Device and method for facilitating infusion of therapeutic fluids and sensing of bodily analytes

• US 8,971,981 B2
• Filed: 07/31/2008
• Issued: 03/03/2015
• Est. Priority Date: 08/01/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Yodfat, Ofer, Gescheit, Iddo M., Gescheit, Illai
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): MESSERSMITH, ERIC J
• Application Number:
  US12/452,928
• Publication Number:
  US 20100137695A1
• Time in Patent Office: 2,406 Days
• Field of Search: 600/309, 600344-366, 604/27, 604157-158, 604/192, 604/198, 604/256, 604/503, 604/519, 604/539, 604/164.01, 604/164.04, 604/164.07, 606/130, 163/19, 163/27, 403/1, 403 46- 47, 403/61, 403 66- 68
• US Class Current: 600/345
• 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 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence

Abstract

Disclosed is an assembly for use with a portable therapeutic device. The assembly includes a mounting housing securable to skin of a patient, and a cannula subcutaneously insertable through a passageway provided within the housing. The cannula is configured to be inserted subsequent to securing of the housing to the skin of the patient.

Claims

1. A therapeutic subcutaneous access apparatus for intermittently receiving a portable therapeutic device and adapted for at least one of delivering a therapeutic fluid into the body of a patient and sensing a bodily analyte, the therapeutic subcutaneous access apparatus comprising:

a housing configured to be securable to the skin of a patient;

a skin-securable cradle having a support surface for securing to the skin of the patient and a recess defined in the support surface for receiving and surrounding the housing to enable connection of the portable therapeutic device to the therapeutic subcutaneous access apparatus; and

a cannula insertable through a passageway provided within the housing so that at least a portion of the cannula is subcutaneously placed in the body of the patient,

wherein;

the housing comprises a well defining the passageway, the well being configured to tilt relative to a surface of the housing that contacts the skin of the patient when the housing is secured to the skin of the patient, for enabling insertion of the cannula at an angle,

the well includes a tilting mechanism to control the angle of tilt of the well, the tilting mechanism comprising one or more rods, at least one of the one or more rods having a first end attached to the well and a second end attached to a gear rotatable within a corresponding groove defined in a base of the housing, wherein the groove includes a first section in which the gear can be rotated, a second section into which the gear is placed to lock the gear and well into place, and the second section is narrower than the first section;

the cannula is configured for insertion through the passageway subsequent to securing of the housing to the skin of the patient, and

the cannula is configured for rigid connection to the housing in a substantially locking configuration upon insertion of the cannula through the passageway.

2. The therapeutic subcutaneous access apparatus according to claim 1, wherein the cannula is inserted through the passageway at a predetermined angle with respect to the surface of the skin of the patient.

3. The therapeutic subcutaneous access apparatus according to claim 1, wherein the cannula is configured for delivering therapeutic fluid.

4. The therapeutic subcutaneous access apparatus according to claim 3, wherein the therapeutic fluid comprises insulin.

5. The therapeutic subcutaneous access apparatus according to claim 1, wherein the cannula is configured for sensing a bodily analyte.

6. The therapeutic subcutaneous access apparatus according to claim 5, wherein the bodily analyte comprises one or more of glucose and ketones.

7. The therapeutic subcutaneous access apparatus according to claim 1, wherein the therapeutic subcutaneous access apparatus is further configured for use with an insertion device for inserting the cannula through the passageway so as to place at least a portion of the cannula subcutaneously in the body of the patient.

8. The therapeutic subcutaneous access apparatus according to claim 1, wherein the cannula further comprises a cannula hub attached to the cannula.

9. The therapeutic subcutaneous access apparatus according to claim 1, wherein the cannula further comprises a self-sealing septum provided on a proximal end thereof.

10. The therapeutic subcutaneous access apparatus according to claim 1, wherein the cannula further comprises a penetrating member having a grip portion.

11. The therapeutic subcutaneous access apparatus according to claim 8, wherein the housing further comprises:

one or more anchors to rigidly connect the cannula hub to the housing, the one or more anchors positioned proximate to the passageway.

12. The therapeutic subcutaneous access apparatus according to claim 1, wherein the housing further comprises an adhesive to secure the housing to the body of the patient.

13. The therapeutic subcutaneous access apparatus according to claim 1, wherein the portable therapeutic device comprises a fluid delivery device selected from the group consisting of:

a standard syringe, a syringe fitted within an adapter coupleable to the therapeutic apparatus, a jet pen, a single-part infusion device and a two-part infusion device.

14. The therapeutic subcutaneous access apparatus according to claim 1, wherein the portable therapeutic device comprises a sensing device.

15. The therapeutic subcutaneous access apparatus according to claim 14, wherein the cannula is further configured for coupling to a sensor configured to sense analytes in the body of the patient, the sensor further configured to communicate with the sensing device.

16. The therapeutic subcutaneous access apparatus according to claim 15 wherein the sensor comprises one or more of:

an optical sensor, an electrochemical sensor, an acoustic sensor and a Continuous Glucose Monitor (CGM).

17. The therapeutic subcutaneous access apparatus according to claim 15, wherein the sensor comprises at least one electrode configured to generate a signal representative of a concentration of the bodily analyte.

18. The therapeutic subcutaneous access apparatus according to claim 17, wherein at least one of the housing and the cannula comprises a communication module to transmit the signal.

19. The therapeutic subcutaneous access apparatus according to claim 17, wherein the communications module communicates via at least one of a wired and a wireless connection.

20. The therapeutic subcutaneous access apparatus according to claim 1, wherein the housing is configured for facilitating alignment between the housing and the portable therapeutic device.

21. The therapeutic subcutaneous access apparatus according to claim 20, wherein the housing includes at least one locking latch for mating with at least one recess defined on the portable therapeutic device.

