The present invention relates generally to medical devices, namely, catheters. More particularly, the present invention is directed to a tearaway sheath introducer having a valve that is molded onto a cap.
Tearaway sheath is generally used to introduce soft catheters (e.g., dialysis catheters) into the blood vessels. More specifically, an introducer sheath with a dilator device is passed over the guide wire to enlarge the venotomy or an incision site on a patient. Once the venotomy is enlarged, the dilator is removed, and then the catheter is inserted into the sheath. Thereafter, the sheath is removed by being split apart. The existing method, however, is disadvantageous in that a patient's blood could spurt from the vessel when the dilator is removed and before the catheter is inserted into the sheath. Additionally, air or other outside elements could be aspirated into the vessel, which is not desirable. In this regard, the invention described herein addresses these problems.
The following discloses a simplified summary of the specification in order to provide a basic understanding of some aspects of the specification. This summary is not an extensive overview of the specification. It is intended to neither identify key or critical elements of the specification nor delineate the scope of the specification. Its sole purpose is to disclose some concepts of the specification in a simplified form as a prelude to the more detailed description that is disclosed later.
In one embodiment, the present invention comprises a sheath with a sheath hub disposed on an end thereof, wherein the sheath is configured to receive a dilator therethrough, further wherein the dilator comprises a hub with a locking mechanism. The sheath hub comprises a cap set having a molded valve thereon. In some embodiments, the cap set and the valve are ultrasonically welded to the sheath hub. The sheath with the dilator is passed over a guide wire at an incision site of a patient. The valve is composed of a resilient material so that it is configured to allow the dilator to be pulled out therefrom while preventing blood from escaping after the dilator is removed, but before the catheter is inserted. In this way, the present invention improves the process of introducing catheters into the blood vessels by preventing blood from coming out and outside elements from being introduced into the sheath.
Referring now to
The opening 104 provides access to a mold cavity 106 of the hub 103 for holding a cap set therein. The mold cavity 106 includes an outer diameter and an inner diameter, wherein the outer diameter is greater than the inner diameter. The mold cavity 106 is shaped and dimensioned to fit a cap set therein. The hub 103 comprises a pair of elongated tabs 107 thereon, wherein the pair of elongated tabs 107 comprises a first tab and a second tab.
In the illustrated embodiment, the tabs 107 comprise rounded terminal ends. The tabs 107 extend outward in opposite directions so that they are substantially collinear to one another. The tabs 107 can be pulled apart such that the first tab and the second tab become separated. Accordingly, the hub 103 can comprise a seam where the first tab and the second tab meet and separate. In some embodiments, the tabs comprise ridges 102 thereon. The hub 103 further comprises a plurality of posts 105 that protrude around the opening 104 thereof, wherein the posts 105 are separated at regular intervals.
Referring now to
In the illustrated embodiment, each of the sections 203, 206 comprises a semicylindrical section 204 having a flange 202 orthogonal thereto, wherein the flange 202 comprises a plurality of apertures 201 thereon. The outer perimeter of the flange 202 is greater than the outer perimeter of the semicylindrical section 204, while the inner perimeter of the flange 202 is equal to the inner perimeter of the semicylindrical section 204. The flange 202 is configured to fit within the outer diameter of the mold cavity 106 (
It is noted that the two sections 203, 206 of the cap set 200 are not bonded or adhered together. Instead, the cap sections 203, 206 are held together when the semicylindrical section 204 of the cap sections 203, 206 are set into the mold cavity 106 (
Additionally, the semicylindrical section 204 of each of the sections 203, 206 can comprise one or more openings 205 or cutouts thereon for aligning within or fitting into the mold cavity 106 (
Referring now to
The back side of the valve 300 is biased toward the semicylindrical section 204 of the cap set 200 (
Referring now to
The lower end 604 of the dilator hub 602 is configured to mate with the inner perimeter of the flange 202 (
Referring now to
The cap set and the valve are inserted into the mold cavity of the sheath hub 103. Thus, the tubular structure 601 of the dilator is inserted through the valve so as to allow the lower end of the dilator hub 602 to be positioned directly within the flange 202 of the cap set. In this regard, the lower end of the dilator hub 602 is adjacent to the valve. Additionally, because the valve is slightly recessed into the valve housing of the cap set, the lower end of the dilator hub 602 can be substantially coplanar or flush with the flange 202 of the cap set.
In use, the complete assembly 700 is inserted over a guide wire. The dilator can be connected to any apparatus via the locking mechanism 603 at a terminal end thereof. The dilator 601 is then removed and exited through the valve, leaving the sheath 101 in the blood vessel. Due to the resilient nature of the valve, the valve is configured to prevent blood from coming out after the dilator is removed, but before a catheter is inserted. Once the catheter is fully inserted through the valve and into the sheath, the sheath hub 103 is separated or broken into two halves at the seam, separating the two tabs.
It is therefore submitted that the instant invention has been shown and described in what is considered to be the most practical and preferred embodiments. It is recognized, however, that departures may be made within the scope of the invention and that obvious modifications will occur to a person skilled in the art. With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention.
Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.
This application claims the benefit of U.S. Provisional Patent Application No. 62/340,231, filed May 23, 2016, which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
---|---|---|---|
62340231 | May 2016 | US |