Apparatus for fastening a medical device to a patient and method for fastening a medical device to a patient - Patents.com

Abstract

Provided are a surgical guide tube 1, a kit including the surgical guide tube 1, a system including the surgical guide tube 1, a clamping unit including a surgical guide tube portion, and a method of providing vascular access to a patient's blood vessel including the step of providing a surgical guide tube, wherein the surgical guide tube 1 includes a body portion having a proximal end, a distal end, and a guide lumen having a longitudinal axis, the guide lumen extending from the proximal end to the distal end of the body portion and configured for inserting a medical device, in particular a catheter of an intravascular blood pump, through the body portion 2. The surgical guide tube 1 further includes a lateral extension 10, the lateral extension 10 defining planar surfaces 12a, 12b, the planar surfaces 12a, 12b configured for attachment to the patient's fascia 26 between the patient's blood vessel 24 and the patient's skin. In particular, the planar surfaces 12a, 12b of the lateral extensions 10 are inclined with respect to the longitudinal axis 8 of the guide lumen by an inclination angle of approximately 30° to 60°, preferably 45°.

Description

[Technical field]

[0001] The present disclosure relates to surgical guide tubes, kits, systems, and clamping units for securing medical devices, particularly catheters of intravascular blood pumps, to a patient, and methods of securing medical devices, particularly catheters of intravascular blood pumps, to a patient. [Background technology]

[0002] An intravascular blood pump is placed in the heart to support the patient's heart and extends into the left or right ventricle. The intravascular blood pump includes a catheter and a pumping device attached to the distal end of the catheter. The pumping device includes a pump section and a drive section for driving an impeller in the pump section. Electrical wiring either connects an electric motor of the drive section through the catheter to an external power source outside the patient's body, or a flexible drive cable running through the catheter connects the drive section to the external motor. In addition to the impeller, the pump section includes a blood flow inlet and a blood flow outlet, where the blood flow inlet (or outlet, depending on the flow direction) can be positioned at the distal end of a cannula that can be located distal to the impeller. A soft flexible extension attached to the distal end of the pump section can complement the intravascular blood pump.

[0003] In particular, an intravascular blood pump operated in the left ventricle of the heart is placed across the aortic valve, i.e. the pump section extends from the aorta into the left ventricle. In a surgical procedure, the pump section is introduced into the aorta and the left ventricle via the subclavian or axillary artery. For this purpose, a vascular graft is attached to the subclavian or axillary artery, for example by anastomosis, and then the pump is introduced through the graft into the subclavian / axillary artery towards the aortic arch and finally across the aortic valve into the left ventricle.

[0004] Once the pump section is placed across the heart valve, the plug portion of the repositioning unit, which is slidably mounted on the catheter, is pushed into the graft and then secured by its distal end portion to the graft and by its proximal end portion to the outer surface of the patient's skin (e.g., in the shoulder area). For example, the repositioning unit includes a butterfly fixation with two lateral extensions that can be secured onto the patient's skin by sutures or taping, thereby preventing relative movement between the repositioning unit and the patient's skin. Furthermore, once the repositioning unit is placed in the intended position, the pump's catheter is fixed inside the repositioning unit, preventing relative movement between the repositioning unit and the catheter.

[0005] However, although the above-mentioned fixation of the repositioning unit and the catheter, on the one hand, prevents relative movements between the repositioning unit and the patient's skin, and on the other hand, prevents relative movements between the catheter and the repositioning unit, any movement of the patient's shoulder (i.e. the skin in the shoulder area) may lead to a movement of the catheter inside the subclavian / axillary artery where the catheter is located. This means that if the patient moves his / her shoulder, the skin part fixed to the repositioning unit (the catheter is fixed inside the repositioning unit) may also move, which may cause a movement of the catheter inside the blood vessel and finally a dislocation of the pump inside the heart. Summary of the Invention [Problem to be solved by the invention]

[0006] It is an object of the present disclosure to overcome or at least mitigate the disadvantages of the prior art, and in particular to prevent or at least reduce pump displacement as a result of shoulder movement. [Means for solving the problem]

[0007] According to the present disclosure there is provided a surgical guide tube, a kit, a system, a clamping unit and a method according to the attached independent claims.

