Drug-induced sleep endoscope mask

Abstract

The utility model discloses a medicine induction sleep endoscope mask in the technical field of medical instruments, which comprises a DISE mask and a body position sensor, the DISE mask comprises a mask body and a breathing inlet connecting piece connected to the mask body, the breathing inlet connecting piece is provided with an anesthetic inlet connector, and the anesthetic inlet connector is connected with the body position sensor. A double-taper hole is formed in the portion, close to the lower portion of the breathing inlet connecting piece, of the cover body, the double-taper hole is in sealed connection with the outer wall of the guide pipe in a double-embedding mode, a conical inner hole is formed in the outer end of the guide pipe, the large-diameter end of the conical inner hole faces outwards, and the inner end of the guide pipe extends towards the inner side of the cover body and is suspended to form a flexible section capable of being deformed and bent. A protrusion suitable for abutting is arranged on the inner wall of the inner end of the catheter, and the inner side of the protrusion allows the bronchoscope to penetrate through and abuts against the outer wall of the bronchoscope in a sealed mode. The problems that an existing mask cannot accurately assist in implementing CPAP operation under DISE and cannot find the optimal CPAP titration position are effectively solved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a drug-induced sleep endoscopic mask. Background Art

[0002] Obstructive sleep apnea (OSA) can cause chronic intermittent hypoxemia, leading to multi-system and multi-organ damage such as hypertension, coronary heart disease, stroke, and diabetes. The prevalence of OSA is high, with about 170 million people suffering from OSA in my country. Continuous positive airway pressure (CPAP) is the first choice for adult OSA treatment, but the long-term compliance of CPAP treatment is low. Some OSA patients have poor CPAP treatment effects, but the reason is unclear.

[0003] In order to find out the reasons for the poor effect of CPAP treatment, drug induced sleep endoscopy (DISE) simulates the sleep state by giving patients anesthetic drugs, and then uses bronchoscopes to dynamically observe the upper airway obstruction of patients in the simulated sleep state. Different treatment measures correspond to different levels of obstruction, thereby guiding the individualized treatment of OSA patients. The ventilator pressure titration under DISE, that is, the process of gradually adjusting the pressure to find and determine the minimum effective treatment pressure required to maintain the upper airway patency, that is, the optimal pressure, can intuitively evaluate the therapeutic effect of CPAP. During the ventilator pressure titration process, the respiratory mask leakage is required to be controlled at 20-30L / min. However, in current clinical practice, the conventional mask is lifted to allow the endoscope to pass under the mask for DISE examination. The leakage is too large, resulting in the inability to successfully and effectively implement the ventilator pressure titration under DISE. Changes in body position can help alleviate some levels of obstruction, such as epiglottal obstruction, but the existing technology usually relies on the doctor's experience to adjust the body position to obtain a relatively good body position. There is a lack of data support, and it is impossible to find the best body position corresponding to different patients.

[0004] Currently, there is no dedicated mask specifically for DISE, which makes it impossible to accurately assist in the implementation of CPAP operations under DISE and find the best CPAP titration position. This seriously affects the implementation of CPAP operations under DISE, causing unclear causes of airway obstruction and affecting subsequent treatment outcomes. Utility Model Content

[0005] The purpose of the utility model is to provide a drug-induced sleep endoscopic mask, which effectively solves the problem that the existing mask cannot accurately assist in implementing CPAP operation under DISE and finding the best CPAP titration position.

[0006] To achieve the above-mentioned purpose, the utility model provides the following technical solutions: a drug-induced sleep endoscopic mask, which includes a DISE mask and a body position sensor, the DISE mask includes a mask body and a breathing inlet connector connected to the mask body, and an anesthetic drug access interface is provided on the breathing inlet connector.

[0007] A double conical hole is provided on the cover body below the respiratory inlet connector, and the double conical hole is sealed and connected to the outer wall of the catheter by a double interlocking manner. The outer end of the catheter has a conical inner hole and the large diameter end of the conical inner hole faces outward, and the inner end of the catheter extends toward the inner side of the cover body and is suspended in the air to form a deformable and bendable flexible section. The inner wall of the inner end of the catheter is provided with a protrusion suitable for pressing, and the inner side of the protrusion is for a bronchoscope to pass through and seal against the outer wall of the bronchoscope.

