METHODS OF USING SAME

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001 ] This patent application claims priority to U.S. Provisional Patent Application Serial No. 61/432,362, entitled "INJURY DETECTION DEVICES, SYSTEMS, AND METHODS OF USING SAME" and filed on January 13, 201 1 , and U.S. Provisional Patent Application Serial No. 61 /484,295, entitled "INJURY DETECTION DEVICES AND SYSTEMS AND METHODS OF USING SAME " and filed on May 10, 201 1 , both of which are incorporated herein by reference in their entireties.

FIELD

[0002] 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.

BACKGROUND

[0003] Patients are frequently injured by unintended perforations (punctures) during surgery on or near the gastrointestinal (GI) tract. This damage can result in significant injuries— and even death— because fluid can leak out of the G I tract, causing severe pain and potentially fatal infection. One of the worst is injury to the esophagus, a vital structure in the neck, during anterior cervical spine operations. Because esophageal injuries can be very difficult to detect during surgery, they often go unnoticed until the patient develops symptoms, many of which can be severe and require further hospitalizations, surgeries, or antibiotics. Esophageal injury is most commonly identified postoperatively with the development of abscess, tracheoesophageal fistula, or mediastinitis. Intraoperative detection of esophageal injury allows for immediate treatment and improved outcomes. There is an estimated 30% fatality rate with this complication with later detection and treatment compared to earlier treatment.

[0004] Currently there are no marketed products or products that are in clinical trials for the detection of perforations or leaks of the GI tract. The current methods of detection lack the ability to immediately and accurately identify anastomotic (the connection of separate parts) leaks or perforations, require expensive imaging procedures, increase operating room times, are inapplicable to some patients, and provide inconsistent results. In the surgical community, no single method is agreed upon as the leading standard of care. [0005] Current detection methods include the Methylene Blue Test, Air and Saline Tests, and Barium Swallow Computed Tomography (CT). The Methylene Blue Test utilizes a safe and inexpensive dye that is delivered throughout the entire esophageal or other GI lumen and is blocked at the distal end with a balloon or pinch. 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.

[0006] 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.

[0007] Barium Swallow Computed Tomography (CT) requires the intravenous or oral administration of a contrast agent. 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.

[0008] Each year, hundreds of people needlessly die and thousands more are severely injured because there is currently no device for detecting perforations of the GI tract during surgery. Studies indicate that complications are significantly reduced when perforations or leaks are detected within 24 hours after they occurred. The incidence of morbidity and mortality significantly increases when the perforations or leaks are not detected until over 24 hours after they occurred. Mortality is almost entirely preventable when the leak or puncture is identified and repaired within the 24 hour window following occurrence of the leak or puncture. Early, post-surgical detection of leaks and perforations in the Gl tract would allow patients to be treated immediately if needed. Early treatment has been shown to improve patient outcomes and reduce patient death after the complication.

[0009] Accordingly, there is a need in the pertinent art for a device, methods and systems that can provide intraoperative identification of esophageal injuries in a subject. There is a further need in the pertinent art a device, methods and systems that can detect an injury within a tubular portion of the body of a subject in a safe and reproducible manner. There is a further need in the pertinent art a device, methods and systems that can provide access to a tubular portion of the body of a subject. SUMMARY

[0010] Disclosed herein are injury detection devices for detecting an injury within the esophagus of a subject. In one aspect, 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. In another aspect, 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.

BRIEF DESCRIPTION OF THE FIGURES

[001 1 ] These and other features of the preferred embodiments of the invention will become more apparent in the detailed description in which reference is made to the appended drawings wherein:

[0012] Figure 1 is an image of an exemplary injury detection device as described herein.

[0013] 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.

[0014] Figure 3 is a perspective view of an exemplary inlet adapter as described herein.

[001 5] 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.

[0016] Figures 6- 13 are images of various aspects of the production of an exemplary injury detection device, as described herein.

[001 7] 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. [0018] Figure 15 is an image of exemplary luer connectors that can be used in conjunction with the first and second syringes of Figure 14.

DETAILED DESCRIPTION

[0019] The present invention can be understood more readily by reference to the following detailed description, examples, drawings, and claims, and their previous and following description. However, before the present devices, systems, and/or methods are disclosed and described, it is to be understood that this invention is not limited to the specific devices, systems, and/or methods disclosed unless otherwise specified, and, as such, can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

[0020] The following description of the invention is provided as an enabling teaching of the invention in its best, currently known embodiment. To this end, those skilled in the relevant art will recognize and appreciate that many changes can be made to the various aspects of the invention described herein, while still obtaining the beneficial results of the present invention. It will also be apparent that some of the desired benefits of the present invention can be obtained by selecting some of the features of the present invention without utilizing other features.

