Needle cover retention
The catheter system addresses the risk of needle stick injuries by using a removably coupled needle cover with a ribbed and bumped design, ensuring secure fixation and easy removal with minimal force, thus enhancing safety for clinicians.
Patent Information
- Application Number
- JP2022575878
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-06-02
- Filing Date
- 2021-06-07
- Publication Date
- 2025-06-17
- Estimated Expiration
- 2041-06-07
AI Technical Summary
Existing catheter systems pose a risk of accidental needle insertion and needle stick injuries to clinicians when removing the needle cover, due to improper fixation or excessive force required.
The catheter system incorporates a needle cover that is removably coupled to the catheter assembly via an interference or friction fit, utilizing a design with ribs and bumps to reduce the surface area contact and facilitate easy removal with minimal force.
This design significantly limits and prevents needle sticks by ensuring secure fixation and easy removal of the needle cover, thereby enhancing safety for clinicians during catheter system assembly and use.
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Abstract
Description
Technical Field
[0001] The present invention relates to a catheter system.
Background Art
[0002] Catheters are generally used for various infusion therapies. For example, a catheter can be used to inject fluids such as saline, various drugs, and total parenteral nutrition into a patient. Also, a catheter can be used to draw blood from a patient.
[0003] A common type of catheter is the over-the-needle peripheral intravenous catheter ("PIVC"). As its name implies, an over-the-needle PIVC can be mounted on a guide needle having a sharp distal tip. The PIVC and the guide needle can be assembled such that the distal tip of the guide needle extends beyond the distal tip of the PIVC with the bevel of the needle facing away from the patient's skin. The PIVC and the guide needle are generally inserted at a shallow angle through the skin into the patient's vasculature.
[0004] To verify proper placement of the guide needle and / or PIVC in a blood vessel, a clinician generally confirms that there is a "flashback" of blood in the flashback chamber of the PIVC assembly. Once the needle placement is confirmed, the clinician may temporarily occlude the flow within the vasculature, withdraw the introducer needle, and leave the PICV in place for subsequent blood sampling or transfusion. The PIVC assembly may be coupled to an extension set, which may enable connection of an injection or blood sampling device at a location removed from the PIVC insertion site.
[0005] If the distal tip of the guide needle is not properly fixed to the needle cover or shield, there is a risk of accidental needle insertion. However, removing the fixed needle cover from the PIVC catheter assembly can pose a risk of needle stick to the clinician if the clinician uses excessive force to remove the needle cover. The present disclosure presents systems and methods for significantly limiting and / or preventing needle sticks. The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in the environments described above. Rather, this background is provided only to illustrate an example of the technical area in which some of the examples described herein may be practiced. SUMMARY OF THE INVENTION
[0006] The present disclosure generally relates to vascular access devices and related systems and methods. In some embodiments, the catheter system may include a catheter (of) assembly and a needle assembly coupled to the catheter assembly. In some embodiments, the needle assembly may include a needle hub and an introducer needle. In some embodiments, the proximal end of the introducer needle may be fixed within the needle hub.
[0007] In some embodiments, the catheter assembly may include a catheter adapter that may include a body and a nose extending distally from the body. In certain embodiments, the catheter assembly may include a catheter fixed within the catheter adapter and extending distally beyond the nose. In some embodiments, the catheter may include a peripheral intravenous catheter (PIVC), a midline catheter, or a peripherally inserted central catheter.
[0008] In some embodiments, the introducer needle may extend through the catheter. In some embodiments, in response to the introducer needle and / or the catheter being inserted into the patient's vasculature, the introducer needle may be withdrawn proximally from the catheter and removed from the catheter assembly. In some embodiments, the catheter can remain within the patient's vasculature for blood sampling and / or fluid infusion.
[0009] In some embodiments, the nose may generally be cylindrical. In some embodiments, the nose may be constructed of a rigid or semi-rigid material. In some embodiments, strain relief ribs may be disposed on the nose. In some embodiments, the strain relief ribs may generally be aligned with the longitudinal axis of the catheter system. In some embodiments, bumps and / or other bumps may be disposed on the strain relief ribs.
