Introducer needle and related catheter insertion device

Abstract

The needle (10) for catheter introduction includes a distal end (12) including a tip (16) and, extending proximally from the tip (16), a first bevel surface (18), a second bevel surface (20), and a third bevel surface. The first bevel surface converges with the second bevel surface to form a first incisal edge (24), the second bevel surface converges with the third bevel surface to form a second incisal edge, and the third bevel surface converges with the first bevel surface to form a third incisal edge (28). The first incisal edge is offset from the second incisal edge by approximately 120 degrees, the second incisal edge is offset from the third incisal edge by approximately 120 degrees, and the third incisal edge is offset from the first incisal edge by approximately 120 degrees.

Description

[Technical field]

[0001] TECHNICAL FIELD The present disclosure relates generally to vascular access systems, vascular access devices, and vascular access methods, and more particularly, in some embodiments, the present disclosure relates to needles and associated devices, systems, and methods. [Background technology]

[0002] Catheters are commonly used to administer parenteral nutrition, intravenous fluids, pain medications and antibiotics. Catheters are also used to draw blood. Catheters can be inserted at the hospital bed using sterile techniques and can remain in place for several weeks.

[0003] A common catheter is the over-the-needle catheter. As the name suggests, an "over-the-needle" catheter is fitted over an introducer needle that has a sharp distal end. The sharp tip may be used to puncture the patient's skin and vein. Insertion of the over-the-needle catheter into the vein may be followed by puncture of the vein with the introducer needle. Typically, the introducer needle has a sharp distal tip to pierce the patient's skin and vein with minimal resistance, minimizing pain to the patient.

[0004] The introducer needle is typically placed at a steep angle relative to the surface of the skin and the longitudinal dimension of the vein being punctured to allow penetration of the skin and vein wall. The needle and catheter are inserted with the introducer needle beveled away from the patient's skin. After the introducer needle tip penetrates the wall, the insertion angle is reduced to allow the introducer needle and catheter to slide into the vein a sufficient distance to properly position the catheter within the vein. Once placement of the introducer needle within the vein is confirmed, the user can temporarily occlude intravenous flow and withdraw the introducer needle, leaving the over-the-needle catheter in place for future fluid infusions and / or blood sampling.

[0005] Inserting and properly placing a catheter on the first attempt generally requires a level of skill that some users do not possess. Accurate placement of the catheter into the vein on the first attempt is a great advantage for reducing the incidence of injury to the vein and / or surrounding tissue. Proper placement of the catheter and needle is important to minimize patient discomfort and pain and to reduce injury and scarring to the vein. Injury caused to the vein during catheter insertion and placement can lead to increased blood clotting, clot formation, and other health problems.

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

[0007] In some embodiments, the needle may include an introducer needle. In some embodiments, the needle tip shape may provide a reduced risk of transfixing a patient's vein when the needle is inserted into the patient's vein. In some embodiments, the needle tip shape may provide a more reliable placement of the catheter within the vein. In some embodiments, the needle may be used to insert a guidewire into the patient for advancing the catheter.

[0008] In some embodiments, the needle may include a distal end, a proximal end, and an elongate body extending between the distal end and the proximal end. In some embodiments, the distal end of the needle may include a distal tip, a first bevel surface extending proximally from the distal tip, a second bevel surface extending proximally from the distal tip, and a third bevel surface extending proximally from the distal tip. In some embodiments, the distal tip may include a sharp point for penetrating the patient's skin and vein.

[0009] In some embodiments, the first bevel surface may converge with the second bevel surface to form a first incisal edge. In some embodiments, the second bevel surface may converge with the third bevel surface to form a second incisal edge. In some embodiments, the third bevel surface may converge with the first bevel surface to form a third incisal edge. In some embodiments, the first incisal edge may be offset from the second incisal edge by about 120 degrees. In some embodiments, the second incisal edge may be offset from the third incisal edge by about 120 degrees. In some embodiments, the third incisal edge may be offset from the first incisal edge by about 120 degrees.

[0010] In some embodiments, the needle may be solid. In some embodiments, the needle may include one or more outflow grooves. In some embodiments, the outflow grooves may extend proximally from one or more of the first bevel surface, the second bevel surface, and the third bevel surface.

[0011] In some embodiments, the needle may include a lumen extending through the proximal end of the needle. In some embodiments, one or more of the first bevel surface, the second bevel surface, or the third bevel surface may include one or more holes in fluid communication with the lumen of the needle. In some embodiments, a guidewire may be disposed within the lumen of the needle and may be advanced distally through a particular one of the holes and beyond the distal tip of the needle.

[0012] In some embodiments, the perimeter of the first bevel surface (which may be referred to in this disclosure as the first perimeter) may include a first incisal edge, a third incisal edge, and a first proximal edge. In some embodiments, the first proximal edge may extend between the first incisal edge and the third incisal edge. In some embodiments, the perimeter of the second bevel surface (which may be referred to in this disclosure as the second perimeter) may include a first incisal edge, a second incisal edge, and a second proximal edge. In some embodiments, the second proximal edge may extend between the second incisal edge and the third incisal edge. In some embodiments, the perimeter of the third bevel surface (which may be referred to in this disclosure as the third perimeter) may include a second incisal edge, a third incisal edge, and a third proximal edge. In some embodiments, the third proximal edge may extend between the second incisal edge and the third incisal edge.

