Fixation of an annular valve within a catheter assembly

Abstract

The catheter system (18) may include a catheter assembly (20, 68, 100, 103). The catheter assembly may include a catheter adapter (22) having a distal end (24), a proximal end (26), an inner surface (28) forming a lumen (30), the lumen extending through the distal and proximal ends, and a side port (32) disposed between the distal and proximal ends. The catheter assembly may include an annular valve (34) disposed within the lumen and aligned with the side port. The annular valve may seal a fluid passage from the side port to the lumen. The catheter assembly may include a retaining ring (36) or ridge (102) disposed within the lumen proximal and / or adjacent to the annular valve. The catheter assembly may include a catheter (12) extending distally from the distal end of the catheter adapter.

Description

[Background technology]

[0001] background Catheters are commonly used for a variety of infusion therapies. Catheters may be used to infuse normal saline, various medications, total parenteral nutrition, or other fluids into a patient. Catheters may also be used to withdraw blood from a patient for diagnostic or other purposes.

[0002] A common type of catheter is the "over-the-needle" peripheral intravenous catheter ("PIVC"). As the name suggests, an over-the-needle PIVC may be placed over an introducer needle with a sharp distal tip. The PIVC and introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC, with the bevel of the needle facing upward and away from the patient's skin. The PIVC and introducer needle are generally inserted at a shallow angle through the skin into the patient's vasculature.

[0003] To confirm proper placement of the introducer needle and / or PIVC within the blood vessel, the practitioner typically checks for a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the practitioner may remove the introducer needle, leaving the PIVC in place for future fluid injection.

[0004] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area in which some embodiments described herein may be practiced.

[0005] overview The present disclosure relates generally to vascular access devices, systems, and methods. In particular, the disclosure relates to annular valve fixation within a catheter assembly. In some embodiments, the catheter system may include a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, an inner surface forming a lumen, the lumen extending through the distal end and the proximal end, and a side port disposed between the distal end and the proximal end.

[0006] In some embodiments, the catheter assembly may include an annular valve, which may be disposed within the lumen and aligned with the side port. In some embodiments, the annular valve may seal a fluid passageway from the side port to the lumen. In some embodiments, the catheter assembly may include a retaining ring or ridge disposed within the lumen proximal and / or adjacent to the annular valve. In some embodiments, the catheter assembly may include a catheter extending distally from the distal end of the catheter adapter.

[0007] In some embodiments, the inner surface of the catheter adapter may include an undercut. In some embodiments, the retaining ring may be disposed within the undercut. In some embodiments, the undercut may correspond to a proximal undercut, and the inner surface of the catheter adapter may further include a distal undercut. In some embodiments, the annular valve may be disposed between the proximal and distal undercuts.

[0008] In some embodiments, the annular valve may comprise silicone. In some embodiments, the annular valve may be cylindrical. In some embodiments, the retaining ring may be formed by molding. In some embodiments, the retaining ring may be plastic.

[0009] In some embodiments, the catheter system may include a needle assembly. In some embodiments, the needle assembly may include a needle hub and an introducer needle extending distally from the needle hub through a retaining ring, an annular valve, and the catheter. In some embodiments, a side port may extend from a top of the catheter adapter. In some embodiments, the side port may be configured to receive a syringe. In some embodiments, the retaining ring or ridge is configured to reduce proximal movement of the annular valve in response to fluid injection through the side port, which opens the annular valve.

[0010] In some embodiments, a method of flushing a catheter assembly may include coupling an infusion device to a side port of a catheter adapter of the catheter assembly. In some embodiments, the method may include activating the infusion device. In some embodiments, in response to activating the infusion device, the annular valve may be opened to allow fluid to flow from the side port into the lumen. In some embodiments, in response to activating the infusion device, a proximal end of the annular valve may be pressed against a retaining ring, which may remain in place. In some embodiments, in response to activating the infusion device, a proximal end of the annular valve may be pressed against a ridge.

[0011] In some embodiments, the injection device may include a syringe. In some embodiments, activating the injection device may include depressing a plunger of the syringe. In some embodiments, the method may include decoupling and removing the needle assembly from the catheter adapter. In some embodiments, the injection device may be activated after the needle assembly is decoupled and removed from the catheter adapter.

