Catheter insertion device and needle

Abstract

The present application relates to a catheter insertion device and needle, the catheter insertion device comprising: a needle comprising a distal end, a proximal end and an elongated body extending therebetween, the distal end comprising: a distal tip; a first beveled surface, a second beveled surface, a third beveled surface extending proximally from the distal tip, the first beveled surface, the second beveled surface, the third beveled surface converging in pairs to form a first cutting edge, a second cutting edge and a third cutting edge, respectively, mutually offset by about 120 degrees; the device further comprising a catheter comprising a distal end, a proximal end and a lumen extending through the distal end of the catheter and the proximal end of the catheter, the needle extending through the catheter. By means of the technical solution of the present application, the discomfort and pain of the patient when placing the catheter and needle is minimized and the damage or injury to the vein is reduced, and the accelerated coagulation, thrombosis and other health problems caused by the damage to the vein during the insertion and placement of the catheter are eliminated.

Description

Background Technology

[0001] Catheters are commonly used for parenteral nutrition, intravenous fluid resuscitation, and the administration of analgesics and antibiotics. They are also used for blood aspiration. Catheters can be inserted bedside using aseptic techniques and can remain in place for several weeks.

[0002] The most common type of catheter is the over-the-needle catheter. As the name suggests, an over-the-needle catheter is attached to a guide needle with a sharp, distal tip. The sharp distal tip can be used to puncture the patient's skin and veins. The over-the-needle catheter can be inserted into the vein after the guide needle has punctured it. The guide needle typically has a sharp distal tip to puncture the patient's skin and veins with minimal resistance, minimizing patient pain.

[0003] The guide needle is typically positioned at a steep angle relative to the skin surface and the longitudinal dimension of the vein to be punctured, allowing penetration through the skin and vein walls. The needle and catheter are usually inserted with the bevel of the guide needle facing away from the patient's skin. After the tip of the guide needle punctures the wall, the insertion angle is lowered to allow the guide needle and catheter to slide a sufficient distance into the vein for proper placement of the catheter. Once the guide needle placement in the vein has been confirmed, the user can temporarily block flow in the vein and withdraw the guide needle, leaving the catheter in place for future fluid infusion and / or blood aspiration.

[0004] Inserting and properly placing a catheter on the first attempt often requires a level of skill that some users do not possess. Accurate placement of the catheter in a vein on the first attempt is a significant advantage, thereby reducing the risk of damage to the vein and / or surrounding tissues. Proper catheter placement and minimizing patient discomfort and pain, as well as reducing damage or injury to the vein, are important. Damage to the vein during catheter insertion and placement can lead to accelerated clotting, thrombosis, and other health problems.

[0005] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely as an example technical field in which certain implementations described herein can be practiced. Summary of the Invention

[0006] This disclosure generally relates to vascular access systems, devices, and methods. More particularly, in some embodiments, this disclosure relates to needles and related devices, systems, and methods.

[0007] In some embodiments, the needle may include a guide needle. In some embodiments, the geometry of the needle tip may reduce the risk of puncturing a patient's vein when inserting the needle into the patient's vein. In some embodiments, the geometry of the needle tip may provide more reliable placement of the catheter within the vein. In some embodiments, the needle may be used to insert a guidewire into the patient to advance the catheter.

[0008] In some embodiments, the needle may include a distal end, a proximal end, and an elongated 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 oblique surface extending proximally from the distal tip, a second oblique surface extending proximally from the distal tip, and a third oblique 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 veins.

[0009] In some embodiments, the first beveled surface may converge with the second beveled surface to form a first cutting edge. In some embodiments, the second beveled surface may converge with the third beveled surface to form a second cutting edge. In some embodiments, the third beveled surface may converge with the first beveled surface to form a third cutting edge. In some embodiments, the first cutting edge may deviate from the second cutting edge by approximately 120 degrees. In some embodiments, the second cutting edge may deviate from the third cutting edge by approximately 120 degrees. In some embodiments, the third cutting edge may deviate from the first cutting edge by approximately 120 degrees.

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

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

[0012] In some embodiments, the periphery of the first beveled surface may include the first cutting edge, the third cutting edge, and a first proximal edge. In some embodiments, the first proximal edge may extend between the first cutting edge and the third cutting edge. In some embodiments, the periphery of the second beveled surface may include the first cutting edge, the second cutting edge, and a second proximal edge. In some embodiments, the second proximal edge may extend between the first cutting edge and the second cutting edge. In some embodiments, the periphery of the third beveled surface may include the second cutting edge, the third cutting edge, and a third proximal edge. In some embodiments, the third proximal edge may extend between the second cutting edge and the third cutting edge.