[0013] In some embodiments, a first portion of the elongate body disposed between the first proximal edge and the second proximal edge may be chamfered. In some embodiments, a second portion of the elongate body disposed between the second proximal edge and the third proximal edge may be chamfered. In some embodiments, a third portion of the elongate body disposed between the second proximal edge and the third proximal edge may be chamfered.

[0014] In some embodiments, the distal end of the needle may be symmetrical. In some embodiments, the first circumference, the second circumference, and the third circumference may be equal. In these and other embodiments, the distal tip may be aligned with the central axis of the needle. In some embodiments, the length of the first bevel surface from the distal tip to the apex of the first proximal edge may be equal to the length of the second bevel surface from the distal tip to the apex of the second proximal edge, which may be equal to the length of the third bevel surface from the distal tip to the apex of the third proximal edge. In some embodiments, the length of the first bevel surface from the proximal end of the first incisal edge to the proximal end of the third incisal edge may be equal to the length of the second bevel surface from the proximal end of the first incisal edge to the proximal end of the second incisal edge, which may be equal to the length of the third bevel surface from the proximal end of the second incisal edge to the proximal end of the third incisal edge.

[0015] In some embodiments, the distal end of the needle may be asymmetric. In some embodiments, one or more of the first circumference, the second circumference, and the third circumference may not be equal to one another. In these and other embodiments, the distal tip may not be aligned with the central axis of the needle. In some embodiments, the length of the first bevel surface from the distal tip to the apex of the first proximal edge may be greater than the length of the second bevel surface from the distal tip to the apex of the second proximal edge and / or the length of the third bevel surface from the distal tip to the apex of the third proximal edge. In some embodiments, the length of the second bevel surface from the distal tip to the apex of the second proximal edge may be greater than the length of the first bevel surface from the distal tip to the apex of the first proximal edge and / or the length of the third bevel surface from the distal tip to the apex of the third proximal edge. In some embodiments, the length of the third bevel surface from the distal tip to the apex of the third proximal edge may be greater than the length of the second bevel surface from the distal tip to the apex of the second proximal edge and / or the length of the first bevel surface from the distal tip to the apex of the first proximal edge.

[0016] In some embodiments, the needle may extend through the catheter of the catheter insertion device. However, it is contemplated that the needle may be used with medical devices other than catheters and / or for any medical purpose, including spinal needles. In some embodiments, the catheter may include a peripheral intravenous catheter (PIVC), a midline catheter, or a peripherally inserted central catheter (PICC).

[0017] In some embodiments, the catheter may include a distal end, a proximal end, and a lumen extending through the distal end of the catheter and the proximal end of the catheter. In some embodiments, the outflow grooves may each include a distal end proximate the first beveled surface, the second beveled surface, or the third beveled surface. In some embodiments, the outflow grooves may each include a proximal end disposed proximate the distal end of the catheter. In some embodiments, the outflow grooves may be in fluid communication with the lumen of the catheter. In some embodiments, blood passing through the outflow grooves and entering the lumen of the catheter may be visible to a user.

[0018] In some embodiments, one or more of the first bevel surface, the second bevel surface, and the third bevel surface may be substantially planar. In some embodiments, the needle may be oriented in the catheter such that the first bevel surface, the second bevel surface, or the third bevel surface faces downward or toward the inner wall of the vein opposite the needle's entry point into the vein. In these embodiments, the particular blade edge toward the top of the catheter may be aligned with the central axis of the catheter insertion device. In some embodiments, when the needle is inserted into a vein with the particular bevel surface facing downward, the risk of piercing the vein may be reduced.

[0019] In some embodiments, the needle tip shape may be used in a phlebotomy needle for drawing blood through the lumen of the needle into a vacuum tube or other suitable blood collection device. In some embodiments, the needle tip shape may also be used in other procedures, such as procedures where it is desired to reduce needle bending due to long bevel needles. In some embodiments, the needle may be used for the introduction and / or withdrawal of fluids from a patient. In some embodiments, the needle tip shape may be used for the aspiration of blood, spinal fluid, or other fluids from a patient.

[0020] 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 claimed. It is to be understood that the various embodiments are not limited to the arrangement and instrumentality shown in the drawings. It is also to be understood that the embodiments may be combined, other embodiments may be utilized, and structural changes may be made, even if not recited in the claims, without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense.

