EP3453012A1

EP3453012A1 - Three-dimensional vascular surgery simulation model and corresponding production method

Info

Publication number: EP3453012A1
Application number: EP17725157.6A
Authority: EP
Inventors: Dr. André KEMMLING
Original assignee: Universitaet zu Luebeck
Current assignee: Universitaet zu Luebeck
Priority date: 2016-05-02
Filing date: 2017-04-28
Publication date: 2019-03-13
Also published as: DE102016108152A1; WO2017190732A1

Abstract

The invention relates to a three-dimensional vascular surgery simulation model having the following: - a container (2) with a receiving chamber (3) and a liquid (4) located in the receiving chamber (3); - an artificially produced vascular system (5) with at least one feed/supplying artery (51) and at least one discharge/peripheral discharging artery branches (52, 53), wherein - the vascular system (5) is arranged in the receiving chamber (3) of the container (2) and the liquid (4) can flow around the vascular system, - the at least one supplying artery (51) can be supplied with the liquid (4) from outside of the container (2), and - the peripheral discharging artery branches (52, 53) end freely in the receiving chamber (3) of the container (2) such that the liquid (4) flowing through the vascular system (5) from the supplying artery (51) to the discharging artery branches (52, 53) flows into the receiving chamber (3) of the container (2); and - a circulation pump (6) and circulation lines (61) for removing the liquid (4) from the receiving chamber (3) of the container (2) and introducing the liquid into the supplying artery (51) of the vascular system (5), wherein the liquid (4) from the receiving chamber (3) of the container (2) can be circulated through the vascular system (2, 51->52/53) by means of the circulation pump (6) and the circulation lines (61). The invention further relates to a corresponding production method.

Description

Three-dimensional vascular surgical simulation model and associated

production method

The invention relates to a three-dimensional vascular surgical simulation model and associated production method.

Different solutions are known from the prior art in order to realize three-dimensional vascular surgical simulation models and associated production methods for a vascular area.

From DE 10 2005 050 000 A1, imaging systems for use in a medical interventional operation are known in the imaging systems, e.g. A series of 2D CT fluoroscopy images are transformed into a 3D model image on a screen to directly assist a surgeon with this image information. Such an imaging method for vascular models is also shown by US 7,739,090 B2.

Furthermore, the document DE 10 2010 008 702 B4 discloses a method for producing a drilling template for introducing implantological bores, in which a physical 3D model is produced on the basis of segmented image data using a rapid prototyping method or 3D printing method, wherein the 3D model is made transparent in a partial area in order to visualize features of a tooth, mouth or jaw area and to simulate a planned intervention on the 3D model and to tune a surgical template thereon. EP 2 287 823 A1 shows a method for producing a vessel model from a polymer in printing technique.

Furthermore, DE 10 2013 004 843 A1 discloses a medical simulation system with a dummy / patient model with input / output device and sensor system which informs the physiological state data during a simulated medical intervention and thus simulates the operating environment.

US 2005 0 186 361 A1 shows a 3D model for blood vessels and the production method.

From WO 2005 010 849 A1, a simulation model for an intervention situation in endovascular interventions at the heart with a blood circulation model is known.

The problems in the prior art are essentially to map the entire dynamic flow vessel situation in a transparent model-carrier 3D model to allow for disturbances, e.g. a closure and the associated effects can be studied.

Because of time, price and anatomical imprecision silicone models are not suitable for the production in large numbers for regular patient-specific Conducting device tests in the model. In addition, silicone models are so far integrated in enclosed pump system, so that each vessel of the arterial outflow needs its own connection; This makes the production complicated and very expensive. Multiple small ramifications of the peripheral cerebral arteries can not be individually provided with a drain port.

The present invention is based on the object, a three-dimensional

Vascular surgical simulation model with a model carrier, which represents the vascular system to provide. Another object is to provide a corresponding

to provide a three-dimensional vascular surgical simulation model production method with which a corresponding three-dimensional vascular surgical

Simulation model can be produced. This should pay particular attention to the

Production costs, the realism as well as the controllability when using the model are placed.

These tasks are achieved with a three-dimensional vaso-surgical simulation model according to the main claim and a manufacturing method according to the independent claim.

