HK1135303B - Device and system for treatment equine airway disorders - Google Patents

Description

Device and system for treating airway diseases in horses

This application claims priority from U.S. provisional patent application 60/871,533 filed 2006, 12, 22, which is hereby incorporated by reference.

Technical Field

The present application relates to relieving airway impairment in horses.

Background

Figure 1 shows various anatomical structures relating to the head of a horse. Among these, the airway structure, particularly the larynx, is susceptible to various diseases, affecting the health of the horse and its ability to function normally. The larynx is innervated by the Recurrent Laryngeal Nerve (RLN), which contains motor fibers that innervate the abductor/opening and adductor/closing muscles of the arytenoid cartilage and its associated vocal folds.

Laryngeal hemiplegia is a distal axonal disease affecting the left recurrent laryngeal nerve, causing a unilateral disease called laryngeal hemiplegia/paresis. Left recurrent laryngeal nerve injury compromises the function of both by stopping the movement of the vocal folds at a position just lateral to the midline. The cause of this disease is unknown, although genetic predisposition is suspected. Other possible causes include direct trauma, lead poisoning, liver disease and viral infection. Despite this left vocal fold paralysis, resting lung ventilation is sufficient, as abduction of the contralateral arytenoid cartilage can still occur with each inspiration. However, during action, the cross-sectional area of the throat is further reduced due to the diseased cartilage collapsing further during inspiration. This results in a significant airflow reduction with abnormal upper airway noise during activity. In horses used for racing, the airflow reduces interference performance and can impair the racing ability of the horse. In rare cases, the disease may be bilateral, with increased arytenoid cartilage collapse, which if there is any increased inspiratory drive, would result in severe airway obstruction at rest, causing dyspnea, and possibly death.

Currently, reconstructive laryngoplasty is the preferred surgical treatment for laryngeal hemiplegia. The paralyzed left arytenoid cartilage is sutured in an open position to restore airflow. Retrospective analysis of post-operative performance of racehorses treated with laryngoplasty showed moderate success rates, but many complications. See, e.g., Kidd JA, Slone DE, Treatment Of laryngel HemiplegiaIn Horses By prosthethethethetic laryngolplant, ventriceculechomy And vocal cord resections for Laryngeal hemiplegia in Horses vet. rec.150: 481-484, 2002; green TRC, Baker GJ, leer, The Effect Of laryngolplant On pharynglobal Function In The Horse eq.ve.j., 11: 153-158, 1979; russell AP, Slone DE, Performance Analysis After construction Laryngoplasty And Bilateral ventrican For Larynggel HemipteraIn Horses: 70 Cases (1986-1991), (analysis of performance after repair laryngoplasty and bilateral laryngeal lumpectomy of laryngeal hemiplegia in horses: 70 Cases (1986-1991)) J.Am.vet.Med.Assoc, 204: 1235-1241, 1994; hawkins JF et al, Largoplastywith Or Without venture ventrickicie For Treatment Of Left Largygeal hemiplegia In 230 Horses, (Treatment Of Left laryngeal hemiplegia with Or Without laryngeal lumpectomy In 230 Horses) Vet. Surg., 26: 484-491, 1997; StrandE, et al, Career rating Performance In thorough trees Treated withth pathological Laryngoplasty For Larynggial neuropathies: 52 Cases (1981-1989), (occupational competition performance of pure horses for treatment of laryngeal neuropathy with obturator laryngoplasty: 52 Cases (1981-1989)) J.Am.vet.Med.Assoc, 217: 1689 1696, 2000; all incorporated herein by reference.

The major complications of such surgery are related to the incomplete abduction of the left arytenoid cartilage, intolerance to continuous motion in approximately 40% of horses, loss of repair suture to a partial degree of initial abduction loss in almost all horses by week 6, and sustained respiratory murmurs in 25% of horses. See, e.g., Ducharme NG, Hackett RP, where is the True Value of Laryngeal Surgery? (what is the true value of laryngeal surgery: 472-; dixon PM et al, Long term surface Of Larynggoplasty And vector recording In An old Mixed-breeed Power Of 200Horses, part 1: maintenance Of Arytenoid Abduction And Complications Of Surgery in the 200-P old blood-mixing horse population Eq Vet J35: 389 396, 2003; dixon PM et al, Long Term surface Of Larynggoplasty and vector recording In An injector Mixed-Breeding Of 200Horses, part 2: owner's Association Of The Value Of Surgery, (long-term investigation Of laryngoplasty and laryngeal ventricular vocal cord resection in 200 aged mixed-blood horse population. second section: evaluation Of surgical Value by The horse Owner), Eq Vet J35: 397-; FerraroGL, Laryngeal Hemiperia In Current Practice Of Equipment Surgery, (Laryngeal Hemiplegia In Current Practice Of Equine Surgery), Main edition by White NA and Moore JN, Philadelphia J.B.Lippincott Co, pp 251-.

Although these conventional treatments are useful in some horses, they are clearly less than ideal because they have a moderate success rate, significant complications, and are unable to slow the progression of the disease. Thus, the disease reaches a state where these methods can no longer help, which is often a matter of months.

While there have been many experiments attempting to develop, and many patents describing implantable electrical therapy systems for human throat disease, no such system has been developed for horses. As summarized in table 1 and explained below, the clinical condition of horses is quite different from that of humans, with much more technical challenges for electrotherapy systems.

Parameter(s)	Horse	Human being
			Vocal fold involved in abductor stimulation	One side	Bilateral, since unilateral paralysis in humans is not a major obstacle to abduction
Laterality of vocal fold	Left side of the	Left or right side
			Vocal fold abduction	Extended for a continuous long time for several hours (as long asHorses are doing any kind of intense movement); most muscles of any other species will fatigue after a few minutes of continuous stimulation.	Abduction by inspiration for 1-2 seconds
Therapy method	Tracheostomy cannot cure	Tracheostomy healing
			Damage or injury	Athletic performance/abnormal noise; life-threatening air reduction	Physical damage/life-threatening due to reduced air
Severity of disease	Mild paresis causes symptoms	Paralysis is required to cause symptoms
			Quiet breathing	Is not damaged	Is damaged
Adduction and adduction	VF adduction may be sacrificed	Loss of adduction results in inspiration and diminished or sacrificed vocalization.

TABLE 1 differences between unilateral laryngeal hemiplegia in humans and horses

Thus, it is clear that unilateral hemiplegia has very different conditions, requiring different treatments to be successful, and that a procedure that works in one species is not necessarily suitable for the other. In humans, airway damage typically occurs when both vocal folds are paralyzed. In contrast, in horses, a condition occurs when a single vocal fold is paralyzed. Even a slight weakening of one vocal fold will pull the vocal fold into the airway due to the large negative pressure created in the airway during inhalation. Horses fully abduct their vocal folds during exercise, allowing PCA muscle to exercise for minutes to hours at high speed. Furthermore, unilateral paralysis in humans primarily affects adduction, and therefore adduction stimulation is a primary target of unilateral paralysis in humans. Adductor stimulation is much simpler because there are four times as many adductor muscles, their threshold is lower (so they can be separately stimulated simply by lower amplitude), and their anatomical location is shallower than the abductor muscles on the dorsal vocal cords.

In humans, us patent 7,069,082 (incorporated herein by reference) describes laryngeal stimulation of vocal cord paralysis in the case of a synkinetic nerve re-innervating muscles. Other laryngeal stimulation patents for the treatment of vocal cord paralysis emphasize the diagnosis of denervated vocal cord muscles. For example, in the case of sleep apnea in humans, the muscles and their innervating nerves are intact. However, equine laryngeal hemiplegia has a different mechanism in which the developing distal axonopathy stops vocal fold movement just lateral to the midline-there is no zonular motor innervation and denervation is in the final stage, but subsequent stimulation by the nerve will no longer work. In contrast, the transmission of natural signals through nerves appears to be impaired (compromised) because the muscles are inactive during any phase of relatively long movement (class IV) or only in the case of intense movement (class III), but the muscles can be maximally activated by electrical nerve stimulation (as in horses without disease).

Since disease in horses is due to axonal loss, it is expected that most motor neurons of horses that exhibit vocal fold immobility will be reduced or absent. Therefore, resuscitating the vocal folds with electrical stimulation would require targeting the denervated PCA muscle. In any case, direct muscle stimulation is difficult, with more technical problems for larger muscles, such as those in horses.

Furthermore, any device for treating conditions in horses is by no means only effective and must comply with the regulations of the authorities supervising the movement of horses. In a pure horse race, this requires that the device never give the horse an unfair advantage. Furthermore, the performance of the horses is not allowed to be impaired. In particular, since the horse is an integral part of the sport, there is no way to adjust the apparatus to manipulate the performance of the horse.

As used herein, the term "paralysis" is used to refer to a complete loss of innervation of muscles, while "paresis" is used to refer to a weakening of muscles due to a decrease in motor distribution or activity, and "synkinesis" refers to an inappropriate co-contraction of antagonistic muscles.

Summary of The Invention

Embodiments of the present invention are directed to treating airway diseases in horses. The pacemaker processor generates an electrical therapy signal that is applied to upper airway tissue of the horse for treating an upper airway disorder. One or more stimulation electrodes interface with the upper airway tissue for delivering a therapeutic signal to the upper airway tissue.

In various more specific embodiments, at least a portion of the device can be implanted in a horse. The implanted portion of the device may communicate percutaneously or transdermally with a portion of the device that is external to the horse. For example, transcutaneous communication may be based on at least one of electromagnetic induction, acoustic energy, optical energy, and capacitive coupling. When the device is operated to provide an external signal to the implanted portion of the device, a portion of the device may be temporarily placed on the surface of the horse. The therapeutic signal may be derived from at least one of electromyography, electroseismic graph, electroglography, electroencephalography, biopotential sensors, ultrasound sensors, Hall (Hall) sensors, microphones, pressure sensors, strain sensors, mechanical deformation sensors, and motion sensors. The implanted portion may contain a transcutaneous or transcutaneous charged power source. In other specific embodiments, at least a portion of the device may be integrated into a horse racing set.

