Improved catheter devices and related methods of use

Abstract

An improved catheter device (20) is used in conjunction with a hemostasis valve (32) having a compression seal (42) for temporarily forming a reduced inner diameter (D3) within a valve cavity (40) of the hemostasis valve (32). The device (20) comprises an elongate conduit (22) having at least one protrusion (44) extending radially outward from an outer surface (30) of the conduit (22), the at least one protrusion (44) having an outer diameter (D4) smaller than a neutral inner diameter (D2) of the valve cavity (40) but larger than a reduced inner diameter (D3) of the valve cavity (40). In use of the device (20), the catheter (22) is located at a distance within the valve cavity (40), and the compression seal (42) then creates a reduced inner diameter (D3) within the valve cavity (40), and the at least one protrusion (44) contacts the compression seal (42) and prevents the catheter (22) from sliding out of the hemostasis valve (32).

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Patent Application 18 / 104,616, filed February 1, 2023. BACKGROUND

[0003] The subject matter of this patent application relates generally to catheters, and more particularly to an improved catheter device that is capable of forming a sufficient seal with a hemostatic valve while maintaining the structural integrity of the catheter and the catheter’s position within a sheath engaged with the hemostatic valve.

[0004] Applicant hereby incorporates by reference any and all patents and published patent applications cited in or referred to in this application.

[0005] BACKGROUND: Hemostatic valves are commonly used in neurovascular procedures for continuous irrigation of catheters, urinary catheters, dilators, etc. (hereinafter collectively referred to for simplicity as “catheters”) to minimize blood loss and reduce the risk of thromboembolic events. Thus, a hemostatic valve is used to leak-proof introduction of a catheter into a patient’s circulatory system or other part of the patient’s body. Typically, a relatively large diameter sheath, catheter, or dilator (hereinafter collectively referred to for simplicity as “sheath”) is connected to a second end of the hemostatic valve, and then a catheter is inserted into a first end and passed through the sheath to a desired location within the patient’s body. After the catheter is inserted into place, the hemostatic valve is closed to prevent blood from escaping from the patient’s body through the sheath and / or catheter.

[0006] Conventional hemostatic valves, commonly referred to as rotating hemostatic valves (“RHVs”), have a rotating compression seal at one end that is rotated open or closed each time a catheter is inserted or removed. In more detail, the compression seal typically includes a deformable grommet that is positioned within a conical opening such that when the seal is rotated to a closed position, the grommet deforms until it pinches the catheter. Each time the catheter is adjusted, the seal must first be rotated to an open position to allow the catheter to move, and then rotated back to a closed position to reestablish the seal after adjustment. During the time the valve is open, blood and other fluids can leak from the patient. Similarly, if the seal is not tight enough around the catheter during the procedure, blood and other fluids can leak from the patient through the sheath and / or catheter, which can cause blood to stagnate within the sheath or catheter and become a potential source of embolization during the procedure. Furthermore, if the seal is not tight enough around the catheter, the sheath and catheter can inadvertently be pushed back a distance, through the sheath, and out of the first end of the hemostatic valve as the sheath and catheter are moved forward within the patient (e.g., during initial insertion or subsequent movement of the sheath). On the other hand, if the seal is too tight around the catheter, the sheath and / or catheter can be damaged.

[0007] Accordingly, there remains a need for an improved catheter that is capable of forming a sufficient seal with a hemostatic valve while maintaining the structural integrity of the catheter and the position of the catheter within the sheath that engages the hemostatic valve. Various aspects of the present invention satisfy these needs, and provide further related advantages as described hereinbelow.

[0008] It is noted that the foregoing description of background art is provided to aid in understanding various aspects of the present invention. It should not be construed as an admission that any of the information provided herein is prior art with respect to the present invention or related to any present claim. SUMMARY

[0009] Various aspects of the present invention teach certain benefits with respect to construction and use, resulting in the following exemplary advantages.

[0010] The present invention addresses the foregoing problems by providing, in at least one embodiment, an improved catheter device for a hemostatic valve. The hemostatic valve is provided with a valve body having a first end and an opposite second end, with a valve lumen extending between the first end and the second end. The hemostatic valve is also provided with an elongated sheath that engages the second end of the valve body and is in fluid communication with the valve lumen, and a compression seal located proximal to the first end of the valve body and configured to temporarily form a reduced inner diameter within the valve lumen. In at least one such embodiment, the device provides an elongated catheter having a first end and an opposite second end, with an outer surface of the catheter having an outer diameter that is less than a neutral inner diameter of the valve lumen, thereby allowing the catheter to be slidably inserted within the valve lumen a distance. At least one protrusion extends radially outward from the outer surface of the catheter, with the at least one protrusion having an outer diameter that is less than the neutral inner diameter of the valve lumen but greater than the reduced inner diameter of the valve lumen. During use of the device, the catheter is positioned within the valve lumen a distance, and the compression seal subsequently forms the reduced inner diameter within the valve lumen, with the at least one protrusion contacting the compression seal and preventing the catheter from sliding toward the first end of the valve body.

[0011] In at least one further embodiment, a catheter and hemostatic valve combination system provides a hemostatic valve including a valve body having a first end and an opposite second end, with a valve lumen extending therebetween, the valve lumen having a neutral inner diameter; an elongated sheath engaged with the second end of the valve body and in fluid communication with the valve lumen; and a compression seal located proximally of the first end of the valve body and configured to temporarily form a reduced inner diameter within the valve lumen. Accordingly, the hemostatic valve is configured to selectively move between a closed state, in which the compression seal is radially collapsed, thereby forming the reduced inner diameter within the valve lumen, and an open state, in which the compression seal is moved radially outward, thereby no longer forming the reduced inner diameter within the valve lumen. The system further provides a catheter device including an elongated catheter having a first end and an opposite second end, an outer diameter of an outer surface of the catheter being less than the neutral inner diameter of the valve lumen, thereby allowing the catheter to be slidably inserted within the valve lumen a distance. At least one protrusion extends radially outward from the outer surface of the catheter, the at least one protrusion having an outer diameter that is less than the neutral inner diameter of the valve lumen but greater than the reduced inner diameter of the valve lumen. In use of the device, the catheter is located within the valve lumen a distance, the hemostatic valve is subsequently moved to the closed state, the at least one protrusion contacts the compression seal, and the catheter is prevented from sliding toward the first end of the valve body.