Accordingly, those who work in the art will recognize that many modifications and adaptations to the present invention are possible and can even be desirable in certain circumstances and are a part of the present invention. Thus, the following description is provided as illustrative of the principles of the present invention and not in limitation thereof.

[0021 ] As used throughout, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise.

[0022] 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.

[0023] As used herein, 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. [0024] As used herein, the term "or" as used herein means any one member of a particular list and also includes any combination of members of that list.

[0025] Without the use of such exclusive terminology, the term "comprising" in the claims shall allow for the inclusion of any additional element— irrespective of whether a given number of elements are enumerated in the claim, or the addition of a feature could be regarded as transforming the nature of an element set forth n the claims. Except as specifically defined herein, all technical and scientific terms used herein are to be given as broad a commonly understood meaning as possible while maintaining claim validity.

[0026] As used herein, the term "fluid" is meant to include any gas or liquid substance.

[0027] ^' As used herein, the term "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.

[0028] As used herein, 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. In exemplary aspects, the balloon can comprise one or more biocompatible materials. In further aspects, 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.

[0029] 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.

[0030] . In exemplary aspects, 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.

[0031 ] It is contemplated that 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. In some aspects, 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. Through control of balloon placement with respect to a potential leak site, 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.

[0032] In exemplary aspects, the device comprises a double lumen catheter that is connected to two syringes. In such aspects, 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.

[0033] In some non-limiting aspects, the disclosed devices can be of varying sizes with three inner cannulated chambers running longitudinally along the length of the device., In additional non-limiting aspects, at one end (the external or input end) of the device, three separated ports are available with adapters to fit commonly utilized medical syringes. In exemplary aspects, 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. It is contemplated that 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.

[0034] In exemplary aspects, the device can be shaped for placement into the esophagus through either the mouth or nasal cavities. In these aspects, 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] Anterior Cervical Spine Surgery (ACSS) 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. As the patient resumes normal eating activity, food can escape the esophagus through the unfixed perforation and enter into the chest cavity, causing inflammation and infection, which can be life threatening. It is contemplated that the disclosed devices, systems, and methods can be used at the end of the surgery to detect perforations. There are approximately 125,000 ACSS's performed annually in the US. About 0.8% or 1000 result in a perforation. This market is growing by 25,000 procedures per year, or 20%.

[0039] 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%. There are approximately 150,000 colectomies performed annually in the U.S.

[0040] With reference to Figures 1-15, disclosed herein are injury detection devices 10 for detecting an injury within a tubular portion of the body of a subject. As described herein, the tubular portion of the body of the subject has a wall. In exemplary aspects, 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. However, it is contemplated that 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.

[0041] In one aspect, the injury detection device 10 can comprise a flexible tube 12 having a longitudinal axis 13. In this aspect, the flexible tube 12 can be configured for insertion within the esophagus of the subject. Optionally, in another aspect, the flexible tube 12 can enclose a first lumen 14 and a second lumen 16. In ^' this aspect, the flexible tube 12 can optionally define the first lumen 14 and the second lumen 16, as depicted in Figure 2. Alternatively, it is contemplated that the first lumen 14 and the second lumen 16 can be distinct structures that are simply enclosed within the flexible tube 12. In another aspect, the first and second lumens 14, 16 can have each have an open, proximal end 17 and a closed, distal end 18. In this aspect, it is contemplated that 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. In exemplary aspects, it is contemplated that the closed, distal ends 1 8 of the first and second lumens 14, 16 can be closed and/or sealed using cured Loctite adhesive. In an additional aspect, 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. In a further aspect, it is contemplated that the proximal port 22 and the distal port 24 can be positioned in

communication with the first lumen 14, while the at least one opening 26 can be positioned in communication with the second lumen 16. In one aspect, 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. In another aspect, 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.

[0042] In still another aspect, 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. In yet another aspect, 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. In a further aspect, it is contemplated that 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. However, it is contemplated that 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. In these aspects, it is contemplated that the first balloon 30 and the second balloon 32 can each be inflatable between a relaxed position and an inflated position. In exemplary aspects, it is contemplated that 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. It is further contemplated that, in the inflated position, the 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. As disclosed herein, it is contemplated that 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.

[0043] In another aspect, the first balloon 30 and the second balloon 32 can each have an outer surface 36, 38. In this aspect, it is contemplated that, as shown in Figures 4-5, in the inflated position, 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. For example, in one aspect, it is contemplated that, in the inflated position, the outer surface 36 of the first balloon 30 can define a diameter 40 of the first balloon. It is further contemplated that, in the inflated position, the outer surface 38 of the second balloon 32 can define a diameter 40 of the second balloon. In exemplary aspects, 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.

