WO2024182596A2

WO2024182596A2 - Cuffed endoluminal tube with medication delivery system

Info

Publication number: WO2024182596A2
Application number: PCT/US2024/017843
Authority: WO
Inventors: Ihab Kamel
Original assignee: Temple University-Of The Commonwealth System Of Higher Education
Priority date: 2023-03-01
Filing date: 2024-02-29
Publication date: 2024-09-06
Also published as: WO2024182596A3

Abstract

The present invention provides an endoluminal medication delivery device and method configured to allow immediate, repeated, precise, and controlled circumferential medication delivery to the interface between the device and the compressed surrounding tissue lining the lumen (e.g., Mucosa/mucous membrane).

Description

Attorney Docket No.: 206017-0214-00WO TITLE Cuffed Endoluminal Tube with Medication Delivery System CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S Provisional Patent Application No. 63/487,632 filed March 1, 2023, which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION There is an increasing demand for endotracheal tubes (ETT) owing to the rising number of surgical procedures due to increasing incidences of chronic diseases such as cardiovascular disease, cancer, and other respiratory diseases. As per World Health Organization 2019 Report, respiratory diseases are the leading cause of death globally, which accounts for around 4.0 million deaths every year. The ETT is used to intubate the respiratory channel (i.e., the trachea) of a patient to deliver air, oxygen, and/or anesthetic gases during general anesthesia and mechanical ventilation. The ETT is a standard component of general anesthesia administered worldwide on a daily basis. The ETT is used to ventilate patients after they stop breathing following the induction of anesthesia and until emergence. Further, the ETT is used to provide respiratory support for critically ill patients in the intensive care unit. The ETT has an air-inflated cuff that exerts circumferential pressure against the tracheal mucous membrane (lining tissue) and tracheal structure to create an air-tight, fluid-tight seal. The purpose of this air-tight, fluid-tight seal is to prevent anesthetics and respiratory gas leaks out of the lungs and prevent secretions from entering into the airway during ventilation. The tracheal mucosa is highly innervated and protected by resilient reflexes rendering it highly sensitive to tactile stimulation. The circumferential pressure resulting from the ETT cuff inflation causes intense stimulation that leads to significant short and long-term adverse consequences. The primary cause of the short-term consequences is the stimulus caused by the endotracheal tube pressure that often exceeds the stimulus from the surgical procedure and leads to major adverse physiologic consequences. Unless appropriately controlled or suppressed, the intense stimulation caused by the inflated endotracheal tube cuff leads to local respiratory and broad Attorney Docket No.: 206017-0214-00WO systemic responses. Local respiratory responses are mediated by reflexes and include closure of the small airways, coughing, retching, and straining. Broad systemic body responses are primarily due to stimulation of the sympathetic nervous system with the resulting tachycardia (increased heart rate), hypertension (increased blood pressure), release of stress response mediators such as epinephrine and norepinephrine, and systemic vasoconstrictors with a resultant reduced blood flow in most tissues. The systemic effects of the ETT stimulation can be appreciated as early as 15 second after intubation while the local effects are usually immediate. The long-term complications of the endotracheal tube are often seen in critically ill patients intubated for prolonged periods of time (days to weeks) due to continued stimulation and compression of the tracheal mucosa with the resultant pathologic morphological and anatomical changes that constitute the body’s and tracheal tissue reaction to the continuous ETT cuff pressure. Also, compression of the inaccessible area of the tracheal mucosa by the inflated cuff prevents proper ventilation and draining of this area leading to colonization of pathogens and infection. The short-term adverse physiologic consequences caused by the intense stimulation of the ETT cuff have numerous clinical implications that can adversely impact patient safety and clinical outcomes. The first adverse consequence of this intense stimulation of the tracheal mucosa is bronchospasm (constriction of the airways, making it very difficult to ventilate the patient and it can be life-threatening if not promptly treated). This complication is exaggerated in patients under light or inadequate anesthesia, smokers, as well as patients with asthma and chronic obstructive pulmonary disease (COPD) who already have sensitive airways even in the absence of the stimulus of the ETT. To avoid bronchospasm, anesthesiologists increase the anesthetic depth to overcome the stimulus through the inhibition of the tracheal and bronchial reflexes that will be triggered by the ETT cuff pressure in addition to administering bronchodilators like albuterol. Increasing the concentration of inhalational anesthetics is associated with prolonged wake-up time (more anesthetics used), higher cost (more anesthetic is used, delayed emergence and inefficient use of operating room time), a reduction in the systemic blood pressure (the main dose-dependent side effect of anesthetic agents) that can lead to deleterious effects especially in patients with cardiovascular and neurological Attorney Docket No.: 206017-0214-00WO disease, and adverse environmental effects caused by excessive use of these agents. Thus, anesthesiologists are usually treating the symptoms rather than preventing the root cause of the problem. The second adverse consequence associated with the stimulation caused by the ETT cuff is emergence reactions (also known as emergence phenomena). In addition to bronchospasm, patients can experience emergence reactions at the conclusion of the anesthetic primarily due to the stimulation caused by the ETT tube while they regain their consciousness, physical strength, and reflexes (including cough reflex). Emergence reactions include violent and combative emergence, coughing, retching, stimulation of the sympathetic nervous system, and bucking. Emergence reactions can lead to serious deleterious consequences that include increased intracranial pressure, increase intraocular pressure, acute increase in heart rate (tachycardia), increase in the blood pressure (hypertension), myocardial ischemia and infarction( increased stress on the heart leading to oxygen supply demand mismatch especially in patients with coronary artery disease), excessive stress on critical surgical repair sutures and anastomosis due to straining, premature extubation by the anesthesiologist to mitigate the emergence reactions, inadvertent premature extubation by the patient due to violent emergence, aspiration pneumonitis (due to vomiting, straining, and early extubation by the anesthesiologist to control violent emergence), and physical injury for the patient and perioperative staff. While these emergence reactions can lead to complications in any procedure involving endotracheal intubation, they can be particularly catastrophic in certain procedures such as eye surgery, neurosurgery, hernia repair, and head and neck surgery. A smooth emergence from anesthesia is necessary for these types of surgeries. Increasing anesthetic concentration dose and depth of anesthesia may help manage the ETT stimulation only during the surgery. However, during emergence when the anesthesiologist discontinues the anesthetic agents and the anesthetic level drops in the body to wake up the patient, the patient is prone to all the complications of the emergence reactions described because ETT is still in the patient’s trachea (stimulus) and should be ideally removed when the patient is awake (minimal residual anesthesia). Thus, high doses of anesthesia during the case will fail to mitigate or prevent emergence reactions because the most vulnerable period during which patients develop these complications is during emergence from anesthesia. The anesthesiologists’ current Attorney Docket No.: 206017-0214-00WO approach to mitigate emergence reactions is administering systemic intravenous opioids, local anesthetics and sedatives such as dexmedetomidine (precedex®). The effect of this approach is unpredictable and not uniformly successful while adding undesirable sedation, somnolence, and delayed extubation due to the excessive time the patient needs to recover from the effects of these systemic drugs. Frequently, the patient wakes up after a significant delay to emergence and extubation while the emergence reactions still ensues because at this point the patient is lightly sedated while being stimulated by the inflated ETT cuff. The major factor behind the ineffectiveness of current approaches is that they don’t treat the stimulus of the tube at the local level (treating the cause) but rather focus on masking the symptoms by providing sedation and analgesia using systemic intravenous drugs that affect the entire nervous system at the level of the brain and the spinal cord. A notable exception is the lidocaine LTA 360, an FDA approved device that allows the injection of lidocaine using an introducer with an atomizer spraying lidocaine in multiple angles (360 degrees’ distribution pattern) to anesthetize the tracheal mucosa immediately before intubation. This device is valuable to prevent the response related to the tube during intubation and shortly afterwards. However, during the emergence Lidocaine LTA 360 is usually ineffective because the duration of most surgical procedures outlasts the effective duration of this single preintubation topical lidocaine application device. Thus, the LTA device is used primarily to mitigate the stimulus of the ETT during intubation. In addition, the LTA 360 does not result in effective saturation of the tracheal mucosa with the sprayed medication at the target area (the ETT cuff abutting the tracheal mucosa) for two reasons. The first reason is that the portion of the sprayed liquid lidocaine that is not immediately absorbed by mucosa during application will trickle distally (further down the bronchial tree) away from the target area. Second, the blind lidocaine injection process is independent from the endotracheal tube placement which may lead to suboptimal local anesthetic distribution to the target tracheal mucosal area determined by final placement of the ETT tube. The third adverse consequence is the hemodynamic change associated with the administration of higher doses of anesthetics to overcome the physiological effects of the ETT cuff stimulation while these higher doses are not necessarily needed for the stimulation caused by the procedure. This includes interventional radiology Attorney Docket No.: 206017-0214-00WO procedures, endovascular percutaneous procedures, interventional cardiology procedures, interventional electrophysiology procedures, minor surgical procedures, hand and foot surgery, skin and plastics procedures, and neurointerventional procedures. The administration of higher doses of anesthetics to mitigate the major adverse physiological responses of the ETT can lead to hypotension and tachycardia in patients with heart disease, cerebral aneurysm, vascular disease, renal disease, and pulmonary disease increasing the risk of perioperative adverse outcomes in this high-risk patient population. The fourth adverse consequence is the hemodynamic change associated with the administration of the lower doses of anesthetics that are inadequate to overcome the ETT stimulation. The administration of lower dose of anesthesia may be due to patient frailty, profound hypotension, significant cardiovascular disease, and shock. In this case the patient may experience cough and increased heart rate response to the ETT cuff stimulation while experiencing critically low blood pressure levels precluding safe administration of high levels of anesthetics. In this case significant hemodynamic support through systemic infusion of vasopressors drugs is needed to enable the safe administration of higher doses of anesthetics. Systemic infusion of vasopressors complicates the management and leads to adverse outcomes such as decreased urine output and tissue ischemia (lack of oxygen delivery to various tissues). The fifth adverse consequence is the need to potentially use higher dose of opioids during the anesthetic. When heart rate and blood pressure of the patient rise during anesthesia, it usually not easy to discern the source if it is the surgical procedure or the ETT stimulation. Opioids are usually used as an integral component of anesthesia to provide analgesia and control the sympathetic nervous system response to pain and stimulation. Intraoperative administration of opioids has been linked to prolonged postoperative opioid use, a contributing factor to the opioid pandemic. The ability to provide regional anesthesia to the tracheal mucosa to mitigate the adverse physiologic consequences of the endotracheal tube cuff inflation can have an opioid sparing effect in the perioperative period. A sixth and long-term adverse consequence associated with the stimulation caused by the ETT is tracheal stenosis. Tracheal stenosis is the result of prolonged endotracheal intubation in critically ill patients in intensive care unit. The Attorney Docket No.: 206017-0214-00WO persistent stimulation and pressure caused by the endotracheal tube cuff or the tracheostomy tube cuff leads to tissue reaction, local inflammation, local infection, and tissue proliferation leading to narrowing of the tracheal lumen referred to as tracheal stenosis. Tracheal stenosis is a significant source of morbidity and mortality for patients as it leads to shortness of breath, limitation of physical activity, inability to lie supine, hypoxia, worsening of cardiac pulmonary disease, and multiple surgical interventions. Current practice to prevent tracheal stenosis include shortening the duration of ETT intubation whenever possible, replacing the ETT with a cuffed tracheostomy tube, minimizing cuff inflation pressures, administering systemic opioids and antibiotics, and treatment of severe acid reflux. These approaches fail to address the root cause of the problem. Systemic administration of steroids is associated with significant risk to patients and is not routinely used. The ability to deliver a small but adequate dose of steroid directly into the target prevention area provides an effective way to prevent tracheal stenosis while avoiding the systemic effects of steroids. In addition to prevention, early intervention to treat tracheal stenosis for causes other than intubation (such as idiopathic stenosis) is usually performed to avoid the progression to severe stenosis. Treatment usually includes intralesional injection of steroids (directly into the narrow tracheal area) and/or laser excision. The ability to apply steroids topically to the narrow tracheal area while avoiding direct injection of steroid in the trachea may assist in early treatment of patient with tracheal stenosis while minimizing local and systemic complications associated direct needle injections. A seventh long-term adverse consequence associated with prolonged endotracheal intubation and continuous endotracheal cuff inflation is pulmonary infection. Infection can be caused by the lack of ventilation and proper drainage of the area of tracheal mucosa continually compressed by the ETT cuff leading to pathogen colonization and multiplication. This can be a contributing factor to tracheal stenosis and pulmonary infections such as pneumonia. Infiltrating the target tracheal mucosa area continually compressed by the ETT cuff with antibiotics can reduce colonization of pathogens and mitigate infectious complications. Thus, there is a need in the art to eliminate the adverse physiologic consequences of the stimulus caused by the ETT cuff, help patients tolerate the ETT for Attorney Docket No.: 206017-0214-00WO long periods, reduce the need for more sedation during intubation, reduce the incidence and severity of anesthesia emergence reactions, reduce the incidence of patients inadvertently pulling out the ETT, reduce the incidence of intraoperative bronchospasm, prevent pathogen colonization around the ETT cuff, avoid delivering higher doses of anesthetics beyond the need for the surgical stimulation to mitigate the adverse physiologic consequences of ETT stimulation, and reduce the incidence and severity of tracheal stenosis in patients who are intubated for prolonged periods of time. A device configured to allow controlled, safe, repeated, precise, and timely application of various medication to the tissues surrounding the ETT cuff during continued normal operations of the inflated ETT is needed. The present invention meets this need. SUMMARY OF THE INVENTION In one aspect, the present invention relates to an endoluminal medication delivery device comprising an elongated tube having proximal and distal ends with a lumen therethrough, a plurality of balloons positioned on the outer surface of the elongated tube, the plurality of balloons comprising a first balloon connected to one or more conduits extending proximally along the elongated tube, wherein the first balloon is configurable between at least first and second configurations as a fluid moves in and out of the balloon and a second balloon at least partially surrounding the first balloon and connected to one or more conduits extending proximally along the elongated tube, wherein the second balloon comprises an impermeable proximal portion, and at least one permeable portion. In some embodiments, the one or more conduits of the second balloon comprise any of: an even number of tubes, symmetrical positioning, symmetrical configuration, collapsible material, impermeable material, equal