Endovascular tube fixation system

Abstract

An endovascular introducer fixation system (100) comprising: an introducer fixation element comprising a first part (101) and a second part (102), wherein the first part (101) comprises a first protrusion configured to accommodate an introducer wherein, when the second part (102) is in a first position, the first protrusion of the first part (101) and the second part (102) form a first opening with a first diameter, and wherein an introducer is placeable in the introducer fixation element, wherein, when the second part (102) is in a second position, the first protrusion of the first part (101) and the second part (102) form a first opening with a second diameter, wherein the second diameter is smaller than the first diameter, wherein the introducer is configured to be coupled to the introducer fixation element, and wherein a third diameter of the introducer is smaller than the first diameter and larger than the second diameter, wherein the second part (102) is i) rotatable with respect to the first part (101) around an axis substantially perpendicular to a longitudinal axis of a tube (104) or ii) slidable with respect to the first part (101) along an axis substantially parallel to a longitudinal axis of the tube (104), and wherein the first position and the second position are different positions; and a first gripping unit (103), wherein a first end of the tube (104) is fixedly coupled to the first part (101) of the introducer fixation element, wherein a second end of the tube (104) is fixedly coupled within the first gripping unit (103), and wherein the first and second ends of the tube (104) are opposite ends of the tube (104).

Description

[0001] UAB Inovatyvi medicina - 1 - 30A-166 904

[0002] ENDOVASCULAR TUBE FIXATION SYSTEM

[0003] FIELD OF THE INVENTION

[0004] The present invention generally relates to an endovascular introducer fixation system comprising a tube, an introducer fixation element and a first gripping unit.

[0005] BACKGROUND TO THE INVENTION

[0006] US 3825001 A relates to catheters and, more particularly, to a unique catheter placement unit which minimizes the trauma to the veins and other body tissue and also minimizes the leakage of blood from the patient during the period the catheter is in use.

[0007] US 2014 / 171919 Al relates to the field of catheter systems for performing diagnostic and / or intervention procedures, and specifically to a guide catheter control in robotic catheter system with an introducer connector.

[0008] US 2018 / 289928 Al relates to enabling a catheter introducer for use on a catheter positioning system to be rotated around an axis and / or traversed backward and / or forward along the axis.

[0009] However, none of the above methods and / or apparatuses allow for a tube to be securely fixed in place by a fixing unit / element while also fixing the introducer in place.

[0010] There is therefore a need for improvements of (endo-) vascular robotic systems.

[0011] SUMMARY OF THE INVENTION

[0012] The invention is set out in the independent claims. Preferred embodiments of the invention are set out in the dependent claims.

[0013] According to a first aspect, we describe an endovascular introducer fixation system comprising: an introducer fixation element comprising a first part and a second part, wherein the first part comprises a first protrusion configured to accommodate an introducer wherein, when the second part is in a first position, the first protrusion of the first part and the second part form a first opening with a first diameter, and UAB Inovatyvi medicina - 2 - 30A-166 904 wherein an introducer is placeable in the introducer fixation element, wherein, when the second part is in a second position, the first protrusion of the first part and the second part form a first opening with a second diameter, wherein the second diameter is smaller than the first diameter, wherein the introducer is configured to be coupled to the introducer fixation element, and wherein a third diameter of the introducer is smaller than the first diameter and larger than the second diameter, wherein the second part is i) rotatable with respect to the first part around an axis substantially perpendicular to a longitudinal axis of a tube or ii) slidable with respect to the first part along an axis substantially parallel to a longitudinal axis of the tube, and wherein the first position and the second position are different positions; and a first gripping unit, wherein a first end of the tube is fixedly coupled to the first part of the introducer fixation element, wherein a second end of the tube is fixedly coupled within the first gripping unit, and wherein the first and second ends of the tube are opposite ends of the tube.

[0014] Although an endovascular robotic system is mentioned herein, the skilled person understands that the invention described herein can also apply to a vascular robotic system, or a medical robotic system of any suitable type.

[0015] The tube may be, in some examples, a fixed length tube. In some examples, the tube may have an attachment in a screw form, a slide form, or any other suitable form to couple to a part of the endovascular robotic system or any other part of the system to the tube. In some examples, the tube may additionally or alternatively comprise an introducer connecter, which may be referred to as an introducer fixation element herein. In some examples, the tube comprises a material which has a low friction coefficient to allow an elongated medical member to move relatively freely within the tube. This is described in more detail below. In some examples, the tube has a diameter that is equal to, or larger than, the diameter of the introducer. The diameter of the tube is preferably between 3 Fr (French scale) and 24 Fr. The stiffness of the tube is preferably a stiffness that prevents the tube being easily kinked while also allowing for a suitable friction coefficient for the elongated medical member.

[0016] The tube in all of the aspects described herein may be any tubular element. The tube may, in some examples, be able to expand, contract, elongate, shorten, change geometry, or any other parameter may be altered, due to the linear and / or rotational forces exerted on it, as described herein. This force may be applied via a user and / or UAB Inovatyvi medicina - 3 - 30A-166 904 via electromechanics. In some examples, the tube may be an accordion-type tube and have an incision be made on at least one side of the tube.

[0017] The introducer fixation element is made from a first part and a second part, which may correspond to a body and a clamping element. The first protrusion of the first part may be large enough to accommodate a large number of different introducer sizes. The size of the first protrusion may be variable to ensure that the introducer has a good fit within and / or on top of the first protrusion. The size of the hole may be alterable according to the wishes of the user of the system, as different introducer sizes can be used for access to different vessels / used in different procedures. The clamping element may, in some examples, be configured to grip and / or clamp the introducer in place when the second part of the introducer fixation element is in the second position.

[0018] The variable diameter of the first opening, caused by the movement of the second part of the introducer fixation element from the first position to the second position, may allow for different introducer sizes to be coupled to the introducer fixation element, this may mean that the system is more accessible and can be used with a large variety of introducers.

[0019] The introducer, as described herein, may be an endovascular cap, or other suitable element. The skilled person is aware of introducers that can be used in such systems as the one described herein. The introducer allows for the elongated medical member to be guided in a direction towards a patient on which the endovascular robotic system is acting on. In some examples, the system further comprises the introducer.

[0020] Additionally, a "fixation element" is described herein, but it is to be understood that his term is synonymous with the term "introducer fixation element".

[0021] In some examples, the second part is i) rotatable via a pin coupled to both the first and second parts of the introducer fixation element or ii) slidable onto or into the first part via a ratcheting mechanism, wherein one of the first and second parts comprises a plurality of teeth, and the other of the first and second parts comprises a pawl. This may allow for the fixation element to accommodate a plurality of different sizes of introducers (in particular introducers with different diameters), thereby improving the usability of the system as it can work with many different introducers. In some examples, this may allow for the second part to be easily moved from the UAB Inovatyvi medicina - 4 - 30A-166 904 first position to the second position and vice versa using only one hand or one digit. The second slidable option may operate similar to a cable tie, or a snap-fit coupling, between the first and second parts. This, in turn, may allow for the system to be more easily used, and for the fixing of the tube to be done in a more efficient manner.

[0022] In some examples, the tube encloses an elongated medical member. This may allow for an elongated medical member such as, for example, a guidewire, a catheter, a stent, a PTA balloon catheter, a stent balloon, or any other suitable element, to be protected from the remainder of the system, thereby extending the lifespan of the medical member. The interior of the tube may be of such a diameter that the medical member can move freely in at least one axis of freedom within the tube, preferably along a longitudinal axis. In some examples, the medical member can move freely in two axes of freedom within the tube, preferably a longitudinal axis and a rotational axis. This may improve patient safety. The tube preferably guides the elongated medical member towards the introducer fixation element and this, in some examples, the introducer and into the introducer.

