Catheter system with swab for site disinfection

Abstract

The catheter system may include a catheter adapter, which may include a distal end, a proximal end, and a lumen. The catheter system may include one or more of: a catheter tube extending distally from the distal end of the catheter adapter; a needle hub; an introducer needle extending distally from the needle hub through the catheter tube, the introducer needle including a sharp distal tip; a needle cover surrounding the catheter tube and the sharp distal tip; a swab holder coupled to the distal end of the needle cover; a swab secured within the swab holder and including an antiseptic; and an end cap proximal to the catheter adapter. The catheter system may include an end cap proximal to the catheter adapter, and the swab holder may be coupled to the swab holder coupled to the proximal end of the end cap.

Description

[Technical Field]

[0001] The present invention relates to a catheter system with a swab for site disinfection. [Background technology]

[0002] A common type of catheter assembly includes an over-the-needle peripheral intravenous catheter ("PIVC"). As the name suggests, an over-the-needle PIVC can be fitted over an introducer needle with a sharp distal tip. The catheter assembly can include a catheter adapter, a PIVC extending distally from the catheter adapter, and an introducer needle extending through the PIVC. The PIVC and introducer needle can be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the PIVC and the bevel of the needle points away from the patient's skin just prior to insertion into the 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 in the vessel, the clinician may confirm the presence of a "flashback" of blood in the flashback chamber of the catheter assembly. Once inserting the introducer needle is confirmed, the clinician may remove the introducer needle and leave the PIVC in place for subsequent blood collection or infusion.

[0004] Alcohol wipes are a common technique used to apply antiseptic to the skin before cannulation or insertion of a PIVC into a vein, as well as other surgical or nonsurgical procedures. It is often inconvenient for clinicians to carry individually packaged alcohol wipes because they occupy additional space and must be purchased and carried in bulk. Individually packaged alcohol wipes are also small and easily lost. Furthermore, many diabetic patients have dexterity issues that make it difficult to open packages containing alcohol wipes. Furthermore, when using separately packaged alcohol wipes, one-handed operation may not be feasible. Furthermore, when the alcohol wipe is removed from the package, some of the alcohol may remain unused in the package. Furthermore, direct contact by clinicians with the alcohol wipe during skin disinfection can result in contamination of the insertion site.

[0005] The subject matter claimed herein is not limited to embodiments that solve the problems or that operate only in the contexts described above. Rather, this background is only provided to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention

[0006] The present disclosure relates generally to vascular access devices and related methods. More specifically, the present disclosure relates to a catheter system having a swab or wipe for site disinfection, and related devices and methods. In some embodiments, the catheter system may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter system may include a catheter tube extending distally from the distal end of the catheter adapter.

[0007] In some embodiments, the catheter system may include a needle hub and an introducer needle extending distally from the needle hub through the catheter tube. In some embodiments, the introducer needle may include a sharp distal tip. In some embodiments, the catheter system may include a needle cover surrounding the catheter tube and the sharp distal tip. In some embodiments, the catheter system may include a swab holder coupled to the distal end of the needle cover. In some embodiments, the catheter system may include a swab secured within the swab holder and containing an antiseptic. Thus, the swab may be integrated with the catheter system.

[0008] In some embodiments, the catheter system may include a film coupled to the swab holder that seals the swab from the external environment. In some embodiments, the swab holder and / or the film may comprise a thermoplastic resin, so that the film may be heat sealed to the swab holder. In some embodiments, the needle cover may be tubular.

[0009] In some embodiments, the swab may be round or oval. In some embodiments, the swab is rectangular or square. In some embodiments, the swab may comprise a sponge. In some embodiments, the sponge may be pre-cut.

[0010] In some embodiments, the swab holder may include a flange that surrounds and contacts the swab. In some embodiments, the swab may extend outward beyond the flange. In some embodiments, the swab may be oval and the flange may be oval. In some embodiments, the swab may be rectangular and the flange may be rectangular. In some embodiments, the needle cover may extend from the distal end of the catheter adapter beyond the sharp distal tip of the introducer needle. In some embodiments, the catheter tube may be disposed within the needle cover.

[0011] In some embodiments, the catheter system may include an end cap proximal to the catheter adapter. In some embodiments, a swab holder may be coupled to the proximal end of the end cap. In some embodiments, a swab may be secured within the swab holder and may include an antiseptic.