length, equal run, or equal flow. In some embodiments, each balloon of the plurality of balloons at least partially surrounds the elongated tube and is formed in one or more shapes selected from: sphere, hemisphere, cylinder, half-cylinder, ellipsoid, flower, petals, star, burst, crescent, oval, polygon, cone, prism, ellipsoid, flower shape, concentric ellipsoids, concentric spheres, or any combination thereof. Attorney Docket No.: 206017-0214-00WO In some embodiments, the plurality of balloons are configured or positioned in one or more patterns along the elongated tube selected from: linear, non- linear, asymmetric, zig-zag, circular, spiral, or any combination thereof. In some embodiments, the at least one permeable portion comprises a plurality of perforations that are patterned or configured in one or more configurations selected from: horizontal pattern, vertical pattern, x-pattern, v-pattern, z-pattern, zig-zag pattern, spiral, or gradient pattern. In some embodiments, the first balloon is completely disposed within the second balloon. In some embodiments, the plurality of perforations are positioned circumferentially on the second balloon and patterned in 1 to 15 lines and comprising at least one central line. In some embodiments, the plurality of perforations are circumferentially limited to 10 – 75% of the at least one central line. In some embodiments, each perforation of the plurality of perforations have similar diameter or different diameters. In some embodiments, the at least one permeable portion comprises at least one porous membrane. In some embodiments, the impermeable proximal portion of the second balloon is a circumferentially impermeable surrounding the elongated tube. In some embodiments, the device further comprises an impermeable distal portion on the second balloon that is circumferentially impermeable surrounding the elongated tube. In some embodiments, each balloon of the plurality of balloons comprises one or more internal chambers. In some embodiments, the plurality of balloons comprises repeating pairs of first and second balloons positioned along the length of the elongated tube. In some embodiments, the device further comprises one or more medication delivery devices positioned within or in fluid connection with the one or more conduits of the second balloon. In some embodiments, an external reservoir is fluidly connected to the one or more conduits of the second balloon and configured to allow the introduction of a fluid or solution to the second balloon. In some embodiments, the fluid used to inflate the first balloon is a gas, solution, or a liquid. Attorney Docket No.: 206017-0214-00WO In some embodiments, the elongated tube is sized and shaped in the form of a tube selected from: an endotracheal tube, an endobronchial tube, a tracheostomy tube, a laryngeal mask airway, an oral airway, a nasal airway, a nasogastric tube, a feeding tube, interventional vascular catheter, compression inflatable balloon, a dilating device, indwelling catheter, an endoscope, topicalization device, or a drainage catheter. In another aspect, the present invention provides a method of providing access to a bodily passage comprising the steps of providing an endoluminal medication delivery device comprising an elongated tube having proximal and distal ends with a lumen therethrough, a plurality of balloons positioned on the outer surface of the elongated tube, the plurality of balloons comprising a first balloon connected to one or more conduits extending proximally along the elongated tube, wherein the first balloon is configurable between at least first and second configurations as a first fluid moves in and out of the balloon, and a second balloon at least partially surrounding the first balloon and connected to one or more conduits extending proximally along the elongated tube, wherein the second balloon comprises an impermeable proximal portion, and at least one permeable portion, wherein the one or more conduit of the second balloon is fluidly connected to an external reservoir, introducing the endoluminal medication delivery device into the bodily passage, configuring the first balloon to the second configuration thereby sealing the bodily passage, and introducing a second fluid to the second balloon through the one or more conduits and diffusing the second fluid through the at least one permeable portion into the bodily passage thereby delivering the second fluid to the tissue surrounding the plurality of balloons in the bodily passage. In some embodiments, the bodily passage is an airway. In some embodiments, the bodily passage is gastrointestinal tract lumen, blood vessel lumen, bodily pouch, external auditory canal, urinary system lumen, intracranial passage, bodily space, bodily passage, and bodily endocrine ducts. In some embodiments, the second fluid comprises at least one therapeutic agent selected from lidocaine, steroid, antibiotics, or vasoactive drug. In some embodiments, the external source is one selected from a pump, a manually operated syringe, or a programmable syringe. Attorney Docket No.: 206017-0214-00WO BRIEF DESCRIPTION OF THE DRAWINGS The following detailed description of embodiments of the invention will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings. FIG.1 depicts an exemplary endoluminal medication delivery device of the present invention. FIG.2 depicts five cross-sections (A, B, C, D, E) in the endoluminal medication delivery device 100 that will represent the cross-sections depicted in FIGS.3- 6. FIG.3A through FIG.3E depict five cross-sections of device 100 where lumen 116 and lumen 122 are embedded in the inner curvature of body 107 of device 100. The 5 cross-sections A, B, C, D, E correspond to those depicted in Fig.2. FIG.4A through FIG.4E depict five cr4oss-sections of device 100 where lumen 116 is embedded in the inner curvature of body 107 of device 100 and lumen 122 is externally attached to the inner curvature of body 107 of device 100. The 5 cross- sections A, B, C, D, E correspond to those depicted in Fig.2. FIG.5A through FIG.5E depict five cross-sections of device 100 where lumen 116 is embedded in the inner curvature of body 107 of device 100 and lumen 122 is embedded in the outer curvature of body 107 of device 100. The 5 cross-sections A, B, C, D, E correspond to those depicted in Fig 2. An alternative but similar design would be reversing the positions of lumen 116 and lumen 122 in the inner and outer curvatures of body 107 of device 100. FIG.6A through FIG.6G depict various designs of opening 119 at the cross-sectional plane B depicted in FIG.2. FIG.7 depicts the second balloon body of an exemplary endoluminal medication delivery device of the present invention having five middle circumferential lines of perforations. FIG.8A through FIG.8C depict examples of various locations of perforations 124 in the second balloon body 118. FIG.8A depicts the location of perforations 124 in the middle 1/3 of the second balloon body. FIG.8B depicts the Attorney Docket No.: 206017-0214-00WO location of perforations 124 in the middle ½ of the second balloon body. FIG.8C depicts the location of perforations 124 in the distal ½ of the second balloon body. FIG.9A through FIG.9S depict various configurations of perforations 124 within a given location in the second balloon body 118. FIG.9A depicts a gradual increase in the size of the perforations 124 with the small perforations located proximally and larger perforations located distally. FIG.9B depicts a smaller number of perforations 124 located proximally and a larger number of perforations 124 located distally. FIG.9C depicts longitudinal columns of the perforations. FIG.9D depicts smaller size perforations 124 located in the hemisphere of the second balloon body on the same side of opening 119 while larger perforations 124 are located in the hemisphere opposite to opening 119. FIG.9E depicts smaller number of perforations 124 located in the hemisphere of the second balloon body on the same side of opening 119 while larger number of perforations 124 are located in hemisphere opposite to opening 119. FIG.9F depicts perforations 124 located at a relatively more distal position in the hemisphere of the second balloon body on the same side of opening 119 while perforations 124 on the hemisphere opposite to opening 119 are located relatively more proximal. FIG.9G depicts the perforations 124 configured in circumferential “V” shaped patterns. FIG.9H depicts perforations 124 configured in circumferential “X” shaped patterns as one layer of large sized “X” shapes or multiple horizontal circumferential layers of small size “X” shaped perforations. FIG.9I depicts perforations 124 configured in multiple circumferential “Z” shaped patterns. FIG.9J depicts perforations 124 configured in multiple horizontal layers of zig-zag patterns. FIG.9K depicts perforations 124 widely spaced on the horizontal axis (horizontal distance between each perforation may range from 2-10 mm) while vertically aligned. FIG.9L depicts perforations 124 widely spaced on the horizontal axis (horizontal distance between each perforation may range from 2-10 mm) while vertically alternating. FIG.9M depicts the medication delivery area of the second cuff being a membrane. FIGs.9N and 9O depicts the truss-cuff design of the medication delivery second cuff in which the medication delivery tube 122 and opening 119 continue as an even numbered network of symmetrically opposing impermeable delivery tubes of equal lengths that open into a circumferential collapsible perforated band shaped second cuff that surrounds the middle and/or distal portion of the first cuff. Attorney Docket No.: 206017-0214-00WO FIG.9N depicts the longitudinal view of the truss-cuff design for the second medication delivery cuff using 2 symmetrically opposing equal-length impermeable delivery tubes ending in the perforated/permeable medication delivery cuff. FIG.9O depicts the top apical view of the truss-cuff design for the second medication delivery cuff using 4 symmetrically opposing equal-length impermeable medication delivery tubes ending in the perforated/permeable medication delivery cuff. FIG.9P depicts the cross-section of the medication delivery system in a hemi-cuff design consisting of 4 separate cuffs (2 inflating first cuffs and 2 medication delivery second cuffs. FIG.9Q depicts the cross- section of the Quad-cuff design consisting of 8 separate cuffs (4 inflating first cuffs and 4 medication delivery second cuffs). FIG.9R depicts a longitudinal view of an endotracheal tube with variable sets of medication delivery system of the invention. A distal medication delivery system (MD 1) consisting of full-cuff design to seal the trachea and provide medication delivery to the tracheal mucosa. A second and separate proximal medication delivery system (MD 2) utilizing a hemi-cuff design along the length of the endotracheal tube. The separate hemi-cuffs of the second medication delivery system (MD2) are located at various sites along the length of the ETT. The second proximal system can be used to inject medications to anesthetize the tissues abutting the body 107 of the endotracheal tube. FIG.9S Depicts a longitudinal view of an endotracheal tube with variable sets of medication delivery system of the invention. A distal medication delivery system (MD 1) consisting of truss-cuff design with 2 delivery tubes to seal the trachea and provide medication delivery to the tracheal mucosa. A second and separate proximal medication delivery system (MD 2) utilizing a hemi-cuff design along the length of the endotracheal tube. The separate hemi-cuffs of the second medication delivery system (MD2) are located at various sites along the length of the ETT. The second proximal system can be used to inject medications to anesthetize the tissues abutting the body 107 of the endotracheal tube. FIG.10 depicts the location of perforations or permeable membrane 124 on various second balloon designs. FIG.11 is a flowchart depicting an exemplary method of providing access and delivering medication to a bodily passage. Attorney Docket No.: 206017-0214-00WO FIG.12A and FIG.12B depict an exemplary endotracheal tube (ETT). FIG.12A depicts an ETT with a first balloon body inflated using a syringe with a manometer. FIG.12B depicts a magnified view of the digital reading of the manometer depicted in FIG.12A. FIG.13A through FIG.13B depict an exemplary ETT positioned within a cylindrical tube with a diameter similar to the average diameter of the adult human trachea. FIG.13A depicts an exemplary ETT with a first balloon body inflated using a syringe with a manometer positioned within the cylindrical tube. FIG.13B depicts a magnified view of the digital reading of the manometer and the inflated first balloon body depicted in FIG.13A. The digital reading indicated represents an average pressure derived from peer-reviewed reports of ETT cuff pressures during clinical use. FIG.14A and FIG.14B depict addition of an absorbent paper towel to the distal end of an exemplary ETT. FIG.14A depicts an exemplary ETT having a paper towel wrapped around the distal half of the second balloon. FIG.14B depicts an exemplary ETT within the cylindrical tube having a paper towel wrapped around the distal half of the second balloon with a first balloon body inflated using a syringe with a digital manometer. FIG.15 depicts an exemplary ETT device having a second balloon body wherein the second balloon body comprises plurality of perforations distributed uniformly throughout its entire surface area (alternative design). FIG.16 depicts movement and delivery pattern of injected dye within an exemplary ETT device having a first balloon body inflated to 42 cmH2O and a second balloon body wherein the second balloon body comprises plurality of perforations distributed uniformly throughout its entire surface area (alternative design). FIG.17A through FIG.17D depict distribution of the injected dye in a model simulating clinical application. First balloon body is inserted in a cylindrical tube and inflated to 42 cmH₂O. FIG.17A depicts an exemplary ETT device having a second balloon body with plurality of perforations distributed uniformly throughout its entire surface area positioned within a cylindrical tube. FIG.17B depicts the distribution of the dye from the first low-pressure pores first encountered by the injected dye without any delivery of the dye to the compressed area between the ETT and the cylindrical tube. Attorney Docket No.: 206017-0214-00WO FIG.17C depicts a magnified view of FIG.17B showing the dye accumulation and failure of delivery of the dye to the target area. FIG.17D depicts an upper view of the cross-section of the lower end of the cylindrical tube demonstrating the accumulated dye. FIG.18A through FIG.18D, depicts movement and delivery pattern of injected dye within an exemplary ETT device having a second balloon body with plurality of perforations distributed uniformly throughout its entire surface area in the presence of a highly absorbent lining positioned within a cylindrical tube. FIG.18A depicts a top view of the exemplary ETT device before dye injection (baseline). FIG.18B depicts the ETT device after dye injection (2 ml). FIG.18C depicts a top view of the exemplary ETT device after dye injection and the inability of the dye to reach the middle part of ETT cuff which is the target high-pressure area. Instead, the dye escaped from the perforations closer to the proximal end of the second balloon body in the low-pressure zone and was spilled as indicated by the arrow. FIG.18D depicts a magnified top view of the exemplary ETT device after dye injection. FIG.19A through FIG.19D depict movement and delivery pattern of injected dye within an exemplary ETT device of the present invention having a second balloon body with plurality of perforations positioned in three middle circumferential lines. The first balloon body is inflated to 42 cmH2O. FIG.19A depicts a top view of an exemplary ETT device of the present invention before dye injection (baseline). FIG.19B depicts a top view of an exemplary ETT device of the present invention after injection of the dye (2 ml). The arrow points to the remaining drops from the diffusion of the dye through the central pores. FIG.19C depicts another top view of an exemplary ETT after injection of the dye to provide a 360-degree view of the ETT device. FIG.19D depicts another top view of an exemplary ETT after injection of the dye to provide a 360-degree view of the ETT device. FIG.20A and FIG.20B depict movement and delivery pattern of injected dye within an exemplary ETT device of the present invention having a second balloon body with plurality of perforations positioned in three middle circumferential lines, wherein the exemplary ETT is positioned within a cylindrical tube simulating clinical application with the first balloon chamber inflated to 42 cmH₂O. FIG.20A depicts a top view of an exemplary ETT device of the present invention before dye injection Attorney Docket No.: 206017-0214-00WO (baseline). FIG.20B depicts a magnified top view of an exemplary ETT device of the present invention after dye injection and depicts the circumferential delivery of the dye to the target high-pressure point. FIG.21A and FIG.21B depict an exemplary ETT device of the present invention with the first balloon chamber inflated to 42 cmH2O after dye injection wherein the circumferential spread of the dye around the center of the second balloon body at the high-pressure area of the balloon-cylinder interface is depicted. FIG.21A depicts a top view of an exemplary ETT device of the present invention after dye injection. FIG.21B depicts a magnified top view of an exemplary ETT device of the present invention after dye injection. The distribution pattern depicted in FIG.21A and FIG.21B indicated the optimal and desired distribution pattern for maximal efficacy and minimal side effects. FIG.22A and FIG.22B depict an exemplary ETT device of the present invention with the first balloon chamber inflated to 42 cmH₂O after dye injection wherein the circumferential spread of the dye around the center of the second balloon body at the high-pressure area of the balloon-cylinder interface is depicted. FIG.22A depicts a perspective view of an exemplary ETT device of the present invention after dye injection. FIG.22B depicts a perspective view of an exemplary ETT device of the present invention after dye injection wherein a small dose of dye is accumulated beyond the high-pressure point. FIG.23A through FIG.23D depict movement and delivery pattern of an exemplary ETT device of the present invention with the first balloon chamber inflated to 42 cmH2O inside the cylindrical tube in the presence of a highly absorbent lining to demonstrating the diffusion pattern and to confirm delivery of the medication to and beyond the middle high-pressure point (target area). FIG.23A depicts a top view of an exemplary ETT device of the present invention before injection of the dye (baseline). FIG.23B depicts a top view of an exemplary ETT device of the present invention after injection of the dye (2 ml). FIG.23C depicts a top view of an exemplary ETT device of the present invention after injection of the dye. FIG.23D depicts a magnified top view of an exemplary ETT device of the present invention after injection of the dye. FIGS.23B- 23D demonstrate a diffusion pattern that indicates the ability of the present invention to deliver the dye to and beyond the middle high-pressure point of the ETT second cuff Attorney Docket No.: 206017-0214-00WO while avoiding loss of dye in the low-pressure area proximal to ETT compressed area (target area) as indicated by the dashed blue arrow. DETAILED DESCRIPTION It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity many other elements found in the field of endoluminal medication delivery system. Those of ordinary skill in the art may recognize that other elements and/or steps are desirable and/or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art. Definitions Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although any methods and materials similar or equivalent to those described herein can be used in the practice for testing of the present invention, exemplary materials and methods are described herein. In describing and claiming the present invention, the following terminology will be used. