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

• US 9,662,440 B2
• Filed: 12/20/2007
• Issued: 05/30/2017
• Est. Priority Date: 12/22/2006
• 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, Iddan, Gavriel J.
• Primary Examiner(s): Schmidt, Emily
• Assistant Examiner(s): FARRAR, LAUREN PENG
• Application Number:
  US12/004,837
• Publication Number:
  US 20080215035A1
• Time in Patent Office: 3,449 Days
• Field of Search: 604513, 60428801, 604151, 604180, 604272
• 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 system for delivering a therapeutic fluid to a body of a patient, the system comprising:

a skin-adherable unit comprising;

a cradle configured on a first side for adhesion to the skin of the patient,

wherein the first side has a periphery,

a cannula, and

a self-sealable septum disposed within a proximal portion of a well portion,

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

a dispensing unit removably attachable to a second side of the skin-adherable unit that is opposite to the first side, the dispensing unit being sized to fully cover over the well portion and the self-sealable septum and 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 dispensing unit in fluid communication with the skin-adherable unit,

wherein the reservoir, at least a portion of the pump and at least a portion of the connecting lumen are contained within a single housing,

wherein the dispensing unit is provided with an end for engagement with a corresponding end of the cradle via a protrusion along a rear end of the dispensing unit, the corresponding end of the cradle having a corresponding recess, the engagement enabling pivotal movement of the dispensing unit with respect to the cradle such that the pivotal movement results in connection of the dispensing unit to the cradle when a front end of the dispensing unit is pivoted toward the cradle and a notch along the front end of the dispensing unit snappingly engages a latch in the cradle, and the dispensing unit is detachably securable to the cradle upon the connection, wherein the latch is elastically deformable and is configured to detach from the notch in an outward direction upon application of an outward pulling-force that pulls the latch outward of the periphery of the first side of the cradle; and

a removable cover for covering the skin-adherable unit;

wherein the cover substantially seals the skin-adherable unit from the external environment when the skin-adherable unit is adhered to the skin of the patient and while the dispensing unit is not connected to the skin-adherable unit, the cover configured to be substantially vertically placeable onto the skin and around the skin-adherable unit to avoid contamination and abrasion of elements protruding from the skin.

2. The system of claim 1, wherein fluid communication between the reservoir and the connecting lumen is established without the use of tubing external to the single housing.

3. The system of claim 1, further comprising a trap-like mechanism having swing arms for removably attaching the dispensing unit to the skin-adherable unit.

4. The system of claim 1, further comprising hooks and loops for removably attaching the dispensing unit to the skin-adherable unit.

5. The system of claim 1, wherein the cannula and the self-sealable septum are configured to be housed, at least in part, within a well.

6. The system of claim 5, wherein the cradle is integral with at least one of the cannula and the well.

7. The system of claim 5, wherein the cradle and the well are configured for matable attachment.

8. The system of claim 5, wherein the well comprises a protrusion having a pass-through bore, wherein the bore is configured for alignment with an opening in the cradle, and wherein the well is configured for receiving an exit port of the dispensing unit.

9. The system of claim 5, wherein at least one of the well and the cannula is directed at an oblique angle relative to at least one of a cradle surface and a skin of the patient.

10. The system of claim 1, wherein the cradle comprises a substantially planar surface, and wherein the planar surface comprises a polymer having an adhesive disposed thereon.

11. The system of claim 1, wherein the dispensing unit comprises one or more buttons or switches for accepting commands from a user for operating the dispensing unit.

12. The system of claim 1, further comprising a penetrating member configured for placement through the cannula, the penetrating member adapted for piercing a skin of the patient to enable the subcutaneous placement of the distal end of the cannula, wherein the penetrating member is removable from the cannula subsequent to the subcutaneous placement.

13. The system of claim 1, wherein the skin-adherable unit is configured for attachment to a cannula insertion device.

14. The system of claim 1, wherein the dispensing unit comprises:

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

a reusable part comprising at least a portion of the pump.

15. The system of claim 1, further comprising means for detaching the dispensing unit from the skin-adherable unit.

16. The system of claim 1, wherein the entire reservoir is contained within the single housing along with the at least a portion of the pump and the at least a portion of the connecting lumen.

17. The system of claim 1, wherein the dispensing unit further comprises a fluid delivery tube to communicate therapeutic fluid from the reservoir to the connecting lumen.

18. The system of claim 17, wherein the entire fluid delivery tube is contained within the single housing along with the reservoir, the at least a portion of the pump and the at least a portion of the connecting lumen.

19. A therapeutic fluid infusion system for delivering a therapeutic fluid to a body of a patient, the system comprising:

a skin-adherable unit comprising;

a cradle configured on a first side for adhesion to the skin of a patient,

a cannula, and

a self-sealable septum disposed within a proximal portion of a well portion,

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

a dispensing unit removably attachable to a second side of the skin-adherable unit that is opposite to the first side, the dispensing unit being sized to fully cover over the well portion and the self-sealable septum and comprising;

a single housing or a plurality of integrally connectable housings, a pump,

a reservoir for containing a therapeutic fluid to be dispensed by the dispensing unit into the body of the patient, and

a connecting lumen configured to penetrate the self-sealable septum in order to bring the dispensing unit in fluid communication with the skin-adherable unit,

wherein the pump, the reservoir and at least a portion of the connecting lumen are contained within the single housing or within the plurality of integrally connectable housings

wherein the dispensing unit is provided with an end for engagement with a corresponding end of the cradle via a protrusion along a rear end of the dispensing unit, the corresponding end of the cradle having a corresponding recess, the engagement enabling pivotal movement of the dispensing unit with respect to the cradle such that the pivotal movement results in connection of the dispensing unit to the cradle when a front end of the dispensing unit is pivoted toward the cradle and a notch along the front end of the dispensing unit snappingly engages a latch in the cradle, and the dispensing unit is detachably securable to the cradle upon the connection; and

a removable cover for covering the skin-adherable unit, wherein the cover substantially seals the skin-adherable unit from the external environment while the dispensing unit is not connected to the skin-adherable unit, the cover configured to be substantially vertically placeable onto the skin and around the skin-adherable unit to avoid contamination and abrasion of elements protruding from the skin.

20. The system of claim 19, wherein:

the dispensing unit comprises;

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

a reusable part comprising at least a portion of the pump; and

the plurality of integrally connectable housings comprises a disposable part housing and a reusable part housing.

21. The system of claim 20, wherein each of the disposable part housing and the reusable part housing comprises at least one connecting area for removable connection to corresponding connecting areas on the skin-adherable unit.

22. The system of claim 21, wherein the at least one connecting area of the disposable part housing and the at least one connecting area of the reusable part housing include a recess or opening for receiving protruding members provided in the corresponding connecting areas of the skin-adherable unit.