POSITIVE DISPLACEMENT PUMP

• US 20100130932A1
• Filed: 05/11/2008
• Published: 05/27/2010
• Est. Priority Date: 05/11/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Neta, Avraham, Yodfat, Ofer, Shalev, Yossi
• Granted Patent: US 9,138,534 B2
• Time in Patent Office: Days
• US Class Current: 604/151
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2210/04 Skin
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: F04B 43/1269 the rotary axes of the rollers lying in a plane perpendicular to the rotary axis of the driving motor

Abstract

Systems, methods and apparatuses for delivering therapeutic fluid to the body of a patient are disclosed. The apparatus includes a dispensing unit having a driving mechanism, a pumping mechanism, a reservoir containing therapeutic fluid, and an outlet port. The driving mechanism causes the pumping mechanism to positively displace therapeutic fluid within the reservoir for delivery of therapeutic fluid to the body of the patient via the outlet port.

Claims

1-40. -40. (canceled)

41. A device for delivering therapeutic fluid into a body of a patient, comprising:

at least one housing accommodating therein;

a reservoir including at least one wall for retaining therapeutic fluid;

an outlet port in fluid communication with the reservoir;

a plunger having a plunger head and a plunger rod for displacing the therapeutic fluid from the reservoir to the outlet port;

a driving mechanism including at least a motor and one or more gears for displacing the plunger within the reservoir; and

electronic components including at least a controller for controlling at least the operation of the driving mechanism;

wherein at least a portion of the at least one housing comprises at least a portion of the at least one wall of the reservoir.

42. The device according to claim 41, wherein the device further comprises:

a reusable part comprising a reusable part housing accommodating the electronic components and the driving mechanism;

a disposable part connectable to the reusable part, the disposable part comprising a disposable part housing accommodating the reservoir, the plunger head and the outlet port; and

an energy supply electrically coupleable to at least one of the electronic components for supplying energy upon connection of the disposable part to the reusable part;

wherein the at least one housing comprises the reusable part housing and the disposable part housing;

wherein at least a portion of the disposable part housing comprises at least a portion of the at least one wall of the reservoir; and

wherein delivery of the therapeutic fluid is enabled upon connecting the disposable part to the reusable part.

43. The device according to claim 42, wherein

the reusable part further comprises the plunger rod, the plunger rod being coupled to the driving mechanism;

and

wherein the plunger rod is coupleable to the plunger head upon connection of the disposable part to the reusable part, thus enabling displacement of the therapeutic fluid within the reservoir toward the outlet port.

44. The device according to claim 43, wherein the plunger rod is partially disposed within the reusable part housing and partially disposed within the disposable part housing when the therapeutic fluid is being displaced within the reservoir.

45. The device according to claim 42, wherein

the disposable part further comprises the plunger rod, the plunger rod being coupled to the plunger head;

and

wherein the plunger rod is coupleable to the driving mechanism upon connection of the disposable part to the reusable part, thus enabling displacement of the therapeutic fluid within the reservoir toward the outlet port.

46. The device according to claim 45, wherein the plunger rod is partially disposed within the reusable part housing and partially disposed within the disposable part housing when the therapeutic fluid is being displaced within the reservoir.

47. The device according to claim 41, wherein the reservoir comprises a non-circular cross-section.

48. The device according to claim 47, wherein the cross-section of at least a portion of the plunger head substantially corresponds to the non-circular cross-section of the reservoir.

49. The device according to claim 41, wherein the reservoir includes a cross-section selected from a group consisting of:

oval, elliptical, rectangular, and multi-curved.

50. The device according to claim 41, wherein the reservoir includes a cross-section comprising at least four curves having at least two different radii.

51. The device according to claim 41, wherein the reservoir includes a height of less than about 12 mm and a maximum capacity of about 2 cc of fluid.

52. The device according to claim 42, further comprising a threaded receiving portion having a plurality of threads disposed therein.

53. The device according to claim 52, wherein the plunger rod includes a plurality of threads disposed along at least a portion of the length of the plunger rod configured to interact with the plurality of threads of the receiving portion.

54. The device according to claim 53, wherein the receiving portion comprises a screw-nut having the plurality of threads disposed therein.

55. The device according to claim 54, wherein the nut is rotated by the motor via the one or more gears, and wherein the rotation of the screw-nut translates the plunger within the reservoir to displace the therapeutic fluid toward the outlet port.

