Needle assembly and related methods

Abstract

A needle assembly (1400), such as a catheter assembly, has a needle shaft (12) and a needle tip (14) formed of a first rigid material for piercing a subject. A shaft section (12) proximal of the needle tip (14) can be formed of a second material different from the first material. The needle tip (14) is attached to the needle shaft (12) to form a needle (10). The first material can have a higher rigidity than the second material, and the needle (10) can protrude through a catheter tube (18) and be used in a catheter assembly.

Description

Technical Field

[0001] The present invention relates to a needle and a catheter assembly including such a needle, as well as related methods. Background Technology

[0002] Intubation is typically a challenging task for both medical professionals and patients. For medical professionals, it requires a certain amount of skill and experience to perform the procedure while minimizing pain or discomfort for the patient.

[0003] Some cannulation systems include methods for healthcare professionals to visualize the primary flashback during the cannulation procedure. For example, some systems include a notched needle that is surrounded by a catheter during insertion. The notch allows blood to flow into the annular space between the needle and the catheter, allowing healthcare professionals to observe when the primary flashback occurs to understand when the bevel of the needle enters the vein.

[0004] Compared to a cylindrical needle forming a closed circumference, incorporating a notch into a metal needle requires additional processing steps. These additional steps complicate the process and require more time and manufacturing costs. Furthermore, blood flowing through the notch may cause blood exposure during needle removal.

[0005] Metal is also a preferred material for routine cannulation systems because it has lower penetrating power compared to needles made of other materials. This lower penetrating power allows the needle to enter the patient's vascular system more easily, thus minimizing patient discomfort during puncture.

[0006] Generally speaking, it is expected that one or more of the above difficulties can be overcome or improved, or at least useful alternatives can be provided. Summary of the Invention

[0007] According to the present invention, a needle is provided, comprising: a sharpened needle tip formed of a first rigid material for puncturing a subject; and a needle shaft comprising a second material, wherein the needle tip is attached to the needle shaft in use to form a needle.

[0008] According to the present invention, a catheter assembly is also provided, comprising: a needle as described above; a catheter hub; and a catheter connected to the catheter hub and surrounding the needle.

[0009] A further aspect of the invention includes a needle comprising: a needle tip formed of a first rigid material, the needle tip including a bevel for puncturing a subject; and a needle shaft comprising a second material, wherein the needle tip is formed separately and subsequently attached to the needle shaft to form a needle.

[0010] The first material can have higher stiffness than the second material.

[0011] The first material can be metal.

[0012] The internal material with the needle tip can be a substrate, and a second material can be attached to the substrate, molded onto the substrate, or deposited on the substrate.

[0013] In one instance, the substrate may be made of a non-metallic material, and a harder metallic material may be deposited onto the substrate.

[0014] In some instances, the base may have both a shaft section and a needle tip section with a needle bevel. The shaft section may be attached to the needle tip section via a connector.

[0015] The second material can be a plastic material.

[0016] The second material can be a light-transmitting material to enable visible detection of primary flashbacks within the needle shaft. The primary flashback can be observed by looking through the needle formed using the second material. When used with a catheter, blood flow occurs in the annular space between the catheter and the needle, obstructing observation of the needle. This flow in the annular space can represent a secondary flashback.

[0017] The second material can be transparent or translucent.

[0018] The needle tip can be attached to the needle shaft via a connector. The connector may have a first connecting portion forming with the needle tip and a second connecting portion forming with a shaft section. The first connecting portion can be engaged with the second connecting portion to form a complete or assembled connector for attaching the needle tip to the needle shaft.

[0019] The connector may include: one or more indentations on one of the needle shaft and the needle tip; and for each indentation, a protrusion on the other of the needle shaft and the needle tip, said protrusion being arranged to be received in the indentation, thereby connecting the needle tip to the needle shaft.

[0020] The connector may include: one or more orifices on one of the needle shaft and the needle tip; and for each orifice, a protrusion on the other of the needle shaft and the needle tip, said protrusion being arranged to be received in the orifice, thereby connecting the needle tip to the needle shaft.

[0021] The needle tip may include: a first material having a bevel; and: a second material formed onto the first material, thereby forming a needle shaft; or the needle shaft is made of the second material and then attached to the first material.

[0022] The needle shaft may include an integral needle tip at the distal end of the needle shaft, and the needle tip may be attached to the needle shaft by depositing a first material onto the integral needle tip form.

[0023] The needle tip may include: a proximal end, which includes one of a depression and a protrusion; and wherein forming the second material onto the needle tip may include depositing the second material along the length of the needle tip from a distal location of the depression or protrusion to and through the proximal end of the needle tip.

[0024] The needle of the present invention may include an intermediate material formed on or attached to a one-piece needle tip molding for heat dissipation during the deposition of the first material. In other words, the needle may be made of the first material. An intermediate layer may be formed on the first material. A second material may be formed on the second material. The three materials may be used to form a needle having the needle tip of the present invention.

[0025] The second material can be molded onto the first material.

[0026] During the cooling or curing of the second material, the first material can be bonded to the second material.

[0027] The needle tip may include an aperture to form a window for observing primary flashbacks. For example, in the case where the needle is formed by coating a second material onto a first material, a portion or section of the internal first material may be masked, such that when the first material is placed on the second material, the masked portion of the first material can serve as an observation window for observing primary flashbacks. The window may have a transparent or translucent solid, non-removable surface.

[0028] The needle hub can be attached to the needle. A cord can be connected between the needle tip and the needle hub to attach the needle tip to the needle hub.

[0029] In some instances, a needle with a tip can be fixed to a needle hub via needle welding. The needle can have at least two different materials. The second material can be deposited on or molded onto the first material, either within or outside the first material.

[0030] The needle shaft may include a mark that can be located on the needle shaft to be visible during primary flashback.

[0031] The catheter assembly may include a needle according to any of the embodiments described herein. The catheter assembly may have a catheter hub and a catheter tube connected to the catheter hub (e.g., using a collar) and surrounding the needle.

[0032] The conduit assembly may include a valve and a valve opener located inside the conduit hub.

[0033] A valve may include multiple slits defining multiple valve flaps. In one example, a valve may include three slits and three valve flaps.

