Catheter Assembly

Abstract

To provide a septum which controls blood flow during a step involving disposition and utility of PIVC and reduces leakage.SOLUTION: A catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending therethrough. The catheter assembly may also include a septum slidably disposed within the lumen. The septum may include a distal end, a proximal end, and a barrier disposed between the distal end of the septum and the proximal end of the septum. The barrier may divide an interior of the septum into a distal cavity and a proximal cavity. A distal face of the barrier may include a protrusion. The barrier may include a slit extending through the protrusion for selectively opening fluid communication between the distal cavity and the proximal cavity.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] The present invention relates to the blood control septum and its associated systems. Catheters are commonly used for various infusion therapies. For example, catheters can be used to infuse fluids, such as saline, various medications, and total parenteral nutrition, into a patient. Catheters can also be used to withdraw blood from a patient. [Background technology]

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

[0003] To verify proper placement of the introducer needle and / or PIVC within the vessel, the user typically confirms the presence of a "flashback" of blood within the flashback chamber of the PIVC assembly. Once needle placement is confirmed, the user temporarily occludes intravenous flow and removes the introducer needle, leaving the PIVC in place within the vein. The user can also attach devices to the PIVC assembly for fluid injection and / or blood withdrawal. This process is somewhat difficult in practice because many catheter placement sites do not allow for easy occlusion of the vessel. Furthermore, even if such occlusion is achieved, it may be incomplete, resulting in blood leaking from the PIVC assembly housing the PIVC, endangering medical personnel.

[0004] Accordingly, catheter assemblies have been provided in the art that provide various seals or "septa" to prevent fluid leakage during and after removal of the introducer needle from the blood vessel. However, in some cases, blood may leak through certain septa after removal of the introducer needle and before the user is able to connect a device to the PIVC assembly to perform an infusion or blood draw. Septal leakage may occur more quickly, particularly with larger introducer needle outer diameters. Therefore, it would be an advancement in the art to provide a septum that controls blood flow and reduces leakage during the steps surrounding the placement and use of a PIVC.

[0005] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where certain implementations described herein may be practiced. Summary of the Invention

[0006] The present disclosure generally relates to septa for blood control, as well as related devices, systems, and methods. In some embodiments, a catheter assembly may include a catheter adapter that may include a distal end, a proximal end, and a lumen extending therethrough. In some embodiments, the catheter assembly may also include a septum slidably disposed within the lumen. In some embodiments, the septum may include a distal end, a proximal end, and a barrier disposed between the distal and proximal ends of the septum. In some embodiments, the barrier may divide the interior of the septum into a distal cavity and a proximal cavity. In some embodiments, the distal surface of the barrier may include a protrusion. In some embodiments, the barrier may include a slit extending through the protrusion to selectively open fluid communication between the distal and proximal cavities.

[0007] In some embodiments, in response to backflow of blood flowing against the protrusions, the opposing surfaces of the slit may press more firmly against each other to seal the slit. This may be due to the radial force of the backflowing blood against the protrusions as well as the axial force of the backflowing blood against the protrusions. In some embodiments, when an axial force acts on the central portion of the protrusion, pushing the central portion of the protrusion axially in the proximal direction, the opposing surfaces of the slit move toward each other with greater interference.

[0008] In some embodiments, the protrusion may be centered on the distal surface. In some embodiments, the slit may extend through the center of the protrusion. In some embodiments, the proximal surface of the barrier may be flat. In some embodiments, the protrusion may be symmetrical.

[0009] In some embodiments, at least a portion of the outer surface of the protrusion can be disposed at an acute angle relative to the transverse axis of the catheter assembly. For example, the protrusion can include a dome. In some embodiments, the diameter of the dome can be larger than the diameter of the slit. As another example, the protrusion can include a truncated dome. In some embodiments, the diameter of the truncated portion of the truncated dome can be larger than the diameter of the slit. As yet another example, the protrusion can include a truncated cone. In some embodiments, the diameter of the truncated portion of the truncated cone can be larger than the diameter of the slit.

[0010] In some embodiments, the septum actuator can be secured within the lumen of the catheter adapter. In some embodiments, the septum can be configured to move between a proximal position and a distal position in response to insertion of a separate device into the proximal end of the catheter adapter. In some embodiments, the septum actuator can penetrate the slit in response to movement of the septum from the proximal position to the distal position. In some embodiments, the slit can extend through the center of the protrusion, such that the septum actuator is located within the center of the protrusion when the septum is located in the distal position.