[0021] Example embodiments are described with additional specificity and detail through the use of the accompanying drawings, in which: [Brief description of the drawings]

[0022] [Figure 1A] FIG. 2 is a top perspective view of an exemplary needle according to some embodiments. [Figure 1B] FIG. 1B is a bottom perspective view of the needle of FIG. 1A according to some embodiments. [Figure 1C] FIG. 1B is a side view of the needle of FIG. 1A according to some embodiments. [Figure 1D] FIG. 1B is an opposite side view of the needle of FIG. 1A according to some embodiments. [Figure 1E] FIG. 1B is a perspective view of the needle of FIG. 1A from the distal end of the needle according to some embodiments. [Figure 1F] 1B is a top perspective view of the needle of FIG. 1A illustrating the needle in comparison to another needle according to some embodiments. [Figure 1G] 1B is a top perspective view of the needle of FIG. 1A inserted into a vein according to some embodiments, illustrating the needle in comparison to other needles. [Figure 2A] 1B is a top perspective view of the needle of FIG. 1A illustrating an example of an outflow groove according to some embodiments. [Figure 2B] FIG. 1B is a side view of the needle of FIG. 1A illustrating multiple outflow grooves according to some embodiments. [Figure 2C]1B is a perspective view of the needle of FIG. 1A from the distal end of the needle illustrating multiple outflow channels according to some embodiments. [Figure 3A] 1B is a top perspective view of the needle of FIG. 1A illustrating an example of a chamfer according to some embodiments. [Figure 3B] FIG. 1B is a perspective view of the distal end of the needle of FIG. 1A illustrating multiple chamfers according to some embodiments. [Figure 4A] 1B is a top perspective view of the needle of FIG. 1A illustrating an exemplary hole according to some embodiments. [Figure 4B] FIG. 1B is a top perspective view of the needle of FIG. 1A inserted through an exemplary catheter, according to some embodiments. [Diagram 5] 1B is a top perspective view of the needle of FIG. 1A inserted through a catheter according to some embodiments, illustrating an exemplary notch. [Figure 6A] 1B is a top perspective view of the needle of FIG. 1A illustrating an asymmetric distal end according to some embodiments. [Figure 6B] 1B is a top perspective view of the needle of FIG. 1A illustrating another asymmetric distal end according to some embodiments. [Figure 7A] FIG. 1 is an exploded view of an exemplary catheter assembly, according to some embodiments. [Figure 7B] FIG. 1 is a partial cross-sectional view of a catheter assembly according to some embodiments. [Figure 7C] 1 is a top perspective view of a catheter assembly according to some embodiments illustrating exemplary backflow. [Figure 7D] FIG. 1 is a top perspective view of another catheter assembly, according to some embodiments. [Figure 7E] 1 is a cross-sectional view of another catheter assembly, according to some embodiments. [Figure 8A] FIG. 13 is a top view of a needle according to some embodiments illustrating two bevel surfaces. [Figure 8B] FIG. 13 is a bottom view of a needle according to some embodiments illustrating two bevel surfaces. [Figure 8C] FIG. 13 is a side view of a needle according to some embodiments illustrating two bevel surfaces. [Figure 8D] 1 is a perspective view from the distal end of a needle according to some embodiments illustrating two bevel surfaces. [Figure 9A] FIG. 13 is a side view of a needle according to some embodiments illustrating four bevel surfaces. [Figure 9B] FIG. 13 is a perspective view from the distal end of a needle according to some embodiments illustrating four bevel surfaces. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] As used in this disclosure, the term "distal" refers to the portion of the needle or catheter assembly or component thereof that is further from the user, and the term "proximal" refers to the portion of the needle or catheter assembly or component thereof that is closer to the user. As used in this disclosure, the term "user" may refer to a clinician, doctor, nurse, or other care provider, and may include support personnel.

[0024] 1A-1E, in some embodiments, needle 10 may include an introducer needle. In some embodiments, needle 10 may include a distal end 12, a proximal end, and an elongated body 14 extending between distal end 12 and the proximal end. In some embodiments, elongated body 14 may be generally cylindrical or another suitable shape that can prevent snagging. In some embodiments, distal end 12 may be generally symmetrical, for example, as shown in FIGS. 1A-1E.

[0025] In some embodiments, the distal end 12 of the needle 10 may include a distal tip 16, a first bevel surface 18 extending proximally from the distal tip 16, a second bevel surface 20 extending proximally from the distal tip 16, and a third bevel surface 22 extending proximally from the distal tip 16. In some embodiments, the distal tip 16 may include a sharp point for penetrating the patient's skin and vein. In some embodiments, the distal tip 16 may be disposed radially inward from an outer surface of the elongate body 14.

[0026] In some embodiments, the first bevel surface 18 may converge with the second bevel surface 20 to form a first incisal edge 24. In some embodiments, the second bevel surface 20 may converge with the third bevel surface 22 to form a second incisal edge 26. In some embodiments, the third bevel surface 22 may converge with the first bevel surface 18 to form a third incisal edge 28. In some embodiments, one or more of the first bevel surface 18, the second bevel surface 20, and the third bevel surface 22 may be symmetric. In some embodiments, two of the first bevel surface 18, the second bevel surface 20, and the third bevel surface 22 may be inverted bevels.

[0027] 1E, in some embodiments, the first incisal edge 24 may be offset from the second incisal edge 26 by about 120 degrees. In some embodiments, the second incisal edge 26 may be offset from the third incisal edge 28 by about 120 degrees. In some embodiments, the third incisal edge 28 may be offset from the first incisal edge 24 by about 120 degrees. In some embodiments, the first incisal edge 24, the second incisal edge 26, and the third incisal edge 28 may divide the circumference of the elongate body 14 into three equal portions, each of which may have the same or different shapes.

[0028] In some embodiments, the periphery of the first bevel surface 18 may include a first incisal edge 24, a third incisal edge 28, and a first proximal edge 30. In some embodiments, the periphery of the first bevel surface 18 may include nothing other than the first incisal edge 24, the third incisal edge 28, and the first proximal edge 30. In some embodiments, the first proximal edge 30 may extend between the first incisal edge 24 and the third incisal edge 28.