In particular embodiments, the electrical treatment signal may be applied to the upper airway tissue of the horse based on a signal derived from a biological function of the horse. Upper airway diseases may include vocal fold paralysis, vocal fold paresis, unilateral vocal fold disease, bilateral vocal fold disease, laryngeal hemiplegia, laryngeal hemiparesis, neuronal degeneration, dorsal displacement of the soft palate, nasopharygeal collapse, epiglottic retroversion, axonal degeneration, distal axonopathy, and nasopterygeal paralysis. The therapeutic signal may be applied to the upper airway tissue using a biphasic waveform. The stimulation electrode may be based on at least one of a cuff electrode (cuff electrode), a multipolar cuff electrode, a tripolar cuff electrode, a flat nerve electrode, an extra-nerve electrode, an axial electrode, a longitudinal nerve bundle inner electrode, a filament electrode, a micromechanical electrode, a gate electrode (sieve electrode), and a staple electrode (staple electrode), any of which may be differentially activated to cause stimulation of specific regions of upper airway tissue.

In particular embodiments, the upper airway tissue includes one or more nerves of the airway structure, such as one or more axons of the abductor branch of the recurrent laryngeal nerve. The upper airway tissue may comprise muscle tissue associated with airway tissue, such as cricoarytenoid muscle tissue including posterior cricoarytenoid muscle tissue. The electrical stimulation signal may cause abduction of vocal cord tissue. The electrical signal may be continuously delivered over a period of hours until the device is shut down.

Particular embodiments may also include one or more treatment sensors for sensing at least one treatment parameter associated with the operation of the device. In particular, the treatment parameter may relate to at least one of an air flow characteristic of an airway of the horse, a contraction characteristic of airway tissue of the horse, an electrical characteristic of a portion of the horse body, a temperature of a portion of the horse body, a pH of a portion of the horse body, a chemical composition of a portion of the horse body, and a physiological state of the horse.

Embodiments may also include a therapy verification monitor for verifying monitoring of the operation of the pacemaker processor. The log may record at least one treatment parameter. The therapy verification monitor may generate an external signal while the pacemaker is operating, such as by stimulating muscles with electrodes to effect visible movement of the horse's muscles.

Embodiments of the invention also include an adaptive airway therapy system for treating upper airway diseases in horses. One or more sensors sense at least one treatment parameter related to the operation of the treatment system. The pacemaker processor is responsive to the at least one treatment parameter to treat the upper airway disorder by generating an electrical treatment signal as a function of the at least one treatment parameter. One or more stimulation electrodes interface with the upper airway tissue to deliver a therapeutic signal to the upper airway tissue of the horse.

In various such embodiments, the treatment sensor may be placed externally on the horse and/or implanted within the horse. The therapy sensor may be connected to the pacemaker by one or more leads and/or integrated into a housing that houses the pacemaker processor. The treatment signal may also be a function of one or more stimulation electrodes, or an equine expert, or some combination thereof.

In other embodiments, the treatment parameter may relate to the efficacy of the treatment signal delivered by the one or more stimulator electrodes, for example to at least one of the function of the vocal cords, the function of another section of upper airway tissue, and some other parameter within the horse. Additionally or alternatively, the treatment parameter may include at least one of pressure, contraction force, airflow rate, airflow pressure, airflow volume, airflow velocity, temperature, impedance, pH, and chemical composition. The treatment parameter may relate to an activity level of the horse based on at least one of cardiac activity, respiratory activity, and electromyographic activity. The treatment parameter may be related to the posture or activity level of the horse, e.g. whether the horse is asleep or awake.

In particular embodiments, the treatment sensor may be implanted in the body of the horse, and/or may comprise an accelerometer that detects the activity level of the horse.

The treatment signal may be a function of a regular periodic analysis of the treatment parameter, or an irregular non-periodic analysis of the treatment parameter. The therapy sensor may sense the physiological condition continuously or periodically. The pacemaker processor may capture the treatment parameters at selected intervals, which may be selected to conserve power connected to the system. Additionally or alternatively, the pacemaker processor may capture therapy parameters in response to user input from a user interface, for example based on magnetic input from a user.

Embodiments of the present invention also include a therapy verification system for verifying proper treatment of an upper airway disorder, such as equine laryngeal hemiplegia, in a subject. The pacemaker processor is responsive to the at least one treatment parameter to treat the upper airway disorder by generating an electrical treatment signal that is a function of the at least one treatment parameter. One or more stimulation electrodes interface with the upper airway tissue to deliver therapeutic signals to the upper airway tissue of the subject. A therapy audit monitor auditively monitors at least one therapy parameter related to the operation of the pacemaker processor.

In other such embodiments, the subject may specifically be a horse. The therapy verification monitor may include a logging system for recording compliance with the stimulation protocol. Verification monitoring may include verifying that required treatment criteria are met to prevent false treatment responses, adverse or improper benefits to the horse; verifying that the device is operational and performing function properly; checking compliance with security measures associated with wagers; and/or to generate external signals to indicate the operation of the system, such as external light or radio signals. The external signal is generated by a separate signal stimulator for stimulating the indicative muscle to produce an externally visible effect, such as tilting or rotating the outer ear by moving the outer ear when the system is in operation.

Particular embodiments may also includeAt least one treatment sensor for sensing at least one of electrical stimulation, biopotentials in tissue activity evoked by the stimulation, vocal fold abduction, and airflow changes related to vocal cord position. The therapy transducer may sense vocal fold abduction by monitoring at least one of the appropriate airflow based on at least one of airway sound, subglottal pressure, and temperature. The treatment sensor may also sense vocal fold movement based on vocal fold displacement, for example as measured by at least one of a laryngeal tissue strain gauge, a transoceanic light sensing, a change in laryngeal tissue impedance, and a video view of the vocal folds. The therapy sensor may sense a disturbance of the inspiratory flow, such as a disturbance of the inspiratory flow based on a pressure associated with at least one of subglottal, tracheal, or intrathoracic trachea. The therapy sensor may be monitored by, for example, systemic physiological signals, including hypoxemia and CO₂At least one of the increases to sense ineffective breathing during the exercise. The treatment sensor may include a radio stethoscope and/or a microphone transducer attached to the skin of the subject near the trachea. For example, an external radio transmitter may communicate with a microphone transducer to monitor the horse's breathing from a distance.

Embodiments of the invention also include axonal therapy systems for treating neurodegenerative airway diseases in horses. The pacemaker processor treats neurodegenerative airway diseases by providing axonal therapy based on electrical stimulation of target tissue in the upper airway of horses. One or more axon electrodes connect the interface component to the neural tissue.

In such embodiments, the target tissue may include one or more nerves of the airway structure, such as motor nerves and/or sensory nerves; such as the recurrent laryngeal nerve of horses. The electrical stimulation may include regional stimulation of the abductor branch axons of the recurrent laryngeal nerve. Regional stimulation refers to stimulation of only selected regions of a nerve cross-section, such that only nerve fibers in that nerve region are activated, rather than all nerve fibers in the nerve. The target tissue may include muscle tissue associated with airway tissue, such as posterior cricoarytenoid muscle tissue, or arytenoid cartilage. The electrical stimulation may include abduction of vocal cord tissue such as giant abduction (titan abducting).

In other specific embodiments, the airway disorder may include unilateral or bilateral vocal fold disorder, laryngeal hemiparesis, or laryngeal hemiplegia. The electrical stimulation may use a biphasic waveform and/or a cathodic waveform. Electrical stimulation may promote axonal regeneration, slow axonal degeneration, or prevent axonal degeneration prior to the onset of airway disease. Additionally or alternatively, the electrical stimulation may be below a threshold that does not cause activity of the muscle fibers.

Brief Description of Drawings

Fig. 1 shows various anatomical structures in a horse head.

Fig. 2 shows various functional modules involved in a representative embodiment of an airway treatment system for airway diseases in horses.

Figures 3A-D show some non-limiting examples of specific electrode arrangements that may be used.

Figure 4 shows various elements of a U-shaped electrode arrangement.

Figure 5 summarizes the trade-off and related interactions between electrode selectivity and invasiveness to diseased tissue for various possible specific electrode configurations.

Fig. 6 shows various components for parameter adjustment for airway therapy.

Detailed description of the specific embodiments

Various embodiments of the present invention are directed to treating airway diseases in horses, such as laryngeal hemiplegia (partial paralysis). Although this disease is known to be a neurological disease (a disease associated with neuronal loss), it has been unexpectedly found that electrical stimulation of the innervating nerves of paralyzed vocal folds results in complete abduction of the vocal folds. Furthermore, this abduction may be maintained continuously for several hours. The abduction is powerful enough to counter the high negative pressure in the airways created by horses during exercise or labor.

Embodiments of the present invention stimulate airway nerves in horses. This is in contrast to previous systems for human therapy directed to muscle tissue (except for us patent 7,069,082 which, as noted above, stimulated the synkinetic re-innervation of humans, as opposed to diseased horses where the nerves were damaged but not de-innervated and thus not re-innervated). Therefore, a sensor for triggering a stimulus synchronized with inspiration is not necessary. Furthermore, the stimulation provided by embodiments of the present invention is not just a few seconds during inspiration as in previous human systems, but is applied for up to several hours. In humans this will fatigue the muscles after a few minutes (view minutes), so after this fatigue phase the stimulation will no longer have the function of moving the muscles until after they have relaxed. By stimulating human nerves for hours using the same parameters as in horses, human muscles will likely be irreversibly damaged.

