JP6960923B2 - Elongated intervention device for optical shape sensing - Google Patents

Description

The present invention relates to an elongated intervention device that can be positioned by optical shape sensing and an intervention system that includes an elongated intervention device.

In some intervention procedures, the physician moves an elongated intervention device, such as a catheter or guidewire, to a target location within the patient's body. The position of the elongated intervention device is determined by optical shape sensing. In optical shape sensing, an optical fiber is incorporated into an elongated intervention device and the light reflected from the strain sensor contained in the optical fiber is measured to determine the shape of the optical fiber and thus the shape of the elongated intervention device.

Based on the shape of the elongated intervention device, the position of the intervention device is determined within a particular reference frame. For this, the optical fiber, and thus the proximal end of the elongated intervention device, is secured in a defined position within the reference frame. However, such fixation of the elongated intervention device limits its maneuverability, especially with respect to the rotational movement of the elongated intervention device around the longitudinal extension of the elongated intervention device. The immobilization causes torsional stress to build up within the elongated intervention device, which makes it difficult to rotate and also keep the device in the desired (rotational) position.

European Patent No. 0369383A2 discloses a flexible catheter that is elastic and contains an elastic flexible tubular layer that is joined to a tubular wire sheath. By varying the strand angle in the wire sheath, different parts of the catheter with different torsional and longitudinal stiffness are realized. In addition, the wire sheath wire adjacent to the proximal end of the catheter is parallel to the axis of the catheter. This provides a portion with high longitudinal stiffness and low torsional stiffness. Further an outer plastic layer is applied on the wire sheath.

An object of the present invention is to improve the maneuverability of the elongated intervention device, especially with respect to rotational motion, when the proximal end of the device is fixed to locate the elongated intervention device by optical shape sensing. do.

In one aspect of the invention, an elongated intervention device is proposed. The elongated intervention device is configured to receive an optical shape sensing fiber and includes an elongated proximal portion with a fixed element at its proximal end. The fixed element can be connected to the receptor in place. In addition, the elongated intervention device includes an elongated distal portion connected to the proximal region. The proximal portion has lower torsional stiffness than the distal portion and also includes at least two substantially coaxial tubes, the outer tube having lower torsional stiffness than the inner tube.

Since the proximal part of the elongated intervention device has less torsional stiffness than the distal part, the torque applied to the distal part is absorbed by the proximal part. Therefore, the distal portion of the elongated intervention device is detached from the fixation of the device in place with respect to the rotational movement of the distal portion. As a result, the maneuverability of the elongated intervention device is maintained even when the elongated intervention device is fixed in place.

The term torsional stiffness specifically refers to resistance to applied torque or torsional moment, with higher torsional stiffness corresponding to higher resistance to applied torque.

In addition, the proximal part comprises at least two substantially coaxial tubes, the outer tube having lower torsional stiffness than the inner tube. According to this configuration, the torque absorption characteristics of the proximal part of the device are ensured by the reduced torsional stiffness of the outer tube, which provides the maximum contribution to the torsional stiffness of the proximal part of the elongated intervention device.

In one embodiment of the invention, the proximal and / or distal portions have substantially uniform torsional stiffness. With respect to the proximal part, uniform (low) torsional stiffness ensures that the proximal part absorbs torque substantially along its entire longitudinal extension. With respect to the distal part, uniform (high) torsional stiffness allows rotation of the proximal end of the distal part to be transmitted to the distal end of the distal part, as is usually desired to facilitate handling of the device. Is ensured.

In one embodiment, the inner tube is more resistant to twisting than the outer tube. In this embodiment, the medial tube ensures a sufficiently high torsional resistance in the proximal part of the elongated intervention device. The term torsional resistance refers to resistance to twisting, with higher torsional resistance corresponding to higher resistance to torsion. Therefore, twisting or pinch points of the optical shape sensing fiber incorporated in the elongated intervention device, which can affect the determination of the shape and position of the elongated intervention device by optical shape sensing, can be particularly avoided. Specifically, torsional resistance is parameterized based on the reciprocal of the minimum bend radius adopted for a portion of the device without producing a twist, or the reciprocal of a bend radius that produces only a twist.

One related embodiment of the present invention comprises only the inner tube comprising at least one metal wire. Further related embodiments include multiple metal wires forming braiding and / or at least one metal wire forming a spiral. The one or more metal wires contained within the inner tube provide the desired twist resistance of the inner tube.

