Catheter assembly with injection port and related methods

Abstract

The present disclosure provides a catheter assembly. The catheter assembly may include a catheter adapter. The body of the catheter adapter may include a distal end, a proximal end, and a first lumen extending through the distal end and the proximal end. The catheter adapter may include a side port that extends outward from the body. The side port may include a second lumen that may be perpendicular to the first lumen. The catheter assembly may include a catheter that extends distally from the distal end of the body. The catheter assembly may include a valve disposed within the first lumen. The valve may include an outer surface that is cylindrical and can seal the first lumen relative to the second lumen. The catheter assembly may include a partition disposed within the second lumen. The partition may divide the second lumen into a plurality of openings and may increase the burst value of the valve.

Description

Technical Field

[0001] The present disclosure relates to the field of medical devices, and in particular, to a catheter assembly and related methods. Background Art

[0002] Catheters are commonly used for parenteral nutrition, intravenous fluids, and the administration of analgesics and antibiotics. They are also used for blood draws. Catheters can be inserted at the bedside using sterile technique and can remain in place for several weeks.

[0003] A common type of catheter is an over-the-needle catheter. As the name suggests, an over-the-needle catheter is mounted on an introducer needle with a sharp distal tip. This sharp distal tip is used to pierce the patient's skin and vein. Insertion of the catheter into the vein can be performed after the introducer needle has penetrated the vein. The introducer needle typically has a sharp distal tip to pierce the patient's skin and vein with minimal resistance, thereby minimizing pain for the patient.

[0004] The introducer needle is typically positioned at a steep angle relative to the skin surface and the longitudinal dimension of the vein to be punctured to allow penetration of the skin and the wall of the vein. The needle and catheter are typically inserted with the bevel of the introducer needle facing away from the patient's skin. After the tip of the introducer needle has penetrated the wall, the angle of insertion is lowered to allow the introducer needle and catheter to be slid into the vein a sufficient distance to properly position the catheter in the vein. Once the introducer needle has been confirmed to be positioned within the vein, the user can temporarily block flow in the vein and withdraw the introducer needle, leaving the catheter in place for future fluid infusions and / or blood draws.

[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 describe one exemplary technology area where some embodiments described herein may be practiced. Summary of the Invention

[0006] The present disclosure generally relates to a catheter assembly that can be used for power injection, and related devices, systems, and methods. "Power injection" can refer to the infusion of a large amount of fluid in a short period of time. In some embodiments, the catheter assembly of the present disclosure can help maintain high flow rates and high pressures within a catheter adapter of the catheter assembly while also maintaining the integrity of a valve disposed within the catheter adapter. In some embodiments, the catheter assembly can increase the rupture threshold (i.e., burst value) of the valve, thereby allowing fluid to be infused into the catheter adapter under high pressure.

[0007] In some embodiments, the catheter adapter can include a body that can include a distal end, a proximal end, and a first lumen extending through the distal and proximal ends. In some embodiments, a side port of the catheter adapter can extend outwardly from the body and can be disposed between the distal and proximal ends. In some embodiments, the side port can include a second lumen perpendicular to the first lumen.

[0008] In certain embodiments, the catheter assembly can include a conduit that can extend distally from the distal end of the main body. In certain embodiments, the catheter assembly can include a valve that is arranged in the first inner chamber. In certain embodiments, the valve can seal the first inner chamber relative to the second inner chamber. In certain embodiments, the outer surface of the valve can be cylindrical.

[0009] In some embodiments, the catheter assembly may include a separator that may be disposed within the second lumen. In some embodiments, the catheter adapter and the separator may be integrally formed as a single unit. In some embodiments, the separator may divide the second lumen into a plurality of openings. In some embodiments, the separator may be proximal to the first lumen. In some embodiments, the separator may contact the valve. In some embodiments, the separator may be symmetrical. In some embodiments, one or more of the plurality of openings may be identical. In some embodiments, the separator may include a variety of shapes and styles.