[0034] The valve opener may include a nose section and two plunger elements extending proximal to the nose section. In one example, two stabilizer elements may be connected to the two plunger elements respectively. The two stabilizer elements and the two plunger elements may define a stabilizing ring at the connection area.

[0035] Two through-holes may be located between the nose section and the stabilizing ring. In one example, the needle protector may include two bends. Each bend may be located in a corresponding through-hole of the valve opener.

[0036] The catheter assembly may have a needle guard located inside the catheter hub.

[0037] The needle protector can be located between the two plunger elements of the valve opener.

[0038] The needle may include a needle tip and a needle shaft, wherein the needle shaft may include markings visible during the primary flashback.

[0039] The needles described in this article may be two-piece needles attached to each other via a connector.

[0040] The needle may be made of a first material and surrounded or supported internally by a second material. The first material may include a needle tip form.

[0041] Methods of making and using needles, needle devices, and catheter devices and components thereof are within the scope of this invention. Attached Figure Description

[0042] Preferred embodiments of the invention are described below by way of non-limiting example only, with reference to the accompanying drawings, in which: Figure 1 It is a needle; Figure 2 Through Figure 1 A cross-sectional view of the needle shown; Figure 3 It includes Figure 1 The cannula of the needle shown in the image; Figure 4A This is an exploded view of the needle; Figure 4B yes Figure 4A The assembly needle shown; Figure 5 It includes Figure 1 A cross-sectional view of the needle assembly of the needle shown; Figure 6A This is an exploded view of the needle; Figure 6B yes Figure 6A The assembly needle shown; Figure 7A This is an exploded view of the needle; Figure 7B yes Figure 7A The cross-sectional view of the assembly needle shown; Figure 8A This is an exploded view of the needle; Figure 8B yes Figure 8AThe cross-sectional view of the assembly needle shown; Figure 8C yes Figure 8A The assembly needle shown; Figure 9A This is an exploded view of the needle; Figure 9B yes Figure 9A The cross-sectional view of the assembly needle shown; Figure 9C yes Figure 9A The assembly needle shown; Figure 10 This is another embodiment of the needle; Figure 11 This is a catheter assembly, showing the catheter tube located above the needle; Figure 12 Alternative embodiments of needles formed from a variety of materials are shown; Figures 13A to 13D Various methods of forming needles according to this teaching are shown; and Figure 14 The catheter assembly, needle hub, and needle are shown in accordance with this teaching. Detailed Implementation

[0043] The detailed description set forth below with reference to the accompanying drawings is intended to describe presently preferred embodiments of needle and catheter assemblies including needles and components provided according to aspects of the present device, system, and method, and is not intended to represent the only form in which the present device, system, and method can be constructed or used. The description sets forth features and steps for constructing and using embodiments of the present device, system, and method in relation to the illustrated embodiments. However, it should be understood that the same or equivalent functions and structures may be implemented by different embodiments that are also intended to be included within the spirit and scope of this disclosure. As noted elsewhere herein, similar element designations are intended to denote similar or analogous elements or features.

[0044] This document describes hybrid material needles and catheter assemblies using hybrid material needles. The hybrid material needles described herein provide a rigid, low-penetration material at the bevel of the needle, and different materials along the shaft or shank of the needle. Thus, the benefits of low penetration are retained, while allowing the shaft to be formed from more cost-effective materials compared to metal needle shafts, materials that are easier to form into columnar needle shafts, and / or materials with different but advantageous properties.

[0045] Advantageously, the bevel of the needle at the tip is made of a rigid material (such as metal), resulting in less deformation of the needle assembly during penetration. Additionally, small-diameter metal bevels are easier to manufacture, for example, compared to plastics. Sharp edges are also easier to achieve on metal bevels, for example, by grinding or machining, compared to plastics.

[0046] Now refer to Figure 1An embodiment of a needle 10 according to aspects of the present invention is shown. Needle 10 is suitable for intravenous catheter insertion, subcutaneous injection, biopsy, central venous catheter (CVC) needles, blood collection needles, dialysis fistula needles, and spinal needles, etc. It should be understood that this teaching is broadly applicable to needles in medical procedures and is not limited to the applications described with reference to the examples herein, nor to specific specifications or lengths. Needle 10 generally comprises a sharpened needle tip 14 and a needle shaft 12. In an exemplary embodiment, the needle tip 14 is formed separately and may be attached to the needle shaft 12. In use, the needle tip 14 is attached to the needle shaft 12 along an interface or attachment point to form needle 10.

[0047] The needle 10 may be formed of one or more materials such as plastic and metal. Furthermore, the needle shaft 12 may be defined by the needle length between the bevel 30 and the point where the needle is gripped (or, if gripping, the needle hub) during use. Therefore, the shaft length can vary depending on where the needle is gripped. Similarly, the needle shaft 12 may be defined by the bevel 30 and the needle hub 16 (… Figure 3 The length between the bevel 30 and the proximal end of the needle is defined. In a specific example, the needle shaft 12 is defined by the length between the bevel 30 and the proximal end of the needle.

[0048] With the needle 10 movable together with the needle hub 16, the needle 10 can have an extended state where it is in place to penetrate the patient and a retracted state where it is withdrawn from the patient. For example, after penetrating the patient, the catheter can advance over the needle 10 and the needle retracts within the catheter and eventually completely separates from it. The needle shaft 12 may include a distal length 12a and a proximal length 12b. The distal length 12a may be the length between the bevel 30 and the hub 16. The distal length 12a may have sufficient rigidity to support the needle tip 14 during insertion of the needle tip into the patient, for example, with substantially no flexure or bending in the needle shaft. Excessive flexure or bending can cause significant discomfort. The needle shaft 12 may also include a proximal length 12b extending proximally from the distal length 12a. The distal and proximal lengths together define the needle shaft. Therefore, references to the needle shaft may refer only to the distal length 12a, or both the proximal and distal lengths 12a.

[0049] The needle tip 14 and needle shaft 12 can be supplied separately and assembled in a hospital or clinic, or assembled immediately before use. Alternatively, the needle 10 can be supplied as an assembled product, wherein the needle tip 14 is attached to the needle shaft 12 at the attachment point shown in the figure. The needle 10 having the needle shaft 12 and needle tip 14 can be hollow or solid, such as a stylet.

