Soft tissue filler safety injection needle and safety injection device

Abstract

The invention provides a soft tissue filler safety injection needle head and a safety injection device which are high in reliability. Comprising a needle base and a needle body. The needle seat comprises a main tube body and a first auxiliary tube body, the main tube body is provided with a first end and a second end which are opposite, the needle body is connected to the first end of the main tube body, and an opening of the second end of the main tube body can be connected with a nipple of a needle cylinder of an injector containing soft tissue filler in a matched mode. The internal space of the main tube body and the internal space of the needle body form a main passage together; the first auxiliary tube body is provided with a first end and a second end which are opposite, the first end of the first auxiliary tube body is connected to the main tube body or the needle body, and the inner space of the first auxiliary tube body, a part of the inner space of the main tube body and the inner space of the needle body jointly form a first auxiliary channel. Or the inner space of the first auxiliary tube body and the inner space of the needle body jointly form a first auxiliary passage.

Description

Technical Field

[0001] This invention relates to the field of medical aesthetics, and more specifically, to a safe injection needle and device for soft tissue fillers. Background Technology

[0002] Soft tissue filler injection is a common treatment method in cosmetic surgery, which can be used to fill depressions in facial tissues, such as nasolabial folds and forehead wrinkles.

[0003] According to statistics from the American Society of Plastic Surgeons, hyaluronic acid injections or other filler injections have been performed more than 5.6 million times per year, making it one of the most popular plastic surgery treatments.

[0004] However, filler injections also carry certain risks, the most serious of which is vascular embolism. Vascular embolism can lead to necrosis of local skin and soft tissue, and in severe cases, it can cause blindness, cerebral vascular embolism, or even death.

[0005] In the prior art, conventional injection devices are used to inject fillers such as hyaluronic acid into soft tissue. These conventional injection devices have a traditional single-channel structure and generally include a syringe, a plunger, and a needle. The needle is mounted on the nipple at the front end of the syringe. The plunger has a piston at its front end, which engages with the syringe. Pushing the plunger moves the piston forward along the syringe to perform the injection.

[0006] In the field of cosmetic injections, when injecting fillers into soft tissue, a safety verification is first required. This involves confirming that the needle tip is completely within the soft tissue and has not entered a blood vessel. When using existing injection devices, the safety verification method involves fixing the needle and syringe, pulling back the plunger, which moves the piston backward along the syringe. Observe whether there is "blood return" in the syringe. If there is no blood return, it indicates the needle tip is correctly positioned within the soft tissue, i.e., "negative," and the injection can proceed. If blood return occurs, it indicates the needle tip is incorrectly positioned (having punctured a blood vessel), i.e., "positive," and injection is not permitted, as this could lead to medical accidents.

[0007] However, in this safety verification method, if the plunger is pulled back too quickly or too forcefully, the excessive suction generated by the pullback will cause the blood vessel to collapse and the blood vessel walls to stick together, making it impossible to show "blood return" and resulting in a "false negative". At the same time, the process of pulling back the plunger can also easily cause the needle tip to shift, which may also cause a "false negative".

[0008] Therefore, the safety and reliability of injecting fillers into soft tissue using existing injection devices is low. Summary of the Invention

[0009] The main objective of this invention is to overcome at least one of the defects of the prior art and provide a safe and reliable soft tissue filler injection needle, as well as an injection device equipped with the soft tissue filler safe injection needle.

[0010] To achieve the above objectives, the present invention adopts the following technical solution:

[0011] According to one aspect of the present invention, a safe injection needle for soft tissue fillers includes a needle hub and a needle body. The needle hub includes a main tube and a first auxiliary tube. The main tube has opposite first and second ends. The needle body is connected to the first end of the main tube. The opening of the second end of the main tube is capable of engaging with the tip of a syringe barrel. The internal space of the main tube and the internal space of the needle body together form a main passage. The first auxiliary tube has opposite first and second ends. The first end of the first auxiliary tube is connected to either the main tube or the needle body. The internal space of the first auxiliary tube, a portion of the internal space of the main tube, and the internal space of the needle body together form a first secondary passage, or the internal space of the first auxiliary tube and the internal space of the needle body together form a first secondary passage.

[0012] According to one aspect of the present invention, a safe injection needle for soft tissue fillers includes a needle hub, a needle body, and an extension tube. The needle hub includes a main tube having opposite first and second ends. The needle body is connected to the first end of the main tube, and the opening of the second end of the main tube is capable of engaging with the tip of a syringe barrel. The internal space of the main tube and the internal space of the needle body together form a main passage. The extension tube is connected to the main tube or the needle body, and a portion of the internal space of the main tube, the internal space of the needle body, and the extension tube together form a first secondary passage.

[0013] According to one aspect of the present invention, a soft tissue filler safety device includes a syringe and a needle, said needle being the soft tissue filler safety injection needle of the present invention.

