Acupuncture device

Abstract

Disclosed is an acupuncture device including a needle tube and a base. The needle tube includes an outer sleeve having a first through-hole, an inner sleeve having a second through-hole, at least a portion of which is accommodated in the first through-hole, the inner sleeve being slidable and rotatable with respect to the outer sleeve, and a spherical adjusting member coupled to the outer sleeve at a side opposite to the side where the inner sleeve is located and having a third through-hole. The base includes a horizontal portion having a plate shape with a circular hole in the center thereof and coupled to the spherical adjusting member through the circular hole, and a vertical portion extending downward from a distal end of the horizontal portion to define a space for accommodating at least a portion of the spherical adjusting member together with the horizontal portion. An inner wall of the vertical portion includes a vertical wall connected to the horizontal portion and an inclined wall extending from the vertical wall in a direction away from the spherical adjusting member. The space includes a cut corner portion adjacent to the inclined wall. The device can be used for an electroacupuncture or general acupuncture clinical randomized controlled trial.

Description

Technical Field

[0001] This disclosure relates to an acupuncture device, more specifically to a device for clinical trials of acupuncture, and more specifically to a device for randomized controlled clinical trials of electroacupuncture or conventional acupuncture. Background Technology

[0002] Randomized controlled trials (RCTs) are currently the most rigorous scientific method for evaluating the clinical efficacy of medical interventions. However, for RCTs of acupuncture treatment, there is no internationally recognized standardized treatment for the placebo acupuncture treatment in the control group. Currently, non-meridian and non-acupoint acupuncture (such as acupoints located 1.5 cun lateral to the acupoint) is more commonly used, but this approach is highly controversial in the academic community.

[0003] Therefore, a thorny issue facing acupuncture treatment RCTs is how to design and select placebo-controlled acupuncture methods. An ideal placebo in an acupuncture treatment RCT should meet the following conditions: (1) The placebo has no or only a very small specific therapeutic effect, so as not to affect the accurate assessment of the therapeutic effect of acupuncture; (2) The placebo is no different from or as similar as possible to the actual experimental acupuncture treatment measures in all aspects, and can successfully achieve blinded research; (3) The placebo should not affect the necessary acupuncture techniques during operation and must ensure the realization of normal therapeutic effect; (4) The placebo should also be as simple, safe, easy to operate and highly applicable as possible.

[0004] In recent years, an increasing number of researchers have used placebo needles for non-invasive treatment, such as the Streitberger device and the Park device. However, these devices all have certain limitations in their use, and there are no devices available for electroacupuncture treatment or trials.

[0005] The information disclosed in this background section is intended to enhance understanding of the background of this disclosure, and therefore may include information that does not constitute related (or prior art). Utility Model Content

[0006] One aspect of this disclosure provides an acupuncture device capable of satisfying at least one of the conditions for an ideal placebo.

[0007] Another aspect of this disclosure provides an acupuncture device capable of solving at least one of the aforementioned technical problems.

[0008] The acupuncture device disclosed herein includes a needle tube and a base coupled to the needle tube. The needle tube includes: an outer tube having a first through-hole and including a filler disposed in the first through-hole for holding the needle; an inner tube, at least a portion of which is received in the first through-hole, the inner tube having a second through-hole for receiving the needle and coaxial with the first through-hole, the inner tube being slidable and rotatable relative to the outer tube, wherein the outer tube has a first side where the inner tube is located and a second side opposite to the first side; and a spherical adjustment member coupled to the outer tube on the second side of the outer tube and having a third through-hole coaxial with the first through-hole, wherein the filler of the outer tube is disposed between the inner tube and the spherical adjustment member. The base includes a horizontal portion and a vertical portion, the horizontal portion having a plate shape with a circular hole at its center and being coupled to the spherical adjustment member through the circular hole such that the spherical adjustment member is rotatable relative to the horizontal portion, the vertical portion extending perpendicularly from the end of the horizontal portion away from the spherical adjustment member in a direction away from the inner tube to define a space together with the horizontal portion for receiving at least a portion of the spherical adjustment member. The vertical portion includes an inner wall adjacent to the space, the inner wall comprising a vertical wall connected to the horizontal portion and an inclined wall extending from the vertical wall in a direction away from the spherical adjusting member. The space includes a chamfered portion adjacent to the inclined wall.

[0009] The horizontal portion may include a horizontally extending body and a protrusion extending from one end of the body near the spherical adjustment member. The one end of the body and the protrusion together may define a circular hole for receiving and holding the spherical adjustment member, such that the spherical adjustment member can rotate relative to the horizontal portion.

