Implantable ventilation system

Abstract

Provided herein are implantable mechanical ventilation systems and methods for improving, supporting and / or treating ventilation insufficiency in a patient in need thereof.

Description

Technical Field

[0001] The present invention relates to implantable mechanical systems and methods for improving, supporting and / or treating ventilatory insufficiency in a subject in need thereof. Background Art

[0002] Mechanical ventilation by manipulating the chest wall is an old paradigm, dating back to the 1930s when the first automated ventilator, the iron lung, was developed to support ventilation of patients suffering from polio. As the chest wall expands, it reduces pressure within the pleural space, thereby forcing air in through the ventilated airways. It then relaxes as the chest wall returns to its resting position, increasing pressure within the pleural space, which expels air from the lungs (expiration).

[0003] The result of this voluntary brain control of chest wall manipulation and diaphragm contraction followed by relaxation is the normal cyclical sequence of spontaneous ventilation. Thus, in theory, mechanical ventilation can be achieved by forcibly moving the chest wall or manipulating the diaphragm, or by inflating and deflating the lungs, as done by modern mechanical ventilators.

[0004] Mechanical manipulation of the chest is valuable in certain situations, including, for example, patients with neurodegenerative conditions who can sometimes still breathe on their own but are unable to fully expand their chest wall; mechanical chest wall manipulation devices can be effective in weaning from mechanical ventilation, for example, by helping to trigger self-initiated breathing by requiring only a partial effort to breathe.

[0005] The underlying mechanism by which patients gradually become accustomed to mechanical ventilators and need to be weaned is not yet fully understood. This may involve the weakening of respiratory muscles during prolonged mechanical ventilation and / or the effect of prolonged mechanical ventilation on respiratory control in the brain (which may weaken the brain's control of the spontaneous respiratory rhythm). Studies have shown that early extubation followed by noninvasive ventilation helps reduce the total number of days of invasive mechanical ventilation, and the shorter the time spent on invasive ventilation, the lower the incidence of ventilator-associated pneumonia. In some cases, weaning is quick and smooth, however, for some patients, the process may take days or weeks.

[0006] Furthermore, some patients require mechanical ventilation partially or entirely due to a medical condition and / or progression of a medical condition. However, restraining a patient to a bed and attaching them to positive pressure ventilation can reduce the patient's quality of life, for example, by limiting their mobility, restricting their ability to communicate, causing symptoms associated with prolonged bed rest, further weakening the patient's musculoskeletal system, and increasing the financial burden on the patient and / or healthcare provider.

[0007] Therefore, there is a need for cost-effective, efficient, and relatively easy-to-implement implantable mechanical systems for supporting and / or treating ventilatory insufficiency. Summary of the Invention

[0008] According to some embodiments, provided herein are implantable systems and methods for improving or supporting breathing and / or for treating various ventilatory insufficiencies in a subject in need thereof.

[0009] According to some embodiments, the implantable systems disclosed herein are advantageous in that they are cost-effective to produce and operate, safe to use, portable (by virtue of being implantable, thereby facilitating portability for the subject); and are highly effective in improving, supporting and / or treating ventilatory insufficiency in a variety of settings, including, for example, disengaging from non-portable ventilation systems or other respiratory support therapies, improving a patient's spontaneous breathing, improving a subject's ability to speak, improving a subject's ability to cough, helping a subject with a neurodegenerative disorder to breathe, and the like.

[0010] According to some embodiments, and without wishing to be bound by any theory or mechanism, the implantable mechanical ventilation system disclosed herein can affect the volume of the thoracic cavity of a subject by inducing physical / mechanical relative movement of the thoracic cage bones, wherein the controlled change in the volume of the thoracic cavity can induce pulmonary ventilation by creating negative pressure and reducing pleural pressure, thereby causing airflow through the patient's airways into the lungs.

[0011] According to some embodiments, the implantable mechanical ventilation system disclosed herein generally includes a movable unit that is configured to be attached / fixed / anchored to the front bone of the subject's thorax (such as the sternum) on the one hand, and is associated (physically and / or functionally) with an actuator on the other hand, which is anchored / held in place by a static unit (inside or outside the rib cage). Thus, when the actuator is activated (e.g., under the regulation of an external controller), the actuator is configured to induce relative movement (displacement) of the movable unit, which in turn induces movement of the associated bones, thereby changing the size of the rib cage and the volume of the thoracic cavity. By promoting at least partial inspiration or expiration relative to the change in the volume of the thoracic cavity, the change in the volume of the thoracic cavity in turn affects the lung volume / activity. According to some embodiments, the system may also include one or more biosensors that can help provide a biosignal for activating the movement of the movable unit so that breathing is coordinated based on the physiological signal.

[0012] According to some embodiments, provided herein is a mechanical system for improving, supporting and / or treating ventilatory insufficiency in a subject in need thereof, the system comprising: a movable unit configured to attach / fix to an anterior bony structure of the thorax, the movable unit being physically and / or functionally associated with an actuator; and a static component configured to anchor the actuator and connected to a posterior segment of at least one rib; wherein, when activated, the actuator is configured to displace the movable unit and the attached bony structure, thereby affecting the volume of the thorax.

[0013] According to some embodiments, affecting the volume of the thoracic cavity may include increasing the volume of the cavity, thereby creating a negative pressure that induces inhalation into the lungs; and / or decreasing the volume of the cavity, thereby inducing exhalation from the lungs.

[0014] According to some embodiments, the actuator may include a stationary motor; and a movable arm or sliding element that is at least partially positioned on top of each other. According to some embodiments, the arm or sliding element is located on the back or underside of the movable unit.

[0015] According to some embodiments, the actuator and static component may be positioned subcutaneously outside of the subject's rib cage.

[0016] According to some embodiments, the actuator and the static component may be positioned within the rib cage of the subject.

[0017] According to some embodiments, the motor may include an electric motor, a pneumatic piston, or a hydraulic piston.

[0018] According to some embodiments, the system may further include a diaphragm band configured to prevent the diaphragm from being drawn into the chest cavity.

[0019] According to some embodiments, the system may further include a controller configured to activate the actuator.

[0020] According to some embodiments, the system may further include one or more biosensors configured to detect the initiation of spontaneous breathing or ventilator-induced breathing by the subject.

[0021] According to some embodiments, the one or more biosensors can be selected from: an oxygen sensor, a carbon dioxide sensor, a pressure sensor, a stretch sensor, an accelerometer, an electrical sensor for detecting nerve and / or muscle stimulation or activity, an electromyography sensor (EMG), or any combination thereof. Each possibility is a separate embodiment.

[0022] According to some embodiments, one or more biosensors may be located externally and / or internally within the body of a subject.

[0023] According to some embodiments, the system may further include a fault sensor selected from the group consisting of: an accelerometer, a voltmeter, a current sensor, or any combination thereof.

[0024] According to some embodiments, the movable unit may include a fixation plate that is rigidly fixed to the anterior bony structure.

[0025] According to some embodiments, the removable unit may be constructed of a biocompatible material.

[0026] According to some embodiments, the biocompatible material may be selected from, but not limited to: stainless steel, cobalt-chromium alloys, titanium and titanium alloys, pyrolytic carbon, thermoplastics, bioceramics, or any combination thereof. Each possibility is a separate embodiment.

[0027] According to some embodiments, the static component may include a strap. In some embodiments, the strap may be rigid, semi-rigid, or flexible.

[0028] According to some embodiments, at least one strap may comprise two parts, each of said parts being configured to be anchored at one end at the rear side to the at least one rib and at the other end at the front side to the actuator.

[0029] According to some embodiments, the at least one strap may be anchored at one end at the rear side to the at least one rib by a plate and / or a hinge.

[0030] According to some embodiments, the bony structure is the subject's anterior rib or sternum.

[0031] According to some embodiments, the movable unit may include a fixation plate configured to be attached to or fixed to a bony structure of the thorax, wherein relative vertical movement of the movable unit induced by the actuator induces a volumetric change of the thorax.

[0032] According to some embodiments, at least a portion of the system is configured for subcutaneous implantation.

[0033] According to some embodiments, the controller may be configured to activate the actuator with a predetermined range of motion, a predetermined timing, and / or a predetermined rate. Each possibility is a separate embodiment.

[0034] According to some embodiments, the controller may be configured to activate the actuator with a range of motion, timing, and / or rate based on information from one or more sensors. Each possibility is a separate embodiment.

[0035] According to some embodiments, the controller may be configured to activate the actuator to expand the volume of the thoracic cavity by a predetermined amount, at a predetermined timing, and / or at a predetermined rate. Each possibility is a separate embodiment.

[0036] According to some embodiments, the controller may be configured to activate the actuator to expand the volume of the thoracic cavity at an amount, timing, and / or rate determined based on information from one or more sensors. Each possibility is a separate embodiment.

[0037] According to some embodiments, the controller may be configured to be worn externally by a user.

[0038] According to some embodiments, the system may further include a power source, such as a rechargeable battery.

