Device and system for reducing amount of fluid when using fluid into body cavity

Abstract

Medical devices and methods are disclosed. An example medical device for accessing a body cavity along the biliary and / or pancreatic tract may include an elongate member having a distal end and a proximal end. The medical device may be in communication with a system configured to provide a pressurized fluid to the medical device. The system configured to provide pressurized fluid to the medical device may be configured to provide the pressurized fluid at an initial first rate that attenuates to a second rate to facilitate intubation of one or more of a bile duct and a pancreatic duct while reducing fluid provided during a procedure.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 357,615, filed on June 30, 2022, entitled "DEVICES, SYSTEMS, AND METHODS FOR REDUCING FLUID VOLUME WHENUSING FLUID TO ACCESS A BODY LUMEN," which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to medical devices, and methods for making and / or using the medical devices. More particularly, the present disclosure relates to medical devices for accessing a body cavity along the biliary and / or pancreatic tract. Background Art

[0004] A variety of intracorporeal medical devices have been developed for medical use, for example, for endoscopic surgery. Some of these devices include guide wires, catheters, catheter systems, endoscopic instruments, etc. These devices are manufactured by any of a variety of different manufacturing methods and can be used according to any of the various methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for making and using medical devices. Summary of the invention

[0005] The present disclosure provides design, material, manufacturing methods, and use alternatives for medical devices and medical systems.

[0006] An example medical device for accessing a body cavity of a subject includes a fluid concentrator, a flexible, elongated tube, a lumen, and a switch; the fluid concentrator having a proximal end and a second end, the proximal end being configured to receive fluid from a pressurized fluid source; the flexible, elongated tube having a proximal end and a distal end, the distal end being configured to guide an opening toward the body cavity; the lumen extending from the distal end of the flexible, elongated tube toward the proximal end of the flexible, elongated tube, wherein the lumen is selectively fluidically connected to the second end of the fluid concentrator; wherein actuation of the switch is configured to regulate fluid communication between the fluid concentrator and the lumen.

[0007] Alternatively or in addition to any of the above examples, actuation of the switch is configured to automatically cause fluid to exit the distal end of the lumen at a first rate at a first time and at a second rate at a second time after the first time, the first rate being faster than the second rate.

[0008] Alternatively or in addition to any of the above examples, the switch is in communication with a valve that selectively blocks fluid flow downstream of the fluid accumulator and upstream of the distal end of the lumen.

[0009] Alternatively or in addition to any of the above examples, the switch is in mechanical communication with the valve.

[0010] Alternatively or in addition to any of the above examples, a first actuation of the switch is configured to cause the fluid accumulator and the lumen to be in fluid communication, and a second actuation of the switch is configured to cause fluid flow between the fluid accumulator and the lumen to be blocked.

[0011] Alternatively or in addition to any of the above examples, the fluid concentrator is a tube coil.

[0012] Alternatively or in addition to any of the above examples, the medical device may also include a first conduit portion, a second conduit portion; the first conduit portion extends between the fluid accumulator and the switch; the second conduit portion extends between the switch and a third conduit portion; and wherein the third conduit portion includes a flexible slender tube.

[0013] Alternatively or in addition to any of the above examples, the medical device may further include a fluid source lumen extending from the fluid accumulator and configured to communicate with the fluid source fluid; and a flow restrictor positioned along the fluid source lumen.

[0014] An example system may include a fluid accumulator and a sphincterotomy device in fluid communication with the fluid accumulator, and wherein the fluid accumulator is upstream of the sphincterotomy device and is configured to accumulate pressurized fluid for selective release through a distal end of the sphincterotomy device at an initial first rate that decays over time to a second rate.

[0015] Alternatively or in addition to any of the above examples, the system may further include a pressurized fluid source upstream of the fluid accumulator and in communication therewith to supply pressurized fluid to the fluid accumulator.

[0016] Alternatively or in addition to any of the above examples, the second rate is based on a fluid flow rate of the fluid exiting the pressurized fluid source.

[0017] Alternatively or in addition to any of the above examples, the system may further include a flow restrictor located between the pressurized fluid source and the fluid accumulator to restrict flow from the pressurized fluid source to the fluid accumulator.

[0018] Alternatively or in addition to any of the above examples, the system may further include a valve upstream of the sphincterotomy and downstream of the fluid accumulator, the valve configured to regulate the flow of fluid from the fluid accumulator to the sphincterotomy.

[0019] Alternatively or in addition to any of the above examples, the system may further include a switch in communication with the valve, wherein the switch is configured to be actuated to switch the valve between a closed position in which fluid flow between the fluid accumulator and the sphincterotomy is blocked and an open position in which fluid flows between the fluid accumulator and the sphincterotomy.

[0020] An example method for accessing a body cavity of a subject may include: extending an elongated tube through a working channel of an endoscope, the elongated tube having a distal end and a lumen, the working channel extending into the subject; directing the distal end of the elongated tube toward an opening of the body cavity; causing a fluid to flow from a fluid source through the lumen and out of the distal end of the elongated tube toward the opening of the body cavity; and wherein causing the fluid to flow from the fluid source through the lumen and out of the distal end of the elongated tube includes initially outputting the fluid from the distal end of the elongated tube at a first predetermined rate, the first predetermined rate automatically decaying to a second non-zero predetermined rate over time.

[0021] Alternatively or in addition to any of the above examples, the first predetermined rate is configured to cause the opening of the body cavity to move from a closed state to an open state.

[0022] Alternatively or in addition to any of the above examples, the second non-zero predetermined rate is configured to cause the opening, once opened, to remain in an open state.

[0023] Alternatively or in addition to any of the above examples, the second non-zero predetermined rate is maintained for a period of time that is longer than the period of time that the fluid is output at the first predetermined rate.

[0024] Alternatively or in addition to any of the above examples, the method may further include opening a valve to cause fluid to flow from the fluid source, through the lumen, and out of the distal end of the elongated tube.

[0025] Alternatively or in addition to any of the above examples, the method may further include closing a valve to cause fluid from a fluid source to accumulate in a fluid accumulator that is in selective fluid communication with the lumen.

[0026] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present disclosure may be more fully understood upon consideration of the following detailed description taken in conjunction with the accompanying drawings, in which:

[0028] Figure 1 is a schematic diagram of an exemplary system for accessing an opening in a body cavity of a subject;

[0029] Figure 2 is the area intercepted along circle 2 Figure 1A schematic diagram of the system shown;

[0030] Figure 3 is a schematic diagram of an exemplary system for accessing a body cavity;

[0031] Figure 4 is a schematic diagram of an exemplary system for accessing a body cavity, showing a cross section of body tissue and an endoscopic device;

[0032] Figure 5 is a schematic diagram of an exemplary system for accessing a body cavity;

[0033] Figure 6 is a schematic diagram of an exemplary system for accessing a body cavity;

[0034] Figure 7 A schematic diagram of an exemplary method for using the system to access a body cavity; and

[0035] Figures 8 to 10 is a schematic diagram of an exemplary system for accessing a body cavity of a subject, the exemplary system being used to access a body cavity.