[0008] According to a first aspect of the present disclosure, a surgical guide tube is provided having a lumen for inserting a medical device (e.g., a catheter of an intravascular blood pump) through the surgical guide tube. The surgical guide tube is adapted to be fixed to a deep fascia of a patient located between the skin and a blood vessel (e.g., the axillary artery and the subclavian artery) into which the medical device is to be introduced. To this end, the surgical guide tube includes an anchoring portion at its proximal end, and the fascia can be fixed to the anchoring portion, such as by suturing and clamping. The distal end of the surgical guide tube can be attached to a vascular graft connected to a target blood vessel, providing access to the blood vessel for the medical device to be inserted into the blood vessel. The vascular graft can be fixed to the blood vessel, for example, by anastomosis. If the access point to the blood vessel is in the area of ​​the patient's shoulder, it is beneficial to adapt the geometry of the surgical guide tube to the anatomy of the shoulder. To this end, the anchoring portion of the surgical guide tube is angled with respect to the longitudinal axis of its lumen through which the medical device is guided, so that the anchoring portion can be brought into contact with and secured to the deep fascia between the vascular access and the patient's skin as naturally as possible, i.e., without substantially stretching, twisting or otherwise distorting the natural course of the deep fascia.

[0009] Specifically, a surgical guide tube configured for insertion into a vascular graft is provided, the surgical guide tube including a body portion, which may have a tubular (particularly linear) shape, the body portion having a guide lumen with a longitudinal axis, a proximal end, and a distal end. The guide lumen extends from the proximal end to the distal end of the body portion and is configured for inserting a medical device (particularly a catheter of an intravascular blood pump) therethrough. The body portion of the surgical guide tube further includes a lateral extension, which extends laterally from the body portion and defines a planar surface, the planar surface being configured for attachment to the patient's fascia between the patient's internal vessel, preferably a blood vessel, more preferably at least one of the axillary and subclavian arteries, and the patient's skin. The particular fascia preferably surrounds or extends adjacent to the blood vessel. The planar surfaces of the lateral extensions are inclined with respect to the longitudinal axis of the guide lumen by an inclination angle of about 30° to 60°, preferably 40° to 50°, more preferably 45°. Preferably, any surface normal on the planar surfaces does not intersect with the longitudinal axis of the guide lumen.

[0010] The inclination angle can prevent or at least reduce stretching, twisting, or otherwise distorting the natural course of the patient's deep fascia during the fixation of the deep fascia to the planar surface of the lateral extension, for example, when the surgical guide tube is applied to the axillary or subclavian artery in the shoulder area. Since the surgical guide tube is fixed to the patient's deep fascia, the surgical guide tube can be positioned completely under the skin. Fascia is a layer of dense connective tissue that surrounds the muscles, bones, nerves, and blood vessels of the patient's body. There is minimal relative movement between the deep fascia that extends very close to the blood vessels. Thus, fixation of the surgical guide tube to the deep fascia under the skin minimizes pump misalignment. This is because movement of the skin in the patient's shoulder area does not necessarily cause the surgical guide tube to move, i.e., movement of the medical device inserted into the blood vessel through the surgical guide tube can be prevented. Thus, the risk of misalignment of the intravascular blood pump can be reduced.

[0011] There, the lateral extension is preferably arranged such that it includes an axis lying in the planar surface of the lateral extension and extending orthogonally through the longitudinal axis of the guide lumen, in particular, the axis of the planar surface extending orthogonally through the longitudinal axis of the guide lumen constitutes a virtual axis of rotation, and the planar surface is effectively rotated about the virtual axis of rotation from a position in which the longitudinal axis of the guide lumen would be oriented perpendicular to the planar surface, to an actual tilted position in which the longitudinal axis of the guide lumen is oriented at a predefined angle (other than 90°) with respect to the planar surface by said tilt angle.

[0012] Preferably, the lateral extensions are attached to the main body in a non-removable manner, preferably being integrally formed therewith, whereby the position of the lateral extensions is predetermined and handling of the surgical guide tube can be simplified.

[0013] Alternatively, the surgical guide tube can include a separate clamping part (i.e., a clamping part that is not non-removably attached to the body part but is independent of the body part of the surgical guide tube), the clamping part having a proximal end, a distal end, and a clamping lumen extending from the proximal end to the distal end of the clamping part, the lateral extension being non-removably attached to the clamping part, preferably integrally formed with the clamping part, the clamping part being configured to clamp onto or around the body part of the surgical guide tube, such that the planar surface of the lateral extension is inclined by said inclination angle with respect to the longitudinal axis of the guide lumen. Thereby, the position of the lateral extension along the longitudinal axis of the surgical guide tube can be individually determined by the surgeon, i.e., the surgeon can place the clamping part at a desired position along the longitudinal axis of the surgical guide tube.

