Fixing device and fixing method for internal heating needle

Abstract

The application discloses a fixing device and fixing method for an internal heat needle, which comprises a fixing suction disc, a fixing plug and an elastic cotton ball. The fixing suction disc can be used for negative pressure adsorption of skin. The fixing plug is matched with the suction disc in a slope opening and is radially contracted and clamped to the internal heat needle under extrusion. The contraction groove of the fixing plug has the functions of deformation and displacement and pressure relief. The cotton ball is arranged on the inner side of the suction disc and is used for automatic plugging and hemostasis of a puncture port during needle extraction. A separation layer is arranged in a double-layer suction disc air cavity to improve the adsorption force. The suction disc can be adsorbed and separated by pinching. A multi-connecting-rod moving support bears the weight of a connecting line, so that the deflection moment of the internal heat needle is reduced. The application realizes the integration of adsorption fixing, locking and limiting, automatic hemostasis and cable support, solves the problems of easy displacement of the internal heat needle, complicated hemostasis and pressure imbalance and failure, is convenient to operate, has high fixing reliability and is suitable for clinical treatment of the internal heat needle.

Description

Technical Field

[0001] This invention relates to a fixation device and fixation method for an internal heating needle, belonging to the field of medical device technology. Background Technology

[0002] Internal heat acupuncture is a treatment method that combines traditional Chinese medicine acupuncture with modern thermotherapy. It involves inserting specially designed needles into acupoints or diseased tissues and heating the needles to achieve therapeutic goals such as releasing soft tissue adhesions, improving local blood circulation, and relieving pain. However, internal heat acupuncture faces numerous technical challenges in clinical application. These problems have long troubled clinicians and hindered the promotion and improvement of the therapy's efficacy.

[0003] During internal heat acupuncture treatment, the needle needs to remain in the patient's body for an extended period. Maintaining a stable insertion depth and angle is a fundamental prerequisite for ensuring therapeutic efficacy. However, in practice, internal heat acupuncture needles are prone to deflection and displacement. Firstly, the needle's tail is connected to a power supply cable. When multiple cables converge into a main line, their weight exerts a downward torque on the needle's tail, causing the needle to rotate and deviate from its intended treatment position within the acupoint. Secondly, patients may experience slight body movements due to discomfort during treatment, further exacerbating needle displacement. This deflection and displacement not only affect the accuracy of the treatment but, in severe cases, may also damage surrounding healthy tissue, posing safety hazards.

[0004] While existing technologies have attempted to address the fixation of internally heated needles, all solutions have significant shortcomings. One approach involves using mechanical clamping devices to rigidly secure each needle. While this method theoretically provides relatively stable support, its complex structure and large size make it extremely inconvenient in clinical practice. When multiple needles are used simultaneously, multiple clamping units are required, occupying considerable treatment space and consuming significant time and effort for installation and adjustment, severely reducing treatment efficiency. More importantly, rigid clamping devices lack flexible cushioning; even slight patient movement can cause the needles to lacerate tissues, compromising safety. Furthermore, the high manufacturing and maintenance costs of such devices hinder their widespread adoption in primary healthcare institutions.

[0005] Another approach is to use adhesive fixation, such as using medical tape to attach the internal heating needle to the patient's skin. While this method is simple and inexpensive, the fixation effect is extremely unreliable. The adhesiveness of the tape is greatly affected by factors such as skin oils and sweat, and it is prone to loosening and failure during prolonged treatment. Furthermore, the tape only provides surface adhesion and cannot effectively restrain the axial movement and radial deflection of the needle, making it difficult to meet the positioning accuracy required for treatment. Even more problematic is that when the needle needs to be removed after treatment, the adhesion between the tape and the skin hinders the removal operation. Moreover, when multiple needles are densely packed, the repeated application and removal of the tape is not only cumbersome but may also damage the patient's skin.

[0006] In the hemostasis process, existing techniques also have significant shortcomings. After the internal heating needle is removed, the puncture site needs to be pressed immediately to stop the bleeding. The traditional approach is for the doctor to apply adhesive tape or cover each puncture site with a cotton ball after needle removal. However, when the treatment involves multiple puncture sites, the dense distribution of puncture sites makes individual treatment not only time-consuming and laborious, but also difficult to apply precise and effective pressure to each puncture site. Some doctors adopt a simplified approach of covering the entire area with a large piece of adhesive tape, but this method cannot apply concentrated pressure to individual puncture sites, greatly reducing the hemostatic effect, and postoperative bleeding and subcutaneous bruising often occur.

[0007] Furthermore, during the heating process of the internal heating needle, the surrounding tissue may expand due to local gas expansion. If a closed cavity forms between the needle fixation device and the skin, the increased internal gas pressure will generate thrust, potentially causing the fixation device to loosen and compromising the stability of the treatment. This problem is rarely considered in current technology, but it can occur in actual clinical practice, becoming a potential hazard affecting the continuity of treatment.

[0008] In summary, existing technologies for internal heat needle fixation, hemostasis, and pressure balancing have consistently failed to provide a comprehensive solution that balances ease of operation, reliable fixation, therapeutic safety, and cost-effectiveness. Rigid clamping methods are costly, complex to operate, and pose safety hazards; adhesive methods offer poor fixation and insufficient reliability; hemostasis lacks integrated design, is cumbersome, and ineffective; and the issue of pressure balancing has long been neglected. These technological bottlenecks severely restrict the practical application of internal heat needle therapy, highlighting the urgent clinical need for an innovative solution that systematically addresses these challenges. Summary of the Invention

[0009] The purpose of this invention is to overcome the shortcomings of the prior art and provide a fixation device and method for internal heating needles. This invention solves the technical problems of easy needle displacement, cumbersome fixation operation, time-consuming needle removal and hemostasis operation, and fixation failure caused by increased intracavitary air pressure during existing internal heating needle treatments. It integrates adsorption fixation, clamping and locking, automatic hemostasis, and cable support, simplifying clinical operation and improving treatment safety and reliability.