According to the invention, the three-dimensional vascular surgical simulation model has:

- A container with a receiving space and located in the receiving space

Liquid;

an artificially prepared vascular system having at least one delivery / delivery artery and at least one discharge / peripheral laxative branch, wherein

- The vascular system is arranged in the receiving space of the container and can be flowed around by the liquid,

- The at least one supplying artery from the outside of the container is wettrömbar with the liquid

and

- the peripheral laxative branches of the artery terminate freely in the receiving space of the container, so that the liquid flowing through the vascular system from the supplying artery to the discharging arterial branches flows out into the receiving space of the container;

a circulation pump and circulation conduits for withdrawing the liquid from the receptacle of the receptacle and introducing it into the afferent artery of the receptacle

Vascular system, wherein the liquid from the receiving space of the container by means of the circulation pump and circulation lines is circulated through the vascular system.

This makes it possible for the first time, a flow model in a very favorable manner

To create vascular systems, in particular the brain region of a patient, to which

Practiced and trained in preparation for actual surgery can be. It is thus possible to work with a very high resolution and detail, in particular, problem areas such as brain aneurysms can be displayed.

In a particularly preferred embodiment, the container and / or the

Vascular system made of a transparent material or transparent plastic. In this way, when exercising and planning vascular surgical procedures, a visual check can be made. At the same time an exercise by means of radiological imaging is possible.

A further preferred embodiment is provided when the liquid in the container is a transparent liquid, in particular a glycerol-water mixture. As a result, an almost absolute transparency is given, so that within the model, the structures from the outside are almost completely to completely transparent.

The technical detail of the open flow system, which allows for the easy production of 3D models on the one hand, with the peripheral lumbar artery branches needing no connection, on the other hand balancing the refractive index by the surrounding fluid for maximum transparency for use under view, as well as the additional visual flow control For use under fluoroscopy are the key components of the system.

In particular, the overall view of these properties is of great importance.

In a further embodiment, access may be provided for one or more instruments, catheters and / or anomalies, artificial closures, thrombi for insertion and / or movement into the afferent artery. It is particularly advantageous in the inventive device that the influence of different devices and their influence on the hydromechanics of the entire system can be studied when guiding instruments in the flow-through vessels. This includes the study of the study of the effects of invasive consequences of the procedure. The aneurysm model has a feeding vessel via a cervical artery (right internal left / right arteries, right / left vertebral artery) and many downstream lumbar peripheral vessels. The laxative vessels of the model do not get their own connection (as previously with silicone models), but end up open in a transparent container as a reservoir. Here, the return of the liquid to a pump. This set-up, in turn, allows for easy fabrication and application of high-resolution 3D models as a block by laser stereolithography (SLA), whereby very small peripheral arteries can be realized in one model.

In particular, the vascular system can be produced by means of 3D printing methods, stereolithography [STL or SLA printing] and / or laser stereolithography. In particular, a plastic produced by means of SLA print technology is suitable. In particular, relevant scales, namely lumen diameter between 1 to 10 mm cost and be realized with little effort, but with very high anatomical accuracy, which are not accessible for example in the prior art by silicone model.

Furthermore, for further embodiment, a control loop with sensors, control and

Automatic control can be provided, wherein the circulation of the liquid is controlled, in addition, a display for visualizing the intensity and / or direction of the flow of the liquid or a rotating wheel can be provided.

Furthermore, the vascular system can advantageously be a replication of an actual human vascular system and / or be designed as a simulation for endovascular interventions in the brain.

In addition, a lighting device and / or an imaging unit, a visual camera and / or an X-ray can be provided to the

Documentation of the practical exercise or realistic adjustment or rehearsal.

It is further according to the invention to provide a three-dimensional vascular surgical simulation model production method for the three-dimensional vascular surgical simulation model according to the invention, the method comprising the steps:

1. preparing a computer readable print record for making / printing / SLA printing the vascular system;

2. manufacture of the vascular system;

3. installing the vascular system in the container;

4. Make the circulation circuit.

In particular, MRI, CT and / or non-invasive imaging of patients may be used to produce the print data set.

Due to the cost-effective production of the 3D model with model carrier is the

Device for studies, training, lectures, as well as an independent if necessary

Preparation and in situ case analysis during operations.