[0039] According to some embodiments, the rechargeable battery may be configured to be worn externally by a user.

[0040] According to some embodiments, the system is portable.

[0041] According to some embodiments, there is provided a method for supporting, improving and / or treating ventilatory insufficiency in a subject in need thereof, the method comprising:

[0042] implanting a ventilation system as disclosed herein into a subject; and

[0043] A controller is used to control operating parameters of the ventilation system.

[0044] According to some embodiments, the operational parameters may include range of motion, volume of expansion of the thorax, timing of activation, rate of activation, timing of expansion of the thorax, rate of expansion of the thorax, or any combination thereof. Each possibility is a separate embodiment.

[0045] According to some embodiments, the method may be used to support weaning a subject from a respiratory support device.

[0046] According to some embodiments, the method can be used to improve a subject's spontaneous breathing.

[0047] According to some embodiments, the method can be used to facilitate speaking and / or coughing in a subject.

[0048] According to some embodiments, the subject may be suffering from a neurodegenerative disorder.

[0049] According to some embodiments, there is provided a surgical method for implanting a system as disclosed herein, the surgical method comprising the steps of:

[0050] securing the removable unit to an anterior bony structure of the subject's thorax;

[0051] Positioning of static components and actuators;

[0052] associating the movable unit with the actuator; and

[0053] controlling operation of the actuator via an external controller such that, when activated, the actuator is configured to displace the movable unit, thereby inducing movement of the bony structure and affecting the volume of the thoracic cavity;

[0054] The subject's breathing is thereby at least partially controlled.

[0055] Certain embodiments of the present disclosure may include some, all, or none of the advantages listed above. One or more additional technical advantages may be apparent to those skilled in the art based on the figures, description, and claims included herein. Furthermore, while specific advantages have been enumerated above, various embodiments may include all, some, or none of the enumerated advantages. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Some embodiments of the present disclosure are described herein with reference to the accompanying drawings. The description, together with the drawings, makes it clear to those skilled in the art how some embodiments may be practiced. The drawings are for illustrative purposes only and are not intended to show structural details of the embodiments in more detail than is necessary for a basic understanding of the present disclosure. For the sake of clarity, some objects depicted in the drawings are not drawn to scale.

[0057] In the attached figure:

[0058] Figure 1A shows a schematic illustration of an implantable mechanical ventilation system according to some embodiments;

[0059] Figure 1B Shown according to some embodiments Figure 1A Schematic illustration of an implantable mechanical ventilation system positioned on the rib cage and connected to a controller;

[0060] Figure 2A shows a schematic illustration of an implantable mechanical ventilation system according to some embodiments;

[0061] Figure 2B Shown according to some embodiments Figure 2A Schematic illustration of an implantable mechanical ventilation system positioned on the rib cage;

[0062] Figure 3A a schematic illustration showing a perspective view of an implantable mechanical ventilation system in a resting (closed) position according to some embodiments;

[0063] Figure 3B shows a side view cross-section of an implantable mechanical ventilation system in a resting position according to some embodiments;

[0064] Figure 3C a schematic illustration showing a perspective view of an implantable mechanical ventilation system in an open (pulled) position according to some embodiments;

[0065] Figure 3D shows a side view cross-section of an implantable mechanical ventilation system in an open (pulled) position according to some embodiments;

[0066] Figure 4A a schematic illustration showing a perspective close-up view of an implantable mechanical ventilation system in a resting (retracted) position, according to some embodiments;

[0067] Figure 4B a schematic illustration showing a front view of an implantable mechanical ventilation system in a resting (retracted) position when positioned on the rib cage, according to some embodiments;

[0068] Figure 4C a schematic illustration showing a perspective close-up view of an implantable mechanical ventilation system in an open position, according to some embodiments;

[0069] Figure 4D a schematic illustration showing a front view of an implantable mechanical ventilation system in an open position when positioned on the rib cage, according to some embodiments;

[0070] Figure 5 a schematic illustration showing an implantable mechanical ventilation system positioned at least partially within a rib cage according to some embodiments;

[0071] Figure 6A shows a schematic illustration of an implantable mechanical ventilation system according to some embodiments;

[0072] Figure 6B Shown according to some embodiments Figure 6A a schematic illustration of an implantable mechanical ventilation system positioned at least partially within the rib cage;

[0073] Figure 6C a schematic illustration showing a perspective view of an implantable mechanical ventilation system in a resting (closed) position according to some embodiments;

[0074] Figure 6D a schematic illustration showing a perspective view of an implantable mechanical ventilation system in an open (evacuated) position according to some embodiments;

[0075] Figure 6Ea schematic illustration showing a perspective view of an actuator of an implantable mechanical ventilation system in a resting (closed) position according to some embodiments;

[0076] Figure 6F a schematic illustration showing a perspective view of an actuator of an implantable mechanical ventilation system in an open (extracted) position according to some embodiments;

[0077] Figure 7A A schematic illustration showing components of an implantable mechanical ventilation system relative to the rib cage according to some embodiments;

[0078] Figure 7B A schematic illustration showing an implantable mechanical ventilation system in a resting position compared to an open position according to some embodiments;

[0079] Figure 7C a schematic illustration showing a perspective view of components of an implantable mechanical ventilation system relative to a rib structure according to some embodiments;

[0080] Figure 7D a schematic illustration showing a perspective view of an implantable mechanical ventilation system positioned at least partially within a rib cage according to some embodiments;

[0081] Figure 7E a schematic illustration showing a perspective view of an implantable mechanical ventilation system positioned on a rib cage according to some embodiments;

[0082] Figure 8 shows a schematic illustration of a rib connecting member according to some embodiments;

[0083] Figure 9A a schematic illustration showing a perspective view of a diaphragm band according to some embodiments;

[0084] Figure 9B a schematic illustration showing a perspective view of a diaphragm band positioned in the rib cage according to some embodiments;

[0085] Figure 10A a schematic illustration showing exemplary biosensor locations relative to a ventilation system according to some embodiments;

[0086] Figure 10B a schematic illustration of a perspective view showing an exemplary biosensor location relative to a subject's chest cavity, according to some embodiments; and

[0087] Figure 11 Flowchart showing steps for respiratory regulation / control using an implantable mechanical ventilation system, according to some embodiments. DETAILED DESCRIPTION

[0088] The principles, uses, and implementations of the teachings herein may be better understood with reference to the accompanying description and drawings. By carefully reading the description and drawings presented herein, those skilled in the art will be able to implement the teachings herein without undue effort or experimentation. In the accompanying drawings, like reference numerals refer to like parts throughout.

[0089] In the following description, various aspects of the present invention will be described. For purposes of explanation, specific details are set forth to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the present invention.

[0090] In the following description, for the purpose of explanation, numerous details are set forth. However, one skilled in the art will appreciate that the present invention can be practiced without these specific details.

[0091] As used herein, the term "ventilation" may refer to the process of exchanging air between the lungs and the surrounding air.

[0092] As used herein, the term "weaning" refers to the gradual removal of a patient from dependence on a life support system for assisted breathing or other forms of mechanical respiratory treatment and / or therapy.

[0093] As used herein, the term "stand-alone ventilator" refers to a ventilator device / system that can supply sufficient tidal volume and minute ventilation gas exchange to support the metabolic needs of a patient without the need for additional equipment.

[0094] As used herein, the term "supportive ventilator" refers to a ventilator that is not completely dependent on the ventilator as a device to supply the patient's entire gas exchange, i.e., a ventilation support device. Some supportive ventilators can enrich the inspired air with oxygen, whether spontaneously or induced by another device, and / or can assist in the mechanical movement of the patient's lungs, chest, diaphragm, etc.

[0095] As used herein, the term "positive pressure ventilator" refers to a ventilation device that insufflates air into the lungs, typically through a ventilation tube inserted through a cannula or tracheotomy.

[0096] As used herein, the term "negative pressure ventilation" refers to a ventilation device / system that typically surrounds the patient's chest externally and periodically applies negative pressure that pulls on the chest wall, causing it to expand and, by doing so, reduces pleural pressure, thereby causing airflow through the patient's airways into the lungs (similar to the mechanism of spontaneous breathing). For example, the iron lung was the first negative pressure ventilator developed. Subsequent negative pressure ventilators are, for example, the HAYEK ventilator.

[0097] As used herein, the term "tidal volume" ("TV") relates to the amount of air that is inhaled.

[0098] As used herein, the term "minute ventilation" ("MV") relates to the volume of air exchanged in one minute, ie, tidal volume x number of ventilation cycles per minute.

[0099] As used herein, the term "posterior" refers to the back side of the body.

[0100] As used herein, the term "front" refers to, for example, the front side of the body.

[0101] As used herein, the term "superior" refers to a position / location closer to the head of a body (e.g., a subject's body). In some embodiments, the term superior is interchangeable with "proximal."

[0102] As used herein, the term "inferior" refers to a location farther from the head of the body (or closer to the lower part of the body). In some embodiments, the term inferior is interchangeable with "distal."

