E.P. de Kater
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Orthopedic surgery relies on bone drills to create tunnels for fracture fixation, bone fusion, or tendon repair. Traditional rigid and straight bone drills often pose challenges in accessing the desired entry points without risking damage to the surrounding anatomical structures, especially in minimal invasive procedures. In this study, we explore the use of hydraulic pressure waves in a flexible bone design to facilitate bone drilling. The HydroFlex Drill includes a handle for generating a hydraulic pressure wave in the flexible, fluid-filled shaft to transmit an impulse to the hammer tip, enabling bone drilling. We evaluated seven different hammer tip shapes to determine their impact on drilling efficiency. Subsequently, the most promising tip was implemented in the HydroFlex Drill. The HydroFlex Drill Validation demonstrated the drill's ability to successfully transfer the impulse generated in the handle to the hammer tip, with the shaft in different curves. This combined with the drill's ability to create indentations in bone phantom material is a promising first step towards the development of a flexible or even steerable bone drill. With ongoing research to enhance the drilling efficiency, the HydroFlex Drill opens possibilities for a range of orthopedic surgical procedures where minimally invasive drilling is essential.
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Orthopedic surgery relies on bone drills to create tunnels for fracture fixation, bone fusion, or tendon repair. Traditional rigid and straight bone drills often pose challenges in accessing the desired entry points without risking damage to the surrounding anatomical structures, especially in minimal invasive procedures. In this study, we explore the use of hydraulic pressure waves in a flexible bone design to facilitate bone drilling. The HydroFlex Drill includes a handle for generating a hydraulic pressure wave in the flexible, fluid-filled shaft to transmit an impulse to the hammer tip, enabling bone drilling. We evaluated seven different hammer tip shapes to determine their impact on drilling efficiency. Subsequently, the most promising tip was implemented in the HydroFlex Drill. The HydroFlex Drill Validation demonstrated the drill's ability to successfully transfer the impulse generated in the handle to the hammer tip, with the shaft in different curves. This combined with the drill's ability to create indentations in bone phantom material is a promising first step towards the development of a flexible or even steerable bone drill. With ongoing research to enhance the drilling efficiency, the HydroFlex Drill opens possibilities for a range of orthopedic surgical procedures where minimally invasive drilling is essential.
Introduction: Orthopedic procedures often require drilling of tunnels through bone, for instance for the introduction of implants. The currently used rigid bone drills make it challenging to reach all target areas without damaging surrounding anatomy. Steerable bone drills are a promising solution as they enable access to larger volumes and the creation of curved tunnels thereby reducing the risk of harm to surrounding anatomical structures.
Method: This review provides a comprehensive overview of steerable bone drill designs identified in patent literature via the Espacenet database and in scientific literature accessed via the Scopus data base. A Boolean search combined with pre-set inclusion criteria returned 78 literature references describing a variety of drill designs.
Results: These drill designs could be categorized based on how the drilling trajectory was defined. Three methods to influence the drilling trajectory were identified: (1) the device (57% of the sources), (2) the environment (15% of the sources): the path is defined based on the tissue interaction forces with the surrounding bone or (3) the user defines the drilling trajectory (28% of the sources).
Discussion: The comprehensive overview of steerable drilling methods provides insights in the possibilities in drill design and may be used as a source of inspiration for the design of novel steerable drill designs. ...
Method: This review provides a comprehensive overview of steerable bone drill designs identified in patent literature via the Espacenet database and in scientific literature accessed via the Scopus data base. A Boolean search combined with pre-set inclusion criteria returned 78 literature references describing a variety of drill designs.
Results: These drill designs could be categorized based on how the drilling trajectory was defined. Three methods to influence the drilling trajectory were identified: (1) the device (57% of the sources), (2) the environment (15% of the sources): the path is defined based on the tissue interaction forces with the surrounding bone or (3) the user defines the drilling trajectory (28% of the sources).
Discussion: The comprehensive overview of steerable drilling methods provides insights in the possibilities in drill design and may be used as a source of inspiration for the design of novel steerable drill designs. ...
