Injection needle having modified surface texture and method for manufacturing the same

Abstract

Provided herein is a method for modifying the surface texturing of hypodermic needles. The method comprises placing one or more hypodermic needles on a support tool, each of which comprises a cylindrical needle body having a terminal end and a proximal end and defining a lumen inside. The method also comprises directing a laser from one or more laser sources onto the outer surface of each needle body of the one or more hypodermic needles. The laser forms a pattern of depressions on the outer surface of each needle body of the one or more hypodermic needles, thereby forming a textured outer surface on the one or more hypodermic needles.

Description

Technical Field

[0001] Reference to Related Applications This application claims the priority of U.S. Utility Patent Application No. 18 / 455,004, filed on August 24, 2023, entitled "Syringe Needle with Modified Surface Texture and Method of Manufacturing the Same", the disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Background of the Invention Field of the Invention The present disclosure relates to needles for use in medical injection devices, more particularly, needles having a modified surface texture and methods of manufacturing the same.

[0003] Description of the Related Art Medical injection devices such as syringes are used in various environments to administer liquids (e.g., drugs or medications) to patients. A syringe typically includes a barrel having a plunger assembly inserted into an open proximal end of the barrel and an opening provided at an opposite distal end adapted to receive a needle therein, whereby fluid is injected into the patient.

[0004] In the manufacture of syringes, a method for fixing a needle within an opening at the distal end of the syringe barrel is required. In some manufacturing techniques, the needle and the syringe barrel are each formed / manufactured separately, and the needle is then fixed within the opening at the distal end of the syringe barrel using a UV curable adhesive or other adhesive. In other manufacturing techniques, the syringe barrel may be formed in such a way that it fixes the needle during the manufacturing process. When the syringe barrel is formed of a polymeric material, the syringe barrel may be overmolded onto the needle to fix the needle within the opening at the distal end of the syringe barrel. When the syringe barrel is formed of glass, the syringe barrel may be glass formed onto the needle to fix the needle within the opening at the distal end of the syringe barrel.

[0005] In any of the above manufacturing techniques, it is desirable to apply surface texturing or "rugosity" to at least the needle portion that is fixed to the syringe barrel to provide improved adhesion / bonding between the needle and the syringe barrel. This surface texturing of the needle is generally provided by sandblasting the needle. However, it is recognized that sandblasting is difficult to apply to small needles and is a time-consuming process. Furthermore, it is recognized that sandblasting can result in a lack of precision in forming the surface texturing, both in terms of controlling the area to which the surface texturing is applied and / or forming a specific surface texturing pattern.

[0006] Therefore, there is a need for a technology for a process in which surface texturing or wrinkles may be provided to an injection needle, as this surface texturing or wrinkles provide improved adhesion and bonding between the needle and its support, thus providing better resistance to pull-out forces. [Overview of the project]

[0007] Provided herein is a method for modifying the surface texturing of hypodermic needles. The method comprises positioning one or more hypodermic needles on a support tool, each of which comprises a cylindrical needle body having a terminal end and a proximal end and defining a lumen inside. The method also comprises directing a laser from one or more laser sources onto the outer surface of each needle body of the one or more hypodermic needles. The laser forms a pattern of depressions on the outer surface of each needle body of the one or more hypodermic needles, thereby forming a textured outer surface on the one or more hypodermic needles.

[0008] In certain configurations, the laser is directed onto the outer surface of the proximal end of the needle body.

[0009] In a particular configuration, when a laser is directed onto the outer surface of each needle body of one or more injection needles, the laser is directed at multiple different locations to form a pattern of indentations.

[0010] In a particular configuration, when the laser is directed onto the outer surface of each needle body of one or more injection needles, the laser is directed multiple times at each of several different locations to provide a repetitive laser application pattern.

[0011] In a particular configuration, the depression pattern includes multiple craters, and the depth of each of these craters is controlled based on the number of times a laser is directed at each of the craters.