[0103] As used herein, the terms "top" and "bottom" refer to the top and bottom directions of a subject. In some embodiments, "top" is relatively closer to the head region, and "bottom" is relatively closer to the leg region. In some embodiments, top and bottom are relative to the transverse plane (axial or horizontal plane), which divides the body into cranial and caudal (head and tail) parts.

[0104] As used herein, the terms "subject" and "patient" are used interchangeably.

[0105] According to some embodiments, the implantable mechanical ventilation systems disclosed herein can be used as a stand-alone ventilator and / or a ventilation support device. According to some embodiments, the mechanical ventilation systems can be used to provide temporary, continuous, and / or permanent ventilation.

[0106] According to some embodiments, the ventilation systems disclosed herein may be used to wean a subject off supportive ventilation therapy.

[0107] According to some embodiments, as described in further detail below, the ventilation system can facilitate pulling the subject's sternum (to which the ventilation system is attached) in a vector that can represent normal sternal movement during spontaneous breathing. According to some embodiments, periodically pulling the sternum and then allowing it to return to a resting position can simulate a spontaneous breathing cycle. According to some embodiments, pulling the sternum can cause the chest to expand, thereby generating a negative pressure in the pleural cavity, which can cause air to be drawn into the lungs through the upper airway. According to some embodiments, the tidal volume of air inhaled during sternal expansion can depend on the distance the sternum expands.

[0108] Advantageously, the ventilation systems disclosed herein may be configured to provide full and / or partial ventilatory assistance.

[0109] Advantageously, according to some embodiments, the ventilation systems disclosed herein can completely replace the mechanical work / action of the respiratory muscles in full control of the ventilation configuration. According to some embodiments, the ventilation system can manipulate the patient's chest alone to produce sufficient tidal volume and minute ventilation. According to some embodiments, full control of ventilation may be desired when the patient's own spontaneous breathing mechanism may be inoperable and the patient may be completely dependent on the ventilator for full control of gas exchange and / or breathing.

[0110] Advantageously, in some embodiments, in partial control of the ventilation configuration, the mechanical ventilation system can be operated to assist the patient's own spontaneous ventilation efforts and / or can assist another ventilator that can also be connected to the patient and can ventilate the patient.

[0111] According to some embodiments, in partial control of the ventilation configuration, the ventilation system may assist a patient who is breathing spontaneously but whose spontaneous breathing does not generate sufficient tidal volume and minute ventilation. According to some embodiments, in partial control of the ventilation configuration, the ventilation system may assist the patient's own breathing efforts, for example, through additional chest wall expansion, which may introduce additional air volume during inspiration. According to some embodiments, in partial control of the ventilation configuration, the ventilation system may begin pulling on the chest wall at any time during spontaneous inspiration (e.g., at the beginning of spontaneous inspiration, and / or at any point during inspiration). According to some embodiments, in partial control of the ventilation configuration, the ventilation system may ignore the self-voluntary force generated by the patient's own respiratory muscles and may apply a full expansion force (e.g., pulling).

[0112] According to some embodiments, a ventilation system may include several units that, when operated in sync, may support the act of inspiration and / or expiration.

[0113] Now refer to Figure 1A , which shows a schematic illustration of an implantable mechanical ventilation system according to some embodiments. Figure 1AAs shown, the system 100 generally includes a movable unit (element) 102, which is configured to attach (permanently or temporarily) to an anterior bony structure of a subject (not shown), in particular to the rib cage. Attachment to the rib cage can be achieved by any suitable means, including but not limited to, for example, by gluing, using fixing members (such as screws), etc. In some embodiments, the movable unit may include a fixation plate that is configured to be fixed to the bony structure and thereby secure the unit to the bone. In some embodiments, as described in more detail below, the bony structure is the sternum, or at least a portion of the sternum. As further described below, the movable unit is configured to move relative to an actuator 104, wherein such movement induces movement of the connected bony structure, and thus, the rib cage volume (i.e., the chest cavity volume) can be changed accordingly. The actuator 104 is associated (physically and / or functionally) with the movable unit 102 so that the movable unit can be translated between various positions, such as Figure 1A , which illustrates the range of vertical motion of the movable unit 102. Figure 1A As shown, the actuator 104 includes at least two parts: a transmission (also referred to as an “arm”) 110 and a motor 108 . Figure 1A The illustrated actuator 110 is configured to move vertically (up and down positions) such that when it strikes / contacts / engages the movable element 102, the actuator facilitates corresponding movement of the movable element 102. Movement of the actuator 110 is facilitated by a motor 108, which can be any type of motor (e.g., an electric motor, a magnetic motor, a hydraulic motor, etc.). The operation of the motor itself is controlled by a controller (not shown), as described in further detail below. Figure 1A 1 and 2. The static unit 106 of the system 100 is further shown. The static unit 106 is configured to anchor / hold / place the actuator 104 to at least one rib (not shown). In some embodiments, the at least one rib to which the actuator is placed is not a thoracic rib. As described in detail herein, the actuator 104 is anchored to the front (distal) side of the movable element and the rib cage. The static element 106 may include any type of suitable anchoring element, including, for example, a belt or strap that latches onto or is attached to the rib, thereby securing the static element in place. As described in further detail below, the static element may include a plurality of elements or combinations thereof, including, for example, a plurality of belts, straps, latches, hinges, hooks, etc.

[0114] Now refer to Figure 1B , which shows that according to some embodiments Figure 1A Schematic illustration of the implantable ventilation system of FIG. 1 as positioned on the rib cage and connected to a controller. Figure 1BAs shown, the system 100 is placed on the internal body part of the subject. In particular, the movable unit 102 is fixed to the sternum 132 of the rib 130. The static element 106 for anchoring / positioning the actuator 104 is associated with the rib at its ends at the posterior side and is associated with the actuator 104 at the anterior region. Figure 1B Further shown in the figure is an external controller (control unit) 150. The external controller 150 is configured to control the operating parameters of the system, including, for example, the timing, rate and / or extent of movement of the actuator, thereby controlling the timing, rate and / or extent of volume changes in the chest cavity. As described in detail below, the controller may include one or more processors, memories, displays, user interfaces (shown as exemplary user interface 152), power sources (shown as exemplary batteries 154), etc. The controller unit may communicate directly or indirectly with one or more units of the system, either wirelessly or using wires. For example, Figure 1B As shown, the controller unit 150 may communicate with one or more internal sensors, such as the exemplary sensor 140. Such sensors may provide information / data about the subject's breathing and / or about the operation of the various units of the system, and the controller unit may use such data to determine / adjust corresponding operating parameters. Figure 1B In the example shown, the sensor can communicate / transmit information with the controller unit via the communication unit 144. The communication unit 144 may include any type of communication unit configured to transmit data, information, power between the various units. In some embodiments, the communication unit 144 may include at least two subunits: a first subunit 144A that is placed internally within the subject's body, and a second subunit 144B that is placed external to the subject (dashed line 160 schematically illustrates the boundary line between the external part and the internal part of the body). The two subunits can communicate wirelessly or using wires (e.g., by penetrating wires) so that information, data, or other signals (such as electrical power) from inside and outside the body can be easily, efficiently, and safely transmitted. In Figure 1BIn the illustrated arrangement, data from sensor 140 is transmitted via electrical wiring (shown as communication wiring 146A) to internal subunit 144A of communication unit 144, and the data is wirelessly transmitted to external subunit 144B, which in turn can transmit the information (wirelessly or using electrical wiring) to controller unit 150. Similarly, communication unit 144 can be used to transmit information to / from the controller to any unit of the system, for example, to actuator 104. As shown, actuator 104 can be connected to internal subunit 144A of communication unit 144 via electrical wiring (shown as power wiring and communication wiring 146B). In this arrangement, the controller unit can control the operation of actuator 104 via communication unit 144 by providing operational instructions, such as the timing of the actuator's operation (i.e., when the actuator will move), the rate of operation (at what frequency the actuator will move), and the degree of operation (to what degree / distance the actuator will move). In some embodiments, the controller can provide predetermined operating parameters (e.g., predetermined according to a predetermined treatment plan, which can be universal or tailored to the subject). In some embodiments, the controller can provide operating parameters based on real-time information / data received and processed. In some embodiments, a user (e.g., a health care provider) can determine one or more operating parameters based on, for example, the condition and characteristics of the subject, the type of plan, the type of treatment, etc. In some embodiments, the user can communicate remotely with the controller unit (e.g., via a Wi-Fi connection, a Bluetooth connection, etc.).