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

[0014] In some embodiments, the distal end of the needle may be symmetrical. In some embodiments, the peripheries of the first beveled surface, the second beveled surface, and the third beveled surface may be identical. 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 beveled surface from the distal tip to the vertex of the first proximal edge may be equal to the length of the second beveled surface from the distal tip to the vertex of the second proximal edge, and this length may be equal to the length of the third beveled surface from the distal tip to the vertex of the third proximal edge. In some embodiments, the length of the first beveled surface from the proximal end of the first cutting edge to the proximal end of the third cutting edge may be equal to the length of the second beveled surface from the proximal end of the first cutting edge to the proximal end of the second cutting edge, and this length may be equal to the length of the third beveled surface from the proximal end of the second cutting edge to the proximal end of the third cutting edge.

[0015] In some embodiments, the distal end of the needle may be asymmetrical. In some embodiments, one or more of the first periphery, the second periphery, and the third periphery may be different from each other. 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 beveled surface from the distal tip to the vertex of the first proximal edge may be greater than the length of the second beveled surface from the distal tip to the vertex of the second proximal edge and / or the length of the third beveled surface from the distal tip to the vertex of the third proximal edge. In some embodiments, the length of the second beveled surface from the distal tip to the vertex of the second proximal edge may be greater than the length of the first beveled surface from the distal tip to the vertex of the first proximal edge and / or the length of the third beveled surface from the distal tip to the vertex of the third proximal edge. In some embodiments, the length of the third beveled surface from the distal tip to the vertex of the third proximal edge may be greater than the length of the second beveled surface from the distal tip to the vertex of the second proximal edge and / or the length of the first beveled surface from the distal tip to the vertex of the first proximal edge.

[0016] In some embodiments, the needle may extend through a catheter inserted into the catheter insertion device; however, it is contemplated that the needle may be used with non-catheter medical devices and / or for any medical purpose, including as a spinal puncture needle. In some embodiments, the catheter may comprise a peripheral venous 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 and proximal ends of the catheter. In some embodiments, each of the flash channels may include a distal end adjacent to the first, second, or third beveled surface. In some embodiments, each flash channel may include a proximal end disposed proximal to the distal end of the catheter. In some embodiments, the flash channels may be in fluid communication with the lumen of the catheter. In some embodiments, blood traveling through the flash channels and into the lumen of the catheter may be visible to the user.

[0018] In some embodiments, one or more of the first, second, and third oblique cut surfaces may be generally planar. In some embodiments, the needle may be oriented within the catheter such that the first, second, or third oblique cut surfaces face downwards or toward the vein, opposite the point of needle entry into the vein. In these embodiments, a specific cut edge facing the tip of the catheter may be aligned with the central axis of the catheter insertion device. In some embodiments, the risk of vein puncture may be reduced when the needle is inserted into the vein with a specific oblique cut surface facing downwards.

[0019] In some embodiments, the geometry of the needle tip can be used on 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 geometry of the needle tip can also be used in other procedures, such as those desiring to reduce needle bending caused by a long beveled needle. In some embodiments, the needle can be used to introduce and / or aspirate fluid from a patient. In some embodiments, the geometry of the needle tip can be used to aspirate blood, cerebrospinal fluid, or other fluids from a patient.

[0020] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, 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 these embodiments may be combined, other embodiments may be utilized, and 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 should not be construed as limiting. Attached Figure Description

[0021] Exemplary embodiments will be described and explained in further detail with reference to the accompanying drawings, wherein:

[0022] Figure 1A This is a top perspective view of an exemplary needle according to certain embodiments;

[0023] Figure 1B for Figure 1A A perspective view of the lower part of a needle according to certain embodiments;

[0024] Figure 1C for Figure 1A A side view of a needle according to certain embodiments;

[0025] Figure 1D for Figure 1A A reverse side view of a needle according to certain embodiments;

[0026] Figure 1Efor Figure 1A A perspective view of a needle from its distal end according to certain embodiments;

[0027] Figure 1F for Figure 1A A perspective view of the upper part of a needle according to certain embodiments, showing the needle in comparison with another needle;

[0028] Figure 1G for Figure 1A A perspective view of the upper part of a needle inserted into a vein according to certain embodiments, showing the needle in comparison with another needle;

[0029] Figure 2A for Figure 1A A perspective view of the upper part of a needle according to certain embodiments, which shows an exemplary flash groove;

[0030] Figure 2B for Figure 1A A side view of a needle according to certain embodiments, which shows multiple flash channels;

[0031] Figure 2C for Figure 1A A perspective view of a needle according to certain embodiments, viewed from the distal end of the needle, showing a plurality of flash grooves;

[0032] Figure 3A for Figure 1A A top view of a needle according to certain embodiments, showing an exemplary chamfered portion;

[0033] Figure 3B for Figure 1A A perspective view of a needle according to certain embodiments, viewed from the distal end of the needle, showing multiple chamfered portions;

