Needle device for inserting catheter
The needle device addresses wound and bending issues in catheter insertion by minimizing sharp edges and enhancing tip sharpness, with an expansion guide to facilitate easy skin puncture and prevent guide wire bending, ensuring a safer and more effective catheter insertion.
Patent Information
- Application Number
- PCT/KR2024/008638
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-06-21
- Publication Date
- 2025-12-26
AI Technical Summary
Existing catheter insertion methods, such as the Seldinger and OTN methods, cause significant skin and blood vessel wounds, pain, and potential guide wire bending, particularly in elderly patients with reduced skin elasticity.
A needle device with minimized sharp edges and enhanced tip sharpness, combined with an expansion guide portion to facilitate easy skin puncture and minimize wounds, and a sheath design to prevent guide wire bending.
Reduces skin and blood vessel wounds and eliminates guide wire bending, providing a safer and more effective catheter insertion process.
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Figure KR2024008638_26122025_PF_FP_ABST
Abstract
Description
Needle device for catheter insertion
[0001] The present disclosure relates to a needle device for catheter insertion.
[0002] Techniques for inserting catheters into blood vessels are known to enable continuous drug administration to patients, especially elderly patients, when necessary. There are two main methods for catheter insertion: the Seldinger method and the over-the-needle (OTN) method.
[0003] The Seldinger method uses a needle, dilator, and guidewire, and the catheter is inserted as follows: First, the skin and blood vessel are punctured with a needle, and a guidewire is inserted through the space within the needle and positioned within the blood vessel. The needle is then removed, and a dilator is inserted along the guidewire to dilate the skin and blood vessel. After the dilator is removed, the catheter is inserted along the guidewire. Once the catheter is inserted, the guidewire is removed from the blood vessel.
[0004] The OTN method uses an OTN needle and an OTN sheath, and the catheter is inserted as follows. First, the skin and blood vessel are punctured with the OTN needle. After the OTN needle is secured, the OTN sheath is inserted into the blood vessel. After insertion of the OTN sheath, the OTN needle is removed and the catheter is inserted into the OTN sheath. Once the catheter is inserted, the OTN sheath is removed by tearing it in both directions.
[0005] The two methods above, the Seldinger method and the OTN method, both use a Lancet Point needle to insert the catheter, as well as a Back-cut Point needle to protect the inner wall of the blood vessel.
[0006] First, the Seldinger method offers the advantage of safety, as the skin and blood vessels adhere closely to the catheter after insertion due to the use of a dilator. However, the skin and blood vessels can be significantly dilated, causing pain to the patient. Furthermore, if a guide wire is inserted, it can become kinked within the blood vessel, potentially resulting in the inconvenience of needing to repeat the procedure in a different blood vessel.
[0007] In addition, the OTN method has the advantage of securing a catheter insertion path by using an OTN sheath instead of a dilator, unlike the Seldinger method. However, because it uses a needle with a larger diameter than the Seldinger method, it may cause large wounds to the skin and blood vessels, and this may have the side effect of causing bleeding as the skin and blood vessels do not adhere to the catheter due to these wounds.
[0008] Furthermore, Back-cut Point needles typically have a less sharp tip than Lancet Point needles to protect the inner lining of blood vessels. Therefore, when using Back-cut Point needles, elderly patients with significantly reduced skin elasticity may experience skin displacement during the puncture process. Furthermore, because Back-cut Point needles have sharp edges, they can cause significant skin wounds during the puncture process. Large wounds can lead to bleeding after catheter insertion.
[0009] Embodiments of the present disclosure solve the problems of the prior art described above.
[0010] Embodiments of the present disclosure provide a needle device for catheter insertion that minimizes wounds by eliminating the sharpness of the edge portion of the needle to minimize wounds caused by the needle and increasing the sharpness of the tip of the needle to easily puncture the skin.
[0011] In addition, embodiments of the present disclosure provide a catheter insertion needle device that complements the shortcomings of the OTN method, which allows insertion of a catheter without the side effect of bending of the guide wire compared to the Seldinger method.
