CN211835732U - Catheter assembly - Google Patents

Abstract

A catheter assembly, comprising: a catheter adapter comprising a body and a nose extending distally from the body, wherein the nose is generally cylindrical; a strain relief rib disposed on the nose, wherein the strain relief rib is constructed of a flexible material; a needle secured within the catheter adapter and extending distally beyond the nose; a needle shield configured to be removably coupled to the nose of the catheter adapter, wherein an inner surface of the needle shield is smooth and configured to contact the strain relief rib. By means of the technical solution disclosed in the present invention, the distal end of the introducer needle can be correctly fixed in the needle shield, thus avoiding the risk of accidental needle sticks.

Description

Catheter assembly

Technical Field

The present application relates to the field of medical devices, and more particularly, to a catheter assembly.

Background

Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids such as saline solutions, various medications, and total parenteral nutrition into a patient. Catheters may also be used to draw blood from a patient.

A common type of catheter is a peripheral intravenous needle catheter ("PIVC"). As the name implies, an intravenous catheter may be mounted over an introducer needle having a sharp distal tip. The intravenous catheter and the introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the intravenous catheter and the bevel of the introducer needle faces upward away from the patient's skin. Intravenous catheters and introducer needles are typically inserted through the skin at a shallow angle into the patient's vasculature.

To verify proper placement of the introducer needle and/or intravenous catheter in the blood vessel, the clinician will typically confirm that there is "flashback" of blood in the flashback chamber of the intravenous catheter assembly. Once placement of the introducer needle is confirmed, the clinician may temporarily occlude blood flow in the vasculature and withdraw the introducer needle, leaving the intravenous catheter in place for future blood and/or fluid withdrawal. The intravenous catheter assembly may be coupled with an extension set that may allow for the coupling of an infusion or blood collection device at a location remote from the insertion site of the intravenous catheter.

If the distal tip of the introducer needle is not properly secured in the needle shield or needle shield, there may be a risk of accidental needle sticks. The present disclosure presents systems and methods that significantly limit and/or prevent needle sticks. 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 application merely provides this background to illustrate one exemplary technology area in which some embodiments described herein may be practiced.

SUMMERY OF THE UTILITY MODEL

The present disclosure relates generally to vascular access devices and related systems and methods. In some embodiments, a catheter assembly may include a catheter adapter that may include a body and a nose extending distally from the body. In some embodiments, the nose may be substantially cylindrical. In some embodiments, strain relief ribs may be disposed on the nose. In some embodiments, the strain relief ribs may be constructed of a compliant or flexible material.

In some embodiments, the catheter assembly may include a catheter that may be secured within the catheter adapter and may extend distally beyond the nose. In some embodiments, the catheter assembly may include a needle that may be disposed within the catheter and may extend distally to the distal tip of the catheter. In some embodiments, the catheter assembly may include a needle shield removably coupled to the nose of the catheter adapter. In some embodiments, the needle shield may be removably coupled to the distal tip of the catheter adapter by a friction fit. In some embodiments, the inner surface of the needle shield may be smooth and may contact the strain relief ribs. In some embodiments, the needle shield may be generally cylindrical and may include an open proximal end or a closed proximal end.

In some embodiments, the flexible material may comprise an elastomer. In some embodiments, the flexible material may comprise a thermoplastic elastomer. In some embodiments, the nose may be constructed of a rigid or semi-rigid material. In some embodiments, the strain relief rib may be generally aligned with a longitudinal axis of the catheter adapter. In some embodiments, a strain relief rib may be provided on the bottom of the catheter adapter.

In some embodiments, a strain relief element may be disposed on the distal end of the nose. In some embodiments, the strain relief element may at least partially surround the needle and/or the catheter. In some embodiments, the strain relief element may be constructed of the flexible material or another flexible material. In some embodiments, the catheter adapter may include a stop configured to prevent proximal movement of the needle shield beyond the stop. In some embodiments, the stop may be proximal to and near the nose. In some embodiments, a strain relief rib may extend from the strain relief element to the stop.

