Access device with valve

• US 9,884,169 B2
• Filed: 08/17/2012
• Issued: 02/06/2018
• Est. Priority Date: 08/17/2011
• 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.
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US14/238,832
• Publication Number:
  US 20140207069A1
• Time in Patent Office: 1,999 Days
• Field of Search: 60416703
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 2039/244 Hinged closure member, e.g. flap valve
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• 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 25/0693 Flashback chambers
• 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 39/22 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

Abstract

A splittable sheath includes a splittable sheath body, a splittable sheath hub, and a valve element. The sheath body comprises a generally flexible tubular structure, a proximal end, and a distal end. The sheath body defines a longitudinal axis and is splittable into two halves along a pre-determined line generally parallel to the longitudinal axis. The sheath hub extends from the proximal end of the sheath body and defines a longitudinal axis generally aligned with the longitudinal axis of the sheath body. The sheath body and sheath hub form an inner cavity along their respective longitudinal axes. The valve element includes a resilient plate and a sealing element. The resilient plate includes a distal portion extending radially inwardly from a side of the inner cavity.

Claims

1. A medical article comprising:

a sheath comprising;

a splittable sheath hub comprising a cylindrical, longitudinally extending hub wall, the longitudinally extending hub wall having an inner surface and an outer surface, the longitudinally extending hub wall defining a longitudinal axis and forming an inner cavity through which the longitudinal axis extends; and

a valve element comprising;

a resilient plate comprising a mounting portion and a sealing portion,

the mounting portion being supported within the longitudinally extending hub wall on an oblique surface formed between the inner surface and the outer surface at a first oblique angle relative to the longitudinal axis and extending inwardly from the inner surface of the longitudinally extending hub wall, and

the sealing portion extending into the inner cavity; and

a sealing element comprising a first sealing surface and being supported by the resilient plate,

wherein the first oblique angle biases the sealing element toward a position against a second sealing surface on the splittable sheath hub to substantially seal at least a portion of the inner cavity.

2. The medical article of claim 1, wherein at least one of the first and second sealing surfaces extends around the substantial entirety of an inner perimeter of the inner cavity.

3. The medical article of claim 1, further comprising a flange extending inwardly from a side of the inner cavity, the flange forming at least a portion of the second sealing surface.

4. The medical article of claim 3, further comprising a rib extending longitudinally within the inner cavity from the flange, wherein the second sealing surface comprises at least a portion of the rib.

5. The medical article of claim 1, wherein the resilient plate comprises a flexible material with properties inhibiting cold-setting when held in a flexed position for extended periods of time.

6. The medical article of claim 5, wherein the resilient plate comprises Nitinol.

7. The medical article of claim 1, further comprising a splittable sheath body having a proximal end, a distal end, and a tubular structure extending therebetween, the sheath body defining a longitudinal axis and being splittable into two portions along two pre-determined split lines generally parallel to the longitudinal axis, wherein the splittable sheath hub extends from the proximal end of the splittable sheath body and the inner cavity extends along the longitudinal axis of the sheath body.

8. The medical article of claim 7, wherein the sealing element further comprises a raised portion with respect to the first sealing surface, wherein the raised portion projects away from the sheath body.

9. The medical article of claim 8, wherein the raised portion has a height sufficient to inhibit contact between the first sealing surface and a device extended through the cavity.

10. The medical article of claim 8, wherein the first sealing surface forms a perimeter surrounding the raised portion.

11. The medical article of claim 8, wherein the raised portion comprises a substantially dome-like shape.

12. The medical article of claim 7, wherein the tubular structure is generally flexible.

13. The medical article of claim 7, wherein the sheath hub is splittable into two sheath hub portions along the two pre-determined split lines, wherein the mounting portion of the resilient plate is supported by a first of the two portions such that the valve element is separable from and movable with respect to a second of the two sheath hub portions.

14. The medical article of claim 13, wherein the sheath hub comprises a distal portion and a proximal portion coupled together with the mounting portion of the resilient plate supported between the distal portion and the proximal portion of the sheath hub.

15. The medical article of claim 14, wherein the sheath hub and the resilient plate comprise a pair of corresponding attachment elements configured to restrict at least one of radial and rotational movement of the resilient plate relative to the longitudinal axis.

16. The medical article of claim 13, wherein the resilient plate has a weakened portion at which the resilient plate can bend such that the sealing portion moves with respect to the mounting portion.

17. The medical article of claim 16, wherein the resilient plate is bent at the weakened portion to be substantially non-planar to preload the first sealing surface against the second sealing surface.

18. The medical article of claim 14, wherein the mounting portion is supported between the distal portion and proximal portion of the sheath hub at the first oblique angle with respect to the longitudinal axis, wherein the distal portion and the proximal portion of the sheath hub each comprise a circular cross-sectional shape such that the longitudinally extending hub wall has an annular shape, and wherein the second sealing surface extends around the inner cavity at a second oblique angle with respect to the longitudinal axis.

19. The medical article of claim 13, wherein at least a portion of the second sealing surface is formed on the second of the two sheath hub portions.

20. The medical article of claim 13, wherein the two pre-determined split lines are parallel to the longitudinal axis of the sheath hub.

21. An access device, comprising:

a needle;

a dilator; and

a splittable sheath comprising;

a splittable sheath body;

a splittable sheath hub extending from a proximal end of the sheath body, the splittable sheath hub comprising a longitudinally extending hub wall having an inner surface and an outer surface, wherein the sheath body and sheath hub forming an inner cavity along a longitudinal axis defined by the sheath body and sheath hub; and

a valve element comprising;

a resilient plate comprising a mounting portion and a sealing portion,

the mounting portion being supported within the longitudinally extending hub wall on an oblique surface formed between the inner surface and the outer surface at a first oblique angle relative to the longitudinal axis and extending inwardly from the inner surface of the longitudinally extending hub wall, and

the sealing portion extending into the inner cavity; and

a sealing element comprising a first sealing surface and being supported by the resilient plate;

wherein the first oblique angle biases the sealing element toward a first position against a second sealing surface on at least one of the splittable sheath body and the splittable sheath hub to substantially seal the inner cavity, and wherein the sealing element is movable from the first position to a second position when at least one of the needle and dilator is extended through the cavity, without substantial contact between the at least one of the needle and dilator and the first sealing surface.

22. The access device of claim 21, wherein the sheath hub comprises a distal portion and a proximal portion coupled together with the mounting portion of the resilient plate supported between the distal portion and the proximal portion of the sheath hub.

23. The access device of claim 22, wherein the mounting portion is supported between the distal portion and the proximal portion of the sheath hub at the first oblique angle with respect to the longitudinal axis, wherein the distal portion and the proximal portion of the sheath hub each comprise a circular cross-sectional shape such that the longitudinally extending hub wall has an annular shape, and wherein the second sealing surface extends around the inner cavity at a second oblique angle with respect to the longitudinal axis.

24. The access device of claim 21, wherein the resilient plate comprises a flexible material with properties inhibiting cold-setting when held in a flexed position for extended periods of time.

25. The access device of claim 21, wherein the sealing element further comprises a raised portion with respect to the first sealing surface, wherein the raised portion projects away from the sheath body.

26. The access device of claim 25, wherein the raised portion comprises a substantially dome-like shape.

27. The access device of claim 21, wherein the resilient plate has a weakened portion at which the resilient plate can bend such that the sealing portion moves with respect to the mounting portion.

28. The access device of claim 21, wherein the sheath body is splittable into two portions along two pre-determined split lines generally parallel to the longitudinal axis.