Catheter system including an introducer needle and a needle

Abstract

A catheter system for reducing the risk of blood vessel penetration. The catheter system may include a catheter adapter, which may include a proximal end, a distal end, and a lumen extending therebetween. The catheter system may include a catheter extending distally from the distal end of the catheter adapter. The catheter system may include an introducer needle extending through the catheter. The introducer needle may include a sharp distal tip and a primary bevel extending from an outer edge of the introducer needle to the sharp distal tip. The outer edge may be parallel to a central axis of the introducer needle and aligned with the sharp distal tip. The primary bevel may include a primary bevel angle relative to the central axis. The primary bevel angle may be between 20° and 33°.

Description

[Technical field]

[0001] The present invention relates to a catheter system and introducer needle and method for reducing the risk of blood vessel perforation. [Background technology]

[0002] Catheters are commonly used to infuse fluids into a patient's vascular system. For example, catheters may be used to infuse saline, various medications, or total parenteral nutrition.

[0003] The catheter may include a peripheral intravenous ("IV") catheter. In this case, the catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the bevel of the needle pointing away from the patient's skin. The catheter and introducer needle are typically inserted at a shallow angle through the skin into the patient's vascular system.

[0004] To verify proper placement of the introducer needle and / or catheter within the blood vessel, the clinician will typically confirm that there is a "flashback" of blood in the flashback chamber of the catheter system. Once introducer needle placement is confirmed, the clinician may remove the introducer needle and leave the catheter in place for future fluid injections.

[0005] During catheter insertion, if the clinician advances the introducer needle too far, the blood vessel may be transfixed. More specifically, the blood vessel may be transfixed by the introducer needle if it enters the top of the blood vessel and also accidentally punctures the bottom of the blood vessel. Piercing the blood vessel may be painful for the patient and increase the risk of bleeding, hematoma, infection, and tissue damage. Furthermore, fluids and medications may be injected into the extravascular space instead of the blood vessel. In response to a blood vessel being transfixed, the introducer needle may be withdrawn and the clinician may perform additional needle sticks, resulting in decreased patient satisfaction.

[0006] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in such environments. Rather, this background is only provided to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention

[0007] The present disclosure relates generally to vascular access devices and associated systems and methods. More specifically, the present disclosure relates to introducer needles and associated devices, systems, and methods. In some embodiments, a catheter system that reduces the risk of puncturing a blood vessel may include a catheter adapter. In some embodiments, the catheter system may include a catheter adapter that may include a proximal end, a distal end, and a lumen extending therebetween.

[0008] In some embodiments, the catheter system may include a catheter extending distally from a distal end of the catheter adapter. In some embodiments, the catheter system may include an introducer needle extending through the catheter. In some embodiments, the introducer needle may include a sharp distal tip and a primary bevel extending from an outer edge of the introducer needle to the sharp distal tip. In some embodiments, the outer edge may be parallel to a central axis of the introducer needle and aligned with the sharp distal tip. The primary bevel may include a primary bevel angle relative to the central axis. The primary bevel angle may be between 20° and 33°.

[0009] In some embodiments, the primary bevel angle may be 22.2°. In some embodiments, the introducer needle may include a first cut opposite a second cut. In some embodiments, the first cut may correspond to a secondary bevel and the second cut may correspond to a tertiary bevel. In some embodiments, the first cut may be a plane and the second cut may be a plane. In some embodiments, the first cut and the second cut may extend downward from the primary bevel. In some embodiments, the first cut may intersect the plane of the primary bevel at a first intersection line and / or the second cut may intersect the plane of the primary bevel at a second intersection line. In some embodiments, the first cut may meet the second cut at another line that may include a sharp distal tip. In some embodiments, the first cut and / or the second cut may be disposed at a secondary angle.

[0010] In some embodiments, the secondary angle may be between 18° and 26°. In some embodiments, the secondary angle may be 22°. In some embodiments, the primary bevel angle may be 22.2°. In some embodiments, the catheter may include a peripheral venous catheter.

