CN113082362B - Split type subcutaneous soft needle and puncture method - Google Patents

Abstract

The invention relates to the field of medical instruments, and particularly discloses a split type subcutaneous soft needle and a puncture method. The split type subcutaneous soft application needle comprises a puncture component and a launching component, wherein the puncture component and the launching component are separately arranged and detachably connected; the puncture assembly is used for pushing the puncture assembly to move from a preparation position to a puncture position relative to the puncture assembly; the puncture assembly comprises an application unit and a puncture unit, wherein the application unit comprises a base and a subcutaneous soft needle; the puncture unit comprises a rigid puncture element, and the puncture element is inserted into the subcutaneous soft needle and can be taken out of the subcutaneous soft needle. The split type subcutaneous soft application needle adopts a split arrangement mode, so that the repeated utilization rate is improved, the use cost of a user is further reduced, and conditions are created for further popularization and application of the subcutaneous soft application needle.

Description

Split type subcutaneous soft needle and puncture method

Technical Field

The invention relates to the field of medical instruments, in particular to a split type subcutaneous soft application needle and a puncture method.

Background

Some patients with chronic diseases require long-term injections of drugs, such as diabetics, and require periodic subcutaneous injections of insulin. In order to relieve the pain of repeated puncture of a patient, the application of the subcutaneous soft needle is widely popularized. The application of the subcutaneous soft needle can inject medicine for a plurality of times after single puncture, the subcutaneous retention time of single puncture can reach a week, and the pain of a patient is greatly relieved.

Due to the aseptic requirement of the medical device for injection, the subcutaneous soft needle for application can only be discarded after single puncture, so that the use cost of a user is higher, and the further popularization and application of the subcutaneous soft needle for application are not facilitated.

Disclosure of Invention

The invention aims to solve the technical problem of providing a split type subcutaneous soft needle and a puncture method, which adopt a split arrangement mode to improve the repeated utilization rate, further reduce the use cost of a user and create conditions for further popularization and application of the subcutaneous soft needle.

In order to solve the technical problems, the technical scheme provided by the invention is as follows: a split type subcutaneous soft application needle comprises a puncture assembly and a launching assembly, wherein the puncture assembly and the launching assembly are separately arranged and detachably connected; the puncture assembly is used for pushing the puncture assembly to move from a preparation position to a puncture position relative to the puncture assembly;

the puncture assembly comprises an application unit and a puncture unit, wherein the application unit comprises a base and a subcutaneous soft needle; the puncture unit comprises a rigid puncture element, and the puncture element is inserted into the subcutaneous soft needle and can be taken out of the subcutaneous soft needle.

Puncture assembly and the components of a whole that can function independently setting of transmission subassembly, transmission subassembly can used repeatedly, only need change puncture assembly, but greatly reduced use cost creates the condition for applying ointment or plaster subcutaneous soft needle's further popularization and application. In addition, the puncture assembly and the launching assembly are arranged in a split mode and can be manufactured and sold independently, the volume of the puncture assembly is far smaller than the combination of the puncture assembly and the launching assembly, and the puncture assembly is more convenient to carry and use.

Preferably, the application unit further comprises a base, the base comprises an adhesive surface, and the subcutaneous soft needle is arranged on the base; the bonding surface is provided with a bonding assembly. After the puncture assembly pierces the skin, the puncture unit is adhered to the skin through the adhesion assembly, so that the subcutaneous soft needle is ensured to be arranged subcutaneously for a long time, and meanwhile, the puncture area can be sealed, and bacterial infection, body fluid or blood backflow is avoided.

Preferably, the bonding assembly comprises a bonding layer arranged on the bonding surface, a separation layer is arranged on one side of the bonding layer away from the bonding surface, and the separation layer can be removed from the bonding layer; the isolation layer comprises a starting part positioned in the middle; the isolating layer is provided with at least one score line, and the score line continuously extends to the starting part from the outer edge of the isolating layer.

The isolation layer can play the guard action to the bond line, guarantees the bonding effect of bond line. The release layer needs to be removed from the adhesive layer before the puncture is made. Common removal methods of the isolation layer are gradual removal from the edge, but for the sealing of the adhesive, the adhesive assembly needs to be arranged around a hypodermic soft needle, which interferes with the isolation layer removal operation if the adhesive is gradually removed from the edge. Meanwhile, because the subcutaneous soft needle and the puncturing element are thin, the removal process of the isolation layer can cause the puncturing element to deform, and the subsequent use is influenced.

