Introducer sheath valves for medical procedures having tubular diaphragm that can be pressed and collapsed

Abstract

To provide improved introducer sheath valves for use in endovascular, laparoscopic and other surgical procedures.SOLUTION: The invention relates to a valve used in medical procedures. More specifically, the invention relates to an introducer sheath valve used in minimally invasive and conventional surgical procedures. The valve may accommodate a wide range of surgical implement diameters, shapes and multiple implements without imposing the high frictional forces of known valves.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 61 / 058,744, filed Jun. 4, 2008.

[0002] 2. Background of the Invention FIELD OF THEINVENTION The present invention relates to valve assemblies for medical procedures. [Background technology]

[0003] Discussion of Related Art Valve assemblies are used in many medical procedures. More particularly, introducer sheath valves are used in a variety of minimally invasive and conventional surgical procedures. For example, laparoscopic and arthroscopic surgical procedures are often performed with a trocar assembly that includes an introducer sheath valve.

[0004] Current introducer sheath valves generally fall into two basic categories: passive and active. Passive introducer sheath valves generally rely on deformation of a resilient sealing body by an instrument inserted through the valve to create the desired fluid-tight seal. Active valves include a mechanism that moves the sealing body into contact with the passing instrument. An example of an active valve would be made from a housing and a tubular resilient valve within the housing. This valve requires a means to change the pressure in the space within the housing but outside the tubular valve, thereby collapsing the resilient valve inwardly to seal around the instrument.

[0005] Another example of an active valve is made from an elastomeric sealing body that will maintain hemostasis by contacting a surgical instrument passing through the valve with a very small contact area. An orifice is formed in a thin elastomeric membrane that extends radially inward from a toroidal balloon having a relatively stiff outer edge and a flexible inner portion. In this example, a vacuum is applied within the toroidal balloon, pulling the elastomeric membrane radially outward for instrument insertion. Sealing around the instrument is achieved by applying a positive pressure within the toroidal balloon, causing the balloon to expand radially inward to block access through the valve. Summary of the Invention [Problem to be solved by the invention]

[0006] While these and other valve designs are fairly versatile for a variety of surgical instrument diameters, all currently available valves have significant limitations with respect to changes in diameter, changes in instrument shape, and how many instruments can be passed through the valve without damaging the valve and with optimal sealing characteristics. For these reasons, it would be desirable to provide an improved introducer sheath valve for endovascular, laparoscopic, and other surgical procedures. Such a valve would preferably be able to seal a wide range of surgical instrument diameters, shapes, and multiple instruments, regardless of the cross-sectional size or shape of the surgical instrument passing through the valve, without imposing the high frictional forces of known valves.

[0007] Although discussed in detail as an introducer sheath valve, the invention encompasses other applications such as valves for insertion sites such as bariatric port access, medical injection ports, vascular access ports, dialysis access ports or feeding tubes. [Means for solving the problem]

[0008] Summary of the Invention A first embodiment provides an introducer sheath valve having an inner tube including a porous substrate and an outer tube with a pressurizable space formed between an outer surface of the inner tube and an inner surface of the outer tube.

[0009] A further embodiment provides an introducer sheath valve having an inner tube having a thickness of about 0.0025 mm to about 1 mm, and an outer tube, with a pressurizable space formed between the outer surface of the inner tube and the inner surface of the outer tube.

[0010] A further embodiment provides an introducer sheath valve having an inner tube comprising ePTFE (expanded polytetrafluoroethylene) and an outer tube with a pressurizable space formed between the outer surface of the inner tube and the inner surface of the outer tube.

[0011] Additional features and advantages of the invention will be set forth in the description or may be learned by practice of the invention.

[0012] These features and advantages of the invention will be realized and attained by the structure particularly pointed out in the written description and claims hereof, as well as the appended drawings.

[0013] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention as claimed. [Brief description of the drawings]

[0014] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the invention, and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and together with the description, serve to explain the principles of the invention. [Figure 1] FIG. 1 is a perspective view of an introducer sheath including one embodiment of an introducer sheath valve. [Diagram 2]FIG. 2 is a cutaway view of an introducer sheath including one embodiment of an introducer sheath valve. [Figure 2A] FIG. 2A is a cutaway view of an introducer sheath including one embodiment of an introducer sheath valve. [Diagram 3] FIG. 3 is a close-up view of one embodiment of an introducer sheath valve. [Figure 4] FIG. 4 is an end view of one embodiment of an introducer sheath valve. [Figure 5A-C] 5A-C show examples of porous substrates. [Figure 6A-C] 6A-C show examples of close-ups of the surface of a porous substrate. [Figure 7A-C] 7A-C show examples of close-ups of the surface of a porous substrate, with a polymer filling the openings or pores in the substrate. [Figure 8] FIG. 8 is a cutaway view of an introducer sheath including one embodiment of an introducer sheath valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS The first embodiment includes an introducer sheath valve constructed from an inner tube comprising a porous substrate and an outer tube with a pressurizable space formed between the outer surface of the inner tube and the inner surface of the outer tube.

