Needle and catheter assembly

Abstract

To make it possible to effectively pierce the skin and the vein while reducing the risk of injury or damage to the vein.SOLUTION: A needle has a body having proximal and distal ends, a first longitudinal side surface, and a second longitudinal side surface opposite the first longitudinal side surface. The distal end has a first bevel extending between the first and second longitudinal side surfaces to define a distal tip at the second longitudinal side surface. The second longitudinal side surface of the needle has a notch defining a blood flashback passage between the needle and a catheter. The notch is oriented on a side opposite the first bevel.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] The present invention is in the field of needles, catheter insertion devices, and methods for introducing needles into patients, the needles having a tip with a shape and configuration that aids insertion into a vein or artery and reduces the occurrence of vein or artery transfix caused by passing through or damaging the inner surface of the vein or artery. The present invention is also directed to methods for introducing needles into patients, with improved ease of insertion and positioning of catheter devices into veins to deliver drugs or medications to the patient. In one embodiment, the present invention is directed to a catheter insertion device that can be operated in a manner that improves the efficiency of catheter insertion into a patient while reducing and minimizing the need for repeated attempts at proper placement of the introducer needle and catheter. [Background technology]

[0002] 2. Description of Related Art Catheters are commonly used for parenteral nutrition, IV fluids, and the administration of pain medications and antibiotics. Catheters can be inserted at the bedside using sterile technique and may remain in place for several weeks. Insertion (venipuncture) is performed above and below the antecubital fossa in the cephalic, basilic, or brachial veins. The tip of the catheter is inserted into the vein and allowed to advance to its full length.

[0003] Inserting and properly placing an IV catheter on the first attempt requires a level of skill that some healthcare professionals do not typically possess. Accurate placement of the catheter and intravenous insertion device on the first attempt is a significant advantage for reducing the incidence of injury to the vein and / or surrounding tissue. Proper placement of the catheter and insertion needle is important not only to minimize patient discomfort and pain, but also to reduce injury or damage to the vein. Injury caused to the vein during insertion and placement of an IV catheter can lead to accelerated clotting and thrombosis.

[0004] Some advantages of certain catheters include reduced frequency of repeat venipuncture for laboratory / restart procedures, reduced incidence of catheter-associated infections, longer implant / indwelling periods, improved clinical outcomes, patient satisfaction, and reduced associated costs. Placing the catheter tip in a larger-diameter vein in the upper arm compared with a smaller vein improves drug delivery therapy and hemodilution. Catheters can be used for infusion of contract media at higher flow rates, typically achieved with CV catheters such as PICC applications.

[0005] Certain conventional catheter devices may include an integrated guidewire that is advanced through the needle lumen and into the vein after the needle has accessed the vein. Often, an ultrasound probe or imaging device is used to position the needle at the desired location. The catheter is then advanced over the guidewire and into the vein. The needle and guidewire are then removed and separated from the catheter, leaving it in place within the vein.

[0006] An insertion needle or other insertion device typically requires a sharp tip to pierce a patient's skin and vein with minimal resistance to minimize pain to the patient. The insertion needle is generally positioned at an acute angle relative to the surface of the skin and the longitudinal dimension of the vein being punctured, allowing penetration of the skin and vein wall. After the tip of the insertion needle punctures the wall of the vein, the angle of insertion is reduced to allow the needle and catheter to slide into the vein a sufficient distance to properly position the catheter within the vein. An initial steep angle of insertion can result in the sharp tip of the needle or insertion device piercing or damaging the inner surface of the vein wall opposite the point of entry.

[0007] While conventional devices are generally suitable for their intended uses, there is a continuing need for improved devices and methods incorporating devices for controlling needle or cannula penetration for drug or agent delivery. In particular, there is a need for an insertion device that can effectively pierce the skin and vein while reducing the risk of vein damage or injury. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] International Publication No. 2015 / 161294 [Patent Document 2] U.S. Patent No. 2017 / 0043134 Summary of the Invention

[0009] The present invention is directed to a needle and method for inserting a guidewire and / or catheter, and to an apparatus for placing an IV catheter at a selected location in a patient, that reduces the risk of puncturing the introducer needle through the wall of the vein. The present invention is particularly directed to a method for orienting a needle for a catheter at a selected position and angle relative to the surface of the skin and inserting and placing the catheter or guidewire into a patient's vein or artery. The needle allows the catheter or guidewire to be placed at a selected location with reduced risk of damaging, puncturing, or injuring the vein in the process. The needle can be used with a guidewire for advancing a catheter, such as an IV catheter or PICC catheter, to insert the guidewire into the patient.

