WO2021263148A1

WO2021263148A1 - Devices, procedures, and systems for isolation, drainage, and infusion for luminal structures

Info

Publication number: WO2021263148A1
Application number: PCT/US2021/039164
Authority: WO
Inventors: Jeremy C. Durack
Original assignee: Memorial Sloan Kettering Cancer Center
Priority date: 2020-06-26
Filing date: 2021-06-25
Publication date: 2021-12-30

Abstract

The present disclosure relates to devices and procedures that can isolate and treat luminal structures within a subject. For example, an operator may need to prevent urine secreted by a kidney from reaching the bladder, such as during a bladder-related medical procedure, or to introduce fluid into the kidney without having the fluid drain through the ureter. The operator can insert a guidewire into the lumen and navigate the device along the guidewire to the lumen. The device can include a fluid port for infusion or drainage between the device and the lumen of the subject. The operator can inflate a balloon of the device to isolate the lumen by preventing fluids from permeating past the balloon within the luminal structure. By isolating the lumen, the operator can divert fluids to the device for drainage or provide fluids to a treatment site while preventing the fluids from draining.

Description

DEVICES, PROCEDURES, AND SYSTEMS FOR ISOLATION, DRAINAGE, AND INFUSION FOR LUMINAL STRUCTURES

FIELD OF DISCLOSURE

[0001] The present disclosure relates to devices, procedures, and systems for isolation of, drainage from, and/or infusion into luminal structures of patients, to balloon-mediated isolation catheters, and to treatments involving luminal isolation, drainage, and/or infusion.

BACKGROUND

[0002] In certain clinical circumstances, isolation of luminal structures is important for therapeutic or palliative benefits. However, there are currently few options to address these needs.

SUMMARY

[0003] In various examples, the luminal structure may involve the urinary tract. Isolation of the kidney(s) and/or ureters (i.e., “upper tract”) from the “lower tract” or bladder may be required for, for example: 1) a urine leak/fistula from the bladder, ureter, ureteral/bladder anastomosis or other surgical site of repair or neobladder/conduit formation; and/or 2) the need to infuse treatments into isolated segments (such as the upper tract) for purposes of tumor control or localized treatment (for example, chemotherapy or BCG introduction). Currently, temporary isolation of the nephroureteral system is difficult to achieve by available ureteroscopic or percutaneous access methods and devices. Nephrostomy tubes, ureteral stents, nephroureteral tubes and similar devices do not effectively isolate anatomic segments, resulting in persistent urine leaks, infections, continued tube drainage requirements and communication of fluids between upper and lower urinary tracts.

[0004] Various embodiments enable temporary isolation of a desired segment of the ureter/renal collecting system to address such clinical needs. In various embodiments, one or more devices may be placed percutaneously under image guidance or endoscopically. In various embodiments, the one or more devices may enable, for example: 1) isolation of urine or other fluids and infused materials from other anatomic segments (e.g., upper urinary tract versus lower urinary tract); 2) drainage of urine, fluids, and infused material from the isolated segment (e.g., upper urinary tract); 3) infusion, circulation, and extraction of materials into/from an isolated segment (e.g., upper urinary tract); 4) conversion, removal, and/or exchange over a guidewire; and/or 5) a sufficient number and variety of external ports allowing for contrast opacification/visualization of anatomic segments, control of luminal occlusion, and infusion of materials into the isolated segments (e.g., chemotherapy, Bacillus Calmette-Guerin (BCG)).

[0005] In various other embodiments, potential anatomic sites where such devices may be applicable include, for example, the biliary system (e.g., bile ducts), gastrointestinal (GI) tract, pancreatic duct, and vascular system.

[0006] In various embodiments, antegrade (e.g., percutaneous image-guided) and retrograde (e.g., endoscopically, fluoroscopically, or using other modality for guidance) approaches may be employed.

[0007] In various embodiments, example devices include an occlusive mechanism that avoids long-term anatomic damage of luminal structures (e.g., strictures, functional impairment, etc.). In various embodiments, compliant balloons, funnel shaped tips, and/or compliant material introduction (e.g., air, water, gel) may be employed.

[0008] In various embodiments, a coating or lining may be employed with various components (e.g., drainage catheter, balloons, etc.), depending on use case or agents to be infused or drained, so as to, for example, enhance integrity, stability, or compatibility when in contact with various agents (such as chemotherapy or other therapeutic agents).

[0009] Multiple treatments may be needed in certain cases, and various embodiments of the device are thus an indwelling device or otherwise include components that may be left in place in a subject to maintain access during subsequent treatments. For example, a catheter of the device may function as a typical drainage catheter (e.g., nephrostomy drainage catheter or biliary drainage catheter).

[0010] At least one aspect relates to a device for isolating luminal structures in a subject. The device can include a plurality of ports. The plurality of ports can include (i) a fluid port configured for infusion into or drainage from a lumen of the subject; and (ii) a balloon inflation-deflation port that is separate from the fluid port. The device can include a catheter tubing extending from the plurality of ports. The catheter tubing can include (i) one or more side holes in communication with the fluid port for fluid infusion or drainage and (ii) a guidewire end-hole. The device can include a balloon in communication with the balloon inflation-deflation port.

[0011] In some embodiments, the plurality of ports can include a guidewire port that is (i) separate from the fluid port and (ii) separate from the balloon inflation-deflation port. In certain embodiments, the guidewire port is in communication with the end-hole.

[0012] In some embodiments, the fluid port also serves as a guidewire port for receiving a guidewire that exits through the end-hole. In some embodiments, the balloon includes radio opaque markers. In certain embodiments, the radio-opaque markers are at opposing ends of the balloon.

[0013] In some embodiments, the catheter tubing includes a loop. In certain embodiments, the one or more side holes are situated in the loop of the catheter tubing. In certain embodiments, the device includes a locking string secured to the loop. In certain embodiments, the plurality of ports are situated at a proximal end of the device, and the loop is situated at a distal end opposing the proximal end. In certain embodiments, the device comprises a guidewire port, and the locking string is situated at the guidewire port.

[0014] In some embodiments, the one or more side holes are situated in the catheter tubing between the balloon and the balloon inflation-deflation port. In certain embodiments, a proximal segment of the catheter tubing extends from the fluid port to the one or more side holes, a distal segment of the catheter tubing extends from the one or more side holes to the balloon, and the proximal segment of the catheter tubing is longer than the distal segment.

[0015] In some embodiments, the balloon is situated between the fluid port and the one or more side holes. In certain embodiments, a proximal segment of the catheter tubing extends from the fluid port to the balloon, a distal segment of the catheter tubing extends from the balloon to the one or more side holes, and the proximal segment of the catheter tubing is longer than the distal segment.

[0016] In some embodiments, the balloon inflation-deflation port communicates with only the balloon. In some embodiments, the device includes an inflation stopcock for controlling inflation of the balloon, the inflation stopcock situated at the balloon inflation-deflation port. In some embodiments, the device includes a fluid stopcock for controlling infused or drained fluid, the fluid stopcock situated at the fluid port. In some embodiments, the device is an antegrade catheter. In some embodiments, the device is a retrograde catheter.

[0017] At least one aspect relates to a method for therapeutic infusion using a catheter apparatus comprising a catheter tubing and a balloon. The method can include inserting a guidewire into an anatomic structure and advancing the catheter tubing over the guidewire under image guidance. The method can include positioning a portion of the catheter tubing and the balloon in an anatomic location. The method can include forming a catheter-locking loop in the portion of the catheter tubing under image guidance. The method can include inflating the balloon via a balloon inflation-deflation port of the catheter apparatus. The method can include injecting a therapeutic agent into the anatomic location via a fluid port of the catheter apparatus and closing a stopcock at the fluid port. The method can include aspirating the therapeutic agent via the fluid port of the catheter apparatus. The method can include deflating the balloon via the balloon inflation-deflation port. The method can include unlocking the catheter locking loop and removing the catheter apparatus from the anatomic location.

