Abstract:
Systems, devices, methods and kits for an inflation system with pressure relief are provided. The system includes an inflatable member, a first shaft connected to the inflatable member, an imaging device extending into said cavity of the inflatable member, a second shaft configured to contain the imaging device, the second shaft having a closed end approximate to the imaging assembly and a open end approximate to the imaging system, the second shaft defining a cavity along a longitudinal axis thereof and configured to be positioned within the cavity of the first shaft; the first shaft and the second shaft defining a channel therebetween in communication with the cavity of the inflatable member; an inflator connected to the first shaft and in communication with the channel for inflating the inflatable member; and a relief valve in communication with the channel and positioned between the inflatable member and the inflator.

Description:
TECHNICAL FIELD 
       [0001]    The present disclosure generally relates to medical devices, systems and methods for that include an inflatable member in biomedical and other medical and non-medical applications, and in particular to apparatuses, systems, methods and kits for preventing over inflation of an inflatable member. 
       BACKGROUND 
       [0002]    Various types of inflatable members are used during medical procedures to expand an internal cavity of a patient in order to perform a medical procedure. 
         [0003]    One type of inflatable member is the balloon catheter. In general, balloon catheters can exist in a deflated state and an inflated state; intermediate states are also available. In use, the balloon catheter in its deflated state is inserted into a cavity of a patient. After positioning within the patient, the balloon catheter is inflated via any of various means using various inflation media, for example, using a syringe to inject a liquid mass into the balloon or using an inflation bulb to provide air into the balloon. Some systems utilize a pressure gauge to monitor the pressure to prevent over pressurization of the balloon. 
         [0004]    In particular, in some medical procedures an imaging device is used to image an internal cavity of a patient. In order to capture clear images of the cavity tissue, the imaging device can be positioned within a balloon catheter that can be inserted into the cavity. The balloon is then inflated to provide clear access to the imaging device of the system. In these balloon catheter systems, the balloon catheter and most components connected thereto require disposal due to being in contact with the patient. 
         [0005]    In some instances, if an operator is not properly monitoring the pressure gauge, the balloon may be inflated to an over inflated or over pressurized state. This over pressurization of the balloon can cause damage to or even rupturing of the balloon, or even worse can cause damage to the surround tissue within the cavity of the patient. Also if the balloon is underinflated, the imaging device may not be able to properly capture and image of the surrounding tissue. This disclosure describes an improvement over these prior art technologies. 
       SUMMARY 
       [0006]    Accordingly, an inflation apparatus with pressure relief is provided that includes an inflatable member having a proximal end and a distal end and defining a deflated state, an inflated state, and a cavity therein; a first shaft having a first end connected to the proximal end of the inflatable member and defining a cavity along a longitudinal axis thereof; an imaging device having an imaging assembly at a distal end thereof and extending into said cavity of said inflatable member and connectable to an imaging system at a proximal end thereof; a second shaft configured to contain said imaging device, said second shaft having a closed end approximate to the imaging assembly and a open end approximate to the imaging system, said second shaft defining a cavity along a longitudinal axis thereof and configured to be positioned within said cavity of said first shaft; said first shaft and said second shaft defining a channel therebetween in communication with said cavity of the inflatable member; an inflator connected to said first shaft and in communication with said channel for inflating said inflatable member; and a relief valve in communication with said channel and positioned between said inflatable member and said inflator. 
         [0007]    In one embodiment, an inflation apparatus with pressure relief includes an inflatable member having a deflated state and an inflated state, and defining a cavity therein; a first shaft defining a cavity therein and having a proximal end and a distal end, said distal end connected to said inflatable member; a second shaft defining a cavity therein and having a closed end and an open end, said second shaft disposed within said first shaft such that said closed end is disposed within said inflatable member, said first shaft and said second shaft defining a channel therebetween in communication with the cavity of the inflatable member; an inflator in communication with the channel configured to inflate the inflatable member; a relief valve in communication with the channel to prevent over pressurization if the inflatable member; and a pass-through component configured to maintain an isolation of the cavity of the second shaft from said channel and permit communication between said inflator and said channel. 
         [0008]    In one embodiment, an inflation kit with pressure relief includes more than one air supply for supplying air through a pathway to an inflatable member; a valve connected in the pathway to control the flow of the inflatable member; a pressure gauge connected in the pathway for monitoring the pressure of the inflatable member; and a pressure relief valve connected in the pathway for venting the pressure at a preset pressure. 
         [0009]    In one embodiment a method for testing an inflation kit includes receiving an inflation kit; attaching a test valve to the pathway and configured to seal the pathway; closing test valve to seal the pathway; opening the valve to increase pressure in the pathway; monitoring pressure gauge; closing the valve upon reaching a preset pressure; determining is the pressure is maintained for a preset period of time; after the preset period of time, opening the valve to again increase the pressure in the pathway; monitoring the pressure gauge; determining if the relief valve opens; identifying on the pressure gauge the pressure at which the relief valve opens. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which: 
           [0011]      FIG. 1  is a schematic diagram of an inflation system with pressure relief in accordance with the principles of the present disclosure; 
           [0012]      FIG. 2  is a partial front view of the inflation system of  FIG. 1 ; 
           [0013]      FIG. 3  is a cross sectional view of the system of  FIG. 1  at a balloon end thereof; and 
           [0014]      FIG. 4  is a cross sectional view of an upper end of the system of  FIG. 1 . 
