JPH0552752B2 - - Google Patents

Description

Claim 1: Outer portions 58, 6 with oxygen supply ports at free ends
8. a subcutaneous insertion section 54 having oxygen evacuation means 12, 78 at the distal end 70 and inserted through the patient's tracheostomy, and for external apposition to the skin of the patient's incision; , 54 having a stereotactic flange 18 externally fixed at the junction of the tube 10
A continuous oxygen supply system for reinforcing spontaneous breathing in patients with chronic hypoxia, including a tracheal catheter having a shape of (b) The oxygen supply port is a coupling 24 that is removably connected to the tube 26 and supplies oxygen at low pressure and at a relatively low flow rate. (c) the coupling ring 24 is spaced apart from the flange 18 by approximately the same length as the tube 10 and can be visually operated by the patient while the catheter is attached; and (d) the subcutaneous insertion portion 54 has a flange 18 and an intermediate portion extending to a distal end 70 and has a feed port 24.
said system, characterized in that: the upper part of the trachea assumes a curved shape while allowing free flow of oxygen between the trachea and the outlet means 12,78. 2. The system of claim 1, wherein the tube 10 has an outer diameter of about 3.3 mm or less and an inner diameter of at least about 1.7 mm. 3. The system of claim 1 or claim 2, wherein the tube 10 has a hardness of about 88-90 Shore A. 4. The distal end 70 of the continuous port 78 has a taper or bevel defining a rear side that is longer than the front side, forming a forwardly sloping outlet for the oxygen means. The system according to any one of Items 3 to 3. 5. The oxygen evacuation means has a plurality of holes 12 spaced around the anterior side of the tube 10 and passing through the side wall of the distal end 70, such that in use the holes are located in the trachea. 5. The system according to claim 1, wherein the system faces the back surface at a distance. 6. A system according to any of claims 1 to 5, wherein the length of the outer portions 58, 68 of the tubes is approximately 110 mm. 7 The pressure of the coupling spring 24 is 13.79KPa (2psi)
Hereinafter, claim 1 is connected to an oxygen supply source 38 having an oxygen flow rate of 1.33×10 ^-7 m ³ /sec (8f/min) or less.
The system according to any one of items 6 to 6. 8. Claim 1, wherein the catheter has a reinforcing portion 72 joined to the tube 10 to prevent the tube 10 from being dented or rolled when the tube 10 is used in the trachea. The system according to any one of items 7 to 8. 9 The flange 18 includes support plates 18', 18'' attached to the tube 10, the support plates being attached to the tube 10.
9. A system according to any one of claims 1 to 8, wherein the system is supported and fixed in its operating position. 10. The system of claim 9 including a retainer 20 for being worn by the patient to support the support plates 18', 18''. 11. The flange 18 is arranged between the larynx and the sternum, around the patient's neck. The system according to any one of claims 1 to 8, wherein the system is supported by a neck support member 20 attached to the neck support member 20. 12. The oxygen supply pipe 26 and the oxygen supply pipe 2.
6 to the patient's body, the coupling 24 being tensioned to connect the supply tube 2 to the patient's body.
12. A system according to any one of claims 1 to 11. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a continuous oxygen supply system for augmenting spontaneous breathing in patients with chronic hypoxia. Such devices are medically desirable for patients requiring long-term oxygen supply, such as those where catheters are attached to long-term treatment outpatients. Research dating back to the 1930s, especially the 1960s and
Research conducted in the early 1670s showed that long-term continuous oxygen inhalation was beneficial in treating hypoxemia in chronic obstructive pulmonary disease (COPD). In other words, the patient's medical condition and length of life are
This can be improved by providing a constant supply of additional oxygen to the patient's lungs. However, with recent demands involving medical costs, there is growing concern about the rising cost of treatment due to the additional cost of continuous oxygen inhalation therapy for chronic lung disease. Therefore, it is desirable that the implementation cost of this oxygen inhalation therapy be as low as possible. For patients requiring additional oxygen, standard treatment continues to be to obtain oxygen from an oxygen cylinder using a nasal cannula. However, such treatments require large amounts of oxygen, can be painful and irritating to the nose, and can worsen the disease. Other undesirable effects have also been reported. Medical approaches that could reduce the cost of continuous oxygen therapy are being investigated. A variety of instruments and methods of use are used to perform emergency thyroidectomy or to line the tubes for periodic incisions to ensure that the patient's airway remains unobstructed and can continue breathing. was devised. Such devices are generally intended for patients who are unable to breathe naturally and are not intended for long-term supplemental oxygen therapy for chronic lung disease. In general, installation of such a device involves making a hole in the skin to make a hole in the thyroid membrane above the trachea, and inserting a
Insert a relatively large curved tracheostomy tube. As previously mentioned, the use of such tubes has been limited to emergency situations where the patient might otherwise suffocate due to airway obstruction. Such emergency tracheostomy tubes are not used for long-term supplemental oxygen therapy after the airway is no longer obstructed. Other satisfactory devices for emergency or ventilation airway control are disclosed in the following US patents: US Pat. Rogers No. 953922, Shelden No. 2873742, Brummelkamp No.
No. 3384087, Toy No. 3511243, Calhoun No. 3556103, Shelden No. 2991787, Weiss No. 3688733, Weiss No. 3817250, Pozzi No. No. 3916903. Although the tracheostomy tube is suitable for that purpose,
It is not intended for long-term outpatient use as a means of providing additional oxygen to spontaneously breathing patients with chronic obstructive pulmonary disease (COPD). Generally, such tracheostomy tubes are designed to provide a sufficient air supply to the patient in a relatively short period of time. Tracheostomy tubes are generally made to be robust or similar, with an outer diameter of 2.5 mm for infants.
Large diameter ones with an outer diameter of 15 mm for adult use are used. These tubes are typically inserted through the thyroid gland capsule in an operating room or emergency room when the tissue is rich in blood vessels and breathing is difficult. Such devices direct air flow in both directions until normal breathing is restored by other means. Another example of a tracheostomy tube is shown in Jacobs U.S. Pat.