[0012] The manufacturing method may include joining a swab to a swab holder configured to couple to the distal end of a needle cover or the proximal end of an end cap of a catheter system. In some embodiments, the method may include loading the swab with a disinfectant after coupling the swab to the swab holder. In some embodiments, the method may include placing a film over the swab after loading the swab with the disinfectant. In some embodiments, the method may include heat-sealing the film to the swab holder after placing the film over the swab.

[0013] In some embodiments, the swab holder may include a flange that surrounds and contacts the swab. In some embodiments, the swab may extend outward beyond the flange. In some embodiments, the flange may form a pocket. In some embodiments, adhering the swab to the swab holder may include disposing an adhesive in the pocket and contacting the swab with the adhesive.

[0014] In some embodiments, the method may include coupling a swab holder to the distal end of the needle cover or the proximal end of the end cap. In some embodiments, the method may include coupling the swab holder to the distal end of the needle cover, and then coupling the needle cover to the distal end of the catheter adapter such that the needle cover covers the introducer needle and the catheter tube. In some embodiments, the catheter system may include a cap coupled to the proximal end of the catheter adapter. In some embodiments, the method may include coupling the swab holder to the proximal end of the end cap, and then coupling the end cap to the connector.

[0015] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed invention. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. Also, it is to be understood that 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 explanation of the drawings]

[0016] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1A] FIG. 1A is a top perspective view of the catheter system. [Figure 1B] FIG. 1B is a top perspective view of a catheter system showing an exemplary needle cover and an exemplary swab holder coupled to the needle cover. [Figure 1C] FIG. 1C is an exploded view of a needle cover, a swab holder, an exemplary swab, and an exemplary film, according to some embodiments. [Figure 2A] FIG. 2A is a top perspective view of a catheter system showing an exemplary rectangular swab and an exemplary rectangular swab holder, according to some embodiments. [Figure 2B] FIG. 2B is a top view of a rectangular swab and a rectangular swab holder, according to some embodiments. [Figure 2C] FIG. 2C is a side view of a rectangular swab and a rectangular swab holder, according to some embodiments. [Figure 2D] FIG. 2D is a top perspective view of a rectangular swab and a rectangular swab holder showing a rectangular swab with a pre-cut sponge, according to some embodiments. [Figure 3A]FIG. 3A is a top perspective view of a catheter system showing an exemplary oval swab and an exemplary oval swab holder, according to some embodiments. [Figure 3B] FIG. 3B is a top view of an oval swab and an oval swab holder, according to some embodiments. [Figure 3C] FIG. 3C is a side view of an oval swab and an oval swab holder, according to some embodiments. [Figure 3D] FIG. 3D is a top perspective view of an oval swab and oval swab holder showing an oval swab with a pre-cut sponge, according to some embodiments. [Figure 4A] FIG. 4A is a top perspective view of a catheter system showing a swab holder coupled to an exemplary end cap, according to some embodiments. [Figure 4B] FIG. 4B is a top perspective view of the catheter system showing the swab holder removed from the end cap, according to some embodiments. [Figure 4C] FIG. 4C is a top perspective view of the catheter system showing the swab holder and end cap removed, according to some embodiments. [Figure 4D] FIG. 4D is a cross-sectional view of a catheter system showing a swab holder coupled to an end cap, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0017] 1A-1C, in some embodiments, a catheter system 10 may include a catheter adapter 12 that may include a distal end 14, a proximal end 16, and a lumen extending through the distal end 14 of the catheter adapter 12 and the proximal end 16 of the catheter adapter 12. In some embodiments, the catheter system 10 may include a catheter tube 18 extending distally from the distal end 14 of the catheter adapter 12. In some embodiments, the catheter system 10 may include a peripheral intravenous catheter system, a midline catheter system, an arterial catheter system, a peripherally inserted central catheter system, or another suitable catheter system.

[0018] In some embodiments, the catheter system 10 may include a needle hub 20 and an introducer needle 22 extending distally from the needle hub 20 and through the catheter tube 18. In some embodiments, the introducer needle 22 may include a sharp distal tip 24 configured to pierce the patient's skin and vasculature to facilitate placement of the catheter tube 18 within the vasculature. In some embodiments, the catheter system 10 may include a needle cover 26 surrounding the catheter tube 18 and the sharp distal tip 24. In some embodiments, the needle cover 26 may be tubular. In some embodiments, the needle cover 26 may extend from the distal end 14 of the catheter adapter 12 beyond the sharp distal tip 24. In some embodiments, the catheter tube 18 may be disposed within the needle cover 26.