[0023] In some particular examples, when the second part of the introducer fixation element is in the second position, the elongated medical member is configured to be moveable relative to the introducer fixation element. This may allow for the medical member to be kept within a tight range of motion in at least one axis of freedom when the medical member is being moved. This, in turn, improves patient safety. The range of motion may be in only a longitudinal axis of the tube. This may also allow for the medical member to be protected from the remainder of the system, thereby extending the lifespan of the medical member.

[0024] In some examples, the introducer fixation element is configured to accommodate a plurality of different sizes of introducers. This may improve the usability and versatility of the fixation as it can work with many different introducers. This may be achieved via the second part closing on a respective section of the first part, thereby allowing the fixation element to grip the introducer, wherein the introducer has a defined diameter. In particular, this diameter may be between 3 and 24 Fr. This is described in more detail below.

[0025] In some examples, when the second part of the introducer fixation element is in the second position, the second part is configured to snap-fit with a portion of the first part of the introducer fixation element. This may further secure the tube and / or UAB Inovatyvi medicina - 5 - 30A-166 904 introducer in place, thereby improving patient safety. The construction of a snap-fit style coupling is known to the skilled person.

[0026] In some examples, the first gripping unit is coupled to a first portion of a medical robotic system. This may further improve patient safety as the tube and / or elongated medical member is further guided within the medical robotic system. In some examples, the gripping unit may be configured to grip the elongated medical member, and to allow for free movement of the elongated medical member within the gripping unit. This may allow for repositioning of the elongated medical member, should it be required. The gripping unit may be of any suitable construction, as long as it is configured to grip the tube. In some preferred examples, the tube is permanently gripped by the first gripping unit.

[0027] In some examples, the first gripping unit is not directly connected to the introducer fixation element. This may further improve patient safety as the elongated medical member is further guided within the endovascular robotic system and the fixation system described herein.

[0028] In some examples, the first gripping unit is configured to grip the tube at a first side of the fixation element, wherein the introducer is configured to be coupled to the introducer fixation element at a second side of the introducer fixation element, and wherein the first and second sides are opposite sides of the introducer fixation element. This may allow for the tube to be fixed within the system and / or for the elongated medical member to be guided within the system, thereby improving patient safety and the lifetime of the system as the parts of the system do not undergo unneeded stresses. In particular, only the cap of the introducer may be coupled to the introducer fixation element.

[0029] In some examples, the system further comprises a second gripping unit coupled to a first module of the medical robotic system, the elongated medical member is configured to be moveable relative to the first gripping unit and the second gripping unit, in particular wherein the second gripping unit is configured to impermanently grip the elongated medical member. The skilled person understands that the same concept applies to any given number of modules, gripping units and elongated medical members within the system. This may allow for the medical member to be kept within a tight range of motion in at least one axis of freedom when the medical member is being moved. This, in turn, improves patient safety. This may also allow UAB Inovatyvi medicina - 6 - 30A-166 904 for the medical member to be protected from the remainder of the system, thereby extending the lifespan of the medical member.

[0030] In some examples, the first gripping unit is coupled to the first module of the medical robotic system. This may mean that the first portion of the robotic system and the first module of the robotic system are the same. This may additionally mean that both the first and second gripping units are coupled to the first module of the medical robotic system. The first module is described in more detail below.

[0031] In some examples, the first module is moveable in one axis of freedom by a motor coupled to the first module. The motor may be any suitable motor such as, for example, a linear drive. The movement of the first module may allow for a movement of the tube and / or the elongated medical member in the same axis of freedom that the first module moves in. This may allow for the improved and customized movement of the tube and / or elongated medical member, thereby improving patient safety.

[0032] In some examples, the axis of freedom is substantially parallel with a longitudinal axis of the tube. This may allow for the elongated medical member to be advanced / retracted, thereby allowing for more precise movement of the elongated medical member before and / or after the second part of the fixation element has been moved into the second position.

[0033] In some examples, the axis of freedom is substantially parallel with a longitudinal axis of the elongated medical member. This may allow for the elongated medical member to be advanced / retracted, thereby allowing for more precise movement of the elongated medical member before and / or after the second part of the fixation element has been moved into the second position

[0034] In some examples, the medical robotic system further comprises a second module, wherein the second module comprises a third gripping unit which is identical to the second gripping unit, in particular wherein the third gripping unit is configured to impermanently grip the elongated medical member. The second module may be of a substantially similar construction as the first module. The first and second modules may be spaced a predetermined distance from each other. In some examples, the first and second modules may be independently movable from one another. This may allow for the improved and customized movement of the tube and / or elongated UAB Inovatyvi medicina - 7 - 30A-166 904 medical member, thereby improving patient safety. In some examples, the system comprises the second module.

[0035] In some examples, the second module is movable in the one axis of freedom by the motor coupled to the second module. The motor coupled to the first and second modules may be the same motor, or may be separate motors. This may allow for synchronized movement of the modules, or independent movement of the modules. Both of these may allow for the improved and customized movement of the tube and / or elongated medical member, thereby improving patient safety.

[0036] In some examples, the first and / or the second module comprises a sensing unit, wherein the sensing unit is configured to sense a movement and / or a position of the elongated medical member. The sensing unit may comprise means for detecting and / or sensing a linear and / or rotational movement of the elongated medical member, in particular, optical and / or magnetic and / or physical means. In some examples, only the first module has this sensing unit. This may allow for sensing information to be transmitted to a controller, wherein the controller may give a command to the motor to move the first module and / or second module and / or elongated medical member accordingly. This may allow for the tube and / or the elongated medical member to be manipulated in a more precise manner, thereby improving patient safety.

[0037] In some examples, the first and / or second module is configured to be moved in the one axis of freedom, by the motor, upon the sensing of the movement and / or position of the elongated medical member by the sensing unit. The sensing unit may detect the linear and / or rotational movement of the elongated medical member and thereby determine a position and / or movement of the elongated medical member based on this. Resultantly, the first and / or second module may be moved based on this sensing to ensure that there is enough slack in the elongated medical member and / or to move the first and / or second module closer to the introducer and / or to move the first and / or second module to a predetermined position.

[0038] In some examples, the first module and / or the second module comprises a toggleable element, wherein when the toggleable element is toggled, the first and / or second module is moveable by the motor from a first module position to a second module position, wherein the first and second module positions are different positions. This may allow for the elongated medical member to be more easily UAB Inovatyvi medicina - 8 - 30A-166 904 inserted into the fixation element manually, thereby improving the fixation of the elongated medical member.

[0039] In some examples, when the first module and / or second module is moved from the first module position to the second module position, the elongated medical member is also configured to move from a first elongated medical member position to a second elongated medical member position. This may allow for the medical member to be moved into the introducer while coupling the introducer to the fixation element and / or during operation of a procedure on a patient.

[0040] In some examples, the system further comprises an indicator configured to indicate that the second part of the introducer fixation element is in the second position. The indicator may be an audio indicator, a visual indication, a haptic indicator, or any other suitable type of indicator. This may allow for a user of the system to easily determine if the introducer is fixed in place before operation of the endovascular robotic system, thereby improving patient safety.

[0041] In some examples, the first part and the second part of the introducer fixation element each comprise a second protrusion, wherein the second protrusions are configured to mate with one another when the second part is in the second position, fixing the second part in place with respect to the first part. The protrusions may be in the form of pins, hooks, or any other suitable construction. This may further secure the introducer in place, thereby improving patient safety.

[0042] In some examples, the first part and / or the second part comprises a plurality of second protrusions. This may allow for different sizes of introducers to be accommodated in the introducer fixation element, thereby improving the versatility of the system.

