Disclosure of Invention
The invention aims to provide a waterproof elastic physiological patch which is convenient to install.
The elastic physiological patch comprises a patch component and an implanted component.
The paster component comprises an electronic device and a soft paster body. The patch body is provided with a containing chamber for containing the electronic device.
The implantable component is mountable to the electronic device and includes an implant. The implant can be operated to partially penetrate out of the chamber and implant into a human body, and the implant and the patch body jointly seal the chamber.
The implanted assembly is arranged in the accommodating chamber and further comprises an implanter, and the implanter is provided with an implanting needle which can be operated to guide the implant to pass through the patch body and retract to the accommodating chamber.
The implanted component is suitable for being guided by the guide needle to penetrate through the patch body from the outer side of the patch component.
The elastic physiological patch of the invention, the electronic device of the patch assembly has a sensing unit, and the implant of the implantable assembly is a sensor.
In the elastic physiological patch of the present invention, the patch body of the patch assembly further has two spaced electrical connection regions, and each electrical connection region contains a conductive material for electrically connecting the electronic device to the sensor.
According to the elastic physiological patch, the patch body of the patch component is also provided with two spaced electric connection regions, the sensor is provided with a signal output end, the implanted component also comprises a conductive piece arranged at the signal output end, and the conductive piece is electrically connected with the electric connection regions and embedded in the patch body.
The elastic physiological patch comprises a patch body and a top wall, wherein the patch body is provided with a bottom wall and a top wall opposite to the bottom wall, the top wall is provided with a precutting hole for embedding the conductive piece, and the aperture of the precutting hole is smaller than the outer diameter of the conductive piece.
According to the elastic physiological patch, the outer diameter of the conductive piece is 0.1mm to 1mm larger than the aperture of the precutting hole.
The elastic physiological patch of the invention, the implant of the implantable assembly is a catheter, the electronic device is provided with a fluid drug pump connected with the catheter, the patch assembly further comprises a storage unit for supplying fluid drug, and the fluid drug stored in the storage unit is controlled by the electronic device to be delivered to the catheter.
The elastic physiological patch comprises a patch body, a storage chamber, a storage unit, an electronic device and a patch component, wherein the patch component comprises a hard shell, the hard shell is wrapped by the patch body and is accommodated in the storage chamber, and the hard shell is internally provided with the storage unit and the electronic device and is provided with an opening through which the catheter penetrates.
The elastic physiological patch comprises an electronic device, a circuit board and a hard shell, wherein the circuit board is provided with a through hole through which the catheter penetrates, the hard shell covers the circuit board, the hard shell and the circuit board are matched to define an accommodating space, and the accommodating space accommodates the catheter, the storage unit and the fluid medicine pump.
The electronic device of the elastic physiological patch of the invention is also provided with an electric control unit for controlling the operation of the fluid drug pump.
According to the elastic physiological patch, the patch body of the patch component is provided with the attaching surface suitable for attaching to a human body, and the attaching surface is provided with a plurality of elongated grooves which are arranged in a line-releasing manner.
The elastic physiological patch is characterized in that the patch body is made of an elastomer, and the ejection temperature of the elastomer is 140-170 ℃.
The elastic physiological patch is characterized in that the material of the patch body is selected from the group consisting of silica gel, silicone, polyurethane and a mixture thereof.
The elastic physiological patch comprises a patch body and a patch cover, wherein the patch body is provided with a bottom wall, the thickness of the bottom wall is 0.2mm to 1mm, and the patch cover is suitable for being attached to a human body.
The invention has the beneficial effects that: the electronic device is completely wrapped by the patch body, and the patch body can be tightly attached to the implant, so that the patch body is tightly attached to the implant to achieve the effect of blocking and preventing water.
