Systems and methods for treating the digestive tract of a subject

Abstract

A medical system for applying negative pressure within a subject's gastrointestinal tract includes an elongated tube defining at least one internal channel, a plurality of orifices in fluid communication with the internal channel, and at least one external channel. The external channel is in fluid communication with the internal channel through at least one of the orifices. The elongated tube has a delivery state and a first actuation state in which the elongated tube forms a coil including a plurality of loops. A fluid-tight lumen is in fluid communication with the elongated tube. The lumen is adapted to be connected to a negative pressure source to deliver negative pressure to the elongated tube. In the first actuation state of the elongated tube, the coil has a length of at least 15 mm and the plurality of loops includes at least four loops.

Description

[Background technology]

[0001] Gastrointestinal wounds, particularly esophageal wounds, such as perforations and postoperative anastomotic leaks, are commonly encountered in endoscopic and open surgery. Their intraluminal location and the naturally moist environment surrounding the wound make their treatment particularly challenging. Treatment options for these wounds are limited and are associated with significant morbidity and mortality or require prolonged hospitalization.

[0002] Vacuum-assisted closure (VAC) therapy can increase wound closure rates. Negative pressure wound therapy (NPWT), or VAC therapy, is the application of subatmospheric pressure to acute or chronic wounds to promote wound healing. In theory, creating negative pressure in the local wound environment increases healing rates by drawing bacteria, exudate, fluids, and necrotic tissue away from the wound site, promoting blood flow, and encouraging local cell migration and proliferation.

[0003] There is a need for improved techniques and devices for assisting wound healing by applying negative pressure adjacent to wounds in the digestive tract, particularly the esophagus. Summary of the Invention [Means for solving the problem]

[0004] Various applications herein relate to medical systems and methods for removing fluid from a target area within the gastrointestinal tract, for example, to aid in the healing of extraluminal or intraluminal wounds.

[0005] In accordance with one embodiment of the disclosed technology, there is provided a medical system for applying negative pressure within a gastrointestinal tract of a subject, comprising: The medical system includes an elongate tube and a fluid-tight lumen; The long thin tube at least one interior channel along at least a longitudinal portion of the elongate tube; a plurality of orifices in fluid communication with the at least one internal channel; and at least one exterior channel extending longitudinally along an exterior surface of the elongate tube, at least one of the at least one exterior channel being in fluid communication with the at least one interior channel through at least one of the plurality of orifices; stipulates, the elongate tube has a delivery state and a first actuation state in which the elongate tube forms a coil including a plurality of loops; the fluid-tight lumen is in fluid communication with an end of the elongated tube, the fluid-tight lumen being adapted to be connected to a negative pressure source and to deliver negative pressure to the elongated tube; A medical system is provided, wherein in the first actuated state of the elongate tube, the length of the coil is at least 15 mm and the plurality of loops includes at least four loops.

[0006] In some embodiments, the at least one internal channel includes a first internal channel adapted to drain fluid from the GI tract via the at least one external channel and the plurality of orifices when negative pressure is applied to the elongate tube.

[0007] In some embodiments, the elongate tube comprises a shape memory, elastic, or superelastic material adapted to form a coil in the first actuation state.

[0008] In some embodiments, the elongate tube has a textured outer surface adapted to frictionally engage the inner surface of the digestive tract.

[0009] In some embodiments, the at least one exterior channel comprises a plurality of exterior channels forming grooves in the exterior surface of the elongate tube and extending longitudinally therealong.

[0010] In some embodiments, the multiple orifices are arranged on a single circumference of the elongate tube.

[0011] In some embodiments, at least one exterior channel extends longitudinally along the exterior surface of the elongate tube between the orifice and the distal end of the elongate tube.

[0012] In some embodiments, the multiple orifices are disposed along the length of the elongate tube.

[0013] In some embodiments, the orifices in a first subset of the plurality of orifices have a first diameter and the orifices in a second subset of the plurality of orifices have a second diameter, the second diameter being different from the first diameter.

[0014] In some embodiments, in the first operating state, at least some of the plurality of orifices face away from the center of the coil, i.e., outward.

[0015] In some embodiments, in the first operating state, at least some of the plurality of orifices face inward, i.e., toward the center of the coil.

[0016] In some embodiments, in the first actuated state of the elongate tube, at least one of the plurality of loops has a sinusoidal configuration.

[0017] In some embodiments, the medical system further includes a straightening element, hi some embodiments, the elongate tube has a delivery state in which it is straight when associated with the straightening element and a first actuation state in which the elongate tube forms a coil when separated from the straightening element.

[0018] In some embodiments, the fluid-tight lumen and the elongate tube in the delivery state are sized and configured to pass through a working channel of a delivery device, the working channel having a diameter of less than 5 mm.

[0019] In some embodiments, the delivery state of the elongate tube is a coiled state, and the elongate tube is adapted to be disposed externally of the delivery device and delivered into the gastrointestinal tract of a subject.

[0020] In accordance with one embodiment of the disclosed technology, there is provided a medical system for applying negative pressure within a gastrointestinal tract of a subject, comprising: an elongated tube defining at least one channel along at least a longitudinal portion thereof and including a plurality of orifices in fluid communication with the at least one channel, the elongated tube having a delivery state and a first actuation state in which the elongated tube forms a coil including a plurality of loops, at least some of the plurality of loops having a sinusoidal configuration; and a fluid-tight lumen in fluid communication with an end of the elongated tube, the fluid-tight lumen being connected to a negative pressure source and adapted to deliver negative pressure to the at least one channel through the end of the elongated tube; Equipped with A medical system is provided, wherein in the first actuated state of the elongate tube, the length of the coil is at least 15 mm and the plurality of loops includes at least four loops.

[0021] In some embodiments, the at least one channel is adapted to expel fluid from the alimentary canal through the plurality of orifices when negative pressure is applied to the elongate tube.

[0022] In some embodiments, the elongate tube comprises a shape memory, elastic, or superelastic material adapted to form a coil in the first actuation state.

[0023] In some embodiments, the elongate tube has a textured outer surface adapted to frictionally engage the inner surface of the digestive tract.

[0024] In some embodiments, the multiple orifices are arranged on a single circumference of the elongate tube.

[0025] In some embodiments, the multiple orifices are disposed along the length of the elongate tube.

[0026] In some embodiments, the orifices in a first subset of the plurality of orifices have a first diameter and the orifices in a second subset of the plurality of orifices have a second diameter, the second diameter being different from the first diameter.

[0027] In some embodiments, in the first operating state, at least some of the plurality of orifices face away from the center of the coil, i.e., outward.

[0028] In some embodiments, in the first operating state, at least some of the plurality of orifices face inward, i.e., toward the center of the coil.

[0029] In some embodiments, the medical system further includes a straightening element, hi some embodiments, the elongate tube has a delivery state in which it is straight when associated with the straightening element and a first actuation state in which the elongate tube forms a coil when separated from the straightening element.

[0030] In some embodiments, the fluid-tight lumen and the elongate tube in the delivery state are sized and configured to pass through a working channel of a delivery device, the working channel having a diameter of less than 5 mm.

[0031] In some embodiments, the delivery state of the elongate tube is a coiled state, and the elongate tube is adapted to be disposed externally of the delivery device and delivered into the gastrointestinal tract of a subject.

[0032] In accordance with one embodiment of the disclosed technology, there is provided a medical system for applying negative pressure within a gastrointestinal tract of a subject, comprising: The medical system includes an elongate tube and a fluid-tight lumen; the elongate tube defining at least one channel along at least a longitudinal portion thereof and including a plurality of orifices in fluid communication with the at least one channel; The long thin tube a coil section forming a coil having a plurality of loops; and a straight section extending through the longitudinal center of the coil section; Including, the fluid-tight lumen is in fluid communication with the elongated tube, the fluid-tight lumen being connected to a negative pressure source and adapted to deliver negative pressure to the coiled portion of the elongated tube; the elongate tube is adapted to be delivered into the gastrointestinal tract of a subject with the coiled portion disposed external to the delivery device and the straight portion extending through an interior of the delivery device; A medical system is provided wherein the coil has a length of at least 15 mm and the plurality of loops includes at least four loops.

[0033] In some embodiments, the fluid-tight lumen is in fluid communication with the end of the straight portion of the elongate tube and is adapted to deliver negative pressure to the coiled portion of the elongate tube via the straight portion of the elongate tube.

[0034] In some embodiments, at least one channel of the elongate tube comprises: at least one interior channel along at least a longitudinal portion of the elongate tube; and at least one external channel extending longitudinally along an exterior surface of the elongate tube, at least one of the at least one external channel being in fluid communication with the at least one internal channel through at least one of the plurality of orifices; Includes.

[0035] In some embodiments, at least the channel is adapted to expel fluid from the GI tract through the plurality of orifices when negative pressure is applied to the elongate tube.

[0036] In some embodiments, at least the coiled portion of the elongate tube has a textured outer surface adapted to frictionally engage the inner surface of the digestive tract.

[0037] In some embodiments, the multiple orifices are arranged on a single circumference of the elongate tube.

[0038] In some embodiments, the multiple orifices are disposed along the length of the elongate tube.

[0039] In some embodiments, the orifices in a first subset of the plurality of orifices have a first diameter and the orifices in a second subset of the plurality of orifices have a second diameter, the second diameter being different from the first diameter.

[0040] In some embodiments, at least some of the plurality of orifices face away from the center of the coil, i.e., outward.

[0041] In some embodiments, at least some of the orifices face inward, i.e., toward the center of the coil.

[0042] In some embodiments, in the first actuated state of the elongate tube, each of the plurality of loops has an at least partially sinusoidal configuration.