[0029] In some embodiments, the periphery of the second bevel surface 20 may include a first incisal edge 24, a second incisal edge 26, and a second proximal edge 32. In some embodiments, the periphery of the second bevel surface 20 may include nothing other than the first incisal edge 24, the second incisal edge 26, and the second proximal edge 32. In some embodiments, the second proximal edge 32 may extend between the second incisal edge 26 and the third incisal edge 28.

[0030] In some embodiments, the perimeter of the third bevel surface 22 may include the second incisal edge 26, the third incisal edge 28, and the third proximal edge 34. In some embodiments, the perimeter of the third bevel surface 22 may include nothing other than the second incisal edge 26, the third incisal edge 28, and the third proximal edge 34. In some embodiments, the third proximal edge 34 may extend between the second incisal edge 26 and the third incisal edge 28.

[0031] In some embodiments, the first incisal edge 24, the second incisal edge 26, and the third incisal edge 28 may be straight or linear. In some embodiments, the first incisal edge 24, the second incisal edge 26, and the third incisal edge 28 may intersect at the distal tip 16. In some embodiments, one or more of the first proximal edge 30, the second proximal edge 32, or the third proximal edge 34 may be a generally proximal edge shape. In some embodiments, one or more of the first proximal edge 30, the second proximal edge 32, or the third proximal edge 34 may include an arc to facilitate smooth entry of the needle 10 through the skin and vein. In some embodiments, one or more of the first proximal edge 30, the second proximal edge 32, and the third proximal edge 34 may be straight or linear.

[0032] In some embodiments, one or more of the first circumference, second circumference, and third circumference may be equal. In some embodiments, one or more of the first bevel surface 18, second bevel surface 20, and third bevel surface 22 may have equal shapes or contours, as shown, for example, in FIGS. 1A-1E. In these and other embodiments, the distal tip 16 may be aligned with the central axis 36 of the needle 10. In some embodiments, one or more of the first bevel surface 18, second bevel surface 20, and third bevel surface 22 may be identical.

[0033] In some embodiments, the length 38 of the first bevel surface 18 from the distal tip to the apex of the first proximal edge 30 may be equal to the length 40 of the second bevel surface 20 from the distal tip 16 to the apex of the second proximal edge 32, which may be equal to the length 42 of the third bevel surface 22 from the distal tip 16 to the apex of the third proximal edge 34. In some embodiments, the length 44 of the first bevel surface 18 from the proximal end of the first incisal edge 24 to the proximal end of the third incisal edge 28 may be equal to the length 46 of the second bevel surface 20 from the proximal end of the first incisal edge 24 to the proximal end of the second incisal edge 26, which may be equal to the length 48 of the third bevel surface 22 from the proximal end of the second incisal edge 26 to the proximal end of the third incisal edge 28.

[0034] In some embodiments, the symmetrical nature of the distal tip 12 can assist an inexperienced user in orienting a needle for insertion into a patient. In some embodiments, the needle 10 may be solid. In some embodiments, the needle 10 may be constructed of metal, steel, or other suitable material. In some embodiments, the needle 10 may be formed as a single unit of monolithic construction. In some embodiments, the distal tip 12 may not include an opening aligned with the central axis 36 of the needle 10. In some embodiments, the distal tip 12 may be closed to prevent fluid from flowing therethrough.

[0035] 1F-1G, in some embodiments, the length 38 of the first bevel surface 18, the length 40 of the second bevel surface 20, and the length 46 of the second bevel surface 20 may be shorter compared to the length of the bevel surface of another needle 52, which is shown in dashed lines for size comparison. The other needle 52 may correspond to an ISO 10555 standard needle, and the other needle 52 may include a reverse grind tip shape or a B-bevel tip shape, as known in the art. The other needle 52 may include an opening 53 along the central axis of the other needle 52.

[0036] In some embodiments, the length 38 of the first bevel surface 18, the length 40 of the second bevel surface 20, and the length 46 of the second bevel surface 20 may be less than or equal to about half the length of the bevel of the other needle 52. In some embodiments, the length 38 of the first bevel surface 18, the length 40 of the second bevel surface 20, and the length 46 of the second bevel surface 20 may facilitate the distal end 54 of the catheter 50 entering the vein 49 before the distal tip 16 pierces or damages the inner surface of the wall of the vein 49 opposite the entry point of the needle 10 into the vein 49. In some embodiments, the length 38 of the first bevel surface 18, the length 40 of the second bevel surface 20, and the length 46 of the second bevel surface 20 may be about half the length of the bevel of the other needle 52, such that the distal tip 16 may be twice as far from the inner surface of the wall of the vein 49 opposite the entry point when the distal end 54 of the catheter 50 enters the vein 49.

