WO2022194012A1 - Tube endotrachéal de neurosurveillance et son procédé de fabrication - Google Patents

Tube endotrachéal de neurosurveillance et son procédé de fabrication Download PDF

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Publication number
WO2022194012A1
WO2022194012A1 PCT/CN2022/080066 CN2022080066W WO2022194012A1 WO 2022194012 A1 WO2022194012 A1 WO 2022194012A1 CN 2022080066 W CN2022080066 W CN 2022080066W WO 2022194012 A1 WO2022194012 A1 WO 2022194012A1
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WIPO (PCT)
Prior art keywords
electrode
spring
distal
proximal
monitoring
Prior art date
Application number
PCT/CN2022/080066
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English (en)
Chinese (zh)
Inventor
朱世杰
Original Assignee
北京术客高鑫科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202110274634.6A external-priority patent/CN112891699A/zh
Priority claimed from CN202110275582.4A external-priority patent/CN112891700A/zh
Application filed by 北京术客高鑫科技有限公司 filed Critical 北京术客高鑫科技有限公司
Publication of WO2022194012A1 publication Critical patent/WO2022194012A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0418—Special features for tracheal tubes not otherwise provided for with integrated means for changing the degree of curvature, e.g. for easy intubation

Definitions

  • the invention relates to the technical field of medical devices, in particular to a nerve monitoring tracheal intubation and a manufacturing method thereof.
  • Nerve monitoring endotracheal intubation is a product used in the prevention and management of airway patency surgery, which can provide an unobstructed patient ventilation airway, and the product is also used to connect with a suitable nerve monitor, which can be used as an intraoperative monitoring of the patient.
  • a suitable nerve monitor which can be used as an intraoperative monitoring of the patient.
  • Tracheal intubation is a key medical device in surgical operations such as thyroidectomy. It directly acts on the patient's body and plays a decisive role in the surgical effect.
  • Many types of tracheal intubation have been developed around the world, but in clinical applications, most of them cannot monitor the nerves in real time and continuously during surgical resection. Often, monitoring and surgical operations cannot be performed at the same time, resulting in a delay in the discovery of neurological damage.
  • the continuous monitoring mode can detect nerve damage in time, but it requires special additional operations and equipment, and it is easy to cause inaccurate displacement of the monitoring point, resulting in misjudgment, and excessive electrical stimulation of the vocal cord nerve is prone to other corresponding adverse reactions. Even if someone has designed a nerve monitoring tracheal intubation, the electrode is made of stainless steel wire electrode, and the contact with the nerve is not good.
  • the nerve monitoring endotracheal intubation consists of a tube body, an inflatable cuff, a tube, a contact electrode and a monitoring wire.
  • the tube body is the main structure
  • the inflatable cuff is arranged in the lower section of the tube body and can be inflated through the pipeline to inflate the inflatable cuff to achieve the positioning of the intubation, while the contact electrode is exposed on the lower section of the tube body, and the monitoring wire is used for Connect the contact electrode to the above-mentioned nerve monitor and form an electrode circuit.
  • an EMG signal will be generated.
  • the contact electrode will transmit the EMG signal to the EMG display screen through the interface box for amplification, and then Record EMG and alarm.
  • the existing nerve monitoring endotracheal intubation has the following shortcomings: one of the tube body is obviously hardened, and the patient obviously feels uncomfortable; the other is the exposed steel wire is used as EMG signal monitoring, and the end of the steel wire is punctured when the endotracheal intubation is bent.
  • the first object of the present invention is to provide a nerve monitoring endotracheal intubation, which is easy to operate, has good safety, and is not easy to damage patient tissue.
  • the second object of the present invention is to provide a method for making an endotracheal tube for nerve monitoring that is convenient to make.
  • the present invention provides a nerve monitoring endotracheal intubation, wherein at least one electrical conductor is assembled in the pipe wall of the pipe body of the endotracheal intubation, and the electrical conductor can be stretched and compressed together with the pipe body after assembly.
  • a tracheal intubation structure that is bent without being damaged, wherein a part of the electrical conductor is exposed outside the tube as a monitoring electrode to collect EMG signals, and the electrical conductor is connected to a monitoring wire for transmitting EMG signals for the monitoring wire.
  • an electrode wire connection area, a first interval area, an electrode area, a second interval area, and a distal end area are sequentially arranged on the pipe wall of the pipe body along the length direction of the pipe body.
  • the same number of electrode holes as the conductors are opened along the length of the pipe body for partially burying the corresponding conductors, and both ends of the electrode holes extend to the electrode line connection area and the far end along the length direction of the pipe body respectively. end area.
  • a first notch is opened at the electrode hole at the electrode wire connection area
  • a second notch is opened at the electrode hole at the electrode area
  • a third notch is opened at the electrode hole at the distal end area.
  • the conductor is a spring
  • a fixing pin is sleeved on the inner side of the spring, the proximal end of the fixing pin is located in the electrode hole in the first interval area, and the distal end of the fixing pin is located in the electrode hole in the distal area.
  • the fixing pin is bonded to the electrode hole.
  • the electrical conductor includes an electrode tension spring, and the proximal end and the distal end of the electrode tension spring are respectively stretched to form a proximal tension spring and a distal tension spring.
  • One end of the tension spring away from the electrode tension spring is a tension end ball, wherein a part of the electrode tension spring is installed in the second gap, and the two tension end balls are respectively installed in the first gap and the third gap.
  • the fixing pin is sleeved on the inner side of the electrode tension spring and the proximal end of the fixing pin is The fixing pin extends into the electrode hole located in the first spacing region and the distal end of the fixing pin extends into the electrode hole located in the distal region through the electrode hole located in the second spacing region.