[0012] The present disclosure provides embodiments of a needle device for catheter insertion. A catheter insertion needle device according to a representative embodiment includes a needle including a needle body extending in a first direction, a tip forming a distal end in the first direction, and a pair of edge portions that meet each other at an acute angle at the tip and widen in both directions perpendicular to the first direction as they go in a second direction opposite to the first direction, and form sharp edges so as to be able to incise the skin of a patient in both directions; and a sheath having a guide hole extending in the first direction therein so as to allow a catheter to be inserted, the needle body being positioned to pass through the guide hole so that the tip and the edge portion of the needle are positioned in the first direction of the guide hole, and an outer diameter of the distal end in the first direction is larger than a maximum width of the pair of edge portions in both directions. The above catheter insertion needle device is provided with an expansion guide portion which is disposed between the ends of the pair of edge portions in the second direction and the ends of the sheath in the first direction, the width in both directions increasing as it goes in the second direction, the width of the ends in the first direction in the both directions being greater than or equal to a maximum width of the pair of edge portions in the both directions, the width of the ends in the second direction in the both directions being less than or equal to an outer diameter of the ends of the sheath in the first direction, and which has an outer surface formed to be rounder than the edge portions in the both directions.
[0013] In one embodiment, the extension induction member may extend roundly from the end of the edge member in the second direction when viewed in a direction perpendicular to the first direction and the two-sided directions.
[0014] In one embodiment, when viewed in a direction perpendicular to the first direction and the both directions, the pair of edge portions may each extend in a straight line, and a tangent line at the end of the expansion inducing portion in the first direction may be the same as a tangent line of the edge portion connected at the end of the expansion inducing portion in the first direction.
[0015] In one embodiment, when viewed in a direction perpendicular to the first direction and the two sides, each of the pair of edge portions may extend in a straight line.
[0016] In one embodiment, when viewed from a direction perpendicular to the first direction and the both directions, the expansion induction member may be formed to be rounded so as to protrude convexly in the both directions.
[0017] In one embodiment, the needle includes a sloped portion whose height increases from the tip in the second direction when viewed from both directions, and the expansion guide portion may be formed in the second direction of the sloped portion.
[0018] In one embodiment, the expansion induction member may have an outer surface in the shape of a cone whose outer diameter increases as it goes in the second direction.
[0019] In one embodiment, the catheter insertion needle device may include a dilator having an extension hole extending in the first direction and passing through the guide hole of the sheath, through which the needle body passes, and having the extension guide portion formed therein.
[0020] In one embodiment, the needle includes a sloped portion whose height increases from the tip in the second direction when viewed from both sides, and the expansion guide portion of the expander may be located in the second direction of the sloped portion.
[0021] According to embodiments of the present disclosure, the width of a pair of sharp edges of a needle can be reduced, thereby minimizing wounds occurring during the puncturing process and making it easier to puncture the skin.
[0022] In addition, according to embodiments of the present disclosure, the above-described disadvantages of the OTN method, which can cause large wounds to the skin and blood vessels, can be overcome, and a catheter can be inserted without the side effect of the guide wire bending, which is a disadvantage of the Sheldinger method.
[0023] FIG. 1 is a perspective view of a needle device for catheter insertion according to a first embodiment of the present disclosure.
[0024] FIG. 2 is an exploded perspective view of a needle device for catheter insertion according to the first embodiment of the present disclosure.
[0025] FIG. 3 is a partial perspective view showing a part of a catheter insertion needle device according to the first embodiment of the present disclosure and a part of a catheter insertion needle device according to a comparative embodiment.
[0026] Fig. 4 is a cross-sectional view taken along lines S1-S1' and S2-S2' shown in Fig. 3.
[0027] FIG. 5 is a partial plan view showing a portion of a catheter insertion needle device according to the first embodiment illustrated in FIG. 3 and a catheter insertion needle device according to a comparative embodiment, viewed from direction A.
[0028] FIG. 6 is a drawing comparing the degree of wound tearing when using a catheter insertion needle device according to the first embodiment and a catheter insertion needle device according to a comparative embodiment.
[0029] FIG. 7 is a perspective view of a needle device for catheter insertion according to a second embodiment of the present disclosure.
[0030] FIG. 8 is an exploded perspective view of a needle device for catheter insertion according to a second embodiment of the present disclosure.
[0031] FIG. 9 is a perspective view of a needle device for catheter insertion according to a third embodiment of the present disclosure.