[0044] In exemplary aspects, and as shown in Figures 4-7, it is contemplated that the 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. For example, it is contemplated that the shape of the esophagus of a subject can be significantly different than the shape of another tubular portion of the body of a subject.

[0045] In an additional aspect, the outer surfaces 36, 38 of the first balloon 30 and the second balloon 32 can each have a selected thickness. In this aspect, it is contemplated that 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 μιτι to about 100 μπι, and, more preferably, from 30 μιη to about 50 μηι. In exemplary aspects, 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.

[0046] In a further aspect, and with reference to Figure 1 , the injury detection device 10 can comprise a first fluid source 50 in communication with the first lumen 14 of the flexible tube 12. In this aspect, the. first fluid source 50 can be configured to contain a selected fluid. Optionally, the selected fluid can be a gas, such as, for example and without limitation, air. Alternatively, 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.

[0047] In still another aspect, and as shown in Figure 1 , the injury detection device 10 can comprise a second fluid source 52 in communication with the second lumen 16 of the flexible tube 12. In this aspect, it is contemplated that the second fluid source 52 can contain an imaging agent. It is further contemplated that 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. In one exemplary aspect, the selected fluid within the first fluid source 50 can be air, and the imaging agent within the second fluid source 52 can be normal saline.

[0048] In yet another aspect, 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. In still a further aspect, 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.

[0049] In exemplary non-limiting aspects, and as shown in Figure 14, the first fluid source 50 can comprise a first syringe 70 having a longitudinal axis 72 and a barrel 74 containing the selected fluid. In these aspects, it is further contemplated that 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. In an additional aspect, the first syringe 70 can be configured to hold about 10 mL of the selected fluid. In this aspect, it is contemplated that the first syringe 70 can comprise a male or a female luer fitting, such as, for example, those shown in Figure 15.

[0050] In exemplary non-limiting aspects, and as shown in Figure 1 4, the second fluid source 52 can comprise a second syringe 80 having a longitudinal axis 82 and a barrel 84 containing the imaging agent. In these aspects, it is further contemplated that 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. In an additional aspect, the second syringe 80 can be configured to hold about 30 mL of the imaging agent. In this aspect, it is contemplated that 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.

[0051 ] Optionally, in another aspect, the injury detection device can comprise an inlet adapter 60 connected thereto the flexible tube 12. In this aspect, the inlet adapter 60 can have a first inlet 62 in communication with the first fluid source 50 and a second inlet 64 in

communication with the second fluid source 52. In this aspect, it is contemplated that the 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. Alternatively, as shown in Figure 1 , it is contemplated that the 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. In an additional aspect, the inlet adapter 60 can comprise a first connector portion 66 in communication with the first inlet 62. In this aspect, it is contemplated that the first connector portion 66 can be configured for fluid-tight receipt therein the first lumen 14 of the flexible tube 12. In a further aspect, the inlet adapter 60 can comprise a second connector portion 68 in communication with the second inlet 64. In this aspect, it is contemplated that the second connector portion 68 can be configured for fluid-tight receipt therein the second lumen 16 of the flexible tube 12. Optionally, in these aspects, it is contemplated that the inlet adapter 60 can be substantially Y-shaped, as shown in Figure 3. In an exemplary aspect, 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. In another exemplary aspect, 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. In a further aspect, it is contemplated that 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.

[0052] In exemplary non-limiting aspects, it is contemplated that the first fluid source 50 can comprise an outlet 51. Although not shown, in these aspects, it is further contemplated that 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. In one aspect, 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. Optionally, in one aspect, 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. It is contemplated that 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. In one aspect, the desired pressure can range from about 1 .50 to about 2.50 psi and, more preferably, be about 2 psi.

[0053] In exemplary non-limiting aspects, it is contemplated that the second fluid source 52 can comprise an outlet 53. Although not shown, in these aspects, it is further contemplated that the means for directing flow of tKe imaging agent can comprise a second pump in

communication with the outlet 53 of the second fluid source 52. In one aspect, 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.

[0054] Optionally, in exemplary aspects, although not shown, the flexible tube 1 2 of the injury detection device 10 can enclose a first lumen, a second lumen, and a third lumen. In these aspects, the flexible tube 12 can optionally define the first lumen, the second lumen, and the third lumen. Alternatively, it is contemplated that the first lumen, the second lumen, and the third lumen can be distinct structures that are simply enclosed within the flexible tube 12. In a further aspect, it is contemplated that 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. It is further contemplated that the at least one opening 26 can be positioned in communication with the second lumen.