[0034] Figure 4A for Figure 1A A perspective view of the upper part of a needle according to certain embodiments, showing an exemplary hole;

[0035] Figure 4B for Figure 1A A perspective view of the upper part of a needle inserted through an exemplary conduit according to certain embodiments;

[0036] Figure 5 for Figure 1A A top view of a needle inserted through the conduit according to certain embodiments, showing an exemplary notch;

[0037] Figure 6A for Figure 1A A perspective view of the upper part of a needle according to certain embodiments, showing an asymmetrical distal end;

[0038] Figure 6B for Figure 1A A perspective view of the upper part of the needle according to certain embodiments, which shows another asymmetrical distal end;

[0039] Figure 7A An exploded view of an exemplary catheter assembly according to certain embodiments;

[0040] Figure 7B This is a partial cross-sectional view of a catheter assembly according to certain embodiments;

[0041] Figure 7C This is a top perspective view of a catheter assembly according to certain embodiments, which illustrates an exemplary blood flashback;

[0042] Figure 7D A top perspective view of another catheter assembly according to certain embodiments;

[0043] Figure 7E A cross-sectional view of another catheter assembly according to certain embodiments;

[0044] Figure 8A This is a top view of a needle according to some embodiments, showing two beveled surfaces;

[0045] Figure 8B This is a bottom view of a needle according to certain embodiments, showing two beveled surfaces;

[0046] Figure 8C A side view of a needle according to some embodiments, showing two beveled surfaces;

[0047] Figure 8D A perspective view of a needle from its distal end according to certain embodiments, showing two beveled surfaces;

[0048] Figure 9A A side view of a needle according to certain embodiments, showing four beveled surfaces; and

[0049] Figure 9B This is a perspective view of a needle from the distal end according to certain embodiments, showing four beveled surfaces. Detailed Implementation

[0050] When used in this disclosure, the term "distal" refers to the portion of the pointer or catheter assembly or its components that is farther from the user, and the term "proximal" refers to the portion of the pointer or catheter assembly or its components that is closer to the user. When used in this disclosure, the term "user" may refer to a clinician, physician, nurse, or any other care provider, and may include assistants.

[0051] Now for reference Figure 1A-1EIn some embodiments, the needle 10 may include a guide needle. In some embodiments, the needle 10 may include a distal end 12, a proximal end, and an elongated body 14 extending between the distal end 12 and the proximal end. In some embodiments, the elongated body 14 may be generally cylindrical (which can prevent snagging), or another suitable shape. In some embodiments, the distal end 12 may be generally symmetrical, for example, as shown in the figure. Figure 1A-1E As shown in the image.

[0052] In some embodiments, the distal end 12 of the needle 10 may include a distal tip 16, a first oblique surface 18 extending proximally from the distal tip 16, a second oblique surface 20 extending proximally from the distal tip 16, and a third oblique 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 veins. In some embodiments, the distal tip 16 may be radially inwardly disposed from the outer surface of the elongated body 14.

[0053] In some embodiments, the first beveled surface 18 may converge with the second beveled surface 20 to form a first cutting edge 24. In some embodiments, the second beveled surface 20 may converge with the third beveled surface 22 to form a second cutting edge 26. In some embodiments, the third beveled surface 22 may converge with the first beveled surface 18 to form a third cutting edge 28. In some embodiments, one or more of the first beveled surface 18, the second beveled surface 20, and the second beveled surface 22 may be symmetrical. In some embodiments, two of the first beveled surface 18, the second beveled surface 20, and the third beveled surface 22 may be opposite bevels.

[0054] like Figure 1E As shown, in some embodiments, the first cutting edge 24 may deviate from the second cutting edge 26 by approximately 120 degrees. In some embodiments, the second cutting edge 26 may deviate from the third cutting edge 28 by approximately 120 degrees. In some embodiments, the third cutting edge 28 may deviate from the first cutting edge 24 by approximately 120 degrees. In some embodiments, the first cutting edge 24, the second cutting edge 26, and the third cutting edge 28 may divide the outer circumference of the elongated body 14 into three equal parts, each part may have the same shape or a different shape.

[0055] In some embodiments, the periphery of the first beveled surface 18 may include a first cutting edge 24, a third cutting edge 28, and a first proximal edge 30. In some embodiments, the periphery of the first beveled surface 18 may include no more than the first cutting edge 24, the third cutting edge 28, and the first proximal edge 30. In some embodiments, the first proximal edge 30 may extend between the first cutting edge 24 and the third cutting edge 28.

[0056] In some embodiments, the periphery of the second beveled surface 20 may include a first cutting edge 24, a second cutting edge 26, and a second proximal edge 32. In some embodiments, the periphery of the second beveled surface 20 may include no more than the first cutting edge 24, the second cutting edge 26, and the second proximal edge 32. In some embodiments, the second proximal edge 32 may extend between the first cutting edge 24 and the second cutting edge 26.