Such three-dimensional vascular surgical simulation models can be used in courses

so-called hands on workshops for neuroradiologists. The possibility to carry out such hands-on workshops is very interesting, especially for device companies. The main aspects are, in particular, the cost reduction and

Flexibility and faster and more cost-effective production of the flow system and 3D models compared to silicone models. It is thus also possible to dispense with animal models, such as hare, pig and the like, as these are more expensive and less suitable for courses with many participants, as these are not hochskalierbar and also ethically questionable.

Patient-specific models, as digitally possible through the use of MRI and other imaging techniques, allow the exerciser to practice on their own planned case, with the image data being provided to make a 3D model.

In summary, the benefits: Low cost, fast production, high resolution, patient-specific flow models.

The entire manufacturing process for a functioning out of the box flow system as well as for the 3D models of brain aneurysms from raw image data to finished model according to SLA technology has already been established by the inventor.

The flow system is usually not suitable for permanent use, but this is compensated by the approach of low production costs. 3D models can be used at any time without great effort on the basis of image data processing

Aneurysm model can be easily reproduced, since the replication in the SLA printer is arbitrarily hochskalierbar.

The flow system according to the invention with integration of the transparent 3D model of the cerebral arteries in an open transparent container allows easy handling and a simple structure, as well as very simple image data processing for the production of the aneurysm models which only need an inflow adapter, through which the liquid is introduced into the vascular system and which exits an open laxative arterial branches into the container.

To achieve maximum transparency of the 3D model, the refractive index of the liquid surrounding the model is adjusted.

The open flow system allows for easy production of models using SLA Rapid Manufacturing. In the SLA technique, an optical process using UV laser light at 405 nm hardens a photocuring plastic, a photopolymer, which conforms to the model based on image data. SLA allows rapid manufacturing of high-resolution models. The photopolymer must ensure a very good transparency of the models. This is necessary for application and placement of devices and devices in the model under X-ray vision.

However, after curing, the surface of the offered transparent resin, for example FLGPCL02, is not completely clear for visual inspection and precise inspection of placed devices in the millimeter range. However, the model in the open flow system of Liquid, wherein the refractive index of the liquid, in particular a mixture of water and glycerol, is adjusted by appropriate mixing ratio of the refractive index of the resin, whereby a maximum transparency for visual review of the 3D model is given. An elaborate surface treatment of the model for

Improvement of transparency is eliminated.

The flow system with integrated visual flow control can be used to quickly set the flow velocity for the realistic use of the flow system

Fluoroscopy or digital subtraction angiography (DSA). A mask image "roadmap" of the catheters for the navigation of the vessels can be generated realistically. The invention thus describes a technical solution for the production or application of patient-specific transparent 3D models, in particular of cerebral and cerebral arteries, which are integrated into a flow system, so that under view or under

X-ray fluoroscopy the introduction of devices for the treatment of arterial

Brain aneurysms or stenoses, e.g. can be practiced by coils, flow diverter, stents or preoperatively tested.

3D rotational angiographic (3D RA) pre-treatment aneurysm data were processed for SLA volume model printing. Cerebral arterial models were printed directly with transparent photopolymer resin.

In a simple design of a 3D model, the arterial connections have been connected to a circulation pump via a PVC tubing, allowing for an optimal simulated environment of aneurysms in a true neurological angio suite.

In the following, embodiments of the invention will be described with reference to the attached figures in the following description of the figures, which are intended to illustrate the invention and are not to be considered as limiting:

Show it:

Fig. 1 is a schematic representation of an embodiment of the inventive three-dimensional vascular surgical simulation model 1;

Figure 2 is a schematic representation of the vascular system 5 used in the embodiment shown in Figure 1;

Fig. 3 is an illustration of a 3D model of a patient vessel and

Fig. 4 is an illustration of the actual patient vessel system. In Fig. 1 is a schematic representation of an embodiment of the

according to the invention three-dimensional vascular surgical simulation model 1 shown.

The main element is the container 2 with the receiving space 3, in which the vascular system 5 with the aneurysm 54, the supplying artery 51 and the schematically shown laxative artery branches 52 and 53 is shown.

The circulation system is designed such that from the container 2, a circulation line 61 is guided to a circulation pump 6. From the circulation pump 6, another connection is made via a further circulation line 61 to a rotating wheel 62, which indicates the flow, and further via a further circulation line 61 to the supplying artery 51 of the vascular system 5.