[0050] In one example, the needle tip 14 is a hollow cylindrical body with a bevel at its distal end. The needle tip 14 has a distal end 20 with a pointed tip, a bevel 30, and a cylindrical portion 21. The needle tip 14 is considered to include a distal portion 22 and a proximal portion 24. The distal portion 22 includes the distal end 20 and the cylindrical portion 21.

[0051] In some embodiments, the proximal portion 24 includes a contour variation portion 26, currently presenting as... Figure 1 and Figure 2 The contour variation 26 is specifically shown in the form of a recess, indentation, or crimp. Advantageously, the contour variation 26 is formed to abut against the needle protector, such as against the periphery defining an opening on the needle protector, to secure the needle protector at the needle tip, and to retract the needle protector and needle tip after successful intravenous puncture to cover the needle tip and prevent accidental puncture. Exemplary needle protectors and the engagement between the contour variation 26 and the needle protector are disclosed in U.S. Patent No. 6,616,630 and U.S. Publication No. 2018 / 0214682, the contents of which are expressly incorporated herein by reference. The crimp 26 may also be referred to as a recess or crimp.

[0052] The needle tip 14 has an elongated body. In one example, the elongated needle tip 14 tapers proximally or in a proximal direction. For example, the elongated body of the needle tip 14 may have an outer diameter that increases in size in a proximal direction. In some embodiments, the taper may guide the needle tip 14 into the catheter 18 prior to use. The proximal portion 24 of the needle tip 14 may be at least partially contained within the catheter 18 before the catheter 18 is inserted into the subject on the needle 10. In some instances, the distal end of the catheter 18 has a taper to guide or facilitate insertion onto the needle into the patient. An opening at the distal catheter may form a tight fit around the needle tip to facilitate insertion.

[0053] In the embodiments described below where the needle tip 14 is assembled to the needle shaft, the needle shaft 12 may at least partially protrude into the needle tip 14, or the needle tip may at least partially surround the needle shaft. In other instances, the needle tip 14 may have a proximal taper for insertion into the needle shaft 12. In some embodiments, the taper for assembly is provided only within the proximal portion 24 of the needle tip 14.

[0054] As described above, the sharpened needle tip 14 includes a bevel 30 at the distal end 20. The bevel 30 may be a standard needle bevel known in the art. Alternatively, the distal end 20 may have alternative needle tips (such as core-taking needle tips), different cutting bevels, or blunt needle tips suitable for certain applications. When the needle tip 14 is made of a metallic material and has a bevel and columnar portion, the needle tip 14 is shorter than a conventional metallic needle, such as less than 38 mm. The needle tip 14 may be coupled to a plastic needle hub 16 via a needle shaft 12. Preferably, the length of the needle tip 14 (including the shape of the bevel) is sufficient to provide low penetration force to maintain rigidity during penetration, which reduces pain or discomfort to the patient during penetration.

[0055] The sharpened needle tip 14 is formed of a first rigid material. In this document, the term "rigid" means that the material is more rigid than the needle shaft 12, or more rigid than a plastic material. The first rigid material maintains the sharp edge and shape of the bevel 30 during penetration of the subject. Therefore, the first material undergoes minimal (if any) deformation at the puncture site during penetration.

[0056] The needle shaft 12 is formed of a second material. This second material may be the same as the first material (i.e., the material forming the needle tip 14). However, in the embodiments described herein, the second material differs from the first material. For example, the second material may be a plastic material or another material with lower stiffness than the material used to form the needle tip 14. The first and second materials may also be selected to facilitate the separation of the needle tip 14 and the needle shaft 12. For example, the shaft may be formed of a plastic material that can be heated (e.g., in an autoclave) to soften or become liquid, facilitating the separation of the needle tip from the shaft. One or both of the first and second materials may be modified to be readily soluble.

[0057] The needle shaft 12 may be formed of a material with sufficient rigidity to support the needle tip 14 during penetration into the patient's body, while the needle shaft 12 remains substantially undeformed. In some embodiments, the first material is a metal, and the second material is a plastic. In some embodiments, the needle shaft 12 includes a ridge 15 ( Figure 3 (or longitudinal ribs) to increase its rigidity. When incorporated, the ridge 15 may be added, for example, during plastic extrusion, or by overmolding when performing overmolding to sharpen the needle shaft to the needle tip.

[0058] In one example, the overmolding process involves forming a portion (such as a needle shaft) onto another portion (such as a needle tip) by using the other portion as part of a mold. For example, the needle tip may be formed from a first material (such as a metal) and a mold is formed to form a portion of the needle shaft. Thus, the mold may include the needle tip as an outer part of the mold and a columnar member or mandrel as an inner part of the mold, creating a cavity between them. A second material may then flow into or inject into the cavity and solidify to form part or all of the needle shaft. After the second material has solidified or solidified, the columnar member or mandrel is then removed, resulting in a hollow needle tip with an overmolded needle shaft.

[0059] In some cases, such as when a solid needle is required instead of a hollow needle, a columnar component or part is not necessary. In the case of a solid needle, the needle tip may be formed with a closed end or a solid body (i.e., not hollow) even before the shaft is molded onto the needle tip. Alternatively, the needle tip may be hollow and the shaft fills the internal volume of the needle tip during molding. The needle tip can then be machined to form a sharp needle tip, which also results in the distal end of the shaft being shaped as part of a sharpened solid needle tip. In other embodiments, the needle tip and the separately formed needle shaft are joined by adhesive / gluing, heat sealing, ultrasonic welding, interference fit, or any other suitable attachment means. In yet another embodiment, the needle is formed entirely of a second material (such as a plastic material), and the needle tip is coated into or on the shaft, such as by applying a metal plating or electroplating to the needle tip, to form a tip with greater rigidity than the uncoated portion of the needle.

[0060] The term "under-moulded" can be used to refer to the same overmolding process described above, but it should be recognized that the needle shaft is formed below the proximal end of the needle tip rather than above or around it. In an alternative embodiment, the needle tip may be rolled from a flat shape into a cylindrical shape onto the needle shaft.

