Guide needle and related devices, systems, and methods

Abstract

A catheter system for reducing the risk of vascular penetration, comprising: a catheter adapter including a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; a catheter extending distally from the distal end of the catheter adapter; and a guide needle extending through the catheter, the guide needle comprising: a sharp distal tip; and a primary bevel extending from an outer edge of the guide needle to the sharp distal tip, wherein the outer edge is parallel to the central axis of the guide needle and aligned with the sharp distal tip, wherein the primary bevel includes a primary bevel angle relative to the central axis, and wherein the primary bevel angle is between 20° and 33°. The present invention also relates to a guide needle and a method for reducing the risk of vascular penetration.

Description

Technical Field

[0001] This application relates to the field of medical devices, and particularly to introducer needles and related devices, systems, and methods. Background Art

[0002] Catheters are commonly used to infuse fluids into a patient's vasculature. For example, a catheter can be used to infuse saline solution, various medications, or total parenteral nutrition.

[0003] The catheter can include a peripheral intravenous ("IV") catheter. In such a case, the catheter can be mounted on an introducer needle having a sharp distal tip. The catheter and the introducer needle can be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter, wherein the bevel of the needle faces upward away from the patient's skin. The catheter and the introducer needle are typically inserted through the skin at a small angle into the patient's vasculature.

[0004] To verify proper placement of the introducer needle and / or catheter within a blood vessel, a clinician typically confirms the presence of a "flashback" of blood in the flashback chamber of the catheter system. Once placement of the introducer needle has been confirmed, the clinician can remove the introducer needle, leaving the catheter in place for future fluid infusion.

[0005] During catheter insertion, when a clinician advances the introducer needle too far, the blood vessel can be penetrated. More specifically, if the introducer needle enters the top of the blood vessel and accidentally also penetrates the bottom of the blood vessel, the blood vessel can be penetrated by the introducer needle. Penetrating the blood vessel can be painful for the patient and can increase the risk of bleeding, hematoma, infection, and tissue damage. Further, fluids and medications may be infused into the extravascular space rather than into the blood vessel. In response to the blood vessel being penetrated, the introducer needle can be withdrawn, and the clinician can perform an additional puncture, resulting in reduced patient satisfaction.

[0006] 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 background is provided only to illustrate an exemplary technical field in which some of the embodiments described herein can be practiced. Summary of the Invention

[0007] The present disclosure generally relates to a vascular access device and related systems and methods. More particularly, the present disclosure relates to an introducer needle and related devices, systems, and methods. In certain embodiments, a catheter system for reducing the risk of penetrating a blood vessel can include a catheter adapter. In certain embodiments, the catheter system can include a catheter adapter that can 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 the distal end of the catheter adapter. In some embodiments, the catheter system may include a guide needle extending through the catheter. In some embodiments, the guide needle may include a sharp distal tip and a primary bevel extending from the outer edge of the guide needle to the sharp distal tip. In some embodiments, the outer edge may be parallel to the central axis of the guide 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 guide needle may include opposing first and second cutouts. In some embodiments, the first cutout may correspond to a second bevel and the second cutout may correspond to a third bevel. In some embodiments, the first cutout may be flat and the second cutout may be flat. In some embodiments, the first and second cutouts may extend downward from the primary bevel. In some embodiments, the first cutout may intersect the plane of the primary bevel at a first intersection line and / or the second cutout may intersect the plane of the primary bevel at a second intersection line. In some embodiments, the first cutout may converge with the second cutout at another line, which may include the sharp distal tip. In some embodiments, the first cutout and / or the second cutout may be set 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 intravenous catheter.

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

[0012] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory and do not limit the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and means shown in the drawings. It should also be understood that embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the present invention, unless so claimed. Accordingly, the following detailed description should not be construed as limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Exemplary embodiments will be described and explained with additional features and details by using the drawings, in which:

[0014] Figure 1 is a top perspective view of an exemplary needle assembly according to certain embodiments, showing an exemplary guide needle;

[0015] Figure 2 is a top cross-sectional view of an exemplary catheter system according to certain embodiments;

[0016] Figure 3 is an upper enlarged perspective view of the distal end of a catheter system according to certain embodiments;

[0017] Figure 4 is a side view of an exemplary distal end of a guide needle of a catheter system according to certain embodiments;

[0018] Figure 5A is a cross-sectional view taken along line 5-5 of the distal end of a guide needle according to certain embodiments; Figure 4 of the distal end of a guide needle;

[0019] Figure 5B is a 30 / 60 isometric view of the distal end of a guide needle according to certain embodiments;