[0014] In a preferred embodiment, the clamping part is configured to clamp onto or around the body of the surgical guide tube such that the longitudinal axis of the clamping lumen of the clamping part is parallel to the longitudinal axis of the guide lumen of the surgical guide tube, meaning that the planar surfaces of the lateral extensions are inclined by about 30° to 60° with respect to the longitudinal axis of the clamping lumen of the clamping part.

[0015] More preferably, the clamping part is configured to reduce the diameter of the guide lumen of the surgical guide tube when clamped on or around the body of the surgical guide tube, in particular between two bumps (in particular adjacent bumps) provided on the surgical guide tube, or between a bump and an adjacent bulge (described in more detail below), when the clamping part is placed in a longitudinal position of the surgical guide tube. In other words, the clamping part reduces the cross section of the guide lumen when clamped on or around the body of the surgical guide tube, whereby the medical device can be held in its longitudinal position relative to the guide lumen when the medical device is inserted into the guide lumen. In a preferred embodiment, the clamping part includes at least two arms, which extend in substantially opposite circumferential directions, each provided with an interlocking profile, and which are arranged such that the cross section of the clamping lumen is narrowed when the arms are moved past each other in the respective circumferential directions, and which interlock with each other via the interlocking profile. In particular, the interlocking profile can form a ratchet mechanism.

[0016] In a preferred embodiment, two of the lateral extensions are provided, which are preferably arranged in mirror symmetry with respect to each other. The two lateral extensions form two wings, which extend in opposite radial directions relative to the longitudinal axis of the guide lumen. Preferably, at the location of the surgical guide tube from which the wings extend radially, the distance between the longitudinal axis of the guide lumen and the radially outermost edge of each of the lateral extensions is between about 5 mm and about 19 mm, preferably between about 8 mm and about 16 mm, and more preferably about 12 mm. In this way, a sufficiently large area can be provided for attachment of the patient's fascia to the planar surface of the lateral extensions, while maintaining the outermost edge of each of the lateral extensions as close as possible to the longitudinal axis of the guide lumen.

[0017] Preferably, the length over which the lateral extension extends in the radial direction (relative to the longitudinal axis of the guide tube) is at least 3 mm. Particularly preferably, said length is between 3 mm and 10 mm, even more preferably about 5 mm. Even more preferably, the extension of the lateral extension in a direction perpendicular to the radial direction is at least 3 mm, especially preferably between 3 mm and 10 mm, even more preferably about 5 mm. Even more preferably, the surface area of ​​the lateral extension is at least 9 mm. 2 and particularly preferably 9 mm 2 From 100mm 2 and even more preferably between about 25 mm 2In the case where the lateral extension includes one or more apertures opening into the surface area of ​​the lateral extension, the opening area of ​​the one or more apertures is considered to be included in the surface area of ​​the lateral extension. More preferably, the radial extension length and the extension of the lateral extension in a direction perpendicular to the radial direction are approximately the same. Such a dimensioned lateral extension allows for easy and safe attachment of the lateral extension to the fascia of the patient.

[0018] Preferably, the body of the surgical guide tube has an outer diameter of between 5 mm and 10 mm, more preferably between 6 mm and 9 mm, and even more preferably about 8 mm. The inner diameter of the body (i.e., the diameter of the guide lumen) is preferably between 4 mm and 9 mm, more preferably between 5 mm and 8 mm, and even more preferably between 6 mm and 7 mm. As such, the surgical guide tube is particularly suitable for use with catheter-based medical devices, such as, for example, heart pumps.

[0019] Preferably, the radial extension of the lateral extension is between 0.6 and 1 times the outer diameter of the body of the surgical guide tube, and more preferably is 0.8 times the outer diameter of the body of the surgical guide tube.

[0020] These dimensions allow for easy attachment of the lateral extension to the fascia while at the same time allowing for easy insertion of the surgical guide tube into the vascular graft.

[0021] Preferably, the axial length of the surgical guide tube is between 10 mm and 30 mm, more preferably between 15 mm and 25 mm, and even more preferably about 20 mm, making it particularly suitable for placement between a blood vessel into which access for a medical device is provided and the patient's skin.

