Valved Sheath Introducer For Venous Cannulation
A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.
This application is a continuation of U.S. patent application Ser. No. 14/749,514, filed Jun. 24, 2015, now U.S. Pat. No. 10,307,182, which is a division of U.S. patent application Ser. No. 12/648,533, filed Dec. 29, 2009, now U.S. Pat. No. 9,108,033, which is a division of U.S. patent application Ser. No. 11/119,599, filed May 2, 2005, now U.S. Pat. No. 7,637,893, which claims the benefit of U.S. Provisional Application No. 60/566,896, filed Apr. 30, 2004, each of which is expressly incorporated by reference as if fully set forth herein.BACKGROUND OF THE INVENTION
Introducer devices are commonly utilized for inserting medical devices, such as venous access catheters, into patients. Typically, such introducer devices comprise a peel-away sheath and a hub/handle assembly which is used in conjunction with a dilator assembly to access the vein of a patient, following insertion of a needle and guidewire. In particular, procedures for introducing a catheter into a blood vessel include the cut-down method and the Seldinger technique. The Seldinger technique involves first inserting a needle through the skin of a patient and into a vein to be catheterized, inserting a guidewire through the needle and into the vein, removing the needle from the guidewire and inserting the dilator and introducer sheath over the guidewire and into the vein, simultaneously removing the dilator and guidewire from the introducer sheath, inserting a catheter through the introducer sheath and into position within the accessed vein. Following insertion of the catheter, the introducer sheaths are generally designed such that they can be peeled away from the catheter, without affecting the catheter positioning within the vein. Such introducer sheaths and assemblies are described, for example, in U.S. Pat. No. 4,772,266 to Groshong, issued Sep. 20, 1988, and U.S. Pat. No. 4,306,562 to Osborne, issued Dec. 21, 1981, each of which is incorporated by reference herein.
Problems, however, with the above-described procedure include, 1) that upon removal of the dilator and guidewire from the sheath, blood loss through the sheath can occur, and 2) that the introducer sheath provides a conduit for the introduction of air into the patient's vein, which can result in air embolism. Moreover, the risk of air embolism increases in proportion to the diameter size of the indwelling sheath, meaning that larger diameter sheaths routinely used for the placement of larger diameter catheters would increase such risk. Thus, there have been a variety of solutions proposed, which involve the incorporation of a valve in the proximal end of the introducer sheath, which would allow passage of a guidewire and dilator while simultaneously preventing blood loss or the introduction of air through the sheath. Such proposed solutions can be found, for example, in U.S. Pat. No. 5,125,904 to Lee, issued Jun. 30, 1992, U.S. Pat. No. 5,397,311 to Walker et al., issued Mar. 14, 1995, U.S. Pat. No. 6,083,207 to Heck, issued Jul. 4, 2000, each of which is incorporated by reference herein.
The aforementioned and similarly directed patents are concerned primarily with providing an elastic valve structure that provides hemostasis and the prevention of blood loss or bleed back for arterial cannulation procedures where there is significant positive blood pressure. On the other hand, with respect to venous cannulation, blood pressure is much lower and negative pressures may be involved, meaning that while prevention of blood loss is an ancillary concern, it is the prevention of air embolism that is the most crucial consideration. Thus, there exists the need for a valved sheath introducer designed for particular use for venous cannulation.BRIEF SUMMARY OF THE INVENTION
Accordingly, the present invention is directed to a valved sheath introducer for venous cannulation. In one embodiment of the invention, the valve in the introducer includes a thin disk with a central slit and includes features such as opposing anchors to allow stretching of the disk when a medical device is inserted therethrough, a thickened central portion through which a self-sealing slit is positioned, which promotes optimal resealing upon removal of a medical device, and mechanical or other means of splitting the disk simultaneous to the breaking and separating of a sheath handle from an inserted medical device. In one embodiment, the thickened central portion or island has a concave surface. Some embodiments of the valve include slits or notches aligned with the central slit to facilitate separation of the valve when the sheath and handle are removed from an inserted medical device.
In another embodiment of the invention, an apparatus for insertion of a medical device into a body comprises a sheath comprising a sheath body and a handle, the handle including at least one receiving section, a valve comprising a slit through a central portion thereof and at least one anchoring member configured for insertion into the handle receiving section, the anchoring member being positioned along an edge of the valve, and a cap attached to the handle, at least a portion of the valve being compressed therebetween. In another embodiment, a wire is looped through a slit positioned in the valve, such that when the handle is separated and removed from medical device inserted through the valved sheath introducer, the wire cuts the valve into two portions.