[0061] In some embodiments, the needle 10, particularly the needle tip 14, is coated. For example, the needle 10 is at least partially coated with an antimicrobial agent to reduce infection at the penetration site. Antimicrobial agents available herein include silver, gold, platinum, copper, and zinc. Antimicrobial metal compounds used herein include oxides and salts of silver and gold, preferably silver and gold, such as silver acetate, silver benzoate, silver carbonate, silver citrate, silver chloride, silver iodide, silver nitrate, silver oxide, silver sulfadiazine, silver sulfate, gold chloride, and gold oxide. Platinum compounds, such as chloroplatinic acid or salts thereof (e.g., sodium and calcium chloroplatinate), may also be used. Additionally, compounds of copper and zinc, such as oxides and salts of copper and zinc, as indicated above for silver, may be used. A single physiological antimicrobial metal compound or a combination of physiological antimicrobial metal compounds may be used. Alternatively, a thin antimicrobial agent may be deposited above the wall surface of the needle. Another example of a coated needle 10 is an echo coating for improving ultrasonic visibility. The needle tip 14 may also include, or in addition to, markings or etchings to improve ultrasonic visibility. In other embodiments, a lubricating coating is applied to the needle tip to reduce pain felt by the patient during penetration.

[0062] Advantageously, the second material in this embodiment is a light-transmitting material to enable visible detection of primary flashbacks in the needle shaft. In some embodiments, the second material is translucent or translucent to enable visible detection of when blood is within the needle shaft 12. The second material may be made transparent instead.

[0063] The needle shaft 12 may comprise more than two materials, or its composition may vary along its length. (See reference...) Figure 12The diagram illustrates a needle 10 having two or more materials or compositions. The needle 10 may include three or more distinct regions A, B, C, each formed of a different material. In some embodiments, regions A, B, and C have different diameters, such as different outer diameters, different inner diameters, and / or different shaft wall thicknesses. This can result in different stiffness across the different regions. For example, region C may have a smaller diameter than regions A and B. In the case where, for example, region C extends through a diaphragm, the reduced diameter relative to regions A and B reduces the amount of space occupied by the needle shaft protruding through the diaphragm. By reducing the shaft diameter, a corresponding amount of cross-sectional space is released inside the catheter hub. This increases the ease with which other components, such as a needle guard, can be installed into the interior of the catheter hub during assembly.

[0064] Region A may include a needle tip 14 formed of metal. In some instances, such as Figure 13A As shown, the needle tip 14 may include a substrate material 1306. The substrate material 1306 may have the shape of a needle tip forming element. That is, the substrate material 1306 may have the shape of tubular segments and beveled segments of a needle tip, referred to as needle tip forming element 1306, or a substrate having both tubular segments and beveled segments. The needle tip forming element 1306 of the substrate material provides a shape on which a first material can be deposited to have the final shape of a needle tip 1304, which has a substrate and tubular segments and beveled segments of the first material deposited thereon to form the final needle tip 1304. For example, the first material may be deposited onto the substrate material 1306, such as by plating, electrolysis, electrolytic plating, or vapor deposition. Therefore, the substrate material 1306 may have an outer material on which the substrate material can be deposited. The substrate material 1306 may be a plastic material, such as medical-grade silicone.

[0065] Refer again Figure 12 In some instances, the needle shaft 12 may include an integral needle tip forming element at the distal end of an elongated tubular segment of the needle shaft. For example, a substrate material on which a first material may be deposited may include the distal end of the needle shaft 12 and the needle tip 14, or the needle shaft and needle tip forming element of the substrate may be attached as described elsewhere herein, and the first material may be deposited over the integral needle tip and shaft, or the substrate may be overmolded onto a pre-formed needle tip.

[0066] Region B may include a rigid plastic material, such as a transparent material used for primary flashback visibility. Region B may be the distal end 12a of the needle shaft 12. Region C may be formed using a relatively more flexible plastic material and may be referred to as the proximal end 12b of the needle shaft 12. It is worth noting that different materials may include different compositions of the same material (such as low-density polyethylene and high-density polyethylene), materials of different colors, materials with different light transmittance, etc.

[0067] Region B may extend proximally from region A of needle 10 to needle hub 16. Region C may then form the proximal portion of needle 10 located proximal to needle hub 16. In other embodiments, instead of having discrete material variations in different or discrete regions of needle 10, needle 10 may be modified to include regions comprising one or more continuous material variations, such as a continuous spectrum ranging from the most rigid to the least rigid. For example, needle 10 may be formed from high-density polyethylene at its distal end 20 to low-density polyethylene at its proximal end located in or proximal to needle hub 16.

[0068] In another embodiment, for example, the proximal end of the needle shaft 12 (i.e., as...) Figure 12 The proximal end of region C, as specifically shown, is sharpened to facilitate penetration into, for example, blood collection tubes. In other words, Figure 12 The needle 10 can be implemented as a needle having a distal needle tip and a proximal needle tip, or a needle having two sharpened needle tips. Therefore, region C (in this embodiment with two needle tips) can be formed of a material with sufficient rigidity so that the sharpened proximal tip can puncture the diaphragm of the blood collection tube (also known as a vacuum blood collection tube). Additionally, if region B defines the area of ​​the needle shaft extending from the needle tip 14, and region C defines the area of ​​the needle shaft extending distally from the proximal end of the needle shaft and including the proximal end of the needle shaft, then additional regions such as regions D, E, and F, or other regions, may exist between regions B and C.

[0069] like Figure 12 The needle shaft 12 specifically shown includes markings, hereinafter referred to herein as markings 32. Markings 32 in this embodiment produce a contrasting color or appearance when exposed to blood to achieve simple visual identification of the markings. It should be understood that each needle may be provided with one or more markings, each marking having the same function as markings 32 described herein. One or more markings achieve a visible distinction between a primary flashback indicating the entry of the bevel 30 into a vein and a secondary flashback indicating the entry of the catheter 18 into the same vein. Markings 32 are visible during the primary flashback as blood flows through the needle lumen. During the secondary flashback, the outer surface of the needle shaft 12 and the inner surface of the catheter 18 (see...) are visible... Figure 1 Blood-masking marking 32 is located in the annular space between the catheters 18 and 19. Therefore, a visual distinction can be made; if blood is visible within the catheter 18 but marking 32 remains visible, this indicates a primary flashback. However, when marking 32 is no longer visible, this indicates a secondary flashback. Marking 32 can be made by means of laser marking, pad printing, or screen printing.

