RU221052U1 - DEVICE FOR TREATMENT OF OPEN PNEUMOTHORAX - Google Patents

Abstract

The utility model relates to medical devices and is intended to eliminate open pneumothorax resulting from gunshot, stab or other chest wounds, providing sealing of the pleural cavity and is intended for use in the field or at the scene of an incident.

The device for the treatment of open pneumothorax uses an occlusive dressing, the upper part of which is made of an airtight transparent polymer film, and the lower part has an adhesive base, as well as a tee attached to it, including a one-way petal valve and a working channel with a diameter commensurate with the outer diameter of the instruments used for diagnostic and therapeutic procedures. The use of a one-way leaf valve and a working channel as a valve ensures more reliable and effective provision of first and foremost medical aid to chest wounds with open pneumothorax. The need to insert a working channel into the device is due to the possibility of performing diagnostic (detection of damage to internal organs, the presence of foreign bodies, ongoing bleeding, etc.) and therapeutic manipulations (suturing a defect in internal organs, stopping bleeding, removing foreign bodies, collecting spilled blood) in a wounded person with open pneumothorax and etc.).

Description

The utility model relates to medical devices and is intended to eliminate open pneumothorax resulting from gunshot, stab or other chest wounds, providing sealing of the pleural cavity and is intended for use in the field or at the scene of an incident.

A device for the treatment of open pneumothorax is known - a therapeutic bandage for the treatment of open chest injuries (Asherman bandage) (US Patent 5478333), consisting of:

1. Flexible plate fastening means with upper and lower sides;

- said means of attachment to the body has a central opening, while it is drawn into a segment of a flexible channel extending in the upper direction of said means, and it has a tubular shape;

- a flexible single-wall one-way valve tube having an inner and outer side, a portion of said inner side at a first end of said one-way valve tube being sealed with the outer side of said flexible duct segment to provide unidirectional air flow.

2. The medical dressing of claim 1, wherein said flexible body attachment means and said flexible one-way valve are substantially impervious to reverse movement of both air and liquids.

3. The medical dressing according to claim 2, wherein a portion of said underside of the flexible body attachment is covered with a double-sided adhesive material attached to a tear-off backing, wherein said flexible body attachment further comprises a non-adhesive finger retainer.

4. The tube according to claim 2, characterized in that the flexible tube of the one-way valve with one wall additionally contains a second end for air outlet with two folding walls:

- the second end is located opposite the specified first end of the one-way valve tube attached to the specified flexible segment of the air duct; And

- the folding walls are in the folded position when the patient inhales, which will prevent air from entering the patient's pleural cavity through the wound opening, and in the non-folded position when said patient exhales, to allow air from the patient's pleural cavity to be expelled through the flexible tubing of the one-way valve .

5. The medical bandage according to claim 4, wherein a portion of said lower side of the flexible body attachment means is coated with a double-sided adhesive material attached to a peel-off backing, wherein the flexible body attachment means further comprises a non-adhesive finger holder to facilitate removal of the tear-off base from the bottom sides of said housing fastening means.

6. Therapeutic bandage consisting of:

- a flexible impervious body attachment having an upper side and a lower side, having a central opening retracted into a flexible impervious duct segment extending towards the upper side of said flexible impermeable body attachment, the flexible impermeable duct segment generally having a tubular shape with an internal and externally, and further comprises a non-adhesive finger release to facilitate removal of said peel-off backing from said underside of said body securing means;

- a flexible one-wall impermeable one-way valve tube having an inner and outer side, a portion of the inner side at the first end of the one-way valve tube being sealed on the outer side, allowing air to flow in substantially one direction from said flexible duct segment through the one-way valve tube;

- the flexible one-wall tube of the one-way valve additionally contains a second end with two folding walls;

- the second end is located opposite the specified first end of the specified one-way valve tube attached to the flexible segment of the air duct;

- the folding walls of said one-way valve tube are in a folded position when the patient inhales, which will prevent air from entering the patient's pleural cavity through the wound opening, and in an unfolded position when said patient exhales, to allow air from the patient's pleural cavity to exit through the flexible tube one way valve.

