Double-balloon dilatation guiding rapid trachea device and using method thereof

Abstract

The invention relates to the technical field of medical instruments, and mainly discloses a double-balloon dilatation guiding rapid trachea device and a using method thereof.The double-balloon dilatation guiding rapid trachea device comprises a trachea cannula and an incision device assembly which are used in cooperation, and the incision device assembly comprises a puncture body and a guide-in hose connected with the rear end of an incision device; the leading-in hose is provided with a first balloon and a second balloon which are tightly arranged front and back, and the first balloon and the second balloon are both connected with overflowing hoses. By arranging the incision device assembly and the trachea cannula, the operation difficulty of operators is reduced, the efficiency of tracheotomy operation is improved, more treatment time is won for patients, the first balloon abuts against the inner wall of the annular cartilage of the trachea of the patient, and the probability that the first balloon abuts against the inner wall of the annular cartilage of the trachea of the patient in the artificial airway expansion process is reduced; the medical risks that the tracheal ring is pressed to collapse or break, the cartilage is inwards rolled and exposed out of the tracheal cavity, granuloma is formed, and tube drawing is difficult are further improved, and the medical safety guarantee is further improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a double-balloon dilation-guided rapid tracheal device and a use method thereof. Background Art

[0002] Rapid and effective establishment of an artificial airway through tracheotomy is a key technology for the treatment of critically ill patients with upper respiratory tract obstruction, respiratory failure, etc. Upper respiratory tract obstruction, lower respiratory tract secretion retention, central or peripheral respiratory depression, cardiopulmonary insufficiency, etc. caused by various reasons, if an artificial airway is not established in time, cardiac arrest may occur after 4 to 6 minutes, followed by ischemia and hypoxia of brain tissue, leading to irreversible damage. Especially for the wounded with upper respiratory tract obstruction, conscious and other reasons who cannot be intubated through the mouth or nose, rapid and effective tracheotomy to establish an artificial airway is the focus of rescue.

[0003] Tracheotomy is divided into traditional tracheotomy and percutaneous dilatational tracheostomy. Traditional tracheotomy takes a long time, has large surgical trauma and complicated operation, and is prone to various adverse events. Percutaneous dilatational tracheostomy (PDT) is an emerging technology that can quickly establish an artificial airway. It is a minimally invasive tracheotomy technology that has gradually developed based on percutaneous vascular intubation. It has the characteristics of simple operation, rapidity, less trauma, short operation time, less bleeding and fewer complications. Compared with traditional tracheotomy, it has significant advantages. In the past decade, it has been increasingly used in the emergency department and ICU for the rescue of critically ill patients, and has been widely recognized clinically. The key step of PDT operation is to fully expand the anterior neck tissue and the anterior wall of the trachea along the guide wire. However, since the commonly used dilation method of PDT is not easy to grasp in terms of strength, depth and angle, the operation is somewhat blind, and there is a risk of squeezing the trachea, causing cartilage involution, luminal granulation hyperplasia, and difficulty in extubation. Balloon catheter dilatation technology is currently used to treat stenosis of blood vessels, esophagus, Eustachian tube, etc. It has the advantages of controllable dilation force, depth, and angle.

[0004] However, the existing percutaneous dilational tracheotomy requires a large number of dilator medical devices to assist, and has high requirements for the operator's operation. If a balloon dilator is used, the dilator needs to squeeze the anterior wall of the trachea from the outside of the trachea while dilating, which will cause the tracheal ring to collapse or break under pressure, and there are risks such as cartilage rolling inward and exposing the tracheal cavity, granuloma formation, and difficulty in extubation. When the trachea is compressed, soft tissues such as the posterior wall of the trachea and the anterior wall of the esophagus protrude into the trachea, which can be easily accidentally injured by the dilator, leading to risks such as intratracheal bleeding and tracheoesophageal fistula. Summary of the invention

[0005] The purpose of the present invention is to provide a double-balloon dilation-guided rapid tracheal device, which has the advantages of low operating difficulty and simple structure, and solves the problems raised in the above-mentioned background technology.

[0006] To achieve the above-mentioned purpose, the present invention provides the following technical solutions: a double-balloon dilatation-guided rapid tracheal device, comprising a tracheal cannula and a cutter assembly used in conjunction with each other, the cutter assembly comprising a puncture body and an introduction hose connected to the rear end of the cutter, the introduction hose is provided with a first balloon and a second balloon arranged closely front and back, and the first balloon and the second balloon are both connected to a flow hose, the first balloon or the second balloon can be filled or discharged through the corresponding flow hose, wherein the diameter of the second balloon after expansion and in a direction perpendicular to the introduction hose is adapted to the diameter of the tracheal cannula, and the diameter of the first balloon after expansion and in a direction perpendicular to the introduction hose is greater than the diameter of the second balloon after expansion and in a direction perpendicular to the introduction hose.