[0036] Although the present disclosure may be modified into various modifications and alternatives, the details thereof have been shown in the drawings by way of example and will be described in detail. However, it should be understood that it is not intended to limit the present disclosure to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and alternative forms that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0037] With respect to the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0038] While configurations of the present disclosure may specifically refer to medical devices and systems (e.g., endoscopic devices, accessory tools, and / or guidewires inserted through, near the papilla, or through a duodenoscope or endoscope, etc.) for selective access, alignment, and / or cannulation of the common bile duct (CBD) or pancreatic duct (PD) during an endoscopic retrograde cholangiopancreatography (ERCP) procedure, it should be understood that such medical devices and systems may be used in a variety of medical procedures that require navigation of one or more accessory tools through ductal, lumen, vascular, or body cavity anatomical structures, including, for example, interventional radiology procedures, balloon angioplasty / angiography procedures, thrombolytic procedures, urological or gynecological procedures, etc. The disclosed medical devices and systems may be inserted via different access points and approaches, for example, percutaneously, endoscopically, laparoscopically, or some combination thereof.

[0039] All numerical values ​​are assumed herein to be modified by the term "about", whether or not explicitly indicated. In the context of numerical values, the term "about" generally refers to an index range that is considered by those skilled in the art to be equivalent to the stated value (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. Other uses of the term "about" (e.g., in contexts other than numerical values) may be assumed to have their ordinary and customary definitions, as understood from and consistent with the context of the specification, unless otherwise indicated.

[0040] Numerical ranges recited by endpoints include all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges, and / or values ​​are disclosed pertaining to various components, features, and / or specifications, those skilled in the art (to which this disclosure pertains) will appreciate that the desired dimensions, ranges, and / or values ​​may deviate from those explicitly disclosed.

[0041] As used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense that includes "and / or", unless the context clearly indicates otherwise. It should be noted that, to facilitate understanding, certain features of the present disclosure may be described in singular form, even if these features may be plural or repeated in one or more disclosed embodiments. Each instance of these features may include singular disclosure content and / or may be covered by it, unless explicitly stated to the contrary. For the purpose of simplicity and clarity, all elements of the present disclosure are not necessarily shown in each figure or discussed in detail below. However, it will be understood that the following discussion may be equally applicable to any one and / or all of more than one component, unless explicitly stated to the contrary. In addition, for clarity, all instances of some elements or features may not be shown in each figure.

[0042] It should be noted that references in the specification to "one embodiment," "some embodiments," "other embodiments," etc. indicate that the described embodiments may include a particular feature, structure, or characteristic, but each embodiment may not necessarily include the particular feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Additionally, when a particular feature, structure, or characteristic is described in conjunction with one embodiment, those skilled in the art will appreciate that the particular feature, structure, or characteristic is affected in conjunction with other embodiments, whether or not explicitly described, unless clearly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are conceived to be combinable or arrangable with each other to form other additional embodiments or to supplement and / or enrich the described embodiments, as those skilled in the art will understand.

[0043] For the purpose of clarity, certain identification numerical names (e.g., first, second, third, fourth, etc.) may be used to name various described and / or claimed features and / or to distinguish between them throughout the specific embodiments and / or claims. It should be understood that the numerical names are not intended to be restrictive and are merely exemplary. In some embodiments, for simplicity and clarity, changes and deviations from the previously used numerical names may be made. That is, the feature identified as a "first" element may be subsequently referred to as a "second" element, a "third" element, etc., or may be ignored as a whole, and / or different features may be referred to as a "first" element. In each case, the meaning and / or title will be apparent to those skilled in the art.

[0044] The detailed description is intended to illustrate but not limit the present disclosure. Those skilled in the art will recognize that the various elements described may be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description shows example embodiments of the present disclosure.

[0045] As discussed herein, it is desirable that the distal tip of a medical device be flexible to effectively navigate through a body cavity. For example, a flexible distal tip of a medical device may be able to facilitate navigation through a narrow passage, such as the papilla of Vater and / or other passages. In some cases, a flexible distal tip of a medical device may be advantageous for steering the medical device into a target body cavity that is proximal to a structure such as a lesion, a calculus, or other aggregate and / or has such a structure located therein.

[0046] In some cases, the devices and methods disclosed herein can be used for diagnostic or therapeutic procedures in the bile duct and / or pancreatic tract, as well as for other purposes. Access to the pancreaticobiliary system (as facilitated by the devices disclosed herein) may be required to diagnose and / or treat various conditions, including, but not limited to, tumors, gallstones, infections, cirrhosis, and pseudocysts. The devices disclosed herein can also be used for navigation in other parts of the body, such as the cardiovascular system, etc.

[0047] Endoscopic retrograde cholangiopancreatography (ERCP) can be used to diagnose and treat common bile duct disorders, including, for example, gallstones, inflammatory strictures, leaks (e.g., caused by trauma, surgery, etc.), cancer, and / or other disorders. During the ERCP procedure, the doctor can observe the interior of the stomach and / or duodenum through an endoscope. During the procedure, dye can be injected into the ducts of the bile duct tree and / or pancreas so that the area can be viewed using X-rays. These procedures may require obtaining and maintaining access to the papilla of Vater, the common bile duct, and / or the pancreatic duct, which can be technically challenging, may require a lot of training and practice to master, and may require one or more expensive tools to perform.

[0048] During the ERCP procedure, while the subject is sedated and / or anesthetized, a number of steps may be performed. For example, the endoscope may be inserted through the mouth, down the esophagus, into the stomach, through the pylorus into the duodenum, and into a position at or near the papilla of Vater (also known as the ampulla of Vater), which is the opening of the common bile duct and pancreatic duct. Due to the shape of the papilla and the angle at which the common bile duct and pancreatic duct intersect the duodenal wall, the distal end of the endoscope is typically placed just behind the papilla. Due to the position of the endoscope beyond the papilla, the endoscopes typically used for these procedures are side-view endoscopes. The side-view feature provides imaging along the lateral aspect of the distal end, rather than imaging from the axial aspect of the terminal end of the endoscope. Such an orientation may allow the physician to obtain an image of the inner wall of the duodenum, where the papilla of Vater is located, even if the distal tip of the endoscope is beyond the opening.