7. A non-invasive method for evacuating accumulated fluid and air from the pleural cavity of a victim with a chest injury, including the steps:

- placing a medical bandage over the wound opening of the patient, consisting of a flexible means of attachment to the body, having a central hole drawn into a segment of a flexible channel, said channel segment is attached to a flexible single-wall tube with a one-way valve in such a way that exhaled air passes from the patient through the flexible segment an air duct and a flexible tube of a one-way valve in substantially one direction;

- attaching a medical bandage to the patient’s skin surrounding the wound opening;

- inserting the suction means into said flexible single-walled one-way valve and said flexible duct segment into a position directly above the wound opening;

- attaching the removal means to said suction means;

- use the specified suction means to remove accumulated fluid and air from the pleural cavity.

8. The method according to claim 7, additionally including the step:

placing said patient on the side of said patient having said wound opening such that fluid flows from the pleural cavity through the wound opening.

9. A method for treating tension pneumothorax, including the steps:

- inserting a catheter towards the chest of a patient having a wound opening to enable the removal of trapped air from the pleural cavity of said patient;

- placing over said catheter a medical dressing consisting of a flexible body attachment means having a central opening retracted into a flexible channel segment, wherein said flexible channel segment is attached to the flexible single-wall tubing of a one-way valve to protect said catheter from moving thereby causing harm to said patient; And

- attaching said medical dressing to the skin of said patient surrounding said catheter.

A significant drawback of this technical solution is the impossibility of monitoring the condition of the chest wound, as well as performing diagnostic and therapeutic manipulations in a victim with an open pneumothorax.

A valve bandage is known (invention patent US 5263922) containing:

1. A sheet of material with an opening formed therein, said sheet having an outer side and an inner side, is flexible to conform to the contour of the chest area adjacent to the open wound;

- a sleeve for placement on the outside of said sheet, wherein said sleeve has an inlet end and an outlet end, the inlet end of the sleeve communicating with the opening so that fluid from the open chest wound flows into the inlet end and through the sleeve to the outlet end;

- a hollow rigid tube attached to the sheet and projecting outward from the outside of the sheet, said tube enclosing the sleeve to provide a protective shield for the sleeve;

- an adhesive substance located along the peripheral border on the inner side of the sheet for its rapid fixation on an open wound, so that the inner side of said sheet is opposite the wound;

- a layer of material attached to the inside of the sheet for absorbing fluid from an open wound, and this layer of material is located inward from the peripheral boundary of the adhesive substance, and the specified layer of material has an opening in communication with the opening in the sheet;

- a spring strip attached to the outlet end of the sleeve to elastically close said outlet end, wherein the outlet end of the sleeve opens in response to fluid flowing into the sleeve from an open wound, and overcoming the elastic force of the spring strip, elastically closing said outlet end when the fluid from the open wound has essentially stopped leaking.

2. Chest bandage for closing the victim’s open wound, consisting of:

- a sheet of material with an opening formed therein, said sheet including an outer side and an inner side;

- a hollow tubular means attached to the sheet and aligned with an opening, the tubular means having an inlet end and an outlet end, the inlet end communicating with an opening through which fluid from the open wound enters said tubular means;

- a one-way valve associated with the outlet end of the tubular means to allow fluid to flow from inside the tubular means to the outside of the housing and to prevent reverse flow of liquid into the tubular means from outside the housing;

- the tubular means is configured in an angular configuration to change the position of the valve to better release liquid from the valve in response to a change in the position of the sheet;

- fastening means for operatively securing said sheet over an open wound so that the inner side of said sheet is opposite the open wound.

3. A bandage for an open wound of a victim, containing:

- a sheet of material with an opening formed therein, which includes an outer side and an inner side;

- an open-ended hollow pipe having an angular configuration, wherein said pipe includes an inner portion and an outer portion, wherein said inner portion extends outwardly from the outside of the sheet, wherein the inner end of the inner portion is secured to the sheet adjacent to the opening such that the inner portion part of the tube is aligned with the hole;

- the outer elbow is made at an angle to the inner elbow and is spaced from the sheet;

- a sleeve located inside the pipe and including an inlet end and an outlet end, the sleeve being angled to fit the inside of the pipe, and the upstream end of the sleeve communicating with the opening so that fluid from the open wound flows into the inlet end and through said sleeve to the output end;

- a one-way valve connected to the outlet end of the bushing to allow fluid to flow from the inside of the bushing to the outside of the housing and to prevent fluid from flowing into the bushing from the outside of the housing;

- an attachment means for operatively securing the sheet over an open wound so that the inner side of the sheet is opposite the wound and the opening in the sheet is in line with the open wound.

