Systems, devices and methods for sustained delivery of a therapeutic fluid

• US 20080215035A1
• Filed: 12/20/2007
• Published: 09/04/2008
• Est. Priority Date: 12/22/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Iddan, Gavriel J., Yodfat, Ofer, Neta, Avraham
• Granted Patent: US 9,662,440 B2
• Time in Patent Office: Days
• US Class Current: 604/513
• 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 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/1424 Manually operated pumps
• 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 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

Embodiments of the present invention are directed to devices, systems and methods for delivering therapeutic fluid (e.g., insulin) into the body, including a skin adherable cradle, for retaining a therapeutic fluid dispenser for delivering a therapeutic fluid to a user.

Claims

1. A therapeutic fluid infusion device cradle adherable to the skin of a user for retaining a therapeutic fluid dispenser for delivering a therapeutic fluid to a user, the cradle comprising:

a structure having a first surface configured for adhering to the skin of a user and having at least a portion of a second surface which substantially corresponds to at least a portion of a therapeutic fluid infusion device;

at least one connecting area for connection with a corresponding connecting area of the infusion device, wherein connection between the two connecting areas enables the cradle and infusion device to be removably affixed to one another;

an opening for receiving a fluid dispensing outlet of the infusion device and for receiving a cannula through which therapeutic fluid is delivered to the user; and

an adhesive provided on at least a portion of the first surface of the cradle for adhering the cradle to the user.

2. The device of claim 1, wherein connection between the respective connecting areas allows for repeated connection and disconnection of the cradle and infusion device.

3. The device of claim 1, wherein the at least one connecting area of the cradle includes a protruding member to be received by a corresponding recess or opening provided in the corresponding connecting area in the infusion device.

4. The device of claim 1, wherein the at least one connecting area of the cradle includes a recess or opening for receiving a protruding member provided in the corresponding connecting area in the in the infusion device.

5. The device of claim 1, wherein the at least one connecting area of the cradle includes a magnet for magnetic connection with either a magnetic material or another magnet provided in the corresponding connecting area in the in the infusion device.

6. The device of claim 1, further comprising a cannula and a self-sealable septum, wherein a distal portion of the cannula is configured for subcutaneous placement within the body of the user and wherein the self sealable septum separates a proximal portion of the cannula from an external environment.

7. The device of claim 1, further comprising crumpling prevention means of the cradle during insertion of a penetrating assembly through the opening.

8. The device of claim 1, further comprising a self-sealable septum.

9. The device of claim 1, wherein the opening further comprises a well.

10. The device of claim 9, wherein the well comprises an upper end having a well inlet port, a lower end having an outlet port through which a cannula is attached to the cradle

11. The device of claim 10, wherein the inlet port is sealable with a self-sealable septum.

12. The device of claim 9, wherein the well is provided at an angle relative to the first surface.

13. The device according to claim 1, further comprising a removable cover for covering at least a portion of the cradle having the opening, wherein the cover substantially seals the at least a portion of the cradle from the external environment while the medical infusion device is not connected to the cradle.

14. A therapeutic fluid infusion system for delivering a therapeutic fluid to a human body, the system comprising:

a first assembly comprising;

a cradle configured for adhesion to a cutaneous region of the human body,

a cannula, and

a self sealable septum, wherein a distal portion of the cannula is configured for subcutaneous placement within the human body and wherein the self sealable septum separates a proximal portion of the cannula from an external environment; and

a second assembly configured for removable attachment to the first assembly, the second assembly comprising;

a pump,

a reservoir for containing a therapeutic fluid, and

a connecting lumen configured to penetrate the self sealable septum in order to bring the second assembly in fluid communication with the first assembly.

15. The system of claim 14, wherein the material for the self sealable septum is selected from the group consisting of:

silicon rubber, chlorobutyl rubber and combinations thereof.

16. The system of claim 14, further comprising at least one magnet for removably attaching the second assembly to the first assembly.

17. The system of claim 14, further comprising a trap-like mechanism for removably attaching the second assembly to the first assembly.

18. The system of claim 14, further comprising hooks and loops for removably attaching the second assembly to the first assembly.

19. The system of claim 14, further comprising an adhesive and/or a hook and loop fastening system for removably attaching the second assembly to the first assembly.

20. The system of claim 14, wherein the cannula and the self sealable septum are housed at least in part within a well.

21. The system of claim 14, wherein the cradle is integral with at least one of the cannula and/or the well.

22. The system of claim 14, wherein the cradle and the well are configured for matable attachment by at least one latch.

23. The system of claim 14, wherein the cradle comprises a substantially planar surface, and wherein the planar surface comprises a polymer having an adhesive disposed thereon.

24. The system of claim 14, wherein the pump is selected from the group consisting of:

a peristaltic pump and a syringe pump.

25. The system of claim 14, wherein the second assembly is configured to communicate wirelessly with a remote control unit.