[0010] In some embodiments, the strain relief ribs may be constructed of a compliant or flexible material. In some embodiments, the bumps and / or other bumps may be constructed of a flexible material or another suitable flexible material. In some embodiments, the distal end of the nose may at least partially surround the catheter and may include a strain relief element constructed of a flexible material or another suitable flexible material. In some embodiments, the flexible material may include an elastomer such as a thermoplastic elastomer or another suitable elastomer. In some embodiments, one or more of the strain relief ribs, bumps, other bumps, and strain relief elements may be formed monolithically as a single unit.
[0011] In some embodiments, the bumps may be aligned with other bumps. In some embodiments, the bumps may be distal to other bumps. In some embodiments, the distal end of the bump may include a first side surface and a second side surface. In some embodiments, the first side surface and the second side surface may be proximate to the strain relief ribs. In some embodiments, the first side surface and the second side surface may be angled towards each other such that the distal end of the bump tapers in the distal direction, which may facilitate the lead-in or smooth movement of the needle cover relative to the catheter assembly.
[0012] In some embodiments, the distal end of the bump may be tapered distally towards the central axis of the bump, which may be aligned with the longitudinal axis of the catheter system. In some embodiments, the height of the distal end of the bump may decrease in the distal direction. In some embodiments, one or more of the strain relief ribs, the bump, and other bumps may be disposed at the bottom of the catheter assembly. In some embodiments, the inclination of the introducer needle may face upwardly away from the bottom of the catheter assembly that may face the patient's skin.
[0013] In some embodiments, the needle cover may be removably coupled to the catheter assembly. In some embodiments, the needle cover is disposed on the catheter assembly during assembly of the catheter system and may be removed from the catheter system before the catheter system is inserted into a patient's vasculature. In some embodiments, the inner surface of the needle cover and / or the outer surface of the catheter assembly may facilitate securing the needle cover on the catheter assembly and / or removing the needle cover from the catheter assembly with a small amount of force by a clinician or manufacturer. More particularly, in some embodiments, when the needle cover is removably coupled to the catheter assembly, the inner surface of the needle cover and / or the outer surface of the catheter assembly may reduce the surface area of the needle cover that contacts the catheter assembly. For example, the inner surface of the needle cover may be surrounded by ribs. Additionally or alternatively, in some embodiments, the catheter assembly may include bumps and / or other protrusions.
[0014] In some embodiments, the needle cover may be removably coupled to the catheter assembly via an interference or friction fit. In some embodiments, the inner surface of the needle cover may contact one or more of a portion of the nose, a bump, and other protrusions in a friction fit. In some embodiments, the needle cover may be tubular with a closed or open proximal end.
[0015] It should be understood that the foregoing summary and the following detailed description are illustrative and explanatory only and are not restrictive of the claimed invention. It should be understood that the various embodiments are not limited to the configurations and means shown in the figures. Also, it should be understood that embodiments may be combined or that other embodiments may be used and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Accordingly, the following detailed description should not be construed in a limiting sense.
Brief Description of the Drawings
[0016] Exemplary embodiments are described and explained in more specific and detail by using the accompanying drawings.
Figure 1A
Figure 1B
Figure 2A
Figure 2B
Figure 2C
Figure 3A
Figure 3B
Figure 3C
Figure 3D
Figure 4A
Figure 4B
Figure 4C
Figure 4D
[0017] Referring now to FIGS. 1A-1B, in some embodiments, catheter system 10 may include a catheter assembly 12 and a needle assembly 14 coupled to catheter assembly 12. In some embodiments, needle assembly 14 may include a needle hub 16 and an introducer needle 18. In some embodiments, the proximal end of introducer needle 18 may be fixed within needle hub 16. In some embodiments, introducer needle 18 may include a sharp distal tip.
[0018] In some embodiments, catheter assembly 12 may include a catheter adapter 20 that may include a body 22 and a nose 24 extending distally from body 22. In certain embodiments, catheter assembly 12 may be fixed within catheter adapter 20 and may include a catheter 26 extending distally beyond nose 24. In some embodiments, catheter 26 may include a peripheral intravenous catheter (PIVC), a midline catheter, or a peripherally inserted central catheter.
[0019] In some embodiments, introducer needle 18 may extend through catheter 26. In some embodiments, in response to introducer needle 18 and / or catheter 26 being inserted into a patient's vasculature, introducer needle 18 may be withdrawn proximally from catheter 26 and removed from catheter assembly 12. In some embodiments, catheter 26 may remain within the patient's vasculature for blood sampling and / or fluid infusion.
