CN114515176B - Anastomotic stoma protection device - Google Patents

Anastomotic stoma protection device Download PDF

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Publication number
CN114515176B
CN114515176B CN202011311144.0A CN202011311144A CN114515176B CN 114515176 B CN114515176 B CN 114515176B CN 202011311144 A CN202011311144 A CN 202011311144A CN 114515176 B CN114515176 B CN 114515176B
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China
Prior art keywords
electromagnetic
protection device
assembly
component
harness
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CN202011311144.0A
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Chinese (zh)
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CN114515176A (en
Inventor
单腾
陈望东
曹元阳
黄柊喻
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Suzhou Tianchen International Medical Technology Co Ltd
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Suzhou Tianchen International Medical Technology Co Ltd
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Priority to CN202011311144.0A priority Critical patent/CN114515176B/en
Application filed by Suzhou Tianchen International Medical Technology Co Ltd filed Critical Suzhou Tianchen International Medical Technology Co Ltd
Priority to EP21894001.3A priority patent/EP4248884A4/en
Priority to KR1020237020778A priority patent/KR20230110568A/en
Priority to AU2021382833A priority patent/AU2021382833A1/en
Priority to JP2023530515A priority patent/JP2023550455A/en
Priority to CA3202605A priority patent/CA3202605A1/en
Priority to US18/253,314 priority patent/US20240024152A1/en
Priority to PCT/CN2021/131647 priority patent/WO2022105854A1/en
Publication of CN114515176A publication Critical patent/CN114515176A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Physiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention provides an anastomotic stoma protection device, which comprises: the protective sleeve is positioned in the tubular tissue at a position corresponding to the anastomotic stoma; a first fixation assembly disposed on an outer wall of the tubular tissue, the first fixation assembly comprising an electromagnetic generating component; the electromagnetic driving assembly is used for supplying power to the electromagnetic generating component so that magnetism is generated after the electromagnetic generating component is electrified, and the output current of the electromagnetic driving assembly is adjustable; and the second fixing assembly is arranged on the inner surface of the protective sleeve, and the second fixing assembly and the electromagnetic generating component of the first fixing assembly are relatively fixed through magnetic adsorption. According to the invention, the protective sleeve for protecting the anastomotic stoma is fixed at a required position through the magnetic adsorption of the electromagnetic generating component and the internal fixing component, and the magnitude of magnetic force generated by the electromagnetic generating component can be adjusted by adopting the electromagnetic driving component with adjustable output current, so that the pressure of the first fixing component and the second fixing component on tubular tissues is adjusted.

Description

Anastomotic stoma protection device
Technical Field
The invention relates to the technical field of medical instruments, in particular to an anastomotic stoma protection device.
Background
After the intestinal tract performs the incising and suturing operation, the anastomotic stoma is generally required to be protected in order to avoid applying tension to the anastomotic stoma by the excrement or to avoid infection of the anastomotic stoma caused by contamination of the anastomotic stoma by the excrement.
The existing anastomotic stoma protection mode is generally as follows: the inside tubular sleeve that sets up at the intestinal, the sleeve pipe covers the intestinal internal surface and corresponds to the position of anastomotic stoma, and through the sleeve pipe with excreta drainage to the human body outside, not only can effectively protect the anastomotic stoma, can also after the anastomotic stoma physiological tissue grows, need not to carry out the secondary operation, directly take out the sleeve pipe can. In order to better secure the cannula in the desired position, a fixation band having a fixed diameter and configured to be positioned around the intestine needs to be provided on the outside of the cannula. However, the band inevitably forms a certain pressure on the intestinal tract, which may form an obstacle to the normal peristalsis of the intestinal tract, and may cause problems such as poor blood supply near the anastomotic orifice due to the continuous pressure of the band.
In addition, the pressure of the fixing band in the prior art on the intestinal tract after encircling the intestinal tract is fixed, and cannot be adjusted.
Disclosure of Invention
Aiming at the problems in the prior art, the invention aims to provide the anastomotic stoma protection device, wherein a protective sleeve for protecting an anastomotic stoma is fixed at a required position through the magnetic adsorption of an electromagnetic generating component and an internal fixing component, and the magnitude of magnetic force generated by the electromagnetic generating component can be adjusted by adopting an electromagnetic driving component with adjustable output current, so that the pressure of a first fixing component and a second fixing component to tubular tissues is adjusted.
The embodiment of the invention provides an anastomotic stoma protection device, which comprises:
the protective sleeve is positioned in the tubular tissue at a position corresponding to the anastomotic stoma;
a first fixation assembly disposed on an outer wall of the tubular tissue, the first fixation assembly comprising an electromagnetic generating component;
the electromagnetic driving assembly is used for supplying power to the electromagnetic generating component so that magnetism is generated after the electromagnetic generating component is electrified, and the output current of the electromagnetic driving assembly is adjustable; and
The second fixing component is arranged on the inner surface of the protective sleeve, and the second fixing component and the electromagnetic generating component of the first fixing component are relatively fixed through magnetic adsorption.
In some embodiments, the electromagnetic drive assembly includes an input power source that sequentially supplies power to the electromagnetic generating component through the current adjusting circuit and the power supply wire harness, a current adjusting circuit, a control element for adjusting an output current value of the current adjusting circuit, and a power supply wire harness.
In some embodiments, the current regulation circuit comprises a transformer having an adjustable number of secondary coil turns, or
The current regulating circuit comprises a voltage dividing circuit or a shunt circuit, and at least one shunt branch of the voltage dividing circuit or the shunt circuit comprises a variable resistor.
In some embodiments, a signal acquisition assembly is further included, the signal acquisition assembly including at least one pressure sensor disposed on a side of the electromagnetic generating component facing the tubular tissue.
In some embodiments, the device further comprises a signal processing component, wherein the signal processing component is used for determining a driving current value according to a preset driving current change period and/or determining the driving current value according to detection data of the pressure sensor;
the signal processing component is further configured to send a drive signal including the drive current value to the electromagnetic drive component, the electromagnetic drive component being configured to control the output current in accordance with the drive current value.
In some embodiments, the electromagnetic driving assembly includes a plurality of electromagnetic driving modules, the electromagnetic driving modules correspond to the pressure sensors, the signal processing assembly determines driving current values of the corresponding electromagnetic driving modules according to detection data of the pressure sensors, and sends driving signals including the driving current values to the corresponding electromagnetic driving modules.
In some embodiments, the signal processing component is further configured to compare the detection data of the pressure sensor with a preset reference value, and determine whether to alarm according to the comparison result; or (b)
The signal processing component is also used for comparing the detection data of the pressure sensors and judging whether to alarm according to the comparison result; or (b)
The signal processing component is further used for comparing the detection data of the pressure sensors with a preset reference value or comparing the detection data of a plurality of pressure sensors, judging whether to generate a driving current value according to the comparison result and sending a driving signal comprising the driving current value to the electromagnetic driving module.
In some embodiments, the system further comprises a display module for displaying detection data of the pressure sensor and/or an output current value of the electromagnetic drive assembly.
In some embodiments, the signal processing assembly and the pressure sensor and the electromagnetic drive assembly respectively transmit data via signal lines or via wireless communication.
In some embodiments, the electromagnetic generating component comprises an electromagnet.
In some embodiments, the first fixing assembly includes a plurality of electromagnetic generating components arranged at intervals, the electromagnetic generating components are sequentially arranged along the circumference of the tubular tissue, and the power supply wire bundles encircle the outer wall of the tubular tissue and are electrically connected with the electromagnetic generating components.
In some embodiments, the power supply wire bundle includes:
a plurality of harness carrying portions surrounding an outside of the electromagnetic generating member;
a plurality of harness connecting portions connected between two adjacent harness carrying portions, the harness carrying portions and the harness connecting portions being combined to form a ring-like structure surrounding an outer wall of the tubular tissue;
And one end of the extension part is connected with the wire harness connecting part, and the other end of the extension part is connected with the current regulating circuit.
In some embodiments, a first mounting groove is formed in a side surface of the electromagnetic generating component along a circumferential direction, and a wire harness bearing part of the power supply wire harness is embedded in the first mounting groove; or alternatively, the first and second heat exchangers may be,
The inner side surface of the wire harness bearing part of the power supply wire harness is provided with a first mounting groove along the circumferential direction, and the electromagnetic generating component is embedded in the first mounting groove.
