Disposable fetal spiral electrode and manufacturing method thereof

Abstract

The present invention provides a disposable fetal spiral electrode and a manufacturing method thereof, comprising a spiral electrode, an auxiliary electrode, a fixing sleeve and a twisted pair, wherein the fixing sleeve comprises an injection inner mold and an injection outer mold, the connecting end of the spiral electrode and one wire of the twisted pair is injection-molded and embedded in the injection inner mold, and the other end is exposed from the top of the injection inner mold, the auxiliary electrode is mounted on the outer side of the injection inner mold, the auxiliary electrode is welded to the other wire of the twisted pair, the injection outer mold is sleeved outside the auxiliary electrode, the protrusion on the outer side of the auxiliary electrode is embedded in the through hole on the outer wall of the injection outer mold, and the spiral electrode, the injection inner mold, the auxiliary electrode, the twisted pair and the injection outer mold are injection-molded into an integrated structure. The manufacturing method performs two injection moldings to make the injection inner mold, the auxiliary electrode and the injection outer mold be injection-molded into an integrated structure. The spiral electrode, the auxiliary electrode and the twisted pair can be subjected to secondary injection molding, which is beneficial to the positioning injection molding of the auxiliary electrode and can improve the degree of automated processing.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and relates to the technology of clinical detection of fetuses and collection of fetal heartbeats, in particular to a disposable fetal spiral electrode and a manufacturing method thereof. Background Art

[0002] At present, the detection of fetal heart rate and uterine contraction is divided into external detection and internal detection. External detection is seriously affected by the outside world, and its acquisition signal is unstable. The signal may be intermittent, which affects the diagnosis, causing misdiagnosis or delaying the disease. Compared with external detection, internal detection is more accurate and needs to be performed when the membrane is ruptured and the cervix is ​​opened to 2 to 3 cm. The fetal scalp spiral electrode is fixed on the fetal scalp to measure human physiological parameters (such as electrocardiogram signals, etc.). The existing fetal scalp electrode is mainly assembled by an electrode fixing column, a single spiral electrode, an auxiliary electrode, a twisted pair, an outer protective sleeve and a twisted pair fixing component. The single spiral electrode and the auxiliary electrode are respectively arranged on the top and side of the electrode fixing column, and the twisted pair is inserted into the outer protective sleeve. A twisted pair fixing component is arranged at one end of the outer protective sleeve, and the electrode fixing column extends or retracts from the other end of the outer protective sleeve.

[0003] The spiral needle electrode, auxiliary electrode and twisted pair of the existing fetal scalp electrode are integrated into one-time injection molding process. During the one-time injection molding process, the positions of the three components, the spiral needle electrode, the auxiliary electrode and the twisted pair, are not easy to locate and fix.

[0004] The auxiliary electrode of the existing fetal scalp electrode is at the bottom of the outer plastic injection molded part, the installation structure and position of the auxiliary electrode are not reasonable, and the joint between the auxiliary electrode and the outer plastic injection molded part is not smooth. When the auxiliary electrode of the fetal scalp electrode enters the body, there is a risk of scratching the skin tissue.

[0005] How to design a disposable fetal spiral electrode and its manufacturing method, with a reasonable auxiliary electrode structure design, which is not easy to scratch the skin tissue when entering the body, and can increase its contact area with the amniotic fluid, which is beneficial to the accuracy of signal extraction, and the manufacturing method is conducive to the positioning and fixation of the auxiliary electrode, easy to process, and highly automated. This is a technical problem that needs to be solved in this field. Summary of the invention

[0006] In order to solve the problems existing in the prior art, the present invention provides a disposable fetal spiral electrode and a manufacturing method thereof. The auxiliary electrode structure is reasonably designed, is not easy to scratch skin tissue during use, and can increase the contact area with amniotic fluid, which is beneficial to the accuracy of signal extraction. The manufacturing method is beneficial to the positioning and fixation of the auxiliary electrode, is easy to process, and has a high degree of automated production.

[0007] In order to achieve the above technical objectives, the present invention adopts the following technical solutions:

[0008] A disposable fetal spiral electrode comprises a spiral electrode, an auxiliary electrode, a fixing sleeve and a twisted pair, wherein the twisted pair comprises two conductors, and is characterized in that the fixing sleeve comprises an injection inner mold and an injection outer mold, the connecting end of the spiral electrode and one of the conductors of the twisted pair is injection-molded and embedded in the injection inner mold, the other end of the spiral electrode is exposed from the top of the injection inner mold, the auxiliary electrode is mounted on the outer side of the injection inner mold, the auxiliary electrode is welded to the other conductor of the twisted pair, a through hole is arranged on the outer wall of the injection outer mold, a protrusion matching the through hole is arranged on the outer side of the auxiliary electrode, the injection outer mold is sleeved on the outside of the auxiliary electrode, the protrusion is embedded in the through hole, and the injection inner mold, the auxiliary electrode, the twisted pair and the injection outer mold are injection-molded into an integrated structure.