[0043] In some examples, the second part of the fixation element comprises a neck. This may allow for the second part to flex when being moved into the second position, thereby allowing for a more secure fixation of the introducer. Additionally or alternatively, it may allow for easier movement of the second part from the second position to the first position as it may allow for more leverage for the user of the system. The neck may allow for the second part of the fixation element to arc / flex when in the second position, thereby enclosing the introducer with greater security. In some examples, this may increase the force being exerted upon the introducer, thereby improving the fixing of the introducer. In some examples, the flexure caused UAB Inovatyvi medicina - 9 - 30A-166 904 by the neck may allow for the snap-fit coupling and / or protrusion mating, as described herein, to take place. Furthermore, as the neck allows for the second part to bend, a variety of introducers with different diameters may resultantly be coupled to the fixation element, thereby improving the accessibility of the system.

[0044] Additionally, in the case of the ratcheting mechanism / slidable coupling, the neck may comprise at least one protrusion / pawl, wherein the protrusion / pawl is configured to interact with the plurality of teeth, thereby leading to a second coupling between the first and second parts of the system. This may allow for the coupling between the first and second parts to be adjustable in the longitudinal direction of the elongated medical member due to the different positions that can be achieved via the interaction between the teeth and the pawl.

[0045] As mentioned above, in some examples, the neck is configured to allow the second part to flex when the second part is in the second position.

[0046] As mentioned above, in some examples, the flexure of the second part is configured to allow facilitation of the snap-fit coupling and / or the mating of the second protrusions. This may further secure the tube and / or introducer in place, thereby improving patient safety. The construction of a snap-fit style coupling is known to the skilled person.

[0047] In some examples, the second part of the introducer fixation element comprises a plurality of necks. This may allow for the second part to flex when being moved into the second position, thereby allowing for a more secure fixation of the tube. Additionally or alternatively, it may allow for easier movement of the second part from the second position to the first position as it may allow for more leverage for the user of the system. The necks may allow for the second part of the fixation element to arc, thereby enclosing the introducer with greater security. In some examples, this may increase the force being exerted upon the tube, thereby improving the fixing of the introducer. In some examples, the flexure caused by the necks may allow for the snap-fit coupling and / or protrusion mating, as described herein, to take place.

[0048] In some examples, the second part of the introducer fixation element comprises an indent for a digit of a user of the system. This may allow for easier movement of the second part from the second position to the first position as it may allow for more leverage for the user of the system. In some examples, the indent may be large enough for a plurality of digits, or a whole hand. UAB Inovatyvi medicina - 10 - 30A-166 904

[0049] The above aspect may lead to a precise and safe connection and fixing procedure, thereby improving patient safety.

[0050] According to a second aspect, we describe an endovascular introducer fixation system comprising: an introducer fixation element comprising a first part and a second part, wherein the first part comprises a first protrusion configured to accommodate an introducer, wherein, when the second part is in a first position, the first protrusion of the first part and the second part form a first opening with a first diameter, and wherein an introducer is placeable in the introducer fixation element, wherein, when the second part is in a second position, the first protrusion of the first part and the second part form the first opening with a second diameter, wherein the second diameter is smaller than the first diameter, wherein the introducer is configured to be coupled to the introducer fixation element when the second part is in the second position, and wherein a third diameter of the introducer is smaller than the first diameter, wherein the first position and the second position are different positions; a first gripping unit, wherein a first end of a tube is fixedly coupled to the first part of the introducer fixation element, wherein a second end of the tube is fixedly coupled within the first gripping unit, and wherein the first and second ends of the tube are opposite ends of the tube, wherein the tube is configured to enclose an elongated medical member; and a second gripping unit coupled to a first module of a medical robotic system, wherein the elongated medical member is configured to be moveable relative to at least the first gripping unit, and wherein the first module is moveable along an axis substantially parallel with a longitudinal axis of the tube, in particular wherein the second gripping unit is configured to impermanently grip the elongated medical member.

[0051] Although an endovascular robotic system is mentioned herein, the skilled person understands that the invention described herein can also apply to a vascular robotic system, or a medical robotic system of any suitable type.

[0052] The tube may be, in some examples, a fixed length tube and / or be of any suitable length. In some examples, the tube may have an attachment in a screw form, a slide form, or any other suitable form to couple to a part of the endovascular robotic system or any other part of the system to the tube. In some examples, the tube may additionally or alternatively comprise an introducer connecter, which may be referred to as an introducer fixation element herein. In some examples, the tube comprises a material which has a low friction coefficient to allow an elongated medical member to UAB Inovatyvi medicina - 11 - 30A-166 904 move relatively freely within the tube. This is described in more detail below. In some examples, the tube has a diameter that is equal to, or larger than, the diameter of the introducer. The diameter of the tube is preferably between 3 Fr (French scale) and 24 Fr. The stiffness of the tube is preferably a stiffness that prevents the tube being easily kinked while also allowing for a suitable friction coefficient for the elongated medical member.

[0053] The introducer fixation element is made from a first part and a second part, which may correspond to a body and a clamping element. The first protrusion of the first part may be large enough to accommodate a large number of different introducer sizes. The size of the first protrusion may be variable to ensure that the introducer has a good fit within and / or on top of the first protrusion. The size of the hole may be alterable according to the wishes of the user of the system, as different introducer sizes can be used for access to different vessels / used in different procedures. The clamping element may, in some examples, be configured to grip and / or clamp the introducer in place when the second part of the introducer fixation element is in the second position.

[0054] The variable diameter of the first opening, caused by the movement of the second part of the introducer fixation element from the first position to the second position, may allow for different introducer sizes to be coupled to the introducer fixation element, this may mean that the system is more accessible and can be used with a large variety of introducers.

[0055] The introducer, as described herein, may be an endovascular cap, or other suitable element. The skilled person is aware of introducers that can be used in such systems as the one described herein. The introducer allows for the elongated medical member to be guided in a direction towards a patient on which the endovascular robotic system is acting on. In some examples, the system further comprises the introducer.

[0056] Additionally, a "fixation element" is described herein, but it is to be understood that this term is synonymous with the term "introducer fixation element".

[0057] The tube encloses an elongated medical member. This may allow for an elongated medical member such as, for example, a guidewire, a catheter, a stent, a PTA balloon catheter, a stent balloon, or any other suitable element, to be protected from the remainder of the system, thereby extending the lifespan of the medical member. UAB Inovatyvi medicina - 12 - 30A-166 904

[0058] The interior of the tube may be of such a diameter that the medical member can move freely in at least one axis of freedom within the tube, preferably along a longitudinal axis. In some examples, the medical member can move freely in two axes of freedom within the tube, preferably a longitudinal axis and a rotational axis. This may improve patient safety. The tube preferably guides the elongated medical member towards the introducer fixation element and this, in some examples, the introducer and into the introducer.

[0059] The system further comprises a second gripping unit coupled to a first module of the medical robotic system, the elongated medical member is configured to be moveable relative to the first gripping unit and the second gripping unit, in particular wherein the second gripping unit is configured to impermanently grip the elongated medical member. The skilled person understands that the same concept applies to any given number of modules, gripping units and elongated medical members within the system. This may allow for the medical member to be kept within a tight range of motion in at least one axis of freedom when the medical member is being moved. This, in turn, improves patient safety. This may also allow for the medical member to be protected from the remainder of the system, thereby extending the lifespan of the medical member.

[0060] In some examples, the first module comprises the first part or the second part of the introducer fixation element, wherein if the first module comprises the first part, the first module is configured to move the first part towards the second part, or wherein if the first module comprises the second part, the first module is configured to move the second part towards the first part. This may allow for one part of the introducer fixation element to be moved towards the other part via movement of the module. This may improve the coupling between the two parts of the introducer fixation element as the movement of the part comprised in the first module may be more precise.