[0043] According to some applications, a medical system for applying negative pressure within a subject's gastrointestinal tract is provided. The system includes an elongated tube defining at least one channel along at least a longitudinal portion thereof. The elongated tube includes a plurality of orifices in fluid communication with the at least one channel. The elongated tube has a delivery state and a first actuation state in which the elongated tube forms a coil including a plurality of loops. The medical system further includes a fluid-tight lumen in fluid communication with an end of the elongated tube. The fluid-tight lumen is connected to a negative pressure source and adapted to deliver negative pressure to the elongated tube via the end of the elongated tube. In the first actuation state of the elongated tube, the coil has a length of at least 15 mm or the plurality of loops includes at least three loops.

[0044] In some embodiments, at least one channel extends longitudinally along the exterior surface of the elongate tube, for example, between the orifices and / or between the orifice and an end of the elongate tube, which in some embodiments can be the distal end of the tube and in some embodiments can be the proximal end of the tube.

[0045] In some embodiments, at least one channel extends longitudinally through the interior of the elongate tube. In some embodiments, at least one channel extends longitudinally through the interior of the entire elongate tube.

[0046] In some embodiments, the elongate tube is formed from a porous material.

[0047] In some embodiments, the elongate tube has antibacterial or anti-inflammatory properties. In some embodiments, the elongate tube comprises an antibacterial or anti-inflammatory material. In some embodiments, the elongate tube is pre-treated or coated with at least one antibacterial or anti-inflammatory agent.

[0048] In some embodiments, the subject's digestive tract has an intraluminal wound, and the elongate tube is adapted to deliver an antibacterial or anti-inflammatory medication to the vicinity of the intraluminal wound for treatment of the intraluminal wound.

[0049] In some embodiments, the elongate tube has a textured outer surface, hi some embodiments, the textured outer surface is adapted to frictionally engage the inner surface of the digestive tract.

[0050] In some embodiments, at least a portion of the elongate tube is detachable from the fluid-tight lumen. In some embodiments, at least a portion of the elongate tube is formed from a biocompatible material and adapted to be naturally excreted from the subject's body after separation from the fluid-tight lumen. In other embodiments, at least a portion of the elongate tube is formed from a biodegradable material and adapted to be degraded within the subject's body after separation from the fluid-tight lumen.

[0051] In some embodiments, the at least one channel includes a first channel adapted to drain fluid from the gastrointestinal tract through the plurality of orifices when negative pressure is applied to the elongate tube, hi some embodiments, the first channel adapted to drain fluid from the gastrointestinal tract is further adapted to deliver fluid (e.g., irrigation fluid containing a contrast agent) to the gastrointestinal tract through the plurality of orifices.

[0052] In some embodiments, the at least one channel includes a second channel adapted to cleanse a portion of the alimentary canal by supplying a cleaning fluid into the alimentary canal through at least some of the elongate tube and orifices.

[0053] In some embodiments, the fluid-tight lumen and the elongate tube are substantially concentric.

[0054] In some embodiments, the elongate tube comprises a shape memory, elastic, or superelastic material adapted to form a coil in the first actuation state. Examples of elastic, superelastic, or shape memory materials include a shape memory alloy, a spring alloy, a polymer, or Nitinol. In some embodiments, the elongate tube consists essentially of an elastic, superelastic, or shape memory material.

[0055] In some embodiments, the elongate tube further includes a plurality of channels extending longitudinally therealong, the plurality of channels forming grooves in an outer surface of the elongate tube, each of the plurality of channels being in fluid communication with at least one of the channels through at least one of the orifices. In some embodiments, negative pressure delivered to the orifices through the fluid-tight lumen creates negative pressure within the plurality of grooves and expels fluid from the plurality of grooves through the orifice and into the at least one channel of the elongate tube.

[0056] In some embodiments, the multiple orifices are arranged on a single circumference of the elongate tube.

[0057] In some embodiments, the multiple orifices are disposed along the length of the elongate tube.

[0058] In some embodiments, the plurality of orifices are evenly distributed along or around the elongate tube, while in other embodiments, the orifices are non-uniformly distributed along or around the elongate tube.

[0059] In some embodiments, each of the plurality of orifices has substantially the same diameter, hi other embodiments, the orifices in a first subset of the plurality of orifices have a first diameter and the orifices in a second subset of the plurality of orifices have a second diameter, the second diameter being different from the first diameter.

[0060] In some embodiments, in the first operating state, at least some of the plurality of orifices face inward, i.e., toward the center of the coil. In some embodiments, in the first operating state, at least some of the plurality of orifices face outward, i.e., away from the center of the coil.

[0061] In some embodiments, in the first operating state, the coil is substantially devoid of orifices facing away from the center of the coil, i.e., outward.

[0062] In some embodiments, the plurality of loops comprises at least two loops having substantially the same diameter, hi some embodiments, the at least two loops comprise the most proximal and most distal loops of the plurality of loops.

[0063] In some embodiments, the diameter of one of the plurality of loops other than the most proximal and most distal loops is less than or equal to the diameter of the most proximal loop, hi some embodiments, the diameter of one of the plurality of loops other than the most proximal and most distal loops is greater than or equal to the diameter of the most proximal loop.

[0064] In some embodiments, the at least two loops having substantially the same diameter include a first loop and a second loop, and the distance between the first loop and the second loop along the longitudinal axis of the coil is greater than 10 mm.

[0065] In some embodiments, in the first actuated state of the elongate tube, the plurality of loops comprises at least four loops. In some embodiments, in the first actuated state of the elongate tube, the plurality of loops comprises at least five loops. In some embodiments, in the first actuated state of the elongate tube, the plurality of loops comprises at least eight loops. In some embodiments, in the first actuated state of the elongate tube, the plurality of loops comprises at least ten loops.

[0066] In some embodiments, when the elongate tube is in a first actuation state, the number of loops in the plurality of loops is in a range of 4 to 25. In some embodiments, when the elongate tube is in a first actuation state, the number of loops in the plurality of loops is in a range of 5 to 25. In some embodiments, when the elongate tube is in a first actuation state, the number of loops in the plurality of loops is in a range of 4 to 15. In some embodiments, when the elongate tube is in a first actuation state, the number of loops in the plurality of loops is in a range of 5 to 15. In some embodiments, when the elongate tube is in a first actuation state, the number of loops in the plurality of loops is in a range of 5 to 12. In some embodiments, when the elongate tube is in a first actuation state, the number of loops in the plurality of loops is in a range of 8 to 12.

[0067] In some embodiments, when the elongate tube is in the first actuation state, the diameter of the coil is in the range of 0.5 cm to 5 cm. In some embodiments, when the elongate tube is in the first actuation state, the diameter of the coil is in the range of 1 cm to 5 cm. In some embodiments, when the elongate tube is in the first actuation state, the diameter of the coil is in the range of 0.5 cm to 4 cm. In some embodiments, when the elongate tube is in the first actuation state, the diameter of the coil is in the range of 1 cm to 4 cm. In some embodiments, when the elongate tube is in the first actuation state, the diameter of the coil is in the range of 2.0 cm to 4.0 cm. In some embodiments, when the elongate tube is in the first actuation state, the diameter of the coil is in the range of 0.5 cm to 3 cm. In some embodiments, when the elongate tube is in the first actuation state, the diameter of the coil is in the range of 1 cm to 3 cm. In some embodiments, when the elongate tube is in the first actuation state, the diameter of the coil is in the range of 0.5 cm to 3 cm. In some embodiments, when the elongate tube is in the first actuation state, the diameter of the coil is in the range of 1 cm to 3 cm. In some embodiments, when the elongate tube is in the first actuated state, the diameter of the coil is in the range of 2 cm to 3 cm. In some embodiments, when the elongate tube is in the first actuated state, the diameter of the coil is in the range of 2.5 cm to 3.5 cm.

[0068] In some embodiments, in the first actuated state of the elongate tube, the diameter of the coil is 1.5 cm or less.

[0069] In some embodiments, in the first actuated state of the elongate tube, each of the plurality of loops has an at least partially sinusoidal configuration.

[0070] In some embodiments, when the elongate tube is in a first actuated state and negative pressure is applied to the elongate tube, the plurality of loops form a stack.

[0071] In some embodiments, in the first actuated state of the elongate tube, the length of the coil is at least 15 mm. In some embodiments, in the first actuated state of the elongate tube, the length of the coil is at least 20 mm.

[0072] In some embodiments, in the first actuation state of the elongate tube, the coil length is up to 200 mm. In some embodiments, in the first actuation state of the elongate tube, the coil length is up to 150 mm. In some embodiments, in the first actuation state of the elongate tube, the coil length is up to 100 mm. In some embodiments, in the first actuation state of the elongate tube, the coil length is up to 80 mm. In some embodiments, in the first actuation state of the elongate tube, the coil length is up to 70 mm. In some embodiments, in the first actuation state of the elongate tube, the coil length is up to 60 mm. In some embodiments, in the first actuation state of the elongate tube, the coil length is up to 50 mm.

[0073] In some embodiments, in the first operating state, the coil pitch is in the range of 2.5 mm to 25 mm. In some embodiments, in the first operating state, the coil pitch is in the range of 5 mm to 25 mm. In some embodiments, in the first operating state, the coil pitch is in the range of 2 mm to 40 mm. In some embodiments, in the first operating state, the coil pitch is in the range of 2 mm to 30 mm. In some embodiments, in the first operating state, the coil pitch is in the range of 2 mm to 25 mm. In some embodiments, in the first operating state, the coil pitch is in the range of 2 mm to 20 mm. In some embodiments, in the first operating state, the coil pitch is in the range of 3 mm to 15 mm.

[0074] In some embodiments, at least one property of the coil is configurable by changing a condition in an environment surrounding the coil. In some embodiments, the at least one property includes a chemical or mechanical property of the coil. In some embodiments, the condition includes temperature.

[0075] In some embodiments, the medical system further includes a straightening element, wherein the elongate tube is in a delivery state when associated with the straightening element and achieves the first actuation state when separated from the straightening element, hi some embodiments, the straightening element is adapted to be removed from the gastrointestinal tract of the subject after delivery of the elongate tube.

[0076] In some embodiments, in the delivery state, the elongate tube is substantially straight.

