Introducer assembly with cap and method of using same

Abstract

An introducer sheath assembly (10) having a sheath tube (12), a hub (16), a valve (30) and a valve-retaining cap (50) on the proximal end of the hub. The cap (50) is so secured to the hub (16) as to have a closed, locked position and also an open position permitting access to the interior of the hub and the valve (30) while the cap (50) remains secured to the hub (16).

Claims

1. An introducer assembly comprising: an introducer sheath tube including a hub secured to a proximal end of the sheath tube and having a passageway aligned with a passageway of the sheath tube; a valve sealing the hub passageway while permitting insertion therethrough of a medical device; and a valve-retaining cap, wherein the cap is pivotally affixed to the hub at a proximal end thereof and configured to move between a closed position securing the valve in the hub, and an open position permitting access to the valve and the hub passageway while remaining pivotally affixed to the hub, wherein the hub includes a cap capture section and the cap includes a cooperating capture section that secures the cap to the hub while permitting the cap to be moved between a closed position and an open position with respect to the hub, and wherein the cap capture section is at least one tab projecting from the hub and each at least one tab defines one of pivot holes extending into sides thereof or pivot pins extending laterally from sides thereof, and the cooperating capture section is at least one tab projecting from the cap and each defines the other of pivot holes extending into sides thereof or pivot pins extending laterally from sides thereof such that the cooperating capture section is snap fitted to the cap capture section such that the pivot pins extend into the pivot holes and thereafter permit pivoting of the cap with respect to the hub between the open and closed position.

2. The introducer assembly of claim 1, wherein the cap capture section is one tab having pivot pins projecting laterally from both sides thereof, and the cooperating capture section of the cap is two tabs that are positionable to respective sides of the one tab and define pivot holes into which are received the pivot pins of the one tab.

3. The introducer assembly of claim 1, wherein the hub includes a catch and the cap includes a latch cooperable with the catch to lock the cap in a latched closed position and an unlatched open position.

4. The introducer assembly of claim 3, wherein the cap includes a lift tab having an inside surface facing the hub when the cap is in the latched closed position and the latch is defined along the inside surface of the lift tab, and the lift tab facilitating manual grasping thereof to unlatch the cap to move it to an open position.

5. The introducer assembly of claim 1, wherein the hub includes a hub proximal end and the cap includes a cap distal end each of which define recesses comprising valve seats that compress the valve into a retained position within the assembly when the cap is in the closed position.

6. The introducer assembly of claim 1, wherein the hub includes at a proximal end thereof the cap capture section and wherein the hub includes a catch on an opposite side from the cap capture section and the cap includes a latch cooperable with the catch to lock the cap in a latched closed position.

7. The introducer assembly of claim 6, wherein the cap includes a lift tab having an inside surface facing the hub when the cap is in the latched closed position and the latch is defined along the inside surface of the lift tab, and the lift tab facilitating manual grasping thereof to unlatch the cap to move the cap to an unlatched open position.

8. The introducer assembly of claim 6, wherein the hub proximal end and a distal end of the cap each define recesses respectively thereinto comprising cooperating valve seats that compress the valve into a retained position within the assembly when the cap is in the latched closed position.

9. The introducer assembly of claim 1, wherein the cap capture section is one tab having pivot pins projecting laterally from both sides thereof, and the cooperating capture section of the cap is two tabs that are positionable to respective sides of the one tab and define pivot holes into which are received the pivot pins of the one tab.

10. A method of using an introducer assembly, comprising: placing an introducer assembly in position accessing a vasculature of a patient, the introducer assembly having a passageway extending therethrough between a distal end and a proximal end, the introducer assembly including a valve-retention cap moveable between a first position and a second positions, said valve-retention cap affixed to the proximal end of the introducer assembly, wherein said first position is a closed position retaining the valve therein and said second position is an open position permitting access to the introducer passageway, and wherein the valve-retention cap defines recesses comprising a valve seat that compresses the valve into a retained position within the introducer assembly when the cap is in the closed position; moving the valve-retention cap to the open position; removing a blockage in the vasculature of the patient; and moving the valve-retention cap to the closed position.

11. The method of claim 10, wherein moving the valve-retention cap to the open position comprises pivoting the cap about a pivot joint with a hub.

12. An introducer assembly comprising: an introducer sheath tube, a hub secured to a proximal end of the sheath tube and having a passageway aligned with a passageway of the sheath tube, a valve sealing the hub passageway while pen fitting insertion therethrough of a medical device, and a valve-retaining cap, wherein the cap is pivotally affixed to the hub at a proximal end thereof and configured to move between a closed position securing the valve in the hub, and an open position permitting access to the valve and the hub passageway while remaining pivotally affixed to the hub; wherein the hub includes a catch and the cap includes a latch cooperable with the catch to lock the cap in a latched closed position and an unlatched open position; and wherein the cap includes a lift tab having an inside surface facing the hub when the cap is in the latched closed position and the latch is defined along the inside surface of the lift tab, and the lift tab facilitating manual grasping thereof to unlatch the cap to move the cap to the unlatched open position.

