Vascular access device

• US 9,566,087 B2
• Filed: 03/12/2014
• Issued: 02/14/2017
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Access Scientific, LLC
• Inventors: Bierman, Steven F., Pluth, Richard A., Nguyen, Tu
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US14/207,120
• Publication Number:
  US 20140276432A1
• Time in Patent Office: 1,070 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• 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 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0006 which can be secured against axial movement, e.g. by using a locking cuff
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 25/0693 Flashback chambers

Abstract

An access device for placing a medical article within a body space includes a needle, a dilator, and a sheath. The dilator can be coaxially and slideably disposed about the needle, and the sheath can be coaxially and slideably disposed about the dilator. The access device can further include a inner member coaxially disposed between the needle and dilator. The needle can include a fenestration in fluid communication with a space between the needle and inner member. When the needle punctures a blood vessel, the fenestration allows blood to flow into the space between the needle and inner member to provide a visual indicator to a physician or healthcare professional that the needle is in a vessel.

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 portions along a pre-determined line generally parallel to the longitudinal axis;

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

a valve element comprising;

a resilient plate comprising a sealing portion extending radially inwardly from a side of the inner cavity;

a sealing element comprising a domed first sealing surface and being supported by the resilient plate such that the sealing element is biased toward a position against a second sealing surface to substantially seal the inner cavity; and

an annular member comprising the second sealing surface, the annular member having a central bore and a tapered surface that slopes from an outer edge of the annular member to the central bore such that the annular member decreases in thickness from the outer edge to an inner edge of the annular member proximate to the central bore, the domed first sealing surface corresponding to the central bore of the annular member.

2. The splittable sheath of claim 1, wherein a lower portion of the annular member comprises the second sealing surface.

3. The splittable sheath of claim 1, wherein the sealing element comprises polyurethane.

4. The splittable sheath of claim 1, wherein the sealing element comprises polycarbonate.

5. The splittable sheath of claim 1, wherein the annular member is relatively softer than the sealing element.

6. The splittable sheath of claim 1, wherein the resilient plate being connected to only one of a two halves of the sheath hub and extending into the inner cavity.

7. The splittable sheath of claim 1, wherein the resilient plate is configured to move between a first position and a second positon, the resilient plate when in the first positon extends substantially perpendicular to a longitudinal axis of the inner cavity and blocks fluid flow through the inner cavity in at least one direction, the resilient plate when in the second position bends about an axis that is transverse to the longitudinal axis of the inner cavity.

8. 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;

a splittable sheath hub coupled with the proximal end of the sheath body, the sheath body and the hub having aligned openings forming a passage therethrough; and

a valve comprising;

an annular member disposed against a surface of the hub facing the sheath body, the annular member having and opening therethrough disposed in the passage; and

a sealing member having an engagement portion coupled with a structure of the sheath assembly disposed generally between the surface of the hub and the distal end of the sheath body, and a seal portion projecting into sealing engagement with the opening in the annular member in a sealing position and disposed away from the opening in the annular member in an open position.

9. The splittable sheath of claim 8, wherein the valve further comprises a resilient plate coupled with the sealing member, the plate extending radially inwardly from a side of an inner cavity of the sheath assembly.

10. The splittable sheath of claim 9, wherein the sealing member comprises a domed first sealing surface and being supported by the resilient plate such that the sealing member is biased toward a position against the annular member to substantially seal the inner cavity.

11. The splittable sheath of claim 10, wherein the domed first sealing surface comprises polycarbonate.

12. The splittable sheath of claim 9, wherein the sheath hub has two halves, and the resilient plate is connected to only one of the two halves of the sheath hub and extends into the inner cavity.

13. The splittable sheath of claim 9, wherein the resilient plate is configured to move between a first position and a second positon, the resilient plate when in the first positon extends substantially perpendicular to a longitudinal axis of the passage and blocks fluid flow through the passage in at least one direction, the resilient plate when in the second position bends about an axis that is transverse to the longitudinal axis of the passage.

14. The splittable sheath of claim 9, wherein the engagement portion is configured to move between a first position and a second positon, the engagement portion when in the first positon extends substantially perpendicular to a longitudinal axis of the passage and blocks fluid flow through the passage in at least one direction, the engagement portion when in the second position bends about an axis that is transverse to the longitudinal axis of the passage.

15. The splittable sheath of claim 10, wherein a lower portion of the annular member comprises a second sealing surface.

16. The splittable sheath of claim 8, wherein the annular member comprises an O-ring.

17. The splittable sheath of claim 8, wherein the annular member is tapered from a top surface thereof to decrease in thickness from an outer portion toward the opening therein.

18. The splittable sheath of claim 8, wherein the splittable sheath is splittable into two portions along a pre-determined line generally parallel to the longitudinal axis.

19. The splittable sheath of claim 8, wherein the annular member comprises an O-ring.

20. 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 lumen along a longitudinal axis;

a splittable hub coupled with the proximal end of the sheath body and having a passage therethrough; and

a soft polymeric diaphragm coupled with a distal face of the hub providing fluid communication between the lumen and the passage when open and having a proximal face configured to seal against a device disposed in the passage, diaphragm and lumen of the sheath assembly.

21. The splittable sheath of claim 20, further comprising a sealing member having an engagement portion coupled with a structure of the sheath assembly disposed generally between the surface of the hub and the proximal end of the sheath body, and a seal portion projecting into sealing engagement the opening in the annular member in a sealing position and disposed away from the opening in the annular member in an open position.

22. The splittable sheath of claim 21, wherein the sheath hub has two halves, and the engagement portion is connected only to one of the two halves of the sheath hub and extends into the inner cavity.

23. The splittable sheath of claim 21, wherein the seal portion comprises polycarbonate.