It is disclosed in the specification of No. 3788326. In this case, the catheter is inserted through the cricothyroid membrane with a 14 or 16 gauge needle passed through it, and
Use air, oxygen, or vacuum in an emergency to treat a patient who is having difficulty breathing. Due to the gas flow resistance created by the small internal diameter of this tube, air or oxygen is delivered at high pressures of 30-100 ^psi to match the patient's lungs and inflation and deflation. Like other tracheostomy tubes previously used, the Jacobs atheter was not intended for long-term outpatient use and could not be modified as such. Due to the limited functionality of tracheostomy tubes, incisional tracheal catheters have been provided and used for long-term supplemental oxygen therapy. For example, developed by Dr. Henry J Heimlich,
Small diameter incisional tracheal catheter (16 gauge) (November 1982)
As described in the Bulletin of Otology, Rhinology, and Throat Science, March to December, respiratory rehabilitation using an open tracheal oxygen inhalation system) is performed at the midpoint between the cricothyroid capsule and the sternal notch. It is used by inserting a relatively large incision needle (14 gauge) into the trachea. For a catheter of this size, 0.14Kg/
Up to about 2 to 3 liters of oxygen can be delivered at low pressures such as 2 psi (cm ² ). However, this flow rate may be insufficient for patients who require more oxygen. For outpatient use, the main reason is that the connection between the catheter and the oxygen supply hose is adjacent to the front of the trachea, facing away from the patient, and cannot be easily seen or handled by the patient. It is not suitable for maintenance such as periodic removal and cleaning. Furthermore, no effective measures have been taken to prevent kinking or breakage of the tube, which would hinder the use of this catheter for outpatient use. Such features are not only desirable but necessary for long-term outpatient and home therapy use. In addition, because of its structure with only the outlet open, oxygen exiting the catheter heads directly down the trachea toward the bifurcation between the bronchi. Because the normal anatomy of a bronchus is that the left bronchus forms a more acute angle to the trachea than the right bronchus, most of the oxygen that comes in through the catheter is diverted to be used equally by both bronchi. Rather than being combined or mixed,
It tends to be directed towards the right bronchus. Also, due to the structure, oxygen hits the mucous membrane of the protrusion on the keel, making you feel uncomfortable and causing you to cough. Moreover, with such devices, if most of the oxygen flows toward the dorsal wall of the trachea, it can irritate the mucous membranes in this area. This is also not desirable. Overall, the oxygen output from this device is limited, so this device does not provide enough oxygen when the patient is exercising, moving, or in critical condition and receiving supplemental oxygen therapy. There is a possibility that the supply will not be possible. Thus, existing artificial devices are not optimal for long-term care outpatients. It is therefore an object of the present invention to provide a continuous oxygen supply system to supplement spontaneous breathing in chronic hypovolemic patients. DESCRIPTION OF THE INVENTION The present invention relates to a device for supplementing oxygen to a patient from an oxygen cylinder that can be transported to the patient. More specifically, the present invention provides an outer portion 58, 68 with an oxygen supply port at the free end, a distal portion 7
A subcutaneous insertion section 54 having an oxygen evacuation means 12, 78 at the tracheostomy of the patient, and a subcutaneous insertion section 54 inserted through the patient's tracheostomy, and said section 5 for external contact with the skin of the patient's incision.
8, 54; 68, 54, comprising a tracheal catheter in the form of a tube 10 having a stereotactic flange 18 externally fixed at the junction of 68, 54; (a) The pipe 10 is continuous, flexible, and resistant to deformation, and the continuous pipe ports 60 and 76 have a constant diameter; (b) The oxygen supply port is removably connected to the pipe 26. (c) the coupling 24 is spaced from the flange 18 by approximately the same length as the tube 10 so that the catheter is and (d) the subcutaneous insert 54 has a flange 18 and an intermediate section extending to a distal end 70 and includes a feed port 24.
and the outflow means 12, 78, while allowing free flow of oxygen, a curved shape of the upper part of the trachea. Oxygen enters through the cervical trachea (below the supracircular cartilage and above the sternal notch), and supplemental oxygen is introduced through the distal end of a catheter extending down the trachea into both lungs of patients on continuous long-term therapy. distributed evenly. For normally breathing patients, the air and introduced oxygen can be mixed properly and located in the lower part of the trachea. The catheter device consists of an extensible tube with a Shore A hardness of about 80 to 90 and long enough to extend the distal end of the device into the trachea above the keel. In order to manually bring the tube connected to the portable oxygen cylinder and the distal end of the catheter protruding outside the neck into the position where they will be connected, the tube of the catheter is
A continuous cylindrical outer surface with a continuous surface and a continuous cylindrical outer surface such that constant diameter and inner diameter define an elongated continuous cylindrical cannulation made of flexible material between 1.7 and 2.5 mm. It has a lumen with an inner surface of constant diameter. The oxygen outlet at the distal end of the tubular structure has a downwardly facing, generally forward facing end hole of the same diameter as the continuous oxygen cannulation when the tubular structure is in place in the trachea. The distal end further includes:
The distal hole has a front end with a number of regularly spaced holes extending from the side wall and oriented anteriorly with respect to the center of the tracheal air column for oxygenation. Because the oxygen supply hole is forward facing,
The backward flow of oxygen towards the back of the trachea is restricted and mucosal sores are prevented. The tubular structure can also be mounted within a sidewall between an outer circumferential surface and an inner circumferential surface;
and suppressing the restriction of the intubation at a preselected position to maintain a constant lumen cross-sectional area within the tubular structure in order to maintain a continuous constant diameter of the central cannulation during oxygen inhalation therapy. Contains reinforcement. Furthermore, the portion of the tubular structure located within the trachea is coated with a hydrophilic paint. This extends to the outer and inner surfaces and sides of the cylindrical shape, the distal holes, and the adhesion of sticky material present in the trachea that might otherwise restrict the flow of oxygen exiting the tubular structure; Suppress subsequent accumulation. Furthermore, the present invention includes a method for treating both bronchi of spontaneously breathing outpatients in the long-term treatment of chronic obstructive pulmonary disease.