[0057] In some embodiments, the periphery of the third beveled surface 22 may include a second cutting edge 26, a third cutting edge 28, and a third proximal edge 34. In some embodiments, the periphery of the third beveled surface 22 may include no more than the second cutting edge 26, the third cutting edge 28, and the third proximal edge 34. In some embodiments, the third proximal edge 34 may extend between the second cutting edge 26 and the third cutting edge 28.

[0058] In some embodiments, the first cutting edge 24, the second cutting edge 26, and the third cutting edge 28 may be straight or linear. In some embodiments, the first cutting edge 24, the second cutting edge 26, and the third cutting edge 28 may intersect at the distal tip 16. In some embodiments, one or more of the following may be generally proximal edge shaped: the first proximal edge 30, the second proximal edge 32, or the third proximal edge 34. In some embodiments, one or more of the following may include arcuate shapes: the first proximal edge 30, the second proximal edge 32, and the third proximal edge 34, which may facilitate smooth entry of the needle 10 through the skin and veins. In some embodiments, one or more of the following may be straight or linear: the first proximal edge 30, the second proximal edge 32, and the third proximal edge 34.

[0059] In some embodiments, one or more of the periphery of the first beveled surface, the periphery of the second beveled surface, and the periphery of the third beveled surface may be identical. In some embodiments, one or more of the first beveled surface 18, the second beveled surface 20, and the third beveled surface 22 may have the same shape or profile, for example, as shown in the figure. Figure 1A-1E As shown in the diagram. 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 beveled surface 18, the second beveled surface 20, and the third beveled surface 22 may be identical.

[0060] In some embodiments, the length 38 of the first beveled surface 18 from its distal tip to the vertex of the first proximal edge 30 may be equal to the length 40 of the second beveled surface 20 from its distal tip 16 to the vertex of the second proximal edge 32, and the length 40 may be equal to the length 42 of the third beveled surface 22 from its distal tip 16 to the vertex of the third proximal edge 34. In some embodiments, the length 44 of the first beveled surface 18 from the proximal end of the first cutting edge 24 to the proximal end of the third cutting edge 28 may be equal to the length 46 of the second beveled surface 20 from the proximal end of the first cutting edge 24 to the proximal end of the second cutting edge 26, and the length 46 may be equal to the length 48 of the third beveled surface 22 from the proximal end of the second cutting edge 26 to the proximal end of the third cutting edge 28.

[0061] In some embodiments, the symmetrical nature of the distal end 12 can assist the user, who may lack experience in orienting the needle for insertion into the patient. In some embodiments, the needle 10 may be solid. In some embodiments, the needle 10 may be constructed of metal, steel, or another suitable material. In some embodiments, the needle 10 may be integrally formed as a single unit. In some embodiments, the distal tip 16 may not include an opening aligned with the central axis 36 of the needle 10. In some embodiments, the distal tip 16 may be closed and may not allow fluid flow through it.

[0062] Now for reference Figure 1F-1G In some embodiments, the lengths 38 of the first beveled surface 18, 40 of the second beveled surface 20, and 46 of the second beveled surface 20 may be shorter than the length of the bevel of the other needle 52, which is shown in dashed lines for dimensional comparison. The other needle 52 may correspond to an ISO 10555 standard needle, which, as is known in the art, may include a reverse-grinding tip geometry or a B-bevel tip geometry. The other needle 52 may include an opening 53 along its central axis.

[0063] In some embodiments, the lengths 38 of the first beveled surface 18, 40 of the second beveled surface 20, and 46 of the second beveled surface 20 may be approximately half the length of the bevel of the other needle 52 or less. In some embodiments, the lengths 38 of the first beveled surface 18, 40 of the second beveled surface 20, and 46 of the second beveled 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 point of entry of the needle 10 into the vein 49. In some embodiments, because the lengths 38 of the first beveled surface 18, 40 of the second beveled surface 20, and 46 of the second beveled surface 20 may be approximately half the length of the bevel of the other needle 52, the distal tip 16 may be twice the distance from the inner surface of the wall of the vein 49 opposite the point of entry as the distal end 54 of the catheter 50 penetrates the vein 49.