Introduction: Orthopedic procedures often require drilling of tunnels through bone, for instance for the introduction of implants. The currently used rigid bone drills make it challenging to reach all target areas without damaging surrounding anatomy. Steerable bone drills are a promising solution as they enable access to larger volumes and the creation of curved tunnels thereby reducing the risk of harm to surrounding anatomical structures.
Method: This review provides a comprehensive overview of steerable bone drill designs identified in patent literature via the Espacenet database and in scientific literature accessed via the Scopus data base. A Boolean search combined with pre-set inclusion criteria returned 78 literature references describing a variety of drill designs.
Results: These drill designs could be categorized based on how the drilling trajectory was defined. Three methods to influence the drilling trajectory were identified: (1) the device (57% of the sources), (2) the environment (15% of the sources): the path is defined based on the tissue interaction forces with the surrounding bone or (3) the user defines the drilling trajectory (28% of the sources).
Discussion: The comprehensive overview of steerable drilling methods provides insights in the possibilities in drill design and may be used as a source of inspiration for the design of novel steerable drill designs.
Method: This review provides a comprehensive overview of steerable bone drill designs identified in patent literature via the Espacenet database and in scientific literature accessed via the Scopus data base. A Boolean search combined with pre-set inclusion criteria returned 78 literature references describing a variety of drill designs.
Results: These drill designs could be categorized based on how the drilling trajectory was defined. Three methods to influence the drilling trajectory were identified: (1) the device (57% of the sources), (2) the environment (15% of the sources): the path is defined based on the tissue interaction forces with the surrounding bone or (3) the user defines the drilling trajectory (28% of the sources).
Discussion: The comprehensive overview of steerable drilling methods provides insights in the possibilities in drill design and may be used as a source of inspiration for the design of novel steerable drill designs.
Journal article
(2024)
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E.P. de Kater, M.N. Blom, T.C. van Doorn, Q.H. Tieu, D.J. Jager, A. Sakes, P. Breedveld
The success rate of spinal fusion surgery is mainly determined by the fixation strength of the spinal bone anchors. This study explores the use of an L-shaped spinal bone anchor that is intended to establish a macro-shape lock with the posterior cortical layer of the vertebral body, thereby increasing the pull-out resistance of the anchor. The performance of this L-shaped anchor was evaluated in lumbar vertebra phantoms (L1-L5) across four distinct perpendicular orientations (lateral, medial, superior, and inferior). During the pull-out experiments, the pull-out force, and the displacement of the anchor with respect to the vertebra was measured which allowed the determination of the maximal pull-out force (mean: 123 N ± 25 N) and the initial pull-out force, the initial force required to start motion of the anchor (mean: 23 N ± 16 N). Notably, the maximum pull-out force was observed when the anchor engaged the cortical bone layer. The results demonstrate the potential benefits of utilising a spinal bone anchor featuring a macro-shape lock with the cortical bone layer to increase the pull-out force. Combining the macro shape-lock fixation method with the conventional pedicle screw shows the potential to significantly enhance the fixation strength of spinal bone anchors.
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The success rate of spinal fusion surgery is mainly determined by the fixation strength of the spinal bone anchors. This study explores the use of an L-shaped spinal bone anchor that is intended to establish a macro-shape lock with the posterior cortical layer of the vertebral body, thereby increasing the pull-out resistance of the anchor. The performance of this L-shaped anchor was evaluated in lumbar vertebra phantoms (L1-L5) across four distinct perpendicular orientations (lateral, medial, superior, and inferior). During the pull-out experiments, the pull-out force, and the displacement of the anchor with respect to the vertebra was measured which allowed the determination of the maximal pull-out force (mean: 123 N ± 25 N) and the initial pull-out force, the initial force required to start motion of the anchor (mean: 23 N ± 16 N). Notably, the maximum pull-out force was observed when the anchor engaged the cortical bone layer. The results demonstrate the potential benefits of utilising a spinal bone anchor featuring a macro-shape lock with the cortical bone layer to increase the pull-out force. Combining the macro shape-lock fixation method with the conventional pedicle screw shows the potential to significantly enhance the fixation strength of spinal bone anchors.