Electric channel treatment system

Embodiments of the electrical tract treatment system comprise an implanted portion that performs one or more functions. For example, the implant may generate the tissue stimulation signal by a separate electronic component or by a dependent processing of the signal from an external component. The implant may also record sensed signals, such as signals related to monitoring the operation of the system. In certain embodiments, one or more implants may simultaneously stimulate and sense surrounding tissue. The leads may be connected in a removable or non-removable manner for transmitting stimulation signals to the electrodes or recording signals from the electrodes and/or sensors.

Fig. 2 shows various functional modules included in a representative embodiment of an airway treatment system 200 for airway disease in horses. The pacemaker processor 201 generates electrical therapy signals for application to upper airway tissue of the horse for treating an upper airway disorder. In addition to providing therapy signals, in particular embodiments, pacemaker processor 201 may also perform other useful functions including, but not limited to, monitoring and analyzing stimulation signals, sensor signals, and/or other therapy signals. The pacemaker processor may also provide a programmable interface for adjusting other elements in the system and controlling the functioning of these other elements.

In the embodiment shown in fig. 2, pacemaker processor 201 is an external element of the system, for example in a housing located on the horse's skin or integrated in the horse gear. In other embodiments, pacemaker processor 201 may be implanted in a horse. In an external embodiment such as that shown in fig. 2, a pacemaker processor 201 provides therapeutic signals (as well as any other signals useful to implanted portions of the system 200, e.g., power signals) to an external coil 202 that inductively couples the signals to a corresponding internal coil 203. Such coil arrangements are similar to those well known in the art of human cochlear implants.

The therapy signals received by implanted coil 203 are input to stimulation assembly 204, and stimulation assembly 204 generates electrical therapy signals for application to one or more stimulation electrodes 206 that interface with target upper airway tissue associated with the upper airway disorder being treated.

The embodiment of fig. 2 also has a sensor 207 that senses one or more treatment parameters associated with the operation of the system 200. Such as airflow characteristics and other physiological data. The signals of the sensor 207 are processed by the sensor component 208, which may provide feedback to the stimulation component 204 and/or returned to the pacemaker processor 201 (e.g., from the internal coil 203 back to the external coil 202 via load modulation). The feedback signal from the sensor 207 may be used by external components of the system, such as the pacemaker processor 201 in general, or by a treatment check monitor 209 more specifically, which checks the proper functioning of the system 200, for example, to ensure compliance with gambling-related safety measures that may be required by one or more regulatory agencies, or more generally, to monitor the functioning of the system 200 based on information received from various system components. The system 200 may also include a log 210 that records various information related to the operation of the system 200, such as periodic values of one or more treatment parameters from the sensors 207.

Particular embodiments of system 200 may be entirely external to the horse, entirely implanted, or have both external and internal components. Embodiments of the system 200 having both external and internal components may transmit information and/or energy through the skin of the horse. The external component may be permanently affixed to the surface of the horse, or temporarily placed while the stimulating assembly 204 is active, or intermittently placed, for example, to charge the implanted battery 205, program the stimulating assembly 204, or turn the stimulating assembly 204 on and off.

Exemplary embodiments include, but are not limited to, a system 200 for transcutaneous or percutaneous energy or information transfer. Transcutaneous systems have direct coils or equivalent hardware to transmit information and energy through the skin or mucosa. In general, foreign objects placed long across the skin or mucosa are at risk of causing infection. However, newer techniques known in the art enable ingrowth of skin or mucosa onto the surface of the coil to protect the coil from percutaneous access. For aesthetic purposes, the transcutaneous device may appear cosmetically as a decorative piercing, such as an earring for human use.

Alternatively or additionally, the implanted and external components of the system 200 may be connected transdermally, as shown by the external coil 202 and corresponding internal coil 203 of fig. 2. Transdermal systems known in the art include acoustic energy, optical energy (e.g., U.S. patent No.5,387,259), and/or capacitive coupling methods in addition to an arrangement of electromagnetic induction coils such as that shown in fig. 2. An energy and/or data delivery system may be present to interconnect the percutaneous wiring to the transducer system of the first implant component, and the first and second implant components (e.g., stimulation assembly 204). Examples of such a system 200 include, but are not limited to, a first inductive connection from an external component to a first implanted coil 203, and an implanted connection for an implanted stimulating assembly 204 to an implanted second inductive connection. Such an arrangement may be used, for example, to replace portions of the system 200 in the event of a failure or upgrade, or to have a staged implantation procedure for different components of the system 200.

The external component may perform various functions, such as altering or adapting parameters of the implanted portion of the system 200. The outer member may be placed under or in the horse's eye shield or other playing piece. Other examples of external components, besides the specific arrangement shown in fig. 2, may include induction coils, electronic circuitry, wireless telemetry, detection systems, processors, and power sources (e.g., batteries). In particular embodiments, the external component may send only power signals (e.g., recharge implanted battery 205), only data signals (e.g., stimulation signals for stimulation component 204), only control signals (e.g., control or change parameters of implanted components such as stimulation component 204, stimulation electrode 206, and/or therapy sensor 207), or any combination thereof.

The outer and inner components require proper mechanical fixation to remain joined during vigorous movements. Furthermore, movement of the component compresses any coils causing them to move closer to or further away from the component, potentially causing the coils to break. Examples of external fixation methods include glue, tape, sutures, magnets, perforations, straps around animals, or using existing horse gear such as halters, eye masks, bristle trainers (mane markers) and saddles. As a non-limiting example, the external coil 202 may be placed in an area on the halter that covers the implanted implant coil 203.

In one embodiment, the stimulating assembly 204 will be turned on and will continue to operate until turned off. In other embodiments, operation of the stimulation component 204 will be triggered by signals obtained from the animal, including, but not limited to, the following.

One method uses Electromyography (EMG) of another inspiratory muscle. In this embodiment, the treatment system 200 includes: a) sensing electrodes 207 adapted to be electrically coupled to normally functioning muscles contracted during inspiration and to provide electrical signals indicative of their muscle activity; b) a stimulation electrode 206 electrically coupled to the dysfunctional posterior cricoarytenoid muscle; c) and a pacemaker processor 201 for receiving the sensing signal from the sensing electrode 207 and providing the stimulating signal to the stimulating electrode 206. In pacemaker operation, the dysfunctional posterior cricoarytenoid muscle is stimulated substantially in synchronism with the activity of the normally functioning muscle. The normally functioning muscle that contracts during inspiration can be the contralateral healthy posterior cricoarytenoid muscle, or the diaphragm, or other muscle whose EMG shows a high correlation with the inspiratory signal.

Another embodiment is an electro-oculogram (ENG) -based therapy system 200, comprising: a) a sensing electrode 207 adapted to electrically couple to a normally functioning nerve that contracts during inspiration and provide an electrical signal indicative of its neural activity; b) a stimulation electrode 206 electrically coupled to the dysfunctional posterior cricoarytenoid muscle; c) coupled pacemaker processor 201 receives the sensing signal from sensing electrode 207 and provides a stimulation signal to stimulation electrode 206 that is substantially synchronized with the electrical signal provided by sensing electrode 207. In pacemaker operation, the dysfunctional posterior cricoarytenoid muscle is stimulated substantially synchronously with the activity of a functioning normal nerve. The normally functioning nerve that contracts during inspiration may be the phrenic nerve, or other nerve whose ENG appears to be highly correlated with the inspiration signal.

An embodiment may be an electro-glottic (EGG) based therapy system 200, comprising: a) sensing electrode 207, adapted to be electrically coupled to measure vocal fold contact area (referred to as electroglottic-EGG). The EGG includes a high frequency, low current signal that passes between the vocal folds with the help of electrodes. Sensing electrodes 207 are placed on either side of the thyroid cartilage plate or near the vocal folds. EGG is based on the principle that tissue conducts current. Thus, when the vocal folds make contact, more current flows. The output of the electroglottography recording can be used to determine when and how quickly the vocal folds close or open) for providing an electrical signal indicative of the vocal folds opening; b) a stimulation electrode 206 electrically coupled to the dysfunctional posterior cricoarytenoid muscle; c) the pacemaker processor 201 receives the sensing signal provided by the sensing electrode 207 and provides the stimulation signal to the stimulation electrode 206. During pacemaker operation, the dysfunctional posterior cricoarytenoid muscle is stimulated substantially in synchronism with the activity of the vocal fold opening signal.

Another embodiment is a therapy system 200 based on the use of electroencephalography (EEG) comprising: a) Sensing electrodes 207 adapted to measure electrical activity in the brain recorded by electrodes placed on, in or under the scalp, or subdural or in the cerebral cortex, in the area where the sensing electrodes 207 are placed, the EEG represents electrical signals from a large number of neurons showing a high correlation with inspiratory signals during inspiration (postsynaptic potentials) and is used to provide electrical signals indicative of its activity; b) a stimulation electrode 206 electrically coupled to the dysfunctional posterior cricoarytenoid muscle; c) the pacemaker processor 201 receives the sensing signal provided by the sensing electrode 207 and provides the stimulation signal to the stimulation electrode 206. In pacemaker operation, the dysfunctional posterior cricoarytenoid muscle is stimulated substantially in synchrony with the activity of the normally functioning brain region activity.

Another embodiment may be a biopotential-based therapy system 200, comprising: a) a sensing electrode 207 for measuring biopotential of electrical signals highly correlated with the flow rate of gas during vocal fold opening or inspiration; b) a stimulation electrode 206 electrically coupled to the dysfunctional posterior cricoarytenoid muscle; c) the pacemaker processor 201 receives the sensing signal from the sensing electrode 207 and provides the stimulation signal to the stimulation electrode 206.