[0014] As can be seen from the above technical solution, the advantages and positive effects of the soft tissue filler safety injection needle proposed in this invention are as follows:

[0015] The soft tissue filler safety injection needle proposed in this invention has a main injection pathway and a first secondary pathway for safety verification, forming a multi-pathway structure. During the safety verification phase, the first secondary pathway is open and connected to the atmosphere, providing a channel for blood return should the needle accidentally puncture a blood vessel. Therefore, using this soft tissue filler safety injection needle eliminates the need to pull back the syringe plunger. Without affecting the needle tip position, blood pressure alone can confirm whether the needle tip is correctly positioned in the patient's blood, providing timely and accurate feedback on whether the needle tip has accidentally entered a blood vessel, thus preventing vascular embolism caused by injection. Traditional injection devices, on the other hand, only have one pathway that is not connected to the outside environment. Even if the needle accidentally enters a blood vessel, the high pressure within this pathway makes it difficult for blood to return. Therefore, using this soft tissue filler safety injection needle greatly improves the safety and reliability of soft tissue filler injections. Attached Figure Description

[0016] Various objects, features, and advantages of the invention will become more apparent from the following detailed description of preferred embodiments of the invention, taken in conjunction with the accompanying drawings. The drawings are merely illustrative of the invention and are not necessarily drawn to scale. In the drawings, the same reference numerals always denote the same or similar parts. Wherein:

[0017] Figure 1 This is a schematic diagram of the structure of the first embodiment of the safe injection needle for soft tissue fillers of the present invention.

[0018] Figure 2A This is a schematic diagram of the second embodiment of the safe injection needle for soft tissue fillers of the present invention.

[0019] Figure 2B yes Figure 2A The diagram shows another connection method between the extension tube and the first auxiliary tube in the soft tissue filler safety injection needle.

[0020] Figure 3 This is a structural schematic diagram of the third embodiment of the safe injection needle for soft tissue fillers of the present invention.

[0021] Figure 4 This is a cross-sectional view of the first seal in the third embodiment of the soft tissue filler safety injection needle of the present invention;

[0022] Figure 5 This is a cross-sectional view showing the first seal fitting with the main body in a third embodiment of the soft tissue filler safety injection needle of the present invention;

[0023] Figure 6 This is a partial exploded view of a third embodiment of the soft tissue filler safety injection needle of the present invention, in which the second seal is hidden.

[0024] Figure 7This is a schematic diagram of the fourth embodiment of the safe injection needle for soft tissue fillers of the present invention.

[0025] Figure 8A This is a structural schematic diagram of the fifth embodiment of the safe injection needle for soft tissue fillers of the present invention.

[0026] Figure 8B yes Figure 8A The diagram shows another negative pressure device in a safe injection needle for soft tissue fillers.

[0027] Figure 9A This is a schematic diagram of the soft tissue filler safety injection needle with a valve according to the present invention, wherein the main passage is in the closed state and the first secondary passage is in the open state.

[0028] Figure 9B This is a schematic diagram of the soft tissue filler safety injection needle with a valve according to the present invention, wherein the main passage is in the open state and the first secondary passage is in the closed state. Detailed Implementation

[0029] Typical embodiments embodying the features and advantages of the present invention will be described in detail in the following description. It should be understood that the present invention can have various variations in different embodiments without departing from the scope of the present invention, and the description and drawings therein are for illustrative purposes only and not intended to limit the present invention.

[0030] In the following description of various exemplary embodiments of the invention, reference is made to the accompanying drawings, which form part of the invention, and in which different exemplary structures, systems, and steps that can implement various aspects of the invention are shown by way of example. It should be understood that other specific solutions to components, structures, exemplary devices, systems, and steps may be used, and structural and functional modifications may be made without departing from the scope of the invention. When describing the elements / components / etc. described and / or illustrated herein, the terms "comprising," "including," and "having" are used to mean an open-ended inclusion and that additional elements / components / etc. may exist in addition to those listed.

[0031] Relative terms such as “down” or “bottom” and “up” or “top” may be used herein to describe the relationship of one element to another, as illustrated in the figures. It should be understood that relative terms are intended to include different orientations of the device beyond those shown in the figures. For example, if a device in one of the figures is flipped, an element described as “down” or “bottom” of another element will be oriented “up” or “top” of that element. Thus, the exemplary term “down” can include both “down” and “up” orientations, and the term “bottom” can include both “bottom” and “top” orientations, depending on the specific orientation of the figure. Similarly, if a device in one of the figures is flipped, an element described as “down” or “bottom” of another element will be oriented “up” or “top” of that element. Thus, the exemplary term “bottom” or “below” can include both “up” and “down” orientations.

[0032] Example 1

[0033] like Figure 1 As shown, the first embodiment of the safe injection needle for soft tissue fillers of the present invention includes a needle hub 1 and a needle body 2. The needle hub 1 includes a main tube body 11 and a first auxiliary tube body 12.

[0034] The main tube 11 has opposite first and second ends. The needle 2 is connected to the first end of the main tube 11, and the center line of the needle 2 and the main tube 11 can coincide. The second end of the main tube 11 is connected to the nipple of the syringe barrel. In the non-use state, a sealing cap can be connected to the second end of the main tube 11.