[0032] FIG. 10 is an exploded perspective view of a needle device for catheter insertion according to a third embodiment of the present disclosure.
[0033] FIG. 11 is a partial plan view showing a portion of a catheter insertion needle device according to the first embodiment of the present disclosure and a portion of a catheter insertion needle device according to the third embodiment.
[0034] The embodiments of this disclosure are provided for the purpose of illustrating the technical concepts of this disclosure. The scope of rights under this disclosure is not limited to the embodiments presented below or the specific descriptions of these embodiments.
[0035] All technical and scientific terms used in this disclosure, unless otherwise defined, have the meanings commonly understood by those of ordinary skill in the art to which this disclosure pertains. All terms used in this disclosure have been selected for the purpose of more clearly explaining this disclosure and are not intended to limit the scope of rights under this disclosure.
[0036] Expressions such as “including,” “comprising,” “having,” and the like used in this disclosure should be understood as open-ended terms that imply the possibility of including other embodiments, unless otherwise stated in the phrase or sentence in which the expression is included.
[0037] The singular forms described in this disclosure may include plural meanings unless otherwise stated, and the same applies to the singular forms described in the claims.
[0038] The expressions “first,” “second,” etc. used in this disclosure are used to distinguish between multiple components, and do not limit the order or importance of the components.
[0039] In this disclosure, when a component is referred to as being "connected" or "connected" to another component, it should be understood that the component can be directly connected or connected to the other component, or can be connected or connected via a new other component.
[0040] The dimensions and values described in this disclosure are not limited to the dimensions and values described. Unless otherwise specified, these dimensions and values can be understood to mean the described values and equivalent ranges including them. For example, the dimension "** mm" described in this disclosure can be understood to include "about ** mm."
[0041] Expressions such as “upper and lower directions (Z1, Z2)”, “longitudinal directions (Y1, Y2)”, and “lateral directions (X1, X2)” used in the present disclosure are defined as shown in the drawings, but this is only for the purpose of explaining so that the present disclosure can be clearly understood, and each direction can be defined differently depending on where the reference is placed. Among the longitudinal directions (Y1, Y2), which are two directions, one direction is defined as the first longitudinal direction (Y1) and the other direction is defined as the second longitudinal direction (Y2), and among the lateral directions (X1, X2), one direction is defined as the first lateral direction (X1) and the other direction is defined as the second lateral direction (X2). However, this is only for the purpose of explaining so that the present disclosure can be clearly understood, and each direction can be defined differently depending on where the reference is placed.
[0042] Hereinafter, embodiments of the present disclosure will be described with reference to the attached drawings. In the attached drawings, identical or corresponding components are assigned the same reference numerals. Furthermore, in the description of the embodiments below, redundant descriptions of identical or corresponding components may be omitted. However, even if a description of a component is omitted, it is not intended that such component is not included in any embodiment.
[0043] FIG. 1 is a perspective view of a catheter insertion needle device according to a first embodiment of the present disclosure. FIG. 2 is an exploded perspective view of a catheter insertion needle device according to a first embodiment of the present disclosure.
[0044] Referring to FIGS. 1 and 2, a method of using a catheter insertion needle device (10) of the present disclosure is described. The patient's skin or blood vessel is punctured using the tip (220c) of the catheter insertion needle device (10), and a needle (200) is fixed within the skin or blood vessel. With the needle (200) fixed, a sheath (100) capable of relative movement with respect to the needle (200) is inserted into the skin or blood vessel, and with the sheath (100) inserted, the needle (200) is removed by pulling the needle (200) in the opposite direction of the skin or blood vessel. Thereafter, a catheter (not shown) can be inserted into the guide hole (100h), which is an internal space of the sheath (100) connected to the skin or blood vessel. After the catheter insertion is completed, the sheath (100) can be removed by tearing in both directions. The description of the catheter insertion needle device described in this paragraph can also be applied to the catheter insertion needle devices of the first, second, and third embodiments. Furthermore, an expansion guide unit that expands the skin or blood vessel may be used during the skin or blood vessel puncture process or the sheath insertion process described above, and a description thereof will be described in detail below, along with drawings illustrating the expansion guide unit.