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. The articles “a” and “an” are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element. “About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, or ±0.1% from the specified value, as such variations are appropriate. Attorney Docket No.: 206017-0214-00WO The terms “patient,” “subject,” “individual,” and the like are used interchangeably herein, and refer to any animal amenable to the systems, devices, and methods described herein. The patient, subject or individual may be a mammal, and in some instances, a human. The terms “cuff” and “balloon”, and the like are used interchangeably herein, and refer to any inflatable portions, regions or members on catheter or tube devices or related methods described herein. The cuff or balloon may be any inflatable portion or member found on any related medical device or system such as an endoluminal medication delivery system. The term “fluid” as used herein may refer to any substance capable of flowing freely and having no fixed shape. The fluid may be any fluid including, but not limited to, gases, liquids, solutions, compositions, agents, drugs, therapeutics, medications, or any combination thereof. Ranges: throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range. Endoluminal Medication Delivery System The present invention provides an endoluminal medication delivery device configured to allow precise and controlled circumferential medication delivery to the interface between the device and the compressed surrounding tissue lining the lumen (e.g., mucosa/mucous membrane). In some embodiments, the endoluminal medication delivery device may be used as one including but not limited to an endotracheal tube (ETT), an endobronchial tube, tracheostomy tube, a laryngeal mask airway, an oral Attorney Docket No.: 206017-0214-00WO airway, a nasal airway, a nasogastric tube, airway topicalization device, feeding tube, a dilating device, an endoscope, a drainage catheter, and etc. In some embodiments, the endoluminal medication delivery device of the present invention may be used with cuffed endoluminal catheters/tubes. In some embodiments, endoluminal device may be a solid tube, stylet, or a boogie. The endoluminal cuffed catheters/tubes aim is to deliver medications, fluids, air, medical gases, or provide access into a lumen within the human body through the patent lumen of the catheter/tube. To provide air-tight and fluid-tight seal of the lumen surrounding the tube, endoluminal catheters/tubes use inflatable circumferential cuffs usually filled with air (most common) or saline (less common). The device of the present invention provides a medication delivery system through a second perforated circumferential cuff (balloon) that overlaps the main air-inflated sealing cuff to reach the tissue surface under compression by the main inflated cuff, an area that is otherwise impossible to reach and medicate using currently available devices and practices. The second cuff is specifically designed to serve as an access port operating at and utilizing the high-pressure created by inflated first cuff and surrounding lumen interface. The invention offers a unique and specific design to deliver a liquid or viscous medication to the target area. In some embodiments, the endoluminal medication delivery device of the present invention may be added to uncuffed endoluminal devices that require the injection of a medication to the surrounding endoluminal tissues or mucosa. In case of uncuffed endoluminal devices, the first cuff can be inflated to enable delivery of the medication to the surrounding lumen surface from the perforated second cuff under the pressure created by the inflated first cuff, then the first cuff can be deflated after medication delivery to maintain the uncuffed configuration within the lumen. Referring now to FIG.1, an exemplary endoluminal medication delivery device 100 is shown. Device 100 comprises a proximal end 102, a distal end 104, a tube 106, a first balloon 108 and a second balloon 110. Tube 106 is within the body (outer wall) 107 of device 100. In some embodiments, body (outer wall) 107 may be oval or circular in cross-section with variable diameter and length defining the shape and capacity of tube 106. In some embodiments, body 107 may have variable length, design, and angles. The space between the inner walls of body 107, the proximal end 102, and distal end 104 define the boundaries of tube 106. Attorney Docket No.: 206017-0214-00WO Tube 106 is positioned between proximal end 102 and distal end 104. In some embodiments, tube 106 may be used to accommodate a guidewire or a stylet for introduction of device 100 into the subject’s body cavity. In some embodiments, tube 106 may have any suitable diameter and length known to one skilled in the art based on various considerations, including the desired bodily passage within which the medical device is intended to be used. In some embodiments, tube 106 may have an internal diameter ranging between 2 - 14 mm. In some embodiments, tube 106 may have an internal diameter ranging between 5 - 36 mm. In some embodiments, tube 106 may have a length ranging between 20 - 450 mm. In some embodiments, tube 106 may have a length ranging between 80 - 1200 mm. In some embodiments, tube 106 may be made with any suitable material known to one skilled in the art based on various considerations, including the desired flexibility, shape (curvature and angle), and rigidity of tube 106. In some embodiments, tube 106 may be straight. In some embodiments, tube 106 may be curved to fit the anatomical curvature of the airway with radius of approximately 140 mm (Magill curve). Example materials considered suitable to form tube 106 may include, but are not limited to, biocompatible materials, materials that can be made biocompatible, metals such as stainless steel, titanium, nickel-titanium alloys (e.g., Nitinol), polymers, polyvinyl chloride (PVC), rubber, nylon, polyethylene, polyurethane, polytetrafluoroethylene (PTFE), ePTFE, silicone, coiled materials, braided materials, and any other material considered suitable for a particular application. In some embodiments, tube 106 may have a tip 105 positioned at distal end 104. In some embodiments, tip 105 may have any diameter known to one skilled in the art. In some embodiments, tip 105 may have a diameter smaller than the diameter of tube 106. In some embodiments, tip 105 may have the same diameter as of the diameter of tube 106. In some embodiments, tip 105 may have any shapes known to one skilled in the art including but not limited to pointed, beveled, etc. In some embodiments, tube 106 may be configured to attach to any device known to one skilled in the art at proximal end 102. In some embodiments, tube 106 may be connected to any device through any method including but not limited to a luer lock connection, a smooth push-in adaptor, and etc. In some embodiments, the proximal end Attorney Docket No.: 206017-0214-00WO 102 is attached using an adaptor to the breathing circuit and respiratory gases delivery system, while the distal end is inserted in the patient’s trachea through vocal cords. In some embodiments, first balloon 108 is externally attached to tube 106 anywhere between proximal end 102 and distal end 104. In some embodiments, first balloon 108 may be positioned closer to distal end 104. First balloon 108 comprises a first balloon body 112 having a proximal end 117 and a distal end 109 and a first opening 111. First balloon body 112 and the portion of the exterior surface of tube 106 define a first balloon chamber 114. First opening 111 is fluidly connected to an external source through an inflation conduit or lumen 116 and is adapted to receive a medium therethrough such that first balloon 108 can be moved between a first, deflated configuration and second, inflated configuration. In some embodiments, any medium known to one skilled in the art including but not limited to air, saline, etc. may be used to inflate first balloon 108. In some embodiments, first opening 111 may have any diameter known to one skilled in the art. In some embodiments, first opening 111 may have a diameter ranging between 0.2 - 3 mm. In some embodiments, first opening 111 may have a diameter ranging between 0.5 - 10 mm. In some embodiments, first opening 111 may be positioned anywhere on first balloon body 112. In some embodiments, first opening 111 may be positioned near proximal end 117 of first balloon body 112. Inflation lumen 116 may have any diameter known to one skilled in the art. In some embodiments, inflation lumen 116 may have a diameter ranging between 0.2 - 3 mm. In some embodiments, inflation lumen 116 may have diameter ranging from 0.5 -10 mm. In some embodiments, inflation lumen 116 may have any length known to one skilled in the art. In some embodiments, inflation lumen 116 may have a length ranging between 10 - 36 cm. In some embodiments, lumen 116 may have a length between 20 - 110 cm. In some embodiments, inflation lumen 116 may further comprise a valve positioned anywhere on its length configured to provide a mechanism for preventing medium from escaping during use. In some embodiments, the valve may be any valve known to one skilled in the art including but not limited to a spring-loaded back-check valve. In some embodiments, spring-loaded back-check valve 126 may be positioned at the proximal end of lumen 116. In some embodiments, a pilot balloon 128 is connecting lumen 116 to spring-loaded back-check valve 126. Attorney Docket No.: 206017-0214-00WO In some embodiments, opening 111 and lumen 116 may be embedded in the body 107 of device 100. In some embodiments, opening 111 and lumen 116 may be attached on the outer surface of body 107 of device 100. In some embodiments, lumen 116 may be positioned inside tube 106 attached to the inner surface of body 107 such as laser ETT with metal body 107. In some embodiments opening 111 may be smaller in diameter than lumen 116. In some embodiments, the external source may be configured to introduce any medium into first balloon chamber 114 to inflate first balloon 108. In some embodiments, the external source is configured to introduce medium into first balloon chamber 114 to adjust the pressure within first balloon chamber 114 between approximately 10 – 120 cmH2O. In some embodiments, the external source is configured to achieve an average pressure of 42 cmH2O within first balloon chamber 114. In some embodiments, the external source is configured to achieve a pressure ranging between 20-30 cmH2O within first balloon chamber 114. In some embodiments, the external source is configured to adjust the pressure within first balloon chamber 114 to more than 120 cmH₂O. In some embodiments, the external source may be configured to apply vacuum pressure to remove any medium within first balloon chamber 114 and to deflate first balloon 108. In some embodiments, the external source may be any device known to one skilled in the art configured to allow inflation and deflation of first balloon 108 including but not limited to manually operated inflation devices, syringes, electromechanical inflation devices, pumps, etc. First balloon 108 may be made of any suitable material known to one skilled in the art. In some embodiments, first balloon 108 may be made from biocompatible materials, materials that can be made biocompatible, flexible materials, substantially flexible materials, polymers, PVC, nylon, polyethylene, polyurethane, and any other material considered suitable for a particular application. In some embodiments, first balloon 108 may comprise any suitable type of balloon, such as a compliant or non- compliant balloon, low-pressure or high-pressure balloon, high-volume or low-volume. In some embodiments the first balloon 108 may be conical (tapered), cylindrical, globular, asymmetric, or spheroid. Attorney Docket No.: 206017-0214-00WO First balloon 108 is disposed within second balloon 110. Second balloon 110 comprises a second balloon body 118 having a proximal end 126, a distal end 128 and an opening 119. In some embodiments, opening 119 may be positioned closer to proximal end 126. In some embodiments, opening 119 may have any diameter known to one skilled in the art. In some embodiments, opening 119 may have a diameter ranging between 0.2 - 3 mm. In some embodiments, opening 119 may have a diameter ranging between 0.5 - 10 mm. In some embodiments, opening 119 and conduit or lumen 122 may be embedded in the body 107 of device 100. In some embodiments, opening 119 and lumen 122 may be attached on the outer surface of body 107 of device 100. In some embodiments, lumen 122 may be positioned inside tube 106 attached to the inner surface of body 107 such as laser ETT with metal body 107. Second inflation conduit or lumen 122 may have any diameter known to one skilled in the art. In some embodiments, second inflation lumen 122 may have a diameter ranging between 0.2 - 3 mm. In some embodiments, second inflation lumen 122 may have a diameter ranging between 0.5-10 mm. In some embodiments, second lumen 122 may have any length known to one skilled in the art. In some embodiments, second lumen 122 may have a length ranging between 10 - 36 cm. In some embodiments, second inflation lumen 122 may have a length between 20 - 110 cm. In some embodiments, second lumen 122 may further comprise a valve positioned anywhere on its length configured to provide a mechanism for preventing fluid from escaping during use. In some embodiments, the valve may be any valve known to one skilled in the art including but not limited to a spring-loaded back-check valve. In some embodiments, spring-loaded back-check valve 127 may be positioned at the proximal end of lumen 122. In some embodiments, a pilot balloon 129 is connecting lumen 122 to spring-loaded back-check valve 127. In some embodiments, valve 127 may be in continuity with a programmable infusion delivery device. In some embodiments, valve 127 is fluidly connected with a programmable infusion delivery device. In some embodiments, second balloon 110 may be made from biocompatible materials, materials that can be made biocompatible, flexible materials, substantially flexible materials, polymers, PVC, nylon, polyethylene, polyurethane, and any other material considered suitable for a particular application. In some embodiments, Attorney Docket No.: 206017-0214-00WO second balloon 110 may comprise any suitable type of balloon, such as a compliant or non-compliant balloon, low-pressure or high-pressure balloon. In some embodiments the second balloon 110 may be conical (tapered), cylindrical, globular, spheroid, asymmetrical. In some embodiments, second balloon 110 is at least partially formed in the shape of a cuff, or comprises a cuff shape or design. In some embodiments, the first and second balloon are at least partially formed in the shape of one or more shapes, the one or more shapes selected from: sphere, hemisphere, cylinder, half-cylinder, ellipsoid, flower, petals, star, burst, crescent, oval, polygon, cone, prism, ellipsoid, flower shape, concentric ellipsoids, concentric spheres, or any combination thereof. In some embodiments, the first and second balloon each comprise a plurality of chambers (or a plurality of portions), each chamber or portion securely attached to and extending outward radially from the elongated tube, wherein each chamber of the second balloon at least partially encloses a respective chamber of the first balloon. (see FIGs.9P & 9Q) In some embodiments, the first balloon is completely disposed within the plurality of chambers of the second