[0012] Other features and advantages of the present application will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of various aspects of the application. BRIEF DESCRIPTION OF DRAWINGS

[0013] The accompanying drawings illustrate various aspects of the application. In such drawings:

[0014] Figure 1 and Figure 2 is a partial side view of an exemplary catheter device according to at least one embodiment;

[0015] Figure 3 is a partial side view of another exemplary catheter device according to at least one embodiment;

[0016] Figure 4 is a partial side view of yet another exemplary catheter device according to at least one embodiment;

[0017] Figure 5 and Figure 6 is a cross-sectional view of an exemplary hemostatic valve according to at least one embodiment; and

[0018] Figure 7 is an exemplary hemostatic valve according to at least one embodiment positioned within an exemplary catheter device as Figure 4 and 5 is an exemplary hemostatic valve according to at least one embodiment positioned within an exemplary catheter device as Figure 1 and 2FIG. 1 is a partial cross-sectional view of an exemplary catheter device.

[0019] The above figures illustrate various aspects of the present application in the form of at least one exemplary embodiment, which will be further described in detail below. Features, elements, and aspects of the present application that are referenced by the same numerals in different figures represent the same, equivalent, or similar features, elements, or aspects in accordance with one or more embodiments. DETAILED DESCRIPTION

[0020] Turning now to Figure 1 , a partial side view of one exemplary embodiment of an improved catheter device 20 is shown. In at least one embodiment, device 20 provides an elongated catheter 22 having a first end 24 and an opposite second end 26, and a hub 28 engaged with first end 24 of catheter 22. In at least one embodiment, catheter 22 is made from one or more of polyether, polyester, polyimide, nylon, polyurethane, polyetherimide, polyether ether ketone, polyamide, silicone, polyether block amide, and polyethylene. However, in other embodiments, catheter 22 can be made from any other known or later-developed material (or combination of materials) - depending at least in part on the particular use environment of device 20 - so long as device 20 is capable of substantially performing the functions described herein. It is initially noted that catheter 22 and hub 28 shown in the figures are merely exemplary and are for illustrative purposes only. Thus, in other embodiments, catheter 22 and hub 28 can take on any other size, shape, and / or dimension (including having multiple lumens instead of the single lumen shown in the figures) - depending at least in part on the particular use environment of device 20 - so long as device 20 is capable of substantially performing the functions described herein. Moreover, in at least one alternative embodiment, hub 28 can be omitted. It is again emphasized that the term "catheter" used herein is intended to refer to any and all types of tubes, catheters, dilators, etc. that can be used in intravascular procedures (e.g., neurovascular, peripheral, and cardiac procedures).

[0021] In at least one embodiment, as shown in Figure 7 , outer surface 30 of catheter 22 has an outer diameter D1 Figure 2 that is sized to allow catheter 22 to be slidably inserted into a hemostatic valve 32 for a distance. In at least one embodiment, outer diameter D1 of catheter 22 is about 1 French to about 34 French - depending at least in part on the particular use environment of device 20; however, in other embodiments, outer diameter D1 of catheter 22 can be less than 1 French or greater than 34 French. In at least one embodiment, hemostatic valve 32 is provided with a valve body 34 having a first end 36 and an opposite second end 38, and a valve lumen 40 extending therebetween, valve lumen 40 having a neutral inner diameter D2Figure 5 ), the inner diameter is relatively larger than the outer diameter D1 of the catheter 22 so as to slidably accommodate a section of the catheter 22 passing therethrough. In addition, in at least one embodiment, as Figure 6 As shown, the second end 38 of the valve body 34 is engageable with an elongated sheath 46 (also sized to slidably receive a length of the catheter 22 therethrough). The sheath 46 is in fluid communication with the valve cavity 40 and has a length that is relatively shorter than the length L1 of the catheter 22, such that the second end 26 of the catheter 22 can extend a distance beyond the distal end 48 of the sheath 46 during use of the device 20. The first end 36 of the valve body 34 is sized and configured to removably receive the second end 26 of the catheter 22 when the catheter 22 is inserted into the hemostasis valve 32, and is further configured to frictionally engage the outer surface 30 of the catheter 22 substantially proximate the first end 24 (after the catheter 22 has been inserted a desired distance into the hemostasis valve 32). In at least one embodiment, the valve body 34 further includes a compression seal 42 that is located substantially proximate the first end 36 of the valve body 34 and is configured to radially collapse or otherwise move inward within the valve cavity 40, thereby clamping the catheter 22. Therefore, the hemostatic valve 32 is configured to be selectively closed in the closed state ( Figure 6 )—wherein the compression seal 42 moves radially inwardly to clamp the conduit 22—and an open state ( Figure 5 ) - wherein the compression seal 42 moves radially outward so as to no longer frictionally engage the catheter 22. In other words, when the hemostatic valve 32 is in the closed state, the compression seal 42 temporarily forms a reduced inner diameter D3 within a portion of the valve cavity 40 that is smaller than the outer diameter D1 of the catheter 22. In at least one embodiment, as Figure 5 As shown, when the hemostatic valve 32 is in the open state, the inner diameter of the compression seal 42 is substantially equal to the neutral inner diameter D2 of the valve cavity 40. It should be noted that the hemostatic valve 32 shown in the figures is merely exemplary and is used for illustrative purposes only. Therefore, in other embodiments, the hemostatic valve 32 may adopt any other size, shape, dimensions, and / or configuration currently known or later developed.