[0077] In some embodiments, the straightening element is a tubular sheath defining a lumen, and the elongate tube is adapted to be delivered to the gastrointestinal tract within the lumen of the tubular sheath, hi some embodiments, the elongate tube is adapted to be removed from the gastrointestinal tract via the lumen of the tubular sheath and to assume a delivery state during removal.

[0078] In some embodiments, the elongate tube is adapted to form coils sequentially from distal to proximal loops as a segment of the elongate tube is pushed distally out of the tubular sheath.

[0079] In some embodiments, during removal of the elongate tube from the GI tract, each loop of the coil is adapted to be converted sequentially, from the proximal loop to the distal loop, into a substantially straight segment.

[0080] In some embodiments, the distal end of the tubular sheath comprises a pointed shape.

[0081] In some embodiments, the straightening element is a first wire, and the elongate tube is adapted to be delivered to the gastrointestinal tract with the first wire extending therethrough. In some embodiments, the first wire is a guidewire. In some embodiments, the medical system further includes a second wire, and the second wire is a guidewire.

[0082] In some embodiments, the elongate tube includes a first channel in fluid communication with the fluid-tight lumen and a second channel.

[0083] In some embodiments, the elongate tube is adapted to form coils sequentially from distal to proximal loops as the wire is withdrawn proximally from the elongate tube.

[0084] In some embodiments, the straightening element terminates at an end thereof with a shoulder adapted to control the orientation of the longitudinal axis of the coil.

[0085] In some embodiments, the medical system further includes a handle portion mechanically connectable to a second end of the fluid-tight lumen distal to the elongate tube, wherein manipulation of the handle portion effects distal movement of the elongate tube. In some embodiments, manipulation includes pushing or turning the handle portion.

[0086] In some embodiments, the handle portion is adapted to be detached from the fluid-tight lumen after delivery of the elongate tube into the alimentary canal.

[0087] In some embodiments, manipulation of the handle transitions the elongate tube from the delivery state to the first actuated state, and in some embodiments, the transition is sequential, adapted to form each of the plurality of loops sequentially from distal to proximal as the elongate tube is delivered into the gastrointestinal tract.

[0088] In some embodiments, the fluid-tight lumen and the elongate tube in the delivery state are sized and configured to pass through a working channel of a delivery device. In some embodiments, the working channel has a maximum cross-sectional diameter of less than 5 mm. In some embodiments, the working channel has a maximum cross-sectional diameter of 4 mm. In some embodiments, the working channel has a maximum cross-sectional diameter of 3.5 mm. In some embodiments, an outer delivery sheath adapted to be disposed over the elongate tube during delivery thereof is sized and configured to pass through the working channel of the delivery device.

[0089] In some embodiments, the elongate tube and fluid-tight lumen are adapted to be mechanically attached to the exterior of the delivery device during delivery into the gastrointestinal tract and to be detached from the delivery device when the elongate tube is positioned within the gastrointestinal tract, hi some embodiments, in the delivery state, the elongate tube is coiled on the exterior of the delivery device.

[0090] In some embodiments, the delivery device comprises a catheter or an endoscope.

[0091] In some embodiments, the delivery device further comprises an image capture element adapted to provide an image of the elongate tube during its delivery into the gastrointestinal tract.

[0092] In some embodiments, the medical system further comprises a delivery device.

[0093] In some embodiments, the medical system further includes a negative pressure source operatively associated with the fluid-tight lumen, the negative pressure source adapted to apply negative pressure to the elongate tube.

[0094] In some embodiments, the negative pressure source includes a controller adapted to adjust the negative pressure provided by the negative pressure source within a predetermined pressure range to remove fluid from near at least a portion of the inner surface of the digestive tract.

[0095] In some embodiments, the elongate tube is adapted to deliver negative pressure to a portion of the digestive tract including an internal wound, e.g., including a fistula, and the controller is adapted to regulate the negative pressure to remove fluid from near an interior surface of the bodily conduit including the internal wound, e.g., including a fistula.

[0096] In some embodiments, the medical system further includes at least one sensor adapted to sense at least one characteristic of fluid removed from near at least a portion of the gastrointestinal tract, and the controller is adapted to adjust one or more operating parameters of the negative pressure source in response to input received from the at least one sensor, the information relating to the at least one characteristic of the fluid.

[0097] In some embodiments, the medical system further includes a fluid source operatively associated with the fluid-tight lumen and adapted to provide fluid to the elongate tube through the fluid-tight lumen to clean the vicinity of the orifice.

[0098] According to some applications, a method for applying negative pressure to a portion of a subject's gastrointestinal tract is provided, the method including: (a) placing within the subject's gastrointestinal tract an elongated tube defining at least one channel along at least a portion of its length, having a plurality of orifices in fluid communication with the at least one channel, and forming a coil including a plurality of loops, one end of the elongated tube being in fluid communication with a first end of a fluid-tight lumen; (b) connecting a second end of the fluid-tight lumen to a negative pressure source; and (c) applying negative pressure to the gastrointestinal tract via the elongated tube and the fluid-tight lumen while the elongated tube is in the coiled form within the gastrointestinal tract.

[0099] In some embodiments, the length of the coil is at least 15 mm, or the plurality of loops comprises at least four loops.

[0100] In some embodiments, the placing step comprises delivering the elongate tube in a delivery state into the gastrointestinal tract of the subject.

[0101] In some embodiments, the delivering step comprises delivering the elongate tube when the elongate tube is substantially straight, and the placing step further comprises forming a coil within the gastrointestinal tract of the subject.

[0102] In some embodiments, the elongate tube comprises a shape memory material, the delivering step comprises delivering the elongate tube in association with a straightening element, the straightening element maintaining the substantially straight state of the elongate tube during delivery, and the forming step comprises separating the straightening element from the elongate tube.

[0103] In some embodiments, the delivering step includes delivering an elongate tube within a tubular sheath, and the forming step includes advancing the elongate element distally from the tubular sheath.

[0104] In some embodiments, the delivering step includes advancing a straightening wire into the elongate tube and delivering the elongate tube together with the straightening wire, and the forming step includes retracting the straightening wire proximally relative to the elongate tube.

[0105] In some embodiments, the forming step includes forming a plurality of loops sequentially from a distal loop to a proximal loop.

[0106] In some embodiments, the delivering and forming steps include manipulating a handle mechanically coupled to the second end of the fluid-tight lumen, where manipulating the handle results in distal movement of the elongate tube. In some embodiments, manipulating includes pushing or turning the handle.

[0107] In some embodiments, the method further comprises the step of detaching the handle portion from the fluid-tight lumen after delivery and prior to connecting the fluid-tight lumen to a source of negative pressure.

[0108] In some embodiments, manipulating the handle portion transitions the elongate tube from a straight configuration into a coil.

[0109] In some embodiments, the delivering step includes advancing an elongate tube through a working channel of the delivery device.

[0110] In some embodiments, the positioning step includes mechanically attaching an elongate tube to the exterior of the delivery device, advancing the delivery device together with the elongate tube into the body lumen, and detaching the elongate tube from the delivery device when the elongate tube is positioned proximate a wound (e.g., a fistula) within the lumen. In some embodiments, the mechanically attaching step includes forming a coil on the exterior of the delivery device, and the method further includes retracting the delivery device from the gastrointestinal tract, thereby leaving the coil positioned within the gastrointestinal tract.

[0111] In some embodiments, the elongate tube is mechanically associated with an imaging device during delivery, and the method further comprises imaging the elongate tube during advancement of the elongate tube into the gastrointestinal tract.

[0112] In some embodiments, applying the negative pressure includes using the controller to regulate the negative pressure applied to the portion of the GI tract to remove fluid from the portion of the GI tract.

[0113] In some embodiments, the method further includes receiving input from the at least one sensor regarding at least one characteristic of the fluid removed from the gastrointestinal tract, and adjusting, using the controller, one or more operating parameters of the negative pressure source in response to the received input.

[0114] In some embodiments, the portion of the digestive tract includes an intraluminal wound, for example, a fistula in the digestive tract, and applying negative pressure removes fluid from near the intraluminal wound, for example, the fistula.

[0115] In some embodiments, the method further includes removing the elongate tube from the gastrointestinal tract after applying the negative pressure. In some embodiments, the removing step includes pulling the second end of the fluid-tight lumen in a proximal direction. In some embodiments, the removing step includes converting the elongate tube from a coil to a substantially straight state, whereby each loop forms a substantially straight segment from the proximal loop to the distal loop.

[0116] In some embodiments, the method further comprises washing a washing solution into the alimentary canal through the fluid-tight lumen, the elongate tube, and the orifice.

[0117] In some embodiments, the method further comprises connecting a fluid source comprising a cleaning fluid to the second end of the fluid-tight lumen prior to the cleaning step.

[0118] In some embodiments, the method further comprises forming the elongate tube from a shape memory material prior to the placing step.

[0119] In some embodiments, the method further comprises pre-treating the elongate tube with at least one antimicrobial or anti-inflammatory agent prior to the step of placing the elongate tube.

[0120] In some embodiments, the method further comprises delivering an antibacterial or anti-inflammatory medication to the portion of the digestive tract via the elongate tube for treatment of an intraluminal wound in the portion of the digestive tract.

[0121] In some embodiments, the method further includes removing at least a portion of the elongate tube from the fluid-tight lumen after application of the negative pressure and while the elongate tube is within the gastrointestinal tract, wherein the elongate tube (a) is at least partially formed from a biocompatible material that is naturally excreted from the subject's body after removal, and / or (b) is at least partially formed from a biodegradable material that degrades within the subject's body after removal.

[0122] In some embodiments, the method further includes modifying conditions in an environment surrounding the coil, thereby configuring at least one characteristic of the coil. In some embodiments, the modifying step includes modifying a temperature in the vicinity of the coil.

[0123] BRIEF DESCRIPTION OF THE DRAWINGS

[0124] The foregoing discussion will be more readily understood by reference to the following detailed description taken in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0125] [Figure 1] FIG. 1 is a schematic illustration of a medical system deployed in the esophagus according to an embodiment of the disclosed technology.