[0010] The inclined wall may have a first edge near the spherical adjustment member and a second edge away from the spherical adjustment member. The vertical portion may include a bottom surface as an application plane, extending from the second edge of the inclined wall to the edge of the outer wall of the vertical portion away from the horizontal portion. The acupuncture device may also include an application patch adhered to the bottom surface.

[0011] The acupuncture device can be used for electroacupuncture treatment or trials, or for conventional acupuncture treatment or trials, and the needle tube and base are made of insulating material.

[0012] The inclined wall may have a first edge near the spherical adjustment member and a second edge away from the spherical adjustment member. The vertical portion may include a bottom surface serving as an application plane, extending from the second edge of the inclined wall to the edge of the outer wall of the vertical portion away from the horizontal portion. The inclined wall may have an angle greater than or equal to 15° and less than 90° relative to the bottom surface.

[0013] The height of the chamfered part can be 1 / 5 to 3 / 4 of the total height of the vertical part, and the width of the chamfered part can be 1 / 5 to 3 / 4 of the total width of the vertical part.

[0014] The distance from the vertical wall to the horizontal center point of the third through hole in the vertical direction can be greater than 1.3 times the radius of the spherical adjusting component.

[0015] The needle may include a shank and a body attached to the shank, the diameter of the shank being larger than the diameter of the body. The shank may be accommodated in a second through-hole and held by an inner sleeve.

[0016] The filler is made of foam. Preferably, the filler is made of polyethylene foam.

[0017] The adhesive film can cover the space and may have a pre-cut line corresponding to the edge of the inclined wall away from the spherical adjustment member.

[0018] The acupuncture device disclosed herein can achieve at least one or all of the following beneficial effects:

[0019] 1. Made of fully insulating materials, this device can be used for electroacupuncture treatment or experiments. During the energizing process, the current is prevented from diverting into the device, ensuring that power loss due to device malfunctions will not affect the treatment effect. In other words, this device can be specifically used for electroacupuncture treatment or experiments, and can also be used for general acupuncture treatment or experiments.

[0020] 2. Through practical testing, the structural design of the base and the adhesion of the adhesive film are sufficient to support the weight of the acupuncture needles and electrode clips, thereby ensuring the connection and normal use of the electroacupuncture device.

[0021] 3. It adopts a spherical adjustment component, which can adjust the needle insertion angle over a wide range.

[0022] 4. By setting inclined walls and beveled sections in the base, the need for angle adjustment in acupuncture treatment is ensured, and the problem of bent needles caused by angle issues is solved, thus ensuring the safety of clinical medical treatment.

[0023] 5. The acupuncture device disclosed herein is simple to operate and can at least achieve side-blind control of subjects. Attached Figure Description

[0024] The accompanying drawings illustrate exemplary embodiments and, together with the detailed description given below, are intended to facilitate understanding of the technical concept of this disclosure. This disclosure is not limited to what is shown in the drawings.

[0025] Figure 1 This is a perspective view of the acupuncture device according to an embodiment, viewed from an obliquely upward angle.

[0026] Figure 2 This is a perspective view of the acupuncture device according to an embodiment, viewed from an oblique angle below.

[0027] Figure 3 This is a cross-sectional perspective view of the acupuncture device according to an embodiment.

[0028] Figure 4 This is a partially enlarged cross-sectional perspective view of the acupuncture device according to an embodiment.

[0029] Figure 5 This is a cross-sectional perspective view of an acupuncture device with a test needle inserted according to an embodiment.

[0030] Figure 6 This is a cross-sectional perspective view of an acupuncture device with a reference needle inserted according to an embodiment.

[0031] Explanation of reference numerals in the attached drawings: 100-needle tube; 110-outer tube; 111-first through hole; 112-filler; 120-inner tube; 121-second through hole; 130-spherical adjustment component; 131-third through hole; 200-base; 210-horizontal part; 211-body; 212-protrusion; 220-vertical part; 220IE-inner wall; 220VP-vertical wall; 220IP-inclined wall; AP-application plane; S-space; S1-corner section; 300-needle; 300A-test needle; 300B-control needle; 310-needle handle; 320-needle body; 330-limiting ring; H1-corner height; H2-vertical part height; W1-corner width; W2-vertical part width; DT-distance; R-radius; 400-application film; PCL-pre-cut line. Detailed Implementation

[0032] In the following, embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. The terms or words used in the specification and claims are not to be limited to their general or dictionary meanings, but should be interpreted as consistent with the technical spirit of the present disclosure, based on the principle that the inventor can be his / her own lexicographer to appropriately define the concepts of the terms in order to best describe his / her application.

[0033] The embodiments described in this specification and the constructions shown in the accompanying drawings are merely some of the embodiments of this disclosure and do not represent the entirety of the technical spirit, aspects, and features of this disclosure. Therefore, it should be understood that various equivalents and modifications may exist to replace or modify the embodiments described herein.