In some embodiments, the power supply wire harness is an elastic wire harness.
In some embodiments, the first fixing assembly further includes a first connector surrounding an outer wall of the tubular tissue, the first connector including a first carrying portion carrying the electromagnetic generating component and a first connecting portion connected between adjacent two of the first carrying portions, the first carrying portion surrounding an exterior of the harness carrying portion.
In some embodiments, the power supply harness includes a first connection structure at which the power supply harness may be connected to encircle the outer wall of the tubular tissue or broken away from the outer wall of the tubular tissue.
In some embodiments, the first fixation assembly further comprises a first connector surrounding an outer wall of the tubular tissue, the first connector being connected to the electromagnetic generating component;
the first fixing assembly comprises an inner fixing block and a second connecting piece for bearing the inner fixing block, the second connecting piece is located on the inner surface of the protective sleeve, and the inner fixing block is a magnetic piece or a structural piece which can be attracted magnetically.
In some embodiments, the first connector includes a second connection structure at which the first connector may be connected to encircle the outer wall of the tubular tissue or disconnected from the outer wall of the tubular tissue at the second connection structure.
In some embodiments, at least a portion of the first connector, the second connector, and/or the internal fixation block is made of a bioabsorbable material.
In some embodiments, the first securing assembly further comprises a first connector carrying the electromagnetic generating component; and/or the second fixing assembly comprises an inner fixing block and a second connecting piece for bearing the inner fixing block;
a first mounting groove is formed in at least part of the circumference of the electromagnetic generating component, the inner circumference of the first connecting piece is embedded with the first mounting groove, or a first mounting groove is formed in at least part of the inner circumference of the first connecting piece, and the electromagnetic generating component is embedded with the first mounting groove;
The circumference of inside fixed block is equipped with the second mounting groove at least partially, the inner periphery of second connecting piece with the gomphosis of second mounting groove, perhaps the inner periphery of second connecting piece is equipped with the second mounting groove at least partially, inside fixed block with the gomphosis of second mounting groove.
The anastomotic stoma protection device provided by the invention has the following advantages:
The inner surface of the anastomotic stoma is protected by the protective sleeve, the anastomotic stoma is not polluted in the process of guiding the tubular tissue contents to pass, and the protective sleeve is fixed at a required position by the magnetic adsorption between the electromagnetic generating component of the first fixing component and the second fixing component; only the magnetic adsorption position between the electromagnetic generating component and the second fixing component in the device is relatively fixed, normal peristalsis of tubular tissues is not hindered, a circumferentially telescopic space is provided for the tubular tissues, and normal blood supply near an anastomotic orifice is ensured. The electromagnetic driving assembly with adjustable output current can adjust the magnetic force generated by the electromagnetic generating component, so that the pressure of the first fixing assembly and the second fixing assembly on the tubular tissue can be adjusted. The tubular tissue applied by the anastomotic stoma protection device can be intestinal tracts or other tubular tissues in human bodies, such as tubular tissues at other positions in the digestive tract, and the like.
Drawings
Other features, objects and advantages of the present invention will become more apparent upon reading of the detailed description of non-limiting embodiments, made with reference to the following drawings.
Fig. 1 is a schematic structural view of a stoma protection apparatus according to a first embodiment of the present invention disposed in intestinal tissue;
Fig. 2 is a schematic structural view of a stoma protection apparatus according to a first embodiment of the invention;
FIG. 3 is an exploded view of a stoma protection appliance of a first embodiment of the invention;
FIG. 4 is a first schematic diagram of a current regulation circuit according to a first embodiment of the present invention;
FIG. 5 is a second schematic diagram of a current regulation circuit according to the first embodiment of the invention;
FIG. 6 is a third schematic diagram of a current regulation circuit according to the first embodiment of the present invention;
FIG. 7 is a schematic structural view of a first anastomosis protection device incorporating a signal acquisition assembly and a signal processing assembly according to a first embodiment of the present invention;
FIG. 8 is a schematic structural view of a second anastomosis protection device incorporating a signal acquisition assembly and a signal processing assembly according to a first embodiment of the present invention;
FIG. 9 is a schematic illustration of the first securing assembly and the power supply wire bundle of the first embodiment of the present invention mated;
FIG. 10 is a schematic illustration of the disconnection of the first connector of the first embodiment of the present invention;
FIG. 11 is a schematic illustration of a power supply line bundle disconnection of a first embodiment of the present invention;
fig. 12 is a front view of a power supply harness of the first embodiment of the present invention;
fig. 13 is a side view of a power supply harness of the first embodiment of the present invention;
fig. 14 is a front view of a first connector of a first embodiment of the present invention;
FIG. 15 is a side view of a first connector of a first embodiment of the present invention;
fig. 16 is a schematic structural view of a stoma protection apparatus according to a second embodiment of the invention;
fig. 17 is a schematic structural view of a stoma protection apparatus according to a third embodiment of the present invention disposed in intestinal tissue;
fig. 18 is a schematic structural view of a stoma protection apparatus according to a fourth embodiment of the present invention disposed in intestinal tissue;
FIG. 19 is a schematic view of the mating of the inner fixed block and the second connector of a fourth embodiment of the present invention;
fig. 20 is a front view of a second connector according to a fourth embodiment of the present invention;
fig. 21 is a side view of a second connector according to a fourth embodiment of the present invention.
Reference numerals:
1. Protective sleeve 5 second connector
11. A second bearing part of the supporting part 51
12. Groove 52 second connecting portion
2. Electromagnet 6 power supply wire bundle
21. Electromagnet fillet 61 wire harness bearing part
22. First mounting groove 62 harness connection portion
3. Extension of the internal fixing block 63
31. Internal fixed block fillet 64 connection end point
32. Second mounting groove 71 current regulating circuit
4. First connector 72 inputs power
41. First bearing portion 73 control element
42. First connection 81 pressure sensor
43. Connection protrusion 82 signal processing assembly
44. Connection groove 83 display module
9. Intestinal tissue
Detailed Description
Example embodiments will now be described more fully with reference to the accompanying drawings. However, the exemplary embodiments can be embodied in many forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concept of the example embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and thus a repetitive description thereof will be omitted.
The invention provides an anastomotic stoma protection device which comprises a protective sleeve, a first fixing component, a second fixing component and an electromagnetic driving component. The protective sleeve is positioned in the tubular tissue at a position corresponding to the anastomotic stoma, the protective sleeve plays a role in protecting the inner surface of the anastomotic stoma, and the anastomotic stoma is not polluted in the process of guiding the tubular tissue contents to pass through. The first fixing component is arranged on the outer wall of the tubular tissue and comprises an electromagnetic generating component, and the electromagnetic generating component can generate magnetism when power supply current is input. The electromagnetic driving assembly is electrically connected with the electromagnetic generating component and is used for supplying power to the electromagnetic generating component, so that magnetism is generated after the electromagnetic generating component is electrified, and the output current of the electromagnetic driving assembly is adjustable. The second fixing component is arranged on the inner surface of the protective sleeve, and the second fixing component is magnetic or can be attracted magnetically and is fixed relative to the electromagnetic generating component through magnetic attraction, so that the protective sleeve is fixed at a required position through the magnetic attraction between the first fixing component and the second fixing component.
Because only the magnetic adsorption position between the first fixing component and the second fixing component in the anastomotic stoma protection device is relatively fixed, normal peristalsis of tubular tissues can not be hindered, a circumferentially telescopic space is provided for the tubular tissues, and normal blood supply near an anastomotic stoma is ensured. The first fixing component comprises an electromagnetic generating component which can be electrified and has magnetism, the existence of magnetism in the electromagnetic generating component can be flexibly controlled by controlling the on-off of the power supply of the electromagnetic driving component, and the magnetic force generated by the electromagnetic generating component can be adjusted by adopting the electromagnetic driving component with adjustable output current, so that the pressure of the first fixing component and the second fixing component to tubular tissues can be adjusted.