[0010] In some embodiments, the catheter adapter can include an inner surface that can form a second lumen. In some embodiments, the outer edges of the plurality of openings can form or be aligned with a shape, and the shape can be symmetrical. In some embodiments, the divider can be linear and can extend from one side of the shape to the other side of the shape. In some embodiments, the divider can be perpendicular to the longitudinal axis of the catheter adapter. In some embodiments, the divider can be parallel to the longitudinal axis of the catheter adapter.

[0011] In some embodiments, the divider can include a plurality of arms that can extend from the shape to the central axis of the second lumen. In some embodiments, the divider can include an X-shape. In these embodiments, the plurality of arms can include a first arm, a second arm, a third arm, and a fourth arm. In some embodiments, two of the first arm, the second arm, the third arm, and the fourth arm can be parallel to the longitudinal axis of the catheter adapter. In some embodiments, the first arm, the second arm, the third arm, and the fourth arm can be offset from the longitudinal axis of the catheter adapter.

[0012] In some embodiments, the divider may comprise a Y-shape. In these embodiments, the plurality of arms may comprise a first arm, a second arm, and a third arm. In some embodiments, one of the first arm, the second arm, and the third arm may be parallel to the longitudinal axis of the catheter adapter and may point distally. In some embodiments, one of the first arm, the second arm, and the third arm may be parallel to the longitudinal axis of the catheter adapter and may point proximally.

[0013] In some embodiments, a method of delivering fluid into a catheter adapter may include coupling a power injection device to a side port of the catheter adapter. In some embodiments, the method may include delivering the fluid under pressure into the side port via the power injection device. In some embodiments, the integrity of a valve may be maintained in response to delivering the fluid under pressure into the side port. In some embodiments, the pressure may not exceed a burst value of the valve.

[0014] In some embodiments, the pressure may be greater than 348 psi. In some embodiments, the pressure may be between 348 psi and 478 psi. In some embodiments, the pressure may be between 348 psi and 728 psi. In some embodiments, the pressure may be between 300 psi and 800 psi. In some embodiments, the pressure may be between 350 psi and 800 psi. In some embodiments, the pressure may be between 700 psi and 1000 psi. In some embodiments, the pressure may be between 300 psi and 400 psi, between 400 psi and 500 psi, between 500 psi and 600 psi, between 600 psi and 700 psi, between 700 psi and 800 psi, or between 800 psi and 900 psi. In some embodiments, in response to delivering fluid under pressure into the side port, the partition may inhibit expansion of the valve and / or displacement of the valve in the proximal and distal directions.

[0015] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative and do not limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that, unless otherwise required, these embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description should not be considered limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0017] Figure 1Ais an upper perspective view of a prior art catheter assembly;

[0018] Figure 1B is a top view of a prior art catheter assembly showing an example cover removed;

[0019] Figure 1C is a cross-sectional view of a prior art catheter assembly;

[0020] Figure 1D is a cross-sectional view of a prior art catheter assembly illustrating an example power injection device delivering fluid into the catheter assembly;

[0021] Figure 2 is a cross-sectional view of another catheter assembly according to some embodiments;

[0022] Figure 3A According to some embodiments Figure 2 a top view of a catheter assembly showing an example divider and an example power injection unit removed;

[0023] Figure 3B According to some embodiments Figure 2 an enlarged top view of the catheter assembly showing the separator;

[0024] Figure 4A According to some embodiments Figure 2 a top view of a conduit assembly showing another example divider with the power injection unit removed;

[0025] Figure 4B According to some embodiments Figure 2 An enlarged top view of the catheter assembly showing Figure 4A Another separator of

[0026] Figure 5A According to some embodiments Figure 2 a top view of a conduit assembly showing another example divider with the power injection unit removed;

[0027] Figure 5B According to some embodiments Figure 2 An enlarged top view of the catheter assembly showing Figure 5A Another separator of ;

[0028] Figure 6A According to some embodiments Figure 2 a top view of a catheter assembly showing another example divider with the power injection unit removed;

[0029] Figure 6B According to some embodiments Figure 2An enlarged top view of the catheter assembly showing Figure 6A Another separator of ;

[0030] Figure 7A According to some embodiments Figure 2 a top view of a catheter assembly showing another example divider with the power injection unit removed;