[0011] In some embodiments, a method for reducing a risk of vascular perforation can include inserting an introducer needle of a catheter system into a patient's vascular system. In some embodiments, in response to the introducer needle being inserted into the vascular system, the method can include withdrawing the introducer needle from the catheter system.

[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 claimed invention. 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] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1] FIG. 1 is a top perspective view of an exemplary needle assembly showing an exemplary introducer needle, according to some embodiments. [Diagram 2] FIG. 2 is a top cross-sectional view of an exemplary catheter system, according to some embodiments. [Diagram 3] FIG. 3 is an enlarged top perspective view of a distal end of a catheter system, according to some embodiments. [Figure 4] FIG. 4 is a side view of an exemplary distal end of an introducer needle of a catheter system, according to some embodiments. [Figure 5A] 5A is a cross-sectional view of the distal end of the introducer needle taken along line 5-5 of FIG. 4, according to some embodiments. [Figure 5B] FIG. 5B is a 30 / 60 isometric view of the distal end of the introducer needle, according to some embodiments. [Figure 5C] FIG. 5C is a distal end view of an introducer needle showing an isometric view of FIG. 5B, according to some embodiments. [Figure 6] FIG. 6 is a close-up top view of an exemplary bevel of an introducer needle, according to some embodiments. [Figure 7A]FIG. 7A is a side view of an exemplary distal end of an introducer needle, according to some embodiments. [Figure 7B] FIG. 7B is a side view of another exemplary distal end of an introducer needle, according to some embodiments. [Figure 8] FIG. 8 is a side view of another exemplary distal end of an introducer needle, according to some embodiments. [Figure 9] FIG. 9 is a table illustrating the relationship between needle tip geometry, overall peak force, and initial peak force, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] 1, in some embodiments, a vascular access device 10 may include a needle 12. In some embodiments, the needle 12 may be configured to reduce the risk of vascular penetration. In some embodiments, the needle 12 may also facilitate vascular penetration such that the force to penetrate the skin and blood vessel of a patient with the needle 12 is not substantially increased beyond the force of a conventional needle tip.

[0015] As shown in FIG. 1 , in some embodiments, the needle 12 may extend distally from a needle hub 13. In some embodiments, the needle 12 may include a shaft 14, which may be cylindrical or generally cylindrical. In some embodiments, a central axis 16 may extend through the center of the shaft 14. In some embodiments, a proximal end 18 of the needle 12 or shaft 14 may be secured within the needle hub 13. In some embodiments, the proximal end 18 of the needle 12 may include an opening, which may facilitate blood flow into the needle hub 13 for flashback and / or blood collection purposes. In some embodiments, the shaft 14 may include an outer edge 20, which may be disposed at the proximal end 18 along the length of the shaft 14.

[0016] In some embodiments, the distal end of the needle 12 may include a primary bevel 22 and a sharp distal tip 24 disposed at the distal end of the primary bevel 22. In some embodiments, the sharp distal tip 24 may facilitate entry of the needle 12 and the over-the-needle catheter into the patient's vasculature. In some embodiments, the primary bevel 22 may include a length 26 that extends from a distal end 23 of the outer edge 20 to the sharp distal tip 24 and may be parallel to the central axis 16. In some embodiments, the outer edge 20 may be aligned with the sharp distal tip 24 and the central axis 16. In some embodiments, the outer edge 20 may be disposed on the opposite side of the needle 12 as the sharp distal tip 24.

[0017] As discussed in more detail below, in some embodiments, the length 26 of the primary bevel 22 may be short, which may reduce the risk of vessel penetration and reduce the force utilized by the clinician to insert the needle 12 into a vessel. In some embodiments, the primary bevel 22 may be angled to increase fluid flow through the sharp distal tip 24.

[0018] 2, in some embodiments, the needle 12 may be included in a catheter system to reduce the risk of blood vessel penetration. In some embodiments, the catheter system may include a catheter adapter 32, which may include a proximal end 34, a distal end 36, and a lumen 38 extending therebetween. In some embodiments, the catheter adapter 32 may include a side port 42 in fluid communication with the lumen 38. In this manner, some embodiments of the side port 42 may be configured to receive an extension set to facilitate infusion and / or blood withdrawal via the catheter 40.