[0070] In one example, as discussed further below, the needle 10 can be manufactured by attaching the needle tip 14 to the needle shaft 12 using a connector. (See also...) Figure 2When the needle tip 14 and needle shaft 12 are joined together, the inner surface 38 of the needle shaft 12 conforms to the outer surface 40 of the needle tip 14. At the interface 42 between the needle shaft 12 and the needle tip 14, the outer surface of the interface 42 has a constant diameter or is otherwise smooth. In some embodiments, the outer diameter of the columnar portion 21 of the needle tip 14 may be larger than the outer diameter of the needle shaft 12. In other embodiments, the outer diameter of the columnar portion 21 of the needle tip 14 may be smaller than the outer diameter of the needle shaft 12. The transition from the needle tip 14 to the needle shaft 12 (i.e., when the puncture moves from the diameter of the needle tip 14 to the diameter of the needle shaft 12) is ideally smooth enough to ensure that the needle shaft 12 does not become lodged in the subject's tissue during insertion of the needle 10 into the subject's body, and to ensure that the needle tip 14 does not become lodged in the subject's tissue during retraction after successful injection or venipuncture.

[0071] In some embodiments, such as Figure 2 As shown, the needle tip 14 includes a metal tube 17 having a hollow cavity 19. A conduit 18 may be located outside the needle and the metal tube. In one example, the conduit 18 may, according to known conduit assemblies, be held against the outer surface of the metal tube 17 and / or the needle shaft 14 by frictional engagement to prevent it from becoming lodged in human tissue.

[0072] According to aspects of the invention, various forms of couplings can be used to attach the needle tip 14 to the needle shaft 12. Specific couplings can be selected to maintain the sterility required for a particular use or application of the needle. The coupling may include one or more recesses on one of the needle shaft 12 and the needle tip 14, and, for each recess, a complementary protrusion on the other of the needle shaft 12 and the needle tip 14. Each protrusion is arranged to be received in a corresponding recess, thereby attaching the needle tip 14 to the needle shaft 12. For example, for Figure 4A In the embodiment shown, the needle shaft 12 includes one or more recesses or channels 402. Preferably, the channel 402 is located near the distal end 403 of the needle shaft 12.

[0073] exist Figure 4A In one embodiment, the needle tip 14 includes a plurality of protrusions, currently in the form of metal beveled claws 404. Preferably, the claws 404 are located at the proximal end of the needle tip 14 and are formed to engage within a complementary channel 402 of the needle shaft 12. To connect the needle shaft 12 and the needle tip 14 to form as... Figure 4B The needle assembly 10 shown in the figure has two components respectively in the form of... Figure 4A As shown, push F1 and F2 towards each other until claw 404 is as Figure 4BThe engagement shown is within channel 402, thereby forming a coupling 85 to attach the needle tip 14 to the needle shaft 12. The claw 404 can be biased radially inward. During insertion of the distal end 403 of the shaft 12 into the needle tip 14, the claw 404 is pushed radially outward against the bias of the claw 404 until the claw 404 aligns with the channel 402. The claw 404 is then biased or springs back into the corresponding channel 402 to engage the needle tip 14 to the shaft 12. As shown, the distal end of the shaft 12 can be tapered to facilitate insertion into the needle tip.

[0074] In such Figure 5 In another embodiment specifically shown, the needle tip 14 includes a proximal protrusion 502. The proximal protrusion 502 is located at the proximal end of the needle tip 14. In this embodiment, a thread, cord, or tether 506 is used to secure the needle tip 14 to the shaft 12 or hub 16. Preferably, one end (such as a first end) of the tether 506 is welded, bound, or otherwise attached to the proximal protrusion 502 adjacent to the needle tip 14, or inserted through an eyelet 504 in the needle tip 14 and heated to form a bundle. Alternatively, this end (i.e., the distal end) of the tether 506 can be attached to the needle tip 14 by coiling (e.g., coiling to prevent the needle 10 from being pulled completely over the needle guard) and by heating the tether as described below to form a bundle larger than the bundle that will fit through the coil.

[0075] Preferably, for example, Figure 5 As specifically shown, the opposite end (such as the second end) of the tether 506 is attached to the plastic needle hub 16 at point 508. Point 508 includes a slit or hole whose width or diameter is equal to or greater than the diameter of the tether 506, but smaller than the diameter of the enlarged section 510 on the second end of the tether 506. In some embodiments, to secure the tether 506 to the plastic hub 16, the proximal or second end of the tether 506 is bundled or coiled to form the enlarged section 510, which is large enough to extend distally outward through point 508. For example, the tether 506 may be heated to form a bundle (some plastics are known to automatically bundle when heated), thereby attaching the tether 506 to point 508 to attach the needle tip 14 to the plastic hub 16. When the tether 506 is wound around the needle tip 14 at the first end and around the needle hub 16 at the second end, the two are connected via the connector 85 provided by the tether, which reduces the possibility that the needle tip 14 will detach from the needle assembly 16 when the needle is removed from the patient.

[0076] Reference Figure 3The diagram illustrates a needle assembly. The needle assembly has a needle tip 14 and a needle shaft 12 coupled to a needle hub 16. In one example, the needle shaft 12 is molded or formed together with the needle hub 16 to form a single integral component between the shaft and the hub. Thus, when molded as described, the needle hub 16 may include a portion of the needle, be attached to the needle, or be molded together with the needle. The needle hub 16 may otherwise be a standard needle hub and include an elongated body for gripping. The body of the needle hub 16 may also include a hollow interior, and an open proximal end may be provided with a hydrophobic filter.

[0077] In other instances, the plastic needle hub 16 may be mechanically or fastened to the needle shaft 12 to form the needle 10. In some instances, the fastening means (such as coupling) include interference fit, friction fit, ultrasonic welding, bonding or bonding, and other attachment methods.

[0078] exist Figure 6A In another embodiment specifically shown, the needle shaft 12 may be provided with a protrusion or bump 604. The bump 604 may be located near the distal end of the needle shaft 12. The bump 604 may be embodied as a raised ring or two or more individual bumps. In one example, the needle tip 14 includes an internally complementary recess 602. The recess 602 extends in a circumferential ring around the inner surface of the tip 14 and is preferably located at the proximal end of the needle tip 14. Preferably, the recess 602 is formed to mate over the bump 604 of the needle shaft 12. To connect the needle shaft 12 and the needle tip 14 to form as... Figure 6B The needle assembly 10 shown in the figure has two components respectively in the form of... Figure 6A As shown, push F3 and F4 towards each other until bump 604 is as Figure 6B As shown, the protrusion 604 is located within the recess 602, thereby forming a connecting member 85 to attach the needle tip 14 to the needle shaft 12. During use of the needle 10, the protrusion 604 is held within the recess 602 by friction or interference fit. As discussed above, once connected, the recess 602 can function as a contour variation similar to that used for engaging the needle guard.

