Medical needles

Abstract

To provide a medical needle that can strike a balance between strength of a needle hub and molding accuracy and provide high reliability.SOLUTION: A puncture instrument includes: a hub 101 having a distal end side to which a needle body 102 is connected and a proximal end side to which a tube 151 is connected; a housing 103 for storing the hub 101; and a biasing part 104 for biasing the hub 101 in an axial direction to move the hub from a first position where the needle body 102 is exposed from the housing 103 to a second position where the needle body 102 is stored in the housing 103, where the housing 103 includes a notch provided to a distal end.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present disclosure relates to a puncture device, and more particularly to a puncture device having a protector. [Background technology]

[0002] In medical settings, various puncture devices with sharp needle tips are used to puncture the skin. For example, medical needles used to inject medicine into blood vessels or withdraw blood have a needle body with a sharp needle tip and a needle hub attached to the base end of the needle body. Because the tip of a puncture device is extremely sharp, accidentally touching it can cause injury. In addition, there is a risk of infection in the case of a used puncture device. For this reason, various protectors that cover the needle tip have been developed to prevent injury caused by puncture devices.

[0003] Among these, puncture devices of the type in which the needle body is retracted and stored together with the needle hub into a protector provided on the base end are easier to operate and less likely to cause accidents than those in which a protector is placed over the needle body.Furthermore, puncture devices of the type that are provided with a biasing means for biasing the needle hub to which the needle body is attached toward the base end and a locking mechanism, and that automatically retract the needle body into the protector by releasing the lock, are even easier to operate and have a higher level of safety (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2005-530540 Summary of the Invention [Problem to be solved by the invention]

[0005] However, puncture devices in which the needle body is automatically retracted into the protector have the problem of being large because of the internal spring or other biasing member. Therefore, when we investigated ways to make the housing and needle hub themselves smaller, we discovered that the solvent or adhesive applied to the tip of the tube could get on not only the base end of the needle hub but also the base end of the protector, connecting the needle hub and protector and preventing the retraction operation even when the lock is released.

[0006] Furthermore, in puncture devices in which the needle body is automatically retracted into the protector, a biasing force is applied to the needle hub until it is used. Therefore, the needle hub needs to be strong enough to withstand long-term loads without deformation. However, high-strength resins have the problem of poor moldability, and it has recently been discovered that needle hubs made from high-strength resins may have a risk of bending the axis of the attachment hole where the needle body is attached.

[0007] An object of the present disclosure is to solve at least one of the problems that cause a decrease in productivity of puncture devices, and to improve productivity of puncture devices. [Means for solving the problem]

[0008] A first aspect of the puncture device of the present disclosure comprises a hub to which a needle body is connected at its distal end and a tube is connected at its proximal end, a housing that houses the hub, and a biasing section that biases the hub in the axial direction to move it from a first position where the needle body is exposed from the housing to a second position where the needle body is housed within the housing, the housing having a notch at its proximal end.

[0009] According to the first aspect of the puncture device, the notch provided at the base end can reduce the possibility that adhesive or the like applied to the tube will come into contact with the housing.

[0010] A second aspect of the puncture device of the present disclosure comprises a hub to which a needle body is connected at its distal end and a tube is connected at its proximal end, a housing that houses the hub, and a biasing section that biases the hub to move it from a first position in which the needle body is exposed from the housing to a second position in which the needle body is housed within the housing, and when the hub is in the first position, the proximal end of the hub protrudes from the proximal end of the housing.

[0011] According to the second aspect of the puncture device, the base end of the hub held in the first position protrudes from the base end of the housing, making it difficult for the solvent used to bond the tube to the hub to adhere to the housing, thereby preventing defects such as welding between the hub and housing.