[0034] It will be understood that when an element or layer is referred to as being "on," "connected to," or "bonded to" another element or layer, the element or layer may be directly on, directly connected to, or directly bonded to the other element or layer, or one or more intermediary elements or intermediary layers may be present. When an element or layer is referred to as being "directly on," "directly connected to," or "directly bonded to" another element or layer, no intermediary element or intermediary layer is present. For example, when a first element is described as being "bonded" or "connected" to a second element, the first element may be directly bonded to or directly connected to the second element, or the first element may be indirectly bonded to or indirectly connected to the second element via one or more intermediary elements.

[0035] In the accompanying drawings, the dimensions of various elements, layers, etc., may be exaggerated for clarity. The same reference numerals denote the same elements. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. Furthermore, when describing embodiments of this disclosure, the use of "may" refers to "one or more embodiments of this disclosure." Expressions such as "at least one of..." and "any one of..." modify the entire list of elements after it, without modifying individual elements within that list. When a list of elements A, B, and C is specified using phrases such as "at least one of A, B, and C", "at least one of A, B, or C", "at least one selected from the group A, B, and C", or "at least one selected from A, B, and C", the phrase may refer to any and all suitable combinations or subsets of A, B, and C, such as A, B, C, A and B, A and C, B and C, or A and B and C. As used herein, the term "use" and its variations may be considered synonymous with the term "utilize" and its variations, respectively. As used herein, the terms "substantially," "about," and similar terms are used as approximate terms rather than as terms of degree, and are intended to explain the inherent variations in measured or calculated values ​​that will be recognized by one of ordinary skill in the art.

[0036] It will be understood that although the terms first, second, third, etc., may be used herein to describe various elements, components, regions, layers, and / or portions, these elements, components, regions, layers, and / or portions should not be limited by these terms. These terms are used to distinguish one element, component, region, layer, or portion from another element, component, region, layer, or portion. Therefore, without departing from the teachings of the exemplary embodiments, the first element, first component, first region, first layer, or first portion discussed below may be referred to as a second element, second component, second region, second layer, or second portion.

[0037] For ease of description, spatial relative terms such as “below,” “under,” “down,” “above,” “above,” etc., are used herein to describe the relationship between one element or feature and another element(s) shown in the figures. It will be understood that, in addition to covering the orientation depicted in the figures, the spatial relative terms are also intended to cover different orientations of the device in use or operation. For example, if the device in the figures is flipped, an element described as “below” or “under” other elements or features will subsequently be oriented “above” or “above” said other elements or features. Thus, the term “below” can cover both above and below orientations. The device may be otherwise oriented (rotated 90 degrees or in other orientations), and the spatial relative descriptive terms used herein should be interpreted accordingly.

[0038] The terminology used herein is for the purpose of describing embodiments of this disclosure and is not intended to be limiting of this disclosure. As used herein, unless the context clearly indicates otherwise, the singular forms “a” and “an” are also intended to include the plural forms. It will also be understood that when the terms “comprising,” “including,” and / or variations thereof are used in this specification, it indicates the presence of the stated features, integrals, steps, operations, elements, and / or components, but does not exclude the presence or addition of one or more other features, integrals, steps, operations, elements, components, and / or groups thereof.

[0039] Furthermore, any numerical range disclosed and / or described herein is intended to include all subranges containing the same numerical precision within the described range. For example, the range “1.0 to 10.0” is intended to include all subranges between the described minimum value of 1.0 and the described maximum value of 10.0 (and including both the described minimum value of 1.0 and the described maximum value of 10.0), i.e., having a minimum value equal to or greater than 1.0 and a maximum value equal to or less than 10.0, such as 2.4 to 7.6. Any maximum numerical limit described herein is intended to include all lower numerical limits contained therein, and any minimum numerical limit described in this specification is intended to include all higher numerical limits contained therein. Therefore, the applicant reserves the right to amend this specification and the claims to expressly describe any subranges contained within the range expressly described herein. All such ranges are intended to be inherently described in this specification such that modifications to expressly describe any such subranges will be required.

[0040] The phrase "same" for two compared elements, features, etc., can indicate that they are "substantially identical." Therefore, the phrase "substantially identical" can include cases with deviations considered low in the art (e.g., 5% or less). Furthermore, when a parameter is said to be uniform over a given region, this can mean that it is uniform in terms of average value.

[0041] Throughout this specification, unless otherwise stated, each element may be a single or multiple.

[0042] Placing any element "above (or below)" or "on (below)" another element can mean that the arbitrary element can be positioned to contact the upper (or lower) surface of the element, and that another element can be placed between the element and the arbitrary element.

[0043] The acupuncture device according to embodiments of the present disclosure will be described below.

