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EP-4739366-A2 - DEVICE AND METHOD FOR POST EXTUBATION DYSPHAGIA, ANTIBACTERIAL THERAPY, AND DETECTION AND DRAINAGE OF PHARYNGEAL SECRETIONS

EP4739366A2EP 4739366 A2EP4739366 A2EP 4739366A2EP-4739366-A2

Abstract

A drainage device includes an elongate flexible conduit comprising a proximal end opening, a distal end opening and a lumen disposed therebetween. A multi-layer distal portion coaxially surrounding the lumen and having a porous outer surface layer, a porous interior layer and an intermediate absorbent layer therebetween. A drainage system and a device and method for treating dysphagia are also disclosed.

Inventors

  • BONDE, PRAMOD
  • GUPTA, Rigu

Assignees

  • Yale University

Dates

Publication Date
20260513
Application Date
20240708

Claims (20)

  1. 1 . A drainage device comprising: an elongate flexible conduit comprising a proximal end opening, a distal end opening and a lumen disposed therebetween; and a multi-layer distal portion coaxially surrounding the lumen and having a porous outer surface layer, a porous interior layer and an intermediate absorbent layer therebetween.
  2. 2. The drainage device of claim 1 , wherein the porous interior layer comprises a multi-channel structure.
  3. 3. The drainage device of claim 2, wherein each channel of the multi-channel structure is in fluid communication with a drainage conduit extending proximally at least to the proximal end opening.
  4. 4. The drainage device of claim 2, wherein the multi-channel structure is a non- collapsible structure.
  5. 5. The drainage device of claim 1 , wherein the porous outer surface layer is a hydrophobic layer.
  6. 6. The drainage device of claim 1 , wherein the intermediate absorbent layer comprises a cellulose material.
  7. 7. drainage system comprising: the drainage device of claim 1 coaxially loaded over a feeding tube.
  8. 8. A drainage system comprising: the drainage device of claim 1 ; and a negative pressure source in fluid communication with channels of the porous interior layer.
  9. 9. A drainage system comprising: the drainage device of claim 1 ; and a sleeve configured to coaxially load over the drainage device and compress the multi-layer distal portion.
  10. 10. The drainage device of claim 1 , wherein the multi-layer distal portion comprises a plurality of struts.
  11. 11 . The drainage device of claim 10, wherein the plurality of struts comprise a shapememory material.
  12. 12. The drainage device of claim 10, wherein the plurality of struts comprises three struts.
  13. 13. The drainage device of claim 10, wherein the plurality of struts are configured to initiate trifoliate compaction upon rotation.
  14. 14. The drainage device of claim 1 , wherein the multi-layer distal portion is configured to reduce in diameter upon actuation of a twisting motion.
  15. 15. The drainage device of claim 1 further comprising: a plurality of surface electrodes at least partially surrounding the lumen.
  16. 16. The drainage device of claim 15, wherein at least one of the plurality of surface electrodes is disposed on the porous outer surface layer.
  17. 17. The drainage device of claim 16 further comprising: i a controller configured to generate a suction signal upon detecting a threshold impedance from at least one of the plurality of surface electrodes.
  18. 18. The drainage device of claim 1 further comprising: a light source configured to apply visible blue light in 400 to 470 nm spectra within the lumen.
  19. 19. The drainage device of claim 1 further comprising: a plurality of electrodes on a distal portion of the elongate flexible conduit coupled to a controller configured to generate an electrode treatment signal.
  20. 20. The drainage device of claim 19, wherein the controller is configured to generate the electrode treatment signal at a frequency of 3Hz.

