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 20110313357A1
• Filed: 01/11/2010
• Published: 12/22/2011
• 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
• Granted Patent: US 9,782,536 B2
• Time in Patent Office: Days
• US Class Current: 604/151
• 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, and an axial opening passing through at least a portion of said catheter body,

wherein said catheter body comprises an element for movably coupling a portion of the catheter body to a hub of an infusion set or patch pump device.

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

3. A infusion device as claimed in claim 1, wherein said element of said catheter body for movably coupling said portion of said catheter body to said hub 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 axial opening and an outer surface of said catheter body.

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

6. A infusion device as claimed in claim 5, 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.

7. A 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 axial opening and said outer surface of said catheter body.

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

9. A 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. A infusion device as claimed in claim 1, wherein said element of said catheter body for movably 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. A 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. A 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. An infusion device as claimed in claim 1, further comprising:

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

14. An infusion device as claimed in claim 1, further comprising:

a first catheter body configured to target a first tissue space; and

a second catheter body configured to target a second tissue space.

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

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

16. A infusion device as claimed in claim 13, wherein said opening for movably 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.

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

an infusion pump, comprising at least one reservoir configured to supply a first substance to a first tissue space, and at least one reservoir configured to supply a second substance to a second tissue space.

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

an infusion pump, 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.

19. An infusion device as claimed in claim 1, further comprising:

an infusion pump, comprising a single reservoir to supply bolus infusion to a first tissue space, and a basal infusion to a second tissue space.

20. An in-dwelling catheter, comprising:

a rigid body portion; and

at least one a flexible body portion, comprising a body wall wherein one or more lengths of said wall are provided with one or more channels, grooves, or separations.

21. An in-dwelling catheter as claimed in claim 20, wherein at least a portion of said in-dwelling catheter is comprised of stainless steel, nitinol, titanium, a rigid plastic, polycarbonate, COC, or similar material.

22. A method of making an in-dwelling catheter, comprising the steps of:

heating a polymer to a desired temperature;

injection molding an in-dwelling catheter using said heated polymer to form a rigid body portion, at least one a flexible body portion comprising a body wall wherein one or more lengths of said wall are provided with one or more channels, grooves, or separations, and a sharpened portion at one end thereof; and

applying an outer sleeve to at least a portion of said in-dwelling catheter.

23. A method of making an in-dwelling catheter as claimed in claim 22, further comprising the step of injection molding the in-dwelling catheter to form a catheter body comprising a plurality of separated axial openings passing through at least a portion of said catheter body.

24. A method of making an in-dwelling catheter as claimed in claim 22, further comprising the step of overmolding at least a portion of said in-dwelling catheter with said outer sleeve.

25. A method of making an in-dwelling catheter as claimed in claim 22, further comprising the steps of:

extruding said outer sleeve; and

assembling said extruded outer sleeve with at least a portion of said in-dwelling catheter.

26. An infusion device, comprising:

an inner catheter hub comprising a skin contacting adhesive layer, at least one catheter sleeve, and an in-dwelling catheter;

an outer hub substantially covering said inner catheter hub and comprising a skin contacting adhesive layer; and

a shock isolating means flexibly extending between said inner catheter hub and said outer hub, wherein said shock isolating member is configured to flexibly secure said inner catheter hub within said outer hub and substantially prevent communication of movement from said outer hub to said inner catheter hub once secured by said skin contacting adhesive layer.

27. An infusion device as claimed in claim 26, further comprising:

a retraction means to retract said in-dwelling catheter relative to said catheter sleeve such that a sharp tip of said in-dwelling catheter is retracted past an end of said catheter sleeve.

28. An infusion device as claimed in claim 26, further comprising:

an inner hub supported by a snap-action mechanism configured to allow a single placement motion to introduce the catheter and introducer needle into the tissue, place the catheter at the correct depth, and retract the introducer needle.

29. An infusion device as claimed in claim 26, further comprising:

an inner hub which extends beyond the flat surface of the outer hub and a retraction system for the inner hub, such that pressing the external surface of the outer hub to the skin will introduce the catheter and cannula into the tissue and retract the introducer needle such that the sharp tip is repositioned above the end of the blunt cannula.

30. An infusion device, comprising:

an inner catheter hub comprising a skin contacting adhesive layer, at least one retractable catheter, and a blunt cannula;

an outer hub substantially covering said inner catheter hub and comprising a skin contacting adhesive layer; and

a shock isolating means flexibly extending between said inner catheter hub and said outer hub, wherein said shock isolating member is configured to flexibly secure said inner catheter hub within said outer hub and substantially prevent communication of movement from said outer hub to said inner catheter hub once secured by said skin contacting adhesive layer.

31. An infusion device as claimed in claim 30, further comprising:

a retraction means to retract said retractable catheter relative to said blunt cannula such that a sharp tip of said retractable catheter is retracted past an end of said blunt cannula.

32. An infusion device as claimed in claim 30, further comprising:

an inner hub supported by a snap-action mechanism configured to allow a single placement motion to introduce the retractable catheter and blunt cannula into the tissue and place the retractable catheter at the correct depth; and

a lever configured to retract the retractable catheter.

33. An infusion device as claimed in claim 30, further comprising:

an inner hub which extends beyond the flat surface of the outer hub and a retraction system for the inner hub, such that pressing the external surface of the outer hub to the skin will introduce the retractable catheter and blunt cannula into the tissue; and

a lever configured to retract the retractable catheter such that the sharp tip is repositioned above the end of the blunt cannula.

34. A method of making an in-dwelling catheter, comprising the steps of:

forming, casting, extruding, injection molding, or machining a solid rod to create a multi-lumen catheter comprising a plurality of separated axial grooves passing over at least a portion of said catheter body; and

applying an outer sleeve to at least a portion of said catheter body.

35. A method of making an in-dwelling catheter as claimed in claim 34, further comprising the step of overmolding at least a portion of said catheter body with said outer sleeve.

36. A method of making an in-dwelling catheter as claimed in claim 34, further comprising the steps of:

extruding said outer sleeve; and

assembling said extruded outer sleeve with at least a portion of said catheter body.

37. A method of making an in-dwelling catheter as claimed in claim 34, further comprising the step of forming a plurality of grooves on an outer surface of said multi-lumen catheter to produce said lumens between an outer surface of said multi-lumen catheter and an inner surface of said outer sleeve.

38. A dual-lumen infusion device, comprising:

a hub;

a dual-lumen catheter, comprising a plurality of separated axial openings passing through at least a portion of said catheter to target a first tissue space, and a second tissue space, respectively; and

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

39. A dual-lumen catheter as claimed in claim 38, wherein said dual-lumen catheter comprises a first catheter body configured to target a first tissue space, and a second catheter body configured to target a second tissue space.

40. An infusion device as claimed in claim 38, further comprising an infusion pump, comprising at least one reservoir configured to supply fast-acting insulin to said first tissue space, and at least one reservoir configured to supply slow-acting insulin to said second tissue space.

41. An infusion device as claimed in claim 38, further comprising an infusion pump, comprising at least one reservoir configured to supply bolus delivery to said first tissue space, and at least one reservoir configured to supply basal delivery to said second tissue space.

42. An infusion device as claimed in claim 38, further comprising an infusion pump, comprising a single reservoir to supply bolus infusion to said first tissue space, and a basal infusion to said second tissue space.