[0009] Improvement on the above technical solution: the injection inner mold is cylindrical, with a straight-edge notch at its lower end, the upper part of the auxiliary electrode is annular, and a straight-edge boss matching the straight-edge notch is provided on the annular inner side wall of the upper part of the auxiliary electrode.

[0010] The first improvement to the above technical solution: the protrusion is arranged on the annular outer surface of the upper part of the auxiliary electrode, there are at least 4 protrusions, and there are 2 protrusions that are symmetrically arranged at intervals, and each bottom extends a fixing plate downward, and the upper end of the twisted pair is arranged between the two fixing plates. The injection molding outer mold is cylindrical, and the through holes on the cylindrical outer wall of the injection molding outer mold that match the two protrusions with fixing plates at the bottom are T-shaped through holes, and the two protrusions with fixing plates at the bottom and their fixing plates are respectively embedded in the corresponding T-shaped through holes.

[0011] The second improvement to the above technical solution: the protrusion is arranged on the annular outer surface of the upper part of the auxiliary electrode, there are at least 4 protrusions, the injection molding outer mold is cylindrical, and the annular bottom of the upper part of the auxiliary electrode extends downward to form a cylindrical side wall, and two embedding grooves are symmetrically arranged on the bottom edge of the cylindrical side wall, and an auxiliary electrode plug is vertically embedded in the two embedding grooves, and the two conductors of the twisted pair are respectively arranged on both sides of the auxiliary electrode plug.

[0012] The third improvement to the above technical solution: the protrusion is arranged on the annular outer surface of the upper part of the auxiliary electrode, there are at least 4 protrusions, and two symmetrically arranged arc fixing plates extend downward from the circular ring-shaped bottom of the upper part of the auxiliary electrode. The injection molding outer mold is cylindrical, and a separator is vertically arranged in the middle of the lower port of the injection molding outer mold, and the two conductors of the twisted pair cable are respectively arranged on both sides of the separator.

[0013] Further improvement to the above technical solution: the inner injection mold and the outer injection mold are both made of plastic.

[0014] The present invention provides a method for manufacturing the disposable fetal spiral electrode, characterized in that it comprises the following steps:

[0015] Step 1: After welding the spiral electrode to one of the twisted pair wires, perform the first injection molding, and inject and embed the connecting end of the spiral electrode and one of the twisted pair wires into an injection inner mold, so that the other end of the spiral electrode is exposed from the top of the injection inner mold;

[0016] Step 2: installing the auxiliary electrode on the outer side of the injection inner mold;

[0017] Step 3: welding the auxiliary electrode to another wire in the twisted pair;

[0018] Step 4: The injection molding outer mold is sleeved outside the auxiliary electrode, so that the protrusions on the outer side of the auxiliary electrode are embedded in the corresponding through holes on the outer wall of the injection molding outer mold;

[0019] Step 5: Perform a second injection molding to form the inner injection mold, the auxiliary electrode, the twisted pair and the outer injection mold into an integrated structure.

[0020] Improvement on the above technical solution: In step 4, a cylindrical side wall is extended downward from the annular bottom of the upper part of the auxiliary electrode, and two embedding grooves are symmetrically arranged on the bottom edge of the cylindrical side wall. An auxiliary electrode plug is vertically embedded in the two embedding grooves, so that the two conductors of the twisted pair are arranged on both sides of the auxiliary electrode plug.

[0021] Compared with the prior art, the present invention has the following advantages and positive effects:

[0022] 1. The disposable fetal spiral electrode of the present invention fixes the auxiliary electrode in the middle of the outer plastic part. The surface of the auxiliary electrode is on the same surface as the surface of the outer plastic part, so that the surface of the spiral needle electrode of the fetal scalp electrode is smooth, and it is not easy to scratch the skin tissue when entering the body, and the contact area between the auxiliary electrode and the amniotic fluid is increased, which is beneficial to the accuracy of signal extraction;

[0023] 2. The manufacturing method of the disposable fetal spiral electrode of the present invention is: after the spiral electrode and the inner mold are injection molded, the auxiliary electrode is fixed on the inner mold, and the spiral electrode, the auxiliary electrode and the twisted pair are subjected to secondary injection molding. This is conducive to the positioning and fixing of the three components of the spiral needle electrode, the auxiliary electrode and the twisted pair, and is easy to process and has a high degree of automated production. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 2 is a schematic diagram of the structure of a disposable fetal spiral electrode embodiment 1 of the present invention;

