Enhanced Multiple Set Screw Insertion Instrument and Methods
Legal Citation
Summary of the Inventive Concept
An improved surgical instrument and methods for delivering multiple set screws during spine surgery, enhancing efficiency, safety, and precision.
Background and Problem Solved
The original patent disclosed a multiple set screw insertion instrument with limitations in set screw advancement, ergonomic design, and training methods. The new inventive concept addresses these limitations by introducing a spiral groove on the shaft, an improved ergonomic handle design, and a simulator-based training method.
Detailed Description of the Inventive Concept
The enhanced instrument features a shaft with a spiral groove, allowing for smoother and more controlled set screw advancement. The ergonomic handle design incorporates a contoured grip and a thumb-activated set screw advancement mechanism with audible and tactile feedback. The system also includes a set screw storage container, designed to work in tandem with the instrument to minimize instrument exchanges. The training method utilizes a simulator with a mock spinal fixation construct and practice set screws to develop surgeon proficiency.
Novelty and Inventive Step
The new inventive concept introduces a spiral groove on the shaft, an improved ergonomic handle design, and a simulator-based training method, which are not obvious from the original patent and provide significant improvements in efficiency, safety, and precision.
Alternative Embodiments and Variations
Alternative embodiments may include varying the spiral groove design, incorporating different materials or coatings for the shaft and handle, or integrating additional features such as set screw counting or automatic advancement. Variations may also include adapting the instrument for use in other surgical procedures or incorporating the technology into robotic-assisted surgery systems.
Potential Commercial Applications and Market
The enhanced multiple set screw insertion instrument and methods have significant commercial potential in the spine surgery market, offering improved efficiency, safety, and precision for surgeons and hospitals. The target industries include medical device manufacturers, hospitals, and surgical centers.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61B17/7091 |
| A | A61 | A61B17/7035 |
| A | A61 | A61B17/7076 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Surgical instrument design, specifically spinal surgery instrumentation for set screw insertion and fixation techniques, requiring expertise in mechanical engineering, medical device design, and orthopedic surgical procedures
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or surgical instrument designer with advanced degree, 5-10 years experience in orthopedic medical device development, familiar with surgical instrument mechanisms, ergonomics, and spinal fixation technologies
Obviousness Rationale
A PHOSITA would recognize that the PTD's variations represent predictable engineering improvements to the source patent's fundamental set screw insertion mechanism. The disclosed enhancements like the spiral groove, ergonomic handle, and training system represent logical extensions of existing surgical instrument design principles. These modifications solve known limitations in surgical instrumentation through straightforward mechanical and ergonomic adaptations.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,225 |
|---|---|
| Title | Multiple set screw insertion instrument and methods |
| Assignee(s) | Medos International Srl |