Through set up the score line on the isolation layer to set up the top at the middle part, when removing the isolation layer, carry and pull the top, the isolation layer can be torn along the score line when progressively breaking away from the bond line, avoids with the contact of piercing the piece and subcutaneous soft needle, reduces mutual interference.

Preferably, the needle protection device further comprises a protection sleeve, a cavity corresponding to the subcutaneous soft needle is arranged in the sleeve, and the starting part of the isolation layer corresponds to the protection sleeve; when the protective sleeve is axially separated from the hypodermic soft needle, the initial part of the isolation layer moves along with the protective sleeve.

The protective sleeve protects the penetration member and the hypodermic needle, and requires removal prior to penetration. And the starting part corresponds to the protective sleeve, so that the isolation layer can be synchronously removed when the protective sleeve is taken down, and the operation convenience is good.

Preferably, the score line is a spiral line.

Preferably, the puncture needle device further comprises a protective cover, wherein the protective cover is detachably connected with the puncture assembly, and a cavity for the subcutaneous soft needle to extend into is formed in the protective cover. The protective cover plays an integral protection role for the bonding component, the puncturing element and the subcutaneous soft needle.

Preferably, the launching assembly comprises a shell and an ejection mechanism, and the ejection mechanism comprises an elastic piece;

when the puncture assembly is in a ready state relative to the launching assembly, the elastic element is in a compressed energy storage state, and the puncture assembly is locked relative to the shell;

the casing is also provided with a release unit for unlocking, and when the puncture assembly is unlocked, the elastic piece can release the elastic piece to push the puncture assembly to move from the preparation position to the puncture position.

The launching component pushes the puncture component to move from the preset position to the puncture position at a certain speed through the ejection mechanism, so that the pain of a user can be reduced, and the use experience is better.

Preferably, the ejection mechanism further comprises a slider, the slider can directionally slide relative to the housing, and the puncture assembly is detachably connected with the slider; when the puncture mechanism is positioned at the preparation position, the sliding block compresses the elastic piece and is clamped with the shell, so that the puncture assembly is locked relative to the shell. The slider provides an intermediate transition between the housing and the spike assembly.

Preferably, an anti-rotation mechanism is further arranged between the puncture seat and the sliding block, the anti-rotation mechanism comprises a directional convex block and a directional sliding groove, one of the directional convex block and the directional sliding groove is arranged on the puncture seat, and the other one of the directional convex block and the directional sliding groove is arranged on the sliding block.

The rotation preventing mechanism can limit the relative rotation between the puncture seat and the sliding block, and plays a role in limiting and bearing in the process of assembling and disassembling the puncture assembly and the launching assembly.

A puncture method adopts the split type subcutaneous soft application needle as described above, and at least comprises the following steps:

connecting the puncture assembly with the launching assembly, and adjusting the puncture assembly to a preparation position relative to the launching assembly;

secondly, the subcutaneous soft needle faces the skin of the part to be punctured, and the puncture assembly is pushed to move from the preparation position to the puncture position through the launching assembly;

and step three, separating the puncture unit from the application unit, and further taking the application unit off the launching assembly to complete puncture.

Drawings

FIG. 1 is a schematic structural view of a split type subcutaneous soft needle for application in the embodiment;

FIG. 2 is a schematic structural view of the split type subcutaneous soft needle application of the embodiment in a separated state;

FIG. 3 is an exploded view of the split type subcutaneous soft needle for application of the present embodiment;

FIG. 4 is a full sectional view of the split type hypodermic soft needle of the present embodiment in the ready position;

FIG. 5 is a full sectional view of the split type hypodermic soft needle of the embodiment in the puncturing position;

FIG. 6 is a full sectional view of the puncture assembly in the split type hypodermic needle for application according to this embodiment;

FIG. 7 is a schematic mechanism diagram of an anti-rotation component in the split type hypodermic needle;

FIG. 8 is a schematic view showing a state that the puncture unit is separated from the application unit after the puncture of the split type subcutaneous soft needle is completed;

FIG. 9 is a schematic view showing a state where the puncturing unit is separated from the firing assembly after the puncturing of the split type subcutaneous soft needle is completed;

FIG. 10 is an exploded view of the adhesive assembly and the puncture assembly in the split type hypodermic needle;

FIG. 11 is a schematic view showing the structure of the separator in the split type hypodermic needle for application according to this embodiment.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

Examples

As shown in figures 1-3, the split type subcutaneous soft needle comprises apuncture assembly 2 and alaunching assembly 1, wherein thepuncture assembly 2 is arranged separately from thelaunching assembly 1 and can be detachably connected. Thefiring assembly 1 is adapted to advance thepuncture assembly 2 relative to thefiring assembly 1 from the ready position to the puncture position.

