Sterile Spinal Screw Mounting Tube
Solution Overview
Problem
Conventional spinal surgery instruments, particularly those used for pedicle screw placement, face challenges such as high contamination risk, complex cleaning and sterilization difficulties, and high costs due to reusable instrument sets, which can lead to instrument loss, breakage, and logistical issues.
Innovation Solution
A pre-assembled, single-use spinal device comprising a pedicle screw with a multifunctional assembly tube, designed for posterior or posterolateral spinal stabilization, featuring a sterile packaging system that includes a mounting tube compatible with various materials and a blocking element holder tube, allowing for secure alignment and attachment of ancillary components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If reusable instrument sets are used for spinal surgery, then instruments can be sterilized and reused to reduce costs, but the risk of contamination, cleaning difficulty, and instrument loss increases
Solution Approach 1:
The patent applies the disposable principle by providing single-use instrument sets packaged in sterile containers. Each instrument set is designed for one-time use only, eliminating the need for complex sterilization processes and reducing contamination risk between patients. The instruments are discarded after a single use, ensuring patient safety while simplifying logistics.
Solution Approach 2:
The patent segments the surgical system into disposable instrument sets that are pre-packaged and sterilized independently. Each instrument set is a self-contained unit that can be prepared in advance and stored, allowing hospitals to maintain inventory without complex sterilization infrastructure. This segmentation isolates potential contamination sources.
2Adaptability or versatility
If complex instrument sets with multiple cavities are used, then complete surgical functions are available, but cleaning and sterilization become almost impossible
Solution Approach 1:
Rather than attempting to sterilize complex instruments with multiple cavities and crevices, the patent adopts disposable versions of these instruments. The complexity is preserved in the design for surgical functionality, but the sterilization problem is solved by making the entire instrument set single-use. This allows complete surgical functionality without the burden of sterilization.
3Reliability
If heavy and costly instrument inventories are maintained for hospital logistics, then surgical readiness is ensured, but storage costs and risk of loss increase
Solution Approach 1:
The patent implements preliminary action by pre-packaging and pre-sterilizing complete instrument sets in factory-sealed containers. These ready-to-use sets can be stored in simple conditions without complex sterilization infrastructure. Hospitals maintain inventory of these pre-prepared sets, ensuring surgical readiness while reducing the need for expensive sterilization equipment and reducing the risk of instrument loss or degradation.
4Reliability
If single-use polymer instruments are used, then sterility and safety are improved, but mechanical strength for high stress applications is reduced
Solution Approach 1:
The patent employs composite materials, particularly titanium alloys, for instruments that require high mechanical strength such as the vertebra distractor and bone anchoring elements. For instruments not subjected to extreme stresses, polymer materials are used to maintain sterility and reduce cost. This material selection strategy ensures that each instrument has the appropriate properties for its specific application.
Solution Approach 2:
The patent applies local quality by using different materials for different instruments based on their specific mechanical requirements. Critical load-bearing instruments use high-strength metals, while less demanding instruments use polymers. This localized material optimization ensures sufficient strength where needed while maintaining the benefits of single-use disposables elsewhere.
Data Source
Figure 1~2
Figure 3a~4b
Figure 3c~3d
AI summary
The device has a vertebral or pedicular screw type bone anchoring element (2) comprising a proximal head part (5) whose interface integrates a rod or plate type connecting element e.g. rod, and a threaded distal part (4). A mounting tube (7) pre-mounted on the anchoring element is dismountable from the anchoring element and is formed of two half-shells. A sealed package (1) provides sterile packaging of the anchoring element and the mounting tube. A blocking element holding tube (8) is provided with dovetails whose shape is complementary to interior shape of the mounting tube. The mounting tube is formed of composite material, polymer, ferrous alloy or non-ferrous such as aluminum. The implants are fabricated of titanium, Polyether ether ketone (PEEK), stainless steel, cobalt-chromium or carbon or glass fiber based composite. Hydroxy apatite tricalcium phosphate (HATCP) type covering is used for the implant.