[0061] In some examples, the elongated medical member is configured to be moveable relative to at least the second gripping unit, or relative to the first and second gripping units.

[0062] In some examples, as the first module is moved along the axis substantially parallel with a longitudinal axis of the tube, the elongated medical member is configured to be inserted or withdrawn from the tube. This may allow for a more accurate control UAB Inovatyvi medicina - 13 - 30A-166 904 of the movement of the elongated medical member, thereby improving patient safety.

[0063] In some examples, the first gripping unit is coupled to the first module of the medical robotic system. This may mean that the first portion of the robotic system and the first module of the robotic system are the same. This may additionally mean that both the first and second gripping units are coupled to the first module of the medical robotic system. The first module is described in more detail below.

[0064] In some examples, the first module is moveable in one axis of freedom by a motor coupled to the first module. The motor may be any suitable motor such as, for example, a linear drive. The movement of the first module may allow for a movement of the tube and / or the elongated medical member in the same axis of freedom that the first module moves in. This may allow for the improved and customized movement of the tube and / or elongated medical member, thereby improving patient safety.

[0065] In some examples, the axis of freedom is substantially parallel with a longitudinal axis of the tube. This may allow for the elongated medical member to be advanced / retracted, thereby allowing for more precise movement of the elongated medical member before and / or after the second part of the fixation element has been moved into the second position.

[0066] In some examples, the axis of freedom is substantially parallel with a longitudinal axis of the elongated medical member. This may allow for the elongated medical member to be advanced / retracted, thereby allowing for more precise movement of the elongated medical member before and / or after the second part of the fixation element has been moved into the second position.

[0067] In some examples, the medical robotic system further comprises a second module, wherein the second module comprises a third gripping unit which is similar or identical to the second gripping unit, in particular wherein the third gripping unit is configured to impermanently grip the elongated medical member. The second module may be of a substantially similar construction as the first module. The first and second modules may be spaced a predetermined distance from each other. In some examples, the first and second modules may be independently movable from one another. This may allow for the improved and customized movement of the tube UAB Inovatyvi medicina - 14 - 30A-166 904 and / or elongated medical member, thereby improving patient safety. In some examples, the system comprises the second module.

[0068] In some examples, the second module is movable in the one axis of freedom by the motor coupled to the second module. The motor coupled to the first and second modules may be the same motor, or may be separate motors. This may allow for synchronized movement of the modules, or independent movement of the modules. Both of these may allow for the improved and customized movement of the tube and / or elongated medical member, thereby improving patient safety.

[0069] In some examples, the first and / or the second module comprises a sensing unit, wherein the sensing unit is configured to sense a movement and / or a position of the elongated medical member. The sensing unit may comprise means for detecting and / or sensing a linear and / or rotational movement of the elongated medical member, in particular, optical and / or magnetic and / or physical means. In some examples, only the first module has this sensing unit. This may allow for sensing information to be transmitted to a controller, wherein the controller may give a command to the motor to move the first module and / or second module and / or elongated medical member accordingly. This may allow for the tube and / or the elongated medical member to be manipulated in a more precise manner, thereby improving patient safety.

[0070] In some examples, the first and / or second module is configured to be moved in the one axis of freedom, by the motor, upon the sensing of the movement and / or position of the elongated medical member by the sensing unit. The sensing unit may detect the linear and / or rotational movement of the elongated medical member and thereby determine a position and / or movement of the elongated medical member based on this. Resultantly, the first and / or second module may be moved based on this sensing to ensure that there is enough slack in the elongated medical member and / or to move the first and / or second module closer to the introducer and / or to move the first and / or second module to a predetermined position.

[0071] In some examples, the first module and / or the second module comprises a toggleable element, wherein when the toggleable element is toggled, the first and / or second module is moveable by the motor from a first module position to a second module position, wherein the first and second module positions are different positions. This may allow for the elongated medical member to be more easily UAB Inovatyvi medicina - 15 - 30A-166 904 inserted into the fixation element manually, thereby improving the fixation of the elongated medical member.

[0072] In some examples, when the first module and / or second module is moved from a first module position to a second module position, the elongated medical member is also configured to move from a first elongated medical member position to a second elongated medical member position. This may allow for the medical member to be moved into the introducer while coupling the introducer to the fixation element and / or during operation of a procedure on a patient.

[0073] According to a third aspect, we describe an endovascular introducer fixation system comprising: an introducer fixation element configured to accommodate an introducer, wherein the introducer fixation element comprises a first part and a second part, wherein the first part comprises a first protrusion configured to accommodate the introducer, wherein, when the second part is in a first position, the first protrusion of the first part and the second part form a first opening with a first diameter, and wherein an introducer is placeable in the introducer fixation element, wherein, when the second part is in a second position, the first protrusion of the first part and the second part form the first opening with a second diameter, wherein the second diameter is smaller than the first diameter, wherein the introducer is configured to be coupled to the introducer fixation element when the second part is in the second position, and wherein a third diameter of the introducer is smaller than the first diameter, wherein the first position and the second position are different positions; a first gripping unit, wherein a first end of a tube is fixedly coupled to the first part of the introducer fixation element, wherein a second end of the tube is fixedly coupled within the first gripping unit, and wherein the first and second ends of the tube are opposite ends of the tube, wherein the first gripping unit is configured to grip the tube at a first side of the fixation element, wherein the introducer fixation element is configured to be coupled to the introducer at a second side of the introducer fixation element, and wherein the first and second sides are opposite sides of the introducer fixation element, wherein the system is configured to determine a length for the tube between the first gripping unit and the introducer based on a patent characteristic.

[0074] Although an endovascular robotic system is mentioned herein, the skilled person understands that the invention described herein can also apply to a vascular robotic system, or a medical robotic system of any suitable type. UAB Inovatyvi medicina - 16 - 30A-166 904

[0075] The tube may be, in some examples, a fixed length tube and / or be of any suitable length. In some examples, the tube may have an attachment in a screw form, a slide form, or any other suitable form to couple to a part of the endovascular robotic system or any other part of the system to the tube. In some examples, the tube may additionally or alternatively comprise an introducer connecter, which may be referred to as an introducer fixation element herein. In some examples, the tube comprises a material which has a low friction coefficient to allow an elongated medical member to move relatively freely within the tube. This is described in more detail below. In some examples, the tube has a diameter that is equal to, or larger than, the diameter of the introducer. The diameter of the tube is preferably between 3 Fr (French scale) and 24 Fr. The stiffness of the tube is preferably a stiffness that prevents the tube being easily kinked while also allowing for a suitable friction coefficient for the elongated medical member.

[0076] The introducer fixation element is made from a first part and a second part, which may correspond to a body and a clamping element. The first protrusion of the first part may be large enough to accommodate a large number of different introducer sizes. The size of the first protrusion may be variable to ensure that the introducer has a good fit within and / or on top of the first protrusion. The size of the hole may be alterable according to the wishes of the user of the system, as different introducer sizes can be used for access to different vessels / used in different procedures. The clamping element may, in some examples, be configured to grip and / or clamp the introducer in place when the second part of the introducer fixation element is in the second position.

[0077] The variable diameter of the first opening, caused by the movement of the second part of the introducer fixation element from the first position to the second position, may allow for different introducer sizes to be coupled to the introducer fixation element, this may mean that the system is more accessible and can be used with a large variety of introducers.

[0078] The introducer, as described herein, may be an endovascular cap, or other suitable element. In some examples, the system comprises the introducer. The skilled person is aware of introducers that can be used in such systems as the one described herein. The introducer allows for the elongated medical member to be guided in a direction towards a patient on which the endovascular robotic system is acting on. In some examples, the system further comprises the introducer. UAB Inovatyvi medicina - 17 - 30A-166 904

[0079] Additionally, a "fixation element" is described herein, but it is to be understood that his term is synonymous with the term "introducer fixation element".

