Patent Grant
8876762
The present invention relates to the field of medical devices. Specifically, the invention relates to an enteral feeding device, which is an orogastric or nasogastric feeding device, comprising expandable means which prevents or significantly reduces aspirations from the alimentary tract to the respiratory system. In further aspects, the invention relates to systems comprising a feeding tube with expandable means, methods and uses thereof.
Hospitalized ventilated patients and patients that require emergent intubation (crush induction) are at increase risk for reflux of gastroesophageal contents. These populations are at risk for longer Length of Staying (LOS) or dying, not only from their critical illness but also from secondary processes such as nosocomial infection. Pneumonia is the second most common nosocomial infection in critically ill patients, affecting 27% of all critically ill patients [1], and is responsible for almost half of the infections in critically ill patients in Europe [2]. Eighty-six percent of nosocomial pneumonias are associated with mechanical ventilation and are termed ventilator-associated pneumonia (VAP). Between 250,000 and 300,000 cases per year occur in the United States alone, which is an incidence rate of 5 to 10 cases per 1,000 hospital admissions [3]. An independent contribution to mortality conferred by ventilator-associated pneumonia was recently suggested [4]. The mortality attributable to VAP has been reported to be as high as 50% [5]. Ventilator-associated pneumonia causes substantial morbidity by increasing the duration of mechanical ventilation and intensive care unit stay [6].
Beyond mortality, the economics of VAP include increased intensive care unit (ICU) LOS from 4 to 13 days, and incremental costs associated with VAP have been estimated at between $5,000 and $20,000 per diagnosis [7].
A growing body of evidence suggests that, in the presence of a functional gut, nutrition should be administered through the enteral route largely because of the morbidity associated with other modes of feeding. Furthermore, enteral alimentation is currently the most widely used modality for providing nutrition support in the ICU [8]. Favorable effects of enteral feeding include better substrate utilization, prevention of mucosal atrophy, and preservation of gut flora, integrity, and immune competence [9]. Therefore, there has been an increased interest among physicians to feed patients through the enteral route as soon as possible. Previous studies looking at critically ill patients with abdominal surgery, hip fracture, burn, and trauma demonstrated beneficial effects of early enteral feeding [10]. However, a report from critically ill medical patients suggested that early feeding to satisfy the patient's nutritive needs resulted in more harm and was associated with greater infectious complications [11].
In the pathogenesis of VAP, bacterial colonization of the oral cavity and subsequent aspiration of oropharyngeal fluids along the endotracheal tube are pivotal and should be prevented [12]. However, infectious hazards, tissue injury, and aspiration associated with placement and maintenance of orogastric and nasogastric tubes used for the delivery of enteral nutrition suggest that not all patients benefit of adequate preventive procedures. Bacterial colonization of the stomach and gastroesophageal aspiration is mainstay in the pathogenesis of VAP [13]. Gastroesophageal aspiration is facilitated by the presence of a nasogastric tube and a supine body position [14]. Experimental studies with radioactive-labeled enteral feeding indeed suggested that endotracheal aspiration of gastric contents occurred more frequently when patients were placed in supine rather than semi recumbent position [15]. On the basis of these findings, the Centers for Disease Control and Prevention advised treatment of mechanically ventilated patients in a semi recumbent position as a VAP-preventive measure [16].
Clinicians can focus on eliminating or minimizing the incidence of VAP through preventive techniques. While little has affected the incidence of late-onset VAP, the occurrence of early-onset VAP can be reduced by simple measures such as placing a patient, in a semi recumbent position. Yet, even apparently simple preventive measures are not easy to control: it was shown that health care team compliance rates is insufficient and varies between 30% and 64% [17]. The medical challenge of preventing contamination of the respiratory pathways by gastrointestinal reflux in ventilated patients is well known in the Art. Several technical solutions were proposed as it can be appreciated in the following brief review.