In one aspect of the valved sheath introducer, the valve is designed to provide optimal sealing when removing an instrument, such as a dilator. The optimal sealing occurs due to the configuration of the valve, such as a central portion or island and one or more anchoring members, and the way in which the valve is tightly held between a handle and a cap. Thus, upon removal of an instrument from the introducer sheath, the valve body, which is stretched as the instrument is inserted therethrough, rebounds toward the handle but cannot resume its original position due to the pressure exerted by the cap and the handle. The result is a bunching or duckbill effect of the valve that provides a desirable seal.
These and other embodiments, features and advantages of the present invention will become more apparent to those skilled in the art when taken with reference to the following more detailed description of the invention in conjunction with the accompanying drawings that are first briefly described.
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
The present invention involves valves and valved sheath introducers used particularly in venous cannulation procedures. However, it should be appreciated that while the designs described herein are intended for such use, they may be equally suitable for a variety of other uses (e.g., arterial cannulation, introduction of pacing leads, etc.) and therefore should not be so limited. Further, while sheath introducers and sheath introducer assemblies are described herein for exemplary purposes of housing and implementation of the subject valves, it should be appreciated that many different configurations and types of sheath introducers and sheath introducer assemblies would be equally suitable for use with the valves of the present invention and therefore should in no way serve to limit the scope of the valves described herein. In addition, as used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a slit” is intended to mean a single slit or more than one slit.
Referring now to
In an exemplary manufacturing process for the valved sheath introducer 20, the handle 30 is insert molded over the proximal end 26 of the sheath body 22. After molding, the valve 100 is placed on the top of the handle 30, and the cap 40 is attached to the handle 30 (e.g., via ultrasonic weld, adhesives, screws, etc.) over the valve 100 under force. In one exemplary manufacturing method, the attachment method is ultrasonic welding wherein the sheath body 22 and handle 30 are placed into an ultrasonic welder and the cap 40 is pressed onto the handle 30 after the valve 100 has been set therein. The ultrasonic welder sends vibrations through the cap 40, causing a portion of the cap 40 and handle 30 to meld together. In one embodiment, the cap 40 is in two part form prior to welding such that a small gap in alignment with the slots 36 can be provided. In a top view of the handle 30, shown in
Referring back to
The anchors 102, 104 allow for a tight tolerance with respect to the positioning of the valve 100 within the handle 30, being tightly secured therein by the cap 40, as explained above. This tight tolerance results in an advantageous reaction by the valve 100 with respect to sealing thereof upon removal of an instrument that had previously been inserted therethrough (e.g., dilator, etc.). In particular, in concert with the island 106, which is a circular feature positioned in the center of the body 108, extending along with the anchors 102, 104 from the bottom thereof, a superior seal is created upon removal of an instrument from the sheath introducer 20, as will be explained below in connection with
In the embodiment shown in
The following materials and dimensions are provided as an example of one embodiment and should not be taken as limiting the invention in any way. The valve 100 in this embodiment is made of silicone (Dow Corning Q7-4840), having a diameter of approximately 0.516 inches, while the diameter of the island 106 is approximately 0.260 inches and the distance between inner edges of the islands 102, 104 is approximately 0.420 inches (the width of the anchors thus being approximately 0.048 inches). The thickness of the valve 100 along the anchors 102, 104 is approximately 0.090 inches, while the thickness of the valve across the island is approximately 0.045 inches, the remainder of the body therefore having a thickness of approximately 0.025 inches. The distance between the anchors 102, 104 is approximately 0.160 inches on both sides of the valve 100. The central slit 110 has a length of approximately 0.204 inches, while the peripheral slits 112, 114 have a length of approximately 0.050 inches. In other embodiments, the dimensions are dependent upon the size of the instrument(s) being inserted through the valve.
With respect to the valve island 106, another embodiment is shown in
Removal of the sheath introducer 20 from an instrument inserted therethrough (e.g., a catheter) is effectuated by grasping the handle 30 on each side thereof and pulling the sides in opposite directions so that the handle 30 cracks along the slots 36. Upon cracking and splitting of the handle 30, the integrated valve 100 tears along the slit line created by central slit 110 and peripheral slits 112, 114, the tearing process enabled, as discussed above, by the anchors 102, 104, which maintain the position of each side of the valve 100 within the respective side of the handle. As the two pieces of the handle are pulled away from one another, the sheath peels down its entire length at the circumferential location of the handle slots (which correspond to the aligned pre-split sections of the sheath). Due to the extrusion process for manufacturing the PTFE, which results in an alignment of the molecules, the peeling of the sheath is continuous down the entire length thereof at the circumferential locations without the need for score line(s). The handle does not detach from the sheath during or after the splitting process. In other embodiments of the invention, the sheath is made from PTFE or another like polymer material with one or more score lines positioned longitudinally along the length of the sheath in line with the slot(s) in the handle.