balloon. In some embodiments, the plurality of second chambers at least partially covers a single circumferential first balloon. In some embodiments, the plurality of chambers of the second balloon may be disposed on the middle 1/3, middle ½ or upper (distal) ½ of the plurality of chambers of the first balloon body. In some embodiments, each chamber or portion may be asymmetrically positioned along the length of the elongated tube. In some embodiments, the endoluminal medication delivery device comprises a plurality of first and second balloons, positioned at any location along the elongated tube. In some embodiments, the plurality of first and second balloons may be positioned on one side of the elongated tube. In some embodiments, the plurality of first and second balloons may be positioned on both sides of the elongated tube. In some embodiments, the plurality of first and second balloons circumferentially surrounds the elongated tube. In some embodiments, the plurality of first and second balloons may be configured in any suitable pattern along the elongated tube selected from: linear, non- linear, zig-zag, spiral, circular, or any combination thereof. Attorney Docket No.: 206017-0214-00WO In some embodiments, second balloon 110 body is made of or manufactured from the same material as first balloon 108. In some embodiments, second balloon 110 body is made of or manufactured from a different material from that of the first balloon 108. In some embodiments, the outer surface of second balloon 110 is at least partially porous or comprises one or more porous or perforated regions. For example, in some embodiments, the outer surface of second ballon 110 comprises at least one membrane. In some embodiments second balloon 110 shape is the same as the first balloon 108 shape. In some embodiments, second balloon 110 shape is different from that of the first balloon 108 shape. In some embodiments, the second balloon 110 size is minimally larger than the size of the first balloon 108. In some embodiments, the second balloon 110 size is significantly larger than the size of the first balloon 108. In some embodiments, the gap between the body of the second balloon 118 and the first balloon body 112 at full inflation of the first balloon measures between 0.2- 5 mm. In some embodiments, second balloon body 118, the portion of the outer surface of body 107 of tube 106 disposed within second balloon 110, and the portion of the exterior surface of first balloon 108 is disposed within second balloon 110 and defines a second balloon chamber 120 that is adapted to receive a fluid or gel through opening 119. Opening 119 is fluidly connected to an external source through a second lumen 122. In some embodiments, the fluid may be any fluid known to one skilled in the art including but not limited to solutions, compositions, agents, drugs, therapeutics, therapeutic medications, or any combination thereof. In some embodiments, the fluid may comprise one or more local anesthetic medications such as lidocaine to provide regional anesthesia to the tracheal mucosa surrounding the inflated endotracheal tube cuff to prevent emergency reactions during anesthesia and reduce the higher anesthetic requirements resulting for the ETT first cuff stimulation. Examples of medications that may be administered may include any medication or therapeutic agent which would be desirably applied locally to a specific, internal tissue site which is accessible by the catheter. Specific examples of such medications or therapeutic agents include but is not limited to anti-thrombogenic agents or other agents for suppressing stenosis or late restenosis such as heparin, streptokinase, urokinase, tissue plasminogen activator, anti- thromboxane B² agents, anti-B-thromboglobulin, prostaglandin E, aspirin, dipyridimol, Attorney Docket No.: 206017-0214-00WO anti-thromboxane A2 agents, murine monoclonal antibody 7E3, triazolopyrimidine, ciprostene, hirudin, ticlopidine, nicorandil, steroids and the like. Anti-platelet derived growth factor may be used as a therapeutic agent to suppress subintimal fibromuscular hyperplasia at an arterial stenosis site, or any other inhibitor of cell growth at the stenosis site may be used. The therapeutic agent also may comprise a vasodilator to counteract vasospasm, for example an antispasmodic agent such as papaverine. The therapeutic agents may be vasoactive agents generally such as calcium antagonists, or alpha and beta adrenergic agonists or antagonists. Additionally, the therapeutic agent may include a biological adhesive such as medical grade cyanoacrylate adhesive or fibrin glue, for example to adhere an occluding flap of tissue in a coronary artery to the wall, or for a similar purpose. In some embodiments, an anti-thrombogenic agent may be applied to its internal tissue site for preferably long-term suppression of thrombogenic activity. Additionally, the therapeutic agent in accordance with this invention may be an anti- neoplastic agent such as 5-fluorouracil or any known anti-neoplastic agent, preferably mixed with a controlled release carrier for the agent, for the application of a persistent, controlled release anti-neoplastic agent. In some embodiments, the therapeutic agent may be an antibiotic for the purpose of minimizing pathogen colonization in a localized tissue site. In some embodiments, the therapeutic agent may comprise steroids for the purpose of suppressing inflammation, stenosis, or for other reasons in a localized tissue site. The therapeutic agent may constitute any desired mixture of individual pharmaceuticals of the like, for the application of combinations of active agents. Additionally, glucocorticosteroids or omega-3 fatty acids may be applied, particularly to stenosis sites to obtain clinical benefit thereby. Any of the above medications may include controlled release agents to prolong the persistence of the medication. In some embodiments, vasoconstrictors may be applied to an endoluminal area of profuse bleeding after applying compression by first balloon 108 and injecting the vasoconstrictor (including but not limited to epinephrine, norepinephrine, vasopressin etc.) through second balloon 110 to the target area to control bleeding. In some embodiments, any other medication may be injected into a vascular bodily lumen (such Attorney Docket No.: 206017-0214-00WO as the trachea) to provide rapid systemic absorption in case of lack of vascular access, unavailability of extremities, lack of access to extremities, or failure of intraosseous and interosseous access. In some embodiments, the external source or reservoir may be configured to introduce any fluid, solution, composition, drug, medium or the like into second balloon chamber 120. In some embodiments, the external source may be any device known to one skilled in the art configured to allow introduction of fluid or medium into second balloon chamber 120 including but not limited to manually operated syringes, programmable syringes, pumps, medication delivery devices, etc. In some embodiments, drug delivery opening 119 opens directly into the second balloon chamber 120 and provides access to the balloon through a second inflation lumen 122, pilot balloon 129, and back-check valve 127. The main purpose of opening 119 is to deliver the medication into the second balloon chamber 120. The design of the drug delivery opening may be a factor determining the pattern of medication distribution within the proximal non-perforated impermeable end of the second balloon body 118 in certain applications. In some embodiments suited for applications with considerable luminal structural support, a large second balloon contact surface area with the surrounding lumen, and considerable compression pressure to the second balloon, position of opening 119 is proximal in the second balloon body 118. In some embodiments suited for applications with considerable luminal structural support, a large second balloon contact surface area with the surrounding lumen, and considerable compression pressure to the second balloon, opening 119 may have the same diameter of inflation lumen 122 while cross-section of opening 119 may be flat, beveled towards the surface of the second cuff body118, or beveled towards outer surface of body 107 of device 100 between the body balloon 118 and the body of balloon 112 as depicted in FIGs.6A-6C. In some embodiments, the cross-section diameter of the tip of opening 119 may be smaller than diameter of lumen 122 as depicted in FIG.6D. In some embodiments, the tip of lumen 122 extending between the body balloon 118 and the body of balloon 112 may be sealed with the most distal aspect of lumen 122 exhibiting 2 side perforations for medication delivery into chamber 120 as depicted in FIG.6E. In some embodiments, suited for low-pressure and ultralow-pressure applications especially with Attorney Docket No.: 206017-0214-00WO a soft non-rigid wide lumen, the tip of lumen 119 may bifurcate into 2 branches within the proximal non-perforated impermeable end of the second balloon with two equilateral medication delivery tips on both sides (180 degrees between both tips) with both medication delivery tips at end of the “Y” shaped bifurcation as depicted in FIG.6F. In some embodiments, suited for low-pressure and ultralow-pressure applications especially with of soft non-rigid wide lumen, the tip of lumen 119 may be sealed with lumen 122 extending between the body balloon 118 and the body of balloon 112 and fixed around the entire circumference of the body 107 of device 100 forming a circular loop, exhibiting multiple circumferential medication release perforations facing distally as depicted in FIG.6G. In some embodiments, second balloon 110 comprises a truss-cuff design wherein second lumen 122 and opening 119 extend into a parallel network of symmetrically opposing, impermeable and equal length delivery tubes that open into a circumferential, collapsible and perforated band shaped cuff that surrounds the middle and/or distal portion of the first balloon (FIG.9N and FIG.9O). In some embodiments, the delivery tubes are compressible and/or collapsible. In some embodiments, the second balloon comprises an even number of delivery tubes. In some embodiments, the second balloon comprises between about 2-12 delivery tubes. In some embodiments, any disclosed device (e.g., device 100) or method comprises a plurality of delivery tubes extending through the second lumen and fluidly connected to the at least one permeable portion. In some embodiments, the plurality of delivery tubes comprise any of: an even number of tubes, symmetrical positioning, symmetrical configuration, collapsible material, impermeable material, equal length, equal run, or equal flow, equal flowrate. In some embodiments, second balloon 110 comprises hemispherical or hemicylindrical second cuffs (hemi-cuff design) (FIG.9P). This hemi-cuff (half) second cuff design applies the same concept of impermeable proximal portion and permeable middle and/or distal potion with both portions existing in separate identical hemi second balloon chambers with two separate medication delivery tubes 122 and two openings 119 for each chamber. In some embodiments, the two hemispherical or hemicylindrical second cuffs may cover the entire circumference of the endoluminal delivery device with each hemi-second cuff covering about 180-degrees of the 360-degree circumference. In Attorney Docket No.: 206017-0214-00WO some embodiments, the 2 hemispherical or hemicylindrical cuffs my cover a portion of the circumference of the endoluminal device ranging between about 60-degrees and 160- degrees leaving part of the outer wall of the endoluminal device uncovered with the cuffs. In some embodiments, the hemi-second cuff design may be used with a single first inflating cuff. In some embodiments, the hemi-second cuff design may comprise two hemi-first inflating cuff design, making a system of 2 separate hemi-second cuff medication delivery chambers with 2 medication delivery tubes 122 and 2 openings 119 and 2 first inflating hemi-cuffs with 2 inflation tubes 116 and opening 111. In some embodiments, the first and second cuffs of the hemi-second cuff design may be elongated. In some embodiments, the first and second cuffs of the hemi-second cuff design can cover an extended length of the outer surface the endoluminal device. In some embodiments, the first and second cuffs of the hemi-second cuff design may cover a variable portion of the length of the outer surface of the endoluminal device. In some embodiments, the first and second cuffs of the hemi-second cuff design can be of shapes other than spherical or cylindrical to better conform to bodily cavity or passage including, but not limited to, elongated, irregular, asymmetrical, symmetrical, curved, tapered, double-balloon shaped. In some embodiments, the first and second cuffs on each side of the hemi-second cuff design may have the same shape. In some embodiments, the first and second medication delivery cuffs on each side of the hemi-cuff design may have different shapes. In some embodiments, the first and second medication delivery cuffs on each side of the hemi-second cuff design may be symmetrical. In some embodiments, the first and second medication delivery cuffs on each side of the hemi-second cuff design may be asymmetrical. In some embodiments, the first and second medication delivery cuffs on each side of the hemi-second cuff design may be made from the same material. In some embodiments, the first and second medication delivery cuffs on each side of the hemi-second cuff design may be made from different material. In some embodiments, second balloon 110 comprises 4 separate hemispherical or hemicylindrical medication delivery cuffs (quad-cuff design) that circumferentially surrounds the endoluminal device with each cuff covering 45-degree to 90-degress of the circumference (FIG.9Q). This quad-second cuff design applies the same concept of impermeable proximal portion and permeable middle and/or distal Attorney Docket No.: 206017-0214-00WO potion with both portions existing in separate quad-second balloon chambers with four separate medication delivery tubes 122 and four openings 119 for each chamber. In the quad-second cuff design, each of the 4 second medication delivery cuffs has a separate medication delivery tubing 122 and opening 119. In some embodiments, the quad-second cuff design may be used with a single first inflating cuff. In some embodiments, the quad-second cuff design may comprise quad first inflating cuff design, making a system of 4 separate second cuff medication delivery chambers with 4 medication delivery tubes 122 and 4 openings 119 and 4 first inflating cuffs with 4 inflation tubes 116 and opening 111. In some embodiments, the first and second cuffs of the quad-second cuff design may be elongated. In some embodiments, the first and second cuffs of the quad-second cuff design may cover an extended length of the outer surface the endoluminal device. In some embodiments, the first and second cuffs of the quad-second cuff design can cover a variable portion of the length of the outer surface the endoluminal device. In some embodiments, the first and second cuffs of the quad-second cuff design can be of shapes other than spherical or cylindrical to better conform to bodily cavity or passage, including, but not limited to, elongated, irregular, asymmetrical, symmetrical, curved, tapered, double-balloon shaped…etc. In some embodiments, the first and second cuffs of the quad-second cuff design may have the same shape. In some embodiments, the first and second cuffs of the quad-cuff design may have different shapes. In some embodiments, the first and second cuffs of the quad-second cuff design may be symmetrical. In some embodiments, the first and second cuffs of the quad-second cuff design may be asymmetrical. In some embodiments, the first and second cuffs may be made from the same material. In some embodiments, the first and second cuffs may be made from different materials. In some embodiments, the endoluminal tube may further comprise a plurality of medication delivery cuffs to achieve medication delivery at variable locations along the length of the endoluminal device during clinical application. In some embodiments, a distal medication delivery system can be added which consists of: full- cuff design (FIG.9R) or truss-cuff design (FIG.9S) at the distal end of the endotracheal tube positioned in the trachea to provide a continuous seal of the trachea (first cuff) and deliver medications on demand to the tracheal mucosa (second cuff).A second and Attorney Docket No.: 206017-0214-00WO separate medication delivery system utilizing a full-cuff design, or truss-cuff design, or a hemi-cuff design, or a quad-cuff design may be utilized along the length of the ETT in the areas abutting the patient’s hypopharynx, base of the tongue, tongue, pharyngeal wall, and palate (FIG.9R and FIG.9S). The second proximal medication delivery system can be used to inject medications (such as local anesthetics) to minimize the stimulation caused by the pressure of the ETT on the surrounding structures and alleviating the gag reflex. The use of the second proximal medication delivery system entails the following steps: inflating the first cuff/s, injecting the medication through the second cuff/s, deflating the first cuff/s. Referring now to FIG.9R and FIG.9S, a third balloon can be secured to the outer surface of the elongated lumen in any position along the elongated lumen. In some embodiments, the third balloon comprises a third balloon chamber in fluid connection with a third lumen. In some embodiments, the third balloon chamber is configurable between a first, deflated configuration and a second, inflated configuration as a fluid moves into and out of the third balloon chamber. In some embodiments, a fourth balloon is secured to the outer surface of the elongated lumen and positioned around the third balloon such that the third