[0012] A third aspect of the puncture device of the present disclosure comprises a hub, a needle body attached to the tip side of the hub, a housing that contains the hub, and a part that biases the hub in the axial direction, the hub having a first part having a needle insertion hole into which the needle body is inserted, and a second part that is located closer to the base end than the first part and includes an engaging part that releasably engages with the housing, and the first part and second part are joined together to form a single unit.

[0013] According to the third aspect of the puncture device, the first and second parts of the hub can be formed from different materials, which allows the hub's strength to be ensured while the shape of the hub can be stabilized, improving productivity. The stable shape also improves the reliability of the puncture device.

[0014] In a third aspect of the medical needle puncture device, the second section has a connecting recess provided at the distal end, and the first section has a connecting protrusion provided at the proximal end that is housed in the connecting recess, and the outer diameter of the section excluding the connecting protrusion can be equal to the outer diameter of the section of the second section where the connecting recess is provided. This configuration allows the first section and the second section to be connected without a step, making it easier to design the biasing section. It also makes it easier to thin the distal section of the medical needle, improving the operability of the puncture device.

[0015] In a third aspect of the puncture device, the first portion can be molded from a material that is more moldable than the second portion, and the second portion can be molded from a material that is stronger than the first portion. By using such a configuration, it is possible to easily achieve both strength and productivity.

[0016] One aspect of the method for manufacturing a puncture device of the present disclosure is a method for manufacturing a hub of a puncture device, comprising the steps of molding a first part having a needle insertion hole into which the needle body is inserted, and joining the first part to a second part having an engagement part that releasably engages with the housing against the biasing force of the biasing part, wherein the hub is held in the first position where the needle body is exposed from the housing against the biasing force of the biasing part until use of the puncture device is finished. According to this aspect of the method for manufacturing a puncture device, the hub can be molded with precision while ensuring the strength of the hub, thereby improving productivity.

[0017] In one aspect of the method for manufacturing a puncture device, the second part can be joined to a pre-molded first part by insert molding in the joining step. This configuration facilitates manufacturing and also improves the reliability of the joined part between the first part and the second part. [Effects of the Invention]

[0018] According to the puncture device of the present disclosure, productivity of the puncture device can be improved. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is an exploded perspective view showing a medical needle according to one embodiment. [Figure 2] FIG. 10 is a cross-sectional view showing a state in which the hub is held in a first position within the housing. [Figure 3] FIG. 10 is a cross-sectional view showing the hub held in a second position within the housing. [Figure 4] FIG. 1 is a cross-sectional view of a hub according to one embodiment. [Figure 5]FIG. 2 is a cross-sectional view showing a first portion of the hub. [Figure 6] FIG. 4 is a cross-sectional view showing a second portion of the hub. [Figure 7] FIG. 4 is an enlarged plan view showing a base end portion of the housing. DETAILED DESCRIPTION OF THE INVENTION

[0020] The puncture device according to one embodiment is a medical needle, and Figures 1 to 3 show a medical needle 100 according to one embodiment. Medical needle 100 of this embodiment has a hub 101, a needle body 102 attached to the tip of hub 101, a housing 103 that houses hub 101, and a spring 104 that is biasing means that biases hub 101 toward the base end.

[0021] As shown in Figures 4 to 6, the hub 101 includes a first section 110 provided on the distal side and a second section 120 provided closer to the proximal end than the first section. The first section 110 has a needle insertion hole 111 that penetrates in the axial direction and into which the needle body 102 is inserted. The distal end of the needle insertion hole 111 is provided with an adhesive filling recess 111A that is filled with adhesive 142 to fix the needle body 102 inserted into the needle insertion hole 111. The proximal end of the needle insertion hole 111 is provided with a narrow diameter section 111B through which the needle body 102 cannot pass. The provision of the narrow diameter section 111B prevents the needle body 102 from slipping out toward the proximal end of the first section 110 when the needle body 102 is inserted into the needle insertion hole 111, facilitating assembly.