[0007] Preferably, the puncture body includes a guide wire and a puncture device, wherein the guide wire is located at the front end of the puncture device and is connected to the tip of the puncture device.

[0008] Preferably, the puncture body is an arc-shaped puncture needle, and a tip extending in an arc shape is provided at the front end of the arc-shaped puncture needle.

[0009] Preferably, the tracheal tube is in the shape of a curved tube, and an annular rib is provided at the rear end of the tracheal tube.

[0010] Preferably, a connecting valve is provided at the end of the flow hose.

[0011] Preferably, the flow hose is located inside the first balloon or the second balloon, and the flow hose passes through the side wall of the introduction hose, the flow hose penetrates into the inner pipe of the introduction hose, and the outer end of the flow hose rushes out of the tail end of the introduction hose channel.

[0012] A method for using a double-balloon dilation-guided rapid tracheal device comprises the following steps:

[0013] Step 1: The connecting valves at the ends of the two flow hoses are connected to the external charging device, the first balloon and the second balloon are in an unfilled and flat state, the first balloon and the second balloon are at the minimum volume, and the puncture body sequentially punctures the patient's skin and tracheal cartilage until the puncture body and the first balloon are both located in the patient's trachea;

[0014] Step 2: The first balloon begins to be filled through the filling device, the first balloon expands until it is filled, the introduction hose is pulled backward, and the first balloon is simultaneously driven to move backward, and the traction is stopped after the filled first balloon contacts the inner wall of the patient's tracheal ring cartilage;

[0015] Step 3: The second balloon is filled with fluid through the filling device, and the second balloon gradually expands until it is fully filled, and drives the punctured part of the patient's trachea to expand, forming an artificial airway on the trachea;

[0016] Step 4: Both connecting valves are disconnected from the filling device, and the connecting valve corresponding to the second balloon is pushed open, so that the second balloon is released to a semi-filled state, and at the same time, the first balloon contacts the artificial airway on the trachea to prevent it from shrinking;

[0017] Step 5: The tracheal tube is inserted into two flow hoses and an introduction hose from the front end, and the tracheal tube passes through the artificial airway on the patient's trachea and contacts the first balloon;

[0018] Step 6: Open the connecting valve corresponding to the first balloon, and the first balloon discharges fluid according to its own elastic force until the first balloon is in a flat state with a minimum volume; open the connecting valve corresponding to the second balloon, and the second balloon discharges fluid according to its own elastic force until the second balloon is in a flat state with a minimum volume;

[0019] Step 7: Pull the cutter assembly backwards and pull it out from the rear end of the tracheal tube to complete the tracheotomy operation.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] The present invention reduces the difficulty of operation for operators and improves the efficiency of tracheotomy surgery by providing a cutter assembly and a tracheal cannula, thereby gaining more treatment time for patients. By having the first balloon contact the inner wall of the patient's tracheal ring cartilage, the medical risks of tracheal ring compression collapse or breakage, cartilage rolling inward and exposed in the tracheal cavity, granuloma formation, and difficulty in extubation during artificial airway expansion are reduced, thereby further improving medical safety assurance. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a structural schematic diagram of a first embodiment of the present invention;

[0023] Figure 2 It is a partial structural schematic diagram of a first embodiment of the present invention;

[0024] Figure 3 It is a partial structural schematic diagram of a second embodiment of the present invention;

[0025] Figure 4 The usage state of the first embodiment of the present invention Figure 1 ;

[0026] Figure 5 The usage state of the first embodiment of the present invention Figure 2 ;

[0027] Figure 6The usage state of the first embodiment of the present invention Figure 3 ;

[0028] Figure 7 The usage state of the first embodiment of the present invention Figure 4 ;

[0029] Figure 8 The usage state of the first embodiment of the present invention Figure 5 ;

[0030] Fig. 9 The usage state of the first embodiment of the present invention Figure 6 . DETAILED DESCRIPTION

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

[0032] See also Figure 1 to Figure 2 The first embodiment provided by the present invention is a double-balloon dilatation-guided rapid tracheal device and a method of using the same, comprising a cutter assembly 10 and a tracheal tube 20 for use together, the cutter assembly 10 comprising an integrally connected puncture body 11 and an introduction hose 12, the introduction hose 12 being provided with a first balloon 13 and a second balloon 14 arranged closely front and back, the first balloon 13 and the second balloon 14 both being made of a high-elasticity rebound material, the first balloon 13 and the second balloon 14 both being connected to a flow hose 15, the first balloon 13 or the second balloon 14 being able to be filled or discharged through the corresponding flow hose 15, the first balloon 13 and the second balloon 14 being in a deflated state when not filled, having the smallest volume, and basically fitting the introduction hose 12.

