Access device with valve

• US 8,827,958 B2
• Filed: 05/12/2010
• Issued: 09/09/2014
• Est. Priority Date: 05/12/2009
• Status: Active Grant

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Access Scientific, LLC (Smiths Group International Holdings Ltd.)
• Inventors: Bierman, Steven F., Pluth, Richard A.
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US13/319,998
• Publication Number:
  US 20120065590A1
• Time in Patent Office: 1,581 Days
• Field of Search: 604/160, 604/161, 604/164.05, 604/167.01, 604/167.02, 604/167.03, 604/167.04, 604/167.06, 604/256
• US Class Current: 604/164.05
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/0666 Flap-valve
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A sheath can include a sheath body and a sheath hub. The sheath body can have a generally flexible tubular structure, a proximal end, and a distal end. The sheath body can further define a longitudinal axis. The sheath hub can attach to the proximal end of the sheath body and define a longitudinal axis generally aligned with the axis of the sheath body. The sheath body and sheath hub can also form a central cavity along their respective axes. The sheath hub can include two plates: a flexible plate and a rigid plate. The rigid plate can have a relief generally centered on the sheath body'"'"'s axis. Advantageously, the flexible plate and rigid plate can overlap to substantially seal the central cavity.

Claims

1. A splittable sheath comprising:

a splittable sheath body comprising a generally flexible tubular structure, a proximal end, and a distal end, the sheath body defining a longitudinal axis and being splittable into two halves along a pre-determined line generally parallel to the longitudinal axis; and

a sheath hub extending from the proximal end of the sheath body defining a longitudinal axis generally aligned with the axis of the sheath body, the sheath body and sheath hub forming a central cavity along their respective axes, the sheath hub additionally comprising;

a flexible body; and

a rigid body, the rigid body comprising a relief generally centered on the longitudinal axis,

wherein the flexible body and rigid body can overlap to substantially seal the central cavity, and allow a medical article to pass through the cavity without holes or slits in the flexible body.

2. The sheath of claim 1, wherein the flexible body is solid.

3. The sheath of claim 1, wherein the flexible body is substantially circular.

4. The sheath of claim 1, wherein the rigid body defines a circular arc along an outer edge of the rigid body.

5. The sheath of claim 1, wherein the rigid body defines a circular arc along an inner edge of the rigid body.

6. The sheath of claim 1, wherein the flexible body has a weakened portion defining a fold line.

7. The sheath of claim 6, wherein the fold line extends from an edge of a splittable half of the sheath.

8. The sheath of claim 1, wherein at least one or both of the flexible and rigid bodies is separately inserted into the sheath hub.

9. The sheath of claim 1, wherein the flexible body comprises a material that does not cold set.

10. The sheath of claim 1, wherein at least one or both of the bodies are press-fit into the sheath hub.

11. The sheath of claim 1, wherein at least one or both of the bodies comprise anchors.

12. An access device comprising:

a needle;

a dilator coaxially mounted on the needle, the dilator comprising a dilator shaft and a dilator hub;

a splittable sheath coaxially mounted on the dilator, the sheath comprising;

a sheath body comprising a proximal end, and a distal end; and

a sheath hub extending from the proximal end of the sheath body at a distal end of the sheath hub, and reversibly attached to the dilator hub at a proximal end of the sheath hub, the sheath body and sheath hub forming a central cavity, the sheath hub comprising a flexible body and a rigid body, wherein the flexible body and rigid body allow the needle and dilator to pass through the cavity without holes or slits in the flexible body, and wherein the flexible body and rigid body can overlap to substantially seal the central cavity when the needle and dilator are removed from the cavity.

13. The access device of claim 12, wherein the flexible body is substantially solid.

14. The access device of claim 12, wherein the flexible body is substantially circular.

15. The access device of claim 12, wherein the rigid body defines a circular arc along an outer edge of the rigid body.

16. The access device of claim 12, wherein the rigid body defines a circular arc along an inner edge of the rigid body.

17. The access device of claim 12, wherein the flexible body has a weakened portion defining a fold line.

18. The access device of claim 17, wherein the fold line extends from an edge of a splittable half of the sheath.

19. The access device of claim 12, wherein at least one or both of the flexible and rigid bodies is separately inserted into the sheath hub.

20. The access device of claim 12, wherein the flexible body comprises a material that does not cold set.

21. The access device of claim 12, wherein at least one or both of the bodies are press-fit into the sheath hub.

22. The access device of claim 12, wherein at least one or both of the bodies comprise anchors.

23. A packaging comprising:

a needle;

a dilator;

a splittable sheath comprising;

a sheath body comprising a proximal end, and a distal end; and

a sheath hub extending from the proximal end of the sheath body at a distal end of the sheath hub, the sheath hub comprising a substantially solid flexible body, a rigid body, and an attachment portion at a proximal end configured to attach to the attachment portion on the dilator hub,

wherein the sheath body and sheath hub form a central cavity that receives the dilator and needle without passing through holes or slits in the flexible body, and the flexible body and rigid body can overlap to substantially seal the central cavity when the dilator and needle are removed; and

wherein the needle, dilator, and sheath are prepackaged together.

24. The packaging of claim 23, wherein the sheath is slideably disposed on the dilator.

25. The packaging of either of claim 23, wherein the dilator is slideably disposed on the needle.

26. The packaging of claim 23, wherein the sheath hub further comprises two outwardly projecting side tabs.

27. The packaging of claim 23, wherein the flexible body is solid.

28. The packaging of claim 23, wherein the flexible body is substantially circular.

29. The packaging of claim 23, wherein the rigid body defines a circular arc along an outer edge of the rigid body.

30. The packaging of claim 23, wherein the rigid body defines a circular arc along an inner edge of the rigid body.

31. The packaging of claim 23, wherein the flexible body has a weakened portion defining a fold line.

32. The packaging of claim 31, wherein the fold line extends from an edge of a splittable half of the sheath.

33. The packaging of claim 23, wherein at least one or both of the flexible and rigid bodies is separately inserted into the sheath hub.

34. The packaging of claim 23, wherein the flexible body comprises a material that does not cold set.

35. The packaging of claim 23, wherein at least one or both of the bodies are press-fit into the sheath hub.

36. The packaging of claim 23, wherein at least one or both of the bodies comprise anchors.