[0019] In some embodiments, the catheter system 10 may include a swab holder 28 coupled to the distal end 30 of the needle cover 26. In some embodiments, the catheter system 10 may include a swab 32 secured within the swab holder 28 and containing a disinfectant. In some embodiments, the disinfectant may include isopropyl alcohol (IPA), such as 70% IPA. In some embodiments, the swab 32 may contain another suitable disinfectant. In some embodiments, the swab 32 may be used to disinfect a site on a patient's skin, such as a catheter system insertion site, prior to inserting the catheter tube 18 and introducer needle 22 at the site.

[0020] In some embodiments, the swab 32 may comprise a nonwoven material, such as paper or another suitable material, configured to retain the antiseptic. In some embodiments, the swab 32 may comprise a woven fabric. In some embodiments, the swab 32 may comprise a porous, absorbent sponge. In some embodiments, the swab holder 28 may retain the antiseptic by absorption and / or may be saturated with the antiseptic. In some embodiments, the antiseptic may be released onto the skin when the swab 32 is placed in contact with the skin and / or compressed.

[0021] In some embodiments, the catheter system 10 may include a film 34 coupled to the swab holder 28 to maintain the sterility of the swab 32 until use. In these embodiments, the film 34 may seal the swab 32 from the external environment to prevent drying and / or bacterial contamination of the swab 32. In some embodiments, the film 34 may comprise a thermoplastic resin. In some embodiments, the swab holder 28 may comprise a thermoplastic resin. In some embodiments, the film 34 and / or the swab holder 28 comprising a thermoplastic resin may facilitate the film 34 being heat-sealed to the swab holder 28. In some embodiments, the film 34 and the swab holder 28 may be sealed together by another suitable method, such as, for example, a hot melt adhesive or a pressure-sensitive adhesive.

[0022] In some embodiments, the swab holder 28 may include a flange 36 that surrounds and contacts the swab 32. In some embodiments, the swab 32 may extend outward beyond the flange 36, which facilitates contact of the swab 32 with the skin for disinfection. In some embodiments, the flange 36 may form a pocket 38 in which the swab 32 may be accommodated. In some embodiments, the distal end 30 of the needle cover 26 may be inserted into a proximal opening 40 of the swab holder 28 and secured via an interference or press fit, adhesive, or another suitable coupling mechanism. In some embodiments, coupling the needle cover 26 and the swab holder 28 together by inserting the distal end 30 of the needle cover 26 into the proximal opening 40 may prevent the swab holder 28 from interfering with and / or contacting the introducer needle 22 and catheter tube 18 within the needle cover 26. In some embodiments, the diameter of pocket 38 may be larger than the diameter of proximal opening 40 to facilitate the use of a swab 32 with an increased surface area to facilitate disinfection of the site. In some embodiments, the bottom of pocket 38 may be solid to provide a barrier.

[0023] In some embodiments, the clinician can remove the film 34 from the swab holder 28, and then the clinician can hold the catheter system 10 to swab and disinfect the site. In some embodiments, the catheter system 10 can provide ergonomic comfort to the clinician compared to traditional methods, such as using wipes. More specifically, in some embodiments, the needle cover 26 can function as a handle that the clinician can hold like a pencil, providing the clinician with good stability and usability for effective swabbing. In these and other embodiments, the exterior surface of the needle cover 26 can be cylindrical. In some embodiments, after swabbing and disinfecting the site, the clinician can remove the needle cover 26 and insert the catheter tube 18 into the vasculature, aided by the introducer needle 22 extending through the catheter tube 18.

[0024] In some embodiments, an adapter or connector 42 may be coupled to the proximal end of the needle hub 20, and / or an end cap 44 may be coupled to the proximal end of the connector 42. In some embodiments, the connector 42 may connect the needle hub 20 to the end cap 44. In some embodiments, the connector 42 may include a vent plug configured to allow air to pass but not blood to pass through. In some embodiments, the end cap 44 may be coupled directly to the needle hub 20. In some embodiments, the end cap 44 may be configured to close the proximal end of the catheter system 10 and may not allow air or liquids to pass through. In some embodiments, the catheter system 10 may include a housing 46 that may be configured to hold one or more folded wings extending from the catheter adapter 12. In some embodiments, the configuration of the catheter system 10 may vary. For example, the catheter system 10 may not include a housing 46. In some embodiments, the catheter system 10 may include another configuration suitable for a peripheral intravenous catheter system, a midline catheter system, an arterial catheter system, a peripherally inserted central catheter system, or another appropriate catheter system.