[0033] The diameter of the second balloon 14 in a direction perpendicular to the introduction hose 12 after being filled and expanded matches the diameter of the tracheal tube 20, and the diameter of the first balloon 13 in a direction perpendicular to the introduction hose 12 after being filled and expanded is greater than the diameter of the second balloon 14 in a direction perpendicular to the introduction hose 12 after being filled and expanded.

[0034] The tail end of the flow hose 15 is connected to a connecting valve 16. The connecting valve 16 in this embodiment is a one-way check valve. Through the connecting valve 16, it can be quickly connected and installed with an external charging device (not shown in the figure). The charging device can be a liquid flow charging device or an air flow charging device to fill the first balloon 13 or the second balloon 14 with liquid or air.

[0035] When the first balloon 13 and the second balloon 14 are not inflated, the puncture body 11 is mainly used to puncture the patient's skin and tracheal cricoid cartilage 30 in sequence, so that the puncture body 11 and the first balloon 13 enter the patient's trachea.

[0036] In this embodiment, the puncture body 11 is an integrated guide wire 17 and a puncture device 18. The guide wire 17 is located at the front end of the puncture device 18, and the guide wire 17 is connected to the tip of the puncture device 18. It is matched with a tracheal dilator (Howard-Kelly forceps) with special grooves on the front end. The guide wire 17 guides the forceps path through the special grooves, and the dilator forceps are opened and closed to quickly establish a tracheostomy.

[0037] See also Figure 3 In a second embodiment provided by the present invention, the puncture body 11 may also be an arc-shaped puncture needle 19, and the front end of the arc-shaped puncture needle 19 is provided with an arc-shaped extending tip, through which the tip supports puncturing the patient's skin and tracheal cartilage 30.

[0038] See also Figures 4 to 9 The use process of the first embodiment of the present invention is as follows: after the puncture body 11 and the first balloon 13 enter the patient's trachea, the connecting valve 16 corresponding to the first balloon 13 is connected and installed with an external charging device, and the first balloon 13 is charged until the first balloon 13 is filled, and then the introduction hose 12 is pulled backward, synchronously driving the first balloon 13 to move backward, and the first balloon 13 in the filled state collides with the inner wall of the patient's tracheal ring cartilage 30 and then the traction is stopped, so as to achieve the effect of positioning the cutter assembly 10, and at the same time, the filled first balloon 13 collides with the inner wall of the tracheal ring cartilage 30, so as to prevent the second balloon 14 from expanding, causing the patient to experience medical risks such as tracheal ring compression collapse or fracture, cartilage inward rolling and exposure in the tracheal cavity, granuloma formation, and difficulty in extubation, thereby further improving medical safety assurance.

[0039] The connecting valve 16 corresponding to the second balloon 14 is connected and installed with an external charging device, and then the second balloon 14 is filled with fluid through the flow hose 15 connected to the second balloon 14. The second balloon 14 gradually expands until it is filled, and drives the punctured part of the patient's trachea to expand, forming an artificial airway on the patient's trachea.

[0040] The two connecting valves 16 are disconnected from the filling device, and the connecting valve 16 corresponding to the second balloon 14 is pushed open, so that the second balloon 14 is discharged to a semi-filled state. At the same time, the first balloon 13 abuts against the artificial airway on the trachea to prevent it from shrinking. The tracheal cannula 20 is inserted into the two flow-through hoses 15 and the introduction hose 12 from the front end. The tracheal cannula 20 passes through the artificial airway on the patient's trachea and abuts against the first balloon 13.

[0041] Finally, the connecting valve 16 corresponding to the first balloon 13 is pushed open, and the first balloon 13 discharges according to its own elastic force until the first balloon 13 is deflated to the minimum volume. The connecting valve 16 corresponding to the second balloon 14 is pushed open, and the second balloon 14 discharges according to its own elastic force until the second balloon 14 is deflated to the minimum volume. The cutter assembly 10 is then pulled backward and pulled out from the rear end of the tracheal tube 20 to complete the tracheotomy operation.

[0042] By providing the tracheotomy assembly 10 and the tracheal cannula 20, the operating difficulty of the operator is reduced, the efficiency of the tracheotomy operation is improved, and more treatment time is gained for the patient.

[0043] In the present embodiment, the tracheal cannula 20 is in the shape of a curved tube. The curved tracheal cannula 20 can keep a distance from the patient's body surface and be relatively level with the patient's body surface after the insertion end of the tracheal cannula 20 is inserted into the patient's respiratory tract, thereby preventing the tracheal cannula 20 from being too high and affecting the medical staff in performing medical operations; an annular rib 21 is provided at the rear end of the tracheal cannula 20, and the annular rib 21 can facilitate the medical staff to hold the tracheal cannula 20 and perform other operations, while preventing the tracheal cannula 20 from slipping into the patient's trachea.