US 2008/0171963 relates to a device that prevent aspiration of gastric fluids in patients being fed or medicated through a gastric tube and placed in a semi-recumbent position. The device comprises an angle sensor fixed to said patient and an electrical control circuit which may stop the flow in the gastric tube if the patient is reclining beyond a predetermined angle, thereby decreasing the risks of aspiration. However, US 2008/0171963 is unsuitable in all the cases were the patient should be placed in supine position and not in semi-recumbent position.
WO 01/24860 relates to an artificial airway device comprising a laryngo-pharyngal mask including a roughly elliptical expandable masking ring. The expandable mask sealingly surrounding the laryngeal inlet when expanded to obstruct communication between the laryngeal inlet and esophagus to avoid reflux of gastric contents. A gastro-tube provides a fluid flow-path to the surface of the mask facing the esophagus when the mask sealingly surrounds the laryngeal inlet. However, this inflatable laryngo-pharyngal mask is blocking the natural flow of saliva from the oral cavity to the stomach. Moreover, laryngo-pharyngal masks cannot be applied for long periods of time as the pressure exerted on the esophagus sidewalls by the expandable element may cause irreversible damages on epithelial tissues.
WO 2009/027864 relates to an enteral feeding unit that helps to reduce the occurrence of gastro-esophageal-pharyngeal reflux during enteral feeding. The unit, comprises a gastric sensor placed within the stomach and a sealing element placed within the esophagus. When the gastric sensor reports a pressure increase into the stomach, the esophagus is sealed to avoid the reflux of gastric contents. However, complete sealing of the esophagus pathway may be problematic as it avoids deglutition of saliva, and reflux of accumulated saliva may be wrongly redirected into the airway system. Furthermore, long time appliance of high pressure on the esophagus sidewalls may cause severe damages to the epithelial tissues.
Therefore, there is a need for a device that is deployable by any trained caregiver personnel for the prevention or reduction of aspirations from the alimentary tract to the respiratory system.
It is therefore an object of the invention to provide a device which enables feeding a patient in need through an enteral route and which also prevents, or significantly reduces, gastro-esophageal reflux from the alimentary tract to the respiratory system.
It is another object of the invention to provide a device which enables feeding a patient in need through an enteral route and allow the swallowing of saliva, nasopharynx and oropharynx secretions.
It is a further object of the invention to provide a device which enables feeding a patient in need through an enteral route without damaging epithelial esophagus tissues.
It is a further object of the invention to provide a system which enables feeding a patient in need through an enteral route, and which can control and monitor the transit of fluids and biological secretions in the esophagus.
It is a further object of the invention to provide a method for significantly reducing vomiting events in an enterally fed patient.
It is a further object of the invention to provide a method for the insertion and the correct positioning of a feeding tube into the esophagus of a patient in need of enteral feeding.
Further purposes and advantages of this invention will appear as the description proceeds.
In a first aspect, the present invention relates to an enteral feeding device comprised of an elongated flexible hollow element, the element comprising:
The elongated flexible hollow element of the enteral feeding device is made of either a single piece of a biocompatible flexible material such as silicone, latex, PVC and polyurethane, or of several rigid or semi-rigid interconnected biocompatible elements. Radiopaque markers may be embedded into the wall of the elongated flexible hollow element. The expandable means, when inflated, have either a round or a cylindrical shape, and are distant from 0 to 10 mm one to each other, preferably about 0 mm. The distal section of the feeding device may comprise at least one expandable means, and the proximal section may comprise a positioning marker. Moreover, the feeding device of the invention may comprise at least one element selected from the group consisting of a sensing element, a stimulating element, a suction element, a sprinkling element.
In a second aspect, the present invention relates to an enteral feeding device comprised of an elongated flexible hollow element, the element comprising:
In a third aspect, the present invention relates to a system for controlling fluids motion into the esophagus of a subject, the system comprising:
The control and monitoring unit typically comprises a first fluidic system adapted to provide a pressurized fluid, a second fluidic system adapted to provide a vacuum, a set of electrical and/or pneumatic valves, and a set of pressure sensors. Additionally, the control and monitoring may comprise one or more components selected from the group consisting of a sensor, a biosensor, a suction system, and a sprinkling system.
