Fixation device delivery system and methods

Inventors

Keating, Ronan • Conroy, Diarmuid • Rabbitte, Gerard

Assignees

Sharp Fluidics Inc

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Publication Number

US-11812955-B2

Patent

Publication Date

2023-11-14

Expiration Date


Abstract

A fixation device delivery system is described. The system includes a driver and a cooperating fixation element featuring a barb which becomes active upon deployment in the inner abdominal wall.

Core Innovation

A mesh fixation system uses a tack and a delivery instrument, where the tack includes a body section with a distal section and a proximal section. A helical threaded element extends outwardly from the body section and at least partially extends longitudinally from the distal section toward the proximal section. Engagement elements are configured to operably engage and interact with the delivery instrument, and the proximal section defines a lumen for receipt of at least a portion of the delivery instrument.

The body section further defines a mouth to the lumen that extends along a longitudinal axis of the body section. On removal of the at least a portion of the delivery instrument from the lumen, the mouth defines a barb. Deployment and retention are enabled by the interaction of tack geometry and delivery instrument engagement, including multiple mechanical retention and decoupling mechanisms to retain tacks until deployment and to decouple the tack from the delivery instrument during release.

The disclosed delivery includes inserting a shaft of the delivery instrument through a trocar or port to a desired location to place the tack to fix the mesh, and deploying the tack at the desired location by applying pressure and rotating the delivery instrument. The system supports sequential presentation of multiple bioabsorbable tacks while maintaining trocar position and retaining tacks until deployment. Tack embodiments include a two-part tack with a deployed barb and a proximal abutment portion securing the mesh against the abdominal wall, with an exposed recessed portion having at least 50% lumen to promote tissue ingrowth, and alternate tack configurations including helical/barb and cut-out configurations with exposed lumen.

Claims Coverage

The independent claims are clm-00001 and clm-00011, and they define two main inventive feature groupings: (i) a mesh fixation system tack geometry configured to mate with a delivery instrument via a proximal lumen and define a barb on instrument removal, and (ii) a method of fixing mesh in an abdominal cavity using trocar/port placement with tack deployment by applying pressure and rotating the delivery instrument.

Helical tack with proximal lumen and mouth forming barb

A tack having a body section with distal and proximal sections, a helical threaded element extending outwardly and at least partially longitudinally, engagement elements configured to interact with a delivery instrument, a proximal section defining a lumen for receipt of at least a portion of the delivery instrument, and a mouth to the lumen that extends along a longitudinal axis and defines a barb on removal of the delivery instrument portion from the lumen.

Trocar/port mesh fixing method using pressure and rotation deployment

A method of fixing a mesh within an abdominal cavity by providing a tack and a delivery instrument with the tack structure including a body section, helical threaded element, engagement elements, proximal lumen, and mouth defining a barb on instrument removal, placing the tack on a step-down portion of the delivery instrument, inserting a shaft through a trocar or port to a desired location, deploying the tack at the desired location by applying pressure and rotating the delivery instrument, repeating placing/inserting/deploying another tack until the mesh is sufficiently fixed, and removing the delivery instrument from the trocar or port.

Across the independent claims, the coverage centers on a tack geometry that receives a delivery instrument through a proximal lumen and creates a barb on removal, combined with deployment at a trocar/port location by applying pressure and rotating the delivery instrument, with repetition of tack placement until the mesh is sufficiently fixed.

Stated Advantages

Promote tissue ingrowth via an exposed recessed portion having at least 50% lumen.

Maintain trocar position while sequentially presenting multiple bioabsorbable tacks and retaining tacks until deployment.

Documented Applications

Fixing a mesh within an abdominal cavity using tack deployment through a trocar or port to a desired location.

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