[0018] In some embodiments, the method can include gaining access to the anatomic structure via an image-guided technique before inserting the guidewire. In certain embodiments, the catheter apparatus is a retrograde catheter apparatus, and the image-guided technique is an endoscopic imaging technique. In certain embodiments, the catheter apparatus is an antegrade catheter apparatus, and the image-guided technique is an image- guided Seldinger technique.

[0019] In some embodiments, the catheter tubing is advanced over the guidewire via fluoroscopic or endoscopic image guidance. In some embodiments, the catheter apparatus is an antegrade catheter apparatus, and the catheter locking loop is formed using a locking loop string at a catheter hub. In some embodiments, the catheter apparatus is a retrograde catheter apparatus, and the catheter locking loop is formed by removing the guidewire under image guidance to allow a distal pigtail loop to form. In some embodiments, unlocking the catheter locking loop and removing the catheter apparatus occurs after a duration of time dictated by a treatment protocol corresponding to treatment with the therapeutic agent. In some embodiments, the anatomic stmcture is a renal collecting system or a biliary system. In some embodiments, the anatomic location is a renal pelvis. In some embodiments, the anatomic structure is a biliary system, and the anatomic location is a confluence of bile ducts.

[0020] At least one aspect relates to a method for anatomic isolation for fluid leaks using an antegrade catheter apparatus comprising a catheter tubing and a balloon. The method can include inserting a guidewire into an anatomic structure and advancing the catheter tubing over the guidewire under image guidance. The method can include positioning a portion of the catheter tubing and the balloon in an anatomic location. The method can include forming a catheter locking loop in the portion of the catheter tubing using a locking loop string at a catheter hub and locking the locking loop string in place. The method can include inflating the balloon via a balloon inflation-deflation port of the catheter apparatus. The method can include attaching a drainage bag to the fluid port for fluid drainage and placing a temporary cap over the balloon inflation-deflation port. The method can include deflating the balloon via the balloon inflation-deflation port following fluid drainage. The method can include unlocking the locking loop string to facilitate removal of the catheter apparatus.

[0021] In some embodiments, the method can include injecting a contrast dye into the fluid port under image guidance to confirm balloon apposition with luminal wall. In some embodiments, the method can include injecting a contrast dye through a guidewire port to assess fluid leak distal to the balloon. In some embodiments, the method can include gaining access to the anatomic structure via an image-guided Seldinger technique.

[0022] At least one aspect relates to a method for using a device to isolate a luminal structure of a subject. The device can include a plurality of ports. The plurality of ports can include a fluid port configured for infusion into or drainage from a lumen of the subject. The plurality of ports can include a balloon inflation-deflation port that is separate from the fluid port. The device can include a catheter tubing extending from the plurality of ports. The catheter can include one or more side holes in communication with the fluid port for fluid infusion or drainage. The catheter can include a guidewire end-hole. The device can include a balloon in communication with the balloon inflation-deflation port.

[0023] In some embodiments, the method can include infusing a therapeutic agent into the isolated luminal structure. In some embodiments, the therapeutic agent is a chemotherapy agent. In some embodiments, the method can include advancing the device into a urinary tract. In some embodiments, the method can include advancing the device into a biliary system, a GI tract, a pancreatic duct, or a vascular system of the subject. In some embodiments, the device further comprises a loop in the catheter tubing, wherein the one or more side holes are situated in the loop, and wherein the method comprises positioning the loop and the balloon in a desired anatomic location.

[0024] These and other aspects and implementations are discussed in detail below. The foregoing information and the following detailed description include illustrative examples of various aspects and implementations and provide an overview or framework for understanding the nature and character of the claimed aspects and implementations. The drawings provide illustration and a further understanding of the various aspects and implementations and are incorporated in and constitute a part of this specification.

BRIEF DESCRIPTION OF THE FIGURES

[0025] The accompanying drawings are not intended to be drawn to scale. Like reference numbers and designations in the various drawings indicate like elements. For purposes of clarity, not every component can be labeled in every drawing. In the drawings:

[0026] FIG. 1 shows a perspective view of the antegrade catheter for isolating luminal structures in a subject, according to embodiments of the present disclosure.

[0027] FIG. 2 shows a perspective view of the retrograde catheter for isolating luminal structures in a subject, according to embodiments of the present disclosure.

[0028] FIG. 3 shows a method of providing therapeutic infusion by using the antegrade catheter, according to embodiments of the present disclosure.

[0029] FIGs. 4A-4F show cross-sectional views of providing therapeutic infusion by using the antegrade catheter.

[0030] FIG. 5 shows a method of providing therapeutic infusion using the retrograde catheter, according to embodiments of the present disclosure. [0031] FIGs. 6A and 6B show cross-sectional views of providing therapeutic infusion using the retrograde catheter, according to embodiments of the present disclosure.

[0032] FIG. 7 shows a method of anatomic isolation of fluid leaks by using the antegrade catheter, according to embodiments of the present disclosure.

[0033] FIGs. 8A-8E show cross-sectional views of anatomic isolation of fluid leaks by using the antegrade catheter, according to embodiments of the present disclosure.

DETAILED DESCRIPTION

[0034] The present disclosure will be more completely understood through the following description, which should be read in conjunction with the drawings. In this description, like numbers refer to similar elements within various embodiments of the present disclosure. Within this description, the claims will be explained with respect to embodiments. The skilled artisan will readily appreciate that the methods, apparatus, and systems described herein are merely exemplary and that variations can be made without departing from the spirit and scope of the disclosure.

[0035] The present disclosure relates to devices and procedures for isolating and treating luminal structures within a subject. For example, urine from the kidneys drains through the ureters and into the bladder. However, an operator may need to prevent urine secreted by a kidney from reaching the bladder, such as during a bladder-related medical procedure, or to introduce fluid into the kidney without having the fluid drain through the ureters. To isolate and treat the luminal structures, the operator can insert the device into the luminal structures. The operator can perform an antegrade procedure by inserting the device through the kidney and down the ureter, or a retrograde procedure by inserting the device through the bladder and up the ureter. The operator can insert a guidewire into the lumen, and navigate the device along the guidewire and into the lumen. The device can include a fluid port for infusion or drainage between the device and the lumen of the subject. The operator can inflate a balloon of the device to fluidly isolate the lumen by preventing fluids from permeating past the balloon within the luminal structure. By isolating the lumen, the operator can either use the balloon to divert fluids to the device for drainage, or to provide fluids to a treatment site while using the balloon to prevent the fluids from draining via the lumen. [0036] FIG. 1 shows a perspective view of a device 100 for isolating luminal structures in a subject, according to embodiments of the present disclosure. In some embodiments, the device is an antegrade catheter. The antegrade catheter can be configured for insertion into a luminal structure in the same direction as the flow of fluid within the luminal structure. For example, the antegrade catheter can be configured for insertion through the kidney and down the ureter. A proximal segment of the antegrade catheter can provide fluids to an upstream portion of the luminal structure, such as at the kidney, while a distal segment of the retrograde catheter can prevent the fluids from draining downstream, such as to the bladder. The device 100 can include a hub 105, a fluid port 110, catheter tubing 115, a loop 120, a locking string 125, side-holes 130, a proximal segment 135, a distal segment 140, a fluid stopcock 145, a guidewire port 150, a guidewire end-hole 155, a balloon 160, radio-opaque markers 165 A and 165B (generally referred to as radio-opaque markers 165), a balloon inflation-deflation port 170, and an inflation stopcock 175.

[0037] The hub 105 can include, maintain, or be coupled to the components of the device 100. The hub 105 can be made from plastic, rubber, or metal suitable for medical environments. The operator can grip or hold the hub 105 while using the device 100.