[0010] A feature of the present invention is to provide a method of introducing a needle into a patient's vein, the needle having a configuration and orientation effective for puncturing the skin and vein during insertion of a catheter, reducing or minimizing the risk of puncture and damage to the inner surface of the vein caused by puncture. The needle of the present invention is configured and oriented to assist in positioning the needle at an angle relative to the surface of the skin and the longitudinal dimension of the vein during insertion into the vein, reducing the risk of damage to the inner surface of the vein that may be caused by a sharp tip of the needle.

[0011] One feature of the present invention is to provide a needle having a sharp-tipped distal end configured to penetrate the skin and a vein or artery while reducing the occurrence of injury or damage to the vein or artery during insertion. The needle can be a cannula for introducing fluids into a patient or can be used as an insertion needle for a catheter. The needle can be solid or can include a lumen. In embodiments where the needle is an insertion needle for a catheter or guidewire, the needle can include an opening or groove to provide for blood flashback as the needle penetrates the vein or artery.

[0012] The method of the present invention involves introducing a needle into a vein, the needle including a distal tip with a sharp point for piercing the skin and penetrating the patient's vein or artery, and introduced in an orientation that minimizes the risk of puncturing, penetrating, or damaging the inner surface of the vein or artery, and the needle has a configuration such that the needle trajectory promotes flattening of the needle to a lower angle relative to the longitudinal direction of the vein or artery after insertion.

[0013] Also provided is a method for introducing a catheter insertion device having a distal tip configured to penetrate the skin and vein or artery with minimal discomfort to the patient and effectively place the catheter in the vein or artery, where the distal tip easily penetrates the vein or artery at an appropriate angle and contact between the distal tip and the inner surface of the vein or artery opposite the point of penetration by the sharp tip is avoided.

[0014] In one embodiment, the needle includes a body having a longitudinal dimension with a proximal end and a distal end. In one embodiment, the body has a substantially cylindrical shape, which may be solid or hollow, and may provide a lumen or passageway therethrough. The body has a first longitudinal side and a second longitudinal side opposite the first longitudinal side. The second longitudinal side has a beveled surface that converges toward the distal tip. In one embodiment, the needle is oriented at an oblique angle relative to the surface of the patient's skin, such that the beveled surface faces the surface of the patient's skin and is introduced into the patient at an angle that facilitates substantially forward movement of the needle relative to the longitudinal dimension of the vein.

[0015] In one embodiment, an insertion needle of the present invention includes a distal tip configured to penetrate a vein or artery, the distal tip having a curved surface oriented toward the opposite wall of the vein opposite the point of penetration. The needle is inserted into a patient with the curved surface oriented to create contact with the inner surface of the vein or artery rather than with the sharp distal tip, reducing damage to or penetration of the inner surface of the vein or artery during insertion. The curved surface promotes a flattened needle angle, aiding in inserting the needle in a direction substantially parallel to the longitudinal dimension of the vein or artery.

[0016] Various aspects and features of the present invention are accomplished by providing a method for introducing a needle, such as an insertion needle, into a patient, the distal end of the needle having a beveled or beveled surface that converges toward the distal tip. The needle is inserted into the patient with the beveled surface facing the surface of the patient's skin, and upon insertion into a vein, the beveled surface faces the wall of the vein opposite the needle entry point, such that contact between the beveled surface and the inner surface of the vein reduces puncture or damage to the vein by the distal tip of the needle during insertion.

[0017] A further feature of the present invention is a method for introducing a catheter into a patient's vein, comprising: an introducer needle having a body with a longitudinal dimension having a proximal end and a distal end, a first longitudinal side, and a second longitudinal side opposite the first longitudinal side. The second longitudinal side has a distal end with a beveled surface that converges to a distal tip. A catheter is positioned on the introducer needle for insertion into the vein. The introducer needle and catheter puncture the skin and vein during insertion, with the beveled surface facing the skin and vein at a first oblique angle relative to the longitudinal dimension of the vein. The distal tip of the needle is introduced into the vein with the beveled surface facing the inner surface of the vein opposite the point of entry so that the distal tip does not contact the inner surface of the vein or the end of the vessel, and the catheter is positioned within the lumen of the vein. The catheter is then advanced forward beyond the distal tip of the needle and positioned within the vein. In another embodiment, a guidewire can be advanced through the lumen of the needle.