[0020] In some embodiments, the nose 24 can be cylindrical or generally cylindrical. In some embodiments, the nose 24 may be constructed of a rigid or semi-rigid material. In some embodiments, the distal end of the nose 24 can be coupled to a strain relief element 28 that at least partially surrounds the catheter 26 and can be constructed of a conformable or flexible material. In some embodiments, the flexible material can include an elastomer such as a thermoplastic elastomer or another suitable elastomer. In some embodiments, the strain relief element 28 can extend distally from the nose 24 and form the most distal portion of the catheter adapter 12.
[0021] In some embodiments, the needle cover 30 can be removably coupled to the catheter assembly 12. In some embodiments, the needle cover 30 can be removably coupled to the catheter assembly 12 via an interference or friction fit. In some embodiments, the needle cover 30 can be disposed on the catheter assembly 12 during assembly of the catheter system 10 and removed from the catheter system 10 before the catheter system 10 is inserted into a patient's vasculature. In some embodiments, the needle cover 30 can extend around the nose 24.
[0022] Referring now to FIGS. 2A - 2C, in some embodiments, the inner surface 31 of the needle cover 30 can facilitate the securing (see or illustrated in FIGS. 1A, 3A, or 4A) of the needle cover 30 on the catheter assembly 12 and / or the removal of the needle cover 30 from the catheter assembly 12 with a small amount of force by a clinician or manufacturer. More particularly, in some embodiments, the inner surface 31 of the needle cover 30 can include a plurality of ribs 32 that can reduce the surface area of the needle cover 30 that contacts a portion of the catheter assembly 12, such as the nose 24. In some embodiments, when the needle cover 30 is secured to the catheter assembly 12, the ribs 32 can contact a portion of the catheter assembly 12, but multiple portions of the inner surface 31 between the ribs 32 may not contact a portion of the catheter assembly 12.
[0023] In some embodiments, the needle cover 30 may generally be tubular. In some embodiments, the proximal end 33 of the needle cover 30 may be closed, for example, as shown in FIG. 2C, which may provide protection from the sharp distal tip of the introducer needle 18. In other embodiments, the proximal end 33 of the needle cover 30 may be open.
[0024] Referring now to FIGS. 3A - 3D, in some embodiments, the strain relief rib 34 may be disposed on the nose 24. In some embodiments, a plurality of strain relief ribs may be disposed on the nose 24. In some embodiments, the strain relief rib 34 may be generally aligned with the longitudinal axis 35 of the catheter system 10.
[0025] In some embodiments, the strain relief rib 34 may be composed of a flexible material. In some embodiments, the distal end of the nose 24 may at least partially surround the catheter 26 and may be coupled to a strain relief element 28 composed of a flexible material or another suitable flexible material.
[0026] In some embodiments, the bump 36 may be disposed on the strain relief rib 34. In some embodiments, the bump 36 may be composed of a flexible material or another suitable flexible material. In some embodiments, the distal end of the bump 36 may include a first side surface 38a and a second side surface 38b. In some embodiments, the first side surface 38a and the second side surface 38b may be proximate to the strain relief rib 34. In some embodiments, the first side surface 38a and the second side surface 38b may be angled towards each other such that the distal end of the bump 36 tapers in the distal direction, which may facilitate the lead - in or smooth movement of the needle cover 30 relative to the catheter assembly 12.
[0027] In some embodiments, the distal end of bump 36 may taper distally toward the central axis of bump 36, which may be aligned with the longitudinal axis 35 of catheter system 10. In some embodiments, the height 37 of the distal end of bump 36 may decrease distally. In some embodiments, bump 36 may contact one or more of the ribs 32 of needle cover 30, reducing the surface area of needle cover 30 that contacts catheter assembly 12.
[0028] Referring now to FIGS. 4A-4D, in some embodiments, bump 36 and / or another bump 40 may be disposed on strain relief rib 34. In some embodiments, bump 36 and / or other bump 40 may be constructed of a flexible material or another suitable flexible material. In some embodiments, one or more of strain relief rib 34, bump 36, other bump 40, and the strain relief element may be formed monolithically as a single unit.