The following describes the structure of the anastomotic stoma protection device according to various embodiments of the present invention in detail with reference to the accompanying drawings, and it is to be understood that the various embodiments are not limiting of the scope of the present invention. In various embodiments, intestinal tissue is described as an example. It is understood that in other embodiments, the tubular tissue is not limited to intestinal tissue, but may be other tubular tissue in the human body, such as tubular tissue at other locations in the digestive tract, and the like, and fall within the scope of the present invention.
Fig. 1 to 8 are schematic structural views showing an application of the anastomotic stoma protection device according to the first embodiment of the present invention to intestinal tissue 9. As shown in fig. 1 to 4, the anastomotic stoma protection device includes: the protective sleeve 1 is positioned in the intestinal tissue 9 at a position corresponding to the anastomotic stoma, plays a role in protecting the inner surface of the anastomotic stoma, and does not pollute the anastomotic stoma in the process of guiding intestinal contents to pass through; a first fixing component, which is arranged on the outer wall of the intestinal tissue 9 and comprises an electromagnetic generating component; the electromagnetic driving assembly is used for supplying power to the electromagnetic generating component so that magnetism is generated after the electromagnetic generating component is electrified, and the output current of the electromagnetic driving assembly is adjustable; and a second fixing component, which is disposed on the inner surface of the protective sleeve 1, and is fixed relative to the electromagnetic generating component of the first fixing component by magnetic attraction.
Because only the magnetic adsorption position between the first fixing component and the second fixing component in the device is relatively fixed, the normal peristaltic movement of the tubular tissue is not hindered, and a circumferential telescopic space is provided for the tubular tissue, so that the normal blood supply near the anastomotic orifice is ensured. The electromagnetic generating component in the first stationary assembly may generate magnetism when powered by the electromagnetic drive assembly. Therefore, the magnetic property in the electromagnetic generating component can be flexibly controlled by controlling the on-off of the power supply of the electromagnetic driving component, and the magnetic force generated by the electromagnetic generating component can be adjusted by adopting the electromagnetic driving component with adjustable output current, so that the pressure of the first fixing component and the second fixing component on the tubular tissue can be adjusted.
In this embodiment, the electromagnetic generating means is an electromagnet 2. The electromagnet is a structure for generating magnetism by energizing, a conductive winding matched with the power of the electromagnet is wound outside the iron core, and when the electromagnet is energized in the conductive winding, the winding with the current has magnetism like a magnet. Therefore, in this embodiment, the magnetic magnitude generated after the current is applied to the electromagnet 2 can also be adjusted by controlling the number of turns of the coil in the electromagnet 2. In other alternative embodiments, the electromagnetic generating component may take other configurations, such as a solenoid, etc., which are within the scope of the present invention.
In this embodiment, as shown in fig. 1 to 4, the first fixing component includes a plurality of electromagnets 2 arranged at intervals, and the plurality of electromagnets 2 are sequentially arranged along the circumference of the intestinal tissue 9 so as to form a uniform and stable fixation for the protective sheath 1. The second fixing assembly comprises inner fixing blocks 3 which are in one-to-one correspondence with the electromagnets 2. The inner fixing block 3 may be made of a material which is not magnetic but attracted to a magnet, for example, a magnetically attracting metal such as iron, nickel, cobalt, or an alloy thereof. Alternatively, the inner fixing block 3 may be made of a magnetic material having magnetism, such as a magnet, etc., which is opposite to that of the electromagnet 2 when energized. In this embodiment, a plurality of electromagnets 2 are provided with a space therebetween, and a plurality of inner fixing blocks 3 are provided with a space therebetween. The number of the electromagnets 2 and the internal fixed blocks 3 can be selected and set according to the needs, and the electromagnets 2 and the internal fixed blocks 3 can form a one-to-one correspondence, a one-to-many correspondence, a many-to-one correspondence, or the like, which are all within the protection scope of the present invention. In other alternative embodiments, the electromagnet 2 may also be provided as 1 and/or the inner fastening block 3 may also be provided as 1.
As shown in fig. 2, the protecting sleeve 1 is a tubular protecting sleeve, so as to form circumferential protection for the anastomotic stoma. The protective sheath 1 may be a thin film sleeve having flexibility, such as a rubber film sleeve, a silicone film sleeve, etc., but the present invention is not limited thereto. In other alternative embodiments, the protective sheath 1 may take other shapes, and all or part of the protective sheath may cover the inner wall of the stoma, which falls within the scope of the invention.
The fixing component is preferably arranged on the upstream side of the anastomotic stoma and is used for fixing the protective sleeve 1, so that the protective sleeve 1 does not move towards the downstream side of the anastomotic stoma and lose the protection of the anastomotic stoma. In the present invention, upstream of the stoma means that the intestinal contents move along the intestine from the upstream side of the stoma to the downstream side of the stoma with reference to the direction in which the intestinal contents move along the intestine. When the stoma protection device is applied in the lower position of the intestine, the protective sheath 1 guides the discharge of faeces along the intestine, moving from the upstream side of the stoma to the downstream side of the stoma.
As shown in fig. 2 and 3, the end of the protective sleeve 1 located at the upstream side of the anastomotic stoma is provided with a support part 11, and the support part 11 is retractable in the radial direction of the protective sleeve 1. When the supporting portion 11 is contracted in the radial direction, the protective sleeve 1 can be integrally put into the intestinal tissue 9 or taken out from the intestinal tissue 9, and after the protective sleeve 1 is put in place, the supporting portion 11 expands in the radial direction to form a support for the protective sleeve 1, and the position of the protective sleeve 1 is maintained. The support 11 may be an inflatable deflated annular balloon which is in a radially expanded state when inflated and in a radially contracted state when deflated. The supporting portion 11 may also adopt other radially telescopic springs or radially movable slider structures, so that the outer diameter of the supporting portion 11 may be increased or decreased. The first fixing component and the second fixing component are arranged between the anastomotic stoma and the supporting portion 11, and the protective sheath 1 can be better kept at the anastomotic stoma position through the cooperation of the first fixing component and the second fixing component with the supporting portion 11.
As shown in fig. 1, in this embodiment, the electromagnetic driving assembly includes a power supply harness 6, a current adjusting circuit 71, a control element 73, and an input power source 72, where the input power source 72 sequentially supplies power to the electromagnet 2 through the current adjusting circuit 71 and the power supply harness 6, the control element 73 is used to adjust an output current value of the current adjusting circuit 71, and the control element 73 may be a manual adjusting switch or an automatic control circuit (implemented by, for example, a programmable logic controller PLC). The input power source 72 may be a rechargeable battery or a non-rechargeable battery, and the current adjusting circuit 71 may supply an ac current or a dc current to the power supply line bundle 6, and the electromagnet 2 may be an ac electromagnet or a dc electromagnet, respectively.
The power supply wire bundles 6 surround the outer wall of the intestinal tissue 9 and are electrically connected to the electromagnets 2, respectively. The power supply wire bundle 6 may be electrically connected to an input power source 72, and the input power source 72 supplies power to the conductive winding of the electromagnet 2 through the current adjusting circuit 71 and the power supply wire bundle 6, so that the electromagnet 2 generates magnetism. The electromagnet 2 may have a magnetic property when energized and a structure that demagnetizes rapidly when deenergized. When the electromagnet 2 needs to be fixed to the outer wall of the intestinal tissue 9, the electromagnet 2 is magnetically attracted to the inner fixing block 3 by energizing the power supply wire harness 6 through the current adjusting circuit 71 by the input power supply 72. During use, the power supply wire bundle 6 continues to supply the electromagnet 2. When it is desired to remove the electromagnet 2 from the outer wall of the intestinal tissue 9, the power supply of the power supply wire bundle 6 by the input power source 72 can be cut off, so that the electromagnet 2 loses magnetism. The magnitude of the power supply current in the power supply wire harness 6 can be controlled by the current adjusting circuit 71, thereby controlling the magnitude of the magnetic strength of the electromagnet 2.
The current adjusting circuit 71 may have a variety of different circuit structures, and may be capable of adjusting the current output by the input driving signal. For example, the current adjusting circuit may include a transformer, the number of turns of the secondary winding of the transformer is adjustable, the primary winding of the transformer inputs the supply current of the input power source 72, the secondary winding of the transformer inputs the supply current to the power supply line bundle 6, and the purpose of adjusting the supply current can be achieved by adjusting the number of turns of the secondary winding of the transformer. For another example, the current adjusting circuit may include a shunt circuit, at least one shunt branch of the shunt circuit includes a variable resistor, and an output current of the shunt circuit may be adjusted by adjusting a resistance value of the variable resistor.
