Devices and methods for closing abdominal fascia and other incisions
Inventors
Assignees
Leland Stanford Junior University
Publication Number
US-12324575-B1
Publication Date
2025-06-10
Expiration Date
2040-06-14
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Abstract
Devices and methods are provided for closing an incision through fascia or other tissue of a subject. A first closure element is positioned against tissue on a first side of the incision, a second closure element is positioned against tissue on a second side of the incision, and a fastener from or through the first closure element is directed through the tissue and the second closure element to secure the closure elements against the tissue to close the incision.
Core Innovation
The invention pertains to devices and methods for closing incisions through fascia or other tissues of a subject, notably in the context of surgical procedures such as laparotomy or laparoscopy. The core approach involves the use of pairs of closure elements that are positioned on opposite sides of an incision. Fasteners from or through one closure element are directed through both the tissue and the second closure element, effectively securing the tissue and closing the incision.
The problem addressed by the invention is that traditional abdominal fascial closure methods rely on manual suture and needle techniques, which are time-consuming, can lead to uneven tension, and may predispose patients to complications such as incisional hernia or burst abdomen, as well as increase infection risks. Automated closure devices for this purpose are currently lacking, and while techniques like the small bite technique (SBT) may reduce hernia incidence, they are tedious and not easily replicated in clinical settings.
The proposed innovation introduces closure elements—often broad, bioabsorbable contact members, potentially square or rectangular in shape, joined by flexible links—that are placed on either side of an incision. Fasteners, which may feature barbs, ratchets, or zip-tie technologies and can be part of a male/female system, are used to draw the pairs together and secure the closure. Delivery may be automated via a stapler device or similar tool, and the elements and fasteners may remain in the body to dissolve after healing. This design aims to distribute closure force more uniformly, follow SBT principles for spacing and tension automatically, and reduce both closure time and the risk of complications.
Claims Coverage
The patent includes two independent claims, each introducing key inventive features centered around the structure of closure elements and delivery tools for automated incision closure.
Automated tool with paired bioabsorbable closure elements and integral fasteners
The invention comprises an apparatus for closing incisions after a surgical procedure, featuring: - A first pair of closure elements formed from bioabsorbable material, each having multiple contact members joined by links, each contact member possessing two surfaces and an integral fastener. - A tool with a proximal handle/hub, a distal pair of arms, and an actuator. Each arm carries a closure element such that their first surfaces face one another for placement against tissue. - The actuator moves the arms together to drive male fasteners from one closure element through tissue into engagement with female fasteners on the opposite closure element. - The tool includes a cartridge holding additional closure element pairs, and an advancement mechanism that reloads new pairs of closure elements after deployment. - The tool may include features such as a tension gauge and mechanisms for engaging and stabilizing tissue before deploying fasteners.
Bioabsorbable closure elements with fasteners receivable through contact members and automated delivery
Another inventive feature comprises: - A first pair of closure elements formed from bioabsorbable material, each with several contact members joined by one or more links and each contact member with two surfaces. - One or more fasteners receivable through the contact members when first surfaces are positioned against tissue on either side of an incision to close fascia. Each contact member may have an aperture or membrane for fastener receipt, and the fasteners may be integral to each contact member. - Delivery via a tool with a handle/hub, pair of arms, and actuator; each arm holds a closure element such that their first surfaces are spaced apart and oriented towards each other enabling placement on opposite sides of tissue. - The actuator operates to drive fasteners through tissue from one closure element to the other, engaging fasteners on both sides to secure the closure. - The tool features a cartridge with extra pairs of closure elements and an advancement mechanism for sequential delivery. - The system may use various types of fasteners, including sutures, zip-ties, t-fasteners, and barbed fasteners. - The configuration allows for the closure elements to have pairs or arrangements along an axis, and may use male/female fastener systems with locking barbs or ratchets and centrally placed fasteners.
The inventive coverage focuses on the configuration of bioabsorbable closure elements, integral or receivable fasteners, and automated delivery and reloading mechanisms. The claimed apparatuses incorporate features that promote uniform and automated incision closure, with options for various fastener types and tension control.
Stated Advantages
The devices and methods may apply more evenly distributed tension to tissue during closure, reducing the risk of tissue cut-through, fascial dehiscence, and complications such as burst abdomen or incisional hernia.
Automated delivery greatly reduces operative closure time compared to conventional suturing methods, with closure potentially up to twenty-five percent faster than small bite technique.
The design may minimize user error by automatically providing uniform spacing and tension along the incision, following the principles of the small bite technique without manual technical demands.
The retained closure elements and fasteners, being bioabsorbable, allow for secure closure during healing and dissolve after sufficient tissue recovery, potentially supporting improved post-operative outcomes.
The approach may also reduce the incidence of surgical site infections compared to traditional closure techniques.
Documented Applications
Closure of abdominal fascia after laparotomy in open surgical procedures.
Fascial wall closure in open or laparoscopic surgical procedures involving incisions through fascia or other tissue.
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