Pedicle screws have long been established as the gold standard for spinal bone fixation. However, their fixation strength can be compromised in cases of low bone density, particularly in osteoporotic bone, due to the reliance on a micro-shape lock between the screw thread and the surrounding bone. To address this challenge, we propose augmenting conventional pedicles screws with a curved compliant anchor. This anchor integrates a curved super-elastic nitinol rod that is advanced through a canulated pedicle screw, forming a macro-shape lock within the vertebral body to aid the fixation strength. Both placement safety and fixation strength of this novel spinal bone anchor were validated on tissue phantoms (Sawbones). The radius of the curved compliant anchor’s path demonstrates high precision while exhibiting strong dependence on the bone density in which the anchor is placed. When the curved compliant anchor is combined with a conventional pedicle screw, the mean maximum pull-out force elevated to 290 N, marking a 14% enhancement in pull-out resistance compared to using pedicle screw alone. Further augmentation with multiple curved compliant anchors holds promise for even greater fixation. The application of a curved compliant spinal bone anchor offers a promising means of increasing the fixation strength of pedicles screws, which is especially relevant in challenging clinical scenarios such a patient suffering from osteoporosis.
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Pedicle screws have long been established as the gold standard for spinal bone fixation. However, their fixation strength can be compromised in cases of low bone density, particularly in osteoporotic bone, due to the reliance on a micro-shape lock between the screw thread and the surrounding bone. To address this challenge, we propose augmenting conventional pedicles screws with a curved compliant anchor. This anchor integrates a curved super-elastic nitinol rod that is advanced through a canulated pedicle screw, forming a macro-shape lock within the vertebral body to aid the fixation strength. Both placement safety and fixation strength of this novel spinal bone anchor were validated on tissue phantoms (Sawbones). The radius of the curved compliant anchor’s path demonstrates high precision while exhibiting strong dependence on the bone density in which the anchor is placed. When the curved compliant anchor is combined with a conventional pedicle screw, the mean maximum pull-out force elevated to 290 N, marking a 14% enhancement in pull-out resistance compared to using pedicle screw alone. Further augmentation with multiple curved compliant anchors holds promise for even greater fixation. The application of a curved compliant spinal bone anchor offers a promising means of increasing the fixation strength of pedicles screws, which is especially relevant in challenging clinical scenarios such a patient suffering from osteoporosis.
Fix(at)ing the Spine
Exploration of Novel Anchors and Steerable Bone Drills for Spinal Fusion Surgery
The spine serves as our literal backbone, providing support and facilitating movement, but spinal issues can greatly impact daily life. Spinal fusion surgery addresses severe problems by fusing adjacent vertebrae using pedicle screws and rods. However, traditional fixation methods like these encounter challenges such as screw loosening, particularly in weaker bone. This thesis presents an exploratory study delving into alternative bone anchor designs to enhance the fixation strength. Additionally, this thesis explores the use of steerable bone drills to enable alternative anchor trajectories, aiming to further enhance the fixation. This thesis also examines additional functionalities, such as tissue removal, to improve medical procedures. Through these investigations, the thesis aims to advance spinal fusion surgery techniques, ultimately enhancing patient outcomes and quality of life.
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The spine serves as our literal backbone, providing support and facilitating movement, but spinal issues can greatly impact daily life. Spinal fusion surgery addresses severe problems by fusing adjacent vertebrae using pedicle screws and rods. However, traditional fixation methods like these encounter challenges such as screw loosening, particularly in weaker bone. This thesis presents an exploratory study delving into alternative bone anchor designs to enhance the fixation strength. Additionally, this thesis explores the use of steerable bone drills to enable alternative anchor trajectories, aiming to further enhance the fixation. This thesis also examines additional functionalities, such as tissue removal, to improve medical procedures. Through these investigations, the thesis aims to advance spinal fusion surgery techniques, ultimately enhancing patient outcomes and quality of life.