[0008] The body position sensor comprises a mask angle sensor module installed on the mask body and a body position sensor module installed on the patient's body. The mask angle sensor module and the body position sensor module are respectively connected to the computer for communication.

[0009] Furthermore, the double tapered hole includes a first tapered hole and a second tapered hole, the small diameter end of the first tapered hole is smoothly connected to the small diameter end of the second tapered hole by a first arcuate convex ring, and a first annular groove is provided on one axial side of the first arcuate convex ring; the outer wall surface of the conduit is correspondingly provided with a second annular groove and a second arcuate convex ring, and when the conduit is connected to the double tapered hole, a double interlocking sealing connection is achieved by the first arcuate convex ring being clamped into the second annular groove and the second arcuate convex ring being clamped into the first annular groove.

[0010] Further, the second annular groove is arranged adjacent to the second arc-shaped convex ring, and the second annular groove is located outside the second arc-shaped convex ring.

[0011] Furthermore, the breathing inlet connector includes a 360° rotating joint connected to the mask body, and the 360° rotating joint is detachably connected with an elbow and an air inlet connector in sequence, a silent air leakage port is arranged on the elbow, and a breathing valve is installed on the elbow.

[0012] Furthermore, the anesthetic drug introduction interface is arranged at the root of the 360° rotating joint, and the anesthetic drug introduction interface is introduced into the interior of the cover body along the radial direction of the 360° rotating joint.

[0013] Furthermore, the elbow includes a horizontal section and a vertical section which are fixed vertically as a whole, and the silent air leakage port includes a plurality of through holes distributed in an arc shape at the end of the horizontal section, and the axis of the through holes is parallel to the axis of the horizontal section.

[0014] Furthermore, the cross section of the protrusion along the axial direction of the catheter is an arc-shaped protrusion, and the middle of the arc-shaped protrusion is high and the two sides are low.

[0015] Furthermore, the outer end of the conduit is detachably connected with a sealing cover.

[0016] Furthermore, the catheter is made of silicone.

[0017] Furthermore, the mask angle sensor module can be detachably mounted on the mask body above the adjacent respiratory inlet connector, and the body position sensor module is adhered to the patient's chest.

[0018] Compared with the prior art, the beneficial effects of the utility model are:

[0019] A special breathing mask for drug-induced sleep endoscopy is designed, which is connected to the ventilator through a breathing inlet connector, and an independent anesthetic drug access interface can flexibly add anesthetic drugs according to clinical needs; a channel matching the bronchoscope is set at the front end of the mask, and the channel is sealed and connected with the catheter in a double interlocking manner through a double cone hole, and a flexible section is set at the inner end of the catheter and a seal is set at the inner end of the flexible section to abut against the endoscope wall, so that the operating space of the bronchoscope is larger, which neither affects the current clinical bronchoscope operation habits nor increases the air leakage of the mask, and can realize the downward ventilator pressure titration during DISE examination, with good results.

[0020] By installing a position sensor on the DISE mask, the angle of head rotation can be accurately assessed, which helps to accurately find the best CPAP titration position. For OSA patients with poor CPAP treatment effects, this mask can be used to develop a combined positional treatment plan. This drug-induced sleep endoscopic mask is conducive to promoting the business of ventilator pressure titration under DISE, thereby achieving endoscopic assessment of whether OSA patients are suitable for CPAP treatment, assessing the reasons for poor CPAP efficacy, and helping to develop a positional treatment plan to achieve individualized treatment for OSA patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a three-dimensional diagram of the overall structure of the DISE mask in the utility model;

[0022] Figure 2 It is an axial section view of the double-conical hole and the conduit in the utility model when they are matched;

[0023] Figure 3 This is an exploded axial section view of the double-conical hole and the conduit in the utility model;