[0064] In some embodiments, the distal end 12 of the needle 10 may be configured for difficult vascular access (where the vein has a small diameter) without damaging or puncturing the vein. In some embodiments, the distance 55 between the uppermost surface of the distal end 54 of the catheter 50 and the lowermost surface of the distal end 12 of the needle 10 may be at most half the distance between the uppermost surface of the distal end 54 of the catheter 50 and the lowermost surface of the distal end of the other needle 52. In some embodiments, when the needle 10 is a 20 gauge and configured for use with an 18 gauge catheter inserted at an insertion angle of 20 to 30 degrees, the distance 55 between the uppermost surface of the distal end 54 of the catheter 50 and the lowermost surface of the distal end 12 of the needle 10 may be approximately 1.1 mm or between 1.0 mm and 1.2 mm. In some embodiments, the distance 55 between the uppermost surface of the distal end 54 of the catheter 50 and the lowermost surface of the distal end 12 of the needle 10 may be within three (3) standard deviations of the normal distribution of human vein diameter.

[0065] Conversely, the bevel of the other needle 52 may be long enough to make it difficult for the user to insert the distal end 54 of the catheter 50 into the vein 49 without damaging or puncturing it. Puncture may occur when the needle enters the top of the vein 49 and then also punctures the bottom of the vein 49. Damage to the vein 49 (including puncture of the vein 49) may accelerate clotting and thrombosis. In some embodiments, as described, the geometry of the needle tip of the needle 10 may reduce the risk of puncturing the patient's vein 49 when 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.

[0066] In some embodiments, when the other needle 52 is inserted through the skin and into the vein 49, the bevel of the other needle 52 may cause it to descend or subside at a steeper insertion angle. The user can compensate for the steeper insertion angle by guessing how much to reduce it. In some embodiments, the distal end 12 of the needle 10 may be symmetrical, which can provide zero descent when the needle 10 is inserted into the patient.

[0067] In some embodiments, one or more of the first oblique surface 18, the second oblique surface 20, and the third oblique surface 22 may be generally planar. In some embodiments, the needle 10 may be oriented within the conduit 50 such that the first oblique surface 18, the second oblique surface 20, or the third oblique surface 22 faces downward or toward the inner wall of the vein 49 opposite to the point where the needle 10 enters the vein 49, which may reduce the risk of puncturing the vein 49. Further, in some embodiments, the use of the needle 10 may create an incision or slit in the skin and the vein 49, the incision or slit having the same or similar dimensions as an incision or slit formed by the other needle 52.

[0068] Now for reference Figure 2A-2C In some embodiments, the needle 10 may include one or more flash channels 56. In some embodiments, the flash channels 56 may extend proximally from one or more of the first chamfered surface 18, the second chamfered surface 20, and the third chamfered surface 22. In some embodiments, the flash channels 56 may provide blood flashback channel features. In some embodiments, in response to the needle 10 penetrating the vein 49, blood can travel through the flash channels 56 to the catheter 50 (e.g., in…). Figure 1G (as shown in the diagram) the inner surface of the needle 10 and / or to another location or device, where the user can visualize blood as an indication of the placement of the needle 10 within a vein.

[0069] Now for reference Figures 3A-3B In some embodiments, the first portion 58 of the elongated body 14, located between the first proximal edge 30 and the second proximal edge 32, may be chamfered. In some embodiments, the second portion 60 of the elongated body 14, located between the second proximal edge 32 and the third proximal edge 34, may be chamfered. In some embodiments, the third portion 62 of the elongated body 14, located between the third proximal edge 34 and the first proximal edge 30, is chamfered. In some embodiments, chamfering or rounding the first portion 58, the second portion 60, and the third portion 62 can prevent accidental abrasion of the inner wall of the vein opposite the point where the needle 10 enters the vein.

[0070] Now for reference Figures 4A-4BIn some embodiments, the needle 10 may include a lumen 64 extending through the proximal end 65 of the needle 10 via an opening, notch, etc. (see, for example, see...) Figure 7E In some embodiments, one or more of the first beveled surface 18, the second beveled surface 20, or the third beveled 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 may be 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 16 may be closed except for the holes 66 and may not allow fluid flow through it except for the holes 66. In some embodiments, the holes 66 may be off-center from the central axis 36.

[0071] Now for reference Figure 5 In some embodiments, the needle 10 may include an opening, such as a notch 70, to provide a flashback of blood as the needle 10 penetrates a vein, providing an indication that the distal tip 16 is positioned within the vein. In some embodiments, in response to the needle 10 penetrating the vein 49, blood may travel proximally through the orifice 66, into the lumen 64 of the needle 10, and exit the notch 70 to travel to the inner surface of the catheter 50 and / or to another location or device, where the user can visualize the blood as an indication of the placement of the needle 10 within the vein.

[0072] In some embodiments, each of the flash channels 56 may include a distal end 71 adjacent to the first chamfered surface 18, the second chamfered surface 20, or the third chamfered surface 22. In some embodiments, the distal end 71 may intersect with a specific vertex of a particular proximal edge. In some embodiments, each of the flash channels 56 may include a proximal end 73 disposed proximal to the distal end 54 of the catheter 50. In some embodiments, the flash channels 56 may be in fluid communication with the lumen of the catheter 50. In some embodiments, blood traveling through the flash channels 56 and into the lumen of the catheter 50 may be visible to the user.