[0038] The fluid port 110 of the device 100 can be configured for infusion or drainage of the fluids between the device 100 and the subject. For example, urine can drain from the subject via the fluid port 110, or treatment can flow into the subject via the fluid port 110.

[0039] The catheter tubing 115 can be configured for insertion into the luminal structures of the subject. The catheter tubing 115 can extend from the hub 105. In certain embodiments, the fluid port 110 is situated adjacent to the proximal segment 135 of the catheter tubing 115. The catheter tubing 115 can be made of rubber, plastics, or any other material suitable for medical operations.

[0040] A loop 120 of the catheter tubing 115 can secure the catheter tubing 115 inside the subject. The loop 120 is a portion of the catheter tubing 115 that is configured to loop, circle, or curve into a circular shape that secures the catheter tubing 115 within the subject. In certain embodiments, the loop 120 is situated at a distal end of the catheter tubing 115.

[0041] The locking string 125 of the device 100 can be configured to loop, curve, or bend the loop 120 of the catheter tubing 115 within the luminal structures. The locking string 125 can be a switch, a toggle, or lock. The operator can apply a force to the locking string 125. The locking string 125 can be configured to cause the loop 120 of the catheter tubing 115 to loop, curve, or bend responsive to receiving the force. The loop 120 of the catheter tubing 115 can secure the catheter tubing 115 within the luminal structure by preventing movement responsive to pulling or pushing forces.

[0042] The side-holes 130 of the loop 120 can be configured to receive or release fluids between the device 100 and the subject. For example, the fluids can flow between the treatment site and the loop 120 through the side-holes 130. In some embodiments, the side- holes 130 can be in fluidic communication with the fluid port 110 for fluid infusion or drainage. For example, the side-holes 130 can be fluidly coupled with the fluid port 110. In another example, fluid can flow along a channel defined between the side-holes 130, the loop 120, and the fluid port 110. In certain embodiments, the side-holes 130 are situated in the loop 120 (or the loop 120 defining the holes) of the catheter tubing 115. In some embodiments, the one or more side-holes 130 are situated in the catheter tubing 115 between the balloon 160 and the balloon inflation-deflation port 170.

[0043] The side-holes 130 can be configured to receive or release fluids at a proximal end of luminal structures of the subject while the balloon 160 is positioned at a distal end of the luminal structures to isolate the luminal structures. In certain embodiments, a proximal segment 135 of the catheter tubing 115 extends from the fluid port 110 to the side-holes 130, and a distal segment 140 of the catheter tubing 115 extends from the side-holes 130 to the balloon 160. In certain embodiments, the proximal segment 135 of the catheter tubing 115 is longer than the distal segment 140. For example, the proximal segment 135 can be 25 cm to reach the treatment site at the luminal structure, and the distal segment 140 can be 10 cm downstream to isolate the 5 cm portion of the luminal structure between the side-holes 130 and the balloon 160 such that the fluids from the treatment site cannot drain downstream past the balloon 160.

[0044] The fluid stopcock 145 (or fluid controller) of the device 100 can enable or disable the flow of fluid between the device 100 and the subject. In some embodiments, the fluid stopcock 145 can control the infusing or draining of fluid. In some embodiments, the fluid stopcock 145 is situated at the fluid port 110. The fluid stopcock 145 can be a toggle, switch, valve, or any other fluid control mechanism. For example, the operator can twist the fluid stopcock 145 between an “on” position to enable fluid flow and an “off’ position to disable fluid flow.

[0045] The guidewire port 150 of the device 100 can be configured to receive a guidewire. The guidewire port 150 can be an opening in the hub 105. In some embodiments, the guidewire port 150 is separate from the fluid port 110 and is separate from the balloon inflation-deflation port 170. However, in other embodiments, the guidewire port 150 and the fluid port 110 can be combined into a single port (similar to fluid port 210 as described herein). In certain embodiments, the guidewire port 150 is situated at a proximal end of the device 100. In certain embodiments, the locking string 125 is situated at the guidewire port 150.

[0046] The guidewire end-hole 155 of the catheter tubing 115 can be configured to allow the guidewire to extend past the catheter tubing 115 and into the subject. In certain embodiments, the guidewire port 150 is in communication with the end-hole. The guidewire port 150 can be configured to receive a seal or stopcock to fluidly seal the channel formed between the guidewire port 150 and the guidewire end-hole.

[0047] The guidewire of the device 100 can be configured to navigate the catheter tubing 115 within the luminal structures of the subject. The guidewire can be configured to receive forces or torque. The guidewire can be configured to be flexible and to receive pushing and pulling force to navigate within the luminal structures of the subject. For example, the operator or a torque instrument can turn the guidewire at one end such that the guidewire turns along its length and at its other end. In another example, the operator can push or pull on the guidewire to move it within the luminal structures. The guidewire can be configured with kink resistance. The guidewire can be made from steel or nitinol. The guidewire can be a wire, coil, or a braid. The guidewire can be configured to be visible with fluoroscopic imaging.

[0048] The balloon 160 of the device can be configured to control the flow of fluid within the luminal structures of the subject. The balloon 160 can include rubber, latex, or fabric. The balloon 160 can inflate with a biologically inert substance including but not limited to sterile water, saline, air, and/or contrast material. By inflating, the balloon 160 expands to fill the volume of the luminal structures to prevent fluid flow. The balloon 160 can deflate to reopen the luminal structure. After deflation, the balloon 160 can be maneuvered and repositioned within the luminal structures.

[0049] One or more radio-opaque markers 165 on the balloon 160 can be configured to assist the operator with visually navigate the balloon 160 inside the subject. In certain embodiments, the radio-opaque markers 165 are at opposing ends of the balloon 160. For example, radio-opaque marker 165 A is at one end, and radio-opaque marker 165B is at the other end. The radio-opaque markers 165 can include materials such as iodine, barium, tantalum, bismuth, or gold. The radio-opaque markers 165 can block radiation to have a distinct (e.g., white) appearance on radiographs or any other image guidance technique.

[0050] The balloon inflation-deflation port 170 of the device can facilitate the inflation or deflation of the balloon 160. For example, the balloon inflation-deflation port 170 can be configured to receive fluid for insertion into the balloon 160 to inflate the balloon 160, or to release the fluid from the balloon 160 to deflate the balloon 160. In some embodiments, the balloon 160 can be in fluidic communication with the balloon inflation-deflation port 170.

For example, fluids for inflating the balloon 160 can flow within the catheter tubing 115 to the balloon 160. In some embodiments, the balloon inflation-deflation port 170 is separate from the fluid port 110. For example, the balloon 160 can be fluidly coupled to the balloon inflation-deflation port 170 such that fluid can flow between the balloon 160 and the balloon inflation-deflation port 170. In some embodiments, the balloon inflation-deflation port 170 communicates with only the balloon 160. For example, the catheter tubing 115 can include a tube or lumen extending between the balloon 160 and the balloon inflation-deflation port 170. The tube can be configured for fluid flow to inflate or deflate the balloon 160. The tube or lumen can be disposed in the catheter tubing 115. In another example, the tube or lumen can be disposed on the outside of the catheter tubing 115. In certain embodiments, the balloon inflation-deflation port 170 is situated adjacent to the proximal segment 135 of the catheter tubing 115.

[0051] The inflation stopcock 175 (or inflation controller) of the device 100 can control the inflation or deflation of the balloon 160. In some embodiments, the inflation stopcock 175 can be configured to control the receiving or releasing of fluid. In some embodiments, the inflation stopcock 175 is situated at the balloon inflation-deflation port 170. The inflation stopcock 175 can be a toggle, switch, valve, or any other inflation control mechanism. For

-li example, the operator can twist the inflation stopcock 175 between an “on” position to enable fluid flow to inflate or deflate the balloon 160 and an “off’ position to disable fluid flow such that the balloon 160 remains in its current inflated or deflated state.

