Patient-matched and surgeon-specific single use surgical instruments system

The system as claimed in 1, is designed to plan, develop, produce (via 3D printing technology), package and sterilize single-use surgical instruments for different applications for knee replacement surgeries.

the system as claimed in 1, placed inside a healthcare institution or hospital (in-house) or as an independent workshop facility.

the system as claimed in 1, delivering knee replacement surgical instruments based on surgeon's demand, according to surgeon's surgical philosophy and approach to surgical philosophy.

The system as claimed in 1, is characterized by inclusion or exclusion of a specific surgical instrument(s) is a surgical decision made only by surgeon.

The system as claimed in 1, is characterized by producing patient-matched and surgeon-specific single-use instruments based the 2D images of the knee resulting from CT-scans, MRI, Ultrasound and/or X-ray.

The system as claimed in 1, is characterized by producing patient-matched and surgeon-specific single-use instruments made from medical-grade and 3D-printable materials that are bioabsorbable, absorbable, non-absorbable, biodegradable, non-biodegradable and recyclable material;

• wherein all materials in delivered in knee surgical instruments set are biocompatible.

The system as claimed in 1, is characterized by producing patient-matched and surgeon-specific single-use instruments made from medical-grade 3D-printable material that is selected from the group of polyamides, polylactic acid and stainless-steel which are successfully utilized for both filament 3D printing and powder 3D printing processes.

The system as claimed in 1, producing patient-matched and surgeon-specific single-use instruments for any of the knee implants and fulfils surgical instruments for any surgical applications.

The system as claimed in 1, the patient-matched and surgeon-specific blocks/guides, offer three options for the surgeon to choose most appropriate version that suits patient's specific needs and adopted surgical philosophy;

• each of offered three options consists of femoral component and tibial component.

The system as claimed in 1, is characterized by allowing faster and less invasive surgical procedure through skipping the need of intramedullary and/or extramedullary alignment rod designed to validate implant positioning during surgical process.

The first option as claimed in 10, is a complete cutting, preparation, and finishing femoral & tibial blocks/guides allowing full surgical access to perform all the joint replacement actions and requirements embedded in bodies of complete cutting, preparation, and finishing femoral & tibial blocks/guides.

Femoral component as claimed in 12, consisting of distal femoral cut, anterior femoral cut, posterior femoral cut, anterior chamfer cut, posterior chamfer cut, box cut for PS femoral component, valgus angle, external rotation angle, Q angle, distal femoral component positioning lugs, anterior position verification marking, anterior grooves for external alignment verification, design-specific anterior cut angle, saw blade-specific cutting-slot thickness and oblique fixation holes.

The tibial component as claimed in 12, consisting of proximal tibia cut, proximal tibia cut posterior slope angle, tibia preparation drill(s), tibia preparation keel/punch, anterior position verification marking, anterior grooves for external alignment verification, saw blade-specific slot thickness and oblique fixation holes.

The second option as claimed in 10, is an initial cutting blocks/guides offering guides for preparation and finishing of femoral and tibial aspects with features embedded in bodies of initial cutting components.

Femoral component as claimed in 15, consisting of distal femoral cut, valgus angle, external rotation angle, q angle, 4in1 cutting block marking, distal femoral component positioning lugs marking, anterior position verification marking, anterior grooves for external alignment verification, saw blade-specific cutting-slot thickness and oblique fixation holes.

The tibial component as claimed in 15, consisting of proximal tibia cut, proximal tibia cut posterior slope angle, anterior position verification marking, anterior grooves for external alignment verification, saw blade-specific slot thickness and oblique fixation holes.

The third option as claimed in 10, is a pin-positioning blocks/guides offering guides for cutting, preparation and finishing of femoral and tibial aspects with features embedded in bodies of pin-positioning blocks/guides.

Femoral component as claimed in 18, consisting of distal femoral cut marking, valgus angle, external rotation angle, Q angle, 4in1 cutting block marking, distal femoral component positioning lugs marking, anterior position verification marking, anterior grooves for external alignment verification, saw blade-specific cutting-slot thickness and oblique fixation holes.

The tibial component as claimed in 18, consisting of proximal tibia cut marking, proximal tibia cut posterior slope angle, anterior position verification marking, anterior grooves for external alignment verification, saw blade-specific slot thickness and oblique fixation holes.

The guide as claimed in 10, is characterized by a marking central slot in allows validation of guide position, alignment, and rotation over the bone throughout surgical procedure.

The guide as claimed in 10, is characterized by alignment slots allow the surgeon to fix a multi-sizes alignment plate and rod to ensure the implant alignment along varus/vulgus, internal/external rotation and axial rotation throughout surgical procedure.

The system as claimed in 1, delivers single-use patient-matched and surgeon-specific conventional instruments “based on surgeon's demand” with different eleven options.

Option 1 as claimed in 23, is designed for primary total knee replacement, custom-made total knee replacement (primary-revision-hinged), revision total knee replacement, hinged total knee replacement and uni-compartmental/partial knee replacement;

• consisting of distal femoral cutting block offers open or sloped cut option, minimally invasive or component dimension option, distal-proximal femoral cut translation [on demand (0 mm), (−1/+1 mm), (−/+2 mm) (−/+3 mm) and (−/+4 mm)] options, anterior grooves for external alignment verification, position validation central mark, saw blade-specific slot thickness, and oblique fixation holes.

Option 2 as claimed in 23, is designed for primary total knee replacement, custom-made total knee replacement (primary-revision-hinged), revision total knee replacement and hinged total knee replacement;

• consisting of distal femoral cutting block offers open or sloped cut option, minimally invasive or component dimension option, distal-proximal femoral cut translation [on demand 0 mm up-to 40 mm in 4 mm increment] options, anterior grooves for external alignment verification, position validation central mark, saw blade-specific slot thickness, and oblique fixation holes.