[0044] The acupuncture device according to embodiments of this disclosure can be used in clinical trials (e.g., randomized controlled trials) of electroacupuncture or conventional acupuncture treatment. Specifically, the device can be used as both experimental needles and control needles. However, the acupuncture device of this disclosure is not limited to clinical trials of electroacupuncture or conventional acupuncture treatment; it can also be used in normal acupuncture treatment, such as for fixing needles during acupuncture treatment.

[0045] The acupuncture device according to embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings.

[0046] Figure 1 This is a perspective view of the acupuncture device according to an embodiment, viewed from an obliquely upward angle. Figure 2 This is a perspective view of the acupuncture device according to an embodiment, viewed from an oblique angle below. Figure 3 This is a cross-sectional perspective view of the acupuncture device according to an embodiment. Figure 4 This is a partially enlarged cross-sectional perspective view of the acupuncture device according to an embodiment.

[0047] To more clearly illustrate the acupuncture device of this disclosure, in Figures 1 to 3 The image shows an acupuncture device with needles 300 inserted. However, it is understood that the acupuncture device of this disclosure may not include needles on its own, but may be used in conjunction with needles.

[0048] Reference Figures 1 to 3 The acupuncture device according to an embodiment of the present disclosure includes a needle tube 100 and a base 200 attached to the needle tube 100. The needle tube 100 is primarily used to receive acupuncture needles 300, i.e., the needles 300 can be inserted into the needle tube 100. One side of the base 200 is attached to the needle tube 100, and the other side is connected via an adhesive film 400 (see...). Figure 5 and Figure 6 The acupuncture device is attached to the subject's body. In other words, the base 200 fixes the acupuncture device to the subject's body, while allowing the needle tube 100 to rotate relative to the base 200 within a certain angular range.

[0049] The needle 100 includes an outer tube 110, an inner tube 120 at least partially housed in the outer tube 110, and a spherical adjustment member 130 attached to the outer tube 110 on the side opposite to the side where the inner tube 120 is housed.

[0050] The outer tube 110 is generally hollow and cylindrical (e.g., cylindrical). The outer tube 110 has a first through-hole 111 inside. A filler 112 is disposed within the first through-hole 111 (e.g., the lower part of the first through-hole 111). The filler 112 is or comprises a soft and elastic material. For example, the filler 112 is made of foam. Preferably, the filler 112 is made of polyethylene (PE) foam. For example, the PE foam can be EPE (physically foamed polyethylene, commonly known as "pearl cotton"), XPE (chemically cross-linked polyethylene foam), IXPE (electron-radiated cross-linked polyethylene foam), or EPO (a mixture of foamed polyethylene and polystyrene). The filler 112 serves to hold and secure the needle 300 when it is inserted into the needle tube 100. Furthermore, the filler 112 can also give the physician the sensation of piercing an object, thereby partially enabling the physician's side-blindness technique.

[0051] The inner sleeve 120 is generally hollow and cylindrical (e.g., cylindrical) and has an outer diameter smaller than the inner diameter of the outer sleeve 110, such that at least a portion of the inner sleeve 120 is accommodated in the first through-hole 111 of the outer sleeve 110 and is located above the filler 112. The inner sleeve 120 can slide up and down relative to the outer sleeve 110 and rotate 360°. The inner sleeve 120 is provided with a second through-hole 121 for accommodating the needle 300 and coaxial with the first through-hole 111.

[0052] The spherical adjusting member 130 is attached to the lower end of the outer sleeve 110. For example... Figure 3 As shown, the lower end of the outer tube 110 can taper inward in a funnel shape and connect to the spherical adjusting member 130 at the end, thereby facilitating the flexible rotation of the spherical adjusting member 130. The spherical adjusting member 130 can be integrally formed with the outer tube 110. Optionally, the spherical adjusting member 130 and the outer tube 110 can be formed from independent components and joined together by a connecting member. The spherical adjusting member 130 has a third through hole 131 that communicates with and is coaxial with the first through hole 111. The third through hole 131 is coaxial with and aligned with the second through hole 121.

[0053] When performing acupuncture treatment or acupuncture treatment experiment, the needle 300 passes sequentially through the second through hole 121 of the inner sleeve 120, the filler 112 in the first through hole 111 of the outer sleeve 110, and the third through hole 131 of the spherical adjustment member 130.

[0054] The needle 300 may include a shank 310 and a body 320. The shank 310 and body 320 are integrally formed, with the body 320 extending from one end of the shank 310. The diameter of the shank 310 is larger than the diameter of the body 320. The inner diameter of the second through-hole 121 is slightly larger than (or substantially equal to) the diameter of the shank 310, such that the shank 310 is held by the inner sleeve 120. The inner diameter of the third through-hole 131 is larger than the diameter of the body 320.

