3D printer

3D printer

see 3D printing.

A 3D printer is a type of industrial robot.


Developing new surgical instruments is challenging. While making surgical instruments could be a good field of application for 3D printers, attempts to do so have proven limited.

Yang et al. designed a new endoscope-assisted spine surgery system, and using a 3D printer, attempted to create a complex surgical instrument and to evaluate the feasibility thereof. Developing the new surgical instruments using a 3D printer consisted of two parts: one part was the creation of a prototype instrument, and the other was the production of a patient model.

They designed a new endoscope-assisted spine surgery system with a cannula for the endoscope and working instruments and extra cannula that could be easily added. Using custom-made patient-specific 3D models, they conducted discectomies for paramedian and foraminal discs with both the newly designed spine surgery system and conventional tubular surgery. The new spine surgery system had an extra portal that can be well bonded in by a magnetic connector and greatly expanded the range of access for instruments without unnecessary bone destruction. In a foraminal discectomy, the newly designed spine surgery system showed less facet resection, compared to conventional surgery.

They were able to develop and demonstrate the usefulness of a new endoscope-assisted spine surgery system relying on 3D printing technology. Using the extra portal, the usability of endoscope-assisted surgery could be greatly increased. They suggested that 3D printing technology can be very useful for the realization and evaluation of complex surgical instrument systems 1).


Disruptive technologies are rare phenomena. However, when they do come about, they have the potential to change the course of entire industries. Such is the case with the new three-dimensional (3D) printing technology from Carbon3D Inc. (Redwood City, California, USA), dubbed Continuous Liquid Interface Production (CLIP). With its innovative approach to additive manufacturing, CLIP has the potential to usurp and revolutionize 3D printing, with reverberations into several fields, including neurologic surgery 2).

A technique using an industrial rapid prototyping process by three-dimensional (3D) printing was developed, from which accurate spatial models of the nasal cavity, paranasal sinuses (sphenoid sinus in particular), and intrasellar/pituitary pathology were produced, according to the parameters of an individual patient. Image-guided surgical (IGS) techniques on two different platforms were used during endoscopic transsphenoidal surgery to test and validate the anatomical accuracy of the sinus models by comparing the models with radiological images of the patient on IGS. RESULTS: It was possible to register, validate, and navigate accurately on these models using commonly available navigation stations, matching accurately the anatomy of the model to the IGS images 3)

Neurosurgeons regularly plan their surgery using magnetic resonance imaging (MRI) images, which may show a clear distinction between the area to be resected and the surrounding healthy brain tissue depending on the nature of the pathology. However, this distinction is often unclear with the naked eye during the surgical intervention, and it may be difficult to infer depth and an accurate volumetric interpretation from a series of MRI image slices.

MRI data are used to create affordable patient-specific 3-dimensional (3D) scale models of the brain which clearly indicate the location and extent of a tumour relative to brain surface features and important adjacent structures.

This is achieved using custom software and rapid prototyping. In addition, functionally eloquent areas identified using functional MRI are integrated into the 3D models.

Preliminary in vivo results are presented for 2 patients. The accuracy of the technique was estimated both theoretically and by printing a geometrical phantom, with mean dimensional errors of less than 0.5 mm observed.

This may provide a practical and cost-effective tool which can be used for training, and during neurosurgical planning and intervention 4).

The advent of multimaterial 3D printers allows the creation of neurosurgical models of a more realistic nature, mimicking real tissues. Warren et al. used the latest generation of 3D printer to create a model, with an inbuilt pathological entity, of varying consistency and density. Using this model the authors were able to take trainees through the basic steps, from navigation and planning of skin flap to performing initial steps in a craniotomy and simple tumor excision. As the technology advances, models of this nature may be able to supplement the training of neurosurgeons in a simulated operating theater environment, thus improving the training experience 5).

Articles

Aoun RJ, Hamade YJ, Zammar SG, Patel NP, Bendok BR. Futuristic Three-Dimensional Printing and Personalized Neurosurgery. World Neurosurg. 2015 Oct;84(4):870-1. doi: 10.1016/j.wneu.2015.08.010. Epub 2015 Aug 20. PubMed PMID: 26299265 6).