Option 3 as claimed in 23, is designed for primary total knee replacement, custom-made total knee replacement (primary-revision-hinged), revision total knee replacement and hinged total knee replacement;

• consisting of 4in1 femoral cutting block offers open or sloped cut option, minimally invasive or component dimension option, anterior-posterior femoral cut translation [on demand (0 mm), (−1/+1 mm), (−/+1.5 mm) (−/+2 mm) and (−/+3 mm)] options, anterior grooves for external alignment verification, position validation central mark, saw blade-specific slot thickness, and oblique fixation holes.

Option 4 as claimed in 23, is designed for primary total knee replacement, custom-made total knee replacement (primary-revision-hinged), revision total knee replacement and hinged total knee replacement;

• consisting of cutting block for box cut for ps femoral component offers open or sloped cut option, minimally invasive or component dimension option, distal femoral component positioning lugs, anterior grooves for external alignment verification, position validation central mark, saw blade-specific slot thickness, and oblique fixation holes.

Option 5 as claimed in 23, is designed for uni-compartmental/partial knee replacement;

• consisting of 3in1 femoral cutting block offers open or sloped cut option, minimally invasive or component dimension option, anterior grooves for external alignment verification, saw blade-specific slot thickness, and oblique fixation holes.

Option 6 as claimed in 23, is designed for primary total knee replacement, custom-made total knee replacement (primary-revision-hinged), revision total knee replacement, hinged total knee replacement and uni-compartmental/partial knee replacement;

• consisting of proximal tibia cutting block offers open or sloped cut option, minimally invasive or component dimension option, distal-proximal tibial cut translation [on demand (0 mm), (−1/+1 mm), (−/+2 mm) (−/+3 mm) and (−/+4 mm)] options, anterior grooves for external alignment verification, position validation central mark, saw blade-specific slot thickness, and oblique fixation holes.

Option 7 as claimed in 23, is designed for primary total knee replacement, custom-made total knee replacement (primary-revision-hinged), revision total knee replacement and hinged total knee replacement;

• consisting of proximal tibia cutting block offers open or sloped cut option, minimally invasive or component dimension option, distal-proximal tibial cut translation [on demand 0 mm up-to 40 mm in 4 mm increment] options, anterior grooves for external alignment verification, position validation central mark, saw blade-specific slot thickness, and oblique fixation holes.

Option 8 as claimed in 23, is designed for primary total knee replacement, custom-made total knee replacement (primary-revision-hinged), revision total knee replacement, hinged total knee replacement and uni-compartmental/partial knee replacement;

• consisting of trial instruments set offers patient size-specific femoral trial, tibia plate trial, tibia insert trials [surface & multiple shims], flexion/extension gap assessment shims, intra-medullary stem extensions [0/offset tibial & femoral stems], intra-medullary sleeves [tibial & femoral sleeves], intra-medullary cones [tibial & femoral cones], tibia wedges [full, hemi, step & block wedges] and femoral augments [distal, anterior & posterior].

Option 9 as claimed in 23, is designed for primary total knee replacement, custom-made total knee replacement (primary-revision-hinged), revision total knee replacement, hinged total knee replacement and uni-compartmental/partial knee replacement;

• consisting of position verification & validation instruments set, allows intra-operative validation to make a double check before performing the final bone resection, offers full limb external alignment plate & rods [plate dimensions, rod diameter & rod length are on surgeon's demand], femoral cut validation c-section tool, tibia bone cut stylus, tibial & femoral bone cuts verification wing, and bone caliber.

Option 10 as claimed in 23, is designed for primary total knee replacement, custom-made total knee replacement (primary-revision-hinged), revision total knee replacement, hinged total knee replacement and uni-compartmental/partial knee replacement;

• consisting of bone preparation and finishing set offers femoral lugs drill, tibia preparation drill, tibia keel/punch preparation, sleeves preparation, stem extension preparation, long-stem preparations, cones preparation and other preparation and finishing instruments based on surgeon's demand

Option 11 as claimed in 23, is designed for primary total knee replacement, custom-made total knee replacement (primary-revision-hinged), revision total knee replacement, hinged total knee replacement and uni-compartmental/partial knee replacement;

• consisting of impaction & extraction instruments set offers modular impaction/extraction handle, femoral trial & final femoral component positioning impactor/extractor, femoral impactor, tibia base plate impactor, tibia insert impactor.

The system as claimed in 23, is characterized by a balancing block for the purpose of flexion/extension gap balancing.

The balancing block as claimed in 35, contains translation holes with +1, −1, +2, −2 to ensure balancing anterior up of posterior down.

The system as claimed in 1, delivers single-use patient-matched and surgeon-specific blocks/guides and conventional instruments that exhibit minimal scratching and no observable debris generation during use.

The system as claimed in 1, comprises one or more material suitable for maintaining sterility of knee replacement surgical instrument contained therein during transportation or storage thereof.

The system as claimed in 1, wherein the one or more materials are selected from the group consisting of stainless-steel, high-density polyamide, polylactic acid, polyethylene, polycarbonate, acrylonitrile-butadiene-styrene, laminates of one or more of these materials, coextruded filament including one or more of these materials, and combinations thereof.

The system as claimed in 1, delivers single-use knee replacement sets of instruments each of these sets is designed for a specific patient based on the surgical needs of such specific patient and surgical philosophy of operating surgeon.

The system as claimed in 1, operates within specifications of “clean room” to minimize rates of contamination and pollutants such as dust, airborne microbes and aerosol particles during the manufacturing and sterilization process.