[0115] Now refer to Figure 2A , which shows a schematic illustration of an implantable mechanical ventilation system according to some embodiments. Figure 2A As shown, the system 200 generally includes a movable unit (element) 202, which is configured to attach (permanently or temporarily) to an anterior bony structure of a subject (not shown), in particular to the rib cage. Attachment to the rib cage can be achieved by any suitable means, including but not limited to, for example, by gluing, using fixing members (such as screws, etc.). In some embodiments, the movable unit may include a fixing plate that is configured to be fixed to the bony structure and thereby secure the unit to the bone. In some embodiments, as described in detail below, the bony structure is the sternum, or at least a portion of the sternum. As described in detail herein, the movable unit is configured to move relative to the actuator 204, wherein such movement induces movement of the connected bony structure, and thus, the rib cage volume (i.e., the chest cavity volume) can be changed accordingly. As Figure 2A As shown, the actuator 204 includes at least two parts: a transmission (also referred to as an “arm”) 210 and a motor 208 . Figure 2AThe transmission 210 is shown connected to the distal region of the movable unit 202 so that when the transmission 210 is rotated and moved about the axis, the transmission promotes corresponding movement of the movable unit 202, so that the movable unit 202 can be extended anteriorly, thereby "pulling" the rib cage and expanding the rib cage, and thus increasing the volume of the thoracic cavity. Similarly, when the transmission returns to its initial (resting) position, the movable unit also returns to the rest position, thereby reducing (i.e., returning / restoring) the volume of the thoracic cavity. The movement of the transmission 210 is promoted by the motor 208, which can be any type of motor (e.g., an electric motor, a magnetic motor, a hydraulic motor, etc.). The operation of the motor itself is controlled by a controller (not shown), as further described herein. Figure 2A 200. The static element 206 is configured to anchor / hold / place the actuator 204 to at least one rib (not shown). The static element 206 may include any type of suitable anchoring element, including, for example, a strap or a band, which may latch onto or be attached to the rib to secure the static element in place. Figure 2A As shown, the static element 206 includes at least two straps, an upper (upper side) strap 212B and a lower (lower side) strap 212A, wherein each of the straps may be continuous or may be composed of two parts, each part extending from the posterior rib to the actuator 204. In addition, anchoring elements 214A-214B may also serve as part of the static unit to allow the static unit to be anchored / connected / fastened to the posterior ribs, for example, by being placed between the ribs.

[0116] Now refer to Figure 2B , which shows that according to some embodiments Figure 2A Schematic illustration of the implantable mechanical ventilation system when positioned on the rib cage. Figure 2B As shown, the system 200 is placed on an internal body part of a subject. Specifically, the movable unit 202 is fixed at its proximal region to the sternum 232 of the ribs 230. The static element 206 (including straps 212A-212B) is associated with the ribs at its ends at the posterior side and is associated with the actuator 204 at the anterior region. Also shown are anchoring elements 214A-214B of the static unit 206, each associated with a posterior rib region. Figure 2B The external controller (control unit) is not shown, and is similar in function and / or structure to the Figure 1B The controller unit 150 is described.

[0117] Now refer to Figures 3A to 3D , which respectively show according to some embodiments Figure 2A The implantable mechanical ventilation system is in the resting (closed) position ( Figures 3A to 3B ) and open (expanded) positions ( Figures 3C to 3D ) is a schematic illustration of a perspective view and a cross-sectional side view. Figures 3A to 3D As shown, the movable unit 202 is configured to move away from / toward the rib cage at its distal portion (ie, the area connected to the actuator) by means of a pull / push / release movement of the actuator 204 (particularly, the arm 210). Figure 3B As illustrated in the cross-sectional side view presented in , in the rest (closed) position, the arms 210 are positioned in a closed / folded position within their housings so that the movable element 202 is also in a rest position where the rib cage is not pulled by the movable unit. Figures 3C to 3D As shown, when the arm 210 of the actuator 204 moves upward and outward, this facilitates the movement of the movable unit 202, causing the distal region of the movable unit (which is connected to the actuator) to move / push in a frontal direction, thereby forcing the proximal region of the movable unit (which is fixed to the rib cage (not shown)) to move. Thus, through the movement of the arm 210, relative movement of the associated movable unit 202 is induced, which in turn causes a change in the volume of the rib cage. In other words, when the movable unit is pulled or otherwise affected in its position, the volume of the rib cage is affected.

[0118] Now refer to Figures 4A to 4D , which shows an implantable mechanical ventilation system in a closed position ( Figures 4A to 4B ) and in the open position ( Figures 4C to 4D ). Figure 4A and Figure 4C As shown, system 400 generally includes a movable unit (element) 402 configured to be attached (permanently or temporarily) to an anterior bony structure of a subject (not shown), particularly the sternum attached to the rib cage. As described in detail herein, the movable unit is configured to move relative to an actuator 404, wherein such movement induces movement of the attached bony structure, and thus, the rib cage volume (i.e., the thoracic cavity volume) can be changed accordingly. Figure 4A As shown, the actuator 404 includes at least two parts: a motor 408 and a transmission (also called an “arm” or “pin”) motor 410 . Figure 4A The actuator 410 is shown in the form of a pin and is positioned in a "closed" (retracted) position. The pin may be connected to a distal region of the movable unit 402. The actuator is positioned using a static component 406. Figure 4C 4. The mechanical ventilation system 400 is shown in an open position, eg, when the pin 410 of the actuator 420 is pushed upward, facilitating a corresponding upward movement (displacement) of the movable unit 402, thereby expanding the rib cage and thereby increasing the volume of the thoracic cage. Figure 4B The system 400 is illustrated in a closed position when placed on the rib cage 430 , with the movable unit 402 anchored to the sternum 432 . Figure 4D The system 400 is illustrated in an open position when placed on a rib cage 430 .

[0119] When the arm (pin) 410 of the actuator 404 moves upward and outward, this promotes the displacement of the movable unit 402, causing the distal region of the movable unit (which is connected to the actuator) to move / push in the frontal direction, thereby forcing the proximal region of the movable unit (which is fixed to the rib cage) to move. By the relative movement of the movable unit 202, the rib cage 430 expands, as shown by arrows 490A to 490C, thereby increasing its volume. As shown in the figure, the static unit is also configurable to expand to accommodate the expansion of the rib cage. In other words, when the movable unit is pulled or otherwise affected in its position, the rib cage volume is affected, for example, by inducing rib expansion due to the force exerted by the movable unit on the sternum.

[0120] Now refer to Figure 5 , which shows a schematic illustration of an implantable mechanical ventilation system positioned at least partially within the rib cage according to some embodiments. Figure 5 As shown in Figure 5A, the mechanical ventilation system 500 can be at least partially positioned within the rib cage 530. In particular, the static unit 506 and the actuator 504 can be positioned within the interior of the rib cage such that the static unit 506 at least partially engages the inner surface of at least some of the ribs of the rib cage 530. The movable unit 502 of the system 500 is positioned / anchored / fixed outside the rib cage, on a bony structure of the rib cage (such as the sternum 532). Thus, while the actuator and the static unit are positioned / anchored within the interior portion of the rib cage, the movable unit is positioned outside, and displacement of the movable unit induced by movement of the actuator's transmission induces expansion of the rib cage and, therefore, increases the volume of the thoracic cavity. As described in further detail below, the static unit can be anchored to (the interior of) the posterior ribs by an anchoring element configured to fit between adjacent ribs.

[0121] Now refer to Figure 6A , which shows a schematic illustration of an implantable mechanical ventilation system according to some embodiments. Figure 6A As shown, system 600 includes a movable unit 602, an actuator 604 having at least one transmission 610 and a motor 608. The transmission is configured to interact with the movable unit 602 (which is configured to be anchored to a bony structure (e.g., the sternum)) and induce movement / displacement of the unit, for example, by pushing the unit (from an anterior position toward a posterior position). Also shown is a static unit 606, which includes straps or bands 614A-614B and posterior anchoring elements 616A-616B, each configured to anchor / hold the static component (unit) 606 to the ribs of a subject. Figure 6B6 shows a system 600 in which the static unit 606 and actuator 604 are positioned within the rib cage (ie, facing the interior surface of the rib), while the movable unit 602 is positioned on the exterior surface of the rib cage, for example, on the sternum.

[0122] Now refer to Figures 6C to 6D , which shows a schematic illustration of a side view of an implantable mechanical ventilation system in a resting (closed) position and in an open (propelled) position according to some embodiments. Figures 6C to 6D As shown, although the actuator 604 and the static unit 606 do not change their relative positions regardless of the position of the movable unit, the movement of the arm 610 of the actuator 604 facilitates the displacement of the movable unit 602, thereby affecting the relative size / volume of the thorax. In particular, as Figure 6C As shown, when in the closed (retracted) position, the movable unit 602 assumes a natural position relative to the rib cage (as marked by the dashed line and arrow 640A). As shown, the movable unit 602 is connected to the arm 610 of the actuator 604 (which is located within the rib cage). Figure 6D In the illustrated open position, arm 610 is in the open position, thereby displacing movable unit 602. This displacement induces a posterosuperior displacement of the movable unit (and thus, by pulling on the sternum, induces a posterosuperior displacement of the rib cage), as indicated by the dashed line and arrow 640B. In some embodiments, the sternum can be displaced at an angle of 90° relative to the subject's back. Thus, by reciprocating movement of arm 610 (activated by motor 608 and controlled by, for example, a controller) between a closed position and an open position (the timing and / or extent of which can be controllable), the volume of the thoracic cavity can be varied / controlled.