[0045] A needle device (10) for catheter insertion may include a needle (200), a sheath (100), a handle (500), and a fixing part (600).
[0046] The needle (200) may include a needle body (210) extending in a first direction. The first direction refers to the direction in which the needle (200) faces the patient's skin (not shown) or blood vessel (not shown). The first direction described in the present disclosure may be a first longitudinal direction (Y1). The second direction described in the present disclosure may be a second longitudinal direction (Y2). The needle body (210) may have a cylindrical shape with a hole therein.
[0047] The needle (200) may include an edge portion (220) forming a tip (220c) and an edge (220e). The edge portion (220) may be formed sharply so as to be able to cut a patient's skin or blood vessel. The tip portion (220c) may form the distal end of the needle (200) in a first direction (Y1). The edge portion (220) may be a pair of edge portions that meet each other at an acute angle at the tip portion (220c). The pair of edge portions (220) may form edges (220e) whose widths increase in a direction perpendicular to the first direction (Y1) as they go toward the second direction (Y2). The direction perpendicular to the first direction (Y1) may be directions (X1, X2) on both sides. The corners (220e) of the edge portion (220) can be formed sharply so as to be able to cut the patient's skin in both directions (X1, X2). Each of the pair of edge portions (220) can extend in a straight line.
[0048] The sis (100) may include a sis connection portion (110) located in a first direction (Y1) and a sis body (120) formed by extending from the sis connection portion (110) in a second direction (Y2). The sis connection portion (110) may be configured to have a height that increases as it goes in the second direction (Y2). The sis connection portion (110) may have an outer surface in the shape of a truncated cone whose outer diameter increases as it goes in the second direction (Y2). The sis body (120) may have a cylindrical shape formed by extending in the length direction on the inside. The sis body (120) may be configured to have a constant height as it goes in the second direction (Y2).
[0049] The sheath (100) may have a guide hole (100h) extending in a first direction (Y1) therein. Although not shown, the second direction (Y2) end of the sheath body (120) may be configured to have an open end to form the guide hole (100h). A catheter may be configured to be inserted into the guide hole (100h) of the sheath (100). A needle body (210) may be positioned to pass through the guide hole (100h). When the needle (200) is coupled to the sheath (100) (see FIG. 1), the tip (220c) and the edge portion (220) may be configured to be positioned in the first direction (Y1) of the guide hole (100h). The outer diameter of the end of the sis (100) in the first direction (Y1) can be configured to be larger than the maximum width of the pair of edge portions (220) in the directions (X1, X2) on both sides.
[0050] The fixed part (600) may be configured to fix the sis (100). The fixed part (600) may include a first fixed part (610) and a second fixed part (620) configured to be coupled to each other to fix the sis. The first fixed part (610) and the second fixed part (620) may be coupled to include a guide (600g) so that a portion of the sis (100) can be secured.
[0051] The handle (500) can form a coupling hole (500h) extending in the first direction (Y1) therein so that the needle body (210) of the needle (200) can be inserted and coupled. During the catheter insertion process, the needle (200) fixed to the handle (500) can be removed by pulling the handle (500).
[0052] A needle device (10) for catheter insertion may be formed with an expansion guide portion for expanding skin or blood vessels. The expansion guide portion may have a rounded outer surface. The expansion guide portion may be formed to be rounded in both directions (X1, X2) relative to the edge portion (220). The expansion guide portion may be formed to be convex in both directions (X1, X2).
[0053] The expansion guide member may be disposed between the ends of the pair of edge portions (220) in the second direction (Y2) and the ends of the sheath (100) in the first direction (Y1). By being disposed between the edge portions (220) and the sheath (100), the expansion guide member may expand the skin and blood vessels before the sheath (100) is inserted. The expansion guide member may have a width in both directions (X1, X2) that increases as it goes in the second direction (Y2). The width of the ends of the expansion guide member in the first direction (Y1) in both directions may be greater than or equal to the maximum width of the pair of edge portions (220) in both directions (X1, X2). The width of the ends of the expansion guide member in the second direction (Y2) in both directions (X1, X2) may be less than or equal to the outer diameter of the ends of the sheath (100) in the first direction (Y1).