[0035] The internal space of the main tube 11 and the internal space of the needle body 2 together form a main passage. This main passage is the injection passage. When the second end of the main tube 11 is connected to the nipple of the syringe barrel, the soft tissue filler in the syringe can be injected into the patient through the main passage.

[0036] The first auxiliary tube 12 has opposite first and second ends, and the first end of the first auxiliary tube 12 is connected to the main tube 11. The first auxiliary tube 12 and the main tube 11 can be integrally formed.

[0037] The internal space of the first auxiliary tube 12, a portion of the internal space of the main tube 11, and the internal space of the needle body 2 together form a first auxiliary passage. This first auxiliary passage is a safety confirmation passage. The first auxiliary tube 12 can be made of transparent or translucent material, such as transparent plastic or glass, for easy observation. Furthermore, the entire needle holder 1 can be made of transparent or translucent material; the needle body 2 can also be made of transparent or translucent material.

[0038] In some other embodiments, the first end of the first auxiliary tube 12 is not connected to the main tube 11, but is connected to the needle body 2 or integrally formed with the needle body 2. In this case, the first auxiliary passage is formed by the internal space of the first auxiliary tube 12 and the internal space of the needle body 2.

[0039] Preferably, this embodiment also includes a sealing cap 3, which is detachably fitted to the second end of the first auxiliary tube 12. The structure of the sealing cap 3 may include, for example, a plunger 31 that can be inserted into the second end of the first auxiliary tube 12 to close the first auxiliary passage.

[0040] Furthermore, the sealing cap 3 may also include an annular wall 32 disposed around the plunger 31 and a connecting part (not shown) that fixes one end of the plunger 31 and one end of the annular wall 32 together. The annular wall 32 has a large area, which is convenient for hand operation.

[0041] In use, the second end of the main tube 11 of the first embodiment of the soft tissue filler safety injection needle of the present invention can be fitted to the nipple of the syringe barrel. The syringe is filled with soft tissue filler, and the needle tip of the needle body 2 is inserted into the area to be filled by the patient. At this time, although the main passage is closed (the needle tip is closed by the patient, and the second end of the main tube 11 is closed by the syringe), the second end of the first auxiliary tube 12 is open, that is, the first auxiliary passage is connected to the outside atmosphere. In other words, in addition to the main injection passage, the soft tissue filler safety injection needle of the present invention also constructs an open safety confirmation passage.

[0042] Therefore, when using the soft tissue filler safety injection needle of the present invention, if the needle tip of the needle body 2 pierces a blood vessel, blood will flow out through the first secondary channel under the combined effect of blood pressure and capillary effect, i.e., backflow occurs, indicating that the needle tip has mistakenly entered a blood vessel. In this case, the injection should not be performed, and the injection site should be changed. If no backflow is observed in the first secondary channel after a period of time, the sealing cap 3 is attached to the second end of the first secondary tube 12, and the injection is performed. The liquid in the syringe can be injected into the patient's body through the main channel. The function of the sealing cap 3 is to seal the first secondary tube 12 and prevent the injection fluid from accidentally flowing out of the first secondary tube 12. In this embodiment, without the sealing cap 3, the doctor can also seal the opening of the second end of the first secondary tube 12 in other ways.

[0043] As can be seen from the above, using the soft tissue filler safety injection needle of the present invention, there is no need to pull back the syringe plunger. Without affecting the position of the needle tip, it is possible to confirm whether the needle tip is correctly inserted into the patient. Using the soft tissue filler safety injection needle of the present invention is safer and more reliable.

[0044] Example 2

[0045] like Figure 2A As shown, the second embodiment of the safe injection needle for soft tissue fillers of the present invention includes a needle hub 1 and a needle body 2. The needle hub 1 includes a main tube 11 and a first auxiliary tube 12. The structures of the needle body 2, the main tube 11, and the first auxiliary tube 1 are basically the same as those in the first embodiment, and will not be described again here.

[0046] The second embodiment differs from the first embodiment in that the soft tissue filler safety injection needle further includes an extension tube 4, which can be a flexible tube made of transparent or translucent material. One end of the extension tube 4 is sealed and connected to the second end of the first auxiliary tube body 12 and communicates with the first auxiliary tube body 12. Specifically, one end of the extension tube 4 is connected to a sealing connector 41, which fits tightly with the second end of the first auxiliary tube body 12. In some other embodiments, the extension tube 4 may also be integrally formed with the first auxiliary tube body 12.

[0047] like Figure 2B As shown, in another embodiment, another connection method between the extension tube 4 and the first auxiliary tube 12 is provided: a sealing cap 3 is provided at the second end of the first auxiliary tube 12; a needle 40 is connected to the end of the extension tube 4, which can pierce the sealing cap 3 or the first auxiliary tube 12, thereby connecting the extension tube 4 with the first auxiliary passage.