56. The device according to claim 55, wherein at least one spring is disposed between the screw-nut and the plunger head to apply force to the plunger head during translational movement of the plunger within the reservoir.

57. The device according to claim 52, wherein the threaded receiving portion is disposed within the disposable part housing.

58. The device according to claim 41, wherein the driving mechanism further comprises a plurality of hinged bars, wherein at least two bars of the plurality of hinged bars are pivotally coupled to the plunger rod.

59. The device according to claim 41, wherein the driving mechanism further comprises:

a threaded rod coupled to at least one of the one or more gears, wherein rotation of the at least one of the one or more gears causes rotation of the threaded rod;

a plurality of auxiliary threaded screw-nuts disposed on the threaded rod, wherein rotation of the threaded rod translates at least two of the auxiliary threaded screw-nuts along the threaded rod in opposite directions with respect to each other;

a plurality of hinged bars, wherein at least two bars of the plurality of hinged bars are pivotally coupled to the plunger rod and pivotally coupled to the auxiliary threaded screw-nuts;

wherein translational movement of the at least two of the auxiliary threaded screw-nuts along the threaded rod in opposite directions with respect to each other causes translational movement of the plunger rod within the reservoir via pivotal movement of the plurality of hinged bars.

60. The device according to claim 41, wherein the plunger rod comprises a first section and a second section, wherein the first section is substantially perpendicular to the second section.

61. The device according to claim 41, wherein the reservoir is configured as half a torus and the plunger rod is configured to include a curve which accommodates insertion of the plunger rod into the reservoir to positively displace the therapeutic fluid toward the outlet port.

62. The device according to claim 41, wherein the reservoir is configured as a sector of a circular-cylinder and the plunger is adapted to pivotally move within the reservoir to positively displace the therapeutic fluid toward the outlet port.

63. The device according to claim 41, wherein the outlet port is configured to enable filling the reservoir with the therapeutic fluid via the outlet port by pulling the plunger head outwardly within the reservoir.

64. The device according to claim 63, wherein the outlet port is configured to allow connection of a therapeutic fluid container directly thereto, and wherein upon connection of the therapeutic fluid container to the outlet port a connecting lumen provided at the outlet port pierces a septum of the container, thus enabling fluid transfer from the therapeutic fluid container to the reservoir.

65. The device according to claim 63, further comprising a filling adaptor having a first port coupleable to a therapeutic fluid container and a second port coupleable to the outlet port, the first port including an adaptor needle for piercing a septum of the therapeutic fluid container, and the second port including an adaptor septum for being pierced by a connecting lumen provided at the outlet port, wherein upon coupling the first port to the therapeutic fluid container and the second port to the outlet port, fluid communication is established between the therapeutic fluid container and the reservoir through the filling adaptor.

66. The device according to claim 65, further comprising a detachable auxiliary rod coupleable to the plunger head when the plunger rod is disconnected from the plunger head, for enabling the pulling of the plunger head outwardly within the reservoir.

67. The device according to claim 42, further comprising at least one gasket for maintaining sealing of the device upon connection of the disposable part to the reusable part.

68. The device according to claim 41, wherein at least a portion of the at least one housing is transparent.

69. The device according to claim 42, wherein the energy supply means is disposed within the disposable part housing, and wherein the reusable part further comprises a plurality of electrical connectors for electrically coupling the energy supply means to the at least one of the electronic components upon connection of the disposable part to the reusable part.

70. The device according to claim 69, wherein each electrical connector in the plurality of electrical connectors includes an end for piercing a corresponding septum in a plurality of self-sealable septa disposed in the disposable part.

71. The device according to claim 41, wherein the device is removably connectable to a skin-adherable needle unit.

72. The device according to claim 41, wherein the device is removably connectable to an infusion set.

73. The device according to claim 41, wherein the therapeutic fluid is insulin.

74. The device according to claim 41, further comprising at least one button disposed on the at least one housing and actuatable by the patient for controlling one or more operations of the device.

75. The device according to claim 41, wherein the electronic components further include a transceiver for communicating with a remote control unit.

76. The device according to claim 75, wherein the remote control unit is selected from a group consisting of:

a personal computer, a laptop, an mp3 player, a PDA, a cellular telephone, and a remote control.

77. The device according to claim 75, wherein the remote control unit communicates with the device using a mode of communication selected from a group consisting of:

wireless, wired, RF, and infrared.