[0018] It will be understood that each of the preferred or optional features of the various embodiments may be combined with other features, and that features described in combination with one or more particular features may be combined with one or more other features of other embodiments.

[0019] These and other features of the present invention will become apparent from the following detailed description of the invention, taken in conjunction with the drawings which disclose various embodiments of the invention.

[0020] The following is a brief description of the drawings. [Brief explanation of the drawings]

[0021] [Figure 1] FIG. 1 is a side perspective view of a standard needle and catheter showing the needle penetrating a patient's skin with the bevel facing away from the patient. [Figure 2] 2 is a side view of the needle of FIG. 1 penetrating the vein and the distal end of the catheter partially positioned within the vein during the insertion step. [Figure 3] FIG. 3 is a side view showing the sharp distal tip puncturing the inner surface of the vein. [Figure 4] FIG. 4 is a side view illustrating needle orientation and needle angle prior to needle penetration into a patient in accordance with an embodiment of the present invention. [Figure 5] FIG. 5 is a side view showing the orientation and initial angle of needle penetration into the patient. [Figure 6] FIG. 6 is a side view showing the needle and catheter of the present invention moving forward within a vein. [Figure 7] FIG. 7 is a side view of the needle and catheter positioned in a vein. [Figure 8] FIG. 8 is a side view of the needle of FIG. 7 showing the catheter advanced over the end of the needle. [Figure 9] FIG. 9 is a perspective view of the needle and catheter showing the flashback notch of the needle. [Figure 10] FIG. 10 is a perspective view of a catheter assembly for introducing a catheter into a patient. [Figure 11] FIG. 11 is an exploded view of the catheter assembly of FIG. [Figure 12] FIG. 12 is a partial cross-sectional view of the catheter assembly. [Figure 13] FIG. 13 is a perspective view of a catheter assembly showing the flashback feature. [Figure 14] Figure 14 is a side view of another embodiment of a needle showing the shape of the needle tip and the orientation for insertion into a patient; and [Figure 15] FIG. 15 is a side view of the needle of FIG. 14 and its orientation during insertion into a patient. DETAILED DESCRIPTION OF THE INVENTION

[0022] A needle, such as a catheter insertion needle or guidewire, is provided for placing a catheter in a patient to deliver a drug or other substance to the patient. As used herein, the terms "needle" and "cannula" can be used interchangeably to refer to a member that may have a sharp or beveled end for insertion into a target injection site. In one embodiment, a needle may be a thin, hollow tubular member. In other embodiments, a needle may be a solid member. As used herein, the "distal" direction is the direction toward the patient and the injection site, and the "proximal" direction is the opposite direction. "Axial" means along or parallel to the longitudinal axis of the needle or other member, and "radial" is the direction perpendicular to the axial direction.

[0023] The present invention relates to methods and devices for introducing a needle, cannula, or guidewire into a patient, which can be used alone to introduce a substance into the patient or can be used in conjunction with a catheter to insert and place the catheter into a patient's vein or artery. In the illustrated embodiment, the needle is used in conjunction with a catheter to place the catheter in a patient's vein, but the needle is not limited to use with catheters. The needle can include a lumen for delivering a substance and providing flashback when the vein or artery is punctured. In other embodiments, the needle can be a solid body with or without flashback capabilities. In further embodiments, the device can be used in conjunction with a guidewire for introducing a catheter into a patient. In the following description, a needle generally refers to a hollow or solid member suitable for placing a catheter or guidewire at a selected location in a patient.

[0024] Referring to the drawings, the needle 10 shown in FIGS. 1 and 2 has a needle body 12 with a first longitudinal side 40 and a second longitudinal side 42, and a lumen 14 extending between a proximal end 16 and a distal end 18. A bevel 20 is formed to provide a major surface at an oblique angle relative to the longitudinal dimension of the body 12, extending from the outer edge of the body distal to the first longitudinal side 40 of the needle body 12, across the diameter of the needle body 12, to the second longitudinal side 42 of the needle body. In the embodiment shown, a single bevel surface 20 is formed and converges to a sharp distal tip 22, where the bevel surface 20 faces outward from the first longitudinal side 40. The bevel surface 20 may be formed at an oblique angle of about 12°-22°, and typically about 15°-17°, relative to the longitudinal axis of the needle. The sharp distal tip 22 is formed on the second longitudinal side 42 in the illustrated embodiment. Bevel surface 20 can be substantially flat, as shown, or convex or concave. In alternative embodiments, second and third reverse bevel surfaces can be formed opposite bevel surface 20. The reverse bevel surfaces can be formed at an angle to one another and converge at bevel surface 20 to form a sharp distal tip. A notch 24 or other opening for providing blood flashback can be provided in the wall of the needle body opposite bevel surface 20 to provide improved visibility of flashback during insertion when bevel surface 20 faces the surface of the skin and vein.