In a fourth aspect, the present invention relates to a method for reducing aspirations from the alimentary tract in an enterally fed patient, the method comprising the steps of:
In this method, the peristaltic waves simulated by the system may be synchronized with the natural peristaltic movements of the esophagus.
In a fifth aspect, the present invention relates to a method for reducing the amount of gastrointestinal fluids that reaches the oropharynx of an enterally fed patient during vomiting events, the method comprising the steps of:
In a sixth aspect, the present invention relates to a method for positioning, in the esophagus of a patient, an enteral feeding device of the first aspect comprising a positioning marker in its proximal section, the method comprising the steps of:
In a seventh aspect, the present invention relates to a method for positioning, in the esophagus of a patient, an enteral feeding device of the first aspect comprising radiopaque markers, the method comprising the steps of:
In the eighth aspect, the present invention relates to a method for positioning a feeding device as described in the second aspect, in the esophagus of a patient, the method comprising the steps of:
All the above and other characteristics and advantages of the invention will be further understood through the following illustrative and non-limitative description of preferred embodiments thereof, with reference to the appended drawings. In the drawings the same numerals are sometimes used to indicate the same elements in different drawings.
The above and other characteristics and advantages of the invention will be more readily apparent through the following examples, and with reference to the appended drawings, wherein:
The first aspect of the present invention relates to an enteral feeding device that enables the administration of nutritive solutions directly into the stomach of a patient, significantly reduces the risks of aspirations from the alimentary tract into the respiratory system (estimated by the Inventors as being at least 50% reduction of the cases), and allows deglutition of biological fluids secreted in the upper part of the digestive system into the stomach (for instance saliva, nasopharynx secretions, and oropharynx secretions). The device of the present invention is preferably disposable.
With reference to
The distal section 5 of the feeding device 1 comprises one or more feeding apertures 6, which are located either in a central position at the end of element 2 or laterally near the end of element 2. These apertures 6 enable the delivery of a nutritive solution through a hollow conduit of element 2 into the stomach. Optionally, at least one expendable element may be placed around the distal end of tube 2 to ease the positioning of the device 1 into the esophagus of the patient or serve as a pressure sensor, as it will be explained later.
The middle section 4 of the feeding device 1 comprises at least three expandable means 7a, 7b and 7c surrounding the flexible element 2, which can be inflated or deflated by introducing or draining a fluid into their interior. The fluid used should be safe for the patient and preferably in a gas or liquid form, e.g. air or water (herein the word fluid is used to designate any medically acceptable gas or liquid used in the art to inflate expandable means). The expandable means 7a, 7b and 7c are typically made of a flexible biocompatible membrane having a thickness of between 0.1 mm and 1 mm, which is attached to the side wall of element 2. When deflated, the expandable means 7a, 7b and 7c lay against the side wall of the flexible element 2, enlarging the diameter of element 2 by less than 1 mm. When inflated, the expandable means 7a, 7b and 7c reach a diameter up to about 20 mm, thereby enabling the sealing of the esophagus lumen. According to the specific embodiment of the device of the invention, the expandable means 7a, 7b and 7c may be placed at diverse position on the middle section 4, but two contiguous expandable means are separated by no more than 10 mm, preferably 0 mm. When inflated, the expandable means 7a, 7b and 7c may have several shapes, but have preferably a round shape or a cylindrical shape. In the later case, the length of the sides of said cylinder is typically between about 10 mm and 30 mm, the side facing the epithelium of the esophagus.