[0054] In some embodiments, the expansion guide portion may be included in the needle (200). In other embodiments, the expansion guide portion may be a separate component from the needle (200), and the catheter insertion needle device (10) may include a perforation portion (not shown) that includes the needle (200) and the expansion guide portion. In the first and second embodiments described below, some of the embodiments are described, and in the third embodiment, the other embodiments are described.
[0055] FIG. 3 is a partial perspective view illustrating a portion of a catheter insertion needle device according to the first embodiment of the present disclosure and a portion of a catheter insertion needle device according to a comparative embodiment. FIG. 3 (a) is a partial perspective view illustrating a portion of a catheter insertion needle device according to the first embodiment of the present disclosure, and FIG. 3 (b) is a partial perspective view illustrating a portion of a catheter insertion needle device according to the comparative embodiment.
[0056] Fig. 4 is a cross-sectional view taken along the lines S1-S1' and S2-S2' shown in Fig. 3. Fig. 4 (a) is a cross-sectional view taken along the line S1-S1', and Fig. 4 (b) is a cross-sectional view taken along the line S2-S2'.
[0057] FIG. 5 is a partial plan view showing a part of a catheter insertion needle device according to the first embodiment illustrated in FIG. 3 and a part of a catheter insertion needle device according to a comparative embodiment, as viewed in direction A. Direction A may be a direction parallel to the Z2 direction illustrated in FIG. 1. FIG. 5 (a) is a partial plan view showing a part of a catheter insertion needle device according to the first embodiment illustrated in FIG. 3, as viewed in direction A. FIG. 5 (b) is a partial plan view showing a part of a catheter insertion needle device according to the comparative embodiment illustrated in FIG. 3, as viewed in direction A.
[0058] Referring to FIGS. 3 to 5, an expansion guide portion (230) may be formed on the needle (200). The expansion guide portion (230) may be formed to be round when viewed in a direction (A) perpendicular to the first direction (Y1) and both directions (X1, X2) (see (a) of FIG. 5). The perpendicular direction (A) may be a downward direction (Z2). The expansion guide portion (230) may extend from an end (220el) of the edge portion (220) in the second direction (Y2). A tangent line at the end of the expansion guide portion (230) in the first direction (Y1) may be the same as a tangent line of the edge portion (220) connected at the end of the expansion guide portion (230) in the first direction (Y1). The intersection point (P) of the tangent at the end (230l) of the second direction (Y2) of the expansion guide portion and the tangent at the end (220el) of the second direction (Y2) of the edge portion (220) can be formed on the outside of the expansion guide portion. Compared to the comparative embodiment (20) in which the expansion guide portion is not formed (see (b) of FIG. 3), by forming the expansion guide portion (230) on the needle (200), the sharp edge portion (220) of the needle (200) can be minimized. The size of the wound is proportional to the maximum width in both directions perpendicular to the first direction of the edge portion, and the maximum width (e1) of the edge portion (220) in both directions according to the first embodiment is smaller than the maximum width (e2) of the edge portion (220) in both directions according to the comparative embodiment, so that the occurrence of the wound can be minimized.
[0059] Referring to (a) of Fig. 4, when looking at the cross-section passing through the edge portion (220), a sharp edge (220e) is formed. On the other hand, referring to (b) of Fig. 4, when looking at the cross-section passing through the expansion guide portion (230), it is formed to be rounded so as to protrude convexly in both directions (X1, X2). According to one embodiment of the present disclosure, the needle device for catheter insertion can minimize the occurrence of a wound on a patient by minimizing the sharp part of the edge portion (220) by forming the expansion guide portion on the needle (200).
[0060] Fig. 6 is a drawing comparing the degree of wound tearing when using a catheter insertion needle device according to the first embodiment and a catheter insertion needle device according to a comparative example. Fig. 6 (a) is a drawing showing a wound formed on an artificial film when the artificial film is punctured with a needle of a catheter insertion needle device according to the first embodiment, and Fig. 6 (b) is a drawing showing a wound formed on an artificial film when the artificial film is punctured with a needle of a catheter insertion needle device according to the comparative example.
[0061] Referring to FIG. 6, the width (A2) between the two ends of the wound according to the comparative example is 1.5 mm, and the width (A1) between the two ends of the wound according to the first embodiment is 1.24 mm, so it can be seen that the width between the two ends of the wound is reduced by about 82.4%.