[0073] like Figure 5 As shown, in some embodiments, the needle 10 within the catheter 50 may be oriented such that the first oblique surface 18, the second oblique surface 20, or the third oblique surface 22 faces downward or toward the inner wall of the vein 49 opposite the point where the needle 10 enters the vein 49, which can reduce the risk of puncturing the vein 49. In these embodiments, the notch 70 may be positioned facing the top of the catheter 50 and is generally oriented opposite to the first oblique surface 18, the second oblique surface 20, or the third oblique surface 22, which may face downward.

[0074] Now for reference Figures 6A-6B In some embodiments, the distal end 12 of the needle 10 may be asymmetrical. In some embodiments, one or more of the first periphery, second periphery, and third periphery may be different from each other. In these and other embodiments, the distal tip 16 may not be aligned with the central axis 36 of the needle 10.

[0075] In some embodiments, the length 38 of the first beveled surface 18 from its distal tip to the vertex of the first proximal edge 30 may be greater than the length 40 of the second beveled surface 20 from its distal tip 16 to the vertex of the second proximal edge 32 and / or the length 42 of the third beveled surface 22 from its distal tip 16 to the vertex of the third proximal edge. In some embodiments, the length 40 of the second beveled surface 20 from its distal tip 16 to the vertex of the second proximal edge 32 may be greater than the length 38 of the first beveled surface 18 from its distal tip 16 to the vertex of the first proximal edge 30 and / or the length of the third beveled surface 22 from its distal tip 16 to the vertex of the third proximal edge 34. In some embodiments, the length 42 of the third beveled surface 22 from the distal tip 16 to the vertex of the third proximal edge 34 may be greater than the length 40 of the second beveled surface 20 from the distal tip 16 to the vertex of the second proximal edge 32 and / or the length 38 of the first beveled surface 18 from the distal tip 16 to the vertex of the first proximal edge 30.

[0076] like Figure 6A As shown, in response to the length 38 of the first beveled surface 18 from the distal tip to the vertex of the first proximal edge 30 being less than the length 40 of the second beveled surface 20 from the distal tip 16 to the vertex of the second proximal edge 32 and / or the length 42 of the third beveled surface 22 from the distal tip 16 to the vertex of the third proximal edge, the distal tip 16 may be offset from the central axis 36. Figure 6B As shown, in response to the length 38 of the first beveled surface 18 from the distal tip to the vertex of the first proximal edge 30 being greater than the length 40 of the second beveled surface 20 from the distal tip 16 to the vertex of the second proximal edge 32 and / or the length 42 of the third beveled surface 22 from the distal tip 16 to the vertex of the third proximal edge, the distal tip 16 may be deviated from the central axis 36.

[0077] Now for reference Figures 7A-7D This illustrates exemplary blood flashback features in a catheter insertion device including an exemplary catheter assembly 72 according to certain embodiments. In some embodiments, a needle 10 may be used in the catheter assembly 72. It should be understood that, according to certain embodiments, the needle 10 can be used with any catheter assembly.

[0078] In some embodiments, catheter assembly 72 may comprise a straight or non-integrated catheter assembly. In some embodiments, catheter assembly 72 may comprise an integrated catheter assembly. More specifically, in some embodiments, the catheter connector 74 of catheter assembly 72 may comprise an integrated extension tube, such as BD NEXIVA. TM Closed intravenous catheter system, BD NEXIVA TM DIFFUSICS TM Closed intravenous catheter system, or Becton Dickinson PEGASUS TM Safe closed-loop intravenous catheter system.

[0079] In some embodiments, the catheter connector 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 secured to the catheter connector 74 and may extend distally from the catheter connector 74. In some embodiments, the catheter 50 may be held in place within the catheter connector 74 via a wedge 87 or another suitable device. In some embodiments, the catheter 50 may include a peripheral venous catheter (PIVC), a midline catheter, or a peripherally inserted central catheter (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 54 and the proximal end 84 of the catheter 50.

[0080] In some embodiments, the catheter assembly 72 may include a needle hub 88, in which the proximal end 65 of the needle 10 may be secured. In some embodiments, when the catheter assembly 72 is in the 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 removed from the catheter connector 74, leaving the catheter 50 in the vein when the needle 10 is discarded. In some embodiments, a diaphragm 91 and / or a diaphragm actuator 92 may be disposed within the lumen 80 of the catheter connector 74.