[0048] The extension tube 4 may be provided with a structure that can open or close the extension tube passage, such as a tube clamp 42. The tube clamp 42 is not limited to the specific shape and structure shown in Figure 2. Other types of tube clamps, as long as they can open and close the extension tube 4 passage, are also applicable to this invention.

[0049] The second embodiment of the soft tissue filler safety injection needle of the present invention has the same main passage as the first embodiment, and the first secondary passage is formed by the internal space of the extension tube 4, the internal space of the first secondary tube body 12, a part of the internal space of the main tube body 11 and the internal space of the needle body 2.

[0050] In use, the second end of the main tube 11 of the second embodiment of the soft tissue filler safety injection needle of the present invention is fitted to the nipple of the syringe barrel. The syringe is filled with soft tissue filler, and the needle of the needle body 2 is inserted into the patient's desired filling site. If the needle tip of the needle body 2 pierces a blood vessel, blood will flow out through the first secondary passage under the action of capillary effect and blood pressure, i.e., backflow occurs. In this case, injection cannot be performed. If no backflow is observed in the first secondary passage after a period of time, the clamp 42 is closed to seal the first secondary passage, and injection is performed. Similarly, without the clamp 42, the doctor can also directly pinch the extension tube 4 or bend the extension tube 4 to seal the first secondary passage.

[0051] On the other hand, if an embolism is found during the injection of soft tissue filler, the injection can be stopped immediately, the opening at the second end of the main tube 11 can be sealed, and the needle of the syringe containing the thrombolytic agent (such as hyaluronidase) can be directly inserted into the extension tube 4 to inject the thrombolytic agent through the first secondary passage to achieve timely thrombolysis.

[0052] In the second embodiment of this soft tissue filler safety injection needle, by pre-filling the needle body 2 and needle hub 1 with liquid, during verification, the extension tube 4 is lowered to a position below the level of the needle body 2, so that the safety verification pathway (first secondary pathway) forms a siphon effect. Once the needle tip of the needle body 2 accidentally enters a blood vessel, the blood in the blood vessel will automatically flow into the first secondary pathway under the combined action of the siphon effect and blood pressure, producing "backflow".

[0053] Example 3

[0054] like Figure 3 As shown, the third embodiment of the safe injection needle for soft tissue fillers of the present invention includes a needle hub 1, a needle body 2, and an extension tube 4. The needle hub 1 includes a main tube 11 and a first auxiliary tube 12. The structures of the needle body 2, the main tube 11, the first auxiliary tube 1, and the extension tube 4 are basically the same as those in the second embodiment, and will not be described again here.

[0055] The difference between this third embodiment and the second embodiment is that the soft tissue filler safety injection needle also includes three seals, namely the first seal 5, the second seal 6 and the third seal 7.

[0056] The first sealing element 5 is disposed at the second end of the main tube 11; the second sealing element 6 is disposed on the needle body 2 and is used to seal the needle tip of the needle body 2; the third sealing element 7 is disposed at the end of the extension tube 4.

[0057] The third embodiment of this soft tissue filler safety injection needle is pre-filled with liquid, such as saline. The first seal 5 and the third seal 7 seal all openings of the soft tissue filler safety injection needle to prevent the pre-filled liquid from leaking out.

[0058] See Figure 4 , Figure 5 and Figure 6 The first sealing element 5 can be a threaded plug, which includes a circumferential wall 51 and an inner plug 52. The inner plug 52 is disposed inside the circumferential wall 51 and can be coaxially disposed with the circumferential wall 51. The circumferential wall 51 is provided with an external thread 53, and the outer surface of the second end of the main pipe 11 is provided with an internal thread 113 that can mate with the external thread 53. The threaded plug is disposed at the second end of the main pipe 11 through threaded engagement; the inner plug 52 is tightly fitted to the inner surface of the second end of the main pipe 11.

[0059] In some other embodiments, the first seal 5 is not limited to a threaded plug cap, but may also be as follows: Figure 1 The sealing cap 3 shown, or other types of sealing structures, are acceptable as long as they can provide a sealing effect.

[0060] See Figure 3 and Figure 7 The second sealing element 6 is a protective cap, which is fitted over the needle body 2 and covers part of the main tube body 11. The protective cap protects the needle body 2; the protective cap extends upward to cover part of the main tube body 11, so that it is not easy to fall off from the needle seat.

[0061] In other embodiments, the second seal 6 is not limited to Figure 3 and Figure 7 The structure shown is not the only one that can protect the needle body 2; other structures are also feasible.

[0062] See Figure 3 The third sealing element 7 includes a sleeve 71, a flexible band 72, and a plug 73. The sleeve 71 is fixed to the end of the extension tube 4; one end of the flexible band 72 is connected to the sleeve 71, and the other end is a free end; the plug 73 is fixed to the lower surface of the flexible band 72. Bending the flexible band 72 can tightly fit the plug 73 inside the sleeve 71, thereby sealing the extension tube 4.