In some embodiments, a plurality of strain relief ribs may be disposed on the nose. In some embodiments, the strain relief rib may be a first strain relief rib. In some embodiments, a second strain relief rib may be disposed on the nose and/or a third strain relief rib may be disposed on the nose. In some embodiments, the second and third strain relief ribs may be constructed of the flexible material or another flexible material. In some embodiments, the inner surface of the needle shield may contact the second and third strain relief ribs.

In some embodiments, the second strain relief rib and/or the third strain relief rib may be aligned with a longitudinal axis of the catheter adapter. In some embodiments, the second and/or third strain relief ribs may be disposed on a side of the nose opposite the side on which the first strain relief rib is disposed. In some embodiments, the second and/or third strain relief ribs may be disposed on top of the nose. In some embodiments, the second strain relief rib and/or the third strain relief rib extend from the strain relief element to the stop. In some embodiments, the first strain relief rib may be larger than the second and/or third strain relief ribs. In more detail, in some embodiments, the height of the first strain relief rib may be greater than the height of the second and/or third strain relief ribs. Additionally or alternatively, in some embodiments, the width of the first strain relief rib may be greater than the width of the second and/or third strain relief ribs.

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 described. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that the embodiments may be combined, or other embodiments may be utilized, and structural changes may be made, unless otherwise specifically required, without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.

By means of the technical solution disclosed in the present invention, the distal end of the introducer needle can be correctly fixed in the needle shield, thus avoiding the risk of accidental needle sticks.

Drawings

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

fig. 1A is a finite element analysis of a cross-section of a prior art needle shield.

Fig. 1B is a longitudinal cross-sectional view of the prior art needle shield of fig. 1A.

Fig. 2A is an upper perspective view of an exemplary catheter assembly according to some embodiments, showing an exemplary needle shield shielding an exemplary needle.

Fig. 2B is an upper perspective view of the needle shield of fig. 2A according to some embodiments.

Fig. 2C is a cross-sectional view of the needle shield of fig. 2A according to some embodiments.

Fig. 3A is an upper perspective view of an exemplary distal tip of the catheter assembly of fig. 2A showing a needle shield removed, according to some embodiments.

FIG. 3B is a cross-sectional view of the catheter assembly of FIG. 2A along line 3B-3B of FIG. 3A, according to some embodiments;

FIG. 3C is a cross-sectional view of the catheter assembly of FIG. 2A along line 3C-3C of FIG. 2A, according to some embodiments;

FIG. 3D is an example finite element analysis of a portion of the cross-section of FIG. 3C, in accordance with some embodiments;

FIG. 4A is an upper perspective view of another example catheter assembly according to some embodiments.

FIG. 4B is an upper perspective view of an exemplary distal tip of the catheter assembly of FIG. 4A according to some embodiments;

FIG. 4C is a cross-sectional view of the catheter assembly of FIG. 4B along line 4C-4C of FIG. 4B according to some embodiments;

FIG. 4D is a cross-sectional view of the catheter assembly of FIG. 4A along line 4D-4D of FIG. 4A according to some embodiments; and

FIG. 4E is an example finite element analysis of a cross-sectional view of a portion of FIG. 4D, according to some embodiments.

Detailed Description

Referring now to fig. 1A, a finite element analysis of a cross-section of a prior art needle shield 10 is shown. The prior art needle shield 10 has three internal lobes 12 protruding from the inner surface 14 of the prior art needle shield 10. Prior art needle shield 10 and catheter adapter 16 are coupled together in a press-fit manner, wherein the internal lobes 12 contact and press against the outer surface of the catheter adapter 16. Referring now to fig. 1B, the inner lobes 12 may extend along a portion of the inner surface 14 of the prior art needle shield 10.

Referring now to fig. 2A, an example catheter assembly 20 is shown, according to some embodiments. In some embodiments, the catheter assembly 20 may include a catheter adapter 22, and the catheter adapter 22 may include a body 24 and a nose 26 extending distally from the body 24. In some embodiments, nose 26 may be generally cylindrical.

In some embodiments, catheter assembly 20 may include a catheter 28, and catheter 28 may include an intravenous catheter. In some embodiments, the proximal end of the catheter 28 may be secured within the catheter adapter 22. In some embodiments, the catheter 28 may extend distally beyond the nose 26.