[0052] FIG. 2 shows a perspective view of the device 200 for isolating luminal structures in a subject, according to embodiments of the present disclosure. In some embodiments, the device is a retrograde catheter. The retrograde catheter can be configured for insertion into a luminal structure in an opposite direction as the flow of fluid within the luminal structure.

For example, the retrograde catheter can be configured for insertion through the bladder and up the ureter. A distal end of the retrograde catheter can provide fluids to an upstream portion of the luminal structure, such as at the kidney, while a proximal end of the retrograde catheter can prevent the fluids from draining downstream, such as to the bladder. The device 200 can include a hub 205, a fluid port 210, catheter tubing 215, a loop 220, side-holes 225, a proximal segment 230, a distal segment 235, a fluid stopcock 240, a balloon 245, radio opaque markers 250A and 250B (generally referred to as radio-opaque markers 250), a balloon inflation-deflation port 255, and an inflation stopcock 260.

[0053] The hub 205 can include, maintain, or be coupled to the components of the device 200. The hub 205 can be made from plastic, rubber, or metal suitable for medical environments. The operator can grip or hold the hub 205 while using the device 200.

[0054] The fluid port 210 of the device 200 can be configured for infusion or drainage of the fluids between the device 200 and the subject. For example, urine can drain from the subject via the fluid port 210, or treatment can flow into the subject via the fluid port 210. In certain embodiments, the fluid port 210 is situated at a proximal end of the catheter tubing 215.

[0055] The catheter tubing 215 can be configured for insertion into the luminal structures of the subject. The catheter tubing 215 can extend from the hub 205. In certain embodiments, the fluid port 210 is situated at a proximal end of the catheter tubing 215. The catheter tubing 215 can be made of rubber, plastics, or any other material suitable for medical operations.

[0056] A loop 220 of the catheter tubing 215 can secure the catheter tubing 215 within the luminal structures inside the subject. The loop 220 is a portion of the catheter tubing 215 that is configured to loop, circle, or curve into a circular shape that secures the catheter tubing 215 within the subject. The loop 220 of the catheter tubing 215 can secure the catheter tubing 215 within the luminal structure by preventing movement responsive to pulling or pushing forces. In certain embodiments, the loop 220 is situated at a distal end of the catheter tubing 215.

[0057] The side-holes 225 (or openings) of the loop 220 can be configured to receive or release fluids between the device 200 and the subject. For example, the fluids can flow between the treatment site and the loop 220 through the side-holes 225. In some embodiments, the side-holes 225 can be in fluidic communication with the fluid port 210 for fluid infusion or drainage. For example, the side-holes 225 can be fluidly coupled to the fluid port 210. In another example, fluid can flow along a channel defined between the side-holes 225, the loop 220, and the fluid port 210. In certain embodiments, the side-holes 225 are situated in the loop 220 (or the loop 220 defining the holes) of the catheter tubing 215. In some embodiments, the one or more side-holes 225 are situated in the catheter tubing 215 between the balloon 245 and balloon inflation-deflation port 255.

[0058] The side-holes 225 can be configured to receive or release fluids at a proximal end of luminal structures of the subject while the balloon 245 is positioned at a distal end of the luminal structures to isolate the luminal structures. In certain embodiments, a proximal segment of the catheter tubing 215 extends from the fluid port 210 to the balloon 245, and a distal segment of the catheter tubing 215 extends from the balloon 245 to the side-holes 225. In certain embodiments, the proximal segment of the catheter tubing 215 is longer than the distal segment. For example, the proximal segment can be 25 cm to reach the isolation site in the luminal structure, and the distal segment can be 10 cm upstream to isolate the 5 cm portion of the luminal structure between the side-holes 225 and the balloon 245 such that the fluids from the treatment site cannot drain downstream past the balloon 245.

[0059] The fluid stopcock 240 (or fluid controller) of the device 200 can enable or disable the flow of fluid between the device 200 and the subject. In some embodiments, the fluid stopcock 240 can control the infusing or draining of fluid. In some embodiments, the fluid stopcock 240 is situated at the fluid port 210. The fluid stopcock 240 can be a toggle, switch, valve, or any other fluid control mechanism. For example, the operator can twist the fluid stopcock 240 between an “on” position to enable fluid flow and an “off’ position to disable fluid flow. [0060] The fluid port 210 of the device 200 can be configured to receive a guidewire. For example, inserting the guidewire and injecting the fluid through the fluid port 210 can allow for a single catheter lumen with a diameter larger than if there were separate ports fluidly coupled to separate lumens within the catheter tubing 215. The guidewire end-hole of the catheter tubing 215 can be configured to allow the guidewire to extend past the catheter tubing 215 and into the subject. In certain embodiments, the guidewire port is in communication with the end-hole.

[0061] The guidewire of the device 200 can be configured to navigate the catheter tubing 215 within the luminal structures of the subject. The guidewire can be configured to receive forces or torque. The guidewire can be configured to be flexible and to receive pushing and pulling force to navigate within the luminal structures of the subject. For example, the operator or a torque instrument can turn the guidewire at one end such that the guidewire turns along its length and at its other end. In another example, the operator can push or pull on the guidewire to move it within the luminal structures. The guidewire can be configured with kink resistance. The guidewire can be made from steel or nitinol. The guidewire can be a wire, coil, or a braid. The guidewire can be configured to be visible with fluoroscopic imaging.

[0062] The balloon 245 of the device can be configured to control the flow of fluid within the luminal structures of the subject. The balloon 245 can include rubber, latex, or fabric. The balloon 245 can inflate with a biologically inert substance, including but not limited to sterile water, saline, air, and/or contrast dye/material. By inflating, the balloon 245 expands to fill the volume of the luminal structures to prevent fluid flow. The inflated balloon 245 can deflate to reopen the luminal structure. The deflated balloon 245 can be maneuvered and repositioned within the luminal structures.

[0063] One or more radio-opaque markers 250 of the balloon 245 can be configured to assist the operator visually navigate the balloon 245 inside the subject. In certain embodiments, the radio-opaque markers 250 are at opposing ends of the balloon 245. For example, radio opaque marker 250A is at one end, and radio-opaque marker 250B is at an opposing end.

The radio-opaque markers 250 can include materials such as iodine, barium, tantalum, bismuth, or gold. The radio-opaque markers 250 can block radiation to have a distinct (e.g., white) appearance on radiographs or any other image guidance technique. [0064] The balloon inflation-deflation port 255 of the device can facilitate the inflation or deflation of the balloon 245. For example, the balloon inflation-deflation port 255 can be configured to receive fluid for insertion into the balloon 245 to inflate the balloon 245, or to release fluid from the balloon 245 to deflate the balloon 245. In some embodiments, the balloon 245 can be in fluidic communication with the balloon inflation-deflation port 255. In some embodiments, the balloon inflation-deflation port 255 is separate from the fluid port 210. For example, fluids for inflating the balloon 245 can flow within the catheter tubing 215 to the balloon 245. For example, the balloon 245 can be fluidly coupled to the balloon inflation-deflation port 255 such that fluid can flow between the balloon 245 and the balloon inflation-deflation port 255. In some embodiments, the balloon inflation-deflation port 255 communicates with only the balloon 245. For example, the catheter tubing 215 can include a tube or lumen extending between the balloon 245 and the balloon inflation-deflation port 255. The tube can be configured for fluid flow to inflate or deflate the balloon 245. The tube or lumen can be disposed in the catheter tubing 215. In another example, the tube or lumen can be disposed on the outside of the catheter tubing 215. In certain embodiments, the balloon inflation-deflation port 255 is situated adjacent to a proximal end of the catheter tubing 215.