Includes a kit for attaching an incisional tracheal catheter for direct, fairly low-pressure oxygen delivery. Preferably, the catheter is a thin, flexible, kink- and break-resistant artificial trachea with an internal and external end. Materials such as wire or other reinforcing materials may be used to form the tube. A reinforcement may be provided around the outer diameter of the extratracheal portion of the catheter. A number of holes are drilled in the front of the distal end to facilitate mixing of the air and oxygen that the patient breathes. These holes are aligned along the front surface of the catheter wall over an arc of about 120 degrees, ie, on either side of its center, with about 60 degrees of lateral spacing. In order for the patient to successfully couple the catheter and oxygen cylinder, the connector is attached to the proximal tubing junction that extends outward at a sufficient distance to allow the patient to see the device. Stabilizers are provided to prevent inadvertent movement of the catheter by the patient when the catheter is in place and in use. Such a configuration allows the patient to see the connector attached to the proximal tubing connector, thereby facilitating attachment and detachment from the oxygen cylinder. For outpatients, the proximal portion of the catheter is optionally extended out of the patient's body to facilitate cleaning of the device. The distal end of the tube is tapered so that the rear surface of the tube is longer than its front surface to allow oxygen to escape away from the back of the trachea where the distal end of the tube is located. The present invention is adapted to insert an incisional tracheal catheter into a patient's trachea. The method of the present invention involves applying local anesthesia and gradually injecting the hypodermic needle into the soft skin covering the front surface of the cervical trachea. When injecting local anesthetic into the trachea, insert the guide wire into the needle, pull out the needle over the guide wire, and place a skin dilator over the guide wire to widen this small channel. Inserting the dilator, orienting the dilator, and inserting the stent along the expanded lumen over the guidewire rather than withdrawing the guidewire and increasing the risk of cervical injury adhesions under the skin. The stent is first inserted in an appropriate manner during initial fusion of the dilated cervical canal to allow air to pass freely through the lumen created by the stent during coughing. to make sure,
removing the stent, inserting a temporary catheter into this duct, attempting to finish the temporary catheter during a slightly longer second attempt until the duct is complete; The procedure consists of removing the catheter, inserting a replacement permanent catheter, and adjusting the catheter so that it fits properly. The unique method of the present invention allows for the insertion of larger catheters using smaller needles, and
This makes it possible to provide inhalation therapy that delivers sufficient oxygen to patients who are not healthy enough to undergo insertion techniques. The best equipment for carrying out the method described above can be provided as a first kit. The dissecting tracheal catheter described above is one of the instruments included in the second kit. A hypodermic needle is inserted into the first kit to create a small canal or fistula through the trachea, and a syringe is used to inject the anesthetic into the trachea after the needle is inserted through the trachea to create the canal. Contains a hypodermic needle for use. The first kit also contains a guide wire that is inserted through the needle to maintain the lumen after the needle is withdrawn. The guide wire is marked at the 11 cm length and there is no deep wire penetration. A dilator is also provided. It is tapered and has a passageway in the middle. A guide wire is passed through this passage and the dilator is pushed into the neck. This is because the dilator is used to gradually stretch the skin to increase the diameter of the duct or hole. The dilator is marked at 7cm so it doesn't go too deep. The dilator is removed while the guidewire is in place. A stent with a passageway in the center is also packaged in a kit. To aid in the initial healing of the cervical canal, the stent is inserted into the dilated canal after the dilator is removed to maintain the dimensions of the canal or hole. The guidewire is then also removed. The stent is held in place while being fused with sutures. The second kit has a hole in the beveled end.
It contains a catheter that replaces the stent. The beveled end of the temporary catheter is longer on its rear or upper side in order to direct the oxygen flow away from the mucous membranes and toward the center of the trachea. The temporary catheter can be connected to an oxygen cylinder during use and remains attached until healing is complete. A cleaning rod is also included in the second kit. This is used periodically to clean mucosal clots that form at the distal end of temporary catheters. The proximal portion of the catheter extends a sufficient length outwardly from the cervical surface and the stabilizing flange on the catheter to facilitate disconnection from the oxygen cylinder, connection, and cleaning of the catheter. this is,
This is so that the patient can see the connector through their chin. Finally, the third kit has a formal catheter that can be removed. It has the same dimensions as the temporary catheter and replaces it at the end of the duct fusion. This formal catheter, like the temporary catheter, has a tapered distal end and a series of spaced holes in the front wall through which oxygen is supplied from the tube and the patient is inhaled. It is becoming easier to mix with air. These holes are placed in the front of the catheter tube at 60°C on both sides from the center.
They are arranged at intervals within an arc of degrees. Along with its own temporary and formal catheters, the kit described above provides a unique means of catheter attachment. These catheters are suitable for long-term outpatient use with chronic obstructive pulmonary disease (COPD). The catheter can be cleaned manually by the patient. Formal catheters can be removed by the patient for cleaning and reinsertion. The proximal portion of the tubing is shown extending outward beyond the fixed joining flange so that the patient can see the connector and attach or detach it from the oxygen vent at will. Other advantages of the invention will become apparent from the following description based on the accompanying drawings.