Electrode mounting

The system electrodes may be placed on the skin or mucosa of the animal, or within the body in proximity to the target tissue. For example, the electrodes may be in direct proximity to the target nerve, where they will be very effective and avoid spreading the current to the surrounding tissue. Multiple electrodes may be placed around the tissue such that differential activation of the electrodes may cause a current to flow through a particular region of the target, thereby activating a portion of the target. This may be referred to as a mountable electric field. An example of an application of such an electrode is to activate a portion of a nerve containing neurons for a particular muscle, while leaving the rest of the neurons unstimulated.

Figures 3A-D show some non-limiting examples of specific electrode arrangements that may be used. For example, in one particular embodiment, as shown in fig. 3A, a pair of electrodes stimulate small nerve branches to confirm their function, wherein the electrodes are spaced 2mm apart and are curved to hook and separate the small nerves for stimulation.

Another type of less invasive electrode is a cuff electrode, an example of which is shown in fig. 3B. Such electrodes may be placed around peripheral nerves or in the spinal cord, like a hollow tube. Therefore, the electrode located inside the cuff is in close contact with the nerve. However, in such embodiments, the constriction may place an epineurium between the electrode and the fiber that covers the nerve. The epineurium functions as an electrical insulator, which will therefore attenuate the recorded signal and increase the stimulation threshold.

The multi-polar cuff electrode can be used for selective stimulation so that different tracts of the nerve can be stimulated. For example, cuff electrodes with an electrode ring at each of the distal, proximal and central locations of the tube may be used for recording neural signals and/or for neural stimulation. The plurality of cuff electrodes can suppress external noise sources, such as line interfaces or bioelectrical signals of muscles, during recording by using a combination of electrodes and a specific amplifier structure. This configuration limits the current spreading outside the ferrule upon stimulation.

An alternative embodiment uses a flat nerve electrode similar to the cuff electrode but with a flat cross-section. See, e.g., d.j.tyler, d.m.durand, functional selective polymeric neutral Electrode: stimulation With A Flat interface nerve Electrode (functional selective peripheral nerve Electrode: Stimulation using Flat interface nerve Electrode), IEEE Transactions On Neural Systems And transduction, 200210(4), pp 294-. By flattening the nerve, the nerve bundles are separated further apart, making more selective stimulation and recording possible. This also increases the selectivity.

Another embodiment uses extra-neural electrodes that are sutured to the epineurium of the nerve, an arrangement that is very effective and very selective.

FIG. 3C shows an example of a more invasive shaft Electrode than a cuff Electrode (see, e.g., T. Stieglitz, M. gross, Flexible BIOMEMS With Electrode arrangement on Front And Back sides As Key components In neuro-prosthetic And biohybrid Systems), Transducers' 01/Euro the sensors XV, 358-. The electrodes have a needle shape with a plurality of sides. The electrode is inserted into the nerve tissue to provide a more intimate contact between the side of the electrode and the nerve fibers. However, the implantation method is a difficulty due to the mechanical rigidity of the peripheral nervous system. Further methods are being developed to improve the stability and penetration properties of such electrodes. In addition, new implantation tools would be useful.

The longitudinal nerve bundle internal electrode is formed by combining a filament electrode ring and a filament ring containing a fine needle. The needle may be used to guide the longitudinal implantation of the thin film electrode into the nerve. Only the filament electrode will remain within the nerve. Depending on the implantation of the electrode, a high selectivity can be obtained. See, for example, K.yoshida, D.Pelilin, P.Rousche, D.Kipke, Development Of The Thin-film longitudinal inner-capacitive Electrode, (Development Of membrane longitudinal nerve bundle inner Electrode), Proceedings Of The 5th annular Conference Of The International functional Electrical Stimulation facility, (fifth Annual meeting Of The International Society for functional Electrical Stimulation), page 279-281, 2000, which is incorporated herein by reference. For the inline nerve bundle inner electrode, the limitation of the small number of electrode sites can be solved by using a polyimide substrate as shown in fig. 9. By using micro-structuring techniques, the number of electrodes can be increased. In addition, the reference electrode and the ground electrode may be contained on a substrate.

As an alternative to thin film electrodes, silicon-based micro-machined electrodes may be used as the needle array. At least two methods are under development. One method uses a combination of sawing and etching to construct the wafer from the normal; see, e.g., R.A. Normann, E.M. Maynard, PJ.Rousche, D.J.Warren, A Neural Interface For A Cortical visual repair services (Neural Interface For Cortical visual repair) Vision Research, 39, 2577-. The second method builds the wafer in a planar orientation; see, e.g., k.d. wise, dj.anderson, j.f. hetke, d.r. kipke, k.najafi, Wireless placeable microsystems: high-sensitivity Electronic Interfaces To The neural System, (Wireless implantable microsystem: High Density electronics interface with Nervous System) IEEEProcedents (IEEE Association (invited paper)), Vol.93 No.1, 2004, incorporated herein by reference. This combines the electrodes with the electronic components. A number of electrodes may be placed on each needle. One disadvantage of this electrode is that the basic structure is simply the arrangement of the needles. Generating the array requires batch processing. For silicon electrode arrays, a particular implantation tool may be required to implant the array at high speed.

One invasive electrode is the gate electrode; see, For example, a. ramachandran, o.brueck, k.p.koch, t.stieglititz, System Test Of a Smart Bi-directional interface For Regenerating Peripheral nerve, (System Test For sensitive Bi-directional interface For Peripheral nerve regeneration) Proceedings 9th Annual Conference Of ifessocity, (Conference Of the IFES society ninth), Bournemouth, pp 425- "427, 2004, incorporated herein by reference. The electrode will be placed between the two incisional ends of the nerve trunk. For guidance and fixation to nerves, silicone tubes can be placed on both sides of the grid; see, e.g., P.Dario et al, Robotics As A Future And emitting Technology: biomimetics, Cybernetics And Neuro-Robotics In European Projects, (Robotics as future And emerging technologies: Biomimetics, Cybernetics, And neurorobotics In European Projects) IEEE Robotics And Automation Magazine, Vol.12, No.2, pp 29-45, 2005; and X.Navarroat et al, Stimulation And Recording from regenerated Peripheral Nerves Through Polyimide gate Electrodes, J Perher NervSyst.3(2) pp 91-101, 1998, incorporated herein by reference. Nerve fibers are then regenerated through the holes of the gate electrode. Some of the holes may be configured with ring electrodes to contact the nerve fibers. For implantation, applications for such electrodes include amputees and basic research; see, e.g., P.Dario et al, Neural Interfaces For regenerative Neural Stimulation and recording, IEEE Trans.Rehab.Eng, Vol.6, No.4, pp.353-363, 1998, incorporated herein by reference.

Fig. 3D shows an example of a gate electrode for contact with the fiber of the regenerative nerve. By placing the micro-grid in the regeneration path, the fibers are regenerated through the different holes of the grid electrode. Annular electrodes around the mesh can be in intimate contact with the regenerated fibers. In this case, selective coupling of sensation and movement is possible; see, e.g., P.Negredo, J.Castro, N.Lago, X.Navarro, Differential Growth Of Axons From The sensor And MotorNeurons Through A Regenerative Electrode: a Stereological, retrogradedracer, And Functional Study In The Rat, (differential growth of axons from sensory And motor neurons by regenerative electrodes: studies of stereology, degenerative tracers And function In rats), Neuroscience, pp.605-615(2004), incorporated herein by reference. As a result, selective stimulation and recording of the neurobiopotentials is achieved. An example of an electrode that can manipulate current is a perineural ring electrode.

Fig. 4 shows the case of an embodiment based on a staple electrode, which can be easily inserted during surgery. In horses, the branches of the PCA that emerge from the RLN are about 1cm below the cricoid cartilage, then pass through the exposed trachea and the length of the cricoid cartilage before entering the PCA. Instead of surgically exposing everything, a small opening may be used to view the PCA branch 502 through a small endoscope. The instrument is then used to hold the electrode staple 504 over the PCA branch 502. The instrument may be passive or articulated. The two prongs of the electrode staple 504 are pressed down into the bone, cartilage or soft tissue 501 beneath the PCA limb 502 and the instrument is removed so that the PCA limb 502 is immobilized for stimulation by electrode lead 503 connected to staple electrode 505. The staple electrode 505 is integrated into the inner surface of the electrode staple 504 and may have a variety of different designs, but even a simple pair of opposing anode-cathode electrodes should be sufficient. For use with soft tissue, the tips of the electrode staples 504 may be snapped together. The outer edge 506 of the staple prevents the electrode staple 504 from entering too deeply and crushing the PCA nerve 502.

Figure 5 summarizes the trade-off and related interactions between electrode selectivity and invasiveness to diseased tissue for various possible specific electrode configurations.

Possible sensors instead of electrodes

Ultrasound sensing may also be used in embodiments of the treatment system 200, which includes: a) a sensing electrode 207 ultrasonically coupled to the vocal fold region or pharynx or lungs or other regions of the body where activity or volume changes are highly correlated with inspiration; b) a stimulation electrode 206 electrically coupled to the dysfunctional posterior cricoarytenoid muscle; c) the pacemaker processor 201 receives the sensing signal provided by the sensing electrode 207 and provides the stimulation signal to the stimulation electrode 206.

Embodiments of the therapy system 200 may be based on sensors using the hall effect. The Hall effect refers to the potential difference (Hall voltage) across opposite sides of a thin sheet of conductive or semiconducting material in the form of a "Hall bar" (or van der Pauw) element, through which a current flows. This is caused by a magnetic field applied perpendicular to the hall element. The potential difference is related to the magnetic field strength. The magnetic field strength may be influenced by propagation of the magnetic field, tissue changes or tissue movements made up of portions of different conductivity near the semiconductor hall sensor element, or changes in the distance or direction of the hall sensor and magnetic field source relative to each other.