  • the outer diameter of the proximal extension spring and the distal extension spring are both smaller than the inner diameter of the electrode hole, and the pitches of the proximal extension spring and the distal extension spring are both larger than the pitch of the electrode extension spring.
  • the conductor includes an electrode spring, and both ends of the electrode spring are respectively welded with a proximal spring and a distal spring, and the proximal spring and the distal spring are both end balls at one end away from the electrode spring, wherein the A part of the electrode spring is installed in the second gap, the two end balls are installed in the first gap and the third gap respectively, the proximal end spring is connected with the monitoring wire, and the two end balls and the electrode spring are both connected to the tube body Adhesion, the fixing pin is sleeved on the inner side of the electrode spring and the proximal end of the fixing pin extends into the electrode hole located in the first interval area and the distal end of the fixing pin extends to the distal area through the electrode hole located in the second interval area inside the electrode hole.
  • the outer diameters of the proximal spring and the distal spring are both smaller than the inner diameter of the electrode hole.
  • a first opening is opened in the electrode hole located in the electrode area
  • a second opening is opened in the electrode hole located in the electrode wire connection area
  • the monitoring wire is connected to the proximal end of the conductor through the second opening
  • the conductive wire is connected to the proximal end of the conductor.
  • a portion of the distal end of the body is exposed outside the tube through the first opening.
  • the conductive body includes a conductive spring and a conductive plastic body, the conductive spring is completely embedded in the electrode hole, the monitoring wire is connected to the proximal end of the conductive spring through the second opening, and the conductive plastic body partially passes through the first opening.
  • the conductive plastic body is buried in the electrode hole located in the electrode area in contact with the conductive spring, and the conductive plastic body is exposed outside the tube on the side away from the conductive spring as a monitoring electrode to collect EMG signals.
  • a first colloid formed by solidification of glue and capable of blocking the electrode hole is provided in the electrode hole located in the first interval area near the end of the electrode area, and the electrode hole located in the second interval area is close to the electrode.
  • One end of the area is provided with a second colloid formed by the solidification of glue that can block the electrode hole, the first colloid and the second colloid are respectively bonded to both ends of the conductive plastic body, and the first colloid and the second colloid are both bonded to the pipe body. catch.
  • the shape of the end face of the conductive plastic body is a T-shape, including an integrally formed rib and an edge, wherein the rib is embedded in the electrode hole through the first opening to contact and cooperate with the conductive spring, and the two ends of the rib are respectively Bonded with the first colloid and the second colloid, the edge is exposed outside the tube, and the edge is fixedly connected with the outer wall of the tube on the side close to the convex rib.
  • the electrical conductor includes an EMG signal transmission film and an EMG signal transmission spring
  • the EMG signal transmission film is arranged on the outer wall of the tube body at the electrode area as a monitoring electrode to collect EMG signals
  • the EMG signal transmission spring is along the line.
  • the length direction of the tube body is arranged in the electrode hole to transmit the EMG signal for the monitoring wire.
  • the tracheal intubation structure can be freely bent, stretched, and compressed without being destroyed.
  • gaps are provided at both ends of the electrode hole, at least one through hole is opened at the electrode hole at the electrode area, the EMG signal transmission film covers the through hole, and the EMG signal transmission film passes through a solidification.
  • the rear silver paste is connected with the EMG signal transmission spring through the through hole.
  • a fixing ring covering the connection between the pipeline and the monitoring wire is sleeved on the tube body at the electrode wire connection area, and the fixing ring is bonded to the tube body.
  • the present invention also provides a method for making a nerve monitoring endotracheal tube, wherein at least one electrical conductor is assembled in the tube wall of the tube body of the endotracheal tube, and the conductive body can be stretched together with the tube body after assembly.
  • a tracheal intubation structure that is compressed and bent without being damaged, wherein a part of the electrical conductor is exposed outside the tube as a monitoring electrode to collect EMG signals, and the electrical conductor is connected to a monitoring wire for transmitting EMG signals for the monitoring wire.
  • the electrical conductor is a spring
  • the shape of the end face of the spring is a circle or an ellipse or a T-shape
  • the assembly process of the spring being assembled in the tube wall of the tube body is as follows:
  • the tube wall of the tube body along the length direction of the tube body, there are the same number of electrode holes as the number of springs for partially burying the corresponding springs, and electrodes are sequentially provided on the tube wall of the tube body along the length direction of the electrode holes.
  • the wire connection area, the first spacer area, the electrode area, the second spacer area, and the distal end area, the outer sidewall of the electrode hole at the electrode line connection area is removed to form a first gap, and the outer sidewall of the electrode hole at the electrode area is removed forming a second gap, and removing the outer sidewall of the electrode hole at the distal region to form a third gap;
  • the spring is inserted into the electrode hole through the second notch, and the two ends of the spring are stretched to the electrode wire connection area and the distal area respectively and fixed, and a part of the spring located at the second notch is exposed outside the tube as a monitoring electrode to collect EMG signals , and, the spring is connected with the monitoring wire at the first notch, in addition, a fixing pin is inserted into the electrode hole from the second notch and the fixing pin is passed through the inner side of the spring, and the two ends of the fixing pin are respectively fixed on the first at the interval region and at the distal region.
  • the spring installed at the position of the second gap is used as an electrode tension spring; wherein, the electrode tension spring is first embedded in the electrode hole through the second gap, and then the proximal end of the electrode tension spring is stretched to The end passes through the first interval area and then extends into the electrode hole located in the electrode wire connection area to form a proximal extension spring and then fix it at the electrode wire connection area, and the distal end of the electrode extension spring is pulled Extend to the end through the second interval area and then extend into the electrode hole located in the distal area to form a distal extension spring and then fix it at the distal area, the spring passes through the proximal extension spring at the first gap Connect to monitoring lead.