[0025] In some embodiments, integrating the swab 32 into the catheter system 10 can increase clinician compliance with pre-cannulation skin preparation protocols, which are often not followed because cleansing agents are not available at the bedside. In some embodiments, integrating the swab 32 also reduces the length of the procedure because the clinician does not have to search for cleansing agents. Additionally, in some embodiments, the catheter system 10 can be used like a marker or applicator after the swab 32 is exposed, facilitating a sterile, non-touch technique in which neither the swab 32 nor the disinfectant is contacted by the clinician.

[0026] In some embodiments, the swab 32 may be round or oval, for example, as shown in Figures 1A-1C. In some embodiments, a swab 32 that is round or oval may reduce the number of strokes required to disinfect a site. More specifically, a particular swab that is rectangular or square may require horizontal and vertical strokes to cover the same surface area as a swab 32 that is round or oval.

[0027] 2A-2D, in some embodiments, the swab 32 may be rectangular or square. In some embodiments, the swab 32 is rectangular, and the flange 36 may be rectangular to fit around the swab 32. For example, as shown in FIG. 2C, in some embodiments, the swab 32 may extend outward beyond the flange 36, which may facilitate contact of the swab 32 with the skin for disinfection. For example, as shown in FIG. 2D, in some embodiments, the swab 32 may include a sponge that may be pre-cut. In some embodiments, a pre-cut swab 32 increases the sponge's surface area so that the sponge can hold a larger volume of disinfectant. In some embodiments, a pre-cut sponge may include multiple arms that may facilitate active scrubbing of the site for improved disinfection. In some embodiments, active scrubbing may involve disinfection due to the combined effects of friction-assisted wiping caused by the disinfectant within the swab 32 and mechanical removal of microorganisms caused by chemical disinfection.

[0028] 3A-3D, in some embodiments, the swab 32 may be oval-shaped and / or the flange 36 may be oval-shaped to fit around the swab 32. For example, as shown in FIG. 3D, in some embodiments, the swab 32 may be pre-cut. In some embodiments, a pre-cut swab 32 increases the surface area of ​​the sponge so that the sponge can hold a larger volume of disinfectant. In some embodiments, a pre-cut sponge may include multiple arms, which may facilitate active scrubbing of the site for improved disinfection.

[0029] 4A-4D, in some embodiments, the catheter system 10 may include an end cap 44 proximal to the catheter adapter 12. In some embodiments, the swab holder 28 may be coupled to the proximal end of the end cap 44. In some embodiments, the distal end of the end cap 44 may include a luer, such as a male luer. In some embodiments, the swab holder 28 may be located at the proximal end or rear of the catheter system 10, which may facilitate easy access to the swab 32.

[0030] In some embodiments, the swab holder 28 may include a distal opening 48 at the distal end of the swab holder 28, and the end cap 44 may be configured to be inserted into the distal opening 48 and secured therein with an interference or press fit. In some embodiments, after swabbing the site with the swab 32, the end cap 44 and swab holder 28 may be removed from the catheter system 10 together and / or discarded, as shown, for example, in FIG. 4C . In these embodiments, the remainder of the catheter system 10 may then be inserted into the patient's vasculature. Shown is a lumen 50 of the catheter adapter 12 through which the introducer needle 22 extends, according to some embodiments.

[0031] 1-4 , a manufacturing method may include coupling a swab 32 to a swab holder 28, the swab 32 being configured to couple to the distal end 30 of a needle cover 26 or the proximal end of an end cap 44 of a catheter system 10. In some embodiments, the method may include loading the swab 32 with a disinfectant after coupling the swab 32 to the swab holder 28. In some embodiments, the method may include placing a film 34 over the swab 32 after loading the swab 32 with the disinfectant. In some embodiments, the method may include sealing the film 34 to the swab holder 28 with heat or pressure after placing the film 34 over the swab 32. Heat or pressure sealing the film 34 to the swab holder 28 may ensure that the disinfectant is not wasted.

[0032] In some embodiments, the swab holder 28 may include a flange 36 that surrounds and contacts the swab 32. In some embodiments, the swab 32 may extend outward beyond the flange 36. In some embodiments, the flange 36 may form a pocket 38 within the flange 36. In some embodiments, adhering the swab 32 to the swab holder 28 may include placing an adhesive within the pocket 38 and contacting the swab 32 with the adhesive.