[0022] Reference again Figure 1 and Figure 2 In at least one embodiment, the outer surface 30 of the conduit 22 is provided with at least one protrusion 44 extending radially outward from the outer surface 30 of the conduit 22, such that the outer diameter D4 of the at least one protrusion is greater than the outer diameter D1 of the conduit 22. In at least one embodiment, the at least one protrusion 44 also extends to the entire circumference of the outer surface 30 of the conduit 22. In at least one alternative embodiment, the at least one protrusion 44 does not extend to the entire circumference of the outer surface 30 of the conduit 22. In at least one embodiment, the outer diameter D4 of the at least one protrusion 44 ( Figure 2) is smaller than the neutral inner diameter D2 of the valve cavity 40, but larger than the reduced inner diameter D3 of the valve cavity 40 when the hemostatic valve 32 is in the closed state. Thus, when the hemostatic valve 32 is in the open state, the catheter 22 can slide freely in the valve cavity 40; and when the hemostatic valve 32 is in the closed state, the at least one protrusion 44 of the catheter 22 prevents the catheter 22 from sliding toward the first end 36 of the valve body 34 (i.e., moving backward) when the at least one protrusion 44 contacts the compression seal 42, as shown in FIG. Figure 7 As shown (i.e., the compression seal 42 constrains the at least one protrusion 44 within the valve cavity 40). In addition, when the hemostatic valve 32 enters the closed state, if the position of the at least one protrusion 44 is substantially consistent with the compression seal 42 when the compression seal 42 radially collapses within the valve cavity 40, the at least one protrusion 44 can increase the structural integrity of the catheter 22, thereby better preventing the catheter 22 from being crushed or otherwise damaged by the compression seal 42.

[0023] In at least one embodiment, the at least one protrusion 44 is made of one or more of the following materials: polyether, polyester, polyimide, nylon, polyurethane, polyetherimide, polycarbonate, polyetheretherketone, polyamide, silicone, polyethylene, acrylic acid, acrylonitrile-butadiene-styrene copolymer, methyl methacrylate-butadiene-styrene copolymer, polypropylene, polyether block amide ("PEBA"), or any common polymer or combination thereof, thereby forming a block copolymer. In at least one further embodiment, the at least one protrusion 44 is made of one or more of the following materials: stainless steel, nitinol, cobalt-chromium alloy, platinum-iridium alloy, or other metal or alloy. In at least one further embodiment, the at least one protrusion 44 is made of a viscous high-friction material to increase the friction between the at least one protrusion 44 and the compression seal 42 when the hemostasis valve 32 is in the closed state. In at least one further embodiment, the at least one protrusion 44 is made of a semi-compliant polymer to cooperate with the compression seal 42 to form a seal when the hemostasis valve 32 is in the closed state. In at least one further embodiment, at least one protrusion 44 is made of one or more radiopaque materials to facilitate positioning of the catheter 22 within the valve cavity 40. In at least one such embodiment, the at least one protrusion 44 is made of a tungsten-containing polymer. In further embodiments, the at least one protrusion 44 can be made of platinum, chromium, cobalt, tantalum, nitinol, gold, silver, bismuth carbonate, barium sulfate, bismuth oxychloride, bismuth trioxide, stainless steel, or alloys thereof, or any other now known or later developed radiopaque material (or combination of materials). In further embodiments, the at least one protrusion 44 can be made of any other material (or combination of materials) now known or later developed—depending at least in part on the specific environment in which the device 20 is to be used—so long as the device 20 is capable of substantially performing the functions described herein.

[0024] In at least one embodiment, the outer diameter D4 of the at least one protrusion 44 is about 100.1% to about 500% of the outer diameter Dl of the conduit 22, depending at least in part on the neutral inner diameter D2 of the valve cavity 40 (assuming that the outer diameter D4 of the at least one protrusion 44 must be less than the neutral inner diameter D2 of the valve cavity 40, as described above). In further embodiments, the outer diameter D4 of the at least one protrusion 44 can be greater than 500% of the outer diameter Dl of the conduit 22— again, depending at least in part on the neutral inner diameter D2 of the valve cavity 40. In at least one embodiment, the length L2 of the at least one protrusion 44 is about 0.001 inches to about 20 inches; however, in other embodiments, the length L2 of the at least one protrusion 44 can be less than 0.001 inches or greater than 20 inches. Thus, in other embodiments (as shown in the non-limiting examples of FIGS. 2-3), the at least one protrusion 44 can take any other known or subsequently developed size, shape, number, dimension, and / or relative position— depending at least in part on the particular use environment of the device 20— so long as the device 20 is capable of substantially achieving the functionality described herein. Figure 3 and Figure 4 Thus, in other embodiments (as shown in the non-limiting examples of FIGS. 2-3), the at least one protrusion 44 can take any other known or subsequently developed size, shape, number, dimension, and / or relative position— depending at least in part on the particular use environment of the device 20— so long as the device 20 is capable of substantially achieving the functionality described herein.