In a further embodiment, the proximal part comprises three substantially coaxial tubes, the innermost tube having a lower coefficient of friction than the other tubes. This is specifically the same material as the surface of the innermost tube, especially between the inner surface and the surface of another material, when the same normal force is applied to the surface. It means that the frictional force is lower than that between. In this embodiment, the innermost tube receives the optical shape detection fiber. The optical shape detection fiber may be manually inserted into the tube. Alternatively, the innermost tube may accept other means of being manually inserted into the tube. The lower coefficient of friction of the tube facilitates the insertion of optical shape sensing fibers or other means.

A further embodiment of the present invention comprises the fixing element fixing only the outer tube to the receptor. In a related embodiment, the inner tube can move relative to the proximal outer tube. In this embodiment, the transmission of torque from the outer tube to the inner tube with higher torsional stiffness is minimized so that the torque is substantially entirely absorbed by the outer tube fixed to the receiver. This further reduces the torsional stiffness of the proximal part of the elongated intervention device.

The elongated intervention device according to the present invention can be configured in various ways depending on the desired purpose of the device. In some embodiments, the elongated intervention device specifically comprises a catheter or a guide wire. Similarly, the elongated intervention device may include, for example, an endoscope.

In a further aspect of the invention, an intervention system is proposed in which the intervention procedure is performed in the patient's body. The intervention system includes the elongated intervention device including the optical shape sensing fiber. The system further includes a receptor that is in place and can be connected to a fixed element of the elongated intervention device. In addition, the intervention system includes an optical shape sensing device. The optical shape sensing device is coupled to the optical shape sensing fiber, and the shape of the optical shape sensing fiber and the position of the optical shape sensing fiber with respect to a predetermined position are determined by the optical shape sensing.

In one embodiment, the optical shape sensing device produces an image of the elongated intervention device based on the determined shape and position. In a related embodiment, the optical shape sensing device superimposes an image of the elongated intervention device and an image of the patient's body, and the image of the patient's body is shown according to the relative position of the patient's body with respect to a given position. Specifically, the optical shape sensing device superimposes the images so that the relative positions of the image of the elongated intervention device and the image of the patient's body correspond to the relative positions of the elongated intervention device and the patient's body.

When the image of the elongated intervention device and the image of the patient's body are superimposed in this way, the doctor can monitor the position of the elongated intervention device in the patient's body, especially during the intervention procedure. Such superposition is made possible by the elongated intervention device or its proximal end being fixed in place, thereby allowing the patient's body (if the relative position between the patient and the position is known). The position of the elongated intervention device with respect to is determined.

The image of the elongated intervention device and / or the image of the patient's body may be a three-dimensional image. In addition, the image of the patient's body preferably shows the interior of the patient's body. Such images are acquired using suitable imaging techniques known to those of skill in the art, such as computed tomography (CT) imaging or magnetic resonance imaging (MRI).

Of course, the elongated intervention device of claim 1 and the intervention system of claim 10 have similar and / or the same preferred embodiments, specifically those defined in the dependent claims.

Of course, a preferred embodiment of the present invention may further be any combination of a dependent claim or each independent claim of the embodiment.

These and other aspects of the invention will become apparent from the embodiments described below and will be described with reference to those embodiments.

FIG. 1 schematically and exemplary shows an intervention system that includes an elongated intervention device. FIG. 2 schematically and exemplary illustrates an elongated intervention device in one embodiment. FIG. 3 schematically and exemplary shows a cross section of the proximal portion of the elongated intervention device in one embodiment.

FIG. 1 illustrates and schematically illustrates an intervention system that includes an elongated intervention device 1. The elongated intervention device is a catheter, guidewire, endoscope, or similar device that the physician inserts into the patient's body 7 during the intervention procedure when the patient's body 7 is placed within the examination area 5. It is composed. In examination area 5, the patient's body is placed on the patient table 8 or a similar support.