[0022] A connecting protrusion 112 having a smaller diameter than the other parts is provided on the base end side of the first part 110. A connecting recess 122 that receives the connecting protrusion 112 is provided on the tip side of the second part 120. The connecting protrusion 112 of the first part 110 is inserted into the connecting recess 122 of the second part 120, and the first part 110 and the second part 120 are joined together.

[0023] A tube connection part 123 to which a tube 151 is connected is provided on the proximal end side of the second part 120. The tube connection part 123 of the second part 120 and the connecting recess 122 are connected by a liquid passage 121 that passes through the second part 120 in the axial direction. This allows communication between the tube 151 connected to the tube connection part 123 and the needle body 102 that is inserted into and fixed in the needle insertion hole 111 of the first part 110.

[0024] The second portion 120 has hub arms 125 extending outward on both sides. The hub arms 125 function as engagement portions that releasably engage the hub 101 with the housing. The hub arms 125 have engagement protrusions 126, and by inserting the engagement protrusions 126 into arm engagement holes 133 provided in the housing 103, the hub 101 can be engaged with the housing 103 and held in a first position within the housing 103.

[0025] A hub-side flange 127 is provided on the second section 120 distal to the hub arm 125. The portion of the second section 120 distal to the hub arm 125 has a smaller outer diameter than the portion proximal to the hub arm 125, excluding the hub-side flange 127. Furthermore, when the first section 110 is connected to the connecting recess 122, the portion of the hub 101 distal to the hub-side flange 127, including the first section 110, constitutes a spring retaining section 115 having a substantially constant outer diameter that is smaller than the inner diameter of the spring 104.

[0026] The housing 103 has a small diameter portion 131 located at the tip end, through which the hub arm 125 cannot pass but through which the spring retaining portion 115 can pass, and a widened portion 132 located closer to the base end than the small diameter portion 131, through which the hub arm 125 can pass. An arm engagement hole 133 is provided between the small diameter portion 131 and the widened portion 132, into which the engagement protrusion 126 of the hub arm 125 is inserted. Housing arms 135 are provided on the outer surface of the housing 103, extending outward on both sides. A pressing protrusion 136 is provided at the tip end of the housing arm 135, which is inserted into the arm engagement hole 133 when the housing arm 135 is pressed inward. When the pressing protrusion 136 is inserted into the arm engagement hole 133, the engagement protrusion 126 of the hub arm 125 is pushed out of the arm engagement hole 133, and the engagement between the hub arm 125 and the housing 103 is released. Thus, the housing arm 135 functions as a release button that disengages the hub arm 125 .

[0027] A housing-side flange 139 is provided at the tip of the small-diameter portion 131, and the spring 104 can be sandwiched between the housing-side flange 139 and the hub-side flange 127. With the spring 104 sandwiched, the engaging protrusion 126 of the hub arm 125 is inserted into and engaged with the arm engaging hole 133, whereby the hub 101 is biased toward the base end by the spring 104 and held at a first position within the housing 103 shown in FIG. 2. In the first position, the needle body 102 protrudes from the tip of the housing 103. Also, in the first position, the base end of the hub 101 protrudes toward the base end from the base end of the housing 103.

[0028] By pressing the housing arms 135 inward, the engagement between the hub arms 125 and the housing 103 is released, and the biasing force of the spring 104 is released. This moves the hub 101 to the second position on the proximal side shown in Figure 3. At the second position, the needle body 102 is housed within the housing 103.

[0029] In a configuration such as this embodiment, the hub-side flange 127, which abuts the spring 104, and the hub arm 125, which engages with the housing 103, are particularly affected by the biasing force applied to the hub 101 by the spring 104. At least these parts require high strength to prevent deformation and breakage due to the biasing force. In particular, the hub arm 125, which is a flexible piece with one free end and the other fixed end, is constantly subjected to a load due to the spring bias, raising concerns about deformation due to the load. If deformation occurs due to the load, problems such as unintentional release of the biased state can arise. Meanwhile, the portion distal to the hub-side flange 127 is hardly affected by the biasing force of the spring 104 and therefore does not require the same strength as the hub-side flange 127 and the hub arm 125. Meanwhile, the needle insertion hole 111 requires higher molding precision than other portions of the hub 101 to ensure that the needle body 102 is fixed in a straight position.

