Sealing assembly for a fluid reservoir of a fluid infusion device

• US 9,339,639 B2
• Filed: 02/17/2012
• Issued: 05/17/2016
• Est. Priority Date: 02/22/2011
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Halili, Edgardo C., Lorenzen, Eric M., Yavorsky, Matthew William
• Primary Examiner(s): Bosques, Edelmira
• Assistant Examiner(s): Meghri, Nicholas
• Application Number:
  US13/399,857
• Publication Number:
  US 20120211947A1
• Time in Patent Office: 1,551 Days
• Field of Search: 604/93.01, 604/167.03, 604/288.01, 604/288.02, 604/288.03
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1623 Details of air intake
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 2039/0081 Means for facilitating introduction of a needle in the septum, e.g. guides, special construction of septum
• CPC Class Codes: A61M 2039/1066 having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• CPC Class Codes: A61M 2039/248 Ball-valve
• CPC Class Codes: A61M 2039/266 where the valve comprises venting channels, e.g. to insure better connection, to help decreasing the fluid space upon disconnection, or to help the fluid space to remain the same during disconnection
• CPC Class Codes: A61M 2039/267 having a sealing sleeve around a tubular or solid stem portion of the connector
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2202/07 Proteins
• CPC Class Codes: A61M 39/00 Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use for respiratory devices, e.g. tracheal tubes A61M16/00; artificial heart valves A61F2/24
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/12 for joining a flexible tube to a rigid attachment
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using 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 5/1456 : with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• 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 5/162 : Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/16881 : Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: A61M 5/31 : Details

Abstract

Disclosed herein is a fluid infusion device of the type that delivers medication fluid to the body of a patient. The device includes or cooperates with a fluid reservoir, and the device has a sealing assembly to receive and form a fluid seal with the fluid reservoir. A retractable sealing element surrounding a hollow fluid delivery needle may be used to seal a port of the fluid reservoir. The port may include a pressure vent that is sealed by the retractable sealing element. In one variation, the reservoir includes a moving valve sleeve that holds a septum. The septum moves to allow the reservoir to vent, and to form a seal with the port when the needle pierces the septum. In another variation, the device includes a needleless sealing assembly. In yet other variations, the device uses a needled fluid reservoir.

Claims

1. A sealing assembly for a fluid infusion device, the sealing assembly comprising:

a durable housing that receives and mates with a removable fluid reservoir having a fluid delivery port extending from the fluid reservoir and having a funnel-shaped interior defined therein, wherein the durable housing houses the removable fluid reservoir and retains the removable fluid reservoir in a particular position and orientation;

a base plate having an adhesive layer of material to adhere the base plate to skin of a patient, and having a coupling structure to removably couple the base plate to the durable housing of the fluid infusion device;

a reservoir port receptacle integrally formed with the base plate to receive and engage the fluid delivery port of the fluid reservoir in the particular position and orientation when the durable housing is coupled to the base plate, wherein the fluid delivery port of the fluid reservoir resides within the reservoir port receptacle when the durable housing is coupled to the base plate;

a hollow fluid delivery needle coupled to the base plate and extending within the reservoir port receptacle to provide a fluid flow path from the fluid reservoir to a user of the fluid infusion device when the durable housing is coupled to the base plate; and

a sealing element coupled to the base plate and overlying at least a portion of the hollow fluid delivery needle, the sealing element comprising;

a base section;

a tip section extending from the base section, the tip section shaped to enter and seal with the funnel-shaped interior of the fluid delivery port when the durable housing is coupled to the base plate;

a retractable body section between the base section and the tip section;

a needle cavity formed in the retractable body section and continuing through the base section to define a needle opening in the base section, the needle cavity sized to receive the hollow fluid delivery needle; and

a self-sealing slit formed in the tip section to accommodate the hollow fluid delivery needle when the sealing element is in a retracted position caused by coupling of the durable housing with the base plate.

2. The sealing assembly of claim 1, wherein the sealing element further comprises a guide channel formed in the tip section and communicating with the needle cavity and the self-sealing slit, wherein the guide channel leads a tip of the hollow fluid delivery needle into the self-sealing slit during retraction of the sealing element caused by coupling of the durable housing with the base plate.

3. The sealing assembly of claim 1, wherein:

the needle cavity defines internal relief features of the retractable body section;

the internal relief features facilitate refraction of the sealing element over the hollow fluid delivery needle in response to a longitudinal force applied to the tip section by the fluid delivery port of the fluid reservoir, the longitudinal force caused by coupling of the durable housing with the base plate; and

the internal relief features cause the sealing element to extend over and cover the hollow fluid delivery needle in response to removal of the longitudinal force.

4. The sealing assembly of claim 3, wherein the internal relief features comprise an accordion structure within the needle cavity.