[0011] In some embodiments, the protrusion can be spaced adjacent to the septum actuator when the septum is in the proximal position prior to insertion of the separate device, hi other embodiments, the septum actuator can contact the outer surface of the protrusion but cannot penetrate the slit when the septum is in the proximal position prior to insertion of the separate device.

[0012] 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 are the claims. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and structural changes may be made, unless otherwise stated, without departing from the scope of the various embodiments of the invention. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0013] Example embodiments will be described and explained with specificity and detail through the use of the accompanying drawings. [Figure 1A] FIG. 1A is a cross-sectional view of an exemplary prior art catheter assembly showing the catheter assembly in an insertion or ready-to-use position, according to some embodiments. [Figure 1B] FIG. 1B is another cross-sectional view of the catheter assembly of FIG. 1A, showing the catheter assembly in a safe position, according to some embodiments. [Figure 1C] FIG. 1C is another cross-sectional view of the catheter assembly of FIG. 1A with the exemplary safety coupling and exemplary introducer needle removed, according to some embodiments. [Figure 1D] FIG. 1D is a cross-sectional view of the catheter assembly of FIG. 1C taken along line 1D-1D in FIG. 1C, according to some embodiments. [Figure 2A]FIG. 2A is a cross-sectional view of another exemplary catheter assembly showing an exemplary septum with an exemplary protrusion, according to some embodiments. [Figure 2B] FIG. 2B is an enlarged cross-sectional view of a portion of the catheter system of FIG. 2A, according to some embodiments. [Figure 2C] FIG. 2C is a cross-sectional view of the catheter assembly of FIG. 2A showing exemplary opposing slits in the septum being pressed more tightly together in response to force from backflow blood flowing proximally through the exemplary septum actuator, according to some embodiments. [Figure 2D] FIG. 2D is a cross-sectional view of the catheter assembly of FIG. 2A taken along line 2D-2D, according to some embodiments. [Figure 2E] FIG. 2E is a cross-sectional view of the catheter assembly of FIG. 2A showing the septum in a distal position, according to some embodiments. [Figure 3] FIG. 3 is a cross-sectional view of the catheter assembly of FIG. 2A showing another exemplary protrusion, according to some embodiments. [Figure 4] FIG. 4 is a cross-sectional view of the catheter assembly of FIG. 2A showing another exemplary protrusion, according to some embodiments. [Figure 5] FIG. 5 is a cross-sectional view of the catheter assembly of FIG. 2A showing another septum having a duckbill valve, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0014] FIELD OF THE DISCLOSURE The present disclosure generally relates to septa for blood control, as well as related devices, systems, and methods. Referring now to Figures 1A-1B, a prior art catheter assembly 10 is shown. Figure 1A shows the catheter assembly 10 in a first, ready-to-use position. The catheter assembly 10 may correspond to a Smiths Medical Via Valve® Safety IV Catheter with Blood Control. The catheter assembly 10 generally includes a catheter 12 coupled to the distal end 14 of a catheter adapter 16. In the ready-to-use position, the catheter 12 is positioned over an introducer needle 17 such that the sharp tip of the introducer needle 17 extends from the distal end of the catheter 12.

[0015] The catheter assembly 10 generally includes a safety coupling 18 that includes an actuator 20, a nose 22, and an engagement arm 24. A collar 26 of the safety coupling 18 is disposed around the catheter adapter 16, the engagement arm 24, and a proximal portion of the actuator 20. In this regard, the collar 26 can prohibit access to these components, or portions thereof. The safety coupling 18 is constructed to engage the catheter adapter 16 with the engagement arm 24 when the catheter assembly 10 is in the ready-to-use position and the actuator 20 is shifted to the distal, engaged position. In the ready-to-use position, the engagement arm 24 is held in contact with the catheter adapter 16 by an engagement portion 27 of the actuator 20.

[0016] 1B, the catheter assembly 10 is shown in a second, safe position. When the catheter assembly 10 is in the safe position, the actuator 20 is shifted to a proximal, released position. In the safe position, the engagement arm 24 is released from engagement with the catheter adapter 16, thereby allowing the safety coupling 18 and introducer needle 17 to be removed from the catheter 12 and catheter adapter 16.

[0017] 1C, catheter assembly 10 is shown with safety coupling 18 and introducer needle 17 removed. Lumen 29 of catheter adapter 16 is in fluid communication with lumen 28 of catheter 12. When inserted into a patient, catheter 12 and catheter adapter 16 provide a fluid conduit to facilitate the delivery of fluids to and / or the withdrawal of fluids from the patient.