[0012] In some embodiments, the inner surface of the catheter adapter may include a stepped surface. In some embodiments, the stepped surface may include a distal surface, a proximal surface, and a transition surface disposed between the distal and proximal surfaces. In some embodiments, an annular valve disposed within the lumen may seal the fluid passage from the side port to the lumen. In some embodiments, the annular valve may contact the distal surface. In some embodiments, the catheter assembly may include a cavity disposed between the outer surface and the proximal surface of the annular valve. In some embodiments, the transition surface may form a distal end of the cavity.

[0013] In some embodiments, a transition surface may be disposed between the distal end of the annular valve and the proximal end of the annular valve. In some embodiments, the annular valve may contact the distal surface and a portion of the proximal surface. In some embodiments, the annular valve may contact a portion of the proximal surface to form the proximal end of the cavity. In some embodiments, the depth of the cavity may decrease proximally.

[0014] In some embodiments, the transition surface and the distal surface may meet at a sharp end. In some embodiments, the step surface and the cavity may be semi-annular. In some embodiments, the annular valve may reduce the size of the cavity in response to injection through the side port. In some embodiments, the catheter assembly may include radial vertical ribs extending from the transition surface to the distal end. In some embodiments, the proximal surface may include sandblasting or chemical etching.

[0015] In some embodiments, the stepped surface may correspond to the first stepped surface. In some embodiments, the inner surface of the catheter adapter may include a second stepped surface proximal to the first stepped surface. In some embodiments, the catheter assembly may include another cavity disposed between the outer surface of the annular valve. In some embodiments, another transition surface of the second stepped surface may form a distal end of the another cavity.

[0016] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention as claimed. It is to be understood that the various embodiments are not limited to the arrangement and instrumentality shown in the drawings. It is also to be understood that embodiments may be combined, other embodiments may be utilized, and structural changes may be made, unless so claimed, without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense.

[0017] A brief description of some of the figures in the drawing Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0018] [Figure 1] FIG. 1 is a cross-sectional view of a prior art catheter system. [Figure 2A] FIG. 2A is a cross-sectional view of a catheter system showing an exemplary retaining ring, according to some embodiments. [Figure 2B] FIG. 2B is a top perspective view of a retaining ring, according to some embodiments. [Figure 2C] FIG. 2C is an enlarged cross-sectional view of a portion of the catheter system of FIG. 2A, according to some embodiments. [Figure 2D] FIG. 2D is a cross-sectional view of the catheter system of FIG. 2A showing an exemplary infusion device coupled to and actuated with an exemplary side port, according to some embodiments. [Figure 2E] FIG. 2E is a top view of the catheter system of FIG. 2A after injection through a side port, according to some embodiments. [Figure 3A] FIG. 3A is a cross-sectional view of a catheter system showing an annular valve removed for illustrative purposes, according to some embodiments. [Figure 3B]FIG. 3B is a cross-sectional view of the catheter system of FIG. 3A showing the annular valve before fluid injection through the side port, according to some embodiments. [Figure 3C] FIG. 3C is a cross-sectional view of the catheter system of FIG. 3A showing the annular valve opened in response to fluid injection, according to some embodiments. [Figure 3D] FIG. 3D is a cross-sectional view of the catheter system of FIG. 3A taken proximally relative to an exemplary transition surface, with the annular valve removed for illustrative purposes, according to some embodiments. [Figure 3E] FIG. 3E is a cross-sectional view of the catheter system of FIG. 3A showing two exemplary step surfaces and an annular valve removed for illustrative purposes, according to some embodiments. [Figure 3F] FIG. 3F is an enlarged cross-sectional view of the catheter system of FIG. 3A showing two exemplary stepped surfaces and annular valves removed for illustration purposes. [Figure 3G] FIG. 3G is a cross-sectional view of the catheter system of FIG. 3A showing two stepped surfaces prior to fluid injection through the side port, according to some embodiments. [Figure 3H] FIG. 3H is a cross-sectional view of the catheter system of FIG. 3A showing two stepped surfaces and annular valves opened in response to fluid injection, according to some embodiments. [Figure 3I] FIG. 3I is a cross-sectional view of the catheter system of FIG. 3A showing a number of exemplary ribs, according to some embodiments. [Figure 3J] FIG. 3J is an enlarged cross-sectional view of the catheter system of FIG. 3A showing a number of exemplary ribs, according to some embodiments. [Figure 3K] FIG. 3K is another cross-sectional view of the catheter system of FIG. 3A, according to some embodiments. [Figure 4A] FIG. 4A is a cross-sectional view of a catheter system showing a number of exemplary protuberances, according to some embodiments. [Figure 4B]FIG. 4B is a cross-sectional view of the catheter system of FIG. 4A showing multiple protuberances with the annular valve removed for illustrative purposes, according to some embodiments. [Figure 4C] FIG. 4C is a cross-sectional view of the catheter system of FIG. 4A taken just distal to the plurality of ridges, according to some embodiments. [Figure 5A] FIG. 5A is a cross-sectional view of a catheter system showing an exemplary proximal undercut and an exemplary distal undercut, with the annular valve removed for illustrative purposes, according to some embodiments. [Figure 5B] FIG. 5B is a cross-sectional view of the catheter system of FIG. 5A, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0019] Description of the embodiment 1 , a prior art catheter system 10 is shown. The prior art catheter system includes an annular valve 12 disposed in a catheter adapter lumen 14. The annular valve 12 is often moved proximally in response to fluid injection through a side port 16 of the prior art catheter system 10. Proximal movement of the annular valve 12 may prevent the annular valve 12 from sealing the side port 16, thus resulting in leakage from the catheter adapter lumen 14 through the side port 16 after fluid injection.