Review
(2023)
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A. R. Meiring, E. P. de Kater, A. Stadhouder, B. J. van Royen, P. Breedveld, T. H. Smit
Purpose: To create an updated and comprehensive overview of the modeling studies that have been done to understand the mechanics underlying deformities of adolescent idiopathic scoliosis (AIS), to predict the risk of curve progression and thereby substantiate etiopathogenetic theories. Methods: In this systematic review, an online search in Scopus and PubMed together with an analysis in secondary references was done, which yielded 86 studies. The modeling types were extracted and the studies were categorized accordingly. Results: Animal modeling, together with machine learning modeling, forms the category of black box models. This category is perceived as the most clinically relevant. While animal models provide a tangible idea of the biomechanical effects in scoliotic deformities, machine learning modeling was found to be the best curve-progression predictor. The second category, that of artificial models, has, just as animal modeling, a tangible model as a result, but focusses more on the biomechanical process of the scoliotic deformity. The third category is formed by computational models, which are very popular in etiopathogenetic parameter-based studies. They are also the best in calculating stresses and strains on vertebrae, intervertebral discs, and other surrounding tissues. Conclusion: This study presents a comprehensive overview of the current modeling techniques to understand the mechanics of the scoliotic deformities, predict the risk of curve progression in AIS and thereby substantiate etiopathogenetic theories. Although AIS remains to be seen as a complex and multifactorial problem, the progression of its deformity can be predicted with good accuracy. Modeling of AIS develops rapidly and may lead to the identification of risk factors and mitigation strategies in the near future. The overview presented provides a basis to follow this development.
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Purpose: To create an updated and comprehensive overview of the modeling studies that have been done to understand the mechanics underlying deformities of adolescent idiopathic scoliosis (AIS), to predict the risk of curve progression and thereby substantiate etiopathogenetic theories. Methods: In this systematic review, an online search in Scopus and PubMed together with an analysis in secondary references was done, which yielded 86 studies. The modeling types were extracted and the studies were categorized accordingly. Results: Animal modeling, together with machine learning modeling, forms the category of black box models. This category is perceived as the most clinically relevant. While animal models provide a tangible idea of the biomechanical effects in scoliotic deformities, machine learning modeling was found to be the best curve-progression predictor. The second category, that of artificial models, has, just as animal modeling, a tangible model as a result, but focusses more on the biomechanical process of the scoliotic deformity. The third category is formed by computational models, which are very popular in etiopathogenetic parameter-based studies. They are also the best in calculating stresses and strains on vertebrae, intervertebral discs, and other surrounding tissues. Conclusion: This study presents a comprehensive overview of the current modeling techniques to understand the mechanics of the scoliotic deformities, predict the risk of curve progression in AIS and thereby substantiate etiopathogenetic theories. Although AIS remains to be seen as a complex and multifactorial problem, the progression of its deformity can be predicted with good accuracy. Modeling of AIS develops rapidly and may lead to the identification of risk factors and mitigation strategies in the near future. The overview presented provides a basis to follow this development.
Tsetse fly inspired steerable bone drill
A proof of concept
The fixation strength of pedicle screws could be increased by fixating along the much stronger cortical bone layer, which is not possible with the current rigid and straight bone drills. Inspired by the tsetse fly, a single-plane steerable bone drill was developed. The drill has a flexible transmission using two stacked leaf springs such that the drill is flexible in one plane and can drill along the cortical bone layer utilizing wall guidance. A proof-of-principle experiment was performed which showed that the Tsetse Drill was able to successfully drill through 5, 10 and 15 PCF cancellous bone phantom which has similar mechanical properties to severe osteoporotic, osteoporotic and healthy cancellous bone. Furthermore, the Tsetse Drill was able to successfully steer and drill along the cortical wall utilizing wall guidance for an insertion angle of 5°, 10° and 15°. The experiments conclude that the tsetse fly-inspired drilling method is successful and even allows the drilling along the cortical bone layer. The Tsetse Drill can create curved tunnels utilizing wall guidance which could increase the fixation strength of bone anchors and limit the risk of cortical breach and damage to surrounding anatomy.