[0012] In a particular configuration, the depth of each of the multiple craters ranges from 1.5 to 9.0 micrometers.

[0013] In certain configurations, each of the multiple craters has a rounded base and a sharp rim surrounding it.

[0014] In a particular configuration, each of the multiple craters has a diameter of 30 micrometers.

[0015] In a particular configuration, the pattern of indentations includes multiple rows, and each of the multiple rows includes multiple indentations.

[0016] In a particular configuration, each of the multiple rows extends circumferentially around the outer surface, covering a semi-cylindrical outer body.

[0017] In a particular configuration, the method further comprises reversing the orientation of each of one or more injection needles, such that each of the multiple rows extends circumferentially around the entire outer surface and covers the entire cylinder of the cylindrical outer body.

[0018] In certain configurations, the laser includes ultraviolet lasers.

[0019] Also provided herein is an injection needle including a cylindrical needle body having a distal end portion and a proximal end portion and defining a lumen, and an inclined injection tip formed at the distal end portion. The proximal end portion of the cylindrical needle body includes a textured outer surface having a plurality of rows, each of the plurality of rows having a plurality of craters recessed radially inwardly within the outer surface, and the plurality of rows being axially disposed along the length of the cylindrical needle body at the proximal end portion. The plurality of craters are configured to enhance the coupling of the textured outer surface to the surrounding needle support.

[0020] In a particular configuration, each of the plurality of rows is directly adjacent to the other plurality of rows.

[0021] In a particular configuration, the plurality of rows includes at least a first row group and a second row group, each of the first row group and the second row group including a plurality of rows, and the first row group being axially spaced from the second row group by only a gap without craters on the outer surface of the cylindrical needle body.

[0022] In a particular configuration, each of the plurality of craters has a rounded bottom and a sharp edge around it.

[0023] In a particular configuration, the depth of each of the plurality of craters is 1.5 to 9. Micrometers.

[0024] In a particular configuration, each of the plurality of craters has a diameter of 30 micrometers.

[0025] In a particular configuration, each of the plurality of rows extends circumferentially around the outer surface and covers a semi-cylinder of the cylindrical outer body.

[0026] In a particular configuration, each of the plurality of rows extends circumferentially around the entire outer surface and covers the entire cylinder of the cylindrical outer body.

Brief Description of the Drawings

[0027] [Figure 1] FIG. 1 is an exploded view of a syringe in which embodiments of the present disclosure may be implemented. [Figure 2] Figure 2 is a cross-sectional view taken along line 2-2 of Figure 1 and shows the needle held within the hub of the syringe barrel. [Figure 3] Figure 3 is a perspective view of an apparatus for modifying the surface texturing of an injection needle according to one aspect of the present disclosure. [Figure 4] Figure 4 is a schematic view of a texturing tool included in the apparatus of Figure 3 and directs a laser onto a plurality of needles to modify their surface texturing. [Figure 5] Figure 5 is a perspective view showing the support plate of the texturing tool included in the apparatus of Figure 3 and the needles held therein in a first orientation. [Figure 6] Figure 6 is a perspective view showing the support plate of the texturing tool included in the apparatus of Figure 3 and the needles held therein in a second orientation. [Figure 7] Figure 7 shows a pattern of recesses formed on the outer surface of a needle according to one aspect of the present disclosure. [Figure 8] Figure 8 shows a pattern of recesses formed on the outer surface of a needle according to another aspect of the present disclosure. [Figure 9] Figure 9 is a cross-sectional view of a needle showing the diameter and depth of recesses formed on the outer surface of the needle according to one aspect of the present disclosure. [Figure 10] Figure 10 is a cross-sectional view of a needle showing the diameter and depth of recesses formed on the outer surface of the needle according to another aspect of the present disclosure. **DETAILED DESCRIPTION OF THE INVENTION**

[0028] Description of the Invention The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the invention. However, various changes, equivalents, modifications, and alternatives will be readily apparent to one of ordinary skill in the art. All such changes, modifications, equivalents, and alternatives are intended to be included within the spirit and scope of the present invention.