[0024] Figure 4 (a) is a schematic diagram of the protrusion being arranged at the outer end of the catheter and sealingly abutting against the bronchoscope;

[0025] Figure 4 (b) is a schematic diagram of the protrusion being arranged at the inner end of the catheter and sealingly abutting against the bronchoscope;

[0026] Figure 5 (a) is a schematic diagram of the range of motion of the bronchoscope in the straight hole;

[0027] Figure 5 (b) is a schematic diagram of the range of motion of the bronchoscope in the single cone hole;

[0028] Figure 5 (c) is a schematic diagram of the range of motion of the bronchoscope in the double cone hole;

[0029] Figure 6 This is a schematic diagram of the patient's Cartesian rectangular coordinate system;

[0030] In the figure: 11, mask body; 12, breathing inlet connector; 121, 360° swivel joint; 122, elbow; 123, air inlet connector; 124, silent air leakage port; 125, breathing valve; 13, anesthetic drug access interface; 2, double tapered holes; 21, first tapered hole; 22, second tapered hole; 23, first arc-shaped convex ring; 24, first annular groove; 3, catheter; 31, protrusion; 32, retaining ring; 33, second annular groove; 34, second arc-shaped convex ring; 35, flexible section; 4, mask angle sensor module. DETAILED DESCRIPTION

[0031] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0032] In the embodiment of the utility model, Figure 1 As shown, the drug-induced sleep endoscopy mask includes a DISE mask and a body position sensor. The DISE mask includes a mask body 11 and a breathing inlet connector 12 connected to the mask body. The breathing inlet connector 12 is used to connect to a ventilator to assist and control breathing. A double-layer detachable silicone pad is adaptively arranged along the inner edge of the mask body 11. The outer layer is thinner to make it softer and more comfortable when in contact with the skin, and the inner layer is thicker to improve stability. Buckle installation grooves for installing buckles are integrally formed on the mask body 11 on both sides of the breathing inlet connector 12, and the mask body is fixed to the patient's face by connecting the elastic band with buckles.

[0033] The breathing inlet connector 12 includes a 360° rotating joint 121 connected to the mask body 11. The 360° rotating joint 121 is rotatably connected to the mask body wall, and a sealing ring is used to seal the rotating connection surfaces. The 360° rotating joint can increase the freedom of wearing, and the direction of the oxygen tube can be adjusted according to the actual body position of the patient.

[0034] The 360° rotating joint 121 is detachably connected with an elbow 122 and an air inlet connector 123 in sequence, and the air inlet connector 123 is detachably connected to the oxygen pipe of the ventilator. The detachable connections here are all detachable connection methods commonly used in the field of breathing masks. A silent air leakage port 124 is provided on the elbow 122, and a breathing valve 125 is installed on the elbow 122. The elbow 122 includes a horizontal section and a vertical section that are vertically fixed as a whole. The silent air leakage port 124 includes a plurality of through holes distributed in an arc shape at the end of the horizontal section, and the axis of the through hole is parallel to the axis of the horizontal section to improve the smoothness of the exhaust. At the same time, the silent air leakage port 124 adopts a multi-hole arc-shaped distribution, which can significantly reduce the noise during exhaust and improve the quiet effect.

[0035] The breathing inlet connector 12 is provided with an anesthetic drug introduction interface 13, through which the patient is given anesthetic drugs to simulate a sleeping state, and then a bronchoscope is used to dynamically observe the upper airway obstruction of the patient when the patient is in a simulated sleeping state through the catheter 3. Specifically, the anesthetic drug introduction interface 13 is provided at the root of the 360° rotating joint 121, so that the drug is closer to the patient's nasal cavity, improving the accuracy of the drug's action, and the anesthetic drug introduction interface 13 is introduced into the mask body 11 along the radial direction of the 360° rotating joint 121, so as to avoid the drug being directly injected into the patient's nasal cavity and causing discomfort.