Three configurations of the current regulation circuit 71 are shown in fig. 4 to 6, and are only examples of regulation principle circuits of the current regulation circuit 71. In practical applications, the current adjusting circuit 71 may include one or several structures thereof, and may further include other required circuit components, for example, a filter circuit, a voltage stabilizing circuit, a current detecting circuit, a voltage detecting circuit, and the like may be further added to the circuits of fig. 4 to 6.
Fig. 4 is a schematic diagram of a first current adjusting circuit in this embodiment. The current regulating circuit comprises a transformer T, wherein a power source Vin is input between two input terminals of a primary winding P of the transformer T, and a power source Vout is output between output terminals O4 and O5 of a secondary winding S of the transformer T. The secondary winding S is led out of four output end points O1, O2 and O3, the first end of the switch K is provided with an adjustable contact, the other end of the switch K is connected with an output power supply O4, the adjustable contact of the switch K is electrically connected with different output end points O1, O2 and O3, the voltage value of an output power supply Vout between the output end points O4 and O5 can be regulated, and under the condition that the number of turns of a coil of the electromagnet 2 is unchanged, the voltage Vout of the input electromagnet 2 is changed, so that the current value transmitted to the electromagnet 2 by the current regulating circuit is changed. The number of turns of the secondary winding S in the structure is equivalent to three adjustable gears, and only two adjustable gears can be arranged, or more gears can be further added.
In this embodiment, the control element may be a manual switch or an automatic control circuit. For example, when the current adjusting circuit includes a transformer T with an adjustable number of secondary windings, the control element may manually adjust a gear switch of the switch K, each gear of the gear switch corresponds to a different position of the adjustable contact of the switch K, and by adjusting the gear switch, the number of secondary windings of the transformer T may be adjusted. In another embodiment, the control element may also be implemented by a control circuit, and the control circuit may generate a control signal to control the connection or disconnection between the adjustable contact of the switch K and the different output terminals O1, O2 and O3, so as to implement the adjustment of the number of turns of the secondary side of the transformer T.
Fig. 5 is a schematic diagram of a second current adjusting circuit in this embodiment. Wherein, a MOS (metal-oxide semiconductor field effect) switching tube M1, M2, M3 is respectively disposed between the secondary winding S and the three output terminals O1, O2, O3, and by respectively controlling the gate voltages of the MOS switching tubes, the conduction between the source and drain electrodes of the switching tubes M1, M2, M3 can be respectively controlled, thereby realizing different output voltages Vout. For example, when only the source and drain of the switching tube M1 are turned on, the output voltage Vout corresponds to the voltage between the output terminals O1 and O4, when only the source and drain of the switching tube M2 are turned on, the output voltage Vout corresponds to the voltage between the output terminals O2 and O4, and when only the source and drain of the switching tube M3 are turned on, the output voltage Vout corresponds to the voltage between the output terminals O3 and O4. In the case of a constant number of turns of the coil of the electromagnet 2, a change in the voltage Vout input to the electromagnet 2 changes the current value supplied to the electromagnet 2 by the current regulation circuit. The number of turns of the secondary winding S in the structure is equivalent to three adjustable gears, and only two adjustable gears can be arranged, or more gears can be further added.
In this embodiment, the control element may be a manual switch or an automatic control circuit. For example, the control element may be a switch capable of manually adjusting the gate voltage of each switching tube, or may be a control circuit capable of automatically adjusting the gate voltage of each switching tube.
Fig. 6 is a schematic diagram of a third current adjusting circuit in this embodiment. The voltage division is realized through the resistor R1 and the variable resistor R2 which are connected in series, when the resistance value of the variable resistor R2 is regulated, the change of the current of the output voltage Vout is realized, and under the condition that the number of turns of the coil of the electromagnet 2 is unchanged, the change of the voltage Vout of the input electromagnet 2 also changes the current value transmitted to the electromagnet 2 by the current regulating circuit. In another alternative embodiment, the shunt circuit may be implemented by using at least two resistors connected in parallel, where at least one resistor is a variable resistor, and the output current is adjustable by adjusting the current value of the variable resistor.
In this embodiment, the control element may be a manual switch or an automatic control circuit. For example, the control element is a switch capable of manually adjusting the variable resistor R2, by toggling the switch, the resistance value of the variable resistor R2 connected to the current adjusting circuit can be adjusted, and the control element can also be a control circuit capable of automatically adjusting the variable resistor R2.
It will be appreciated that in the above embodiments, only the voltage or current adjusting circuit is exemplified as a circuit for adjusting according to a gear, and may be a voltage adjusting circuit for stepless voltage adjustment or a variable resistance circuit for stepless speed adjustment.
As shown in fig. 7 and 8, in this embodiment, the anastomotic stoma protection device may further comprise a signal acquisition assembly comprising at least one pressure sensor 81, the pressure sensor 81 being arranged on the side of the electromagnet 2 facing the tubular tissue and/or on the side of the inner fixation block 3 facing the protective sheath, or the pressure sensor 81 being arranged on the protective sheath 1 in a position corresponding to the first fixation assembly or the second fixation assembly. Fig. 7 shows a structure in which a pressure sensor 81 is provided on the inner side surface of the electromagnet 2, and the pressure sensor 81 may be provided on the inner side surface of one or more electromagnets 2. Fig. 8 shows a structure in which the pressure sensor 81 is provided on the outer side surface of the inner fixing block 3, and the pressure sensor 81 may be provided on the outer side surface of one or more inner fixing blocks 3. In another embodiment, the pressure sensor 81 may be provided on the inner side surface of part or all of the electromagnet 2, and the pressure sensor 81 may be provided on the outer side surface of part or all of the inner fixing block 3. The pressure sensor 81 can collect the pressure between the electromagnet 2 and the internal fixed block 3, namely the magnitude of the magnetic attraction force, so that the magnetic attraction force is monitored. The signal processing assembly may further include an a/D converter to convert the analog signal collected by the pressure sensor 81 into a digital signal.
As shown in fig. 7 and 8, the anastomotic stoma protection device may further comprise a signal processing component 82, the signal processing component 82 may adjust a driving current value of the electromagnetic driving component, and then send a driving signal including the driving current value to the electromagnetic driving component, and the electromagnetic driving component is configured to control an output current according to the driving current value. Specifically, the control element 73 includes a control circuit that can implement automatic current control, and the driving signal is sent to the control element 73 by the signal processing component 82. The control element 73 may adjust the output current value of the current adjusting circuit 71 according to the driving signal, for example, for the configuration of fig. 4, the control element 73 may be electrically connected to the corresponding output terminal O1, O2 or O3 by adjusting the adjustable contact point of the switch K according to the relationship between the driving current value and the gear of the switch K, for the configuration of fig. 5, the control element 73 may control the gate voltages of the switching transistors M1, M2 and M3 according to the relationship between the driving current value and the gear, so as to adjust the on or off of the switching transistors M1, M2 and M3, thereby realizing the output current adjustment of the current adjusting circuit 71, and for the configuration of fig. 6, the control element 73 may adjust the resistance value of the variable resistor according to the relationship between the driving current value and the variable resistance value, thereby realizing the output current adjustment of the current adjusting circuit 71.
The signal processing component 82 may take different forms in determining the drive current value. For example, in one embodiment, the signal processing component 82 may determine the driving current value according to a preset driving current variation period, so as to implement periodic adjustment of the magnetic attraction force between the electromagnet 2 and the inner fixed block 3, that is, implement periodic adjustment of the fixing force between the first fixed component and the second fixed component. In another embodiment, the signal processing component 82 may also determine the driving current value according to the detection data of the pressure sensor 81, for example, the signal processing component 82 may compare the detection data of the pressure sensor 81 with a preset reference value, if the detection data of the pressure sensor 81 is smaller than the preset reference value, it indicates that the magnetic attraction force is smaller, the driving current value may be increased, and otherwise, the driving current value may be decreased. Further, when the difference between the detected data of the pressure sensor 81 and the preset reference value is greater than the first preset threshold, the signal processing component may alarm, for example, control the alarm to emit an alarm sound or alarm light, or send an alarm signal to the user terminal.