[0062] Fig. 7 is a perspective view of a needle device for catheter insertion according to a second embodiment of the present disclosure. Fig. 8 is an exploded perspective view of a needle device for catheter insertion according to a second embodiment of the present disclosure.
[0063] The description of the system, needle body, pair of edge portions, handle and fixing part according to the first embodiment described above with reference to FIGS. 1 to 5 also applies to the catheter insertion needle device (10') according to the second embodiment described below with reference to FIGS. 7 and 8. Hereinafter, the catheter insertion needle device (10') according to the second embodiment will be described with reference to FIGS. 7 and 8, focusing on the differences from the first embodiment described above.
[0064] The needle (200') may include an inclined portion (250) whose height increases from the tip (220c) in the second direction (Y2) when viewed from both directions (X1, X2). As an example, FIG. 8 illustrates the inclined portion (250) when the needle (200') is viewed from the second side direction (X2). An expansion guide portion (252) may be formed in the second direction (Y2) of the inclined portion (250). The expansion guide portion (252) may be formed integrally with the needle body (210) and the pair of edge portions (220). In the removal process of the needle (200'), the expansion guide portion (252) may be removed from the skin and blood vessels together with the pair of edge portions (220) and the needle body (210).
[0065] The expansion guide portion (252) may be formed so that its outer diameter increases as it goes in the second direction (Y2). The expansion guide portion (252) may have an outer surface in the shape of a truncated cone. The expansion guide portion (252) may be inserted into the skin or blood vessel after the tip (220c) and the edge (220e) of the needle (200') are inserted, thereby playing a role in expanding the skin and blood vessels.
[0066] Fig. 9 is a perspective view of a catheter insertion needle device according to a third embodiment of the present disclosure. Fig. 10 is an exploded perspective view of a catheter insertion needle device according to a third embodiment of the present disclosure.
[0067] The description of the system, needle body, pair of edge portions, handle and fixing part according to the first embodiment described above with reference to FIGS. 1 to 5 also applies to the catheter insertion needle device (10'') according to the third embodiment described below with reference to FIGS. 9 and 10. Hereinafter, the catheter insertion needle device (10'') according to the third embodiment will be described with reference to FIGS. 9 and 10, focusing on the differences from the first and second embodiments described above.
[0068] Referring to FIGS. 9 and 10, a needle device (10'') for catheter insertion may include a dilator (300) having an expansion guide portion (310) formed therein. The dilator (300) may pass through a guide hole (100h) of the sheath (100). A portion of the dilator (300) may be positioned so as to pass through the interior of the sheath (100). The dilator (300) may have an extension hole (300h) through which a needle body (210) passes. The needle body (210) may be positioned by passing through the extension hole (300h).
[0069] The expander (300) may include an expansion guide portion (310) and an expander body (320). The expansion guide portion (310) may have an outer surface in the shape of a truncated cone whose outer diameter increases as it goes in the second direction (Y2). The expansion guide portion (310) may be positioned in the second direction (Y2) of an inclined portion whose height increases as it goes in the second direction (Y2) from a tip (220c) when viewed from both directions (X1, X2). The expander body (320) may be formed to extend from the expansion guide portion (310) in the second direction (Y2).
[0070] FIG. 11 is a partial plan view illustrating a portion of a catheter insertion needle device according to a first embodiment of the present disclosure and a portion of a catheter insertion needle device according to a third embodiment. FIG. 11 (a) is a partial plan view illustrating a portion of a catheter insertion needle device according to the first embodiment, and FIG. 11 (b) is a partial plan view illustrating a portion of a catheter insertion needle device according to the third embodiment.
[0071] Referring to FIGS. 1 to 5 and 9 to 11, a tip (220c) is formed at the end in the first direction of a catheter insertion needle device (10) according to the first embodiment, and the catheter insertion needle device (10) includes a pair of edge portions (220e) whose widths in both directions increase as they go in the second direction. An expansion guide portion (230) is formed in a needle (200) of the catheter insertion needle device (10) according to the first embodiment, which extends roundly from the end of the edge portion (220e) in the second direction. The expansion guide portion (230) may be configured so that its width in both directions increases as it goes in the second direction. A tip (220c) is formed at the end in the first direction of a catheter insertion needle device (10'') according to the third embodiment, and the catheter insertion needle device (10'') includes a pair of edge portions (220e) whose width in both directions increases as it goes in the second direction.
