Vacuum Bell for Non-Invasive Treatment of Pectus Excavatum

To be used only after a medical examination and in accordance with a doctor's recommendations

Purpose: Non-invasive treatment of pectus excavatum. Please note that this device is not intended for intraoperative use and cannot be used in the presence of open wounds.

Patent Formula: Non-invasive elevation of the pectus excavatum and maintaining it in the raised position. The vacuum bell lifts the chest with the help of partial vacuum. In most cases, initial effects may be noticeable immediately. Subsequently, the goal of the applied vacuum is to maintain the deformed chest in an elevated position.

Key Mechanisms:

In principle, the action of the vacuum bell is strong enough to overcome resistance from bones, cartilage, and ligaments that collectively form the chest indentation. However, internal muscles, including the diaphragm and the transverse chest muscle, tend to maintain the chest's deformed state by pulling it inward. The vacuum bell also stretches these muscles to weaken their tension.

It would be a mistake to rely on a substantial increase in vacuum (with the force applied to the chest deformation) to significantly improve results. In most cases, a significant increase in vacuum is unproductive and can reduce the overall rigidity of the chest bones. Reducing the rigidity of the ribcage is undesirable as it needs to withstand the tension of internal muscles.

Upon removing the vacuum bell after each treatment session, the deformed chest begins to return to its previous sunken state. It may take several seconds, minutes, hours, days, or weeks for this effect to become truly noticeable, depending on each patient's individual condition and the stage of treatment. To maximize the effectiveness of treatment, the use of the vacuum bell should be regular and continue for a considerable period. The first sign of sustained success is when the deformed chest partially retains elements of elevation between two treatment sessions.

The vacuum bell can be used throughout the day without affecting regular daily activities: you can lie down, sit, stand, walk, run, go to school or work, and engage in specific types of physical activities. This advantageous feature allows the evolving chest shape to adapt to the biomechanical demands of everyday life.

Possible Course of Therapy:

At the outset, the patient must undergo a thorough examination by a specialist doctor to ensure there are no contraindications for using the vacuum bell. The initial application of the vacuum bell should be done under the supervision of medical personnel. The vacuum bell should be properly fitted while the patient is in a horizontal position, ensuring a snug and comfortable fit. Under the guidance of medical staff, the patient should evacuate air according to the doctor's recommendations. During the air evacuation process, the patient may experience only slight discomfort. After creating the vacuum effect, the patient can cautiously stand up and walk. The first treatment session should last for 15 minutes, after which an evaluation is necessary. Subsequently, the patient can use the vacuum bell independently.

Subsequent treatment sessions can be conducted at the discretion of the patient in the comfort of their home. In the initial stages of the treatment course, if desired, the patient can interrupt the procedures for a few days to allow any chest discomfort, resembling muscle pain, to subside. Once the chest becomes accustomed to the elevation of the chest indentation, the patient can use the vacuum more frequently (reducing the break time between treatment sessions) and extend the total duration of treatment to several hours per day.

During the initial stage of treatment, medical supervision is required every week, and later on, it can be reduced to monthly or quarterly check-ins.

The day when the chest indentation remains adequately elevated after the previous treatment session is a crucial moment in the evolution of treatment. From this point on, the treatment should continue for about a year to maintain the progress achieved.

In combination with this treatment, it is recommended to undergo physiotherapeutic procedures and exercises, especially those aimed at increasing lung capacity and those designed to stretch the upper part of the body. These measures can significantly contribute to improving the physical appearance of patients with pectus excavatum.

Regarding the concept and use of the vacuum bell:

The concept of the vacuum bell was primarily designed for male individuals and does not take into account the contours of the female breast. When female patients use the vacuum bell, special care and caution are required.

The Large Vacuum Bell (longitudinal diameter approximately 26 cm) is mainly intended for individuals with a height ranging from 1.70 m to 2.00 m, with an average weight and body build. If the patient is too small or too large, the vacuum bell may not function optimally. The specified sizes are approximate, and the appropriate type of vacuum bell is determined during the fitting of the device.

The Small Vacuum Bell (longitudinal diameter approximately 19 cm) is mainly designed for individuals with a height ranging from 1.40 m to 1.70 m, with an average weight and body build. If the patient is too small or too large, the vacuum bell may not function optimally. The specified sizes are approximate, and the appropriate type of vacuum bell is determined during the fitting of the device.