13. An introducer assembly comprising: an introducer sheath tube, a hub secured to a proximal end of the sheath tube and having a passageway aligned with a passageway of the sheath tube, a valve sealing the hub passageway while permitting insertion therethrough of a medical device, and a valve-retaining cap, wherein the cap is pivotally affixed to the hub at a proximal end thereof and configured to move between a closed position securing the valve in the hub, and an open position permitting access to the valve and the hub passageway while remaining pivotally affixed to the hub; and wherein the hub includes a hub proximal end and the cap includes a cap distal end each of which define recesses comprising valve seats that compress the valve into a retained position within the assembly when the cap is in the closed position.

14. An introducer assembly comprising: an introducer sheath tube, a hub secured to a proximal end of the sheath tube and having a passageway aligned with a passageway of the sheath tube, a valve sealing the hub passageway while permitting insertion therethrough of a medical device, and a valve-retaining cap, wherein the cap is pivotally affixed to the hub at a proximal end thereof and configured to move between a closed position securing the valve in the hub, and an open position permitting access to the valve and the hub passageway while remaining pivotally affixed to the hub; and wherein the hub includes at a proximal end thereof a cap capture section and the cap includes a cooperating capture section that secures the cap to the hub while permitting the cap to be moved between the closed position and the open position with respect to the hub, and wherein the hub includes a catch on an opposite side from the cap capture section and the cap includes a latch cooperable with the catch to lock the cap in a latched closed position.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:

(2) FIG. 1 is an isometric view of an introducer sheath with dilator inserted therethrough and also showing an extension tube extending from a side port of the introducer hub;

(3) FIG. 2 is an isometric distal end view of the assembly of FIG. 1;

(4) FIG. 3 is an enlarged isometric view of the proximal end of the assembly of FIG. 1 with the components shown exploded from the introducer sheath's elongate tube;

(5) FIGS. 4 and 5 are elevation and exploded elevation views, respectively, of the hub assembly of the introducer sheath of FIGS. 1 to 3, showing the introducer hub, the extension tube and the cap of the present invention; and

(6) FIGS. 6 and 7 are, respectively, an exploded isometric view of the proximal end, and an isometric view of the proximal introducer sheath end with the cap attached to the introducer hub and rotated to an open position with the valve exploded outwardly from the hub, exposing the passageway.

DETAILED DESCRIPTION OF THE INVENTION

(7) In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terms distal and proximal refer, respectively, to directions closer to and away from the insertion tip of a catheter in an implantable catheter assembly. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed. These embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention.

(8) Introducer assembly 10 is seen in FIGS. 1 and 2, and includes an elongate tubular sheath 12 extending to a distal end 14, an introducer hub 16 affixed to a proximal end of the sheath 12 and having a side port 18 from which extends an extension tube 20 with luer fitting 22, and a strain relief 24 at a distal end of the sheath hub 16 and around the tubular sheath 12. A dilator 40 includes an elongate dilator shaft 42 extending from a distal tip 44 to a proximal end onto which is affixed a dilator hub 46; the dilator's distal tip 44 protrudes beyond the distal end 14 of the tubular introducer sheath 12 when the dilator is fully inserted into and through the introducer assembly 10.

(9) With reference to FIG. 3, hub 16 defines therethrough a passageway 26 extending to the passageway of the sheath 12. Recessed into the proximal end of the hub 16 is a valve seat 28 into which is placed a valve 30 that preferably includes a slit 32 (see FIG. 7) at the valve center enabling insertion therethrough of dilator shaft 42 and eventually a catheter (not shown). Also, the proximal end of the hub includes on one side a cap capture tab 34 projecting proximally that includes pivot pins 36 projecting laterally from both sides thereof. On the opposite side of the hub proximal end is a catch 38 to which the cap will latch in its closed position.

(10) Cap 50 includes a recess 52 along its distal surface defining a valve seat (see FIGS. 5 and 7), and when cap 50 is attached to the hub 16 and in its closed position, retains valve 30 compressed in position within the valve seat 28,52. Referring to FIGS. 3 to 7, cap 50 is seen to have a lift tab 54 depending from one side thereof that will extend alongside the hub when cap 50 is in position but project somewhat outwardly enabling manual grasping thereof to rotate cap 50 to an open position, as shown in FIG. 7. Cap 50 will pivot as a result of cooperating tabs 56 on the opposite cap side from lift tab 54, which tabs includes holes 58 therethrough associated with pivot pins 36 of cap capture tab 34 of hub 16. A latch ledge 60 is defined on the inner surface of lift tab 54 that latches to catch 38 of hub 16, to secure cap 50 in its closed position. Proximal aperture 62 of cap 50 permits insertion thereinto of dilator shaft 42 and eventually the catheter (not shown); additionally proximal aperture 62 may includes threads or other features that cooperate with a complementary locking section of the dilator hub 46 to releasably lock the dilator to the introducer sheath assembly.

(11) with the present invention, the cap remains secured to the hub not only in the closed position but also in its open position and is thus not a loose piece, if the practitioner must obtain access to the introducer sheath passageway to remove a blockage such as a clot.

(12) It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.