[0025] Figure 21 is a schematic diagram of the assembly and decomposition of the disposable fetal spiral electrode embodiment 1 of the present invention;

[0026] Figure 3 It is a schematic diagram of the three-dimensional structure of the pipeline in the embodiment 1 of the disposable fetal spiral electrode of the present invention;

[0027] Figure 4 It is a schematic diagram of the structure of the physiological signal acquisition system of the disposable fetal spiral electrode embodiment 1 of the present invention;

[0028] Figure 5 It is a schematic diagram of the structure of the plug and the socket in the physiological signal acquisition system of the disposable fetal spiral electrode embodiment 2 of the present invention;

[0029] Figure 6 It is a schematic diagram of the structure of the spiral electrode, the injection mold and the twisted pair wire in Embodiment 2 of the disposable fetal spiral electrode of the present invention;

[0030] Figure 7 It is a schematic diagram of the structure of the spiral electrode, the injection inner mold, the auxiliary electrode and the twisted pair in Embodiment 2 of the disposable fetal spiral electrode of the present invention;

[0031] Figure 8 It is a schematic diagram of the structure of the spiral electrode, the injection inner mold, the auxiliary electrode, the auxiliary electrode insert and the twisted pair in Embodiment 2 of the disposable fetal spiral electrode of the present invention;

[0032] Fig. 9 It is a schematic diagram of the structure of the spiral electrode, injection mold, convex edge and twisted pair in Embodiment 2 of the disposable fetal spiral electrode of the present invention;

[0033] Fig.10 It is a schematic diagram of the specific structure of the spiral electrode, the injection inner mold, the auxiliary electrode, the injection outer mold, the twisted pair and the inner tube in Embodiment 3 of the disposable fetal spiral electrode of the present invention;

[0034] Fig.11 It is a schematic diagram of the structure of the spiral electrode, the injection inner mold and the twisted pair wire in Embodiment 3 of the disposable fetal spiral electrode of the present invention;

[0035] Fig.12 It is a schematic diagram of the structure of the spiral electrode, the injection mold, the auxiliary electrode and the twisted pair in Embodiment 3 of the disposable fetal spiral electrode of the present invention;

[0036] Fig.13 It is a schematic diagram of the structure of the spiral electrode, injection mold, flange, separator and twisted pair in Example 3 of the disposable fetal spiral electrode of the present invention.

[0037] In the figure, 1, spiral electrode; 2, injection molding inner mold; 2.1, straight-edge notch; 3, auxiliary electrode; 3.1, straight-edge protrusion; 3.2, convex edge; 3.3, fixing plate; 3.4, cylindrical side wall; 3.4.1, embedded groove; 3.5, auxiliary electrode insert; 3.6, arc fixing plate; 4, injection molding outer mold; 4.1, through hole; 4.2, separator; 5, twisted pair; 6, inner tube; 6.1, inner tube slot. DETAILED DESCRIPTION

[0038] To make the purpose, technical solution and advantages of the embodiments of the present invention more clear, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0039] See also Figure 1-Figure 4 , Embodiment 1 of a disposable fetal spiral electrode of the present invention comprises a spiral electrode 1, an auxiliary electrode 3, a fixing sleeve and a twisted pair 5, wherein the twisted pair 5 comprises two conductors, and the fixing sleeve comprises an injection inner mold 2 and an injection outer mold 4. The connection end between the spiral electrode 1 and one of the conductors of the twisted pair 1 is injection-molded and embedded in the injection inner mold 2, and the other end of the spiral electrode 1 is exposed from the top of the injection inner mold 2. The auxiliary electrode 3 is mounted on the outer side of the injection inner mold 2, and the auxiliary electrode 3 is welded to the other conductor of the twisted pair 5. A through hole 4.1 is provided on the outer wall of the injection outer mold 4, and a protrusion 3.2 matching the through hole 4.1 is provided on the outer side of the auxiliary electrode 3. The injection outer mold 4 is sleeved outside the auxiliary electrode 3, and the protrusion 3.2 on the auxiliary electrode 3 is embedded in the through hole 4.1 on the injection outer mold 4. The injection inner mold 2, the auxiliary electrode 3, the twisted pair 5 and the injection outer mold 4 are injection-molded into an integral structure.