[0030] The hub 101 of this embodiment is formed by combining a first portion 110 including the needle insertion hole 111 and a second portion 120 including the hub-side flange 127 and hub arm 125 into a single unit. Therefore, the first portion 110 can be molded from a first resin that can achieve high molding accuracy, and the second portion 120 can be molded from a second resin that can achieve high strength. This makes it easy to create a hub that combines the required strength and molding accuracy. Furthermore, by forming multiple types of first portions 110 with different inner diameters of the needle insertion hole 111 to match the thickness and length of the needle body 102, the second portion 120 can be made common, which is advantageous in terms of manufacturing costs and production control.

[0031] The hub arm 125 is the portion that is most affected by the biasing force of the spring 104 over a long period of time. Furthermore, the portion that requires high molding precision is the needle insertion hole 111, which secures the needle body 102. Therefore, the portion where at least the needle insertion hole 111 is provided can be designated the first portion 110, and the portion where at least the hub arm 125 is provided can be designated the second portion 120. Because a large force is also applied to the hub-side flange 127, if the hub-side flange 127 is provided, it is preferable that the portion where the hub-side flange 127 is provided also be designated the second portion 120. However, the hub-side flange 127 may be provided only if necessary. Alternatively, the hub arm 125 and the hub-side flange 127 can be integrated, with the base of the hub arm 125 abutting the spring 104. Alternatively, the needle insertion hole 111, the hub-side flange 127, and the hub arm 125 can each be separate components.

[0032] In this embodiment, the connecting protrusion 112 provided on the first portion 110 is fitted into the connecting recess 122 provided on the second portion 120. This configuration ensures the strength of the connecting portion between the first portion 110 and the second portion 120 while easily preventing an enlarged diameter portion from occurring at the connecting portion between the first portion 110 and the second portion 120. By preventing an enlarged diameter portion from occurring at the connecting portion between the first portion 110 and the second portion 120 and making the spring holding portion 115 a straight portion with a fixed diameter, attachment of the spring 104 becomes easy. In addition, the outer diameter of the small diameter portion 131 of the housing 103 that houses the spring holding portion 115 can be reduced. Reducing the outer diameter of the tip of the housing 103 prevents it from interfering with the puncture operation, improving the operability of the medical needle.

[0033] It is also possible to use a configuration in which the base end of the first section 110 fits onto the tip end of the second section 120. Alternatively, a connecting mechanism may be used in which an enlarged diameter section is formed at the connecting section between the first section 110 and the second section 120. Furthermore, it is also possible to use a configuration in which the base end of the first section 110 and the tip end of the second section 120 are connected via a separate connecting member.

[0034] The method for connecting and joining the first portion 110 and the second portion 120 together is not particularly limited, but for example, a technique called two-color molding can be used during insert molding, in which the first portion 110 is molded in advance and then the second portion 120 is molded and integrated. Alternatively, the first portion 110 and the second portion 120 can be formed separately and then joined with an adhesive or by welding using heat or ultrasound, for example. Among these, insert molding is preferred because it makes it easy to mold the hub 101 and also increases the reliability of the joint between the first portion 110 and the second portion 120.

[0035] In this embodiment, an example in which the hub is formed from two parts has been shown, but it may also be formed from three or more parts.

[0036] The medical needle 100 of this embodiment has wings 141 attached to a small diameter portion 131 provided at the tip of the housing 103. By providing wings 141 that extend out on both sides from the small diameter portion 131, it becomes possible to stably fix the medical needle 100 on the patient's skin. The wings 141 are preferably formed from a soft resin that can be bent by hand. Specifically, they can be formed from polyethylene resin, polypropylene resin, vinyl chloride resin, urethane resin, silicone resin, or the like. The wings 141 may be provided as needed, or may not be provided at all.

