WO2012096885A1 - Dispositif de détection de lésions et systèmes et procédés d'utilisation associés - Google Patents

Dispositif de détection de lésions et systèmes et procédés d'utilisation associés Download PDF

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Publication number
WO2012096885A1
WO2012096885A1 PCT/US2012/020642 US2012020642W WO2012096885A1 WO 2012096885 A1 WO2012096885 A1 WO 2012096885A1 US 2012020642 W US2012020642 W US 2012020642W WO 2012096885 A1 WO2012096885 A1 WO 2012096885A1
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WO
WIPO (PCT)
Prior art keywords
balloon
lumen
flexible tube
detection device
communication
Prior art date
Application number
PCT/US2012/020642
Other languages
English (en)
Inventor
Alpesh A. Patel
Original Assignee
University Of Utah Research Foundation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by University Of Utah Research Foundation filed Critical University Of Utah Research Foundation
Publication of WO2012096885A1 publication Critical patent/WO2012096885A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A61B5/4222—Evaluating particular parts, e.g. particular organs
    • A61B5/4233—Evaluating particular parts, e.g. particular organs oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/105—Oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/005—Devices for introducing or retaining media, e.g. remedies, in cavities of the body for contrast media

Definitions

  • This invention relates to devices, systems, and methods for accessing the wall of an esophagus or other body lumen or other tubular portion of the body of a subject.
  • This invention relates to devices, systems, and methods for detecting an injury within the esophagus or other body lumen or other tubular portion of the body of a subject.
  • Leaks or perforations are detected by visual inspection. In some cases a catheter for dye distribution is used. Although this procedure has a moderate detection success rate, it has only limited ability to detect small perforations. The Methylene Blue Test is not recommended for a large subgroup of anastomoses.
  • the Air and Saline Tests are similar to the Methylene Blue Test, but use air or saline instead of a dye.
  • the clear saline and the air can be difficult to detect.
  • the Air Test beneficially creates pressure, but it remains challenging to identify a leak or perforation without the draining of colored dye.
  • CT Barium Swallow Computed Tomography
  • Empirical validation is used to see if any leaks or perforations exist. This requires additional consulting with a radiologist familiar with the procedure. The cost of the scan alone is roughly $ 1 500. Further, the scans are inaccurate 30% of the time.
  • the injury detection device includes a flexible tube with a longitudinal axis that inserted within the esophagus of the subject.
  • the flexible tube encloses a first lumen and a second lumen.
  • the flexible tube also has an outer surface that defines a proximal port, a distal port, and one or more openings positioned between the proximal port and the distal port along the longitudinal axis of the flexible tube.
  • the proximal port and the distal port are positioned in communication with the first lumen, while the one or more openings are positioned in communication with the second lumen.
  • the injury detection device includes a first balloon positioned in communication with the first lumen through the proximal port. In an additional aspect, the injury detection device includes a second balloon positioned in communication with the first lumen through the distal port. In a further aspect, the first balloon and the second balloon are each inflatable between a relaxed position and an inflated position. In the inflated position, the first balloon and the second balloon contact the wall of the esophagus to define an isolated zone that contains the one or more openings of the flexible tube. Systems and methods for detecting an injury within the esophagus of a subject are also disclosed.
  • Figure 1 is an image of an exemplary injury detection device as described herein.
  • Figure 2 is an image showing a front view of the proximal end of the flexible tube of the injury detection device of Figure 1 , as described herein.
  • Figure 3 is a perspective view of an exemplary inlet adapter as described herein.
  • Figures 4 and 5 are close-up images of balloons positioned thereon the flexible tube of the injury detection device of Figure 1 , as described herein.
  • Figures 6- 13 are images of various aspects of the production of an exemplary injury detection device, as described herein.
  • Figure 14 is an image of first and second syringes that function as exemplary first and second fluid sources within an injury detection device, as described herein.
  • Figure 15 is an image of exemplary luer connectors that can be used in conjunction with the first and second syringes of Figure 14.
  • Ranges can be expressed herein as from “about” one particular value, and/or to "about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
  • the terms “optional” or “optionally” mean that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.
  • the term “or” as used herein means any one member of a particular list and also includes any combination of members of that list.