[0020] 2A-2C, a catheter system 18 is shown according to some embodiments. In some embodiments, the catheter system 18 may include a catheter assembly 20. In some embodiments, the catheter assembly 20 may include a catheter adapter 22, which may include a distal end 24, a proximal end 26, and an inner surface 28 forming a lumen 30. In some embodiments, the catheter assembly 20 may include the lumen 30 extending through the distal end 24 and the proximal end 26. In some embodiments, the catheter assembly 20 may include a side port 32 disposed between the distal end 24 and the proximal end 26. In some embodiments, the catheter assembly 20 may include a cap 33 removably coupled to the side port 32.

[0021] In some embodiments, the catheter assembly 20 may include an annular valve 34, which may be disposed within the lumen 30 and aligned with the side port 32. In some embodiments, the annular valve 34 may seal the fluid passageway from the side port 32 to the lumen 30. In some embodiments, the annular valve 34 may comprise silicone or another suitable material to allow an end of the annular valve 34 to depress and open the fluid passageway from the side port 32 to the lumen 30 in response to injection of fluid through the side port 32. In some embodiments, the annular valve 34 may be cylindrical.

[0022] In some embodiments, the catheter assembly 20 may include a retaining ring 36 disposed proximal and / or adjacent to the annular valve 34 within the lumen 30. In some embodiments, the retaining ring 36 may contact the annular valve 34. In some embodiments, the catheter assembly 20 may include a catheter 38 extending distally from the distal end 24 of the catheter adapter 22. In some embodiments, the catheter 38 may include a peripheral intravenous catheter (PIVC), a midline catheter, a peripherally inserted central catheter, or another suitable type of catheter.

[0023] In some embodiments, the catheter assembly 20 may include a septum 40, which may be disposed proximally relative to the retaining ring 36 and the annular valve 34. In some embodiments, the septum 40 may comprise silicone or other suitable material.

[0024] In some embodiments, the inner surface 28 of the catheter adapter 22 may include an undercut 42, which may be annular. In some embodiments, the retaining ring 36 may be disposed within the undercut 42. In some embodiments, the width 44 of the retaining ring 36 may be approximately equal to the length 46 of the undercut 42, such that a distal edge 48 of the retaining ring 36 and a proximal edge 50 of the retaining ring 36 abut the edges of the undercut 42. In some embodiments, the distal edge 48 and the proximal edge 50 may be annular. In some embodiments, the retaining ring 36 may fit snugly within the undercut 42. In some embodiments, the outer diameter may be slightly larger than the diameter of the undercut 42, such that the retaining ring 36 is a snap fit within the undercut 42.