Another embodiment may have treatment system 200 comprising: a) a sensing microphone for producing an electrical signal representative of activity in an internal sensing location coupled to a region of vocal folds, pharynx, lungs, or other region of the body where motion or volume changes are highly correlated with inspiration; b) a stimulation electrode 206 electrically coupled to the dysfunctional posterior cricoarytenoid muscle; c) and the pacemaker processor 201 receives the sensing signals provided by the sensing microphone and provides stimulation signals for the stimulation electrode 206. See, for example, U.S. patent No.6,174,278.

An embodiment may also be a pressure sensing based therapy system 200, comprising: a) a pressure sensor for generating an electrical signal representative of activity in an internal sensing location coupled to a vocal fold region, pharynx, lung or other region of the body where movement or volume changes are highly correlated with inspiration; b) a stimulation electrode 206 electrically coupled to the dysfunctional posterior cricoarytenoid muscle; c) and a pacemaker processor 201 for receiving the sensing signal provided by the pressure sensor and providing a stimulation signal to the stimulation electrode 206.

A strain sensor may be used in the treatment system 200, the system comprising: a) a strain sensor for generating an electrical signal representative of elongation or compression in an internal sensing location coupled to a vocal fold region, pharynx, larynx, chest, lung or other region of the body where motion or volume changes are highly correlated with inspiration; b) a stimulation electrode 206 electrically coupled to the dysfunctional posterior cricoarytenoid muscle; c) and a pacemaker processor 201 for receiving the sensing signal provided by the strain sensor and providing a stimulation signal to the stimulation electrode 206.

Torsion or bending may also be used in treatment system 200, which includes: a) a mechanical deformation sensor for generating an electrical signal representative of mechanical stress in an internal sensing location coupled with the vocal fold region, pharynx, larynx, chest, lung or other region of the body where motion or volume changes are highly correlated with inspiration; b) a stimulation electrode 206 electrically coupled to the dysfunctional posterior cricoarytenoid muscle; c) and a pacemaker processor 201 for receiving the sensing signal provided by the mechanical deformation sensor and providing a stimulation signal to the stimulation electrode 206.

For example, a torsion or bending based treatment system 200 may use a piezoelectrically active material. Piezoelectricity is the ability of certain crystals to generate a voltage in response to an applied mechanical stress. The piezoelectric effect is reversible, in that a piezoelectric crystal can change shape by a small amount when subjected to an applied voltage. This deformation is about 0.1% of the original dimensions, typically on the order of nanometers, but has found useful applications, for example in the generation and detection of sound, the generation of high voltages, the generation of electronic frequencies, and the hyperfine focusing of optical components. In piezoelectric sensors, the physical dimensions are changed by applying a mechanical force to two opposing faces of the sensing element. Depending on the design of the sensor, the piezoelectric element can be loaded in different "modes": longitudinal, transverse and tangential.

The piezoresistive effect is different from the piezoelectric effect. The piezoresistive effect describes the change in resistance of a material due to an applied mechanical stress. In contrast to the piezoelectric effect, the piezoresistive effect merely causes a change in resistance, and no charge is generated. The charge is generated by other electrical circuitry.

Other airway disorders

Horses develop other upper airway disorders including, but not limited to, dorsal displacement of the soft palate (DDSP), various forms of laryngeal, pharyngeal and nasopharyngeal collapse, or airway stenosis. In certain embodiments of treatment system 200, the methods and devices described herein may be effectively used as described in the examples below.

One embodiment may be used to treat soft palate posterior displacement (DDSP). The pathophysiology of this disease is that horses typically interlock their soft palate and epiglottis to form a direct open airway from the nasal cavity to the trachea. In some horses, however, the soft palate is displaced posteriorly during exercise and then the free end of the soft palate is positioned in the airway, causing severe obstruction to exhalation. The exact cause of DDSP is unknown, but is believed to be caused by direct mechanical displacement resulting from the posterior movement of the tongue, or weakening of the muscles of the soft palate or of the raised epiglottis or entire pharynx. Using the implantable systems described herein, electrodes may be placed on one or more of the following nerve branches: the hypoglossal nerve leads to nerve branches of the genioglossus muscle, the geniohyoid muscle and the hyoepiglottis muscle; vagal or glossopharyngeal nerves lead to palatoglossus, palatopharyngeal, or neural branches adjacent to pharyngeal muscles; the nerve branch leading to the hyoid nail muscle. In another embodiment, the electrodes are placed directly in or around the muscle. In another embodiment, the electrodes are placed near above, below, or near the upper airway mucosa. Electrical stimulation is applied to the mucosa or to the sensory innervated mucosa to evoke swallowing or reflex motor changes.

Embodiments may also be used to treat nasopharyngeal collapse. The electrodes may be placed on or around the nerve branches leading to the stylopharyngeal muscle forming the top of the nasopharynx and the palatopharyngeal muscle forming the peripheral wall of the nasopharynx.

Embodiments may be used to treat epiglottic retroversion. The electrodes are placed on or around the nerve branch leading to the hyoepiglottis and a stimulus is applied to retract the epiglottis anteriorly. In another embodiment, the electrodes are placed on or around the hyoid epiglottis.

Likewise, embodiments may be used to treat nasal alar groove paralysis. The electrodes may be placed on or around the nerve branches leading to the nasal dilator muscles or the muscles themselves. Other embodiments may be used to treat eye and face paralysis. The electrodes are placed on or around the nerve branches leading to the orbicularis oculi muscle or the muscle itself. Certain embodiments are directed to the treatment of Homer's syndrome. The electrodes are placed around the cervical ganglia or sympathetic branches. In another embodiment, the electrodes are placed on or around the nerve branches leading to the ethmoid nerve. Application of electrical stimulation causes nasal mucosal vasoconstriction and mucosal contraction.

System implementation

Embodiments also include surgical techniques and tools for safely implanting the prosthetic device so as not to cause damage to the horse. For example, particular embodiments avoid spreading current into surrounding tissue structures when implanting the electrodes, thereby avoiding unwanted side effects. Other embodiments allow the implanted treatment device to withstand the harsh environment within the horse neck and operate reliably for months. In certain embodiments, the implanted device may signal during normal operation so that it can be monitored by a manager, and this may be confirmed before, during, or after an event by other methods and devices that are embodiments of the present invention. Other embodiments include methods and devices for reversing neuronal degeneration such as found in such diseases, as well as for treating other airway diseases in horses.

Experiments were performed in horses with 5 normal horses and 3 horses with naturally occurring disease, attempting unilateral resuscitation of the arytenoid cartilage and its associated vocal cords. The Med-E1 cochlear implant system is implanted and provides stimulation signals. In some cases, the implant was modified by changing the generally linear 12-channel electrode to a cuff electrode. Other modifications were made to replace the wire made of platinum iridium with stainless steel to prevent the wire from breaking.

In horses No.1 and 2, resuscitation was obtained by placing the linear array electrodes under dca (pca) via the extrajugular route. In these cases, vocal fold abduction is achieved by electrical stimulation during surgery, but this response disappears after the animal recovers from surgery. In horse No. 3, a cuff electrode was placed on the abductor branch of the left recurrent laryngeal nerve via the cervico-ventral approach. In horses No.1 and 2, resuscitation was achieved by placing a subperiosteal linear array electrode via the extracervical approach. Resuscitation is successful, but only acute (i.e., intraoperative). Resuscitation was performed by surgical implantation of a device into the dca (pca) muscle. In horse # 3, the cuff electrode was placed on the abductor branch of the left recurrent laryngeal nerve, with surgical success. Resuscitation was then achieved by placing a cuff electrode on the left recurrent laryngeal nerve via the cervical-ventral approach. In addition, the abductor branch of the left recurrent laryngeal nerve was transected and ligated. Horses No.4 and 5 had normal laryngeal function, while the remaining 3 had naturally occurring laryngeal hemiplegia/paralysis. Horses 6 had hemiplegia (grade III), and horses 7 and 8 had hemiplegia (grade IV). The duration of disease was unknown in horses 6 and 8, and 1 year in horse 7. After surgery, horses were stimulated for 1 hour per day using the following parameters to stimulate axon regeneration and to suppress axon degeneration:

● waveform: two-phase, cathode

● Current: 500 milliamperes per phase

● phase duration 0.427 ms

● number of pulses per burst (burst): 480(20 seconds)

● pulse spacing: 40 milliseconds

● pulse frequency (calculated): 24Hz

● number of bursts per stimulus: 164

● burst frequency (calculated): 0.09Hz

● burst spacing: 2 seconds

● the electrodes in groups 1 to 12 were activated at 98 to 1300 microamperes per electrode.

Abduction of stimulated arytenoid cartilage in horses No.5, 6 and 7 can be induced continuously for one hour in a "strong straight" manner. During exercise, sustained abduction is obtained by using the following stimulation parameters:

● waveform: biphase (range: single phase, biphase, triphase), cathode (range: cathode, anode, alternating)

● Current: 500 milliamperes per phase (range: 250- & 1000, possible range: 50-10,000)

● phase duration: 427 ms (Range: 250-1000, possible Range: 50-10,000)

● pulse frequency: 24Hz (range: 10-40, possible range: 0.1-200, approximate range 0.1-20,000)

Parameter adjustment technique

In embodiments that include a therapy sensor 207, the pacemaker processor 201 and/or the stimulation component 204 may receive information from the therapy sensor 207 by wireless telemetry. The therapy sensor 207 may be an external component that is not implanted. In alternative embodiments, the therapy sensor 207 may be integrated into the housing of the stimulation component 204 and/or the pacemaker processor 201, or connected to one or both of them by one or more leads. Fig. 6 shows an embodiment in which external processor 603 may also send information to treatment system 200, such as adjusting stimulation parameters to be applied by stimulation component 204. Adjustments may be made based on information received from the therapy system, e.g., from the stimulation component 204 or the therapy sensor 207, or from a source external to the therapy system 200, e.g., a human expert user 606 of a horse, received via a clinician terminal 604 user interface with an external processor 603, or some combination thereof.