Puncture component 2 and the components of a whole that can function independently setting ofemission subassembly 1, the emission subassembly can used repeatedly, only needchange puncture component 2, but greatly reduced use cost creates the condition for the further popularization and application of applying ointment or plaster subcutaneous soft needle. In addition, thepuncture component 2 and theemission component 1 are arranged in a split mode and can be manufactured and sold independently, the volume of thepuncture component 2 is far smaller than the combination of thepuncture component 2 and theemission component 1, and therefore the puncture component is more convenient to carry and use.

As shown in fig. 3, thepuncture assembly 2 comprises anapplication unit 22 and apuncture unit 21, wherein theapplication unit 22 comprises a subcutaneoussoft needle 221 and abase 222, and the subcutaneoussoft needle 221 is arranged on the base. As shown in fig. 3 and 6, the puncturing unit includes apuncturing seat 212, and arigid puncturing element 211 disposed on abase 222, wherein thepuncturing element 211 is inserted into a softhypodermic needle 221, and plays a role of rigidly supporting and guiding the softhypodermic needle 221 into the skin during puncturing, and thepuncturing element 211 can be removed from the softhypodermic needle 221 after the puncturing is completed.

As shown in fig. 3-5, the firing assembly includes a housing, aslider 14 and an ejection mechanism, theslider 14 is disposed in the housing and can slide relative to the housing, and theslider 14 is used for connecting with thepuncture assembly 2, and can be in a threaded connection or a snap connection. The ejection mechanism comprises anelastic member 13, and theelastic member 13 is preferably a spring.

As shown in fig. 3-5, further, the housing includes ahousing 11 and amounting bracket 12 disposed on an inner wall of thehousing 11, and thehousing 11 and themounting bracket 12 are separately disposed and clamped. The release button is arranged on theshell 11, and the directional sliding groove is arranged on the mountingbracket 12.

When thepuncture assembly 2 is in the ready state relative to the firingassembly 1, i.e. the state shown in fig. 4, theslider 14 is integrally connected with thepuncture assembly 2 and compresses theelastic element 13 to be in the energy storage state, and at this time, theslider 14 is locked relative to the housing, and thecorresponding puncture assembly 2 can also be stably in the ready state. The housing is further provided with arelease unit 111 for unlocking, and when thepuncture assembly 2 is unlocked, theelastic member 13 can release and push thepuncture assembly 2 to move from the preparation position to the puncture position, namely the state shown in fig. 5. The launching component pushes thepuncture component 2 to move from a preset position to a puncture position at a certain speed through the ejection mechanism, so that the pain of a user can be reduced, and the use experience is better.

Theslider 14 and the housing may be locked in a snap-fit manner, and thecorresponding release unit 111 is a release button disposed on the housing, and when the release button is pressed, theslider 14 and the locking mechanism are released and move to the puncturing position.

After the puncturing is completed, the puncturing unit is first moved together with the shooting assembly and separated from the application unit as shown in fig. 8, and then further separated from the shooting assembly as shown in fig. 9.

As shown in fig. 1, 4 and 5, the puncture needle assembly further comprises aprotective cover 25, theprotective cover 25 is detachably connected with thepuncture assembly 2, and a cavity for inserting the hypodermicsoft needle 221 is formed in theprotective cover 25. Theprotective cap 25 provides an integral protection for theadhesive assembly 24, the piercingelement 211 and thehypodermic needle 221. Theprotective cap 25 is preferably threadedly attached to thespike assembly 2.

As shown in fig. 3 and 7, an anti-rotation mechanism is further disposed between the puncture seat and theslider 14, the anti-rotation mechanism includes adirectional protrusion 212 and a directional slidinggroove 141, one of thedirectional protrusion 213 and the directional slidinggroove 141 is disposed on the puncture seat, and the other is disposed on theslider 14. The rotation-proof mechanism can limit the relative rotation between the puncture seat and the slidingblock 14, and can play a role in limiting and bearing in the process of assembling and disassembling thepuncture component 2 and thefiring component 1 and the process of assembling and disassembling theprotective cover 25 and thepuncture component 2.

