Methods and apparatus for surgical anastomosis
Inventors
Assignees
Publication Number
US-8894699-B2
Publication Date
2014-11-25
Expiration Date
2028-04-07
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Abstract
Methods and apparatus for anastomosis of a lumen according to various aspects of the present invention operate in conjunction with an impermeable stent. The impermeable stent may comprise a scaffold and, if needed, a sealant, such as a membrane and/or adhesive. In one embodiment, the scaffold, membrane and/or adhesive comprise biocompatible materials suitable for bio-absorption and/or degradation.
Core Innovation
The invention provides methods and apparatus for anastomosis of a lumen using an impermeable stent, which may comprise a scaffold and, if needed, a sealant such as a membrane and/or adhesive. The scaffold, membrane, and adhesive can be composed of biocompatible materials suitable for bio-absorption and/or degradation. This impermeable stent is configured to be inserted into the separated lumen ends during the surgical anastomosis to prevent leakage.
The impermeable stent acts as a prophylactic measure against leakage and soilage at the anastomosed site, thereby reducing the common risks associated with traditional anastomosis procedures, such as contamination, sepsis, or death. It may further prevent scarring and constrictions (strictures) by providing structural support and can promote healing in the affected lumen area.
The scaffold may include various designs such as metal, plastic, nylon, or polymer frameworks that are either expandable, flexible, self-expanding or pressure-expandable, with possible use of shape change materials that expand at body temperature. The scaffold can be combined with a membrane and adhesive to form a substantially leak-free seal that adheres the separated lumen ends together. Additionally, the materials can be biodegradable or bioabsorbable, allowing the scaffold and sealant to degrade or be absorbed by the body after the healing process.
The apparatus and method are suitable for anastomosis in various lumens within the body, including those in the gastrointestinal, urinary, cardiovascular, biliary, and genitourinary tracts. Specific sites include the intestines, esophagus, stomach, bile ducts, pancreas, and urethra. The method involves inserting the impermeable stent between the lumen ends during resection and anastomosis procedures to inhibit leakage and improve surgical outcomes.
Claims Coverage
The patent contains two independent claims outlining methods for prophylactically treating leakage of a lumen during anastomosis using an impermeable stent. These claims include a set of inventive features related to applying sealants and attaching a scaffold within separated lumen ends.
Use of an impermeable stent with a scaffold and sealant during anastomosis
During surgery, applying a sealant to an external surface of a scaffold, disposing the scaffold into separated ends of the lumen, and attaching the scaffold to internal surfaces of the lumen ends via the sealant. Then, attaching the separated lumen ends to each other such that they are in contact.
Use of adhesives comprising biocompatible materials
The sealant includes adhesives such as purified bovine serum albumin with glutaraldehyde or polyethylene glycol, and may comprise bioabsorbable or biodegradable materials.
Scaffold materials and expandability
The scaffold may be made from bioabsorbable and/or biodegradable materials. It may be expandable or removable, and formed from shape change materials with phase transition temperatures below the lumen temperature.
Use of fixation devices for attachment
Attaching separated lumen ends via fixation devices including adhesives, tacks, spiral wires, staples, or sutures, where these fixation devices can also be bioabsorbable or biodegradable.
Balloon-assisted radial expansion of the scaffold
Disposing a balloon within the scaffold which is configured to radially expand the scaffold to contact the inner luminal tissue surfaces.
Use of sealant on scaffold and lumen surfaces
Applying a sealant to both an external surface of the scaffold and an external surface of at least one of the separated lumen ends prior to disposing the scaffold.
The inventive features encompass the use of an impermeable stent composed of a scaffold combined with a sealant to prevent leakage during lumen anastomosis. These features include specific materials for adhesives and scaffolds, methods for scaffold deployment and expansion, as well as securing the anastomosed lumen ends, thereby providing a comprehensive approach to improving surgical anastomosis outcomes.
Stated Advantages
Prevention of leakage and soilage at anastomosis sites, reducing complications such as peritoneal or thoracic contamination, sepsis, and death.
Reduction or elimination of scarring and constrictions (strictures) caused by closure of the lumen through mechanical support provided by the scaffold.
Promotion of healing at the anastomosed area using biocompatible materials, possible inclusion of growth factors, antimicrobial agents, or antibodies.
Provision of an impermeable layer that forms a substantially leak-free seal between lumen ends.
Use of bioabsorbable or biodegradable materials enabling scaffold and adhesive to disintegrate or be absorbed, thus avoiding more invasive removal procedures.
Documented Applications
Anastomosis of lumens in the gastrointestinal tract, including the esophagus, small intestine, large intestine, and colon.
Anastomosis of lumens in the urinary tract, cardiovascular system, biliary tract, and genitourinary tract.
Resection and anastomosis procedures for removal of diseased or cancerous luminal tissue, such as in the esophagus, colon, or intestines.
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