[0055] The length of the inner sleeve 120 (i.e., the length of the second through hole 121) is substantially equal to the length of the needle shank 310, but this disclosure is not limited thereto. Alternatively, the length of the inner sleeve 120 may also be greater than or less than the length of the needle shank 310.

[0056] The inner sleeve 120 may include, or be made of, an elastic material such as rubber. In this case, since the inner diameter of the second through hole 121 is slightly larger than (or substantially equal to) the diameter of the needle handle 310, the needle handle 310 can be tightly clamped by the inner sleeve 120. During acupuncture treatment or trials, the physician can move and rotate the needle up and down by sliding and rotating the inner sleeve 120, thereby using techniques such as "lifting, inserting, and twisting" to achieve the "deqi sensation" (a specific reaction produced during acupuncture treatment, often considered a necessary condition for the therapeutic effect of acupuncture treatment).

[0057] Optionally, the inner sleeve 120 may also include a clamping member located in the second through hole 121. In this case, the clamping member may include, or be made of, an elastic material such as rubber. The body of the inner sleeve 120 (i.e., the portion excluding the clamping member) may include, or be made of, plastic.

[0058] At least one of the outer sleeve 110 and the inner sleeve 120 may also include a limiting element or a limiting part to prevent the inner sleeve 120 from completely sliding out of the outer sleeve 110 when the inner sleeve 120 slides up and down relative to the outer sleeve 110.

[0059] The upper side of the base 200 is connected to the spherical adjustment member 130. Specifically, as shown... Figure 3 As shown, the base 200 may include a horizontal portion 210 and a vertical portion 220. The horizontal portion 210 and the vertical portion 220 may be integrally formed. The horizontal portion 210 and the vertical portion 220 may together define a space S.

[0060] The horizontal portion 210 has a plate shape with a circular hole at its center and includes a horizontally extending body 211 and a protrusion 212 projecting upward from the inner end of the body 211. The inner end of the body 211 and the protrusion 212 together define a circular hole for receiving a spherical adjustment member 130. More specifically, the inner end of the body 211 and the protrusion 212 clamp the spherical adjustment member 130 in the circular hole of the horizontal portion 210, such that the spherical adjustment member 130 can rotate relative to the horizontal portion 210.

[0061] When viewed in a top view, the horizontal portion 210 may appear as a ring, but this disclosure is not limited thereto. The horizontal portion 210 may also appear as an elliptical ring or a polygonal ring shape such as a quadrilateral ring, a pentagonal ring, a hexagonal ring, etc. in a top view.

[0062] The vertical portion 220 extends downward from the outer end of the main body 211 of the horizontal portion 210 (i.e., the end away from the spherical adjusting member 130) to form an annular support portion of the base 200 for supporting the horizontal portion 210. The portions where the vertical portion 220 and the horizontal portion 210 meet each other may have an arc-shaped (e.g., circular) outer surface. When viewed from below, the vertical portion 220 may appear as a ring, but this disclosure is not limited thereto; the vertical portion 220 may also appear as an elliptical ring or a polygonal ring shape such as a quadrilateral ring, a pentagonal ring, a hexagonal ring, etc., in the bottom view.

[0063] The lower surface of the vertical portion 220 can form an application plane AP for attaching an adhesive film to the subject's skin (see...). Figure 5 and Figure 6 The 400 can be pasted onto the application plane AP.

[0064] like Figure 3 and Figure 4 As shown, the vertical portion 220 includes an inner wall 220IE adjacent to the space S. The inner wall 220IE includes a vertical wall 220VP connected to the horizontal portion 210 and an inclined wall 220IP extending outward from the vertical wall 220VP (i.e., away from the side of the spherical adjustment member 130). Accordingly, the space S includes a chamfered portion S1 adjacent to the inclined wall 220IP. That is, the space S has a shape that combines a cylinder at the top and a frustum at the bottom including the chamfered portion S1.

[0065] Reference Figure 3 and Figure 4The inclined wall 220IP forms an angle α relative to the application plane AP. Angle α can be greater than or equal to 15° and less than 90°, for example, within the ranges of 20° to 85°, 25° to 80°, 30° to 75°, 35° to 70°, 40° to 65°, and 45° to 60°. For example, angle α can be 45°. When angle α is within the above range, the test needle can be inserted into the subject's skin at an appropriate (e.g., more) inclined angle. In other words, because the inner wall 220IE of the vertical portion 220 includes an inclined wall 220IP with an angle within the above range relative to the application plane AP, when the test needle is inserted into the subject's skin at an appropriate inclined angle, the vertical portion 220 will not affect or obstruct the adjustment angle of the needle, avoiding needle bending due to angle issues and ensuring the safety of clinical medicine.