[0025] In this regard, in at least one embodiment, the position of the at least one protrusion 44 relative to the first end 24 of the conduit 22 is configured to indicate the distance that the opposite second end 26 of the conduit 22 extends from the terminal end 48 of the sheath 46 engaged with the hemostatic valve 32 when the protrusion 44 is substantially aligned with the compression seal 42. Given that the terminal end 48 of the sheath 46 (along with the second end 26 of the conduit 22) will be positioned within the patient (and thus, not visible to the medical service provider operating the device 20) during use of the device 20, providing such a visual indicator near the first end 24 of the conduit 22 allows the medical service provider to determine the distance that the second end 26 of the conduit 22 extends beyond the terminal end 48 of the sheath 46. Moreover, given that the at least one protrusion 44 in at least one embodiment can be frictionally engaged by the compression seal 42 (as described above), the medical service provider can substantially set the distance that the opposite second end 26 of the conduit 22 extends from the terminal end 48 of the sheath 46 prior to actually inserting the device 20 into the patient by positioning the at least one protrusion 44 relative to the compression seal 42 as desired, and then moving the hemostatic valve 32 to the closed state. In at least one such embodiment, as shown in the non-limiting example of FIG. 3, the at least one protrusion 44 can be configured to extend beyond the terminal end 48 of the sheath 46 when the protrusion 44 is substantially aligned with the compression seal 42. Figure 3As shown, the outer surface 30 of the conduit 22 is provided with a plurality of spaced-apart protrusions 44 along its length, each protrusion 44 spaced apart from one another by a distance S (the spacing can be uniform or varied). In such embodiments, the location of each protrusion 44 indicates a different distance that the opposite second end 26 of the conduit 22 extends beyond the distal end 48 of the sheath 46 when the respective protrusion 44 is substantially aligned with the compression seal 42. In at least one embodiment, the distance S between each protrusion 44 is about 0.001 inches to about 20 inches; however, in other embodiments, the distance S between each protrusion 44 can be less than 0.001 inches or greater than 20 inches. In at least one embodiment, when the outer surface 30 of the conduit 22 is provided with a plurality of spaced-apart protrusions 44, each protrusion 44 has substantially similar size, shape, dimensions, material of construction, and relative spacing. In at least one alternative embodiment, one or more protrusions 44 have different size, shape, dimensions, material of construction, and / or relative spacing as compared to one or more other protrusions 44.

[0026] Various aspects of the present specification can also be described as the following embodiments:

[0027] 1. A conduit device for use with a hemostatic valve, the hemostatic valve providing a valve body having a first end and an opposite second end, a valve lumen extending between the first end and the second end, an elongated sheath engaged with the second end and in fluid communication with the valve lumen, and a compression seal positioned generally proximal to the first end and configured to temporarily create a reduced inner diameter within the valve lumen, the device comprising: an elongated conduit having a first end and an opposite second end, an outer diameter of an outer surface of the conduit being less than a neutral inner diameter of the valve lumen, thereby allowing the conduit to be slidably inserted within the valve lumen a distance; and at least one protrusion extending radially outward from the outer surface of the conduit substantially proximal to the first end of the conduit, the at least one protrusion having an outer diameter that is less than the neutral inner diameter of the valve lumen but greater than the reduced inner diameter of the valve lumen; whereby, when the conduit is positioned within the valve lumen a distance and the compression seal subsequently creates the reduced inner diameter within the valve lumen, the at least one protrusion contacts the compression seal and prevents the conduit from sliding toward the first end of the valve body.

[0028] 2. The conduit device of embodiment 1, further comprising a hub engaged with the first end of the conduit.

[0029] 3. The conduit device of embodiments 1-2, wherein the conduit is constructed from one or more of polyether, polyester, polyimide, nylon, polyurethane, polyetherimide, polyether ether ketone, polyamide, silicone, polyether block amide, and polyethylene.

[0030] 4. The conduit device of embodiments 1-3, wherein the outer diameter of the conduit is about 1 French to about 34 French.

[0031] 5. The catheter device of embodiments 1-4, wherein the outer diameter of the catheter is less than 1 French or greater than 34 French.

[0032] 6. The catheter device of embodiments 1-5, wherein the length of the catheter is greater than the length of the sheath such that the second end of the catheter can extend beyond the terminal end of the sheath by a distance during use of the device.

[0033] 7. The catheter device of embodiments 1-6, wherein the at least one protrusion extends around the entire circumference of the outer surface of the catheter.

[0034] 8. The catheter device of embodiments 1-7, wherein the at least one protrusion extends around less than the entire circumference of the outer surface of the catheter.

[0035] 9. The catheter device of embodiments 1-8, wherein the at least one protrusion is comprised of one or more of polyether, polyester, polyimide, nylon, polyurethane, polyetherimide, polycarbonate, polyether ether ketone, polyamide, silicone, polyethylene, acrylic, acrylonitrile butadiene styrene, methyl methacrylate butadiene styrene, polypropylene, polyether block amide ("PEBA"), or a block copolymer of any common polymer or combination.

[0036] 10. The catheter device of embodiments 1-9, wherein the at least one protrusion is comprised of one or more of stainless steel, nitinol, cobalt-chrome, platinum-iridium, or other metals or alloys.

[0037] 11. The catheter device of embodiments 1-10, wherein the at least one protrusion is comprised of a tacky high-friction material to increase friction between the at least one protrusion and a compression seal as the compression seal creates a reduced inner diameter within the valve cavity.

[0038] 12. The catheter device of embodiments 1-11, wherein the at least one protrusion is comprised of a semi-flexible polymer to cooperate with a compression seal to form a seal therebetween as the compression seal creates a reduced inner diameter within the valve cavity.

[0039] 13. The catheter device of embodiments 1-12, wherein the at least one protrusion is comprised of one or more radiopaque materials to facilitate positioning of the catheter within the valve cavity.

[0040] 14. The catheter device of embodiments 1-13, wherein the at least one protrusion is comprised of a tungsten-containing polymer.

[0041] 15. The catheter device of embodiments 1-14, wherein the at least one protrusion is comprised of one or more of platinum, chromium, cobalt, tantalum, nitinol, gold, silver, bismuth carbonate, barium sulfate, bismuth oxychloride, bismuth trioxide, stainless steel, or alloys thereof.

[0042] 16. The catheter device of embodiments 1-15, wherein the at least one protrusion has an outer diameter that is about 100.1% to about 500% of the outer diameter of the catheter.