[Brief explanation of the drawing]

FIG. 1 shows an incisional tracheal catheter of the present invention inserted into the trachea through the skin of a patient;
FIG. 3 is a perspective view of the oxygen supply junction tube being fastened to the patient's clothing, with the junction to the dissecting tracheal catheter and the connector tube to the oxygen cylinder; FIG. 2 is a schematic illustration of local anesthesia being injected into the trachea. FIG. 3 is a schematic diagram of the guide wire inserted into the injection needle after removal of the syringe. FIG. 4 is a schematic illustration of the needle being withdrawn and then the skin dilator with the guide wire passing through it. FIG. 5 is a schematic diagram of the dilator being removed and the stent inserted with the guide wire passing through it. Figure 6 is after the stent has been removed. FIG. 2 is a schematic diagram of a temporary incision tracheal catheter inserted. FIG. 7 is a schematic view of the temporary catheter being removed and the permanent catheter being inserted. FIG. 8 is a schematic diagram of a conventional open trachea with a ring-shaped distal end of the tube showing the catheter and the direction of oxygen flow exiting the catheter and into the patient. FIG. 9 is the same schematic diagram of the trachea as in FIG. 8, but additionally showing the complete mixing of oxygen and air by the catheter of the present invention. FIG. 10 is a side view of the guide wire, which is a component of the first kit of the present invention. FIG. 11 is a side view of the dilator used to insert the dissection tracheal catheter, which is part of the first kit of the present invention. FIG. 12 is an end view of the distal portion of the dilator of FIG. 11; FIG. 13 is a side view of a stent, which is a component of the first kit of the present invention. FIG. 14 is a side view of the cleaning rod, which is a component of the second kit of the present invention. FIG. 15 is a side view of a temporary catheter that is part of the second kit of the present invention. FIG. 16 is a side view of the formal removable catheter that is part of the third kit of the present invention. FIG. 17 is an enlarged sectional view taken along line 17-17 of FIG. 16 and showing the angular spacing of the holes. FIG. 18 is an enlarged sectional view taken along line 18-18 of FIG. 16 and showing the reinforcing material inside the tube. FIG. 19 is an enlarged cross-sectional view taken along line 19-19 of FIG. 16 showing the attachment of the dissecting tracheal catheter. FIG. 20 is a graph showing a comparison between the present invention and other oxygen inhalation therapies based on blood oxygen analysis during catheter operation. FIG. 21 is an example of a reinforced catheter useful in practicing the present invention. FIG. 22 is a detailed cross-sectional view of the flange used in the catheter shown in FIG. 21.

[Detailed description of the invention]

As can be seen in FIG. 1, an incisional tracheal catheter C is attached to the patient P. The catheter has a flexible, reinforced tube 10 with many holes 12 at its distal end. These holes have
It has special orientation to help mix the air the patient breathes with the oxygen delivered.
The detailed explanation is as follows. The distal end extending through the duct into the trachea 14 is
It is located on the keel-shaped projection 15 to distribute oxygen evenly to the right and left bronchi 16 and 17. The catheter is inserted into the cervical trachea, as explained fully below. After insertion, the flange 18 is used so that the catheter C wraps tightly around the patient's neck with the chain 20 surrounding the neck. The proximal end of catheter C protrudes from the patient's body and has a coupling ring 24 attached thereto, and oxygen is delivered to the patient through tube 10. Many of the tubes 10 are reinforced. Especially reinforced with coils that are successfully inserted into the lumen. As shown, the patient will be required to attach the oxygen supply tube,
In order to remove it, put the cutlet ring 2 over the chin.
4 and even remove the catheter. For outpatients, the catheter can be replaced at home for cleaning and reconnected to the oxygen cylinder. The acidity supply source may be a pressurized oxygen tank, a liquid oxygen tank, or an oxygen concentrator, but the fluctuation in the specified flow rate shall be small. As shown in FIG. 1, an intermediate reinforcing tube 26 is located between the coupling 24 and the clip 30.
The two are tied together, and the clip 30 is attached to a narrow belt 32 that is worn under the patient's clothing. However, the clip 30 can be attached directly to the patient's clothing without being attached to a belt. The coupling 34 is then connected to a tube 36 and an oxygen source 38. This structure was chosen because the patient is moving around and the patient does not move as far as the tube allows.
This is to prevent pressure on the catheter C. If this happens, the catheter may be pulled out of the trachea, causing injury or anxiety to the patient. With the intermediate tube arrangement as shown, any tension is placed on tube 36 and not on tube 26. Furthermore, the coupling 24 is 0.45 to 1.35Kg.
It is made to snap apart when subjected to a tensile force of (1 to 3 pounds). There are two catheters in the catheter system of the present invention. The first is a tube created through the trachea or a temporary catheter that is used for a limited time while the fistula heals. The second type is said to be a formal catheter, which can be used for a long period of time and can be removed manually by the patient at home for periodic cleaning. The differences between these catheters will be explained in detail later. The two catheters are made of the same material,
There are some differences, but the dimensions are the same. for example,
For adult patients, the length of the catheter is about 20 cm and the material is preferably polyurethane or an elastomer with a Shore A hardness of about 80-90. Flange 18
is attached near the middle of the catheter tube after installation. That is, when the catheter is properly installed in the trachea, approximately 9 cm from the coupling ring 24 at the proximal end of the tube and approximately 9 cm from the distal end of the catheter.
The position is 11cm. For adults, the preferred diameter is about an 8 French catheter. In some cases, products with an inner diameter as small as 1.7 mm are being considered. Also, for pediatric patients, devices as small as 1.0 mm in inner diameter are being considered. The length is, of course, made relatively short to prevent the problems discussed above. The method of inserting the incisional tracheal catheter C is shown in FIGS. 2 to 7. This method is performed using equipment contained in three kits. The first kit contains a hypodermic needle, a conductor wire, a dilator, and a stent. The second kit contains a temporary catheter and cleaning rod. The official catheter and cleaning rod are included in the third kit. As shown in FIG. 2, a local anesthetic is applied to a hypodermic needle 40 attached to a syringe 41 containing the anesthetic.
It is injected into the soft skin that lines the cervical trachea. Typically, a 5 c.c. syringe is filled with 1% lidocaine and a concentration of 1:100,000 epinephrine.