[0123] Now refer to Figures 6E to 6F , which show schematic illustrations of perspective views of an actuator of an implantable mechanical ventilation system in a rest (closed) position and in an open position, respectively. Figures 6E to 6F As shown, the actuator 604 includes at least a motor 608 and a movable arm 610. The movable arm may be capable of moving between closed / retracted / pull positions, as shown in FIG. Figure 6E When activated by motor 608 (and controlled by a controller, as described in detail herein), arm 610 may be urged such that the arm may extend upward / forward (e.g., to extend beyond the rib cage (where the attached movable unit is located)), thereby urging the attached movable unit, as shown. Figures 6C to 6D exemplified. like Figures 6E to 6F As shown, arm 610 may be comprised of several sections (eg, sections 620A-620B) that are hinged to one another (eg, at region 622) to facilitate extension of the arm to a desired extent and direction.

[0124] Now refer to Figure 7A, which shows a schematic illustration of components of an implantable mechanical ventilation system relative to the rib cage according to some embodiments. Figure 7A As shown, the system 700 generally includes a removable unit (element) 702 that is configured to attach (permanently or temporarily) to an anterior bony structure of a subject (not shown), particularly to a rib cage. In some embodiments, the removable unit may include a fixation plate that is configured to be fixed to the bony structure and thereby secure the unit to the bone. In some embodiments, as described in more detail below, the bony structure is the sternum, or at least a portion of the sternum. Figure 7A As shown, actuator 704 includes at least two parts: movable plates or platforms 720A- 720B (also collectively referred to herein as arms 710 ) and motor 708 . Figure 7A The arm 710 shown is composed of two independent movable plates / platforms 720A to 720B, which are located one on top of the other (i.e., the first plate 720A is positioned on the upper or front side relative to the second plate 720B). These plates, which may be substantially parallel to each other, are configured to move along a horizontal axis (laterally) so that when the plates are moved in opposite directions (i.e., in the respective directions of arrows 740A to 740B), the raising of the arm induces corresponding movement of the movable unit 702 connected to the arm (i.e., to the front side and to the upper side), thereby moving the connected sternum and inducing expansion of the chest cavity, as further described below. In this arrangement, the movable member is raised due to the lateral expansion of the ribs induced by the actuator. The relative movement of the plates can be facilitated by any suitable member (including, for example, a ratchet mechanism) that can be operated by the gear 724. The movement of the gear is controlled by the motor 708 of the actuator 704, and the operation of the motor itself is controlled by a controller (not shown) as described in detail herein. Figure 7A As shown, when the gears rotate in the direction of the circular arrows, the plates move in the opposite direction, and when the gears rotate in the opposite direction, the plates move toward each other. Figure 7A 7. Further shown in FIG. 7 is a static unit (component) 706 of the system 700. The static unit 706 is configured to anchor / hold / place the actuator 704 to at least one rib (not shown). The static element 706 may include any type of suitable anchoring element, including, for example, a strap or webbing that may latch onto or attach to the rib to secure the static element in place. As described in further detail below, the static element may include a plurality of elements or combinations thereof, including, for example, a plurality of straps, webbing, latches, hinges, hooks, etc. Figure 7A In the example shown, the static unit 706 consists of at least two parts: a strap and anchoring elements 716A-716B at the rear end of the strap, which are configured to anchor the strap to the ribs.

[0125] refer to Figure 7B, which shows a schematic illustration of an implantable mechanical ventilation system 700 in a rest position (760) versus an open position (760'), wherein the two illustrated positions are superimposed (overlapped) to illustrate the change in relative position of the movable unit and the rib cage. Figure 7B As shown, when the plates 720A-720B (closed position) are moved in opposite directions (marked by arrows 740A'-740B') to adopt the open position 720A'-720B', the movable element moves together with the sternum 732, which moves anteriorly and superiorly (to adopt position 732'), thereby inducing lateral movement of the ribs, causing the rib cage 760 (resting position) to expand as a whole to adopt the open position 760'. 7A to 7B In the illustrated configuration, the actuator is movable together with the movable unit and the sternum. Figure 7C A schematic illustration of a perspective view of components of system 700 relative to rib structure 750 is shown. Figure 7C As shown, when activated, the arm 710 of the actuator 704 induces the movable unit 702, along with the attached sternum, to move superiorly and anteriorly (in the direction of arrows 770A to 770B). Figure 7C As shown, in this configuration, both the actuator and the movable unit are configured to move together with the sternum. According to some embodiments, the system 700 can be positioned outside the rib cage 730, such as Figure 7C exemplified, or positioned internally within the rib cage 730 (at least relative to the static unit 706), as Figure 7D exemplified.

[0126] According to some embodiments, the static component (unit) may include an anchoring member for anchoring its posterior portion to one or more ribs. In some embodiments, the anchoring member may include a hinge to allow the static unit to perform pivotal movement to accompany or facilitate the opening movement of the rib cage. Figure 8 , which shows a schematic illustration of a rib connecting member according to some embodiments. Figure 8 As shown, system 800 is configured to be positioned on a rib cage such that static member 806 (which may be comprised of any suitable member, as detailed herein) is connected / anchored / associated with the posterior portion of the rib. For this purpose, one or more anchoring members may be used. Figure 8, an exemplary anchoring member 816A is shown in FIG. Anchoring member 816A is configured to attach to / between ribs and allow connection to straps 814A to 814B of static component 806. The connection between anchoring member 816A and straps 814A to 814B can be rigid, or can be flexible. In some embodiments, the connection can be flexible so that the straps can at least partially rotate relative to the anchoring member. As shown in the enlarged view in example FIG. B, the anchoring member can be attached to straps 814A to 814B via a hinge. In this arrangement, the straps can at least partially rotate about hinge 820 in the direction marked by white arrow 730, thereby facilitating opening of the rib cage.

[0127] According to some embodiments, the connection / attachment / anchoring of the rib can be any suitable rib. For example, the rib can be any one of claims 8 to 10. In some embodiments, the rib is rib 10. In some embodiments, the attachment / fixation point / area can be a posteromedial rib. According to some embodiments, the systems disclosed herein can facilitate sternal movement of approximately 10-50 mm. In some embodiments, the systems disclosed herein can facilitate sternal movement of approximately 20-40 mm. In some embodiments, the systems disclosed herein can facilitate sternal movement of approximately 30-35 mm. In some embodiments, this induced movement can result in a sufficient increase in the volume of the thoracic cavity to at least partially induce breathing in the subject. In some embodiments, the tidal volume of the subject can be in the range of 300-600 ml, or any sub-range thereof.

[0128] According to some embodiments, the systems disclosed herein may further comprise a diaphragm band. In some embodiments, the band may be part of the system. In some embodiments, the diaphragm band may be used as an optional accessory to the system. In some embodiments, the use of the diaphragm band is configured to prevent the diaphragm from being drawn into the chest cavity. In some embodiments, the diaphragm may gradually lose its stiffness and may counteract the volume changes induced by the system. Thus, a diaphragm band may be used. Now referring to Figure 9A , which shows a schematic illustration of a perspective view of a diaphragm band according to some embodiments. Figure 9A As shown, the diaphragm cuff 360 can be placed / positioned over the subject's diaphragm 970 to prevent undesirable movement (particularly suction) of the diaphragm into the thoracic cavity. Figure 9A As shown, the band can be anchored to at least some of the ribs by using static elements 914A-914B to hold / fix the band in place. In addition, the actuator 904 of the ventilation system (other parts of the ventilation system are not shown in this illustration) can also be associated with the diaphragm band. Now referring to Figure 9B , which shows a schematic illustration of a perspective view of a diaphragm band positioned in the rib cage according to some embodiments. Figure 9BAs shown, the band 960 is positioned within the rib cage 930, above (on top of) the diaphragm, so that the band prevents the diaphragm from being sucked in. According to some embodiments, the band can be rigid and made of any suitable biocompatible material, including, for example, but not limited to: plastic, fiberglass reinforced plastic, polycarbonate, polyetheretherketone (Peek), polyplastic polymer, titanium, etc., or any combination thereof. Each possibility is a separate embodiment. In some embodiments, the size, shape and / or composition of the band can be customized to the patient. In some embodiments, the band is placed within the chest cavity, while the other units of the system (such as actuators, movable elements) are placed (subcutaneously) on the external surface of the rib cage.

