Catheter Assembly

The catheter assembly addresses the challenge of bacterial ingress and fluid management by using a side port valve with a sealed cannula and a compressible valve for controlled fluid flow, enhancing the reliability and safety of medical procedures.

JP7670630B2Active Publication Date: 2025-04-30BECTON DICKINSON & CO
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Patent Information

Application Number
JP2021573895
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-05-19
Filing Date
2020-05-21
Publication Date
2025-04-30
Estimated Expiration
2040-05-21

AI Technical Summary

Technical Problem

Existing catheter assemblies lack effective mechanisms to prevent bacterial ingress and ensure reliable fluid management during medical procedures.

Method used

The catheter assembly incorporates a side port valve with a cannula having a blunt, closed end that seals the channel, preventing bacterial entry, and a valve that compresses to expose openings for fluid flow.

Benefits of technology

This design effectively prevents bacterial contamination and ensures reliable fluid management by sealing the cannula and allowing controlled fluid flow through the valve.

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Patent Text Reader

Abstract

The catheter assembly may include a catheter adapter. The body of the catheter adapter may include a distal end, a proximal end, and a lumen extending through the distal and proximal ends. The catheter may extend distally from the distal end of the body. The catheter adapter may include a side port extending outwardly from the body. The catheter assembly may include a valve disposed within the lumen. The valve may include a channel extending through the valve. The catheter assembly may include a cannula secured within the side port and disposed within the channel. The cannula may include an opening, and the valve may be configured to compress to expose the opening from within the valve.
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Description

[Technical field]

[0001] The present invention relates to a catheter assembly with a side port valve. [Background technology]

[0002] Catheters are typically used to administer parenteral nutrition, intravenous fluids, pain medications, and antibiotics. Catheters are also used to draw blood. Catheters can be installed at the bedside using sterile techniques and left in place for several weeks.

[0003] A common type of catheter is the over-the-needle catheter. As the name suggests, an "over-the-needle" catheter may be mounted over an introducer needle that has a sharp distal tip. The sharp distal tip can be used to penetrate the patient's skin and vascular system. Insertion of the catheter into a vein may follow puncture of the vein with the introducer needle. The introducer needle usually has a sharp distal tip to penetrate the patient's skin and vein with minimal resistance to minimize pain to the patient.

[0004] The introducer needle is typically placed at a steep bevel angle relative to the surface of the skin and the longitudinal dimension of the vein being punctured, allowing it to penetrate the skin and the wall of the vein. The needle and catheter are typically inserted with the bevel of the introducer needle pointing away from the patient's skin. After the tip of the introducer needle penetrates the wall, the angle of insertion is lowered to allow the introducer needle and catheter to slide a sufficient distance to properly place the catheter within the vein. Once placement of the introducer needle within the vein is confirmed, the user can withdraw the introducer needle with a temporary occlusion of flow within the vein, leaving the catheter in place for future 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 certain environments such as those described above. Rather, this background is provided only to illustrate one example technology area in which some of the embodiments described herein may be practiced. Summary of the Invention

[0006] The present disclosure relates generally to catheter assemblies, as well as related devices, systems, and methods. In some embodiments, the catheter assembly may include a catheter adapter that may include a body and a side port extending outwardly from the body. In some embodiments, the body may include a distal end, a proximal end, and a lumen extending through the distal end of the body and the proximal end of the body. In some embodiments, the side port may be disposed between the distal end and the proximal end. In some embodiments, the side port may include an exterior opening.

[0007] In some embodiments, the catheter assembly may include a valve disposed within the side port. In some embodiments, the valve may include a channel extending through the valve. In some embodiments, the catheter assembly may include a cannula that may be secured within the side port. In some embodiments, the cannula may be disposed within the channel. In some embodiments, the cannula may include one or more openings. In some embodiments, the valve may be configured to compress to expose the openings from within the valve. In some embodiments, the catheter assembly may include a catheter extending distally from a distal end of the body. In some embodiments, the catheter assembly may include another valve that may be generally cylindrical and / or disposed within a lumen.

[0008] In some embodiments, the side port and the body may be integrally formed as a single unit. In some embodiments, the valve may be constructed of rubber or another suitable resilient material. In some embodiments, the valve may include a first end, a second end, and an accordion portion between the first end and the second end. In some embodiments, the diameter of the first end and the diameter of the second end may be greater than the diameter of the accordion portion. In some embodiments, the valve may include a rim and the side port may include a groove. In some embodiments, the rim may be disposed within the groove to secure the valve within the side port.