[0025] The needle 10 is typically used with a catheter assembly 112 and includes a blood flashback feature to provide an indication that the distal end of the needle is positioned within a vein. The flashback feature is shown in FIG. 9 , where a lumen extends from the bevel surface 20 through the needle 10 between the needle and the catheter to a location and / or device where blood can be visualized by the practitioner during needle and catheter insertion. The flashback feature may be a notch forming an opening 110 in the sidewall of the needle, shown in FIG. 9 , that allows blood to exit the needle and pass between the catheter 28 and the needle, where it can be visualized by the medical practitioner and provide an indication that the distal tip 22 of the needle has entered the lumen 32 of the vein 26. The catheter is configured such that the distal end of the catheter is constricted at 115 around the distal end of the needle, and a gap or passageway 113 is formed at the base of the constricted end 115 to receive blood passing through the notch, where it is visible to the medical practitioner. In the illustrated embodiment, a notch 110 is formed on the longitudinal side of the needle opposite the bevel surface 20 to improve flashback visibility when the needle bevel is oriented toward the surface of the patient's skin during catheter placement and insertion.

[0026] As shown in Figures 10-13, the catheter assembly 112 includes a needle 10, which functions as an introducer needle, a catheter hub 114, and a needle hub 116. The needle 10 can have a sharp distal end 18 extending through the catheter hub 114. An example of a catheter hub assembly with a blood flashback function is disclosed in International Publication No. WO 2015 / 161294, which is incorporated herein by reference in its entirety. A flexible catheter 28 extends from the distal end of the catheter hub 114 and includes a needle 10 that penetrates the catheter 28. First, the needle 10 is inserted into a patient's vein. The catheter 28 is pushed into the vein, following the needle 10, along with the tab on the catheter hub. After inserting the catheter 28, the needle 10 is removed from the patient's vein and the catheter hub 114, leaving the catheter 28 in the patient. The needle 10 is discarded after being withdrawn from the catheter.

[0027] The catheter hub 114 has a distal end, a proximal end, and an exterior surface. The distal end includes a catheter opening, and the proximal end includes a luer connector opening with a protrusion for coupling with a luer connector. A passageway 117, shown in FIG. 12, allows fluid to pass through the catheter hub 114. The exterior surface of a first longitudinal side 118 of the catheter hub 114 includes one or more protrusions 120, such as thumb or finger tabs, for manually manipulating the catheter hub 114 during insertion into a patient. The protrusions may be thumb tabs that assist a medical professional in holding and manipulating the catheter assembly 112 during use. In the illustrated embodiment, a second longitudinal side 122 opposite the first longitudinal side 118 is substantially flat so that it easily lies against the patient's skin during use without interference from protrusions, tabs, or the like. The catheter hub 114 may be made of a transparent or translucent polymeric material so that fluid flow through the catheter hub can be observed by the user, or it may be made of an opaque material. In the illustrated embodiment, the needle 10 is oriented with the first longitudinal side 40 of the needle 10 facing away from the second longitudinal side 122 of the catheter hub 112, such that the flat bevel 20 faces away from the second longitudinal side 122 when the catheter hub 112 is in use. The sharp distal tip 22 is aligned with the first longitudinal side 118 and the protrusion 120 of the catheter hub 112.

[0028] The flexible catheter 28 extends through the catheter opening and is secured to the catheter hub 114. A pre-slit elastomeric septum 124 is disposed in the passageway to form a fluid-tight seal and selectively admit fluid to or from the flexible catheter 28. The septum selectively allows or blocks fluid flow through the flexible catheter 28.

