Detachable Double-Balloon Catheter for Precise LAMS Deployment
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Solution Overview
Problem
Existing methods for treating gastric outlet obstruction (GOO) such as duodenal stent delivery and endoscopic ultrasound guided gastroenterostomy (EUS-GE) face issues like tissue ingrowth, overgrowth, suboptimal distention, gastrointestinal perforation, and difficulty in locating the small intestine, leading to complications and mis-puncture.
Innovation Solution
A double-balloon catheter with attachable and detachable catheter hubs, featuring multiple lumens and inflatable occlusion balloons, allows for precise distention and deployment of a lumen apposing metal stent (LAMS) by facilitating navigation through the gastrointestinal tract using a gastrointestinal endoscope.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a modified nasogastric tube with media infusion port is used for balloon-occluded gastrojejunostomy, then small intestine distention can be achieved, but the procedure becomes very difficult due to difficulty in delivering the tube to the small intestine over a guidewire
Solution Approach 1:
The catheter body is designed to be nested within the overtube during delivery. The overtube serves as a protective sheath that guides the catheter through the gastrointestinal tract and facilitates positioning in the small intestine. Once positioned, the catheter can be deployed while the overtube is withdrawn or left in place as needed.
Solution Approach 2:
The overtube acts as an intermediary device that simplifies the delivery of the catheter to the target location. By providing a rigid or semi-rigid conduit, the overtube makes it easier to navigate the catheter through the complex anatomy of the GI tract and position it accurately in the small intestine.
2Ease of operation
If an overtube is used to help deliver the double-balloon tube to the desired location, then delivery difficulty is reduced, but the procedure becomes further complicated
Solution Approach 1:
The catheter hub is designed with multi-functionality, integrating both the balloon inflation ports and the media infusion port into a single component. This allows for both balloon occlusion and fluid infusion through the same hub, reducing the number of separate components needed and simplifying the overall procedure.
Solution Approach 2:
The function of the catheter hub and the media infusion port are merged into a single integrated component. This consolidation reduces the number of separate devices needed and simplifies the procedure by allowing both balloon inflation and media infusion to be controlled from one hub.
3Productivity
If rapid infusion of large volume of water is used to distend the small intestine, then LAMS delivery is facilitated, but gastrointestinal perforation and cardiovascular complications occur
Solution Approach 1:
Instead of rapidly infusing large volumes of water, the system uses controlled inflation of balloons to achieve localized distention. The balloons are inflated to a controlled extent to provide sufficient distention for LAMS deployment without the excessive forces that would cause perforation or cardiovascular complications.
Solution Approach 2:
The balloons serve as intermediaries between the infusion system and the small intestine. By inflating the balloons, the system achieves controlled local distention that facilitates LAMS deployment without the need for rapid large-volume water infusion, thereby reducing the risk of perforation and cardiovascular complications.
4Reliability
If duodenal stent is delivered through endoscope working channel, then GOO can be treated, but tissue ingrowth and overgrowth occur requiring multiple follow-up interventions
Solution Approach 1:
The system extracts the problematic duodenal stent approach and replaces it with a balloon-occluded gastrojejunostomy technique using LAMS. By creating a bypass through the small intestine rather than placing a stent in the duodenum, the solution avoids the tissue ingrowth and overgrowth issues that plague duodenal stents, thereby extending the duration of effective treatment.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The catheter enables effective deployment of LAMS by optimizing small intestine distention, reducing procedural complications, and enhancing the accuracy of enterostomy procedures, thereby minimizing tissue damage and improving surgical outcomes.
Implementation Method 1
The first and second inflatable occlusion balloons are configured to receive fluid through at least one of the plurality of lumens
Implementation Method 2
The infusion port is in fluid communication with another of the plurality of lumens and situated between the first inflatable occlusion balloon and the second inflatable occlusion balloon
Data Source
AI summary
A double-balloon multi-lumen catheter is disclosed. The catheter comprises an elongate catheter body including a plurality of lumens. The catheter also includes a plurality of occlusion balloons connected to one or more lumens, and one or more entry ports associated with the plurality of lumens. The catheter also includes an attachable catheter hub comprising a plurality of entry ports. The catheter hub is arranged to receive a proximal end of the elongate catheter body and fluidly connect one or more of the plurality of lumens to associated one of more of the plurality of entry ports. The entire length of the catheter body is configured to pass through the working channel of a gastrointestinal endoscope. The catheter hub is configured to be attached to the proximal end of the elongate catheter body allowing endoscope removal from the catheter body without disrupting the balloon position.