  • the step of fixing the proximal extension spring at the electrode wire connection area is as follows: destroying the redundant proximal extension spring by means of laser fusing, and in the fusing process, in the process of fusing the proximal extension spring One of the tensile end balls is naturally formed at the fuse point, and then the proximal tensile spring is fixed at the connection area of the electrode wire.
  • the step of fixing the distal extension spring at the distal region is as follows: destroying the redundant distal extension spring by means of laser fusing, and naturally at the fusing point of the distal extension spring during the fusing process. Another extension end ball is formed and the distal extension spring is secured at the distal region.
  • one end of the proximal extension spring away from the electrode extension spring is connected to the monitoring wire, and the connection point and the extension end ball connected to the proximal extension spring are embedded in the electrode hole located under the first gap, After injecting glue from the first gap to fix the connection point and the stretch end ball, the glue fills the entire first gap;
  • glue is also injected from the second notch to fix the electrode tension spring and the fixing pin.
  • the spring installed in the second notch position is used as the electrode spring, and the two ends of the electrode spring are respectively welded with the proximal spring and the distal spring; the welded electrode spring, the proximal spring and the distal spring are embedded through the second notch.
  • the proximal end of the proximal spring extends through the first interval area into the electrode hole located in the electrode wire connection area and is fixed at the electrode wire connection area, and the distal end of the distal spring passes through
  • the second spacer area extends into the electrode hole located at the distal end area and is fixed at the distal end area, and the spring is connected to the monitoring wire through the proximal end spring at the first gap.
  • the step of fixing the proximal spring at the electrode wire connection area is as follows: destroying the redundant proximal spring by means of laser fusing, and naturally forming the proximal spring at the fusing point of the proximal spring during the fusing process. An end ball, and then fix the proximal spring at the connection area of the electrode wire;
  • the step of fixing the distal spring at the distal region is: destroying the redundant distal spring by means of laser fusing, and forming another end ball naturally at the fusing point of the distal spring during the fusing process, The distal spring is then secured at the distal region.
  • the end of the proximal spring away from the electrode spring is connected to the monitoring wire, the connection point and the end ball connected to the proximal spring are embedded in the electrode hole below the first gap, and glue is injected from the first gap to fix the connection. After the point and the end ball, the glue fills the entire first gap;
  • the conductive body includes a conductive spring and a conductive plastic body.
  • the same number of electrode holes as the conductive springs are opened along the length direction of the tube body for burying the corresponding conductive springs, and electrodes are arranged on the tube wall of the tube body in sequence along the length direction of the electrode holes
  • the wire connection area, the first spacer area, the electrode area, the second spacer area, and the distal end area, the outer sidewall of the electrode hole at the electrode line connection area is removed to form a second opening, and the outer sidewall of the electrode hole at the electrode area is removed
  • a first opening is formed, the conductive spring is inserted into the electrode hole through the first opening, and the two ends of the conductive spring are respectively located in the electrode wire connection area and the electrode area, and the conductive spring is connected to the monitoring wire at the second opening and injected from the second opening.
  • the glue fills the entire second opening.
  • Glue is injected into the electrode hole located in the first spacer area near the end of the electrode area and the glue is solidified to form a first colloid that blocks the electrode hole
  • glue is injected into the electrode hole located in the second spacer area near the end of the electrode area and the glue is solidified
  • a second colloid that blocks the electrode hole is formed, and a conductive plastic body is formed by injection molding in the cavity enclosed by the first colloid, the second colloid, the electrode hole and the first opening.
  • the lower side of the conductive plastic body is connected to the conductive spring located at the electrode area. welded and the upper side of the conductive plastic body protrudes from the outer wall of the pipe body.
  • a conductive plastic body with a T-shaped end face is prefabricated by an injection molding process, and the prefabricated conductive plastic body includes an integrally formed rib and an edge; wherein, the rib is pressed into the electrode hole from the first opening to abut against the conductive spring , the side of the edge close to the convex rib is fixed on the outer wall of the pipe by means of bonding or welding.
  • the electrical conductor includes an EMG signal transmission spring and an EMG signal transmission film.
  • the same number of electrode holes as the EMG signal transmission springs are opened along the length direction of the pipe body for burying the corresponding EMG signal transmission springs, and along the length direction of the electrode holes on the pipe wall of the pipe body
  • the electrode wire connection area, the first interval area, the electrode area, the second interval area, and the distal area are arranged in sequence.
  • the electrode holes are located in the electrode wire connection area and the outer sidewall of the distal area is removed to form a gap, and the EMG signal is transmitted.
  • the spring is installed into the electrode hole through one of the notches, and the EMG signal transmission spring is connected to the monitoring wire through the notch at the connection area of the electrode wire. Glue is injected from the two notches to fix the EMG signal transmission spring and the glue fills the two notches.
  • the assembly process of the EMG signal transmission film being assembled on the outer wall of the tube body is as follows:
  • the outer sidewall of the distal end of the electrode hole is removed to form at least one through hole, a silver paste in a liquid state is poured into the electrode hole from the through hole to be fused with the EMG signal transmission spring, and part of the silver paste diffuses from the top of the through hole.
  • a silver paste in a liquid state is poured into the electrode hole from the through hole to be fused with the EMG signal transmission spring, and part of the silver paste diffuses from the top of the through hole.
  • On the outer wall of the tube spread the part of the silver paste and bond the EMG signal transmission film to the outer wall of the tube through the part of the silver paste.