As shown in fig. 10 and 11, thebase 222 includes an adhesive surface, the hypodermicsoft needle 221 is disposed on the base, and the adhesive surface is provided with theadhesive assembly 24. After thepuncture assembly 2 is punctured into the skin, the puncture unit is adhered to the skin through theadhesion assembly 24, so that the subcutaneoussoft needle 221 is ensured to be placed under the skin for a long time, meanwhile, the puncture area can be sealed, and bacterial infection, body fluid or blood backflow are avoided.

As shown in fig. 10 and 11, theadhesive assembly 24 includes anadhesive layer 241 disposed on the adhesive surface, arelease layer 242 is disposed on a side of theadhesive layer 241 away from the adhesive surface, and therelease layer 242 is removable from theadhesive layer 241. Therelease layer 242 includes astarter 244 in the middle; the isolatinglayer 242 is provided with at least onescore line 243, and thescore line 243 is a spiral line. Thescore line 243 extends continuously from the outer edge of thebarrier layer 242 to theinitiation portion 244.

Theisolation layer 242 can protect theadhesive layer 241, and ensure the bonding effect of theadhesive layer 241. Before the piercing, therelease layer 242 needs to be removed from theadhesive layer 241. The common removal of theisolation layer 242 is performed gradually from the edge, but for the sealing of the adhesive, theadhesive assembly 24 needs to be disposed around the hypodermicsoft needle 221, and if the adhesive is removed gradually from the edge, the hypodermicsoft needle 221 will interfere with the removal of theisolation layer 242. Meanwhile, due to the thin subcutaneoussoft needle 221 and the piercingelement 211, the removal process of theisolation layer 242 may cause the piercingelement 211 to deform, which may affect the subsequent use.

By providing thescore line 243 on theseparation layer 242 and providing theinitiation portion 244 at the middle portion, when theseparation layer 242 is removed, theinitiation portion 244 is pulled, and theseparation layer 242 is torn along thescore line 243 while gradually separating from theadhesive layer 241, so as to avoid contact with the piercingelement 211 and thehypodermic needle 221, and reduce mutual interference. Theinitiator 244 may be in the form of a ring-shaped structure disposed around thehypodermic needle 221.

As shown in fig. 10 and 11, the number of the score lines 243 is at least two, and twoscore lines 243 do not intersect with each other, and preferably at least twoscore lines 243 are distributed in a symmetrical manner with thehypodermic needle 221 as the center; in the process of removing theisolation layer 242, theisolation layer 242 is torn from multiple directions and separated from theadhesive layer 241, so that the stress is more uniform and the removal process is smoother.

As shown in fig. 3, 10 and 11, the needle sheath also comprises aprotective sleeve 23, a cavity corresponding to the subcutaneoussoft needle 221 is arranged in the sleeve, and theinitial part 244 of theisolation layer 242 corresponds to theprotective sleeve 23. When theprotective sleeve 23 is axially separated from the hypodermicsoft needle 221, theinitiator 244 of thespacer 242 moves with theprotective sleeve 23.

Theprotective sleeve 23 protects the penetratingelement 211 and thehypodermic needle 221 and theprotective sleeve 23 needs to be removed before penetration. The startingportion 244 corresponds to theprotection sleeve 23, so that theisolation layer 242 can be removed simultaneously when theprotection sleeve 23 is removed, and the operation convenience is excellent.

Theprotective sleeve 23 may be disposed outside theinsulation layer 242 and connected to theinsulation layer 242. It is also possible to provide a circumferential rim on theprotective sleeve 23 while theprotective sleeve 23 passes over theinitiation 244, the circumferential rim being located inside theinitiation 244, the circumferential rim initiating theinitiation 244 in a synchronized movement when theprotective sleeve 23 is removed, enabling removal of thebarrier layer 242.

As shown in fig. 11, the startingportion 244 is further provided withguide holes 245 corresponding to thescore lines 243 one by one, and one ends of thescore lines 243 extend to the guide holes 245. When theinitiator 244 is pulled, theseparator 242 will tear accurately from thescore line 243 due to stress concentration under the guidance of theguide hole 245. Theguide hole 245 is preferably an arc-shaped hole around the center of the hypodermicsoft needle 221.