The needle may be 27 gauge x 3.18 cm (1.25 inches). Once the local anesthetic has taken effect on the skin, an incision is made in the skin with a No. 15 scalpel. It's in the first kit
An 18-gauge thin-walled needle is attached to the syringe containing the remaining anesthetic solution, and the needle is driven into the trachea. Correct position is confirmed by the return of air bubbles on the surface of the syringe and within it. The remainder of the anesthetic then settles into the trachea. Because of the small size of the needle, there is very little chance of bleeding, even if the skin the needle pierces is filled with blood vessels. As shown in FIG. 3, a 32 cm diameter guidewire 42 is inserted through an 18 gauge thin-walled needle 40 into the trachea. The beveled end and insertion angle of the needle
It has been developed for lowering a guidewire into the trachea. A notch-like marking on the hub of the needle is provided to indicate the direction of the bevel. The injection needle 40 is then withdrawn leaving the guidewire inside. As shown in FIG. 10, the guide wire 42 has an atraumatic distal end 43 constructed so that it does not scratch or injure the mucous membrane or trachea when the wire is inserted. ing. This traumatic end is about 5 cm long. The guidewire has a central longitudinal wire forming a core and a wire 42 spiraled around the core wire. The core wire extends beyond one end of the spiral to form a flexible atraumatic end. This guidewire is marked with reference marks as described above. That is, approximately 11 cm from the atraumatic end, which tells the physician the correct insertion depth. The first kit then has a 10 French, 15 cm long Teflon tube 47 with an inner diameter 46 through which the guide wire is passed and inserted into the trachea. The initial small diameter tract or fistula tract created by the hypodermic needle 40 is generally dilated by inserting the taper at the distal end 45 of the dilator. As previously mentioned (see FIG. 11), the physician makes sure to insert the dilator to mark 48 so that the duct is lengthened and dilated slightly without cutting. The tapered end 45 has a length of about 12 mm. The dilator is left in place for approximately 1 minute to allow the skin tissue to fully expand. The expansion incision is then removed and the stent S, which is the final component of the first kit, passes through the guide wide 42 passed through it and enters the trachea through the duct, as best seen in FIG. . Flange 18
The structure of stent S with attached is shown in FIG. The flange 18 has sutures placed through its eyelets to stabilize the stent and to suppress coughing.
Replaces taper cup ring. The body pull of the stent is made of a material that is stiff enough to maintain the conduit created to open the trachea. The stent body 51 typically has a 9 French diameter and is approximately 11 cm long from its tapered distal end 52 to its proximal end 50. The tapered tip 52 makes it easy to insert the stent S into the trachea through the duct. Conduit 53 runs through the stent and is kept unobstructed so that exhaust air from the patient can pass through, preventing air from collecting under the elbow during the installation procedure, and preventing the patient from developing subcutaneous emphysema. You don't have to worry about it anymore. Usually after one week, or longer if necessary, the stent S is removed by the doctor. Then, as shown in FIG. 6, a temporary catheter T is inserted. The structure of this catheter is shown in detail in FIG. The temporary catheter is longer than the stent, approximately 20 cm.
It is. In fact, the length of the temporary catheter T inserted inside the trachea to the distal end is approximately 11 cm.
This length is the same as the end of the stent. This temporary catheter has a coupling 56 at its proximal end 58 for connection to an oxygen cylinder. The extra length of tube created by the proximal end 58 allows the patient to
6 can be seen. Therefore, as will be described later, the patient can easily attach and detach the oxygen cylinder and clean the catheter. The catheter has a longitudinal passage 60 along its entire length and a reinforcement 6 that can take any shape.
1, the proximal end 58 and distal end 54 of the temporary catheter T are shown in the form of coiled wires or embedded cords in the tubular sections.
This exterior design was designed to maintain a constant cross-sectional area of the catheter lumen, to ensure a constant supply to the patient, and to prevent the catheter from breaking or kinking when handled by the patient. . This is important because this temporary catheter may be used on an outpatient basis without constant medical supervision. An alternative construction is shown in FIGS. 21 and 22, which strengthens the catheter at necessary points to prevent it from kinking or breaking during use. Flange 98 (which is of similar shape and construction to flanges 18, 18' and 18'').
has a shoulder part 90. This is shaped to support a coil reinforcement 91 (shown in phantom in FIG. 22). This coil reinforcement material is
5 and prevents the tube 95 from twisting or breaking during use. Referring again to FIG. 21, catheter tube 95
The extent to which external reinforcement 91 is applied to provide the desired reinforcement is shown. Up to about 8 cm (about 3 inches) of coil reinforcement is considered sufficient for such applications. To achieve the desired function, the coil reinforcement is made of plastic or metal. The end of the portion 54 below the flange forms a tapered portion 62. The rear side of this tube is
It is longer to aid in insertion, to divert oxygen introduced through the catheter from the mucous membrane behind the trachea, and to direct the oxygen downward and slightly forward. After correct positioning, temporary catheter T
is connected to an oxygen cylinder. The oxygen supply is then adjusted to achieve blood oxygen saturation of 90% or greater by audio oximetry or arterial blood gas analysis. Since oxygen is being delivered to the patient via the temporary catheter T, the conduit or lumen 60 must not be obstructed. This is accomplished using a cleaning rod, such as cleaning rod R of FIG. This cleaning rod is made of flexible plastic, with a right angle bend at the top end. handle 6
It has an elongated shaft 64 having a diameter of 6. The shaft 64 is slightly longer than the entire length of the temporary catheter T. To clean the catheter, the oxygen supply is cut off and the catheter is inserted through the coupling 56 and along the line 60. The length of the shaft 64 is sufficient to completely drain mucus buildup in the catheter lumen. In addition, the diameter of the shaft 64 is
It is only slightly smaller than the inner diameter of conduit 58. This cleaning is normally done twice daily, or more often if necessary. After cleaning, the cleaning rod R is withdrawn and the coupling 56 is reconnected to deliver oxygen. The temporary catheter, fitted with flange 18' and reinforced as described above, remains in place for six weeks or more to allow the tracheal passageway or fistula to heal. Once the patient is completely healed, the doctor removes the temporary catheter T and inserts and positions the permanent catheter relative to the patient as shown in FIG. The official catheter is almost the same as the temporary catheter T, although there are some differences. The structure of the formal dissection tracheal catheter, which is part of the third kit, is shown in FIGS. 16-18. This catheter tube 10 may also be embedded in the tube (see FIG. 18) or reinforced, such as by a coil spring 72, partially shown in FIGS. 21 and 22. The purpose of this sheath is also to reduce fraying and kinking of the dissection tracheal catheter, which can limit oxygen delivery to the patient. The coil spring 72 is connected to the tube 1
0 extending a sufficient distance along the length of the flange or fastener 18'' approximately 9 cm from the proximal connector 24 and approximately 11 cm from the distal end to provide the characteristics described above. There is an aperture 74 (FIG. 19) for receiving a chain 20 or other retainer. Catheter tube 10 has a longitudinal channel or lumen 76 at its distal end that conducts oxygen from the tracheal mucosa. There is a longer posterior taper 78 that deflects the trachea.The multiple holes 12 are spaced anteriorly over an approximately 120 degree arc.All holes extend medially from the posterior wall of the trachea. On the part of the side wall facing
and located above the short end of beveled end 78'. In other words, as shown in FIG.