  • fluid is meant to include any gas or liquid substance.
  • imaging agent is meant to include any biocompatible fluid that can be positioned within a tubular portion of the body of a subject to assist a medical practitioner in determining the presence or absence of a puncture or leak within the tubular portion of the body of the subject.
  • the term "balloon” is meant to include any container, such, for example and without limitation, as a non-porous bag, that is configured for inflation by a selected fluid, including air, a selected gas, or a selected liquid.
  • the balloon can comprise one or more biocompatible materials.
  • the balloon can be configured to maintain its inflated condition when acted upon by external forces within the body of a subject, such as, for example, flow of bodily fluids within the tubular portion of the body in which the balloon is positioned.
  • Disclosed herein are devices, systems and methods for detecting leaks and perforations during surgery. It is contemplated that the disclosed devices, systems and methods can be used to detect leaks and perforations of the GI tract within the 24-hour window following their occurrence, thereby avoiding unneeded patient suffering and death.
  • the disclosed devices, systems and methods can be used to test the esophagus during surgery to detect injuries that may have occurred to the subject. It is contemplated that if an injury is found within the esophagus of the subject, treatment can quickly be initiated, potentially saving the subject's life.
  • the disclosed devices can be inserted into an appropriate GI lumen, such as, for example and without limitation, an esophagus, substantially immediately after performance of a surgical procedure.
  • the balloons of the devices can be inflated inside the lumen to define an isolated, sealed area.
  • the space between the balloons can be filled with dye.
  • higher pressures can be applied to a smaller, isolated area to detect possible leaks or perforations. It is contemplated that, if leaking is observed, the operator/user of the device can quickly repair the damage before any life-threatening consequences arise.
  • the device comprises a double lumen catheter that is connected to two syringes.
  • one syringe can be for the injection of dye and the other can be for air to inflate the balloons.
  • the balloons can then dilate the esophageal or other GI lumen, and dye can be injected between the balloons. It is contemplated that, if there is any perforation or anastomotic leak, the dye will release and be detected.
  • the disclosed devices can be of varying sizes with three inner cannulated chambers running longitudinally along the length of the device.
  • three separated ports are available with adapters to fit commonly utilized medical syringes.
  • at the other end (the internal or output end) of the device there can be, in sequence from proximal to distal, an inflatable balloon, one or more slotted openings, and another inflatable balloon.
  • the materials of the device can be commonly utilized materials for other devices, such as, for example and without limitation, urinary catheters, endotracheal tubes, and the like.
  • the device can be shaped for placement into the esophagus through either the mouth or nasal cavities.
  • the device can be placed into an area of interest as determined by an operator. Dual balloon inflation can be carried out, thereby creating a sealed, isolated space or zone within the esophagus. Then, either a dye or air can be injected through the remaining device port. In use, the dye or the air can fill the esophagus, and leaks of either air or dye can be visually identified by the treating surgeon or other operator. The choice of dye type or the use of air is at the discretion of the operator.
  • the disclosed devices, systems and methods can be used to help surgeons detect injuries to the esophagus during surgery. Early detection in the operating room can allow patients to be treated immediately if needed. Early treatment has been shown to improve patient outcomes and reduce patient death after the complication.
  • the disclosed devices, systems and methods can be used in a variety of different surgical procedures, including, but not limited to gastrointestinal bypass surgery, anterior cervical spine surgery (ACSS), and colectomy surgery.
  • ACS anterior cervical spine surgery
  • colectomy surgery including, but not limited to gastrointestinal bypass surgery, anterior cervical spine surgery (ACSS), and colectomy surgery.
  • Gastrointestinal Bypass Surgery is a procedure to dramatically reduce the size of the stomach pouch by connecting the lower intestine to the esophagus, thus bypassing the stomach. It is contemplated that the disclosed devices, systems, and methods can be used at the end of the surgery to detect leaks at the point of connection. There are approximately 225,000 gastric bypass surgeries performed yearly with a leak rate of 1.4%. This market is growing at 13,000 procedures per year, or 6%, and is the fastest growing market of all laparoscopic surgeries.