[0031] Figure 7B According to some embodiments Figure 2 An enlarged top view of the catheter assembly showing Figure 7A Another divider, and the power injection unit has been removed;

[0032] Figure 8A According to some embodiments Figure 2 a top view of a conduit assembly showing another example divider with the power injection unit removed;

[0033] Figure 8B According to some embodiments Figure 2 An enlarged top view of the catheter assembly showing Figure 8A The other partition of the power injection unit has been removed. DETAILED DESCRIPTION

[0034] Now refer to Figures 1A-1B , shows a prior art catheter assembly 10. The prior art catheter assembly 10 may correspond to the BD VENFLON™ Pro Safety Shield IV catheter or another catheter assembly. The prior art catheter assembly 10 includes a catheter adapter 12 and a catheter 13 extending distally from the catheter adapter 12. The catheter adapter 12 includes a body 16 including a distal end 18, a proximal end 20, and a lumen 22 extending through the distal end 18 and the proximal end 20. The catheter adapter 12 includes a side port 14 extending outward from the body 16 and may be covered by a removable cover 15. A valve 24 is disposed in the lumen 22 and seals the side port 14 relative to the lumen 22.

[0035] The prior art catheter assembly 10 may not be able to withstand the pressure delivered by the power injection device 26 coupled to the side port 14, which may be used for power injection. According to ISO 10555-1, the minimum pressure required for power injection is 300 psi. However, it has been shown that even pressures below 300 psi may exceed the rupture value of the valve 24 in the prior art catheter assembly 10, thereby causing the valve 24 to fracture or rupture 25, such as Figure 1B The valve 24 may be the weakest component of the catheter assembly 10 of the prior art.

[0036] Furthermore, the valve 24 can be displaced in the distal or proximal direction in response to power injection. Figures 1C-1D In response to the power injection device 26 delivering fluid at a high pressure (e.g., greater than 300 psi), the fluid may flow between the inner surface of the catheter adapter 12 and the outer surface of the valve 24, causing the valve 24 to move from its initial position ( Figure 1C shown) to the distal position ( Figure 1D Thus, after power injection is complete, valve 24 may be prevented from resealing side port 14 relative to lumen 22 and valve 24 may no longer function.

[0037] In some embodiments, the prior art catheter assembly 10 can be removably coupled to a prior art needle assembly 28, which can include a needle hub 30 and an introducer needle 32. In some embodiments, the introducer needle 32 can include a sharp distal tip 34. In some embodiments, the proximal end of the introducer needle 32 can be fixed within the needle hub 30. In some embodiments, for example, Figure 1A As shown, when the prior art catheter assembly 10 is in an insertion position ready for insertion into a patient's vasculature, the introducer needle 32 may extend through the catheter 13 .

[0038] In some embodiments, in response to inserting the introducer needle 32 into the patient's vasculature, a flashback of blood can flow through the sharp distal tip 34 of the introducer needle 32, and the clinician can see the flashback of blood between the introducer needle 32 and the catheter 13 and / or at another location within the catheter assembly 10 of the prior art.

[0039] In some embodiments, in response to confirming via blood flashback that the catheter 13 is within the patient's vasculature, Figure 1B As shown, the prior art needle assembly 28 can be removed from the prior art catheter assembly 10. In some embodiments, when the prior art needle assembly 28 is coupled to the prior art catheter assembly 10, for example, Figure 1A As shown, the introducer needle 32 of the prior art needle assembly 28 is extendable through the valve 24 disposed within the lumen 22 of the catheter adapter 12 .

[0040] Now refer to Figure 2 , shows a catheter assembly 29 according to some embodiments. In some embodiments, the catheter assembly 29 may include or correspond to the prior art catheter assembly 10. For example, one or more components of the catheter assembly 29 may include or correspond to one or more components of the prior art catheter assembly 10.