[0029] For the purposes described below, “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “side,” “vertical,” and their derivatives shall be used in relation to the orientation of the invention as described herein in the drawings. However, it should be understood that the invention may take various alternative modifications unless explicitly otherwise specified. It should also be understood that the particular devices shown in the accompanying drawings and described below are merely embodiments of the invention. Therefore, the specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0030] In this disclosure, the term "end end" of a component or device means the end furthest from the user's hand when the component or device is in use, i.e., when the user is holding the syringe and preparing or using it, and the term "proximal end" means the end closest to the user's hand. Similarly, in this application, the terms "end direction" and "to the end" mean the direction toward the end tip of the syringe, and the terms "proximal direction" and "to the proximal end" mean the direction opposite to the direction of the end tip of the syringe.

[0031] Aspects and embodiments of this disclosure are directed toward methods for modifying the surface texturing or rugosity of an injection needle, where the surface texturing or roughness improves adhesion and bonding between the needle and its support, thereby providing better resistance to pull-out forces.

[0032] Referring to Figure 1, the figures shown are non-limiting embodiments of medical injectors in which aspects or embodiments of the present disclosure may be implemented. The medical injector is referred to and described below as a syringe ("Syringe 10"), but it will be understood that other medical injectors may also incorporate aspects of the present disclosure, as will be discussed later.

[0033] As shown in Figure 1, the syringe 10 generally comprises a syringe barrel 12 and a plunger assembly 14 (including a rod 36 and a stopper 38). The plunger assembly 14 is movable along its longitudinal axis to an advanced position within the syringe barrel 12 to facilitate the administration of an injectable fluid (e.g., a drug) to a patient, for example. The syringe barrel 12 is formed from a generally cylindrical outer wall 16 and an end member 18, which together define a chamber 20 in which the fluid is held. The syringe barrel 12 includes an open proximal end 22 configured to receive the plunger assembly 14 internally and a distal end 24 in which the end member 18 is positioned. The proximal end 22 of the syringe barrel 12 may include a flange 26 to facilitate handling and positioning of the syringe 10 and to maintain the relative position of the syringe barrel 12 and the plunger assembly 14 during drug administration. At the end portion 24, the end member 18 may include a shoulder portion 28 that narrows relative to the cylindrical outer wall 16 and a hub portion 30 extending from the shoulder portion 28 to the end. The hub portion 30 is formed as a partially hollow member that defines a through channel 32 that fluidly communicates with the chamber 20. The needle 34 is a stake needle that is attached to the hub portion 30 within the channel 32, i.e., bonded to the hub portion 30 or otherwise fixed.

[0034] The fixation of the needle 34 within the hub is shown in more detail in Figure 2. As shown there, the needle 34 is formed from a cylindrical body 40 having a terminal end 42 and a proximal end 44, the body 40 defining a lumen 46 extending from the terminal end 42 to the proximal end 44 along the length of the needle 34. The terminal end 42 of the needle 34 includes an inclined injection tip 48 for injecting the needle 34 into the patient when the syringe 10 is in use. The proximal end 44 of the needle 34 is held within a channel 32 of the hub 30 to ensure secure retention of the needle 34 during use of the syringe 10. In some embodiments, the needle 34 is fixed within the channel 32 by glue or other suitable adhesive, such as UV-curing adhesive. In other embodiments, the needle 34 is fixed by overmolding the needle 34 onto the syringe barrel 12 (i.e., the hub 30) (if the syringe barrel 12 is made of a polymer material) or by glass formation onto the needle 34 onto the syringe barrel 12 (i.e., the hub 30) (if the syringe barrel 12 is made of glass).