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The fixation strength of pedicle screws could be increased by fixating along the much stronger cortical bone layer, which is not possible with the current rigid and straight bone drills. Inspired by the tsetse fly, a single-plane steerable bone drill was developed. The drill has a flexible transmission using two stacked leaf springs such that the drill is flexible in one plane and can drill along the cortical bone layer utilizing wall guidance. A proof-of-principle experiment was performed which showed that the Tsetse Drill was able to successfully drill through 5, 10 and 15 PCF cancellous bone phantom which has similar mechanical properties to severe osteoporotic, osteoporotic and healthy cancellous bone. Furthermore, the Tsetse Drill was able to successfully steer and drill along the cortical wall utilizing wall guidance for an insertion angle of 5°, 10° and 15°. The experiments conclude that the tsetse fly-inspired drilling method is successful and even allows the drilling along the cortical bone layer. The Tsetse Drill can create curved tunnels utilizing wall guidance which could increase the fixation strength of bone anchors and limit the risk of cortical breach and damage to surrounding anatomy.
Introduction: Bone biopsies have great value for the diagnosis of, amongst others, hematologic diseases. Although the bone biopsy procedure is mostly performed minimally invasive with the use of a slender cannula, the patient may still experience discomfort, especially when the procedure has to be repeated due to an unsuccessful biopsy. Areas covered: This review presents a comprehensive overview of bone biopsy devices presented in the patent literature. The patents were obtained using a classification search combined with keywords in the Espacenet patent database and were subsequently verified using pre-set eligibility criteria. This resulted in 62 unique patents included in this review. Expert opinion: The included patents were categorized based on the used strategies for the three steps that can be identified during a bone biopsy (1) biopsy sampling, (2) biopsy severing and (3) biopsy harvesting. Most patents described strategies for multiple steps. Insight into the used strategies and the comprehensive overview may serve as a source of inspiration for the design of novel bone biopsy devices.
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Introduction: Bone biopsies have great value for the diagnosis of, amongst others, hematologic diseases. Although the bone biopsy procedure is mostly performed minimally invasive with the use of a slender cannula, the patient may still experience discomfort, especially when the procedure has to be repeated due to an unsuccessful biopsy. Areas covered: This review presents a comprehensive overview of bone biopsy devices presented in the patent literature. The patents were obtained using a classification search combined with keywords in the Espacenet patent database and were subsequently verified using pre-set eligibility criteria. This resulted in 62 unique patents included in this review. Expert opinion: The included patents were categorized based on the used strategies for the three steps that can be identified during a bone biopsy (1) biopsy sampling, (2) biopsy severing and (3) biopsy harvesting. Most patents described strategies for multiple steps. Insight into the used strategies and the comprehensive overview may serve as a source of inspiration for the design of novel bone biopsy devices.
Review
(2022)
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Esther P. de Kater, Aimée Sakes, Erik Edström, Adrian Elmi-Terander, Gerald Kraan, Paul Breedveld
Purpose: This review provides an overview of the patent literature on posteriorly placed intrapedicular bone anchors. Conventional pedicle screws are the gold standard to create a fixation in the vertebra for spinal fusion surgery but may lack fixation strength, especially in osteoporotic bone. The ageing population demands new bone anchors that have an increased fixation strength, that can be placed safely, and, if necessary, can be removed without damaging the surrounding tissue. Methods: The patent search was conducted using a classification search in the Espacenet patent database. Only patents with a Cooperative Patent Classification of A61B17/70 or A61B17/7001 concerning spinal positioners and stabilizers were eligible for inclusion. The search query resulted in the identification of 731 patents. Based on preset inclusion criteria, a total of 56 unique patents on different anchoring methods were included, reviewed and categorized in this study. Results: Five unique fixation methods were identified; (1) anchors that use threading, (2) anchors that utilize a curved path through the vertebra, (3) anchors that (partly) expand, (4) anchors that use cement and (5) anchors that are designed to initiate bone ingrowth. Of the anchor designs included in this study, eight had a corresponding commercial product, six of which were evaluated in clinical trials. Conclusion: This review provides insights into worldwide patented intrapedicular bone anchors that aim to increase the fixation strength compared to the conventional pedicle screw. The identified anchoring methods and their working principles can be used for clinical decision-making and as a source of inspiration when designing novel bone anchors.