[0049] In some cases, a fluid (e.g., a compressible fluid, such as a compressible gas, air, nitrogen, carbon dioxide, etc., and / or other suitable fluid) may be delivered to an opening of a body cavity (e.g., the papilla of Vater) of a subject via a catheter, an endoscope (e.g., inserted through a subject as discussed above, or otherwise inserted), an endoscopic attachment device, or other suitable elongated medical device. Application of the fluid to the opening may facilitate identification and / or entry into the body cavity by at least partially dilating the opening with the fluid prior to and / or during delivery of the catheter, endoscope, guidewire, etc. to a target anatomical structure or tissue (e.g., a catheter or other suitable structure or tissue) at or distal to the opening of the body cavity. While a flow of fluid may be used to identify and / or dilate an opening to a lumen, it may be desirable during a procedure to limit or reduce the total amount of fluid delivered to a body cavity, space, or cavity of the subject.

[0050] The fluid may be delivered to the opening of the body cavity in any suitable manner via a catheter, endoscope, etc. Some example techniques and systems for delivering fluid to the opening of a body cavity are described in U.S. Patent Application Publication No. 2019 / 0380565, filed on June 13, 2019, entitled “DEVICES, SYSTEMS AND METHOD FOR ACCESSING A BODY LUMEN,” which is hereby incorporated by reference for any and all purposes.

[0051] A system for delivering a compressible fluid to a body cavity opening can result in a volume of gas being delivered to a closed cavity of a subject. In some cases, the subject's body may require an extended period of time to fully absorb the gas. The volume of gas may cause pain, discomfort, and / or abnormal sensations to the subject until the gas is fully absorbed or otherwise passed. The amount of fluid provided to the subject may result in tissue barotrauma, destruction, rupture, and / or other adverse effects that may be present on the subject's body tissues.

[0052] Therefore, it is desirable to provide a system that can facilitate opening a body cavity and maintaining the body cavity in an open state while limiting the amount of fluid provided to the subject. Such systems can be configured to deliver a fluid with a high initial flow rate to the subject to facilitate identification and / or expansion of the opening of the subject's body cavity, and then deliver a fluid with a lower flow rate to the subject to facilitate maintaining the body cavity in an open state. Such systems can reduce or mitigate the amount of fluid required to open the body cavity and maintain the body cavity in an open state. Such reductions in the total amount of fluid provided to the body cavity can reduce the possibility of causing tissue drying, destruction and / or other damage (when expanding the tissue, it can be caused by using large flow and / or high-speed gas).

[0053] Turning to the attached figure, Figure 1 and Figure 2 Selective intubation during an ERCP procedure is shown, which includes positioning the distal portion of a medical device 22 (e.g., a duodenoscope, an endoscope, etc.) within the descending duodenum 18, and passing a guidewire 12 and / or an endoscope accessory device 14 through the medical device 22 toward, against, and / or through a body cavity, such as the major papilla 16 (e.g., the inlet of the ampulla) near the descending duodenum 18, to access the sphincter of Oddi complex 20. The guidewire 12 and endoscope accessory device 14 may be advanced through a working channel 23 of the medical device 22 toward the major papilla 16. In addition, the guidewire 12 and / or endoscope accessory device 14 may be advanced against and / or through the major papilla 16 to a desired one of the common bile duct 17, the pancreatic duct 19, and / or other suitable body cavities.

[0054] Access to the papilla 16 may be difficult because the opening is small compared to the size (e.g., diameter) of many medical devices, the opening may be completely collapsed / closed, and / or the opening may extend into the descending duodenum 18 at an angle that is difficult to view and / or access. Therefore, the medical professional may be required to manipulate the endoscope adjunct device 14 and guidewire 12 by manually rotating the medical device 22 and / or using an elevator within the distal end of the medical device 22 in an attempt to better align or orient the endoscope adjunct device 14 and / or guidewire 12 relative to the opening of the medical device 22 and the papilla 16. Difficult cannulation procedures, in which the medical professional is unable to access the sphincter papilla within a certain time limit or after a certain number of unsuccessful attempts, may lead to serious postoperative complications, such as post-ECRP pancreatitis (PEP).

[0055] As discussed above, a medical professional who enters a body cavity (e.g., a catheter, such as a nipple, etc.) by manipulating a medical device against or into the opening of the body cavity may subject the walls of the opening of the body cavity to compressive forces. Compression of the body cavity opening or the body cavity itself may cause buckling that may be described as an "accordion effect." If a medical device is inserted into a body cavity without an accordion effect, opening the body cavity and / or maintaining its patency by repeated insertion of a medical device and / or guidewire or other instrument may cause irritation of body tissue due to friction.

[0056] Figure 3 An exemplary system 24 for accessing a body cavity without touching a medical device to open an opening to the body cavity and to maintain the opening open during surgery and / or otherwise while the medical device is positioned in the body cavity is shown. In some cases, the system 24 may include a medical device 22 having a flexible elongated tube 26 and other components.

[0057] The tube 26 may have a proximal end 26a and a distal end 26b. The distal end 26b of the tube 26 may be configured to direct toward and / or through an opening of a body cavity. The proximal end 26a of the tube 26 may be connected to the handle 28, coupled thereto, or otherwise in communication therewith.

[0058] The wire filament 30 may extend along the elongated tube 26 and may be energized for the purpose of cutting tissue in a subject. The wire filament 30 may have a proximal end (not shown) and a proximal portion connected to an actuating portion 32 of the handle 28, the proximal portion extending at least partially within the tube 26. The wire filament 30 may also have a distal portion 34 extending outside the elongated tube 26, and the distal end 36 of the filament 30 may be connected to the distal end 26b of the elongated tube 26.

[0059] The wire filament 30 can be received within the lumen of the tube 26 at least along the proximal portion of the filament 30 and can be configured to slide within the lumen. In some cases, the actuation portion 32 of the handle 28 can be manipulated to slide the wire filament 30 along the tube 26 (e.g., within the lumen of the tube 26).

[0060] The sliding of the wire filament 30 may cause the distal end 26b of the elongated tube 26 to move in response to the sliding of the wire filament 30. Thus, the actuation portion 32 of the handle 28 may be manipulated to control or adjust the position of the distal end 26b of the elongated tube 26. In one example, the actuation portion 32 of the handle 28 may be manipulated to guide the distal end 26b of the tube 26 toward the opening of the body cavity.

[0061] In some cases, the wire filament 30 can be used to electrically cut, remove and / or cauterize tissue of a subject. Therefore, the handle 28 or other suitable portion of the medical device 22 may include an electrical connection 38 to an energy source (e.g., a radiofrequency energy source, etc.) to energize the wire filament 30 and facilitate cutting tissue. When the actuation portion 32 of the handle 28 is manipulated to apply tension to the wire filament 30 and adjust the position of the distal end 26b of the tube 26, the wire filament 30 can be spaced apart from the tube 26 and energized to facilitate cutting tissue at or adjacent to the opening of the body cavity.

[0062] The medical device 22 may include one or more lumens extending from at least the proximal end 26a of the tube 26 to the distal end 26b of the tube 26. Although not required, at least a portion of the one or more lumens may move along with the distal end 26b of the tube 26 (e.g., toward the opening of the body cavity).