[0063] In some other embodiments, the third seal 7 may include a sleeve 71 and a threaded plug, the structure of which may be the same as that of the first seal 5 described above. In this case, the sleeve 71 is provided with an internal thread that mates with the external thread of the threaded plug.

[0064] The third seal 7 can also be any other type of sealing structure, as long as it can seal the extension tube 4.

[0065] When using the third embodiment of the safe injection needle for soft tissue fillers of the present invention, firstly, remove the first seal 5 and the second seal 6; then, attach the second end of the main body 11 of the safe injection needle to the nipple of the syringe barrel, with the syringe containing soft tissue fillers, and insert the needle tip of the needle body 2 into the area to be filled; lower the extension tube 4 to a horizontal position below the needle tip of the needle body 2, and open the third seal 7 at the end of the extension tube 4. According to the siphon principle, if the needle tip of the needle body 2 pierces a blood vessel, the blood in the blood vessel will be automatically drawn into the first secondary passage (including the extension tube). If the doctor observes the blood, it can be determined that the needle tip of the needle body 2 has been inserted into a blood vessel, and no injection action is performed; if no blood return is observed after waiting for a period of time, it can be determined that the needle tip has not entered a blood vessel, and then the tube clamp 42 is closed (or the third seal 7 can be closed) to close the first secondary passage, preventing the soft tissue filler from flowing back into the extension tube during injection, and normal injection of soft tissue fillers begins.

[0066] See Figure 9A and Figure 9BIn this embodiment, the soft tissue filler safety injection needle has a valve 10 installed inside the needle hub 1. The valve 10 can be located at the connection between the main tube 11 and the first auxiliary tube 12. The valve 10 can selectively close the main passage while simultaneously opening the first auxiliary passage (e.g., Figure 9A (as shown), or close the first secondary path and open the main path (as shown). Figure 9B (As shown). During the injection process, valve 10 opens the main passage while closing the first secondary passage, allowing the soft tissue filler to be injected smoothly. During the verification process, valve 10 opens the first secondary passage while closing the main passage, preventing the soft tissue filler from being sucked into the first secondary passage due to an unexpectedly strong siphon effect.

[0067] It should be noted that when a valve 10 is installed inside the needle seat 1, it is not necessary to install a structure such as a pipe clamp 42 on the extension tube 4 that can open or close the extension tube passage. Figure 9A and Figure 9B The valve 10 shown can also be applied to other embodiments.

[0068] The third embodiment of the soft tissue filler safety injection needle of the present invention mainly utilizes the siphon principle to complete safety confirmation more quickly and accurately. The length of the extension tube 4 is preferably greater than the sum of the lengths of the needle hub 1 and the needle body 2. This ensures that, regardless of the orientation of the needle body 2 during injection, the end of the extension tube 4 is always lower than the needle tip in the vertical direction, guaranteeing a siphon effect. In some application scenarios, such as when the needle body 2 is injected horizontally or at an angle, even if the length of the extension tube 4 is equal to or even less than the sum of the lengths of the needle hub 1 and the needle body 2, the end of the extension tube 4 can still be lower than the needle tip in the vertical direction, thus generating a siphon effect.

[0069] Example 4

[0070] like Figure 7 As shown, the fourth embodiment of the soft tissue filler safety injection needle of the present invention, based on the third embodiment, further includes a second auxiliary tube 13. The second auxiliary tube 13 has opposite first and second ends. The first end of the second auxiliary tube 13 is connected to or integrally formed with the main tube 11. The opening of the second end of the second auxiliary tube 13 can be connected to the nipple of the syringe barrel.

[0071] The internal space of the second auxiliary tube 13, a portion of the internal space of the main tube 11, and the internal space of the needle 2 together form a second auxiliary passage. This second auxiliary passage can be a thrombolytic passage. Of course, in some other embodiments, this second auxiliary passage is a backup passage for implementing other functions.

[0072] The fourth embodiment of the soft tissue filler safety injection needle of the present invention further includes a fourth seal 8, which is connected to the second end of the second auxiliary tube 13 to ensure that the pre-filled liquid in the safety injection needle does not leak through the second auxiliary passage. The specific structure of the fourth seal 8 can be the same as that of the first seal 5 or the third seal 7.

[0073] In some other embodiments, the second auxiliary tube 13 is not connected to the main tube 11, but is connected to the first auxiliary tube 12 or integrally formed with the first auxiliary tube 12. In this case, the second auxiliary passage is formed by the internal space of the second auxiliary tube 13, a part of the internal space of the first auxiliary tube 12, a part of the internal space of the main tube 11, and the internal space of the needle 2.

[0074] In some other embodiments, the second auxiliary tube 13 is not connected to the main tube 11, but is connected to the needle body 2 or integrally formed with the needle body 2. In this case, the second auxiliary passage is formed by the internal space of the second auxiliary tube 13 and a portion of the internal space of the needle body 2. The injection process and the pre-injection safety confirmation process using the fourth embodiment of the soft tissue filler safety injection needle of the present invention are the same as those in the third embodiment, and will not be described again here.