[0019] In some embodiments, the catheter 40 may extend distally from the distal end 36 of the catheter adapter 32. In some embodiments, the needle hub 13 may be coupled to the proximal end 34 of the catheter adapter 32 such that the needle 12 extends through the catheter 40. In some embodiments, the primary bevel 22 and sharp distal tip 24 are thus disposed distal to the distal end of the catheter 40 and can penetrate the patient's skin and vasculature. In some embodiments, the needle 12 may include an introducer needle configured to introduce the catheter 40 into the vasculature. In some embodiments, the gauge and / or type of the needle 12 may vary.

[0020] 3, in some embodiments, the shaft 14 of the needle 12 may be disposed longitudinally along the central axis 16 between the proximal end 18 (see, e.g., FIGS. 1-2) and the distal end 23 of the outer edge 20. Thus, in some embodiments, the shaft 14 may have a length corresponding to the distance between the proximal end 18 and the distal end 23 of the outer edge 20. In some embodiments, the distal end 44 of the shaft 14 may be proximate to the primary bevel 22. In some embodiments, the primary bevel 22 of the needle 12 may extend from the distal end 23 of the outer edge 20 of the shaft 14 to the sharp distal tip 24. In some embodiments, the length of the shaft 14 may extend through the catheter 40 such that the primary bevel 22 and the sharp distal tip 24 of the needle 12 may be exposed at the distal end of the catheter 40.

[0021] In some embodiments, the primary bevel 22 may be configured to face away from the patient's skin, toward the top of the catheter system, as shown in Figure 3. Thus, the opposing outer edge 30 may be the portion of the catheter system closest to the patient's skin 46 during insertion of the needle 12 into the patient.

[0022] 4, in some embodiments, the primary bevel 22 may include a length 26 extending between a distal end 23 of the outer edge 20 and a sharp distal tip 24 and parallel to the central axis 16. In some embodiments, the distal end of the needle 12 may include a line 28 where the first cut 29a and the second cut 29b may meet (see also FIGS. 3 and 5). In some embodiments, the line 28 may include a straight edge that may facilitate cutting. In some embodiments, the first cut 29a may be similar or identical to the second cut 29b on the opposing side of the needle 12.

[0023] In some embodiments, the primary bevel 22 may be straight or generally straight. In some embodiments, the needle 12 may include an opposing outer edge 30, which may be opposed to or directly opposite the outer edge 20. In some embodiments, the opposing outer edge 30 may extend distally of the shaft 14 and the line 28. In some embodiments, the length of the line 28 may extend proximally from the sharp distal tip 24 to the distal end 37 of the opposing outer edge 30. In some embodiments, the opposing outer edge 30 may be aligned with the central axis 16 and the sharp distal tip 24.

[0024] In some embodiments, the primary bevel 22 may include a primary bevel angle 50, which may be measured relative to the central axis 16. In some embodiments, the length 26 of the primary bevel 22 may be determined by the primary bevel angle 50, such that the length 26 may decrease in response to the primary bevel angle 50 increasing. In some embodiments, the primary bevel angle 50 and the length 26 resulting from the primary bevel angle 50 may reduce the likelihood of a blood vessel being pierced upon insertion of the needle 12 into a patient's vasculature. In some embodiments, for the same diameter of a patient's vein, a particular primary bevel 22 having a shorter length 26 reduces the likelihood of the sharp distal tip 24 contacting the rear wall of the vein when the clinician observes flashback indicative of venipuncture and during catheter advancement after venipuncture.

[0025] In some embodiments, line 28 may include an angle 52 that may be measured relative to opposing outer edge 30. In some embodiments, angle 52 may promote sharpness of sharp distal tip 24. In some embodiments, decreasing angle 52 may increase the sharpness of sharp distal tip 24. Similarly, in some embodiments, decreasing angle 52 may decrease the needle penetration force required to insert needle 12 into a patient's vascular system, thereby decreasing insertion pain.