[0036] A double-cone hole 2 is provided on the cover body 11 below the respiratory inlet connector 12. The double-cone hole 2 can increase the angle between the bronchoscope and the axial direction, further increasing the operating space and working range of the bronchoscope. Figure 5 As shown, Figure 5 In (a), when the hole type is a straight hole, the inclined straight line A is the angle range within which the bronchoscope can move; Figure 5 In (b), when the hole type is a single cone hole, the inclined straight line B is the angle range in which the bronchoscope can move, which is larger than the range when the hole type is a straight hole; Figure 5 In (c), when the hole type is a double-cone hole, the inclined straight line C is the angle range within which the bronchoscope can move, which is larger than the range when the hole type is a single-cone hole.

[0037] The double-conical hole 2 and the outer wall of the conduit 3 are sealed and connected by double interlocking. Figure 2 and Figure 3As shown, the double tapered hole 2 includes a first tapered hole 21 and a second tapered hole 22. The small diameter end of the first tapered hole 21 is smoothly connected with the small diameter end of the second tapered hole 22 through a first arcuate convex ring 23. A first annular groove 24 is provided on one side of the first arcuate convex ring 23 along the axial direction. A second annular groove 33 and a second arcuate convex ring 34 are provided on the outer wall surface of the conduit 3. When the conduit 3 is connected to the double tapered hole 2, the first arcuate convex ring 23 is inserted into the second annular groove 33 and the second arcuate convex ring 34 is inserted into the first annular groove 24 to achieve a double interlocking sealing connection. The second annular groove 33 is arranged adjacent to the second arcuate convex ring 34, and the second annular groove 33 is located on the outside of the second arcuate convex ring 34. When the conduit 3 is installed, the second arcuate convex ring 34 can slide into the first annular groove 24 along the conical surface of the first tapered hole 21 and the arcuate surface of the first arcuate convex ring 23 until it is installed in place.

[0038] The outer end of the catheter 3 has a conical inner hole with the large diameter end of the conical inner hole facing outward. The inner end of the catheter 3 extends to the inner side of the cover body 11 and is suspended in the air to form a deformable and bendable flexible section 35. The inner wall of the inner end of the catheter 3 is provided with a protrusion 31 suitable for pressing. The cross section of the protrusion 31 along the axial direction of the catheter 3 is an arc-shaped protrusion, and the middle of the arc-shaped protrusion is high and the two sides are low. The inner side of the protrusion 31 is for the bronchoscope to pass through and is sealed against the outer wall of the bronchoscope. The material of the catheter 3 is silicone. The silicone material is safer for medical use, and it is moderately soft and hard. It has a suitable hardness to provide space for the bronchoscope to pass through, and it has enough elasticity to allow the protrusion 31 to be squeezed on the outer wall of the bronchoscope to achieve a good sealing effect.

[0039] The protrusion 31 is arranged at the inner end of the conduit 3 (the inner end refers to the end located in the cover body 11), such as Figure 4 As shown in (a), if the protrusion 31 is set at the outer end of the catheter 3, that is, at the opening of the cover body, the protrusion 31 presses against the outer wall of the bronchoscope to form a fulcrum there, so that the bronchoscope loses its space for movement, thereby limiting the doctor's operation and making it impossible for the doctor to obtain a sufficient field of view; the present application sets the protrusion 31 at the inner end of the catheter 3 and enlarges the opening of the cover body, so that the radial range of movement is increased, as shown in FIG. Figure 4 As shown in (b), the restriction on the range of motion of the endoscope during the doctor's operation is reduced, which is conducive to the doctor swinging and rotating the handle to allow the doctor to achieve the best observation field of the endoscope in the cavity, thereby achieving a sealing effect while ensuring the best inspection effect.

[0040] A sealing cap is inserted into the inner wall of the outer end of the catheter 3, and the outer wall of the sealing cap is squeezed and sealed with the inner wall of the outer end. When the bronchoscope is not in use, the sealing cap can be used to block the channel. To be suitable for bronchoscopes with different outer diameters, it is only necessary to replace the silicone catheter 3 with different specifications.