  • the EMG signal transmission spring is fixedly connected to the EMG signal transmission film.
  • a fixing ring is sleeved on the outside of the pipe body at the electrode wire connection area, the fixing ring covers the electrode wire connection area, and glue is injected into the covering area to bond and fill the gap.
  • the nerve monitoring endotracheal cannula of the present invention is assembled by assembling at least one electrical conductor on the tube body, and the electrical conductor can form a stretched, compressed, and bent trachea together with the tube body after assembly without being damaged.
  • the nerve monitoring tracheal intubation of the present invention has good safety, is not easy to damage the patient's tissue, and is easy to operate, and conducts electrical conductors during surgery.
  • a part of the exposed electrode is used as a monitoring electrode to collect EMG signals and transmit them to an external monitor for display, so that monitoring and surgical operations can be performed at the same time, reducing surgical risks.
  • the electrical conductor in the tube wall of the tube body, can form the tracheal intubation structure that is stretched, compressed, and bent without being damaged together with the tube body after assembly, so , the method of the present invention is convenient to manufacture.
  • Fig. 1 is the overall structure schematic diagram of the present invention
  • Fig. 2 is the schematic diagram of the internal structure of the present invention.
  • Fig. 3 is the partial enlarged schematic diagram of A part of the present invention.
  • Fig. 4 is the sectional view of the a-a direction of the present invention.
  • Fig. 5 is the partial enlarged schematic diagram of B part of the present invention.
  • Fig. 6 is the sectional view of the b-b direction of the present invention.
  • Fig. 7 is the partial enlarged schematic diagram of E part of the present invention.
  • Fig. 8 is the partial enlarged schematic diagram of D part of the present invention.
  • Fig. 9 is the partial enlarged schematic diagram of F part of the present invention.
  • Fig. 10 is the partial enlarged schematic diagram of G part of the present invention.
  • Fig. 11 is the partial enlarged schematic diagram of H part of the present invention.
  • Figure 12 is a schematic front view of the pipe body of the present invention.
  • Figure 13 is a schematic top view of the pipe body of the present invention.
  • Fig. 14 is the sectional view of the c-c direction of the present invention.
  • Figure 15 is a cross-sectional view in the d-d direction of the present invention.
  • Fig. 16 is the sectional view of the e-e direction of the present invention.
  • Fig. 17 is the sectional view of the f-f direction of the present invention.
  • Figure 18 is a schematic front view of the spring of the present invention.
  • 19 is one of the schematic front views of the spring when the spring of the present invention is loaded into the tube body;
  • 21 is an enlarged schematic diagram of the right side view of the circular spring of the present invention.
  • FIG. 23 is a schematic cross-sectional view of the T-shaped spring of the present invention loaded into the electrode hole located in the electrode region;
  • Figure 24 is the second schematic front view of the spring when the spring of the present invention is loaded into the tube body
  • Fig. 26 is the partial enlarged schematic diagram of M part of the present invention.
  • Fig. 27 is the sectional view of the j-j direction of the present invention.
  • Fig. 28 is the partial enlarged schematic diagram of N part of the present invention.
  • Figure 29 is a cross-sectional view in the k-k direction of the present invention.
  • Fig. 30 is the partial enlarged schematic diagram of O part of the present invention.
  • Fig. 31 is the partial enlarged schematic diagram of P part of the present invention.
  • Fig. 32 is the partial enlarged schematic diagram of the Q part of the present invention.
  • FIG. 33 is a schematic front view of a pipe body according to Embodiment 3 of the present invention.
  • 35 is a schematic front view of the conductive plastic of the present invention.
  • FIG. 36 is a schematic end view of the conductive plastic of the present invention.
  • Embodiment 4 of the present invention is a schematic diagram of the internal structure of Embodiment 4 of the present invention.
  • Figure 38 is a partial enlarged schematic view of part C of the present invention.
  • Fig. 39 is the sectional view of the g-g direction of the present invention.
  • Figure 40 is a partial enlarged schematic view of part I of the present invention.
  • Fig. 41 is the sectional view of the h-h direction of the present invention.
  • Figure 42 is a partial enlarged schematic view of part J of the present invention.
  • Fig. 43 is the partial enlarged schematic diagram of K part of the present invention.
  • Fig. 44 is the partial enlarged schematic diagram of L part of the present invention.
  • Fig. 46 is a cross-sectional view in the i-i direction of the present invention.
  • a nerve monitoring endotracheal intubation provided in this embodiment, at least one electrical conductor 06 is assembled in the tube wall of the tube body 05 of the endotracheal intubation, and the electrical conductor 06 can be assembled after the assembly.
  • a tracheal intubation structure that is stretched, compressed, and bent without being damaged is formed, wherein a part of the conductor 06 is exposed outside the tube body 05 as a monitoring electrode to collect EMG signals, and the conductor 06 is connected
  • the monitoring wire 01 is used to transmit the EMG signal for the monitoring wire 01 .
  • the trachea 05 is a tube body with a reinforced spring steel wire in the inner cavity, and the number of the conductors 06 is 4, because the four conductors 06 are similar in product structure, only the tube body 05
  • the position on the wall of the tube is different, that is, the subsequent text description only describes the mechanism, function and assembly relationship of one of the conductors 06, and this conductor 06 also represents the other conductors 06; according to Conductor 06 can be increased or decreased as clinical needs dictate.
  • an electrode wire connection area 106 , a first interval area 107 , an electrode area 108 , a second interval area 109 , and a distal end area 110 are sequentially provided on the pipe wall of the pipe body 05 along the length direction of the pipe body 05 .