[0129] According to some embodiments, as further detailed below, the system may also include one or more biosensors that can be used to sense / detect various biological or physiological parameters related to breathing and determine / control the operation of the ventilation system based thereon. According to some embodiments, such sensors may include, for example, but not limited to: oxygen sensors, carbon dioxide sensors, pressure sensors, stretch sensors, accelerometers, electrical sensors for detecting nerve and or muscle stimulation or activity (electromyography sensors (EMG)), or any combination thereof. Each possibility is a separate embodiment. The sensors may be positioned within a unit of the system, or placed elsewhere, whether at an internal or external location on or associated with the subject's body. As detailed above, the sensors may communicate with a controller of the system to transmit sensed data and allow the controller to determine operating parameters based at least on the data. Now referring to FIG. 10A to FIG. 10B , which illustrates relative to a ventilation system ( Figure 10A ) and thoracic cavity ( Figure 10B ) is a schematic illustration of exemplary biosensor locations. Figure 10A As shown, ventilation system 1000 (which may be similar to Figure 2A The illustrated ventilation system 200) comprises at least a movable unit 1002, an actuator 1004, and a static unit 1006. Further shown are sensors 1080A to 1080C associated with the system. Figure 10B The corresponding physiological positions of the sensors are shown in FIG, which are placed in the rib cage 1030 close to the diaphragm 1070. Figure 10A In the examples shown, the sensors are physically and functionally associated with the system. For example, FIG. 10A to FIG. 10BThe sensors shown may include EMG leads (implantable or packaged) configured to detect respiratory muscle movement and, based thereon, allow the controller to control the timing, extent, and / or rate of operation to facilitate optimal respiratory assistance for the subject (e.g., based on the subject's condition, type of desired treatment (e.g., weaning, supportive care), etc.).

[0130] According to some embodiments, the system disclosed herein may further include one or more fault sensors configured to detect faults in various units of the system. In some embodiments, such sensors may include, for example, but not limited to: ammeters, accelerometers, voltmeters, thermometers, force gauges, strain gauges, etc., or any combination thereof. Each possibility is a separate embodiment. In some embodiments, each sensor or multiple sensors may be associated with various units of the system. For example, a current sensor may be associated with a motor to detect the resistance of the motor (indicating whether the motor is operating normally). For example, an accelerometer may be associated with a motor to detect changes in its frequency. For example, an accelerometer may be associated with a movable unit to detect its movement. For example, an accelerometer may be associated with a static unit to detect its movement.

[0131] According to some embodiments, the actuator disclosed herein may include a "contraction and expansion" driver and a connecting arm. According to some embodiments, the connecting arm may be connected to a movable unit (fixation plate). According to some embodiments, the movable unit may be connected to the patient's rib cage, sternum and / or spine. According to some embodiments, the movable unit may be connected to the patient's sternum to generate sternal movement. According to some embodiments, the movable unit may be similar to a standard sternal surgical fixation plate, may be a subcutaneous magnetic implant attached to the sternum, etc. According to some embodiments, the pressure on the skin may be controlled by applying an electric field and / or a magnetic field that is synchronized with the patient's breathing movements, for example, the electric field and / or the magnetic field may be applied only during inspiration to eliminate skin ischemia.

[0132] According to some embodiments, the dedicated connection between the arm and the movable unit may not be rigid. According to some embodiments, the dedicated connection between the arm and the movable unit may be by means of hinges and / or joints, which may allow relative movement between the components.

[0133] According to some embodiments, the fixation plate and / or fixation frame can be connected to the front of the sternum. According to some embodiments, the posterior connection of the spine can be a connection to the vertebra, for example, at the pedicles (such as in spinal fixation). According to some embodiments, the posterior connection to the spine can be made by two or more artificial ribs (e.g., between one and twelve per side, etc.). According to some embodiments, during inspiration, the movement of the two or more artificial ribs can force the sternum to move upward to expand the rib cage.

[0134] According to some embodiments, the ventilation system can include a wearable suit. According to some embodiments, the wearable suit can include one or more elastic straps and / or one or more pads. According to some embodiments, one or more pads can include quick locks to enable easy connection and / or operation of the mechanical ventilation system. According to some embodiments, one or more pads can be connected to a drive device arm and can distribute weight and / or force across the patient's body.

[0135] According to some embodiments, as described in detail herein, the controller of the system can be used to determine, control and / or influence various operating parameters to ensure that an appropriate respiratory assistance regimen is provided. Figure 11 , which shows a flow chart of the steps for performing respiratory regulation / control using an implantable ventilation system according to some embodiments. Figure 11 As shown, at step 1102, the controller of the system provides operating instructions to the actuator to induce the movement of the movable unit, thereby physically expanding the chest cavity. The operating instructions can be based on information received from various biosensors (such as EMG or other sensors, as described in detail above), or autonomously (i.e., automatic mode) based on predetermined instructions. Therefore, at step 1104, negative pressure is formed, which results in air being drawn into the lungs at step 1106. Thereafter, at step 1108, the chest cavity is restored to its unexpanded size by moving the movable unit configured to return to its resting position (or any desired position). Due to the reduction in the volume of the chest cavity, at step 1110, air is expelled from the lungs. Thus, through each such step cycle, the desired breathing cycle is achieved. As described in detail above, the degree of activation (i.e., the range of movement of the movable unit), the rate of activation (i.e., the number of times the movable unit moves per minute) and / or the timing of activation (i.e., when the movable unit moves) are determined by the controller. In some embodiments, the controller's determination of operating parameters may be based at least in part on sensory data. In some embodiments, the controller's determination of operating parameters may be performed in real time. In some embodiments, the controller's determination of operating parameters may be predetermined. In some embodiments, the controller's determination of operating parameters may be patient-specific. In some embodiments, the determination of operating parameters may be adjustable by a user, who may be in remote or physical communication with the controller (e.g., via its user interface).

[0136] According to some embodiments, the actuator can include a controllable "neutral mode" / "neutral position" in which the arm is not activated and is passive, thereby facilitating the option of disengaging the system (e.g., to allow the subject to take natural, uncontrolled breaths). In some embodiments, the neutral position serves as a safety measure. In some embodiments, the neutral position can be achieved mechanically or physically (e.g., by disconnecting the motor from the transmission, using a clutch, etc.). In some embodiments, control of the neutral mode can be facilitated by a controller of the system.

[0137] In some embodiments, one or more components of the system can be disengaged from the system. In some embodiments, one or more units / components of the system can be removed from the subject. In some embodiments, once treatment has been completed, the actuator and / or movable unit can be removed.

[0138] According to some embodiments, in partial control of the ventilation configuration, the ventilation system can sense the patient's spontaneous respiratory effort. According to some embodiments, in partial control of the ventilation configuration, the ventilation system can apply only a partial expansion force, which can supplement the patient's own muscle strength to jointly produce sufficient chest wall expansion and inspiration.

[0139] According to some embodiments, in partial control of the ventilation configuration, the ventilation system can use various sensors (such as, for example, pressure sensors, e.g., piezoelectric sensors) to sense the patient's own voluntary muscle work. According to some embodiments, the ventilation system can sense and / or measure the force (e.g., pressure) generated by the patient's muscles against the movable unit of the system. According to some embodiments, the ventilation system can sense and / or measure the force (e.g., pressure) by an accelerometer sensor that can be connected to the device arm and can sense the distance the arm is moved by the patient's respiratory muscles. According to some embodiments, such sensors and / or other sensors (e.g., stretch sensors) can be installed in an elastic band that can be positioned around the patient's chest to measure (e.g., sense) chest expansion by replacing and / or adding sensors. According to some embodiments, carbon dioxide sensors, oxygen sensors, sensors for detecting nerve stimulation to muscles. According to some embodiments, various sensors can be located at various locations on the patient's body and / or device.

[0140] According to some embodiments, information from sensors may be collected in a data processing unit. According to some embodiments, the data processing unit may be part of a mechanical ventilation system. According to some embodiments, the data processing unit may be remotely connected to the mechanical ventilation system. According to some embodiments, real-time sensing processing may be used for real-time automatic response of the ventilation system. According to some embodiments, the ventilation system may sense the initiation of spontaneous inspiration and / or ventilator-induced inspiration. According to some embodiments, the ventilation system may sense the rate of spontaneous breathing. According to some embodiments, the ventilation system may sense the amplitude of the patient's spontaneous breathing in order to produce an optimal complementary mechanical response, for example in terms of rate, degree of expansion of the chest wall and / or overall behavior of the ventilation system during each breathing cycle or at least one breathing cycle in the breathing cycle.

[0141] According to some embodiments, in partial control of the ventilation configuration, the ventilation system disclosed herein can be used to disengage from mechanical ventilation (e.g., mechanical ventilation performed by a non-portable ventilator / respiratory support device). According to some embodiments, in a clinical environment, a non-portable mechanical ventilator can be used in the process of exchanging air between the lungs and the surrounding air. According to some embodiments, a mechanical ventilator can function in patients facing severe respiratory diseases to exchange air between the lungs and the surrounding air. According to some embodiments, once the patient is stable and / or in a state where they can breathe independently, it is important to take measures to free the patient from dependence on the respiratory support device. According to some embodiments, weaning can be the gradual withdrawal of the patient from assisted breathing and / or other forms of respiratory treatment and / or therapy performed by a life support system. According to some embodiments, disengaging the patient from the ventilator can occur when the patient's condition improves. According to some embodiments, the decision to disengage the patient from the ventilator can be made by conducting a spontaneous breathing experiment with the aid of an endotracheal tube and / or a tracheostomy tube and / or extubation (e.g., removing the tube).