[0016] FIG. 1 illustrates one embodiment of an introducer sheath valve 100. The introducer sheath valve 100 assembly can be attached to an introducer sheath 102. The sheath 102 can be made from fluorinated ethylene propylene (FEP) or extruded high density polyethylene or any other material having suitable biocompatibility and mechanical properties. One skilled in the art can readily appreciate that there are a variety of possible materials that can be used to practice the present invention. The sheath 102 can be any size, but is preferably sized between about 12-26 Fr. At the proximal-most end of the sheath 102 is a threaded adapter 104. The threaded adapter 104 can be made from any biocompatible plastic or any biocompatible metal having suitable biocompatibility and mechanical properties. The threaded adapter 104 can be attached to the sheath 102 by a variety of means, including but not limited to an adhesive, such as a polyurethane adhesive, a fast-curing cyanoacrylate adhesive, or a UV-curable adhesive. Other means for attaching the threaded adapter 104 to the sheath 102 include ultrasonic welding, interference fitting, thermal bonding, and insert molding. One skilled in the art can readily appreciate that there are a variety of possible means for attaching the threaded adapter 104 to the sheath 102. The distal end of the front fitting 106 can be attached to the proximal end of the threaded adapter 104. The threaded adapter 104, the front fitting 106, the snap ring 108, and the snap ring 108' with fill port 112 can be made of any biocompatible metal or plastic with suitable biocompatibility and mechanical properties. The snap ring 108 and the snap ring 108' with fill port 112 will be described below. The front fitting 106 can be attached to the threaded adapter 104 by similar means as described for the attachment of the threaded adapter 104 and the sheath 102. Among the many features and characteristics of the front fitting 106, some are described below. The front fitting 106 is designed to allow the user to have a firm grip on the device.Grip may be aided by protrusions 107 on the sides of the fitting 106. The protrusions 107 may be made of the same material as the fitting 106, or may be made of a material with a high coefficient of friction or a material that is more flexible than the material of the front fitting 106. These protrusions may be made with grids, roughened surfaces, raised company logos or designs, or grooves in combination with the above materials to further aid grip of the device. These features on the surface of the front fitting 106 may also be used to aid grip without the use of grip protrusions 107, and may be provided directly on the sides of the front fitting 106. The front fitting 106 also includes a flush port 109 with the fitting. The function and use of the flush port 109 and the fitting are generally known in the art.

[0017] As illustrated in FIG. 2, a cross-sectional view of FIG. 1, and FIG. 3, an exploded view of FIG. 1, the outer sheath assembly can be made of a snap ring 108, an outer tube 110, and a snap ring 108' with a fill port 112. As mentioned above, the snap ring 108 and the snap ring 108' with a fill port 112 can be made of any biocompatible metal or plastic having suitable biocompatibility and mechanical properties. The fill port 112 can be located anywhere along the snap ring 108 or 108'. The outer tube 110 preferably features a sealing lip 204. The sealing lip 204 aids in the secure fastening of the snap ring 108 and the snap ring 108' with a fill port 112 to the outer tube 110. The sealing lip 204 also provides a seal between the tube 110 and the tube 200. The outer tube 110 can be attached to the snap ring 108 and the snap ring 108' with a fill port 112 by a variety of methods. The preferred method for joining the parts is by insert molding as commonly practiced in the art. Other methods for attachment include interference fitting, gluing or adhesives, ultrasonic welding, and thermal bonding. The outer tube 110 may be made of any elastomer, latex, or polycarbonate having the desired mechanical properties and biocompatibility. In one embodiment, the outer tube 110 comprises silicone and has an hourglass shape when unpressurized. When pressurized, the outer tube 110 expands to exhibit the desired pressure in the pressurizable space 206. Methods and means for pressurization will be described below. This feature of the outer tube 110 allows the user of the device to easily and quickly identify the optimum pressure for the device.

[0018] 2 and 3 also show an inner tube 200. The inner tube 200 is formed with a ring 202 at each end of the inner tube 200. The inner tube 200 may be made from any very thin, strong, drape-able material, such as ePTFE, fabric, silk, or Kevlar® brand fiber. These materials may be manufactured as single layer or multi-layer structures. In one embodiment, the inner tube 200 may be made from ePTFE, a thin porous substrate, similar to that described in U.S. Patent Application Publication No. 2007 / 0012624 A1 or U.S. Patent Application Publication No. 2008 / 0053892 A1. The structure may include multiple layers of ePTFE, which may be filled or imbibed with a polymer. The polymer that is filled or imbibed may be the same or different polymer as the structure. One construction can be similar to that disclosed in U.S. Patent No. 7,049,380. The construction of the porous substrate will be further discussed with reference to Figures 5A-C, 6A-C, and 7A-C.