[0081] Flashback provides visibility of the blood, confirming that the distal tip 16 has entered the vein. In some embodiments, this occurs as blood travels through the flash groove 56 (e.g., see...). Figure 2A-2C And as it travels into the space between the needle 10 and the guide tube 50, a flashback can be seen through the guide tube 50. This flashback may be referred to as a "quickflash". Alternatively, in some embodiments, it can be seen exiting the slot 70 (e.g., see...). Figure 5And a flashback enters the space between the needle 10 and the catheter 50. This can be referred to as an "instaflash". Alternatively, in some embodiments, the flashback can be seen in a flash chamber, which may be located in another suitable location within the needle holder 88 or the catheter assembly 72.

[0082] In some embodiments, the needle 10 can be used with non-catheter medical devices and / or for any medical purpose, including as a spinal puncture needle. In some embodiments, the needle 10 can also be used in other procedures, such as those desiring to reduce needle bending caused by a long bevel needle. In some embodiments, the needle 10 can be used to introduce fluid and / or aspirate fluid from a patient. In some embodiments, the needle 10 can be used to aspirate blood, cerebrospinal fluid, or other fluids from a patient.

[0083] Now for reference Figures 7D-7E This illustrates another catheter assembly 94, which can be used with needle 10 according to certain embodiments. In some embodiments, catheter assembly 94 may include or correspond to catheter assembly 72. Figure 7E As shown, in some embodiments, the flash chamber may be disposed within the needle holder 88, which may be vented. In some embodiments, the needle 10 may be solid. In other embodiments, the hole 66 (e.g., see...) Figures 4A-4B It can provide access to the lumen 64 of the needle 10.

[0084] In some embodiments, the needle 10 can be used with various technologies. For example, in some embodiments, the distal tip 16 can be magnetic or magnetized and can allow ultrasound guidance and interaction with an ultrasound system to track the position of the distal tip 16.

[0085] In some embodiments, needle 10 may include one or more features further described in U.S. Patent Application No. 15 / 286,223, filed October 5, 2016, entitled "Compliant Catheter Adapter Having Self-Slitting Needle," which is incorporated herein by reference in its entirety. In some embodiments, needle 10 may include one or more features further described in U.S. Patent Application No. 15 / 286,162, filed October 5, 2016, entitled "Integrated Catheter with Independent Fluid Paths," which is incorporated herein by reference in its entirety.

[0086] In some embodiments, the needle 10 may be used with a catheter having an asymmetrical tip, as further described, for example, in U.S. Patent Application No. 15 / 286,261, filed October 5, 2016, entitled “Catheter with an Asymmetric Tip,” which is incorporated herein by reference in its entirety. In some embodiments, the needle 10 may be used with a strain relief feature, as described, for example, in U.S. Patent Application No. 15 / 285,601, filed October 5, 2016, entitled “Catheter Adapter with Distal Inner Diameter Diameter Curvature Providing Kink Resistance,” which is incorporated herein by reference in its entirety.

[0087] Now for reference Figures 8A-8D In some embodiments, many of the beveled surfaces can vary. For example, as... Figures 8A-8D As shown, the needle 10 may include two beveled surfaces, a first beveled surface 18 and a second beveled 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 each other by approximately 180 degrees. As previously described, in some embodiments, the first beveled surface 18 and the second beveled surface 20 may have the same shape or profile. In some embodiments, the distal end 12 may be symmetrical. In other embodiments, the distal end 12 may be asymmetrical. For example, as described above, the length 38 of the first beveled surface 18 from the distal tip to the vertex of the first proximal edge 30 may be greater than the length 40 of the second beveled surface 20 from the distal tip 16 to the vertex of the second proximal edge 32. In some embodiments, the first beveled surface 18 and / or the second beveled surface 20 may include a specific hole 66.

[0088] Now for reference Figures 9A-9B In some embodiments, the needle 10 may include more than three beveled surfaces. For example, as... Figures 9A-9B As shown, the needle 10 may include four beveled surfaces and four cutting edges, which may converge at the distal tip 16. According to some embodiments, Figure 9BA fourth beveled surface 96 is shown. In some embodiments, the four beveled surfaces may be offset from each other by approximately 90 degrees. As another example, the needle 10 may comprise five beveled surfaces and five cutting edges that converge at the distal tip 16. In some embodiments, the five beveled surfaces may be offset from each other by approximately 72 degrees. As yet another example, the needle 10 may comprise six beveled surfaces and six cutting edges that converge at the distal tip 16. In some embodiments, the six beveled surfaces may be offset from each other by approximately 60 degrees.

[0089] In some embodiments, the four, five, or six beveled surfaces may have the same shape or profile. In some embodiments, the distal end 12 may be symmetrical. In other embodiments, the distal end 12 may be asymmetrical, for example, in which one of the four, five, or six beveled surfaces is longer than another of the four, five, or six beveled surfaces. In some embodiments, one or more particular beveled surfaces of the four, five, or six beveled surfaces may include a hole 66.