Further, the signal processing component 82 may compare the detection data of the pressure sensor 81 with a preset reference value, calculate an absolute value of a difference between the detection data of the pressure sensor 81 and the preset reference value, determine whether the absolute value of the difference is greater than a preset difference threshold, if so, indicate that the difference between the actual detection data and the preset reference value is greater, and the signal processing component 82 needs to calculate a driving current value according to the difference between the detection data of the pressure sensor 81 and the preset reference value, and send a driving signal including the driving current value to the control element 73. If the absolute value of the difference is smaller than or equal to a preset difference threshold, the error is within an acceptable range, and the driving current value does not need to be calculated according to the difference. When there are a plurality of pressure sensors 81, the signal processing component 82 may compare the detection data of the plurality of pressure sensors 81, determine whether the error of the detection data of each two pressure sensors 81 is greater than a preset error threshold, and if so, adjust the output data of the current adjusting circuit 71 corresponding to one or more pressure sensors 81, that is, the signal processing component 82 generates a corresponding driving signal and sends the driving signal to the corresponding control element 73.
When a plurality of electromagnets 2 and a plurality of pressure sensors 81 are provided, the plurality of electromagnets 2 may be supplied with power by one integrated current regulation circuit 71, or the plurality of current regulation circuits 71 may be provided to supply power to the respective electromagnets 2. When the integrated current regulation circuit 71 is provided, the signal processing unit 82 may determine the driving current value based on the average detection data of the plurality of pressure sensors 81. Further, when the difference between the plurality of pressure sensors 81 is greater than the second preset threshold, the signal processing component 82 may alarm, for example, control the alarm to emit an alarm sound or alarm light, or send an alarm signal to the user terminal. When a plurality of current adjusting circuits 71 are provided to supply power to the respective electromagnets 2, the signal processing unit 82 may determine driving current values based on the detection data of the respective pressure sensors 81, respectively, and then output driving signals to the corresponding current adjusting circuits 71.
Data may be transmitted between the signal processing assembly 82 and the pressure sensor 81 and the current regulating circuit 71 of the electromagnetic drive assembly via signal lines, respectively. The signal lines may be arranged around the outer wall of the intestinal tissue 9, or other arrangements may be used. In another embodiment, the signal processing component 82 and the pressure sensor 81 and the current adjusting circuit 71 of the electromagnetic driving component can also transmit data in a wireless communication manner. For example, wireless communication modules are added at the pressure sensor 81 and the current adjusting circuit 71, respectively. The signal processing component 82 may also communicate with the pressure sensor 81 via a signal line and with the current regulation circuit 71 via wireless communication, or with the pressure sensor 81 via wireless communication and with the current regulation circuit 71 via a signal line. The signal processing assembly 82 may be further coupled to a display module 83 that displays the monitored pressure value of the pressure sensor 81. The signal processing component 82 may be implemented by a processor chip, or the signal processing component 82 and the display module 83 may be implemented by a user terminal, such as a mobile phone, a notebook, a tablet computer, a desktop computer, or the like, or the display module 83 may be implemented by a separate display screen. The display module 83 and the signal processing component 82 may communicate through a signal line or a wireless communication manner. The display module 83 may further display the driving current value to display the control state of the electromagnetic driving assembly in real time. Further, the display module 83 may further display the alarm signal and information related to the alarm signal, such as the reason for the alarm, the detection data of the pressure sensor at the time of the alarm, the position of the pressure sensor at the time of the alarm, etc., when the signal processing module 82 alarms.
As shown in fig. 9, the power supply wire bundle 6 includes a plurality of bundle carrying parts 61 and a plurality of bundle connecting parts 62, the bundle carrying parts 61 are ring-shaped hollow structures, surrounding the outside of the electromagnet 2, the bundle connecting parts 62 are connected between two adjacent bundle carrying parts 61, and the bundle carrying parts 61 and the bundle connecting parts 62 are combined to form a ring-shaped structure surrounding the outer wall of the intestinal tissue 9. As shown in fig. 9, a first mounting groove 22 is formed in a side surface of the electromagnet 2 in a circumferential direction, and a harness carrying portion 61 of the power supply harness 6 is fitted into the first mounting groove 22, so that stable connection between the electromagnet 2 and the power supply harness 6 is ensured. In another alternative embodiment, a first mounting groove in the circumferential direction may be provided on the inner side surface of the harness support portion 61 of the power supply harness 6, and the electromagnet 2 may be fitted into the first mounting groove. In order to more conveniently mount the electromagnet 2 on the power supply wire bundle 6 and remove the electromagnet from the power supply wire bundle 6, each side wall of the electromagnet 2, which is attached to the inner wall of the mounting groove, has a rounded corner 21 structure.
In this embodiment, the power supply wire harness 6 is an elastic wire harness 6, and at least the position of the harness connecting portion 62 is elastic, so that elastic deformation can occur along with peristaltic movement of the intestinal tract, without applying a limiting pressure to the intestinal tract, providing a telescopic movement space for the intestinal tract. When the wire harness carrying portion 61 and the wire harness connecting portion 62 are both elastic, the elastic deformation amount of the wire harness connecting portion 62 is preferably larger than that of the wire harness carrying portion 61 when the same tensile force is applied to the wire harness carrying portion 61 and the wire harness connecting portion 62, the wire harness carrying portion 61 can form a more stable connection with the electromagnet 2, the elastic deformation force of the wire harness connecting portion 62 is better, and a better circumferential expansion space can be provided.
As shown in fig. 9, the power supply wire harness 6 further includes an extension portion 63, one end of the extension portion 63 is connected to the harness connection portion 62, the other end of the extension portion 63 extends out of the body, and the extension portion 63 may be electrically connected to the current adjusting circuit 71.
In this embodiment, the power supply harness 6 includes a first connection structure in order to facilitate the installation and removal of the power supply harness 6 at the intestinal tissue 9. As shown in fig. 11, when the power-supplying wire harness 6 is installed at the intestinal tissue 9, the power-supplying wire harness 6 may be connected at the first connection structure so as to surround the outer wall of the intestinal tissue 9, for example, to form a closed loop structure. The loop structure of the power-supplying wire bundle 6 may also be broken at the connection point 64, so that the power-supplying wire bundle 6 may be formed as an unclosed loop or strip structure, which may be detached from the outer wall of the intestinal tissue 9. The connection at the connection end 64 of the power supply wire bundle 6 may be by means of a buckle, a hook, an adhesive, an additional fixing member, etc., which are all within the scope of the present invention. The power supply harness 6 can be used in two ways: one way is that the power supply wire harness 6 is initially in a closed loop, and when it needs to be removed from the intestinal tissue 9, the first connecting structure is broken to be separated from the intestinal tissue 9; alternatively, the power-supplying wire harness 6 is in an initial state of a non-closed structure, and is closed into a loop at a connecting structure after being installed outside the intestinal tissue 9.
As shown in fig. 12, the width w11 of the harness carrying portion 61 may be larger than the width w13 of the harness connecting portion 62. Therefore, the wire harness bearing part 61 can bear the electromagnet 2 with wider width so as to realize better fixing effect of the electromagnet 2 on the protective sleeve 1, and the wire harness connecting part 62 has smaller width, so that the elastic deformation capacity of the wire harness connecting part 62 can be improved, and the peristaltic influence on intestinal tissues 9 is greatly reduced. Further, the width w12 of the annular wall of the wire harness carrying portion 61 may be larger than the width w13 of the wire harness connecting portion 62, improving the connection stability of the wire harness carrying portion 61 and the electromagnet 2. As shown in fig. 13, the thickness t11 of the harness support portion 61 may be substantially equal to the thickness t12 of the harness connection portion 62. In another alternative embodiment, the thickness t11 of the wire harness carrying portion 61 may be greater than the thickness t12 of the wire harness connecting portion 62, so as to carry the thicker electromagnet 2, and further improve the elastic deformability of the wire harness connecting portion 62, so that a better circumferential expansion space may be provided. The thickness direction corresponds to the radial direction of the feeder harness 6 after forming the annular structure (corresponds to the radial direction of the protective sheath 1).