[0020] Figure 5C is a distal end view of a guide needle according to certain embodiments, showing an isometric view of; Figure 5B ;

[0021] Figure 6 is an enlarged top view of an exemplary bevel of a guide needle according to certain embodiments;

[0022] Figure 7A is a side view of an exemplary distal end of a guide needle according to certain embodiments;

[0023] Figure 7B is a side view of another exemplary distal end of a guide needle according to certain embodiments;

[0024] Figure 8Side view of another exemplary distal end of a guide needle according to certain embodiments; and

[0025] Figure 9 Table illustrating the relationship between needle tip geometry, overall peak force, and initial peak force according to certain embodiments. Detailed Description

[0026] Now referring to Figure 1 In certain embodiments, the vascular access device 10 may include a needle 12. In certain embodiments, the needle 12 may be configured to reduce the risk of vascular penetration. In certain embodiments, the needle 12 may also facilitate vascular puncture such that the force used to puncture the patient's skin and blood vessel through the needle 12 does not increase significantly beyond the force of a conventional needle tip.

[0027] As Figure 1 shown, in certain embodiments, the needle 12 may extend distally from a needle hub 13. In certain embodiments, the needle 12 may include a shaft 14, which may be cylindrical or substantially cylindrical. In certain embodiments, a central axis 16 may extend through the center of the shaft 14. In certain embodiments, the proximal end 18 of the needle 12 or shaft 14 may be fixed within the needle hub 13. In certain 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 certain embodiments, the shaft 14 may include an outer edge 20, which may be disposed along the length of the shaft 14 up to the proximal end 18.

[0028] In certain 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 certain embodiments, the sharp distal tip 24 may facilitate entry of the needle 12 and cannula into the patient's vasculature. In certain embodiments, the primary bevel 22 may include a length 26, which may extend from the distal end 23 of the outer edge 20 to the sharp distal tip 24 and be parallel to the central axis 16. In certain embodiments, the outer edge 20 may be aligned with the sharp distal tip 24 and the central axis 16. In certain embodiments, the outer edge 20 may be disposed on the side of the needle 12 opposite the sharp distal tip 24.

[0029] As discussed in more detail below, in certain embodiments, the length 26 of the primary bevel 22 may be short, which may reduce the risk of vascular penetration and the force used by the clinician to insert the needle 12 into the blood vessel. In certain embodiments, the primary bevel 22 may be angled to increase fluid flow through the sharp distal tip 24.

[0030] Now referring to Figure 2, in certain embodiments, the needle 12 may be included in a catheter system for reducing the risk of vascular penetration. In certain 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 certain embodiments, the catheter adapter 32 may include a side port 42 in fluid communication with the lumen 38. In this way, certain embodiments of the side port 42 may be configured to receive an extension device to facilitate infusion and / or blood withdrawal through the catheter 40.

[0031] In certain embodiments, the catheter 40 may extend distally from the distal end 36 of the catheter adapter 32. In certain 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 certain embodiments, the primary bevel 22 and the sharp distal tip 24 may thus be disposed distally of the distal end of the catheter 40 to pierce the patient's skin and vasculature. In certain embodiments, the needle 12 may include a guide needle configured to guide the catheter 40 into the vasculature. In certain embodiments, the gauge and / or type of the needle 12 may vary.

[0032] Now referring to Figure 3 , in certain embodiments, the shaft 14 of the needle 12 may be longitudinally disposed along a central axis 16 between the proximal end 18 of the outer edge 20 (e.g., see Figure 1-2 ) and the distal end 23. In this way, in certain 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 certain embodiments, the distal end 44 of the shaft 14 may be proximate to the primary bevel 22. In certain 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 certain 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.

[0033] In certain embodiments, as shown in Figure 3 , the primary bevel 22 may be configured to face away from the patient's skin and point towards the top of the catheter system. 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.

[0034] Now referring to Figure 4, in certain embodiments, the primary bevel 22 may extend between the distal end 23 of the outer edge 20 and the sharp distal tip 24 and have a length 26 parallel to the central axis 16. In certain embodiments, the distal end of the needle 12 may include a line 28, and a first cutout portion 29a and a second cutout portion 29b may converge at the line 28 (see also Figure 3 and Figure 5C ). In certain embodiments, the line 28 may include a straight edge, which may facilitate cutting. In certain embodiments, on opposite sides of the needle 12, the first cutout portion 29a may be similar or identical to the second cutout portion 29b.