60 on both sides with the center line 80 on the front side of the tube 10.
They are spaced within degrees. The advantages of this arrangement are clear from FIGS. 8 and 9. In Figure 8, the front incision catheter K
The tubular body 8 has a flat end 84 and no holes in the side walls.
It turns out that it is 2. As shown, most of the oxygen falls straight into the right mainstream bronchus 16. The reason for this is that, rather than proceeding to the left bronchus 17, oxygen proceeds along a straight downward path when viewed from the trachea. As a result, the air drawn into the patient's lungs during normal breathing is replaced by an oxygen flow (arrow 88
(indicated by ) do not mix well. On the other hand, in a preferred embodiment as shown in FIG.
The oxygen is expelled through the beveled or tapered end 78 and hole 12 of the catheter C to avoid the mucous membranes on the dorsal wall of the trachea and enter the trachea, as shown in FIG. . Air enriched with almost the same amount of oxygen flows uniformly to both the right bronchus 16 and left bronchus 17, and in order to reduce the drying effect of oxygen on the mucous membranes, oxygen is discharged in a multidirectional flow. As a result, the above reduction occurs. Between the previous incision catheter K and catheter C,
Another important difference is that the proximal end, or extension 68, of catheter C extends approximately 9 cm externally, whereas the connector of catheter K is flush with the trachea. For this reason, catheter C is suitable for outpatient use, but catheter K is not. The extension 68 allows the patient to see the coupling 24 through the chin. The patient can therefore easily attach and detach the oxygen supply tube and can periodically remove the catheter for cleaning. Oxygen is exhausted at very low pressures with small flows of less than 0.14 Kg/cm ² (2 psi). This is usually 50% or less of the amount required for canyule. This catheter is limited to use by spontaneously breathing outpatients. Patients who require more than 3 per minute with an incisional tracheal catheter, either at rest or during physical activity, will receive 6 to 8 per minute with the catheter of the present invention.
It is possible to accept up to If a 16 gauge catheter and a catheter of the present invention receive oxygen at the same flow rate (liters per minute), the amount of oxygen delivered to the blood will be:
This chart shows that there is an improvement. It is clear that the nasal cannula, even when used at high flow rates, is not as effective as the incisional tracheal catheter of the present invention. Thus, while providing high blood gas values to the patient during treatment, less oxygen is used, resulting in significant cost savings. With long-term use, this difference in efficiency provides further benefits to the patient, both in terms of prolonging the lifespan of the vital essence. From the foregoing, the advantages of the present invention have already been realized. Open tracheal catheters should be safe and comfortable for naturally breathing patients, and can be installed in the doctor's office without hospitalization for outpatient care. The dissection tracheal catheter can be inserted under local anesthesia and installed while still allowing ambulation. Due to the small size of the device, insertion can be done without damaging the artery. In order to provide a constant supply of oxygen to the patient, the dissection tracheal catheter is sheathed to prevent the tube from slipping and breaking. Additionally, the device can be conveniently removed by the patient for cleaning and reinsertion. Disconnection and reconnection of the oxygen supply tube is facilitated by the extended outer end. A constant stream of low-pressure oxygen flows into the damaged airways of emphysema patients, opening up the bronchi, improving lung function and easing breathing movements. The enrichment described above is accomplished using the equipment included in kits 1, 2, and 3. The first kit includes: a needle to make the initial passage into the trachea; an atraumatic guidewire that is threaded through the needle to hold the passage after the needle is removed; There are dilators that are passed inside and used to widen the canal, and stents that can replace dilators. The second kit contains a temporary catheter, which replaces the stent and is left in place for several weeks while the ducts are fully healed, and a cleaning rod to clean the temporary catheter. The third kit contains a permanent catheter that can be removed and replaced with a temporary catheter and a cleaning rod after healing is completed. An important feature of this method is that a smaller diameter catheter is inserted using a smaller diameter needle to create a duct that is later expanded. On the other hand, with the previous incisional trachea, a small diameter catheter and a large needle were required to resuscitate a patient who was unable to breathe.
A large tracheostomy tube requires a large conduit. The first kit is an insertion tray that contains all the components necessary to create a lumen for the incisional tracheal catheter of the present invention, except for sterile gloves and facial tissues. A paper drape around the tray is unfolded to serve as a Mayo stand cover. The insertion tray has two layers. The upper preliminary layer is
Must be used cleanly. It also serves for puncture positioning, local anesthesia, and skin care. The lower and second treatment layer should be used sterile and serves to create a catheter lumen and stabilize the stent device. Intricate items included in the upper layer include a surgical marking pen, two #3 stainless steel beat chains with coupling rings, approximately 5 cm in length, a flexible wire cutter, three alcohol spare butts, and two 5 c.c. reuel tip syringe with 100000% lidocaine and epineurin, 21 gauge x 1.5 ¹¹ syringe needle Hibiclens soap, spare well sponge stanchion, 4 x 4 ¹¹ gauze sponges for skin insertion 2
There are several. The lower layer is Steri Drape.