[0079] The bump 604 and the shaft 12 may be made of a material that is less rigid than the material used to form the needle tip 14 (such as a metal or a plastic material coated or plated with a harder material), such that the shaft 12 can deform and fit into the opening of the needle tip 14 when a relative force is applied. As shown, the distal end of the shaft 12 may be tapered to facilitate insertion into the needle tip.

[0080] Of course, the design of the bumps and corresponding recesses or depressions can be different shapes, such as circumferential ribs or one or more protrusions. For example, as... Figure 7ASpecifically, as shown, the needle shaft 12 includes a plurality of protrusions or bumps 704. Preferably, the bumps 704 are located at or near the distal end 706 of the needle shaft 12. In this embodiment, the needle tip 14 is provided with a complementary aperture 702 for each bump 704, preferably located at the proximal end of the needle tip 14. Preferably, the aperture 702 is formed to receive the bumps 704 of the needle shaft 12. To connect the needle shaft 12 and the needle tip 14 to form as shown... Figure 7B The needle assembly 10 shown in the figure has two components respectively in the form of... Figure 7A As shown, push F5 and F6 towards each other until bump 704 is as follows. Figure 6B As shown, the protrusions 704 are located within the aperture 702, thereby forming a connector 85 to attach the needle tip 14 to the needle shaft 12. The protrusions 704 may be arranged with irregular spacing, such that the needle tip 14 and the shaft 12 can only be assembled together in a single orientation. As shown, the distal end of the shaft 12 may be tapered to facilitate insertion into the needle tip.

[0081] In such Figure 8A In another embodiment specifically shown, the needle shaft 12 includes one or more holes 804. Preferably, the one or more holes 804 are located at or near the distal end of the needle shaft 12. In this embodiment, the needle tip 14 includes one or more outwardly flared fingers 802. The outwardly flared fingers 802 extend proximally from the proximal end 803 of the needle tip 14. Preferably, the outwardly flared fingers 802 are formed to fit within one or more corresponding holes 804 of the needle shaft 12. To connect the needle shaft 12 and the needle tip 14 to form as shown... Figure 8C The needle assembly 10 shown in the figure has two components respectively in the form of... Figure 8A As shown, F7 and F8 push towards each other until one or more outward-spreading fingers 802 are as follows Figure 8B As shown, the corresponding one is located in the hole 802, thereby forming a connector 85 to attach the needle tip 14 to the needle shaft 12. The outwardly flared finger 802 can be fitted into the distal opening of the shaft 12 by edge-to-edge motion or torsional motion.

[0082] exist Figure 9A In another embodiment specifically shown, the needle shaft 12 includes arms 904, which may include a pair of pointed or forked teeth with a gap between them and each including a barbed end. Preferably, the arms 904 are located at the distal end of the needle shaft 12. In this embodiment, the needle tip 14 includes a metal rib 902, such as an annular recess, extending inwardly from the needle tip 14. The metal rib 902 is located near the proximal end of the needle tip 14. Preferably, the arms 904 are formed to flex into the rib 902. This is achieved by biasing to Figure 9AThe two opposing halves of the arms 904 at the position shown are formed. As the arms 904 are pushed past the ribs 902, the arms move in direction F10 and the ribs move in direction F9, pushing the opposing halves of the arms 904 together, thereby generating an outward bias. Once the recesses in the halves of the arms 904 align with the ribs 902, they swing radially, thereby connecting the shaft 12 to the needle tip 12. This connection defines a coupling 85 to attach the needle tip 14 to the needle shaft 12.

[0083] Figures 13A to 13D Alternative attachment mechanisms are shown. Figure 13A In this configuration, the needle shaft 1306 extends the entire length of the needle 1302, from the proximal end to the tip. A first material, which may be metallic, can then be deposited on the needle shaft 1306 to form the tip 1304. The proximal portion 1300 of the bevel of the shaft 1306 may be formed of the same material as the needle shaft 1306, or may be formed of a heat-resistant or heat-resistant material (such as a silicon composite) that is relatively resistant to deformation during the deposition of the first material during the formation of the tip 1304. Alternatively, a second material may be overmolded or embedded into the tip 1304, depending on the situation.

[0084] like Figure 13B As shown, a needle having a predetermined length and two tips 1308, 1310 can be simultaneously formed from a first material body 1312 by depositing a first material onto a tube 1314 of a certain length. Alternatively, a second material can be overmolded into the first material body 1312. Then, the two tips 1308, 1310 are formed, for example, along... Figure 13B The line DD shown is formed by diagonally cutting through the first material 1312.

[0085] exist Figure 13C In the alternative embodiment shown, the shaft 1316 is formed around the tube 1318, or the tube 1318 is inserted into the shaft 1316. A first material is then deposited over the shaft 1316 to form a needle tip 1320. This allows the first material to mask the front portion of the shaft at region 1322. The tip can then be machined to ensure a sharp bevel 1324. Similarly, a second material can alternatively be molded or deposited into the needle tip 1320, wherein the needle tip 1320 is pre-formed to have the shape shown.

[0086] Figures 13A to 13CAn embodiment is illustrated in which a first material is deposited over a second material to form a needle tip on a pre-existing shaft. The second material may be a substrate on which the first material is deposited or molded. In some cases, an intermediate material is formed over the second material to act as an interface between the first and second materials during the deposition step of the first material. Thus, an embodiment with an intermediate material can be considered as a needle embodiment having three material layers (an inner material or second material, an intermediate layer, and an outermost material or first material). This interface may be bonded to the second material and have higher heat resistance than the second material to facilitate the deposition of the first material onto the intermediate layer. Alternatively, the intermediate material may be bonded to the second material and be conductive to facilitate the electrolytic deposition of the first material over the intermediate material.