[0065] The inflation stopcock 260 (or inflation controller) of the device 200 can control the inflation or deflation of the balloon 245. In some embodiments, the inflation stopcock 260 can be configured to control the receiving or releasing of fluids for the balloon 245. In some embodiments, the inflation stopcock 260 is situated at the balloon inflation-deflation port 255. The inflation stopcock 260 can be a toggle, switch, valve, or any other fluid control mechanism. For example, the operator can twist the inflation stopcock 260 between an “on” position to enable fluid flow to inflate or deflate the balloon 245 and an “off’ position to disable fluid flow such that the balloon 245 remains in its current inflated or deflated state.

[0066] Referring to FIG. 3 in conjunction with FIGs. 4A-4F, shown is a method 300 of providing therapeutic infusion by using the antegrade catheter (e.g., device 100), according to embodiments of the present disclosure. For example, an operator can use the catheter to treat carcinomas in luminal structures. The carcinomas can be malignant neoplasms of epithelial origin (cancer of the internal or external lining of the body) that account for up to 90 percent of all cancer cases (e.g., kidney/bladder, bile duct, pancreatic, GI tract cancers, an urothelial carcinoma of the “upper tract” of the urinary system, etc.). The operator can use the antegrade catheter to perform an antegrade procedure that involves delivering chemotherapy to the carcinomas located in the “upper tract.”

[0067] As shown in FIG. 4 A, the operator can operate on the subject 405. The operator can operate on the kidney 410, the ureter 415, and the bladder 420 of the subject 405. However, as shown in FIG. 4B, the subject 405 can have urothelial carcinoma 425 in the kidney 410. The operator can treat the urothelial carcinoma 425 by using the antegrade catheter.

[0068] The operator can insert a guidewire into an anatomic structure (STEP 305). In some embodiments, the anatomic structure is a renal collecting system or a biliary system. In some embodiments, the anatomic location is a renal pelvis. In some embodiments, the anatomic structure is a biliary system. In some embodiments, the anatomic location is a confluence of bile ducts. In some embodiments, the treatment involves a urinary tract. In some embodiments, the treatment involves a biliary system, a GI tract, a pancreatic duct, or a vascular system of the subject. In some embodiments, the operator can access the anatomic structure via an image-guided technique before inserting the guidewire. For example, the operator can access relevant anatomic structure (e.g., renal collecting system, biliary system, etc.) via an image-guided Seldinger technique. The operator can create a port or opening configured to receive a guidewire. As shown in FIG. 4C, the operator can create the port 430 in the subject 405. For example, the port can be sized to receive a 0.035" guidewire. The operator can insert the guidewire into the port 430.

[0069] The operator can advance the catheter tubing over the guidewire under image guidance (STEP 310). Image guidance can rely on cameras, ultrasonic, electromagnetic, or any image-guided surgery systems to assist the operator navigate within the subject 405. As shown in FIG. 4C, the operator can advance the catheter tubing 115 into the subject 405 via the port 430. In some embodiments, the catheter tubing is advanced over the guidewire via fluoroscopic or endoscopic image guidance. In certain embodiments, the image-guided technique is an image-guided Seldinger technique. The operator can position a portion of the catheter tubing and the balloon in an anatomic location (STEP 315). As shown in FIG. 4C, the operator can position the catheter tubing 115 such that the balloon 160 is positioned in the ureter 415. In another example, the anatomic location can be a renal pelvis or confluence of right and left bile ducts. [0070] The operator can form a catheter-locking loop in the portion of the catheter tubing under image guidance (STEP 320). In some embodiments, the operator can form the catheter loop under image guidance by using locking loop string (e.g., locking string 125) at the hub (e.g., hub 105) of the catheter. As shown in FIG. 4C, the operator can form the loop 120 adjacent to the kidney 410. The loop 120 secures the position of the catheter tubing in the subject 405. The operator can release or drain fluids between the loop 120 and the kidney 410.

[0071] The operator can inflate the balloon via a balloon inflation-deflation port of the catheter apparatus (STEP 325). Under image guidance, the operator can inject contrast dye via the fluid port 110 to confirm balloon 160 apposition in the ureter 415 or any other luminal wall of the subject 405. The contrast dye can be released into the subject 405 via the guidewire end-hole (e.g., guidewire end-hole 155). In another example, the operator can inject contrast dye via the guidewire port (e.g., guidewire port 150). The operator can identify a volume of injected fluid to inflate the balloon 160 to fill the ureter 415, or any other anatomic structures such as renal collecting system/calyces or bile ducts. The operator can aspirate the contrast dye via the fluid port 110 fluidly coupled to the loop 120 into which the contrast dye is aspirated. In another example, the operator can aspirate the contrast dye via the guidewire port fluidly coupled to the guidewire end-hole into which the contrast dye is aspirated. In one example, the operator can introduce fluid (e.g., saline water) for inflating the balloon 160 via the fluid port 110 fluidly coupled to the balloon 160. In another example, the operator can inflate the balloon 160 under image guidance via the balloon inflation- deflation port 170, such as by introducing saline water via the balloon inflation-deflation port 170 fluidly coupled to the balloon 160. As shown in FIG. 4D, the operator can inflate the balloon 160 to create an inflated balloon 435 in the ureter 415. The operator can inflate the balloon 160 such that inflated balloon 435 is positioned to isolate fluids proximal to the inflated balloon 435. The operator can maintain inflation of the balloon 160 by sealing the balloon inflation-deflation port 170 with an inflation stopcock (e.g., inflation stopcock 175). The operator can also seal the guidewire port to facilitate a fluidic seal between the opening 835 and the kidney 810. The operator can periodically unseal the guidewire port to inject contrast dye to use image guidance to inspect the ureter 415 or the inflated balloon 435.

[0072] The operator can inject a therapeutic agent into the anatomic location via a fluid port of the catheter apparatus (STEP 330). As shown in FIG. 4D, the therapeutic agent can be chemotherapy 440 in a bag or container 445 A fluidly coupled to the fluid port 110. In some embodiments, the operator can infuse the therapeutic agent into the isolated luminal structure. For example, the operator can infuse the therapeutic agent via the loop 120 and into the kidney 410. The operator can identify a quantity of therapeutic agent to inject based on the positioning of the inflated balloon 435 in the ureter 415. For example, the operator can identify a quantity of therapeutic agent that can fill an area defined between the treatment site in the kidney 410 and the inflated balloon 435. As shown in FIG. 4E, the operator can inject the chemotherapy 440 into the subject 405 to the area defined between the treatment site in the kidney 410 and the inflated balloon 435. The operator can close a fluid stopcock (e.g., fluid stopcock 145) at the fluid port (STEP 335). By closing the fluid stopcock, the operator can create a fluidly isolated area between the fluid stopcock and the balloon 160. The therapeutic agent can dwell in the isolated area to treat the subject 405. For example, the operator can allow the chemotherapy 440 to dwell in the subject 405 for a duration dictated by treatment protocol recommendations. The operator can aspirate the therapeutic agent via the fluid port of the catheter apparatus (STEP 340). For example, the operator can open the fluid stopcock and suction the chemotherapy 440 out of the subject 405 via the fluid port 110. In another example, the operator can aspirate the therapeutic agent and then inject saline or rinse agent via the fluid port 110 to rinse the treated area. As shown in FIG. 4F, operator can replace the container 445 A with a container 445B to receive drainage from the subject 405. The inflated balloon 435 can force urine 450 secreted by the kidney 410 to drain into the container 445B.

