Apparatuses and methods for improving post-operative recovery from surgery

Inventors

Balasubramaniam, Swarna

Assignees

Noleus Technologies Inc

Publication Number

US-12303356-B2

Publication Date

2025-05-20

Expiration Date

2036-07-27

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Abstract

This disclosure relates to apparatuses and methods for preventing the onset and progression of POI. In one example, a fan-like polyurethane heat-sealed bilayer that surrounds a plurality of wedge-shaped foam strips that join at a collecting foam portion, is subjected to negative pressure provided through silicone tubing which is sealed to the perforated collecting foam portion. Such negative pressure applied for approximately 48 to 72 hours after closure of the abdomen, helps prevent POI which in turn enhances patient recovery, and reduces the length of their hospital stay.

Core Innovation

The invention relates to apparatuses and methods for improving post-operative recovery from bowel surgery, specifically by preventing the onset and progression of Postoperative Ileus (POI), a transient impairment of bowel motility that commonly follows abdominal surgery. The disclosed apparatus consists of a fan-like polyurethane heat-sealed bilayer that surrounds multiple wedge-shaped foam strips joined at a collecting foam portion, which is connected to silicone tubing that applies negative pressure through vacuum therapy. This negative pressure therapy is applied for approximately 48 to 72 hours after closure of the abdomen to help prevent POI, enhance patient recovery, and reduce hospital stay duration.

The problem being solved addresses the lack of a single effective strategy to reduce POI and its associated impact on length of hospital stay and costs. POI often delays the return to normal gastrointestinal function after surgery, especially when directly involving the gastrointestinal tract. Traditional treatments such as mobilization, laxatives, open abdominal techniques, and prokinetic agents have limitations. Existing negative pressure wound therapies are designed for open wounds and cannot be applied after abdominal closure to prevent POI. Therefore, there is a need for an apparatus and method that can be temporarily placed around the bowels, enclosed within the abdomen, and apply negative pressure to prevent POI following surgery.

The apparatus of the invention is three-dimensional, flexible, and designed to encompass the bowels inside the abdominal cavity, providing cushioned support similar to a hammock. It maximizes contact surface area with the bowel to apply negative pressure effectively to promote fluid removal and improve blood flow, thereby enhancing healing. The device is designed to be introduced into the abdominal cavity during surgery, then the abdomen is closed. After the negative pressure therapy period and restoration of bowel function, the device is retractable and removable via a small surgical incision, facilitated by pleats in the bilayer, preventing the need for further surgery and minimizing patient discomfort.

Claims Coverage

The patent claims cover eleven inventive features across three independent claims related to apparatus design, negative pressure application, and device removal methods.

Method for preventing POI using foam strips in a bilayer with negative pressure

A method comprising placing a device with multiple foam strips enveloped in a bilayer around the bowels, applying negative vacuum pressure through tubing connected to the bilayer to draw fluid from bowel tissue to prevent POI, collapsing the device, and removing it in one piece through an incision less than 2 cm.

Method for treating tissue region with a device enabling retraction and removal

A method involving positioning a pre-manufactured device with pliable members encompassed by one or more layers upon tissue in an internal cavity, tensioning a connecting tube to collapse the device into a retracted configuration, and withdrawing the entire device through a surgical incision, ensuring fluid communication with the device for negative pressure application.

Method for preventing POI with device positioning, negative pressure actuation, and minimal incision removal

A method that includes deploying a device comprising pliable members encapsulated in layers upon tissue, actuating negative pressure to draw fluid and prevent POI, tensioning the connecting tube to collapse the device, and withdrawing it in one piece through a surgical incision under 2 cm in diameter.

The claims encompass methods for applying negative pressure therapy via a bilayer-encapsulated foam apparatus placed around the bowels or tissues to prevent POI by fluid removal, along with features enabling device collapse and minimally invasive removal through a small surgical incision.

Stated Advantages

Helps prevent the onset and progression of Postoperative Ileus, enhancing patient recovery.

Reduces length of hospital stay by enabling quicker restoration of bowel function.

Provides a pliable, adequately supported apparatus that cushions the bowels to promote healing.

Facilitates removal through a minimal (approximately 2 cm) incision, avoiding additional surgical procedures.

Enables efficient fluid removal and increased blood flow to the bowel area through controlled negative pressure therapy.

Potential to reduce post-operative infections and hematomas by draining blood and fluid in the abdominal cavity.

Documented Applications

Use in post-operative care following abdominal or bowel surgery to prevent the development and progression of Postoperative Ileus.

Application in any surgery involving laparotomy or laparoscopy that may cause ileus, including transplant and non-transplant surgeries affecting abdominal organs such as digestive, urogenital, lymphatic, and respiratory systems.

Use in treating tissue regions within internal body cavities to promote recovery by applying negative pressure therapy.

Potential use to decrease post-operative infections or hematoma by removing blood and fluid via negative pressure.

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