[0037] In this embodiment, the widened portion 132 of the housing 103 and the wings 141 coincide and extend laterally, and the hub arms 125 and the housing arms 135 also extend laterally in the same direction as the wings 141. This allows the height of the medical needle 100 to be kept low when the medical needle 100 is fixed onto the patient's skin, improving the operability and stability of the medical needle 100. However, the hub arms 125 may extend in another direction, or there may be only one hub arm.

[0038] In this embodiment, an example has been shown in which the housing arm 135 is provided as a release button for releasing the engagement between the hub 101 and the housing 103, but other configurations may be employed as long as they can release the engagement between the hub 101 and the housing 103. For example, the hub arm 125 may be directly pressed.

[0039] In the present embodiment, an example has been shown in which the engaging protrusion 126 provided on the hub arm 125 is inserted into the arm engaging hole 133, thereby engaging the hub 101 with the housing 103 and holding it in the first position. However, other configurations can be adopted as long as the hub 101 and the housing 103 can be releasably engaged. Also, although the hub arm 125 has a shape that extends toward the distal end, the hub arm 125 can also have a shape that extends toward the proximal end.

[0040] In this embodiment, a base-end retaining hole 138 for retaining the hub 101 in the second position is provided on the base-end side of the housing 103. The base-end retaining hole 138 is provided on both side surfaces at the base end of the housing 103 that intersect with the direction in which the hub arms 125 expand. When the hub 101 moves to the second position, the engaging protrusions 126 of the hub arms 125 are inserted into the base-end retaining hole 138, and the hub 101 does not move any further in the front-to-rear direction. By providing the base-end retaining hole 138, it is possible to prevent the hub 101 from falling out of the housing 103, further improving safety.

[0041] 7, in this embodiment, a notch 137 is provided at the base end of housing 103. Notch 137 is formed by cutting out both sides of the base end along the width direction in which hub arms 125 of housing 103 extend, leaving both side surfaces of the base end where base-end holding holes 138 are provided. Therefore, the base end of hub 101 held at a first position within housing 103 can be gripped at the portion of notch 137 in the vertical direction intersecting the width direction in which hub arms 125 extend.

[0042] It is extremely difficult to insert and assemble hub 101 into housing 103 with tube 151 connected to hub 101. For this reason, typically, after hub 101 is assembled to housing 103, tube 151 is connected to tube connecting portion 123 provided at the base end of hub 101. If hub 101 is not firmly fixed when connecting tube 151 to tube connecting portion 123, the axis may become unstable, making it impossible to connect tube 151.

[0043] In this embodiment, the base end of hub 101 held in the first position can be gripped by an automatic assembly machine at notch 137. Therefore, when connecting tube 151 to tube connecting portion 123, hub 101 can be firmly fixed in position to prevent axial wobble, thereby improving productivity.

[0044] The tube 151 and the tube connection portion 123 are welded or glued to prevent the tube 151 from coming loose. If a solvent or adhesive applied to the tube 151 adheres between the hub 101 and the housing 103, the hub 101 and the housing 103 will be welded or glued together, resulting in a defective product. The provision of the notch 137 at the base end of the housing 103 reduces the possibility of adhesive or the like applied to the tube coming into contact with the housing. Furthermore, in this embodiment, the base end of the hub 101 protrudes further proximally than the base end of the housing in the first position. This significantly reduces the likelihood of solvent or adhesive adhering between the hub 101 and the housing 103 when connecting the tube 151 to the tube connection portion 123. Simply providing the notch 137 or having the hub 101 protrude toward the base end can effectively prevent adhesive or the like from adhering, and the combination of both configurations can further enhance the effect.