Drawings
Other features and effects of the present invention will become apparent from the following detailed description of the embodiments with reference to the drawings, in which:
FIG. 1 is an exploded perspective view illustrating a prior art sensing patch;
FIG. 2 is a side cross-sectional view illustrating the prior art sensing patch;
FIG. 3 is a perspective view of a first embodiment of the flexible physiological patch of the present invention;
FIG. 4 is a front cross-sectional view illustrating the first embodiment;
FIG. 5 is a top cross-sectional view illustrating the first embodiment;
FIG. 6 is a block diagram illustrating a sensing unit of the first embodiment;
FIG. 7 is a bottom plan view of one of the facing surfaces of the first embodiment;
figure 8 is a front cross-sectional view illustrating an implantable assembly of the first embodiment mounted to an introducer needle of an implant device and aligned with a patch assembly;
fig. 9 is a front cross-sectional view illustrating the implantable component of the first embodiment penetrating into the patch component;
fig. 10 is a front cross-sectional view illustrating the implantable assembly of the first embodiment mounted to an introducer needle and into the patch assembly;
FIG. 11A is a partial top view of a second embodiment of the elastic physiological patch of the present invention wherein a trigger of the implantable assembly is in a pre-fired state;
FIG. 11B is a partial top view illustrating the firing mechanism of the second embodiment fired to advance the implantation needle and a sensor for implantation;
FIG. 11C is a partial top view illustrating the second embodiment of the trigger in a post-firing state;
FIG. 12A is a partial side cross-sectional view illustrating the second embodiment of the firing device in a pre-firing state;
FIG. 12B is a side cross-sectional view illustrating the firing of the second embodiment of the firing mechanism;
FIG. 12C is a side sectional view of the trigger of the second embodiment after firing;
figure 13 is a front cross-sectional view of a third embodiment of the flexible physiological patch of the present invention wherein the implantable assembly is not yet incorporated into the patch assembly;
fig. 14 is a front cross-sectional view illustrating the implantable assembly of the third embodiment incorporated into the patch assembly;
FIG. 15 is a front cross-sectional view illustrating a fourth embodiment of the elastic physiological patch of the present invention;
FIG. 16A is a partial top view illustrating the cocking of the fourth embodiment;
FIG. 16B is a partial top view illustrating the fourth embodiment of the trigger after firing;
FIG. 17A is a partial side cross-sectional view illustrating the cocking of the fourth embodiment;
FIG. 17B is a partial side cross-sectional view illustrating the fourth embodiment of the firing mechanism after firing;
FIG. 18 is a front cross-sectional view illustrating a fifth embodiment of the elastic physiological patch of the present invention; and
figure 19 is a front cross-sectional view illustrating a sixth embodiment of the elastic physiological patch of the present invention.
Detailed Description
Referring to fig. 3, 4 and 5, a first embodiment of the elastic physiological patch of the present invention is suitable for being attached to a human body. In the first embodiment, the elastic physiological patch is suitable for measuring the blood glucose level of a human body, and comprises apatch component 2 and an implantedcomponent 3.
Thepatch component 2 comprises anelectronic device 4 and asoft patch body 5. Theelectronic device 4 has acircuit board 41, asensing unit 42, and abattery 43 for supplying power to thesensing unit 42. Thecircuit board 41 has twosignal reading areas 411 for receiving signals and spaced apart from each other, and a throughhole 412. Thecircuit board 41 may be a soft board or a hard board, however, in order to obtain better mechanical strength, a hard board is used in the first embodiment.
Referring to fig. 4 and 6, thesensing unit 42 is disposed on thecircuit board 41 for receiving an electrical signal from thesignal reading section 411 and outputting a corresponding blood glucose signal. Thesensing unit 42 has asignal amplifier 421, an Analog-to-Digital Converter (Analog-to-Digital Converter)422, aprocessor 423, and atransmitter 424 connected thereto. Thesignal amplifier 421 is used for receiving and amplifying the electrical signal. The analog-to-digital converter 422 converts the amplified electrical signal into a corresponding digital signal. Theprocessor 423 converts the digital signal into the blood glucose level signal. Thetransmitter 424 is used to transmit the blood glucose level signal to anexternal receiving device 91. One of ordinary skill in the art can adjust the internal configuration of thesensing unit 42 as desired, and is not limited by the present disclosure.