[0072] The expansion guide portion (310) of the catheter insertion needle device (10'') according to the third embodiment is a separate component from the needle (200'') and is positioned between the edge portion (220) of the needle (200'') and the sheath (100). Since the catheter insertion needle device (10'') according to the third embodiment has a separate expander (300), a needle (200'') having a smaller diameter than the needle (200) of the catheter insertion needle device (10) according to the first embodiment can be used. For example, a 17Ga needle can be used as the needle (200) of the catheter insertion needle device (10') according to the third embodiment, and a 19Ga needle can be used as the needle (200'') of the catheter insertion needle device (10').
[0073] While the technical concept of the present disclosure has been described above with reference to certain embodiments and examples illustrated in the accompanying drawings, it should be understood that various substitutions, modifications, and variations may be made without departing from the technical concept and scope of the present disclosure, which would be understood by those skilled in the art to which the present disclosure pertains. Furthermore, such substitutions, modifications, and variations should be considered to fall within the scope of the appended claims.
Claims
1. A needle including a needle body extending in a first direction, a tip forming a terminal in the first direction, and a pair of edges meeting each other at an acute angle at the tip and widening in both directions perpendicular to the first direction as they go in a second direction opposite to the first direction, thereby forming sharp edges capable of cutting the skin of a patient in both directions; and A sheath having a guide hole extending in the first direction so that a catheter can be inserted therein, the needle body being positioned so that the tip and the edge of the needle are positioned in the first direction of the guide hole, and the outer diameter of the end in the first direction is larger than the maximum width of the pair of edge portions in the two directions, An expansion guide portion is formed between the ends of the pair of edge portions in the second direction and the ends of the sheath in the first direction, and the width in the both-side directions increases as it goes in the second direction, the width of the ends in the first direction in the both-side directions is greater than or equal to the maximum width of the pair of edge portions in the both-side directions, the width of the ends in the second direction in the both-side directions is less than or equal to the outer diameter of the ends of the sheath in the first direction, and the outer surface is formed to be rounder than the edge portion in the both-side directions. Needle device for catheter insertion.
2. In paragraph 1, The above expansion induction part is formed on the needle, Needle device for catheter insertion.
3. In paragraph 2, The above-mentioned expansion induction portion extends roundly from the end of the edge portion in the second direction when viewed in a direction perpendicular to the first direction and the both directions. Needle device for catheter insertion.
4. In paragraph 3, When viewed from a direction perpendicular to the first direction and the both directions, the pair of edge portions each extend in a straight line, and the tangent line at the end of the expansion induction portion in the first direction is the same as the tangent line of the edge portion connected at the end of the expansion induction portion in the first direction. Needle device for catheter insertion.
5. In paragraph 4, When viewed from a direction perpendicular to the first direction and the two sides, each of the pair of edge portions extends in a straight line. Needle device for catheter insertion.
6. In paragraph 3, When viewed from a direction perpendicular to the first direction and the both sides, the expansion induction portion is formed to be rounded so as to protrude convexly in the both sides. Needle device for catheter insertion.
7. In paragraph 2, The above needle includes a sloped portion whose height increases from the tip in the second direction when viewed from the two sides, The above expansion induction part is formed in the second direction of the above inclined part, Needle device for catheter insertion.
8. In paragraph 2, The above-mentioned expansion induction part has an outer surface in the shape of a cone whose outer diameter increases as it goes in the second direction. Needle device for catheter insertion.
9. In paragraph 1, An expander including an extender extending in the first direction and passing through the guide hole of the sheath, having an extension hole through which the needle body passes, and having the extension guide portion formed therein. Needle device for catheter insertion.
10. In paragraph 9, The above needle includes a sloped portion whose height increases from the tip in the second direction when viewed from the two sides, The expansion induction part of the above expander is located in the second direction of the above inclined part, Needle device for catheter insertion.
11. In paragraph 9, The above-mentioned expansion induction part has an outer surface in the shape of a cone whose outer diameter increases as it goes in the second direction. Needle device for catheter insertion.
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