[0037] In some embodiments, the distal end 12 of the needle 10 may be configured for difficult access to small diameter veins without causing vein trauma and puncture. In some embodiments, the distance 55 between the top surface of the distal end 54 of the catheter 50 and the bottom surface of the distal end 12 of the needle 10 may be half the distance between the top surface of the distal end 54 of the catheter 50 and the bottom surface of the distal end of the other needle 52. In some embodiments, the distance 55 between the top surface of the distal end 54 of the catheter 50 and the bottom surface of the distal end 12 of the needle 10 may be about 1.1 mm or 1.0-1.2 mm when the needle 10 is 20 gauge and configured for use with an 18 gauge catheter inserted at an insertion angle of 20-30 degrees. In some embodiments, the distance 55 between the top surface of the distal end 54 of the catheter 50 and the bottom surface of the distal end 12 of the needle 10 may be within 3 times the standard deviation of the normal distribution of human vein diameters.

[0038] In contrast, the bevel surface of the other needle 48 may be long enough to make it difficult for a user to insert the distal end 54 of the catheter 50 into the vein 49 without damaging and piercing the vein 49. A piercing may occur if the needle enters the top of the vein 49 and then also pierces the bottom of the vein 49. Damage to the vein 49, including piercing the vein 49, may promote clotting and clot formation. In some embodiments, the needle tip configuration of the needle 10 as described provides a reduced risk of piercing the patient's vein 49 as the needle 10 is inserted into the patient's vein 49, and may provide a more reliable placement of the catheter 50 within the vein 49.

[0039] In some embodiments, the beveled surface of the other needle 52 may cause the other needle 52 to drop or plummet at a steeper insertion angle as the other needle 52 is inserted through the skin and into the vein 49. The user may try to compensate for the steeper insertion angle by guessing how far to drop. In some embodiments, the distal end 12 of the needle 10 may be symmetrical, which may provide a zero drop upon insertion of the needle 10 into the patient.

[0040] In some embodiments, one or more of the first bevel surface 18, the second bevel surface 20, and the third bevel surface 22 may be generally planar. In some embodiments, the needle 10 may be oriented within the catheter 50 such that the first bevel surface 18, the second bevel surface 20, or the third bevel surface 22 are directed downward or toward the inner wall of the vein 49 opposite the point of entry of the needle 10 into the vein 49, which may reduce the risk of piercing the vein 49. Additionally, in some embodiments, the needle 10 may be used to create a cut or slit in the skin and vein 49 that is the same size or similar to the dimensions of the other needles 52.

[0041] 2A-2C, in some embodiments, the needle 10 may include one or more outflow grooves 56. In some embodiments, the outflow grooves 56 may extend proximally from one or more of the first bevel surface 18, the second bevel surface 20, and the third bevel surface 22. In some embodiments, the outflow grooves 56 may provide a passageway for blood flashback. In some embodiments, in response to the needle 10 penetrating the vein 49, blood may travel through the outflow grooves 56 to an inner surface of the catheter 50 (e.g., as illustrated in FIG. 1G) and / or to another location or device where the blood may be viewed by the user as an indication of the placement of the needle 10 within the vein.

[0042] 3A-3B, in some embodiments, a first portion 58 of the elongate body 14 disposed between the first proximal edge 30 and the second proximal edge 32 may be chamfered. In some embodiments, a second portion 60 of the elongate body 14 disposed between the second proximal edge 32 and the third proximal edge 34 may be chamfered. In some embodiments, a third portion 62 of the elongate body 14 disposed between the second proximal edge 32 and the third proximal edge 34 may be chamfered. In some embodiments, the chamfering or rounding of the first portion 58, second portion 60, and third portion 62 may prevent inadvertent scraping of the inner wall of the vein opposite the entry point of the needle 10 into the vein.

[0043] 4A-4B, in some embodiments, the needle 10 may include a lumen 64 extending through a proximal end 65 of the needle 10 (see, e.g., FIG. 7E) via an opening, notch, or the like. In some embodiments, one or more of the first bevel surface 18, the second bevel surface 20, or the third bevel surface 22 may include one or more holes 66 in fluid communication with the lumen 64 of the needle 10. In some embodiments, a guidewire 68 may be disposed within the lumen 64 of the needle 10 and configured to extend through a particular one of the holes 66. In some embodiments, the guidewire 68 may be advanced distally through a particular one of the holes 66 beyond the distal tip 16 of the needle 10. In some embodiments, the needle 10 may be used to insert the guidewire 68 into a patient to advance the catheter 50. In some embodiments, the distal tip 12 may be closed except for the holes 66 and may not allow fluid to flow therefrom except for the holes 66. In some embodiments, the hole 66 may be offset from the central axis 36 .

[0044] 5, in some embodiments, the needle 10 includes an opening, such as a notch 70, to provide backflow of blood when the needle 10 enters a vein to indicate that the distal tip 16 is located within the vein. In some embodiments, in response to the needle 10 entering the vein 49, blood may travel proximally through the hole 66 into the lumen 64 of the needle 10 and then out the notch 70 to the interior surface of the catheter 50 and / or to another location or device where the blood can be viewed by the user as an indication that the needle 10 has been placed within the vein.

[0045] In some embodiments, each of the outflow grooves 56 may include a distal end 71 proximate the first bevel surface 18, the second bevel surface 20, or the third bevel surface 22. In some embodiments, the distal end 71 may intersect a particular apex of a particular proximal edge. In some embodiments, each of the outflow grooves 56 may include a proximal end 73 disposed proximally relative to the distal end 54 of the catheter 50. In some embodiments, the outflow grooves 56 may be in fluid communication with the lumen of the catheter 50. In some embodiments, blood passing through the outflow grooves 56 and into the lumen of the catheter 50 may be visible to a user.