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Purpose: This review provides an overview of the patent literature on posteriorly placed intrapedicular bone anchors. Conventional pedicle screws are the gold standard to create a fixation in the vertebra for spinal fusion surgery but may lack fixation strength, especially in osteoporotic bone. The ageing population demands new bone anchors that have an increased fixation strength, that can be placed safely, and, if necessary, can be removed without damaging the surrounding tissue. Methods: The patent search was conducted using a classification search in the Espacenet patent database. Only patents with a Cooperative Patent Classification of A61B17/70 or A61B17/7001 concerning spinal positioners and stabilizers were eligible for inclusion. The search query resulted in the identification of 731 patents. Based on preset inclusion criteria, a total of 56 unique patents on different anchoring methods were included, reviewed and categorized in this study. Results: Five unique fixation methods were identified; (1) anchors that use threading, (2) anchors that utilize a curved path through the vertebra, (3) anchors that (partly) expand, (4) anchors that use cement and (5) anchors that are designed to initiate bone ingrowth. Of the anchor designs included in this study, eight had a corresponding commercial product, six of which were evaluated in clinical trials. Conclusion: This review provides insights into worldwide patented intrapedicular bone anchors that aim to increase the fixation strength compared to the conventional pedicle screw. The identified anchoring methods and their working principles can be used for clinical decision-making and as a source of inspiration when designing novel bone anchors.
Tissue transport is a challenge during Minimally Invasive Surgery (MIS) with the current suction-based instruments as the increasing length and miniaturisation of the outer diameter requires a higher pressure. Inspired by the wasp ovipositor, a slender and bendable organ through which eggs can be transported, a flexible transport mechanism for tissue was developed that does not require a pressure gradient. The flexible shaft of the mechanism consists of ring magnets and cables that can translate in a similar manner as the valves in the wasp ovipositor. The designed transport mechanism was able to transport 10wt% gelatine tissue phantoms with the shaft in straight and curved positions and in vertical orientation against gravity. The transport rate can be increased by increasing the rotational velocity of the cam. A rotational velocity of 25 RPM resulted in a transport rate of 0.8 mm/s and increasing the rotation velocity of the cam to 80 RPM increased the transport rate to 2.3 mm/s though the stroke efficiency decreased by increasing the rotational velocity of the cam. The transport performance of the flexible transport mechanism is promising. This means of transportation could in the future be an alternative for tissue transport during MIS.
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Tissue transport is a challenge during Minimally Invasive Surgery (MIS) with the current suction-based instruments as the increasing length and miniaturisation of the outer diameter requires a higher pressure. Inspired by the wasp ovipositor, a slender and bendable organ through which eggs can be transported, a flexible transport mechanism for tissue was developed that does not require a pressure gradient. The flexible shaft of the mechanism consists of ring magnets and cables that can translate in a similar manner as the valves in the wasp ovipositor. The designed transport mechanism was able to transport 10wt% gelatine tissue phantoms with the shaft in straight and curved positions and in vertical orientation against gravity. The transport rate can be increased by increasing the rotational velocity of the cam. A rotational velocity of 25 RPM resulted in a transport rate of 0.8 mm/s and increasing the rotation velocity of the cam to 80 RPM increased the transport rate to 2.3 mm/s though the stroke efficiency decreased by increasing the rotational velocity of the cam. The transport performance of the flexible transport mechanism is promising. This means of transportation could in the future be an alternative for tissue transport during MIS.