[0010] To achieve the above objectives, the present invention adopts the following technical solution: In a first aspect, the present invention provides a device for fixing an internally heated needle, comprising: The fixed suction cup has an internal needle passage channel I for the internal heating needle to pass through, and the fixed suction cup can be negatively attached to the patient's skin surface; The fixing plug has an internal needle passage channel II for the internal heating needle to pass through. The fixing plug is assembled on the fixing suction cup. The fixing plug and the fixing suction cup cooperate to radially clamp and limit the internal heating needle passing through them, maintaining a constant insertion depth of the internal heating needle in the patient's body. An elastic cotton ball is placed inside the fixed suction cup near the skin end. The internal heating needle passes through the cotton ball and pierces the patient's skin. The cotton ball has the function of sealing the puncture site with its own elasticity after the needle is removed to stop bleeding.

[0011] In some embodiments, the top of the fixed suction cup extends outward from the central axis of the needle channel I to form a bevel, and the bevel is a circumferentially inclined slope; the bottom outer circumferential surface of the fixed plug is a conical surface, and the angle of the bevel is smaller than the angle of the conical surface; when the fixed plug is pushed into the bevel for assembly, the bottom of the fixed plug is squeezed by the bevel and undergoes radial contraction, clamping the inner heating needle.

[0012] In some embodiments, at least one shrinkage groove is provided at the bottom of the fixed plug, and the shrinkage groove extends upward through the conical region to the cylindrical section of the fixed plug body; the shrinkage groove provides radial shrinkage deformation allowance for the bottom of the fixed plug, and also forms a gas passage to discharge the gas inside the needle channel I, thereby realizing gas pressure relief.

[0013] In some embodiments, the fixed suction cup includes an inner layer and an outer layer, the tops of the inner layer and the outer layer are connected to each other, the bottoms of the inner layer and the outer layer are separated from each other, and an air cavity is formed between the inner layer and the outer layer; the needle passage I is formed inside the inner layer; the air cavity is configured such that it is compressed under the action of external force squeezing, and can elastically recover after the external force is removed to generate negative pressure and be adsorbed onto the skin surface.

[0014] In some embodiments, the bottom of the inner layer of the fixed suction cup is configured as a small flared structure, and the bottom of the outer layer is configured as a large flared structure, with the bottom surfaces of the inner and outer layers flush; the cotton ball is housed inside the small flared opening at the bottom of the inner layer.

[0015] In some embodiments, two symmetrically arranged partition layers are provided inside the air cavity along its circumference. The partition layers extend from the connection between the top of the inner layer and the outer layer to the top of the large horn opening and the small horn opening. The two partition layers divide the air cavity above the large horn opening and the small horn opening into two chambers. The outer layers corresponding to the two chambers form a pressing area for pinching with two fingers. Each partition layer has a rounded angle on both sides of the end where it connects to the outer layer of the fixed suction cup.

[0016] In some embodiments, the inner diameters of both needle passage I and needle passage II are larger than the outer diameter of the inner heating needle. After the fixing plug is assembled onto the fixing suction cup, needle passage II is arranged coaxially with needle passage I; and / or, the top of the cylindrical section of the fixing plug is provided with a disc as a pressing part.

[0017] In some embodiments, a movable support is further included, wherein a clamping member is provided on the movable support for clamping the internal heating needle power supply connection cable; the position of the clamping member can be adjusted to support the weight of the power supply connection cable.

[0018] In some embodiments, the movable support is a multi-link adjustable structure; the bottom of the movable support is a bed edge gripper or a movable base with wheels, the gripper is a clamp, and the spatial position and pitch angle of the clamp can be adjusted by means of the multi-link structure.

[0019] Secondly, the present invention provides a method for fixing an internal heating needle, using the aforementioned fixing device for the internal heating needle, comprising the following steps: S1: Assemble the cotton ball on the end of the fixed suction cup that is close to the skin, and pass the internal heating needle through the needle passage of the fixed plug and the fixed suction cup in sequence, and then through the cotton ball; S2: Insert the internal heating needle into the patient's target acupoint, squeeze the fixed suction cup to expel the air in the air cavity, attach the fixed suction cup to the patient's skin, release the fixed suction cup, and the air cavity elastically recovers to generate negative pressure, so that the fixed suction cup is negatively attached to the patient's skin surface. S3: Push the fixing plug into the bevel of the fixing suction cup for assembly. The conical surface at the bottom of the fixing plug is squeezed by the bevel and undergoes radial contraction, which radially clamps and limits the inner hot needle. S4: Multiple internal heating pins are fixed sequentially according to steps S1-S3; S5: Connect the power supply cable to the tail of the internal heating needle, clamp the power supply cable on the clamp of the movable bracket, and adjust the position and angle of the clamp so that the clamp supports the weight of the power supply cable. S6: After treatment, hold the fixation plug and pull it out together with the internal heating needle. The cotton ball will seal the puncture site to stop bleeding due to its own elasticity. Squeeze the fixation suction cup to reduce the volume of the air chamber, increase the air pressure inside the air chamber and release the negative pressure, then the fixation suction cup can be removed.

[0020] Beneficial effects of this invention: 1. The present invention sets up a fixed suction cup with negative pressure adsorption, which restricts the rotation range of the internal heating needle to inside the needle passage, significantly reduces the deflection angle of the internal heating needle, and provides stable auxiliary support by relying on the negative pressure adsorption between the suction cup and the skin, thereby suppressing the radial displacement of the internal heating needle.

[0021] 2. The fixing plug is pushed into the bevel of the suction cup, causing radial contraction, which achieves radial clamping and limiting of the internal heated needle, restricting the axial movement of the needle body and ensuring the stability of the insertion depth of the internal heated needle during treatment. The fixing suction cup and fixing plug adopt a split structure, which can complete the adsorption positioning and locking clamping in steps. The reliability of the two operation steps can be confirmed separately, reducing the risk of positioning deviation and improving treatment accuracy.