[0063] In some cases, the first lumen of the one or more lumens of the elongated shaft 26 may have a fluid connection for a pressurized fluid source 40 (e.g., a CO2 tank or container of other suitable fluids) at the proximal end. The first lumen may be configured to apply a fluid (e.g., gas) from the fluid source 40 to an opening at the body cavity of the subject to open or at least partially open the opening for entering the body cavity through the guide wire 12 and / or the elongated tube 26 without or substantially without the elongated tube 26 contacting the body cavity. Once the body cavity is opened or partially opened, the user can energize the wire filament 30 to cut or remove body tissue to further expand the opening.

[0064] A second lumen of the one or more lumens may be configured to receive a guidewire 12. The second lumen may extend at least partially along the tube 26 from the distal end 26b of the tube 26 toward the proximal end 26a of the tube 26. In some cases, the guidewire 12 may extend proximally away from the orifice port 45 and / or distally away from the distal opening at the distal end 26b of the tube 26. Once in the target body cavity, the tube 26 may be withdrawn from the guidewire 12, and the guidewire 12 may be used to guide the medical device 22 or other instrument to the target area in the body cavity of the subject.

[0065] The orifice port 45 may be located at the distal end of the handle 28, at the proximal end 26b of the tube 26, and / or at one or more other suitable locations. In some cases, the orifice port 45 and the tube 26 may be configured so that the guidewire 12 can be peeled through the side of the tube 26 for rapid removal or exchange of the device, but this is not required.

[0066] The third lumen of the one or more lumens can be configured to be in fluid communication with a source of contrast agent and deliver the contrast agent to the subject's body cavity and / or associated tissue. The contrast agent can be supplied to the third lumen, for example, via a syringe and / or through one or more other suitable connectors, which is attached to the Luer connector on the handle 28. The contrast agent can be delivered to the body cavity and can be used to temporarily improve imaging of the inside of the body cavity by, for example, x-rays, fluoroscopy, computed tomography (CT) or magnetic resonance (MR) imaging, ultrasound, etc.

[0067] Although not required, a filter (e.g., a 0.1 micron filter and / or other suitable filter) in conduit 42 can be in fluid communication with a first lumen that is distal or downstream of fluid source 40 and proximal or upstream of the first lumen. In some cases, a flow regulator 44 can be in fluid communication with the first lumen and can be used to regulate the flow of fluid from fluid source 40, through the filter in conduit 42 (when included), and to or within the first lumen of tube 26.

[0068] The flow regulator 44 may include a valve configured to allow a user to change the flow rate and / or pressure of fluid through the device 22. In some configurations, the flow regulator 44 may be or may include an open / close valve. In one example, the flow regulator 44 may be or may include a trumpet valve.

[0069] A pressure relief vent and / or valve may be positioned along the fluid path of the fluid source 40 and upstream of the elongated tube 26 to relieve pressure in the system 24 in the event that the pressure of the fluid is too high for surgery or patient safety due to, for example, blockage of the lumen or possible failure of the regulator 44. The pressure relief vent may include a one-way valve that opens at a certain pressure threshold, and / or may have one or more other suitable configurations.

[0070] In some cases, the pressure of the fluid at the fluid source 40 may be higher than the desired pressure of the fluid at the accessory device 14. Therefore, the fluid of the fluid source 40 may be supplied by the regulator 44 to reduce the fluid pressure before the pressure relief orifice or pressure relief valve. The regulator 44 and / or the pressure relief valve may protect the subject and the accessory device 14 from the higher pressure of the fluid source 40 by lowering the pressure at the regulator 44 or providing a pressure relief threshold at the pressure relief orifice or valve to release the fluid pressure if the pressure at the orifice or valve exceeds the pressure relief threshold.

[0071] In some cases, a pressure relief orifice or valve may be located downstream of the flow regulator 44. In such cases, if the regulator 44 fails or is incorrectly set, the pressure relief valve may open to prevent an undesirably high pressure and / or high flow of fluid from entering the accessory device 14. A suitable fluid pressure range for the system or device delivered from the downstream side of the regulator 44 and / or the pressure relief valve may be, for example, about 10 psi to about 50 psi, and / or other suitable pressure value ranges.

[0072] Figure 4 An enlarged distal end of system 24 is shown that provides fluid 46 to an opening 48 (e.g., an opening defined by major papilla 16) of a body cavity 50 (e.g., a body cavity defined by sphincter of Oddi 20). Although not shown, fluid 46 may be from a fluid source (e.g., fluid source 40 and / or other suitable fluid source) and exit the distal end of tube 26 at a constant or substantially constant rate and / or pressure to adjust opening 48 to an open state and maintain opening 48 in an open state.

[0073] In order to reduce the amount of fluid provided to the subject during surgery and the amount of time that the subject is subjected to high pressure and / or flow rate fluid, system 24 can be configured to provide fluid to the subject with a non-constant flow rate. For example, system 24 can be configured to provide fluid to the subject with an initial flow rate or outlet speed, and then reduce to the flow rate or outlet speed at which fluid is provided to the subject, until the flow reaches the desired flow rate or outlet speed of the fluid. In some cases, after initially using fluid to adjust the opening from a closed state to an open state, the desired flow rate or outlet speed of the fluid is to maintain the opening of the body cavity at the flow rate or outlet speed required for the open state. The flow rate or outlet speed of the fluid provided to the subject can be carried out in a linear manner, a step-wise manner, and / or one or more other suitable manners from a first flow rate or outlet speed to a lower second flow rate or outlet speed. Figures 5 to 10 Systems, components, and methods are described for providing fluid to a subject at a decreasing flow rate or velocity over time during a procedure until a predetermined flow rate or velocity is reached.

[0074] Figure 5A configuration of a system 24 is shown, which is configured to provide a fluid to a subject at a first flow rate or outlet velocity (e.g., an initial flow rate or outlet velocity), wherein the flow rate or outlet velocity of the fluid provided to the subject may decrease (e.g., decay) over time to a second flow rate or outlet velocity. In some cases, the second flow rate or outlet velocity may be based at least in part on the fluid flow rate or outlet velocity of the fluid exiting a pressurized fluid source. The first flow rate or outlet velocity may be greater than the second flow rate or outlet velocity.