[0018] The catheter assembly 10 includes a septum 30 slidably received within the lumen 29 of the catheter adapter 16. The catheter assembly 10 also includes a septum actuator 32, which is generally fixedly disposed within a distal fluid chamber 34. The septum 30 is tubular with a barrier 36 disposed between the distal and proximal ends of the septum 30. The barrier 36 divides the interior of the septum 30 into a distal fluid chamber 34 and a proximal fluid chamber 38. A distal surface 40 of the barrier 36 is flat. Referring now to FIG. 1D , a Y-shaped slit 42 is formed in the barrier 36 to selectively open fluid communication between the distal fluid chamber 34 and the proximal fluid chamber 38. However, in some cases, fluid may leak through the slit 42 when the slit 42 is closed.

[0019] 2A, a catheter assembly 50 is shown, according to some embodiments. In some embodiments, the catheter assembly 50 may include or correspond to the catheter system 10. In some embodiments, the catheter assembly 50 may include one or more features or elements of the catheter system 10. In some embodiments, the catheter system 50 may include a safety coupling 18 and / or an introducer needle 17.

[0020] In some embodiments, the catheter assembly 50 may include a catheter adapter 52, which may include a distal end 54, a proximal end 56, and a lumen 58 extending therethrough. In some embodiments, a catheter 59 may extend distally from the catheter adapter 52. In some embodiments, the catheter 59 may include a peripheral intravenous catheter ("PIVC").

[0021] In some embodiments, the catheter assembly 50 may also include a septum 60 slidably disposed within the lumen 58. In some embodiments, the septum 60 may be comprised of an elastomeric or elastic material. In some embodiments, the septum actuator 61 may be fixed within the lumen 58 of the catheter adapter 52. In some embodiments, the septum 60 may include a distal end 62, a proximal end 64, and a barrier 66 disposed between the distal end 62 of the septum 60 and the proximal end 64 of the septum 60. In some embodiments, the barrier 66 may divide the interior of the septum 60 into a distal cavity 68 and a proximal cavity 70. In some embodiments, the septum 60 may control or restrict the passage of fluid between the distal cavity 68 and the proximal cavity 70.

[0022] In some embodiments, septum 60 may comprise a flexible or semi-flexible polymer plug having an outer diameter configured to fit within lumen 58. In some embodiments, septum 60 may be held in place within lumen 58 via contact with one or more interior surfaces of the internal lumen, contact with an anti-pathogenic material, or another suitable means. In some embodiments, barrier 66 may be positioned at or near distal end 62 or proximal end 64 of septum 60. In some embodiments, septum 60 may have a substantially H-shaped cross-section.

[0023] In some embodiments, the distal surface 72 of the barrier 66 may include a protrusion 74. In some embodiments, the barrier 66 may include a slit 76 extending through the protrusion 74 to selectively open fluid communication between the distal cavity 68 and the proximal cavity 70. In some embodiments, the protrusion 74 may be centrally disposed on the distal surface 72. In some embodiments, the slit 76 may extend through the center of the protrusion 74. In some embodiments, the proximal surface 80 of the barrier 66 may be flat. In some embodiments, the protrusion 74 may be symmetrical.

[0024] 2B, in some embodiments, at least a portion of the outer surface of the protrusion 74 can be disposed at an acute angle a relative to a transverse axis 82 of the catheter assembly 50. In some embodiments, the transverse axis can be perpendicular to the longitudinal axis of the catheter assembly 50. In some embodiments, the protrusion 74 can include a dome, for example, as shown in FIG. 2B. In some embodiments, a diameter 84 of the dome can be larger than a diameter 86 of the slit 76.

[0025] In some embodiments, retrograde blood can flow from the patient's vein through catheter 59 and into the distal cavity 68. The retrograde blood can include radial and axial components 88 and 90 that can exert radial and axial forces, respectively, on protrusions 74.

[0026] 2C, in some embodiments, in response to backflow of blood flowing against protrusion 74, the opposing surfaces of slit 76 may be forced more firmly against each other to seal slit 76, as shown in FIG. 2C, for example. This may be due to the radial force of the backflowing blood against the protrusion, as well as the axial force of the backflowing blood against protrusion 74. When the axial force acts on the central portion of protrusion 74, pushing the central portion of protrusion 74 axially in the proximal direction, the opposing surfaces of slit 76, particularly the distal ends of the opposing surfaces, move toward each other with greater interference.

[0027] 2D, the slits 76 can include any number of configurations. For example, as shown in FIG. 2D, the slits 76 can be Y-shaped. In other embodiments, the slits 76 can be X-shaped. In some embodiments, the slits 76 can be linear.