Indications

Large format (ie, >25 cm) cranioplasty is a challenging procedure not only from a cosmesis standpoint, but also in terms of ensuring that the patient’s brain will be well-protected from direct trauma. Until recently, when a patient’s own cranial flap was unavailable, these goals were unattainable. Recent advances in implant computer-aided design and 3-dimensional (3-D) printing are leveraging other advances in regenerative medicine. It is now possible to 3-D-print patient-specific implants from a variety of polymer, ceramic, or metal components. A skull template may be used to design the external shape of an implant that will become well integrated in the skull, while also providing beneficial distribution of mechanical force in the event of trauma. Furthermore, an internal pore geometry can be utilized to facilitate the seeding of banked allograft cells. Implants may be cultured in a bioreactor along with recombinant growth factors to produce implants coated with bone progenitor cells and extracellular matrix that appear to the body as a graft, albeit a tissue-engineered graft. The growth factors would be left behind in the bioreactor and the graft would resorb as new host bone invades the space and is remodeled into strong bone. As described in a review, such advancements will lead to optimal replacement of cranial defects that are both patient-specific and regenerative 7).

References

1)

Yang HS, Park JY. 3D Printer Application for Endoscope-Assisted Spine Surgery Instrument Development: From Prototype Instruments to Patient-Specific 3D Models. Yonsei Med J. 2020 Jan;61(1):94-99. doi: 10.3349/ymj.2020.61.1.94. PubMed PMID: 31887805.
2) , 6)

Aoun RJ, Hamade YJ, Zammar SG, Patel NP, Bendok BR. Futuristic Three-Dimensional Printing and Personalized Neurosurgery. World Neurosurg. 2015 Oct;84(4):870-1. doi: 10.1016/j.wneu.2015.08.010. Epub 2015 Aug 20. PubMed PMID: 26299265.
3)

Waran V, Menon R, Pancharatnam D, Rathinam AK, Balakrishnan YK, Tung TS, Raman R, Prepageran N, Chandran H, Rahman ZA. The creation and verification of cranial models using three-dimensional rapid prototyping technology in field of transnasal sphenoid endoscopy. Am J Rhinol Allergy. 2012 Sep-Oct;26(5):e132-6. doi: 10.2500/ajra.2012.26.3808. PubMed PMID: 23168144.
4)

Spottiswoode BS, van den Heever DJ, Chang Y, Engelhardt S, Du Plessis S, Nicolls F, Hartzenberg HB, Gretschel A. Preoperative three-dimensional model creation of magnetic resonance brain images as a tool to assist neurosurgical planning. Stereotact Funct Neurosurg. 2013;91(3):162-9. doi: 10.1159/000345264. Epub 2013 Feb 27. PubMed PMID: 23446024.
5)

Waran V, Narayanan V, Karuppiah R, Owen SL, Aziz T. Utility of multimaterial 3D printers in creating models with pathological entities to enhance the training experience of neurosurgeons. J Neurosurg. 2014 Feb;120(2):489-92. doi: 10.3171/2013.11.JNS131066. Epub 2013 Dec 10. PubMed PMID: 24321044.
7)

Bonda DJ, Manjila S, Selman WR, Dean D. The Recent Revolution in the Design and Manufacture of Cranial Implants: Modern Advancements and Future Directions. Neurosurgery. 2015 Nov;77(5):814-24. doi: 10.1227/NEU.0000000000000899. PubMed PMID: 26171578; PubMed Central PMCID: PMC4615389.

Woven EndoBridge (WEB)

Woven EndoBridge (WEB)

The Woven EndoBridge (WEB) (Sequent Medical, Aliso Viejo, California), is a ellipsoid braided-wire embolization device designed to provide flow disruption along the aneurysm neck 1).