[0043] 17. The catheter device of embodiments 1-16, wherein the at least one protrusion has an outer diameter that is greater than 500% of the outer diameter of the catheter.

[0044] 18. The catheter device of embodiments 1-17, wherein the at least one protrusion has a length of about 0.001 inches to about 20 inches.

[0045] 19. The catheter device of embodiments 1-18, wherein the at least one protrusion has a length of less than 0.001 inches or greater than 20 inches.

[0046] 20. The catheter device of embodiments 1-19, wherein the position of the at least one protrusion relative to the first end of the catheter indicates a corresponding distance that the opposite second end of the catheter extends from the terminal end of the sheath when the protrusion is substantially aligned with the compression seal.

[0047] 21. The catheter device of embodiments 1-20, further comprising a plurality of spaced apart protrusions along the length of the catheter, each protrusion positioned relative to the first end so as to indicate a corresponding distance that the opposite second end of the catheter extends from the terminal end of the sheath when the protrusion is substantially aligned with the compression seal.

[0048] 22. The catheter device of embodiments 1-21, wherein the protrusions are spaced apart from each other by about 0.001 inches to about 20 inches.

[0049] 23. The catheter device of embodiments 1-22, wherein the protrusions are spaced apart from each other by less than 0.001 inches or greater than 20 inches.

[0050] 24. A catheter device for use with a hemostatic valve providing a valve body having a first end and an opposite second end, a valve lumen extending between the first end and the second end, an elongated sheath engaged with the second end and in fluid communication with the valve lumen, and a compression seal positioned substantially proximal to the first end and configured to temporarily create a reduced inner diameter within the valve lumen, the device comprising: an elongated catheter having a first end and an opposite second end, an outer diameter of an outer surface of the catheter being less than the neutral inner diameter of the valve lumen to allow the catheter to be slidably inserted into the valve lumen a distance; the length of the catheter being greater than the length of the sheath such that when the catheter is inserted into the valve lumen the distance, the second end of the catheter extends a distance beyond the distal end of the sheath; and at least one protrusion extending radially outward from the outer surface of the catheter and having an outer diameter less than the neutral inner diameter of the valve lumen but greater than the reduced inner diameter of the valve lumen, the at least one protrusion being positioned relative to the first end of the catheter to indicate the respective distance that the opposite second end of the catheter extends beyond the distal end of the sheath when the protrusion is substantially aligned with the compression seal; whereby when the catheter is positioned within the valve lumen the distance and the compression seal subsequently creates the reduced inner diameter within the valve lumen, the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body.

[0051] 25. A combined catheter and hemostatic valve system comprising: a hemostatic valve including a valve body having a first end and an opposite second end, a valve lumen extending between the first end and the second end, the valve lumen having a neutral inner diameter; an elongated sheath engaged with the second end of the valve body and in fluid communication with the valve lumen; and a compression seal positioned substantially proximal to the first end of the valve body and configured to temporarily create a reduced inner diameter within the valve lumen; the hemostatic valve being configured to selectively move between one of a closed state in which the compression seal is radially collapsed to create the reduced inner diameter within the valve lumen and an open state in which the compression seal is moved radially outward to no longer create the reduced inner diameter within the valve lumen, and a catheter device including an elongated catheter having a first end and an opposite second end, an outer diameter of an outer surface of the catheter being less than the neutral inner diameter of the valve lumen to allow the catheter to be slidably inserted into the valve lumen a distance; and at least one protrusion extending radially outward from the outer surface of the catheter substantially proximal to the first end of the catheter, the at least one protrusion having an outer diameter less than the neutral inner diameter of the valve lumen but greater than the reduced inner diameter of the valve lumen; whereby when the catheter is positioned within the valve lumen the distance and the hemostatic valve is subsequently moved to the closed state, the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body.

[0052] 26. The combined catheter and hemostatic valve system of embodiment 25, further comprising a hub engaged with the first end of the catheter.

[0053] 27. The combination catheter and hemostasis valve system of embodiments 25-26, wherein the catheter is constructed of one or more of polyether, polyester, polyimide, nylon, polyurethane, polyetherimide, polyether ether ketone, polyamide, silicone, polyether block amide, and polyethylene.

[0054] 28. The combination catheter and hemostasis valve system of embodiments 25-27, wherein the catheter has an outer diameter of about 1 French to about 34 French.

[0055] 29. The combination catheter and hemostasis valve system of embodiments 25-28, wherein the catheter has an outer diameter of less than 1 French or greater than 34 French.

[0056] 30. The combination catheter and hemostasis valve system of embodiments 25-29, wherein the length of the catheter is greater than the length of the sheath such that the second end of the catheter can extend beyond the terminal end of the sheath by a distance during use of the device.

[0057] 31. The combination catheter and hemostasis valve system of embodiments 25-30, wherein the at least one protrusion extends around the entire circumference of the outer surface of the catheter.

[0058] 32. The combination catheter and hemostasis valve system of embodiments 25-31, wherein the at least one protrusion extends around less than the entire circumference of the outer surface of the catheter.

[0059] 33. The combination catheter and hemostasis valve system of embodiments 25-32, wherein the at least one protrusion is constructed of one or more of polyether, polyester, polyimide, nylon, polyurethane, polyetherimide, polycarbonate, polyether ether ketone, polyamide, silicone, polyethylene, acrylic, acrylonitrile butadiene styrene, methyl methacrylate butadiene styrene, polypropylene, polyether block amide (“PEBA”), or a block copolymer of any common polymer or combination.

[0060] 34. The combination catheter and hemostasis valve system of embodiments 25-33, wherein the at least one protrusion is constructed of one or more of stainless steel, nitinol, cobalt-chrome, platinum-iridium, or other metals or alloys.

[0061] 35. The combination catheter and hemostasis valve system of embodiments 25-34, wherein the at least one protrusion is constructed of a tacky high-friction material to increase friction between the at least one protrusion and the compression seal as the compression seal creates a reduced inner diameter within the valve cavity.