[0041] The body position sensor includes a mask angle sensor module 4 installed on the mask body 11 and a body position sensor module installed on the patient's body. The mask angle sensor module 4 and the body position sensor module are respectively connected to the computer via Bluetooth or WIFI communication. The mask angle sensor module 4 is detachably installed on the mask body 11 above the respiratory inlet connector 12, and the body position sensor module is attached to the patient's chest.

[0042] In this embodiment, the mask angle sensor module 4 and the body position sensor module can both adopt the body position gyroscope in the prior art, and the preferred model is WT9011G4K.

[0043] In clinical practice, the airway is affected differently by gravity in different body positions. The degree of airway collapse can be reduced by adjusting different body positions. The impact of gravity on the respiratory tract can be reduced by adjusting body position. This factor is defined as A. The change in the relative position of the head and body affects the deformation of the airway. By adjusting the relative position of the two, the airway resistance can be reduced. This factor is defined as B.

[0044] In order to standardize the different body positions of patients, a Cartesian rectangular coordinate system is established with the bed surface as the reference, in which the X-axis is perpendicular to the bed side, the Y-axis is parallel to the bed side, and the Z-axis is perpendicular to the bed surface, such as Figure 6 shown.

[0045] The detachable mask angle sensor module 4 is installed on the mask body 11 to monitor the patient's head angle. , , .

[0046] A body position sensor module is attached to the patient's chest to monitor the patient's body angle. , , ; The relative angle between the patient's head and body can be obtained based on the patient's head angle and body angle , , .

[0047] The mask angle sensor module 4 and the body position sensor module communicate internally via WiFi or Bluetooth, and the LCD screen can display the head angle, body angle, and the relative angle between the head and body in real time, and can export the body position data to a computer.

[0048] When the patient lies flat on the bed in the standard position without any deflection of the head, this position is defined as the initial position. The head angle at this time is: , , ; Body angle: , , ; Head angle relative to body: , , .

[0049] In the standard position, Indicates that the patient's head rotates around the Z axis, that is, the head tilts left and right. .when When , it means that the patient's head rotates to the right side around the Z axis; when , it means that the patient's head is rotated to the left side around the Z axis.

[0050] Indicates that the patient's head rotates around the Y axis, that is, shaking his head. .when When , it means that the patient's head rotates to the right side around the Y axis; when , it means that the patient's head is rotated to the left side around the Y axis.

[0051] Indicates that the patient's head rotates around the X-axis (i.e. nodding), .when When , it means that the patient's head rotates around the X-axis to its supine position; when , it indicates that the patient's head rotates around the X-axis to its prone position.

[0052] Indicates that the patient's body rotates around the Z axis, .when When , it means that the patient's body rotates to the right side around the Z axis; when , it means that the patient's body rotates to its left side around the Z axis.

[0053] Indicates that the patient's body rotates around the Y axis (i.e. lying on the side), .when When , it means that the patient's body rotates to the right side around the Y axis; when , it means that the patient's body rotates to the right side around the Y axis.

[0054] Indicates that the patient's body rotates around the X axis, .when When , it means that the patient's body rotates around the X-axis to its supine position; when , it indicates that the patient's body rotates around the X-axis to its prone position.

[0055] Indicates that the head is rotated to the left side around the Z axis relative to the body. Indicates that the head is rotated to the right side around the Z axis relative to the body; Indicates that the head is rotated relative to the body around the Y axis to its sideways position. It means that the head is rotated relative to the body around the Y axis to its supine position; Indicates that the head is rotated to the left side around the X axis relative to the body. Indicates that the head is rotated to the right side around the X axis relative to the body.

[0056] The factor A that affects the patient's airway due to gravity in different body positions should be superimposed on the patient's body position and head position, and weights should be added. The weight of the body is W, and the weight of the head is 1-W. The weight value should be determined based on the patient's height and weight. Therefore, factor A is expressed using the following formula (1):

[0057] ··(1)

[0058] The airway deformation caused by the relative position of the head and body is factor B, which is expressed by formula (2).

[0059] ··(2)

[0060] By expressing the two factors of body position A and B, it can be used to evaluate the relationship between the patient's body position and airway obstruction.