[0080] The first gripping unit is configured to grip the tube at a first side of the fixation element, wherein the introducer is configured to be coupled to the introducer fixation element at a second side of the introducer fixation element, and wherein the first and second sides are opposite sides of the introducer fixation element. This may allow for the tube to be fixed within the system and / or for the elongated medical member to be guided within the system, thereby improving patient safety and the lifetime of the system as the parts of the system do not undergo unneeded stresses. In particular, only the cap of the introducer may be coupled to the introducer fixation element.

[0081] Additionally, the system is configured to determine a length for the tube between the first gripping unit and the introducer based on a patent characteristic. This may allow for the length of the tube to be chosen based on a characteristic of the patient, thereby improving patient safety.

[0082] In some examples, the patient characteristic comprises at least one of a height of a patient, a weight of the patient, and a circumference measurement of the patient, access point of the patient vessel. The skilled person understands that any other suitable characteristic for determining a length of a tube may additionally or alternatively be used.

[0083] In some examples, the system further comprises a processor configured to determine the length of the tube based on the patient characteristic. The processor may be located in any suitable part of the system. The patient characteristic may be input into the processor by a user interface, a controller, or any other suitable way. This may allow for the processor to determine the length of the tube, which may be output into a display, a user interface, or any other suitable communication method.

[0084] Additionally or alternatively, a user of the system determines the length of the tube based on the patient characteristic. The user may determine the length of the tube based on experience and / or the patient characteristic and / or the elongated medical members to be used. In such a scenario, the user may use the shortest tube length possible. This may allow for the reduction of (side) forces being exerted on the elongated medical member as it is inserted and / or extracted from the tube, thereby extending the lifetime of the elongated medical member. Additionally or alternatively, UAB Inovatyvi medicina - 18 - 30A-166 904 this may also allow for shorter elongated medical members to be used, thereby reducing costs and / or improving patient safety.

[0085] In some examples, the tube encloses an elongated medical member. This may allow for an elongated medical member such as, for example, a guidewire, a catheter, a stent, a PTA balloon catheter, a stent balloon, or any other suitable element, to be protected from the remainder of the system, thereby extending the lifespan of the medical member. The interior of the tube may be of such a diameter that the medical member can move freely in at least one axis of freedom within the tube, preferably along a longitudinal axis. In some examples, the medical member can move freely in two axes of freedom within the tube, preferably a longitudinal axis and a rotational axis. This may improve patient safety. The tube preferably guides the elongated medical member towards the introducer fixation element and this, in some examples, the introducer and into the introducer. In particular, the elongated medical member may be inserted and extracted from the tube by a user of the system.

[0086] In some examples, the processor is configured to select the shortest tube length possible based on the patient characteristic. This may allow for the reduction of (side) forces being exerted on the elongated medical member as it is inserted and / or extracted from the tube, thereby extending the lifetime of the elongated medical member. Additionally or alternatively, this may also allow for shorter elongated medical members to be used, thereby reducing costs.

[0087] In some examples, the first gripping unit is coupled to a first module of a medical robotic system. This may mean that the first portion of the robotic system and the first module of the robotic system are the same. This may additionally mean that both the first and, if present, second gripping units are coupled to the first module of the medical robotic system. The first module is described in more detail below.

[0088] In some examples, the first module is moveable in one axis of freedom by a motor coupled to the first module. The motor may be any suitable motor such as, for example, a linear drive. The movement of the first module may allow for a movement of the tube and / or an elongated medical member in the same axis of freedom that the first module moves in. This may allow for the improved and customized movement of the tube and / or elongated medical member, thereby improving patient safety. UAB Inovatyvi medicina - 19 - 30A-166 904

[0089] In some examples, the axis of freedom is substantially parallel with a longitudinal axis of the tube. This may allow for the elongated medical member to be advanced / retracted, thereby allowing for more precise movement of the elongated medical member before and / or after the second part of the fixation element has been moved into the second position.

[0090] In some examples, the axis of freedom is substantially parallel with a longitudinal axis of an elongated medical member, wherein the elongated medical member is insertable into, and extractable from, the tube. This may allow for the elongated medical member to be advanced / retracted, thereby allowing for more precise movement of the elongated medical member before and / or after the second part of the fixation element has been moved into the second position

[0091] In some examples, the medical robotic system further comprises a second module, wherein the second module comprises a third gripping unit which is identical to the second gripping unit, in particular wherein the third gripping unit is configured to impermanently grip the elongated medical member. The second module may be of a substantially similar construction as the first module. The first and second modules may be spaced a predetermined distance from each other. In some examples, the first and second modules may be independently movable from one another. This may allow for the improved and customized movement of the tube and / or elongated medical member, thereby improving patient safety. In some examples, the system comprises the second module.

[0092] In some examples, the second module is movable in the one axis of freedom by the motor coupled to the second module. The motor coupled to the first and second modules may be the same motor, or may be separate motors. This may allow for synchronized movement of the modules, or independent movement of the modules. Both of these may allow for the improved and customized movement of the tube and / or elongated medical member, thereby improving patient safety.

[0093] In some examples, the first and / or the second module comprises a sensing unit, wherein the sensing unit is configured to sense a movement and / or a position of the elongated medical member. The sensing unit may comprise means for detecting and / or sensing a linear and / or rotational movement of the elongated medical member, in particular, optical and / or magnetic and / or physical means. In some examples, only the first module has this sensing unit. This may allow for sensing information to be transmitted to a controller, wherein the controller may give a UAB Inovatyvi medicina - 20 - 30A-166 904 command to the motor to move the first module and / or second module and / or elongated medical member accordingly. This may allow for the tube and / or the elongated medical member to be manipulated in a more precise manner, thereby improving patient safety.

[0094] In some examples, the first and / or second module is configured to be moved in the one axis of freedom, by the motor, upon the sensing of the movement and / or position of the elongated medical member by the sensing unit. The sensing unit may detect the linear and / or rotational movement of the elongated medical member and thereby determine a position and / or movement of the elongated medical member based on this. Resultantly, the first and / or second module may be moved based on this sensing to ensure that there is enough slack in the elongated medical member and / or to move the first and / or second module closer to the introducer and / or to move the first and / or second module to a predetermined position.

[0095] In some examples, the first module and / or the second module comprises a toggleable element, wherein when the toggleable element is toggled, the first and / or second module is moveable by the motor from a first module position to a second module position, wherein the first and second module positions are different positions. This may allow for the elongated medical member to be more easily inserted into the fixation element manually, thereby improving the fixation of the elongated medical member.

[0096] In some examples, when the first module and / or second module is moved from a first module position to a second module position, the elongated medical member is also configured to move from a first elongated medical member position to a second elongated medical member position. This may allow for the medical member to be moved into the introducer while coupling the introducer to the fixation element and / or during operation of a procedure on a patient.

[0097] It is clear to a person skilled in the art that certain features of the system set forth herein may be implemented under use of hardware (circuits), software means, or a combination thereof. The software means can be related to programmed microprocessors or a general computer, an ASIC (Application Specific Integrated Circuit) and / or DSPs (Digital Signal Processors). For example, a processing unit may be implemented at least partially as a computer, a logical circuit, an FPGA (Field Programmable Gate Array), a processor (for example, a microprocessor, microcontroller (pC) or an array processor) / a core / a CPU (Central Processing Unit), UAB Inovatyvi medicina - 21 - 30A-166 904 an FPU (Floating Point Unit), NPU (Numeric Processing Unit), an ALU (Arithmetic Logical Unit), a Coprocessor (further microprocessor for supporting a main processor (CPU)), a GPGPU (General Purpose Computation on Graphics Processing Unit), a multi-core processor (for parallel computing, such as simultaneously performing arithmetic operations on multiple main processor(s) and / or graphical processor(s)) or a DSP.