[0029] The septum 124 includes a plurality of axial flow passages 126 around its circumference. The flow passages 126 have a suitable width and depth to allow blood to enter the open proximal end of the septum 124 at the front of the catheter hub and allow air to escape when the septum 124 is not opened. At the same time, the flow passages 126 are large enough to prevent blood from passing through the septum for a period of time. When the catheter 28 is initially inserted into a patient and the introducer needle 10 is removed, the septum 124 prevents blood from passing through the passage and exiting the distal end. The septum 124 is made of a resilient material, such as silicone rubber. Other resilient materials may be used, and non-resilient materials may be incorporated into the septum 124 as desired.

[0030] An actuator 128 is positioned within the passageway and is axially movable within the passageway to engage and open a slit in the septum 124. The actuator is a substantially tubular member having an internal passageway that allows fluid to flow through the actuator 128 and through the septum 124 when the septum 124 is opened or pierced by the actuator 128.

[0031] FIG. 13 illustrates an exemplary embodiment of a blood flashback feature within the catheter assembly 112. Flashback is the visibility of blood confirming the needle tip's entry into the vein. Primary flashback, indicated by reference numeral 130 in FIG. 13, is seen through the catheter 58 as blood travels to the open end of the hollow needle 10, exits a notch or opening in the needle 10 near the needle tip, and rises through the internal annular space between the needle 10 and the inside of the catheter 28. Secondary flashback 132 is seen within the needle hub / grip 134, which forms the blood control member, as blood exits the back of the needle 10 and enters a flash chamber within the needle hub / grip 134. Air is evacuated by a plug behind the needle hub / grip 132 via a porous membrane or microgrooves. Tertiary flashback 136 is seen within the catheter hub 114 as blood from the primary flashback flows into the catheter hub and is stopped by the blood control septum. A safety mechanism 138, shown in Figure 13, such as a spring clip or other blocking member, is provided to capture the end of the needle to prevent accidental needle sticks and needle reuse. Examples of safety mechanisms and needle protection members are disclosed in U.S. Patent Publication No. 2017 / 0043134, which is incorporated herein by reference in its entirety.

[0032] In the illustrated embodiment, the catheter 28 is disposed within the needle body 12 within the catheter assembly 112, with the distal end 30 of the catheter 28 disposed at the distal end of the needle body 12. The distal end of the needle body 12 extends from the catheter a distance that allows the needle to pierce the vein and place the catheter in the lumen of the vein. A guidewire 102, such as that shown in FIG. 13, can be used with the assembly 112 to pass through the needle during placement of the catheter within the patient's vein.

[0033] 1-3 illustrate a method of inserting a needle 10 and catheter 28 into a patient's vein 26, with the bevel 20 of the needle 10 oriented so that it faces generally upward and away from the patient relative to the surface of the skin, generally designated by the reference numeral 50. As shown in FIG. 1, the needle 10 and catheter 28 are positioned at a first oblique angle relative to the surface of the skin and the longitudinal dimension of the vein 26 or artery, with the sharp distal tip 22 facing toward the vein and the bevel surface 20 facing upward and away from the vein, away from the surface of the skin 50. The needle 10 is advanced in a substantially linear direction to puncture the vein 26 at the first oblique angle relative to the longitudinal dimension of the vein 26, as shown in FIG. 2, where the distal tip 22 is positioned in the lumen 32 of the vein 26. As shown in FIG. 2 , when the distal tip 22 is positioned in the lumen 32 with the bevel surface 20 facing away from the inner surface of the distal side 34 of the vein 26, the distal tip 22 contacts the surface of the vein at the distal side 34 of the vein 26 before the distal end 30 of the catheter 28 is fully received within the lumen 32 of the vein 26.

[0034] The needle 10 and catheter 28 in the position shown in FIG. 2 with the flashback feature enabled provides an inaccurate indication of the proper positioning of the needle 10 and catheter 28 within the vein 26 as the catheter 28 cannot easily slide off the end of the needle. As shown in FIG. 2, the distal tip 22 may contact the far side 34 of the vein 26, which could damage the vein 26 and cause trauma or thrombosis. Furthermore, because the upper portion of the distal end of the catheter 28 is not positioned within the lumen 32 of the vein 26, attempts to slide the catheter 28 off the needle 10 are hindered by the distal end of the catheter 28 directly contacting the outer surface of the wall of the vein 26 at the insertion and penetration site. Interference between the catheter 28 and the outer surface of the wall of the vein 26 can lead to twisting of the catheter 28 and / or difficulty in sliding it off the needle 10 into the lumen 32 of the vein 26, as well as discomfort to the patient. In the illustrated embodiment, the blood flashback feature is provided by the lumen 14 of the needle 10, which is capable of delivering a volume of blood to the point where it can be visualized before the distal end of the catheter 28 is fully seated within the lumen 32 of the vein 26. Premature flashback before the entire tip of the catheter is positioned within the vein or artery provides the medical practitioner with an inaccurate indication of the catheter's position within the vein. Premature flashback provides an inadequate indication that the catheter is positioned within the lumen of the vein 26, even when the catheter 28 is properly advanced into the lumen of the vein 26.

