Smart surgical spacer for tissue-implant interface
Inventors
Borazjani, Ali • WEED, Benjamin C
Assignees
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Publication Number
US-10582993-B2
Publication Date
2020-03-10
Expiration Date
Abstract
A surgical spacer equipped to measure important parameters for determining the optimal placement of a surgically-implanted sling.
Core Innovation
The disclosure relates to implantation of a sling into a patient using a spacer that acts as a spacing tool between a predetermined portion of the bodily tissue of the patient and the sling. A sensor-equipped portion of the spacer determines a load applied from the sling to the first end of the spacer, and the operator simultaneously quantifies the load and adjusts a tension of the sling. The spacer includes a first end insertable into the patient and a distal end external to the patient during use.
The spacer includes a tip disposed at an end of the first end and a flex-beam coupled between the tip and a distal end of the first end, wherein the flex-beam bends in response to load applied by the sling. The spacer further includes a first sensor for measuring a load applied to the flex-beam by the sling. In some configurations, the tip is flexibly coupled to the flex-beam and an arrangement including a gap and a paddle is provided so that a sensor can isolate bending load near the tip from bending load on the flex-beam.
In further aspects, a probe is inserted into a urethra and attached to a mounting forming part of the spacer, where angular movement of the probe relative to the spacer is determined based on electrical output from a first sensor forming another part of the spacer. A reference for the probe’s angular position relative to the spacer is established upon an action of a first operator with respect to a user input interface on the spacer, and a microprocessor automatically quantifies an angular change of the probe to determine placement of the sling.
Claims Coverage
The document includes three independent claims. The inventive features center on a spacer with a sensor-equipped portion for simultaneous load quantification and sling tension adjustment, a spacer structure having a tip and bending flex-beam with a load-measuring first sensor, and a urethral probe whose angular change is sensed and automatically quantified to determine sling placement.
Spacer used as a spacing tool for simultaneous load quantification and tension adjustment
A method relating to implantation of a sling into a patient comprising inserting a first end of a spacer into a patient, attaching first and second portions of the sling to a sensor-equipped portion of the first end of the spacer and to body tissue, displaying to an operator the load applied from the sling to the first end of the spacer, wherein the spacer allows the operator to simultaneously quantify the load and adjust a tension of the sling while employing the spacer as a spacing tool between the predetermined portion of bodily tissue and the sling.
Tip flexibly coupled to a bending flex-beam with a load-measuring first sensor
A spacer for use in implanting a sling into a patient comprising a first end with a tip disposed at an end of the first end and a flex-beam coupled between the tip and a distal end of the first end, the flex-beam comprising a first sensor for measuring a load applied to the flex-beam by the sling, and wherein the tip is flexibly coupled to the flex-beam and the flex-beam bends in response to the load applied by the sling.
Probe angular-change quantification for determining sling placement
A method relating to implantation of a sling into a patient comprising inserting a first end of a probe into a urethra of the patient, attaching the probe to a mounting forming part of a spacer wherein angular movement of the probe relative to the spacer is determined in dependence upon an electrical output from a first sensor forming another part of the spacer, establishing a reference for the probe's angular position relative to the spacer upon establishing an action of a first operator with respect to a user input interface upon the spacer, and automatically quantifying an angular change in the probe via a microprocessor and determining placement of the sling in dependence upon the quantified angular change.
Overall claim coverage centers on a spacer/tip/flex-beam architecture that bends under sling-applied load and includes sensing for measuring load, and a related approach where a probe inserted into the urethra produces a sensed angular movement that is referenced by operator interaction, automatically quantified by a microprocessor, and used to determine sling placement.
Stated Advantages
Allows an operator to simultaneously quantify the load and adjust a tension of the sling while employing the spacer as a spacing tool between the predetermined portion of bodily tissue of the patient and the sling.
Documented Applications
Implantation of a sling into a patient, using the spacer to measure sling-applied load and to support determining sling placement during sling implantation.
Performing Valsalva maneuver by the patient and Crede maneuver upon the patient by a second operator to support probe angular measurement and subsequent sling placement determination.
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