  • Anterior Cervical Spine Surgery is performed to repair damaged vertebrae in the cervical (neck) region of the spine.
  • the surgeon enters through an incision made next to the throat.
  • the incision is then expanded so the cervical spine is exposed.
  • the esophagus is flimsy tissue and can easily be perforated during the procedure.
  • Sometimes the perforation goes undetected and the patient is sewn up without fixing the surgical error.
  • food can escape the esophagus through the unfixed perforation and enter into the chest cavity, causing inflammation and infection, which can be life threatening.
  • the disclosed devices, systems, and methods can be used at the end of the surgery to detect perforations.
  • About 0.8% or 1000 result in a perforation. This market is growing by 25,000 procedures per year, or 20%.
  • Colectomies are any surgery where a portion of the colon is removed, usually due to cancer or diverticular disease. After the section is removed it is reattached to itself, thereby creating a potential for leaks.
  • the leak rate for colectomies is between 2% - 5%.
  • the tubular portion of the body of the subject has a wall.
  • the tubular portion of the body of the subject can be the esophagus of a subject, and, in the description which follows, the injury detection device 10 is described with respect to its use within the esophagus of a subject.
  • the disclosed injury detection device 10 can be used as described herein within any tubular portion of the body of the subject, including, for example and without limitation, the ureter, the stomach, the small intestine, the large intestine, a vein, or an artery of the subject.
  • the injury detection device 10 can comprise a flexible tube 12 having a longitudinal axis 13.
  • the flexible tube 12 can be configured for insertion within the esophagus of the subject.
  • the flexible tube 12 can enclose a first lumen 14 and a second lumen 16.
  • the flexible tube 12 can optionally define the first lumen 14 and the second lumen 16, as depicted in Figure 2.
  • the first lumen 14 and the second lumen 16 can be distinct structures that are simply enclosed within the flexible tube 12.
  • the first and second lumens 14, 16 can have each have an open, proximal end 17 and a closed, distal end 18.
  • the closed, distal ends 18 of the first and second lumens 14, 16 can be closed of or otherwise sealed such that fluid within the respective lumens cannot exit the lumen through the closed, distal end.
  • the closed, distal ends 1 8 of the first and second lumens 14, 16 can be closed and/or sealed using cured Loctite adhesive.
  • the flexible tube 12 has an outer surface 20 that defines a proximal port 22, a distal port 24, and at least one opening 26 positioned therebetween the proximal port and the distal port along the longitudinal axis 13 of the flexible tube.
  • the proximal port 22 and the distal port 24 can be positioned in
  • the flexible tube 12 can have a length ranging from about 20 cm to about 60 cm, and, more preferably, from about 30 cm to about 50 cm. In an exemplary aspect, the length of the flexible tube 12 can be about 40 cm.
  • each respective lumen 14, 16 of the injury detection device 10 can have an inner, cross- sectional diameter (or height or width) ranging from about 1 mm to about 5 mm, and more preferably being about 2 mm.
  • the injury detection device 10 can comprise a first balloon 30 positioned in communication with the first lumen 14 through the proximal port 22 of the flexible tube 12.
  • the injury detection device 10 can comprise a second balloon 32 positioned in communication with the first lumen 14 through the distal port 24 of the flexible tube 12.
  • the first balloon 30 can be spaced from the second balloon 32 along the longitudinal axis 13 of the flexible tube 12 by a separation distance 34 ranging from about 1 cm to about 20 cm. In the esophagus, it is contemplated that the separation distance 34 can range from about 5 cm to about 10 cm.
  • the separation distance 34 can vary significantly depending on the particular location of the balloons 30, 32 within the body of the subject, as well as the localized conditions within the body of the subject.
  • the first balloon 30 and the second balloon 32 can each be inflatable between a relaxed position and an inflated position.
  • the flexible tube 12 can be labeled with distance markings to allow a user to monitor the separation distance 34 of the balloons 30, 32 and to monitor the overall positioning and penetration depth of the flexible tube within the esophagus.
  • first balloon 30 and the second balloon 32 can be configured to contact the wall of the esophagus to thereby define an isolated zone containing the at least one opening 26 of the flexible tube 12.