balloon is at least partially disposed within the fourth balloon. In some embodiments, the fourth balloon comprises a fourth balloon chamber in fluid connection with a fourth lumen. In some embodiments, the fourth balloon comprises a fourth balloon body having an impermeable proximal end, and at least one permeable portion in the fourth balloon body fluidly connecting to the fourth balloon chamber. In some embodiments, the fourth balloon comprises a truss-cuff design. In some embodiments, the fourth balloon comprises a hemi-cuff design. In some embodiments, the fourth balloon comprises a quad-cuff design. In some embodiments, a fifth balloon is secured to the outer surface of the elongated lumen in any position along the elongated lumen. In some embodiments, the fifth balloon comprises a fifth balloon chamber in fluid connection with a fifth lumen. In some embodiments, the fifth balloon chamber is configurable between a first, deflated configuration and a second, inflated configuration as a fluid moves into and out of the fifth balloon chamber. In some embodiments, a sixth balloon is secured to the outer surface of the elongated lumen and positioned around the fifth balloon such that the fifth balloon is at least partially disposed within the sixth balloon. In some embodiments, the sixth balloon comprises a sixth Attorney Docket No.: 206017-0214-00WO balloon chamber in fluid connection with a sixth lumen. In some embodiments, the sixth balloon comprises a sixth balloon body having an impermeable proximal end, and at least one permeable portion in the sixth balloon body fluidly connecting to the sixth balloon chamber. In some embodiments, the sixth balloon comprises a truss-cuff design. In some embodiments, the sixth balloon comprises a hemi-cuff design. In some embodiments, the sixth balloon comprises a quad-cuff design. In some embodiments, second balloon body 118 comprises plurality of perforations 124 extending through second balloon body 118, providing access to second balloon chamber 120 and positioned circumferentially in at least one central line around second balloon body 118. In some embodiments, second balloon body 118 may comprise three circumferential central lines of perforations 124. In some embodiments, second balloon body 118 may comprise 1 - 15 circumferential central lines of perforations 124 (FIG.7). The number of circumferential lines depends on the shape, size of the ETT second balloon and the size of the perforations. The perforations must only be present on the second balloon surface abutting the tracheal mucosa or part of that surface. In some embodiments, perforations 124 are present on second, fourth and sixth balloon surfaces with the second, fourth, and sixth balloons overlapping the first, third and fifth underlying balloons respectively. In some embodiments, plurality of perforations 124 may be vertically alternating between the horizontal rows. In some embodiments, plurality of perforations 124 may be vertically aligned between the horizontal rows. In some embodiments, plurality of perforations 124 may be positioned in the middle third of second balloon body 118 (FIG.8A). In some embodiments, plurality of perforations 124 may be positioned in the middle half of second balloon body 118 (FIG.8B). In some embodiments, plurality of perforations 124 may be positioned in the upper (distal) half of second balloon body 118 (FIG.8C). In some embodiments, the second balloon surface that abuts the surrounding lumen may comprise at least one membrane (FIG.9M). In some embodiments, the membrane can be made from or formed of the same material as the second cuff or can be of a different material and structure. In some embodiments, the second cuff medication delivery system can be reduced to a truss-cuff design consisting of a truss delivery tubes design. In some embodiments, the truss delivery tubes design comprises even numbered, equal-length, symmetrically positioned, impermeable Attorney Docket No.: 206017-0214-00WO collapsible delivery tubes emerging from the medication delivery tube 122 and opening 119. In some embodiments, the delivery tubes in the truss design open into a band-shaped perforated second cuff that circumferentially surrounds the middle and/or distal portion of the first cuff. In some embodiments, plurality of perforations 124 is limited to a fraction of the external circumference of second balloon 110 (10% to 75%) for specific, directional, and targeted medication delivery to limited aspect of the lumen. In some embodiments, the vertical distance between each two lines may be ranging between about 0.5 - 5 mm. In some embodiments, the vertical spaces between horizontal lines of perforations 124 may be equal. In some embodiments, the vertical spaces between the horizontal lines of perforations 124 may be larger between the proximal perforations and smaller between distal perforations. In some embodiments, horizontal spaces between vertical longitudinal lines of perforations 124 may be equal. In some embodiments, horizontal spaces between vertical lines of perforation 124 may be larger between the proximal end of these vertical lines and smaller in the middle and distal ends of the vertical lines. In some embodiments the horizontal or vertical distance between perforations on each line may range between 1 - 15 mm. Each perforation extends through second balloon body 118 and allows fluid to pass through second balloon body 118 with the application of pressure within the second balloon chamber 120. In some embodiments, plurality of perforations 124 may have any shape known to one skilled in the art including but not limited to circular, oval, etc. In some embodiments, plurality of perforations 124 may have any diameter ranging between approximately 0.1 - 0.8 mm. In some embodiments, plurality of perforations 124 may have any diameter gauge ranging between approximately 34 – 23 Gauge. In some embodiments, plurality of perforations 124 may have any diameter gauge ranging between approximately 32 – 28 Gauge for low viscosity liquids. In some embodiments, the diameter of plurality of perforations 124 may be uniform throughout the centrally located horizontal layers. In some embodiments, the diameter of plurality of perforations 124 may vary throughout each layer. In some embodiments, plurality of perforations 124 having larger diameters may be positioned centrally and/or distally towards distal end 128 of the middle 1/3 or the middle ½ or upper ½ of the second balloon body 118 while plurality of Attorney Docket No.: 206017-0214-00WO perforations 124 having smaller diameters are positioned towards proximal end 126 of the middle 1/3 or middle ½ or upper ½ of second balloon body 118 to augment the pressure buildup within second balloon 108 for maximal central circumferential delivery of the medication to the high pressure contact area between the second balloon body 118 abutting the tracheal mucosa. In some embodiments, a larger number of similar size plurality of perforations 124 may be positioned centrally and/or distally towards distal end 128 of the middle 1/3 or the middle ½ or upper ½ of the second balloon body 118 while lesser number of similar size plurality of perforations 124 are positioned towards proximal end 126 of the middle 1/3 or middle ½ or upper ½ of second balloon body 118 to augment the pressure build within second balloon 108 for maximal central circumferential delivery of the medication to the high pressure contact area between the second balloon body 118 abutting the tracheal mucosa. In some embodiments, lesser number of similar size of plurality of perforations 124 may be positioned vertically on the longitudinal axis of the balloon body on the same side of the fluid delivery port 119, while a larger number of similar size of the plurality of perforations 124 are positioned vertically on the longitudinal axis of the balloon body opposing the medication delivery port 119 between proximal and distal ends of the middle 1/3 or middle ½ or upper(distal) ½ of second balloon body 118 to allow for circumferential and vertical pressure build up between both sides ( the medication release side containing port 119 and the opposite side) in addition to augmenting the pressure build within second balloon 108 for maximal central circumferential delivery of the medication to the high-pressure contact area between the second balloon body 118 and the tracheal mucosa. In some embodiments, smaller size plurality of perforations 124 may be positioned vertically on the longitudinal axis of the balloon body on the same side of the fluid delivery port 119, while larger size of plurality of perforations 124 are positioned vertically on the longitudinal axis of the balloon body opposing the medication delivery port 119 positioned between the proximal and distal ends of the middle 1/3 or middle ½ or upper(distal) ½ of second balloon body 118 to allow for vertical pressure build up between both sides ( the medication release side containing port 119 and the opposite Attorney Docket No.: 206017-0214-00WO side) in addition to augmenting the pressure build within second balloon 108 for maximal central circumferential delivery of the medication to the high-pressure contact area between the second balloon body 118 and the tracheal mucosa. In some embodiments, allocation of plurality of perforations 124 of the same size may be positioned at a vertically higher position on the longitudinal axis of the second balloon body on the same side of the fluid delivery port 119, while perforations 124 of the same size are positioned vertically lower on the longitudinal axis of the second balloon body opposing the medication delivery port 119 positioned between the proximal and distal ends of the middle 1/3 or middle ½ or upper(distal) ½ of second balloon body 118 to allow for vertical pressure build up between both sides (the medication release side containing port 119 and the opposite side) in addition to augmenting the pressure build within second balloon 108 for maximal central circumferential delivery of the medication to the high pressure contact area between the second balloon body 118 and the tracheal mucosa. In some embodiments, various combinations of size, pattern, and position of perforations aforementioned may be used to optimize vertical and circumferential distribution of medication within the second balloon. In some embodiments, in order to allow circumferential pressure build up within second balloon body 118, no perforations are positioned at proximal end 126 and distal end 128 of second balloon body 118. In some embodiments, in order to allow circumferential pressure build up within second balloon body 118, no perforations are positioned at proximal end 126. In some embodiments, plurality of perforations 124 may have varying diameters based on different applications and physical structure of the injected material. In some embodiments, the configuration and size of the plurality of perforations may vary depending on the type of medication, application type, level of pressure in system, and rigidity of the surrounding lumen. In some embodiments suited for applications with considerable luminal structural support, a large second balloon contact surface area with the surrounding lumen, and considerable compression pressure to the second balloon, similar size Attorney Docket No.: 206017-0214-00WO plurality of perforations 124 can be configured circumferentially as depicted in Figs, 7, 8A-C. In some embodiments suited for applications with considerable luminal structural support, a large second balloon contact surface area with the surrounding lumen, and considerable compression pressure to the second balloon and other devices with elongated and longer balloon design, variable size perforations can be used with the smaller perforations 124 placed proximally and larger perforations 124 placed distally as depicted in FIG.9A. In some embodiments suited for applications with considerable luminal structural support, a large second balloon contact surface area with the surrounding lumen, and considerable compression pressure to the second balloon and other devices with elongated and longer balloon design, same size perforations 124 can be used with lesser number of perforations 124 placed proximally and larger number of perforations 124 placed distally as depicted in FIG.9B. In some embodiments suited for applications with considerable luminal structural support, a large second balloon contact surface area with the surrounding lumen, and considerable compression pressure to the second balloon and other devices with elongated and longer balloon design, same size perforations 124 can be vertically aligned as depicted in FIG.9C. In some embodiments, suited for high-pressure, or low-pressure and ultralow-pressure applications especially with soft non-rigid lumen, smaller size perforations 124 are located in the hemisphere of the second balloon body on the same side of opening 119 while larger perforations 124 are located in the hemisphere opposite to opening 119 as depicted in FIG.9D. In some embodiments, suited for high-pressure, or low-pressure and ultralow-pressure applications especially with soft non-rigid lumen, a smaller number of perforations 124 are located in the hemisphere of the second balloon body on the same side of opening 119 while larger number of perforations 124 are located in hemisphere opposite to opening 119 as depicted in FIG.9E. In some embodiments, suited for high-pressure, or low-pressure and ultralow-pressure applications especially with soft non-rigid lumen, perforations 124 are Attorney Docket No.: 206017-0214-00WO located at a relatively more distal position in the hemisphere of the second balloon body on the same side of opening 119 while perforations 124 on the hemisphere opposite to opening 119 are located relatively more proximal as depicted in FIG.9F. In some embodiments, plurality of perforations 124 can have variable configurations within the middle 1/3 or middle ½ or upper(distal) ½ of second balloon body 118 that include but are not limited to circumferential “V” shaped pattern (FIG. 9G). In some embodiments, plurality of perforations 124 can have variable configurations within the middle 1/3 or middle ½ or upper(distal) ½ of second balloon body 118 that include but are not limited to a single large or multiple small circumferential “X” shaped pattern (FIG.9H). In some embodiments, plurality of perforations 124 can have variable configurations within the middle 1/3 or middle ½ or upper(distal) ½ of second balloon body 118 that include but are not limited to “Z” shaped pattern (FIG.9I). In some embodiments, plurality of perforations 124 can have variable configurations within the middle 1/3 or middle ½ or upper(distal) ½ of second balloon body 118 that include but are not limited to horizontal layers of zig-zag patterns (FIG.9J). In some embodiments, plurality of perforations 124 can have variable configurations within the middle 1/3 or middle ½ or upper(distal) ½ of second balloon body 118 that include but are not limited to perforations widely spaced on horizontal axis while vertically aligned (FIG.9K). In some embodiments, plurality of perforations 124 can have variable configurations within the middle 1/3 or middle ½ or upper(distal) ½ of second balloon body 118 that include but are not limited to perforations widely spaced on a horizontal axis while vertically alternating (FIG.9L). In some embodiments, plurality of perforations 124 can have variable configurations within the middle 1/3 or middle ½ or upper(distal) ½ of second balloon body that include but are not limited to a gradient pattern or a spiral pattern. In one exemplary embodiment, injected materials with viscus and gel-like forms, require larger diameter perforations than materials with liquid form. In some embodiments, at least a portion of the second balloon surface abutting the surrounding lumen and containing the plurality of perforations can be made or formed from the same material and comprise the same structure as that of the second balloon or can be made of a different material and structure. In some embodiments, the medication delivery area of the second cuff is a membrane as depicted in FIG.9M. Attorney Docket No.: 206017-0214-00WO Depending on the application and the characteristics of the surrounding tissues and the material injected into the second balloon, membrane molecular structure and design may vary. In some embodiments, the membrane can be natural, synthetic, biological or non- biological. In some embodiments, the membrane may be dense, semipermeable, or permeable. In some embodiments, the membrane may be neutral or charged, homogeneous or heterogeneous. In some embodiments, the membrane may apply microscopic and/or macroscopic conceptual structural design characteristics. In some embodiments, the membrane may apply one or more of the following microscopic conceptual structural design characteristics and membrane processes types: dense, porous, microporous, symmetric (both sides are structurally similar; having the same molecular and design structure), asymmetric (both sides are structurally different; having different molecular and design structure), isotropic (uniform pore size and porosity), anisotropic (variable pore size and porosity), temperature regulated membrane permeability (the molecular structure and porosity changes at different temperature allowing molecules to cross), temperature regulated diffusion of the injected material, pressure regulated membrane permeability (the molecular structure and porosity changes at different pressures allowing molecules to cross), bioreactive membrane, and nanostructured membranes. In some embodiments, the membrane may apply macroscopic conceptual structure design characteristics and configurations such as hollow fiber, laminar flow sheet, plate and frame, ceramic and polymeric sheets, tubular, and spiral wound. In some embodiments, the membrane may include one or more of the following principles and