[0044] In this embodiment, the flow hose 15 is located inside the first balloon 13 or the second balloon 14, and the flow hose 15 passes through the side wall of the introduction hose 12, the flow hose 15 penetrates the inner pipe of the introduction hose 12, and the outer end of the flow hose 15 rushes into the tail end of the channel of the introduction hose 12 and passes out; the above is an example of one embodiment. In other embodiments, the first balloon 13 or the second balloon 14 can be directly connected to the flow hose 15.

[0045] It will be apparent to those skilled in the art that the invention is not limited to the details of the exemplary embodiments described above and that the invention can be implemented in other specific forms without departing from the spirit or essential features of the invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations falling within the meaning and scope of the equivalent elements of the claims be included in the invention. Any reference numeral in a claim should not be considered as limiting the claim to which it relates.

Claims

1. A double-balloon dilatation-guided rapid tracheal device, comprising a tracheal cannula and a cutter assembly for use together, characterized in that: The cutter assembly includes a puncture body and an introduction hose connected to the rear end of the cutter, the introduction hose is provided with a first balloon and a second balloon arranged closely front and back, and the first balloon and the second balloon are both connected to a flow hose, the first balloon or the second balloon can be filled or discharged through the corresponding flow hose, wherein the diameter of the second balloon after expansion and in a direction perpendicular to the introduction hose is adapted to the diameter of the tracheal cannula, and the diameter of the first balloon after expansion and in a direction perpendicular to the introduction hose is greater than the diameter of the second balloon after expansion and in a direction perpendicular to the introduction hose.

2. A double-balloon dilatation-guided rapid tracheal device according to claim 1, characterized in that: The puncture body comprises a guide wire and a puncture device, wherein the guide wire is located at the front end of the puncture device and is connected to the tip of the puncture device.

3. A double-balloon dilatation-guided rapid tracheal device according to claim 1, characterized in that: The puncture body is an arc-shaped puncture needle, and a tip extending in an arc shape is provided at the front end of the arc-shaped puncture needle.

4. A double-balloon dilatation-guided rapid tracheal device according to claim 1, characterized in that: The tracheal tube is in the shape of a curved tube, and a circular retaining edge is arranged at the rear end of the tracheal tube.

5. A double-balloon dilatation-guided rapid tracheal device according to claim 1, characterized in that: The ends of the flow hoses are all provided with connecting valves.

6. A double-balloon dilatation-guided rapid tracheal device according to claim 1, characterized in that: The flow hose is located inside the first balloon or the second balloon, and the flow hose penetrates the side wall of the introduction hose, penetrates into the inner pipe of the introduction hose, and the outer end of the flow hose rushes out from the tail end of the introduction hose channel.

7. A method for using a double-balloon dilation-guided rapid tracheal device, characterized in that: The following steps are involved: Step 1: The connecting valves at the ends of the two flow hoses are connected to the external charging device, the first balloon and the second balloon are in an unfilled and flat state, the first balloon and the second balloon are at the minimum volume, and the puncture body sequentially punctures the patient's skin and tracheal cartilage until the puncture body and the first balloon are both located in the patient's trachea; Step 2: The first balloon begins to be filled through the filling device, the first balloon expands until it is filled, the introduction hose is pulled backward, and the first balloon is simultaneously driven to move backward, and the traction is stopped after the filled first balloon contacts the inner wall of the patient's tracheal ring cartilage; Step 3: The second balloon is filled with fluid through the filling device, and the second balloon gradually expands until it is fully filled, and drives the punctured part of the patient's trachea to expand, forming an artificial airway on the trachea; Step 4: Both connecting valves are disconnected from the filling device, and the connecting valve corresponding to the second balloon is pushed open, so that the second balloon is released to a semi-filled state, and at the same time, the first balloon contacts the artificial airway on the trachea to prevent it from shrinking; Step 5: The tracheal tube is inserted into two flow hoses and an introduction hose from the front end, and the tracheal tube passes through the artificial airway on the patient's trachea and contacts the first balloon; Step 6: Open the connecting valve corresponding to the first balloon, and the first balloon discharges fluid according to its own elastic force until the first balloon is in a flat state with a minimum volume; open the connecting valve corresponding to the second balloon, and the second balloon discharges fluid according to its own elastic force until the second balloon is in a flat state with a minimum volume; Step 7: Pull the cutter assembly backwards and pull it out from the rear end of the tracheal tube to complete the tracheotomy operation.

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