[0075] Starting from the proximal end of the system 24, Figure 5 The illustrated system 24 may include one or more fluid sources 40 (e.g., cylinders or containers including pressurized fluid), one or more cylinder pressure gauges 52 configured to provide an indication of the pressure in the one or more fluid sources 40, one or more pressure controllers 54 (e.g., pressure adjustment knobs and / or other suitable pressure controllers) configured to control the pressure or flow rate (e.g., volumetric flow rate) of fluid exiting the one or more fluid sources 40, one or more outlet pressure gauges 56 configured to provide an indication of the pressure or flow rate of fluid exiting the one or more fluid sources 40 downstream of the one or more pressure controllers 54, a fluid source outlet conduit 58, a pressurization system configured to receive fluid from the fluid source outlet conduit 58 and to discharge the fluid to the pressurized fluid. And includes a flow restrictor 62 and a fluid accumulator 64, an accumulator outlet conduit 66, which is connected to the outlet of the fluid accumulator 64 and is configured to receive fluid from the fluid accumulator 64, a flow regulator, which is connected to the accumulator outlet conduit 66 and is configured to receive fluid from the accumulator outlet conduit 66, and a flow regulator outlet conduit 72, which is connected to the flow regulator 44 and connector 74 (e.g., a Luer connector and / or other suitable type of connector) of an endoscopic accessory device 14 (e.g., a sphincterotomy and / or other suitable accessory device) to provide fluid passing through the flow connector 44 to the accessory device 14 to cause the opening of the subject's body cavity to open and remain open over time, etc. The lumen of the elongated tube 26 of the accessory device 14 may extend from the distal end of the elongated tube 26 toward the proximal end of the elongated tube 26 and extend through the connector 74 to the flow regulator outlet conduit 72, which is selectively connected to the flow accumulator 64 via a flow valve 68 (e.g., within the housing, as shown in the drawings).

[0076] Although multiple tubes 58, 66, 72 are Figure 5 24 and discussed above, but a single tube or more than one tube may be utilized as desired. In some cases, the tubing of system 24 may be combined to form a single lumen or multiple lumens through which the fluid of fluid source 40 passes to the subject and through accessory device 14 to the subject.

[0077] The pressure controller 54 may be regulated to control the pressure or flow rate of the fluid exiting the fluid source 40. In some cases, when included, the fluid source pressure gauge 52 may display or otherwise provide an indication of the pressure upstream of the pressure controller 54 (e.g., in the fluid source 40). When included, the fluid source outlet pressure gauge 56 may display or otherwise provide an indication of the pressure or flow rate of the fluid downstream of the pressure controller 54 (e.g., output therefrom), as set by the pressure controller 54 and at which the fluid is provided to the pressurized system 60.

[0078] The pressurization system 60 may be configured to facilitate providing fluid to the subject at a pressure or flow rate set by the pressure controller 54 or at a pressure or flow rate less than that, and the pressurization system 60 may include a flow restrictor 62 and a fluid accumulator 64. In some cases, the pressurization system 60 may include a housing that accommodates the flow restrictor 62, the fluid accumulator 64, and / or other suitable components of the pressurization system 60, but this is not necessary. The flow restrictor 62 may be configured to narrow the flow path of the fluid to limit the flow rate of the fluid from the fluid source 40 traveling through the flow path at a given inlet pressure. The flow restrictor 62 may be fixed, or optionally may be variable. Other suitable flow restrictors 62 are envisioned. In some cases, the flow restrictor 62 may be omitted.

[0079] The fluid concentrator 64 may have a proximal end configured to receive fluid from the pressurized fluid source 40 and a second end (eg, a distal end). Figure 5 As shown, the fluid accumulator 64 may be a cylinder configured to accumulate fluid when the flow regulator 44 is in the closed state. Other suitable types of fluid accumulators are contemplated, including but not limited to a tube coil, a length of tubing, one or more tanks, a chamber (which is consistent with the flow path of the fluid of the pipeline or system 24); and / or other suitable volumes that are configured to add a compressed fluid volume between the flow restrictor 62 and the flow regulator 44 (e.g., configured to be filled with pressurized fluid) when the flow regulator 44 is in the closed state and output the pressurized fluid when the flow regulator 44 is switched to the open state.

[0080] Fluid accumulator 64 may be any suitable type of fluid accumulator. In some cases, fluid accumulator 64 may be a fixed volume. In such cases, when pressurized fluid is supplied to accumulator 64 at a constant rate and flow regulator 44 is open, the flow rate of the fluid provided to the subject may decay linearly from an initial flow rate to a steady-state flow rate over time.

[0081] The flow regulator 44 may include a flow valve 68 and a switch actuator 70 (e.g., a switch). As shown, the flow valve 68 may be located within a housing and may be configured to regulate the flow from the accumulator outlet conduit 66 through the flow regulator outlet conduit 72 (e.g., regulate the flow through one or more lumens of the conduits 66, 72). The conduits 66, 72 and / or one or more lumens thereof may be coupled to and / or communicated with the flow valve 68 in any suitable manner, such that actuation of the flow valve 68 regulates the flow through one or more lumens of the conduits 66, 72.

[0082] The flow valve 68 can be any suitable type of valve that is in communication with the flow path of the pressurized fluid from the fluid source 40 to the accessory device and is adjustable between an open state and a closed state. When the flow valve 68 is in the closed state, the flow accumulator 64 can accumulate pressurized fluid for release under pressure when the flow valve 68 is adjusted to an open state or position.

[0083] In some configurations, the flow valve may be an open / close valve. Additionally or alternatively, the flow valve 68 may be an adjustable valve having a closed configuration that blocks flow through one or more lumens of the conduits 66, 72 and an adjustable "open" configuration that allows different adjustable levels of flow through one or more lumens of the conduits 66, 72. In one example configuration, the flow valve 68 may be or may include a trumpet valve, but this is not required.

[0084] The switch or switch actuator 70 can be in mechanical, electromechanical and / or electrical communication with the flow valve 68 such that the switch actuator 70 can be adjusted to adjust the flow valve 68 between an open state and a closed state. In one example, a first actuation of the switch actuator 70 can cause the lumen of the accessory device 14 and the fluid accumulator 64 to be in fluid communication, and a second or subsequent actuation of the switch actuator 70 can cause fluid flow between the lumen of the accessory device 14 and the fluid accumulator 64 to be blocked.

[0085] The switch actuator 70 may be any suitable type of actuator that is configured to be adjusted to switch the state of the flow valve 68. Figure 5 As shown, the switch actuator 70 can be a foot switch. Alternatively or in addition, the switch actuator 70 can be a button, a dial, a knob, a touch screen controller, an on / off switch, and / or other suitable types of switch actuators 70.