[0025] In some embodiments, the retaining ring 36 may be plastic, metal, or other suitable material. In some embodiments, the retaining ring 36 may be rigid or semi-rigid. In some embodiments, the durometer of the retaining ring 36 may be greater than the durometer of the annular valve 12. In some embodiments, the retaining ring 36 may be formed by molding. More specifically, in some embodiments, the retaining ring 36 may be formed by molding a liquid or malleable material using a fixed frame, such as a mold or matrix. In some embodiments, the mold may include a hollow cavity receptacle into which the liquid or malleable material may be poured. In some embodiments, the liquid or malleable material may include plastic, metal, or other suitable material. When the liquid or malleable material hardens inside the mold, it forms the retaining ring 36.

[0026] In some embodiments, the catheter system 18 may include a needle assembly 52. ​​In some embodiments, the needle assembly 52 may include a needle hub 54 and an introducer needle 56 extending distally from the needle hub 54 through the retaining ring 36, the annular valve 34, and the catheter 38. In some embodiments, the introducer needle 56 may include a sharpened distal tip, which may facilitate placement of the catheter 38 within the patient's vasculature.

[0027] In some embodiments, the side port 32 may extend from the top of the catheter adapter 22 or from the portion of the catheter adapter 22 that faces the patient's skin, which may be located below the catheter adapter 22 and / or under one or more wings 58 that extend outward from the catheter adapter 22.

[0028] 2D , in some embodiments, the side port 32 may be configured to receive an injection device 60, which may include a syringe or other suitable injection device configured to inject a fluid into the lumen 30 through the side port 32. In some embodiments, the retaining ring 36 is configured to maintain the annular valve 34 in the same or a similar position in response to injection of a fluid through the side port 32, which opens the annular valve 34. More specifically, in some embodiments, the retaining ring 36 may be configured to reduce proximal movement of the annular valve 34 in response to injection of a fluid through the side port 32, which opens the annular valve 34. In some embodiments, the proximal end 62 of the annular valve 34 may not move in the proximal and / or distal directions in response to injection of a fluid through the side port 32, which opens the annular valve 34. Thus, in some embodiments, the retaining ring 36 may prevent fluid, such as blood and / or another fluid, from leaking through the annular valve 34 and out the side port 32.

[0029] In some embodiments, the infusion device 60 may be activated to flush the catheter system 18 or to inject a bolus. In some embodiments, a method of flushing the catheter assembly 20 may include coupling the infusion device 60 to the side port 32 of the catheter adapter 22 of the catheter assembly 20. In some embodiments, the side port 32 may include a luer, such as a female luer, that may be configured to mate with a corresponding luer on the infusion device 60.

[0030] In some embodiments, the method may include actuating the infusion device 60. In some embodiments, in response to actuating the infusion device 60, the annular valve 34 may be opened to allow fluid to flow from the side port 32 into the lumen 30. In some embodiments, in response to actuating the infusion device 60, the proximal end 62 of the annular valve 34 opposite the distal end 64 of the annular valve 34 may be pressed against the retaining ring 36, and the retaining ring 36 may remain in place. In these and other embodiments, the proximal end 62 of the annular valve 34 may not move proximally and / or distally and may remain in place.

[0031] In some embodiments, the injection device 60 may include a syringe, as shown, for example, in FIG. 2D . In some embodiments, actuating the injection device 60 may include depressing the syringe plunger 66 or otherwise causing fluid to be expelled from the injection device into the catheter assembly 20. In some embodiments, the method may include decoupling and removing the needle assembly 52 from the catheter adapter 22, as shown, for example, in FIG. 2D . In some embodiments, the injection device 60 may be actuated after the needle assembly 52 is decoupled and removed from the catheter adapter 22.

[0032] 2E, catheter assembly 20 is shown with cap 33 open after fluid injection through side port 32. As shown, annular valve 34 is still in place after fluid injection, sealing side port 32.

[0033] 3A-3D, a catheter assembly 68 according to some embodiments is illustrated. In some embodiments, the catheter assembly 68 may be similar or identical in one or more features and / or operation to the catheter assembly 20 described with respect to FIG. 2. In some embodiments, the inner surface 28 of the catheter adapter 22 may include a stepped surface 70. In some embodiments, the stepped surface 70 may include a proximal surface 72, a distal surface 74, and a transition surface 76 disposed between the proximal surface 72 and the distal surface 74. In some embodiments, an annular valve 34 disposed within the lumen 30 may seal the fluid passage from the side port 16 to the lumen 30, as shown, for example, in FIG. 3B.