Placed in the aneurysm, the device will modify the blood flow at the level of the neck and induce aneurysmal thrombosis. The WEB shape was designed to treat wide necked aneurysm. The device has been developed progressively from a dual-layer version (WEB DL) to single-layer versions (WEB SL and WEB SLS [single-layer spherical]).

This device does not require long-term antiplatelet use.

Indications

For the treatment of both ruptured and unruptured aneurysms. The WEB has received the CE mark and to date has been used to treat a wide variety of more than 1,400 aneurysms in Europe, Latin America and New Zealand. The WEB is not available for sale or use in the United States.

The WEB is a self-expanding, oblate, braided nitinol mesh.

The device is composed of an inner and outer braid held together by proximal, middle, and distal radiopaque markers, creating 2 compartments: 1 distal and 1 proximal. Depending on the device diame- ter, the inner and outer braids are 108 wires or 144 wires. Therefore, blood flow into a WEB-embolized aneurysm initially encounters 2 layers of wires comprising 216 or 288 wires, with the largest interwire distance ranging from 106 to 181 􏰅m, respectively, depending on the device size. The WEB implant is deployed—or retrieved before de- tachment—in a manner similar to that in endovascular coil systems, through microcatheters with an internal diameter 􏰆0.027 inch. For devices with a diameter of 􏰇7 mm, microcatheters with an internal diameter of 0.027 inch are used; and for devices with a diameter 􏰁7 mm, microcatheters with an internal diameter 0.032 inch are used. The detachment system is electrothermal and instantaneous. 2).


In a study, there was no difference in the early clinical course between those treated with WEB embolization, coil embolization, or neurosurgical clipping. Since WEB embolization is a valuable treatment alternative to coiling, it seems not justified to exclude this procedure from upcoming clinical SAH trials, yet the clinical long-term outcome, aneurysm occlusion, and retreatment rates have to be analyzed in further studies 3).

Trials

The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide necked aneurysm of the bifurcation.

Procedure

Limitations

It does not immediately secure the aneurysm in most subarachnoid hemorrhage cases. Second, it may not be suitable for embolization of wide-neck aneurysms with an unfavorable aspect ratio. To overcome these limitations, Zanaty et al., used the WEB device in conjunction with stenting and/or coiling.

They presented a technical note with an illustrated case-series, and provide a detailed step-by-step description on how the WEB device can be used in adjunct to coiling and/or stenting to achieve successful angiographic results. Accurate sizing of the WEB device before deployment is critical. Larger case-series are required to further assess the safety and success of these combined techniques 4).

Systematic review and meta-analysis

Zhang et al. searched the PubMedOvid MEDLINE, and EMBASE databases between December 1, 2012 and June 30, 2018.

Studies that included five or more patients undergoing WEB for Wide necked intracranial aneurysms, reported an angiographic or clinical outcomeand risk factors, and were published after December 1, 2012 were eligible.

Major outcomes included initial or short-term complete and adequate occlusion. Secondary outcomes included treatment failure, recanalizationmortalitymorbidity, and complication (e.g., thromboembolism or intraoperative rupture) rates. A random-effect model was used to pool the data. To assess risk factors for short-term angiographic outcomes and the most common complications, they conducted subgroup analyses and obtained odds ratios with 95% confidence intervals.

They included 36 studies (1759 patients with 1749 aneurysms). The initial complete and adequate occlusion rates were 35% and 77%, respectively. After a mean follow-up of 9.34 months, the short-term complete and adequate occlusion rates were 53% and 80%, respectively. Thromboembolism and recanalization were the most common complications (both 9%), followed by mortality (7%), morbidity (6%), failure (5%) and intraoperative rupture (3%). The following factors were related to higher short-term obliteration rates: unruptured status, in the anterior circulation, a medium neck (4-9.9 mm), newer-generation WEB and treatment without additional devices. Ruptured status, anterior circulation, preoperative antiplatelet therapy and newer-generation WEB were not significantly related to withto thromboembolism.

WEB has a satisfactory safety profile and shows promising efficacy in treating wide-neck intracranial aneurysms. They preliminarily identified several risk factors for short-term angiographic outcomes 5).