The Mini Vacuum Bell (longitudinal diameter approximately 16 cm) is primarily intended for individuals with a height ranging from 1.04 m to 1.40 m, with an average weight and body build. If the patient is too small or too large, the vacuum bell may not function optimally. The specified sizes are approximate, and the appropriate type of vacuum bell is determined during the fitting of the device.

With proper fitting, the vacuum bell should be positioned so that the tip of the tube is centered in the upper part of the sternum.

Performing the treatment procedure is facilitated when the stomach is full or partially full: this helps the vacuum bell adhere to the abdominal cavity and support the upper abdomen, which can contribute to improved results.

For safety reasons, the inflating force of the bulb is limited. The proper functioning of the bulb helps maintain a pressure difference of 15% compared to atmospheric pressure, which is generally sufficient to lift the chest indentation and keep it in an elevated position. When the pressure difference exceeds 15%, the volume of air pumped out decreases. And when the pressure difference reaches 30%, the air displacement level tends to approach zero.

The suction effect is created when the patient releases the bulb after squeezing it. Typically, it's sufficient to press the bulb again when it returns to its round shape.

For safety reasons, the bulbs provided as part of the vacuum bell kit cannot be replaced with other models.

The inflow of air into the vacuum bell (for example, after the end of a treatment session) is facilitated by turning the intake valve, which helps avoid sudden air movement.

Technical Recommendations:

1. The viewing glass of the vacuum bell is made of polycarbonate (optical plastic) and is sensitive to exposure to alkalis, ammonia, certain organic solvents, and steam sterilization. (The manufacturer does not have information about other sterilization methods and therefore cannot provide any guarantees in this regard.)

2. The nozzle on the tube is made of polyamide. The nozzle and the viewing glass are fastened together with a screw connection. Improper use of the screw connection can lead to reduced strength. Nozzles on the tube that have been screwed on very tightly at room temperature can be repaired by the manufacturer, while the thread inside the viewing glass, which has been deformed due to high temperatures, cannot be repaired.

3. Before each use of the vacuum bell, it is necessary to visually inspect the device and ensure that the bell, tube, air inlet valve, and bulb are properly connected. If necessary, the connections should be adjusted. During the inspection, also ensure that the nozzle on the tube is undamaged and fully screwed into the viewing glass. Damaged nozzles on the tube can break and should be sent to the manufacturer, who will provide a replacement.

How Long Do Need to Wear the Vacuum Bell?

At first, the vacuum bell should be worn about 30 minutes, twice a day. Over the following 4–6 weeks, you'll slowly increase the amount of time patient wears it, up to about 2 hours twice a day (or as recommended by your health care provider).

Most peatients need to use the vacuum bell for a year or more.

Are There Any Problems With Using a Vacuum Bell?
Usually, the vacuum bell causes no problems except a little redness or bruising where it attaches to the chest. This usually goes away on its own after a few hours. Sometimes a health care provider will lower the amount of suction to lessen the chance of redness or bruising.

Less commonly, someone can have back pain or a burning or prickly feeling in the arms while wearing the vacuum bell. If this happens, take off the vacuum bell and try a lower pressure in a few hours.

Physical and Physiological Conditions:

Bending Moments: The vacuum lifts the chest bone from its concave position to an elevated position. The cartilaginous ends of the ribs and the rib arches connected to the chest bone are also stretched into an elevated position. Simultaneously, the frame of the vacuum bell presses against the person's body with equal force. The load from these simultaneously acting forces creates a bending moment, initially in the area of the chest bone and along the edges of the chest indentation. The bending moment at the edges of the chest indentation is balanced by the attachment of the ribs to the spine (vertebral column).

These bending moments transform the cartilaginous ends and rib curvatures, as well as both mobile joints of the chest bones. Correction of the chest indentation primarily occurs due to this transformation.

The elevation of the chest indentation is a three-part process that affects the bones, cartilage, and ligaments of the chest:

1. Initial, reversible (elastic) deformation.
2. Gradual, permanent transformation.
3. Micro-tears, most of which occur at the beginning of treatment.

Until these tears heal, the patient's chest will experience a slight temporary loss of rigidity.

The return of the chest indentation to its original position after removing the vacuum bell can be explained by an analogy to the "competition" between the rigidity of the chest and the tension of muscles, including the diaphragm.

Optimal response to therapy occurs through a slow and steady elevation of the chest indentation, carried out in such a way as to minimize the temporary loss of chest rigidity.

Gradual progress is preferable: it may take some time (possibly even 2 to 4 weeks) for the chest to rise to a level where the chest indentation makes contact with the viewing glass.