[0019] 2 and 3 show a ring 202 at the end of the inner tube 200. The ring 202 is used to form a rigid member that helps attach the inner tube 200 to the front fitting 106 and the rear fitting 208. The ring 202 may be made of any material having the desired biocompatibility and mechanical properties. The ring is preferably made of fluorinated ethylene propylene (FEP). The inner tube 200 with the attached ring 202 can be inserted through the outer tube 110 and attached to the protruding end of the front fitting 106. The snap ring 108 can then be attached to the front fitting 106 with an adhesive, although other suitable attachment methods would suffice. The remaining unattached ring 202 can then be attached to the protruding end of the rear fitting 208. The snap ring 108' with the fill port 112 can then be snapped onto the rear fitting 208. The method of attachment of the snap ring 108' with the fill port 112 to the rear fitting 208 is similar to that described above. The materials used to manufacture both the snap ring with fill port 112 108 ′ and the rear fitting 208 are as discussed above.

[0020] Figure 2A shows an embodiment in which the pressurizable volume 206 is filled prior to use and thereafter the fill port 112 is closed with a plug 207. This embodiment has nearly the same components as shown in Figure 2, but with the addition of plug 207.

[0021] 4 is an end view of the device, showing the inner tube 200 in a collapsed state. The snap ring 108' with fill port 112 has features that allow the pressurizable space 206 to be filled to a pressure sufficient to collapse the inner tube 200. The pressurizable space 206 may be filled with any suitable material or materials. For example, the pressurizable space 206 may be filled with one or more of the following substances: air, silicone, water, saline solution, low volatility biocompatible liquids, glycerin, propylene glycol, polyethylene glycol, compressible foam, elastomeric spheres, and cross-linked silicone gel.

[0022] 5A-C show perspective views of various porous substrates. The porous substrates may be in a variety of shapes or forms suitable for a particular application.

[0023] Figure 5A shows a flat, planar substrate 500A having an outer surface 502 and a thickness 504. Figure 5B shows a cylindrical or tubular porous substrate 500B having an outer surface 502 and a thickness 504.

[0024] The porous substrate may be in any form or shape, such as a flat planar shape, a cylindrical or tubular shape, or any other shape commonly known in the art. The dimensions of the porous substrate may vary depending on the particular application. For example, the wall thickness 504 may vary, as may the length, width, diameter, etc. A particular dimension may vary along the length, width, or across the substrate surface 502 of the substrate. For example, FIG. 5C illustrates a tubular porous substrate 500C in which the diameter varies along the length of the substrate, forming a "dogbone" shape.

[0025] The porous substrate may comprise a variety of materials, including, for example, ePTFE, fabric, silk, Kevlar® brand fiber, or other materials known in the art. A “porous substrate” is defined as a substrate having openings or pores that may be interconnected. In Figures 6A-C, close-up partial views of the surface of a porous substrate are shown. In Figure 6A, a porous substrate 600A is shown having nodes 602 interconnected by fibrils 604. The openings or pores are shown as 606A. This type of porous substrate may be similar to any expanded polymer. Similarly, in Figure 6B, a porous substrate 600B is shown comprising a solid material 608 having openings or pores 606B. This type of porous substrate may be similar to any biocompatible plastic. The openings or pores may be formed by mechanical or etching means. Other opening or pore forming means in plastics are commonly known in the art. In Figure 6C, a porous substrate 600C is shown comprising fibers or filaments 610 having openings or pores 606C. Porous substrates of this type may be similar to any woven fabric or porous substrate fabricated from woven fibers or fibers.

[0026] A porous substrate may be filled with a substance such as a polymer. The polymer used to fill the openings or pores may be the same polymer as the substrate polymer or a different polymer. Figures 7A-C show enlarged partial views of the surface of a porous substrate filled with a substance. Figure 7A shows a porous substrate 700A with nodes 602 interconnected by fibrils 604 and filled pores 702. Figure 7B shows a porous substrate 700B with a solid material 608 and filled pores 704. Figure 7C shows a porous substrate 700C with fibers 610 and filled openings or pores 706.