In some embodiments, catheter assembly 20 may include a needle assembly 30 removably coupled to the proximal end of catheter adapter 22. In some embodiments, needle assembly 30 may include an introducer needle 32. Introducer needle 32 may extend through catheter 28.

In some embodiments, flashback blood may flow through the sharp distal tip 34 of the introducer needle 32 in response to insertion of the introducer needle 32 into the vasculature of a patient, and may be visible to the clinician between the introducer needle 32 and the catheter 28, and/or at another location within the catheter assembly 20.

In some embodiments, the needle assembly 30 may be removed from the catheter assembly 20 in response to confirmation that the catheter 28 is located within the vasculature of the patient by way of blood flashback. In some embodiments, when the needle assembly 30 is coupled to the catheter assembly 20, the introducer needle 32 of the needle assembly 30 may extend through a septum disposed within the lumen of the catheter adapter 22.

In some embodiments, catheter assembly 20 may include a needle shield 36. In some embodiments, needle shield 36 may be removably coupled to the distal tip of catheter adapter 22 by a friction fit. In some embodiments, the needle shield 36 may be removably coupled to the nose 26 of the catheter adapter 22 via a friction fit. In some embodiments, the needle shield 36 may be removed prior to inserting the catheter 28 into the vasculature of a patient to expose the distal tip 34 of the introducer needle 32.

Referring now to fig. 2B-2C, in some embodiments, the needle shield 36 may be substantially cylindrical. In some embodiments, the needle shield 36 may include a distal tip 38, and the distal tip 38 may be closed as shown in fig. 2C. In some embodiments, the distal tip 38 of the needle shield 36 may be open. In some embodiments, the inner surface 40 of the needle shield 36 may be smooth, which may prevent a clinician or manufacturer from orienting the needle shield 36 to secure the needle shield 36 to the introducer needle 32.

Referring now to fig. 3A-3B, in some embodiments, a strain relief rib 42 may be provided on the nose 26. In some embodiments, the strain relief ribs 42 may be constructed of a compliant or flexible material, which may be illustrated with a dot pattern in the present disclosure. In some embodiments, the inner surface 40 of the needle shield 36 may be smooth and may contact the strain relief ribs 42. In some embodiments, the strain relief ribs 42 may reduce the size of the needle shield 36 compared to the prior art needle shield 10 and may also allow the nose 26 to be smaller while facilitating the securing of the needle shield 36 to the catheter adapter 22.

In some embodiments, the flexible material may comprise an elastomer. In some embodiments, the flexible material may comprise a thermoplastic elastomer. In some embodiments, nose 26 may be constructed of a rigid or semi-rigid material. For example, nose 26 may comprise copolyester, plastic, or another suitable material. In some embodiments, the flexible material may have a higher coefficient of friction relative to the material of the needle shield 36 than the rigid or semi-rigid material. In some embodiments, the needle shield 36 may be constructed of a rigid or semi-rigid material or another suitable material.

In some embodiments, the strain relief ribs 42 may be generally aligned with a longitudinal axis 44 of the catheter adapter 22 (e.g., shown in fig. 2A). In some embodiments, strain relief ribs 42 may be provided at the bottom of catheter adapter 22, as shown in fig. 3A. In some embodiments, the strain relief ribs 42 may relieve bending strain on the catheter 28 when the catheter 28 is inserted into the vasculature of a patient. In some embodiments, the bevel of introducer needle 32 may point upward or away from the bottom of catheter adapter 22, as shown in fig. 3A.

In some embodiments, the catheter adapter 16 may comprise any suitable catheter adapter. In some embodiments, the catheter adapter 16 may include a fixed platform 46, which may include a first wing 48 and/or a second wing 50. In some embodiments, first wing 48 may overlie a grip portion 52 that may extend from needle assembly 30. In some embodiments, grip 52 and/or second wing 50 can contact and rest on the skin of the patient when catheter 28 is inserted into the skin of the patient. The bottom of catheter adapter 22 may be configured to face the patient's skin when catheter 28 is inserted into the patient's skin. In some embodiments, the catheter adapter 16 may not include the fixed platform 46 and/or the grip 52. In some embodiments, the catheter adapter 16 may be integrated, with an integrated extension tube 54, for example, as shown in fig. 2A. In other embodiments, the catheter adapter 16 may not include an integrated extension tube 54.