[0022] 3. The fixed plug is provided with a shrinkage groove extending to the cylindrical section of the body, which not only provides deformation allowance for the fixed plug to be deformed and clamped, but also forms a gas conduction channel. When the internal heating needle heats up and causes the gas inside the channel to expand, the gas can be discharged outward through the shrinkage groove, balancing the gas pressure inside and outside the cavity and preventing the gas pressure from rising and pushing the fixed plug open, causing fixation failure. During the needle removal stage, it can also prevent the formation of negative pressure inside the channel from hindering the needle removal operation.

[0023] 4. The cotton ball is pre-held in the small flared opening at the bottom of the inner layer of the fixed suction cup. When the needle is removed, the cotton ball automatically seals the puncture site due to its own elasticity, eliminating the need for the doctor to take out the cotton ball to press, thus simplifying the operation process. The cotton ball can apply uniform pressure to the puncture point, providing reliable hemostasis, and is especially suitable for multi-needle intensive puncture treatment scenarios.

[0024] 5. A multi-link movable support is set up. The clamps on the support support support the weight of the internal heating needle connection cable, eliminating the deflection torque exerted by the cable weight on the tail of the internal heating needle and reducing the risk of needle body displacement. The position and angle of the clamps are adjustable, and the base can be selected to be clamped on the edge of the bed or a roller movable base, which can be adapted to different clinical scenarios and has strong versatility.

[0025] 6. The fixed suction cup can be used to remove air and adsorb by squeezing, and the negative pressure can be broken by squeezing again to complete the separation. No additional air suction equipment is required, making the operation simple. There is no need to forcefully tear the suction cup during separation, reducing traction and irritation to the patient's skin. The angle between the partition layer inside the air chamber and the arc at the end improves the air removal efficiency and structural resilience, further enhancing the suction cup's negative pressure adsorption capacity. Attached Figure Description

[0026] The accompanying drawings, as part of this invention, are provided to further illustrate the invention. The illustrative embodiments and descriptions of the invention are used to explain the invention, but do not constitute an undue limitation thereof. Clearly, the drawings described below are merely some embodiments, and those skilled in the art can obtain other drawings based on these drawings without any creative effort.

[0027] In the attached diagram: Figure 1 This is a schematic diagram and a partial enlarged view of a fixing device for an internal heating needle according to the present invention; Figure 2 This is a cross-sectional view of the fixed suction cup, fixed plug, and cotton ball in conjunction with the present invention; Figure 3 This is an overall sectional view of the fixing plug of the present invention; Figure 4 This is a partial cross-sectional view of the fixed suction cup of the present invention; Figure 5 This is a flowchart of a method for fixing an internal heating needle according to the present invention.

[0028] Attached diagram labels: 1. Fixed suction cup; 1-1. Inner layer; 1-2. Outer layer; 1-3. Air cavity; 1-4. Needle passage channel I; 1-5. Bevel; 1-6. Separating layer; 1-7. Rounded angle; 2. Fixed plug; 2-1. Disc; 2-2. Shrink groove; 2-3. Needle passage channel II; 3. Cotton ball; 4. Internal heating needle; 5. Skin; 6. Movable support; 7. Power supply connection cable.

[0029] It should be noted that these accompanying drawings and textual descriptions are not intended to limit the scope of the invention in any way, but rather to illustrate the concept of the invention to those skilled in the art by referring to specific embodiments. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments will be clearly and completely described below with reference to the accompanying drawings. The following embodiments are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0031] In the description of this invention, it should be noted that the terms "upper", "lower", "front", "rear", "left", "right", "horizontal", "vertical", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0032] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0033] like Figure 1 , Figure 2 As shown, the present invention provides a fixing device for an internally heated needle, including a fixing suction cup 1, a fixing plug 2, an elastic cotton ball 3, and a movable support 6; the fixing suction cup 1 has a needle passage channel I1-4 for the internally heated needle 4 to pass through, and the fixing suction cup 1 can be negatively pressure adsorbed onto the surface of the patient's skin 5; the fixing plug 2 has a needle passage channel II2-3 for the internally heated needle 4 to pass through, and the fixing plug 2 is assembled on the fixing suction cup 1; the fixing plug 2 and the fixing suction cup 1 cooperate to radially clamp and limit the internally heated needle 4 passing through them, maintaining a constant insertion depth of the internally heated needle 4 in the patient's body; the cotton ball 3 is located inside the fixing suction cup 1 near the end close to the skin 5, and the internally heated needle 4 pierces the patient's skin 5 after passing through the cotton ball 3; the cotton ball 3 has the hemostatic function of sealing the puncture site with its own elasticity after the needle is removed; the movable support 6 is provided with a clamping member for holding the power supply connection line 7 of the internally heated needle 4; the position of the clamping member can be adjusted to support the weight of the power supply connection line 7.

[0034] It should be noted that the fixing suction cup 1 and fixing plug 2 are integrally molded from medical-grade elastic silicone or medical-grade TPE elastic polymer material, possessing good elastic deformation ability and biocompatibility, and can be used once or reused after sterilization; the cotton ball 3 is made of medical-grade elastic hemostatic cotton, possessing elastic deformation ability, can be compressed under pressure, and can rebound and expand after the external force is removed. The internal heating needle 4 is a conventional internal heating acupuncture needle in this field, with acupuncture and electric heating functions; the power supply connection cable 7 is the matching cable for the internal heating needle.

[0035] As can be seen, the present invention constrains the rotation range of the internal heating needle 4 within the needle passage by fixing the suction cup 1, thereby significantly reducing the deflection angle of the internal heating needle 4 to a controllable range. The fixing suction cup 1 is attached to the surface of human skin 5, and with the help of a large area of ​​epidermis to provide auxiliary support, it ensures that the fixing suction cup 1 obtains sufficient and stable support on human skin 5, thereby effectively suppressing the radial displacement of the internal heating needle 4.