[0073] The operator can deflate the balloon via the balloon inflation-deflation port (STEP 345). The operator can open the balloon inflation-deflation stopcock and suction the fluid in the balloon 160 to deflate the balloon. The operator can deflate the balloon 160 under image guidance to ensure complete deflation. For repeated treatment sessions, the operator can remove the container 445A or 445B, close the fluid stopcock and the balloon inflation- deflation stopcock, and leave the catheter tubing 115 in the subject 405. The deflated balloon can allow urine from the kidney 410 to drain to the bladder 420, and the closed fluid stopcock and the balloon inflation-deflation stopcock can prevent infections or accidental discharges. The operator can unlock the catheter-locking loop (STEP 350). In some embodiments, the operator can unlock the catheter-locking loop after a duration of time dictated by a treatment protocol corresponding to treatment with the therapeutic agent. For example, the operator can toggle the locking string to unlock the loop to straighten the catheter tubing. The operator can remove the catheter apparatus from the anatomic location (STEP 355). In some embodiments, the operator can remove the catheter apparatus after a duration of time dictated by a treatment protocol corresponding to treatment with the therapeutic agent. The operator can remove the catheter tubing along the guidewire, which can then also be removed from the subject 405.

[0074] Referring to FIG. 5 in conjunction with FIGs. 6A and 6B, shown is a method 500 of providing therapeutic infusion using the retrograde catheter (e.g., device 200), according to embodiments of the present disclosure. For example, an operator can use the catheter to treat carcinomas in luminal structures. The carcinomas can be malignant neoplasms of epithelial origin (cancer of the internal or external lining of the body) that account for up to 90 percent of all cancer cases (e.g., kidney/bladder, bile duct, pancreatic, GI tract cancers, an urothelial carcinoma of the “upper tract” of the urinary system, etc.). The operator can use the retrograde catheter to perform a retrograde procedure that involves delivering chemotherapy to the carcinomas located in the “upper tract.”

[0075] The operator can insert a guidewire into an anatomic structure (STEP 505). As shown in FIG. 6 A, the operator can operate on the subject 605. The operator can operate on the kidney 610, the ureter 615, and the bladder 620 of the subject 605 to treat urothelial carcinoma 625. In some embodiments, the anatomic structure is a renal collecting system or a biliary system. In some embodiments, the anatomic location is a renal pelvis. In some embodiments, the anatomic structure is a biliary system. In some embodiments, the anatomic location is a confluence of bile ducts. In some embodiments, the treatment involves a urinary tract. In some embodiments, the treatment involves a biliary system, a GI tract, a pancreatic duct, or a vascular system of the subject. In some embodiments, the operator can access the anatomic structure via an image-guided technique before inserting the guidewire. For example, the operator can access relevant anatomic structure (e.g., renal collecting system, biliary system, etc.) via an endoscopic imaging technique, such as by inserting a guidewire through an endoscopic cavity and using the imaging to navigate the guidewire within the subject 605. As shown in FIG. 6B, the operator can access the anatomic structure via a urethra of the bladder 620. The guidewire can be a .035" guidewire. [0076] The operator can advance the catheter tubing over the guidewire under image guidance (STEP 510). As shown in FIG. 6B, the operator can advance the catheter tubing 215 into the subject 605 via the bladder 620. In some embodiments, the catheter tubing is advanced over the guidewire via fluoroscopic or endoscopic image guidance. The operator can position a portion of the catheter tubing 215 and the balloon 245 in an anatomic location (STEP 515). As shown in FIG. 6B, the operator can position the catheter tubing 215 such that the balloon 245 is positioned in the ureter 615. In another example, the anatomic location can be a renal pelvis or confluence of right and left bile ducts.

[0077] The operator can form a catheter-locking loop (e.g., loop 220) in the portion of the catheter tubing under image guidance (STEP 520). In some embodiments, the operator can form the catheter loop under image guidance by removing the guidewire to allow the loop to form. Under image guidance, the operator can inject contrast dye via the fluid port 210 to confirm the position of the loop in the kidney 610 or any other luminal wall of the subject 605. As shown in FIG. 6B, the operator can form the loop adjacent to the kidney 610. The loop secures the position of the catheter tubing in the subject 605. The operator can release or drain fluids between the loop and the kidney 610.

[0078] The operator can inflate the balloon via a balloon inflation-deflation port of the catheter apparatus (STEP 525). Under image guidance, the operator can inject contrast dye via the fluid port 210 to confirm balloon apposition in the ureter 615 or any other luminal wall of the subject 605. The contrast dye can be released via the side holes of the catheter tubing. The operator can identify a volume of injected fluid to inflate the balloon to fill the ureter 615, or any other anatomic structures such as renal collecting system/calyces or bile ducts. The contrast dye can drain into the side holes, and the operator can aspirate the contrast dye via the fluid port 210. The operator can introduce fluid (e.g., saline water) for inflating the balloon via the fluid port 210. The operator can inflate the balloon under image guidance via the balloon inflation-deflation port, such as by introducing saline water via the balloon inflation-deflation port into the balloon. As shown in FIG. 6B, the operator can inflate the balloon to create an inflated balloon 630 in the ureter 615. The operator can inflate the balloon such that the inflated balloon 630 isolates the fluid distal to the inflated balloon 630. The operator can maintain inflation of the balloon by sealing the balloon inflation- deflation port with an inflation stopcock (e.g., inflation stopcock 260). [0079] The operator can inject a therapeutic agent into the anatomic location via a fluid port of the catheter apparatus (STEP 530). As shown in FIG. 6B, the therapeutic agent can be chemotherapy 635 in a bag or container 640 fluidly coupled to the fluid port 210. In some embodiments, the operator can infuse the therapeutic agent into the isolated luminal structure. For example, the operator can infuse the therapeutic agent via the loop 220 and into the kidney 410. The operator can identify a quantity of therapeutic agent to inject based on the positioning of the inflated balloon 630 in the ureter 615. For example, the operator can identify a quantity of therapeutic agent that can fill an area defined between the treatment site in the kidney 610 and the inflated balloon 630. As shown in FIG. 6B, the operator can inject the chemotherapy 635 into the subject 605 to the area defined between the treatment site in the kidney 610 and the inflated balloon 630. The operator can close a fluid stopcock (e.g., fluid stopcock 240) at the fluid port (STEP 535). By closing the fluid stopcock, the operator can create a fluidly isolated area between the fluid stopcock and the balloon. The therapeutic agent can dwell in the isolated area to treat the subject 605. For example, the operator can allow the chemotherapy 635 to dwell in the subject 605 for a duration dictated by treatment protocol recommendations. The operator can aspirate the therapeutic agent via the fluid port of the catheter apparatus (STEP 540). For example, the operator can open the fluid stopcock and apply suction to the fluid port 210 to suction the chemotherapy 635 out of the subject 605 via the side holes fluidly coupled to the fluid port 210. In another example, the operator can aspirate the therapeutic agent and then inject saline or rinse agent via the fluid port 210 to rinse the treated area via the side holes.

[0080] The operator can deflate the balloon via the balloon inflation-deflation port (STEP 545). The operator can open the balloon inflation-deflation stopcock and suction the fluid in the balloon to deflate the balloon. The operator can deflate the balloon under image guidance to ensure complete deflation. The operator can unlock the catheter-locking loop (STEP 550). In some embodiments, the operator can unlock the catheter-locking loop after a duration of time dictated by a treatment protocol corresponding to treatment with the therapeutic agent. For example, the operator can toggle the locking string to unlock the loop to straighten the catheter tubing. The operator can remove the catheter apparatus from the anatomic location (STEP 555). The operator can remove the catheter tubing along the guidewire, which can then also be removed from the subject 605. [0081] Referring to FIG. 7 in conjunction with FIGs. 8A-8E, shown is a method 700 of anatomic isolation of fluid leaks by using the antegrade catheter (e.g., device 100), according to embodiments of the present disclosure. The operator can use the antegrade catheter to isolate leaking luminal structures to prevent fluid leaks that can cause infections and inhibit healing. The fluid leaks can occur after surgery, injury, trauma, or from tumor/malignant invasion through a wall of a fluid-bearing structure (e.g., ureter, bile duct, or bowel). For example, a urinary leak can occur after bladder resection and anastomosis of ureters to a neobladder. The operator can use the antegrade catheter to perform an antegrade procedure that involves inserting the antegrade catheter upstream from the leak, isolating the leak, and diverting drainage to the antegrade catheter.