As shown in fig. 3, the surface of the electromagnet 2 opposite to the intestinal tissue 9 is an arc-shaped surface, and the shape of the arc-shaped surface is basically adapted to the outer wall of the intestinal tissue 9, so as to achieve better fitting between the electromagnet 2 and the outer wall of the intestinal tissue 9. The surface of the inner fixing block 3 opposite to the protective sleeve 1 is an arc surface, and the shape of the arc surface is basically matched with that of the inner surface of the protective sleeve 1, so that the inner fixing block 3 is better attached to the inner surface of the protective sleeve 1.
Further, in another alternative embodiment, the surface of the electromagnet 2 and/or the inner fixing block 3 may also be wavy. Specifically, the surface of the electromagnet 2 facing the intestinal tissue 9 is a wavy surface with high and low fluctuation along the length direction (S direction in fig. 3) of the intestinal tissue 9, so that the surface can be better adapted to the outer wall of the intestinal tissue 9, the contact area between the electromagnet 2 and the intestinal tissue 9 is increased, and the matching degree of the electromagnet 2 and the outer wall of the intestinal tissue 9 is improved. The surface of the inner fixing block 3 facing the protective sleeve 1 is a wavy surface with high and low fluctuation along the length direction (S direction in fig. 3) of the intestinal tissue 9, so that the contact area between the inner fixing block 3 and the protective sleeve 1 is increased, and the matching degree of the inner fixing block 3 and the inner wall of the protective sleeve 1 can be improved.
In this embodiment, the first fixing assembly further includes a first connecting member 4 surrounding the outer wall of the intestinal tissue 9, the first connecting member 4 includes a first carrying portion 41 carrying the electromagnet 2 and a first connecting portion 42 connected between two adjacent first carrying portions 41, and the first carrying portion 41 surrounds the outside of the harness carrying portion 61. The first connecting piece 4 is elastic, can elastically deform along with the peristaltic movement of the intestinal canal, does not apply limiting pressure to the intestinal canal, and provides a telescopic movement space for the intestinal canal. For example, the first connecting member 4 may be an elastic connecting member made of rubber, silicone, or the like and having a certain elasticity. When the first connection portion 42 and the first bearing portion 41 each have elasticity, the amount of elastic deformation occurring in the first bearing portion 41 may be smaller than the amount of elastic deformation occurring in the first connection portion 42 when the same tensile force is applied to the first bearing portion 41 and the first connection portion 42. So that the first bearing portion 41 better fixes the electromagnet 2, and the first connecting portion 42 can provide better circumferential expansion and contraction capability.
As shown in fig. 10, the first connecting member 4 is further provided with a connecting structure, and the first connecting member 4 may be connected at the second connecting structure to surround the outer wall of the intestinal tissue 9 or disconnected at the second connecting structure to be separated from the outer wall of the intestinal tissue 9. The connection structure shown in fig. 10 includes a connection protrusion 43 and a connection groove 44 provided at both end portions, respectively, and when the connection protrusion 43 is fitted into the connection groove 44, the first connection member 4 is ring-shaped, and when the connection protrusion 43 is separated from the connection groove 44, the first connection member 4 is bar-shaped or otherwise non-closed. In other alternative embodiments, the connection structure may take other forms, for example, a connection ring and a connection hook are respectively disposed at two ends, and the two ends are hooked together or separated to achieve two states of the first connecting piece 4, or two ends are disposed with an adhesive structure, and two states of the first connecting piece 4 are achieved through adhesion or adhesion separation, or the like.
As shown in fig. 14, the width w21 of the first bearing portion 41 is greater than the width w23 of the first connecting portion 42. Therefore, the first bearing part 41 can bear the electromagnet 2 with wider width so as to realize better fixing effect of the electromagnet 2 on the protective sleeve 1, and the width of the first connecting part 42 is smaller, so that the elastic deformation capacity of the first connecting part 42 can be improved, and the peristaltic influence on intestinal tissues 9 is greatly reduced. Further, the width w22 of the annular wall of the first bearing portion 41 may be greater than the width w23 of the first connecting portion 42, so as to improve the connection stability between the first bearing portion 41 and the electromagnet 2. In this embodiment, as shown in fig. 15, the thickness t21 of the first bearing portion 41 and the thickness t22 of the first connecting portion 42 are substantially equal. In a further alternative embodiment, the thickness t21 of the first carrier part 41 may also be greater than the thickness t22 of the first connecting part 42. Thereby, the first carrying portion 41 can carry the electromagnet 2 with a thicker thickness, so as to realize a better fixing effect of the electromagnet 2 on the protective sleeve 1. And the thickness of the first connecting portion 42 is smaller, the elastic deformability of the first connecting portion 42 can be further improved. The thickness direction corresponds to the radial direction of the first connector 4 after the annular structure is formed (corresponds to the radial direction of the protective sheath 1).
The first bearing portion 41 and the first connecting portion 42 are integrally formed, and the first bearing portion 41 is of a hollow annular structure surrounding the electromagnet 2, that is, a mounting hole is formed in the first bearing portion 41, and the electromagnet 2 is embedded in the mounting hole. In other alternative embodiments, the first bearing portion 41 may take other shapes, and may also be formed separately from the first connecting portion 42 and fixedly connected thereto. As shown in fig. 9, a first circumferential mounting groove 22 is provided at least partially on a side surface of the electromagnet 2, and the annular first bearing portion 41 is fitted into the first mounting groove 22. In another alternative embodiment, a circumferential mounting groove may be at least partially provided on the inner side of the edge of the hollow annular structure of the first bearing part 41, and the side surface of the electromagnet 2 is embedded in the mounting groove, so as to realize stable connection between the electromagnet 2 and the first bearing part 41. In this embodiment, the first bearing portion 41 is located outside the harness bearing portion 61 of the power-supplying harness 6.
The first connecting member 4 may be partially or entirely made of a bioabsorbable material, for example, a bioabsorbable medical film, and has flexibility or elasticity while ensuring a certain strength. Thereby omitting the step of post-operative removal of the first connector 4.
As shown in fig. 3, the inner surface of the protecting cover 1 may be further provided with grooves 12 corresponding to the inner fixing blocks 3 one by one, so as to better realize the positioning of the inner fixing blocks 3 on the inner surface of the protecting cover 1. The inner fixing block 3 is embedded in the corresponding groove 12, so that the inner fixing block 3 and the inner surface of the protective sleeve 1 can be detachably fixed.
In this embodiment, the inner fixing block 3 may be partially or entirely made of a bioabsorbable material, for example, a bioabsorbable iron-based material, or a magnetized bioabsorbable iron-based material, or the like, thereby omitting the step of removing the inner fixing block 3 after the operation.
Fig. 16 is a schematic structural view of an anastomotic stoma protection device according to a second embodiment of the present invention applied to intestinal tissues. In this embodiment, the first securing assembly does not include a first connector. The power supply harness 6 can simultaneously play a role of fixing the electromagnet 2 and supplying power to the electromagnet 2. The power supply wire harness 6 may take the specific structure in the first embodiment described above, but the present invention is not limited thereto. In other alternative embodiments, the power supply wire bundle 6 may be designed in other structures, and may be connected to the electromagnet 2 in other manners, which are all within the scope of the present invention.
Fig. 17 is a schematic structural view of an anastomotic stoma protection device according to a third embodiment of the present invention applied to intestinal tissues. In this embodiment, the stoma protection device may be used for high-end stoma protection of the intestinal tract. A group of electromagnets 2 are arranged on the outer wall of the intestinal tissue 9 at the upstream side of the anastomotic stoma, an internal fixed block is correspondingly arranged in the protective sleeve 1, another group of electromagnets 2 are arranged on the outer wall of the intestinal tissue 9 at the downstream side of the anastomotic stoma, and an internal fixed block is correspondingly arranged in the protective sleeve 1. The structure can greatly save the length of the needed protective sleeve 1, and the protective sleeve 1 is only arranged at a proper position from the upstream to the downstream of the anastomotic stoma, and does not need to extend to the anus all the time; and more make things convenient for the placement of protective sheath 1 and the removal of protective sheath 1 behind the anastomotic stoma resumes in the operation in-process, on the other hand can fix protective sheath 1 in the position that needs better, guarantee the stability in the use. The driving of the two groups of electromagnets 2 is respectively connected through two power-supply-line bundles 6, the two power-supply-line bundles 6 can be simultaneously connected to one current adjusting circuit 71 and one input power source 72, the magnetism of the two groups of electromagnets 2 can be simultaneously adjusted through one current adjusting circuit 71, and the two groups of electromagnets 2 can also be respectively connected to the two current adjusting circuits 71, so that the magnetism of the two groups of electromagnets 2 can be respectively adjusted.