[0046] 5, in some embodiments, needle 10 may be oriented within catheter 50 such that first bevel surface 18, second bevel surface 20, or third bevel surface 22 faces downward or toward the inner wall of vein 49 opposite the point of entry of needle 10 into vein 49, thereby reducing the risk of piercing vein 49. In these embodiments, notch 70 may be positioned facing the top of catheter 50 and generally opposite the downward-facing first bevel surface 18, second bevel surface 20, or third bevel surface 22.

[0047] 6A-6B, in some embodiments, the distal end 12 of the needle 10 may be asymmetric. In some embodiments, one or more of the first circumference, the second circumference, and the third circumference may not be equal to one another. In these and other embodiments, the distal tip 16 may not be aligned with the central axis 36 of the needle 10.

[0048] In some embodiments, the length 38 of the first bevel surface 18 from the distal tip to the apex of the first proximal edge 30 may be greater than the length 40 of the second bevel surface 20 from the distal tip 16 to the apex of the second proximal edge 32 and / or the length 42 of the third bevel surface 22 from the distal tip 16 to the apex of the third proximal edge 34. In some embodiments, the length 40 of the second bevel surface 20 from the distal tip 16 to the apex of the second proximal edge 32 may be greater than the length 38 of the first bevel surface 18 from the distal tip 16 to the apex of the first proximal edge 30 and / or the length of the third bevel surface 22 from the distal tip 16 to the apex of the third proximal edge 34. In some embodiments, the length 42 of the third bevel surface 22 from the distal tip 16 to the apex of the third proximal edge 34 may be greater than the length 42 of the second bevel surface 20 from the distal tip 16 to the apex of the second proximal edge 32 and / or the length 38 of the first bevel surface 18 from the distal tip 16 to the apex of the first proximal edge 30.

[0049] As illustrated in Fig. 6A, the distal tip 16 may be offset from the central axis 36 in response to the length 38 of the first bevel surface 18 from the distal tip to the apex of the first proximal edge 30 being less than the length 40 of the second bevel surface 20 from the distal tip 16 to the apex of the second proximal edge 32 and / or the length 42 of the third bevel surface 22 from the distal tip 16 to the apex of the third proximal edge. As illustrated in Fig. 6B, the distal tip 16 may be offset from the central axis 36 in response to the length 38 of the first bevel surface 18 from the distal tip to the apex of the first proximal edge 30 being greater than the length 40 of the second bevel surface 20 from the distal tip 16 to the apex of the second proximal edge 32 and / or the length 42 of the third bevel surface 22 from the distal tip 16 to the apex of the third proximal edge.

[0050] 7A-7D, exemplary backflow features are illustrated in a catheter insertion device including an exemplary catheter assembly 72, according to some embodiments. In some embodiments, a needle 10 may be used with the catheter assembly 72. It is understood that the needle 10 may be used with any catheter assembly, according to some embodiments.

[0051] In some embodiments, the catheter assembly 72 may include a linear or non-integral catheter assembly. In some embodiments, the catheter assembly 72 may include an integrated catheter assembly. More specifically, in some embodiments, the catheter adapter 74 of the catheter assembly 72 may include an integrated extension tube, such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BD NEXIVA™ DIFFUSICS™ Closed IV Catheter System, or the Becton Dickinson PEGASUS™ Safety Closed IV Catheter System.

[0052] In some embodiments, the catheter adapter 74 may include a distal end 76, a proximal end 78, and a lumen 80 extending between the distal end 76 and the proximal end 78. In some embodiments, the catheter 50 may be fixed to the catheter adapter 74 or may extend distally from the catheter adapter 74. In some embodiments, the catheter 50 may be held in place within the catheter adapter 74 via a wedge 87 or other suitable means. In some embodiments, the catheter 50 may include a PIVC, a midline catheter, or a PICC. In some embodiments, the catheter 50 may include a distal end 54, a proximal end 84, and a lumen 86 extending through the distal end 82 of the catheter 50 and the proximal end 84 of the catheter 50.

[0053] In some embodiments, the catheter assembly 72 may include a needle hub 88 to which the proximal end 65 of the needle 10 is secured. In some embodiments, when the catheter assembly 72 is in an insertion position ready for insertion into a patient, the needle 10 may extend through the catheter 50 such that the distal end 12 of the needle 10 is distal to the distal end 54 of the catheter 50. In some embodiments, after the catheter 50 is inserted into a patient's vein, the needle 10 and needle hub 88 may be detached from the catheter adapter 74, leaving the catheter 50 in the vein when the needle 10 is discarded. In some embodiments, a septum 91 and / or a septum actuator 92 may be disposed within the lumen 80 of the catheter adapter 74.