[0034] In some embodiments, the annular valve 34 may contact or rest on the distal surface 74. In some embodiments, the catheter assembly 20 may include a cavity 78 disposed between the outer surface 80 of the annular valve 12 and the proximal surface 72. In some embodiments, the outer surface of the annular valve 12 may be generally cylindrical. In some embodiments, the transition surface 76 may form the distal end of the cavity 78.

[0035] In some embodiments, the transition surface 76 may be disposed between the distal end 64 of the annular valve 12 and the proximal end 62 of the annular valve 34. In some embodiments, the annular valve 34 may contact the distal surface 74 and a portion 80 of the proximal surface 72, which may be spaced apart from the transition surface 76. In some embodiments, the annular valve 34 may contact the proximal surface 72 to form the proximal end of the cavity 78. In some embodiments, the depth of the cavity 78 may decrease in the proximal direction, as illustrated, for example, in FIG. 3B .

[0036] In some embodiments, the transition surface 76 and the end surface 74 may meet at a sharp edge 82, which may reduce slippage and migration of the annular valve 34. In some embodiments, the step surface 70 and / or the cavity 78 may be semi-annular or arcuate, which may facilitate ejection during demolding. In some embodiments, the step surface 70 and / or the cavity 78 may be semi-circular.

[0037] In some embodiments, the transition surface 76 may include a shoulder or an undercut. In some embodiments, the transition surface 76 may be disposed at approximately 90 degrees relative to the longitudinal axis 83 of the catheter assembly 68, which may facilitate the formation of the cavity 78. In some embodiments, the transition surface 76 may be disposed at an angle other than 90 degrees relative to the longitudinal axis of the catheter assembly 10. In some embodiments, the transition surface 76 may be smooth and / or planar. In some embodiments, the transition surface 76 may be uneven, rough, or irregular. In some embodiments, the first transition surface 36 may be curved.

[0038] In some embodiments, injecting fluid 84 may include flushing catheter system 18 or injecting a bolus by actuating infusion device 60 (see, e.g., FIG. 2D). In some embodiments, in response to actuating infusion device 60, annular valve 34 may be opened to allow fluid to flow from side port 32 into lumen 30, as illustrated, for example, in FIG. 3C.

[0039] In some embodiments, in response to the injection of fluid 84 through the side port 32, the annular valve 34 may reduce the size or volume of the cavity 78, as shown, for example, in FIG. 3C . In these embodiments, the annular valve 34 may be forced against the proximal surface 72. In some embodiments, in response to the injection of fluid 84 through the side port 32, the annular valve 34 may conform to a sharp edge 82 that clinches, reducing slippage of the annular valve 34. In some embodiments, the stepped surface 70 and sharp edge 82 may reduce movement of the annular valve 34 in the distal and / or proximal directions, allowing the annular valve 34 to continue to seal the side port 32 after the injection of fluid 84 is complete.

[0040] In some embodiments, cavity 78 may be empty and free of fluid prior to injection of fluid 84 through side port 32. In some embodiments, in response to injection of fluid 84 through side port 32, annular valve 34 may be biased against proximal surface 72 and may not allow fluid to enter cavity 78 during injection of fluid 84, causing cavity 78 to be a dead space.

[0041] In some embodiments, the transition surface 76 may be disposed toward the distal end 64 and / or may be disposed distal to the opening of the side port 32 proximate the lumen 30 and the inner surface 28, which may facilitate anchoring of the annular valve 34 and opening or depression of the proximal end 62 in response to injection of a fluid 84 through the side port 32. For example, as illustrated in FIG. 3A , in some embodiments, at least the proximal surface 72 of the stepped surface 70 may include a roughened surface, which may include sandblasting or chemical etching. In some embodiments, the roughened surface is mottled in the drawings for illustrative purposes. In some embodiments, the roughened surface may increase friction between the annular valve 34 and the proximal surface 72, reducing movement of the annular valve 34.

