015
• Est. Priority Date: 08/18/2009
• Status: Active Grant

• Current Assignee: CeQur SA
• Original Assignee: CeQur SA
• Inventors: Gravesen, Peter, Arndt, Heiko, Chiriaev, Serguei
• Granted Patent: US 10,300,196 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3358 Measuring barometric pressure, e.g. for compensation
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• 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 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

A fluid medicament delivery device includes a patient attachment unit and a separate indicator unit. The patient attachment unit includes a housing and a fluid channel located therein, wherein at least a portion of the fluid channel includes a flexible member substantially coterminous with the housing. The separate indicator unit is adapted to be detachably coupled to the housing of the patient attachment unit and includes a first sensing element for contacting the flexible member when the indicator unit is coupled to the housing to sense a flexure of the flexible member.

Claims

1-48. -48. (canceled)

49. A fluid medicament delivery device comprising:

a disposable patient attachment unit adapted to deliver a fluid medicament contained therein to a patient; and

a separate reusable indicator unit, wherein the indicator unit is;

adapted to;

(i) detachably connect to the patient attachment unit, (ii) notify the patient when to disconnect the indicator unit from the patient attachment unit, and (iii) connect to a different patient attachment unit; and

not adapted to change a flow rate of the medicament.

50. The fluid medicament delivery device of claim 49, wherein the patient attachment unit further comprises a micro-fluidic circuit adapted to transport the medicament.

51. The fluid medicament delivery device of claim 50, wherein the patient attachment unit comprises a flexible sensor membrane in fluidic communication with the micro-fluidic circuit and adapted to communicate the pressure in the micro-fluidic circuit.

52. The fluid medicament delivery device of claim 49, wherein the patient attachment unit further comprises an adhesive adapted for adhesion to a skin surface of the patient.

53. The fluid medicament delivery device of claim 49, wherein the patient attachment unit is adapted to mate with a cannula adapted for insertion into the skin of the patient.

54. The fluid medicament delivery device of claim 49, wherein the indicator unit detachably connects to the patient attachment unit with at least one of a screw, snap-fit, and press connection.

55. The fluid medicament delivery device of claim 49, further comprising a feedback unit adapted to notify the patient when to disconnect the indicator unit from the patient attachment unit.

56. The fluid medicament delivery device of claim 55, wherein the feedback unit provides at least one of a visual, an audible, and a tactile feedback.

57. The fluid medicament delivery device of claim 49, wherein the indicator unit further comprises a pressure sensor for sensing a pressure in a micro-fluidic circuit of the patient attachment unit.

58. The fluid medicament delivery device of claim 49, wherein the indicator unit is adapted to notify the patient to disconnect the indicator unit from the patient attachment unit when at least one of:

(i) the patient attachment unit has experienced an occlusion event, (ii) the patient attachment unit is functionally depleted of medicament, and (iii) a component of the indicator unit has functionally failed.

59. The fluid medicament delivery device of claim 58, wherein the indicator unit is adapted to determine that the patient attachment unit has experienced an occlusion event by sensing a change in pressure in a micro-fluidic circuit of the patient attachment unit.

60. The fluid medicament delivery device of claim 58, wherein the indicator unit is adapted to determine that the patient attachment unit is functionally depleted of medicament by sensing a change in pressure in a micro-fluidic circuit of the patient attachment unit.

61. The fluid medicament delivery device of claim 58, wherein the failed component of the indicator unit comprises a battery.

62. The fluid medicament delivery device of claim 49, wherein the indicator unit further comprises a textured edge to facilitate removal from the patient attachment unit.

63. The fluid medicament delivery device of claim 49, wherein the patient attachment unit and the indicator unit comprise complementary contoured surfaces adapted to mate with one another when the patient attachment unit and the indicator unit are connected.

64. A method of using a medicament delivery device, the method comprising the steps of:

connecting a reusable indicator unit to a disposable patient attachment unit adapted to deliver a fluid medicament contained therein to a patient, wherein the indicator unit is not adapted to change a flow rate of the medicament;

receiving a notification from the indicator unit that it is to be disconnected from the patient attachment unit;

disconnecting the indicator unit from the patient attachment unit; and

connecting the indicator unit to a different patient attachment unit.

65. The method of claim 64, wherein the connecting step comprises mating complementary contoured surfaces of the patient attachment unit and the indicator unit.

66. The method of claim 64, wherein the receiving a notification step occurs when at least one of:

(i) the patient attachment unit has experienced an occlusion event, (ii) the patient attachment unit is functionally depleted of medicament, and (iii) a component of the indicator unit has functionally failed.

67. The method of claim 64, wherein the receiving a notification step comprises receiving at least one of a visual, an audible, and a tactile feedback.

68. The method of claim 64, wherein the disconnecting step comprises engaging a textured edge of the indicator unit.

69. The method of claim 64, further comprising adhering the patient attachment unit to a skin surface of a patient.

70. A method of operating a medicament delivery device comprising a disposable patient attachment unit adapted to deliver a fluid medicament contained therein to a patient, and a separate reusable indicator unit, wherein the indicator unit is not adapted to change a flow rate of the medicament, the method comprising the steps of:

determining that an event has occurred, the event selected from the group consisting of;

(i) the patient attachment unit has experienced as occlusion event, (ii) the patient attachment unit is functionally depleted of medicament, and (iii) a component of the indicator unit has functionally failed; and

notifying a patient to disconnect the indicator unit from the patient attachment unit.

71. The method of claim 70, wherein determining step comprises sensing a change in pressure in a micro-fluidic circuit of the patient attachment unit.

72. The method of claim 70, wherein the notifying step comprises providing at least one of a visual, an audible, and a tactile feedback.