       
    
    
       [0015]    Like reference numerals indicate similar parts throughout the figures. 
       DETAILED DESCRIPTION 
       [0016]    The present disclosure may be understood more readily by reference to the following detailed description of the disclosure taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this disclosure is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed disclosure. 
         [0017]    The present disclosure is described herein in connection with an imaging system. It is understood that the present disclosure is applicable to any systems that include an inflatable member, the pressure of which is to be monitored and controlled. 
         [0018]    Also, as used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment 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 embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references “superior” and “inferior” are relative and used only in the context to the other, and are not necessarily “upper” and “lower”. 
         [0019]    Reference will now be made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. 
         [0020]    System  10  includes an imaging device  20 , e.g. an optical coherence tomography (OCT) imaging device. Although the present disclosure is described using an OCT imaging device, other imaging devices are contemplated. For example, imaging device can include a visual light camera, an ultrasound imaging device or other imaging devices. OCT imaging device  20  includes an imaging assembly  21  comprising one or more components commonly found in rotating and/or translating imaging devices. These components can include mirrors, lenses, filters, prisms and combinations thereof; other components are contemplated. OCT imaging device  20  is connected to a distal end  23  of an inner member  22 . When used in connection with OCT imaging device  20 , inner member  22  can include a fiber optic cable configured to transmit light energy. A proximal end  24  of inner member  22  is connected to one or more imaging systems  150 , e.g. an OCT visualization system. 
         [0021]    OCT imaging device  20  is contained within an inner shaft  30  having a distal end  31  and a proximal end  32 . Inner shaft  30  is sealed at distal end  31  and can attach to imaging system  150  at proximal end  32 . Inner shaft  30  provides a working environment for OCT imaging device  20  to freely rotate and/or translate within. Inner channel  33  is defined between inner member  22  and inner shaft  30 . Inner shaft  30  can be rigid or flexible depending on the system requirements. 
         [0022]    Distal end  31  of inner shaft  30  containing OCT imaging device  20  is contained within an inflatable member  40 , e.g. a balloon, having a proximal end  41  and a distal end  42 . Balloon  40  defines an inner cavity  43 . Balloon  40  can be manufactured from various compliant and/or non-compliant materials, for example, latex and/or polyethylene terephthalate (PET), polyurethane, nylon or polyether block amide. Other materials are contemplated. Whichever material is used, balloon  40  is designed to transition between a deflated state and an inflated state; intermediate states are contemplated. Balloon  40  is shown in an inflated state. 
         [0023]    Proximal end  41  of balloon  40  is connected to a distal end  51  of an outer shaft  50 . Outer shaft  50  can be rigid or flexible depending on the system requirements. Outer shaft  50  is configured to slidingly receive inner shaft  30  and OCT imaging device  20 . Distal end  31  of inner shaft  30  can be attached to distal end  42  of balloon  40 . An outer channel  53  is defined between inner shaft  30  and outer shaft  50 . Outer channel  53  is in communication with cavity  43  of balloon  40 . Outer channel  53  is used to deliver or remove air to/from cavity  43  to inflate or deflate balloon  40 . Inner channel  33  is sealed from and does not communicate with outer channel  53 . 
         [0024]    A proximal end  52  of outer shaft  50  is connected to a first end  61  of a branch tee  60 . Although a branch tee is described herein, other fillings are contemplated, for example, a heal tee or Y shaped fitting can also be used. Branch tee  60  is designed to allow inner shaft  30  and inner member  22  to pass therethrough but retain the seal between inner channel  33  and outer channel  53 . Inner shaft  30  and inner member  22  extend from a second end  62  of branch tee  60  to connect to imaging system  150 . As shown in  FIG. 4 , inner shaft  30  and inner member  22  extend from second end  66  of branch tee  60 . A space  64  between an outer surface of inner shaft  30  and an inner surface of second end  62  is sealed to seal channel  53  from the outside environment. Seal of space  64  can be a sealant or can be monolithically formed with tee  60  to tightly seal around inner shaft  30 . As another example, branch tee  60  can be molded over the inner shaft  30  and thermally bonded thereto to seal around it. 
         [0025]    The bull  63  of branch tee  60  is connected to a first end  73  of a branch tee  72  via tube  71 . A second end  74  of branch tee  72  is connected to a first end  83  of a branch tee  82  via tube  81 . A second end  84  of branch tee  82  is connected to an outlet  92  of a valve  90  via tube  91 . An inlet  93  of valve  90  is connected to air supply  100  via tube  101 . Tubes  71 ,  81 ,  91  and/or  101  can be rigid or flexible depending on system requirements. Although tubes are described as connecting various components (e.g. tees  72  and  82 ), direct connections between the components are contemplated. In addition, the orientation of the components can vary depending on system configuration. 