[0036] The following provides a further explanation of the specific structure of the aforementioned fixed suction cup.

[0037] like Figure 2 , Figure 4 As shown, the fixed suction cup 1 includes an inner layer 1-1 and an outer layer 1-2, which are connected together at the top of the fixed suction cup 1. The bottom of the inner layer 1-1 is separate from the bottom of the outer layer 1-2, forming an air cavity 1-3 between them. The hollow interior of the inner layer 1-1 forms a needle passage Ⅰ1-4, through which the internal heating needle 4 can pass freely. The air cavity 1-3 is compressed under external pressure, and can elastically recover after the external force is removed to generate negative pressure and adhere to the skin surface 5.

[0038] Further plans will continue to be considered. Figure 2 , Figure 4As shown, the bottom of the inner layer 1-1 is processed into a small flared structure, and the bottom of the outer layer 1-2 is processed into a large flared structure; the bottom end face of the inner layer 1-1 and the bottom end face of the outer layer 1-2 are flush with each other. When the fixed suction cup 1 is attached to the patient's skin 5, the large flared end face of the outer layer 1-2 forms a sealed contact with the skin, so that the air chamber 1-3 and the skin form a closed chamber.

[0039] As can be seen, this invention achieves convenient control of the adsorption and separation processes by pinching the middle of the fixed suction cup 1. During the adsorption phase, the doctor pinches the middle of the fixed suction cup 1 to reduce the volume of the air chamber 1-3, expelling the air inside. The suction cup is then attached to the patient's skin. Releasing the fixed suction cup 1 restores the elasticity of the air chamber 1-3 and creates negative pressure within the sealed chamber, ensuring the fixed suction cup 1 adheres tightly to the patient's skin surface 5. The operation is simple and intuitive, achieving stable and reliable adsorption without the need for additional suction equipment. During the separation phase, again, only the middle of the fixed suction cup 1 needs to be pinched. This reduces the volume of the air chamber 1-3, increases the internal air pressure, and releases the negative pressure, allowing the fixed suction cup 1 to easily detach from the skin 5. This avoids the discomfort caused by pulling the suction cup during separation, a problem common with traditional negative pressure adsorption devices. The entire adsorption and separation process is completed through the same pressing point, resulting in a unified and easy-to-master operating logic, significantly reducing the difficulty of clinical use and improving operational efficiency and patient experience.

[0040] Further plans will continue to be considered. Figure 4 As shown, two symmetrically arranged partition layers 1-6 are arranged circumferentially inside the air cavity 1-3. The partition layers 1-6 extend from the top connection of the inner layer 1-1 and the outer layer 1-2 to the top of the large and small flared mouths. The two partition layers 1-6 divide the air cavity 1-3 above the large and small flared mouths into two chambers. The outer layer 1-2 corresponding to the two chambers constitutes the pressing area for pinching with two fingers. Each partition layer 1-6 has a rounded angle 1-7 on both sides of the end where it connects to the outer layer 1-2 of the fixed suction cup 1.

[0041] It should be noted that since the flared area does not participate in the squeezing operation, and only the squeezing area has a separator layer 1-6, the separator layer 1-6 extends from the top of the fixed suction cup 1 to the top of the flared area, but not to the bottom of the inner layer 1-1 or the outer layer 1-2. During the squeezing process, the air chamber 1-3 cannot be squeezed synchronously as a whole, and air is easily trapped in the unsqueezed area; the separator layer 1-6 fills the unsqueezed space in the air chamber 1-3, maximizing the expulsion of air from the air chamber 1-3 to increase the negative pressure. No separator layer is set at the flared position, and the air chamber 1-3 remains connected at this position, increasing the contact area between the negative pressure area and the human skin, and improving the adsorption force; the arc angle 1-7 at the connection between the separator layer and the outer layer 1-2 can eliminate structural stress concentration and improve the structural rigidity of the outer layer 1-2, so that the outer layer 1-2 has a stronger rebound recovery ability after squeezing and expelling air, and obtains a higher negative pressure adsorption force.

[0042] It can be seen that the partition layer 1-6 of the fixed suction cup 1 divides the air chamber 1-3 into two chambers, which can effectively improve the adsorption force. When the air chamber is squeezed, the deformable area is occupied by the air chamber, and the non-squeezed area is occupied by the partition layer, which is conducive to the maximum emptying of air in the air chamber 1-3, increasing the proportion of the volume of the expelled air in the sealed cavity formed between the fixed suction cup 1 and the skin 5, thereby correspondingly increasing the adsorption force. At the same time, the arc angle 1-7 set on both sides of the contact end between the partition layer 1-6 and the outer layer of the fixed suction cup 1 can improve the structural elastic stiffness of the outer layer of the fixed suction cup 1, so that the recovery force of the outer layer of the fixed suction cup 1 after releasing the hand is increased, further improving the adsorption force accordingly.

[0043] Further plans will continue to be considered. Figure 2 , Figure 4 As shown, the top of the fixed suction cup 1 extends outward from the central axis of the needle passage I1-4 to form a bevel 1-5, which is a ring of inwardly sloping surfaces. A cotton ball 3 is pre-placed and housed inside the small funnel-shaped opening at the bottom of the inner layer 1-1; a perforation is pre-drilled in the middle of the cotton ball 3 to allow the internal heating needle 4 to pass through smoothly. The cotton ball 3 is confined inside the small funnel-shaped opening and will not move into the air chamber 1-3.