[0061] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes within the technical scope disclosed by the present invention according to the technical scheme and the utility model concept of the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A drug-induced sleep endoscopic mask, characterized in that: It comprises a DISE mask and a body position sensor, wherein the DISE mask comprises a mask body (11) and a breathing inlet connector (12) connected to the mask body, and the breathing inlet connector (12) is provided with an anesthetic drug introduction interface (13); A double-conical hole (2) is provided on the cover body (11) below the respiratory inlet connector (12), and the double-conical hole (2) is sealedly connected to the outer wall of the catheter (3) by a double interlocking manner. The outer end of the catheter (3) is a conical inner hole with the large diameter end of the conical inner hole facing outward. The inner end of the catheter (3) extends toward the inner side of the cover body (11) and is suspended in the air to form a deformable and bendable flexible section (35). The inner wall of the inner end of the catheter (3) is provided with a protrusion (31) suitable for abutment, and the inner side of the protrusion (31) allows a bronchoscope to pass through and seal against the outer wall of the bronchoscope. The body position sensor comprises a mask angle sensor module (4) mounted on the mask body (11) and a body position sensor module mounted on the patient's body, and the mask angle sensor module (4) and the body position sensor module are respectively connected to a computer for communication.

2. The drug-induced sleep endoscopic mask according to claim 1, characterized in that: The double tapered hole (2) comprises a first tapered hole (21) and a second tapered hole (22); the small diameter end of the first tapered hole (21) and the small diameter end of the second tapered hole (22) are smoothly connected via a first arc-shaped convex ring (23); a first annular groove (24) is provided on one axial side of the first arc-shaped convex ring (23); a second annular groove (33) and a second arc-shaped convex ring (34) are correspondingly provided on the outer wall surface of the conduit (3); when the conduit (3) is connected to the double tapered hole (2), the first arc-shaped convex ring (23) is inserted into the second annular groove (33) and the second arc-shaped convex ring (34) is inserted into the first annular groove (24) to achieve a double interlocking sealed connection.

3. The drug-induced sleep endoscopic mask according to claim 2, characterized in that: The second annular groove (33) is arranged adjacent to the second arc-shaped convex ring (34), and the second annular groove (33) is located outside the second arc-shaped convex ring (34).

4. The drug-induced sleep endoscopic mask according to claim 1, characterized in that: The breathing inlet connection piece (12) comprises a 360° rotating joint (121) connected to the mask body (11); an elbow (122) and an air inlet joint (123) are detachably connected to the 360° rotating joint (121); a silent air leakage port (124) is provided on the elbow (122); and a breathing valve (125) is installed on the elbow (122).

5. The drug-induced sleep endoscopic mask according to claim 4, characterized in that: The anesthetic drug introduction interface (13) is arranged at the root of the 360° rotating joint (121), and the anesthetic drug introduction interface (13) is introduced into the interior of the cover body (11) along the radial direction of the 360° rotating joint (121).

6. The drug-induced sleep endoscopic mask according to claim 4, characterized in that: The elbow (122) comprises a horizontal section and a vertical section which are fixed vertically as one, and the silent air leakage port (124) comprises a plurality of through holes distributed in an arc shape at the end of the horizontal section, and the axis of the through holes is parallel to the axis of the horizontal section.

7. The drug-induced sleep endoscopic mask according to claim 1, characterized in that: The cross section of the protrusion (31) along the axial direction of the conduit (3) is an arc-shaped protrusion, and the middle of the arc-shaped protrusion is high and the two sides are low.

8. The drug-induced sleep endoscopic mask according to claim 1, characterized in that: The outer end of the conduit (3) is detachably connected to a sealing cover.

9. The drug-induced sleep endoscopic mask according to claim 1, characterized in that: The material of the catheter (3) is silicone.

10. The drug-induced sleep endoscopic mask according to claim 1, characterized in that: The mask angle sensor module (4) is detachably mounted on the mask body (11) above the respiratory inlet connector (12), and the body position sensor module is adhered to the patient's chest.

Images