[0126] [Figure 2A] 2A, 2B, and 2C are side and end views, respectively, of an exemplary configuration of an elongated tube forming part of the medical system of FIG. 1 in accordance with an embodiment of the disclosed technology. [Figure 2B-2C] 2A, 2B, and 2C are side and end views, respectively, of an exemplary configuration of an elongated tube forming part of the medical system of FIG. 1 in accordance with an embodiment of the disclosed technology.

[0127] [Figure 3A-3C] 3A, 3B, and 3C are schematic illustrations of exemplary configurations of coils formed from elongated tubing that form part of the medical system of FIG. 1, in accordance with embodiments of the disclosed technology.

[0128] [Figures 4A-4C] 4A, 4B, and 4C are schematic illustrations of deployment steps of the medical system of FIG. 1 into the esophagus in accordance with an embodiment of the disclosed technology.

[0129] [Figure 5A-5B] 5A and 5B are schematic illustrations of deployment steps of the medical system of FIG. 1 into the esophagus in accordance with an embodiment of the disclosed technology.

[0130] [Figures 6A-6B] 6A and 6B are schematic illustrations of deployment steps of the medical system of FIG. 1 into the esophagus in accordance with an embodiment of the disclosed technology.

[0131] [Figures 7A-7B] 7A and 7B are schematic illustrations of deployment steps of the medical system of FIG. 1 into the esophagus in accordance with an embodiment of the disclosed technology.

[0132] [Figure 8A-8B] 8A and 8B are schematic illustrations of a method of deploying the medical system of FIG. 1 into the esophagus using a delivery device, in accordance with an embodiment of the disclosed technology.

[0133] [Figure 9A-9B] 9A and 9B are schematic illustrations of a deployment procedure for a medical system similar to that of FIG. 1 within a subject's body, according to an embodiment of the disclosed technology.

[0134] [Figures 10A-10B] 10A, 10B, 10C, 10D, and 10E are schematic illustrations of steps for maintaining the medical system of FIG. 1 within a subject via a nasal wire or tube. [Figures 10C-10D] 10A, 10B, 10C, 10D, and 10E are schematic illustrations of steps for maintaining the medical system of FIG. 1 within a subject via a nasal wire or tube. [Figure 10E]10A, 10B, 10C, 10D, and 10E are schematic illustrations of steps for maintaining the medical system of FIG. 1 within a subject via a nasal wire or tube. DETAILED DESCRIPTION OF THE INVENTION

[0135] The principles of the medical system and method may be better understood with reference to the drawings and the following description.

[0136] In the following description, various aspects of the present disclosure are described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of different aspects of the present disclosure. However, it will be apparent to those skilled in the art that the present disclosure may be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified so as not to obscure the disclosure. Furthermore, to avoid undue clutter from having too many reference numbers and callouts in a particular drawing, some elements may not be explicitly identified in all drawings in which they appear.

[0137] It is to be understood that the scope of the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Moreover, it is to be understood that the phraseology and terminology employed in this disclosure is for the purpose of description and should not be regarded as limiting.

[0138] For the purposes of this application, the term "subject" relates to any mammal, particularly humans.

[0139] In the context of this specification and the claims, the terms "proximal" and "distal" are defined relative to the direction in which the system is deployed within the subject's body. Thus, an element is said to be "proximal" if it is closer to the point where the system enters the subject's body than other elements, and "distal" if it is farther from the point where the system enters the subject's body than other elements.

[0140] In the context of this specification and the claims, the term "wound" relates to any form of damage to tissue, including, but not limited to, a leak, perforation, rupture, laceration, incision, or fistula, for example, in the wall of the digestive tract.

[0141] In the context of this specification and claims, the term "negative pressure" refers to a pressure that is less than atmospheric pressure, which may be applied, for example, to remove fluids or debris from a body lumen.

[0142] In the context of this specification and the claims, the term "elongate tube" relates to an elongate structure that is at least partially tubular, i.e., at least partially contains an internal channel. The internal channel does not have to pass through the entire elongate structure for the structure to be considered an "elongate tube."

[0143] 1 is a schematic illustration of a medical system 100 according to an embodiment of the disclosed technology deployed near an intraluminal or extraluminal wound, for example, in a subject's esophagus 10. Typically, system 100 is configured to remove fluid from near the wound 12 and / or to aid in its healing.

[0144] The system 100 includes an elongated tube 102 defining at least one channel (see, e.g., interior channel 125 in FIG. 2A ) along at least its longitudinal portion. In some embodiments, the at least one channel may extend along the entire longitudinal length of the elongated tube. In other embodiments, the at least one channel may extend only within a proximal portion of the elongated tube. The elongated tube 102 is shaped and dimensioned for delivery to the human esophagus or another portion of the human digestive tract. The elongated tube 102 includes multiple orifices 104 in fluid communication with the channels. In some embodiments, such as shown in FIG. 1 , the orifices 104 may be distributed longitudinally along at least a portion of the elongated tube 102. In other embodiments, such as shown in FIG. 2A , the orifices may be distributed around a single circumference of the elongated tube 102.

[0145] The elongate tube 102 has a delivery state and a first actuation state, also referred to as a resting actuation state, as seen, for example, in FIG. 1 . The resting actuation state occurs when the elongate tube is deployed within a subject's body. In the resting state, the elongate tube forms a coil including multiple loops 106 arranged about a longitudinal coil axis 107. In the following description, the terms "first actuation state" and "resting actuation state" are used interchangeably.

[0146] The fluid-tight lumen 108 is in fluid communication with an end of the elongated tube 102, typically a channel thereof. The fluid-tight lumen 108 is adapted to or connects the elongated tube 102 to a negative pressure source (e.g., a negative pressure system) 110 for delivering negative pressure through the elongated tube 102 and its channel to the orifice 104. The negative pressure delivered to the orifice results in the removal or evacuation of fluid and / or debris from the vicinity of the wound 12, thereby aiding in wound healing.

[0147] 1, the fluid-tight lumen 108 is in fluid communication with the proximal end 102a of the elongate tube 102. Additionally, the fluid-tight lumen 108 is adapted to be connected to a negative pressure source 110 and to deliver negative pressure to the elongate tube 102 via the proximal end 102a. However, depending on the orientation of deployment, the fluid-tight lumen 108 may instead be connected to the distal end of the elongate tube, as long as it is connected to the negative pressure source 110.

[0148] In some embodiments, the system includes a negative pressure source 110, for example in the form of a fixed or portable vacuum generator. In other embodiments, the system does not include a negative pressure source, but is simply adapted to interact with or connect to a negative pressure source, such as a vacuum system.

[0149] In some embodiments, the negative pressure source 110 includes a controller 112 adapted to regulate the negative pressure provided by the negative pressure source 110 within a predetermined pressure range to remove at least fluid from a region of the esophagus 10 that includes an extraluminal or intraluminal wound, a portion of the inner surface of the esophagus 10, or the digestive tract. For example, the controller 112 may be adapted to regulate the negative pressure to remove fluid from a region of the esophagus 10 that includes an extraluminal or intraluminal wound.

[0150] In some embodiments, the negative pressure source 110 may further include or be associated with at least one sensor 114 adapted to sense at least one characteristic of the fluid removed from the GI tract, such as pressure or flow rate. The sensor 114 is operatively associated with the controller 112, which is adapted to adjust one or more operating parameters of the negative pressure source 110 in response to input received from the sensor, the input related to the at least one characteristic of the fluid. The sensor 114 may be located near the controller 112 or near the elongated tube 102.

[0151] In some embodiments, the channel extends along the length of the elongate tube 102 between the orifice 104 and the proximal end of the elongate tube connected to the fluid-tight lumen 108, but need not extend along the entire length of the elongate tube. In some embodiments, the channel extends along the entire length of the elongate tube 102. In some embodiments, the channel is an internal channel, such as channel 125 shown in FIG. 2A.

[0152] In some embodiments, the elongate tube 102 and the fluid-tight lumen 108 are substantially concentric, with their elongate axes substantially coinciding. However, the coil axis 107 typically does not coincide with the elongate axis of the fluid-tight lumen 108.

[0153] In some embodiments, or at certain times, the elongated tube 102 may be disconnected from the negative pressure source 110 and instead connected to a fluid source, indicated in FIG. 1 by reference numeral 116. The fluid source 116 includes a fluid 118, which may be a irrigation or treatment fluid. In some embodiments, the fluid 118 may be delivered into the GI tract via the channels and orifices 104. For example, the fluid may be delivered to remove debris lodged in the orifices or channels. As another example, the fluid may include an irrigation or irrigation fluid, a medicinal agent (e.g., an anti-inflammatory agent), and / or an antimicrobial agent (e.g., an antibiotic or antimicrobial agent) to aid in healing of the wound 12.

[0154] In some embodiments, the fluid may be a cleaning fluid. In some embodiments, the fluid may be a medicinal fluid, such as an antibacterial fluid or a tissue growth promoting fluid. In some embodiments, the fluid may be a contrast fluid. In some embodiments, the fluid may be an ionized gas. In some embodiments, the fluid may be carbon dioxide. In some embodiments, the fluid may be a fluid configured to alter the properties of the coil, such as a cryogenic fluid.

[0155] In other embodiments, both the fluid source 116 and the negative pressure source 110 may be connected to the elongated tube 102. For example, the at least one channel may include multiple channels, with a first channel (e.g., 125 in FIG. 2A ) connected to the negative pressure source 110 and another channel (not explicitly shown) connected to the fluid source 116, such that negative pressure and fluid may be provided near the elongated tube 102 through different channels or orifices, substantially simultaneously, or through different channels at different times.

[0156] In some embodiments, upon completion of treatment, the entire elongate tube 102 and fluid-tight lumen 108 are removed from the subject's body.