A puncture method adopts the split type subcutaneous soft needle for application, which at least comprises the following steps:

firstly, connecting thepuncture component 2 with thelaunching component 1, and adjusting thepuncture component 2 to a preparation position relative to thelaunching component 1, wherein thepuncture component 2 is locked relative to the shell;

step two, theprotective cap 25, theprotective sleeve 23 and the insulatinglayer 242 are removed from thepuncture assembly 2;

thirdly, the subcutaneoussoft needle 221 faces the skin of the part to be punctured, and the relative position between the puncturingcomponent 2 and the skin is adjusted; the releasingunit 111 releases, thepuncture unit 21 and theslider 14 are unlocked, the launchingassembly 1 pushes thepuncture assembly 2 to move from the preparation position to the puncture position until the subcutaneoussoft needle 221 and thepuncture piece 211 enter the skin, and theadhesive layer 241 is adhered to the skin;

step four, the puncturing unit is separated from theapplication unit 22, the piercingelement 211 is synchronously withdrawn from the hypodermicsoft needle 221, and theapplication unit 22 is further removed from the firingassembly 1, completing the puncturing.

In summary, the above description is only a preferred embodiment of the present invention and should not be taken as limiting the invention, and any modifications, equivalents, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (6)

1. The utility model provides a soft needle of split type application hypodermis which characterized in that: the puncture assembly and the launching assembly are arranged in a split manner and are detachably connected; the puncture assembly is used for pushing the puncture assembly to move from a preparation position to a puncture position relative to the puncture assembly;

the puncture assembly comprises an application unit and a puncture unit, wherein the application unit comprises a base and a subcutaneous soft needle; the puncture unit comprises a rigid puncture element, and the puncture element is inserted into the subcutaneous soft needle and can be taken out of the subcutaneous soft needle;

the application unit further comprises a base, the base comprises an adhesive surface, and the subcutaneous soft needle is arranged on the base; the bonding surface is provided with a bonding assembly;

the bonding assembly comprises a bonding layer arranged on a bonding surface, one side of the bonding layer, which is far away from the bonding surface, is provided with an isolation layer, and the isolation layer can be removed from the bonding layer; the isolation layer comprises a starting part positioned in the middle; the isolating layer is provided with at least one score line, and the score line continuously extends to the starting part from the outer edge of the isolating layer;

the needle protection device is characterized by also comprising a protection sleeve, wherein a cavity corresponding to the subcutaneous soft needle is arranged in the protection sleeve, and the starting part of the isolation layer corresponds to the protection sleeve; when the protective sleeve is axially separated from the hypodermic soft needle, the initial part of the isolation layer moves along with the protective sleeve.

2. The split type applied subcutaneous soft needle according to claim 1, characterized in that: the cutting line is a spiral line.

3. The split type applied subcutaneous soft needle according to claim 1, characterized in that: the puncture needle assembly is characterized by further comprising a protective cover, wherein the protective cover is detachably connected with the puncture assembly, and a cavity for the subcutaneous soft needle to extend into is formed in the protective cover.

4. The split type hypodermal patch soft needle according to any one of claims 1 to 3, wherein: the launching assembly comprises a shell and an ejection mechanism, and the ejection mechanism comprises an elastic piece;

when the puncture assembly is in a ready state relative to the launching assembly, the elastic element is in a compressed energy storage state, and the puncture assembly is locked relative to the shell;

the casing is also provided with a release unit for unlocking, and when the puncture assembly is unlocked, the elastic piece can release the elastic piece to push the puncture assembly to move from the preparation position to the puncture position.

5. The split type applied hypodermic soft needle according to claim 4, wherein: the ejection mechanism further comprises a sliding block, the sliding block can directionally slide relative to the shell, and the puncture assembly is detachably connected with the sliding block;

when the puncture mechanism is located at the preparation position, the sliding block compresses the elastic piece and is clamped with the shell, so that the puncture assembly is locked relative to the shell.

6. The split type hypodermic needle patch according to claim 5, wherein: the puncture unit comprises a puncture seat, an anti-rotation mechanism is further arranged between the puncture seat and the sliding block, the anti-rotation mechanism comprises a directional convex block and a directional sliding groove, one of the directional convex block and the directional sliding groove is arranged on the puncture seat, and the other one of the directional convex block and the directional sliding groove is arranged on the sliding block.

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