  • the isolated zone can correspond to a substantially sealed area that is defined between the first balloon 30 and the second balloon 32 within the esophagus.
  • first balloon 30 and the second balloon 32 can each have an outer surface 36, 38.
  • the outer surfaces 36, 38 of the first balloon 30 and the second balloon 32 can be symmetrically positioned about the longitudinal axis 13 of the flexible tube 12.
  • the outer surface 36 of the first balloon 30 can define a diameter 40 of the first balloon.
  • the outer surface 38 of the second balloon 32 can define a diameter 40 of the second balloon.
  • the diameter 40 of the first and second balloons 30, 32 can range from about 20 mm to about 50 mm, and, more preferably, be about 25 mm. In an additional, exemplary aspect, it is contemplated that, in the inflated position, each respective balloon 30, 32 can have a length 42 of about 15 mm, as measured along an axis substantially parallel to the longitudinal axis 13 of the flexible tube 12.
  • first balloon 30 and the second balloon 32 can be shaped such that, when the first and the second balloons are in the inflated position, the outer surfaces 36, 38 of the first and the second balloons conform to the shape of the wall of the esophagus (or other tubular portion of the body) of the subject.
  • shape of the esophagus of a subject can be significantly different than the shape of another tubular portion of the body of a subject.
  • the outer surfaces 36, 38 of the first balloon 30 and the second balloon 32 can each have a selected thickness.
  • the selected thickness of the outer surface 26 of the first balloon 30 and the selected thickness of the outer surface 38 of the second balloon 32 can each range from about 20 ⁇ to about 100 ⁇ , and, more preferably, from 30 ⁇ to about 50 ⁇ .
  • the outer surfaces 36, 38 of the first balloon 30 and the second balloon 32 can each comprise polyurethane, such as, for example and without limitation, polyurethane manufactured by Deerfield Urethane, Inc.
  • the injury detection device 10 can comprise a first fluid source 50 in communication with the first lumen 14 of the flexible tube 12.
  • the. first fluid source 50 can be configured to contain a selected fluid.
  • the selected fluid can be a gas, such as, for example and without limitation, air.
  • the selected fluid can be a liquid, such as, for example and without limitation, 0.9% normal saline solution, 0.45% normal saline solution, sterile water, lactated ringer's solution, and the like.
  • the injury detection device 10 can comprise a second fluid source 52 in communication with the second lumen 16 of the flexible tube 12.
  • the second fluid source 52 can contain an imaging agent.
  • the imaging agent can be, for example and without limitation, at least one of air, normal saline, indigo carmine, methylene blue, sterile water, conventional biocompatible fluorescent fluids, one or more conventional food dyes, and one or more conventional radiopaque fluids, whether ionic or non-ionic, such as Diatrizoate, Metrizoate Isopaque, loxaglate, lopamidol, lohexol, and Iodixanol.
  • the selected fluid within the first fluid source 50 can be air
  • the imaging agent within the second fluid source 52 can be normal saline.
  • the injury detection device 10 can comprise means for directing flow of the selected fluid from the first fluid source 50 to the first lumen 14 such that the first balloon 30 and the second balloon 32 are inflated to the inflated position.
  • the injury detection device 10 can comprise means for directing flow of the imaging agent from the second fluid source 52 to the second lumen 16 such that the imaging agent exits the at least one opening 26 of the flexible tube 12.
  • the first fluid source 50 can comprise a first syringe 70 having a longitudinal axis 72 and a barrel 74 containing the selected fluid.
  • the means for directing flow of the selected fluid can comprise a plunger 76 positioned within the barrel 74 of the first syringe 70 and configured for selective movement along the longitudinal axis 72 of the first syringe to thereby direct the selected fluid into the first lumen 14 of the flexible tube 12.
  • the first syringe 70 can be configured to hold about 10 mL of the selected fluid.
  • the first syringe 70 can comprise a male or a female luer fitting, such as, for example, those shown in Figure 15.
  • the second fluid source 52 can comprise a second syringe 80 having a longitudinal axis 82 and a barrel 84 containing the imaging agent.
  • the means for directing flow of the imaging agent can comprise a plunger 86 positioned within the barrel 84 of the second syringe 80 and configured for selective movement along the longitudinal axis 82 of the second syringe to thereby direct the imaging agent into the second lumen 16 of the flexible tube 12.