[0035] In certain embodiments, the primary bevel 22 may be straight or substantially straight. In certain embodiments, the needle 12 may include an opposing outer edge 30, which may be opposite or facing the outer edge 20. In certain embodiments, the opposing outer edge 30 may extend distally to the shaft 14 and the line 28. In certain embodiments, the length of the line 28 may extend proximally from the sharp distal tip 24 to the distal end 31 of the opposing outer edge 30. In certain embodiments, the opposing outer edge 30 may be aligned with the central axis 16 and the sharp distal tip 24.

[0036] In certain embodiments, the primary bevel 22 may include a primary bevel angle 50, which may be measured relative to the central axis 16. In certain 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 an increase in the primary bevel angle 50. In certain embodiments, the primary bevel angle 50 and the length 26 resulting from the primary bevel angle 50 may reduce the likelihood of vascular penetration when the needle 12 is inserted into a patient's vasculature. In certain embodiments, for the same diameter of a patient's vein, a particular primary bevel 22 with a shorter length 26 will reduce the likelihood of the sharp distal tip 24 contacting the posterior wall of the vein during clinician observation of a flash indicating venipuncture and during catheter advancement after venipuncture.

[0037] In certain embodiments, the line 28 may include an angle 52, which may be measured relative to the opposing outer edge 30. In certain embodiments, the angle 52 may contribute to the sharpness of the sharp distal tip 24. In certain embodiments, reducing the angle 52 may increase the sharpness of the sharp distal tip 24. Similarly, in certain embodiments, reducing the angle 52 may reduce the needle penetration force required to insert the needle 12 into a patient's vasculature, thereby reducing insertion pain.

[0038] Figure 5A Shows the needle 12 along Figure 4The cross-section taken along line 5A-5A as shown. In certain embodiments, the needle 12 may include a lumen 54 extending through the needle 12. In certain embodiments, the needle 12 may include a distal opening 55 surrounded by a primary bevel 22. In certain embodiments, the distal opening 55 may be formed in the primary bevel 22 to provide fluid communication between the lumen 54 and the external environment.

[0039] In certain embodiments, the shaft 14 may include an inner diameter 56 and an outer diameter 57. In certain embodiments, the outer surface of the needle 12 may include a first cutout 29a and a second cutout 29b (which may be referred to in this disclosure as "cutout 29"), and the first cutout 29a and the second cutout 29b may assist in inserting the needle 12 into a patient and increase the sharpness of the needle 12. In certain embodiments, the first cutout 29a and the second cutout 29b may form a cut-away portion from the outer diameter 57, which may be generally circular. In certain embodiments, the first cutout 29a and / or the second cutout 29b may be flat and separated by an angle 62, such as as Figure 5A shown. In other embodiments, the first cutout 29a and / or the second cutout 29b may be curved.

[0040] In certain embodiments, the first cutout 29a may be opposite the second cutout 29b. In certain embodiments, the first cutout 29a may correspond to a second bevel and the second cutout 29b may correspond to a third bevel. In certain embodiments, the first cutout 29a and the second cutout 29b may extend downward from the primary bevel 22. In certain embodiments, the first cutout 29a may intersect the plane of the primary bevel 22 at a first intersection line 31a and / or the second cutout 29b may intersect the plane of the primary bevel 22 at a second intersection line 31b. In certain embodiments, the first cutout 29a may converge with the second cutout 29b at a line 28, and the line 28 may include a sharp distal tip 24. In certain embodiments, the first cutout 29a and the second cutout 29b may each extend proximally from the primary bevel 22 until the opposite outer edge 30 that is directly opposite the outer edge 20.

[0041] In certain embodiments, it may be as Figure 5B-5CThe secondary angle 58 as shown in. In certain embodiments, in a 30 / 60 isometric view, the secondary angle 58 may correspond to the angle between the first intersecting line 31a and the reference line 33. In certain embodiments, in a 30 / 60 isometric view, the secondary angle 58 may also correspond to the angle between the second intersecting line 31b and the reference line 33. In certain embodiments, reducing the secondary angle 58 may increase the sharpness of the sharp distal tip 24. Similarly, in certain embodiments, reducing the secondary angle 58 may reduce the needle penetration force required to insert the needle 12 into the patient's vasculature, thereby reducing insertion pain.

[0042] In certain 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 certain embodiments, the cutout portion 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 certain embodiments, the cutout portion 29 may be disposed below the midline 59 or on the side of the needle 12 that is configured to be closest to the patient's skin during insertion into the vasculature. In certain embodiments, the thickness of the wall of the shaft 14 may be reduced below the midline 59, which may intersect the intersecting axis 60 to divide the cross-section into four equal quadrants. In certain embodiments, the central axis 16 may extend perpendicular to the midline 59 and the intersecting axis 60.