The laxative arterial branches 52 and 53 terminate open in the container 2, namely in the

Receiving space 3, in which the vascular system 5 is arranged.

To control a camera 7 is provided with a monitor 71 arranged thereon.

The liquid 4 used throughout the system 1 is a glycerin-water solution.

The circulation pump 6 works with: Pulsatile Flow 1.2 Hz, Pressure gradient ~ 40 mmHg and a volume ~ 300 ml / min to realize a typical flow.

The vascular system 5 has been created by means of 3D SLA technology.

Fig. 2 shows a schematic representation of that shown in Figure 1

Embodiment used vascular system 5.

Here, the afferent artery 51 and a plurality of the discharging arterial branches are shown by way of example as 52 and 53. It is an ICA

Aneurysm.

Fig. 3 shows a representation of a 3D model of a patient vessel. Fig. 4 shows a representation of the actual patient vessel system. LIST OF REFERENCE NUMBERS

1 three-dimensional vascular surgical simulation model

2 container

3 recording room

4 liquid

5 vascular system

51 supplying artery

52, 53 laxative arterial branches

54 aneurysm

6 circulation pump

61 circulation pipes

62 rotating wheel

7 camera

71 monitor

Claims

Three-dimensional vascular surgical simulation model (1)

including

- A container (2) having a receiving space (3) and a in the receiving space (3) located liquid (4);

an artificially produced vascular system (5) with at least one feeder /

afferent artery (51) and at least one lumen / peripheral laxative branches (52, 53), wherein

- The vascular system (5) in the receiving space (3) of the container (2) is arranged and from the liquid (4) can flow around,

- The at least one supplying artery (51) from the outside of the container (2) with the liquid (4) is siegable

and

- The peripheral laxative artery branches (52, 53) free in the receiving space (3) of the container (2) terminate, so that the vascular system (5) from the supplying artery (51) to the laxative arterial branches (52, 53) flowing liquid (4) flows into the receiving space (3) of the container (2);

- a circulation pump (6) and circulation conduits (61) for withdrawing the liquid (4) from the receiving space (3) of the container (2) and introduction into the supplying artery (51) of the vascular system (5), wherein the liquid (4) from the receiving space (3) of the container (2) by means of the circulation pump (6) and circulation lines (61) through the vascular system (2, 51-> 52/53) is circulated.

Three-dimensional vascular surgical simulation model (1) according to claim 1,

characterized in that

the container (2) and / or the vascular system (5) are made of a transparent material or transparent plastic.

Three-dimensional vascular surgical simulation model (1) according to claim 1 or 2, characterized in that

the liquid (4) in the container (2) is a transparent liquid, a glycerol-water mixture.

Three-dimensional vascular surgical simulation model (1) according to claim 1, 2 or 3, characterized in that

an access for one or more instruments, catheters and / or anomalies, artificial Closures, thrombi for insertion and / or movement in the afferent artery (51) is provided.

Three-dimensional vascular surgical simulation model (1) after one of

previous claims,

characterized in that

the vascular system (5) is produced by means of 3D printing, stereolithography [STL or SLA printing] and / or laser stereolithography.

Three-dimensional vascular surgical simulation model (1) after one of

previous claims,

characterized in that

a control loop with sensors, control and automatic control is provided, wherein the circulation of the liquid (4) is controlled, in addition to a display for

Visualization of the intensity and / or direction of the flow of liquid or a rotating wheel is provided.

Three-dimensional vascular surgical simulation model (1) after one of

previous claims,

characterized in that

the vascular system (5) is a replication of an actual human vasculature and / or designed as a simulation for endovascular interventions in the brain.

Three-dimensional vascular surgical simulation model (1) after one of

previous claims,

characterized in that

a lighting device and / or an imaging unit, visual camera (7) and / or X-ray diagnostics is provided.

Three-dimensional vascular surgical simulation model manufacturing method for a three-dimensional vascular surgical simulation model (1) according to one of

preceding claims comprising the steps:

1. preparing a computer-readable print data set for making / printing / SLA printing of the vascular system (5);

2. manufacture of the vascular system (5);

3. Installing the vascular system in the container (2);

4. Make the circulation circuit.

A three-dimensional vascular surgical simulation model manufacturing method according to claim 9,

characterized in that

for making the print data set MRI, CT and / or non-invasive

Imaging method used by patients.