[0075] Treatment for vascular embolism following the injection of soft tissue fillers such as hyaluronic acid is generally performed by injecting hyaluronidase. However, because it is necessary to change the syringe containing hyaluronidase, the position of the needle tip can easily change during the change process. Therefore, it is difficult for hyaluronidase to be injected into the blocked blood vessel, and it may deviate from the original blocked blood vessel, leading to thrombolysis failure.

[0076] The fourth embodiment of the safe injection needle for soft tissue fillers of the present invention includes a thrombolytic channel. If an embolism is detected during the injection of soft tissue filler, the safe injection needle can remain in its original position. Only the fourth seal 8 of the safe injection needle needs to be removed, and the tip of the syringe containing a thrombolytic agent (such as hyaluronidase) can be attached to the second end of the second auxiliary tube 13. The thrombolytic agent is then injected through the second auxiliary channel, achieving immediate thrombolysis. Simultaneously, because the safe injection needle can remain in its original position, the needle tip position is less likely to change, resulting in a high success rate and good effect of thrombolysis. In the fourth embodiment of the safe injection needle for soft tissue fillers of the present invention, the construction of the thrombolytic channel integrates prevention and treatment, providing double insurance for soft tissue filler injection.

[0077] In some other embodiments, when thrombolysis is required, it is not necessary to remove the fourth seal 8. Instead, the needle of the syringe containing the thrombolytic agent is directly pierced through the fourth seal 8 at the second end of the second auxiliary tube 13 to inject the thrombolytic agent, which is faster.

[0078] Optionally, a valve can be installed inside the needle hub 1, located at the connection between the main tube 11 and the first auxiliary tube 12. During thrombolysis, the valve closes the main passage and opens the second auxiliary passage. This helps reduce the reaction between the soft tissue filler inside the needle hub and the thrombolytic agent, thereby saving the amount of thrombolytic agent used.

[0079] In addition, when the valve is positioned above the connection between the main tube 11 and the first auxiliary tube 12, the valve can be closed before safety verification, which can effectively prevent soft tissue filler from being accidentally sucked into the first auxiliary passage.

[0080] Example 5

[0081] like Figure 8A As shown, the fifth embodiment of the soft tissue filler safety injection needle of the present invention adds a negative pressure device based on the first embodiment. The negative pressure device can be connected to the second end of the first auxiliary tube 12.

[0082] exist Figure 8A In the illustrated embodiment, the negative pressure device is a suction bulb 9. The suction bulb 9 is soft, fits well with the first auxiliary tube 12, and is easy to operate, minimizing its impact on the needle tip position.

[0083] In use, the second end of the main body 11 of the fifth embodiment of the soft tissue filler safety injection needle of the present invention can be fitted to the nipple of the syringe barrel. The syringe is filled with soft tissue filler, and the needle tip of the needle body 2 is inserted into the area to be filled by the patient. The bulb of the ear bulb 9 is squeezed with the fingers to reduce its volume, and the handle of the ear bulb 9 is inserted into the second end of the first auxiliary tube 12. The fingers are gradually released to generate negative pressure. If the needle tip of the needle body 2 pierces a blood vessel at this time, under the action of blood pressure and negative pressure, blood will quickly flow out through the first auxiliary passage, i.e., backflow occurs. In this case, the injection action cannot be performed. If no backflow is observed in the first auxiliary passage, the ear bulb 9 is removed, the sealing cap 3 is fitted to the second end of the first auxiliary tube 12, and the injection action is performed. The liquid in the syringe can be injected into the patient's body through the main passage.

[0084] Optionally, a valve may be installed inside the main tube 11, positioned above the connection between the main tube 11 and the first auxiliary tube 12 (near the second end of the main tube 11). The valve serves two purposes: firstly, to allow the soft tissue filler to be injected smoothly; and secondly, to prevent the soft tissue filler from being sucked into the first auxiliary passage under unexpectedly excessive negative pressure.

[0085] In other embodiments, the negative pressure device is not limited to ear suction bulbs, but can be other types of negative pressure devices. For example... Figure 8BAs shown, the negative pressure device includes an airbag 91 and an air needle 92. In use, the air needle 92 is inserted into the first auxiliary tube 12, so that the airbag 91 is connected to the first auxiliary passage.

[0086] In some other embodiments, the negative pressure device includes a control switch for opening or closing the first secondary passage. A certain negative pressure already exists within the negative pressure device, but the control switch closes the first secondary passage. During safety verification, the control switch can be opened to allow negative pressure to be conducted throughout the entire first secondary passage. If the needle tip of needle 2 pierces a blood vessel at this time, under the influence of blood pressure and negative pressure, blood will rapidly flow out through the first secondary passage, resulting in backflow. Injection cannot be performed under these circumstances.

[0087] The fifth embodiment of the safe injection needle for soft tissue fillers of the present invention can more quickly reflect the blood return situation under the combined action of blood pressure and negative pressure, thus improving efficiency.