         [0026]    Air supply  100  can include mechanical, electromechanical or pressurized air supplies. For example, air supply can include an inflation bulb, a syringe, an electric pump or an air tank containing pressurized air. Other air supplies are contemplated. In addition, as stated above, the present disclosure is not limited to using air to inflate the balloon. For example other gases such as nitrogen or helium or liquids such as saline or contrast media are contemplated. 
         [0027]    A relief valve  70  is connected to bull  75  of tee  72 . Relief valve  70  is designed to prevent an over pressuring of balloon  40 . For example, in a system wherein an esophagus of a patient is to be imaged, balloon  40 , in a deflated state and containing OCT imaging device  20 , is inserted into the patient. Before imaging can commence, balloon  40  requires inflation. A PET balloon for this application may require a pressure of 5 pounds per square inch (psi) as a nominal pressure to properly inflate. Such a PET balloon  40  may have a pressure tolerance rating of +5 psi. As such, a relief valve  70  designed to release at 8 psi +/−2 can be used to. maintain balloon  40  within its tolerance ranges. Based on the specifications of the balloon  40 , differing pressure valves can be used. 
         [0028]    A pressure gauge  80  is connected to bull  85  of tee  82 . Pressure gauge  80  is used to monitor the pressure in the balloon  40  as cavity  43  is connected to pressure gauge  80  through channel  53 . 
         [0029]    The present disclosure describes a inflation apparatus with pressure relief that can be reused. That is, the components from branch tee  60  through air supply  100  are tangential to the path of balloon  40  and shaft  50 , and thus the patient, and therefore can be reused and remain non-sterile. 
         [0030]    In use and operation, balloon  40 , in a deflated state and containing imaging device  20 , is inserted into a cavity of a patient to be imaged. Once at the desired position, air pressure created by air supply  100  is allowed to enter the system  10  by the opening of valve  90 . As the air pressure increases, balloon  40  transitions from its deflated state to its inflated state. During this process, pressure gauge  80  can be monitored to monitor the increasing pressure in the system  10 . In normal operation this process continues until a desired pressure, e.g. 5 psi, is reached, at which time valve  90  would be closed to prevent over pressurization. In the event the monitoring of pressure gauge  80  is interrupted, thus allowing the air pressure in the system to continue to increase, relief valve will open at its set pressure, e.g. 8 psi +/−2, to prevent damage to the system  10  or the patient. 
         [0031]    Due to the design of the system  10 , the system  10  can maintain a required balloon  40  pressure and allow the operation of the OCT imaging device  20  to translate and/or rotate the image  21  within the patient. 
         [0032]    An inflation kit is also contemplated. The kit can include more than one air supply  100 , for example, an inflation bulb and a syringe. Also included in the kit are relief valve  70 , pressure gauge  80  and valve  90  connected via tubing as described herein. The kit comes ready to connect to branch tee  60 . 
         [0033]    The inflation apparatus with pressure relief can also be subject to a pressure testing procedure. A sub-system of components  71  through  100  are assembled as described. A test valve (not shown) is attached to end of tubing  71 , replacing branch tee  60 . With the test valve in a closed position and valve  90  in an opened position, pressure is applied to the sub-system via air supply  100 . Pressure gauge  80  is monitored until a preset pressure is obtained, e.g. 5 psi. This pressure is maintained, i.e. valve  90  is closed, for a preset time period, e.g. 30 seconds. After the preset time period has elapsed, the pressure is again increased by opening valve  90 . The pressure is monitored via pressure gauge  80  until relief valve  70  opens at its preset pressure, e.g. 8 psi. A calibrated and tested secondary relief valve can be incorporated into the sub-system to prevent damage to the sub-system should relief valve  70  fail to operate properly. In addition, a calibrated and tested secondary pressure gauge can be incorporated into the sub-system to accurately determine if the relief valve opens within its specified range and determine if pressure gauge  80  is accurate. 
         [0034]    The present disclosure has been described herein in connection with an imaging system including an OCT imaging device contained within a balloon. It is understood that the present disclosure is applicable to any systems that include an inflatable member, the pressure of which is to be monitored, with or without imaging devices as disclosed herein. For example, the present disclosure is applicable to systems for performing procedures such as angioplasty. Other applications are contemplated. 
         [0035]    Where this application has listed the steps of a method or procedure in a specific order, it may be possible, or even expedient in certain circumstances, to change the order in which some steps are performed, and it is intended that the particular steps of the method or procedure claim set forth herebelow not be construed as being order-specific unless such order specificity is expressly stated in the claim. 
         [0036]    While the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the inventions. Modification or combinations of the above-described assemblies, other embodiments, configurations, and methods for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the art are intended to be within the scope of the claims.