[0082] As shown in FIG. 8 A, the subject 805 can have a kidney 810, a ureter 815, and a bladder 820. However, the subject 805 can have bladder carcinoma 825. As shown in FIG. 8B, the operator can remove the bladder carcinoma 825 from the subject by performing a surgery that removes the bladder 820 and constructs a neobladder 830 in its place. The operator can attach the ureter 815 to the neobladder 830 to allow urine from the kidney 810 to drain to the neobladder 830. As shown in FIG. 8C, ureter 815 can decouple or detach from the neobladder 830. For example, the ureter 815 can tear or be unable to heal after the surgery. The detachment can create an opening 835 in the ureter 815. Urine secreted by the kidney 810 into the ureter 815 can leak out of the opening 835 to cause a urine 840 to leak into the subject 805. The operator can use the antegrade catheter to divert the urine away from the opening 835 to prevent the urine 840 from leaking.

[0083] The operator can insert a guidewire into an anatomic structure (STEP 705). In some embodiments, the anatomic structure is a renal collecting system or a biliary system. In some embodiments, the anatomic location is a renal pelvis. In some embodiments, the anatomic structure is a biliary system. In some embodiments, the anatomic location is a confluence of bile ducts. In some embodiments, the treatment involves a urinary tract. In some embodiments, the treatment involves a biliary system, a GI tract, a pancreatic duct, or a vascular system of the subject. In some embodiments, the operator can access the anatomic structure via an image-guided technique before inserting the guidewire. For example, the operator can access relevant anatomic structure (e.g., renal collecting system, biliary system, etc.) via an image-guided Seldinger technique. The operator can create a port or opening configured to receive a guidewire. As shown in FIG. 8D, the operator can create the port 845 in the subject 805. For example, the port can be sized to receive a 0.035" guidewire. The operator can insert the guidewire into the port 845.

[0084] The operator can advance the catheter tubing over the guidewire under image guidance (STEP 710). As shown in FIG. 8D, the operator can advance the catheter tubing 115 into the subject 805 via the port 845. In some embodiments, the catheter tubing is advanced over the guidewire via fluoroscopic or endoscopic image guidance. In certain embodiments, the image-guided technique is an image-guided Seldinger technique. The operator can position a portion of the catheter tubing and the balloon in an anatomic location (STEP 715). The operator can position the catheter tubing 115 such that the balloon is positioned in the ureter 815. In another example, the anatomic location can be a renal pelvis or confluence of right and left bile ducts.

[0085] The operator can form a catheter-locking loop in the portion of the catheter tubing under image guidance (STEP 720). In some embodiments, the operator can form the catheter loop under image guidance by using locking loop string (e.g., locking string 125) at the hub (e.g., hub 105) of the catheter. As shown in FIG. 8D, the operator can form the loop 120 adjacent to the kidney 810. The loop 120 secures the position of the catheter tubing in the subject 805. Fluids (e.g., urine 840) from the kidney 810 can drain into side holes (e.g., side- holes 130) in the loop 120 and into the container 850 that stores the drained urine 840.

[0086] The operator can inflate the balloon (e.g., balloon 160) via a balloon inflation- deflation port of the catheter apparatus (STEP 725). Under image guidance, the operator can inject contrast dye via the fluid port 110 fluidly coupled to the side holes to confirm balloon apposition in the ureter 815 or any other luminal wall of the subject 805. In another example, the operator can inject contrast dye via the guidewire port (e.g., guidewire port 150) fluidly coupled to the guidewire end-hole (e.g., guidewire end-hole 155). The operator can seal the guidewire port with a cap or stopcock between injections of the contrast dye. The operator can use the contrast dye to assess or analyze the fluid leak distal to the balloon. For example, the operator can use the contrast dye and image guidance to identify a location the opening 835 where the urine 840 leaks into the subject 805 as shown in FIG. 8C. Upon identifying the opening 835, the operator can use the contrast dye and use image guidance to position the balloon between the kidney 810 and the opening 835 to prevent the urine 840 from leaking. The operator can identify a volume of injected fluid to inflate the balloon to fill the ureter 815, or any other anatomic structures such as renal collecting system/calyces or bile ducts. The operator can aspirate the contrast dye via the fluid port 110. In another example, the operator can aspirate the contrast dye via the guidewire port. The operator can introduce fluid (e.g., saline water) for inflating the balloon via the fluid port 110. The operator can inflate the balloon under image guidance via the balloon inflation-deflation port 170, such as by introducing saline water via the balloon inflation-deflation port 170 into the balloon. As shown in FIG. 8D, the operator can inflate the balloon to create an inflated balloon 855 in the ureter 815. The operator can position the inflated balloon 855 such that fluid can be isolated proximal to the inflated balloon 855. The operator can maintain inflation of the balloon by sealing the balloon inflation-deflation port 170 with an inflation stopcock (e.g., inflation stopcock 175). The operator can also seal the guidewire port to fluidly seal the channel formed between the guidewire port and the guidewire end-hole to prevent any fluidic leakage via said channel. The operator can periodically unseal the guidewire port to inject contrast dye to use image guidance to inspect the ureter 815, the opening 835, or the inflated balloon 855.

[0087] The operator can drain fluid or urine via the fluid port of the catheter apparatus (STEP 730). For example, the operator can suction urine out of the subject 805 by applying suction to the fluid port 110 fluidly coupled to the side holes into which the urine 840 drains. The inflated balloon 855 can facilitate the drainage of urine 840 into the container 850. As shown in FIG. 8D, the urine 840 does not leak within the subject 805 because the urine 840 can be diverted into the container 850. The operator can attach the container 850 to the fluid port 110 via which urine 840 can drain into the container 850. As shown in FIG. 8E, the ureter 815 can heal or be reattached to the neobladder 830 while the urine is drained into the container 850.

[0088] When the urine 840 of the subject 805 can safely drain from the kidney 810 to the neobladder 830, the operator can deflate the balloon via the balloon inflation-deflation port (STEP 735). The operator can open the balloon inflation-deflation stopcock and suction the fluid in the balloon to deflate the balloon. The operator can deflate the balloon under image guidance to ensure complete deflation. The operator can unlock the catheter-locking loop (STEP 740). For example, the operator can toggle the locking string to unlock the loop to straighten the catheter tubing. The operator can remove the catheter apparatus from the anatomic location (STEP 745). The operator can remove the catheter tubing along the guidewire, which can then also be removed from the subject 805.

[0089] Non-limiting examples of various embodiments are disclosed herein. Features from one embodiment disclosed herein may be combined with features of another embodiment disclosed herein as someone of ordinary skill in the art would understand. The foregoing description is illustrative only and is not intended to be in any way limiting. Further non limiting aspects and features of various potential embodiments are found in the images and supplemental materials in the Appendix.

[0090] As utilized herein, the terms “approximately,” “about,” “substantially” and similar terms are intended to have a broad meaning in harmony with the common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. It should be understood by those of skill in the art who review this disclosure that these terms are intended to allow a description of certain features described without restricting the scope of these features to the precise numerical ranges provided. Accordingly, these terms should be interpreted as indicating that insubstantial or inconsequential modifications or alterations of the subject matter described and are considered to be within the scope of the disclosure.

[0091] For the purpose of this disclosure, the term “coupled” means the joining of two members directly or indirectly to one another. Such joining may be stationary or moveable in nature. Such joining may be achieved with the two members or the two members and any additional intermediate members being integrally formed as a single unitary body with one another or with the two members or the two members and any additional intermediate members being attached to one another. Such joining may be permanent in nature or may be removable or releasable in nature.

[0092] It should be noted that the orientation of various elements may differ according to other exemplary embodiments, and that such variations are intended to be encompassed by the present disclosure. It is recognized that features of the disclosed embodiments can be incorporated into other disclosed embodiments.