Internal tensioning muscles, such as the diaphragm, become stretched when the chest wall is lifted. Over the course of the full treatment regimen, these muscles "adapt" to their new position and pull the chest indentation inward less forcefully. In many cases, this "adaptation" process takes up most of the treatment time.

CONTRAINDICATIONS
(Cases where the vacuum bell should not be used):
• In cases of skeletal disorders that affect bone rigidity, such as imperfect osteogenesis and osteoporosis (reduction in bone tissue density).
• In cases of vascular or lymphatic diseases, such as Marfan syndrome or aneurysm (bulging of artery walls).
• In cases of blood clotting disorders, including thrombopathies (impaired blood clotting function) or hemophilia.

Medical Precautions, Advice, and Precautionary Measures:

Warning: Throughout the entire process of correcting pectus excavatum with the vacuum bell, temporary reduction in the rigidity of the chest bones should be expected. This implies that work or sports activities involving very high loads on the chest, such as boxing or wrestling, should not take place during the entire treatment process. Additionally, the patient should avoid the use of excessive vacuum or extreme changes in vacuum depth, which is not necessary and may contribute to a reduction in chest bone rigidity.

At the beginning of the treatment session, dizziness can be avoided by preferring a horizontal position and slow air removal. Once the vacuum is created under the bell, the patient can try to gently stand up and walk.

The vacuum bell should not be used in situations associated with blood saturation with dissolved gas (such as after diving underwater) or during short-term travel at high altitudes (airplane, high-altitude train, etc.).

Specific types of chest muscles in bodybuilders may affect the fit of the vacuum bell. Additionally, these muscles, when drawn into the vacuum bell, occupy a certain space and may hinder the effectiveness of the device.

Fractures.

 If a patient reaches an age where the possibility of a sternum or rib fracture should be considered, extra caution is required. Adequate examination and precautions should be taken.

Hematomas (bruises, contusions).

 The appearance of hematomas may be a sign of (micro) fractures of bones or (micro) tears in cartilage. They can also simply be a result of the device suction. In case of the appearance of dark (black) hematomas, the patient should consult a doctor. Prevention measures: shorter duration of device application procedures and reduced vacuum intensity.

Temporary back or lower back pain may occur due to resistance to lifting the chest indentation at the attachment point of the ribs to the spine. Prevention measures: shorter duration of device application procedures and reduced vacuum intensity.

Blood droplets appearing on the skin.

 Prevention measures: shorter duration of device application procedures and reduced vacuum intensity.

Skin abrasions: Skin abrasions may occur due to contact with the viewing glass, especially if the vacuum bell is used during the patient's physical activity. In such cases, treatment should be paused for several days until the abrasions heal. Failure to allow the skin to heal can lead to bleeding when applying the vacuum. Prevention measures: shorter duration of device application procedures, reduced vacuum intensity, and reduced activity intensity during vacuum bell application.

"Tingling" in the hands: A condition resembling numbness, especially in the extensor muscles of the shoulder (the part of the arm from the elbow to the shoulder joint) and to a lesser extent in the muscles of the forearm. Despite the apparent connection between treatment and "tingling," the specific cause of this phenomenon is unclear. Prevention measures: shorter duration of device application procedures and reduced vacuum intensity.

Saggy, wrinkled skin.

This is caused by fluid accumulation in the body tissues. Prevention measures: shorter duration of device application procedures and reduced vacuum intensity.

Irritation of breast nipples: It may occur due to contact with the vacuum bell, often when the rim of the vacuum bell comes into contact with the nipple. Prevention measures: Apply the vacuum bell in a way that its rim does not touch the nipples. For example, completely cover one nipple with the vacuum bell and leave the other nipple completely exposed.

Gynecomastia (enlargement of male breast tissue).

In rare cases, teenagers and young men may experience nipple or breast tissue enlargement, possibly due to the use of the vacuum bell.

Presumed origin:Repeated contact of the vacuum bell with the breast nipples may stimulate the growth process.

Correction: Medical supervision is required for the patient. Depending on the specific situation, the doctor decides whether it is sufficient to discontinue the use of the vacuum bell for several weeks or if additional medication is necessary.

Feverish bronchitis.

This case was observed once after the very first use of the device. The nature of the correlation is unclear: it may have been a "common" cold due to exposure of the upper body. Prevention measures: shorter duration of device application procedures and reduced vacuum intensity, especially at the beginning of the treatment.