5. The sealing assembly of claim 3, wherein the internal relief features comprise a plurality of internal annular channels within the needle cavity.

6. The sealing assembly of claim 3, wherein the internal relief features comprise a plurality of internal annular ridges within the needle cavity.

7. The sealing assembly of claim 3, wherein the internal relief features comprise a plurality of bottleneck structures within the needle cavity.

8. The sealing assembly of claim 1, wherein:

the sealing element has a nominal state and a refracted state caused by coupling of the durable housing with the base plate;

when in the nominal state, a tip of the hollow fluid delivery needle resides within the needle cavity, and the self-sealing slit forms a fluid seal to inhibit fluid ingress into the needle cavity; and

when in the retracted state, an end section of the hollow fluid delivery needle resides in the self-sealing slit, and the tip of the hollow fluid delivery needle extends from the tip section of the sealing element.

9. The sealing assembly of claim 8, wherein:

the retractable body section expands when the sealing element is retracting; and

the retractable body section forms a fluid seal with the funnel-shaped interior of the fluid delivery port when the sealing element is in the retracted state.

10. The sealing assembly of claim 1, further comprising a circumferential compression element coupled around the tip section to impart an inward biasing force to the self-sealing slit.

11. The sealing assembly of claim 10, wherein the circumferential compression element comprises a rigid ring.

12. The sealing assembly of claim 10, wherein the circumferential compression element comprises a resilient band.

13. A sealing assembly for a fluid infusion device, the sealing assembly comprising:

a durable housing that receives and mates with a removable fluid reservoir having a fluid delivery port extending from the fluid reservoir and having a funnel-shaped interior defined therein, wherein the durable housing houses the removable fluid reservoir and retains the removable fluid reservoir in a particular position and orientation;

a base plate having an adhesive layer of material to adhere the base plate to skin of a patient, and having a coupling structure to removably couple the base plate to the durable housing of the fluid infusion device;

a reservoir port receptacle integrally formed with the base plate to receive and engage the fluid delivery port of the fluid reservoir in the particular position and orientation when the durable housing is coupled to the base plate, wherein the fluid delivery port of the fluid reservoir resides within the reservoir port receptacle when the durable housing is coupled to the base plate;

a hollow fluid delivery needle coupled to the base plate and extending within the reservoir port receptacle to provide a fluid flow path from the fluid reservoir to a user of the fluid infusion device when the durable housing is coupled to the base plate; and

a sealing element coupled to the base plate and overlying at least a portion of the hollow fluid delivery needle, the sealing element comprising;

a base section;

a tip section extending from the base section, the tip section shaped to enter and seal with the funnel-shaped interior of the fluid delivery port when the durable housing is coupled to the base plate;

a retractable body section between the base section and the tip section; and

a needle cavity formed in the retractable body section and continuing through the base section to define a needle opening in the base section, the needle cavity sized to receive the hollow fluid delivery needle, and the needle cavity defining internal relief features of the retractable body section;

wherein;

the internal relief features promote deformation of the sealing element and retraction of the sealing element over the hollow fluid delivery needle in response to a longitudinal force applied to the tip section of the sealing element by the funnel-shaped interior of the fluid delivery port, the longitudinal force caused by coupling of the durable housing with the base plate; and

the internal relief features cause the sealing element to automatically extend over the hollow fluid delivery needle into a nominal state in response to removal of the longitudinal force.

14. The sealing assembly of claim 13, wherein the sealing element encloses the hollow fluid delivery needle when the sealing element is in the nominal state.

15. The sealing assembly of claim 13, wherein the sealing element further comprises a self-sealing slit formed in the tip section to accommodate the hollow fluid delivery needle when the sealing element is in a retracted state caused by coupling of the durable housing with the base plate.

16. The sealing assembly of claim 15, wherein the sealing element further comprises a guide channel formed in the tip section and communicating with the needle cavity and the self-sealing slit, wherein the guide channel leads a tip of the hollow fluid delivery needle into the self-sealing slit during retraction of the sealing element caused by coupling of the durable housing with the base plate.

17. The sealing assembly of claim 13, wherein the internal relief features comprise an accordion structure within the needle cavity.

18. The sealing assembly of claim 13, wherein the internal relief features comprise a plurality of internal annular channels within the needle cavity.

19. The sealing assembly of claim 13, wherein the internal relief features comprise a plurality of internal annular ridges within the needle cavity.

20. The sealing assembly of claim 13, wherein the internal relief features comprise a plurality of bottleneck structures within the needle cavity.

21. The sealing assembly of claim 13, wherein:

the retractable body section comprises an exterior surface;

the exterior surface moves outward when the sealing element is retracting; and

the exterior surface forms a fluid seal with the funnel-shaped interior of the fluid delivery port when the sealing element is retracted.