4. The bandage of claim 3, wherein the inner portion of the pipe is substantially perpendicular to the sheet, and the outer portion is substantially perpendicular to the inner portion, the inner portion of the pipe being substantially at right angles, said sleeve having a substantially regular angular shape to conform specified passage inside the pipe.

The disadvantage of this technical solution is the impossibility of performing diagnostic and therapeutic manipulations in a wounded person with open pneumothorax.

Thus, there is a need to create a reliable device for use in providing first aid and first aid to a victim (wounded) with an open pneumothorax and performing diagnostic and therapeutic procedures.

The technical problem lies in the need to develop an easy-to-use device for the treatment of open pneumothorax with increased efficiency and the ability to carry out diagnostic and therapeutic manipulations during video thoracoscopy.

The technical result is to increase the reliability of eliminating open pneumothorax and the possibility of carrying out diagnostic and therapeutic manipulations in wounded patients with open pneumothorax.

The technical result is achieved by the fact that the device for the treatment of open pneumothorax uses an occlusive dressing, the upper part of which is made of an airtight transparent polymer film, and the lower part has an adhesive base, as well as a tee attached to it, including a one-way petal valve and a working channel with a diameter commensurate with the outer diameter of instruments used for diagnostic and therapeutic procedures. The use of a one-way leaf valve and a working channel as a valve ensures more reliable and effective provision of first and foremost medical aid to chest wounds with open pneumothorax.

The need to insert a working channel into the device is due to the possibility of performing diagnostic (detection of damage to internal organs, the presence of foreign bodies, ongoing bleeding, etc.) and therapeutic manipulations (suturing a defect in internal organs, stopping bleeding, removing foreign bodies, collecting spilled blood) in a wounded person with open pneumothorax and etc.). This fact is due to the fact that through the working channel it is possible to carry out diagnostic visualization of the pleural cavity using endovideothoracoscopic instruments in order to assess the extent of damage to the lung, heart, diaphragm and other chest organs, and to monitor the adequacy of the drainage tubes. In addition, with thoracoscopy it is possible to stop ongoing low-intensity intrapleural bleeding, remove foreign bodies, evacuate coagulated hemothorax, sanitation and drainage of the pleural cavity due to the developed consequences and complications of chest injuries.

The one-way reed valve allows air to flow in only one direction and prevents it from flowing in the opposite direction, acting automatically. When air moves in the forward direction, the petal valve (5) acts as a shut-off and control element. The outlet end of the petal valve forms two folds that are in a folded position when a wounded person with an open pneumothorax inhales, which will prevent air from entering the pleural cavity, and in an open position when the victim exhales to allow air from the pleural cavity to escape. The force created by the air determines the pressure gradient between the intrapleural cavity and the atmospheric one, in which case the valve opens; in the absence of flow of the working medium or when it moves backward, the one-way leaf valve closes.

The claimed device for the treatment of open pneumothorax is illustrated in the drawing (Fig).

A device for treating open pneumothorax includes a tee (1), a working channel (2), a plug (3), a valve body (4), a one-way petal valve (5), an adhesive base (6), and a transparent polymer sheet (7).

The occlusive dressing and one-way flap valve are made of transparent material to allow the user or victim to accurately apply the valve dressing to the center of the wound. The transparency of the device for the treatment of open pneumothorax also greatly simplifies visual monitoring of the operation of the valve and the condition of the wound.