Optical shape sensing techniques are applied to determine the shape of the elongated intervention device 1 during the intervention procedure. Therefore, the optical shape sensing fiber 9 is suitable for the optical fiber 9 along the longitudinal extension of the elongated intervention device 1, but not necessarily, but in the overall length of the elongated intervention device 1. It is incorporated within the elongated intervention device 1 so as to extend over. The optical shape sensing fiber 9 is coupled to an optical shape sensing device 2 that determines the shape of the optical shape sensing fiber 9 using any shape sensing technique. Specifically, the optical fiber 9 is provided with a strain sensing fiber Bragg grating (FBG) sensor, and the optical shape sensing device 2 injects light into the optical shape sensing fiber 9 and reflects the light reflected by the FBG sensor. The shape of the optical shape sensing fiber 9 is determined from. An example of a suitable technique for determining the shape of an optical fiber 9 in this way is disclosed in International Patent Publication WO 2013/136247A1, which is incorporated herein by reference.

Further, the position of the elongated intervention device 1 is determined with respect to a fixed predetermined position 3. For this purpose, the proximal end of the elongated intervention device 1 is fixed in place 3. As a result, the position of the proximal end of the elongated intervention device 1 is known and corresponds to the predetermined position 3. The position of any other point or portion of the elongated intervention device 1 is determined within the optical shape sensing device 2 based on the determined shape of the optical shape sensing fiber 9. Therefore, the optical shape sensing device 2 can determine the position of the entire elongated intervention device 1 with respect to the predetermined position 3.

The determined shape and position of the entire elongated intervention device 1, or at least the shape and position of the distal portion of the device 1 that includes a portion of the device that is inserted into the patient's body 7, is preferably. It is displayed on the display device 4 connected to the optical shape sensing device 2. To this end, the optical shape sensing device 2 is an elongated shape that is displayed on the display device 4 and dynamically adapted according to the shape and position of the optical shape sensing fiber 9 that is quasi-continuously (ie, at short time intervals) determined. Generate an image of the intervention device 1. Therefore, a physician using an elongated intervention device 1 during an intervention procedure can monitor the position of the device, including a portion of the device 1 that cannot be seen, by being inserted into the patient's body 7. ..

In one embodiment, the optical shape sensing device 2 further displays a three-dimensional image of the inside of the patient's body 7 and displays the three-dimensional image of the inside of the patient's body 7 so as to overlay the image of the elongated intervention device 1. Control device 4. The superposition is performed based on the determined position of the elongated intervention device 1, and specifically, the relative position between the image of the patient's body 7 and the image of the elongated intervention device 1 is the relative position of the patient's body 7 and the device 1. It is done so as to correspond to the relative position with. To superimpose the image of the patient's body 7 and the image of the elongated intervention device 1 in this way, the patient is required to ensure that the body part shown in the image has a relative position defined with respect to a predetermined position 3. It is arranged in the inspection area 5.

A three-dimensional image of the patient's body 7 is acquired using any suitable imaging modality known to those of skill in the art. Examples of such imaging modality include computed tomography (CT) imaging and magnetic resonance imaging (MRI), and images are acquired using an imaging device 6 configured according to the adopted imaging modality. ..

In one embodiment, the imaging device 6 is incorporated into an intervention system that includes an elongated intervention device 1. In this embodiment, the imaging device 6 acquires a three-dimensional image with respect to a field of view that includes at least a portion of the inspection area 5. The field of view is defined with respect to a predetermined position 3 so that the shape sensing device 2 can superimpose the image generated using the imaging device 6 and the image of the elongated intervention device 1 in the manner described above. Has a relative position. Further, the imaging device 6 acquires images quasi-continuously at specific time intervals during the intervention procedure, and at each time point, the shape sensing device 2 is one of the current image of the elongated intervention device 1 and the patient's body 7. Superimpose the most recently acquired 3D image. Thus, the physician can monitor the position of the elongated intervention device in the current environment, along with the patient's body 7, in substantially real time.

As an alternative, a 3D image of the patient's body 7 is acquired using an external imaging device that is not built into the intervention system. The external imaging device captures the patient's image prior to the intervention procedure and sends it to the shape sensing device 2. To perform the intervention procedure, the patient is placed such that a portion of the patient's body 7 shown in the image has a defined relationship position with respect to a predetermined position 3. This enables the above-mentioned superposition of the three-dimensional image of the patient's body 7 and the image of the elongated intervention device 1.

FIG. 2 shows, schematically and exemplary, an embodiment of the slender intervention device 1. As shown, the elongated intervention device 1 includes a distal portion 21 and a proximal portion 22.