[0042] 3E-3H, in some embodiments, step surface 70 may correspond to first step surface 74. In some embodiments, inner surface 28 of catheter adapter 22 may include second step surface 86 proximal to first step surface 74. In some embodiments, second step surface 86 may include a distal surface that may correspond to proximal surface 72 of step surface 74. In some embodiments, second step surface 86 may include a proximal surface 90 and a transition surface 92 disposed between proximal surface 72 and distal surface 74. In some embodiments, second step surface 86 may be similar or identical to step surface 74 in one or more characteristics and / or operation. As shown in FIGS. 3E-3F compared to FIGS. 3G-3H, in some embodiments, the position of first step surface 74 and / or second step surface 86 may vary along inner surface 28.

[0043] In some embodiments, the transition surface 92 and the distal surface of the second step surface 86 may meet at a sharp edge 94, which may reduce slippage and migration of the annular valve 34. In some embodiments, a cavity 96 may be disposed between the outer surface of the annular valve 34. In some embodiments, the transition surface 92 of the second step surface 86 may form the distal end of another cavity 94. In these embodiments, the sharp edge 94 may contact the annular valve 34. In some embodiments, the sharp edge 94 may not contact the annular valve 34 prior to injection, and a single semi-annular cavity may extend between the outer surface and the inner surface 28 of the annular valve 34.

[0044] In some embodiments, second step surface 86 and / or cavity 96 may be semi-annular. In some embodiments, second step surface 86 and / or cavity 78 may be semi-annular. In some embodiments, in response to injection of fluid 84 through side port 32, annular valve 34 may reduce the size or volume of cavity 96. In these embodiments, annular valve 34 may be biased against proximal surface 90 and proximal surface 72. In some embodiments, in response to injection of fluid 84 through side port 32, annular valve 34 may conform and clamp against sharp edge 94 in addition to sharp edge 82, which reduces slippage of annular valve 34.

[0045] In some embodiments, cavity 96 may be empty and free of fluid prior to injection of fluid 84 through side port 32. In some embodiments, in response to injection of fluid 84 through side port 32, annular valve 34 may be forced against proximal surface 90, not allowing fluid to enter cavity 96 during injection of fluid 84, causing cavity 96 to be a dead space.

[0046] 3I-3J, in some embodiments, catheter assembly 68 may include a plurality of ribs 98 extending distally from a particular transition surface, such as transition surface 76 and / or second transition surface 92. In some embodiments, ribs 98 may be radial and / or spaced apart along a particular transition surface. In some embodiments, ribs 98 may be evenly spaced apart along a particular transition surface. In some embodiments, ribs 98 may extend along a portion of the length of proximal surface 72. In some embodiments, ribs 98 may extend along less than half of the entire length of proximal surface 72. In some embodiments, ribs 98 may be aligned with longitudinal axis 83 and / or with the demolding direction.

[0047] 3K, proximal surface 72 is shown from above, according to some embodiments. In some embodiments, proximal surface 72 and / or distal surface 74 may be partially cylindrical. In some embodiments, proximal surface 72, but not distal surface 74, may include a roughened surface, which may facilitate insertion of annular valve 34 during manufacturing and fixation of annular valve 34 during injection through side port 16. In some embodiments, proximal surface 72 and distal surface 74 may include a roughened surface, which may facilitate fixation of annular valve 34 during injection through side port 16.

[0048] 4A-4C, a catheter assembly 100 according to some embodiments is illustrated. In some embodiments, the catheter assembly 100 may be similar or identical in one or more features and / or operation to the catheter assembly 20 described with reference to FIG. 2 and / or the catheter assembly 68 described with reference to FIG. 3. In some embodiments, the inner surface 28 of the catheter adapter 22 may include one or more ridges 102, which may be arranged in a ring around the inner surface 28. In some embodiments, the inner surface 28 may include four ridges 102 or three ridges 102. In some embodiments, the inner surface 28 may include more than four ridges 102. In some embodiments, the ridges 102 may include different lengths, heights, and / or angles, which may enhance fixation of the annular valve 32 in response to injection through the side port 16. In some embodiments, the ridges 102 may include the same length, height, and / or angle as each other. In some embodiments, the inner surface 28 may include no more than one ridge 102, which may include an annular ring.

[0049] In some embodiments, the ridges 102 may be positioned proximal and / or adjacent to the annular valve 34 within the lumen 30. In some embodiments, the ridges 102 may contact the annular valve 34. In some embodiments, the ridges 102 may be rigid or semi-rigid. In some embodiments, the durometer of the ridges 102 may be greater than the durometer of the annular valve 34. In some embodiments, the ridges 102 may be integrally formed with the inner surface 28 as a single unit.