Referring to fig. 4 and 7, thepatch body 5 covers theelectronic device 4, is in a disc shape, and is made of a thermosetting or thermoplastic elastomer. The elastomer has an exit temperature of 140 to 170 ℃, preferably the elastomer is selected from the group consisting of silica gel (silica gel), silicone (silicone), Polyurethane (PU) or a combination of at least two of the foregoing.
Thepatch body 5 has abottom wall 51, atop wall 52 opposite to thebottom wall 51, achamber 53 for accommodating theelectronic device 4, and two spaced apartelectrical connection regions 54. Thebottom wall 51 is circular and has acovering surface 511 adapted to be attached to a human body, and a plurality ofelongated grooves 512 and a plurality ofannular grooves 513 formed on thecovering surface 511. Theelongated grooves 512 are arranged in a line. Theannular grooves 513 are arranged in concentric circles. Thetop wall 52 is connected to thebottom wall 51 and has a circular arc-shapedtop surface 521. Thechamber 53 is located between thebottom wall 51 and thetop wall 52. Theelectrical connection regions 54 are disposed in theaccommodating chamber 53, and each of the electrical connection regions includes a conductive material for electrically connecting with thesignal reading region 411 of thecircuit board 41.
Thechip assembly 2 is manufactured by first placing theelectronic device 4 in a mold (not shown), then injecting conductive silica gel on thesignal reading area 411 of thecircuit board 41 to serve as theelectrical connection area 54 of thechip body 5, and then injecting silica gel to completely cover theelectronic device 4. In another manufacturing method, two metal elastic pieces are respectively welded to thesignal reading area 411, the weldedelectronic device 4 is placed in the mold, and then silica gel is injected to completely cover theelectronic device 4, wherein the metal elastic pieces are partially exposed from the silica gel to be electrically connected with the implantedcomponent 3. The metal elastic sheet can be replaced by the silica gel conductive strip by the manufacturing method, and other steps are the same. Thepatch assembly 2 may be manufactured by other methods besides the above methods, as long as theelectronic device 4 is covered by thepatch body 5 in an integrally molded manner.
Referring to fig. 4, 8 and 9, when the first embodiment of the elastic physiological patch of the present invention is to be used, thepatch assembly 2 is first placed on the epidermis of the human body, and then theimplantable assembly 3 is disposed on thepatch assembly 2 and connected to theelectrical connection region 54 of thepatch body 5 to be electrically connected to theelectronic device 4. Theimplantable component 3 comprises animplant 31, and in the present embodiment, theimplant 31 of theimplantable component 3 is asensor 311 for measuring blood glucose, thesensor 311 having asignal output terminal 312 and asensing terminal 313. Thesensor 311 is linear, and has electrodes on both sides to be electrically connected to theelectrical connection regions 54, respectively.
In detail, theimplantable component 3 is mounted by first mounting thesensor 311 on aguide needle 901 of animplant device 90, aligning theguide needle 901 with the throughhole 412 of the circuit board 41 (as shown in fig. 8), and then firing theguide needle 901 so as to sequentially penetrate through thetop wall 52, theelectrical connection area 54, the throughhole 412 and thebottom wall 51 of thepatch body 5 from the outside (as shown in fig. 9) and enter the epidermis of the human body. At the same time, thesensor 311 is mounted to thepatch body 5 along with the driving of the guidingneedle 901, and the guidingneedle 901 is retracted by the implantingdevice 90, so that thesensor 311 is fixed on thepatch assembly 2, as shown in fig. 4.
Referring to fig. 4 and 10, another installation method is to combine thesensor 311 and aguide needle 901, and then insert the sensor directly into thechamber 53 of thepatch assembly 2. When the elastic physiological patch is to be mounted on a human body, thepatch module 2 is adhered to the body surface, theintroducer needle 901 is pushed by the implanting device 90 (see fig. 9) to pierce through thebottom wall 51 of thepatch body 5 and be implanted into the human body, and then theintroducer needle 901 is withdrawn by the implanting device 90 (see fig. 8). It should be noted that theimplantation device 90 may be not used, but the implantation may be performed by a manual operation, as long as the insertion and extraction of theguide needle 901 are performed, which also achieves the result of implanting thesensor 311.