In the embodiment shown in FIG. 2, the distal portion 21 and the proximal portion 22 are connected to each other by a transition element 23. To this end, both the distal portion 21 and the proximal portion 22 are secured to the transition element 23 with proper connections. For example, the distal portion 21 and the proximal portion 22 are attached to the transition element 23, respectively. Alternatively, the associated ends of the distal portion 21 and the proximal portion 22 are fitted within the transition element 23. It is also possible to secure the distal portion 21 and the proximal portion 22 to the transition element 23 by bolting. The transition element 23 is individually configured such that the tube and / or lumen of the proximal portion 22 of the elongated intervention device 1 is connected to the corresponding tube and / or lumen of the distal portion.

As an alternative, the distal 21 and proximal 22 of the elongated intervention device 1 may be directly connected to each other. This specifically means that the tube and / or lumen of the proximal portion 22 of the elongated intervention device 1 is directly connected to the corresponding tube and / or lumen of the distal portion. The connection is established by any suitable means selected based on the materials contained in the distal 21 and the proximal 22. Specifically, the distal portion 21 and the proximal portion 22 are thermally coupled or adhered. If the distal portion 21 and the proximal portion 22 contain metals as further described below, they may be soldered to each other.

At the time of use, the physician holds the elongated intervention device 1 at its distal portion 21, specifically at the proximal end of the distal portion 21. The distal portion 21 includes a portion of an elongated intervention device 1 that is (possibly) inserted into the patient's body 7 during the intervention procedure. The distal portion 21 is configured in the same manner as the corresponding portion of a conventional elongated intervention device of the relevant type. When the elongated intervention device 1 is a catheter, the distal portion 21 includes, for example, one tube or a plurality of coaxial tubes made of a suitable material and having a well-formed end. When the elongated intervention device 1 is a guide wire, the distal portion 21 includes one tube or a plurality of coaxial tubes and a guide wire core, for example each component is made of a suitable material.

Further, the optical shape sensing fiber 9 is incorporated into the distal portion 21 in an appropriate manner. For example, if the distal portion 21 includes one tube or a plurality of coaxial tubes, the optical shape sensing fiber 9 is guided in the tube or in the inner tube of the coaxial tube. As an alternative, an additional lumen may be provided to receive the optical shape sensing fiber 9. When the distal portion 21 includes a plurality of coaxial tubes, this lumen is specifically provided between the outer surface of the inner tube and the inner surface of the outer tube.

As with conventional elongated intervention devices, the material of the components of the distal portion 21 is selected so that the distal portion 21 has the desired properties. These properties usually include sufficient twist resistance. The twist resistance specifically prevents the light beam traveling in the optical shape sensing fiber 9 from interfering with the light beam. If the twist resistance is high, a greater force must be applied to the device to generate the twist. One parameter used to quantify torsional resistance is the reciprocal of the minimum bend radius adopted for some of the devices without producing twist, or the reciprocal of the bend radius that produces only twist. A parameter derived from the corresponding and / or reciprocal. Further, the distal portion 21 preferably has high torque stiffness so that subtle rotational movements at the proximal end of the distal portion 21 are also transmitted directly to the distal end of the distal portion 21. This ensures excellent maneuverability of the elongated intervention device 1 during the intervention procedure.

The (proximal) end of the proximal portion 22 is fixed at a predetermined position 3. Fixation is achieved in principle in any suitable way. In one embodiment, the fixing element 24 is provided at the proximal end of the proximal portion 22. The fixation element 24 is configured to be connectable to the corresponding receiver 25 of the intervention system located at a predetermined position 3. In principle, the fixing element 24 and the receiving part 25 are configured by any suitable method known to the parties. In one embodiment, the receiver 25 is configured as a socket and the fixing element 24 is configured as a plug, inserted into the socket and held in place in the socket by suitable means. In a further configuration, the fixing element 24 and the receiving portion 25 can be connected to each other by screw coupling. To this end, the fixing element 24 includes a male thread connected to the female thread of the receiving portion 25 and vice versa.

It is preferable that the optical shape sensing fiber 9 incorporated in the elongated intervention device 1 is also coupled to the optical shape sensing device 2 via the receiving portion 25. In addition, the components of the slender intervention device 1 may be connected to additional devices in the intervention system. For example, the elongated intervention device 1 or the tube contained therein is connected to the suction device when the elongated intervention device 1 is configured as a suction catheter. In a further embodiment, the elongated intervention device 1 is connected to a component of the stent delivery system, or the intervention device, if the elongated intervention device 1 is used to insert a stent into the patient's body 7. If 1 is used, for example, as a balloon catheter, it will be connected to a pump.