[0062] 36. The combination catheter and hemostatic valve system according to embodiments 25-35, wherein the at least one protrusion is comprised of a semi-flexible polymer to cooperate with the compression seal to form a seal therebetween as the compression seal creates a reduced inner diameter within the valve lumen.

[0063] 37. The combination catheter and hemostatic valve system according to embodiments 25-36, wherein the at least one protrusion is comprised of one or more radiopaque materials to facilitate positioning of the catheter within the valve lumen.

[0064] 38. The combination catheter and hemostatic valve system according to embodiments 25-37, wherein the at least one protrusion is comprised of a tungsten-containing polymer.

[0065] 39. The combination catheter and hemostatic valve system according to embodiments 25-38, wherein the at least one protrusion is comprised of one or more of platinum, chromium, cobalt, tantalum, nitinol, gold, silver, bismuth carbonate, barium sulfate, bismuth oxychloride, bismuth trioxide, stainless steel, or alloys thereof.

[0066] 40. The combination catheter and hemostatic valve system according to embodiments 25-39, wherein the at least one protrusion has an outer diameter that is about 100.1% to about 500% of the outer diameter of the catheter.

[0067] 41. The combination catheter and hemostatic valve system according to embodiments 25-40, wherein the at least one protrusion has an outer diameter that is greater than 500% of the outer diameter of the catheter.

[0068] 42. The combination catheter and hemostatic valve system according to embodiments 25-41, wherein the at least one protrusion has a length of about 0.001 inches to about 20 inches.

[0069] 43. The combination catheter and hemostatic valve system according to embodiments 25-42, wherein the at least one protrusion has a length of less than 0.001 inches or greater than 20 inches.

[0070] 44. The combination catheter and hemostatic valve system according to embodiments 25-43, wherein the position of the at least one protrusion relative to the first end of the catheter indicates a corresponding distance that the opposite second end of the catheter extends from the terminal end of the sheath when the protrusion is substantially aligned with the compression seal.

[0071] 45. The combination catheter and hemostatic valve system according to embodiments 25-44, further comprising a plurality of spaced apart protrusions along the length of the catheter, each protrusion positioned relative to the first end to indicate a corresponding distance that the opposite second end of the catheter extends from the terminal end of the sheath when the protrusion is substantially aligned with the compression seal.

[0072] 46. The combination catheter and hemostatic valve system according to embodiments 25-45, wherein the protrusions are spaced apart from each other by about 0.001 inches to about 20 inches.

[0073] 47. The combination catheter and hemostatic valve system of embodiments 25-46, wherein the protrusions are spaced less than 0.001 inches or more than 20 inches from each other.

[0074] Finally, with regard to the exemplary embodiments of the application illustrated and described herein, it is to be understood that the application discloses an improved catheter device configured to form a sufficient seal with a hemostatic valve while maintaining the structural integrity of the catheter and the position of the catheter within the sheath engaged with the hemostatic valve. As such, the application contemplates that the principles of the application can be embodied in a variety of configurations other than the exemplary embodiments specifically disclosed herein, and that the application can be practiced with other structures and materials in addition to and in conjunction with the specific structures and materials disclosed. It is understood that the application is not limited in any way to the exemplary embodiments disclosed herein, but rather the application is broadly applicable to an improved catheter device, and as such, the application contemplates the use of any and all combinations of the features described herein and any and all equivalents thereof, in as many values as can be taken by them alone or in combination with other values. It will also be understood that the application is not limited in any way to the particular geometry and materials of construction disclosed, but rather, other functionally equivalent structures or materials can be employed without departing from the spirit and scope of the application.

[0075] Certain embodiments of the application are described herein, including the best mode known to the inventors. Of course, those skilled in the art will recognize that various modifications can be made to the embodiments described herein without departing from the scope and spirit of the application. It is therefore intended that such modifications come within the scope of the application. Accordingly, while the application is susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the application to the particular methods and forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the application as defined by the appended claims.

[0076] The grouping of alternative embodiments, elements, or steps of the present application should not be interpreted as limiting. Each member of a group can be referred to and claimed individually or in any combination with other members of the group. One or more members of a group can be expected to be added or removed from the group for reasons of convenience and / or patentability. When any such addition or removal occurs, the specification shall be read to include only those groups that are modified to include the addition or removal. The specification shall be read to include the addition or removal of any member of a group to the extent that such addition or removal renders the group non-compliant with the written description requirement of 35 U.S.C. § 112, para. 6.

[0077] Unless otherwise indicated, all numbers expressing features, amounts, quantities, parameters, terms, etc. in the specification are to be understood as approximations based on the data and are intended to convey within a range of values understood by one of ordinary skill in the art, even though precision is not of utmost importance. As used herein, the terms "about" and "approximately" mean that the value in question is within a percentage of ten of the value being modified. Thus, unless otherwise stated, the numerical parameters listed in the specification and attached claims are approximations. As used herein, the term "at least" followed by a comma and a series of values is meant to include the minimum value of the series of values and to also include values greater than the minimum of the series. For example, "at least X, Y, Z" means "about X to about Z inclusive" or "about X to about Z inclusive and values greater than Z." As used herein, the terms "up to" and "at most" mean the maximum value of the range stated. For example, "up to X" means "about X" or less. As used herein, the term "substantially" means that the recited characteristic, parameter, or value needs not be achieved exactly, but that deviations, if any, are insignificant in terms of the desired purpose. As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having" or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of features is not necessarily limited only to those features but can include other features not expressly listed or inherent to such process, method, article, or apparatus. As used herein, the terms "about" and "approximately" mean that the value in question is within a percentage of ten of the value being modified. Thus, unless otherwise stated, the numerical parameters listed in the specification and attached claims are approximations. As used herein, the term "at least" followed by a comma and a series of values is meant to include the minimum value of the series of values and to also include values greater than the minimum of the series. For example, "at least X, Y, Z" means "about X to about Z inclusive" or "about X to about Z inclusive and values greater than Z." As used herein, the terms "up to" and "at most" mean the maximum value of the range stated. For example, "up to X" means "about X" or less. As used herein, the term "substantially" means that the recited characteristic, parameter, or value needs not be achieved exactly, but that deviations, if any, are insignificant in terms of the desired purpose. As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having" or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of features is not necessarily limited only to those features but can include other features not expressly listed or inherent to such process, method, article, or apparatus.

