Access device

• US 8,956,327 B2
• Filed: 02/08/2011
• Issued: 02/17/2015
• Est. Priority Date: 02/08/2010
• 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): BERDICHEVSKY, AARTI
• Application Number:
  US13/577,653
• Publication Number:
  US 20120316500A1
• Time in Patent Office: 1,470 Days
• Field of Search: 60416401-16706
• US Class Current: 604/164.1
• 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 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 25/0662 Guide tubes
• 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 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• 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

An access device for placing a medical article within a body space includes a needle, a dilator, and a medical article. The needle can include an elongated needle body with a distal end and a hub from which the needle body extends. The elongated needle body can include at least one side fenestration and an outer diameter. The dilator can be slideably disposed on the needle body and include a dilator hub and an elongated dilator shaft that extends from the dilator hub. The dilator shaft can include at least one side fenestration in communication with the needle side fenestration. The dilator shaft can also include an inner diameter that is less than the outer diameter of the needle. The medical article can include a tubular section and a hub. The tubular section can be disposed on the dilator and define a space between the medical article and the dilator in communication with the needle side fenestration through the dilator side fenestration. At a least portion of the medical article can be configured to allow visual determination of the presence of a body fluid within the space.

Claims

1. An access device for placing a medical article within a body space, comprising:

a needle having an elongated needle body with a distal end and a hub from which the needle body extends, the elongated needle body comprising at least one side fenestration and an outer diameter;

a dilator slideably disposed on the needle body, comprising a dilator hub and an elongated dilator shaft that extends from the dilator hub, wherein the dilator shaft comprises at least one side fenestration in communication with the needle side fenestration, wherein the dilator shaft comprises an inner diameter that is less than the outer diameter of the needle, and wherein the dilator hub comprises a receiving portion;

a medical article comprising a tubular section and a hub, the tubular section being disposed on the dilator and defining a space between the medical article and the dilator in communication with the needle side fenestration through the dilator side fenestration, wherein at a least portion of the medical article is configured to allow visual determination of the presence of a body fluid within the space; and

an insert disposed within the dilator receiving portion, the insert comprising a through-hole configured to receive the needle body therethrough, the through-hole being slightly larger than the needle body so as to form a passage between the insert and the needle body that allows gases to pass through the passage and to the atmosphere but hinders the passage of a body fluid.

2. The access device of claim 1, wherein the inner diameter of the dilator is approximately 3% smaller than the outer diameter of the needle.

3. The access device of claim 1, wherein the dilator shaft comprises nylon.

4. The access device of claim 1, wherein the space comprises a surfactant or lubricious coating.

5. The access device of claim 1, wherein the fenestrations comprise different aspect ratios.

6. The access device of claim 1, wherein the fenestrations are aligned such that fluid can flow substantially unobstructed through both fenestrations.

7. The access device of claim 1, wherein at least one of the fenestrations forms an oblong opening.

8. The access device of claim 1, wherein both fenestrations form oblong openings that are generally perpendicular to each other when aligned.

9. The access device of claim 1, further comprising at least one elongated channel disposed between the needle and an exterior surface of the medical article that extends along at least a substantial portion of the length of the dilator shaft, the channel communicating with the fenestration in the needle and having a span angle of less than 360 degrees about a longitudinal axis of the dilator.

10. The access device of claim 1, wherein at least one of the dilator and medical article further comprise a vent in communication with the space that allows for the escape of air from the space and inhibits the escape of the bodily fluid from the space.

11. The access device of claim 1, wherein the needle and dilator are moveable relative to each other from a first position, wherein the distal end of the needle lies distal of the dilator, and a second position wherein the distal end of the needle lies within the dilator.

12. The access device of claim 11, further comprising a locking mechanism operating between the needle and the dilator to inhibit movement of the needle relative to the dilator when in the second position, the locking mechanism being configured to allow movement of the needle from the first position toward the second position without engagement by the locking mechanism so as to lessen resistance to the movement.

13. The access device of claim 12, wherein an elongated support suspends the first member of the locking mechanism at a location spaced from the dilator hub.

14. An access device for placing a medical article within a body space, comprising:

a needle having an elongated needle body with a distal end and a hub comprising a distal portion from which the needle body extends, the elongated needle body comprising at least one side fenestration;

a dilator comprising a dilator hub and an elongated dilator shaft that extends from the dilator hub, the dilator slideably disposed on the needle body and defining a space between the dilator shaft and the needle body in communication with the needle side fenestration, wherein the dilator hub comprises a receiving portion and at least a portion of the dilator shaft is configured to allow visual determination of the presence of a body fluid within the space; and

an insert disposed within the dilator receiving portion, the insert comprising a through-hole configured to receive the needle body therethrough, the through-hole being slightly larger than the needle body so as to form a passage between the insert and the needle body that allows gases to pass through the passage and to the atmosphere but hinders the passage of a body fluid.

15. The access device of claim 14, wherein the insert is shaped and sized to substantially match the inner surface of the receiving portion of the dilator to form a seal.