[0086] In operation, the system 24 can be used to accumulate or pressurize fluid in the fluid accumulator 64 so that when the switch actuator 70 is adjusted or actuated to cause the flow valve 68 to adjust from the closed state to the open state, the pressurized fluid can be delivered from the fluid source 40 and the fluid accumulator 64 to the subject at a relatively high flow rate at a relatively high exit velocity through the lumen of the accessory device 14. The first flow rate can be determined by the source pressure set at the pressure controller 54, which can be the maximum pressure achieved in the fluid accumulator 64 when the flow valve is in the closed state. Therefore, when the fluid accumulator 64 is located downstream of the flow restrictor 62, has a determined volume, and is pressurized by the fluid from the fluid source 40, the maximum value of the flow rate of the fluid leaving the fluid accumulator 64 can be determined by the first pressure in the accumulator 64 and the inherent flow resistance of the flow path downstream of the fluid accumulator 64. When the flow valve 68 is in the open state, due to the flow restrictor 62 between the fluid source 40 and the fluid accumulator 64, the fluid flowing out of the fluid accumulator 64 flows out of the fluid accumulator 64 faster than the fluid that can enter the fluid accumulator 64, and therefore, the initial higher flow rate and fluid outlet velocity of the fluid from the distal end 26b of the slender tube 26 decreases over time until it reaches a steady-state flow rate or outlet velocity (e.g., a second flow rate or velocity) indicated by 1) the pressure set by the pressure controller 54 and 2) the configuration of the flow restrictor 62, etc. The second flow rate or velocity can be regarded as a steady-state flow rate or velocity, which occurs when the fluid enters the fluid accumulator 64 at the same rate as it leaves the fluid accumulator 64. Then, once the flow valve 68 is closed or begins to close, the system 24 can reset itself and the pressurized fluid will fill the fluid accumulator 64 again, so that the process of supplying high pressure or high flow rate fluid to the subject can be repeated as needed.

[0087] The configuration of system 24 may be configured and / or adjustable to obtain a desired flow rate, velocity, or pressure of the fluid provided to the subject over time. For example, the configuration (e.g., size, shape, etc.) of fluid accumulator 64, the fluid pressure set at pressure controller 54, and the configuration (e.g., size, shape, etc.) of flow restrictor 62 may be configured or adjustable such that a peak flow rate (e.g., an initial or first flow rate), a flow rate decay rate (e.g., a slope from a peak flow rate to a steady-state flow rate), a ramp-down duration (e.g., a transition time from a peak pressure or flow rate to a steady-state pressure or flow rate), and / or a steady-state pressure or flow rate (e.g., a second flow rate) may be set to a desired level (e.g., a level sufficient to open an opening at a body cavity, maintain the opening in an open state, provide no more than a desired amount of fluid to the subject, etc.). In some cases, the fluid pressure value set at the pressure controller 54 may determine a peak or first flow rate or outlet velocity; the fluid pressure and / or flow rate set at the pressure controller 54 and the configuration of the flow restrictor 62 may determine a steady-state or second flow rate or outlet velocity; and the size of the fluid accumulator 64 and the characteristics of the fluid path downstream of the accumulator 64 may determine the pressure or flow rate decay rate, and / or the duration between a peak or first flow rate or outlet velocity and a steady-state or second flow rate or outlet velocity, and so on.

[0088] Figure 5 The illustrated system 24 may allow, when the flow valve 68 is enabled or opened to facilitate expansion or otherwise opening of a body cavity opening, gas to be delivered from the accessory device 14 at a higher initial flow rate or outlet fluid velocity; and then the flow rate or outlet velocity of the fluid delivered to the subject is automatically reduced to a level sufficient to maintain the opening of the body cavity to allow placement of one or more medical devices within the body cavity. The reduction in flow rate may result in a significant reduction in the total amount of gas delivered to the subject during the procedure, as compared to existing systems for delivering fluid to the subject to open the body cavity. The reduction in the total amount of gas delivered to the subject may reduce the risks associated with the expansion and pressurization of a closed or normally closed body cavity of the subject undergoing surgery. In addition, the reduction in fluid flow rate or pressure may reduce the overall stress applied to affected tissues and structures when the pressurized fluid is delivered to the subject, and may also reduce the risk of incidental effects such as tissue desiccation and / or other effects due to exposure of the tissue to a volume of dry fluid expanded from a compression source.

[0089] Figure 6 Another configuration of the system 24 is shown, which is similar to the above configuration with respect to Figure 5 The system 24 discussed is configured to operate in a manner wherein Figure 6The configuration of the system 24 has a pressurized system 60, which includes a fluid source 40, a flow restrictor 62, and a fluid accumulator 64. In some cases, the pressurized system 60 may include a housing that houses the fluid source 40, the flow restrictor 62, the fluid accumulator 64, and / or one or more other suitable components of the pressurized system 60.

[0090] When the pressurized system 60 is Figure 6 When configured as shown, the pressurized system can have a releasable connection to the accumulator outlet conduit 66. In such a configuration, the pressurized system 60 can be disconnected from the accumulator outlet conduit 66 and reused for subsequent procedures on other subjects while allowing the conduits 66, 72 and flow regulator 44 to be set.

[0091] In addition, if Figure 6 As shown, the flow regulator 44 can be configured to be handheld. Figure 5 A flow regulator 44 configured as a foot switch is shown, and Figure 6 A handheld flow regulator 44 is shown, but Figure 5 and Figure 6 The illustrated configuration of the system 24 may utilize a foot-operated flow regulator 44 , a hand-held flow regulator 44 , and / or other suitable configurations of flow regulators 44 .

[0092] In one configuration of the handheld flow regulator 44, the flow valve 68 may include a plurality of positions 76 configured to receive a user's fingers when the flow valve 68 is grasped (e.g., grasping positions). Additionally, when the flow valve 68 is configured to be grasped by a user's hand, the switch actuator 70 may be configured as a button (e.g., Figure 6 In operation, a user may grasp flow valve 68 so that their fingers surround flow valve 68 and may actuate switch actuator 70 by depressing switch actuator 70 with the thumb of the hand grasping flow valve 68 or in one or more other suitable manners to facilitate providing a desired flow of pressurized fluid to a subject, although other configurations are contemplated.

[0093] Figure 7 1 is a schematic flow chart of an exemplary technique 100 for accessing a body cavity of a subject. In some cases, the system 24 discussed above or a system similar to the system 24 can be used to access a body cavity of a subject. Although the technique 100 can be used to access openings of other body cavities, in one example, the technique 100 can be used to access the major papilla of a subject to access the common bile duct and / or the pancreatic duct.

[0094] Exemplary technique 100 may include extending 102 an elongated tube of an accessory device (e.g., elongated tube 26 of accessory device 14, such as a sphincterotomy and / or other suitable elongated tube) through a working channel of an endoscope that is inserted into a lumen of a subject (e.g., a lumen of the duodenum of a subject and / or other suitable body lumen). The endoscope may be inserted into the lumen using any suitable known technique. The elongated tube may be extended through the working channel of the endoscope before or after the endoscope has been positioned in the lumen of the subject, as desired.

[0095] The distal end of the elongated tube extending through the working channel of the endoscope can be guided 104 toward the opening of the body cavity of the subject. In some cases, after the endoscope has been positioned adjacent to the opening of the body cavity, the distal end of the elongated tube is pushed through the endoscope, which can automatically cause the distal end of the elongated tube to be guided toward the opening of the body cavity. For example, a visualization system associated with the endoscope can be used to position the opening at the end of the endoscope adjacent to the opening of the body cavity. In addition, the endoscope may have a ramp feature or other lifting feature to guide the elongated tube away from the opening in the endoscope so that the distal opening of the elongated tube (which is in communication with the fluid lumen) is positioned in addition to or near the opening of the body cavity. Alternatively or in addition, the elongated tube may include or may be connected to a wire that can be tensioned at the proximal end to cause the distal end of the elongated tube to bend in a predetermined direction to control the position of the distal opening of the elongated tube as the distal end leaves the endoscope.