  • the same number of electrode holes 112 as the conductors 06 for partially burying the corresponding conductors 06 are opened, and both ends of the electrode holes 112 It extends to the electrode wire connection area 106 and the distal end area 110 along the length direction of the tube body 05 , respectively.
  • the electrode hole 112 is located at the electrode wire connection area 106 with a first notch, the electrode hole 112 is located at the electrode area 108 with a second notch, and the electrode hole 112 is located at the distal end
  • the area 110 is provided with a third gap, and the monitoring wire 01 is connected to the proximal end of the conductor 06 through the first gap.
  • the conductor 06 is a spring, and a fixing pin 102 is sleeved inside the spring.
  • the above-mentioned fixing pin 102 is bonded to the electrode hole 112 .
  • the spring can be assembled together with the tube body 05 to form a tracheal intubation structure that is stretched, compressed, and bent without being damaged.
  • the conductor 06 includes an electrode tension spring 0618, and the proximal end and the distal end of the electrode tension spring 0618 are respectively stretched to form a proximal tension spring 0603 and a distal tension spring 0604.
  • the end extension spring 0603 and the distal extension spring 0604 are both extension end balls 0601 at one end away from the electrode extension spring 0618, wherein a part of the electrode extension spring 0618 is installed in the second gap, and the two extension springs
  • the end balls 0601 are installed in the first gap and the third gap respectively
  • the proximal tension spring 0603 is connected to the monitoring wire 01
  • the two tension end balls 0601 and the electrode tension spring 0618 are both bonded to the tube body 05
  • the fixing pin 102 is sheathed inside the electrode tension spring 0618 and the proximal end of the fixing pin 102 extends into the electrode hole 112 located in the first interval area 107 and the distal end of the fixing pin 102 passes through the electrode located in the second interval area 109
  • the hole 112
  • the outer diameters of the proximal extension spring 0603 and the distal extension spring 0604 are both smaller than the inner diameter of the electrode hole 112
  • the pitches of the proximal extension spring 0603 and the distal extension spring 0604 are both larger than that of the electrode hole 112 .
  • the shape of the end surface of the conductor 06 is either a circle, an ellipse, or a T-shape.
  • the end faces of the proximal extension spring 0603, the distal extension spring 0604, and the electrode extension spring 0618 may all be circular, oval, or T-shaped, or the electrode tension springs may be all T-shaped.
  • the end face shape of the extension spring 0618 is T-shaped, and the end face shapes of the proximal end extension spring 0603 and the distal end extension spring 0604 are all circular or oval or even a combination of other end face shapes; wherein, the end face shape is T-shaped.
  • the conductor 06 includes a longitudinal protruding head and two lateral protruding heads, the two lateral protruding heads are collinear and both the lateral protruding heads are perpendicular to the longitudinal protruding heads; when the electrode tension spring 0618 is partially embedded in the electrode hole 112 , the longitudinal protruding head of the electrode tension spring 0618 located in the electrode area 108 is buried in the electrode hole 112 located in the electrode area 108 and fixed with glue; , the bottoms of the two lateral protruding heads are attached to the outer wall of the tube body 05 and are firmly bonded by glue, and the tops are used for EMG signal monitoring.
  • a fixing ring 04 covering the connection between the pipeline 02 and the monitoring wire 01 is sleeved on the pipe body 05 at the electrode wire connection area 106, and the fixing ring 04 is bonded to the pipe body 05.
  • the exposed pipeline 02 and the monitoring wire 01 are clamped to prevent them from being pulled at will.
  • the distal end of the tube body 05 extends into the human body from the trachea, and its outer wall is in contact with the cavity wall of the human body.
  • a part of 0618 exposed in the electrode hole 112 is in contact with the human body cavity wall and monitors the EMG signal.
  • the monitored EMG signal is sequentially transmitted to the external monitor through the electrode tension spring 0618, the proximal tension spring 0603, and the monitoring wire 01, so that the Monitoring and surgical operations can be performed simultaneously, reducing surgical risk.
  • the conductor 06 includes an electrode spring 0619 , a proximal spring 0607 , and a distal spring 0608 , and the proximal spring 0607 and the distal spring 0608
  • the connection method between 0608 and electrode spring 0619 adopts welding method, the specific description is as follows:
  • the conductor 06 includes an electrode spring 0619, and two ends of the electrode spring 0619 are respectively welded with a proximal spring 0607 and a distal spring 0608, and the proximal spring 0607 and the distal spring 0608 are far away from the electrode spring
  • One end of the 0619 is an end ball 0605, wherein a part of the electrode spring 0619 is installed in the second gap, the two end balls 0605 are installed in the first gap and the third gap respectively, and the proximal spring 0607 is connected to the monitoring
  • the lead wire 01 is connected, the two end balls 0605 and the electrode spring 0619 are bonded to the tube body 05, the fixing pin 102 is sleeved inside the electrode spring 0619 and the proximal end of the fixing pin 102 extends to the electrode located in the first interval area 107 Inside the hole 112 and the distal end of the fixing pin 102 extends through the electrode hole 112 located in the second spacing region 109 into the electrode hole 112 located in the distal region 110 .
  • the outer diameters of the proximal spring 0607 and the distal spring 0608 are both smaller than the inner diameter of the electrode hole 112, so that the proximal spring 0607 can pass through the first interval region 107 and enter the electrode wire connection region 106, and the distal end The spring 0608 can pass through the second spacer region 109 into the distal region 110 .