[0044] As can be seen, this invention pre-places the cotton ball 3 in the small funnel-shaped opening at the inner end of the fixed suction cup 1, achieving integrated operation of puncture, fixation, and hemostasis. Compared to the cumbersome steps of using a cotton ball to apply pressure for hemostasis after needle removal in traditional methods, this invention automatically seals the puncture site with the cotton ball 3's elasticity at the same time as needle removal, achieving hemostasis without additional doctor intervention, simplifying the treatment process and reducing the doctor's workload. Simultaneously, the cotton ball 3 adheres tightly to the skin surface 5 under the pressure of the fixed suction cup 1, applying continuous and uniform pressure to the puncture point, resulting in more reliable hemostasis, especially suitable for situations where multiple needles are treated simultaneously, with densely packed puncture points and difficulty in applying pressure individually.

[0045] The following provides a further explanation of the specific structure of the aforementioned fixing plug.

[0046] like Figure 2 , Figure 3As shown, the fixing plug 2 is an elastic component, comprising an upper disc 2-1, a middle cylindrical section, and a bottom conical section. The diameter of the disc 2-1 is larger than the outer diameter of the cylindrical section, facilitating pressure and movement by the doctor's fingers. A needle passage II 2-3 is centrally located on the fixing plug 2; the inner diameter of the needle passage II 2-3 is slightly larger than the outer diameter of the inner heated needle 4, allowing the inner heated needle 4 to slide smoothly within the passage. Two contraction grooves 2-2 are formed in the bottom conical section of the fixing plug 2; the contraction grooves 2-2 extend upwards from the bottom of the conical section, completely penetrating the conical area and continuing upwards to the cylindrical section of the fixing plug. The contraction grooves 2-2 provide deformation allowance for the bottom of the fixing plug and form a gas conduction path. A larger outer diameter disc 2-1 is provided at the top of the fixing plug 2, increasing the contact area with the fingers, reducing slippage during push-fit assembly and needle removal, and improving the clinical operation feel.

[0047] It should be noted that the above description indicates that the bottom conical section of the fixed plug 2 has two contraction grooves 2-2; in actual design, only one contraction groove 2-2 is provided at the bottom of the fixed plug 2. A single contraction groove 2-2 can also achieve radial contraction deformation at the bottom to make room, while forming a gas conduction channel to achieve the pressure relief function.

[0048] For details, please refer to... Figure 2 , Figure 3 As shown, the angle of the bevel 1-5 is smaller than the cone angle of the bottom conical surface of the fixing plug 2. When the doctor pushes the fixing plug 2 downward into the bevel 1-5, the conical surface and the bevel 1-5 press against each other. Under the action of the cone force, the bottom of the fixing plug 2 contracts radially inward along the contraction groove 2-2, clamping the inner heated needle 4 against the inner wall of the needle channel II 2-3, thus achieving radial clamping and limiting of the inner heated needle 4. After clamping, the fixing plug 2 remains in the assembled position by relying on the friction of the contact surface, restricting the radial deflection and axial movement of the inner heated needle 4, and maintaining the insertion depth of the inner heated needle 4.

[0049] It is understood that after the fixing plug 2 is embedded in the fixing suction cup 1, it can clamp and position the internally heated needle 4, preventing axial movement during treatment and maintaining a constant insertion depth of the internally heated needle 4 in the patient's body, thereby ensuring the stability and consistency of the treatment effect. This invention designs the fixing plug 2 and the fixing suction cup 1 as separate structures, which can slide independently or lock together. During the treatment preparation stage, the fixing suction cup 1 can slide independently along the internally heated needle 4 to the skin surface 5 to complete the adsorption and positioning, without interference from the fixing plug 2, allowing for flexible operation. After positioning, the fixing plug 2 is pushed into the bevel 1-5 of the fixing suction cup to complete the locking. This step-by-step operation design allows the doctor to separately confirm the reliability of the adsorption positioning and clamping locking stages, avoiding positioning deviations caused by the coupling of the operation sequence, and improving the accuracy and safety of the treatment.

[0050] For details, please refer to... Figure 2 , Figure 3As shown, the contraction groove 2-2 extends upwards to the cylindrical body. Therefore, even if the fixing plug 2 clamps the internal heating needle 4, the needle passage II 2-3 can still maintain gas communication with the outside through the contraction groove 2-2. During the treatment process, the needle body of the internal heating needle 4 is heated, and the air inside the channel expands due to the heat. The gas can be discharged outwards along the contraction groove 2-2, balancing the air pressure inside the cavity and preventing the internal air pressure from rising and pushing the fixing plug outwards, causing clamping failure. At the same time, during the needle removal process, the contraction groove 2-2 can also prevent the formation of negative pressure adsorption inside the channel, reducing the resistance to needle removal.

[0051] As can be seen, the contraction groove 2-2 extends beyond the conical region at the tail of the fixed plug 2, keeping the needle passage of the fixed suction cup 1 connected to the outside. When the internal heating needle 4 is heated, the internal air pressure in the needle passage of the fixed suction cup 1 increases. If the passage is closed, the internal air pressure will push the fixed plug 2 outward, causing the internal heating needle 4 to shift and the fixed plug 2 to fail. By setting this type of contraction groove 2-2, the present invention, on the one hand, allows the increased air pressure in the passage to be discharged in time, achieving a balance between internal and external air pressure and ensuring the smooth progress of the treatment process; on the other hand, during needle removal, the contraction groove 2-2 can prevent the formation of negative pressure in the passage, which would hinder the needle removal action, eliminating the hidden danger of poor needle removal and improving the smoothness of clinical operation.

[0052] For details, please refer to... Figure 2 , Figure 3 As shown, the inner diameters of needle passages I1-4 and II2-3 are both larger than the outer diameter of the internal heating needle 4. After the fixing plug 2 is fully pushed into the bevel 1-5 and assembled in place, needle passages II2-3 and I1-4 are automatically arranged coaxially to ensure smooth needle insertion. In clinical use, the fixing suction cup 1 is attached to the skin surface under negative pressure, and the central axis of needle passage I1-4 is approximately perpendicular to the skin surface to ensure that the internal heating needle maintains an ideal insertion angle.