[0098] Even if some of the aspects described above have been described in reference to the first aspect, these aspects may also apply to the second and / or third aspects and / or a method.

[0099] BRIEF DESCRIPTION OF THE DRAWINGS

[0100] These and other aspects of the invention will now be further described, by way of example only, with reference to the accompanying figures, wherein like reference numerals refer to like parts, and in which:

[0101] Figure 1 shows a cross-sectional schematic view of an endovascular introducer fixation system according to some example implementations as described herein;

[0102] Figure 2 shows a perspective schematic view of an endovascular introducer fixation system according to some example implementations as described herein;

[0103] Figure 3 shows cross-sectional schematic views of an endovascular introducer fixation system according to some example implementations as described herein;

[0104] Figure 4 shows schematic views of an endovascular introducer fixation system according to some example implementations as described herein;

[0105] Figure 5 shows perspective views of an endovascular introducer fixation system according to some example implementations as described herein; UAB Inovatyvi medicina - 22 - 30A-166 904

[0106] Figure 6 shows a flow chart of a method for fixing an introducer according to some example implementations as described herein; and

[0107] Figures 7 to 9 show perspective schematic views of an endovascular introducer fixation system according to some example implementations as described herein.

[0108] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0109] Figure 1 shows a cross-sectional schematic view of an endovascular introducer fixation system according to some example implementations as described herein.

[0110] Figure 1 shows the endovascular introducer fixation system 100 comprising the first part 101 of the fixation element, the second part 102 of the fixation element, the first gipping unit 103, the tube 104 and the introducer 106.

[0111] The tube 104 is preferably of a fixed length. The length may be dependent on the robotic system, described in more detail below, and the introducer 106. Additionally, the length may be dependent on the patient anatomy and the positioning of the robotic system. The tube 104 may also have with a screw and / or slide type attachment on one side so that the tube can be screwed and / or coupled and / or attached to the first module, as described below, and / or the first gripping unit 103, and the fixation element on another side. Additionally or alternatively, the tube 104 may be glued to the first module and / or the first gripping unit 103 and / or the fixation element. The tube 104 may be coupled to the first module and / or the first gripping unit 103 and / or the fixation element during assembly of the system 100, thereby meaning the user does not need to do this themselves. The above may allow for the tube 104 to be secured between the fixation element and the first gripping unit 103, thereby improving patient safety. In some examples, the tube 104 comprises a material which has a low friction coefficient to allow an elongated medical member to move relatively freely within the tube 104. In some examples, the tube 104 has a diameter that is equal to, or larger than, the diameter of the introducer 106. The diameter of the tube 104 is preferably between 3 Fr (French scale) and 24 Fr. The stiffness of the tube 104 is preferably a stiffness that prevents the tube 104 being easily kinked while also allowing for a suitable friction coefficient for the elongated medical member. UAB Inovatyvi medicina - 23 - 30A-166 904

[0112] The tube 104 is preferably 7.5 cm, 12.5 cm or 18 cm long and may be selected according to the patient access site position and / or the position of the endovascular tube fixation system 100. The skilled person understands that other lengths are available.

[0113] The tip of the elongated medical member, discussed below, may be introduced into the introducer 106 so that it is passed through the introducer valve. In some examples, the introducer 106 may comprise and / or be a hemostatic valve. The introducer 106 may be any suitable commercially available introducer, or an introducer that is specifically made for the scenario the system 100 is in. Additionally or alternatively, the introducer may be suitable for and / or comprise elements suitable for an endovascular procedure.

[0114] In some examples, the tube 104 may not be bent during the processes described herein during operation of the endovascular robotic system and / or coupling of the tube 104 to the assembly 100. Bending the tube 104 may lead to access site damage during the procedure.

[0115] In some examples, the tube 104 is not bent at more than a 60-degree angle. Excessive bending of the tube 104 may lead to access site damage during the procedure.

[0116] The first gripping unit 103 may use any suitable means, such as, for example, clamping and / or screwing and / or fixing and / or gluing and / or (ultrasound) welding in order to grip the tube 104. In some preferred examples, the first gripping unit 103 may permanently grip the tube 104.

[0117] Figure 2 shows a perspective schematic view of an endovascular introducer fixation system according to some example implementations as described herein.

[0118] The fixation element is made from a first part 101 and a second part 102, which are coupled to each other via, preferably, a pin 107, although any other suitable coupling may be used. The second part 102 can be lifted up / down from a first position to a second position by one hand / finger. The second part 102 forms an opening, when in the second position, to be able to fix various sized introducers 106 in place. Any part of the introducer 106 may be coupled to the fixation element via this method, but it is preferable that only the cap of the introducer is coupled. The fixation element also has a "click" and / or a snap-fit coupling between the first 101 and second parts 102 UAB Inovatyvi medicina - 24 - 30A-166 904 to safely fasten these parts together, with the introducer 106 being fixed in place between the first 101 and second parts 102. This coupling may be facilitated by the protrusions of the first and / or second parts 101, 102, and / or the neck of the second part 102. Uncoupling the parts 101, 102 may be aided by an indent in the second part 102.

[0119] Figure 3 shows cross-sectional schematic views of an endovascular introducer fixation system according to some example implementations as described herein.

[0120] The left of figure 3 shows when the second part 102 of the fixation element is in the second position as described herein, and the right of figure 3 shows the second part 102 in the first position, the first 101 and second parts 102 preferably comprise plastic, but may additionally or alternatively comprise metal.

[0121] When the introducer 106 is correctly positioned between the first 101 and second parts 102, the introducer is fixed in place by moving the second part 102 from the first position to the second position. A click, via, for example, the snap-fit coupling mentioned herein, indicates that the introducer 106 is fixed in place. Additionally or alternatively, there may be an additional indicator to indicate that the second part 102 is in the second position. This additional indicator may comprise a visual and / or an audio and / or a haptic feedback. This may allow for a user of the endovascular tube fixation system 100 to ensure that the introducer 106 is fixed in place, thereby improving patient safety.

[0122] Figure 4 shows schematic views of an endovascular introducer fixation system according to some example implementations as described herein.

[0123] Introducer fixation system 100 is coupled to the first module 202, in this example, by screwing the first gripping unit 103 into the first module 202.

[0124] The robotic system shown in figure 4 may need to be adjusted during the mounting of introducer fixation system 100. For this, the first module 202, to which the introducer fixation system 100 is coupled, may be moved linearly by pressing the button 204, 205, 206 on the corresponding module 202. The skilled person understands that the same applies to the second module 203. The module 202, 203 may have two buttons 206 indicating a movement in one direction of the axis of freedom and a movement in the other direction of the axis of freedom, or the first module 202 may have one button 204 indicating one direction and the second UAB Inovatyvi medicina - 25 - 30A-166 904 module 203 may have another button 205 indicating another direction. The skilled person further understands that although a button is mentioned here, any element suitable of being actuated by a user in order to move the modules 202, 203 may be used such as, for example, a lever and / or a switch. In some examples, if only one of the buttons 204, 205, 206 is pressed on one of the modules 202, 203, both of the modules 202, 203 are (synchronously) linearly moved in the same direction along the axis of freedom, or in different directions along the axis of freedom. In some examples where there is a plurality of modules, the pressing of a button 204, 205, 206 on one module 202, 203 may cause all of the modules 202, 203 to move. That is to say, if the modules are, e.g., 20 cm apart, the pressing of a button 204, 205, 206 on one module 202, 203 may cause all of the modules 202, 203 to move so that the same 20 cm gap between the modules 202, 203 is maintained during the movement, and at the end of the movement. This may be particularly important in scenarios where endovascular devices and / or elongated medical members 210 coupled to the module(s) 202, 203 are already within a patient and keeping a particular distance between the endovascular devices and / or elongated medical members 210 is important. This may, in turn, improve patient safety. The above-described maintaining of gaps / distances may also apply to endovascular devices and / or elongated medical members 210 coupled to the module(s) 202, 203, with this coupling being described in more detail below.