Because thepatch body 5 integrally covers theelectronic device 4, theelectronic device 4 can be well protected, and due to the material characteristics of thepatch body 5, when theimplant 31 passes through thetop wall 52, theimplant 31 will rebound to press thegap 523 left by the passage of theimplant 31, so as to achieve the effect of sealing and waterproofing, and when theimplant 31 passes through thebottom wall 51, thepatch body 5 will rebound to tightly cover theimplant 31 and cooperate with theimplant 31 to jointly seal thechamber 53, that is, thepatch body 5 has no gap except the position punctured by thesensor 311, so that the isolation effect is very good. It should be noted that, in order to take account of the sealing effect of the tight fit between theimplant 31 and thebottom wall 51 of thepatch body 5 and the installation resistance to be overcome when theimplant 31 is inserted into thepatch body 5, the thickness of thebottom wall 51 of thepatch body 5 is 0.2mm to 1 mm. Preferably, the thickness of thebottom wall 51 of thepatch body 5 is 0.2mm to 0.5mm, so as to ensure that thesensor 311 can smoothly pass through thepatch body 5 and has a sufficient contact area with thepatch body 5, so as to prevent moisture from entering theaccommodating chamber 53, thereby achieving an effective waterproof effect.
From the above description, the advantages of the present invention can be summarized as follows:
firstly, theimplantable component 3 is assembled when being arranged in thepatch component 2, the installation is convenient, and thepatch body 5 completely covers theelectronic device 4 and can be contracted and adhered to theimplant 31, so that the implantable component and theimplant 31 are tightly closed to achieve the effect of blocking and preventing water.
Thepatch component 2 is simple to manufacture, and only a soft material is filled in the mold to coat theelectronic device 4 and solidify theelectronic device 4, and thesignal reading area 411 outside theelectronic device 4 is also formed with theelectric connection area 54 by filling glue in a fractional manner, so that no other conductive component is required to be additionally arranged, and the manufacturing cost can be reduced.
Thirdly, the material adopted by thepatch body 5 is selected from elastomers with the ejection temperature of 140 to 170 ℃, and the temperature range can ensure that theelectronic device 4 coated inside can not be damaged when thepatch body 5 is formed.
And fourthly, thepatch body 5 is made of soft materials, can be bent according to the radian of the epidermis of a human body, can be attached to the body surface more conveniently, and effectively reduces the possibility of falling off.
And fifthly, when thepatch body 5 is attached to a human body, thelong grooves 512 and theannular grooves 513 on the patch body can increase the ventilation degree and reduce the possibility of skin allergy of the human body.
Referring to fig. 11A to 11C and 12A to 12C, the second embodiment of the elastic physiological patch of the present invention is substantially the same as the first embodiment, except that theimplantable component 3 further includes twoconductive members 32 and animplanter 33, and theelectronic device 4 further has aguide member 46 disposed on thecircuit board 41.
Theconductive members 32 are disposed at thesignal reading regions 411 at intervals, respectively.
Theimplanter 33 has atrigger 331 and an implantingneedle 332. Thetrigger 331 is operable to actuate the implantingneedle 332, and includes arail 333, a movingseat 334, a pivoting arm set 335, and atorsion spring 336. Themovable seat 334 is slidably disposed on thetrack 333 and connected to the implantingneedle 332. The pivoting arm set 335 is composed of two pivotingarms 337a, 337b pivotally connected to each other, and thepivoting arm 337a is pivotally disposed on the movingseat 334, and a distal end portion of the pivotingarm 337b is fixed to thetorsion spring 336. The implantingneedle 332 is internally provided with thesensor 311.