technologies of molecular transfer: pressure-drive membrane technology, passive diffusion principles, active transport, microfiltration, ultrafiltration, osmosis, reverse osmosis, nanofiltration, and membrane bioreactors. The membrane technology, design, and material can be based on any of the following parameters to facilitate and regulate diffusion: molecular weight (mass), molecular size, polarity, ionization, biosynthesis, charge number, chemical gradient, electrical gradients, concentration gradient, pressure gradient, osmolality, pressure regulated diffusion, and temperature regulated diffusion. In some embodiments, the membrane may include various flow geometries (operation modes) such as cross-flow filtration and dead-end filtration. Attorney Docket No.: 206017-0214-00WO In some embodiments, second balloon chamber 120 acts as an immediate variable high-pressure delivery conduit and not as a reservoir for the injected fluid. The system allows the delivery of medication to the target area while the endotracheal tube first balloon 112 is continually and fully inflated maintaining the seal and full functionality of the endoluminal device. Forces determining the pattern of distribution of the injected medication within the second balloon chamber are the presence of most or all of the non-perforated impermeable surface area of body of the second balloon in the proximal and/or proximal and distal area that is not abutting the surrounding lumen (Key factor), the presence of perforations 124 only on the second balloon surface abutting (in direct contact with) the surrounding lumen (key factor), continued normal and/or augmented temporary inflation of the first balloon(key factor), the degree of circumferential pressure exerted by the surrounding lumen on both balloons (key factor), the ratio of the surface area of the impermeable non-perforated proximal balloon body to the perforated middle and/or distal perforations 124, relationship between the viscosity of the injected medication and the size of perforations 124, the capacity of the second balloon chamber 120, the injection pressure at the valve 127 by the operator, the distance between plurality of perforations 124 and opening 119, and design pattern of the perforations within the perforated middle and/or distal area of the second balloon body. The presence of an unperforated impermeable proximal portion is responsible for circumferential and vertical pressure build up within the second balloon chamber 120 by avoiding the loss of the injected medication through proximal and/or proximal and distal perforations that are not abutting the mucosa. The external pressure exerted by the surrounding rigid luminal structure contributes to even circumferential distribution of the injected medication minimizing disproportionately higher medication delivery to the hemisphere on the same side of opening 119 thus causing even horizontal circumferential distribution of the injection medication thought the second balloon lumen by providing moderate pressure opposing the rapid expulsion of the medication through perforation 124 from the hemisphere on the same side of opening 119 resulting in less delivery of the medication to the hemisphere on the opposite side of opening 119. Second balloon chamber 120 capacity should be kept to a minimum in high-pressure applications with considerable luminal structural support such as the endotracheal tube. In Attorney Docket No.: 206017-0214-00WO applications leading to moderate or high-pressure inside the first and second balloon due to a well–supported lumen structure such as the ETT, the second balloon body 110 should have the same shape of the first balloon 108 body. The capacity of the second balloon chamber 120 at full inflation of the first balloon body 108 should be kept to a minimum to the extent permitted by manufacturing methodology and logistics. The capacity (volume) of the second balloon chamber 120 and inflation lumen 122 during inflation of the first balloon body at a certain compression pressure measured directly thought back-check valve 126 of the first balloon body within a specific lumen is considered the dead space of the second balloon and of the medication injected at this specific pressure for this lumen. Minimal to no residual medication is expected to remain in the dead space with this invention and the embodiments discussed. However, the manufacturer should measure the balloon dead space at various clinically relevant inflation pressures to help the operator determine the ratio of dead space medication waste with precision when applicable or clinically relevant. To deliver the fluid, sufficient pressure buildup and circumferential distribution must be achieved within the second balloon chamber 120 to develop a high-pressure point at plurality of perforations 124 of second balloon 110 abutting the mucosa (in case of an ETT). In certain operations, especially in the absence of a rigid structure surrounding the endoluminal tube cuffs, the pressure inside the first balloon can be temporarily increased by injecting more air into it before injecting the medication into the second balloon, with the extra air injected being withdrawn from the first balloon immediately after medication delivery to bring the first balloon back to its original pressure. In some embodiments, after injection of the fluid through second lumen 122, the fluid distributes within second balloon chamber 120 starting with circumferential distribution in the non-porous non-permeable proximal end 126. After the drug in the lower unperforated proximal end of second balloon chamber 120 is circumferentially distributed, pressure builds up in this section (end) of second balloon chamber 120. Any additional injected fluid is then delivered in the middle high-pressure zone achieving adequate pressure to overcome the compressive forces induced by first balloon body 112 and the surrounding tissue (e.g., tracheal mucosa interface in case of an ETT). After reaching the middle high-compression portion of second balloon chamber 120 with at Attorney Docket No.: 206017-0214-00WO least one line of perforations 124, it is immediately expelled out of plurality of perforations 124 by virtue of existing high-compression pressure into the surrounding tissue (highly absorbent compressed tracheal mucosa in case of an ETT). This configuration allows for delivery of fluid under pressure from second balloon chamber 120 and directly into the mucosa with minimal waste of the administered fluid. This configuration does not cause any excessive pressure to expel the medication out of the perforations as it uses the existing high-pressure generated by the first inflated balloon 112 to expel the medication from the perforations 124 of the second balloon 118. Further, this configuration provides adequate distancing between plurality of perforations 124 and opening 119. This adequate distancing allows for adequate circumferential pressure build-up and even circumferential distribution of the injected fluid within second balloon chamber 120 before it reaches plurality of perforations 124 compressed by the surrounding tissue (e.g., tracheal mucosa and rigid external tracheal structure). Moreover, this configuration prevents the leak of the injected fluid at the low-pressure proximal end 126 of second balloon body 118 (path of least resistance for the fluid) that is not compressed by the surrounding tissue (e.g. tracheal mucosa). This configuration allows this system to function as intended irrespective of gravitation forces, pressure variability in the first cuff, and independent of patient positing, type of ventilation, orientation of the ETT, repositioning of the ETT during surgery or during intubation in the intensive care unit, or other variables existing outside this delivery system. The presence of plurality of perforations 124 in low-pressure proximal end 126 of second balloon body 118 may lead to the loss of injected fluid in an area that is at minimal or no contact with the target delivery area (e.g., tracheal mucosa). In some embodiments, opening 119 and second lumen 122 may be positioned on the inner concave edge or outer convex edge of the ETT or can be embedded in the concave inner or convex outer curvatures of the ETT. In the case of outer placement of lumen 122 on the outer surface of ETT, placement on the inner convex surface is preferred to avoid injury to the vocal cord during periods of prolonged intubation. In some embodiments, the free non-attached portion of the lumen 122 should start proximally as customary in ETT design to avoid trauma and injury to the vocal cords. Lumen 122 should be attached to the ETT tube or embedded in the tube in the ETT portion going through the vocal cords and into the trachea. Lumen 122 can be Attorney Docket No.: 206017-0214-00WO embedded in the inner curvature or outer curvature of body 107 of the endoluminal device 100. In some embodiments, lumen 122 may be positioned inside tube 106 attached to the inner surface of body 107 such as laser ETT with metal body 107. In some embodiments, high-pressure within the first and second balloons may be required for optimal delivery of the medication into the surrounding lumen, therefore inflation pressure in the first balloon chamber 114 may be temporarily increased by injection more air (or saline) through lumen 116 before delivery of the medication into the second balloon through lumen 122, while removing excessive air (or saline) after the injection of the medication and returning to the original normal first balloon inflation pressure. In some embodiments, device 100 may be used during general anesthesia. In some embodiments, device 100 may be used in the intensive care unit. In some embodiments, device 100 may be used in tracheostomy tubes. In some embodiments, device 100 may be used for urological, gastroenterological, neurological, critical care, and vascular procedures. In some embodiments, device 100 enables flexible application of any medium including but not limited to any medicine known to one skilled in the art at any time throughout any procedure regardless of the duration of surgery. In some embodiments, device 100 is configured to allow application of any medication (e.g., local anesthetic) where it is exactly needed, in small doses that can be repeated and thereby minimizing systemic absorption. The dose absorbed systemically is minimal and well- below the threshold of systemic toxicity even with repeated applications and thereby minimizes any drug side effects. In some embodiments, device 100 is configured to allow for drug titration, appropriate and exact timing of drug delivery and sustained delivery for long duration and thereby allows for a reduced dose of intravenous and inhalational anesthetics and unnecessary deeper levels of anesthesia needed to overcome the stimulating effect of the endotracheal tube. In some embodiments, device 100 may be used as a port for delivering medications emergently and electively. Examples of emergent applications include but is not limited to medical emergencies, lack of intravenous access as in trauma patients, or Attorney Docket No.: 206017-0214-00WO resuscitation in the field by paramedics. In some embodiments, examples of elective applications include but is not limited to delivering medications such as lidocaine, steroids, vasoactive drugs, and antibiotics at the ETT-mucosa interface for patients with prolonged intubation times. In some embodiments, device 100 may be used in any patient regardless of age and hemodynamic stability as it involves delivering the medication to the effect site without considerable systemic exposure. In some embodiments, device 100 may be placed and function anywhere in the body including but not limited to a low-pressure position (intestines) or a high- pressure position (endotracheal intubation) as the design involves a circumferential pressure build up and distribution mechanism. In some embodiments, device 100 is configured to have high patient safety profile because a specific amount of medication may be injected to the target area and after a specific time a second dose may be safely administered again with minimal systemic effects. Although described elsewhere herein as an inflatable portion of an endoluminal device (e.g., truss-cuff design, quad-cuff design, etc.), an aspect of the invention is a separate device comprising an annular or ring-shaped elastic structure comprising one or more permeable portions. It should be appreciated that this structure may be formed separately from other devices, or formed as one unit, and may be used with any medical device with inflatable portions for accurately dispensing fluid (e.g., medication or lubricant) to a portion surrounding the inflatable member or balloon of the medical device. The present innovation allows standardizing the dispensing of fluids in bodily passages with many different devices. Aspects of the invention include applying the device separately to, or using the device with, any medical device. In some embodiments, the ring structure comprises a hollow portion forming a lumen inside the ring, with one or more conduits extending out of the structure fluidly connected to the lumen and one or more permeable portions. In some embodiments, the ring structure and/or one or more conduits comprise one or more inflatable sections. In some embodiments, the one or more conduits comprise a plurality of channels extending therethrough. In some embodiments, a portion of the channels are Attorney Docket No.: 206017-0214-00WO connected at their distal end to one or more inflatable members positioned inside the lumen of the ring, wherein inflating the portion of the channels allows fluid to flow freely through the other portion of channels to the one or more permeable portions. It should be appreciated that any conduit, lumen, tube or structure disclosed herein may be appropriately terminated with any connector known by one of ordinary level of skill in the art. This includes, but is not limited to, tube connectors, locking connectors, Luer locks, syringe connectors, surgical connectors, medical connectors, and the like. Method of Use The present invention provides a method configured to allow precise, immediate, repeated, and controlled circumferential endoluminal medication delivery to any bodily passage known to one skilled in the art. In some embodiments, the method of the present invention may be used in a low-pressure position within a soft non-rigid lumen (intestines) or a high-pressure position within a well-supported lumen structure (endotracheal intubation). In some embodiments, the method of the present invention may provide access to an airway, such as the trachea. In some embodiments, the method of the present invention allows medication delivery to the interface between an endotracheal tube and the compressed surrounding tissue lining the lumen (e.g., Mucosa/mucous membrane). In some embodiments, the method of the present invention may be used during general anesthesia. In some embodiments, the method of the present invention may be used in the intensive care unit. In some embodiments, the method of the present invention may be used for urological, gastroenterological, neurosurgical, critical care, and vascular procedures. In embodiment, the method of the present invention may be used in humans. In some embodiments, the method of the present invention may be used in all animal species. In some embodiments, the method of the present invention is configured to have a high patient safety profile because a specific amount of medication may be injected to the target area and after a specific time a second dose may be safely administered again. Further, as the method is configured to allow application of any medication where it is exactly needed and in small doses that can be repeated with minimal systemic absorption. The dose absorbed systemically is minimal and well-below Attorney Docket No.: 206017-0214-00WO the threshold of systemic toxicity even with repeated applications and thereby minimizes any drug side effects. Referring now to FIG.11, an exemplary method 200 of providing access and delivering medication to a bodily passage is depicted. Method 200 begins with step 202, wherein an endoluminal medication delivery device comprising an elongated lumen having an outer surface, a proximal end, and a distal end; a first balloon secured to the outer surface of the elongated lumen, wherein the first balloon comprises a balloon chamber in fluid connection with an inflation lumen; and a second balloon secured to the outer surface of the elongated lumen and positioned around the first balloon such that the first balloon is at least partially disposed within the second balloon, wherein the second balloon comprises a second balloon body having an impermeable proximal end, and at least one permeable portion in the second balloon body fluidly connecting to a second balloon chamber, and wherein the second balloon chamber is fluidly connected to an external reservoir or source through a second lumen, is provided. In step 204, the endoluminal medication delivery device is introduced into the bodily passage. In step 206, the first balloon is inflated with a medium through the first inflation lumen, such that the inflated first balloon seals the bodily passage. In some embodiments, any medium known to one skilled in the art including but not limited to a gas, viscous solution, or liquid may be used to inflate the first balloon. In some embodiments, medium may be saline. In some embodiments, medium may be air, saline, gas or oxygen. In step 208, a fluid is introduced to the second balloon chamber through the second lumen and results in an increase in circumferential pressure within the proximal impermeable cavity of the balloon leading to immediate circumferential delivery and distribution of the fluid under high-pressure of the inflated first balloon to the middle and distal portions within the balloon cavity. The fluid exits