In a particular embodiment, pacemaker processor 201 may record the received information, analyze the information, and adjust stimulation parameters based on the information, or some combination thereof. Alternatively, the pacemaker processor 201 may record information and transmit the information to the external processor 603 over the data network 602. In this case, external processor 603 analyzes the information to generate adjustments to system characteristics, such as stimulation parameters, and sends the adjustments to treatment system 200 for application by pacemaker processor 201 to stimulation component 204. Those skilled in the art will also understand and appreciate that the therapy system 200 may also have associated therewith a separate processor that is responsible for analyzing the received information and formulating or setting up the adjusted stimulation parameters. Associated, as used herein, refers to a structure that is placed with or within a device or connected to a device by a wire.

One or more clinician terminals 604 may be connected to the data network 602 to receive or access notifications of system operation, such as may be adjusted by stimulation parameters generated by the pacemaker processor 201 or external processor 603. In one embodiment, the clinician terminal 604 may be used by the clinician user 606 to overrule or approve stimulation parameter adjustments. With approval, therapy system 200 proceeds to cause pacemaker processor 201 to make adjustments to stimulation parameters by downloading or inputting the adjustments into implanted stimulation component 204 as, for example, a new stimulation program, new parameters, or parameter adjustments. Alternatively, the clinician user 604 may need to have a clinical visit to the horse so that the clinician user 604 can use the clinician terminal 604 or a separate user programmer device to oversee the adjustment of the parameters.

The data network 602 may take the form of a local area network, a wide area network, or a global network, such as the internet. The external processor 603 may comprise a web server to generate a web page containing proposed parameter adjustments for viewing through the clinician terminal 604. In addition, the external processor 604 may contain an email server for delivering the proposed parameter adjusted email notification 605. The clinician terminal 604 may be any client device connected to the data network 602, such as a personal computer, personal digital assistant, interactive television, mobile phone, and the like. Using the clinician terminal 604, the clinician user 606 accesses a web page generated by the external processor 603 and receives an email notification 605 suggesting new information or proposed horse parameter adjustments to the clinician user 606.

If the treatment system 200 itself (e.g., pacemaker processor 201) controls the information analysis and generation of the proposed parameter adjustments, the adjustments and information may still be sent to the external processor 603 so that the clinician user 606 can view the information and adjustments through the clinician terminal 604. In this case, the pacemaker processor 201 provides intelligence for analysis and adjustment, but the external processor 603 supports reporting and approval before performing the adjustment if needed. In other embodiments, the external processor 603 provides intelligence for analysis and adjustment, as well as reporting and approval mechanisms. In this case, the external processor 603 serves as a conduit for collecting and communicating horse information and programs the implanted stimulation component 204 to perform stimulation parameter adjustments. In certain embodiments, approval by the clinician user 606 may be necessary only for the adjustment of certain stimulation parameters; for example, the adjustment magnitude is greater than a predetermined limit.

In certain embodiments, stimulation parameter adjustments may be made automatically by the external processor 603, however, in many cases it may be appropriate to obtain approval from the clinician user 606 prior to downloading or inputting the stimulation parameter adjustments into the therapy system 200. To do so, the external processor 603 is required to support the generation of email notifications 605 and web pages containing detailed reports so that the clinician user 606 has the information necessary to make decisions on stimulation parameter adjustments. The external processor 603 may manage information and parameter adjustment decisions for multiple horses and multiple clinicians. In each case, the external processor 603 and the processing system 200 cooperate to provide adaptive adjustment of stimulation parameters applied by the stimulation component 604 for managing a disease.

The information obtained by the external processor 603 may be provided by the stimulation component 604, the therapy sensor 207, and the horse 100, or some combination thereof. In the case of stimulation component 204, the information may include operational information related to the stimulation therapy delivered by stimulation electrodes 205. Examples of operational information include battery status, state of charge, lead impedance, parameter settings applied by stimulation component 204, telemetry status, time since stimulation component 204 was implanted, and information about time elapsed since stimulation parameter adjustment. In certain embodiments, the parameter settings may include details regarding the frequency, amplitude, and pulse width of the stimulation, cycling parameters, identification of the stimulation electrodes 205 used, and other similar parameters. Further, in certain embodiments, the implanted stimulation component 204 may be used to receive information from the therapy sensor 207 and to communicate the information to the external processor 603. Alternatively, in other embodiments, the therapy sensor 207 may transmit information directly to the external processor 603.

One or more therapy sensors 207 may provide a variety of information indicative of the level of efficacy achieved by the neurostimulation therapy delivered by stimulation component 204. The information may be any information related to the function of the vocal cords or any other section of the horse's airways, or any parameter within the horse's body. For example, the therapy sensors 207 may monitor parameters such as pressure, contraction force, flow rate, flow pressure, airflow, and the like. Other examples of information that is sensed include flow rate, temperature, impedance, pH, or chemical composition. Any such information may reveal the effect of neurostimulation therapy on the physiological function of the horse 100. For example, if the therapy sensor 207 indicates that excessive pressure, excessive contractility, or unintended flow (i.e., leakage) has occurred in response to a set of stimulation parameters, dynamic adjustments to the stimulation parameters may be needed to reduce the pressure or contractility to improve efficacy.

In other embodiments, one or more therapeutic sensors 207 may be implanted in the horse 100 to sense a physiological state of the horse 100. For example, therapy sensors 207 may be deployed to sense cardiac activity, respiratory activity, electromyographic activity, etc., as an indication of horse activity level. Such activity level information, along with other information, may be used to determine adjustments to stimulation parameters. Other types of treatment sensors 207 may also detect the posture or activity level of the horse 100. For example, an accelerometer may detect an elevated activity level, for example, during exercise, while other sensors may detect whether the horse 100 is sitting, standing, or lying. In addition, certain information obtained by such therapy sensors 207, such as respiratory activity, may be analyzed to determine, for example, whether the horse 100 is sleeping.

Obtaining information from the horse 100 includes information entered into the external processor 603 through a clinician terminal 604, the clinician terminal 604 having a user interface, such as a set of buttons, a keypad, a touch screen, or other input medium. As with the information obtained from the treatment sensor 207, the information obtained from the horse 100 may also indicate the level of efficacy obtained by the neurostimulation therapy. Other information obtained from the horse 100 may be indicative of the physiological state of the horse 100, such as the type of activity (e.g., work, eating, sleeping), activity level (e.g., intense, moderate, resting), or posture (standing, sitting, lying down). Inputting such information is relevant because the efficacy of a particular stimulation parameter may change as the physiological state of the horse 100 changes. Information relating to the comfort of the horse 100 may also be obtained. For example, the user 606 may notice discomfort by the clinician and grade on a relative scale. In another embodiment, the clinician user 606 may enter information related to the overall subjective perception of the stimulation therapy by the horse 100. Such input may also be ranked based on overall perception on a relative scale.

Further, in some embodiments, the clinician user 606 may be allowed to enter horse preferences, for example, based on subjective sensory experience with the horse 100. For example, the clinician user 606 may input information indicating that a stimulation level, such as amplitude, pulse width, or pulse frequency, is unpleasant or even painful. Further, the clinician user 606 may input information of stimulus levels that appear to have little appreciable efficacy from the standpoint of horses. All information obtained by the external processor 603 or the therapeutic system 200 may be temporally correlated so that the state experienced by the horse 100 may be assessed at, for example, a significant event.

The adaptation logic (adaptation logic) may take the form of a function or a set of functions, expressed mathematically or in a look-up table, weighting the different information items using predetermined coefficients, and adding the weighted items together to produce the parameter adjustment. In one embodiment, the adaptive logic may be based at least in part on some combination of safety ranges (e.g., determined by the manufacturer or clinician user 604), stimulation efficacy, and battery life. In another embodiment, the adaptive logic includes weighting all information received by the external processor 603 and/or the therapy system 200 (e.g., the stimulation component 204, the therapy sensor 207, etc.). In other embodiments, the adaptive logic may also include weighting other parameters input from the clinician user 606 by the external processor 603 and/or the initiating program of the therapy system 200 (e.g., pacemaker processor 201). In one embodiment, the safety margin, whether determined by the manufacturer or the clinician user 606, sets limits for parameter adjustments and/or is weighted most heavily by the adaptive logic.

The adjustment of the stimulation parameters may be expressed as an upward or downward variation of one or more parameters, such as amplitude, pulse width or frequency. The adjustment of the stimulation parameter may be expressed as an absolute amplitude or incremental adjustment of the adjustment. In other words, the adjustment of the stimulation parameters may be performed in a single step in an amount dictated by the output of the external processor 603. If the adaptive logic, after analyzing the information, specifies an increase in the frequency of the stimulation pulses applied by stimulation component 204 of 20Hz, then the 20Hz increase is intended as a direct adjustment to the stimulation parameters. In some cases, the absolute adjustment may be limited by the manufacturer or clinician user 606 to within a maximum adjustment to avoid sudden discomfort of the horse 100 caused by transient changes.

Alternatively, the adaptation logic may simply indicate that an increase is necessary, in which case a series of incremental increments is applied at regular intervals until the adaptation logic no longer indicates that an increase is required. For example, the frequency may be increased in 1Hz increments whenever the adaptation logic indicates that an increase is required. In this case, a hysteresis function may be built into the logic to avoid repeated up/down switching of the stimulation parameters. The adjustment may be performed at different time intervals, such as seconds, minutes, hours, or even days, depending on the discretion of the clinician user 606. In addition to an increase or decrease in the parameter, the adaptive logic may also indicate that the power is within an acceptable range and provide an output indicating that no adjustment is required.