[0096] In addition, technology 100 may include causing fluid to flow 106 from a fluid source (e.g., fluid source 40 and / or other suitable fluid sources) through the lumen of the elongated tube and toward the opening of the body cavity to flow away from the distal opening of the elongated tube. The flow of fluid from the fluid source through the lumen of the elongated tube can be caused by adjusting or actuating a switch controller (e.g., switch actuator 70 or other suitable switch controller) that is communicated with a valve (e.g., valve 68 or other suitable valve) to open the valve and allow pressurized fluid to flow from the accumulator and the fluid source to the lumen of the elongated tube and flow to the subject. The accumulator can be selectively fluidically connected to the lumen of the elongated tube via a flow valve, and the actuation or regulation of the valve (e.g., in response to actuating the switch controller) can automatically cause fluid to flow from the accumulator and flow away from the lumen of the elongated tube.

[0097] Once the valve is in an open state, the pressurized fluid from the fluid source and the accumulator can flow to or toward the opening of the body cavity at an initial first predetermined flow rate and then at a non-zero second predetermined flow rate. The flow rate of the fluid to or toward the opening of the body cavity can automatically decay from the first predetermined flow rate to the second predetermined flow rate. Although not required, one or more of the configurations of the system 24 described herein can be used to provide fluid to the opening of the body cavity at an initial predetermined fluid flow rate that automatically decays to the second predetermined flow rate in a linear decay manner.

[0098] Additionally, after all or at least some of the fluid has been drained from the accumulator, adjusting the switch control to cause the valve to close can prevent fluid from the fluid source and the accumulator from reaching or otherwise flowing to the accessory device. Thus, the closure of the valve can cause fluid from the fluid source to accumulate in the fluid accumulator, which causes the system to "refill" to be able to provide fluid at the first predetermined flow rate at a second or subsequent time.

[0099] A first predetermined flow rate or pressure of a fluid provided to an opening of a body cavity may result in a force acting on the opening of the body cavity, which is sufficient to cause the opening of the body cavity to be adjusted to an open state. A second predetermined flow rate or pressure of a fluid provided to an opening of a body cavity may result in a force acting on the opening of the body cavity, which is sufficient to maintain the opening of the lumen in an open state during surgery. A lower pressure or flow rate of the fluid may be used to maintain the opening of the lumen in an open state than to open the opening, because the fluid acts on a larger surface area when maintaining the opening of the body cavity in an open state than when the fluid is being used to adjust the opening of the body cavity to an open state. Such use of a lower flow rate, outlet velocity, or stagnation pressure to maintain the opening of the body cavity in an open state may result in less fluid being injected into the subject during surgery, which reduces damage to the subject.

[0100] While the steps presented above may provide methods for accessing a body cavity, variations of these methods are also contemplated for achieving the same or similar objectives.

[0101] Figures 8 to 10 4. It is shown that fluid 46 acts on opening 48 of major papilla 16 at the sphincter of Oddi complex (e.g., which defines the lumen leading to common bile duct 17 and pancreatic duct 19) of a subject to adjust opening 48 from a closed state to an open state, and to maintain opening 48 in the open state. Fluid 46 may be provided to the subject from a system (such as system 24 discussed herein) and / or from other suitable systems configured to reduce the fluid flow rate from an initial fluid flow rate to a second fluid flow rate when or after adjusting the opening of the body cavity to the open state, and to maintain the opening in the open state using the reduced second fluid flow rate. Assuming that a force substantially the same or similar to the force required to open opening 48 is required to maintain opening 48 in the open state, a lower pressure of fluid 46 may be used to maintain opening 48 in the open state compared to the force required to open opening 48, because force is equal to pressure multiplied by the surface area contacting the pressure.

[0102] like Figure 8As shown, the medical device 22 (e.g., endoscope, duodenoscope, etc.) has been placed in the duodenum of the subject, wherein its opening 75 faces the opening 48 of the major papilla 16, wherein the opening 48 is in a closed state. The distal tip of the elongated tube 26 of the system 24 can be directed away from the opening 75 of the medical device 22, and the fluid 46 can be output toward the opening 48 at a first predetermined rate. The fluid 46 can contact the surface area of ​​the opening 48 in the closed state, and must have a pressure that is sufficient to overcome the natural force of the sphincter of Oddi complex 20 to adjust the opening 48 from the closed state to the open state. In some cases, the initial flow rate or exit velocity of the fluid 46 (which results in a stagnation pressure at the tissue surface) can be set based on the expected size of the first surface area (but this is not necessary) to generate a desired force at the surface area of ​​the closed opening 48 to open the opening 48, while reducing the volume used to open the opening 48.

[0103] The first surface area may depend on the geometry of the large nipple 16 in the closed position (e.g. Figure 8 ), and the configuration of the fluid 46 leaving the attachment device 14 and contacting the large nipple 16. However, to schematically illustrate the first surface area in one example, it can be assumed that the first surface area can be approximated by a circle having a diameter SA1, such as Figure 8 When the circle has a diameter of SA1, the circle can define a surface area: half the distance of SA1 (D SA1 ) squared and multiplied by π, ~3.14×(1 / 2×D SA1 )^2.

[0104] Fig. 9 The opening 48 is shown in an open state. At this point, the fluid 46 may enter the body cavity 50, and the flow rate of the fluid 46 may have begun to decay from the first predetermined flow rate to a second predetermined flow rate that is slower than the first flow rate and sufficient to maintain the opening 48 of the body cavity 50 in an open state.

[0105] Fig.10 The opening 48 is shown maintained in an open position. Fig.10 As shown, the fluid 46 can act on the surface area (e.g., the second surface area) of the opening 48 of the body cavity 50 along the length SA2 to maintain the opening 48 in an open state during surgery on the subject. Figure 8 When comparing the second surface area (e.g., when the opening 48 is in the open state) with the second surface area on which the fluid 46 acts, it can be seen that the second surface area (e.g., when the opening 48 is in the open state) is larger than the first surface area (e.g., when the opening 48 is in the closed state). Therefore, a lower flow rate or fluid pressure at the opening 48 than is required to adjust the opening 48 to the open state can be used to maintain the opening 48 in the open state.

[0106] The second surface area may depend on the geometry of the opening 48 of the body cavity 50 along the length SA2 (e.g. Fig.10 ), and the configuration of the fluid 46 leaving the attachment device 14 and contacting the large nipple 16. However, to schematically illustrate the second surface area in one example, it can be assumed that the second surface area can be represented by a length or height (D SA2 ) is approximated by a bottomless and topless cylinder, so that the second surface area can be approximately (D SA2 )×the circumference of the opening 48.