[0027] FIG. 8 illustrates another embodiment of the present invention. A sheath 800, similar to sheath 102, is attached to a front fitting 802. Sheath 800 may be of similar dimensions and material to sheath 102, but is formed with a cuff at its most proximal end. Front fitting 802 may then be formed around or attached to sheath 800. Attachment methods are well known in the art and may include adhesives or insert molding. Front fitting 802 may be formed from a material similar to that of front fitting 106. It will be appreciated that front fitting has similar features and advantages as gripping projection 107 (not shown) and flush port with fitting 109. Snap ring 108, outer tube 110, inner tube 200, and pressurizable space 206 have already been described in detail. Rear snap ring 108' is made from a similar material to snap ring with fill port 112 108' and has similar features to snap ring with fill port 112 108'. The rear snap ring 804 may have a fill port featured therein, but preferably does not include a fill port. The pressurizable space 206 may be filled during assembly using special equipment. Filling materials are described above. EXAMPLES

[0028] Without intending to limit the scope of the invention, the following examples illustrate how various embodiments of the invention can be made and / or used.

[0029] Example 1 An introducer sheath valve assembly similar to that shown in FIG. 1 was fabricated using the following parts and assembly method. The parts were fabricated using a stereolithography (SLA) process for rapid prototyping. The parts were fabricated by ProtoCam (Northampton, PA) using an SLA material designated as Accura® 25 plastic. This material, when cured, had a published tensile strength of about 38 MPa, a tensile modulus of about 1590-1660 MPa, an elongation at break of about 13-20%, and a hardness of about 80 Shore D. Tensile and elongation data were obtained using test method ASTM D638. Five parts were fabricated using this SLA process and the Accura® 25 plastic material. The parts included a threaded adapter, a front fitting, a snap ring with a fill port, and a rear fitting.

[0030] Other materials required for the assembly of the introducer sheath valve were purchased from MacMaster-Carr (Santa Fe Springs, CA). A silicone O-ring with a round cross-sectional shape of about 14 mm OD, about 12 mm ID, and about 1 mm width was obtained from MacMaster-Carr (Santa Fe Springs, CA). An FEP ring was fabricated and cut to have an OD of about 12.7 mm (0.475 inch), an ID of about 10.5 mm (0.415 inch), and a thickness of about 0.76 mm (0.030 inch). The FEP sheet used to fabricate the ring was obtained from Saint-Gobain (Hoosick Falls, NY). The outer tube was fabricated using a prototype design mold making rubber, Silastic® T-4 base / hardener, which was ordered from Dow Corning (KR Anderson, Inc. Morgan Hill, CA). The material, when cured, had a published tensile strength of about 970 psi, tear strength of about 150 ppi, hardness of about 40 Shore D, and elongation at break of about 390%. Tear strength data was obtained using test method ISO 34. The sheaths used to manufacture the devices were either FEP or extruded high density polyethylene, had outside diameters ranging from about 7.52 mm to 7.70 mm, and inside diameters ranging from about 6.71 mm to 5.76 mm, and were obtained from various suppliers. Polyvinyl chloride (PVC) tubing, having an outside diameter of about 2.7 mm (0.107 in), an inside diameter of about 1.7 mm (0.068 in), and a length of about 19.05 cm, was obtained from in-house stock. A stainless steel mandrel (used to make the inner tube), having a diameter of about 11.0 mm and a length of about 304.8 mm, was supplied from in-house stock. Polycarbonate 3-way stopcock valves with standard Luer fittings were supplied from in-house stock. Fast-curing cyanoacrylate adhesive and two-part polyurethane adhesive were supplied from in-house stock. Sharpie® fine point permanent markers were obtained from in-house stock.

[0031] The introducer sheath valve was then assembled using the above components. For the sheath assembly, the non-threaded end of the threaded adapter was glued to the proximal end of the sheath using a two-part polyurethane adhesive. A silicone O-ring was then placed into the groove on the threaded end of the threaded adapter.

[0032] For the outer tube assembly, an hourglass shaped silicone tube (outer tube) was insert molded with Silastic® T-4 around a snap ring with a fill port. Silastic® T-4 was mixed according to the manufacturer's instructions, degassed as commonly known in the art, and poured into a custom two-part mold containing the snap ring with fill port and cured. Cure time was about 1 hour minimum at about 75°C. Insert molding was performed in-house as commonly known in the art. The outer tube assembly was then removed from the mold and flash removed. The final outer tube dimensions were tube wall thickness of about 2.7 mm, maximum outer diameter of about 17.8 mm, minimum outer diameter (smallest part of the hourglass shape) of about 12.75 mm, and length of about 22.5 mm.

[0033] An inner tube assembly was then made with a thin porous ePTFE membrane. The thin porous ePTFE membrane was made as described in US Patent Application Publication No. 2007 / 0012624A1 or US Patent Application Publication No. 2008 / 0053892A1. The thin porous membrane was rolled onto a stainless steel mandrel for 5 complete turns and then cut. A thin membrane made according to the teachings of US Patent No. 7,049,380 was rolled onto the same roll for 2 complete turns and then cut. The thin porous ePTFE membrane was rolled for an additional 5 complete turns and then cut. The final thickness of the construct was about 30 microns. The FEP ring was then stretched by hand over a Sharpie® fine point permanent marker, removed from the marker, and placed onto the rolled tube construct with the inner rings spaced about 32.5 mm apart. The assembly was then placed in an ESPEC laboratory furnace (Model No. STPH-201) at about 320° C. for about 14 minutes. The assembly was then removed from the furnace and allowed to cool to room temperature. The assembly was then stripped from the mandrel and cut into segments, each containing two FEP rings.