[0041] In some embodiments, the catheter assembly 29 can include a catheter adapter 36. In some embodiments, the catheter adapter 36 can include a body 38 that can include a distal end 40, a proximal end 42, and a first lumen 44 extending through the distal end 40 and the proximal end 42. In some embodiments, the catheter adapter 36 can include a side port 46 extending outward from the body 38. In some embodiments, the side port 46 can be disposed between the distal end 40 and the proximal end 42. In some embodiments, the side port 46 can include a second lumen 48 that can be perpendicular to the first lumen 44. In some embodiments, the second lumen 48 can extend through the side port 46 to the first lumen 44. In some embodiments, the first lumen 44 can be generally cylindrical, and the second lumen 48 can be generally cylindrical.

[0042] In some embodiments, the catheter assembly 29 may include a catheter 50 that can extend distally from the distal end 40 of the body 38 and can be fixed within the catheter adapter 36. In some embodiments, the catheter assembly 29 may include a valve 52 that is disposed within the first lumen 44. In some embodiments, the valve 52 can seal the first lumen 44 relative to the second lumen 48, thereby preventing fluid from traveling between the first lumen 44 and the second lumen 48. In some embodiments, the outer surface of the valve 52 can be cylindrical. In some embodiments, the valve 52 can be solid. In other embodiments, the valve 52 can include an opening extending through the distal end of the valve 52 and the proximal end of the valve 52. In some embodiments, the valve 52 can be made of silicon or other suitable materials.

[0043] In some embodiments, the catheter assembly 29 can include a divider 54 that can be disposed within the second lumen 48. In some embodiments, the catheter adapter 36 and the divider 54 can be integrally formed as a single unit that can secure the divider 54 in response to power injection through the side port 46. In some embodiments, the divider 54 can divide the second lumen 48 into a plurality of openings 56. In some embodiments, the divider 54 can be made of plastic, metal, or other suitable material. In some embodiments, the divider 54 can be rigid.

[0044] In some embodiments, the divider 54 can be proximate to the first lumen 44. In some embodiments, the divider can be disposed between an outer surface 58 of the body 38 and an inner surface 60 of the body 38 that forms the first lumen 44. In some embodiments, the divider 54 can be disposed between the side port 46 and the inner surface 60 of the body 38. In some embodiments, the divider 54 can be disposed within the side port 46 or within a portion of the second lumen 48 that is disposed within the side port 46.

[0045] In some embodiments, the divider 54 can contact the valve 52. In some embodiments, the divider 54 can be symmetrical, which can provide an evenly distributed amount of pressure on the valve 52 during power injection. In some embodiments, the divider 54 can be asymmetrical. In some embodiments, one or more of the plurality of openings 56 can be identical. In some embodiments, the divider 54 can include a variety of shapes and styles.

[0046] In some embodiments, partition 54 can facilitate high flow rates and high pressures within catheter adapter 36 while also maintaining the integrity of valve 52. In some embodiments, partition 54 can increase the burst value of valve 52, enabling valve 52 to withstand high pressures without rupturing during high-pressure power injection into catheter adapter 36. Thus, in some embodiments, valve 52 can comprise a multi-use valve that can be used for multiple power injections.

[0047] In some embodiments, in response to fluid being delivered under pressure into the side port 46 during a power injection procedure, the partition 54 can reduce or eliminate expansion of the valve 52 when the valve 52 contacts and presses against the partition 54. In some embodiments, in response to fluid being delivered under pressure into the side port 46 during a power injection procedure, the partition 54 can reduce or eliminate displacement of the valve 52 in both the proximal and distal directions.

[0048] In some embodiments, the pressure may be greater than 348 psi. In some embodiments, the pressure may be between 348 psi and 478 psi. In some embodiments, the pressure may be between 348 psi and 728 psi. In some embodiments, the pressure may be between 300 psi and 800 psi. In some embodiments, the pressure may be between 350 psi and 800 psi. In some embodiments, the pressure may be between 700 psi and 1000 psi. In some embodiments, the pressure may be between 300 psi and 400 psi, between 400 psi and 500 psi, between 500 psi and 600 psi, between 600 psi and 700 psi, between 700 psi and 800 psi, or between 800 psi and 900 psi. In some embodiments, in response to delivering fluid to the side port 46 at this pressure, the partition 54 may inhibit expansion of the valve 52 and / or displacement of the valve 52 in the proximal and distal directions. In some embodiments, the plurality of openings 56 can be configured to allow fluid to flow from the side port 46 to the body 38 at a flow rate and / or pressure between approximately 3 mL and 8 mL per second. In some embodiments, the plurality of openings 56 can be configured to allow fluid to flow from the side port 46 to the body 38 at other suitable flow rates.