In some embodiments, the distal tip of nose 26 may include a strain relief element 56, which may at least partially surround introducer needle 32 and/or catheter 28. In some embodiments, strain relief element 56 may be made of the flexible material or other flexible materials. In some embodiments, catheter adapter 22 may include a stop 58, the stop 58 configured to prevent needle shield 36 from moving proximally beyond stop 58. In some embodiments, the stop 58 may include a flange or a stepped surface. In some embodiments, the stop 58 may be angled relative to the longitudinal axis 44 or perpendicular to the longitudinal axis 44. In some embodiments, the stop 58 may be disposed proximal of the nose 26 and proximate to the nose 26. In some embodiments, strain relief ribs 42 may extend from strain relief element 56 to stops 58.

Referring now to fig. 3C-3D, in some embodiments, needle shield 36 may be removably coupled to the distal tip of catheter adapter 22 by a friction fit. In some embodiments, the needle shield 36 may be removably coupled to the nose 26 of the catheter adapter 22 via a friction fit. In these embodiments, friction between the strain relief ribs 42 and the needle shield 36 may retain the needle shield 36 over the distal tip 34 of the introducer needle 32. In some embodiments, the strain relief ribs 42 may be compressed when the needle shield 36 is removably coupled to the nose 26 by means of a friction fit.

Fig. 3D illustrates that the needle shield 36 may experience a bending bunch effect (as opposed to an annular hoop stress) that may occur if the catheter assembly 20 includes a flexible ring extending around the outer circumference of the nose 26. As shown in fig. 3D, a bending beam effect may occur at a "concave" portion of the inner surface 40 of the needle shield 36 in a region that does not contact the strain relief ribs 42 or the nose 26. The disadvantage of the annular press fit of the two cylindrical bodies (e.g. needle shield 36 and flexible ring) is that: under typical molding tolerances, the difference between the minimum and maximum material state disturbances may be up to a factor of 10.

Referring now to fig. 4A, another catheter assembly 60 is shown according to some embodiments. In some embodiments, catheter assembly 60 may include or correspond to catheter assembly 20. In some embodiments, catheter assembly 60 may include one or more features of catheter assembly 20 and/or catheter assembly 10 may include one or more features of catheter assembly 60.

In some embodiments, one or more other strain relief ribs 62 may be provided on nose 26 in addition to or in place of strain relief ribs 42. In some embodiments, the additional strain relief ribs 62 may include one or more features of the strain relief ribs 42. In some embodiments, the additional strain relief ribs 62 may be constructed of the flexible material or another flexible material. In some embodiments, the inner surface 40 of the needle shield 36 may contact and compress the other strain relief ribs 62 to secure the needle shield 36 to the distal tip 34 of the introducer needle 32 in a friction fit.

In some embodiments, the additional strain relief ribs 62 may be aligned with the longitudinal axis 44 of the catheter adapter 22. In some embodiments, one or more of the other strain relief ribs 62 may be disposed on the opposite side of the nose 26 from the strain relief rib 42. In some embodiments, such as shown in fig. 4B, one or more other strain relief ribs 62 may be provided on top of the nose 26.

In some embodiments, the nose 26 and the strain relief ribs 42 and/or other strain relief ribs 62 may be constructed in at least two injection molds. In some embodiments, a first hard shot (hard shot) may form the nose 26 from a rigid or semi-rigid material, and a second soft shot (soft shot) may form the strain relief ribs 42 and/or other strain relief ribs 62 from a flexible material.