[0034] The inner tube assembly was then inserted through the outer tube assembly so that an FEP ring extended from each end of the outer tube assembly. The FEP ring on the fill port snap ring was fitted over the protruding diameter of the front fitting. Cyanoacrylate adhesive was applied to the inside surface of the snap ring. The front fitting and outer tube assembly were snapped together by hand. The remaining FEP ring was fitted over the protruding diameter of the rear fitting. Cyanoacrylate adhesive was applied to the inside surface of the fill port snap ring and the rear fitting and fill port snap ring were snapped together by hand.

[0035] The valve assembly was then screwed onto the sheath assembly. PVC tubing was glued to the fill port with cyanoacrylate adhesive, and a three-way stopcock valve was attached to the end of the tubing. The pressurizable space between the outer and inner tubes was pressurized to the desired pressure through the stopcock valve before testing with a water-filled syringe.

[0036] This example introducer sheath valve may be provided in a pre-filled configuration by pressurizing the space between the outer and inner tubes and then blocking the fill port with a plug or occlusive material.

[0037] Example 2 An introducer sheath valve assembly similar to that of FIG. 8 was constructed using the following parts and assembly method. Parts were manufactured by ProtoCam (Northampton, PA) using an SLA material designated as Accura® 25 plastic. This material, when cured, had a published tensile strength of about 38 MPa, a tensile modulus of about 1590-1660 MPa, an elongation at break of about 13-20%, and a hardness of about 80 Shore D. Tensile and elongation data was obtained using test method ASTM D638. Three parts were manufactured using this SLA method and Accura® 25 plastic material. The parts included two snap rings and a rear fitting.

[0038] Other materials required for the assembly of the introducer sheath valve were purchased items. The front fitting was manufactured in-house using a prototype design urethane plastic, Smooth-Cast® 300, ordered from Protocam (Northampton, PA). This material, when cured, had a published tensile strength of about 3000 psi and a hardness of about 70 Shore D. Silicone O-rings of round cross-sectional shape with an outer diameter of about 14 mm, an inner diameter of about 12 mm, and a width of about 1 mm were obtained from MacMaster-Carr (Santa Fe Springs, CA). FEP rings were manufactured in-house and cut to have an outer diameter of about 12.7 mm (0.475 inches), an inner diameter of about 10.5 mm (0.415 inches), and a thickness of about 0.76 mm (0.03 inches). The FEP sheet used to manufacture the rings was obtained from Saint-Gobain (Hoosick Falls, NY). The outer tube was manufactured in-house using a prototype design mold making rubber, Silastic® T-4 base / curative, ordered from Dow Corning (KR Anderson, Inc. Morgan Hill, CA). The material, when cured, had a published tensile strength of about 970 psi, tear strength of about 150 ppi, hardness of about 40 Shore D, and elongation at break of about 390%. Tear strength data was obtained using test method ISO 34. The sheath used to manufacture the device was an extruded high density polyethylene with an outer diameter ranging from about 7.52 mm to 7.70 mm and an inner diameter ranging from about 6.71 mm to 5.76 mm, and was obtained from in-house stock. A stainless steel mandrel (used to make the inner tube) measuring about 11.0 mm in diameter and about 304.8 mm in length was supplied from in-house stock. A fast-curing cyanoacrylate adhesive and a two-part polyurethane adhesive were supplied from in-house stock. Sharpie® fine point permanent markers were obtained from in-house stock.

[0039] The introducer sheath valve was then assembled using the above components. To fabricate the sheath assembly, the polyethylene sheath was RF (radio frequency) machined to form a cuff at its most proximal end. The cuff was approximately 0.94 mm thick and had an outside diameter of 8.59 mm. The front fitting was insert molded over the cuff on the sheath using Smooth-Cast® 300 urethane. The Smooth-Cast® 300 was mixed according to the manufacturer's instructions and poured into a custom two-part mold. The insert molding was performed in-house as known in the art. The assembly was then removed from the mold and flash removed.