[0009] In some embodiments, the cannula may include a blunt closed end. In some embodiments, the blunt closed end of the cannula may seal the end of the channel, which may prevent bacteria from entering the catheter assembly. More specifically, in some embodiments, the blunt closed end may include a first circumference and the end of the channel may include a second circumference approximately equal to the first circumference, which may facilitate sealing at the end of the channel.

[0010] In some embodiments, the openings may include a first opening, a second opening, and / or a third opening. In some embodiments, one or more of the first opening, the second opening, and the third opening may be spaced around the circumference of the cannula. In some embodiments, one or more of the first opening, the second opening, and the third opening may be proximate the blunt closed end. In some embodiments, the cannula may include an annular body. In some embodiments, the first opening, the second opening, and / or the third opening may be disposed between the blunt closed end of the cannula and the annular body.

[0011] In some embodiments, the catheter assembly may include a base that may be secured to the cannula. In some embodiments, the cannula may include an opening that may extend along the length of the cannula from the blunt closed end to the base. In these and other embodiments, the blunt closed end of the cannula may be semicircular and the end of the channel may be generally semicylindrical, which may facilitate sealing at the end of the channel. In some embodiments, the channel may be generally semicylindrical. In some embodiments, the base may include a hole that may be aligned with the opening.

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

[0013] Exemplary embodiments will be described and explained with additional specificity and detail through the use of accompanying drawings. [Figure 1A] FIG. 1A is a top perspective view of a catheter assembly according to some embodiments. [Figure 1B] FIG. 1B is a top view of the catheter assembly showing an example of an open cap. [Figure 2A] FIG. 2A is a partial cross-sectional view of a catheter assembly, according to some embodiments. [Figure 2B] FIG. 2B is a top view of an exemplary side port of a catheter assembly, according to some embodiments. [Figure 2C]FIG. 2C is a partial cross-sectional view of a catheter assembly showing an exemplary medical device inserted into a side port to compress an exemplary valve, according to some embodiments. [Figure 3A] FIG. 3A is a top perspective view of a valve of a catheter assembly, according to some embodiments. [Figure 3B] FIG. 3B is a cross-sectional view of a valve according to some embodiments. [Figure 3C] FIG. 3C is a top perspective view of an exemplary cannula of a catheter assembly, according to some embodiments. [Figure 3D] FIG. 3D is a cross-sectional view of the cannula taken along line 3D-3D of FIG. 3C, according to some embodiments. [Figure 3E] FIG. 3E is another cross-sectional view of a cannula, according to some embodiments. [Figure 4A] FIG. 4A is a cross-sectional view of a catheter assembly showing another exemplary cannula and another exemplary valve, according to some embodiments. [Figure 4B] FIG. 4B is a top view of a side port of the catheter assembly, according to some embodiments. [Figure 4C] FIG. 4C is a cross-sectional view of a catheter assembly showing a medical device inserted into a side port to compress another valve, according to some embodiments. [Figure 5A] FIG. 5A is a top perspective view of another valve, according to some embodiments. [Figure 5B] FIG. 5B is a cross-sectional view of another valve, according to some embodiments. [Figure 5C] FIG. 5C is a top perspective view of another cannula, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] 1A-3E, a catheter assembly 10 may include a catheter adapter 12 that may include a body 14 and a side port 16 extending outwardly from the body 14. In some embodiments, the side port 16 and the body 14 may be integrally formed as a single unit. In some embodiments, the body 14 may include a distal end 18, a proximal end 20, and a lumen 22 that extends through the distal end 18 of the body 14 and the proximal end 20 of the body 14. In some embodiments, the side port 16 may be disposed between the distal end 18 and the proximal end 20. In some embodiments, the side port 16 may include an outer opening 24.

[0015] In some embodiments, the catheter assembly 10 may include a valve 26 disposed within the side port 16. In some embodiments, the valve 26 may be constructed of rubber or another suitable resilient material. In some embodiments, the valve 26 may include a channel 27 extending through the valve 26. In some embodiments, the catheter assembly 10 may include a cannula 28. In some embodiments, the cannula 28 may be disposed within the channel 27. In some embodiments, the cannula 28 may include a blunt closed end 30.