[0043] Now referring to Figure 6 , in certain embodiments, the length 26 of the primary bevel 22 may be measured from the distal end 23 of the outer edge 20 to the sharp distal tip 24. In certain embodiments, the distal opening 55 may comprise an oval, polygon, circle, or any other suitable shape.

[0044] Now referring to Figure 7A , in certain embodiments, the primary bevel angle 50 may be between 20° and 33°, which may reduce the length 26 and the risk of piercing through the blood vessel during insertion of the needle 12 into the blood vessel. In certain embodiments, for example, as Figure 7A shown, the primary bevel angle 50 may be 22.2°. As Figure 7B shown, in certain embodiments, the primary bevel angle 50 may be 31.4°.

[0045] Now referring to Figure 8 , in certain 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, thereby also reducing the associated insertion pain. In certain embodiments, for example, as Figure 8 shown, the primary bevel angle 50 may be 22.2°, and the secondary angle 58° may be 22°.

[0046] In some embodiments, a method for reducing the risk of vascular penetration can include inserting the needle 12 of the catheter system into a patient's vasculature. In some embodiments, in response to the needle 12 being inserted into the vasculature, the method can include withdrawing the needle 12 from the catheter system.

[0047] Now referring to Figure 9 , in some embodiments, a primary bevel angle 50 between 20° and 33° greatly reduces the risk of vascular penetration and, unexpectedly compared to the prior art, only slightly increases the overall peak force and the initial peak force. In some embodiments, the combination of a primary bevel angle 50 between 20° and 33° and a secondary angle 58 between 18° and 26° greatly reduces the risk of vascular penetration and, unexpectedly compared to the prior art, reduces the initial peak force. The overall peak force and the initial peak force can be measured during insertion of the needle 12 into a patient's blood vessel. Lower overall peak force and initial peak force are desirable to assist a clinician in inserting the needle 12 into the blood vessel.

[0048] All of the examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the invention and the concepts contributed by the inventor to further the art and are to be construed as not being limited to such specifically recited examples and conditions. Although the embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made without departing from the spirit and scope of the invention.

Claims

1. A catheter system for reducing the risk of penetration through blood vessels, the catheter system comprising: A catheter adapter, the catheter adapter including a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; A catheter extending distally from the distal end of the catheter adapter; And A guide needle extending through the catheter, the guide needle including: A sharp distal tip; and A primary bevel extending from the outer edge of the guide needle to the sharp distal tip, wherein the primary bevel is straight, wherein the outer edge is parallel to the central axis of the guide needle and aligned with the sharp distal tip, wherein the primary bevel includes a primary bevel angle relative to the central axis, and wherein the primary bevel angle is between 20° and 33°; Wherein the guide needle further includes: A first cut portion and a second cut portion, both the first cut portion and the second cut portion extending proximally from the primary bevel to a relative outer edge that is directly opposite the outer edge, wherein the relative outer edge is parallel to the central axis and the outer edge of the guide needle; Wherein the first cut portion intersects the plane of the primary bevel at a first intersection line, and wherein, in a 30 / 60 isometric view, a secondary angle formed between the first intersection line and a reference line of the guide needle is between 18° and 26°.

2. The catheter system according to claim 1, wherein The primary bevel angle is 22.2°.

3. The catheter system according to claim 1, wherein The secondary angle is 22°.

4. The catheter system according to claim 3, characterized in that, The primary bevel angle is 22.2°.

5. The catheter system according to claim 1, wherein The first cut portion is flat and the second cut portion is flat.

6. A guide needle, comprising: A sharp distal tip; And A primary bevel extending from the outer edge of the guide needle to the sharp distal tip, wherein the outer edge is parallel to the central axis of the guide needle and aligned with the sharp distal tip, wherein the primary bevel includes a primary bevel angle relative to the central axis, and wherein the primary bevel angle is between 20° and 33°, and wherein the primary bevel is straight; Wherein the guide needle further includes a first cut portion and a second cut portion, both the first cut portion and the second cut portion extending proximally from the primary bevel to a relative outer edge that is directly opposite the outer edge, wherein the relative outer edge is parallel to the central axis and the outer edge of the guide needle; Wherein the first cut portion intersects the plane of the primary bevel at a first intersection line, and wherein, in a 30 / 60 isometric view, a secondary angle formed between the first intersection line and a reference line of the guide needle is between 18° and 26°.

7. The guiding needle according to claim 6, wherein The primary bevel angle is 22.2°.

8. The guide needle according to claim 6, wherein, The secondary angle is 22°.

9. The guiding needle according to claim 8, wherein The primary bevel angle is 22.2°.

10. The guide needle according to claim 6, characterized in that, The first cut portion is flat and the second cut portion is flat.

Images