[0050] In some embodiments, the ridge 102 may be configured to hold the annular valve 34 in the same or a similar position in response to fluid injection through the side port 32, which opens the annular valve 34. More specifically, in some embodiments, the ridge 102 may be configured to reduce proximal movement of the annular valve 34 in response to fluid injection through the side port 32, which opens the annular valve 34. In some embodiments, the proximal end 62 of the annular valve 34 may not move proximally in response to fluid injection through the side port 32, which opens the annular valve 34. In some embodiments, proximal movement of the annular valve 34 may be reduced in response to fluid injection through the side port 32, which opens the annular valve 34. Thus, in some embodiments, the ridge 102 may prevent fluid, such as blood and / or another fluid, from leaking through the annular valve 34 and out the side port 32.

[0051] 5A-5B, a catheter assembly 103 according to some embodiments is shown. In some embodiments, the catheter assembly may be similar or identical in one or more features and / or operation to one or more of the catheter assembly 20 described with respect to FIG. 2, the catheter assembly 68 described with respect to FIG. 3, and the catheter assembly 100 described with respect to FIG. 4.

[0052] In some embodiments, the inner surface 28 may include a proximal undercut 104 and a distal undercut 106, and the annular valve 34 may be disposed between the proximal undercut 104 and the distal undercut 106. In some embodiments, the proximal undercut 104 and / or the distal undercut 106 may be annular. In some embodiments, the length of the annular valve 34 may be approximately equal to the distance between the proximal undercut 104 and the distal undercut 106, such that the annular valve 34 abuts the proximal undercut 104 and the distal undercut 106. In some embodiments, the distal edge 48 and the proximal edge 50 may be annular. In some embodiments, the annular valve 34 may fit snugly within the proximal undercut 104 and the distal undercut 106. In some embodiments, the proximal undercut 104 and the distal undercut 106 may form a cavity in which the annular valve 34 may be seated.

[0053] All examples and conditional language incorporated herein are intended for educational purposes to aid the reader in understanding the concepts contributed by the inventors to further develop the present invention and the art, and should not be construed as being limited to such specifically incorporated examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations may be made therein without departing from the spirit and scope of the present invention.

Claims

1. The catheter system a catheter assembly, the catheter assembly comprising: a catheter adapter comprising a distal end, a proximal end, an inner surface forming a lumen extending through the distal end and the proximal end, and a side port disposed between the distal end and the proximal end, the inner surface of the catheter adapter comprising a stepped surface, the stepped surface comprising a distal surface, a proximal surface, and a transition surface disposed between the distal surface and the proximal surface; an annular valve disposed within the lumen, the annular valve sealing a fluid passageway from the side port to the lumen, the annular valve contacting the proximal surface; a cavity disposed between the outer surface of the annular valve and the proximal surface, the transition surface forming a proximal end of the cavity; and a catheter extending distally from the distal end of the catheter adapter; Equipped with a depth of the cavity decreasing in a proximal direction, and wherein in response to injection of fluid through the side port, the annular valve is biased against the proximal surface of the stepped surface to reduce the size of the cavity and prevent the annular valve from moving in a distal direction.

2. The catheter system of claim 1 , wherein the transition surface is disposed between the distal end of the annular valve and the proximal end of the annular valve.

3. 10. The catheter system of claim 1, wherein the annular valve contacts the distal surface and a portion of the proximal surface, and the annular valve contacts the portion of the proximal surface to form a proximal end of the cavity.

4. The catheter system of claim 1 , wherein the transition surface and the distal end surface meet at a sharp edge.

5. The catheter system of claim 1 , wherein the stepped surface and the cavity are semi-annular.

6. The catheter system of claim 1 , further comprising radial vertical ribs extending from the transition surface to a distal end.

7. The catheter system of claim 1 , wherein the proximal surface comprises sandblasting or chemical etching.

8. 2. The catheter system of claim 1, wherein the stepped surface is a first stepped surface, the inner surface of the catheter adapter further comprises a second stepped surface proximal to the first stepped surface, and further comprises another cavity disposed between the outer surface of the annular valve and the inner surface of the catheter adapter, and a transition surface of the second stepped surface forms a distal end of the another cavity.

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