Before thetrigger 331 is unfired, in the state shown in fig. 11A and 12A, themovable base 334 is fixed on therail 333 without moving. As shown in fig. 11B and 12B, when themovable base 334 is released, thetorsion spring 336 rotates to drive the pivoting arm set 335 connected thereto to move themovable base 334 toward theconductive member 32, and the implantingneedle 332 penetrates through thebottom wall 51 of thepatch body 5 and guides thesensor 311 out of thepatch body 5 to be implanted into the human body through the guidance of a guidingmember 46 disposed on thecircuit board 41. As shown in fig. 11C and fig. 12C, when thetorsion spring 336 continues to rotate, themovable seat 334 is pulled back to its original position along with the actuation of the pivotingarm assembly 335, and theimplantation needle 332 is withdrawn, so that thesensor 311 is implanted into the human body, and the resilience of theconductive element 32 clamps thesensor 311 to electrically connect with each other. In order to ensure the operation of thetrigger 331, acover 338 may be further provided, and thecover 338 covers theimplant 33 to prevent the elastomer from flowing into thetrigger 331 and damaging the trigger during the manufacture of thepatch body 5.
Thus, the second embodiment of the elastic physiological patch of the present invention not only has the effects of the first embodiment, but also is based on the fact that the implantedcomponent 3 is disposed in theaccommodating chamber 53 of thepatch body 5, and the step of mounting to the human body can be completed without the cooperation of theexternal implantation device 90, which is more convenient and superior to the first embodiment in use.
Referring to fig. 13 and 14, the third embodiment of the elastic physiological patch of the present invention is substantially the same as the first embodiment, except that theimplantable component 3 further comprises aconductive member 32, and thetop wall 52 of thepatch body 5 has apre-cut hole 522.
Theconductive members 32 are disposed at thesignal output end 312 of thesensor 311, and conductive regions are formed at two sides of the two electrodes corresponding to thesensor 311. In this embodiment, the outer diameter of theconductive component 32 is slightly larger than thepre-cut hole 522 of thepatch body 5, and therefore is embedded and tightly fitted in thepre-cut hole 522, and therefore, preferably, the outer diameter of theconductive component 32 is larger than the aperture of thepre-cut hole 522, and more preferably, the outer diameter of theconductive component 32 is larger than the aperture of thepre-cut hole 522 by 0.1mm to 1 mm.
Thepre-cut hole 522 may have a depth reaching the throughhole 412 of thecircuit board 41 or only reaching theelectrical connection region 54 of thepatch body 5, so that, when theimplantable component 3 is mounted on thepatch body 5, theconductive element 32 is embedded in thepre-cut hole 522 and connected to theelectrical connection region 54 of thepatch body 5. The installation manner is also the same as that of the first embodiment, and is not repeated herein, because the external implantation device 90 (see fig. 8) is used to install theimplantable component 3 on thepatch component 2, or the implantable component is manually installed through theguide needle 901. In addition, to further improve the sealing performance inside the elastic physiological patch, a sealing member (not shown) may be added to seal thepre-cut hole 522. For example, a sealing member (not shown) may be additionally disposed at thesignal output end 312 of thesensor 311, wherein the sealing member and theconductive member 32 are engaged in thepre-cut hole 522 to achieve a good sealing effect when theimplantable component 3 is inserted into thepatch body 5 through thepre-cut hole 522. However, the present invention is not intended to be limited to the above embodiments, and a sealing member may be added to seal thepre-cut hole 522 after theimplantable component 3 is inserted into thepatch body 5.
In this way, the third embodiment also has the same function as the first embodiment, and because thepre-cut hole 522 is formed in thepatch body 5, when theimplantable component 3 is inserted, theguide needle 901 does not need to drill through thetop wall 51 of thepatch body 5, so that the installation resistance is small.
Referring to fig. 15, 16A-16B and 17A-17B, a fourth embodiment of the elastic physiological patch of the present invention is suitable for delivering drugs to a human body, and the structure of thepatch body 5 is substantially the same as that of the second embodiment, except that theimplantable component 3 and theelectronic device 4 are different.