  • the second syringe 80 can be configured to hold about 30 mL of the imaging agent.
  • the second syringe 80 can comprise a male or a female luer fitting, such as, for example, those shown in Figure 1 5. It is further contemplated that when the first and second fluid sources 50, 52 each comprise a respective syringe 80, 82, the syringe of the first fluid source can have a different luer fitting than the syringe of the second fluid source such that user error is reduced.
  • the injury detection device can comprise an inlet adapter 60 connected thereto the flexible tube 12.
  • the inlet adapter 60 can have a first inlet 62 in communication with the first fluid source 50 and a second inlet 64 in
  • first and second inlets 62, 64 can be luer fittings that are suitably sized for communication with the first and second fluid sources 50, 52.
  • first and second inlets 62, 64 can be configured for connection to tubing 70, such as 1/16" silicon tubing from Cole-Parmer, which can, in turn, be connected to the respective fluid sources 50, 52.
  • the inlet adapter 60 can comprise a first connector portion 66 in communication with the first inlet 62.
  • the first connector portion 66 can be configured for fluid-tight receipt therein the first lumen 14 of the flexible tube 12.
  • the inlet adapter 60 can comprise a second connector portion 68 in communication with the second inlet 64.
  • the second connector portion 68 can be configured for fluid-tight receipt therein the second lumen 16 of the flexible tube 12.
  • the inlet adapter 60 can be substantially Y-shaped, as shown in Figure 3.
  • the inlet adapter 60 can be securely attached therein the open, proximal ends 17 of each respective lumen 14, 16 of the flexible tube 12.
  • the connector portions 66, 68 of the inlet adapter 60 can be substantially parallel to one another and can have lengths of about 10 cm.
  • the connector portions 66, 68 of the inlet adapter 60 can each have an outer, cross-sectional diameter (or width or height) ranging from about 1 mm to about 5 mm, and more preferably being about 2 mm.
  • the first fluid source 50 can comprise an outlet 51.
  • the means for directing flow of the selected fluid can comprise a first pump in communication with the outlet 51 of the first fluid source 50.
  • the first pump can be configured for selective activation by a user. It is still further contemplated that the first pump can be configured to direct the selected fluid into the first lumen 14 of the flexible tube 12.
  • the first pump can be configured to direct the selected fluid into the first lumen 14 of the flexible tube 12 at a desired rate.
  • the first pump can be configured to direct the selected fluid into the first lumen 14 such that the first balloon 30 and the second balloon 32 are inflated to a desired pressure.
  • the desired pressure can range from about 1 .50 to about 2.50 psi and, more preferably, be about 2 psi.
  • the second fluid source 52 can comprise an outlet 53.
  • the means for directing flow of tKe imaging agent can comprise a second pump in
  • the second pump can be configured for selective activation by a user. It is still further contemplated that the second pump can be configured to direct the imaging agent into the second lumen 16 of the flexible tube 12. Optionally, in one aspect, the second pump can be configured to direct the imaging agent into the second lumen 16 of the flexible tube 12 at a desired rate.
  • the flexible tube 1 2 of the injury detection device 10 can enclose a first lumen, a second lumen, and a third lumen.
  • the flexible tube 12 can optionally define the first lumen, the second lumen, and the third lumen.
  • the first lumen, the second lumen, and the third lumen can be distinct structures that are simply enclosed within the flexible tube 12.
  • the proximal port 22 of the flexible tube 12 can be positioned in communication with the first lumen, while the distal port 24 of the flexible tube can be positioned in communication with the third lumen.
  • the at least one opening 26 can be positioned in communication with the second lumen.
  • the injury detection device 10 can comprise a first balloon positioned in communication with the first lumen through the proximal port 22 of the flexible tube.
  • the injury detection device can comprise a second balloon positioned in communication with the third lumen through the distal port 24 of the flexible tube 12.
  • the first balloon and the second balloon can each be inflatable between a relaxed position and an inflated position.
  • the first balloon and the second balloon can be configured to contact the wall of the esophagus to thereby define an isolated zone containing the at least one opening of the flexible tube.