to a compressed area between the second balloon body and the bodily passage through the plurality of perforations. The fluid diffuses into the compressed area by virtue of existing compression and is readily absorbed by the surrounding lumen. The fluid injected into the body cavity through the second balloon perforations while the first balloon is continually inflated at normal pressure without interruption in functionality or safety profile of the endoluminal device. The fluid exits to a compressed area between the second balloon Attorney Docket No.: 206017-0214-00WO body and the bodily passage through the at least one permeable portion of the second balloon body wherein single or repeated, immediate, precise delivery of the the fluid in the lumen of the cavity is required. p. In some embodiments, any fluid known to one skilled in the art may be introduced to the balloon chamber including but not limited to medications, etc. EXPERIMENTAL EXAMPLES The invention is further described in detail by reference to the following experimental examples. These examples are provided for purposes of illustration only, and are not intended to be limiting unless otherwise specified. Thus, the invention should in no way be construed as being limited to the following examples, but rather, should be construed to encompass any and all variations which become evident as a result of the teaching provided herein. Without further description, it is believed that one of ordinary skill in the art can, using the preceding description and the following illustrative examples, make and utilize the compounds of the present invention and practice the claimed methods. The following working examples, therefore, specifically point out exemplary embodiments of the present invention, and are not to be construed as limiting in any way the remainder of the disclosure. Example 1: Endoluminal Medication Delivery Device Functionality Fundamental facts, Materials and Methods In this study, the functionality of the device is investigated and tested in a controlled setup simulating real-life intraoperative conditions. This was achieved by creating a controlled experimental platform comparing various designs to elucidate the efficacy of each design. The experiment can be used to compare the functionality and efficacy of the results of the device of the present invention to other designs to identify fundamental design superiority, advantages, and flaws. Materials used for the experiments: Attorney Docket No.: 206017-0214-00WO 1. Commercially available, FDA approved endotracheal tubes size 6.5 mm ID (Shiley ^TM Hi-LO oral/nasal tracheal tube cuffed, Coviden, Mansfield, MA. Ref 86110) 2. Second medication delivery ETT cuffs (second balloon) were designed using ETT cuffs for 8.5 mm ID tubes (Shiley ^TM Lo-Pro oral/nasal tracheal tube cuffed, Coviden, Mansfield, MA. Ref 86054). The cuffs were cut from the ETT, perforated in the desired pattern using insulin syringe tip (item #12). 3. Clear plastic elastic rubber bands (10 mm diameter) 4. Commercially available clear silicone. 5. Second ETT cuff medication delivery tubing (second inflation lumen): the ETT cuff inflating tubing was separated from the 8.5 mm ID ETT (Shiley ^TM Lo-Pro oral/nasal tracheal tube cuffed, Coviden, Mansfield, MA. Ref 86054) 6. A- 30 ml plastic B-D syringe (20 mm internal diameter) used to simulate the human trachea (Becton-Dickinson, Franklin Lakes, NJ). 7. Digital endotracheal tube cuff manometer and inflation syringe (AG Cufffill manometer) (https://www.healthproductsforyou.com/p-ag-cuffill- manometer.html?utm_source=google&utm_medium=surfaces&utm_campaign=shopping %20feed&utm_content=free%20google%20shopping%20clicks&gclid=Cj0KCQiA- K2MBhC-ARIsAMtLKRujSxWBhL8tEzTQpd2uwhae3iRqrbIu- Bs3IX7NsS0zzgvDSwCFZ2saAslmEALw_wcB) 8. White commercially available Paper towel 9. B-D 10 cc syringe (for air inflation of the main ETT cuff) (Becton- Dickinson, Franklin Lakes, NJ). 10. B-D 5 cc syringe (for medication solution injection in the second medication delivery cuff) (Becton-Dickinson, Franklin Lakes, NJ). 11. McCormick® Culinary Blue Food Color (simulating the medication injected in the second ETT cuff). (McCormick & Company, Baltimore, Maryland) 12. Insulin Vanish Point 29 G (0.33 MM) 1 ML syringe. The 29 G needle was used to perforate the second cuff creating a medication delivery surface. (Retractable technologies, Inc., Littles Elm, Texas) Attorney Docket No.: 206017-0214-00WO 13. Bostik ® blue tack reusable putty-like adhesive. This adhesive was used to temporarily secure the plunger of the digital pressure measuring inflation syringe to avoid plunger movement under pressure. Thus, maintaining constant intracuff pressure throughout the experiment. 14. iPhone 10 for picture capture (Apple Technology, Cupertino, CA). 15. Sharpie® permanent ink marker pen. Assembly Method 1. The second balloon (#2) body having plurality of perforations was placed over the first balloon body of the 6.5 mm ETT tube (#1) to fully encompass/engulf the first balloon body. 2. After placing the second balloon body (#2), the ETT was labelled indicating the pattern of perforation of the second balloon body placed on the 6.5 mm ETT. This step was performed because the plurality of perorations are not visible to naked eye even under simple lens magnification. Thus, the ETT with a second balloon body that is perforated over the entire surface area of the second balloon body was marked at the ETT proximal end using the unique identifier “I………I” using a permanent marker. The endotracheal tube assembly of the present invention was marked by 3 circumferential dotted line at the center of the second balloon body using a permanent market in addition to marking it at the ETT proximal end using the unique identifier “__...__”. 3. The second inflation lumen (#5) was inserted between the first balloon body of the 6.5 mm ETT (#1) and the second balloon (#2) body having plurality of perforations. The tip of the second lumen was inserted between the proximal ends of both first and second balloon body. 4. The second inflation lumen (#5) extending beyond the proximal end of the second balloon body having plurality of perforations was positioned at the inner concave curvature of the ETT (#1). 5. The second inflation lumen (#5) and the second balloon (#2) were secured using multiple clear elastic rubber bands (#3) at proximal and distal ends of the second balloon body using multiple silicone layers on both proximal and distal ends for Attorney Docket No.: 206017-0214-00WO proper sealing. Multiple clear elastic bands (#3) were also used to secure the second inflation lumen part extending outside the second balloon (#2) on the concave inner curvature of the ETT tube (#1). The second lumen was secured in the inner concave curvature of the tube to fit in the space between the vocal cords and avoid touching the cords and causing trauma to the cords during prolonged intubation. 6. Multiple clear silicone (#4) layers were applied to both proximal and distal ends of the second balloon and the second lumen. The layers were allowed to cure and were tested for leak using clear water. Multiple resealing was performed after allowing adequate time for silicone to cure. Experiments and Goals Three experiments were conducted to verify functionality, efficacy, and superiority of the device of the present invention. The goal of the first experiment (Example 2) was to establish and test a simulated experimental platform to be used in the second and third experiments (Examples 3 and 4 respectively). The goal of the second experiment (Example 3) was to test the functionality of an alternative design other than invention. The goal of the third experiment (Example 4) was to test the functionality of the invention. Each of the three of experiments included 3 independent methods to derive conclusions. These methods are described in detail in the experiments and referred to as Method 1, 2 and 3. Fundamental Scientific Information For Conducting The Experiments Average Inflation Pressures Within the First Balloon Chamber of an ETT during clinical intraoperative use Average inflation pressure for the first balloon chamber of an ETT during anesthesia as reported by 2 peer-reviewed studies is 35.5-47.3 cmH₂O (L Gillilanda et al., 2015, Southern African Journal of Anesthesia and Analgesia; 21(3):81–84; P Sengupta et al., 2004, BMC Anesthesiology 4(1): 1-6). For the following experiments an average pressure of the results of the two studies were used. Thus, the average inflation pressure maintained within the first balloon chamber during the experiments is 42 cmH₂O. This pressure is essential for the functionality of the device as it represents the actual condition Attorney Docket No.: 206017-0214-00WO of medication application through the endotracheal tube. This pressure is the function of interaction between the inflated first balloon body and inner tracheal lining mucosa supported by the outer rigid tracheal structure. The ETT balloon pressure provides a seal that protects the patient’s lungs from secretions entering and maintains a closed-circuit system for delivery of anesthetic and respiratory gases (to provide anesthesia and support life). Endotracheal Diameter in Humans The average internal diameter of the trachea is 15-25 mm. For the purpose of these experiments, a 20 mm internal diameter clear cylindrical plastic 30 ML capacity plastic syringe was used to simulate the rigid external tracheal rings. Tracheal Mucosa The tracheal mucosa is an inner mucous membrane lining the rigid cylindrical tracheal structure created by the cartilaginous rings. The tracheal mucous membrane is a delicate layer of tissue that is in direct contact with the endotracheal tube cuff and the target tissue for the injected medication delivery. The tracheal mucous membrane is normally compressed between the rigid external structure of the trachea and pressure generated by the inflated first balloon body of the ETT. For the experiments, absorbent white paper towel was used to simulate the absorption of the injected medication by the tracheal mucosa to evaluate the delivery and distribution pattern of the injected medication. However, the white paper towel is highly absorbent compared to the tracheal mucosa which will lead to movement of injected material across the paper towel fabric regardless of the point of origin, thus leading to inaccurate conclusion. To avoid this and improve the accuracy of the experiments, the paper towel simulating the tracheal mucosa was not applied over the entire first balloon body of the ETT. Instead, the paper towel was applied over the target medication delivery area (middle and distal aspect of the second balloon) to be conclusive of the distribution being observed. In this configuration, if the medication readily diffuses into the paper towel compared to bassline, this indicates the efficacy of the invention design by confirming the ability to deliver the medication to and beyond the high-pressure compressed portion of the second Attorney Docket No.: 206017-0214-00WO cuff (target area) and vice versa. Injected Medication Culinary blue food color was chosen to simulate the medication delivered through the second lumen for optimal clarity and objective observation of the results. Example 2: Experiment 1: “Establishing Experimental Platform and Rationale” The device of the present invention was used as an endotracheal tube (ETT). The goal of this experiment was to create a platform that simulates ETT intraoperative conditions and observe the delivery of the medication through an ETT inflated to pressures observed in clinical studies. Development of This platform is quintessential to the validity of results and the successful use of any medication delivery device because a successful endoluminal medication delivery system must deliver the medication under similar conditions to that when the device is in clinical use. Method 1: Referring now to FIG.12A and FIG.12B, the pattern of the injected medication distribution and delivery outside the human body while maintaining average clinically used inflation pressure of 42 cmH₂O was tested. The goal of this experiment was to observe the distribution of the medication outside the body (in vitro) while the first balloon body of the endotracheal tube is inflated to clinically relevant pressures. Further, this experiment demonstrates the ability to inflate the first balloon body of the ETT to a pressure of 42 cmH₂O and the ability to maintain this pressure as needed. While this setup does not parallel the conditions of the injecting the medication inside the body (in vivo), it establishes baseline functionality with the original configuration of the ETT design before allowing the distortion of the shape to conform to the tracheal cylindrical structure. A design that fails to deliver the injected medication as intended using this method is highly unlikely (essentially impossible) to deliver medications under clinical circumstances. Also, a design that fails to deliver the injected medication as intended using this method in the absence of second balloon compression by the surrounding lumen, is inherently flawed to an extent that it is unlikely to be improved or modified. Attorney Docket No.: 206017-0214-00WO For this experimental setup, a commercial stock (non-modified) 6.5 mm ETT with a digital inflation syringe manometer was used. To maintain constant pressure within the first balloon body, the plunger position of the manometer syringe was temporarily secured using blue-tack putty–like adhesive. FIG.12A reflects the ability to inflate the first balloon chamber of the ETT to achieve an inflation pressure of 42 cmH₂O. The blue tack reversible putty–like adhesive was used to secure the plunger. FIG.12B depicts a magnification of the digital reading and inflated ETT balloon as depicted in FIG.12A. Method 2: Referring now to FIG.13A and FIG.13B, the 6.5 mm ETT used, was inserted into a 30 ml syringe, and then inflated. The first balloon body was inflated to achieve an intraballoon inflation pressure of 42 cmH₂O. This experiment simulates actual clinical application with endotracheal tube inside the patient’s trachea. FIG.13A demonstrates the ability to inflate the first balloon body of the endotracheal tube inside a 30-ml syringe to achieve an inflation pressure of 42 cmH₂O. FIG.13B depicts a magnification of the digital manometer reading the inflated first balloon body inside the plastic cylinder from FIG.13A. Method 3: Referring now to FIG.14A and FIG.14B, an absorbent paper towel lining was added to the distal end of the ETT to test for medication diffusion. The paper towel has a lateral diffusion capacity that matches or exceeds that of tracheal mucosa. However, pattern and surface area of the dye diffusion in the paper towel indicates the direction, position, and extent of medication delivery to the distal one-half of the tube. The challenge to medication delivery is the high-pressure middle zone of the ETT balloon created by compression against the trachea. Placing the paper towel in the distal (one- half) end of the ETT allows to test for the delivery of the medication at and beyond the middle high-pressure point of the ETT balloon (target medication delivery area). If significant diffusion of the dye simulating the injected medication in noticed in the paper towel, this indicates that design is functioning as intended and was able to deliver a Attorney Docket No.: 206017-0214-00WO significant dose of the medication to and beyond the height pressure middle point in the system. If minimal or no diffusion of the medication is noticed in the paper towel, then the design failed to deliver the medication to and beyond the high-pressure middle point in the system and is therefore wasted, useless and potentially hazardous. FIG.14A depicts wrapping the distal end of the endotracheal tube with paper towel. FIG.14B reflects the ability to inflate the first balloon body of the endotracheal tube inside a 30-ml syringe to achieve an inflation pressure of 42 cmH₂O while wrapping the distal end of the ETT with paper towel. The blue-tack reusable adhesive was used to prevent movement of the manometer syringe plunger to maintain the pressure within the first balloon chamber at 42 cmH₂O throughout the inflation period. This experiment established a platform to investigate the distribution of injected medication within the second balloon body while maintaining variables simulating intraoperative clinical conditions (e.g., under normal inflation pressure, physical contact, compression, and deformation of the ETT by the tracheal structure). A design that delivers the medication as intended under these 3 methods can deliver the same results when being used intraoperatively in anesthetized or sedated patients. Example 3: Experiment 2: “Investigating an alternative design” In this study, the functionality and efficacy of an ETT with a second balloon body having plurality of perforations distributed uniformly throughout the entire surface area of the second balloon body was investigated (alternative design) (FIG.15). Method 1: First, the medication movement and delivery pattern were investigated with the alternative design ETT, wherein the first balloon body was inflated to 42 cmH2O outside the body. Referring now to FIG.16, distribution of the injected dye (2 ml) from the pores located at proximal end (arrow) of the of the second balloon body is shown. The results were photographed from various angles to provide a 360-degree view. Also, the distribution was observed in real-time while the dye was injected and leaking through the pores. Because of the slippery surface of the second inflated ETT, most of the medication escaping the second balloon body slipped and was collected in the absorbent Attorney Docket No.: 206017-0214-00WO paper towel. Residual dye outside the ETT indicates the location of medication diffusion which is from perforations positioned at the proximal end of second balloon body. The entire