[0142] According to some embodiments, the goal during the weaning period may be to restore the spontaneous physiological breathing rhythm and / or restore the respiratory muscles to full function. According to some embodiments, in partial control of the ventilation configuration, the mechanical ventilation system may be operable to support spontaneous breathing. According to some embodiments, support for spontaneous breathing may be triggered by patient effort. According to some embodiments, once triggered, the ventilation system may only provide partial support to the patient, rather than full support, that is, full mechanical ventilation may not be provided. According to some embodiments, suboptimal mechanical ventilation and / or supportive ventilation may be provided to the patient during the weaning period, with the aim of promoting the patient to resume spontaneous breathing.

[0143] According to some embodiments, weaning may be a gradual reduction of mechanical ventilation assistance. According to some embodiments, weaning may involve terminating mechanical ventilation and / or removing any artificial airway.

[0144] Advantageously, the ventilation system disclosed herein can be used as an optimal respiratory support device, and since the ventilation system can accurately measure the autonomous mechanical work of breathing and / or can provide the best automatic support response in each respiratory cycle, the ventilation system can be used to take the mechanically ventilated patient offline. Advantageously, the ventilation system can be set to provide different responses in each respiratory cycle, including initiating the start of the inspiratory time and / or the participation of the device during inspiration. According to some embodiments, the participation of the mechanical ventilation system can be through the dedicated support of the inspiratory effort by gently expanding the sternum throughout the inspiratory process and / or during part of the inspiratory period. According to some embodiments, the patient's respiratory gases can be monitored by a separate device and / or ventilation system (e.g., by a sensing and processing unit of the ventilation system). According to some embodiments, the mechanical ventilation system can be equipped with a ventilator measurement unit, which can be configured to measure the tidal volume and / or gas (O2 and CO2) partial pressure in the inhaled and / or exhaled air.

[0145] According to some embodiments, the ventilation system may be implemented subcutaneously, intercostally, and / or intrathoracically.

[0146] Advantageously, the ventilation system can be used to support breathing permanently and / or temporarily. According to some embodiments, the mechanical ventilation system can be portable. According to some embodiments, the mechanical ventilation system can be implantable. According to some embodiments, the mechanical ventilation system can be partially implantable. According to some embodiments, the wearable suit can support the drive device and / or position the base of the drive device at a desired location on the body, for example, on the clavicle and / or pelvis (for example, on one or both sides of the pelvis). According to some embodiments, the wearable suit can be worn under and / or over the patient's clothes (for example, as a vest). According to some embodiments, the patient can carry a mechanical ventilation system that is firmly attached to his or her body and / or partially or completely implanted in his or her body, for example, to maintain breathing when the patient performs daily movements and in daily situations (such as sitting, moving, walking, talking, etc.).

[0147] According to some embodiments, there is provided a method for treating ventilatory insufficiency in a subject in need thereof, the method comprising:

[0148] detecting, by at least one sensor, the initiation of spontaneous inspiration or ventilator-induced inspiration by the subject;

[0149] processing data from at least one sensor in real time by a controller;

[0150] applying a force that expands the subject's chest cavity using the movable unit in response to the processed data, thereby generating negative pressure in the pleural cavity, causing air to be drawn into the lungs through the upper airway; and

[0151] Releasing the applied force and returning the chest cavity to its resting position forces air out of the lungs, simulating a spontaneous breathing cycle.

[0152] In some embodiments, applying a force via the movable unit includes retracting the subject's sternum with a vector representing normal sternal movement during spontaneous breathing. In some embodiments, retraction of the sternum facilitates contraction of the intercostal muscles of the chest cavity. Thus, the systems disclosed herein can facilitate speaking, coughing, expectoration, or any other type of intentional exhalation.

[0153] In some embodiments, the tidal volume of a breathing cycle depends on the force applied to expand the chest cavity.

[0154] According to some embodiments, the method includes assisting the subject's own respiratory effort by applying a force to expand the chest cavity. In some embodiments, the assistance can be applied at any time during inspiration. In some embodiments, the assistance can be applied when the subject's own respiratory effort is detected and a partial force is applied, thereby supplementing the subject's own respiratory effort to collectively generate sufficient chest cavity expansion to draw air into the lungs through the upper airway.

[0155] According to some embodiments, the method may further comprise gradually increasing the assistance applied as the degenerative disease progresses.

[0156] According to some embodiments, the method may further comprise weaning the subject from the independent ventilator or ventilation support device by gradually reducing the force applied to replace the subject's own breathing effort.

[0157] According to some embodiments, detection may include sensing the initiation of spontaneous or ventilator-induced inspiration, the rate of spontaneous breathing, the amplitude of spontaneous breathing, the tidal volume of the respiratory cycle, and any combination thereof. Each possibility is a separate embodiment.

[0158] According to some embodiments, the method may further include storing data collected by the at least one sensor in the controller.

[0159] According to some embodiments, the method may further comprise monitoring, by the controller, the subject's own breathing effort.

[0160] According to some embodiments, the method may further comprise adjusting the applied force according to the subject's monitored own breathing effort.

[0161] According to some embodiments, the method may further include controlling the applied force by a controller.

[0162] According to some embodiments, the method may further comprise performing the monitoring, adjusting and / or controlling remotely.

[0163] According to some embodiments, the method may further comprise monitoring, adjusting, and / or controlling performed by a healthcare provider.

[0164] According to some embodiments, there is provided a method for weaning a subject in need thereof from a separate ventilator or ventilation support device, the method comprising:

[0165] detecting, using at least one sensor, the initiation of spontaneous inspiration or ventilator-induced inspiration by the subject;

[0166] processing data from at least one sensor in real time by a controller;

[0167] applying a force to assist in expanding the subject's chest cavity using the movable unit in response to the processed data, thereby generating negative pressure in the pleural cavity, causing air to be drawn into the lungs through the upper airway;

[0168] Releasing the force and returning the chest cavity to its resting position, forcing air out of the lungs, thus simulating a spontaneous breathing cycle; and

[0169] The force applied to said assist in expanding the subject's chest cavity is gradually reduced over a series of breathing cycles.

[0170] According to some embodiments, weaning may include gradually strengthening the intercostal muscles, re-tuning the intercostal muscle motor units, sending afferent triggers to the brain's breathing-related sensations, activating breathing-related centers, and any combination thereof.

[0171] According to some embodiments, the mechanical ventilation system is used to wean the patient from mechanical ventilation. According to some embodiments, the mechanical ventilation system can be used temporarily and / or permanently as a support ventilation system in various degenerative conditions, such as multiple sclerosis, amyotrophic lateral sclerosis, spinal muscular atrophy, all muscular dystrophies (e.g., Duchenne muscular dystrophy, Becker muscular dystrophy, etc.), cervical spine injuries, etc.

[0172] Having thus described several embodiments for practicing the method of the present invention, its advantages and objects can be readily understood. Modifications can and will be made to the above description by those skilled in the art without departing from the scope of the present invention.

[0173] Thus, the present invention should not be limited to the embodiments as described, which are presented by way of example only and not by way of limitation.

[0174] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by a person of ordinary skill in the art to which the present invention relates. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and materials are described below. In the event of a conflict, the patent specification (including definitions) will prevail. In addition, the materials, methods, and examples are illustrative only and are not intended to be limiting.

[0175] As used herein, the term "about" may be used to specify that a value of a quantity or parameter (e.g., the length of an element) is within a continuous range of values around (including) a given (specified) value. According to some embodiments, "about" may specify that a value of a parameter is between 80% and 120% of the given value. According to some embodiments, "approximately" specifies that a value of a parameter is between 90% and 110% of the given value. According to some embodiments, "approximately" specifies that a value of a parameter is between 95% and 105% of the given value.

[0176] According to some embodiments, the controller unit includes a processing unit or module. According to some embodiments, terms such as "processing", "calculating", "calculating", "determining", "estimating", "evaluating", "measuring", etc. may refer to the action and process of a computer or computing system or similar electronic computing device to manipulate and / or transform data represented as physical (e.g., electronic) quantities within the registers and / or memory of the computing system into other data similarly represented as physical quantities within the memory, registers or other such information storage, transmission or display devices of the computing system. The embodiments of the present disclosure may include devices for performing the operations herein. The devices may be specially constructed for the desired purpose, or the devices may include general-purpose computers that are selectively activated or configured by a computer program stored in the computer. Such computer programs may be stored in computer-readable storage media, such as, but not limited to, any type of disk, including floppy disks, optical disks, CD-ROMs, magneto-optical disks, read-only memories (ROMs), random access memories (RAMs), electrically programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), magnetic cards or optical cards, or any other type of medium suitable for storing electronic instructions and capable of being coupled to a computer system bus. The processes and displays presented are essentially independent of any particular computer or other device. Various general purpose systems can be used together with the programs according to the teachings herein, or it may prove convenient to construct more specialized equipment to perform the desired method. In addition, the embodiments of the present disclosure are not described with reference to any particular programming language. It should be understood that a variety of programming languages can be used to implement the teachings of the present disclosure as described herein.