  • the conductor 06 includes a conductive spring 301 and a conductive plastic body 302 , and the specific description is as follows:
  • a first opening 306 is opened in the electrode hole 112 in the electrode region 108
  • a second opening 307 is opened in the electrode hole 112 in the electrode wire connection region 106
  • the monitoring wire 01 passes through the second opening 307 It is connected to the proximal end of the conductor 06 for transmitting EMG signals; a part of the distal end of the conductor 06 is exposed to the outside of the tube body 05 through the first opening 306 , and is used as a monitoring electrode to collect EMG signals.
  • the conductive body 06 includes a conductive spring 301 and a conductive plastic body 302.
  • the conductive spring 301 is completely embedded in the electrode hole 112, and the monitoring wire 01 is connected to the proximal end of the conductive spring 301 through the second opening 307.
  • the conductive plastic body 302 is partially embedded in the electrode hole 112 located in the electrode region 108 through the first opening 306 to be in contact with the conductive spring 301, and the conductive plastic body 302 is exposed on the side away from the conductive spring 301 outside the tube body 05 as a monitoring electrode Acquire EMG signals.
  • the bottom of the conductive plastic body 302 is abutted against the conductive spring 301 or the conductive plastic body 302 is welded with the conductive spring 301 through an injection molding process, which can prevent the distal end of the conductive spring 301 from penetrating the tube wall of the tube body 05 from the first opening 306, and simultaneously form The electrical connection is thus able to transmit the EMG signal.
  • a first colloid 303 formed by solidification of glue and capable of blocking the electrode hole 112 is provided at one end of the electrode hole 112 located in the first interval region 107 near the electrode region 108 .
  • the first colloid 303 and the second colloid 304 are both bonded to the tube body 05 .
  • the first colloid 303 and the second colloid 304 respectively block the two ends of the first opening 306 to enclose a cavity for injection molding the conductive plastic body 302 to prevent the sizing material from flowing along the electrode hole 112 during the injection molding process.
  • the shape of the end surface of the conductive plastic body 302 is a T-shape, and includes an integrally formed rib 308 and an edge 309 , wherein the rib 308 is embedded in the electrode hole 112 through the first opening 306 and is connected to the conductive spring 301
  • the two ends of the rib 308 are in contact with the first colloid 303 and the second colloid 304 respectively.
  • the edge 309 is exposed outside the tube body 05 and the edge 309 close to the rib 308 is fixedly connected to the outer wall of the tube body 05 , can be fixed by bonding or welding.
  • the conductor 06 includes an EMG signal transmission film 201 and an EMG signal transmission spring 202 , which are specifically described as follows:
  • the conductor 06 includes an EMG signal transmission film 201 and an EMG signal transmission spring 202.
  • the EMG signal transmission film 201 is disposed on the outer wall of the tube body 05 at the electrode area 108 as a monitoring electrode to collect EMG signals
  • the EMG signal transmission spring 202 is arranged in the electrode hole 112 along the length direction of the tube body 05 to transmit the EMG signal for the monitoring wire 01.
  • the EMG signal transmission film 201 is a conductive, extensible and bendable film and the EMG
  • the signal transmission membrane 201 is connected with the EMG signal transmission spring 202 to form an endotracheal intubation structure that can be arbitrarily bent, stretched, and compressed with the tube body 05 without being damaged.
  • gaps are formed at both ends of the electrode hole 112 , at least one through hole 205 is formed at the electrode hole 112 at the electrode region 108 , and the EMG signal transmission film 201 covers the through hole 205 and The EMG signal transmission film 201 is connected to the EMG signal transmission spring 202 through a solidified silver paste 203 through a through hole 205.
  • the signals collected by the EMG signal transmission film 201 are sequentially passed through the silver paste 203, the EMG signal transmission spring 202, and the monitoring wire 01. Transfer to external monitor display.
  • the silver paste 203 can also be replaced by graphene ink, carbon fiber ink, conductive glue and other materials that are conductive, viscous, and can be solidified.
  • the present embodiment is a method for manufacturing a nerve monitoring endotracheal tube according to the present invention.
  • At least one conductor 06 is assembled in the tube wall of the tube body 05 of the endotracheal tube.
  • the tracheal intubation structure that can be stretched, compressed, and bent without being damaged can be formed together with the tube body 05, wherein a part of the electrical conductor 06 is exposed outside the tube body 05 as a monitoring electrode to collect EMG signals, and conduct electricity.
  • the body 06 is connected to the monitoring wire 01 for transmitting EMG signals to the monitoring wire 01 .
  • the conductor 06 is a spring
  • the shape of the end face of the spring is a circle, an ellipse, or a T-shape
  • the assembly process of the spring assembling in the tube wall of the tube body 05 is as follows:
  • Electrode holes 112 In the tube wall of the tube body 05, along the length direction of the tube body 05, there are electrode holes 112 with the same number as the number of springs for partially burying the corresponding springs.
  • the electrode line connection area 106, the first spacer area 107, the electrode area 108, the second spacer area 109, and the distal area 110 are arranged in sequence in the direction.
  • the outer sidewall of the electrode hole 112 at the electrode line connection area 106 is removed to form a first gap.
  • the outer sidewall of the electrode hole 112 at the electrode region 108 is removed to form a second gap
  • the outer sidewall of the electrode hole 112 at the distal region 110 is removed to form a third gap;
  • the spring is inserted into the electrode hole 112 through the second gap, and the two ends of the spring are stretched to the electrode wire connection region 106 and the distal region 110 respectively and fixed, and a part of the spring located at the second gap is exposed outside the tube body 05 as
  • the monitoring electrode collects the EMG signal, and the spring is connected to the monitoring wire 01 at the first notch.
  • a fixing pin 102 is inserted into the electrode hole 112 from the second notch and the fixing pin 102 is passed through the inner side of the spring to fix the above Both ends of the pin 102 are fixed at the first spacing region 107 and the distal region 110, respectively.