In another embodiment of a valved sheath introducer, a very thin wire is associated with the valve, as shown in
The valved sheath introducer described herein is used according to one embodiment as follows. After an access site on a body is determined and an incision made, the valved sheath introducer assembly is inserted into the body with a distal end of the sheath body extending into a body vessel to be accessed. Following optional preparatory steps (e.g., flushing), the dilator is removed from the valved sheath introducer. As the dilator is removed, the valve closes as described above in connection with
This invention has been described and specific examples of the invention have been portrayed. While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations or figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Therefore, to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent covers those variations as well. Finally, all publications and patent applications cited in this specification are herein incorporated by reference in their entirety as if each individual publication or patent application were specifically and individually put forth herein.
1. A method of making a sheath introducer, comprising:
- coupling a handle to a sheath having a lumen, the handle including: a bore communicating with the lumen; a first receiving section; and a second receiving section;
- inserting a valve into the handle, comprising: inserting a central portion of the valve into the bore, the central portion having a first thickness, the central portion including a slit through the first thickness; inserting a first anchoring member of the valve into the first receiving section, the first anchoring member having a second thickness; and inserting a second anchoring member of the valve into the second receiving section, the second anchoring member having the second thickness; and
- attaching a cap to the handle under pressure to compress a portion of the valve between the cap and the handle.
2. The method of making according to claim 1, wherein the coupling step comprises insert molding the handle over a proximal end of the sheath.
3. The method of making according to claim 1, wherein the first receiving section of the handle is on a first side of the bore, and wherein the second receiving section of the handle is on a second side of the bore opposite of the first side of the bore.
4. The method of making according to claim 1, wherein the central portion of the valve has a thickness greater than a portion of the valve surrounding the central portion.
5. The method of making according to claim 1, wherein the central portion of the valve has a concave surface on one side thereof.
6. The method of making according to claim 5, wherein the central portion of the valve has opposing concave surfaces.
7. The method of making according to claim 1, wherein the central portion of the valve has a diameter approximately equal to a diameter of the bore of the handle.
8. The method of making according to claim 1, wherein the handle includes opposing slotted regions between the first receiving section and the second receiving section.
9. The method of making according to claim 8, wherein the slit of the valve is perpendicularly aligned with the opposing slotted regions.
10. The method of making according to claim 9, further comprising looping a wire through the slit, wherein the inserting step comprises disposing both a first end of the wire and a second end of the wire in either the first receiving section or the second receiving section of the handle.
11. The method of making according to claim 1, wherein the slit forms an acute angle with respect to a top surface of the valve.
12. The method of making according to claim 1, wherein the slit of the valve is positioned in a center of the central portion, and wherein the valve further comprises a second slit aligned with the slit, the second slit positioned at an outer edge of the valve.
13. The method of making according to claim 12, wherein the valve further comprises a third slit aligned with the slit, and wherein the third slit is positioned at a first edge of the valve and the second slit is positioned at a second edge of the valve opposite of the first edge of the valve.
14. The method of making according to claim 13, wherein the handle includes opposing slotted regions between the first receiving section and the second receiving section, and wherein the second slit and the third slit are aligned with the opposing slotted regions.
15. The method of making according to claim 1, wherein the slit of the valve is positioned in a center of the central portion, and wherein the valve further comprises a first notch aligned with the slit, the first notch positioned at an outer edge of the valve.
16. The method of making according to claim 15, wherein the valve further comprises a second notch aligned with the slit, wherein the first notch is positioned at a first edge of the valve and the second notch is positioned at a second edge of the valve opposite of the first edge of the valve.
17. The method of making according to claim 16, wherein the handle includes opposing slotted regions between the first receiving section and the second receiving section, and wherein the first notch and the second notch are aligned with the opposing slotted regions.
18. The method of making according to claim 1, wherein the attaching step comprises ultrasonically welding the cap to the handle.
19. The method of making according to claim 1, wherein the coupling step comprises coupling a first part of the cap to a first side of the handle and attaching a second part of the cap to a second side of the handle such that a gap between the first part of the cap and the second part of the cap is aligned with one or more slotted regions in the handle.
20. The method of making according to claim 1, wherein the first thickness is less than the second thickness.