[0066] In addition, in order to avoid limiting the adjustment angle of the vertical part 220 to the needle as much as possible, the inventors also studied the relationship between the size of the chamfered part S1 and the size of the vertical part 220.

[0067] like Figure 4 As shown, the chamfer height H1 of the chamfered portion S1 can be 1 / 5 to 3 / 4 of the vertical portion height H2 (i.e., the total height of the vertical portion 220). For example, the chamfer height H1 of the chamfered portion S1 can be 1 / 4 to 3 / 4, 1 / 4 to 2 / 3, 1 / 4 to 1 / 2, or 2 / 5 to 1 / 2 of the vertical portion height H2.

[0068] Furthermore, the chamfer width W1 of the chamfered portion S1 can be 1 / 5 to 3 / 4 of the vertical portion width W2. For example, the chamfer width W1 of the chamfered portion S1 can be 1 / 4 to 3 / 4, 1 / 4 to 2 / 3, 1 / 4 to 1 / 2, or 2 / 5 to 1 / 2 of the vertical portion width W2.

[0069] When the relationship between the chamfer height H1 and chamfer width W1 and the vertical part height H2 and vertical part width W2 meets the above range, the test needle can be inserted into the subject's skin at an appropriate (e.g., more) inclined angle, which can minimize the limitation of the vertical part 220 on the adjustment angle of the needle, avoid the bending of the needle due to angle problems, and ensure the safety of clinical medicine.

[0070] In addition, to minimize the limitation on the adjustment angle of the needle by the vertical portion 220, the inventors also investigated the relationship between the distance of the inner wall 220IE (specifically, the vertical wall 220VP) of the vertical portion 220 from the needle (or the distance from the horizontal center point of the third through hole 131) and the radius R of the spherical adjustment member 130. In the embodiments of this disclosure, the distance DT of the vertical wall 220VP from the horizontal center point of the third through hole 131 in the horizontal direction can be greater than 1.3 times the radius R of the spherical adjustment member 130. For example, the distance DT can be 1.35 to 2 times, 1.4 to 1.8 times, 1.45 to 1.6 times, or 1.5 times the radius R.

[0071] When the relationship between the distance DT of the vertical wall 220VP from the horizontal center point of the third through hole 131 in the horizontal direction and the radius R of the spherical adjustment member 130 meets the above range, the test needle can be inserted into the subject's skin at an appropriate (e.g., more) inclined angle, the limitation of the vertical part 220 on the adjustment angle of the needle can be minimized, the bending of the needle due to angle problems is avoided, and the safety of clinical medicine is guaranteed.

[0072] Therefore, the embodiments of this disclosure set the angle α of the inclined wall 220IP relative to the application plane AP, the relationship between the chamfer height H1 and the vertical height H2, the relationship between the chamfer width W1 and the vertical width W2, and the relationship between the distance DT of the vertical wall 220VP from the horizontal center point of the third through hole 131 and the radius R of the spherical adjustment member 130 within the above-mentioned preferred range, thereby maximally avoiding the limitation of the adjustment angle of the vertical part 220 to the needle.

[0073] On the other hand, in the acupuncture device according to the embodiments of this disclosure, all components of the needle tube 100 and the base 200 are made of fully insulating material. Therefore, the device can be used for electroacupuncture treatment and can ensure that the current is not dispersed into the device. During the power-on process, the power loss due to device problems will not affect the treatment effect. That is to say, the device can be used specifically for electroacupuncture treatment or experimentation, and can also be used for ordinary acupuncture treatment or experimentation.

[0074] Since the acupuncture device according to the embodiments of this disclosure can be used for electroacupuncture, the needle 300 may also include a limiting ring 330 located at the end of the needle handle 310 opposite to the needle body 320. When the needle body 320 and the needle handle 310 are inserted into the needle tube 100, the limiting ring 330 may be exposed outside the needle tube 100. At this time, an energizing device (e.g., the electrodes of the energizing device) may be clamped in the limiting ring 330 to output current to the needle 300.

[0075] Reference Figure 6 and Figure 5The acupuncture device according to embodiments of the present disclosure may further include an adhesive patch 400 adhered to the application plane AP of the vertical portion 220 for attachment to the skin of a subject. The adhesive patch 400 may include a release film and an adhesive disposed between the release film and the application plane AP. Alternatively, the adhesive patch 400 may include an adhesive patch body, a first adhesive disposed between the adhesive patch body and the application plane AP, a release film disposed on the side of the adhesive patch body opposite to the side where the first adhesive is disposed, and a second adhesive disposed between the adhesive patch body and the release film. The adhesive patch 400 may have a pre-cut line PCL corresponding to (e.g., overlapping) the inner edge of the application plane AP. As described later, during the control needle procedure, the physician can remove the release film and, without removing the central portion (excluding the part overlapping the application plane AP) along the pre-cut line PCL, apply the entire application film 400 to the skin of the subject's corresponding acupoint. During the test needle procedure, the physician can remove the release film and, along the pre-cut line PCL, remove the central portion (excluding the part overlapping the application plane AP), then apply the application film 400, including only the annular portion set on the application plane AP, to the skin of the subject's corresponding acupoint. Therefore, regardless of whether the physician will perform the control needle procedure or the test needle procedure, the appearance of the acupuncture device according to the embodiments of this disclosure is consistent for the subject before the physician's operation, thereby achieving a degree of lateral blindness in the subject.