  • the isolated zone can correspond to a substantially sealed area that is defined between the first balloon and the second balloon within the esophagus.
  • conventional surgical tools can be inserted into the esophagus (or other tubular portion of the body) of the subject through the at least one opening 26 of the flexible tube 12.
  • conventional surgical tools can be inserted and advanced through the second lumen 16 of the flexible tube 12 to access the isolated zone through the openings 26 of the flexible tube.
  • fiber-optic devices, forceps, suture tools, scissors, grafting tools, and other conventional, flexible surgical tools can be positioned within the isolated zone by passing through the second lumen 16 and the openings 26 of the flexible tube 12.
  • a flexible endoscope can be passed through the second lumen 16 and the openings 26 of the flexible tube 12 to provide visualization of potential areas of injury or leak within the isolated zone. It is contemplated that the dimensions of the lumens 14, 16 of the flexible tube 12 can be altered as required to permit access of the conventional, flexible surgical tools.
  • the disclosed injury detection device can be incorporated into a method for detecting an injury within a tubular portion of the body of a subject.
  • the method will be described with reference to use of the injury detection device within the esophagus of the subject and with reference to use of an injury detection device having a flexible tube that encloses two lumens.
  • the disclosed methods can be used in conjunction with an injury detection device having a flexible tube that encloses three lumens, as disclosed herein.
  • the methods can be used to detect injuries within other tubular portions of the body of the subject, such as, for example and without limitation, within the ureter, the stomach, the small intestine, the large intestine, a vein, or an artery of the subject. It is contemplated that the disclosed methods can be performed by a surgeon, an anesthesiologist, or a supervised health care provider, such as an anesthetist, a nurse practitioner, a physician's assistant and the like, during or following another surgical procedure.
  • the method comprises positioning a first fluid source in
  • the method comprises positioning a second fluid source in communication with the second lumen of the flexible tube.
  • the method comprises positioning the flexible tube, the first balloon, and the second balloon within the esophagus of the subject.
  • the step of positioning the flexible tube, the first balloon, and the second balloon within the esophagus can comprise inserting the flexible tube, the first balloon, and the second balloon into the nasal or oral cavity of the subject and then guiding the flexible tube, the first balloon, and the second balloon through the pharynx of the subject until the esophagus is reached.
  • the method comprises directing flow of the selected fluid from the first fluid source to the first lumen such that the first balloon and the second balloon are each inflated to the inflated position.
  • the inflated position can correspond to the inflation of the balloons to the desired pressure and/or the position at which the balloons contact the wall of the esophagus to thereby define the isolated zone, as described herein.
  • the method can comprise directing flow of the imaging agent from the second fluid source to the second lumen such that the imaging agent exits the at least one opening of the flexible tube.
  • the imaging agent will enter into the isolated zone within the esophagus that is defined by the first balloon and the second balloon. It is further contemplated that leakage of the imaging agent through the wall of the esophagus of the subject can be indicative of an injury to the esophagus of the subject.
  • the method can further comprise removing the imaging agent through the second lumen.
  • the method can further comprise deflating the first and the second balloon by suction of the selected fluid out of the first and the second balloon.
  • the method can comprise deflating the first and the second balloon and then allowing the imaging agent to pass through the esophagus, or other tubular portion, of the body of the subject.
  • the method can further comprise the step of inserting one or more flexible instruments, such as, without limitation, a flexible endoscope, into the isolated zone through the second lumen. It is contemplated that the flexible instruments can be employed to visualize the isolated zone and/or to facilitate repair of leaks or other damaged portions of the tissue within the isolated zone.
  • one or more flexible instruments such as, without limitation, a flexible endoscope
  • the method can further comprise the step of removing the injury detection device through its site of insertion.
  • the method can further comprise applying pressure, sterile dressings, and other conventional precautions as appropriate to prevent infection and promote healing of any wounds resulting from insertion of the injury detection device.
  • the disclosed methods can be used to detect injuries in other tubular portions of the body, including, for example and without limitation, the stomach, the small intestine, the large intestine, a vein, or an artery of the subject.