26. The system of claim 14, wherein the second assembly comprises one or more inputs for accepting commands from a user.

27. The system of claim 14, wherein the first assembly further comprises a penetrating member configured for placement through the cannula during adhesion of the first assembly to the cutaneous region and the subcutaneous placement of the cannula, and for removal from the cannula subsequent to the subcutaneous placement and adhesion.

28. The system of claim 14, wherein the first assembly is configured for attachment to an inserter device for use in attaching the first assembly to the human body.

29. The system of claim 14, wherein the second assembly comprises:

a disposable part comprising the reservoir and the connecting lumen; and

a reusable part comprising the pump.

30. The system of claim 14, further comprising a connecting area on the first assembly for removable connection to a corresponding connecting area on the second assembly, for removably attaching the second assembly to the first assembly.

31. The system of claim 14, wherein the first and second assemblies are connectable by at least one of:

sliding relative movement between the assemblies and pivoting relative movement between the assemblies.

32. The system of claim 14, wherein upon connection of the first and second assemblies, the lumen from the second assembly pierces the septum of the first assembly.

33. The system according to claim 32, wherein the piercing of the septum by the lumen occurs vertically, horizontally, or at an angle.

34. The system of claim 14, further comprising crumpling prevention means of the cradle during insertion of a penetrating assembly through the opening.

35. The system of claim 14, further comprising a removable cover for the first assembly for covering at least a portion of the cradle having the self-sealable septum, wherein the cover substantially seals the at least a portion of the cradle from the external environment while the medical infusion device is not connected to the cradle.

36. A method for delivering a therapeutic fluid to a human body, the method comprising:

securing a first assembly to a cutaneous region of the human body, said first assembly is provided with an opening;

penetrating the cutaneous region through the opening and bringing the first assembly in fluid communication with the human body;

removably attaching a second assembly to the first assembly in order to bring the second assembly in fluid communication with the human body;

37. The method according to claim 36, wherein the step of penetrating is performed using an inserter device.

38. The method for delivering a therapeutic fluid to a human body according to claim 36, the method further comprising:

detaching the second assembly from the first assembly; and

substantially simultaneously with the detaching, sealing the first assembly to prevent fluid communication between the human body and an external environment.

39. The method of claim 38, wherein the securing a first assembly to a cutaneous region of the human body comprises adhering the first assembly to the cutaneous region of the human body.

40. Apparatus for delivering a therapeutic fluid to a human body, the apparatus comprising:

means for securing a first assembly to a cutaneous region of the human body;

means for penetrating the cutaneous region in order to bring the first assembly in fluid communication with the human body;

means for removably attaching a second assembly comprising the therapeutic fluid infusion device to the first assembly in order to bring the second assembly in fluid communication with the first assembly;

means for detaching the second assembly from the first assembly; and

means for sealing the first assembly, substantially simultaneously with the detaching, to prevent fluid communication between the human body and an outside environment.

41. An inserter device for at least partially automating the placement of a penetrating assembly at least in part in a subcutaneous region of the human body, the inserter device comprising:

a housing comprising at least one activation trigger

an actuator; and

a spring-loaded plunger coupled to the activation trigger via the actuator, wherein the plunger is configured for attachment to a penetrating assembly prior to a user pressing the activation trigger and for detachment from at least a portion of the penetrating assembly subsequent to the placement.

42. The inserter device of claim 41, wherein the a footprint of the housing matches a footprint of the penetrating assembly.

43. The inserter device according to claim 41, further comprising a cradle having an opening for receiving the penetrating assembly.

44. The inserter device according to claim 41, wherein the penetrating assembly comprises at least a cannula and penetrating member.

45. The inserter device according to claim 44, wherein the penetrating member comprises a needle.

46. The inserter device according to claim 44, wherein the penetrating assembly further comprises a grip portion.

47. The inserter device according to claim 41, further comprising a plurality of legs for being receiving by corresponding recesses/openings in a medical infusion device and/or a medical infusion device cradle, wherein the legs of the inserter device insure substantially perpendicular positioning of the inserter device relative to the infusion device and/or cradle.

48. An inserter device for at least partially automating the placement of a penetrating assembly at least in part in a subcutaneous region of the human body, the inserter device comprising:

a housing comprising at least one activation means;

actuator means; and

projection means coupled to the activation means via the actuator means, wherein the projection means is configured for attachment to a penetrating assembly prior to a user activating the activation means for detachment from at least a portion of the penetrating assembly subsequent to the placement.

49. A medical infusion penetrating assembly comprising:

a needle;

a cannula;

a grip portion; and

at least one strip of material for preventing crumpling of a surface of a medical infusion device cradle, wherein

a portion of the at least one strip is provided adjacent to the grip portion;

a portion of the at least one strip is slightly adhered to the cradle; and

the at least one strip includes a size and shape configured for positioning between adjacent slits provided around an opening in the medical infusion device cradle which receives the penetrating assembly; and

wherein the size and shape of the at least one strip is selected to ensure that the cradle remains in a horizontal position relative to a vertical position of an insertion device for driving/projecting the cannula and needle into the cutaneous tissue of a user during the activation of the insertion device.