  • the spring installed at the second gap is used as the electrode tension spring 0618; wherein, the electrode tension spring 0618 is first embedded in the electrode hole 112 through the second gap, and then the electrode tension spring 0618 is inserted into the electrode hole 112.
  • the proximal end is stretched until the end passes through the first spacing region 107 and then protrudes into the electrode hole 112 located in the electrode wire connection region 106 to form a proximal extension spring 0603 and then fixed at the electrode wire connection region 106
  • the distal end of the electrode tension spring 0618 is stretched until the end passes through the second spacer region 109 and then extends into the electrode hole 112 located in the distal region 110 to form the distal extension spring 0604 and then fixed at the distal end.
  • the spring is connected to the monitoring lead 01 through the proximal extension spring 0603 at the first notch.
  • the pitch of the proximal stretching spring 0603 is increased, the outer diameter of the proximal stretching spring 0603 becomes smaller, and the proximal stretching spring 0603 is smoothly stretched to the point located in the electrode wire connection area 106
  • the pitch of the distal extension spring 0604 is increased, the outer diameter of the distal extension spring 0604 is reduced, and the distal extension spring 0604 is smoothly stretched to the electrode located in the distal region 110 inside the hole 112 .
  • the step of fixing the proximal tension spring 0603 at the electrode wire connection area 106 is as follows: destroying the redundant proximal tension spring 0603 by means of laser fusing, and in the fusing process, One of the tension end balls 0601 is naturally formed at the fusing point of the end tension spring 0603 , and then the proximal end tension spring 0603 is fixed at the electrode wire connection area 106 .
  • the steps of fixing the distal extension spring 0604 at the distal region 110 are as follows: destroying the redundant distal extension spring 0604 by means of laser fusing, and in the fusing process, the distal extension spring 0604 is blown away. Another tension end ball 0601 is naturally formed at the fuse point, and then the distal tension spring 0604 is fixed at the distal region 110 .
  • connection method can be riveting or soldering or kinking of parts or other methods that can ensure a firm and smooth connection and transmit EMG monitoring.
  • the connection method of the signal; the connection point and the extension end ball 0601 connected to the proximal extension spring 0603 are embedded in the electrode hole 112 under the first gap, and glue is injected from the first gap to fix the connection point and the extension end After the ball 0601, the glue fills the entire first gap;
  • the extension end ball 0601 connected to the distal extension spring 0604 is buried in the electrode hole 112 located under the third gap, and glue is injected from the third gap to fix the extension end ball 0601, and then the glue fills the entire third gap. gap;
  • glue is injected from the second gap to fix the electrode tension spring 0618 and the fixing pin 102.
  • the distal end of the fixing pin 102 and the portion of the fixing pin 102 located in the electrode area 108 are both bonded to the tube body 05 by glue.
  • the spring installed at the second notch is used as the electrode spring 0619, and the two ends of the electrode spring 0619 are welded with the proximal spring 0607 and the distal spring 0608 respectively;
  • the end spring 0608 is embedded in the electrode hole 112 through the second notch, and the proximal end of the proximal spring 0607 extends through the first spacer region 107 into the electrode hole 112 located in the electrode line connection region 106 and is then fixed in the electrode line connection region.
  • the distal end of the distal spring 0608 extends through the second spacer region 109 into the electrode hole 112 located in the distal region 110 and is fixed at the distal region 110, and the spring passes through the proximal end at the first gap
  • the spring 0607 is connected to the monitoring wire 01.
  • the steps of fixing the proximal spring 0607 at the electrode wire connection area 106 are as follows: destroying the redundant proximal spring 0607 by means of laser fusing, and in the fusing process, the proximal spring 0607 is fused One of the end balls 0605 is naturally formed at the fuse point, and then the proximal spring 0607 is fixed at the electrode wire connection area 106;
  • the steps of fixing the distal spring 0608 at the distal region 110 are as follows: destroy the redundant distal spring 0608 by means of laser fusing, and naturally form another distal spring 0608 at the fusing point of the distal spring 0608 during the fusing process. An end ball 0605, and then a distal spring 0608 is secured at the distal region 110.
  • the end of the proximal spring 0607 away from the electrode spring 0619 is connected to the monitoring wire 01.
  • the connection method can be riveting, soldering or kinking of parts, or other connection methods that can ensure a firm and smooth connection and transmit the EMG monitoring signal.
  • the connection point and the end ball 0605 connected to the proximal spring 0607 are buried in the electrode hole 112 below the first gap, and glue is injected from the first gap to fix the connection point and the end ball 0605 and fill the entire first gap. ;
  • the end ball 0605 connected to the distal spring 0608 is buried in the electrode hole 112 located under the third gap, and glue is injected from the third gap to fix the distal ball 0605, and the glue fills the entire third gap;
  • the conductive body 06 includes a conductive spring 301 and a conductive plastic body 302 .
  • the assembly process of the conductive spring 301 in the tube wall of the tube body 05 is as follows:
  • Electrode holes 112 for burying the corresponding conductive springs 301 are provided in the pipe wall of the pipe body 05 along the length direction of the pipe body 05 along the length direction of the pipe body 05. 112 There are electrode wire connection area 106, first spacer area 107, electrode area 108, second spacer area 109, and distal area 110 in sequence in the longitudinal direction.
  • Two openings 307 the outer sidewall of the electrode hole 112 at the electrode area 108 is removed to form a first opening 306, the conductive spring 301 is inserted into the electrode hole 112 through the first opening 306, and the two ends of the conductive spring 301 are located in the electrode wire connection area 106, In the electrode area 108, after connecting the conductive spring 301 with the monitoring wire 01 at the second opening 307, inject glue from the second opening 307 to fix the proximal end of the conductive spring 301, and then the glue fills the entire second opening 307.