[0026] 5A shows a cross-section of needle 12 taken along line 5-5 shown in FIG. 4. In some embodiments, needle 12 may include a lumen 54 extending therethrough. In some embodiments, needle 12 may include a distal opening 55 surrounded by primary bevel 22. In some embodiments, distal opening 55 may be formed in primary bevel 22 to provide fluid communication between lumen 54 and the external environment.

[0027] In some embodiments, the shaft 14 may include an inner diameter 56 and an outer diameter 57. In some embodiments, the outer surface of the needle 12 may include a first cut 29a and a second cut 29b (which may be referred to in this disclosure as "cuts 29"), which may facilitate insertion of the needle 12 into a patient and increase the sharpness of the needle 12. In some embodiments, the first cut 29a and the second cut 29b may form a cut portion from the outer diameter 57, which may be generally circular. In some embodiments, the first cut 29a and / or the second cut 29b may be planar and separated by an angle 62, as shown, for example, in FIG. 5A. In other embodiments, the first cut 29a and / or the second cut 29b may be curved.

[0028] In some embodiments, the first cut 29a may be opposite the second cut 29b. In some embodiments, the first cut 29a may correspond to a secondary bevel and the second cut 29b may correspond to a tertiary bevel. In some embodiments, the first cut 29a and the second cut 29b may extend downwardly from the primary bevel 22. In some embodiments, the first cut 29a may intersect the plane of the primary bevel 22 at a first intersection line 31a and / or the second cut 29b may intersect the plane of the primary bevel 22 at a second intersection line 31b. In some embodiments, the first cut 29a may merge with the second cut 29b at a line 28 that may include a sharp distal tip 24. In some embodiments, the first cut 29a and the second cut 29b may each extend proximally from the primary bevel 22 to an opposing outer edge 30 that is directly opposite the outer edge 20.

[0029] In some embodiments, the secondary angle 58 may be measured as shown in FIGS. 5B-5C. In some embodiments, the secondary angle 58 may correspond to the angle between the first intersection line 31a and the reference line 33 in a 30 / 60 isometric view. In some embodiments, the secondary angle 58 may also correspond to the angle between the second intersection line 31b and the reference line 33 in a 30 / 60 isometric view. In some embodiments, decreasing the secondary angle 58 may increase the sharpness of the sharp distal tip 24. Similarly, in some embodiments, decreasing the secondary angle 58 may decrease the needle penetration force required to insert the needle 12 into the patient's vasculature, thereby decreasing insertion pain.

[0030] In some embodiments, the inner diameter 56 of the shaft 14 and / or the outer diameter 57 of the shaft 14 may be constant along all or a portion of the length of the shaft 14. In some embodiments, the cut 29 may reduce the thickness of the wall of the needle 12 at the primary bevel 22 such that the thickness is less than the thickness of the wall of the shaft 14. In some embodiments, the cut 29 may be located below the midline 59 or on the side of the needle 12 configured to be closest to the patient's skin during insertion into the vasculature. In some embodiments, the wall thickness of the shaft 14 may be reduced below the midline 59, which may intersect with a cross axis 60 that divides the cross section into four equal quadrants. In some embodiments, the central axis 16 may run perpendicular to the midline 59 and the cross axis 60.

[0031] 6, in some embodiments, the length 26 of the primary bevel 22 can be measured from the distal end 23 of the outer edge 20 to the sharp distal tip 24. In some embodiments, the distal opening 55 can include an oval, a polygon, a circle, or any other suitable shape.

[0032] 7A, in some embodiments, the primary bevel angle 50 may be between 20° and 33°, which may reduce the length 26 and the risk of penetrating the blood vessel during insertion of the needle 12 into the blood vessel. In some embodiments, the primary bevel angle 50 may be, for example, 22.2°, as shown in FIG. 7A. In some embodiments, the primary bevel angle 50 may be 31.4°, as illustrated in FIG. 7B.