[0076] As described above, the acupuncture device according to embodiments of this disclosure can be used for acupuncture treatment in randomized controlled trials (RCTs). Therefore, the device can be used as both the test needle in the experimental group and the control needle in the control group.

[0077] Figure 5 This is a cross-sectional perspective view of an acupuncture device with a test needle inserted according to an embodiment. Figure 6 This is a cross-sectional perspective view of an acupuncture device with a reference needle inserted according to an embodiment.

[0078] like Figure 5 and Figure 6 As shown, the test needle 300A has a sharp tip, while the control needle 300B is a blunt needle without a sharp tip. Furthermore, the test needle 300A is longer than the control needle 300B; therefore, when the test needle 300A is used to perform acupuncture treatment on the subject, it can penetrate the subject's skin. However, when the control needle 300B is used, the blunt needle will not penetrate the subject's skin.

[0079] However, during the RCT, since both the experimental and control groups used the acupuncture device according to the present disclosure, and the control group subjects also experienced the illusion of being pierced by the pressure applied to the skin by the control needle 300B, the acupuncture device according to the present disclosure can achieve the lateral blindness state of the subjects.

[0080] The operation method of the acupuncture device according to this disclosure will be described below.

[0081] Refer to needle 300B operation:

[0082] Needles: Hua Tuo brand blunt-tipped needles (0.25mm×25mm), total needle length 5.1cm.

[0083] Step 1: Disinfect the corresponding acupoints of the subject, remove the release film of the patch 400, and without removing the central part of the patch 400 except for the part overlapping with the application plane AP along the pre-cut line PCL, apply the entire patch 400 to the skin of the corresponding acupoints of the subject.

[0084] Step 2: Adjust the needle insertion angle by rotating the spherical adjustment component 130, and insert the needle through the second through hole 121 of the inner sleeve 120. Insert the needle body 320 and needle handle 310 almost completely into the needle tube 100, leaving only the limiting ring 330 outside the device (at this time, due to the multiple effects of the sleeve length of about 5cm, the blunt needle and the adhesive film, the patient only has a needle-like sensation, and the needle tip does not penetrate the skin).

[0085] Step 3: Connect the special electroacupuncture device (which has only a timing function and no current output, and its appearance is consistent with that of a regular electroacupuncture device): Clamp the electrode to the limiting ring 330, and use the adhesive electrode to stick the other electrode to the corresponding skin area (such as one inch away from the corresponding acupoint).

[0086] Step 4: Stop timing after 15-30 minutes, remove the device and apply the adhesive film.

[0087] Operation of test needle 300A:

[0088] Needles: Hua Tuo brand acupuncture needles (0.25mm×40mm), total needle length 7.6cm.

[0089] Step 1: Disinfect the corresponding acupoints of the subject, remove the release film of the patch 400, and remove the central part of the patch 400 along the pre-cut line PCL, except for the part overlapping with the application plane AP (or remove the central part first and then remove the release film). Then apply the patch 400, which only includes the annular part set on the application plane AP, to the skin of the corresponding acupoints of the subject.

[0090] Step 2: Adjust the needle insertion angle by rotating the spherical adjustment component 130, insert the needle through the second through hole 121 of the inner sleeve 120, insert the needle body 320 and needle handle 310 almost completely into the needle tube 100, leaving only the limiting ring 330 outside the device (at this time, the needle tip penetrates the skin about 2.6cm), perform the "lifting, inserting and twisting" operation through the inner sleeve 120, and stop at the appropriate needle insertion depth after achieving the "deqi sensation".

[0091] Step 3: Connect the electroacupuncture device: Clamp the electrode to the limiting ring 330, and attach the other electrode to the corresponding skin area (e.g., one inch away from the corresponding acupoint) using the adhesive electrode. Adjust the electroacupuncture parameters to achieve electrical stimulation of specific acupoints.

[0092] Step 4: Stop timing after 15-30 minutes, remove the device and apply the adhesive film.

[0093] According to one aspect, the acupuncture device disclosed herein is made of fully insulating materials and can be used for electroacupuncture therapy. During the energizing process, it ensures that the current does not divert into the device, and that the treatment effect is not affected by power loss due to device malfunctions.