[0157] In some embodiments, at least a portion of the elongate tube 102, or the entire elongate tube 102, may be detachable from the fluid-tight lumen 108. In some embodiments, the detachable portion (or the entire elongate tube 102) is formed from a material that can be naturally excreted from the subject's body after separation from the fluid-tight lumen 108. In other embodiments, the detachable portion (or the entire elongate tube 102) is formed from a biodegradable material that can degrade within the subject's body after separation from the fluid-tight lumen 108.

[0158] In some embodiments, at least a portion of, or the entire elongate tube 102 is further covered with an additional layer of material, such as a mesh configured to apply friction to the surface of the elongate tube.

[0159] 2A, 2B, and 2C, which are side and end views, respectively, of an exemplary configuration of an elongated tube forming part of the medical system of FIG. 1, in accordance with an embodiment of the disclosed technology.

[0160] 2A-2C show an elongated tube 122 that functions similarly to, but differs in some respects from, the elongated tube of FIGURE 1. Similar to elongated tube 102, which includes orifice 104 and forms a coil including multiple loops 106, elongated tube 122 includes orifice 124 and forms a coil including multiple loops 126.

[0161] Elongated tube 122 includes an internal channel 125 and further includes one or more external channels 127, shown here as multiple grooves extending longitudinally along the outer surface of the elongated tube. In the embodiment of FIGS. 2A-2C, orifices 124 disposed on a single circumference of the elongated tube adjacent the distal end thereof are in fluid communication with internal channel 125 as well as at least one of external channels 127, facilitating fluid flow between the internal and at least one of the external channels. However, in some embodiments, orifices 124 may be distributed longitudinally along a portion of the elongated tube, as shown in FIG. 1, for example. In the illustrated embodiment, fluid-tight lumen 128 has a structure similar to elongated tube 122 and also includes an external channel.

[0162] 2B, in some embodiments, each of the orifices 124 spans the width of a plurality of grooves or outer channels 127. In other words, the cross-sectional area or diameter of the grooves 127 is smaller than the diameter of the orifices 124.

[0163] Channel 125 is in fluid communication with negative pressure source 110 via fluid-tight lumen 128 and functions substantially as described above with respect to Figure 1. Negative pressure is applied to the vicinity of elongated tube 122 via orifice 124 and groove 127, expelling fluid and debris from the vicinity of the tube, through groove 127 and orifice 124, and into channel 125.

[0164] It should be appreciated that in some embodiments, orifice 124 may be located on a single circumference of elongate tube 122 adjacent the elongate tube's proximal end. In such embodiments, interior channel 125 should extend along the proximal longitudinal portion of the elongate tube up to or slightly beyond orifice 124, but not necessarily beyond orifice 124. In such embodiments, negative pressure is delivered from the fluid-tight lumen through a portion of interior channel 125 and orifice 124 to the proximal end of groove 127, thereby drawing fluid and debris from the vicinity of the coil longitudinally along groove 127 from the distal end toward the proximal end, where it enters interior channel 125 through orifice 124.

[0165] The grooves 127 serve multiple purposes in treatment using the system of the disclosed technology. The presence of the grooves 127 helps to keep the orifices 124 open, particularly when the elongated tube loops 126 are positioned directly on top of each other without any gaps. Under such conditions, the grooves 127 can form channels through which negative pressure can be applied adjacent to the loops, even when the coils are engaged with each other. Additionally, the grooves 127, which have narrow cross-sectional areas, are bounded by ridges 129. These ridges provide irregularities on the outer surface of the elongated tube 122 and can engage with surrounding tissue, such as that of the esophagus 12, promoting tissue in-growth and thereby accelerating healing. Furthermore, in some embodiments, fluid can be drained into the orifices 124 through the grooves 127, thereby facilitating drainage from a larger area using fewer orifices and reducing the likelihood of the orifices becoming blocked or obstructed by debris.

[0166] In some embodiments, the elongated tube 122 may optionally further include a second channel associated with a fluid delivery orifice (not explicitly shown) for delivering fluid to the vicinity of the elongated tube 122, substantially as described above with respect to FIG.

[0167] Reference is now made to Figures 3A, 3B, and 3C, which are schematic illustrations of exemplary configurations of coils formed from elongated tubing that form part of the medical system of Figure 1, in accordance with embodiments of the disclosed technology.

[0168] Figure 3A shows a coil formed from an elongated tube 132 similar in construction to the elongated tube 102 of Figure 1. Specifically, the elongated tube 132 includes an internal channel (not explicitly shown), multiple orifices 104 distributed longitudinally along the tube, forming a coil including multiple loops 106.

[0169] However, the coil formed by elongated tube 132 differs from the coil formed by elongated tube 102, in which all loops have the same inner and outer diameters (see FIG. 1). In the embodiment shown in FIG. 3A, loops 106 have multiple different diameters. Furthermore, some loops having the same diameter are not adjacent to each other. For example, FIG. 3A shows a first pair of loops 106a having a first, largest diameter and spaced a distance d1 from each other. A second pair of loops 106b has a second diameter smaller than the first diameter of loops 106a and spaced a second distance d2 from each other.

[0170] Varying the loop diameter can form many different configurations, all of which are considered within the scope of the presently disclosed technology. For example, in some embodiments, loops having different diameters can cause the coil to have an external shape resembling that of a spindle or hourglass, as shown in FIG. 3A. In other embodiments, loops having various diameters can form a coil having an overall conical or frusto-conical structure. In still other embodiments, the loops of the coil can alternate between loops having a first, larger diameter and loops having a second, smaller diameter.

[0171] FIG. 3B illustrates a coil formed from an elongated tube 142 similar in structure to the elongated tube 102 of FIG. 1. Specifically, the elongated tube 142 includes an internal channel (not explicitly shown), multiple orifices (not explicitly shown) distributed longitudinally along the tube, and forms a coil including multiple loops 146. However, each of the loops 146 has at least a partial sinusoidal structure. As such, a space may be created between each pair of adjacent loops 146. The at least a partial sinusoidal structure illustrated in FIG. 3B may be adapted to maintain a space between adjacent pairs of loops 146 when negative pressure is applied to the elongated tube 142, thereby maintaining the length of the coil when negative pressure is applied.

[0172] In the context of this application, a loop has a "sinusoidal structure" if it is not flat but undulates (in the theta direction as it circles the center of the loop). In other words, a loop has a "sinusoidal structure" if, within the loop (i.e., a 360-degree journey in theta direction), there are multiple changes in the length of the loop (e.g., from up to down and back up again) or multiple changes in the sign of the slope of the loop. Thus, as an ant walks along a loop, it will change from walking "uphill" to walking "downhill" along the loop multiple times.

[0173] FIG. 3C illustrates a coil formed from an elongated tube 152 similar in structure to the elongated tube 102 of FIG. 1. Specifically, the elongated tube 152 includes an internal channel (not explicitly shown), a plurality of orifices 154 distributed longitudinally along the tube, and a coiled portion 155 that forms a coil including a plurality of loops 156. However, the elongated tube 152 also includes a straight portion 157 that extends from an end 158 of the coiled portion 155 toward the fluid-tight lumen 108 (see FIG. 1) as indicated by arrow 159. The straight portion 157 extends through the longitudinal center of the coil. When the straight portion 157 is connected to the fluid-tight lumen 108 and a negative pressure source, negative pressure delivered to the elongated tube 152 from the fluid-tight lumen 108 reaches the coiled portion 155 and traverses the straight portion 157 of the elongated tube before being delivered to the vicinity of the coil via the orifices 154. A straight section 157 extending from the distal end of the coil, passing through the center of the coil section 155, and connected to the fluid-tight lumen 108 may be advantageous in preventing the coil from extending further into the digestive tract or widening the pitch between the coil loops 156 when the coil is deployed in the digestive tract and negative pressure is applied to it, thereby maintaining the length of the coil.

[0174] The following description refers to elongated tubes 102, 122, 132, 142, and 152 shown in Figures 1-3C. The description uses reference numerals related to Figure 1, but it should be understood that the description is equally applicable to the same elements in Figures 2A-3C, even though those elements are designated with different reference numerals.

[0175] In some embodiments, the elongate tube 102 has a diameter d, shown in FIG. 1, in the range of 1 mm to 8 mm, 1 mm to 5 mm, or 2 mm to 4 mm.

[0176] In some embodiments, the elongated tube 102 may be formed from a porous material such as ePTFE, PTFE foam, EVA, PU foam, and PP foam, etc. In some embodiments, the orifice 104 may be or include a pore in the porous material.

[0177] In some embodiments, the elongated tube 102 may include or consist of radiopaque markers, radioactive markers, magnetic markers, and / or magnetic resonance markers. In some embodiments, the elongated tube 102 may include or consist of metals, natural or elastic polymers, plastics, shape memory alloys, superelastic alloys, biocompatible materials, biodegradable materials, bioabsorbable materials, and / or bioresorbable materials.

[0178] In some embodiments, the elongate tube 102 may be formed from a material that is relatively unlikely to irritate the digestive tract.

[0179] In some embodiments, the elongated tube 102 may be configured for antimicrobial or anti-inflammatory effects. In some embodiments, the elongated tube 102 includes an antimicrobial or anti-inflammatory material. In some embodiments, the elongated tube 102 is pre-treated or coated with an antimicrobial or anti-inflammatory agent.

[0180] In some embodiments, the elongate tube 102 is adapted to deliver antimicrobial or anti-inflammatory medication to the vicinity of the wound 12 for treatment of the wound. For example, this may be accomplished by delivery of a medicinal liquid through channels and orifices in the elongate tube, as described above.

[0181] In some embodiments, the elongate tube 102 has a textured outer surface adapted to frictionally engage the inner surface of the digestive tract. Examples of such textured outer surfaces are shown in Figures 2A-2C, the benefits of which are described above.

[0182] In some embodiments, the elongate tube 102 may include or consist of a shape memory material, an elastic material, a superelastic material, or another polymeric material adapted to direct or cause the formation of a predetermined coil shape.

[0183] In some embodiments, the elongate tube 102 may have any suitable cross-sectional shape, including a circular cross-section, an oval cross-section, a D-shaped cross-section, or a rectangular cross-section.