[0040] Preferably, the injection inner mold 2 is cylindrical, with a straight-edge notch 2.1 at its lower end, the upper portion of the auxiliary electrode 3 is annular, and a straight-edge boss matching the straight-edge notch 3.1 is provided on the annular inner side wall of the upper portion of the auxiliary electrode 3 .

[0041] Specifically, the protrusions 3.2 are arranged on the annular outer surface of the upper part of the auxiliary electrode 3. There are four protrusions 3.2, of which two protrusions 3.2 are arranged symmetrically at intervals, and a fixing plate 3.3 is extended downward from the bottom of each protrusion 3.3. The upper end of the twisted pair 5 is arranged between the two fixing plates 3.3. The above-mentioned injection mold 4 is cylindrical, and the through holes 4.1 on the cylindrical outer wall of the injection mold 4 that match the two protrusions 3.2 with fixing plates 3.3 at the bottom are T-shaped through holes, and the two protrusions 3.2 with fixing plates 3.3 at the bottom and their fixing plates 3.3 are respectively embedded in the corresponding T-shaped through holes 4.1. The other two through holes 4.1 are rectangular, and the protrusions 3.2 are also rectangular, and the rectangular protrusions 3.2 are embedded in the corresponding rectangular through holes 4.1.

[0042] See also Figure 5-Figure 9, Embodiment 2 of a disposable fetal spiral electrode of the present invention, most of the structures of Embodiment 2 are basically the same as those of Embodiment 1, so it will not be repeated. The difference is that the auxiliary electrode 3 is different. The auxiliary electrode 3 of Embodiment 2 includes an auxiliary electrode main body and an auxiliary electrode plug 3.5. The annular bottom of the upper part of the auxiliary electrode main body extends downwardly to form a cylindrical side wall 3.4. Two embedded grooves 3.4.1 are symmetrically arranged on the bottom edge of the cylindrical side wall 3.4. The auxiliary electrode plug 3.5 is vertically embedded in the two embedded grooves 3.4.1. The two wires of the twisted pair 5 are respectively arranged on both sides of the auxiliary electrode plug 3.5.

[0043] See also Figure 10-13 , Embodiment 3 of a disposable fetal spiral electrode of the present invention, most of the structures of Embodiment 3 are basically the same as those of Embodiment 1, so it will not be repeated. The differences are: 1. The auxiliary electrode 3 is different, and two symmetrically arranged arc fixing plates 3.6 extend downward from the annular bottom of the upper part of the auxiliary electrode 3; 2. The injection molding outer mold 4 is different, and a separator 4.2 is vertically arranged in the middle of the lower port of the cylindrical injection molding outer mold 4, and the two conductors of the twisted pair 5 are respectively arranged on both sides of the separator 4.2.

[0044] Preferably, the inner injection mold 2 and the outer injection mold 4 in the above embodiments are both made of plastic.

[0045] An embodiment of a method for manufacturing the disposable fetal spiral electrode of the present invention comprises the following steps:

[0046] Step 1: After the spiral electrode 1 and one of the twisted pair wires 5 are welded, the first injection molding is performed, and the connecting end of the spiral electrode 1 and one of the twisted pair wires 5 is injection-molded and embedded in the injection inner mold, so that the other end of the spiral electrode 1 is exposed from the top of the injection inner mold 2;

[0047] Step 2: Install the auxiliary electrode 3 on the outer side of the injection inner mold 2;

[0048] Step 3: Weld the auxiliary electrode 3 to another wire in the twisted pair 5;

[0049] Step 4: Cover the injection outer mold 4 on the outside of the auxiliary electrode 3 so that the protrusions 3.2 on the outer surface of the auxiliary electrode 3 are embedded in the corresponding through holes 4.1 on the outer wall of the injection outer mold 4;

[0050] Step 5: Perform a second injection molding to form the inner injection mold 2, the auxiliary electrode 3, the twisted pair 5 and the outer injection mold 4 into an integrated structure.

[0051] Furthermore, in the above step 4, a cylindrical side wall 3.4 is extended downward from the annular bottom of the upper part of the auxiliary electrode 3, and two embedding grooves 3.4.1 are symmetrically arranged on the bottom edge of the cylindrical side wall 3.4. The auxiliary electrode plug 3.5 is vertically embedded in the two embedding grooves 3.4.1, so that the two conductors of the twisted pair 5 are respectively arranged on both sides of the auxiliary electrode plug 3.5.

[0052] The above is only a preferred embodiment of the present invention, and does not limit the present invention in other forms. Any technician familiar with the profession may use the above disclosed technical content to change or modify it into an equivalent embodiment with equivalent changes. However, any simple modification, equivalent change and modification made to the above embodiment according to the technical essence of the present invention without departing from the technical solution of the present invention still belongs to the protection scope of the technical solution of the present invention.