[0016] In some embodiments, the catheter assembly 10 may include a catheter 32 extending distally from the distal end 18 of the body 14. In some embodiments, the catheter 32 may include a peripheral intravenous catheter ("PIVC"), a peripherally inserted central catheter ("PICC"), a midline catheter, or another suitable catheter. In some embodiments, a needle assembly including an introducer needle 33 may extend through the catheter adapter 12, for example, as shown in FIG. 1A. In some embodiments, in response to the introducer needle 33 and catheter 32 being inserted into the patient's vasculature, the needle assembly may be detached from the catheter adapter 12, for example, as shown in FIG. 1B. In some embodiments, a blood collection device may be coupled to the catheter adapter 12, and when the catheter 32 is inserted into the patient's vasculature, blood may flow from the vasculature, distally through the catheter 32, through the catheter adapter 12, and to the blood collection device.

[0017] In some embodiments, the cannula 28 may include one or more openings 34. As shown in FIG. 2C, in some embodiments, the valve 26 may be configured to compress to expose the openings 34 from within the valve 26. In some embodiments, a medical device 36 may be inserted into and / or coupled to the side port 16, which may compress the valve 26 to expose the openings 34 from within the valve 26 and may allow fluid to flow from the medical device 36 through the openings 34 and through the annular body 38 of the cannula 28. In some embodiments, in response to the medical device 36 being removed and / or disconnected from the side port 16, the valve 26 may resiliently return to a position in which the openings 34 are within the valve 26.

[0018] In some embodiments, the openings 34 may include a first opening 34a, a second opening 34b, and / or a third opening 34c (which may be collectively referred to in this disclosure as "openings"). In some embodiments, the openings 34 may include more than three openings or only one opening. In some embodiments, as shown, one or more openings 34 may be spaced around the circumference of the cannula 28. In these embodiments, the openings 34 may be aligned with one another.

[0019] In some embodiments, one or more of the openings 34 may be proximate the blunt closed end 30. In some embodiments, the one or more openings 34 may be disposed between the blunt closed end 30 and the annular body 38 of the cannula 28. In some embodiments, the annular body 38 may include a fluid pathway 39 or channel extending through the annular body 38. In some embodiments, the openings 34 may be in fluid communication with the fluid pathway 39. In some embodiments, the openings 34 may be spaced apart from one another by a beam or separator that may extend between the blunt closed end 30 and the annular body 38. In some embodiments, the beam or separator may monolithically form the blunt closed end 30 and / or the annular body 38 as a single unit.

[0020] In some embodiments, the catheter assembly 10 may include another valve 40, which may be generally cylindrical and / or disposed within a lumen. In some embodiments, the other valve 40 may be solid or include a channel extending therethrough and aligned with the longitudinal axis of the body. In some embodiments, the side port 16 may be approximately perpendicular to the body 14, which may facilitate fluid from the medical device 36 contacting the other valve 40 at an angle of about 90°, which may facilitate manipulation and opening of the other valve 40. In some embodiments, the other valve 40 may be open to allow fluid communication between the side port 16 and the lumen 22. In some embodiments, the other valve 40 may be open when a portion of the other valve 40 is depressed in response to contact with a fluid. In some embodiments, the other valve 40 may include any suitable valve, which may be generally perpendicular to the valve 26.

[0021] In some embodiments, valve 26 may include a first end 41, a second end 42, and an accordion portion 44 between first end 41 and second end 42. In some embodiments, the diameter of first end 41 and the diameter of second end 42 may be greater than the diameter of accordion portion 44. In some embodiments, the outer surface of accordion portion 44 may be curved.

[0022] In some embodiments, the cannula 28 may be secured within the side port 16. As one example, the cannula 28 may be secured to the side port and / or the catheter adapter 12. As another example, the valve 26 may be coupled to the side port 16 and the cannula 28 may fit snugly within the valve 26. In some embodiments, the end of the cannula 28 opposite the blunt closed end 30 may have a larger diameter than the end 56 of the channel 27 before and / or after insertion of the medical device 36, which may facilitate the cannula 28 being secured within the valve 26. In some embodiments, the end of the cannula 28 opposite the blunt closed end 30 may contact and / or be secured to a stepped surface, which may facilitate the securing of the cannula 28 within the side port 16.

[0023] In some embodiments, the valve 26 can be coupled to the catheter adapter 12 in any number of suitable ways. In some embodiments, the valve 26 can include a rim 52 and the side port 16 can include a groove 54. In some embodiments, the rim 52 can be disposed within the groove 54 to secure the valve 26 within the side port 16. In some embodiments, the rim 52 and / or the groove 54 can be annular.

[0024] In some embodiments, the blunt closed end 30 of the cannula 28 can seal the end 56 of the channel 27, which can prevent bacteria from entering the catheter assembly 10. More specifically, in some embodiments, the blunt closed end 30 can include a first circumference and the end 56 of the channel 27 can include a second circumference approximately equal to the first circumference, which can facilitate a seal at the end 56 of the channel 27. In some embodiments, the catheter assembly 10 may not include a cap 58, as the blunt closed end 30 and the valve 26 can seal the catheter adapter 12 from the external environment.