  • the assembly process of the conductive plastic body 302 in the tube wall of the tube body 05 is as follows:
  • Glue is injected into the electrode hole 112 located in the first spacer region 107 near the end of the electrode region 108 and the glue is solidified to form a first gel 303 that blocks the electrode hole 112 , and the electrode hole 112 located in the second spacer region 109 is close to the electrode region
  • One end of 108 is injected with glue and solidified to form a second colloid 304 that blocks the electrode hole 112
  • a conductive plastic body is formed by injection molding in the cavity surrounded by the first colloid 303 , the second colloid 304 , the electrode hole 112 and the first opening 306 302 , the lower side of the conductive plastic body 302 is welded with the conductive spring 301 located at the electrode area 108 , and the upper side of the conductive plastic body 302 protrudes from the outer wall of the tube body 05 .
  • the assembly process of the conductive plastic body 302 on the pipe wall of the pipe body 05 is as follows:
  • the conductive plastic body 302 having a T-shaped end face is prefabricated by an injection molding process, and the prefabricated conductive plastic body 302 includes an integrally formed rib 308 and an edge 309; wherein, the rib 308 is pressed into the electrode from the first opening 306
  • the inside of the hole 112 is in contact with the conductive spring 301 , and the side of the edge 309 close to the rib 308 is fixed to the outer wall of the tube body 05 by bonding or welding.
  • the conductor 06 includes an EMG signal transmission spring 202 and an EMG signal transmission film 201.
  • the assembly process of the EMG signal transmission spring 202 in the tube wall of the tube body 05 is as follows:
  • Electrode holes 112 for burying the corresponding EMG signal transmission springs 202 are opened in the tube wall of the tube body 05 along the length direction of the tube body 05 along the length direction of the tube body 05 .
  • the electrode hole 112 is provided with an electrode wire connection area 106, a first interval area 107, an electrode area 108, a second interval area 109, and a distal area 110 in sequence in the longitudinal direction.
  • the electrode hole 112 is located in the electrode wire connection area 106, the distal end area The outer sidewall of the end region 110 is removed to form a gap, the EMG signal transmission spring 202 is installed into the electrode hole 112 through one of the gaps, and the EMG signal transmission spring 202 is connected to the monitoring wire 01 through the gap located at the electrode wire connection region 106, Glue is injected from the two gaps to secure the EMG signal transmission spring 202 and the glue fills the two gaps.
  • the assembly process of the EMG signal transmission film 201 on the outer wall of the tube body 05 is as follows:
  • the outer side wall of the distal end of the electrode hole 112 is removed to form at least one through hole 205, and a silver paste 203 in a liquid state is poured into the electrode hole 112 from the through hole 205 to fuse with the EMG signal transmission spring 202, and part of the silver paste 203 diffuses out of the outer wall of the tube body 05 from the top of the through hole 205, spreads the part of the silver paste 203 and adheres the EMG signal transmission film 201 to the outer wall of the tube body 05 through this part of the silver paste 203, when the silver paste 203 solidifies, the EMG The signal transmission spring 202 is fixedly connected to the EMG signal transmission film 201 .
  • a fixing ring 04 is sleeved on the outer side of the pipe body 05 at the electrode wire connection area 106 and the fixing ring 04 covers the electrode wire connection area 106, and glue is injected into the covering to bond and fill the gap, thereby Clamp and wrap the exposed pipeline 02 and the monitoring wire 01 to prevent the connection point between the monitoring wire 01 and the spring from being pulled at will.

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

La présente invention concerne un tube endotrachéal de neurosurveillance. Au moins un corps conducteur (06) est ajusté dans une paroi de tube d'un corps de tube (05) d'un tube endotrachéal, et après avoir été ajusté, le corps conducteur (06) peut former, conjointement avec le corps de tube (05), une structure de tube endotrachéal qui ne peut pas être endommagée même si elle est étirée, comprimée ou pliée, une partie du corps conducteur (06) étant exposée à l'extérieur du corps de tube (05) en tant qu'électrode de surveillance pour acquérir un signal d'électromyogramme (EMG) et le corps conducteur (06) est connecté à un fil de surveillance (01) pour transmettre le signal d'EMG au fil de surveillance (01). Le tube endotrachéal de neurosurveillance présente les avantages d'être facile à mettre en œuvre, de bonne sécurité et de ne pas être susceptible d'endommager les tissus d'un patient.
PCT/CN2022/080066 2021-03-15 2022-03-10 Tube endotrachéal de neurosurveillance et son procédé de fabrication WO2022194012A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
CN202110274634.6 2021-03-15
CN202110274634.6A CN112891699A (zh) 2021-03-15 2021-03-15 一种神经监测气管插管的制作方法及其神经监测气管插管
CN202110275582.4A CN112891700A (zh) 2021-03-15 2021-03-15 神经监测气管插管
CN202110275582.4 2021-03-15
CN202110589917.X 2021-05-28
CN202110589917.XA CN113304369B (zh) 2021-03-15 2021-05-28 一种神经监测气管插管及其制作方法

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CN113304369B (zh) * 2021-03-15 2024-01-16 北京术客高鑫科技有限公司 一种神经监测气管插管及其制作方法

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CN200987823Y (zh) * 2006-12-14 2007-12-12 天津市塑料研究所 带电极的加强气管插管
CN105233392A (zh) * 2014-07-09 2016-01-13 山东百多安医疗器械有限公司 带有心电信号指示导管位置功能的中心静脉导管
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