# US 12,108,961 B2 · Multi-purpose medical device for streamlined biliary and other interventions

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- Number: US 12,108,961 B2
- Document ID: US12108961B2
- Status: Granted
- Kind: B2
- Application number: 18/480,394
- Filed: 2023-10-03
- Published: 2024-02-22
- Granted: 2024-10-08
- Earliest claimed: 2023-10-03
- Applicants: Mohammad Fayyaz
- Inventors: Mohammad Fayyaz
- Web page: https://patentgrep.com/patent/US12108961B2

## CPC

- A61B 17/22032: {having inflatable gripping elements (balloon catheters A61M25/10)}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 2017/22038: {with a guide wire}
- A61B 2018/00166: {Multiple lumina}
- A61B 2018/00202: {rotating}
- A61B 2018/00285: {Balloons}
- A61B 2018/00494: {Stomach, intestines or bowel}
- A61B 2018/00601: {Cutting}
- A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes}
- A61B 2018/144: {Wire}
- A61B 2090/3933: {Liquid markers}
- A61M 25/1011: {Multiple balloon catheters}
- A61M 25/10182: {Injector syringes}
- A61M 2025/0008: {having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type}
- A61M 2025/0036: {with more than four lumina}
- A61M 2025/1079: {having radio-opaque markers in the region of the balloon}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The present invention relates to a methodology of, and an apparatus for, performing multiple interventions within the biliary tree without requiring multiple catheter exchanges. The device consists of a flexible elongate tube, introduced through an endoscope, having a proximal end towards the operator and a distal end directed towards a body lumen. The exposed part of an electrosurgical cutting wire near the distal end is used to cut the sphincter of Oddi. Two lumens extend from the proximal to the distal end, one configured to accept a guidewire, and the other to allow contrast injection. In some renderings, a single lumen may serve both functions. Another lumen extends from the proximal end to a dilator balloon housed distally on the catheter to further widen the biliary orifice. An additional lumen extends from the proximal end to an extractor balloon near the distal end of the catheter for stone extraction.

## Claims

### Claim 1

A medical device configured for large stone extraction comprising:
a flexible elongate catheter comprising a plurality of lumens, a proximal end and a distal end, a longitudinal axis extending from said proximal end to said distal end, an electrosurgical wire assembly that has a distal cutting part for performing a sphincterotomy and a non-conductive part that extends proximally through a first lumen towards the proximal end to be attached to a heat source and a handle that controls tip deflection/manipulation, wherein a distal tip of the catheter is curved towards the first lumen such that a distal end of the electrosurgical cutting wire is attached to the distal tip, and wherein the first lumen terminates proximal to the distal tip such that the cutting part is exposed within a recess defined by the curvature of the distal tip and the end of the first lumen;
a second lumen extending from the distal end to the proximal end, configured to accept a contrast injection through the proximal end for cholangiography or similar uses;
a third lumen extending from the distal end to the proximal end, configured to accept a guidewire, wherein the lumen may be constructed without a split for the catheter to operate as a long-wire catheter or alternatively may be configured to have a splitable channel in the form of a C, U, O configuration or other similar channels for use as a short-wire catheter;
a low-compliance, high-pressure dilator balloon located on the catheter towards the distal end, configured for dilation of an ampulla of Vater or a stricture, wherein the dilator balloon is filled via infusion of a fluid through a fourth lumen that extends proximally from one or more dilator balloon entry ports to the proximal end of the catheter, with a luer lock or another compatible connector at the proximal end to be attached to a pressure gauge and an inflation device, configured to be dilated to one fixed diameter or several different predetermined diameters dependent on the pressure level achieved;
a second low-pressure, high-compliance extractor balloon located distal of the dilator balloon on the catheter for extraction/retrieval of stones or other objects, wherein the extractor balloon is filled through a fifth lumen that extends proximally from one or more extractor balloon entry ports to the proximal end of the catheter with a connector for a syringe, configured to be inflated to one fixed or several different predetermined diameters based on a volume of air introduced through a syringe;
an additional side-hole, optionally incorporated near the distal end of the third lumen for the catheter to have additional guidewire exchange capability as an ultra-short wire exchange catheter; and
one or more radiopaque markers, optionally incorporated to mark certain areas of the catheter, with or without color coded visual markers at various locations as desired.

### Claim 2

A medical device configured for large stone extraction comprising:
a flexible elongate catheter comprising a plurality of lumens, a proximal end and a distal end, a longitudinal axis extending from said proximal end to said distal end, an electrosurgical wire assembly that has a distal cutting part for performing a sphincterotomy and a non-conductive part that extends proximally through a first lumen towards the proximal end to be attached to a heat source and a handle that controls tip deflection/tip manipulation, wherein a distal tip of the catheter is curved towards the first lumen, such that a distal end of the electrosurgical cutting wire is attached to the distal tip, and wherein the first lumen terminates proximal to the distal tip such that the cutting part is exposed within a recess defined by the curvature of the distal tip and the end of the first lumen;
a second lumen extending from the distal end to the proximal end, configured to accept a contrast injection through the proximal end for cholangiography or similar uses and also configured to accept a guidewire, with a Tuohy-Borst adapter that may be built in or attached to the proximal end;
a low-compliance, high-pressure dilator balloon located on the catheter towards the distal end, configured for dilation of an ampulla of Vater or a stricture, wherein the dilator balloon is filled via infusion of a fluid through a third lumen that extends proximally from one or more dilator balloon entry ports to the proximal end of the catheter, with a luer lock or another compatible connector at the proximal end to be attached to a pressure gauge and an inflation device, configured to be dilated to one fixed diameter or several different predetermined diameters dependent on the pressure level achieved;
a second low-pressure, high-compliance extractor balloon located distal of the dilator balloon on the catheter for extraction/retrieval of stones or other objects, wherein the extractor balloon is filled through a fourth lumen that extends proximally from one or more extractor balloon entry ports to the proximal end of the catheter with a connector for a syringe, configured to be inflated to one fixed or several different predetermined diameters based on a volume of air introduced through a syringe;
an additional side-hole, optionally incorporated near the distal end of the second lumen for the catheter to have additional guidewire exchange capability as an ultra-short wire exchange catheter; and
one or more radiopaque markers, optionally incorporated to mark certain areas of the catheter, with or without color coded visual markers at various locations as desired.

### Claim 3 (depends on 1)

A method of using a medical device described in claim 1, comprising the steps of:
introducing the medical device through a duodenoscope or another videoscope, port, sheath or opening in order to streamline bile duct stone extraction by eliminating the need for multiple catheter exchanges in an attempt to improve efficiency, ensure patient safety, reduce healthcare costs and minimize medical waste;
cutting a biliary sphincter with said electrosurgical cutting wire;
dilating a biliary orifice with said low-compliance, high-pressure dilator balloon; and
extracting bile duct stones or other objects from the biliary tree with the use of said low-pressure, high-compliance extractor balloon, without requiring any catheter exchanges, as all three components are housed within one catheter.