The proposed device ensures the creation of reliable sealing of the pleural cavity due to the tight contact of the surface of the chest skin with the adhesive base (6) and the transparent polymer sheet (7), which does not allow the bandage to move or come off. A one-way petal valve in combination with a working channel makes it possible to perform diagnostics, therapeutic manipulations and at the same time decompression of the pleural cavity, i.e. significantly reduces the likelihood of such a formidable and fatal complication as tension pneumothorax and the resulting arrest of breathing and circulation. The valve body (4) is designed in such a way that it makes it possible to cover the victim (wounded) in order to prevent hypothermia, and also to apply it to any side of the injured chest (front, back and side) without giving a special position to the victim, without disrupting his work. The use of a one-way leaf valve with a working channel significantly reduces the likelihood of blocking the valve lumen with blood clots, fibrin and fragments of destroyed tissue. Removing the plug (3) from the working channel (2) provides direct access to the wound, without the need to remove the bandage, and also allows you to perform video thoracoscopy on the victim (wounded) in order to diagnose injury to internal organs and assess the stability of hemostasis, etc. Using the working channel (2) and pleural drainage, it is possible to restore the patency of the wound canal, which can be blocked due to displacement of the soft tissues of the chest wall and thereby neutralize the occurrence of such a formidable complication as tension pneumothorax, which is completely excluded by analogues. The working channel of the occlusive dressing in victims with a chest injury complicated by intrapleural bleeding allows one to minimize the failure of the valve, and also makes it possible to collect and store the spilled autologous blood.

The valve body (4) reliably protects the one-way reed valve from contact with surrounding objects that could cause malfunction.

The inventive device for the treatment of open pneumothorax is used as follows. Having discovered damage in the chest area, a U-shaped dissection of the clothing is made for more adequate access to the wound. The dimensions of the exposed surface of the chest should exceed the size of the occlusive dressing. If signs of open pneumothorax are detected, that is, the release of air when exhaling from a chest wound, the skin is cleaned of contaminants with a napkin, which is part of the occlusive dressing. Then the proposed device for the treatment of open pneumothorax with an adhesive base (6) is applied to the open wound of the chest wall, tightly fixing it, regardless of the location of the wound and the breathing phase so that the opening of the working channel (2) is above the center of the wound defect. Through the working channel (2) of the one-way petal valve, it is possible for the victim to perform video thoracoscopy in order to diagnose damage to internal organs, assess the stability of hemostasis and the presence of foreign bodies in the pleural cavity, and also perform therapeutic manipulations as necessary in the form of suturing a defect in internal organs (damaged lung, diaphragm, esophagus and other organs), stopping bleeding, removing foreign bodies, etc. Using the working channel (2) and pleural drainage, it is possible to restore the patency of the wound channel, which can be blocked due to the displacement of the soft tissues of the chest wall in case of small penetrating wounds of the chest and thereby level out the occurrence of such a formidable and fatal complication as tension pneumothorax. The use of a working channel (2) and a one-way petal valve in wounded patients with chest injuries complicated by intrapleural bleeding makes it possible to minimize its failure to operate, as well as to collect and store autologous blood spilled into the pleural cavity.

With an open pneumothorax, air during exhalation by the wounded from the pleural cavity through the working channel (2) enters the cavity of the one-way petal valve, leading to the opening of its valves, which provides unidirectional automatic release of air into the environment. During the inhalation of a victim with an open pneumothorax, the leaflets of the one-way petal valve are in a folded position, which prevents the penetration of air into the pleural cavity. All this together leads to decompression of the pleural cavity and the elimination of life-threatening conditions of the victim (wounded), thereby achieving the main goal of first aid.

The proposed device for the treatment of open pneumothorax can be used to fix pleural drainage to the skin of the victim.

An example of the use of a device for the treatment of open pneumothorax.

The experimental study was carried out on an adult Merino sheep weighing 31 kg. The selection of this animal for the experimental study was determined by the following factors:

- presence of a reaction comparable to a person’s to open pneumothorax;

- similar homeostasis system;

- optimal size and anatomical structure (Rozov A.I. Improving methods of providing medical care to military personnel with life-threatening consequences of chest wounds in the combat area. Dissertation for the degree of Candidate of Medical Sciences. St. Petersburg. - 2017).

The laboratory animal was in the vivarium of the VmedA named after. S.M. Kirov and passed the 10-day quarantine. The conditions for keeping the animal in the vivarium provided them with a normal biological background and fully complied with the requirements of the Sanitary Rules for the design, equipment and maintenance of experimental biological clinics (vivariums) dated 04/06/1973. The animal’s diet corresponded to the diet determined by order of the USSR Ministry of Health No. 179 of 1983 .