[0107] Examples of Fluid Flow During Surgery

[0108] In one example configuration of the system 24, carbon dioxide gas (CO2) may be delivered to the distal end of the sphincterotomy catheter to enter and dilate the major duodenal papilla (Vater's papilla). In this example, the CO2 lumen of the catheter may have an outlet diameter of 0.016 inches; and the gas delivery system may be designed to deliver fluid out of the catheter at a first predetermined flow rate and outlet velocity when gas flow is initially triggered, and then decrease in a linear decaying manner to a second predetermined flow rate and outlet velocity.

[0109] When the flow rate for CO2 delivery is set at 1.0 liter per minute (lpm) at the fluid source (e.g., 16.67 ml / sec), the resulting exit velocity of the gas leaving the sphincterotomy device and entering the subject will be 128.5 meters per second (m / s), which is sufficient to regulate the major duodenal papilla to an open state. When the flow rate for CO2 delivery is set at 0.5 lpm, the exit velocity of the gas leaving the sphincterotomy device and entering the subject will be 64.25 m / s, which is sufficient to maintain the opening at the major duodenal papilla in an open state.

[0110] In some procedures, gas is provided to the major duodenal papilla for forty-five (45) seconds to adjust the papilla to an open state and maintain the papilla in an open state during the procedure. If gas is provided to the papilla at a rate required to initially open the papilla (e.g., in this example, 1.0 liters per minute), for the full forty-five seconds of gas delivery, then 750.15 milliliters of fluid will be delivered to the subject. If gas is provided to the subject via a system configured to reduce the pressure or flow rate of fluid provided to the subject in the manner described herein or otherwise, wherein the first predetermined flow rate is 1.0 lpm, the second predetermined flow rate is 0.5 lpm, and the decay rate from the first predetermined flow rate to the second predetermined flow rate is 0.52 ml / s, then the volume of fluid delivered to the subject within forty-five seconds of providing the fluid to the subject is 441.73 milliliters.

[0111] The amount of fluid provided to the subject during the forty-five seconds of providing fluid (using a custom decaying flow rate system that utilized the parameters of the present example) was approximately 58.89% of the volume provided in the system, which did not reduce the flow rate after opening the nipple. Additionally, in the decaying system using a decay rate of 0.52 ml / s, the flow rate decreased from the first predetermined flow rate (1.0 lpm) for sixteen seconds and was maintained at the second non-zero predetermined steady-state flow rate (0.5 lpm) for twenty-nine seconds (e.g., which is longer than the amount of time that the fluid was provided at the first predetermined flow rate), which results in less force on body tissue (e.g., less trauma) that comes into contact with the flow of fluid when compared to a constant flow rate system (which supplies fluid at a constant rate that is set to the rate required to create a force sufficient to open the opening at the nipple).

[0112] It should be understood that the present disclosure is in many respects illustrative only. Variations may be made in detail without exceeding the scope of the present disclosure, particularly with respect to the arrangement of shapes, sizes, and steps. To an appropriate degree, this may include the use of any one of the features of an example embodiment being used in other embodiments. Of course, the scope of the present invention is defined in the language of the appended claims.

Claims

1. A medical device for accessing a body cavity of a subject, the medical device comprising: a fluid concentrator having a proximal end and a second end, the proximal end being configured to receive fluid from a pressurized gas source; a flexible elongated tube having a proximal end and a distal end, the distal end being configured to be directed toward an opening of a body cavity; a lumen extending from a distal end of the flexible elongated tube toward the proximal end of the flexible elongated tube, wherein the lumen is in selective fluid communication with the second end of the fluid concentrator; and A switch, wherein actuation of the switch is configured to regulate the fluid communication between the fluid accumulator and the lumen.

2. The medical device according to claim 1, wherein: The actuation of the switch is configured to automatically cause fluid to exit the distal end of the lumen at a first rate at a first time and at a second rate at a second time after the first time, the first rate being faster than the second rate.

3. The medical device according to claim 1, wherein: The switch is in communication with a valve that selectively blocks fluid flow downstream of the fluid concentrator and upstream of the distal end of the lumen.

4. The medical device according to claim 1, wherein: A first actuation of the switch is configured to cause the fluid accumulator to be in fluid communication with the lumen; and The second actuation of the switch is configured to cause fluid flow between the fluid accumulator and the lumen to be obstructed.

5. The medical device according to claim 1, wherein: The fluid concentrator is a pipe coil.

6. The medical device according to claim 1, further comprising: a first conduit portion extending between the fluid concentrator and the switch; a second conduit portion extending between the switch and a third conduit portion; and Wherein, the third pipeline portion includes the flexible elongated tube.

7. The medical device according to claim 1, further comprising: a fluid source lumen extending from the fluid accumulator and configured to be in fluid communication with a fluid source; and A flow restrictor is positioned along the fluid source lumen.

8. A system comprising: Fluid concentrator; and a sphincterotomy device in fluid communication with the fluid accumulator; and Wherein the fluid accumulator is upstream of the sphincterotomy and is configured to accumulate pressurized fluid for selective release through the distal end of the sphincterotomy at an initial first rate that decays over time to a second rate.

9. The system according to claim 8, further comprising: A pressurized fluid source is upstream of and in communication with the fluid accumulator to supply pressurized fluid to the fluid accumulator.

10. The system according to claim 8, further comprising: A valve is upstream of the sphincterotomy and downstream of the fluid accumulator, the valve being configured to regulate the flow of fluid from the fluid accumulator to the sphincterotomy.

11. A method of accessing a body cavity of a subject, the method comprising: extending an elongated tube through a working channel of an endoscope, the elongated tube having a distal end and a lumen, the working channel extending into a subject; directing the distal end of the elongated tube toward an opening of the body cavity; causing fluid to flow from a fluid source through the lumen and out of the distal end of the elongated tube toward the opening of the body cavity; and Wherein, flowing fluid from the fluid source through the lumen and out of the distal end of the elongated tube includes initially outputting the fluid from the distal end of the elongated tube at a first predetermined rate, the first predetermined rate automatically decaying to a second non-zero predetermined rate over time.

12. The method according to claim 11, wherein: The first predetermined rate is configured to cause the opening of the body cavity to move from a closed state to an open state.

13. The method according to claim 11, wherein: The second non-zero predetermined rate is configured to cause the opening, once opened, to remain open.

14. The method according to claim 11, wherein: The second non-zero predetermined rate is maintained for a period of time that is longer than the period of time that the fluid is output at the first predetermined rate.

15. The method according to claim 11, further comprising: opening a valve to cause fluid to flow from the fluid source through the lumen and out of the distal end of the elongated tube; and Closing the valve causes fluid from the fluid source to accumulate in a fluid accumulator that is in selective fluid communication with the lumen.

Images