[0088] In addition, another embodiment of a safe injection needle for soft tissue fillers includes a needle hub, a needle body, and an extension tube. The needle hub includes a main body having opposite first and second ends. The needle body is connected to the first end of the main body, and the opening at the second end of the main body can mate with the tip of a syringe barrel. The internal space of the main body and the internal space of the needle body together form a main passage. The extension tube is connected to either the main body or the needle body, and a portion of the internal space of the main body, the internal space of the needle body, and the extension tube together form a first secondary passage.

[0089] The difference between this embodiment and the previous embodiments is that: the needle hub only has a main body and does not include a first auxiliary body; the extension tube is connected to the main body; the first auxiliary passage is formed by a portion of the internal space of the main body, the internal space of the needle body, and the extension tube; or the extension tube is connected to the needle body; the first auxiliary passage is formed by a portion of the internal space of the needle body and the extension tube.

[0090] In this embodiment, the soft tissue filler safety injection needle has a first access path that is closer to the needle tip, allowing for faster observation of blood return during safety verification.

[0091] The soft tissue filler safety device of the present invention includes a syringe, a needle plug and a needle tip that are fitted into the syringe, wherein the needle tip is the soft tissue filler safety injection needle described above in the present invention.

[0092] The foregoing describes and / or illustrates exemplary embodiments of the safe injection needle and safe injection device for soft tissue fillers proposed in this invention. However, the embodiments of the invention are not limited to the specific embodiments described herein; rather, components and / or steps of each embodiment may be used independently and separately from other components and / or steps described herein. Each component and / or step of one embodiment may also be used in combination with other components and / or steps of other embodiments. In describing the elements / components / etc. described and / or illustrated herein, the terms "a," "an," and "the above" are used to indicate the presence of one or more elements / components / etc.

[0093] The embodiments of the present invention are not limited to the specific embodiments described herein. Rather, components of each embodiment may be used independently and separately from other components described herein. Each component of one embodiment may also be used in combination with other components of other embodiments. In the description of this specification, the terms "one embodiment," "some embodiments," "other embodiments," etc., refer to a specific feature, structure, material, or characteristic described in connection with that embodiment or example, which is included in at least one embodiment or example of the claims. In this specification, illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0094] In the embodiments, the term "multiple" refers to two or more unless otherwise explicitly defined. The terms "install," "connect," "link," and "fix" should be interpreted broadly. For example, "connect" can be a fixed connection, a detachable connection, or an integral connection; "link" can be 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 the embodiments according to the specific circumstances.

[0095] Although the safe injection needle and safe injection device for soft tissue fillers proposed in this invention have been described according to different specific embodiments, those skilled in the art will recognize that modifications can be made to the implementation of this invention within the spirit and scope of the claims.

Claims

1. A safe injection needle for soft tissue fillers, comprising a needle hub and a needle body, characterized in that, The needle hub includes a main tube and a first auxiliary tube. The main tube has opposite first and second ends. The needle body is connected to the first end of the main tube. The opening of the second end of the main tube can be connected to the nipple of the syringe barrel. The internal space of the main tube and the internal space of the needle body together form a main passage. The first auxiliary tube has opposite first and second ends. The first end of the first auxiliary tube is connected to the main tube or the needle. The internal space of the first auxiliary tube, a portion of the internal space of the main tube, and the internal space of the needle together form a first auxiliary passage, or the internal space of the first auxiliary tube and the internal space of the needle together form a first auxiliary passage.

2. The safe injection needle for soft tissue fillers as described in claim 1, characterized in that, The needle hub is equipped with a valve that can selectively open the main passage while closing the first secondary passage, or open the first secondary passage while closing the main passage; and / or the centerline of the needle body coincides with that of the main tube body; and / or the first secondary tube body is made of transparent or translucent material.

3. The safe injection needle for soft tissue fillers as described in claim 1, characterized in that, The second end of the first auxiliary tube is fitted with a sealing cap; and / or the second end of the main tube is fitted with a detachable sealing cap; and / or the needle body is provided with a protective cap.

4. The safe injection needle for soft tissue fillers as described in any one of claims 1-3, characterized in that, The aforementioned soft tissue filler safety injection needle also includes an extension tube; One end of the extension tube is sealed and connected to the second end of the first secondary tube body or is integrally formed with the second end of the first secondary tube body, and the interior of the extension tube is in communication with the first secondary passage. Alternatively, one end of the extension tube is connected to a needle that can pierce the sealing cap located at the second end of the first sub-tube body; The extension tube is connected to the first secondary tube body, and the extension tube is provided with a structure that can open or close the extension tube passage.

5. The safe injection needle for soft tissue fillers as described in any one of claims 1-3, characterized in that, The soft tissue filler safety injection needle further includes an extension tube, a first sealing element, a second sealing element, and a third sealing element. One end of the extension tube is sealed and connected to the second end of the first auxiliary tube body or is integrally formed with the second end of the first auxiliary tube body. The first sealing element can be sealed and disposed at the second end of the main tube body. The second sealing element can be disposed on the needle body to seal the needle tip of the needle body. The third sealing element can be sealed and disposed at the end of the extension tube that is not connected to the first auxiliary tube body. The soft tissue filler safety injection needle is pre-filled with liquid.