[0087] Whether formed from a substrate independent of the needle shaft or as part of it, the integral needle tip forming member can be heated such that a first material is at least partially embedded in a second material during the deposition of the first material over the substrate. After the deposition of the first material, the first material can bind to the second material during the cooling or solidification of the needle tip. Preferably, depositing the first material over the needle tip should include exposing a portion of the needle tip to form a window for observing primary flashbacks. For example, the first material forming the interior of the substrate can be transparent or translucent, and the opening or aperture can be located anywhere on the needle tip during the deposition of the first material. In one example, the window can be located near the proximal end of the needle tip, where the needle tip connects to or transitions to the needle shaft. This can be achieved by applying a mask over a portion of the needle tip forming member so that the first material is not deposited over the masked area. In this embodiment, exposure is understood to mean "not covered by the first material" or "masked" or "formed by masking a portion of the second material during deposition."

[0088] The needle mentioned above has a needle shaft, at the distal end of which a one-piece needle tip molded part serves as a base. By depositing a first material over the one-piece needle tip molded part of the base, the final needle tip 14 is attached to the needle shaft 12. As... Figure 2 and Figure 6A As shown, to reduce the possibility of the first material detaching from the substrate or needle shaft, the needle shaft may include recesses or protrusions, and the first material may be deposited along the length of the needle shaft from the bevel to at least the recesses or protrusions (and including both the bevels and at least the recesses or protrusions). Similarly, a second material may be overmolded into the needle tip including the recesses or protrusions to fill the recesses or surround the protrusions and cure to form a shaft fixed to the tip.

[0089] Advantageously, the fact that one material forms a depression or protrusion in another material means that the two materials will hold together under forces that would otherwise cause the first material to detach from the second material.

[0090] Figure 13DAlternative forming methods are illustrated. In the illustrated embodiment, a pre-formed needle tip 1326 is provided and a tube 1330 is inserted into the pre-formed tip 1326. Thus, a cavity 1328, which may be generally cylindrical, is created between the tube 1330 and the pre-formed tip 1326. A second material is then flowed, injected, or otherwise driven or deposited into the cavity 1328 to form a needle shaft, such as by using overmolding techniques described elsewhere herein.

[0091] like Figure 13D As shown, the pre-formed needle tip 1326 may include one or more protrusions 1332. The protrusions 1332 may be guided inward into or toward the cavity 1328. The protrusions 1332 may extend radially inward. The protrusions 1332 may each be formed as a circumferential rib or as individual protrusions spaced apart circumferentially around the pre-formed needle tip 1326. The protrusions may be embodied as helical or spiral rib material formed inward from the outer surface of the pre-formed needle tip. The protrusions 1332 prevent the pre-formed tip 1326 from slipping out from the distal end of the completed needle shaft after the needle shaft is formed.

[0092] In another embodiment, such as Figure 10 As specifically shown, the needle assembly 10 includes an echo pattern or strip 1002. The strip 1002 reflects ultrasound signals to provide an indication of the position of the needle 10 during ultrasound-guided insertion. The echo pattern or strip may be disposed on the shaft or on the needle tip 14 for ultrasound-guided insertion of a peripheral venous catheter (PIVC).

[0093] Figure 11 It shows Figure 10 The needle assembly 10 includes a catheter 18 positioned above the needle 10. The catheter 18 may be attached to a catheter hub via a collar or bushing. Optionally, the catheter hub may include a valve, a valve opener, and a needle guard located within a hollow interior of the catheter hub. In this embodiment, the echo strip 1100 may also be used as a marker upon exposure to blood, similar to... Figure 12 The mark 32 indicates that the band 1100 is visible during the primary flashback and is obscured or blocked by blood in the catheter during the secondary flashback.

[0094] Figure 14 This is a schematic cross-sectional perspective view showing the catheter assembly 1400, which includes a reference... Figures 1 to 1The needle 10 described in section 3. The catheter assembly 14 includes the needle 10, the catheter hub 1402, and the catheter 18. The catheter 18 is connected to the catheter hub 1402, as if using a collar 1500, and surrounds the needle 10. The catheter hub 1402 is shown with wings 1502. The catheter assembly 1400 can be used in a standard manner. As described in U.S. Patent Publication No. 2018 / 0214682, the contents of which are expressly incorporated herein by reference, a valve 1504, a valve opener 1506 for opening one or more valve discs (e.g., three valve discs) on the valve 1504, and a needle guard 1508 may be located within the interior space of the catheter hub 1402. A removable protective cap 1510 and a gas or air outlet 1512 are also shown.

[0095] The catheter 18 may be transparent or translucent. As discussed earlier, a mark or symbol 32 may be located on the needle 10 to be obscured by body fluids during secondary flashbacks.

[0096] In some embodiments, the catheter assembly 1400 includes a conduit or port for coupling a valve, for selectively fluidly connecting the conduit to a container. For example, the catheter hub may be an integral catheter having a port, a tube attached to the port, and a needleless connector connected to the opposite end of the tube. Alternatively, the catheter hub may be a conduit with a port, wherein the port can directly receive a needle tip or male Luer tip without a tube. As described in U.S. Patent Publication No. 2018 / 0214682, the catheter assembly may also include a needle protector for protecting the needle tip 14 after use against needlestick injury.

[0097] In another embodiment, the catheter assembly 1400 further includes a blood diaphragm control mechanism. Preferably, the blood diaphragm control mechanism is a valve having a plurality of slits defining a plurality of valve flaps. The valve can be selectively positioned in an open or closed position. For example, the valve flaps close the valve when the needle is retracted to prevent blood from flowing out of the catheter hub, and open the valve when connected to an external container, such as when the needle tip or IV adapter is inserted into the proximal opening of the catheter hub (which may be embodied as a female Luer connector or a threaded female Luer connector).

[0098] Of course, the shape of the needle shaft 12 can be, for example, hollow, solid, or semi-circular. The profile of the needle shaft 12 can be adapted to match the requirements of a specific application. Advantageously, for embodiments where the needle shaft 12 is solid, its manufacture can be easier and cheaper than that of a hollow needle shaft, such as by forming the shaft using molding. However, a disadvantage of such a construction is that secondary flashbacks may not be visualized. Primary flashbacks can be visualized by including notches or grooves on the needle shaft 12, such as longitudinal (i.e., extending along the needle) grooves extending from or near the needle tip to a location outside the patient's body during needle insertion.