Claims

1. A disposable fetal spiral electrode, comprising a spiral electrode, an auxiliary electrode, a fixing sleeve and a twisted pair, wherein the twisted pair comprises two conductors, characterized in that: The fixing sleeve comprises an injection inner mold and an injection outer mold. The connecting end of the spiral electrode and one of the twisted pair wires is injection-molded and embedded in the injection inner mold. The other end of the spiral electrode is exposed from the top of the injection inner mold. The auxiliary electrode is mounted on the outer side of the injection inner mold. The auxiliary electrode is welded to the other wire of the twisted pair wire. A through hole is arranged on the outer wall of the injection outer mold. A protrusion matching the through hole is arranged on the outer side of the auxiliary electrode. The injection outer mold is sleeved on the outside of the auxiliary electrode. The protrusion is embedded in the through hole. The injection inner mold, the auxiliary electrode, the twisted pair wire and the injection outer mold are injection-molded into an integrated structure.

2. The disposable fetal spiral electrode according to claim 1, characterized in that: The injection inner mold is cylindrical, and a straight-edge notch is arranged at the lower end thereof. The upper part of the auxiliary electrode is annular, and a straight-edge boss matching the straight-edge notch is arranged on the annular inner side wall of the upper part of the auxiliary electrode.

3. The disposable fetal spiral electrode according to claim 2, characterized in that: The protrusion is arranged on the annular outer surface of the upper part of the auxiliary electrode, there are at least 4 protrusions, and there are 2 protrusions that are symmetrically arranged at intervals, and a fixing plate extends downward from the bottom of each protrusion. The upper end of the twisted pair is arranged between the two fixing plates. The injection molding outer mold is cylindrical, and the through holes on the cylindrical outer wall of the injection molding outer mold that match the two protrusions with fixing plates at the bottom are T-shaped through holes, and the two protrusions with fixing plates at the bottom and their fixing plates are respectively embedded in the corresponding T-shaped through holes.

4. The disposable fetal spiral electrode according to claim 2, characterized in that: The protrusion is arranged on the annular outer surface of the upper part of the auxiliary electrode, and there are at least 4 protrusions. The injection molding outer mold is cylindrical, and the annular bottom of the upper part of the auxiliary electrode extends downward to form a cylindrical side wall. Two embedding grooves are symmetrically arranged on the bottom edge of the cylindrical side wall, and an auxiliary electrode plug is vertically embedded in the two embedding grooves. The two conductors of the twisted pair are respectively arranged on both sides of the auxiliary electrode plug.

5. The disposable fetal spiral electrode according to claim 2, characterized in that: The protrusion is arranged on the annular outer surface of the upper part of the auxiliary electrode, and there are at least 4 protrusions. Two symmetrically arranged arc fixing plates extend downward from the annular bottom of the upper part of the auxiliary electrode. The injection molding outer mold is cylindrical, and a separator is vertically arranged in the middle of the lower port of the injection molding outer mold. The two conductors of the twisted pair are respectively arranged on both sides of the separator.

6. The disposable fetal spiral electrode according to any one of claims 1 to 5, characterized in that: The inner injection mold and the outer injection mold are both made of plastic.

7. A method for manufacturing a disposable fetal spiral electrode according to any one of claims 1 to 6, characterized in that: The steps include: Step 1: After welding the spiral electrode to one of the twisted pair wires, perform the first injection molding, and inject and embed the connecting end of the spiral electrode and one of the twisted pair wires into an injection inner mold, so that the other end of the spiral electrode is exposed from the top of the injection inner mold; Step 2: installing the auxiliary electrode on the outer side of the injection inner mold; Step 3: welding the auxiliary electrode to another wire in the twisted pair; Step 4: The injection molding outer mold is sleeved outside the auxiliary electrode, so that the protrusions on the outer side of the auxiliary electrode are embedded in the corresponding through holes on the outer wall of the injection molding outer mold; Step 5: Perform a second injection molding to form the inner injection mold, the auxiliary electrode and the outer injection mold into an integrated structure.

8. The method for making a disposable fetal spiral electrode according to claim 7, characterized in that: In step 4, a cylindrical side wall is extended downward from the annular bottom of the upper part of the auxiliary electrode, and two embedding grooves are symmetrically arranged on the bottom edge of the cylindrical side wall. An auxiliary electrode plug is vertically embedded in the two embedding grooves, so that the two conductors of the twisted pair are arranged on both sides of the auxiliary electrode plug.

Images