[0184] In some embodiments, the orifices 104 are positioned on a single circumference of the elongated tube, as shown, for example, in Figures 2A and 2B. In some embodiments, the orifices 104 may be positioned along a single longitudinal position along the longitudinal axis of the elongated tube 102 (as shown in Figure 1), such that when the elongated tube is uncoiled, the orifices form a straight line along the length of the tube. In some embodiments, the orifices 102 may be positioned along multiple longitudinal positions along the longitudinal axis of the elongated tube, or along the entire elongated tube.

[0185] In some embodiments, at least one longitudinal channel extends along the exterior longitudinal portion of the elongate tube, as shown in Figures 2A and 2B.

[0186] In other embodiments, the orifices 104 are positioned longitudinally along the length of the elongate tube 102 or at different longitudinal positions along the longitudinal axis.

[0187] In some embodiments, the orifices 104 may be evenly spaced along or around the elongated tube 102, as shown in FIG. 1 . In other embodiments, the orifices 104 may be unevenly distributed along or around the elongated tube 102. For example, a first pair of adjacent orifices 104 may have a first longitudinal distance therebetween, and a second pair of adjacent orifices 104 may have a second longitudinal distance therebetween, where the second longitudinal distance is different from the first longitudinal distance. As another example, a first pair of adjacent orifices 104 may have a first circumferential distance therebetween, and a second pair of adjacent orifices 104 may have a second circumferential distance therebetween, where the second circumferential distance is different from the first circumferential distance.

[0188] In some embodiments, each of the orifices 104 has substantially the same diameter. In other embodiments, the orifices 104 in a first subset of the orifices have a first diameter and the orifices 104 in a second subset of the orifices have a second diameter, the second diameter being different from the first diameter.

[0189] In some embodiments, as shown in FIG. 1 , each of the orifices 104 has substantially the same cross-sectional area. In some embodiments, the orifices 104 in a first subset of the orifices have a first cross-sectional area and the orifices 104 in a second subset of the orifices have a second cross-sectional area, the second cross-sectional area being different from the first cross-sectional area. For example, the cross-sectional area of ​​the orifices 104 may increase along the length of the elongated tube or coil from the proximal end to the distal end. In some such embodiments, the cross-sectional area of ​​the most distal orifice is at least 50% greater than the cross-sectional area of ​​the most proximal orifice.

[0190] In some embodiments, the maximum dimension of each of the orifices 104 is in the range of 0.5 mm to 10 mm, 0.5 mm to 8 mm, 0.5 mm to 5 mm, 0.5 mm to 3 mm, or 1 mm to 2 mm.

[0191] In some embodiments, in the resting, operating state of the elongate tube 102, at least some of the orifices 104 face inward toward the center of the coil, as shown, for example, in Figure 2A. In some embodiments, in the resting state of the elongate tube 102, at least some of the orifices 104 face outward, away from the center of the coil, as shown, for example, in Figure 1.

[0192] In some embodiments, in a static operating state, the elongated tube 102 is substantially devoid of orifices 104 facing away from the center of the coil, i.e., outward, such that all of the orifices 104 face toward the center of the coil.

[0193] In some embodiments, in the first resting operating state of the elongate tube 102, the length of the coil, indicated by L in FIG. 1, is at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, at least 30 mm, at least 35 mm, or at least 40 mm, at least 50 mm, at least 60 mm, or at least 80 mm.

[0194] In some embodiments, in the first resting operating state of the elongate tube 102, the length L of the coil is at most 200 mm, at most 150 mm, at most 100 mm, at most 80 mm, at most 70 mm, at most 60 mm, or at most 50 mm.

[0195] In some embodiments, in the first resting operating state of the elongate tube 102, the length L of the coil is within the range of 10 mm to 200 mm, 10 mm to 150 mm, 10 mm to 120 mm, 10 mm to 100 mm, 10 mm to 80 mm, 10 mm to 70 mm, 10 mm to 60 mm, 10 mm to 50 mm, 20 mm to 50 mm, 30 mm to 50 mm, 40 mm to 50 mm, 10 mm to 40 mm, 15 mm to 40 mm, 10 mm to 35 mm, or 15 mm to 35 mm.

[0196] In some embodiments, the elongate tube 102 has a second evacuation operating state when negative pressure is applied to the elongate tube.

[0197] In some embodiments, in the first, resting, operating state of elongate tube 102, the coil has a uniform pitch between each pair of adjacent loops, as seen, for example, in FIGS. 1-2B.

[0198] In some embodiments, in the first operating state, the coil pitch is in the range of 2.5 mm to 25 mm. In some embodiments, in the first operating state, the coil pitch is in the range of 5 mm to 25 mm. In some embodiments, in the first operating state, the coil pitch is in the range of 2 mm to 40 mm. In some embodiments, in the first operating state, the coil pitch is in the range of 2 mm to 30 mm. In some embodiments, in the first operating state, the coil pitch is in the range of 2 mm to 25 mm. In some embodiments, in the first operating state, the coil pitch is in the range of 2 mm to 20 mm. In some embodiments, in the first operating state, the coil pitch is in the range of 3 mm to 15 mm.

[0199] In some embodiments, at least one property of the coil is configurable by changing the conditions of the environment surrounding the coil, hi some embodiments, the property may be or may include a chemical or mechanical property of the coil.

[0200] For example, the condition that is altered may be the temperature of the coil or the temperature in the vicinity of the coil during deployment.

[0201] In some embodiments, in the first resting state of the elongate tube 102, the number of loops 106 in the coil formed from the elongate tube is at least 3, at least 4, at least 5, at least 8, or at least 10.

[0202] In some embodiments, in the first resting operating state of the elongate tube 102, the number of loops 106 in the coil is in the range of 3-15, 5-15, 5-12, 8-12, 3-30, 5-30, 5-30, or 8-30.

[0203] In some embodiments, in the first resting operating state of the elongate tube 102, the diameter of each loop 106 within the coil or the diameter of the entire coil (designated D in FIG. 1 ) is within the range of 0.5 cm to 5 cm, 1 cm to 5 cm, 0.5 cm to 4 cm, 1 cm to 4 cm, 2 cm to 4 cm, 0.5 cm to 3 cm, 1 cm to 3 cm, 1 cm to 2.5 cm, 1 cm to 2 cm, or 2 cm to 3.5 cm.

[0204] In some embodiments, in the first, resting, operating state of the elongate tube 102, at least one of the loops 106 within the coil, and in some embodiments each loop 106, has a diameter of 1.5 cm or less.

[0205] In some embodiments, as shown in FIG. 1, all of the loops 106 have substantially the same outer diameter.

[0206] In some embodiments, at least two loops 106 have substantially the same diameter. In some embodiments, the two loops having substantially the same diameter are the proximal and distal loops of the coil. In some embodiments, the diameters of loops 106 other than the proximal and distal loops are equal to or less than the diameter of the proximal loop. In some embodiments, the diameters of loops 106 other than the proximal and distal loops are equal to or greater than the diameter of the proximal loop.

[0207] In some embodiments, when negative pressure is applied to the elongated tube 102, the loops 106 form a stack, which provides mechanical strength to the coil during application of negative pressure.

[0208] Reference is now made to Figures 4A, 4B, and 4C, which are schematic illustrations of steps for deploying a medical system 100 into the digestive tract, or esophagus 10, in accordance with one embodiment of the disclosed technology. Reference is also made to Figures 5A and 5B, which are schematic illustrations of variations of the steps of Figures 4A-4C.

[0209] 4A, the elongate tube 102 is disposed within the lumen of a tubular sheath 200, which serves as a delivery mechanism for delivering the elongate tube 102 into the digestive tract. Thus, in the embodiment of Figures 4A through 5B, the elongate tube 102 is delivered within the lumen of the tubular sheath 200 into the digestive tract of a subject.

[0210] The elongate tube 102 is in a delivery state when associated with the tubular sheath 200, and when separated from the sheath, it attains a quiescent, actuated state in which the elongate tube is coiled. The tubular sheath 200 is adapted to be removed from the gastrointestinal tract after delivery of the elongate tube 102.

[0211] The tubular sheath 200 acts as a straightening element for the elongated tube 102 so that in the delivery state, when the elongated tube is within the sheath 200, the elongated tube 102 is substantially straight, suitable for delivery, for example, through the lumen of a working channel.

[0212] In some embodiments, the elongate tube 102 is adapted to be removed from the gastrointestinal tract through the lumen of the tubular sheath 200. In such embodiments, the elongate tube 102 is retracted into the tubular sheath from the proximal end of the tube and assumes the delivery state during removal from the gastrointestinal tract.

[0213] In some embodiments, during deployment of the elongate tube, the elongate tube 102 is adapted to sequentially form coils as segments of the elongate tube are pushed distally from the tubular sheath 200 in the direction of arrow 201, as can be seen clearly by comparing Figures 4B and 4C. As seen in Figures 4B and 4C, the elongate tube 102 is pushed distally from the sheath 200, causing the distal end of the elongate tube to form a first distal loop 106' shown in Figure 4B. Subsequently, as additional portions of the elongate tube 102 are pushed out of the sheath, they form additional loops 106, as shown in Figure 4C.

[0214] Conversely, during removal of the elongated tube 102 from the digestive tract through the sheath 200, each of the loops 106 is adapted to be converted into a substantially straight segment sequentially from the proximal loop to the distal loop upon entry into the sheath.

[0215] In some embodiments, the distal end of the tubular sheath 200 includes a pointed shape. For example, a pointed shape may be desirable to pass through debris or wound scabs on the way to the target destination of the elongated tube.

[0216] 4C, in some embodiments, the longitudinal axis 202 of the coil is angled (e.g., at a 90 degree angle) relative to the longitudinal axis 204 of the remainder of the elongate tube 102, for example, disposed within the sheath 200 or connected (e.g., via a fluid-tight lumen) to the negative pressure source 110 (FIG. 1). In some embodiments, it is desirable for the longitudinal axes 202 and 204 to be parallel.