[0049] In some embodiments, the burst value of valve 52 may be greater than 348 psi. In some embodiments, the burst value of valve 52 may be between 348 psi and 478 psi. In some embodiments, the burst value of valve 52 may be between 348 psi and 728 psi. In some embodiments, the burst value of valve 52 may be between 300 psi and 800 psi. In some embodiments, the burst value of valve 52 may be between 350 psi and 800 psi. In some embodiments, the burst value of valve 52 may be between 700 psi and 1000 psi. In some embodiments, the burst value of valve 52 may be between 300 psi and 400 psi, between 400 psi and 500 psi, between 500 psi and 600 psi, between 600 psi and 700 psi, between 700 psi and 800 psi, or between 800 psi and 900 psi. In some embodiments, valve 52 may be stronger than body 38, such that body 38 may break or rupture at lower pressures than valve 52.

[0050] 3-4 , in some embodiments, the catheter adapter 36 can include another inner surface 62 that can form the second lumen 48. In some embodiments, the outer edge 64 of the plurality of openings 56 can form or be aligned with a shape 66, which can be an ellipse or a geometric shape (e.g., a circle or a triangle). In some embodiments, the shape 66 can be symmetrical. In some embodiments, the outer edge 64 can include an arc that connects two lines forming the inner edges of the plurality of openings 56 or the ends of a line forming the inner edges of the plurality of openings 56. In some embodiments, the two lines can intersect at a corner or a rounded edge.

[0051] In some embodiments, the diameter of shape 66 (which may include the maximum diameter of shape 66) may be smaller than the diameter of a portion of the other inner surface 62 proximal to shape 66 and closer to the external opening 68 of side port 46, as shown in, for example, FIG3-4. Thus, in some embodiments, second lumen 48 may have a step, and divider 54 may extend from the stepped surface. In other embodiments, the diameter of shape 66 may be equal to the diameter of a portion of the other inner surface 62 proximal to shape 66 and closer to the external opening 68 of side port 46. In these embodiments, divider 54 may not extend from the stepped surface.

[0052] In some embodiments, the divider 54 may include a plurality of arms 70 that may extend from the shape 66 to a central axis 72 of the second lumen 48 (see also FIG. Figure 2). In some embodiments, the divider 54 may include an X-shape. In these embodiments, the plurality of arms 70 may include a first arm 70a, a second arm 70b, a third arm 70c, and a fourth arm 70d. In some embodiments, as Figures 3A-3B As shown, two of the first arm 70a, the second arm 70b, the third arm 70c, and the fourth arm 70d may be parallel to the longitudinal axis 74 of the catheter adapter 36 (see also FIG. Figure 2 ).like Figures 4A-4B As shown, in some embodiments, the first arm 70a, the second arm 70b, the third arm 70c, and the fourth arm 70d can be offset from the longitudinal axis 74 of the catheter adapter 36, such as by approximately 45° or other suitable angles.

[0053] 5-6, in some embodiments, the divider 54 can include a Y-shape. In these embodiments, the plurality of arms 70 can include a first arm 70a, a second arm 70b, and a third arm 70c. In some embodiments, as shown in FIG. Figures 5A-5B As shown, one of the first arm 70a, the second arm 70b, and the third arm 70c can be parallel to the longitudinal axis 74 of the catheter adapter 36 and can point distally. Figures 6A-6B As shown, in some embodiments, one of the first arm 70a, the second arm 70b, and the third arm 70c can be parallel to the longitudinal axis 74 of the catheter adapter 36 and can point proximally. In some embodiments, none of the first arm 70a, the second arm 70b, or the third arm 70c can be aligned with the longitudinal axis 74 of the catheter adapter 36.