[0040] For the outer tube assembly, an hourglass shaped silicone tube (outer tube) was molded using Silastic® T-4 silicone. Silastic® T-4 was mixed as per manufacturer's instructions, degassed as commonly known in the art, and poured into a custom two-part mold and cured. Cure time was about 1 hour minimum at about 75°C. Insert molding was performed in-house as commonly known in the art. The outer tube was then removed from the mold and flash removed. The final outer tube dimensions were about 2.7 mm tube wall thickness, about 17.8 mm maximum outside diameter, about 12.75 mm minimum outside diameter (smallest part of the hourglass shape), and about 22.5 mm length. Snap rings were snapped onto the ends of the silicone tube. The silicone tube lip was lifted and cyanoacrylate adhesive was applied between the lip of the silicone tube and the snap ring. The assembly was then placed at room temperature until the adhesive was fully cured as per manufacturer's instructions.

[0041] The inner tube assembly was prepared according to the method described in Example 1.

[0042] The inner tube assembly was then inserted through the outer tube assembly so that an FEP ring extended from each end of the outer tube assembly. Cyanoacrylate adhesive was applied to the protruding diameter of the front fitting on the sheath assembly and the FEP ring was fitted over the protruding diameter of the front fitting. Cyanoacrylate adhesive was applied to the inside surface of the snap ring on the outer tube assembly. The front fitting and outer tube assembly were snapped together by hand. Cyanoacrylate adhesive was applied to the base of the protruding diameter of the rear lifting. The remaining FEP ring was fitted over the protruding diameter of the rear fitting.

[0043] The pressurizable space between the outer tube and the inner tube was pressurized with glycerin. To pressurize the space with glycerin, the valve assembly was placed into a fixture manufactured in-house. The fixture consisted of a movable housing that gripped the rear fitting and a stationary housing that gripped the snap ring and outer tube assembly. The fixture maintained a gap of approximately 2.0 mm between the rear fitting and the snap ring during pressurization. The fixture also consisted of a cuff with two O-rings therein whose diameter was designed to form a tight seal around the rear fitting and the snap ring. The cuff was fitted into an opening extending through the cuff and a tube was connected to the opening. The tube was connected to a syringe filled with glycerin. The cuff was fitted over the gap between the rear fitting and the snap ring and the pressurizable space was filled with glycerin to the desired pressure. Once the space was filled, the movable housing was pushed towards the snap ring while the cuff was fitted over the gap between the rear fitting and the snap ring, closing the gap. Excess glycerin was removed from the outside of the introducer sheath valve assembly.