[0177] Aspects of the present disclosure may be described in the general context of computer-executable instructions (such as program modules) executed by a computer. Or processing unit. In general, program modules include routines, programs, objects, components, data structures, etc. that perform specific tasks or implement specific abstract data types. The disclosed embodiments may also be practiced in a distributed computing environment, where tasks are performed by remote processing devices linked through a communication network. In a distributed computing environment, program modules may be located in local and remote computer storage media, including memory storage devices.

[0178] In the description and claims of this application, the words "including" and "having" and forms thereof are not necessarily limited to the members of the list with which the words are associated.

[0179] As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly indicates otherwise.

[0180] Throughout this application, various embodiments of the present invention may be presented in a range format. It should be understood that the description in range format is for convenience and brevity only and should not be construed as an inflexible limitation on the scope of the invention. Therefore, the description of a range should be considered to have specifically disclosed all possible subranges and individual numerical values within that range.

[0181] Whenever a numerical range is indicated herein, it is intended to include any cited numeral (fractional or integer) within the indicated range. The phrases "a range between a first indicated numeral and a second indicated numeral" and "a range from a first indicated numeral to a second indicated numeral" are used interchangeably herein and are intended to include the first indicated numeral and the second indicated numeral and all fractions and integers therebetween.

[0182] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by a person of ordinary skill in the art to which this disclosure relates. In the event of a conflict, the patent specification, including definitions, will prevail. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise.

[0183] It will be appreciated that certain features of the present disclosure that are described, for the sake of clarity, in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the present disclosure that are described, for the sake of brevity, in the context of a single embodiment may also be provided separately or in any suitable subcombination, or as appropriate in any other described embodiment of the present disclosure. Any feature described in the context of an embodiment should not be considered an essential feature of that embodiment unless expressly stated to be so.

[0184] Although the steps of the method according to some embodiments may be described in a particular order, the method of the present disclosure may include some or all of the described steps performed in a different order. The method of the present disclosure may include several of the steps described or all of the steps described. Any specific step in the disclosed method should not be considered an essential step of the method unless expressly stated to be so.

[0185] Although the present disclosure has been described in conjunction with specific embodiments thereof, it is apparent that numerous alternatives, modifications, and variations are possible that will be apparent to those skilled in the art. Therefore, the present disclosure encompasses all such alternatives, modifications, and variations that fall within the scope of the appended claims. It should be understood that the present disclosure is not necessarily limited in its application to the details of construction and arrangement of the components and / or methods set forth herein. Other embodiments may be practiced, and embodiments may be implemented in a variety of ways.

[0186] The terms and expressions used herein are for descriptive purposes and should not be construed as limiting. The citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art for the present disclosure. Section headings are used herein to facilitate understanding of the specification and should not be construed as necessarily limiting.

[0187] Although the present invention has been described in conjunction with specific embodiments thereof, it is apparent that many alternatives, modifications and variations will be apparent to those skilled in the art. It is therefore intended to encompass all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

Claims

1. A mechanical system for improving, supporting and / or treating ventilatory insufficiency in a subject in need thereof, the system comprising: a movable unit configured to be attached / fixed to an anterior bony structure of the thorax, the movable unit being physically and / or functionally associated with the actuator; as well as a static member configured to anchor the actuator and connected to a rear section of at least one rib; Wherein when activated, the actuator is configured to displace the movable unit and the attached bony structure, thereby affecting the volume of the thoracic cavity.

2. The system of claim 1 , wherein affecting the volume of the thoracic cavity comprises: increasing the volume of the cavity, thereby creating a negative pressure that induces inhalation into the lungs; and / or reducing the volume cavity, thereby inducing exhalation from the lungs.

3. The system of any one of claims 1 to 2, wherein the actuator comprises: Stationary motor; and movable arms or sliding elements that are positioned at least partially on top of each other.

4. The system of claim 3, wherein the arm or sliding element is located on the rear or underside of the movable unit.

5. The system of any one of claims 1 to 4, wherein the actuator and the static component are positioned subcutaneously outside of the subject's rib cage.

6. The system of any one of claims 1 to 4, wherein the actuator and the static component are positioned within the rib cage of the subject.

7. The system of claim 3, wherein the motor comprises an electric motor, a pneumatic piston, or a hydraulic piston.

8. The system according to any one of claims 1 to 7, further comprising: A diaphragm band is configured to prevent the diaphragm from being drawn into the thoracic cavity.

9. The system of any one of claims 1 to 8, wherein the system further comprises a controller configured to activate the actuator.

10. The system of any one of claims 1 to 9, wherein the system further comprises one or more biosensors configured to detect the initiation of spontaneous breathing or ventilator-induced breathing by the subject.

11. The system of claim 10, wherein the one or more biosensors are selected from the group consisting of: an oxygen sensor, a carbon dioxide sensor, a pressure sensor, a stretch sensor, an accelerometer, an electrical sensor for detecting nerve and / or muscle stimulation or activity, an electromyography sensor (EMG), or any combination thereof.

12. The system of any one of claims 10 to 11, wherein the one or more biosensors are located externally and / or internally within the body of the subject.

13. The system according to any one of claims 1 to 12, further comprising: A fault sensor is selected from the group consisting of an accelerometer, a voltmeter, a current sensor, and any combination thereof.

14. The system according to any one of claims 1 to 13, wherein the movable unit comprises a fixation plate rigidly fixed to the anterior bony structure.

15. The system according to any one of claims 1 to 14, wherein the removable unit is constructed of a biocompatible material.

16. The system of claim 15, wherein the biocompatible material is selected from the group consisting of stainless steel, cobalt-chromium alloys, titanium and titanium alloys, pyrolytic carbon, thermoplastics, bioceramics, and combinations thereof.

17. The system of any one of claims 1 to 16, wherein the static component comprises at least one strap.

18. The system of claim 17, wherein the at least one strap comprises two portions, each of the portions being configured to be anchored rearwardly to at least one rib at one end and to be anchored frontwardly to the actuator at another end.

19. The system according to any one of claims 17 to 18, wherein the at least one strap is anchored at one end at the rear side to the at least one rib by a plate and / or a hinge.

20. The system of any one of claims 1 to 19, wherein the bony structure is an anterior rib or sternum of the subject.

21. The system of any one of claims 1 to 20, wherein the movable unit comprises a fixation plate configured to be attached to or fixed to the bony structure of the thoracic cavity, wherein relative vertical movement of the movable unit induced by the actuator induces a volumetric change of the thoracic cavity.

22. The system of any one of claims 1 to 21, wherein at least a portion of the system is configured for subcutaneous implantation.

23. The system of any one of claims 1 to 22, wherein the controller is configured to activate the actuator in predetermined amounts, at predetermined timings, and / or at a predetermined rate.

24. The system of any one of claims 1 to 23, wherein the controller is configured to activate the actuator in an amount, timing and / or rate determined based on information from one or more sensors.

25. The system of any one of claims 1 to 24, wherein the controller is configured to be worn externally by a user.

26. The system according to any one of claims 1 to 25, further comprising: Rechargeable battery.

27. The system of claim 26, wherein the rechargeable battery is configured to be worn externally by a user.

28. The system of any one of claims 1 to 27, wherein the system is portable.

29. A method for supporting, improving and / or treating ventilatory insufficiency in a subject in need thereof, the method comprising: implanting a ventilation system according to any one of claims 1 to 28 into the subject; as well as The controller is used to control operating parameters of the ventilation system.

30. The method of claim 29, wherein the operating parameters include a range of motion of the actuator, an expansion volume of the thorax, a timing of motion of the actuator, a timing of expansion of the thorax, a rate of motion of the actuator, a rate of expansion of the thorax, or any combination thereof.

31. The method of claim 30, used to support weaning a subject from respiratory support.

32. The method of any one of claims 29 to 31 , for improving the subject's spontaneous breathing.

33. The method according to any one of claims 29 to 32, for promoting speech and / or coughing in the subject.

34. The method of any one of claims 29 to 33, wherein the subject suffers from a neurodegenerative disorder.

35. A surgical method for implanting a system for improving, supporting and / or treating ventilatory insufficiency in a subject in need thereof, the system comprising: a movable unit configured to be attached / fixed to an anterior bony structure of the thorax, the movable unit being physically and / or functionally associated with the actuator; and a static member configured to anchor the actuator and connected to a rear section of at least one rib; The surgical method comprises the following steps: securing the removable unit to the anterior bony structure of the thorax of the subject; positioning the static component and the actuator; associating the movable unit with the actuator; and controlling operation of the actuator via an external controller such that, when activated, the actuator is configured to displace the movable unit, thereby inducing movement of the bony structure and affecting the volume of the thoracic cavity; The subject's breathing is thereby at least partially controlled.

Images