The proximal section 3 of the feeding device 1 is terminated by at least three fluid connectors 8a, 8b and 8c, each one being prolonged, within the flexible element 2, by three distinct fluid conveying channels 9a, 9b and 9c (see
Referring now to
Referring to
Some embodiments of the device of the invention are totally free of any electrical elements but other embodiments of the device of the invention may comprise sensing and/or stimulating elements based on a mechanical, optical, electrical, chemical or biological signal, or any combination thereof. Sensing elements are preferably placed in internal channels, on expandable means, inside expandable means, or on the side wall of the flexible element. The sensing elements may be used to measure internal parameters such as the intra-esophagus pressure, intra-esophagus and/or stomach pH, etc. Stimulating elements are preferably placed on expandable means or on the side wall of the flexible element. The stimulating elements may be used, for instance, to stimulate an esophageal peristaltic wave, by employing either an electrical, chemical or mechanical stimulating signal. Stimulating elements 42 may be placed, for example, before the expandable means 7a. After insertion of device 1 in the patient's esophagus 13, a stimulating element 42 may be localized at the upper esophagus level 43, or next to the larynx/uvula 44, or at both places if required (see
Ideally, the sensing elements and the stimulating elements are interconnected in order to coordinate the stimulation with the data gathered by the sensing elements. Furthermore, receiving and/or emitting elements can be included in the device of the invention, in order to communicate with the surrounding environment without the addition of electrical wires.
The feeding device of the invention not only enables the administration of a nutritive solution directly into the stomach of a patient but is also able to control the movement of fluids in the lumen of the esophagus thanks to expandable means, which can be independently inflated or deflated. The expandable means, when inflated, are used to interrupt the flow of fluid in the esophagus; when deflated, they allow the free flowing of the fluid in the esophagus; when expanding (i.e. from a deflated to an inflated condition) they exert a pressure on the fluids located in the space between the esophageal epithelium and the expanding membrane, thereby pushing the fluid out of said space. When synchronized, the sequential inflation/deflation of the expandable means can simulate a peristaltic wave, thereby forcing the fluids contained in the esophagus to move in a determined direction.
A further aspect of the invention relates to a system suitable to provide a patient with a nutritive solution, to avoid or considerably reduce occurrences of gastrointestinal reflux, and to enable fluids and secretions transiting through the oropharynx to be swallowed.
Referring to
The system 15 comprises a feeding device 1 (as described above) which is introduced via either nasal or oral routes into the esophagus 13. The end of the distal section 5 of device 1 is positioned into the stomach 37 of the patient, and the expandable means 7a, 7b and 7c, of the middle section 4, are preferably placed 5 cm beneath the carina. Methods for precise positioning of device 1 into the esophagus of a patient will be described more specifically herein below. The fluid connectors 8a, 8b and 8c of the feeding device 1 are plugged into a control and monitoring unit 16, and the food connector 10 is plugged into a feeding unit 17. The system shown in
The control and monitoring unit 16 is able to control and monitor the fluid pressure inside the body of each of the expandable means 7a, 7b and 7c individually. Moreover, when the expandable means are inflated, the control and monitoring unit 16 is able to sense any external pressure applied on the outer surface of an expandable means. When such external pressure is applied, a significant increase of the internal pressure of the expandable means is observed. Therefore, the peristaltic movement of the esophagus 13 may be assessed by the control and monitoring unit 16 thanks to the variations of pressure exerted on inflated expandable means, which are in direct contact with the esophageal epithelium.
The processing unit 18 collects, stores and processes in real-time the data coming from the control and monitoring unit 16. Software is included in the processing unit 18, and is used to analyze and show the critical information to the medical staff caring for the patient, onto the display. The system 15 may include an automatic or manual turn-off element that enables simultaneous deflation of all the expandable means 7, and which can be used in cases of emergency (such as uncontrolled increase of the pressure in one or more of the expandable elements).
Referring to
The first fluidic system, shown in black lines on
The actuation of the fluidic systems and valves is done through a controller 33 connected to the processing unit 18. The control and monitoring unit 16 is designed to control and/or monitor inflation/deflation of all the expandable means 7 either in parallel or in a predetermined sequence, and to independently control the pressure in each of them. For instance, by proper timing of the inflation/deflations of the expandable means, a peristaltic wave can be simulated, as described herein below.
