Temporary Anastomosis Anchor with Variable Diameter Sheath
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Solution Overview
Problem
Current methods for protecting anastomosis in the colon, rectum, or anal passage require invasive procedures, such as intestinal stoma or bypass, which are costly, complicated, and carry significant risks, including the need for additional surgical interventions and high mortality rates due to complications like anastomotic fistulas.
Innovation Solution
A semi-rigid hollow longitudinal anchor element with a variable diameter and a flexible elastomer sheath that can be inserted post-anastomosis, expanding to anchor temporarily against the intestinal wall without requiring fixation maneuvers, and spontaneously migrating once healing is complete, ensuring protection for several days without surgical intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a stoma is created to divert intestinal flow upstream of the anastomosis, then the anastomosis is protected from fecal contact, but the patient suffers from significant socio-professional repercussions, local complications, and requires additional surgical intervention for closure
Solution Approach 1:
The invention extracts the protective function from the permanent stoma configuration and implements it through a temporary, removable device (coloplast) that can be introduced and eliminated without major surgical intervention, thereby maintaining anastomosis protection while avoiding the complexities of stoma creation and closure
Solution Approach 2:
The coloplast device is designed as a temporary, short-term solution that remains in place only for the necessary healing period (typically 7-14 days) and then eliminates spontaneously or is easily removed, avoiding the permanent commitment and long-term complications of a stoma
2Ease of operation
If a bypass is used to protect the anastomosis area from fecal contact, then no digestive diversion is required, but the interface tube requires fixation maneuvers that may injure the intestine and cannot accommodate automatic circular staplers
Solution Approach 1:
The coloplast device is designed to self-anchor through radial expansion against the intestinal wall without requiring external fixation maneuvers, thereby protecting the anastomosis area while eliminating the need for suturing or clipping operations that could cause intestinal injury
Solution Approach 2:
The device utilizes changes in radial dimension (expanded vs. compressed state) to achieve anchoring and protection functions, allowing it to expand to a diameter that provides effective sealing against the intestinal wall while maintaining compatibility with standard surgical instruments
3Reliability
If the anchor element has a large outside diameter to remain fixed against the intestinal wall, then temporary protection is achieved, but the device cannot be introduced per anum in its expanded state
Solution Approach 1:
The anchor element is designed with dynamic dimensional characteristics, transitioning from a compressed low-diameter state for introduction through the anus to an expanded high-diameter state for anchoring against the intestinal wall, thereby resolving the contradiction between introducibility and anchoring stability
Solution Approach 2:
The device employs a nested configuration where the anchor element is contained within an introducer device or delivery catheter in its compressed state, allowing per anum introduction, and then deployed to its expanded protective configuration once positioned at the anastomosis site
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 device effectively prevents anastomotic fistulas by maintaining temporary protection of the anastomosis for several days, reducing the risk of complications and eliminating the need for additional surgical interventions, while allowing for natural migration and elimination, thus minimizing socio-professional and local complications.
Implementation Method 1
a hollow longitudinal element (2) called temporary anchor element, a first wall of which defines a surface of revolution about a longitudinal axis XX, including a substantially cylindrical main portion with a substantially circular section, and said first wall having an outside diameter that can be varied in a controlled manner between: a reduced outside diameter D1' of at most 10 mm in a radially retracted configuration of said first wall; and a maximum outside diameter D1 in a maximum radial expansion configuration of the main portion of said first wall
Implementation Method 2
After an average delay of ten days necessary for proper healing of the anastomosis, and once the fixing sutures have been resorbed, the tube is spontaneously eliminated per anum with the fecal bolus
Data Source
AI summary
A surgical device for temporary protection of an anastomosis in the colon, the rectum, or the anal passage, including: a semi-rigid hollow longitudinal temporary anchor element, a first wall of which includes a substantially cylindrical main portion with a substantially circular section having a length of at least 50 mm, the first wall having an outside diameter that may be varied in a controlled manner; and a flexible sheath fixed to the anchor element against, preferably around, the first wall and having a length downstream of the anchor element of at least 50 cm, and an outside diameter when at rest in the range 20 mm to 40 mm, and the sheath is made from a biocompatible elastomer material having a wall thickness in the range 0.05 mm to 1 mm.