injected volume diffused (and was wasted) from the perforations positioned at the proximal end as they are the first low-pressure point encountered by the injected dye. No injected dye was able to reach beyond the proximal one-fifth of the second balloon body. This indicates an inherent failure of this design to deliver the medication beyond the initial aspect of the second balloon body and into middle aspect of the balloon (target area). Method 2: Next, the medication movement and delivery pattern were investigated with the alternative design ETT, wherein the first balloon body was inflated to 42 cmH2O inside the plastic cylinder simulating the human trachea. Referring now to FIG.17A through FIG.17D, distribution of the injected blue dye (2 ml) in a model simulating clinical application is shown. FIG.17A depicts the setup prior to starting the experiment with the ETT inserted inside the cylindrical plastic tube while the first balloon chamber is inflated to a pressure of 42 cmH₂O. FIG.17B demonstrates the distribution of the dye at proximal end of the second balloon body as all the dye was expelled from the first low- pressure perforations encountered without any delivery of the dye to the compressed area of the balloon (target area). This led to the accumulation of the injected dye at the bottom of the cylindrical tube in an area of no contact (least resistance) between the second balloon body and the cylindrical tube. This confirms the finding as above (FIG.16) that failure of this design to build pressure in the second balloon body and deliver the medication beyond the low-pressure initial point to the target area. FIG.17C is a magnified view of FIG.17B for better visualization of the dye accumulation and failure of delivery of the dye to the target area. FIG.17D is an upper view of the cross section of the lower end of the tube placed in reverse (proximal end) after dye injection (2 ml is shown). This is demonstrating the accumulated dye around the tube due to inability to overcome the high-pressure mid-cuff area and inability to reach to the target area. Method 3: Attorney Docket No.: 206017-0214-00WO Last, the medication movement and delivery pattern were investigated with the alternative design ETT, wherein the first balloon body was inflated to 42 cmH2O inside the plastic cylinder simulating the human trachea in the presence of a highly absorbent lining to demonstrating lateral diffusion pattern and to confirm delivery of the medication to and beyond the middle high-pressure point (target area). Referring now to FIG.18A through FIG.18D, the arrow indicates the placement of the absorbent paper towel edge at the middle section of the high-pressure area of the ETT balloon (target area). FIG.18A depicts the setup before injection of the dye (baseline). FIG.18B depicts the setup after injection of the dye (2 ml). This experiment demonstrates failure of the dye to diffuse and reach the high-pressure zone as indicated by the lack of absorption in the paper towel compared to baseline (FIG.18A). Instead, the dye escaped from the perforations positioned at the proximal end of the second balloon body in the low- pressure zone and was spilled as indicated by the solid arrows in FIG.18C and FIG.18D. Further, this experiment showed accumulation of the dye in the low-pressure air gap between the proximal end of the ETT cuff and plastic cylinder as indicated by the dotted arrow in FIG.18D. Thus, an ETT having a second (or triple balloon body design) that is entirely permeable, perforated, or has perforations in the proximal section of the second balloon body fails to deliver the medication to the target compressed area between the ETT and the surrounding tracheal tissue due to the leak of the injected medication through the proximal pores being the path of least resistance. This resulted in failure of the delivery of the medication to the target area in all 3 methods while testing this design. Example 4: Experiment 3: “Investigating the present invention design” In this study, the functionality and efficacy of an ETT with a second balloon body having plurality of perforations distributed circumferentially in three central lines around the perimeter of the second balloon body was investigated (FIG.1, FIG.2, FIG.4, and FIG.7). Method 1: Attorney Docket No.: 206017-0214-00WO First, the medication movement and delivery pattern were investigated with the device of the present invention, wherein the first balloon body was inflated to 42 cmH₂O outside the plastic cylinder simulating the human trachea. FIG.19A depicts the ETT with 3 middle circumferential lines of perforations indicated by the permanent block dots before injection of the dye. The main syringe was inflated to 42 cmH2O as indicated on the digital screen. FIG.19B depicts the ETT after injection of the dye (2 ml). The arrow points to the remaining drops from the diffusion of the dye through the central pores (target area). Most of the dye fell on the absorbent paper towel below due to the slippery smooth surface of the ETT in an inflated state. Also, the distribution was observed in real-time while the dye was injected and leaking through the pores. This experiment indicated the ability of this device to deliver the medication to target location with minimal or no waste. FIG.19C depicts the ETT after injection of the dye (2 ml) from a different angle of the ETT to provide a 360-dgreee view. FIG.19D depicts the ETT after injection of the dye (2 ml) from different angle to provide a 360-degree view of the ETT. Please note that the drops at both proximal end and the distal end of the second balloon body (indicated by the arrows) were not leaking from the edges of the tube as there are no perforations at the edges but they are the result of accumulation of the dye that leaked from the central pores and accumulated at the lower point by gravity and due to the slippery surface of the second balloon body and the lack of absorptive surface. Method 2: Next, the medication movement and delivery pattern were investigated with the device of the present invention, wherein the first balloon body was inflated to 42 cmH2O inside a plastic cylindrical tube simulating intraoperative clinical application inside the patient’s body. FIG.20A depicts the ETT with 3 middle circumferential lines of perforations indicated by the permanent block dots before injection of the dye. The first balloon chamber was inflated to 42 cmH₂O using air. The blue-tack reusable adhesive was used to prevent movement of the manometer syringe plunger to maintain the pressure within the first balloon body at 42 cmH₂O throughout the inflation period. FIG.20B depicts the ETT after injection of the dye (2 ml) and demonstrates a clearly delineated central circumferential distribution pattern of the dye around the center of the Attorney Docket No.: 206017-0214-00WO second balloon body, at the compressed area between the ETT and circular tubing. This is the target area for medication delivery inside the human trachea for maximal efficacy and safety. FIG.21A depicts the ETT after injection of the dye (2 ml) with the experiment tube rotated to provide a view at a different angle providing a 360-degree view. FIG.21A and FIG.21B demonstrate a clearly delineated circumferential spread of the dye around the center of the second balloon body at the high pressure point of the ETT-tube interface. This is the target area for medication delivery inside the human trachea for maximal efficacy and safety. FIG.21B depicts a magnified view of FIG.21A. The pattern observed here under magnification is exactly the pattern required for effective and safe administration of the medication to the target area. FIG.22A and FIG.22B depict the ETT after injection of the dye (2 ml) with the experiment tube rotated to provide a view at a different angle providing a 360- degree view. FIG.22A demonstrates a clearly delineated circumferential spread of the dye around the center of the second balloon body at the high-pressure area of the ETT- tube interface. This is the target area for medication delivery inside the human trachea for maximal efficacy and safety. FIG.22B depicts accumulation of a small dose of dye beyond the high pressure point after injection of the dye (2 ml). This indicates the ability of the invention to overcome the high-pressure point at the central portion of the second balloon body. Under intraoperative condition, this dye does not accumulate as shown in the experiment but is readily absorbed by the tracheal mucosa. However, because of the limited ability of the ETT and the plastic tube interface to accommodate large volume due to the lack of absorption capacity, a portion of the injected medication trickled beyond the middle portion of the second balloon body. Method 3: Last, the medication movement and delivery pattern were investigated with the device of the present invention, wherein the first balloon body was inflated to 42 cmH₂O inside a plastic cylindrical tube simulating intraoperative clinical application inside the patient’s body in the presence of a highly absorbent lining to demonstrating lateral diffusion pattern and to confirm delivery of the medication to and beyond the Attorney Docket No.: 206017-0214-00WO middle high-pressure point (target area). FIG.23A depicts the ETT device with 3 middle circumferential lines of perforations before injection of the dye. An absorbent white paper towel was wrapped around distal half of the second balloon body (baseline). The first balloon body was inflated to 42 cmH2O using air. The blue-tack reusable adhesive was used to prevent movement of the manometer syringe plunger to maintain the pressure within the first balloon chamber at 42 cmH₂O throughout the inflation period. FIG.23B depicts the ETT device after injection of the dye (2 ml). The majority of the injected dye was delivered to the target area at the second balloon body-cylinder cylinder interface which was readily absorbed entirely by the paper towel as demonstrated in the picture (indicated by the solid arrow) while no dye was wasted in the low-pressure area that is not in contact with the cylinder inner surface (dashed arrow). This indicates that the design is capable of delivering the medication to and beyond the high pressure point without any waste of the dye away from the balloon-cylinder interface. FIG.23C depicts the ETT device with 3 middle circumferential lines of perforations after injection of the dye. The majority of the injected dye was delivered to the target area at the ETT balloon- cylinder interface which was readily absorbed entirely by the paper towel as demonstrated and indicated by the solid arrow, while none of the injected dye leaked behind the tube or was wasted (which was observed with the alternative design in Example 3) as indicated by the dashed arrow. FIG.23D depicts the magnified version of FIG.23C. In conclusion, the device of the present invention is capable of delivering medication to the high-pressure target area of compression between the ETT balloons and the tracheal mucosa with minimal waste of the medication. As it was shown in Example 3, the alternative design failed to deliver the medication to the target area with most the medication being wasted away from the target area. Thus, the device of the present invention is superior in functionality and efficacy compared to alternative ETT design with medication delivery systems. The disclosures of each and every patent, patent application, and publication cited herein are hereby each incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by Attorney Docket No.: 206017-0214-00WO others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.

Claims

Attorney Docket No.: 206017-0214-00WO CLAIMS What is claimed is: 1. An endoluminal medication delivery device comprising: an elongated tube having proximal and distal ends with a lumen therethrough; a plurality of balloons positioned on the outer surface of the elongated tube, the plurality of balloons comprising: a first balloon connected to one or more conduits extending proximally along the elongated tube, wherein the first balloon is configurable between at least first and second configurations as a fluid moves in and out of the balloon; and a second balloon at least partially surrounding the first balloon and connected to one or more conduits extending proximally along the elongated tube, wherein the second balloon comprises an impermeable proximal portion, and at least one permeable portion. 2. The device of claim 1, wherein the one or more conduits of the second balloon comprise any of: an even number of tubes, symmetrical positioning, symmetrical configuration, collapsible material, impermeable material, equal length, equal run, or equal flow. 3. The device of claim 2, wherein each balloon of the plurality of balloons at least partially surrounds the elongated tube and is formed in one or more shapes selected from: sphere, hemisphere, cylinder, half-cylinder, ellipsoid, flower, petals, star, burst, crescent, oval, polygon, cone, prism, ellipsoid, flower shape, concentric ellipsoids, concentric spheres, or any combination thereof. 4. The device of claim 3, wherein the plurality of balloons are configured or positioned in one or more patterns along the elongated tube selected from: linear, non-linear, asymmetric, zig-zag, circular, spiral, or any combination thereof. 5. The device of claim 4, wherein the at least one permeable portion comprises a plurality of perforations that are patterned or configured in one or more configurations selected from: horizontal pattern, vertical pattern, x-pattern, v-pattern, z-pattern, zig-zag pattern, spiral, or gradient pattern. Attorney Docket No.: 206017-0214-00WO 6. The device of claim 5, wherein the first balloon is completely disposed within the second balloon. 7. The device of claim 5, wherein the plurality of perforations are positioned circumferentially on the second balloon and patterned in 1 to 15 lines and comprising at least one central line. 8. The device of claim 7, wherein the plurality of perforations are circumferentially limited to 10 – 75% of the at least one central line. 9. The device of claim 8, wherein each perforation of the plurality of perforations have similar diameter or different diameters. 10. The device of claim 5, wherein the at least one permeable portion comprises at least one porous membrane. 11. The device of claim 5, wherein the impermeable proximal portion of the second balloon is a circumferentially impermeable surrounding the elongated tube. 12. The device of claim 11, further comprising an impermeable distal portion on the second balloon that is circumferentially impermeable surrounding the elongated tube. 13. The device of claim 5, wherein each balloon of the plurality of balloons comprises one or more internal chambers. 14. The device of claim 5, wherein the plurality of balloons comprises repeating pairs of first and second balloons positioned along the length of the elongated tube. 15. The device of claim 5, further comprising one or more medication delivery devices positioned within or in fluid connection with the one or more conduits of the second balloon. Attorney Docket No.: 206017-0214-00WO 16. The device of claim 5, wherein an external reservoir is fluidly connected to the one or more conduits of the second balloon and configured to allow the introduction of a fluid or solution to the second balloon. 17. The device of claim 16, wherein the fluid used to inflate the first balloon is a gas, solution, or a liquid. 18. The device of claim 5, wherein the elongated tube is sized and shaped in the form of a tube selected from: an endotracheal tube, an endobronchial tube, a tracheostomy tube, a laryngeal mask airway, an oral airway, a nasal airway, a nasogastric tube, a feeding tube, interventional vascular catheter, compression inflatable balloon, a dilating device, indwelling catheter, an endoscope, topicalization device, or a drainage catheter. 19. A method of providing access to a bodily passage comprising the steps of: providing an endoluminal medication delivery device comprising an elongated tube having proximal and distal ends with a lumen therethrough, a plurality of balloons positioned on the outer surface of the elongated tube, the plurality of balloons comprising a first balloon connected to one or more conduits extending proximally along the elongated tube, wherein the first balloon is configurable between at least first and second configurations as a first fluid moves in and out of the balloon, and a second balloon at least partially surrounding the first balloon and connected to one or more conduits extending proximally along the elongated tube, wherein the second balloon comprises an impermeable proximal portion, and at least one permeable portion, wherein the one or more conduit of the second balloon is fluidly connected to an external reservoir; introducing the endoluminal medication delivery device into the bodily passage; configuring the first balloon to the second configuration thereby sealing the bodily passage; introducing a second fluid to the second balloon through the one or more conduits and diffusing the second fluid through the at least one permeable portion into the bodily passage Attorney Docket No.: 206017-0214-00WO thereby delivering the second fluid to the tissue surrounding the plurality of balloons in the bodily passage. 20. The method of claim 19, wherein the bodily passage is an airway. 21. The method of claim 19, wherein the bodily passage is gastrointestinal tract lumen, blood vessel lumen, bodily pouch, external auditory canal, urinary system lumen, intracranial passage, bodily space, bodily passage, and bodily endocrine ducts. 22. The method of claim 19, wherein the second fluid comprises at least one therapeutic agent selected from lidocaine, steroid, antibiotics, or vasoactive drug. 23. The method of claim 19, wherein the external source is one selected from a pump, a manually operated syringe, or a programmable syringe.