[0090] All examples and conditional language cited herein are intended for pedagogical purposes to aid the reader's understanding of the invention and the inventors' ideas for advancing the field, and should be construed as not being limited to such specifically cited examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and alternatives may be made thereto without departing from the spirit and scope of the invention.

Claims

1. A catheter insertion device, comprising: A needle, the needle including a distal end, a proximal end, and an elongated body extending between the distal end and the proximal end, wherein the distal end includes: distal tip; A first oblique surface extending from the distal tip toward the proximal side; A second oblique surface extending from the distal tip toward the proximal side; and A third oblique cut surface extending from the distal tip towards the proximal side, The first and second beveled surfaces converge to form a first cutting edge, the second and third beveled surfaces converge to form a second cutting edge, and the third and first beveled surfaces converge to form a third cutting edge. Wherein the first cutting edge deviates from the second cutting edge by approximately 120 degrees, wherein the second cutting edge deviates from the third cutting edge by approximately 120 degrees, wherein the third cutting edge deviates from the first cutting edge by approximately 120 degrees; and A catheter, the catheter including a distal end, a proximal end, and a lumen extending through the distal end and the proximal end of the catheter, wherein the needle extends through the catheter; Wherein, the periphery of the first beveled surface includes the first cutting edge, the third cutting edge, and a first proximal edge extending between the first cutting edge and the third cutting edge; wherein the periphery of the second beveled surface includes the first cutting edge, the second cutting edge, and a second proximal edge extending between the first cutting edge and the second cutting edge; and wherein the periphery of the third beveled surface includes the second cutting edge, the third cutting edge, and a third proximal edge extending between the second cutting edge and the third cutting edge. Wherein, the first portion of the elongated body disposed between the first proximal edge and the second proximal edge is chamfered, the second portion of the elongated body disposed between the second proximal edge and the third proximal edge is chamfered, or the third portion of the elongated body disposed between the third proximal edge and the first proximal edge is chamfered; Wherein, the first beveled surface has a length from the distal tip to the vertex of the first proximal edge; the second beveled surface has a length from the distal tip to the vertex of the second proximal edge; and the third beveled surface has a length from the distal tip to the vertex of the third proximal edge. Wherein, the length of the first beveled surface, the length of the second beveled surface, and the length of the second beveled surface from the proximal end of the first cutting edge to the proximal end of the second cutting edge are set to be half or less of the length of the bevel of the ISO 10555 standard needle; When the catheter insertion device is used, the distance between the uppermost surface of the distal end of the catheter and the lowermost surface of the distal end of the needle can be at most half the distance between the uppermost surface of the distal end of the catheter and the lowermost surface of the distal end of the ISO 10555 standard needle.

2. The catheter insertion device according to claim 1, characterized in that, The needle includes a flash groove, wherein the flash groove includes a distal end adjacent to the first beveled surface, the second beveled surface, or the third beveled surface, and wherein the flash groove further includes a proximal end disposed near the distal end of the conduit.

3. The catheter insertion device according to claim 1, characterized in that, The needle includes a lumen extending through a proximal end of the needle, wherein the first beveled surface, the second beveled surface, or the third beveled surface includes a hole in fluid communication with the lumen of the needle.

4. The catheter insertion device according to claim 1, characterized in that, The length of the first beveled surface from the distal tip to the vertex of the first proximal edge is equal to the length of the second beveled surface from the distal tip to the vertex of the second proximal edge, and is equal to the length of the third beveled surface from the distal tip to the vertex of the third proximal edge.

5. The catheter insertion device according to claim 1, characterized in that, The periphery of the first beveled surface, the periphery of the second beveled surface, and the periphery of the third beveled surface are the same.

6. The catheter insertion device according to claim 1, characterized in that, The length of the first beveled surface from the distal tip to the vertex of the first proximal edge is greater than the length of the second beveled surface from the distal tip to the vertex of the second proximal edge.

7. The catheter insertion device according to claim 1, characterized in that, The first oblique surface, the second oblique surface, and the third oblique surface are all planar.

8. The catheter insertion device according to claim 1, characterized in that, The needle is oriented within the catheter such that the first oblique surface, the second oblique surface, or the third oblique surface faces downward.

9. The catheter insertion device according to claim 1, characterized in that, The needle is solid.

10. The catheter insertion device according to claim 9, characterized in that, The needle includes a flash groove extending proximally from the first beveled surface, the second beveled surface, or the third beveled surface.

11. The catheter insertion device according to claim 1, characterized in that, The periphery of the first beveled surface, the periphery of the second beveled surface, and the periphery of the third beveled surface are identical, and the distal tip is aligned with the central axis of the needle.

12. The catheter insertion device according to claim 1, characterized in that, The peripheries of the first beveled surface, the second beveled surface, and the third beveled surface are different, and the distal tip is not aligned with the central axis of the needle.

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