[0054] Backflow is the visibility of blood confirming entry of the distal tip 16 into the vein. In some embodiments, backflow may be recognized through the catheter 50 as blood moves through the outflow channel 56 (see, e.g., FIG. 2A-2C) and into the space between the needle 10 and the catheter 50. This backflow may be referred to as a "Quickflash." Also, in some embodiments, backflow may be recognized by blood exiting the notch 70 (see, e.g., FIG. 5) and entering the space between the needle 10 and the catheter 50. This may be referred to as an "Instaflash." Additionally or alternatively, in some embodiments, backflow may be visible in an outflow chamber, which may be located in the needle hub 88 or other suitable location in the catheter assembly 72.

[0055] In some embodiments, the needle 10 can be used with non-catheter medical devices and / or for any medical purpose, including spinal needles, etc. In some embodiments, the needle 10 can also be used for other procedures, such as procedures where it is desirable to reduce needle bending due to long bevel needles. In some embodiments, the needle 10 can be used for the introduction of fluids into and / or the withdrawal of fluids from a patient. In some embodiments, the needle 10 may be used to aspirate blood, spinal fluid, or other fluids from a patient.

[0056] 7D-7E, another catheter assembly 94 is shown in which the needle 10 can be used, according to some embodiments. In some embodiments, the catheter assembly 94 may include or correspond to the catheter assembly 72. As illustrated in FIG. 7E, in some embodiments, the outflow chamber may be disposed within the needle hub 88, which may have a vent. In some embodiments, the needle 10 may be solid. In other embodiments, a hole 66 (see, e.g., FIGS. 4A-4B) may provide access to the lumen 64 of the needle 10.

[0057] In some embodiments, the needle 10 may be used in conjunction with a variety of technologies. For example, in some embodiments, the distal tip 12 may be magnetic or magnetized, allowing for ultrasound guidance and interaction with an ultrasound system to track the position of the distal tip 12.

[0058] In some embodiments, needle 10 may include one or more features further described in U.S. patent application Ser. No. 15 / 286,223, entitled "COMPLIANT CATHETER ADAPTER HAVING SELF-SLITTING NEEDLE," filed Oct. 5, 2016, which is hereby incorporated by reference in its entirety. In some embodiments, needle 10 may include one or more features further described in U.S. patent application Ser. No. 15 / 286,162, entitled "INTEGRATED CATHETER WITH INDEPENDENT FLUID PATHS," filed Oct. 5, 2016, which is hereby incorporated by reference in its entirety.

[0059] In some embodiments, the needle 10 may be used with a catheter having an asymmetric tip, as further described, for example, in U.S. patent application Ser. No. 15 / 286,261, entitled "CATHETER WITH AN ASYMMETRIC TIP," filed Oct. 5, 2016, which is hereby incorporated by reference in its entirety. In some embodiments, the needle 10 may be used with a strain relief feature, as further described, for example, in U.S. patent application Ser. No. 15 / 285,061, entitled "CATHETER ADAPTER WITH DISTAL INNER DIAMETER CURVATURE PROVIDING KINK RESISTANCE," filed Oct. 5, 2016, which is hereby incorporated by reference in its entirety.

[0060] 8A-8D, in some embodiments, the number of bevel surfaces may vary. For example, as illustrated in FIGS. 8A-8D, the needle 10 may include two bevel surfaces, a first bevel surface 18 and a second bevel surface 20. In these and other embodiments, the needle 10 may include two cutting edges (a first cutting edge 24 and a second cutting edge 26), which may be offset from one another by approximately 180 degrees. As previously mentioned, in some embodiments, the first bevel surface 18 and the second bevel surface 20 may have equal shapes or contours. In some embodiments, the distal end 12 may be symmetrical. In other embodiments, the distal end 12 may be asymmetrical. For example, as described, the length 38 of the first bevel surface 18 from the distal tip to the apex of the first proximal edge 30 may be greater than the length 40 of the second bevel surface 20 from the distal tip 16 to the apex of the second proximal edge 32. In some embodiments, the first bevel surface 18 and / or the second bevel surface 20 may include specific holes 66 .

[0061] 9A-9B, in some embodiments, the needle 10 may include four or more bevel surfaces. For example, as illustrated in FIGS. 9A-9B, the needle 10 may include four bevel surfaces and four cutting edges that may converge at the distal tip 16. FIG. 9B illustrates a fourth bevel surface 96, according to some embodiments. In some embodiments, the four bevel surfaces may be offset from one another by approximately 90 degrees. As another example, the needle 10 may include five bevel surfaces and five cutting edges that may converge at the distal tip 16. In some embodiments, the five bevel surfaces may be offset from one another by approximately 72 degrees. As yet another example, the needle 10 may include six bevel surfaces and six cutting edges that may converge at the distal tip 16. In some embodiments, the six bevel surfaces may be offset from one another by approximately 60 degrees.

[0062] In some embodiments, the four, five, or six bevel surfaces may have equal shapes or contours. In some embodiments, the distal end 12 may be symmetrical. In other embodiments, the distal end 12 may be asymmetrical, such as, for example, one of the four, five, or six bevel surfaces being longer than another of the four, five, or six bevel surfaces. In some embodiments, one or more particular bevel surfaces of the four, five, or six bevel surfaces may include holes 66.

[0063] All examples and conditional descriptions described herein are for educational purposes to help the reader understand the present invention and the concepts provided by the inventors that contribute to the advancement of the art, and should be construed as not being limited to those specifically described examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention.