[0025] 4A-5C, in some embodiments, catheter assembly 10 may include a valve 60 and a cannula 62. In some embodiments, valve 60 may include or correspond to valve 26 described with respect to Figures 1A-3E, and / or cannula 62 may include or correspond to cannula 28 described with respect to Figures 1A-3E. In some embodiments, valve 60 may include one or more features of valve 26 described with respect to Figures 1A-3E, and / or cannula 62 may include one or more features of cannula 28 described with respect to Figures 1A-3E.

[0026] In some embodiments, the catheter assembly 10 may include a base 64 that may be secured to the cannula 28. In some embodiments, the cannula 28 and the base 62 may be monolithically formed as a single unit. In some embodiments, the cannula 28 may include an opening 66 that may extend along the length of the cannula 28. In some embodiments, the cannula 28 may include an opening 66 that may extend along the length of the cannula 28 from the blunt closed end 30 to the base 64. In these and other embodiments, the blunt closed end 30 of the cannula 28 may be semicircular and the end 56 of the channel 27 may be generally semicylindrical, which may facilitate sealing at the end 56 of the channel 27. In some embodiments, the channel 27 may be generally semicylindrical. In some embodiments, the base 64 may include a hole 68 that may be aligned with the opening 66.

[0027] 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 arrangements and instrumentalities shown in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense.

[0028] All examples and conditional language described herein are intended for educational purposes to help the reader understand the concepts provided by the inventor to promote the invention and technology, and should be interpreted as not being limited to the specifically recited examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention.

Claims

1. a body including a distal end, a proximal end, and a lumen extending therethrough between 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, the side port having an exterior opening; a valve disposed within the side port, the valve including a channel extending therethrough; a cannula secured within the side port and disposed within the channel, the cannula including a plurality of openings, the plurality of openings being within the valve when the valve is in a first position, the valve being configured to compress to a second position in which the valve is below the plurality of openings and the plurality of openings are exposed from within the valve; a catheter extending distally from the distal end of the body; a catheter adapter including: the cannula includes a blunt closed end, the blunt closed end of the cannula sealing an end of the channel; The catheter assembly, wherein the channel is semi-cylindrical.

2. The catheter assembly of claim 1 , wherein the side port and the body are monolithically formed as a single unit.

3. The catheter assembly of claim 2 , further comprising another valve, the another valve being cylindrical and disposed within the lumen.

4. The catheter assembly of claim 2 , wherein the valve is constructed of rubber.

5. The catheter assembly of claim 4 , wherein the valve includes a first end, a second end, and an accordion portion between the first end and the second end.

6. The catheter assembly of claim 5 , wherein a diameter of the first end and a diameter of the second end are larger than a diameter of the accordion portion.

7. The catheter assembly of claim 6, wherein the valve further comprises a rim, and the side port comprises a groove, the rim being disposed within the groove to secure the valve within the side port.

8. The catheter assembly of claim 1 , wherein the blunt closed end has a first circumference and the channel end has a second circumference approximately equal to the first circumference.

9. 2. The catheter assembly of claim 1, wherein the opening is a first opening, the cannula includes a second opening and a third opening, the first opening, the second opening, and the third opening being spaced apart around a circumference proximate the blunt closed end of the cannula.

10. 2. The catheter assembly of claim 1, further comprising a base secured to the cannula and including a hole, the opening extending along the length of the cannula from the blunt closed end to the base, the opening being aligned with the hole.

11. The catheter assembly of claim 1 , wherein the blunt closed end of the cannula is semicircular and the end of the channel is semicircular.

12. a body including a distal end, a proximal end, and a lumen extending therethrough between 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, the side port having an exterior opening; a valve disposed within the side port, the valve including a channel extending therethrough, the channel being semi-cylindrical; a cannula secured within the side port and disposed within the channel and including an opening, the cannula being configured to be compressed by the valve to expose the opening from within the valve, the cannula including a blunt closed end, the blunt closed end sealing an end of the channel; a catheter extending distally from the distal end of the body; A catheter assembly comprising a catheter adapter including:

13. 13. The catheter assembly of claim 12, further comprising a base secured to the cannula and including a hole, the opening extending along a length of the cannula from the blunt closed end to the base, the opening being aligned with the hole.

14. The catheter assembly of claim 12 , wherein the side port and the body are monolithically formed as a single unit.

Citation Information

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