[0094] According to another aspect, practical testing has shown that the acupuncture device disclosed herein, through the structural design of the base and the viscosity of the adhesive film, can support the weight of the acupuncture needles and electrode clips, thereby ensuring the connection and normal use of the electroacupuncture device.

[0095] According to another aspect, the acupuncture device disclosed herein employs a spherical adjustment component, which can adjust the needle insertion angle over a wide range.

[0096] Furthermore, the acupuncture device disclosed herein, by setting an inclined wall and a chamfered part in the base, not only ensures the need for angle adjustment in acupuncture treatment, but also solves the problem of needle bending caused by angle issues, thus ensuring the safety of clinical medical treatment.

[0097] Furthermore, the acupuncture device disclosed herein is simple to operate and can at least achieve side-blind control of subjects.

[0098] The present disclosure has been described above using only some embodiments and accompanying drawings, and the present disclosure is not limited to the described embodiments and drawings. Instead, those skilled in the art can make various modifications and changes within the technical spirit of the present disclosure. Therefore, the true scope of protection of the present disclosure should be determined by the claims.

Claims

1. An acupuncture device, characterized by, The acupuncture device includes a needle tube and a base attached to the needle tube. The needle tube includes: an outer tube having a first through-hole and including filler disposed in the first through-hole for holding a needle; an inner tube, at least a portion of which is received in the first through-hole, the inner tube having a second through-hole for receiving a needle and coaxial with the first through-hole, the inner tube being slidable and rotatable relative to the outer tube, wherein the outer tube has a first side where the inner tube is located and a second side opposite to the first side; and a spherical adjusting member coupled to the outer tube on the second side of the outer tube and having a third through-hole coaxial with the first through-hole, wherein the filler of the outer tube is disposed between the inner tube and the spherical adjusting member. The base includes a horizontal portion and a vertical portion. The horizontal portion has a plate shape with a circular hole at its center, and is connected to a spherical adjusting member through the circular hole, allowing the spherical adjusting member to rotate relative to the horizontal portion. The vertical portion extends perpendicularly from the end of the horizontal portion away from the spherical adjusting member in a direction away from the inner sleeve, defining a space together with the horizontal portion for accommodating at least a portion of the spherical adjusting member. The vertical portion includes an inner wall adjacent to the space, the inner wall comprising a vertical wall connected to the horizontal portion and an inclined wall extending from the vertical wall in a direction away from the spherical adjusting member. The space includes a chamfered portion adjacent to the inclined wall.

2. The acupuncture device of claim 1, wherein, The horizontal portion includes a horizontally extending body and a protrusion extending from one end of the body near the spherical adjustment member. The one end of the body and the protrusion together define a circular hole for receiving and holding the spherical adjustment member, such that the spherical adjustment member can rotate relative to the horizontal portion.

3. The acupuncture device of claim 1, wherein, The inclined wall has a first edge close to the spherical adjusting member and a second edge far from the spherical adjusting member. The vertical portion includes a bottom surface that serves as an application plane, extending from the second edge of the inclined wall to the edge of the outer wall of the vertical portion away from the horizontal portion. The acupuncture device also includes an adhesive patch that is adhered to the bottom surface.

4. The acupuncture device of claim 1, wherein, The acupuncture device is used for electroacupuncture treatment or experiment or conventional acupuncture treatment or experiment, and both the needle tube and the base are made of insulating material.

5. The acupuncture device of claim 1, wherein, The inclined wall has a first edge close to the spherical adjusting member and a second edge far from the spherical adjusting member. The vertical portion includes a bottom surface that serves as an application plane, extending from the second edge of the inclined wall to the edge of the outer wall of the vertical portion away from the horizontal portion. The inclined wall has an angle of greater than or equal to 15° and less than 90° relative to the bottom surface.

6. The acupuncture device of claim 1, wherein, The height of the chamfered portion is 1 / 5 to 3 / 4 of the total height of the vertical portion, and the width of the chamfered portion is 1 / 5 to 3 / 4 of the total width of the vertical portion.

7. The acupuncture device of claim 1, wherein, The distance between the vertical wall and the horizontal center point of the third through hole in the vertical direction is greater than 1.3 times the radius of the spherical adjusting component.

8. The acupuncture device according to claim 1, characterized in that, The needle includes a shank and a body attached to the shank, wherein the diameter of the shank is larger than the diameter of the body. The needle shank is housed in the second through hole and held by the inner sleeve.

9. The acupuncture device of claim 1, wherein, The filling material is made of polyethylene foam.

10. The acupuncture device of claim 3, wherein, An adhesive film is applied to cover the space and has a pre-cut line corresponding to the second edge of the inclined wall.

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