[0029] In some embodiments, bump 36 may be aligned with other bump 40. In some embodiments, bump 36 may be distal to other bump 40. In some embodiments, one or more of strain relief rib 34, bump 36, and other bump 40 may be disposed at the bottom of catheter assembly 12. In some embodiments, the inclination of introducer needle 18 may face upwardly away from the bottom of catheter assembly 12 that faces the patient's skin.
[0030] In some embodiments, the outer surface of the catheter assembly 12 can facilitate the fixing of the needle cover 30 on the catheter assembly 12 and / or the removal of the needle cover 30 from the catheter assembly 12 with a small amount of force by a clinician or manufacturer. More specifically, in some embodiments, when the needle cover 30 is removably coupled to the catheter assembly 12, the outer surface of the catheter assembly 12 can reduce the surface area of the needle cover 30 that contacts the catheter assembly 12. For example, the catheter assembly can include bumps 36 and / or other bumps 40. In some embodiments, the inner surface 31 of the needle cover 30 can contact one or more of a portion of the nose 24, the bump 36, and the other bumps 40 in a friction fit. In some embodiments, the portion of the nose 24 that the inner surface 31 contacts can be the lower or bottom portion of the nose 24 that can be on the opposite side of the bump 36 and / or the other bumps 40.
[0031] All examples and conditional language recited herein are intended for educational purposes to aid in understanding the invention and the concepts provided by the inventors to promote the art, and are to be construed as not being limited to the specifically recited examples and conditions. Although embodiments of the invention have been described in detail, it is to be understood that various changes, substitutions, and modifications can be made herein without departing from the spirit and scope of the invention.
Claims
1. A catheter adapter, comprising a body, a nose extending distally from the body, the nose being generally cylindrical, the nose, a strain-relief rib disposed on the nose, the strain-relief rib being composed of a flexible material, the strain-relief rib, a bump disposed on the strain-relief rib, a catheter fixed within the catheter adapter and extending distally beyond the nose, and comprising the catheter adapter, a catheter system.
2. The catheter system according to claim 1, wherein the catheter adapter further comprises another bump disposed on the strain-relief rib.
3. The catheter system according to claim 2, wherein the strain-relief rib, the bump, and the other bump are formed monolithically as a single unit.
4. The catheter system according to claim 2, wherein the bump is aligned with the other bump.
5. The catheter system according to claim 4, wherein the bump is distal to the other bump.
6. The distal end of the bump includes a first side surface and a second side surface proximate to the strain-relief rib, and the first side surface and the second side surface are angled towards each other. The catheter system according to claim 1.
7. The catheter system according to claim 1, wherein the height of the distal end of the bump decreases in the distal direction.
8. The catheter system according to claim 1, wherein the strain-relief rib and the bump are disposed at the bottom of the catheter assembly and are aligned with the longitudinal axis of the catheter adapter.
9. The catheter system according to claim 1, wherein the bump is made of the flexible material.
10. The catheter system according to claim 9, further comprising another bump disposed on the strain relief rib and aligned with the bump, wherein the another bump is made of the flexible material.
11. The catheter system according to claim 1, further comprising a needle assembly including a needle hub and an introducer needle fixed in the needle hub and extending through the catheter, wherein the needle hub is coupled to the catheter adapter.
12. The catheter system according to claim 1, further comprising a needle cover removably coupled to the catheter assembly, wherein an inner surface of the needle cover includes a plurality of ribs that contact the bump.
13. The catheter system according to claim 12, wherein the needle cover is removably coupled to the catheter assembly via a friction fit.
14. The catheter system according to claim 12, wherein the needle cover is tubular.
15. The catheter system according to claim 12, wherein the catheter assembly further comprises another bump disposed on the strain relief rib and aligned with the bump, and the inner surface of the needle cover includes a plurality of ribs that contact the another bump.
16. The catheter system according to claim 1, wherein the flexible material includes an elastomer.
17. The catheter system according to claim 1, wherein the nose is made of a rigid or semi-rigid material.
18. The catheter system according to claim 1, wherein the strain relief rib is generally aligned with a longitudinal axis of the catheter assembly.
19. The catheter system according to claim 1, wherein a distal end of the nose is coupled to a strain-relieving element that at least partially surrounds the catheter and is composed of the flexible material.
Citation Information
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