Case series

References

1)

Ding YH, Lewis DA, Kadirvel R, Dai D, Kallmes DF. The Woven EndoBridge: a new aneurysm occlusion device. AJNR Am J Neuroradiol. 2011 Mar;32(3):607-11. doi: 10.3174/ajnr.A2399. Epub 2011 Feb 17. PubMed PMID: 21330397.
2)

Pierot L, Liebig T, Sychra V, Kadziolka K, Dorn F, Strasilla C, Kabbasch C, Klisch J. Intrasaccular flow-disruption treatment of intracranial aneurysms: preliminary results of a multicenter clinical study. AJNR Am J Neuroradiol. 2012 Aug;33(7):1232-8. doi: 10.3174/ajnr.A3191. Epub 2012 Jun 7. PubMed PMID: 22678844.
3)

Sauvigny T, Nawka MT, Schweingruber N, Mader MM, Regelsberger J, Schmidt NO, Westphal M, Czorlich P. Early clinical course after aneurysmal subarachnoid hemorrhage: comparison of patients treated with Woven EndoBridge, microsurgical clipping, or endovascular coiling. Acta Neurochir (Wien). 2019 Jul 6. doi: 10.1007/s00701-019-03992-4. [Epub ahead of print] PubMed PMID: 31280480.
4)

Zanaty M, Roa JA, Dandapat S, Samaniego EA, Jabbour P, Hasan D. Diverse Use of the WEB Device: A Technical Note on WEB Stenting and WEB Coiling of Complex Aneurysms. World Neurosurg. 2019 Jul 10. pii: S1878-8750(19)31933-3. doi: 10.1016/j.wneu.2019.07.027. [Epub ahead of print] PubMed PMID: 31301439.
5)

Zhang SM, Liu LX, Ren PW, Xie XD, Miao J. Effectiveness, safety and risk factors of Woven EndoBridge device in the treatment of wide-neck intracranial aneurysms : systematic review and meta-analysis. World Neurosurg. 2019 Aug 13. pii: S1878-8750(19)32175-8. doi: 10.1016/j.wneu.2019.08.023. [Epub ahead of print] PubMed PMID: 31419591.

p64 Flow Modulation Device

p64 Flow Modulation Device

(Phenox, Bochum, Germany).

https://phenox.net/products/p64.html

The p64 Flow Modulation Device is a flow diverter. It allows complete deployment and full recoverability. This provides added safety and security.

• Complete deployment and recoverability ensures optimal placement

• Greater neck coverage due to the 64 Nitinol wire braid maximizes hemodynamic flow effect in the aneurysm

• Visualization is achieved by 2 helical strands along entire length of the implant and eight proximal markers

• p64 is mechanically detached once optimally placed

• Implanted via a 0.027“ ID microcatheter

The p64 is a flow modulation device designed to be used in endovascular treatment of intracranial aneurysms. There is limited data on the long-term effectiveness of the device. A study of Sirakov et al. sought to determine the safety and long-term efficacy of this device.

A retrospective review of aprospectively maintained database was performed to identify all patients treated with a p64 between March 2015 and November 2018 at University Hospital St. Ivan Rilski. Anatomical features, intraprocedural complications, clinical, and angiographic outcomes were also taken into account and reviewed.

A total of 72 patients with 72 aneurysms who met the inclusion criteria were identified. Device placement was successful in all patients. Follow-up angiographic imaging at 6 months showed complete occlusion (O’Kelly-Marotta grading scale [OKM] D) in 55 (76.3%) patients, subtotal aneurysmal filling (OKM B) in 10 (13.8%) patients, and neck remnant (OKM C) in 7 (9.7%) patients. Catheter angiography at 12 months was available for 70 patients (97.2%) and of these patients 91.4% of the aneurysms were completely occluded (OKM D) (64/72). Delayed angiography at 24 months was available for 68 patients (94.4%) and of these 98.5% (67/68) had completely occluded aneurysms. A 36-month angiography was available for 61 patients (84.4%) by which point all aneurysms had been completely occluded (100%). Permanent morbidity due to delayed aneurysmal rupture occurred in one patient (1.38%). The mortality rate was 0%. Self-limiting mild intimal hyperplasia was seen in 2 patients (2.72%).