[0045] In addition, the configuration of providing a notch in the housing and the configuration of having the base end of the hub protrude from the housing are useful not only in cases where hub 101 is used, which is an integrated unit of multiple parts with different strengths, but also in various puncture devices that are assembled by connecting a tube to a hub housed in a housing.

[0046] If the length of the portion of the hub 101 protruding from the housing 103 in the first position is sufficiently long, the hub 101 can be gripped when connecting the tube 151 to the tube connection portion 123 without providing the notch 137. However, providing the notch 137 allows the length of the hub 101 to be shortened. Furthermore, the portion of the hub arm 125 exposed from the housing 103 can be reduced when the hub 101 is held in the second position. This reduces the likelihood of a finger or the like touching the hub arm 125 and unintentionally disengaging the engaging protrusion 126 from the base-end retaining hole 138. In this embodiment, the width w of the notch 137 is reduced so that a surface extending along the width direction remains in the portion of the housing 103 where the base-end retaining hole 138 is provided. This further reduces the exposed portion of the hub arm 125 engaged with the base-end retaining hole 138, making unintentional disengagement less likely to occur.

[0047] The spring 104 can be a metal compression coil spring, but can also be made of resin. The spring 104 is not limited to the spring 104, and any other spring that can bias the hub 101 can be used as the biasing means, such as a leaf spring or rubber.

[0048] The housing 103 can be formed from commonly used materials such as polycarbonate resin, acrylic resin, polyethylene resin, polypropylene resin, or vinyl chloride resin. The needle body 102 can be a metal needle made of stainless steel or the like. There are no particular limitations on the thickness or length of the needle body 102, but if the needle body 102 is a thin needle with a gauge greater than 23G, the hub 101 is more likely to deform due to the biasing force, and therefore the configuration of the present disclosure is particularly useful.

[0049] The tube 151 can be a normal medical tube made of vinyl chloride resin, urethane resin, or the like. The tube 151 can be attached to the tube connection part 123 by gluing, fusing, or the like. In this embodiment, the tube connection part 123 is shaped so that the tube 151 fits inside, but it can also be shaped so that the tube 151 fits outside.

[0050] In this embodiment, the hub, which is formed by connecting and joining multiple parts with different strengths, is useful not only for medical needles with a tube directly attached to the base end, but also for medical needles with a configuration in which a luer connector or the like is provided at the base end.Furthermore, the hub is not limited to medical needles, and is useful in various puncture devices in which a hub with a sharp needle tip fixed thereto is accommodated in a housing by a biasing force.For example, a lancet used to collect a small amount of blood can be configured in a similar manner. [Industrial Applicability]

[0051] The puncture device of the present disclosure is highly productive and useful. [Explanation of symbols]

[0052] 100 medical needles 101 Hub 102 Needle body 103 Housing 104 Spring 110 First Part 111 Needle insertion hole 111A Adhesive filling recess 111B Narrow diameter part 112 Connecting protrusion 115 Spring retainer 120 Second Part 121 Liquid passage 122 connecting recess 123 Tube connection 125 hub arm 126 Engagement protrusion 127 Hub side flange 131 Small diameter section 132 Widening section 133 Arm engagement hole 135 Housing Arm 136 Pressing convex part 137 Notch 138 Proximal retention hole 139 Housing side flange 141 Wing 142 Adhesive 151 tubes

Claims

1. a hub to which the needle body is connected at its distal end and to which a tube is connected at its proximal end; a housing that accommodates the hub; a biasing portion that biases the hub in the axial direction to move the needle body from a first position where the needle body is exposed from the housing to a second position where the needle body is accommodated within the housing, The housing has a notch at a proximal end, The notches are provided on both sides of the hub, and expose a portion of the hub when the hub is in the first position.

2. The puncture device of claim 1 , wherein a proximal end of the hub protrudes from a proximal end of the housing when the hub is in the first position.

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