[0035] In aspects of the present disclosure, it is desirable that at least a portion of the needle 34, such as the proximal end 44, be textured such that the outer surface 50 (of the body 40) has wrinkles that can help secure the needle 34 within the hub 30. The textured outer surface 50 enhances the bond between the needle 34 and the hub 30 of the syringe barrel 12, whether the needle 34 is bonded to the hub 30 or the hub 30 is overmolded or glass-formed onto the needle 34. A method for modifying the surface texturing of a syringe needle 34 is provided, as will be described in detail below, and the method provides a textured outer surface by manufacturing a needle 34 having a desired recess pattern on its outer surface 50.

[0036] Referring to Figures 3-6, an apparatus 52 is provided which may be used to modify the surface texturing of an injection needle 34 according to one aspect of the present disclosure. The apparatus 52 may comprise a base 54 and a texturing tool 56 provided on the base 54. In one embodiment, the texturing tool 56 includes a fixing or locking unit 58 in which one or more needles 34 may be fixed for processing, and one or more laser emitters or sources 60 configured to direct a laser toward the needles 34 to provide texturing thereto.

[0037] Each of the base 54 and the locking unit 58 may be formed of aluminum or other suitable material. The base 54 may be configured to provide a raised surface or platform 62 to which the locking unit 58 may be secured via alignment pins 64 or the like, and has a concave central region 66 to which the needles 34 may be laser-processed. The locking unit 58 includes an outer housing 68 mounted on the base 54 and a support plate 70 positioned within the housing 68 and generally positioned across the concave central region 66 of the base 54, the support plate 70 may have a plurality of grooves 72 in which the needles 34 may be arranged. In the illustrated embodiment, the locking unit 58 is configured to hold within it 10 needles 34 for surface texturing, but it is recognized that more or fewer needles 34 may be held therein. The needles 34 may be fixed to the locking unit 58 so that the portion of the needle 34 to be processed, i.e., its proximal end 44, is positioned on an opening 74 provided in the support plate 70.

[0038] One or more laser sources 60 included in the texturing tool 56 are configured to direct a laser toward a needle 34 to provide it with texturing. In some embodiments, the laser source 60 generates an ultraviolet (UV) laser for processing the needle 34. The laser source(s) 60 may be mounted on the texturing tool 56 (i.e., its housing 68) by a laser guidance structure 76 including a mount 78 and an actuator 80 (e.g., an electric motor), the guidance structure 76 enabling the movement (i.e., linear and / or rotational movement) of the laser source 60 to provide a desired positioning / orientation relative to the needle 34 held on a support plate 70. By controlling the positioning / orientation of the laser source 60, the laser may be directed toward a predetermined position on the needle 34 to form a desired pattern of recesses 82 on the outer surface 50 of the needle 34.

[0039] In some embodiments, the texturing tool 56 may further include a rotation axis 84 that provides rotation of the support plate 70 (and needle 34) relative to the laser source(s) 60. The rotation of the rotation axis 84 may reorient the support plate 70 and needle 34 so that the bottom surface of the needle 34 (i.e., the lower semi-cylindrical portion of the proximal end 44 of the needle 34) is machined to have surface texturing thereon. That is, when the needle 34 and support plate 70 are held in a stationary position, the laser source 60 can direct the laser only to the upper semi-cylindrical portion of the needle 34 to provide surface texturing thereon, but the rotation of the rotation axis 84 provides reorientation of the positions of the support plate 70 and needle 34 (see Figures 5 and 6), making it possible to provide circumferential surface texturing around the entire outer surface 50 of the proximal end 44 of the needle 34. Therefore, based on the selective rotation of the support plate 70 and the needle 34 by the rotating shaft 84, the surface texturing of the needle 34 may be controlled to form a semi-cylindrical recess pattern only in half of the area of ​​the cylindrical outer surface 50 of the needle 34 (at the base end 44), or a cylindrical recess pattern may be formed circumferentially around the entire cylindrical outer surface 50 of the needle 34 (at the base end 44).