[0033] 8, in some embodiments, the primary bevel angle 50 may be between 20° and 33° and the secondary angle 58 may be between 18° and 26°, which may reduce the needle penetration force required to insert the needle 12 and thereby reduce the associated insertion pain. In some embodiments, the primary bevel angle 50 may be 22.2° and the secondary angle 58 may be 22°, for example, as shown in FIG.

[0034] In some embodiments, a method for reducing a risk of vascular perforation may include inserting a needle 12 of a catheter system into a patient's vascular system. In some embodiments, in response to the needle 12 being inserted into the vascular system, the method may include withdrawing the needle 12 from the catheter system.

[0035] 9, in some embodiments, a primary bevel angle 50 between 20° and 33° significantly reduces the risk of penetrating the blood vessel and also unexpectedly increases the overall peak force and initial peak force by only a small amount compared to the prior art. In some embodiments, a combination of a primary bevel angle 50 between 20° and 33° and a secondary angle 58 between 18° and 26° significantly reduces the risk of penetrating the blood vessel and also unexpectedly reduces the initial peak force compared to the prior art. The overall peak force and initial peak force may be measured during insertion of the needle 12 into a patient's blood vessel. Lower overall peak force and initial peak force are desired to facilitate insertion of the needle 12 into the blood vessel by the clinician.

[0036] All examples and conditional language described herein are intended for educational purposes to aid the reader in understanding concepts provided by the inventors to further the invention and technology, and should not be construed as being limited to the specifically recited examples and conditions.

[0037] Although the embodiments of the present invention have been described in detail, it should be understood that the 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 for reducing the risk of vascular puncture, comprising: a catheter adapter including a proximal end, a distal end, and a lumen extending therebetween; a catheter extending distally from the distal end of the catheter adapter; an introducer needle extending through the catheter; The introducer needle a sharp distal tip; a primary bevel extending from an outer edge of the introducer needle to the sharp distal tip, the primary bevel being straight, the outer edge being parallel to a central axis of the introducer needle and aligned with the sharp distal tip, the primary bevel including a primary bevel angle relative to the central axis, the primary bevel angle being between 20° and 33°; Equipped with The introducer needle may further include: a first cut and a second cut, each extending proximally from the primary bevel to an opposing outer edge directly opposite the outer edge, the opposing outer edges being parallel to the central axis and the outer edge; the first cut intersects the plane of the primary bevel at a first intersection line, and a secondary angle between the first intersection line and a reference line of the introducer needle in a 30 / 60 isometric view is between 18° and 26°.

2. The catheter system of claim 1 , wherein the primary bevel angle is 22.2°.

3. The catheter system of claim 2 , wherein the secondary angle is 22°.

4. The catheter system of claim 3 , wherein the primary bevel angle is 22.2°.

5. The catheter system of claim 1 , wherein the first cut is a plane and the second cut is a plane.

6. An introducer needle, a sharp distal tip; a primary bevel extending from an outer edge of the introducer needle to the sharp distal tip, the outer edge being parallel to a central axis of the introducer needle and aligned with the sharp distal tip, the primary bevel including a primary bevel angle relative to the central axis, the primary bevel angle being between 20° and 33°, and the primary bevel being straight; further comprising first and second cuts, each extending proximally from the primary bevel to an opposing outer edge directly opposite the outer edge, the opposing outer edges being parallel to the central axis and the outer edge; the first cut intersects the plane of the primary bevel at a first intersection line, and a secondary angle between the first intersection line and a reference line of the introducer needle in a 30 / 60 isometric view, the secondary angle being between 18° and 26°.

7. The introducer needle of claim 6 , wherein the primary bevel angle is 22.2°.

8. The introducer needle of claim 6, wherein the secondary angle is 22°.

9. The introducer needle of claim 8 , wherein the primary bevel angle is 22.2°.

10. The introducer needle of claim 6 , wherein the first cut is a planar surface and the second cut is a planar surface.

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