In one embodiment, the external processor 603 may also determine or modify the frequency of analyzing and adjusting the stimulation parameters. For example, after implantation and shortly thereafter, further adjustments may be necessary or desirable in order to achieve the most favorable stimulation settings. In one embodiment, the time setting when to analyze the stimulation parameters may be determined at least in part by analyzing the history of the stimulation parameters and their adjustments. Alternatively, the time to set the adjustment analysis may be predetermined by the clinician user 606, the manufacturer, or both. In another embodiment, the clinician user 606 treating the horse 100 may instruct the external processor 603 that the stimulation parameters should be analyzed to determine if adjustments are necessary based on a subjective analysis of the efficacy of the current parameters.

In embodiments that allow the external processor 603 or the therapy system 200 to directly and automatically adjust the stimulation parameters, the information may be analyzed on a periodic basis, such as at intervals on the order of seconds, minutes, hours, or days. In certain embodiments, the external processor 603 and the treatment system 200 may employ different analysis modalities. In the first mode, the analysis and adjustment of the information may be performed at relatively infrequent regular intervals, on the order of hours or days. In the second mode, the external processor 603 or the therapy system 200 can operate in a more intensive analysis and adjustment mode, where the evaluation of information and adjustment of parameters is very frequent until the desired level of efficacy is reached. This second, denser mode may continue until the efficacy level enters an acceptable range. Dense mode may be entered when the analysis performed in the first infrequent mode indicates that the efficacy level requires stimulation parameter adjustments. Likewise, adjustments of stimulation parameters made in either mode may be made automatically or approved by the clinician user 606.

In one embodiment, the external processor 603 may enter and use new stimulation parameters without further input or approval from any other source. As discussed above, another embodiment requires approval by the clinician user 606 through the external processor 603 before new stimulation parameters can be set up and used. In another embodiment, the external processor 603 may send new stimulation parameters to the clinician terminal 604 for review and/or approval by the clinician user 606 for use in treating the horse 100. This embodiment may allow the clinician user 606 to treat the horse 100 to subjectively compare the efficacy of the two stimulation parameters and pick out which setting they prefer. In addition, a number of previous stimulation parameters may be stored in memory to allow the clinician user 606 to pick therefrom to perform a treatment of the horse 100, or to designate certain as being particularly effective, particularly unsuitable, or particularly effective for one or more activity levels or types (i.e., settings that are particularly appropriate for exercise).

The sensor assembly 208 and/or the therapy sensor 207 may be implanted in the horse 100 for extended periods of time. In this case, sensor module 208 is provided with sufficient battery resources, rechargeable batteries, or an inductive electrical interface to allow long term operation. The sensor assembly 208 and/or therapy sensor 207 may be implanted with minimally invasive endoscopic techniques, capturing information useful in the analysis and adjustment of stimulation parameters over time or for a limited time. In other words, the sensor assembly 208 and/or the therapy sensor 207 may be chronically implanted to support parameter adjustments made during a long-term session spanning months to years, or beneficially implanted for a short period of time to support one parameter adjustment or a few parameter adjustments over a relatively short period of time, such as hours, days, or weeks.

In certain embodiments, the sensor component 208 continuously or periodically transmits sensed information to the stimulation component 204 or the external processor 603. In this case, the sensor assembly 208 continuously or periodically monitors the physiological condition. Alternatively, the stimulation component 204 or the external processor 603 may trigger activation of the sensor component 208 for a desired time interval to capture information. In some cases, the triggered activation may occur when a clinician user 606 treating the horse 100 enters information into the external processor 603. The triggered activation of the sensor assembly 208, if applicable, can be used to preserve the battery life of the sensor assembly 208 or the stimulating assembly 204. In each case, multiple treatment sensors 207 may be provided and dedicated to different parameters or different locations in the horse 100.

Rather than immediately communicating the information to the stimulation component 204 or the external processor 603, the sensor component 208 may initially store the information internally for subsequent wireless transmission 601. Thus, in certain embodiments, information can be stored in the sensor component 208 and then communicated to the stimulation component 204 or the external processor 603. In such a case, the stimulation component 204 or the external processor 603 may query the sensor component 208 for stored information for analysis and possible adjustment of stimulation parameters. As another alternative, the clinician user 604 who treats the horse 100 may trigger activation by swiping a magnet in close proximity to the treatment sensor 207, in which case the sensor monitor 208 would contain appropriate sensing circuitry to detect the use of the magnet.

Embodiments may include a monitoring server, a web server, an email server, a programming server, a network connection, a horse database, or some combination thereof. The horse database may store information for a plurality of horses 100 in an organized fashion that allows for easy retrieval of the information for analysis, reporting, and historical archiving. The web server generates a web page containing information obtained from one or more horses 100, including information obtained from an external processor 603. The information may be presented in a variety of different formats and levels of detail. Using a web browser equipped clinician terminal 604, a clinician user 606 may browse the information contained in the horse database by accessing a web server. The web server may also be configured to execute database access commands to retrieve the desired information. In some embodiments, the information may be organized using a hierarchy of XML tags. The information contained in the web page may also include proposed stimulation parameter adjustments. The adjustment of the stimulation parameters may be generated by the external processor 603 or the therapy system 200. The clinician user 606 may approve the adjustment of the stimulation parameters by clicking a button in a web page. Once approved by the clinician, the therapy system 200 may then proceed to interact with the external processor 603 to implement stimulation parameter changes in the stimulation component 204. The web page generated by the web server may also provide the clinician user 606 with the opportunity to modify the proposed stimulation parameter adjustments prior to approval, e.g., using a box, a drop down menu, a slider bar, radio buttons, etc. In this case, the therapy system 200 performs the adjustment of the stimulation parameters as modified by the clinician user 606.

The email server will provide an email notification 605 to the clinician terminal 604 if desired. Email notification 605 may report newly acquired information for a particular horse 100 or a proposed stimulation parameter adjustment for horse 100. Email notification 605 may include a link to a web page for approving or modifying the proposed stimulation parameter adjustment. Optionally, in certain embodiments, the clinician user 606 may approve the adjustment of the stimulation parameters by replying to the email notification 605. In either case, the proposed stimulation parameter adjustments are not performed until approval is received. However, in other embodiments, it is contemplated that the stimulation parameter adjustment may be fully automatic, requiring no approval from the clinician user 606, particularly if the adjustment of the stimulation parameter is subject to pre-programmed limits within the external processor 603 or the stimulation component 204.

Certain embodiments may be used to support clinical studies. For example, external processor 603, treatment system 200, and clinician terminal 604 may allow a researcher of clinician user 606 to access information obtained from implanted stimulation component 204 for research purposes without having to adjust stimulation parameters. Instead, the researcher of the clinician user 606 may access information obtained from the external processor 603 and the therapy system 200 through the clinician terminal 604 to gather information supporting short-term or long-term studies for constructing improved or enhanced therapies. In certain embodiments, the adaptive logic may be configured to apply a specific algorithm such as a genetic algorithm, bayesian classification, neural network, or decision tree. In those cases, adaptive logic may be configured to perform algorithms similar to those described in U.S. patent application serial No. 10/767,674, U.S. patent application serial No. 10/767,922, U.S. patent application serial No. 10/767,545, and U.S. patent application serial No. 10/767,692, each of which is incorporated herein by reference.

Treatment verification monitoring

In connection with the above, compliance with regulatory agency regulations is also required in horse racing so that the treatment system 200 or treatment method does not produce undue superiority, inferiority or incorrect responses. The goal of treatment is to restore function rather than outweigh the greatest or physiological advantages. Thus, embodiments may allow various security measures to not affect the betting. The recording system may record the use and frequency of the stimulation protocol. For example, as shown in fig. 2, the audit detector 209 and corresponding log 210 may be used as a logging system, allowing equipment personnel in a paddock or a sports arena to easily assess that the treatment system 200 is active and functioning properly. Under conditions of the game, the recording system should be easy to monitor.

Embodiments also include a treatment system 200 that does not affect other biological functions of the horse 100 in addition to the airway disease being treated. In particular, it is not expected that the treatment system 200 will cause any other effect that can stimulate or impair the athletic performance of the horse 100. This is partially met by the design of treatment system 200 discussed herein. However, a method of ensuring that no extraneous effects are present is to test the therapy system 200 and measure physiological parameters including, but not limited to, contralateral vocal cord abduction, heart rate, blood pressure, respiratory rate, or a variety of other physiological parameters mentioned herein or known in the art.

Embodiments include methods of meeting the spirit and regulations of the institution managing equine sporting events, including monitoring devices and methods, such as audit monitors 209 and/or log records 210 that allow only correction by attending veterinarians, where stimulation parameters are fixed and can only be adjusted by the racetrack staff or attending veterinarians. Additionally or alternatively, the motion management authority may monitor the effectiveness of the therapy system 200 before, during, or after the athletic performance. The monitoring mechanism may want to know that the therapy system 200 is open and delivering the appropriate electrical stimulation, that the vocal folds are abducted, and that air is passing unrestricted through the larynx during inspiration by the therapy system 200. Along these lines, various physiological parameters may be sensed and stored (data recorded in the log 210), or transmitted to the outside of the horse 100. Examples of data records of such information include, but are not limited to, stimulation parameters, nerve action potentials, microphone monitoring the airway, acoustic or subglottic pressure, tracheal pressure, and vocal fold abduction as reflected by electroglottic maps (EGG, pharyngeal impedance to high frequency electric fields). In addition, light generated by a light source located on one side of the pharynx may be sensed by a light sensor located on the other side.

In a particular embodiment, the external signal may be generated when the treatment system 200 is in operation; for example, light on an external component is activated and visible using an appropriate stimulus. Another example is a radio signal that can be sensed by a remote receiver. In another embodiment, separate leads and electrodes stimulate another muscle of the horse 100 so that its effect is clearly visible, e.g., stimulating the muscles that move the outer ear when the treatment system 200 is active, causing the outer ear to tilt or rotate.