[0040] Referring to Figures 7-10, detail views of the outer surface 50 of the needle 34 according to various embodiments of the present disclosure are shown for the purpose of illustrating surface texture patterns that may be formed on the needle 34. As shown therein, when a laser is directed onto the outer surface 50 of the needle 34, the laser is directed at a plurality of different locations, forming a pattern of depressions 82 therein. Each of the depressions 82 may consist of a point or crater (hereinafter "crater 82") extending radially inward into the needle 34. As most clearly shown in Figures 9 and 10, each of the craters 82 may be configured to have a rounded bottom and a sharp edge around it. The diameter (D_crater) and depth (H_crater) of the craters 82 may be controlled based on surface texturing considerations and by the configuration and control of the laser source 60. With respect to the diameter D_crater of each of the plurality of craters 82, in some embodiments the craters 82 may be formed to have a diameter of about 30 micrometers, although larger or smaller diameters are also possible. With respect to the depth of each of the multiple craters 82, it is recognized that the depth may be controlled based on the number of passes / exposures of the laser from each laser source 60 to the crater 82. That is, the depth of each crater 82 may be increased by repeatedly directing the laser thereto, with each exposure of the crater 82 to the laser removing additional material from it and increasing the depth of the crater 82. For example, according to a non-limiting embodiment, the laser source(s) 60 and laser guidance structure 76 are controlled so that the laser is directed to each crater 82 multiple times, and each crater 82 is treated / exposed to the laser 1 to 4 times. With such single or repeated laser exposures, the depth of each of the multiple craters 82 may be controlled to about 1.5 micrometers (1 laser exposure) to 9.0 micrometers (4 laser exposures).

[0041] As shown in Figures 7 and 8, the pattern of indentations (i.e., craters 82) formed on the outer surface 50 of the needle 34 can vary based on the selective control / positioning of the laser directed onto the needle 34. In each embodiment, the craters 82 are arranged / patterned to form a plurality of rows 86 extending circumferentially around the outer surface 50, with each row 86 of craters 82 covering a semi-cylindrical or entire cylindrical outer body 40 (as described in detail above) at the proximal end 44 of the needle 34. The rows 86 of craters are arranged axially along the needle 34 (along axis A_needle). In some embodiments, the craters 82 are patterned such that each of the plurality of rows 86 of craters is adjacent to one another (i.e., there are no axial gaps 88 between adjacent rows 86 of craters), as shown in Figure 7. In other embodiments, the craters 82 are patterned such that axial gaps 88 are provided between groups of rows 86 of craters, as shown in Figure 8. That is, the rows 86 of craters 82 are arranged in groups, with the first row group 90 including multiple rows 86 (e.g., 3 rows) of craters 82, and the second row group 92 including multiple rows 86 (e.g., 3 rows), and the first row group 90 may be spaced axially from the second row group 92 by a gap 88 where there are no craters 82 on the outer surface 50 of the cylindrical needle body 40.

[0042] While specific recess patterns are shown in Figures 7 and 8, other recess patterns 82 may be formed / provided on the outer surface 50 of the needle 34, and it is recognized that aspects of the present disclosure are not limited to those shown and described herein in detail. Generally, the recess pattern 82 should provide the needle 34 with a textured outer surface 59, which should provide improved adhesion and bonding between the needle 34 and the support (e.g., the hub 30 in Figure 1) in which it is held.

[0043] Beneficially, embodiments of the present invention are directed toward a method of modifying the surface texturing of an injection needle to provide wrinkles on the outer surface 50 of the needle, thereby providing improved adhesion and bonding between the needle and its support. Such surface texturing / wrinkles provide the needle with improved resistance to pull-out forces from the support, whether the needle is bonded to the support or the support is overmolded or glass-formed onto the needle.