[0093] It is important to note that the constructions and arrangements of apparatuses or the components thereof as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter disclosed. For example, elements shown as integrally formed may be constructed of multiple parts or elements, the position of elements may be reversed or otherwise varied, and the nature or number of discrete elements or positions may be altered or varied. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes and omissions may also be made in the design, operating conditions and arrangement of the various exemplary embodiments without departing from the scope of the present disclosure.

[0094] While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other mechanisms and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that, unless otherwise noted, any parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein.

It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure. [0095] Also, the technology described herein may be embodied as a method, of which at least one example has been provided. The acts performed as part of the method may be ordered in any suitable way unless otherwise specifically noted. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[0096] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.” As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and/or” as defined above. For example, when separating items in a list, “or” or “and/or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of’ will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e., “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.”

[0097] As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and/or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one,

B (and optionally including other elements); etc.

Claims

WHAT IS CLAIMED IS:

1. A device for isolating luminal structures in a subject, the device comprising:

(A) a plurality of ports comprising:

(i) a fluid port configured for infusion into or drainage from a lumen of the subject; and

(ii) a balloon inflation-deflation port that is separate from the fluid port;

(B) a catheter tubing extending from the plurality of ports, the catheter tubing comprising:

(i) one or more side holes in communication with the fluid port for fluid infusion or drainage; and

(ii) a guidewire end-hole; and

(C) a balloon in communication with the balloon inflation-deflation port.

2. The device of claim 1, wherein the plurality of ports further comprises a guidewire port that is (i) separate from the fluid port; and (ii) separate from the balloon inflation-deflation port.

3. The device of claim 2, wherein the guidewire port is in communication with the end-hole.

4. The device of claim 1, wherein the fluid port also serves as a guidewire port for receiving a guidewire that exits through the end-hole.

5. The device of claim 1, wherein the balloon comprises radio-opaque markers.

6. The device of claim 5, wherein the radio-opaque markers are at opposing ends of the balloon.

7. The device of claim 1, wherein the catheter tubing comprises a loop.

8 The device of claim 7, wherein the one or more side holes are situated in the loop of the catheter tubing.

9. The device of claim 7, further comprising a locking string secured to the loop.

10. The device of claim 9, wherein the plurality of ports are situated adjacent to a proximal end of the catheter tubing, and the loop is situated at a distal end opposing the proximal end.

11. The device of claim 9, wherein the device comprises a guidewire port, and wherein the locking string is situated at the guidewire port.

12. The device of claim 1, wherein the one or more side holes are situated in the catheter tubing between the balloon and the balloon inflation-deflation port.

13. The device of claim 12, wherein a proximal segment of the catheter tubing extends from the fluid port to the one or more side holes, and a distal segment of the catheter tubing extends from the one or more side holes to the balloon, and wherein the proximal segment of the catheter tubing is longer than the distal segment.

14. The device of claim 1, wherein the balloon is situated between the fluid port and the one or more side holes.

15. The device of claim 14, wherein a proximal segment of the catheter tubing extends from the fluid port to the balloon, and a distal segment of the catheter tubing extends from the balloon to the one or more side holes, and wherein the proximal segment of the catheter tubing is longer than the distal segment.

16. The device of claim 1, wherein the balloon inflation-deflation port communicates with only the balloon.

17. The device of claim 1, further comprising an inflation stopcock for controlling inflation of the balloon, the inflation stopcock situated at the balloon inflation-deflation port.

18. The device of claim 1, further comprising a fluid stopcock for controlling infused or drained fluid, the fluid stopcock situated at the fluid port.

19. The device of claim 1, wherein the device is an antegrade catheter.

20. The device of claim 1, wherein the device is a retrograde catheter.

21. A method for therapeutic infusion using a catheter apparatus comprising a catheter tubing and a balloon, the method comprising: inserting a guidewire into an anatomic structure, and advancing the catheter tubing over the guidewire under image guidance; positioning a portion of the catheter tubing and the balloon in an anatomic location; forming a catheter locking loop in the portion of the catheter tubing under image guidance; inflating the balloon via a balloon inflation-deflation port of the catheter apparatus; injecting a therapeutic agent into the anatomic location via a fluid port of the catheter apparatus and closing a stopcock at the fluid port; aspirating the therapeutic agent via the fluid port of the catheter apparatus; deflating the balloon via the balloon inflation-deflation port; and unlocking the catheter locking loop and removing the catheter apparatus from the anatomic location.

22. The method of claim 21, further comprising gaining access to the anatomic structure via an image-guided technique before inserting the guidewire.

23. The method of claim 22, wherein the catheter apparatus is a retrograde catheter apparatus, and wherein the image-guided technique is an endoscopic imaging technique.

24. The method of claim 22, wherein the catheter apparatus is an antegrade catheter apparatus, and wherein the image-guided technique is an image-guided Seldinger technique.

25. The method of claim 21, wherein the catheter tubing is advanced over the guidewire via fluoroscopic or endoscopic image guidance.

26. The method of claim 21, wherein the catheter apparatus is an antegrade catheter apparatus, and wherein the catheter locking loop is formed using a locking loop string at a catheter hub.

27. The method of claim 21, wherein the catheter apparatus is a retrograde catheter apparatus, and wherein the catheter locking loop is formed by removing the guidewire under image guidance to allow a distal pigtail loop to form.

28. The method of claim 21, further comprising unlocking the catheter locking loop and removing the catheter apparatus after a duration of time dictated by a treatment protocol corresponding to treatment with the therapeutic agent.

29. The method of claim 21, wherein the anatomic structure is a renal collecting system or a biliary system, and wherein the anatomic location is a renal pelvis.

30. The method of claim 21, wherein the anatomic structure is a biliary system, and wherein the anatomic location is a confluence of bile ducts.

31. A method of anatomic isolation for fluid leaks using an antegrade catheter apparatus comprising a catheter tubing and a balloon, the method comprising: inserting a guidewire into an anatomic structure, and advancing the catheter tubing over the guidewire under image guidance; positioning a portion of the catheter tubing and the balloon in an anatomic location; forming a catheter locking loop in the portion of the catheter tubing using a locking loop string at a catheter hub and locking the locking loop string in place; inflating the balloon via a balloon inflation-deflation port of the catheter apparatus; attaching a drainage bag to the fluid port for fluid drainage and placing a temporary cap over the balloon inflation-deflation port; deflating the balloon via the balloon inflation-deflation port following fluid drainage; and unlocking the locking loop string to facilitate removal of the catheter apparatus.

32. The method of claim 31, further comprising injecting a contrast dye into the fluid port under image guidance to confirm balloon apposition with luminal wall.

33. The method of claim 31, further comprising injecting a contrast dye through a guidewire port to assess fluid leak distal to the balloon.

34. The method of claim 31, further comprising gaining access to the anatomic structure via an image-guided Seldinger technique.

35. A method of using a device to isolate a luminal structure of a subject, wherein the device comprises:

(A) a plurality of ports comprising:

(ii) a balloon inflation-deflation port that is separate from the fluid port;

(ii) a guidewire end-hole; and

(C) a balloon in communication with the balloon inflation-deflation port.

36. The method of claim 35, further comprising infusing a therapeutic agent into the isolated luminal structure.

37. The method of claim 36, wherein the therapeutic agent is a chemotherapy agent.

38. The method of claim 35, further comprising advancing the device into a urinary tract.

39. The method of claim 35, further comprising advancing the device into a biliary system, a gastrointestinal (GI) tract, a pancreatic duct, or a vascular system of the subject.

40. The method of claim 35, wherein the device further comprises a loop in the catheter tubing, wherein the one or more side holes are situated in the loop, and wherein the method comprises positioning the loop and the balloon in a desired anatomic location.