[0028] 2E, in some embodiments, septum actuator 61 can be secured within lumen 58 of catheter adapter 52. In some embodiments, septum 60 can be configured to move between a proximal position and a distal position in response to insertion of a separate device into the proximal end 56 of catheter adapter 52. The separate device can include, for example, a Luer adapter 96, as shown in FIG.

[0029] In some embodiments, septum actuator 61 can extend through slit 76 when septum 60 is in the distal position, as shown, for example, in FIG. 2E. In some embodiments, slit 76 can extend through the center of protrusion 74 such that septum actuator 61 is located within the center of protrusion 74 when septum 60 is disposed in the distal position. In some embodiments, protrusion 74 can abut septum actuator 61 when septum 60 is in the proximal position prior to insertion of a separate device, as shown, for example, in FIGS. 2A-2C. In some embodiments, protrusion 74 can contact septum actuator 61 when septum 60 is in the proximal position prior to insertion of a separate device.

[0030] In some embodiments, the septum actuator 61 may be fixedly disposed within the distal cavity 68 and may include a portion that is disposed adjacent the septum 60 prior to activation of the catheter assembly 50. In some cases, the septum actuator 61 may include a base 98 coupled to the catheter adapter 52. For example, as shown, the base 98 may be at least partially inserted into the proximal end of the catheter 59. In some embodiments, the base 98 may function as a wedge that forms a press-fit between the catheter 59 and the catheter adapter 52 to at least partially hold the catheter 59 and base 98 in place. In some embodiments, the base 98 may be directly coupled to the catheter adapter 52 via fasteners, adhesives, bonding techniques, or molding. As shown, the septum actuator 61 may have a tubular configuration having a hollow interior that forms a lumen 100 in fluid communication with a lumen 102 of the catheter 59.

[0031] In some embodiments, the proximal end 56 of the catheter adapter 52 includes a flange 104. The flange 104 provides a positive surface that can be configured to allow coupling of an intravenous tubing or a Luer adapter 96 to the catheter assembly 50. In some embodiments, the flange 104 further includes threads for receiving the Luer adapter 96 via a threaded connection.

[0032] 3, in some embodiments, the protrusion 74 may include a truncated dome. In some embodiments, the diameter 92 of the truncated portion of the truncated dome may be larger than the diameter 86 of the slit 76.

[0033] 4, in some embodiments, the protrusion 74 may comprise a truncated cone. In some embodiments, the diameter 94 of the truncated portion of the truncated cone may be greater than the diameter 86 of the slit 76.

[0034] Referring now to FIG. 5 , in some embodiments, another septum 93 that can be used with the catheter assembly 50 can include a duckbill valve 96. A non-limiting example of a duckbill valve is described in U.S. Patent No. 9,126,012, filed October 3, 2012, entitled "Intravenous Catheter with Duckbill Valve," which is incorporated herein by reference in its entirety. In some embodiments, the flaps of the duckbill valve 96 can extend inward and proximally. In some embodiments, the two inward flaps can be pushed apart by a septum actuator 61 to open a gap between the flaps in response to insertion of a luer device, such as the luer device 96 of FIG. 2E, and movement of the septum 93 to a distal position. In some embodiments, the septum 93 can include or correspond to the septum 60 described with respect to FIGS. 2-5 . More specifically, in some embodiments, the septum 93 can include one or more features of the septum 60.

[0035] 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 are the claims. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and structural changes may be made, unless otherwise stated, without departing from the scope of the various embodiments of the invention. Therefore, the following detailed description is not to be taken in a limiting sense.

[0036] All examples and conditional terms listed herein are intended for educational purposes to aid the reader in understanding the invention and the concepts contributed by the inventors in furthering this technology, and they should not be construed as being limited to such specifically listed examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made thereto without departing from the spirit and scope of the invention.

Claims

[Claim 1] a catheter adapter including a distal end, a proximal end, and a lumen extending therethrough; a septum actuator secured within the lumen of the catheter adapter; a septum slidably disposed within the lumen, the septum configured to be opened by the septum actuator in response to movement of the septum to a distal position, the septum comprising: a distal end defining a distal cavity; a proximal end defining a proximal cavity; and a barrier disposed between the distal cavity and the proximal cavity, a distal surface of the barrier comprising a duckbill valve, the duckbill valve comprising opposing flaps extending inwardly and distally, the opposing flaps configured to be pushed apart by the septum actuator in response to movement of the septum to a distal position. Catheter assembly.

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