[0055] In still another aspect, where the flexible tube 12 encloses three lumens, 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. In yet another aspect, 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. In these aspects, it is contemplated that the first balloon and the second balloon can each be inflatable between a relaxed position and an inflated position. It is further contemplated that, in the 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. As disclosed herein, it is contemplated that the isolated zone can correspond to a substantially sealed area that is defined between the first balloon and the second balloon within the esophagus.

[0056] In exemplary aspects, it is contemplated that 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. Thus, it is contemplated that 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. For example, and without limitation, it is contemplated that 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. In one non- limiting example, 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.

[0057] In use, 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. In the description which follows, 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. However, it is contemplated that the disclosed methods can be used in conjunction with an injury detection device having a flexible tube that encloses three lumens, as disclosed herein. It is further contemplated that 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.

[0058] In one aspect, the method comprises positioning a first fluid source in

communication with the first lumen of the flexible tube. In another aspect, the method comprises positioning a second fluid source in communication with the second lumen of the flexible tube. In an additional aspect, the method comprises positioning the flexible tube, the first balloon, and the second balloon within the esophagus of the subject. In this aspect, it is contemplated that 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. In a further aspect, 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. In this aspect, it is contemplated that 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. In still a further aspect, 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. In this aspect, it is contemplated that 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.

[0059] In another aspect, after monitoring the leakage of the imaging agent within the isolated zone, the method can further comprise removing the imaging agent through the second lumen. In this aspect, following the removal of the imaging agent, 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. Alternatively, when appropriate for the imaging agent, 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.

[0060] At any point when the imaging agent is not present within the isolated zone, it is contemplated that 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.

[0061 ] After deflation of the balloons, it is contemplated that the method can further comprise the step of removing the injury detection device through its site of insertion. When a vascular insertion site is selected, it is contemplated that 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. [0062] It is contemplated that 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. For vascular applications, it is contemplated that 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. For gastric and upper intestinal applications, it is contemplated that 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.

[0063] Optionally, prior to positioning the injury detection device within the body of the subject, the disclosed methods can comprise the step of inflating the first and the second balloons to verify the structural integrity of the balloons. In exemplary aspects, it is contemplated that, following positioning of the injury detection device within the body of the subject, the method can comprise confirming proper positioning of the injury detection device within the body of the subject. In these aspects, 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.

[0064] When the injury detection device comprises three lumens as disclosed herein, it is contemplated that 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.

EXAMPLE

[0065] In the following example, one experimental method of constructing the disclosed injury detection device is described.

[0066] 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 μιτι.

[0067] 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.

[0068] 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. After a desired number of increasingly larger circles was added, a small circle (of about 0.5 mm diameter) was added in the center of the balloon. The inner circles (black layers) were welded at a low power while the largest circle and the central alignment circle (red layers) were welded at a higher power setting, as shown in the following chart.

[0069] As shown in Figure 10, after preparation of the balloon, this small circle was cut out to provide a guide for centering the balloon on the disclosed flexible tube.

[0070] After the laser cut and welded the balloons, 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.

[0071 ] Next, 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. Before the balloon was placed on the tubing, both of the lumens in the tube were filled with Loctite 3301 UV-cure adhesive, which sealed the distal ends of the lumens.

[0072] Before the balloons were stretched over the tubing, 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.

[0073] As shown in Figure 12, 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.

[0074] After the balloons were properly positioned, the balloons were attached to the flexible tube using a two stage process. First, when the balloons were stretched over the tubing to create an overlap, the respective overlapping portions of each half of each balloon were positioned so that they flared outwardly (away from the notch in the tubing). A polyester thread was used to create 4 turns around the lip of each balloon. Secondly, a UV cure adhesive (Loctite 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.

[0075] After the careful application of the glue, a UV lamp was used in the curing process. Several seconds of exposure were sufficient to make a strong bond. Protection goggles were used during this process.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] Although several embodiments of the invention have been disclosed in the foregoing specification, it is understood by those skilled in the art that many modifications and other embodiments of the invention will come to mind to which the invention pertains, having the benefit of the teaching presented in the foregoing description and associated drawings. It is thus understood that the invention is not limited to the specific embodiments disclosed herein, and that many modifications and other embodiments are intended to be included within the scope of the appended claims. Moreover, although specific terms are employed herein, as well as in the claims which follow, they are used only in a generic and descriptive sense, and not for the purposes of limiting the described invention, nor the claims which follow.

[0080] All patents, patent applications and publications cited herein, whether supra or infra, are hereby incorporated by reference in their entireties into this application in order to more fully describe the state of the art as known to those skilled therein as of the date of the invention described and claimed herein.

EQUIVALENTS

[0081 ] Those skilled in the art will recognize, or be able to ascertain, using no more than routine experimentation, numerous equivalents to the specific embodiments described specifically herein. Such equivalents are intended to be encompassed in the scope of the following claims.