6. The safe injection needle for soft tissue fillers as described in claim 5, characterized in that, The length of the extension tube is greater than the sum of the lengths of the needle hub and the needle body.

7. The safe injection needle for soft tissue fillers as described in claim 6, characterized in that, The first sealing element is a threaded plug, comprising a circumferential wall and an inner plug, the inner plug being disposed within the circumferential wall, the circumferential wall having an external thread, and the outer surface of the second end of the main pipe having an internal thread capable of engaging with the external thread, the inner plug being tightly fitted to the inner surface of the second end of the main pipe; and / or The third sealing element includes a sleeve, a flexible band, and a plug. The sleeve is fixed to the end of the extension tube. One end of the flexible band is connected to the sleeve, and the other end is a free end. The plug is fixed to the surface of the flexible band and can be tightly fitted inside the sleeve.

8. The safe injection needle for soft tissue fillers as described in claim 5, characterized in that, The second sealing element is a protective cap that coincides with the center line of the needle body. The protective cap is located outside the needle body and covers a part of the main tube body.

9. The safe injection needle for soft tissue fillers as described in any one of claims 1-3, characterized in that, It also includes a second auxiliary tube and a fourth seal. The second auxiliary tube has opposite first and second ends. The first end of the second auxiliary tube is connected to the main tube or integrally formed with the main tube. The internal space of the second auxiliary tube, a portion of the internal space of the main tube, and the internal space of the needle together form a second auxiliary passage, or the internal space of the second auxiliary tube, a portion of the internal space of the first auxiliary tube, a portion of the internal space of the main tube, and the internal space of the needle together form a second auxiliary passage, or the internal space of the second auxiliary tube and a portion of the internal space of the needle together form a second auxiliary passage. The opening at the second end of the second auxiliary tube can be connected to the nipple of the syringe barrel, and the fourth seal is connected to the second end of the second auxiliary tube.

10. The safe injection needle for soft tissue fillers as described in claim 4, characterized in that, It also includes a second auxiliary tube and a fourth seal. The second auxiliary tube has opposite first and second ends. The first end of the second auxiliary tube is connected to the main tube or integrally formed with the main tube. The internal space of the second auxiliary tube, a portion of the internal space of the main tube, and the internal space of the needle together form a second auxiliary passage, or the internal space of the second auxiliary tube, a portion of the internal space of the first auxiliary tube, a portion of the internal space of the main tube, and the internal space of the needle together form a second auxiliary passage, or the internal space of the second auxiliary tube and a portion of the internal space of the needle together form a second auxiliary passage. The opening at the second end of the second auxiliary tube can be connected to the nipple of the syringe barrel, and the fourth seal is connected to the second end of the second auxiliary tube.

11. The safe injection needle for soft tissue fillers as described in claim 5, characterized in that, It also includes a second auxiliary tube and a fourth seal. The second auxiliary tube has opposite first and second ends. The first end of the second auxiliary tube is connected to the main tube or integrally formed with the main tube. The internal space of the second auxiliary tube, a portion of the internal space of the main tube, and the internal space of the needle together form a second auxiliary passage, or the internal space of the second auxiliary tube, a portion of the internal space of the first auxiliary tube, a portion of the internal space of the main tube, and the internal space of the needle together form a second auxiliary passage, or the internal space of the second auxiliary tube and a portion of the internal space of the needle together form a second auxiliary passage. The opening at the second end of the second auxiliary tube can be connected to the nipple of the syringe barrel, and the fourth seal is connected to the second end of the second auxiliary tube.

12. The safe injection needle for soft tissue fillers as described in any one of claims 1-3, characterized in that, It also includes a negative pressure device, which can be connected to the second end of the first sub-tube.

13. The safe injection needle for soft tissue fillers as described in claim 12, characterized in that, The negative pressure device includes an airbag and an air needle fixed to the airbag and communicating with the interior of the airbag.

14. The safe injection needle for soft tissue fillers as described in claim 12, characterized in that, The negative pressure device includes a control switch for opening or closing the first secondary passage.

15. A safe injection needle for soft tissue fillers, comprising a needle hub, a needle body, and an extension tube, characterized in that, The needle hub includes a main body with opposite first and second ends. The needle body is connected to the first end of the main body, and the opening of the second end of the main body can be connected to the nipple of the syringe barrel. The internal space of the main body and the internal space of the needle body together form a main passage. The extension tube is connected to the main tube or the needle body, and a portion of the internal space of the main tube, the internal space of the needle body, and the extension tube together form a first secondary passage.

16. A safe injection device for soft tissue fillers, comprising a syringe, a plunger and a needle fitted into the syringe, characterized in that, The needle is a soft tissue filler safety injection needle as described in any one of claims 1-15.

Images