Claims

1. A catheter insertion device including a needle and a catheter, The needle includes a distal end, a proximal end, and an elongate body extending between the distal and proximal ends, the distal end including: a distal tip; a first bevel surface extending proximally from the distal tip; a second bevel surface extending proximally from the distal tip; and a third bevel surface extending proximally from the distal tip; and Including, the first bevel surface converges with the second bevel surface to form a first incisal edge, the second bevel surface converges with the third bevel surface to form a second incisal edge, and the third bevel surface converges with the first bevel surface to form a third incisal edge; the first incisal edge is offset from the second incisal edge by approximately 120 degrees, the second incisal edge is offset from the third incisal edge by approximately 120 degrees, the third incisal edge is offset from the first incisal edge by approximately 120 degrees; the catheter includes a distal end, a proximal end, and a lumen extending through the distal end of the catheter and through the proximal end of the catheter; the needle extends through the catheter; The periphery of the first bevel surface includes a first incisal edge, a third incisal edge, and a first proximal edge extending between the first and third incisal edges, the periphery of the second bevel surface includes a first incisal edge, a second incisal edge, and a second proximal edge extending between the first and second incisal edges, and the periphery of the third bevel surface includes a second incisal edge, a third incisal edge, and a third proximal edge extending between the second and third incisal edges, and A first portion of the elongate body disposed between the first proximal edge and the second proximal edge is chamfered, a second portion of the elongate body disposed between the second proximal edge and the third proximal edge is chamfered, or a third portion of the elongate body disposed between the third proximal edge and the first proximal edge is chamfered. A catheter insertion device.

2. the needle further comprises an outflow groove; the outflow groove includes a distal end proximate the first beveled surface, the second beveled surface, or the third beveled surface; The outflow channel further includes a proximal end disposed adjacent the distal end of the catheter.

2. The catheter insertion device according to claim 1.

3. the needle includes a lumen extending through a proximal end of the needle; The first bevel surface, the second bevel surface, or the third bevel surface includes a hole in fluid communication with the lumen of the needle.

2. The catheter insertion device according to claim 1.

4. 2. The catheter insertion device of claim 1, wherein a length of a first bevel surface from the distal tip to an apex of a first proximal edge is equal to a length of a second bevel surface from the distal tip to an apex of a second proximal edge, and a length of a third bevel surface from the distal tip to an apex of a third proximal edge.

5. 2. The catheter insertion device of claim 1, wherein the perimeter of the first bevel surface, the perimeter of the second bevel surface, and the perimeter of the third bevel surface are equal.

6. 2. The catheter insertion device of claim 1, wherein a length of a first bevel surface from the distal tip to an apex of a first proximal edge is greater than a length of a second bevel surface from the distal tip to an apex of a second proximal edge.

7. 2. The catheter insertion device of claim 1, wherein the first bevel surface, the second bevel surface, and the third bevel surface are each flat.

8. 2. The catheter insertion device of claim 1, wherein the needle is oriented within the catheter such that a first bevel surface, a second bevel surface, or a third bevel surface faces downward.

9. A needle including a distal end, a proximal end, and an elongate body extending between the distal and proximal ends, The distal end includes: a distal tip; a first bevel surface extending proximally from the distal tip; a second bevel surface extending proximally from the distal tip; and a third bevel surface extending proximally from the distal tip; and Including, the first bevel surface converges with the second bevel surface to form a first incisal edge, the second bevel surface converges with the third bevel surface to form a second incisal edge, and the third bevel surface converges with the first bevel surface to form a third incisal edge; The first incisal edge is offset from the second incisal edge by approximately 120 degrees, the second incisal edge is offset from the third incisal edge by approximately 120 degrees, and the third incisal edge is offset from the first incisal edge by approximately 120 degrees. the periphery of the first bevel surface includes a first incisal edge, a third incisal edge, and a first proximal edge extending between the first and third incisal edges, the periphery of the second bevel surface includes a first incisal edge, a second incisal edge, and a second proximal edge extending between the first and second incisal edges, and the periphery of the third bevel surface includes a second incisal edge, a third incisal edge, and a third proximal edge extending between the second and third incisal edges; A first portion of the elongate body disposed between the first proximal edge and the second proximal edge is chamfered, a second portion of the elongate body disposed between the second proximal edge and the third proximal edge is chamfered, or a third portion of the elongate body disposed between the third proximal edge and the first proximal edge is chamfered. A needle characterized by:

10. 10. The needle of claim 9, which is solid.

11. 11. The needle of claim 10, wherein the needle further comprises an outflow groove extending proximally from the first bevel surface, the second bevel surface, or the third bevel surface.

12. 10. The needle of claim 9, wherein the needle comprises a lumen extending through a proximal end of the needle, and the first bevel surface, the second bevel surface, or the third bevel surface includes a hole in fluid communication with the needle lumen.

13. 10. The needle of claim 9, wherein the perimeter of the first bevel surface, the perimeter of the second bevel surface, and the perimeter of the third bevel surface are equal, and the distal tip is aligned with a central axis of the needle.

14. 10. The needle of claim 9, wherein the perimeter of the first bevel surface, the perimeter of the second bevel surface, and the perimeter of the third bevel surface are not equal, and the distal tip is not aligned with a central axis of the needle.

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