Before the experiment, premedication was performed with the drug “Zolitel 100” at a dose of 10 mg/kg, which achieved immobilization and analgesia necessary for preoperative preparation. Next, the animal was intubated with a standard endotracheal tube with a cuff. Anesthesia was selected in such a way that sufficient anesthesia was achieved, but independent breathing with atmospheric air was maintained. Monitoring was carried out using an IM-10 Zoomed veterinary monitor. The following parameters were monitored: blood pressure, respiratory rate, heart rate, saturation, central venous pressure, red blood cell count, hemoglobin and hematocrit levels, as well as intrapleural pressure.

To create a model of open pneumothorax, the following operations and manipulations were performed. A penetrating wound was inflicted on the right half of the chest, resulting in a 6 cm long stab wound in the fifth intercostal space. To create a gaping chest wound, a fragment of the fifth rib was bitten off over a length of 4 cm. As a result, a chest wall defect measuring 4x6 cm was formed. The pleural cavity communicated freely with the environment. Exposure for 10 minutes. At the time of injury, disturbances in the cardiovascular and respiratory systems were clearly visible. During the experiment, there was a natural tachycardia (120 beats per minute), an average decrease in blood pressure (70 mm Hg), respiratory rate (29 per 1 minute) and saturation (79%) as a result of a violation of the integrity of the chest. An X-ray of the chest organs revealed that the right lung was collapsed, a fragment of the fifth rib was missing; during ultrasound control, air was detected in the pleural cavity and no sliding of the lung relative to the chest wall was observed; a small hemothorax was detected.

Next, the proposed device was removed from the packaging and the adhesive base was applied to the area of the simulated chest wall defect. Exposure 5 minutes. As a result of its use, open pneumothorax was eliminated by unidirectional discharge of excess air from the pleural cavity through the operation of a one-way leaf valve. The reliability of fixation of the occlusive dressing to the skin along its entire perimeter was assessed, which showed its reliable fixation. After applying the proposed occlusive dressing for open pneumothorax without damaging the lung, the amount of air escaping from the pleural cavity gradually decreases, and changes in indicators towards stabilization are also noted. So the average blood pressure was 74 mm Hg, heart rate - 90 beats per 1 minute, respiratory rate - 22 per 1 minute and saturation 95%. X-ray of the chest organs shows that the right lung is expanded, a small amount of air is in the pleural cavity, and a fragment of the fifth rib is missing. During ultrasound control, air and fluid in the pleural cavity are not detected. When performing thoracoscopy through the working channel, it was found that the lung was expanded, occupied the entire hemithorax and approached the edge of the wound defect.

Then the proposed occlusive dressing was removed from this animal and a stab wound was applied to the lung with dimensions of 2.0×1.0 cm and a depth of 3.0 cm. Thus, the occurrence of an open pneumothorax with damage to the lung was simulated. After applying another occlusive dressing to an open wound of the chest with damage to the lung, the amount of air released from the pleural cavity, as a rule, was constant over the entire observation period until the defects in the lung tissue and chest wall were eliminated.

To diagnose and eliminate damage in this case, video thoracoscopy through the working channel of the valve is widely used. It should be considered as a valuable diagnostic and therapeutic intervention, allowing one to determine the volume and nature of damage and choose the optimal surgical treatment tactics. The use of endovideosurgical techniques ensures reliable stopping of bleeding from damaged vessels of the chest wall, aerostasis in case of lung damage, fixation of rib fragments protruding into the lumen of the pleural cavity, etc.

Thus, a simple, highly effective and compact device has been developed and created for the treatment of open pneumothorax in chest wounds, including those complicated by damage to the internal organs of the chest, as well as external and internal bleeding.

Claims (1)

A device for the treatment of open pneumothorax, consisting of an occlusive dressing, the upper part of which is made of an airtight transparent polymer film, and the lower part has an adhesive base, with a tee attached to it, including a one-way petal valve made of transparent material, with a valve body designed to protect one-way valve from contact with surrounding objects, and a working channel configured to place the opening of the working channel above the center of the wound, with a diameter commensurate with the outer diameter of the instruments used for diagnostic and therapeutic manipulations, with a plug configured to be removed from the working channel for direct access to the wound, while the one-way petal valve is designed in such a way that during inhalation the flaps of the one-way petal valve are in the folded position.

Images