Fixing the proximal end of the elongated intervention device 1 in place may limit the maneuverability of the device 1. Specifically, the fixation makes the rotational movement of the device 1 more difficult, and makes it more difficult to keep the device 1 in an appropriate position after the torsional stress is accumulated.

In order to avoid such restrictions on the maneuverability of the elongated intervention device 1, the proximal portion 22 of the elongated intervention device 1 has a low torsional rigidity, specifically, the distal portion 21 of the elongated intervention device 1. It is configured to have lower torsional rigidity than. The torsional rigidity corresponds to a parameter for quantifying the resistance to the applied torque, and a high torsional rigidity means a high resistance to the applied torque. Therefore, the proximal portion of the elongated intervention device has lower resistance to the applied torque than the distal portion of the device. As a result, the torque applied to the distal portion 21 of the elongated intervention device 1 is absorbed in the proximal portion 22, and therefore the proximal portion 22 applies no torque to the distal portion 21 or is very low. Apply torque. Specifically, the torsional rigidity is parameterized by the ratio of torque to torsion angle, that is, k = M / θ. Here, k is the torsional rigidity, M is the applied torque, and θ is the resulting torsional angle. Here, the helix angle is specifically related to the relative angle of rotation between one end and the opposite end of the body with respect to the axis of rotation resulting from the applied torque.

In some embodiments, the proximal portion 22 of the elongated intervention device 1 comprises two or three concentric tubes. FIG. 3 illustrates these embodiments schematically and exemplary. FIG. 3 shows a cross section of a proximal portion 22 of the device 1 having an outer tube 31 and a first inner tube 32. Optionally, an additional second inner tube 33 is provided within the first inner tube 32. The inner tubes 32, 33 of the proximal portion 22 are connected to one or more corresponding tubes of the distal portion 21 of the elongated intervention device 1 by a direct connection or transition element 23, as described above. The outer tube 31 is similarly connected to the corresponding tube at the distal portion 21. It is similarly possible that the distal portion 21 does not have a tube corresponding to the outer tube 31 of the proximal portion 22 and only the outer tube 31 is connected to the transition element 23.

In one embodiment, the optical shape sensing fiber 9 is guided through the innermost tubes 32, 33 of the proximal portion 22. The innermost tubes 32, 33 are connected to a tube or lumen for receiving the optical shape sensing fiber 9 in the distal portion 21 of the elongated intervention device 1, or are the innermost of the proximal portion 22. Tubes 32, 33 extend within the distal portion 21 such that the tube also forms a tube for receiving the optical shape sensing fiber 9 in the distal portion 21. Therefore, the optical shape sensing fiber 9 extends along the entire length of the elongated intervention device 1.

The optical shape sensing fiber 9 may be fixedly incorporated in the elongated intervention device 1 or may be manually inserted into the elongated intervention device 1 if necessary. In the latter case, the optical shape sensing fiber 9 is inserted into the elongated intervention device 1 from its proximal end. In order to facilitate the insertion, the proximal portion 21 of the elongated intervention device 1 preferably includes the second inner tube 33, which receives the optical shape sensing fiber 9 and is made of a material having a low coefficient of friction. Provided. In a further embodiment, the optical shape sensing fiber 9 is guided into a further dedicated lumen of the proximal portion 22 of the elongated intervention device 1. This lumen is connected to a corresponding lumen that receives the optical shape sensing fiber 9 in the distal portion 21, or the lumen extends into the distal portion. When the proximal portion 22 includes a plurality of coaxial tubes, the lumen is arranged, for example, between the two tubes.

The desired low torsional stiffness of the proximal portion 22 of the elongated intervention device 1 is ensured by the outer tube 31 in particular by having the outer tube 31 having the maximum diameter and providing the greatest contribution to the torsional stiffness of the proximal portion 22. NS. Therefore, the outer tube 31 is made of a suitable material that ensures that the outer tube 31 has lower torsional stiffness than the distal portion 21 of the elongated intervention device 1. The inner tubes 31 and 32 further ensure additional desired features of the proximal portion 22 of the device 1, such as twist resistance. This requires that at least one inner tube 32 or 33 be made of a material that provides higher torsional stiffness. Therefore, the outer tube 31 also has a lower torsional rigidity than one or both of the inner tubes 32 and 33.