[0035] As shown in Figure 3, further advancement of the needle 10 and catheter 28 could cause the distal tip 22 to puncture or damage the interior surface of the vein 26 on the far side 34 of the vein 26 opposite the puncture site. The catheter 28 is forced against the interior surface of the vein 26 to properly position the distal end 30 of the catheter 28 within the vein 26, where the distal end 34 is fully seated within the vein 26. In the position shown in Figure 3, the catheter 28 does not easily slide off the end of the needle 10 but instead exerts force against the wall of the far side 34 of the interior surface of the vein 26 opposite the puncture site. Additionally, the angle of the needle requires the catheter to bend around the sharp distal tip 22, which could cause stripping and damage to the interior surface of the catheter 28 and / or could impede the sliding movement of the catheter 28 from the needle 10 into the vein.

[0036] Figures 4-8 illustrate one embodiment of a method for introducing a needle and catheter into a vein that increases reliability, reduces the chance of vein puncture or false flashback indication, and reduces the risk of improper placement within the vein. As shown in Figure 4, the needle 10 and catheter 28 are oriented relative to the surface of the skin and vein 26, with the bevel 20 pointing downward toward the surface of the vein 26 and skin 50. In one embodiment, the needle is 18-22 gauge, and the bevel angle of the bevel surface is approximately 10-20°. In other embodiments, the needle may have a bevel angle of approximately 12-15°. The needle 10 is introduced into the vein 26 by orienting it in the position shown in Figure 5, where the tip 22 of the distal end 18 contacts the vein 26 and the bevel 20 faces the superior or outer surface of the vein 26. An insertion force is applied to the needle 10 and catheter 28 in the direction of arrow 36 at a first oblique angle relative to the surface of the skin and the longitudinal dimension of the vein, puncturing the surface of the skin and vein 26 as shown in Figure 5. In one embodiment, the insertion force is applied linearly relative to the longitudinal dimension of the needle. The bevel surface 20 is angled relative to the longitudinal dimension of the vein 26 to assist the needle 10 in sliding longitudinally substantially forward into the vein relative to the direction of needle and catheter insertion by the clinician. The insertion force and bevel 20 facilitate flattening of the needle angle, with the bevel sliding longitudinally substantially forward through the slit or cut at the entrance 33 formed in the vein 26, as shown in Figures 6 and 7. In the illustrated embodiment, the orientation of the bevel surface relative to the outer surface of the vein and the surface of the skin at the initial puncture is at an oblique angle, with the longitudinal axis of the needle oriented obliquely at an angle of approximately 55° to 65°, typically approximately 60°, to provide perforation of the skin and vein relative to the surface of the skin. As the tip 22 penetrates the vein, as shown in Figure 6, the bevel angle facilitates a change in the angle of the needle and bevel surface relative to the longitudinal dimension of the vein. After penetration of the vein, the angle of the needle is reduced to about 25° to 35°, typically about 30°, relative to the longitudinal dimension of the vein.

[0037] 7, further advancement of the needle 10 and catheter 28 causes the needle 10 and catheter 28 to penetrate the vein 26, with the bevel 20 and distal end 30 of the catheter 28 positioned fully within the lumen 32 of the vein 26, reducing the risk of the distal tip puncturing or anchoring the vein distal to the entry point. As shown in FIG. 7, the distal tip 18 and bevel 20 can penetrate the wall of the vein 26 at the entry point and be fully positioned within the lumen 32 without the distal tip 22 penetrating the distal side 34 of the vein 26 during the insertion step, reducing the occurrence and preventing a puncture by the needle 10. The bevel 20 can contact the interior surface of the vein 26 and the distal end of the catheter 28 within the lumen 32 for effective needle placement, reducing the occurrence of damage to the interior surface of the vein. As shown in FIG. 7, the distal end of catheter 28 is completely within lumen 32 of vein 26, so that blood flashback through lumen 14 of needle 10, as indicated by arrow 38, accurately indicates that the distal end of catheter 28 is properly positioned in lumen 32 of vein 26.