[0044] Although specific embodiments of the present invention have been illustrated and described herein, the present invention should not be limited to such illustrations and descriptions. It should be apparent that modifications and variations are incorporated and included as part of the present invention that fall within the scope of the claims. Some aspects of the present invention are described in the following items 1-49. (1) Outer tube, an inner tube comprising a porous substrate; and An introducer sheath valve including a pressurizable space formed between an inner surface of the outer tube and an outer surface of the inner tube. (2) 2. The introducer sheath valve of claim 1, wherein the porous substrate comprises a polymer. (3) 2. The introducer sheath valve of item 1, further comprising at least one polymer filling at least a portion of the porous substrate. (4) 3. The introducer sheath valve of item 2, further comprising at least one polymer filling at least a portion of the porous substrate. (5) 2. The introducer sheath valve of item 1, wherein the pressurizable space is pressurized with at least one substance to a pressure sufficient to collapse the inner tube. (6) 6. The introducer sheath valve of claim 5, wherein the pressure is sufficient to prevent back bleeding. (7) 6. The introducer sheath valve of item 5, wherein at least one interventional device can be advanced through the inner tube. (8) 2. The introducer sheath valve of claim 1, wherein the inner tube comprises a lubricious material. (9) 2. The introducer sheath valve of item 1, wherein the inner tube comprises a material selected from the group consisting of ePTFE (expanded polytetrafluoroethylene), fabric, silk and Kevlar®. (10) 10. The introducer sheath valve of item 9, wherein the inner tube comprises ePTFE. (11) 6. The introducer sheath valve of item 5, wherein the at least one substance comprises a material selected from the group consisting of air, silicone, water, saline, low volatility biocompatible liquids, glycerin, propylene glycol, polyethylene glycol, compressible foam, elastomeric spheres, and cross-linked silicone gel. (12) 2. The introducer sheath valve of item 1, wherein the pressurizable space is formed by sealing a first end of the outer tube to a first end of the inner tube and sealing a second end of the outer tube to a second end of the inner tube. (13) Item 13. The introducer sheath valve of item 12, wherein the seal is provided by at least one of the following: interference fit, adhesive, thermal bonding, and insert molding. (14) Item 14. The introducer sheath valve of item 13, wherein the interference fit is formed using at least one O-ring. (15) 2. The introducer sheath valve of item 1, wherein the pressurizable space maintains a pressure obtained by an external source. (16) Item 16. The introducer sheath of item 15, wherein the pressure is obtained by at least one of the following: finger pressure, a leaf spring, and a pre-filled syringe. (17) Outer tube, an inner tube having a thickness of about 0.0025 mm to about 1 mm; and An introducer sheath valve including a pressurizable space formed between an inner surface of the outer tube and an outer surface of the inner tube. (18) 18. The introducer sheath valve of item 17, wherein the porous substrate comprises a polymer. (19) 18. The introducer sheath valve of item 17, further comprising at least one polymer filling at least a portion of the porous substrate. (20) 20. The introducer sheath valve of item 18, further comprising at least one polymer filling at least a portion of the porous substrate. (twenty one) Item 18. The introducer sheath valve of item 17, wherein the pressurizable space is pressurized with at least one substance to a pressure sufficient to collapse the inner tube. (twenty two) 22. The introducer sheath valve of claim 21, wherein the pressure is sufficient to prevent back bleeding. (twenty three) 22. The introducer sheath valve of item 21, wherein at least one interventional device can be advanced through the inner tube. (twenty four) Item 18. The introducer sheath valve of item 17, wherein the inner tube comprises a lubricious material. (twenty five) 18. The introducer sheath valve of item 17, wherein the inner tube comprises a material selected from the group consisting of ePTFE, fabric, silk and Kevlar®. (26) 26. The introducer sheath valve of item 25, wherein the inner tube comprises ePTFE. (27) 22. The introducer sheath valve of item 21, wherein the at least one substance comprises a material selected from the group consisting of air, silicone, water, saline, low volatility biocompatible liquids, glycerin, propylene glycol, polyethylene glycol, compressible foam, and cross-linked silicone gel. (28) Item 18. The introducer sheath valve of item 17, wherein the pressurizable space is formed by sealing a first end of the outer tube to a first end of the inner tube and sealing a second end of the outer tube to a second end of the inner tube. (29) 30. The introducer sheath valve of item 28, wherein the seal is provided by at least one of the following: interference fit, adhesive, thermal bonding, and insert molding. (30) 30. The introducer sheath valve of claim 29, wherein the interference fit is formed using at least one O-ring. (31) Item 18. The introducer sheath valve of item 17, wherein the pressurizable space maintains a pressure obtained by an external source. (32) Item 32. The introducer sheath of item 31, wherein the pressure is obtained by at least one of the following: finger pressure, a leaf spring, and a prefilled syringe. (33) Outer tube, an inner tube comprising ePTFE; and An introducer sheath valve including a pressurizable space formed between an inner surface of the outer tube and an outer surface of the inner tube. (34) 34. The introducer sheath valve of item 33, wherein the porous substrate comprises a polymer. (35) 34. The introducer sheath valve of item 33, further comprising at least one polymer filling at least a portion of the porous substrate. (36) 35. The introducer sheath valve of item 34, further comprising at least one polymer filling at least a portion of the porous substrate. (37) Item 34. The introducer sheath valve of item 33, wherein the pressurizable space is pressurized with at least one substance to a pressure sufficient to collapse the inner tube. (38) Item 38. The introducer sheath valve of item 37, wherein the pressure is sufficient to prevent back bleeding. (39) Item 38. The introducer sheath valve of item 37, wherein at least one interventional device can be advanced through the inner tube. (40) Item 38. The introducer sheath valve of item 37, wherein the at least one substance comprises a material selected from the group consisting of air, silicone, water, saline solution, low volatility biocompatible liquids, glycerin, propylene glycol, polyethylene glycol, compressible foam, and cross-linked silicone gel. (41) Item 34. The introducer sheath valve of item 33, wherein the pressurizable space is formed by sealing a first end of the outer tube to a first end of the inner tube and sealing a second end of the outer tube to a second end of the inner tube. (42) Item 42. The introducer sheath valve of item 41, wherein the seal is provided by at least one of the following: interference fit, adhesive, thermal bonding, and insert molding. (43) Item 43. The introducer sheath valve of item 42, wherein the interference fit is formed using at least one O-ring. (44) Item 34. The introducer sheath valve of item 33, wherein the pressurizable space maintains a pressure obtained by an external source. (45) Item 45. The introducer sheath of item 44, wherein the pressure is obtained by at least one of the following: finger pressure, a leaf spring, and a prefilled syringe. (46) (a) providing an outer tube; (b) attaching a snap ring to one end of said outer tube and a snap ring with a fill port to the other end of said outer tube to form an outer tube assembly; (c) attaching a ring to each end of the inner tube to form an inner tube assembly; (d) threading the inner tube assembly through the outer tube assembly; (e) attaching the inner tube assembly to a front fitting; (f) snapping the outer tube assembly onto a surface of the front fitting; (g) attaching the inner tube assembly to a rear fitting; (h) snapping the fill port snap ring and the rear fitting closed onto the outer tube assembly; (i) filling the pressurizable space through said fill port prior to use; Including, How to assemble the introducer sheath valve. (47) (a) providing an outer tube; (b) attaching a snap ring to one end of said outer tube and a snap ring with a fill port to the other end of said outer tube to form an outer tube assembly; (c) attaching the inner tube to the front fitting; (d) threading the inner tube through the outer tube assembly; (e) snapping the outer tube assembly onto a surface of the front fitting; (f) attaching the inner tube to a rear fitting; (g) snapping the fill port snap ring and the rear fitting closed onto the outer tube assembly; (i) filling the pressurizable space through said fill port prior to use; Including, How to assemble the introducer sheath valve. (48) (a) providing an outer tube; (b) attaching snap rings to both ends of said outer tube to form an outer tube assembly; (c) attaching a ring to each end of the inner tube to form an inner tube assembly; (d) threading the inner tube assembly through the outer tube assembly; (e) attaching the inner tube assembly to a front fitting; (f) snapping the outer tube assembly onto a surface of the front fitting; (g) attaching the inner tube assembly to a rear fitting; (h) filling a space formed between the inner tube and the outer tube assembly with a substance; (i) snapping a snap ring onto the outer tube assembly and the rear fitting closed; (j) removing all excess fluid from the outer tube-housing unit; Including, How to assemble the introducer sheath valve. (49) (a) providing an outer tube; (b) attaching snap rings to both ends of said outer tube to form an outer tube assembly; (c) attaching the inner tube to the threaded adapter; (d) threading the inner tube through the outer tube assembly; (e) snapping the outer tube assembly onto a surface of the threaded adapter; (f) attaching the inner tube to a rear fitting; (g) filling a space formed between the inner tube and the outer tube housing with a substance; (h) snapping the inner tube and the rear fitting closed; (i) Removing all excess fluid from the outer tube-housing unit; Including, How to assemble the introducer sheath valve.

