Disposable Bone Fusion Instrument with Polygonal Coupling
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Solution Overview
Problem
Existing surgical instruments for bone fusion surgeries, such as those for interphalangeal arthrodesis to correct hammer toe, are typically reusable, expensive, and require time-consuming cleaning and sterilization, limiting their availability and increasing operational costs.
Innovation Solution
A sterilizable disposable surgical instrument comprising a bone fusion implant with a proximal, distal, and coupling section, enclosed within an implant sleeve that includes a protective cap and handle, allowing for easy insertion and secure fixation of the implant into the bone, with a polygonal coupling section for positive engagement, enabling efficient and sterile single-use procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If reusable surgical instruments are used for bone fusion surgery, then the instruments can be used multiple times, but they require time-consuming cleaning and sterilization between operations, limiting availability and increasing operational costs
Solution Approach 1:
The patent implements a disposable surgical instrument system where the entire instrument including handle, shaft, and implant is designed as a single-use sterile package. This eliminates the need for cleaning and sterilization between operations, allowing hospitals to maintain stock of sterile instruments without time-consuming reprocessing cycles. The instrument is discarded after a single use, ensuring sterility while eliminating downtime for sterilization.
2Reliability
If reusable surgical instruments are manufactured with high quality standards, then they provide reliable performance, but they are expensive to manufacture and purchase
Solution Approach 1:
The patent combines the surgical instrument handle, shaft, and implant into a single integrated disposable unit. This merging allows the entire assembly to be manufactured as one piece using cost-effective processes like injection molding, eliminating the need for expensive precision machining required for reusable instruments. The integrated design maintains functional reliability while significantly reducing manufacturing costs through economies of scale and simplified production.
Solution Approach 2:
By designing the instrument as a disposable item, the patent enables use of cheaper materials and manufacturing processes compared to reusable instruments that must withstand repeated sterilization cycles. The disposable nature allows optimization for cost-effective production while maintaining sufficient performance for single-use surgical procedures.
3Productivity
If reusable instruments are kept in stock for multiple operations, then surgical availability increases, but the cost of maintaining and sterilizing large inventories increases
Solution Approach 1:
The disposable design allows hospitals to maintain stock of pre-sterilized instruments without the ongoing resource consumption associated with reprocessing. Each instrument comes sterile from manufacturing, eliminating the need for sterilization facilities, chemicals, and energy consumption that would be required to maintain a reusable instrument inventory.
4Ease of operation
If the implant is exposed during storage and handling, then it can be easily accessed for surgery, but the risk of contamination and mechanical damage increases
Solution Approach 1:
The patent designs the implant to be nested within the instrument shaft, which itself is contained within a sterile package. This nested configuration protects the implant from contamination and mechanical damage during storage and transport. During surgery, the implant is accessed by sequential removal of protective layers, maintaining sterility while providing easy access when needed.
Data Source
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Figure 4.1~4.2
AI summary
The invention relates to a sterilizable disposable surgical instrument formed by an implant for bone fusion (1) as well as an implant sleeve (2) surrounding the implant for bone fusion, wherein the implant for bone fusion has a distal implant section (3), a proximal implant section (4), and a coupling section (5) with a polygonal cross-section profile located between the distal and proximal implant section, wherein the implant sleeve is formed by a protective cap (6) and a handle (7), which are configured such that they can be connected to one another, wherein a first bore (8) is configured in the protective cap running in the longitudinal direction and prepared for receiving the proximal implant section of the implant for bone fusion, wherein a second bore (9) is configured in the handle running in the longitudinal direction and prepared for receiving the distal implant section of the implant for bone fusion, wherein a coupling region (10) having a through-opening with a polygonal cross-section is configured in the second bore in the handle, into which the coupling section of the implant for bone fusion engages in an integral and force-locking manner.