[0053] The following provides a further explanation of the specific structure of the aforementioned movable support.

[0054] like Figure 1 As shown, the movable support 6 is a multi-link hinged adjustable structure. In this embodiment, the bottom of the movable support 6 adopts a movable base with universal casters, which can be placed directly on the ground and moved freely. A clamp is provided at the end of the movable support 6 as a clamping component; the clamp can be arbitrarily adjusted in spatial position and pitch angle with the multi-link. The clamp is used to clamp the power supply connection cable 7 of the internal heating needle or the bus after the connection cables converge, transferring the weight of the power supply connection cable 7 to the movable support 6, eliminating the downward deflection torque exerted by the cable's own weight on the tail of the internal heating needle, and preventing the internal heating needle from rotating or shifting.

[0055] It should be noted that the bottom of the movable support 6 can also be set as a bed edge holder. The bed edge holder can be directly clamped and fixed to the side edge of the treatment bed without taking up floor space, which is suitable for use scenarios where the treatment room floor is small and the beds are compact.

[0056] As can be seen, this invention uses a movable bracket 6 to fix and suspend the main bus of the internal heating needle connection line above the connection line, effectively preventing the internal heating needle 4 and the fixed suction cup 1 from deflecting. Without the movable bracket 6, the cable and main bus connected to the tail end of the internal heating needle 4 would exert a downward rotational torque on the tail end of the internal heating needle 4 under the action of gravity, which is a major reason for the internal heating needle 4 deviating from the target acupoint. This invention transfers most of the gravity of the cable and main bus to the bracket 6 through the movable bracket 6, significantly reducing the deflection torque on the internal heating needle 4. Combined with the limiting effect of the fixed suction cup 1, this makes it less likely for the internal heating needle 4 to deflect during treatment, thus ensuring the accuracy and stability of the entire treatment process. The movable bracket 6 adopts a multi-link structure, and the position and angle of the clamp can be flexibly adjusted to adapt to different patient positions, different treatment sites, and different wiring directions of multiple internal heating needles 4. Compared to fixed supports, the multi-link structure offers greater flexibility in adjustment, allowing doctors to quickly adjust the suspension position of the connecting cable bus according to the actual treatment scenario, ensuring that the weight of the connecting cable is always effectively distributed, thus enhancing the versatility and clinical applicability of the device.

[0057] like Figure 5 As shown, the present invention also provides a method for fixing an internal heating needle, using the above-mentioned fixing device for the internal heating needle, comprising the following steps: Step 1: Assembly Pre-treatment: Place the cotton ball 3 into the small flared opening at the bottom of the inner layer 1-1 of the fixed suction cup 1; take the inner heating needle 4 and pass it through the needle passage II 2-3 of the fixed plug 2 and the needle passage I 1-4 of the fixed suction cup 1 in sequence, and pass it through the middle hole of the cotton ball 3. At this time, the fixed plug 2 and the fixed suction cup 1 are in a separated sliding state, and the inner heating needle 4 can slide freely inside the needle passage.

[0058] Step 2: Needle insertion and suction cup adhesion: The doctor holds the internally heated needle 4 and inserts it into the patient's target acupoint. After the needle is inserted, the doctor pinches the middle of the fixed suction cup 1 with one hand and squeezes the air chambers 1-3 to expel most of the air from inside the air chambers 1-3. While maintaining the pinching pressure, the doctor presses the funnel-shaped end of the fixed suction cup 1 against the puncture site on the patient's skin 5. The doctor releases the hand that is pinching the fixed suction cup 1, and the air chambers 1-3 recover their elasticity, creating a negative pressure inside the air chambers 1-3. The fixed suction cup 1 is then firmly attached to the surface of the patient's skin 5 by this negative pressure.

[0059] Step 3: Needle body locking: Keep the fixed suction cup 1 attached to the skin 5, press down on the disc 2-1 at the upper end of the fixed plug 2, and push the bottom conical section of the fixed plug 2 into the bevel 1-5 at the top of the fixed suction cup 1; under the squeezing action of the bevel, the bottom of the fixed plug 2 contracts radially along the shrinkage groove 2-2, holding the inner heated needle 4 tightly, completing the radial clamping and limiting of the needle body, and restricting the radial deflection and axial movement of the inner heated needle 4.

[0060] Step 4: Repeated fixation with multiple needles: Clinical internal heat needle treatment often requires multiple needles to be placed at the same time. The remaining internal heat needles are punctured, suction cup adsorbed, and fixed plug locked in sequence according to steps 1-3.

[0061] Step 5: Cable weight distribution: Connect the power supply connection cable 7 to the tail of each internal heating needle, and the multiple connection cables are combined into a bus; adjust the multi-link of the moving bracket 6 to adjust the spatial position and angle of the clamp, clamp the bus of connection cables inside the clamp, so that the clamp bears most of the weight of the bus of connection cables, eliminating the deflection torque of the needle body caused by the gravity of the cables; after completion, the internal heating needle 4 can be turned on to start heat therapy.

[0062] Step 6: Treatment Completion and Needle Removal for Hemostasis: After treatment, first disconnect the power supply to the device; gently press the outer edge of the large flared opening of the fixed suction cup 1 with one hand, and pinch the upper disc 2-1 of the fixed plug 2 with the other hand, pulling the fixed plug 2 outward together with the internal heating needle 4; the moment the internal heating needle 4 is pulled out, the cotton ball 3, which was originally squeezed and stretched by the needle body, loses the support of the needle body, and the cotton ball 3 rebounds and contracts inward due to its own elasticity, directly sealing the puncture needle hole on the skin 5, achieving automatic pressure hemostasis at the puncture point, without the need for the doctor to press with a cotton ball. After hemostasis is completed, pinch the middle of the fixed suction cup 1 again, the volume of the air chamber 1-3 decreases, the air pressure inside the air chamber 1-3 increases and the negative pressure is released, allowing the fixed suction cup 1 to easily detach from the skin 5, and directly remove the fixed suction cup 1, completing all operations.

