TRANSCUTANEOUS DEVICE FOR REMOVAL OF FLUID FROM A BODY
A single step body insertion device comprises a cannula and a Veress needle which penetrates the skin surface and relevant tissue layers to reach fluid and/or gases that need to be removed from the body. The cannula shaft and tapered tip are of a polymeric material which is flexible and kink resistant. The Veress needle has an engagement feature for engagement with the tapered tip of the cannula for delivery of the cannula into the body as the Veress needle is inserted into the body. The device is used for the management of conditions such as pneumothoraxes and pleural effusions as well as other conditions that require release of fluid and/or gas from the body.
1 .- 20 . (canceled)
21 . A single step body insertion device for removal of fluid from a body comprising a cannula having:
a cannula shaft;
a tapered tip at the distal end of the cannula shaft; and
a hub at the proximal end of the cannula shaft, the hub having:
a sealing valve aligned with the longitudinal axis of the cannula shaft for sealingly engaging a Veress needle which is adapted to extend through the cannula to penetrate the skin surface to facilitate delivery of the distal end of the cannula for fluid to be removed from the body; and
a side port with a one-way valve which permits flow of fluid through the valve only in the proximal direction,
wherein the cannula shaft is flexible and kink resistant, the main body of the cannula shaft is of a uniform thickness and the wall thickness progressively reduces inwardly distally along the distal tip of the cannula,
wherein the Veress needle has a proximal hub and the cannula has a proximal hub and wherein a releasable interlock is provided between the needle proximal hub and the cannula proximal hub so that when the interlock is engaged the needle and the cannula move together on insertion into the body and when the interlock is released the Veress needle is removable through the cannula hub, and
an indicator to provide a visual indication when the interlock between the Veress needle proximal hub and the cannula proximal hub is engaged.
22 . A device as claimed in claim 21 wherein the cannula shaft is of a polymeric material with a shore hardness of about 63D.
23 . A device as claimed in claim 21 wherein the cannula shaft is of an aliphatic polyether-based thermoplastic polyurethane.
24 . A device as claimed in claim 21 wherein the cannula shaft is radiopaque.
25 . A device as claimed in claim 21 wherein the inner diameter (IDt) along at least a portion of the tip is less than the inner diameter (IDb) of the main body of the cannula shaft.
26 . A device as claimed in claim 25 wherein the difference between IDb and IDt is less than 0.4 mm.
27 . A device as claimed in claim 25 wherein the difference between IDb and IDt is less than 0.2 mm.
28 . A device as claimed in claim 25 wherein the difference between IDb and IDt is approximately 0.16 mm.
29 . A device as claimed in claim 21 wherein the taper angle of the outer surface of the distal tip is from 4° to 13°.
30 . A device as claimed in claim 29 wherein the taper angle is from 7° to 11°.
31 . A device as claimed in claim 29 wherein the taper angle is approximately 9°.
32 . A device as claimed in claim wherein the length of the tapered distal tip is less than 10 mm.
33 . A device as claimed in claim 21 wherein the length of the cannula shaft is from 100 to 150 mm.
34 . A device as claimed in claim 21 wherein the cannula shaft has an outer diameter in the range of from 2 to 5 mm.
35 . A device as claimed in claim 21 wherein the main body of the cannula shaft has a wall thickness in the range of from 0.5 mm to 1 mm.
36 . A device as claimed in claim 21 wherein the main body of the cannula shaft has at least one opening in the wall thereof adjacent to the distal tip to provide a further pathway for fluid entry into the cannula shaft.
37 . A device as claimed in claim 21 wherein the cannula shaft has indicia thereon to indicate the depth of penetration of the cannula shaft into the body.
38 . A device as claimed in claim 21 wherein the side port comprises a connector for mounting of ancillary components to the side port, a three way tap for attachment to the side port, and a syringe for attachment to one of the ports of the three way tap.
39 . A device as claimed in claim 21 wherein the one-way valve is a low pressure cracking valve having a cracking pressure of 12 mbar or less.
40 . A device as claimed in claim 39 wherein the one-way valve has a backward pressure of up to 6 bar.