Optionally, the control and monitoring unit 16 may comprise further sensors and/or biosensors, such as pH sensor and immunosensors, suction systems, and/or sprinkling systems. Suction systems and sprinkling systems are connected to one or more conduits going through element 2 and having at least one aperture located in the lumen of the esophagus. This aperture(s) may be located at any place in the side wall of element 2, but preferably in front of the dead volume 14 situated between two expandable means of the middle section 4 (see
Referring now to
The second screen (
It is noted that the description of the control and monitoring unit and display screens shown in
In the initial stage (
In the second stage, the first expandable means 7a is inflated up to the maximal pressure (
In the third stage (
In the fourth stage (
In the fifth stage (
In the last stage (
It should be noted that the maximal pressure exerted by the expandable means onto the esophagal epithelium may be optionally calibrated by the medical staff after the correct positioning of the feeding device of the invention into a patient. This maximal pressure may vary according to the gender, age and medical antecedents of said patient and may be determined and stored in the processing unit of the system of the invention before use. Furthermore, in order to improve the efficacy of the device, the peristaltic waves simulated by the device can be synchronized with the natural esophageal peristalsis. To this end, a stimulating element can be placed in the device of the invention, and may be used to provide an electrical, chemical or mechanical signal to the muscles of the esophagus, and start “natural” peristaltic movements. The synchronization of natural and simulated peristaltic waves may lead to an optimal evacuation of the different esophageal fluids in the direction of the stomach.
As shown, the above-described method blocks the progression of the gastrointestinal fluids in the esophagus, allows the redirection of the gastrointestinal fluids towards the stomach, and enables the swallowing of the oropharynx fluids naturally secreted by the patient. This method has several advantages over the Prior Art: only low and intermittent pressures are exerted on the esophageal epithelium, which considerably reduces the risk of ischemic and venous congestion; gastrointestinal fluids are not only blocked by the expandable means but are pushed back towards the stomach by the peristaltic waves simulated by the device of the invention; oropharynx fluids can be swallowed almost naturally; the peristaltic wave generated by the system of the invention can be synchronized with the natural peristaltic movements of the esophagus. The system of the invention can be preprogrammed in a mode that simulates peristaltic at specific times, for instance in synchronization with the delivery of a nutritive solution by the feeding pump, or can be preprogrammed in a mode that achieve automatic cycles with durations and frequencies that may be variable. A combination of both modalities is also possible.
Additionally, the method of the invention enables reducing the amount of gastrointestinal fluids that reaches the oropharynx of an enterally fed patient during vomiting events. As shown in
In standard conditions, expandable means 7a, 7b and 7c are either deflated or used to generate peristaltic waves as described herein above. When vomit 39 is expelled from the stomach 37 and reaches the expandable means 7d, the event is detected by the control and monitoring unit 16. The expandable means 7d is then totally deflated to allow the passage of fluids and the expandable means 7a, 7b and 7c are immediately inflated to seal the esophageal lumen. The vomit is sent back towards the stomach by gravitation, and after few seconds (typically 10 s), the initial configuration of the expandable means 7a, 7b, 7c and 7d is restored.
Still another aspect of the invention relates to a method for positioning the feeding device of the invention in the esophagus of a patient in need of enteral feeding. In one embodiment, correct positioning of the device of the invention is accomplished with the assistance of an external apparatus which is able to locate specific markers attached to the feeding device (such as radiopaque markers for X-ray positioning). The markers are typically embedded within the sidewalls of the elongated flexible hollow element. In another embodiment, the positioning of the feeding device is performed as shown in
It is noted that the latter positioning method may be also performed without the help of the fourth expandable means 7d localized at the distal end. In that case, one of the expandable means 7a, 7b or 7c, placed in the middle section 4 of the device 1 is used as a sensor, and part of the middle section 4 is introduced into the stomach together with the distal section 5. Thereafter, one of the expandable means is inflated at the maximal pressure and the feeding device 1 is slowly pulled back in the direction of the oropharynx until a significant increase of the pressure inside the body of the chosen expandable means is observed. Then, the inflated expandable means is deflated, and the device further pulled back in the direction of the oropharynx by a predetermined distance (typically few centimeters).