[0044] While this disclosure is described in detail based on the most practical and preferred embodiments or aspects currently available, it should be understood that such details are for illustrative purposes only and that this disclosure is not limited to the disclosed embodiments or aspects, but rather intended to encompass modifications and equivalent configurations within the spirit and scope of the appended claims. For example, it should be understood that, to the extent possible, this disclosure also envisions combining one or more features of any embodiment with one or more features of other embodiments.

Claims

1. A method for modifying the surface texturing of an injection needle, wherein the method is Placing one or more injection needles on a support tool, wherein each of the one or more injection needles has a terminal end and a proximal end and comprises a cylindrical needle body that defines a lumen inside, and This includes directing a laser from one or more laser sources towards the outer surface of each of the needle bodies of the one or more injection needles, A method comprising using the laser to form a recessed pattern on the outer surface of each of the needle bodies of the one or more injection needles, thereby forming a textured outer surface on the one or more injection needles.

2. The method according to claim 1, wherein the laser is directed at the outer surface of the base end of the needle body.

3. The method according to claim 1, wherein when a laser is directed at the outer surface of each of the needle bodies of the one or more injection needles, the laser is directed at a plurality of different positions to form the pattern of indentations.

4. The method according to claim 3, wherein when the laser is directed at the outer surface of the needle body of each of the one or more injection needles, the laser is directed multiple times at each of a plurality of different positions to repeatedly form a laser application pattern.

5. The method according to claim 4, wherein the pattern of depressions includes a plurality of craters, and the depth of each of the plurality of craters is controlled based on the number of times the laser is directed at each of the plurality of craters.

6. The method according to claim 5, wherein the depth of each of the plurality of craters is 1.5 to 9.0 micrometers.

7. The method according to claim 5, wherein each of the plurality of craters has a rounded bottom and a sharp rim around it.

8. The method according to claim 5, wherein each of the plurality of craters has a diameter of 30 micrometers.

9. The method according to claim 1, wherein the recess pattern includes a plurality of rows, and each of the plurality of rows includes a plurality of recesses.

10. The method according to claim 9, wherein each of the plurality of rows extends circumferentially around the outer surface and covers the semi-cylindrical portion of the cylindrical outer body.

11. The method further includes reversing the orientation of each of the one or more injection needles, The method according to claim 10, wherein each of the plurality of rows extends circumferentially around the entire outer surface of the cylindrical outer body, covering the entire cylinder.

12. The method according to claim 1, wherein the laser includes an ultraviolet laser.

13. It is an injection needle, A cylindrical needle body having a terminal end and a proximal end that defines the lumen, and The end portion is equipped with an inclined injection tip, The base end of the cylindrical needle body has a textured outer surface, the textured outer surface includes a plurality of rows, each of the plurality of rows has a plurality of craters recessed radially inward within the outer surface, the plurality of rows are arranged axially along the length of the cylindrical needle body at the base end, and An injection needle having a plurality of craters configured to enhance the adhesion of the textured outer surface to the surrounding needle support.

14. The injection needle according to claim 13, wherein each of the plurality of rows is directly adjacent to the other plurality of rows.

15. The injection needle according to claim 13, wherein the plurality of rows include at least a first group of rows and a second group of rows, each of the first group of rows and the second group of rows includes a certain number of rows, and the first group of rows is spaced axially from the second group of rows by a gap without craters on the outer surface of the cylindrical needle body.

16. The injection needle according to claim 13, wherein each of the plurality of craters has a rounded bottom and a sharp edge surrounding it.

17. The injection needle according to claim 13, wherein the depth of each of the plurality of craters is 1.5 to 9.0 micrometers.

18. The injection needle according to claim 13, wherein each of the plurality of craters has a diameter of 30 micrometers.

19. The injection needle according to claim 13, wherein each of the plurality of rows extends circumferentially around the outer surface and covers the semi-cylindrical part of the cylindrical outer body.

20. The injection needle according to claim 13, wherein each of the plurality of rows extends circumferentially around the entire outer surface and covers the entire cylinder of the cylindrical outer body.

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