[0054] 7-8 , in some embodiments, the divider 54 can be linear and can extend from one side of the shape 66 to the other side of the shape 66. In some embodiments, the divider 54 is linear and / or oriented perpendicular to the longitudinal axis 74 of the catheter adapter 36, which can reduce fluid leakage between the outer surface of the valve 52 and the inner surface 60 of the body 38, which could otherwise displace the valve 52 in a proximal or distal direction during power injection. In some embodiments, as Figures 7A-7B As shown, the divider 54 can be perpendicular to the longitudinal axis 74 of the catheter adapter 36. In some embodiments, as shown in FIG. Figures 8A-8B As shown, the divider 54 may be parallel to the longitudinal axis 74 of the catheter adapter 36 .

[0055] In some embodiments, a method of delivering fluid into the catheter adapter 36 may include coupling the power injection device 26 to the side port 14 of the catheter adapter 12. In some embodiments, the method may include delivering the fluid under pressure into the side port 14 via the power injection device 26. In some embodiments, the integrity of the valve 52 may be maintained in response to delivering the fluid under pressure into the side port 14. In some embodiments, the pressure may not exceed a burst value of the valve 52.

[0056] All examples and conditional language recorded herein are intended to be used for teaching purposes to help readers understand the present invention and the concepts contributed by the inventors to further develop this field, and should be interpreted as not being limited to these specific recorded examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions and modifications may be made thereto without departing from the spirit and scope of the present invention.

Claims

1. A catheter assembly, characterized in that The catheter assembly comprises: A catheter adapter, comprising: a body comprising a distal end, a proximal end, and a first lumen extending through the distal end and the proximal end; a side port extending outwardly from the body and disposed between the distal end and the proximal end, wherein the side port includes a second lumen perpendicular to the first lumen; a catheter extending distally from the distal end of the body; a valve disposed in the first lumen and sealing the first lumen from the second lumen, wherein an outer surface of the valve is cylindrical; and A partition is disposed in the second inner cavity, wherein the partition divides the second inner cavity into a plurality of openings.

2. The catheter assembly according to claim 1, wherein The partition is adjacent to the first inner cavity.

3. The catheter assembly according to claim 1, wherein The partition contacts the valve.

4. The catheter assembly according to claim 1, wherein The dividers are symmetrical.

5. The catheter assembly according to claim 4, wherein Each of the plurality of openings is identical.

6. The catheter assembly according to claim 1, wherein Outer edges of the plurality of openings form a symmetrical shape, wherein the partition is linear and extends from one side of the symmetrical shape to the other side of the symmetrical shape.

7. The catheter assembly according to claim 6, wherein: The divider is perpendicular to the longitudinal axis of the catheter adapter.

8. The catheter assembly according to claim 6, wherein The divider is parallel to the longitudinal axis of the catheter adapter.

9. The catheter assembly according to claim 1, wherein Outer edges of the plurality of openings form a symmetrical shape, wherein the divider includes a plurality of arms extending from the symmetrical shape to a central axis of the second inner cavity.

10. The catheter assembly according to claim 9, wherein The divider comprises an X-shape.

11. The catheter assembly according to claim 10, wherein: The plurality of arms includes a first arm, a second arm, a third arm, and a fourth arm, wherein two of the first arm, the second arm, the third arm, and the fourth arm are parallel to a longitudinal axis of the catheter adapter.

12. The catheter assembly according to claim 10, wherein The X-shape includes a first arm, a second arm, a third arm, and a fourth arm, wherein the first arm, the second arm, the third arm, and the fourth arm are offset relative to a longitudinal axis of the catheter adapter.

13. The catheter assembly according to claim 9, wherein The divider includes a Y-shape.

14. The catheter assembly according to claim 13, wherein The plurality of arms includes a first arm, a second arm, and a third arm, wherein one of the first arm, the second arm, and the third arm is parallel to a longitudinal axis of the catheter adapter and points distally.

15. The catheter assembly according to claim 13, wherein The plurality of arms includes a first arm, a second arm, and a third arm, wherein one of the first arm, the second arm, and the third arm is parallel to a longitudinal axis of the catheter adapter and points proximally.

16. The catheter assembly according to claim 1, wherein The catheter adapter and the separator are integrally formed as a single unit.

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