[0063] In summary, the present invention provides a fixing device and method for internal heating needles, achieving the following functions and effects: 1. This invention uses a fixed suction cup to confine the rotation range of the internal heating needle within the needle passage, significantly reducing the deflection angle of the internal heating needle to a controllable range. The fixed suction cup adheres to the surface of human skin, utilizing a large area of ​​epidermis for auxiliary support, ensuring that the fixed suction cup receives sufficient and stable support on the human skin, thereby effectively suppressing the radial displacement of the internal heating needle.

[0064] 2. After the fixing plug is embedded in the fixing suction cup, it can clamp and position the internally heated needle, preventing axial movement during treatment and maintaining a constant insertion depth of the internally heated needle in the patient's body, thereby ensuring the stability and consistency of the treatment effect. This invention designs the fixing plug and fixing suction cup as separate structures, which can slide independently or be locked together. During the treatment preparation stage, the fixing suction cup can slide independently along the internally heated needle to the skin surface to complete the adsorption and positioning, without interference from the fixing plug, allowing for flexible operation. After positioning, the fixing plug is pushed into the bevel of the fixing suction cup to complete the locking. This step-by-step operation design allows the doctor to separately confirm the reliability of the adsorption and positioning and clamping and locking stages, avoiding positioning deviations caused by the coupling of the operation sequence, and improving the accuracy and safety of the treatment.

[0065] 3. The contraction groove extends beyond the conical area at the tail of the fixing plug, maintaining communication between the needle passage of the fixing suction cup and the outside environment. When the internal heating needle is heated, the internal air pressure in the needle passage of the fixing suction cup increases. If the passage is closed, the internal air pressure will push the fixing plug outward, causing displacement of the internal heating needle and failure of the fixing plug. This invention, by setting this type of contraction groove, allows the increased air pressure in the passage to be discharged in a timely manner, achieving a balance between internal and external air pressure and ensuring a smooth treatment process. On the other hand, during needle removal, the contraction groove can prevent negative pressure from forming in the passage, which could hinder the needle removal action, eliminating the potential for poor needle removal and improving the smoothness of clinical operations.

[0066] 4. This invention pre-places a cotton ball in the small funnel-shaped opening at the inner end of the fixed suction cup, achieving integrated puncture, fixation, and hemostasis. Compared to the cumbersome steps of traditional methods where a cotton ball needs to be used separately to apply pressure for hemostasis after needle removal, this invention automatically seals the puncture site with the cotton ball's elasticity at the same time as needle removal, achieving hemostasis without additional doctor intervention, simplifying the treatment process and reducing the doctor's workload. Simultaneously, the cotton ball adheres tightly to the skin surface under the pressure of the fixed suction cup, applying continuous and uniform pressure to the puncture point, resulting in more reliable hemostasis, especially suitable for situations where multiple needles are being treated simultaneously, with numerous puncture points and difficulty in applying pressure individually.

[0067] 5. This invention employs a movable support to fix and suspend the main bus of the internal heating needle connection line above the connection line, effectively preventing the internal heating needle and the fixed suction cup from deflecting. Without the movable support, the cable and main bus connected to the tail end of the internal heating needle would exert a downward rotational torque on the tail end of the internal heating needle under the action of gravity, which is a major reason for the internal heating needle deviating from the target acupoint. This invention transfers most of the gravity of the cable and main bus to the support by using the movable support, significantly reducing the deflection torque on the internal heating needle. Combined with the limiting effect of the fixed suction cup, this makes it less likely for the internal heating needle to deflect during treatment, thereby ensuring the accuracy and stability of the entire treatment process.

[0068] 6. The movable support in this invention adopts a multi-link structure, and the position and angle of the clamps can be flexibly adjusted to adapt to different patient positions, different treatment sites, and different wiring directions of multiple internal heating needles. Compared with a fixed support, the multi-link structure provides greater adjustment freedom, allowing doctors to quickly adjust the suspension position of the connecting cable bus according to the actual treatment scenario, ensuring that the weight of the connecting cable is always effectively distributed, thus enhancing the versatility and clinical applicability of the device.

[0069] 7. This invention achieves convenient control of the adsorption and separation processes by pinching the middle of the fixed suction cup. During the adsorption phase, the doctor pinches the middle of the fixed suction cup to reduce the volume of the air chamber and expel the air inside. The suction cup is then attached to the patient's skin. Releasing the fixed suction cup restores the elasticity of the air chamber and creates negative pressure within the sealed cavity, ensuring a tight fit between the fixed suction cup and the patient's skin surface. The operation is simple and intuitive, achieving stable and reliable adsorption without the need for additional suction equipment. During the separation phase, again, pinching the middle of the fixed suction cup reduces the volume of the air chamber, increases the internal air pressure, and releases the negative pressure, allowing the fixed suction cup to easily detach from the skin. This avoids the discomfort caused by pulling the suction cup during separation, a problem common with traditional negative pressure adsorption devices. The entire adsorption and separation process is completed through the same pressing point, resulting in a unified and easy-to-master operating logic, significantly reducing the difficulty of clinical use and improving operational efficiency and patient experience.

[0070] 8. The separator layer of the fixed suction cup divides the air chamber into two compartments, effectively enhancing the suction force. When the air chamber is squeezed, the deformable area is occupied by the air chamber, while the non-squeezable area is occupied by the separator layer. This facilitates the maximum expulsion of air from the air chamber, increasing the proportion of the expelled air volume in the sealed cavity formed between the fixed suction cup and the skin, thereby correspondingly increasing the suction force. Simultaneously, the rounded angles on both sides of the contact end between the separator layer and the outer layer of the fixed suction cup enhance the structural elastic stiffness of the outer layer of the fixed suction cup, increasing its recovery force after release, further enhancing the suction force.