To ensure that the outer tube 31 has low torsional stiffness, the outer tube 31 is made of a flexible material such as rubber or polymer material. Also, preferably, the outer tube 31 does not include metal braiding or coiling (unlike one of the inner tubes 32, 33 in one embodiment). Suitable materials for making the outer tube 31 include polyether blockamide (PEBA), also known as Pebag, nylon, polyurethane, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyether ether ketone. (PEEK) and polyethylene (PE), specifically high density polyethylene (HDPE), low density polyethylene (LDPE) and high molecular weight polyethylene (HMWPE).

As mentioned above, the inner tube 32 ensures sufficient twist resistance, in particular, to the proximal portion 22 of the elongated intervention device 1. As a result, twisting or pinching points of the optical shape sensing fiber 9 are particularly avoided. In order to obtain sufficient twist resistance, the inner tube 32 contains metal. Specifically, the inner tube 32 includes one or more metal wires arranged in a coiling or braiding pattern. As a result, when a torsional stress is applied to the proximal portion 22, the extension of the proximal portion 22 can be minimized. In addition to this, the inner tube 32 also also contains a rubber or polymer material and coiling or braiding is incorporated into the rubber or polymer material, or the inner tube 32 contains multiple layers, one layer of rubber. Alternatively, it may contain a polymeric material, with another layer containing metal coiling or braiding. When the inner tube contains rubber or polymer material, there is a certain larger spacing between the coiling or braiding metal wires. This reduces the flexural rigidity of the proximal portion 22 and improves its flexibility and thus maneuverability. Flexural rigidity corresponds to the resistance of the pipe to bending deformation. This is specifically quantified by the ratio of the applied force to the resulting tube deflection.

In some embodiments, the proximal portion 22 of the elongated intervention device 1 preferably comprises an aramid fiber instead of a metal wire. These fibers are incorporated into the outer tube 31 or the inner tube 32. Alternatively, tubular braiding or webbing of aramid fibers may also be included in the proximal portion 22 between the outer tubing 31 and the inner tubing 32. Due to the high tensile strength and flexibility of the aramid fiber, the aramid fiber minimizes the elongation of the proximal portion 22 of the elongated intervention device 1 and ensures low flexural rigidity.

Optionally, as described above, an additional inner tube 33 is provided within the first inner tube 32. Specifically, the additional inner tube 33 is provided when the optical shape sensing fiber 9 is manually inserted into the elongated intervention device 1. Similarly, the additional inner tube 33 is provided when the intended use of the elongated intervention device 1 involves (manual) insertion of other means such as a wire or (further) catheter into the elongated intervention device 1. .. To facilitate the insertion of the optical shape sensing fiber 9 or other means, the additional inner tube 33 is made of a material having a low coefficient of friction, especially a lower coefficient of friction than the other tubes. The coefficient of friction is specifically the dynamic friction force between the (inner) surface of the tube 33 (or the other tube of the elongated intervention device 1) and the surface of another material and the normal force pushing both of these surfaces. Corresponds to the ratio. More specifically, the coefficient of friction is the ratio with respect to other materials that normally come into contact with the tube 33 (or other tube) when using an elongated intervention device, such as the optical shape sensing fiber 9 and / or the material of the other means. Corresponds to the average coefficient of friction of.

To obtain the desired low coefficient of friction, the additional inner tube 33 is made of a suitable material such as polytetrafluoroethylene (PTFE), polyimide (PI), a combination of PI and PTFE or high density polyethylene (HDPE). .. Further, the additional inner tube 33 is preferably thinner in wall than the first inner tube 32. This minimizes the space required for the additional inner tube 33 within the elongated intervention device 1 and reduces the contribution of the additional inner tube 33 to the mechanical properties of the elongated intervention device 1. Preferably, the additional inner tube 33 and inner tube 32 are joined together. This ensures a smooth transition between these tubes.

When the proximal portion 22 of the elongated intervention device 1 includes an outer tube 31 and one or more inner tubes 32, 33, preferably only the outer tube 31 is fixed in place 3. Therefore, only the outer tube 31 is fixed to the fixing element 24. The inner tube 32 is in contact with the outer tube 31, but is not joined to the outer tube 31 so that the inner tube 32 and the outer tube 31 are movable to each other and are specifically rotatable. Suitable. Therefore, when torque is applied to the proximal portion 22 of the elongated intervention device 1, the outer tube 31 moves (twists) and the inner tube 32 does not follow or minimize the movement of the outer tube 31. I don't obey. As a result, the torsional rigidity of the proximal portion 22 of the device 1 is further reduced.