22. The therapeutic subcutaneous access apparatus according to claim 20, wherein the housing defines a concave depression to receive a convex-shaped section of a body of the portable therapeutic device.

23. The therapeutic subcutaneous access apparatus according to claim 20, wherein the housing includes magnetic material to enable magnetic connection with another magnetic material provided in or on at least one corresponding connecting area in the portable therapeutic device.

24. The therapeutic subcutaneous access apparatus according to claim 1, further including an adapter for connecting the portable therapeutic device to the housing.

25. The therapeutic subcutaneous access apparatus according to claim 24, wherein the adapter comprises an angular adapter to connect the portable therapeutic device to the therapeutic subcutaneous access apparatus at an angle.

26. The therapeutic subcutaneous access apparatus according to claim 13, further including a connector to establish fluid communication between the fluid delivery device and the therapeutic subcutaneous access apparatus.

27. The therapeutic subcutaneous access apparatus according to claim 1, wherein the housing is configured for fitting with a protective cover connectable to the housing to protect at least the passageway.

37. The therapeutic subcutaneous access apparatus according to claim 1, wherein the skin-securable cradle comprises one or more indentations disposed around the recess, and the housing comprises one or more latches disposed around a perimeter of the housing for securing the housing to the one or more indentations of the skin-securable cradle.

28. A therapeutic system for at least one of delivering a therapeutic fluid into the body of a patient and sensing a bodily analyte, the therapeutic system comprising:

a portable therapeutic device for at least one of delivering a therapeutic fluid into the body of a patient and sensing a bodily analyte;

a therapeutic subcutaneous access apparatus configured for intermittently receiving the portable therapeutic device, the therapeutic subcutaneous access apparatus comprising;

a housing configured to be securable to the skin of a patient;

a skin-securable cradle having a support surface for securing to the skin of the patient and a recess defined in the support surface for receiving and surrounding the housing to enable connection of the portable therapeutic device to the therapeutic subcutaneous access apparatus; and

a cannula insertable through a passageway provided within the housing so that at least a portion of the cannula is subcutaneously placed in the body of the patient,

wherein;

the housing comprises a well defining the passageway, the well is configured to tilt relative to a surface of the housing that contacts the skin of the patient when the housing is secured to the skin of the patient, for enabling insertion of the cannula at an angle,

the well includes a tilting mechanism to control the angle of tilt of the well, the tilting mechanism comprising one or more rods, at least one of the one or more rods having a first end attached to the well and a second end attached to a gear rotatable within a corresponding groove defined in a base of the housing, wherein the groove includes a first section in which the gear can be rotated, a second section into which the gear is placed to lock the gear and well into place, and the second section is narrower than the first section;

the cannula is configured for insertion through the passageway subsequent to securing of the housing to the skin of the patient, and

the cannula is configured for rigid connection to the housing in a substantially locking configuration upon insertion of the cannula through the passageway.

29. The therapeutic system according to claim 28, wherein a connecting area in the portable therapeutic device substantially corresponds to a connecting area in the therapeutic subcutaneous access apparatus to facilitate alignment between the portable therapeutic device and the therapeutic subcutaneous access apparatus.

30. The therapeutic system according to claim 29, wherein the connecting area in the portable therapeutic device includes at least one recess and the connecting area in the therapeutic subcutaneous access apparatus includes at least one locking latch for mating with at least one recess.

31. The therapeutic system according to claim 28, wherein the connecting area in the portable therapeutic device includes a convex-shaped section in a body of the portable therapeutic device and the connecting area in the therapeutic subcutaneous access apparatus includes a concave depression to receive the convex-shaped section of the portable therapeutic device.

32. The therapeutic system according to claim 29, wherein the connecting area in the therapeutic subcutaneous access apparatus includes magnetic material to enable magnetic connection with another magnetic material provided in or on the connecting area in the portable therapeutic device.

34. The therapeutic system according to claim 28, further comprising an insertion device comprising means for reducing resultant pain associated with piercing of the skin of the patient when performing subcutaneous insertion of the cannula.

35. The therapeutic system according to claim 28, further comprising an insertion device configured to automatically subcutaneously insert the cannula.

36. The therapeutic system according to claim 35, wherein the insertion device is further configured to automatically retract a penetrating member subsequent to subcutaneous insertion of the cannula.

33. A therapeutic subcutaneous access apparatus for intermittently receiving a portable therapeutic device and adapted for at least one of delivering a therapeutic fluid into the body of a patient and sensing a bodily analyte, the therapeutic subcutaneous access apparatus comprising:

a housing configured to be securable to the skin of a patient, the housing including a well defining a passageway provided within the housing;

a skin-securable cradle having a support surface for securing to the skin of the patient and a recess defined in the support surface for receiving and surrounding the housing to enable connection of the portable therapeutic device to the therapeutic subcutaneous access apparatus; and

a cannula insertable through the well so that at least a portion of the cannula is subcutaneously placed in the body of the patient, wherein;

the cannula is configured for insertion through the well subsequent to securing of the housing to the skin of the patient,

the cannula is configured for rigid connection to the well in a substantially locking configuration upon insertion of the cannula through the well,

the well is configured to tilt relative to a surface of the housing that contacts the skin of the patient when the housing is secured to the skin of the patient, for enabling insertion of the cannula at an angle; and

the well includes a tilting mechanism to control the angle of tilt of the well, the tilting mechanism comprising one or more rods, at least one of the one or more rods having a first end attached to the well and a second end attached to a gear rotatable within a corresponding groove defined in a base of the housing, wherein the groove includes a first section in which the gear can be rotated, a second section into which the gear is placed to lock the gear and well into place, and the second section is narrower than the first section.