[0078] The use of the terms "may" and "can" with reference to an embodiment or aspect of an embodiment, also carries the alternative meaning of "may not" or "can not". Thus, if the specification discloses that an embodiment or aspect of an embodiment can or can be included in the inventive subject matter, it is explicitly intended that the negative limitation or disclaimer is also meant - that the embodiment or aspect of the embodiment can not or can not be included in the inventive subject matter. Similarly, the use of the term "optionally" with reference to an embodiment or aspect of an embodiment means that the embodiment or aspect of the embodiment can or can not be included in the inventive subject matter. Whether such negative limitation or disclaimer applies will depend on whether the negative limitation or disclaimer is recited in the claimed subject matter.

[0079] The use of the terms “a” and “an” and “the” and similar referents in the context of describing the application (especially in the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Further, the use of ordinal adjectives (e.g., “first,” “second,” “third,” etc.) to identify elements in a number of embodiments is to explicitly indicate that any such elements so identified can in fact be replaced with alternative elements, not merely similar ones. The indefinite articles “a” and “an” and “the” used in the context of describing the application (especially in the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. All of the methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the application and does not pose a limitation on the scope of the application unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the application.

[0080] In the claims, whether in independent or dependent form, the open-ended transitional phrases "comprising," "including" and "having," (and any variations thereof, such as "comprise," "comprises," "comprised," "comprised of," "include," "includes" and "including" ) encompass the subject matter identified, but also anything not expressly recited that is essential to practicing the claimed application. The elements, limitations, steps and / or features that are named in the claims are essential to the application, but other unrecited elements, limitations, steps and / or features can be added and still be within the scope of the claimed application. The specific embodiments disclosed herein can be further limited, in the claims using closed transitional phrases such as "consisting of" and "consisting essentially of." The transition phrases "consisting of" and "consisting essentially of" preclude any element not specified in the claim from being present in the application. The transition phrase "consisting essentially of" limits the scope of a claim to the specified elements and to the additional elements that do not materially affect the basic and novel characteristic(s) of the claimed application. Accordingly, the meaning of the transitional phrase "comprising," as used in the specification, is defined to encompass all of the elements specified in the claim, as well as any optional, additional elements, limitations, steps and / or features not specified in the claim. The meaning of the transitional phrase "consisting of," as used in the specification, is defined to include only the elements specified in the claim, and the meaning of the transitional phrase "consisting essentially of," as used in the specification, is defined to include only the elements specified in the claim, as well as additional elements that do not materially affect the basic and novel characteristic(s) of the claimed application. Accordingly, the open-ended transitional phrase "comprising" (and its equivalents, such as "comprise," "comprises," "comprised," and "comprised of") is intended to be used in its broadest sense as encompassing all of the elements listed in the claim, as well as any optional, additional elements, limitations, steps and / or features not specified in the claim. The specific embodiments described herein or claimed in the claims using the phrase "comprising" have been explicitly or inherently described, enabled and supported by the phrase "consisting essentially of" and "consisting of."

[0081] Any claim intended to be interpreted under 35 U.S.C. § 112(f) will be referred to as "means" for performing a specified function, but in any other case, the word "for" will not be used and the claim will not be interpreted under 35 U.S.C. § 112(f). Thus, the Applicant(s) reserve(s) the right to continue to pursue additional claims under 35 U.S.C. § 112(f) in this or a continuation-in-part application.

[0082] It should be understood that the order of execution of the various elements of any method disclosed herein and of each element of every method is merely exemplary. Unless otherwise specified, they can be executed in any order or in parallel, depending on the implementation.

[0083] All patents, patent publications, and other publications referenced and identified in the specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing the compositions and methodologies described in such publications that might be used in connection with the present application. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as a representation or admission that the inventors are not entitled to antedate such disclosure by virtue of prior application or for any other reason. All statements as to the date or dates of

[0084] While various aspects of the application have been described in connection with at least one example embodiment, it will be appreciated that the application is not limited to any embodiment or aspect, but rather, the scope of the application is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent arrangements. Accordingly, the application is not intended to be limited by the recitation of any particular method, system, or device, nor is it intended to be limited by the use of any particular language in the description of the disclosure.

Claims

1. A catheter device for use with a hemostatic valve, the hemostatic valve comprising a valve body having a first end and an opposite second end, a valve lumen extending between the first end and the second end, an elongated sheath engaged with the second end and in fluid communication with the valve lumen, and a compression seal configured to temporarily create a reduced inner diameter within the valve lumen substantially proximal to the first end, the device comprising: an elongated catheter comprising a first end and an opposite second end, an outer diameter of an outer surface of the catheter being less than a neutral inner diameter of the valve lumen, thereby allowing the catheter to be slidably inserted within the valve lumen a distance; and at least one protrusion extending radially outward from the outer surface of the catheter, an outer diameter of the at least one protrusion being less than the neutral inner diameter of the valve lumen but greater than the reduced inner diameter of the valve lumen; whereby, when the catheter is positioned within the valve lumen a distance and the compression seal subsequently creates the reduced inner diameter within the valve lumen, the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body.

2. The catheter device of claim 1, wherein, the catheter device further comprising a hub engaged with the first end of the catheter.