(#1010), 2 x 4 x 4 ¹¹ gauze sponges, #15 Barad-parker scalpel blade on swivel plastic handle, 7 x 18 gauge
cm thin-walled needle, 5 c.c. reuel tip syringe with 2 c.c. medicated salts, 11 cm stamped 32 x 0.38 ¹¹ straight guidewire, 8 cm stamped 10 French x 15 cm skin dilator, Lubafax packet,
Includes a 9 French stent, a flexible needle holder, flexible scissors, a 3-0 nylon suture threaded through an FS-1 needle, and an H bandage. The insertion tray thus has all the parts necessary to create a conduit for the dissecting tracheal catheter, except for the sterilizing means and the facial tissue. Most of the components contained in the tray can be purchased on the open market and assembled in an orderly manner at the clinician's convenience. Manufacturer of Insertion Tray Components Surgical Engraving Pens Dayvon Industries
Devonn Industris, Chatsworth CA91311 Stainless Steel Beet Chain McMaster-Carr, Chiago, IL60680 Chicago, IL60680 Beet Chain Cutting Shears #32048-022 American Hospital Supply, Illinois 60085 Margaux Park (American
Hospital Supply, McGaw Park, IL60085) Alcohol Reserve The Kkendall Company Hospital Products, Boston, MA 02101
Producats, Boston, MA02101) 5 c.c. Reuel Taper Syringe with 2% Lidocaine and Epinephrine 1:100000 American Phamaseal Laboratories Glendale, California 91209
Glendale CA91209) Monoject 27 Gauge x 1.25 ¹¹ Needles Shouted Medical Missouri 63103
St. Louis (Sherwood Medical, St.
Louis, MO63103) Hibiclens Soap Stuart Pharmaceuticals Wilmington, Delaware (Stuart
Pharmaceuticals, Wilmington, DE) Johnson & Johnson, New Brunswick, New Jersey 08903
NJ08903) Satellite-Drape #1010 Surgical Products Division/3M
St. Paul, MN 55144 (Surgical
Products Division 134 St. Paul, MN 55144) 4 x 4 ¹¹ Gauze Sponge Johnson & Johnson New Jersey 08903 New Brunswick #15 Bard-Parker Mess Becton Deitzkinson & Company New Jersey 08903 07035 Lincoln Park (Becton Dickinson & Co, Lincoln)
Park, NJ07035) 18 Gauge x 7cm Thin Wall Syringe Needle Cook Inc. Bloomington, Indiana 47402 (Cook Inc,
Bloomington, In47402) 5 c.c. Reuel Syringe Tapered Syringe with 2 c.c. Medicinal Salts American Pharma Seal Laboratories Glendale, California 91209 Lubafax Burroughs Wellcome Company, Research Triangle Park
Wellcome Co, Research Triangle Park) Webster Needle Holder #32042-042 American Hospital Supply, IL 60085 Matsuku Go Park Suture Scissors American Hospital Supply, Illinois 60085 Matsuku Go Park FS-1 Injection Needle Threaded 3-0 Nylon Suture Thread Ethicon Incorporated Somerville, New Jersey 08876
Somerville, NJ 08876) H-Bandages Johnson & Johnson New Brunswick, New Jersey 08903 The remaining components are optionally made of biocompatible materials as described above. For example, temporary and permanent catheters are made of medical standard polyurethane coated with a hydrophilic polymer at locations hidden in the trachea, as discussed above. The use of polymers facilitates insertion and removal until the surface is smooth. The polymer also does not allow mucus to adhere to the catheter. The beveled ends of the temporary and permanent catheters and the permanent catheter side holes direct oxygen from the tracheal mucosa to the center of the air column within the trachea. This provides comfort to the patient. The presence of asymmetrical flanges, such as fasteners (see Figure 9), facilitates proper placement. Improper placement may be comfortable for the patient, but is not effective. The tube extends 9 cm from the flange to the hole-type reuel taper coupling, so the coupling is missing from the collar. This makes it easier for the patient to handle the coupling. Since the force required to remove the hole-type Riuetel taper is 0.9Kg (2 pounds) (between 0.4Kg and 1.2Kg, 1 pound and 3 pounds), the front end of the oxygen hose must be pulled hard evenly. The catheter can be safely removed without becoming dislodged. A cleaning rod is adapted to be passed through the lumen of a temporary or permanent catheter to remove debris. The rod is 5 mm longer than the catheter and has a 2 cm handle bent at right angles and a small head at the end of the handle to prevent over-insertion into the catheter and the rod being dropped. Both temporary and permanent catheters according to the invention are made of medical standard clear polyurethane, 8 French reinforced tubing, specifically reinforced with nylon coil springs, and have a length of approximately 20 cm (7.875 ¹¹ ).
It is. The attachments and safety flanges are in particular made of Kraton or polyethylene and are transparent. Treatment Candidates for this procedure must have a _PaO2 arterial blood gas analysis of less than 55 torr and, when appropriate medical care is provided,
The need for long-term oxygen therapy with an SaO ₂ analysis of less than 90% room air must be demonstrated. Open tracheal oxygen therapy also allows patients increased mobility, improved cosmesis, and avoidance of nasal discomfort due to cannulation. Patients who receive inadequate blood oxygenation with a nasal cannula or 16 gauge incisional tracheal catheter will experience improved blood oxygenation through use of the catheter of the present invention. The preferred pre-puncture method must identify those for whom open endotracheal oxygen therapy is contraindicated and those who require special considerations during treatment. The puncture technique uses an 18-gauge needle, a guide wire, and a tracheostomy dilator, which causes less discomfort. Approximately 1 hour before the puncture, the patient takes the prophylactic resistance organism by mouth while sipping water. If no contraindications are found, a caliber anesthetic is administered for mild sedation and cough suppression. The patient takes off his upper body clothing and puts on a hospital gown. The patient rests his or her head on the surgical chair and lifts the head slightly to recreate the position of the neck while looking in the mirror while the catheter is being replaced. Oxygen is continuously supplied throughout the process. However, the canyule can be repositioned so that it does not extend from the back of the head and interfere with the front of the neck. The insertion tray is removed from its plastic bag and placed on a mayo stand at chest height in front of the patient. Unfold the paper wrapper enough to act as a sterilizing drape for the mayo stand. Carefully palpate the anterolateral side of the neck to detect the notch in the thyroid cartilage, cricothyroid capsule, and manubrium.