Treatment of intracranial aneurysms with a p64 flow modulation device is safe and effective with a high success rate and only infrequent complication 1).


Girdhar et al., reported the thrombogenic potential of the following flow diversion devices measured experimentally in a novel human blood in-vitro pulsatile flow loop model: Pipeline™ Flex Embolization Device (Pipeline), Pipeline™ Flex Embolization Device with Shield Technology™ (Pipeline Shield), Derivo Embolization Device (Derivo), and P64 Flow Modulation Device (P64). Thrombin generation (Mean ± SD; μg/mL) was measured as: Derivo (28 ± 11), P64 (21 ± 4.5), Pipeline (21 ± 6.2), Pipeline Shield (0.6 ± 0.1) and Negative Control (1.5 ± 1.1). Platelet activation (IU/μL) was measured as: Derivo (4.9 ± 0.7), P64 (5.2 ± 0.7), Pipeline (5.5 ± 0.4), Pipeline Shield (0.3 ± 0.1), and Negative Control (0.9 ± 0.7). They found that Pipeline Shield had significantly lower platelet activation and thrombin generation than the other devices tested (p < .05) and this was comparable to the Negative Control (no device, p > .05). High resolution scanning electron microscopy performed on the intraluminal and cross-sectional surfaces of each device showed the lowest accumulation of platelets and fibrin on Pipeline Shield relative to Derivo, P64, and Pipeline. Derivo and P64 also had higher thrombus accumulation at the flared ends. Pipeline device with Phosphorylcholine surface treatment (Pipeline Shield) could mitigate device material related thromboembolic complications 2).


In preliminary in vivo experiments, antithrombogenic hydrophilic coating (HPC) p64 FDSs appeared to be biocompatible, without acute inflammation 3).


Treatment with p64 is associated with an overall rate of 8.5% moderate in stent stenosis (ISS) (50-75%) and 2.7% severe ISS (>75%), which is comparable with the rate of ISS reported in the literature for other flow diverting stents. There is a tendency for ISS to spontaneously improve over time 4)

References

1)

Sirakov S, Sirakov A, Bhogal P, Penkov M, Minkin K, Ninov K, Hristov H, Karakostov V, Raychev R. The p64 Flow Diverter-Mid-term and Long-term Results from a Single Center. Clin Neuroradiol. 2019 Aug 9. doi: 10.1007/s00062-019-00823-y. [Epub ahead of print] PubMed PMID: 31399749.
2)

Girdhar G, Ubl S, Jahanbekam R, Thinamany S, Belu A, Wainwright J, Wolf MF. Thrombogenicity assessment of Pipeline, Pipeline Shield, Derivo and P64 flow diverters in an in vitro pulsatile flow human blood loop model. eNeurologicalSci. 2019 Jan 8;14:77-84. doi: 10.1016/j.ensci.2019.01.004. eCollection 2019 Mar. PubMed PMID: 30723811; PubMed Central PMCID: PMC6350389.
3)

Martínez Moreno R, Bhogal P, Lenz-Habijan T, Bannewitz C, Siddiqui A, Lylyk P, Hannes R, Monstadt H, Henkes H. In vivo canine study of three different coatings applied to p64 flow-diverter stents: initial biocompatibility study. Eur Radiol Exp. 2019 Jan 22;3(1):3. doi: 10.1186/s41747-018-0084-z. PubMed PMID: 30671686; PubMed Central PMCID: PMC6342750.
4)

Aguilar Pérez M, Bhogal P, Henkes E, Ganslandt O, Bäzner H, Henkes H. In-stent Stenosis after p64 Flow Diverter Treatment. Clin Neuroradiol. 2018 Dec;28(4):563-568. doi: 10.1007/s00062-017-0591-y. Epub 2017 May 9. PubMed PMID: 28488025; PubMed Central PMCID: PMC6245240.
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