In the above embodiment of the proximal portion 22 of the elongated intervention device 1, the desired properties of the proximal portion 22, such as low torsional stiffness and high torsional resistance, are such that the outer tube 31 is configured to provide low torsional stiffness and the inner tube. 32 is obtained by a plurality of coaxial tubes configured to provide high torsional resistance.

In a further embodiment, the proximal portion 22 of the elongated intervention device 1 consists of a single tube into which the fixation element 24 and the transition element 23 are anchored. To ensure sufficient twist resistance, the tubing comprises a metal or aramid reinforcement such as coiling or braiding formed of one or more metal wires or aramid fibers. The use of coiling is preferred to ensure the desired low torsional and low flexural rigidity. If braiding is provided, the braiding preferably has a small braiding angle to ensure the desired low torsional stiffness. In addition, the diameter of the tube and its wall thickness are appropriately selected to ensure the desired properties such as low torsional rigidity, low flexural rigidity and high torsional resistance. The optical shape sensing fiber 9 may be inserted into a lumen provided in the tube for the optical shape sensing phi to receive the 9.

Modifications of the disclosed embodiments will be understood and implemented by those skilled in the art who will implement the claimed invention from the examination of the drawings, disclosure content and the accompanying claims.

In the claims, the term "contains" does not exclude other elements or steps, nor does the indefinite article "a" or "an" exclude the plural.

A single unit or other device may perform the function of some of the items described in the claims. The fact that specific means are described in different dependent claims does not indicate that the combination of these means cannot be used in an advantageous manner.

Any reference code in the claims should not be construed as limiting the scope.

Claims (14)

An elongated intervention device that accepts optical shape sensing fibers
At the proximal end of the elongated proximal portion, said elongated proximal portion containing a fixing element that can be connected to a receptor in place.
An elongated distal portion connected to the elongated proximal portion and
Including
The elongated proximal portion has lower torsional stiffness than the elongated distal portion, the elongated proximal portion comprises at least two substantially coaxial tubes, and the outer tube has a lower torsion than the inner tube. Rigid, elongated intervention device. The elongated intervention device according to claim 1, wherein the elongated proximal portion and / or the elongated distal portion has substantially uniform torsional rigidity. The elongated intervention device according to claim 1, wherein the inner tube has a higher twist resistance than the outer tube. The elongated intervention device of claim 1 or 3, wherein only the inner tube comprises at least one metal wire. The elongated intervention device of claim 4, wherein the plurality of metal wires form braiding and / or at least one metal wire forms a spiral. The elongated intervention device of claim 1, wherein the elongated proximal portion comprises three substantially coaxial tubes, the inner tube having a lower coefficient of friction than the other two tubes. The elongated intervention device according to claim 1, wherein the fixing element fixes only the outer tube to the receiving portion. The elongated intervention device of claim 7, wherein the inner tube can move relative to the outer tube in the elongated proximal portion. The elongated intervention device of claim 1, comprising a catheter or a guide wire. An intervention system that performs interventions in the patient's body
The elongated intervention device according to claim 1, which includes the optical shape sensing fiber.
With the receiver located in place and connectable to the fixed element of the elongated intervention device.
Optical shape sensing device and
Including
The optical shape sensing device is an intervention system that is coupled to the optical shape sensing fiber and determines the shape of the optical shape sensing fiber and the position of the optical shape sensing fiber with respect to the predetermined position by optical shape sensing. The intervention system of claim 10, wherein the optical shape sensing device produces an image of the elongated intervention device based on the determined shape and position. The optical shape sensing device superimposes an image of the elongated intervention device and an image of the patient's body, and the image of the patient's body is shown according to the relative position of the patient's body with respect to the predetermined position. 11. The intervention system according to 11. The optical shape sensing device superimposes the images so that the relative positions of the image of the elongated intervention device and the image of the patient's body correspond to the relative positions of the elongated intervention device and the patient's body. The intervention system according to claim 12, which is combined. The intervention system according to claim 11 or 12, wherein the image of the elongated intervention device and / or the image of the patient's body is a three-dimensional image.

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