[0125] This movement is conducted via a motor 201. The motor 201 may be coupled to each of the first 202 and second modules 203, or each module 202, 203 may have its own motor 201.

[0126] The endovascular robotic system may, in some examples, have endovascular devices and / or elongated medical members 210 loaded before attachment to the introducer 106. The attachment process may, therefore, require to move these devices and / or members 210 to be moved. In this case, the sensing and gripping mechanisms in a module 202, 203 enables such functionality. The first and / or second module 202, 203 may comprise a second and / or a third gripping unit, respectively. These gripping units may comprise any suitable means, such as, for example, clamping and / or screwing and / or fixing in order to impermanently grip the elongated medical member. In some examples, the second and third gripping units are identical in construction. When manually moving the endovascular device and / or member 210 forward or backward, the module 202, 203 may sense this movement. This sensing information may be transmitted to a controller (not shown) coupled to one or both of the modules 202, 203, and the controller may give a command to the motor 201 to UAB Inovatyvi medicina - 26 - 30A-166 904 move module(s) 202, 203, and resultantly the medical member 210, accordingly. The sensing unit (not shown), which provides the sensing information, may detect the linear and / or rotational movement of the elongated medical member and thereby determine a position and / or movement of the elongated medical member based on this. Resultantly, the first and / or second module may be moved based on this sensing to ensure that there is enough slack in the elongated medical member and / or to move the first and / or second module closer to the introducer and / or to move the first and / or second module to a predetermined position. This may be done by the controller tracking a linear position of the first 202 and / or second module 203 via liner encoder and / or by counting the motor steps, should a stepper motor be used. The determination of how far to move the first 202 and / or second module 203 may be determined via the user keeping the button 204, 205, 206 pressed and / or by sensing a force being exerted on the medical member 210. In such a case, the movement is halted when the sensing unit detects that there is a force being exerted on the medical member 210 is below a predetermined threshold. This threshold may be chosen by a user of the system, and may be any suitable threshold.

[0127] In some examples, at least two modules 202, 203 are needed. The first module 202 may be needed to attach the introducer fixation system 100, and the second module 203 may be needed to move the elongated medical member 210 as described herein. The elongated medical member 210 may be a guide wire, a stent, a catheter, a balloon, a PTA balloon catheter, a stent balloon, or any other suitable member preferably suitably for endovascular uses.

[0128] The endovascular robotic system may move more than one elongated medical member 210 synchronically for this purpose, keeping the initial positions in relation to each member 210 the same while moving the members 210 relative to the fixation element and introducer 106.

[0129] Such a method and process as described herein can be used to adjust more than elongated medical member 210 and / or endovascular device, where each member 210 and / or device would require separate sensing and only a moving module 202, 203. This does not limit the number of the members 210 and / or devices used. In some examples, all of the sensing data is sent to a main controller. Each of the sensing modules may, in principle, be of the same construction, but sensor stiffnesses and sensing ranges may be different for different elongated members 210. For example, a catheter may require more force than a guidewire and so, the sensing units may be altered accordingly. UAB Inovatyvi medicina - 27 - 30A-166 904

[0130] Precise positioning of the elongated medical member 210 may be initiated by pressing the buttons 204, 205, 206 as mentioned herein.

[0131] Figure 5 shows perspective views of an endovascular introducer fixation system according to some example implementations as described herein.

[0132] Adjusting the position of the module(s) 202, 203 may impact the position of elongated medical member 210 inside the tube 104. The proximal end of the member 210 may be outside the fixation element and may be passed through a hole in the first part 101 of the fixation element and an opening of the introducer 106. Coupling the introducer 106 to the fixation element before passing the medical member 210 through the first part 101 and introducer 106 may result in damage to the medical member 210.

[0133] Figure 6 shows a flow chart of a method for fixing an introducer.

[0134] The method 200 comprises placing S202 the elongated medical member 210 through a hole in the first part 101 of the fixation element; placing S204 the elongated medical member 210 within the introducer 106, wherein the introducer 106 is configured to guide the elongated medical member 210 at a first side of the fixation element; placing S206 the introducer 106 within and / or on top of a first protrusion of the first part 101, when the second part 102 of the fixation element is in a first position; and moving S208 the second part 102 of the fixation element from the first position to a second position to fix the introducer 106 in place relative to the fixation element.

[0135] Figures 7 to 9 show perspective schematic views of an endovascular introducer fixation system according to some example implementations as described herein.

[0136] Figures 7 to 9 show an embodiment of coupling the first part 101 to the second part 102. Here, the second part 102 comprises a plurality of teeth, and the first part 101 comprises a corresponding protrusion or pawl. This may allow for the coupling between the first and second parts 101, 102 to act as a cable tie / ratcheting mechanism. This may also allow for a secure coupling between the parts 101, 102. Figure 7 shows this coupling between the parts 101, 102 during coupling, and figure 8 shows the parts 101, 102 once they have been coupled. Figure 9 shows a cross- sectional view of the coupling of this embodiment which shows that the teeth of the UAB Inovatyvi medicina - 28 - 30A-166 904 first part interact with the protrusion / pawl of the second part, and also a perspective view showing an end-on view of the coupling.

[0137] Although in the embodiment of figures 7 to 9 show the first part 101 comprising the protrusion or pawl and the second part 102 comprising the plurality of teeth, the skilled person understands that the first part 101 may comprise the plurality of teeth and the second part 102 the protrusion or pawl.

[0138] No doubt many other effective alternatives will occur to the skilled person. It will be understood that the invention is not limited to the described embodiments and encompasses modifications apparent to those skilled in the art and lying within the scope of the claims appended hereto.

Claims

UAB Inovatyvi medicina - 29 - 30A-166 904CLAIMS1. An endovascular introducer fixation system (100) comprising: an introducer fixation element comprising a first part (101) and a second part (102), wherein the first part (101) comprises a first protrusion configured to accommodate an introducer (106), wherein, when the second part (102) is in a first position, the first protrusion of the first part (101) and the second part (102) form a first opening with a first diameter, and wherein an introducer (106) is placeable in the introducer fixation element, wherein, when the second part (102) is in a second position, the first protrusion of the first part (101) and the second part (102) form the first opening with a second diameter, wherein the second diameter is smaller than the first diameter, wherein the introducer (106) is configured to be coupled to the introducer fixation element when the second part (102) is in the second position, and wherein a third diameter of the introducer (106) is smaller than the first diameter, wherein the second part (102) i) is rotatable with respect to the first part (101) around an axis substantially perpendicular to a longitudinal axis of a tube (104) or ii) slidable with respect to the first part (101) along an axis substantially parallel to a longitudinal axis of the tube (104), and wherein the first position and the second position are different positions; and a first gripping unit (103), wherein a first end of the tube (104) is fixedly coupled to the first part (101) of the introducer fixation element, wherein a second end of the tube (104) is fixedly coupled within the first gripping unit (103), and wherein the first and second ends of the tube (104) are opposite ends of the tube (104).

2. The system (100) of claim 1, wherein the second part (102) is i) rotatable via a pin (107) coupled to both the first (101) and second parts (102) of the introducer fixation element or ii) slidable onto or into the first part (101) via a ratcheting mechanism, wherein one of the first (101) and second (102) parts comprises aUAB Inovatyvi medicina - 30 - 30A-166 904 plurality of teeth, and the other of the first (101) and second (102) parts comprises a pawl.