Mark with a surgical marking pen. Mark the anterior jugular vein visible. #3 Wrap the stainless steel bead chain necklace around the patient's neck until it fits snugly.
However, leave one finger's worth of room and cut it out with wire cutters. The chain is lowered over the trapezius muscle, marking the intersection of the cervical trachea and the neticles for later puncture. The upper limit that can be punctured is the tracheal gap just below the cricoid cartilage (cricotracheal ligament), and the lower limit is the manubrium of the sternum. Sometimes it is better to have a tighter neckline to accommodate the low cricotracheal puncture site. The length of the second cut of the beat chain is in consideration of the case where the first cut was cut much shorter. Custom-made chains are removed, wrapped, and labeled for later use. Disinfect the skin at the puncture site with an alcohol swab without erasing the directional markings. Attach a 27 gauge x 1.25 ¹¹ needle to a 5 c.c. syringe containing 1:100,000 epinephrine and 2% lidocaine. Approximately 2 c.c. of this liquid is injected into approximately 2 cm of skin on either side of the midline at the selected site, and approximately 1 c.c. of local anesthetic is injected into the deep anterior tracheal tissue.
Then replace it with a 22 gauge x 1.5 ¹¹ needle. A facial tissue is applied to the patient who is informed of an initial cough, bad taste, and sensory bulbs due to local anesthetic. The needle is inserted so that it reaches the trachea at the puncture point and the remainder of the anesthetic is quickly deposited in the tracheal mucosa. There may be brief coughing fits. The front of the neck is treated with HibiCleanse soap using a sponge stick. HibiCleanse soap is preferred over various iodine soaps because it does not stain and is ideal for such outpatient settings. Wipe the skin with gauze so that the treatment tape is on the skin and allow it to dry. The reserve top layer is removed from the mayo stand to reveal the reserve bottom layer, which should remain sterile. Put on surgical gloves and place the SteriDrape over the upper part of the lung at the level of the collarbone. A 1 cm vertical incision is made in the center of the puncture site using a #15 scalpel. To maintain the direction of the puncture, place a gauze sponge on the palm of the other hand while piercing the trachea. The incision must extend beyond the skin and extend into the fat. The jugular vein, which is immediately visible, must be avoided. An 18-gauge needle attached to a syringe containing medicated salts is inserted through this incision and into the trachea. Feel the tracheal cartilage and insert the needle into the gap. Air is drawn into the syringe. This needle is then withdrawn. Turn the notch on the hub of the needle until it reaches the lower membrane. Place the tip of the needle against the keel-shaped protrusion,
Point downward at 45 degrees. The atraumatic tip of the wire guide should pass comfortably into the lower airway to a depth of 11 cm. If the wire does not thread properly, the needle must be repositioned. Withdraw the needle and place the 11cm mark on the wire guide on the skin surface. Push the 10 French dilator firmly into the trachea through the wire guide. However, 8
Do not push in more than cm. Remove the 1 minute dilator and replace with 9 French. The stent can be easily inserted by applying a small amount of water-soluble jelly to the tip and gently pushing while rotating it. Then, pull out the wire. A disposable needle holder and scissors are used to stitch the stent and skin with 3-0 nylon suture. Pass the suture through one of the two eyelets on the flange of the stent, being careful not to approach the midline incision. The skin and stent lumen must remain unobstructed to eliminate the risk of subcutaneous emphysema. Next, carefully wrap the H bandage so that it does not become an occlusive bandage. The patient is moved along the radiology and undergoes anteroposterior, side-to-side lung X-rays to confirm catheter position and the absence of pneumothorax and subcutaneous emphysema. Oxygen was delivered continuously through a nasal cannula for the next week with stainless steel. Oxygen must be delivered through the stent. This method is relatively atraumatic, so to date no significant bleeding has been observed. Since the stent acted as a drain, no bacterial invasion into the incision channel was observed. After one week of stent, the doctor manually inserts a temporary incisional tracheal catheter through a wire guide and begins open tracheal oxygen therapy. The temporary catheter remains in place for several weeks while the initial incision channel of open tracheal oxygen therapy hardens. The catheter is cleaned with a cleaning rod and sterile medicated salts. Kink and break resistant oxygen hoses
Preferred for connecting standard oxygen cylinders to the catheter. Inadvertent dislodgment of the cannula is prevented by suspender-style safety clips on the belt of the pants or the top of the dress, and a safety release device weighing approximately 1 kg (2 lbs) on the reuel taper coupling between the hose and the catheter. protected. In summary, approximately 80 to 90
A durometer value of is desirable, and indeed necessary, for proper insertion and long-term treatment patient comfort. In this regard, the distance between the positions of the distal holes of the permanent catheter is such that it can be placed in the desired location and correctly oriented, and within the range of the above-mentioned placement, correct insertion,
It is designed to retain sufficient flexibility and stiffness to aid in removal and cleaning. The 8th French size for temporary and permanent catheters is such that for a preselected range of oxygen flow rates, this size is the minimum diameter that is compatible with back pressure.
We know the results of various tests. The inventive concept described above can be embodied in various ways, and numerous changes and modifications are possible without departing from the scope of the claims.