  • the step of positioning the flexible tube, the first balloon, and the second balloon can comprise forming a peripheral entry into the venous or arterial system of the subject. After the peripheral entry is formed, it is further contemplated that the flexible tube, the first balloon, and the second balloon can be positioned within a selected vein or artery after passage through the peripheral entry.
  • the step of positioning the flexible tube, the first balloon, and the second balloon can comprise inserting the flexible tube, the first balloon, and the second balloon into the nasal or oral cavity of the subject and then guiding the flexible tube, the first balloon, and the second balloon through the pharynx of the subject until a desired location within the gastric or intestinal system is reached.
  • the disclosed methods can comprise the step of inflating the first and the second balloons to verify the structural integrity of the balloons.
  • the method can comprise confirming proper positioning of the injury detection device within the body of the subject.
  • the step of confirming proper positioning of the injury detection device can comprise at least one of direct visualization of the injury detection device, endoscopic visualization of the injury detection device, palpation (direct or indirect) of the injury detection device, and radiographic imaging of the injury detection device. It is further contemplated that the described visualization, palpation, and imaging techniques can be employed to confirm the integrity of the isolated zone defined by the balloons.
  • the described methods can be modified to comprise positioning the first fluid source in communication with the first lumen and the third lumen of the flexible tube and directing flow of the selected fluid from the first fluid source to the first lumen and the third lumen such that the first balloon and the second balloon are each inflated to the inflated position.
  • the balloons of the injury detection device were constructed from polyurethane obtained from Deerfield Urethane (Part Number PS5410S).
  • the polyurethane of the balloons had a thickness of 40 ⁇ .
  • the balloon design consisted of several concentric circles of increasing diameter. Multiple circular constructs were used to provide a seam that can be welded multiple times, thereby forming a better seal as shown in Figure 9.
  • the polyurethane sheets were welded together using a 40W versa laser manufactured by ULS Inc.
  • the base circle was 25mm in diameter.
  • the next circle was .5mm larger, or 25.5mm in diameter.
  • a small circle (of about 0.5 mm diameter) was added in the center of the balloon.
  • the inner circles black layers
  • the largest circle and the central alignment circle red layers
  • the balloons were attached to the flexible tube. Initially, the balloons were centered using the laser-weld lines. As shown in Figure 1 1 , a tip of a pencil was placed in the small hole created by a tack weld, and the balloon was stretched over the tip of the pencil to create an opening that could be placed over the flexible tube.
  • the balloon was removed from the pencil tip.
  • the opening in the center of the balloon was made wide enough to fit around a double-lumen 15french/5mm catheter tube.
  • the double lumen tube was constructed of polyurethane and had a length of 40cm.
  • both of the lumens in the tube were filled with Loctite 3301 UV-cure adhesive, which sealed the distal ends of the lumens.
  • a perforation was made in one of the lumens so that air could enter the balloon once it was sealed around the flexible tube.
  • This perforation was formed by cutting out a notch of one lumen using an Xacto® blade. In total, three notches were made. Two notches were made in the first lumen; these notches coincided with two spaced balloons as disclosed herein. The balloons were spaced apart by 4 cm. The third notch was located between the two previously mentioned notches but was formed in the second lumen. This notch corresponded to the point at which an imaging agent would be ejected from the flexible tube.
  • the balloons were subsequently stretched over the double lumen tubing.
  • the balloons were placed directly over each notch.
  • the two opposing faces of each balloon were spaced along the double-lumen tubing by 0.5 cm, with a notch positioned exactly in the middle of the two faces of the balloon.
  • the balloons were attached to the flexible tube using a two stage process.
  • a polyester thread was used to create 4 turns around the lip of each balloon.
  • a UV cure adhesive Lictite 3301 was used to seal the thread junction so that no air leaked out of the balloons. The results of this process are demonstrated in Figure 13.
  • Measurement markings were added to give the clinician a depth-of-penetration gauge. The units of cm were used to mark off the tubing. Numbering was only included every two cm so as not to make the markings too close to one another. The zero mark corresponded to the apex of the first balloon.
  • a 10 mL syringe was used as the first fluid source.
  • the balloons were calibrated to receive a total of 10ml of air, thereby permitting the balloons to be filled through only a single retraction and depression of the syringe.