[0033] In some embodiments, the method may include coupling the swab holder 28 to the distal end of the needle cover 26 or the proximal end of the end cap 44. In some embodiments, the method may include coupling the swab holder 28 to the distal end 30 of the needle cover 26, and then coupling the needle cover 26 to the distal end 14 of the catheter adapter 12 such that the needle cover 26 covers the introducer needle 22 and the catheter tube 18. In some embodiments, the catheter system 10 may include a connector 42 coupled to the proximal end of the needle hub 20. In some embodiments, the method may include coupling the swab holder 28 to the proximal end of the end cap 44, and then coupling the end cap 44 to the connector 42.

[0034] All examples and conditional language described herein are intended for educational purposes to help the reader understand the present invention and the concepts provided by the inventors to facilitate the present technology, and should be construed as not being limited to the specifically recited examples and conditions. Although 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. 1. A catheter system comprising: a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter tube extending distally from the distal end of the catheter adapter; A needle hub and an introducer needle extending through the catheter tube distally from the needle hub, the introducer needle having a sharp distal tip; a needle cover surrounding the catheter tube and the sharp distal tip; a swab holder coupled to a distal end of the needle cover; a swab secured within the swab holder and containing a disinfectant; A catheter system comprising:

2. The catheter system of claim 1 , further comprising a film coupled to the swab holder to seal the swab from the external environment.

3. The catheter system of claim 2 , wherein the swab holder or the film comprises a thermoplastic or pressure-sensitive material, and the film is heat or pressure sealed to the swab holder.

4. The catheter system of claim 1 , wherein the needle cover is tubular.

5. The catheter system of claim 1 , wherein the swab is round or oval.

6. The catheter system of claim 1 , wherein the swab is rectangular or square.

7. The catheter system of claim 1 , wherein the swab comprises a sponge.

8. The catheter system of claim 7 , wherein the sponge is pre-cut.

9. The catheter system of claim 1 , wherein the swab holder includes a flange that surrounds and contacts the swab, the swab extending outward beyond the flange.

10. The catheter system of claim 9, wherein the swab is oval and the flange is oval.

11. The catheter system of claim 9, wherein the swab is rectangular and the flange is rectangular.

12. The catheter system of claim 1 , wherein the needle cover extends from the distal end of the catheter adapter beyond the sharp distal tip of the introducer needle, and the catheter tube is disposed within the needle cover.

13. 1. A catheter system comprising: a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter tube extending distally from the distal end of the catheter adapter; A needle hub and an introducer needle extending through the catheter tube distally from the needle hub, the introducer needle having a sharp distal tip; a proximal end cap of the catheter adapter; a swab holder coupled to the proximal end of the end cap; a swab secured within the swab holder and containing a disinfectant; A catheter system comprising:

14. The catheter system of claim 13, further comprising a film coupled to the swab holder to seal the swab from the external environment.

15. 14. The catheter system of claim 13, wherein the swab holder or the film comprises a thermoplastic or pressure sensitive material, and the film is heat or pressure sealed to the swab holder.

16. 14. The catheter system of claim 13, wherein the swab holder includes a flange that surrounds and contacts the swab, the swab extending outward beyond the flange.

17. A manufacturing method comprising: adhering the swab to a swab holder configured to couple to a distal end of a needle cover of a catheter system or a proximal end of an end cap of said catheter system; loading the swab with a disinfectant after adhering the swab to the swab holder; placing a film over the swab after loading the swab with the disinfectant; placing the film over the swab and then sealing the film to the swab holder with heat or pressure; A method comprising:

18. 18. The method of claim 17, wherein the swab holder includes a flange that surrounds and contacts the swab, the swab extending outwardly beyond the flange, the flange forming a pocket, and wherein adhering the swab to the swab holder includes placing an adhesive in the pocket and contacting the swab with the adhesive.

19. The catheter system comprises: a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter tube extending distally from the distal end of the catheter adapter; A needle hub and an introducer needle extending through the catheter tube distally from the needle hub, the introducer needle having a sharp distal tip; Including, 18. The method of claim 17, further comprising coupling the swab holder to the distal end of the needle cover, and after coupling the swab holder to the distal end of the needle cover, coupling the needle cover to the distal end of the catheter adapter such that the needle cover covers the introducer needle and the catheter tube.

20. The catheter system comprises: a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter tube extending distally from the distal end of the catheter adapter; A needle hub and an introducer needle extending through the catheter tube distally from the needle hub, the introducer needle having a sharp distal tip; a proximal end cap of the catheter adapter; a connector coupled to a proximal end of the needle hub; Including, 18. The method of claim 17, further comprising coupling the end cap to the connector after coupling the swab holder to the proximal end of the end cap.

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