In some embodiments, one or more of the other strain relief ribs 62 may extend from the strain relief element 56 to the stop 58. In some embodiments, the strain relief ribs 42 may be larger than the other strain relief ribs 62. More specifically, in some embodiments, the height 64 of the strain relief ribs 42 may be greater than the height 66 of the other strain relief ribs 62. Additionally or alternatively, in some embodiments, the width 68 of the strain relief ribs 42 may be greater than the width 70 of the other strain relief ribs 62. The height 64 of the strain relief rib 42 may be measured from the nose 26 perpendicular to the longitudinal axis 44 to the outermost edge of the strain relief rib 42, while the height 66 of the other strain relief rib 62 may be measured from the nose 26 perpendicular to the longitudinal axis 44 to the outermost edge of the other strain relief rib 62. In some embodiments, the other strain relief ribs 62 and the strain relief ribs 42 may be substantially the same size.

All examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the concepts of the invention and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.

Claims (20)

1. A catheter assembly, comprising:

a catheter adapter comprising a body and a nose extending distally from the body, wherein the nose is generally cylindrical;

a strain relief rib disposed on the nose, wherein the strain relief rib is constructed of a flexible material;

a needle secured within the catheter adapter and extending distally beyond the nose; and

a needle shield configured to be removably coupled to the nose of the catheter adapter, wherein an inner surface of the needle shield is smooth and configured to contact the strain relief rib.

2. The catheter assembly of claim 1, wherein the flexible material comprises an elastomer.

3. The catheter assembly of claim 1, wherein the flexible material comprises a thermoplastic elastomer.

4. The catheter assembly of claim 1, wherein the nose is constructed of a rigid or semi-rigid material.

5. The catheter assembly of claim 1, wherein the strain relief rib is generally aligned with a longitudinal axis of the catheter adapter.

6. The catheter assembly of claim 1, wherein the strain relief rib is disposed on a bottom portion of the catheter adapter.

7. The catheter assembly of claim 1, wherein a distal tip of the nose includes a strain relief element at least partially surrounding the needle and constructed of a flexible material.

8. The catheter assembly of claim 1, wherein the catheter adapter further comprises a stop configured to prevent proximal movement of the needle shield beyond the stop, wherein the stop is disposed proximal to and proximate to the nose.

9. The catheter assembly of claim 8, further comprising a strain relief element disposed on a distal tip of the nose, wherein the strain relief element at least partially surrounds the needle and is constructed of a flexible material, wherein the strain relief rib extends from the strain relief element to the stop.

10. The catheter assembly of claim 1, wherein the nose comprises a plurality of strain relief ribs.

11. The catheter assembly of claim 1, wherein the strain relief rib is a first strain relief rib, further comprising a second strain relief rib disposed on the nose and a third strain relief rib disposed on the nose, wherein the second and third strain relief ribs are constructed of a flexible material, wherein an inner surface of a needle shield contacts the second and third strain relief ribs.

12. The catheter assembly of claim 11, wherein the second and third strain relief ribs are aligned with a longitudinal axis of the catheter adapter.

13. The catheter assembly of claim 11, wherein the flexible material comprises an elastomer.

14. The catheter assembly of claim 11, wherein the flexible material comprises a thermoplastic elastomer.

15. The catheter assembly of claim 11, wherein a side of the nose on which both the second and third strain relief ribs are disposed is opposite a side of the nose on which the first strain relief rib is disposed.

16. The catheter assembly of claim 11, wherein the first strain relief rib is disposed at a bottom of the nose, wherein the second and third strain relief ribs are disposed at a top of the nose.

17. The catheter assembly of claim 11, further comprising a strain relief element disposed on a distal tip of a nose, wherein the strain relief element at least partially surrounds the needle and is constructed of a flexible material, wherein the catheter adapter further comprises a stop configured to prevent proximal movement of a needle shield beyond the stop, wherein the stop is disposed proximal of and proximate to the nose, wherein the first and second strain relief ribs extend from the strain relief element to the stop.

18. The catheter assembly of claim 11, wherein the first strain relief rib is larger than the second and third strain relief ribs.

19. The catheter assembly of claim 1, wherein the needle shield is removably coupled to the distal tip of the catheter adapter by means of a friction fit.

20. The catheter assembly of claim 1, wherein the needle shield is generally cylindrical and has an open proximal end.

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