Infusion set and/or patch pump having at least one of an in-dwelling rigid catheter with flexible features and/or a flexible catheter attachment

• US 9,782,536 B2
• Filed: 01/11/2010
• Issued: 10/10/2017
• Est. Priority Date: 01/12/2009
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Skutnik, Peter, Horvath, Joshua, Banik, Robert, Searle, Gary, Bene, Eric
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US13/138,128
• Publication Number:
  US 20110313357A1
• Time in Patent Office: 2,829 Days
• Field of Search: 604151, 604174, 604265
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 39/1055 Rotating or swivel joints in general F16L27/00
• CPC Class Codes: A61M 39/12 for joining a flexible tube to a rigid attachment
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• 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 5/46 having means for controlling depth of insertion

Abstract

An infusion set, patch pump, or elements thereof, having an exemplary catheter (14) provided with one or more channels, grooves and coatings (24, 34, 44), configured and arranged to provide a degree of strength and flexibility. The catheter (14) can also have an exemplary flexible union with the hub (12) having at least one of a ball-and-socket joint (66, 68), a sliding plate (86), and a flexible bushing (106), and which is sealed to allow even further movement of the catheter (14) while preventing leakage of medication through the junction. In doing so, a number of benefits associated with the use of rigid materials in catheter construction can be provided while at the same time, benefits associated with the use of flexible materials in catheter construction and/or flexible engagement with the hub can also be provided.

Claims

1. An infusion device, comprising:

a catheter body extending between distal and proximal ends, comprising an axis extending between said distal and proximal ends, and one or more axial openings parallel to said axis, and one or more radial openings perpendicular to said axis, passing through at least a portion of said catheter body,

wherein said catheter body comprises a flexible element for flexibly coupling an indwelling portion of the catheter body to a hub of an infusion set or patch pump device, the hub comprising a skin attachment surface comprising an adhesive for attaching the skin attachment surface to a skin surface; and

wherein said catheter body comprises;

a first catheter body portion comprising a first flow path configured to target a first tissue space; and

a second catheter body portion comprising a second flow path configured to target a second tissue space.

2. The infusion device as claimed in claim 1, wherein said catheter body comprises a plurality of separated radial openings passing through at least a portion of said catheter body to target the first tissue space, and the second tissue space, respectively.

3. The infusion device as claimed in claim 1, wherein said infusion device further comprises:

a flexible catheter body portion, comprising a catheter body wall wherein one or more lengths of said wall are provided with one or more channels, grooves, or separations, extending between said one or more axial openings and an outer surface of said catheter body.

4. The infusion device as claimed in claim 3, wherein said catheter body further comprises a coiled spring, and said separations comprise contacting adjacent coils created by said coiled spring of said catheter body.

5. The infusion device as claimed in claim 3, wherein:

said catheter body is substantially closed at said distal end; and

at least one of said channels, grooves, or separations are configured to provide fluid communication between said one or more axial openings and said outer surface of said catheter body.

6. The infusion device as claimed in claim 1, wherein said catheter body further comprises an outer sheath disposed upon at least a portion of said catheter body.

7. The infusion device as claimed in claim 6, wherein said outer sheath comprises at least one of a Teflon®

outer coating layer disposed over a portion of said catheter body, and a Vialon®

outer coating layer disposed over a portion of said catheter body.

8. The infusion device as claimed in claim 1, wherein the catheter body comprises a beveled surface configured to pierce an insertion site during insertion.

9. The infusion device as claimed in claim 1, wherein said catheter further comprises a heparin coating, or one of a family of anti-coagulants, disposed upon at least a portion of said catheter body.

10. The infusion device as claimed in claim 1, wherein said element of said catheter body for flexibly coupling said portion of said catheter body to said hub comprises:

a flexible union element at said proximal end of said catheter body, configured to flexibly couple said proximal end of said catheter body with said hub.

11. The infusion device as claimed in claim 10, wherein said flexible union element comprises at least one of a:

a ball element, wherein said ball element is configured to be rotatably captured within said hub to provide said flexible union;

a sliding plate, wherein said sliding plate is configured to be slidably captured within said hub to provide said flexible union;

a flexible bushing, wherein said flexible bushing is configured to be captured within said hub to provide said flexible union; and

a bellows joint, wherein said bellows joint is configured to be secured to said hub to provide said flexible union.

12. The infusion device as claimed in claim 10, wherein said flexible union element at said proximal end of said catheter body further comprises at least one sealing element disposed between said catheter body and said hub.

13. The infusion device as claimed in claim 1, further comprising:

a hub body comprising an opening for flexibly coupling a portion of the catheter body.

14. The infusion device as claimed in claim 13, wherein said opening for flexibly coupling said hub to said catheter body comprises at least one of a:

a ball detent opening configured to rotatably secure a ball element of said catheter to provide said flexible union;

a chamber opening configured to slidably secure a sliding plate of said catheter to provide said flexible union;

a chamber opening configured to secure a flexible bushing of said catheter to provide said flexible union; and

a bellows joint configured to secure said catheter to provide said flexible union.

15. The infusion device as claimed in claim 1, further comprising:

an infusion pump in fluid communication with the catheter body; and

a valve to direct a bolus infusion from said infusion pump to a first tissue space and a basal infusion from said infusion pump to a second tissue space.

16. The infusion device as claimed in claim 1, further comprising:

an infusion pump, comprising a first reservoir configured to supply a first substance to a first tissue space through said catheter body, and a second reservoir configured to supply a second substance to a second tissue space through said catheter body.

17. The infusion device as claimed in claim 1, further comprising:

an infusion pump in fluid communication with the catheter body, comprising at least one reservoir configured to supply bolus delivery to a first tissue space, and at least one reservoir configured to supply basal delivery to a second tissue space, and a device for delivering the second substance to the second tissue space.

18. The device as claimed in claim 1, further comprising:

an infusion pump in fluid communication with the catheter body, comprising a single reservoir to supply bolus infusion to a first tissue space, and a basal infusion to a second tissue space, and a device for delivering the second substance to the second tissue space.

19. A dual-lumen infusion device, comprising:

a hub;

a dual-lumen catheter, comprising an axis extending between distal and proximal ends of said catheter, and comprising a plurality of axially separated openings in said catheter to target a first tissue depth, and a second tissue depth, respectively; and

a valve, configured to direct a bolus infusion to a first opening of said dual-lumen catheter to target said first tissue depth, and direct a basal infusion to a second opening of said dual-lumen catheter to target said second tissue depth.

20. The dual-lumen infusion device as claimed in claim 19, wherein said dual-lumen catheter comprises a first catheter body configured to target a first tissue depth, and a second catheter body configured to target a second tissue depth.

21. The dual-lumen infusion device as claimed in claim 19, further comprising an infusion pump, comprising at least one reservoir configured to supply fast-acting insulin to said first tissue depth, and at least one reservoir configured to supply slow-acting insulin to said second tissue depth.

22. The dual-lumen infusion device as claimed in claim 19, further comprising an infusion pump, comprising at least one reservoir configured to supply bolus delivery to said first tissue depth, and at least one reservoir configured to supply basal delivery to said second tissue depth.

23. The dual-lumen infusion device as claimed in claim 19, further comprising an infusion pump, comprising a single reservoir to supply bolus infusion to said first tissue depth, and a basal infusion to said second tissue depth.