  • a male luer fitting was used on the 10 mL syringe.
  • the second fluid source was a 30 mL syringe that had a female leur fitting so as to mitigate user error that could result from using the incorrect syringe.
  • the respective syringes are shown in Figure 14. As shown in Figure 15, because the syringe tips had different genders, their corresponding fittings were also different.
  • the disclosed inlet adapter was glued into the double lumen tubing using UV-light cure adhesive.
  • the two barbs of the inlet adapter were attached to 10cm lengths of 1 /16" silicon tubing from Cole-Parmer.
  • the silicon tubing was then attached to corresponding luer fittings of the two syringes.

Abstract

La présente invention concerne des dispositifs de détection de lésions destinés à détecter une lésion à l'intérieur de l'œsophage d'un sujet. Le dispositif de détection de lésions comprend un tube flexible destiné à être inséré à l'intérieur de l'œsophage d'un sujet. Le tube flexible enceint une première lumière et une seconde lumière et définit un orifice proximal, un orifice distal, et des ouvertures positionnées entre l'orifice proximal et l'orifice distal. L'orifice proximal et l'orifice distal sont positionnés en communication avec la première lumière, alors que les ouvertures sont positionnées en communication avec la seconde lumière. Le dispositif de détection des lésions comprend également des premiers et seconds ballonnets en communication avec la première lumière par les orifices proximaux et distaux. Le premier ballonnet et le second ballonnet peuvent être gonflés pour contacter la paroi de l'œsophage et définir une zone isolée contenant les ouvertures du tube flexible.
PCT/US2012/020642 2011-01-13 2012-01-09 Dispositif de détection de lésions et systèmes et procédés d'utilisation associés WO2012096885A1 (fr)

Applications Claiming Priority (4)

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US201161432362P 2011-01-13 2011-01-13
US61/432,362 2011-01-13
US201161484295P 2011-05-10 2011-05-10
US61/484,295 2011-05-10

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016139552A1 (fr) * 2015-03-05 2016-09-09 Medfact Engineering Gmbh Dispositif pour déplacer un organe creux d'un patient
CN106510857A (zh) * 2016-12-21 2017-03-22 无锡圣诺亚科技有限公司 三囊消化道密闭性检测器
CN109464124A (zh) * 2018-12-17 2019-03-15 博罗县妇幼保健计划生育服务中心 一种用于检测新生婴儿食管气管瘘的简易检测装置

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Publication number Priority date Publication date Assignee Title
US20010029349A1 (en) * 1996-04-12 2001-10-11 Boris Leschinsky Method and apparatus for treating aneurysms
US6638242B2 (en) * 2001-01-24 2003-10-28 Jon S. Wilson Multi-lumen catheter with attachable hub
US20050059992A1 (en) * 2003-09-17 2005-03-17 Leiboff Arnold R. Air introduction device for anastomotic leak testing
US20070123781A1 (en) * 2005-11-28 2007-05-31 Tyco Healthcare Group Lp Surgical anastomosis leak detection system

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010029349A1 (en) * 1996-04-12 2001-10-11 Boris Leschinsky Method and apparatus for treating aneurysms
US6638242B2 (en) * 2001-01-24 2003-10-28 Jon S. Wilson Multi-lumen catheter with attachable hub
US20050059992A1 (en) * 2003-09-17 2005-03-17 Leiboff Arnold R. Air introduction device for anastomotic leak testing
US20070123781A1 (en) * 2005-11-28 2007-05-31 Tyco Healthcare Group Lp Surgical anastomosis leak detection system

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016139552A1 (fr) * 2015-03-05 2016-09-09 Medfact Engineering Gmbh Dispositif pour déplacer un organe creux d'un patient
CN106510857A (zh) * 2016-12-21 2017-03-22 无锡圣诺亚科技有限公司 三囊消化道密闭性检测器
CN106510857B (zh) * 2016-12-21 2024-03-12 无锡市人民医院 三囊消化道密闭性检测器
CN109464124A (zh) * 2018-12-17 2019-03-15 博罗县妇幼保健计划生育服务中心 一种用于检测新生婴儿食管气管瘘的简易检测装置

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