A simplified version of the device of the invention is shown in
In this specific embodiment, the control and monitoring unit 16 comprises the inflation mechanism 40, a relief valve 32, and a pressure sensor 31.
Although embodiments of the invention have been described by way of illustration, it will be understood that the invention may be carried out with many variations, modifications, and adaptations, without exceeding the scope of the claims.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IL2009/000745 | 7/30/2009 | WO | 00 | 1/20/2011 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2010/016054 | 2/11/2010 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 4180076 | Betancourt | Dec 1979 | A |
| 5222980 | Gealow | Jun 1993 | A |
| 5456251 | Fiddian-Green | Oct 1995 | A |
| 5560747 | McCue et al. | Oct 1996 | A |
| 5765559 | Kim | Jun 1998 | A |
| 6468200 | Fischi | Oct 2002 | B1 |
| 6488653 | Lombardo | Dec 2002 | B1 |
| 6773452 | Shaker | Aug 2004 | B2 |
| 8303567 | Stedman et al. | Nov 2012 | B2 |
| 20050096636 | Freyman et al. | May 2005 | A1 |
| 20050215948 | Adams | Sep 2005 | A1 |
| 20060020278 | Burnett et al. | Jan 2006 | A1 |
| 20060276746 | Burnside et al. | Dec 2006 | A1 |
| 20070080223 | Japuntich | Apr 2007 | A1 |
| 20070270892 | Makower et al. | Nov 2007 | A1 |
| 20070282219 | Holte | Dec 2007 | A1 |
| 20080071202 | Nardi et al. | Mar 2008 | A1 |
| 20080077043 | Malbrain et al. | Mar 2008 | A1 |
| 20080086076 | Gerber | Apr 2008 | A1 |
| 20080154191 | Gobel | Jun 2008 | A1 |
| 20080171963 | Gerber | Jul 2008 | A1 |
| 20080249461 | Foreman et al. | Oct 2008 | A1 |
| 20080319504 | Loushin et al. | Dec 2008 | A1 |
| Number | Date | Country |
|---|---|---|
| 2072842 | Mar 1991 | CN |
| 2072842 | Mar 1991 | CN |
| 2336816 | Sep 1998 | CN |
| 2336816 | Sep 1999 | CN |
| 1892010 | Feb 2008 | EP |
| 2008049160 | Mar 2008 | JP |
| 2008509730 | Apr 2008 | JP |
| 0124860 | Apr 2001 | WO |
| 0172221 | Oct 2001 | WO |
| 2006020441 | Feb 2006 | WO |
| 2008121603 | Oct 2008 | WO |
| 2009027864 | Mar 2009 | WO |
| Entry |
|---|
| International Preliminary Report on Patentability for parent (priority) PCT application serial No. PCT/IL2009/000745, issued Oct. 28, 2011. |
| International Preliminary Report on Patentability (IRPR) for parent PCT application serial No. PCT/IL2009/000745, issued Feb. 8, 2011. |
| Patent Office for Australia, Office Action, issued Aug. 22, 2013, for counterpart patent application serial No. 2009278778. |
| Patent Office for the People Republic of China. Office Action, issued Sep. 29, 2013, for counterpart patent application serial No. 20090130448.2 (with translation). |
| Patent Office for the European Patent Office, Extended European Search Report, issued Feb. 7, 2014, for counterpart patent application serial No. 09804643.6. |
| Patent Office for Japan, Office Action, mailed Mar. 4, 2014, for counterpart patent application serial No. 2011-521683 (with translation). |
| Number | Date | Country | |
|---|---|---|---|
| 20110130650 A1 | Jun 2011 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61085864 | Aug 2008 | US |