[0099] Advantageously, embodiments of the invention achieve low-force penetration into the patient while providing high flashback visibility via visual feedback through the surface layer of the needle. Embodiments of the invention incorporate plastic within the needle, thereby reducing the proportion of metal in the needle and lowering costs. Using both plastic and metal also provides manufacturers with flexibility in how the needle is formed. Keeping the needle tip metal advantageously results in less discomfort for the subject.

[0100] Additionally, in some embodiments, certain plastic portions of the needle may be transparent. Using transparent plastic facilitates observation of primary flashbacks within the needle shaft without creating windows / notches in the needle or allowing blood to flow from the proximal end of the needle.

[0101] Advantageously, embodiments of the invention provide a solution to space constraints in catheters such as intravenous catheters. Certain features of plastic catheter hubs, which typically rely heavily on conventional systems, lead to significant space limitations. Embodiments of the invention instead allow such features to be transferred to the plastic needle 12. In other words, the needle shaft can be molded with a reduced-diameter section to then provide space for other components to utilize the space freed up by the reduced-diameter needle section. Examples of such features include blood control diaphragms and safety mechanisms (such as a minimum diameter safety clip).

[0102] Throughout this specification, unless the context otherwise requires, the words “comprising” and variations such as “including” are to be understood as implying inclusion of the stated integers or steps or groups of integers or steps, but not excluding any other integers or steps or groups of integers or steps. The words “having or including” may have a similar meaning. Furthermore, features from different embodiments may be combined with other embodiments, and features may be substituted for or removed without departing from this teaching.

[0103] Any reference to prior art in this specification is not and should not be construed as an admission or in any way imply that the prior art constitutes part of common general knowledge.

[0104] Unless the context otherwise indicates, the use of “first” and “second” is intended only to distinguish between two different items or components, and not to impose restrictions on the distinction between two different items or components.

[0105] Methods for manufacturing and using multi-piece needle and catheter assemblies and their components are within the scope of this invention.

[0106] Although limited embodiments of needle and catheter assemblies and their components have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. Therefore, it should be understood that needle and catheter assemblies and their components constructed according to the principles of the disclosed devices, systems, and methods may be embodied in ways other than those specifically described herein. This disclosure is also defined in the following claims.

Claims

1. A catheter assembly (1400) comprising: Needles (10); The guide hub (1402); as well as A conduit (18) is connected to the conduit hub (1402) and surrounds the needle (10). The needle (10) comprises: a needle tip (14) formed of a first rigid material, the needle tip (14) including a bevel (30) for puncturing a subject; and a needle shaft (12) comprising a second material, wherein the needle tip (14) is formed separately and subsequently attached to the needle shaft (12) to form the needle (10), and the second material is a light-transmitting material to enable visible detection of primary flashbacks in the needle shaft (12). The needle shaft is formed of the second material, and The needle shaft (12) includes a mark (32) located on the needle shaft (12) to be visible during primary flashback and to be obscured by body fluid between the catheter and the needle shaft during secondary flashback.

2. The catheter assembly (1400) according to claim 1, wherein, The first rigid material has higher stiffness than the second material.

3. The catheter assembly (1400) according to claim 1, wherein, The first rigid material is a metal.

4. The catheter assembly (1400) according to claim 1, wherein, The second material is plastic.

5. The catheter assembly (1400) according to claim 1, wherein, The second material is transparent or translucent.

6. The catheter assembly (1400) according to any one of the preceding claims, wherein, The needle tip (14) is attached to the needle shaft (12) via a connector (85).

7. The catheter assembly (1400) according to claim 6, wherein, The connecting member (85) includes: One or more recesses on one of the needle shaft (12) and the needle tip (14); and For each recess, there is a protrusion on the other of the needle shaft (12) and the needle tip (14), and the protrusion is arranged to be received in the recess, thereby connecting the needle tip (14) to the needle shaft (12).

8. The catheter assembly (1400) according to claim 6, wherein, The connecting member (85) includes: One or more orifices (702) on one of the needle shaft (12) and the needle tip (14); and For each orifice (702), there is a protrusion (704) on the other of the needle shaft (12) and the needle tip (14), and the protrusion is arranged to be received in the orifice (702), thereby connecting the needle tip (14) to the needle shaft (12).

9. The catheter assembly (1400) according to any one of claims 1-5, wherein, The needle tip (14) includes: The first rigid material having the inclined surface (30); and (i) The second material is formed onto the first rigid material, thereby forming the needle shaft (12); or (ii) The needle shaft (12) is formed of the second material and is then connected to the first rigid material.

10. The catheter assembly (1400) according to any one of claims 1-5, wherein, The needle shaft (12) includes an integral needle tip (14) at the distal end of the needle shaft (12), and the needle tip (14) is attached to the needle shaft (12) by depositing the first rigid material onto the integral needle tip forming member (1306).

11. The catheter assembly (1400) according to any one of claims 1-5, wherein, The needle tip (14) includes: The proximal end includes one of a depression and a protrusion; and The process of forming the second material onto the needle tip (14) includes depositing the second material along the length of the needle tip (14) from the distal position of the recess or the protrusion to the proximal end of the needle tip (14) and beyond the proximal end of the needle tip.

12. The conduit assembly (1400) of claim 10, further comprising an intermediate material formed on or attached to the integral needle tip forming member for heat dissipation during the deposition of the first rigid material.

13. The catheter assembly (1400) according to claim 9, wherein, The second material is formed onto the first rigid material by molding.

14. The catheter assembly (1400) according to claim 9, wherein, During the cooling or curing of the second material, the first rigid material is bonded to the second material.

15. The catheter assembly (1400) according to claim 9, wherein, The needle tip includes an aperture to form a window for observing primary flashbacks.

16. The catheter assembly (1400) according to any one of claims 1-5, further comprising: Needle hub (16); and A cord (506) is attached between the needle tip (14) and the needle hub (16) to connect the needle tip (14) to the needle hub (16).

17. The catheter assembly (1400) according to claim 1, wherein, The catheter (18) is transparent or translucent.

18. The catheter assembly (1400) according to claim 1 or 17, further comprising a needle hub (16) attached to the needle (10).

19. The catheter assembly (1400) according to claim 18, wherein, The needle hub (16) is integrally formed with the needle (10).

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