Fig. 18 to 21 are schematic structural views showing an application of the stoma protection apparatus according to the fourth embodiment of the present invention to intestinal tissues. In this embodiment, the second fixing assembly further comprises a second connector 5. When the second connecting piece 5 is installed at the intestinal tract assembly 9, the second connecting piece 5 surrounds the inner surface of the protective sleeve 1 to form a connecting annular structure, so that the second connecting piece and the inner fixing block 3 form a circumferential fixing for the protective sleeve 1. The second connecting piece 5 corresponds to the position of the first connecting piece 4, and forms a fixing ring for the protective sleeve 1. As shown in fig. 19, the second connector 5 includes a second bearing portion 51 and a second connecting portion 52. The second bearing parts 51 are in one-to-one correspondence with the internal fixing blocks 3, and bear the corresponding internal fixing blocks 3. The second connecting portion 52 is connected between two adjacent second bearing portions 51. The second coupling member 5 is circumferentially telescopic when the second coupling member 5 is mounted at the enteral assembly 9. Further, the second connecting member 5 may be an elastic connecting member, and at least the second connecting portion 52 thereof is elastic. Therefore, during intestinal peristalsis, the second connecting piece 5 can elastically deform along with the peristalsis of the intestinal tract, and the limiting pressure is not applied to the intestinal tract, so that a telescopic movement space is provided for the intestinal tract. For example, the second connecting piece 5 may be an elastic connecting piece made of rubber, silica gel, or the like and having a certain elasticity. The second connection member 5 may be disposed parallel to the support portion 11. The second connecting piece 5 may be a closed ring structure, or may be a connecting piece with a connector, and when installed at the intestinal tract assembly 9, the connecting pieces are connected end to form a connecting ring. When the second connection portion 52 and the second bearing portion 51 each have elasticity, the amount of elastic deformation occurring in the second bearing portion 51 may be smaller than the amount of elastic deformation occurring in the second connection portion 52 when the same tensile force is applied to the second bearing portion 51 and the second connection portion 52. So that the second bearing portion 51 better fixes the inner fixing block 3, and the second connecting portion 52 can provide better circumferential expansion and contraction capability.
Further, the second connecting member 5 may be partially or entirely made of a bioabsorbable material, for example, a bioabsorbable medical film, and may have flexibility or elasticity while ensuring a certain strength. Thereby omitting the step of removing the second connecting member 5 after operation.
As shown in fig. 20, in this embodiment, the width w31 of the second bearing portion 51 is larger than the width w33 of the second connecting portion 52. Therefore, the second bearing part 51 can bear the inner fixing block 3 with wider width so as to realize better fixing effect of the inner fixing block 3 on the protective sleeve 1, and the width of the second connecting part 52 is smaller, so that the elastic deformation capacity of the second connecting part 52 can be improved, and the peristaltic influence on intestinal tissues 9 is greatly reduced. Further, the width w32 of the annular wall of the second bearing portion 51 may be greater than the width w33 of the second connecting portion 42, so as to improve the connection stability between the second bearing portion 51 and the inner fixing block 3. In this embodiment, as shown in fig. 21, the thickness t31 of the second bearing portion 51 and the thickness t32 of the second connecting portion 52 are substantially equal. In a further alternative embodiment, the thickness t31 of the second carrier part 51 may also be greater than the thickness t32 of the second connecting part 52. Thereby, the second bearing portion 51 can bear the inner fixing block 3 with a thicker thickness, so as to realize better fixing effect of the inner fixing block 3 to the protective sleeve 1. And the thickness of the second connection portion 52 is smaller, the elastic deformability of the second connection portion 52 can be further improved.
As shown in fig. 19, the second bearing portion 51 is integrally formed with the second connecting portion 52, and the second bearing portion 51 is a hollow annular structure surrounding the inner fixing block 3, that is, a mounting hole is provided in the second bearing portion 51, and the inner fixing block 3 is embedded in the mounting hole. In order to more conveniently mount and remove the internal fixing block 3 to and from the second coupling member 5, each side wall of the internal fixing block 3, which is attached to the inner wall of the mounting hole, has a rounded corner 31 structure. In other alternative embodiments, the second bearing part 51 may take other shapes, and may also be formed separately from the second connecting part 52 and fixedly connected thereto. As shown in fig. 19, a second mounting groove 32 is provided at least partially in the side surface of the inner fixing block 3, and the annular second bearing portion 51 is fitted into the second mounting groove 32. In another alternative embodiment, a second mounting groove in the circumferential direction of the second fixing block may be at least partially provided on the inner side of the edge of the hollow annular structure of the second bearing portion 51, and the side surface of the inner fixing block 3 is embedded in the second mounting groove, so as to achieve stable connection between the inner fixing block 3 and the second bearing portion 51.
In this embodiment, the second connector 5 may also be integrally formed with the protective sleeve 1. In an alternative embodiment, the second connecting piece 5 may be fixed to the protective casing 1 by gluing or the like after being formed separately. In another alternative embodiment, the second connection element 5 may also be not fixed in advance in the protective sheath 1, but placed in the corresponding position of the protective sheath 1 by the doctor at the time of the operation.
The fifth embodiment of the invention also provides a stoma protection device with a magnetic particle coating. In this embodiment, the second fixing component comprises a magnetic particle coating applied to the inner surface of the protective sleeve 1, the position of the magnetic particle coating corresponds to the electromagnet 2, and the magnetism of the magnetic particle coating is opposite to that of the electromagnet 2 when the electromagnet is electrified. The magnetic particle coating may be applied to the inner surface of the protective cover 1 by making magnetic particles into magnetic slurry with a binder, a solvent, or the like. Therefore, the second fixing component and the protective sleeve 1 are formed into an integral structure, and can be placed at a required position in the intestinal tissue 9 together during operation, and can be taken out of the intestinal tissue 9 together after the postoperative anastomotic stoma is restored. The second fixing member structure of this embodiment may also be combined with the structure of the electromagnet 2 of each of the above embodiments. Likewise, by controlling the distribution density of the magnetic particles and the total number of the magnetic particles, the purpose of controlling the magnitude of the magnetic attraction force between the electromagnet 2 and the magnetic particle coating can be achieved. And, the magnetic particle coating is provided integrally with the protective sheath 1, omitting the steps of mounting the second fixing assembly onto the protective sheath 1 and removing it from the protective sheath 1. And, the second fixed subassembly adopts the mode of magnetic particle coating, and the space that occupies is less in the inside of protective sheath 1.
The sixth embodiment of the invention also provides a anastomotic stoma protection device with magnetic particles. In this embodiment, all or part of the surface of the inner fixing block 3 is coated with a magnetic particle coating or magnetic particles are distributed inside. The magnetic particles of each internal fixed block 3 have the same magnetism and are opposite to the magnetism of the electromagnet 2.
The materials of all the embodiments of the anastomotic stoma protection device provided by the invention are all materials meeting the biocompatibility.
In summary, the anastomotic stoma protection device provided by the invention has the following advantages:
The inner surface of the anastomotic stoma is protected by the protective sleeve, the anastomotic stoma is not polluted in the process of guiding the tubular tissue contents to pass, and the protective sleeve is fixed at a required position by the magnetic adsorption between the electromagnetic generating component of the first fixing component and the second fixing component; only the magnetic adsorption position between the electromagnetic generating component and the second fixing component in the device is relatively fixed, normal peristalsis of tubular tissues is not hindered, a circumferentially telescopic space is provided for the tubular tissues, and normal blood supply near an anastomotic orifice is ensured. The electromagnetic driving assembly with adjustable output current can adjust the magnetic force generated by the electromagnetic generating component, so that the pressure of the first fixing assembly and the second fixing assembly on the tubular tissue can be adjusted. The tubular tissue applied by the anastomotic stoma protection device can be intestinal tracts or other tubular tissues in human bodies, such as tubular tissues at other positions in the digestive tract, and the like.