[0217] 5A and 5B, the tubular sheath 200 may have a shoulder 206 disposed at its distal end. The shoulder 206 is adapted to redirect the elongated tube 102 prior to its coil formation. Thus, as shown in FIG. 5B, once the coil is formed, the longitudinal axis 202′ of the coil is parallel to the longitudinal axis 204 of the straight portion of the sheath 200 that houses the straight remainder of the elongated tube 102.

[0218] Reference is now made to Figures 6A and 6B, which are schematic illustrations of steps for deploying a medical system 100 into the digestive tract, or esophagus 10, in accordance with one embodiment of the disclosed technology. Reference is also made to Figures 7A and 7B, which are schematic illustrations of modifications of the steps of Figures 6A-6B.

[0219] As seen in FIG. 6A , wire 210, which may be a guidewire, is positioned within a channel of elongated tube 102, such as channel 125 ( FIG. 2A ). Wire 210 is adapted to be delivered along with the elongated tube into the GI tract. Thus, in the embodiments of FIGS. 6A-7B , elongated tube 102 is delivered into the GI tract of a subject with wire 210 extending longitudinally therethrough. In some embodiments, wire 210 may extend through a channel within the elongated tube that is separate from the channel used to connect to negative pressure source 110 ( FIG. 1 ). For example, wire 210 may extend through an irrigation channel or a dedicated channel.

[0220] In some embodiments, the elongated tube 102 is in a delivery state when associated with the wire 210 and, when separated from the wire, achieves a quiescent, actuated state in which the elongated tube is coiled. The wire 210 is adapted to be removed from the gastrointestinal tract after delivery of the elongated tube 102 by pulling the wire in the direction of arrow 211 shown in FIG. 6A . In this case, the wire 210 functions as a straightening element for the elongated tube 102, such that, in the delivery state, the elongated tube 102 is substantially straight when the wire 210 is within the elongated tube. In some embodiments, the elongated tube 102 is adapted to sequentially form coils as segments of the wire 210 are withdrawn proximally from the elongated tube in the direction of arrow 211, as can be seen clearly by comparing FIGS. 6A and 6B . As seen in FIGS. 6A and 6B , the wire 210 is withdrawn proximally from the elongated tube 102, causing the distal end of the elongated tube to form the first distal loop 106′ shown in FIG. 6A . Subsequently, as the wire 210 is pulled from those sections and additional sections of the elongate tube 102 are separated from the wire 210, they form additional loops 106 as shown in Figure 6B.

[0221] 6B, in some embodiments, the longitudinal axis 212 of the coil is angled (e.g., at a 90 degree angle) relative to the longitudinal axis 214 of the remainder of the elongate tube 102, e.g., within which the wire 210 is disposed or which is connected to the negative pressure source 110 (FIG. 1). In some embodiments, it is desirable for the longitudinal axes 212 and 214 to be parallel.

[0222] 7A and 7B, the wire 210 may have a shoulder 216 at its distal end. The shoulder 216 is adapted to redirect the elongate tube 102 prior to its coiling. Thus, as shown in FIG. 7B, once the coil is formed, the longitudinal axis 212′ of the coil is parallel to the longitudinal axis 214 of the straight portion of the elongate tube 102.

[0223] It should be understood that in some embodiments, the elongated tube 102 may be delivered into the gastrointestinal tract within a working channel of a delivery device. In some such embodiments, the elongated tube 102 may be delivered into the working channel along with a straightening element, such as a sheath 200 (FIGS. 4A-5B) or a guidewire 210 (FIGS. 6A-7B). In such embodiments, the elongated tube 102 (and associated straightening element) is sized and configured to pass through the working channel of the delivery device.

[0224] In some embodiments, the delivery device may be a catheter or an endoscope.

[0225] In some embodiments, the delivery device may include an image capture element adapted to provide an image of the elongated tube 102 during its delivery into the gastrointestinal tract.

[0226] Reference is now made to Figures 8A and 8B, which are schematic illustrations of a method of deployment of a medical system 100 into the gastrointestinal tract or esophagus 10 using a delivery device 220, in accordance with one embodiment of the disclosed technology. The method illustrated in Figures 8A and 8B results in the coil shape shown in Figure 3C and described above. Accordingly, the following description will refer to the reference numbers shown in Figure 3C.

[0227] As seen in FIG. 8A , elongate tube 152 is mechanically attached to the exterior of delivery device 220 during its delivery into the GI tract. In some embodiments, as shown in FIG. 8A , during delivery of the elongate tube into the GI tract, coiled portion 155 of elongate tube 152 is coiled on the exterior of delivery device 220, while straight portion 157 of the elongate tube extends through working channel 221 of delivery device 220. Thus, in the embodiment of FIGS. 8A and 8B , the delivery state of elongate tube 152 may be in a coiled or partially coiled state. End 157′ of straight portion 157 is adapted to be connected to fluid-tight lumen 108.

[0228] In some embodiments, the straight portion 157 extending through the delivery device 220 can be used to change the tension of the coil portion 155 external to the delivery device or to change the diameter of the loop of the coil portion external to the delivery device prior to introduction of the delivery device into a body lumen.

[0229] As a result, after elongate tube 152, and particularly coil portion 155, is severed from delivery device 220, the diameter of the loop of coil portion 155 may change relative to the diameter maintained while the coil was wound externally on the delivery device. For example, the diameter of loop 156 may increase after removal of coil portion 155 from delivery device 220.

[0230] As seen in Figure 8B, once elongate tube 152 has been delivered into the gastrointestinal tract and the coil has been placed at a desired location within the gastrointestinal tract (e.g., near a wound), the elongate tube is adapted to be detached from delivery device 220. As shown in Figure 3C, after detachment of elongate tube 152 from delivery device 220, straight line 157 of the elongate tube extends through the coil formed by coil portion 155, typically through its center.

[0231] In some embodiments, the delivery device 220 may be a catheter or an endoscope.

[0232] In some embodiments, delivery device 220 may include an image capture element 222 adapted to provide images of the elongated tube during its delivery into the digestive tract. For example, image capture element 222 may be a video camera adapted to capture images of the interior of the digestive tract during placement of the elongated tube.

[0233] In some embodiments, the system 100 includes a handle (not explicitly shown) mechanically coupleable to an end of the fluid-tight lumen 108 that is distal to the elongate tube 102 and typically remains outside the body during deployment of the elongate tube into the gastrointestinal tract. Manipulation of the handle, for example, by pushing or turning, results in distal movement of the elongate tube 102. In some embodiments, the handle is adapted to be detached from the fluid-tight lumen 108 after delivery of the elongate tube 102 into the gastrointestinal tract.

[0234] In some embodiments, manipulation of the handle transitions the elongate tube 102 from a delivery state to a coiled, quiescent, actuated state. In some embodiments, the transition of the elongate tube 102 to a coil is sequential, adapted to form each of the loops 106 sequentially, from distal to proximal, as the handle delivers the elongate tube 102 into the gastrointestinal tract, in a manner similar to that shown in FIGS. 4A-7B .

[0235] 9A and 9B, which are schematic illustrations of a procedure for deploying a medical system 730, similar to medical system 100 including any of elongate tubes 102, 122, 132, 142, or 152, within the body of a subject, in accordance with an embodiment of the disclosed technology.

[0236] 9A, system 730, and specifically the elongated tube thereof, can be fed through the subject's mouth and into the subject's digestive tract. For example, in the illustrated embodiment, an endoscope is used to deliver the elongated tube through the subject's mouth and into the subject's esophagus.

[0237] In FIG. 9B , the elongated tube of system 730 is surgically delivered to the esophagus. Specifically, a hole is drilled in the subject's abdominal wall, and the elongated tube is delivered via the stomach into the digestive tract, specifically the subject's esophagus. Alternatively, a hole is drilled in the subject's submental triangle (not shown), and the elongated tube is delivered through the drilled hole into the digestive tract, specifically the subject's esophagus. In some such applications, the distal end of the elongated tube may be sharp or may include a needle suitable for drilling the necessary hole in the abdominal wall. In other embodiments, the process may be similar to the process of placing a percutaneous endoscopic gastrostomy (PEG) device, except that the elongated tube may be delivered further into the esophagus than the stomach.

[0238] 10A, 10B, 10C, 10D, and 10E, which are schematic illustrations of steps for maintaining a medical system 730, such as medical system 100 including any of elongated tubes 102, 122, 132, 142, or 152, within a subject's body via a nasal wire or tube after being introduced as shown in FIG. 9A. For simplicity, the description will refer to the elongated tube 102 of medical system 730 relative to the elongated tube of FIG. 1. However, any of the other elongated tubes described above can be substituted for the elongated tube 102.

[0239] As seen in FIG. 10A , a delivery device 720 is deployed through the subject's mouth 740 and into the subject's esophagus. For example, the delivery device may be the delivery device 220 described above with respect to FIG. 8A . In FIG. 10B , at least a portion of the fluid-tight lumen 108, as well as the elongate tube 102, are delivered into the user's esophagus using the delivery device 720 (not shown). The elongate tube 102 acquires a coil in its resting, actuated orientation, and the delivery device is removed from the subject's mouth, leaving the elongate tube 102 and the fluid-tight lumen 108 in place. After placement of the medical system 730 in the subject's esophagus, the delivery device 720 is removed from the body, as seen in FIG. 10C .

[0240] In FIG. 10D , wire 750 is inserted into the subject's nose, passed through the subject's sinuses, and into and out of the subject's mouth. The proximal end of fluid-tight lumen 108 is then associated with end 752 of wire 750 extending from the subject's mouth. In FIG. 10E , wire 750 is withdrawn from the subject's nose. As wire 750 is withdrawn from the subject's nose, end 752 of the wire, along with the proximal end of fluid-tight lumen 108, is withdrawn into the subject's nose. Once wire 750 is completely removed from the subject's nose, fluid-tight lumen 108 continues to extend through the subject's nose, connecting elongated tube 102 to the exterior of the subject's body and allowing connection to negative pressure source 110. Fluid-tight lumen 108 may further be associated with a nasal retention element configured to maintain the longitudinal position of the coil within the subject.