16. The access device of claim 14, wherein the insert comprises a proximal face that faces the needle hub and comprises one or more projections or grooves that can preserve a passage for gases between the insert and the needle hub.

17. The access device of claim 14, wherein the distal portion of the needle hub comprises a distal face that faces the insert and comprises one or more projections or grooves configured to preserve a passage for gases between the insert and the needle hub.

18. The access device of claim 14, further comprising a medical article comprising a tubular section and a hub, the tubular section being disposed on the dilator, wherein at least a portion of the medical article is configured to allow visual determination of the presence of a body fluid within the space.

19. The access device of claim 14, wherein a distal portion of the dilator shaft comprises an inner diameter that is less than the outer diameter of the needle.

20. The access device of claim 14, wherein the through-hole is disposed axially central within the insert.

21. The access device of claim 14, wherein the insert is disposed distal of the needle hub.

22. The access device of claim 14, wherein the insert comprises ridges or grooves that make the through-hole slightly larger than the needle body so as to form the passage.

23. An access device for placing a medical article within a body space, comprising:

a guidewire section comprising a guidewire and a guidewire hub;

a needle disposed on the guidewire and having an elongated needle body with a distal end and a hub from which the needle body extends;

a dilator disposed on the needle body, the needle and the dilator being moveable relative to each other from a first position, wherein the distal end of the needle lies distal of the dilator, and a second position wherein the distal end of the needle lies within the dilator, the dilator including a dilator hub and an elongated dilator shaft that extends from the dilator hub, and wherein the dilator hub comprises a receiving portion;

an insert disposed within the dilator receiving portion, the insert comprising a through-hole configured to receive the needle body therethrough, the through-hole being slightly larger than the needle body so as to form a passage between the insert and the needle body that allows gases to pass through the passage but hinders the passage of a body fluid;

a locking mechanism operating between the needle and the dilator, the locking mechanism comprising a portion spaced from the dilator that inhibits movement of the needle relative to the dilator when in the second position, the locking mechanism being configured to allow movement of the needle from the first position toward the second position without engagement by the locking mechanism so as to lessen resistance to the movement; and

a coupling mechanism operating between the dilator and the guidewire, the coupling mechanism comprising a T-shaped locking section disposed on the guidewire that interengages with the guidewire hub to form a reversible snap-fit grip.

24. The access device of claim 23, wherein the guidewire hub comprises two bendable tines that form a portion of the snap-fit grip.

25. The access device of claim 24, wherein the guidewire hub comprises an end recess in-line with a path between the tines.

26. An access device for placing a medical article within a body space, comprising:

a needle having an elongated needle body with a distal end and a hub from which the needle body extends, the elongated needle body comprising at least one needle side fenestration;

a dilator slideably disposed on the needle body, comprising a dilator hub and an elongated dilator shaft that extends from the dilator hub, wherein the dilator shaft comprises at least one dilator side fenestration in communication with the needle side fenestration and a raised ridge through which the dilator side fenestration passes, and wherein the dilator hub comprises a receiving portion;

a medical article comprising a tubular section and a hub, the tubular section being disposed on the dilator and defining a space between the medical article and the dilator in communication with the needle side fenestration through the dilator side fenestration, wherein at a least portion of the medical article is configured to allow visual determination of the presence of a body fluid within the space; and

an insert disposed within the dilator receiving portion, the insert comprising a through-hole configured to receive the needle body therethrough, the through-hole being slightly larger than the needle body so as to form a passage between the insert and the needle body that allows gases to pass through the passage and to the atmosphere but hinders the passage of a body fluid.

27. The access device of claim 26, wherein the ridge is oriented in a generally axial direction.

28. The access device of claim 26, wherein the ridge is narrower than the dilator side fenestration.

29. An access device for placing a medical article within a body space, comprising:

a needle having an elongated needle body with a distal end and a hub from which the needle body extends, the elongated needle body comprising at least one side fenestration;

a dilator slideably disposed on the needle body, comprising a dilator hub and an elongated dilator shaft that extends from the dilator hub to a distal end, wherein the dilator shaft comprises at least one side fenestration in communication with the needle side fenestration, wherein the dilator distal end tapers at approximately 30 degrees, and wherein the dilator hub comprises a receiving portion;

a medical article comprising a tubular section and a hub, the tubular section being disposed on the dilator and defining a space between the medical article and the dilator in communication with the needle side fenestration through the dilator side fenestration, wherein at a least portion of the medical article is configured to allow visual determination of the presence of a body fluid within the space; and

an insert disposed within the dilator receiving portion, the insert comprising a through-hole configured to receive the needle body therethrough, the through-hole being slightly larger than the needle body so as to form a passage between the insert and the needle body that allows gases to pass through the passage and to the atmosphere but hinders the passage of a body fluid.

30. The access device of claim 29, wherein the dilator has a secondary taper at approximately 3 degrees proximal from the 30 degree taper.