[0038] Once the needle 10 and catheter 28 are positioned within the lumen 32 of the vein 26, the catheter 28 is advanced in a forward direction, sliding the catheter off the needle and into the vein 26 with reduced resistance and interference compared to conventional methods and the orientation of the needle's bevel surface relative to the longitudinal dimension of the vein. The flexible catheter 28 can slide over the bevel 20 with minimal resistance without sliding or bending past the sharp distal tip 22, avoiding stripping or damage to the catheter 28. In the illustrated embodiment, the proximal end of the bevel surface at the surface of the needle forms an obtuse angle, allowing the inner surface of the catheter to slide past the intersection between the bevel surface and the outer surface of the needle without damaging the inner surface of the catheter. The bevel surface can be oriented at an angle such that the tip 22 is angled relative to the longitudinal dimension of the vein to prevent or minimize damage or injury to the inner surface of the vein. The needle 10 can then be removed from the catheter 28 in the usual manner.

[0039] In another embodiment, shown in FIGS. 14 and 15, a needle 60 has a longitudinal cylindrical body 62 with a proximal end and a distal end 66. The distal end 66 has a first major bevel 68 cut at an angle of approximately 16-22° and two opposing reverse bevels 70, forming a sharp tip 72 formed by three cutting edges between each bevel. The reverse bevels 70 converge at the first bevel 68 to form the tip 72. The bevels 70 converge at an acute angle at the first bevel 68 to form a plurality of angled cutting edges 74 extending from the tip 72. The plurality of cutting edges 74 are angled relative to one another at approximately 75-85°. The reverse bevels 70 converge to form angled cutting edges 76 that extend from the tip 72 toward the exterior surface of the needle body, opposite the bevels 66, toward the proximal end of the needle body. A rounded distal portion 78 extends from the outer periphery of the body 62 to the cutting edge 76 such that the cutting edge 76 is spaced radially inward relative to the outer periphery of the body.

[0040] The needle 60 supports the catheter 82 in a manner similar to the previous embodiment. To insert the needle and catheter into a patient, the needle 60 is oriented so that the bevel 68 faces the patient's skin and the surface of the vein 80. The needle is advanced in a substantially straight line into the vein, with the cutting edge penetrating the vein 80, until the curved surface 78 on the distal end contacts the wall of the vein 80, as shown in FIG. 15 . The curved surface 78 contacts the vein and slides through the opening formed in the vein without further cutting. The curved surface spaced radially outward from the cutting edge facilitates sliding of the needle tip into the vein while reducing discomfort to the patient. The catheter 82 then slides over the end of the bevel 68 and into the vein. In other embodiments, a guidewire can be used in combination with the needle.

[0041] Other examples of flashback features include substantially V-shaped grooves or recesses on the outer surface of the needle. In one embodiment, the needle wall can be corrugated to form grooves and protruding portions that extend into the axial passage of the needle. The protruding portions can form surfaces that reduce the inner diameter of the needle to reduce the occurrence of coring during insertion into the patient's skin and vein.

[0042] In the illustrated and described embodiments, the needle is used in combination with a catheter to puncture the vein and place the catheter into the vein with the needle positioned in a position or orientation that complements the insertion and positioning of the catheter into the vein, reducing puncture and injury or damage to the vein that could result in clotting and / or thrombosis. In other embodiments, the needle may be used alone without a catheter to draw blood or introduce fluids into the patient. Alternatively, the needle may be solid core with or without grooves or lumens to provide blood flashback.

[0043] The above description of preferred embodiments should not be construed as limiting the invention, which is defined by the appended claims. The present disclosure is intended to enable those skilled in the art to practice variations of the invention described without departing from the scope of the invention. In the specification and claims, numerical limitations herein are understood to be qualified by the modifier "about," and slight deviations achieving equivalent results are within the scope of the invention. Features disclosed in connection with one embodiment or independent claim or limitations of a dependent claim can be combined with another embodiment or different independent claim without departing from the scope of the invention.

Claims

[Claim 1] A needle, a body having a proximal end and a distal end, a first longitudinal side and a second longitudinal side opposite the first longitudinal side, the distal end having a first bevel extending between the first and second longitudinal sides and defining a distal tip at the second longitudinal side; The second longitudinal side of the needle has a notch defining a blood flashback passage between the needle and the catheter, the notch being oriented opposite the first bevel.

Images