The foregoing is a further detailed description of the invention in connection with the preferred embodiments, and it is not intended that the invention be limited to the specific embodiments described. It will be apparent to those skilled in the art that several simple deductions or substitutions may be made without departing from the spirit of the invention, and these should be considered to be within the scope of the invention.

Claims (20)

1. An anastomotic stoma protection device, comprising:
the protective sleeve is positioned in the tubular tissue at a position corresponding to the anastomotic stoma;
The first fixing assembly is arranged on the outer wall of the tubular tissue and comprises a plurality of electromagnetic generating components which are arranged along the circumferential direction of the tubular tissue and form a circumferentially telescopic structure;
the electromagnetic driving assembly is used for supplying power to the electromagnetic generating component so that magnetism is generated after the electromagnetic generating component is electrified, and the output current of the electromagnetic driving assembly is adjustable; and
The second fixed subassembly, set up in the internal surface of protective sheath, the second fixed subassembly with the electromagnetism of first fixed subassembly takes place the part and is fixed relatively through magnetic attraction, the second fixed subassembly includes a plurality of inside fixed blocks, a plurality of inside fixed blocks are followed the circumference arrangement of tubular tissue, just a plurality of inside fixed blocks form circumference telescopic structure.
2. The anastomotic stoma protection device according to claim 1, wherein the electromagnetic drive assembly comprises an input power source, a current adjusting circuit, a control element and a power supply wire harness, the input power source sequentially supplies power to the electromagnetic generating component through the current adjusting circuit and the power supply wire harness, and the control element is used for adjusting an output current value of the current adjusting circuit.
3. The anastomotic stoma protection device according to claim 2, wherein the current regulating circuit comprises a transformer, the secondary winding of which is adjustable in number of turns, or
The current regulating circuit comprises a voltage dividing circuit or a shunt circuit, and at least one shunt branch of the voltage dividing circuit or the shunt circuit comprises a variable resistor.
4. The stoma protection device of claim 1, further comprising a signal acquisition assembly comprising at least one pressure sensor disposed on a side of the first fixation assembly facing the tubular tissue and/or a side of the second fixation assembly facing the protective sheath.
5. The anastomotic stoma protection device according to claim 4, further comprising a signal processing component for determining a driving current value according to a preset driving current variation period and/or according to detection data of the pressure sensor;
the signal processing component is further configured to send a drive signal including the drive current value to the electromagnetic drive component, the electromagnetic drive component being configured to control the output current in accordance with the drive current value.
6. The anastomotic stoma protection device according to claim 5, wherein the electromagnetic driving assembly comprises a plurality of electromagnetic driving modules, the electromagnetic driving modules correspond to the pressure sensors, the signal processing assembly determines driving current values of the corresponding electromagnetic driving modules according to detection data of the pressure sensors, and sends driving signals comprising the driving current values to the corresponding electromagnetic driving modules.
7. The anastomotic stoma protection device according to claim 6, wherein the signal processing component is further configured to compare detection data of the pressure sensor with a preset reference value, and determine whether to alarm according to the comparison result; or (b)
The signal processing component is also used for comparing the detection data of the pressure sensors and judging whether to alarm according to the comparison result; or (b)
The signal processing component is further used for comparing the detection data of the pressure sensors with a preset reference value or comparing the detection data of a plurality of pressure sensors, judging whether to generate a driving current value according to the comparison result and sending a driving signal comprising the driving current value to the electromagnetic driving module.
8. The stoma protection device of claim 5, further comprising a display module for displaying detection data of the pressure sensor and/or an output current value of the electromagnetic drive assembly.
9. The stoma protection device of claim 5, wherein data is transmitted between the signal processing assembly and the pressure sensor and the electromagnetic drive assembly via a signal line or via wireless communication, respectively.
10. The stoma protection device of claim 1, wherein the electromagnetic generating component comprises an electromagnet.
11. The anastomotic stoma protection device according to claim 2, wherein the plurality of electromagnetic generating members are arranged at intervals, and the power supply wire bundle surrounds the outer wall of the tubular tissue and is electrically connected with the electromagnetic generating members.
12. The anastomosis protection device of claim 11, wherein the power supply wire bundle comprises:
a plurality of harness carrying portions surrounding an outside of the electromagnetic generating member;
a plurality of harness connecting portions connected between two adjacent harness carrying portions, the harness carrying portions and the harness connecting portions being combined to form a ring-like structure surrounding an outer wall of the tubular tissue;
And one end of the extension part is connected with the wire harness connecting part, and the other end of the extension part is connected with the current regulating circuit.
13. The anastomotic stoma protection device according to claim 12, wherein a first mounting groove in a circumferential direction is provided on a side surface of the electromagnetic generating member, and a harness carrying portion of the power supply harness is fitted in the first mounting groove; or alternatively, the first and second heat exchangers may be,
The inner side surface of the wire harness bearing part of the power supply wire harness is provided with a first mounting groove along the circumferential direction, and the electromagnetic generating component is embedded in the first mounting groove.
14. The anastomosis protection device of claim 12, wherein the power supply harness is an elastic harness.
15. The anastomosis protection device of claim 12, wherein the first securing assembly further comprises a first connector surrounding an outer wall of the tubular tissue, the first connector comprising a first carrier portion carrying the electromagnetic generating component and a first connector connected between adjacent two of the first carrier portions, the first carrier portion surrounding an exterior of the harness carrier portion.
16. The anastomosis protection device of claim 11, wherein the power cord bundle comprises a first connection structure, the power cord bundle being connectable at the first connection structure to encircle an outer wall of the tubular tissue or being disconnected at the first connection structure to disengage from the outer wall of the tubular tissue.
17. The stoma protection device of claim 1, wherein the first fixation assembly further comprises a first connector surrounding an outer wall of the tubular tissue, the first connector being coupled to the electromagnetic generating component;
The second fixing assembly further comprises a second connecting piece for bearing the inner fixing block, the second connecting piece is located on the inner surface of the protective sleeve, and the inner fixing block is a magnetic piece or a structural piece which can be attracted magnetically.
18. The stoma protection device of claim 15 or 17, wherein the first connector includes a second connection structure at which the first connector is connectable around the outer wall of the tubular tissue or is disconnected from the outer wall of the tubular tissue at the second connection structure.
19. The stoma protection device of claim 17, wherein at least a portion of the first connector, the second connector, and/or the internal fixation block is comprised of a bioabsorbable material.
20. The stoma protection device of claim 1, wherein the first securing assembly further comprises a first connector carrying the electromagnetic generating component; the second securing assembly further includes a second connector carrying the inner securing block;
a first mounting groove is formed in at least part of the circumference of the electromagnetic generating component, the inner circumference of the first connecting piece is embedded with the first mounting groove, or a first mounting groove is formed in at least part of the inner circumference of the first connecting piece, and the electromagnetic generating component is embedded with the first mounting groove;
The circumference of inside fixed block is equipped with the second mounting groove at least partially, the inner periphery of second connecting piece with the gomphosis of second mounting groove, perhaps the inner periphery of second connecting piece is equipped with the second mounting groove at least partially, inside fixed block with the gomphosis of second mounting groove.
CN202011311144.0A 2020-11-20 2020-11-20 Anastomotic stoma protection device Active CN114515176B (en)

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Application Number Priority Date Filing Date Title
CN202011311144.0A CN114515176B (en) 2020-11-20 2020-11-20 Anastomotic stoma protection device
KR1020237020778A KR20230110568A (en) 2020-11-20 2021-11-19 anastomosis protector
AU2021382833A AU2021382833A1 (en) 2020-11-20 2021-11-19 Anastomotic stoma protection device
JP2023530515A JP2023550455A (en) 2020-11-20 2021-11-19 Anastomotic mouth protection device
EP21894001.3A EP4248884A4 (en) 2020-11-20 2021-11-19 Anastomotic stoma protection device
CA3202605A CA3202605A1 (en) 2020-11-20 2021-11-19 Anastomosis protection device
US18/253,314 US20240024152A1 (en) 2020-11-20 2021-11-19 Anastomosis protection device
PCT/CN2021/131647 WO2022105854A1 (en) 2020-11-20 2021-11-19 Anastomotic stoma protection device

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