3. The system (100) of claim 1 or 2, wherein the tube (104) encloses an elongated medical member (210).

4. The system (100) of claim 3, wherein, when the second part (102) of the introducer fixation element is in the second position, the elongated medical member (210) is configured to be moveable relative to the introducer fixation element.

5. The system (100) of any one of the preceding claims, wherein the introducer fixation element is configured to accommodate a plurality of different sizes of introducers (106).

6. The system (100) of any one of the preceding claims, wherein, when the second part (102) of the introducer fixation element is in the second position, the second part (102) is configured to snap-fit with a portion of the first part (101) of the introducer fixation element.

7. The system (100) of any one of the preceding claims, wherein the first gripping unit (103) is coupled to a first portion of a medical robotic system.

8. The system (100) of any one of the preceding claims, wherein the first gripping unit (103) is not directly connected to the introducer fixation element.

9. The system (100) of any one of the preceding claims, wherein the first gripping unit (103) is configured to grip the tube (104) at a first side of the fixation element, wherein the introducer (106) is configured to be coupled to the introducer fixation element at a second side of the introducer fixation element, and wherein the first and second sides are opposite sides of the introducer fixation element.

10. The system (100) of any one of the preceding claims, when dependent on claim 3, further comprising a second gripping unit coupled to a first module (202) of the medical robotic system, wherein the elongated medical member (210) is configured to be moveable relative to the first gripping unit (103) and the second gripping unit, in particular wherein the second gripping unit is configured to impermanently grip the elongated medical member (210).UAB Inovatyvi medicina - 31 - 30A-166 90411. The system (100) of any one of claims 7 to 10, wherein the first gripping unit (103) is coupled to the first module (202) of the medical robotic system.

12. The system (100) of claim 11, wherein the first module (202) is moveable in one axis of freedom by a motor (201) coupled to the first module (202).

13. The system (100) of claim 12, wherein the axis of freedom is substantially parallel with a longitudinal axis of the tube (104).

14. The system of claim 12 or 13, when dependent on claim 3, wherein the axis of freedom is substantially parallel with a longitudinal axis of the elongated medical member (210).

15. The system (100) of any one of claims 7 to 14, wherein the medical robotic system further comprises a second module (203), wherein the second module (203) comprises a third gripping unit which is identical to the second gripping unit (103), in particular wherein the third gripping unit is configured to impermanently grip the elongated medical member (210).

16. The system (100) of claim 15, wherein the second module (203) is movable in the one axis of freedom by the motor (201) coupled to the second module (203).

17. The system (100) of any one of claims 11 to 16, when dependent on claim 3, wherein the first (202) and / or the second module (203) comprises a sensing unit, wherein the sensing unit is configured to sense a movement and / or a position of the elongated medical member (210).

18. The system (100) of claim 17, wherein the first (202) and / or second module (203) is configured to be moved in the one axis of freedom, by the motor (201), upon the sensing of the movement and / or position of the elongated medical member (210) by the sensing unit.

19. The system (100) of any one of claims 11 to 18, wherein the first module (202) and / or the second module (203) comprises a toggleable element (204, 205, 206), wherein, when the toggleable element (204, 205, 206) is toggled, the first (202) and / or second module (203) is moveable by the motor (201) from a first module position to a second module position, wherein the first and second module positions are different positions.UAB Inovatyvi medicina - 32 - 30A-166 90420. The system (100) of claim 19, when dependent on claim 3, wherein, when the first module (202) and / or second module (203) is moved from the first module position to the second module position, the elongated medical member (210) is also configured to move from a first elongated medical member position to a second elongated medical member position.

21. The system (100) of any one of the preceding claims, further comprising an indicator configured to indicate that the second part (102) of the introducer fixation element is in the second position.

22. The system (100) of any one of the preceding claims, wherein the first part and the second part of the introducer fixation element (101, 102) each comprise a second protrusion, wherein the second protrusions are configured to mate with one another when the second part (102) is in the second position, thereby fixing the second part (102) in place with respect to the first part (101).

23. The system (100) of claim 22, wherein the first part and / or the second part (101, 102) comprises a plurality of second protrusions.

24. The system (100) of any one of the preceding claims, wherein the second part (102) of the introducer fixation element comprises a neck.

25. The system (100) of claim 24, wherein the neck is configured to allow the second part (102) to flex when the second part (102) is in the second position.

26. The system (100) of claim 25, when dependent on claim 6 or 22, wherein the flexure of the second part (100) is configured to allow facilitation of the snap-fit coupling and / or the mating of the second protrusions.

27. The system (100) of any one of claims 24 to 26, wherein the second part (102) of the introducer fixation element comprises a plurality of necks.

28. The system (100) of any one of the preceding claims, wherein the second part (102) of the introducer fixation element comprises an indent for a digit of a user of the system (100).UAB Inovatyvi medicina - 33 - 30A-166 90429. The system (100) according to any one of the preceding claims, wherein the system (100) further comprises the introducer (106).

30. An endovascular introducer fixation system (100) comprising: an introducer fixation element configured to accommodate an introducer (106), a first gripping unit (103), wherein a first end of a tube (104) is fixedly coupled to the first part (101) of the introducer fixation element, wherein a second end of the tube (104) is fixedly coupled within the first gripping unit (103), and wherein the first and second ends of the tube (104) are opposite ends of the tube (104), wherein the tube (104) is configured to enclose an elongated medical member (210); and a second gripping unit coupled to a first module (202) of a medical robotic system, wherein the elongated medical member (210) is configured to be moveable relative to the at least first gripping unit (103) and wherein the first module (202) is moveable along an axis substantially parallel with a longitudinal axis of the tube (104), in particular wherein the second gripping unit is configured to impermanently grip the elongated medical member (210).

31. The system of claim 30, wherein the first module (202) comprises the first part (101) or the second part (102) of the introducer fixation element, wherein if the first module (202) comprises the first part (101), the first module (202) is configured to move the first part (101) towards the second part (102), or wherein if the first module (202) comprises the second part (102), the first module (202) is configured to move the second part (102) towards the first part (101).

32. The system of claim 30 or 31, wherein as the first module (202) is moved along the axis substantially parallel with a longitudinal axis of the tube (104), the elongated medical member (210) is configured to be inserted or withdrawn from the tube (104).

33. An endovascular introducer fixation system (100) comprising: an introducer fixation element configured to accommodate an introducer (106), a first gripping unit (103),UAB Inovatyvi medicina - 34 - 30A-166 904 wherein a first end of a tube (104) is fixedly coupled to the first part (101) of the introducer fixation element, wherein a second end of the tube (104) is fixedly coupled within the first gripping unit (103), and wherein the first and second ends of the tube (104) are opposite ends of the tube (104), wherein the first gripping unit (103) is configured to grip the tube (104) at a first side of the fixation element, wherein the introducer fixation element is configured to be coupled to the introducer (106) at a second side of the introducer fixation element, and wherein the first and second sides are opposite sides of the introducer fixation element, wherein the system is configured to determine a length for the tube (104) between the first gripping unit (103) and the introducer (106) based on a patent characteristic.

34. The system of claim 33, wherein the patient characteristic comprises at least one of a height of a patient, a weight of the patient, and a circumference measurement of the patient.

35. The system of claim 34, further comprising a processor configured to determine the length for the tube (104) based on the patient characteristic.

36. The system of claim 35, wherein the processor is configured to select the shortest tube (104) length possible based on the patient characteristic.

37. The system of any one of claims 33 to 36, wherein a user of the system determines the length of the tube based on the patient characteristic.

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