Description

DEVICE AND METHOD FOR POST EXTUBATION DYSPHAGIA, ANTIBACTERIAL THERAPY, AND DETECTION AND DRAINAGE OF PHARYNGEAL SECRETIONS CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. provisional application No. 63/512,358, filed July 7, 2023, and U.S. provisional application No. filed on 63/640,342, filed April 30, 2024, both of which are incorporated herein by reference in their entireties. BACKGROUND OF THE INVENTION [0002] When an endotracheal tube (ET), a breathing tube is inserted to support the respiration of a patient (using artificial breathing, i.e.; ventilation), it impairs the normal swallowing and clearance mechanisms that keep bacteria from entering the airway. Aspiration of oral colonization has been identified as one of the common causes of ventilatory associated pneumonia (VAP) in the ICU as a result of poor oral care. Whenever an ET is in place, most defenses against pneumonia are impaired. The ET tube bypasses normal filtration and physical capture functions as there is no nasal warming or humidification. The mucociliary defense mechanism is also compromised by the ET tube. The ET tube disrupts normal mucus clearance and there is a collection of secretions above the cuff, which contaminates the subglottic pool. Contaminated secretions can drain into the trachea and can be aspirated into lungs. [0003] These issues lead to VAP in up to 25% of the ventilated patients and causes death in up to 50% of ventilated patients. VAP results from a microbial invasion of the normally sterile lower respiratory tract and lung parenchyma, which can then overwhelm the host’s defenses to establish infection. The primary route of bacterial entry into the lower respiratory tract is via aspiration of bacteria-contaminated secretions which accumulate above the endotracheal tube cuff. The repeated micro-aspirations of these secretions, so-called subglottic secretions occurs in upwards of 75% of intubated patients. [0004] One cubic millimeter of dental plaque contains about 100 million bacteria (Thoden van Velzen et al, 1984) and may serve as a persistent reservoir for potential pathogens, both oral and respiratory bacteria. It is likely that oral and respiratory bacteria in the dental plaque are shed into the saliva and are then aspirated into the lower respiratory tract and the lungs to cause infection (Scannapieco, 1999; Scannapieco et al, 2001 ). Cytokines and enzymes induced from the periodontally inflamed tissues by the oral biofilm may also be transferred into the lungs where they may stimulate local inflammatory processes preceding colonization of pathogens and the actual lung infection (Scannapieco, 1999; Scannapieco et al, 2001 ). Other possible mechanisms of pulmonary infection are inhalation of airborne pathogens or translocation of bacteria from local infections via bacteremia. [0005] In a healthy subject, the respiratory tract is able to defend against aspirated bacteria. Patients with diminished salivary flow, decreased cough reflex, swallowing disorders, poor ability to perform good oral hygiene, or other physical disabilities have a high risk for pulmonary infections. Mechanically ventilated patients in ICUs with no ability to clear oral secretions by swallowing or by coughing, are at risk for VAP especially if the ventilation lasts for more than 48 hours (Estes and Meduri, 1995). Oral bacterial load increases during intubation and higher dental plaque scores predict risk of pneumonia (Munro et al, 2006). Anaerobic bacteria are frequently found to colonize the lower respiratory tract in mechanically-ventilated patients (Estes and Meduri, 1995; Robert et al, 2003). Colonization of bacteria in the digestive tract has been suggested to be a source for nosocomial pneumonia, but recently oral and dental bacterial colonization has been proposed to be the major source of bacteria implicated in the etiology of VAP (Garcia, 2005). In the institutionalized elderly the aspiration of saliva seems to be the main route of bacteria into the lungs causing aspiration pneumonia. Dysphagia seems to be an important risk factor, even a predictor, for aspiration pneumonia (Langmore et al, 1998). The major oral and dental risk factors for aspiration pneumonia in veteran residents of nursing homes were number of decayed teeth, periodontitis, oral S. aureus colonization, and requirement of help feeding (Terpenning et al, 2001 ). Inadequate oral care and swallowing difficulties were associated with pneumonia in 613 elderly nursing home patients (Quagliarello et al, 2005). [0006] Animal models, 3D printed models of human CT scans and extensive review of CT imaging data shows that there is pooling of secretions as shown for example in Fig. 1 with the subject head 20 at a 30-degree elevation. An endotracheal tube 10 is shown terminating distally just above the upper esophageal sphincter 12. Secretions 14 gather in the posterior pharynx 16 behind the nasal cavity 18. Animal studies on rats and