[0071] Numerous specific details are set forth in the specification provided herein. However, it will be understood that embodiments of the invention may be practiced without these specific details. In some instances, well-known methods, structures, and techniques have not been shown in detail so as not to obscure the understanding of this specification.

[0072] Furthermore, those skilled in the art will understand that although some embodiments described herein include certain features found in other embodiments but not others, combinations of features from different embodiments are also within the scope of protection of this invention and form different embodiments. For example, in the embodiments described above, those skilled in the art can use them in combination based on known technical solutions and the technical problems to be solved by this application.

[0073] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-described technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A fixing device for an internal heating needle, characterized in that, include: The fixed suction cup has an internal needle passage channel I for the internal heating needle to pass through, and the fixed suction cup can be negatively attached to the patient's skin surface; The fixing plug has an internal needle passage channel II for the internal heating needle to pass through. The fixing plug is assembled on the fixing suction cup. The fixing plug and the fixing suction cup cooperate to radially clamp and limit the internal heating needle passing through them, maintaining a constant insertion depth of the internal heating needle in the patient's body. An elastic cotton ball is placed inside the fixed suction cup near the skin end. The heated needle passes through the cotton ball and pierces the patient's skin. The cotton ball has the function of sealing the puncture site with its own elasticity after the needle is removed to stop bleeding.

2. The fixing device for an internal heating needle according to claim 1, characterized in that, The top of the fixed suction cup extends outward from the central axis of the needle channel I to form a bevel, which is a circumferentially inclined slope; the bottom outer circumferential surface of the fixed plug is a conical surface, and the angle of the bevel is smaller than the angle of the conical surface; when the fixed plug is pushed into the bevel for assembly, the bottom of the fixed plug is squeezed by the bevel and undergoes radial contraction, clamping the inner heating needle.

3. The fixing device for an internal heating needle according to claim 2, characterized in that, At least one contraction groove is provided at the bottom of the fixed plug. The contraction groove extends upward through the conical region to the cylindrical section of the fixed plug body. The contraction groove provides radial contraction deformation allowance for the bottom of the fixed plug and also forms a gas passage to discharge the gas inside the needle channel I, thereby achieving gas pressure relief.

4. The fixing device for an internal heating needle according to claim 1, characterized in that, The fixed suction cup includes an inner layer and an outer layer. The tops of the inner and outer layers are connected to each other, and the bottoms of the inner and outer layers are separated from each other. An air cavity is formed between the inner and outer layers. The needle passage I is formed inside the inner layer. The air cavity is configured such that it is compressed under external pressure and can elastically recover after the external force is removed to generate negative pressure and adhere to the skin surface.

5. The fixing device for an internal heating needle according to claim 4, characterized in that, The bottom of the inner layer of the fixed suction cup is designed with a small flared opening, and the bottom of the outer layer is designed with a large flared opening. The bottom surfaces of the inner and outer layers are flush. The cotton ball is contained inside the small flared opening at the bottom of the inner layer.

6. The fixing device for an internal heating needle according to claim 5, characterized in that, The air cavity is provided with two symmetrically arranged partition layers along its circumference. The partition layers extend from the connection between the top of the inner and outer layers to the top of the large and small flared mouths. The two partition layers divide the air cavity above the large and small flared mouths into two chambers. The outer layers corresponding to the two chambers form a pressing area for pinching with two fingers. Each partition layer has a rounded angle on both sides of the end where it connects to the outer layer of the fixed suction cup.

7. The fixing device for an internal heating needle according to claim 1, characterized in that, The inner diameters of both needle passage I and needle passage II are larger than the outer diameter of the inner heating needle. After the fixing plug is assembled into the fixing suction cup, needle passage II and needle passage I are arranged coaxially. And / or, the top of the cylindrical section of the fixed plug is provided with a disc as a pressing part.

8. A fixing device for an internal heating needle according to any one of claims 1-7, characterized in that, It also includes a movable support, on which a clamping member is provided for holding the internal heating needle power supply connection cable; the position of the clamping member can be adjusted to support the weight of the power supply connection cable.

9. The fixing device for an internal heating needle according to claim 8, characterized in that, The movable support is a multi-link adjustable structure; the bottom of the movable support is a bed edge gripper or a movable base with wheels, the gripper is a clamp, and the spatial position and pitch angle of the clamp can be adjusted by means of the multi-link structure.

10. A method for fixing an internal heating needle, characterized in that, The fixing device for the internal heating needle according to any one of claims 1-9 includes the following steps: S1: Assemble the cotton ball on the end of the fixed suction cup that is close to the skin, and pass the internal heating needle through the needle passage of the fixed plug and the fixed suction cup in sequence, and then through the cotton ball; S2: Insert the internal heating needle into the patient's target acupoint, squeeze the fixed suction cup to expel the air in the air cavity, attach the fixed suction cup to the patient's skin, release the fixed suction cup, and the air cavity elastically recovers to generate negative pressure, so that the fixed suction cup is negatively attached to the patient's skin surface. S3: Push the fixing plug into the bevel of the fixing suction cup for assembly. The conical surface at the bottom of the fixing plug is squeezed by the bevel and undergoes radial contraction, which radially clamps and limits the inner hot needle. S4: Multiple internal heating pins are fixed sequentially according to steps S1-S3; S5: Connect the power supply cable to the tail of the internal heating needle, clamp the power supply cable on the clamp of the movable bracket, and adjust the position and angle of the clamp so that the clamp supports the weight of the power supply cable. S6: After treatment, hold the fixation plug and pull it out together with the internal heating needle. The cotton ball will seal the puncture site to stop bleeding due to its own elasticity. Squeeze the fixation suction cup to reduce the volume of the air chamber, increase the air pressure inside the air chamber and release the negative pressure, then the fixation suction cup can be removed.

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