Claims

1. Outer tube, an inner tube comprising a multi-layer structure; and 1. A valve including a pressurizable space formed between an inner surface of the outer tube and an outer surface of the inner tube, the pressurizable space being configured to expand when pressurized and to expand due to radially inward deformation of the inner tube and radially outward deformation of the outer tube.

2. The valve of claim 1, wherein the multi-layer structure comprises multiple layers of a porous substrate.

3. The valve of claim 2, wherein the porous substrate comprises ePTFE (expanded polytetrafluoroethylene).

4. The valve of claim 2, wherein one or more layers of the multi-layer structure are imbibed with a polymer.

5. Providing an outer tube having both ends and formed of an elastomeric material; providing an inner tube having opposite ends and formed of a drapable material; inserting the inner tube assembly into the outer tube assembly; sealing the space between the inner tube and the outer tube; and providing a fitting in fluid communication with the space between the inner tube and the outer tube, the fitting causing the outer tube to expand from an hourglass shape upon pressurization of the space to provide a visual indication that a desired pressure has been reached in the space; A method for assembling an introducer sheath valve, comprising:

6. The method of claim 5, wherein sealing the space is achieved by at least one of the following: interference fit, adhesive bonding, thermal bonding, and insert molding.

7. The method of claim 6, wherein the interference fit is formed using at least one O-ring.

8. The method of claim 5, wherein the space is configured to maintain a desired pressure applied in the space by an external source.

9. The method of claim 8, wherein the desired pressure is obtained by at least one of the following: finger pressure, a leaf spring, and a pre-filled syringe.

10. Providing an outer tube; Providing an inner tube; attaching a first ring to one end of the outer tube and a second ring with a fill port to the other end of the outer tube to form an outer tube assembly; attaching the inner tube to a front fitting; threading the inner tube through the outer tube assembly; attaching said outer tube assembly to a surface of said front fitting; attaching the inner tube to a rear fitting; attaching the second ring to the rear fitting; and pressurizing a space between the inner tube and the outer tube; A method for assembling an introducer sheath valve, comprising:

11. The method of claim 10, wherein pressurizing the space crushes a crushable portion of the inner tube by filling the space with the fill port.

12. The method of claim 11, wherein the outer tube expands upon pressurization of the space to provide a visual indication that the space is pressurized.

13. Providing an outer tube; Providing an inner tube; attaching snap rings to both ends of said outer tube to form an outer tube assembly; attaching a ring to each end of the inner tube to form an inner tube assembly; threading the inner tube assembly through the outer tube assembly; attaching the inner tube assembly to a front fitting; snapping said outer tube assembly onto a surface of said front fitting; attaching the inner tube assembly to a rear fitting; filling a space formed between said inner tube and said outer tube assembly with a substance; snapping the snap ring and the rear fitting closed onto the outer tube assembly; and removing any excess fluid from said outer tube housing unit; A method for assembling an introducer sheath valve, comprising:

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