[0241] The use of "and / or" should be understood to be inclusive, such that the term "a and / or b" should be read to include the sets "a and b," "a or b," "a," and "b."

[0242] The various systems, devices, instruments, etc. in the present disclosure may be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein may include such sterilization of the associated systems, devices, instruments, etc. Additionally, the scope of the present disclosure includes, in some applications, sterilizing one or more of the various systems, devices, instruments, etc. in the present disclosure.

[0243] The present invention is not limited to what has been particularly shown and described above. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof that are not present in the prior art and that would occur to one skilled in the art upon reading the foregoing description. Furthermore, the techniques, methods, operations, steps, etc. described or suggested herein may be performed on live animals or non-living simulations, such as cadavers, cadaver digestive tracts, simulators (e.g., where body parts, tissues, etc. are simulated).

[0244] Although operations in some disclosed examples are described in a particular order for convenient presentation, it should be understood that this description encompasses rearrangement unless a particular order is required by the specific language above. For example, operations or steps described sequentially may in some cases be rearranged or performed simultaneously. Moreover, for the sake of brevity, the accompanying figures may not show the various ways in which the disclosed methods can be used in combination with other methods. Furthermore, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are discernible by those skilled in the art.

Claims

1. 1. A medical system for applying negative pressure within a gastrointestinal tract of a subject, comprising: the medical system comprises an elongate tube and a fluid-tight lumen; The elongated tube at least one internal channel along at least a longitudinal portion of said elongate tube; a plurality of orifices in fluid communication with the at least one internal channel; and at least one external channel extending longitudinally along an exterior surface of the elongated tube, at least one of the at least one external channel being in fluid communication with the at least one internal channel through at least one of the plurality of orifices; stipulates, the elongate tube has a delivery state and a first actuation state in which the elongate tube forms a coil including a plurality of loops; the fluid-tight lumen is in fluid communication with an end of the elongate tube, the fluid-tight lumen being adapted to be connected to a negative pressure source and to deliver negative pressure to the elongate tube; The medical system, wherein in the first actuated state of the elongate tube, the length of the coil is at least 15 mm and the plurality of loops includes at least four loops.

2. 10. The medical system of claim 1, wherein the at least one internal channel comprises a first internal channel adapted to drain fluid from the digestive tract through the at least one external channel and the plurality of orifices when negative pressure is applied to the elongate tube.

3. 3. A medical system according to claim 1, wherein the elongated tube comprises a shape memory material, an elastic material, or a superelastic material adapted to form the coil in the first actuation state.

4. 4. The medical system according to claim 1, wherein the elongated tube has a textured outer surface adapted to frictionally engage the inner surface of the digestive tract.

5. 5. A medical system according to claim 1, wherein the at least one external channel comprises a plurality of external channels forming grooves in the outer surface of the elongate tube and extending longitudinally therealong.

6. 6. The medical system according to claim 1, wherein the plurality of orifices are arranged on a single circumference of the elongated tube.

7. 7. The medical system of claim 6, wherein the at least one external channel extends longitudinally along the outer surface of the elongate tube between the orifice and a distal end of the elongate tube.

8. 6. The medical system according to claim 1, wherein the plurality of orifices are arranged along the longitudinal direction of the elongated tube.

9. A medical system according to any one of claims 1 to 8, the orifices in the first subset of the plurality of orifices have a first diameter; the orifices in a second subset of the plurality of orifices have a second diameter; The second diameter is different from the first diameter.

10. A medical system as described in any one of claims 1 to 9, wherein in the first operating state, at least some of the plurality of orifices face away from the center of the coil, i.e., outward.

11. A medical system as described in any one of claims 1 to 9, wherein in the first operating state, at least some of the plurality of orifices face inward, i.e., toward the center of the coil.

12. 12. The medical system of claim 1, wherein in the first actuation state of the elongate tube, at least one of the plurality of loops has a sinusoidal configuration.

13. 13. The medical system of claim 1, further comprising a straightening element; The medical system, wherein the elongated tube has a delivery state in which it is straight when associated with the straightening element, and a first actuation state in which the elongated tube forms the coil when separated from the straightening element.

14. A medical system according to any one of claims 1 to 12, the fluid-tight lumen and, in a delivery state, the elongate tube are sized and configured to pass through a working channel of a delivery device; The medical system, wherein the working channel has a diameter of less than 5 mm.

15. A medical system according to any one of claims 1 to 12, the delivery state of the elongate tube is a coiled state; The medical system, wherein the elongate tube is adapted to be delivered into the gastrointestinal tract of the subject while positioned external to a delivery device.

16. 1. A medical system for applying negative pressure within a gastrointestinal tract of a subject, comprising: an elongate tube defining at least one channel along at least a longitudinal portion thereof and including a plurality of orifices in fluid communication with the at least one channel, the elongate tube having a delivery state and a first actuation state in which the elongate tube forms a coil including a plurality of loops, at least some of the plurality of loops having a sinusoidal configuration; and a fluid-tight lumen in fluid communication with an end of the elongated tube, the fluid-tight lumen being connected to a negative pressure source and adapted to deliver negative pressure to the at least one channel through the end of the elongated tube; Equipped with The medical system, wherein in the first actuated state of the elongate tube, the length of the coil is at least 15 mm and the plurality of loops includes at least four loops.

17. 17. The medical system of claim 16, wherein the at least one channel is adapted to drain fluid from the gastrointestinal tract through the plurality of orifices when negative pressure is applied to the elongate tube.

18. 18. A medical system according to any one of claims 16 to 17, wherein the elongated tube comprises a shape memory material, an elastic material, or a superelastic material adapted to form the coil in the first actuation state.

19. 19. The medical system according to any one of claims 16 to 18, wherein the elongate tube has a textured outer surface adapted to frictionally engage the inner surface of the gastrointestinal tract.

20. 20. The medical system according to claim 16, wherein the plurality of orifices are arranged on a single circumference of the elongate tube.

21. 20. The medical system according to claim 16, wherein the plurality of orifices are arranged along the longitudinal direction of the elongated tube.

22. A medical system according to any one of claims 16 to 21, the orifices in the first subset of the plurality of orifices have a first diameter; the orifices in a second subset of the plurality of orifices have a second diameter; The second diameter is different from the first diameter.

23. A medical system as described in any one of claims 16 to 22, wherein in the first operating state, at least some of the plurality of orifices face away from the center of the coil, i.e., outward.

24. A medical system as described in any one of claims 16 to 22, wherein in the first operating state, at least some of the plurality of orifices face in a direction toward the center of the coil, i.e., inward.

25. 25. The medical system of claim 16, further comprising a straightening element; The medical system, wherein the elongated tube has a delivery state in which it is straight when associated with the straightening element, and a first actuation state in which the elongated tube forms the coil when separated from the straightening element.

26. A medical system according to any one of claims 16 to 24, the fluid-tight lumen and, in a delivery state, the elongate tube are sized and configured to pass through a working channel of a delivery device; The medical system, wherein the working channel has a diameter of less than 5 mm.

27. A medical system according to any one of claims 16 to 24, the delivery state of the elongate tube is a coiled state; The medical system, wherein the elongate tube is adapted to be delivered into the gastrointestinal tract of the subject while positioned external to a delivery device.

28. 1. A medical system for applying negative pressure within a gastrointestinal tract of a subject, comprising: the medical system comprises an elongate tube and a fluid-tight lumen; the elongate tube defining at least one channel along at least a longitudinal portion thereof and including a plurality of orifices in fluid communication with the at least one channel; The elongated tube a coil section forming a coil having a plurality of loops; and a straight portion extending through a longitudinal center of the coil portion; Including, the fluid-tight lumen is in fluid communication with the elongate tube, the fluid-tight lumen being connected to a negative pressure source and adapted to deliver negative pressure to the coiled portion of the elongate tube; the elongate tube is adapted to be delivered into the gastrointestinal tract of the subject with the coiled portion disposed external to a delivery device and the straight portion extending through an interior of the delivery device; The medical system, wherein the coil has a length of at least 15 mm and the plurality of loops includes at least four loops.

29. 29. The medical system of claim 28, wherein the fluid-tight lumen is in fluid communication with an end of the straight portion of the elongate tube and is adapted to deliver negative pressure to the coiled portion of the elongate tube via the straight portion of the elongate tube.

30. 30. The medical system of claim 28 or 29, wherein the at least one channel of the elongate tube comprises: at least one internal channel along at least a longitudinal portion of the elongate tube; and at least one external channel extending longitudinally along an exterior surface of the elongate tube, at least one of the at least one external channel being in fluid communication with the at least one internal channel through at least one of the plurality of orifices; including the health care system.

31. 31. A medical system according to any one of claims 28 to 30, wherein the at least one channel is adapted to drain fluid from the gastrointestinal tract through the plurality of orifices when negative pressure is applied to the elongate tube.

32. 32. A medical system according to any one of claims 28 to 31, wherein at least the coiled portion of the elongate tube has a textured outer surface adapted to frictionally engage the inner surface of the digestive tract.

33. 33. The medical system according to any one of claims 28 to 32, wherein the plurality of orifices are arranged on a single circumference of the elongate tube.

34. 33. The medical system according to claim 28, wherein the plurality of orifices are arranged along the length of the elongate tube.

35. A medical system according to any one of claims 28 to 34, the orifices in the first subset of the plurality of orifices have a first diameter; the orifices in a second subset of the plurality of orifices have a second diameter; The second diameter is different from the first diameter.

36. 36. The medical system according to claim 28, wherein at least some of the plurality of orifices face away from the center of the coil, i.e., outward.

37. 37. The medical system according to claim 28, wherein at least some of the plurality of orifices face inward, i.e., toward the center of the coil.

38. 38. The medical system of claim 28, wherein in the first actuation state of the elongate tube, each of the plurality of loops has an at least partially sinusoidal configuration.

Images