In a fourth embodiment, theimplantable component 3 does not have the conductive member 32 (see fig. 11A to 11C), and theimplant 31 is acatheter 314 with a tube diameter of less than 0.5 mm. Theimplanter 33 is substantially the same as the second embodiment except for the further presence of acatheter hub 339 disposed in the track. Theguide pipe 314 is disposed on theguide pipe seat 339 and is disposed in therail 333. Theimplantation needle 332 on themovable seat 334 penetrates through thecatheter 314. When themovable seat 334 is released and moved, thecatheter seat 339 moves along, and theimplantation needle 332 penetrates through thebottom wall 51 of thepatch body 5 and guides thecatheter 314 to be implanted into the human body. Themovable hub 334 is then pulled back into place and theneedle 332 is withdrawn, at which time thecatheter hub 339 is clamped in place by the twoclips 330 in theimplanter 32, thereby fixing the position of thecatheter 314.
Theelectronic device 4 does not have the sensing unit 42 (see fig. 4), but has afluid drug pump 44 and anelectronic control unit 45 for controlling the operation of thefluid drug pump 44. Thefluid medicine pump 44 is connected to astorage unit 6 disposed in thechamber 53 and communicates with thecatheter 314, which can transfer the fluid medicine stored in thestorage unit 6 to thecatheter 314 and infuse the fluid medicine into the human body. In the fourth embodiment, thestorage unit 6 is a flexible storage bag for storing the fluid medicine.
Thus, the fourth embodiment also has the advantages of convenient use and water resistance, and the manufacturing method of the fourth embodiment only needs one-time glue filling to completely coat the implantedcomponent 3, theelectronic device 4 and thestorage unit 6, so that the manufacturing process is simple.
Referring to fig. 18, a fifth embodiment of the flexible physiological patch of the present invention is substantially the same as the fourth embodiment except that thepatch assembly 2 further includes a rigid housing 7.
The hard shell 7 is covered by thepatch body 5 and is accommodated in theaccommodating chamber 53, and theimplantable component 3, theelectronic device 4 and thestorage unit 6 are arranged inside the hard shell 7, and have anopening 71 through which theconduit 314 passes.
The hard shell 7 is made of acrylonitrile-butadiene-styrene copolymer (ABS), Polycarbonate (PC), Polypropylene (PE), Polyetheretherketone (PEEK), polyethylene terephthalate (PET), polymethyl methacrylate (PMMA), Polyoxymethylene (POM), polyvinyl chloride (PVC), chlorinated polyvinyl chloride (CPVC), Polytetrafluoroethylene (PTFE), Nylon (Nylon), phenol resin (PF), glass Fiber (FRP), or a combination of at least two of the foregoing.
In the fifth embodiment, the hard case 7 is manufactured, thestorage unit 6, theelectronic device 4, and theimplantable component 3 are disposed in the inner space of the hard case 7, and then an elastomer is wrapped outside the hard case 7 to form thepatch body 5.
Thus, the fifth embodiment not only has the effects of the fourth embodiment, but also has the waterproof effect by only changing the structural design and coating thesoft patch body 5 on the outside, compared with the waterproof process of the hard structure in the prior art, and the process is simpler.
Referring to fig. 19, a sixth embodiment of the flexible physiological patch of the present invention is substantially the same as the fifth embodiment, except for the structure of the rigid housing 7.
The hard shell 7 covers thecircuit board 41, and defines anaccommodating space 72 in cooperation with thecircuit board 41. Theaccommodation space 72 accommodates thecatheter 314, thestorage unit 6 and other components of theelectronic device 4, such as thefluid medicine pump 44, theelectronic control unit 45, etc.
Thus, the sixth embodiment not only has the functions of the fifth embodiment, but also provides another structure of the hard case 7, which can be selected by the user as required.
In summary, thepatch module 2 and theimplantable module 3 can be sealed together, so as to achieve the effect of sealing and waterproofing, and effectively protect the internalelectronic device 4. Therefore, the object of the present invention can be achieved.
The above description is only an example of the present invention, and the scope of the present invention should not be limited thereby, and the invention is still within the scope of the present invention by simple equivalent changes and modifications made according to the claims and the contents of the specification.