The therapy sensor 207 and sensor assembly 208 may sense electrical stimulation, biopotentials from nerve or muscle activity evoked by stimulation, mechanically sense vocal fold abduction, or airflow changes related to vocal fold position. Proper stimulation abducts the vocal folds and allows maximum airflow, which can be monitored by the sound of air flowing through the airway, subglottic pressure, or temperature. The vocal fold movement can be sensed by vocal fold displacement, by any of a variety of specific methodsTo measure, for example, strain gauges in the laryngeal tissue, the amount of light across the glottis, changes in tissue impedance across the larynx, or direct viewing of the vocal folds using an indwelling video camera. The disturbance of the inspiratory flow may be sensed by a pressure sensor subglottal or in the trachea, or within the chest cavity but outside the trachea. Such a pressure sensor will exhibit an abnormally high negative pressure as the resistance to airflow increases due to the vocal folds being in the middle. Ineffective breathing in motion will be quickly reflected into the systemic physiological signals: blood oxygen reduction and CO₂And (4) increasing.

Horses with laryngeal hemiplegia produce inspiratory sound characterized by three frequency bands centered at about 0.3, 1.6 and 3.8 kHz; see Derksen FJ et al, spectral Analysis Of respiratory Analysis In Experimental Horses With Experimental inductive Larynageal Sound Spectroscopy Of Dorsal Displacement Of The Soft Panel, (respiratory sound Spectroscopy In sports Horses With Experimentally induced laryngeal Hemiplegia Or Dorsal Displacement Of The Soft Palate), Am J Vet Res.2001 May; 62(5): 659-64, incorporated herein by reference. Horse breathing sounds are recorded using radio auscultators, such as those disclosed in antenburow et al, respiratory Frequency and scientific and Whistling, (resonance frequencies of Lateral chambers, sachets and Whistling), acquire expert Physiology, horse sports Physiology, pp 27-32, and U.S. patent No.4,218,584 to antenburow, both of which describe stethoscopes that detect and record data from horses while they are walking, fast walking, jogging, jumping, and sprinting. A transducer, such as a microphone, is attached to the skin of the animal near the trachea. The electrical output from the transducer is transmitted to a radio transmitter fixed to the animal or its harness. The radio transmitter can transmit signals from the horse beyond a certain distance, allowing monitoring of the horse's breathing from a distance. Us patent No.6,228,037 describes a method and apparatus for recording and analyzing breathing sounds in a moving horse and us patent No.6,659,960 describes a method and system for continuously monitoring and diagnosing body sounds in which a portable apparatus is disclosed for recording the breathing sounds of the upper airway of a moving horse to determine whether the horse has an upper airway obstruction condition.

Axon regeneration

Another embodiment of the invention stimulates regeneration of damaged axons, or prevents such degeneration, and/or monitors axon regeneration, for example, measures nerve action potential and conduction velocity. An example of performing electrical stimulation to enhance regeneration is applying 20Hz stimulation (100 microseconds, 3-5V) to electrodes placed at (anode) and near (cathode) the injured nerve region.

Although various exemplary embodiments of this invention have been disclosed, it will be apparent to those skilled in the art that various changes and modifications can be made which will achieve some of the advantages of the invention without departing from the true scope of the invention.

Claims (46)

1. A device for treating laryngeal hemiplegia in horses, the device comprising:

one or more treatment sensors configured to sense at least one treatment parameter associated with an activity level of a horse, at least one of the treatment sensors comprising an accelerometer configured to detect the activity level;

a pacemaker processor configured to generate an electrical signal as a function of at least one treatment parameter, the electrical signal being applied to upper airway tissue of the horse to treat laryngeal hemiplegia; and

one or more stimulation electrodes interfaced with the upper airway tissue for delivering electrical signals to the upper airway tissue.

2. The device of claim 1, wherein at least a portion of the device is implanted in a horse.

3. The device of claim 2, wherein the implanted portion of the device is in transdermal or transcutaneous communication with a portion of the device external to the horse.

4. The device of claim 3, wherein the transdermal communication is based on at least one of electromagnetic induction, acoustic energy, optical energy, and capacitive coupling.

5. The device of claim 2, wherein a portion of the device is configured to be temporarily placed on a surface of a horse to provide an external signal to an implanted portion of the device when the device is in operation.

6. The device of claim 1, wherein the electrical signal is derived from at least one of electromyography, electroseismic chart, electroglottiogram, electroencephalography, biopotential sensor, ultrasound sensor, hall sensor, microphone, pressure sensor, strain sensor, mechanical deformation sensor, and motion sensor.

7. The device of claim 2, wherein the implanted portion comprises a transdermal or transcutaneous charged power source.

8. The device of claim 1, wherein at least a portion of the device is integrated into a horse racing set.

9. The device of claim 1, wherein the electrical signal is applied to the upper airway tissue of the horse using a biphasic waveform.

10. The device of claim 1, wherein the one or more stimulation electrodes are based on at least one of a cuff electrode, a flat nerve electrode, an extra-nerve electrode, an axial electrode, an intra-longitudinal nerve bundle electrode, a filament electrode, a micromechanical electrode, a gate electrode, and a staple electrode.

11. The device of claim 1, wherein the one or more stimulation electrodes are capable of differential activation to cause stimulation of a specific region of the upper airway tissue.

12. The device of claim 1, wherein the upper airway tissue includes one or more nerves of an airway structure.

13. The device of claim 12, wherein the one or more nerves comprises the recurrent laryngeal nerve of the horse.

14. The device of claim 12, wherein the upper airway tissue includes one or more axons of the abductor branch of the recurrent laryngeal nerve.

15. The device of claim 1, wherein the upper airway tissue comprises muscle tissue associated with the airway tissue.

16. The device of claim 15 wherein the muscle tissue comprises cricoarytenoid muscle tissue.

17. The device of claim 16 wherein the cricoarytenoid muscle tissue comprises posterior cricoarytenoid muscle tissue.

18. The device of claim 1, wherein the electrical signal causes abduction of vocal cord tissue.

19. The device of claim 1, wherein the electrical signal is continuously delivered over a period of hours until the device is shut down.

20. The apparatus of claim 1, wherein:

the at least one treatment parameter includes at least one of pressure, contractile force, airflow rate, airflow volume, airflow velocity, temperature, impedance, pH, and chemical composition.

21. The apparatus of claim 1, wherein the at least one treatment parameter further relates to at least one of an airflow characteristic of an airway of the horse, a contraction characteristic of airway tissue of the horse, an electrical characteristic of a portion of a body of the horse, a temperature of a portion of a body of the horse, a pH of a portion of a body of the horse, a chemical composition of a portion of a body of the horse, and a physiological state of the horse.

22. The apparatus of claim 1, further comprising:

a therapy verification monitor for verifying monitoring of operation of the pacemaker processor.

23. The apparatus of claim 1, further comprising:

a log for recording at least one treatment parameter.

24. The device of claim 22, wherein the therapy verification monitor generates the external signal while the pacemaker processor is operating.

25. The apparatus of claim 24, wherein the external signal comprises visible movement of the muscles of the horse achieved by stimulating the muscles with electrodes.

26. An adaptive airway treatment system for treating laryngeal hemiplegia in a horse, the system comprising:

one or more treatment sensors for sensing at least one treatment parameter related to operation of the treatment system, at least one of the treatment sensors comprising an accelerometer configured to detect an activity level of the horse;

a pacemaker processor for treating laryngeal hemiplegia in response to at least one treatment parameter by generating an electrical treatment signal as a function of the at least one treatment parameter; and

one or more stimulation electrodes interfaced with the upper airway tissue for delivering a therapeutic signal to the upper airway tissue of the horse.

27. The system of claim 26, wherein the one or more treatment sensors are configured to be placed on the exterior of the horse.

28. The system of claim 26, wherein the one or more therapy sensors are implanted in the horse.

29. The system of claim 28, wherein the one or more therapy sensors are coupled to the pacemaker processor through one or more leads.

30. The system of claim 28, wherein the one or more therapy sensors are integrated in a housing containing the pacemaker processor.

31. The system of claim 26, wherein the therapy signal is further adjustable based on information received from one or more therapy sensors, a pacemaker processor, a human user through a clinician terminal, or a combination thereof.

32. The system of claim 26, wherein the delivery of the therapeutic signal is triggered in response to an instruction from an external user.

33. The system of claim 26, wherein the at least one treatment parameter is related to an efficacy of the one or more stimulation electrodes to deliver the treatment signal.

34. The system of claim 26, wherein the at least one treatment parameter relates to at least one of vocal cord function and function of another segment of the upper airway tissue.

35. The system of claim 26, wherein the at least one treatment parameter includes at least one of pressure, contractile force, airflow rate, airflow volume, airflow velocity, temperature, impedance, pH, and chemical composition.

36. The system of claim 26, wherein the one or more therapy sensors are configured to be implanted in the horse.

37. The system of claim 36, wherein the at least one treatment parameter relates to an activity level of the horse, the activity level based on at least one of cardiac activity, respiratory activity, and electromyographic activity.

38. The system of claim 26, wherein the at least one treatment parameter is related to a posture or activity level of the horse.

39. The system of claim 26, wherein the at least one treatment parameter is related to whether the horse is asleep or awake.

40. The system of claim 26, wherein the treatment signal is a function of a regular periodic analysis of the at least one treatment parameter.

41. The system of claim 26, wherein the treatment signal is a function of irregular, aperiodic analysis of the at least one treatment parameter.

42. The system of claim 26, wherein the one or more therapy sensors also continuously or periodically sense the physiological condition.

43. The system of claim 26, wherein the pacemaker processor captures the at least one treatment parameter at selected time intervals.

44. The system of claim 43, wherein the time interval is selected to conserve power associated with the system.

45. The system of claim 26, wherein the pacemaker processor is responsive to user input from the user interface to capture at least one treatment parameter.

46. The system of claim 45, wherein the user interface is based on magnetic input from a user.