3. The catheter device of claim 1, wherein, the catheter is constructed of one or more of polyether, polyester, polyimide, nylon, polyurethane, polyetherimide, polyether ether ketone, polyamide, silicone, polyether block amide, and polyethylene.

4. The catheter device of claim 1, wherein, the catheter has an outer diameter of about 1 French to about 34 French.

5. The catheter device of claim 1, wherein, the length of the catheter is greater than the length of the sheath such that, during use of the device, the second end of the catheter can extend beyond the terminal end of the sheath a distance.

6. The catheter device of claim 1, wherein, the at least one protrusion extends around an entire circumference of the outer surface of the catheter.

7. The catheter device of claim 1, wherein, the at least one protrusion is constructed of one or more of polyether, polyester, polyimide, nylon, polyurethane, polyetherimide, polycarbonate, polyether ether ketone, polyamide, silicone, polyethylene, acrylic, acrylonitrile butadiene styrene, methyl methacrylate butadiene styrene, polypropylene, polyether block amide ("PEBA"), or a block copolymer of any common polymer or combination.

8. The catheter device of claim 1, wherein, the at least one protrusion is constructed of one or more of stainless steel, nitinol, cobalt chromium, platinum iridium, or other metals or alloys.

9. The catheter device of claim 1, wherein, the at least one protrusion is constructed of a tacky high-friction material, thereby increasing friction between the at least one protrusion and the compression seal when the compression seal creates the reduced inner diameter within the valve lumen.

10. The catheter device of claim 1, wherein, the at least one protrusion is constructed of a semi-flexible polymer, thereby cooperating with the compression seal to form a seal therebetween when the compression seal creates the reduced inner diameter within the valve lumen.

11. The catheter device of claim 1, wherein, the at least one protrusion is constructed of one or more radiopaque materials to facilitate positioning of the catheter within the valve lumen.

12. The catheter device of claim 11, wherein, the at least one protrusion is constructed of a tungsten-containing polymer.

13. The catheter device of claim 12, wherein, the at least one protrusion is constructed of one or more of platinum, chromium, cobalt, tantalum, nitinol, gold, silver, bismuth carbonate, barium sulfate, bismuth oxychloride, bismuth suboxide, stainless steel, or alloys thereof.

14. The catheter device of claim 1, wherein, the outer diameter of the at least one protrusion is about 100.1% to about 500% of the outer diameter of the catheter.

15. The catheter device of claim 1, wherein, The at least one protrusion has a length of about 0.001 inches to about 20 inches.

16. The catheter device of claim 1, wherein, The position of the at least one protrusion relative to the first end of the catheter indicates a corresponding distance that an opposite second end of the catheter extends from a terminal end of the sheath when the protrusion is substantially aligned with the compression seal.

17. The catheter device of claim 1, wherein, The catheter device further comprises a plurality of spaced apart protrusions along the length of the catheter, each of the protrusions positioned relative to the first end of the catheter so as to indicate a corresponding distance that an opposite second end of the catheter extends from a terminal end of the sheath when the protrusion is substantially aligned with the compression seal.

18. The catheter device of claim 17, wherein, The protrusions are spaced apart from each other by a distance of about 0.001 inches to about 20 inches.

19. A catheter device for use with a hemostatic valve, the hemostatic valve providing a valve body having a first end and an opposite second end, a valve lumen extending between the first end and the second end, the hemostatic valve further providing an elongated sheath engaged with the second end, and a compression seal substantially located proximally proximal to the first end, the compression seal configured to temporarily create a reduced inner diameter within the valve lumen, the device comprising: an elongated catheter having a first end and an opposite second end; an outer diameter of an outer surface of the catheter being less than the neutral inner diameter of the valve lumen, thereby allowing the catheter to be slidably inserted into the valve lumen a distance; a length of the catheter being greater than a length of the sheath, such that when the catheter is inserted into the valve lumen a distance, the second end of the catheter is capable of extending beyond a terminal end of the sheath a distance; and the at least one protrusion extending radially outward from an outer surface of the catheter, and having an outer diameter that is less than the neutral inner diameter of the valve lumen, but greater than the reduced inner diameter of the valve lumen, the at least one protrusion positioned relative to the first end of the catheter so as to indicate a corresponding distance that the second end of the catheter extends from a terminal end of the sheath when the protrusion is substantially aligned with the compression seal; whereby, when the catheter is located within the valve lumen a distance and the compression seal subsequently creates a reduced inner diameter within the valve lumen, the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body.

20. A combined system of a catheter and a hemostatic valve comprising: a hemostatic valve comprising: a valve body having a first end and an opposite second end, a valve lumen extending between the first end and the second end, the valve lumen having a neutral inner diameter; an elongated sheath engaged with the second end of the valve body and in fluid communication with the valve lumen; and a compression seal substantially located proximally proximal to the first end of the valve body and configured to temporarily create a reduced inner diameter within the valve lumen; the hemostatic valve configured to selectively move between a closed state in which the compression seal is radially collapsed, thereby creating a reduced inner diameter within the valve lumen, and an open state in which the compression seal is moved radially outward, thereby no longer creating a reduced inner diameter within the valve lumen; and a catheter device comprising: an elongated conduit having a first end and an opposite second end, an outer diameter of an outer surface of the conduit being less than the neutral inner diameter of the valve cavity, thereby allowing the conduit to be slidably inserted into the valve cavity a distance; and at least one protrusion extending radially outward from the outer surface of the conduit, an outer diameter of the at least one protrusion being less than the neutral inner diameter of the valve cavity, but greater than the reduced inner diameter of the valve cavity; therefore, when the conduit is located a distance into the valve cavity and the hemostatic valve is subsequently moved to a closed state, the at least one protrusion contacts the compression seal and prevents the conduit from sliding toward the first end of the valve body.

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