[0022] Preferably, the lateral extension includes attachment points (e.g., one or more openings, recesses, or protrusions, etc.) for anchoring to the fascia. For example, the lateral extension includes an opening (more preferably, two or more of said openings) configured to receive a suture or clamp therethrough to facilitate attachment of the surgical guide tube to the patient's fascia (e.g., by suturing or clamping). In particular, the longitudinal axis of the opening extends substantially perpendicular to the planar surface of the lateral extension, where the opening can be substantially D-shaped in transverse cross-section.

[0023] More preferably, the lateral extension is arranged at the proximal end of the surgical guide tube. In particular, the lateral extension can form the proximal end of the surgical guide tube. Thereby, the total length of the surgical guide tube can be kept short. Alternatively, the proximal bulge surrounds the main body and forms the proximal end of the surgical guide tube, the proximal bulge being preferably annular, more preferably having the shape of a circular ring. This is particularly useful when the lateral extension is provided on a separate clamping part.

[0024] In a preferred embodiment, the surgical guide tube is provided with one or more circumferential bumps extending radially from its body, each of said bumps surrounding the body, preferably annular, more preferably having the shape of a circular ring. The bumps can be arranged in a spaced apart relationship along the longitudinal axis of the guide lumen. In other words, adjacent circumferential bumps are arranged with a predetermined distance relative to each other along the longitudinal axis of the guide lumen. The circumferential bumps are useful for providing a seal between the surgical guide tube and the vascular graft when the surgical guide tube is inserted into the vascular graft by its distal end. The circumferential bumps also provide a predetermined clamping position for the separate clamping parts. For these purposes, it is preferred that there are at least two of said circumferential bumps, and that they are aligned parallel to each other along the longitudinal axis of the guide lumen, have the same outer diameter, or both. Further preferably, some or all of the circumferential bumps are positioned on the surgical guide tube distal to the lateral extension, and preferably there are at least two distally positioned circumferential bumps that are aligned parallel to one another along the longitudinal axis of the guide lumen, have the same outer diameter, or both.

[0025] Preferably, the distal bulge surrounds the body and forms the distal end of the surgical guide tube, the distal bulge being preferably annular, more preferably having the shape of a circular ring, which improves sealing properties and may be useful when the lateral extension is provided on a separate clamping part. More preferably, all of the circumferential bumps positioned proximal to the distal bulge are aligned parallel to one another along the longitudinal axis of the guide lumen, have the same outer diameter, or both. Also preferably, all of the circumferential bumps positioned between the lateral extension and the distal bulge are aligned parallel to one another along the longitudinal axis of the guide lumen, have the same outer diameter, or both.

[0026] Specifically, the periphery of the distal end of the surgical guide tube can lie in a plane that is inclined by about 30° to 60°, preferably by 40° to 50°, more preferably by 45°, relative to the longitudinal axis of the guide lumen. Thereby, the surgical guide tube can be further adapted to the anatomical structure of the target site (e.g., the patient's shoulder). Moreover, the plane is preferably inclined in the same direction and preferably by the same inclination angle relative to the longitudinal axis of the guide lumen as the planar surface of the lateral extension. In other words, the plane in which the distal end of the surgical guide tube lies and the planar surface of the lateral extension of the surgical guide tube are preferably parallel.

[0027] In a preferred embodiment, the circumferential bumps on the surgical guide tube are arranged concentrically with the longitudinal axis of its guide lumen, and the outer diameter of each of the bumps relative to the longitudinal axis of the guide lumen is about 0.8 to about 1.8 times larger than the outer diameter of the body of the surgical guide tube, preferably about 1 to about 1.6 times larger, and more preferably about 1.3 times larger. Specifically, the circumferential bumps can have an outer diameter of about 9 mm, and the body of the surgical guide tube can have an outer diameter of about 7 mm. This means that the bumps preferably have the same outer dimensions. This facilitates the insertion of the surgical guide tube into the vascular graft and provides good sealing and fixation properties, for example for additional fixation means described later. Also, preferably, the body of the surgical guide tube has a constant outer diameter relative to the longitudinal axis of the guide lumen.

[0028] In particular, all of the circumferential bumps of the surgical guide tube are positioned along the longitudinal axis of its guide lumen at a common mutual distance greater than the distance from the proximal end to the distal end of the clamping part. More preferably, at least one of the distances (a) between the proximal end of the surgical guide tube and one of the circumferential bumps located closest to the proximal end of the surgical guide tube, and (b) between the distal end of the surgical guide tube and one of the circumferential bumps located closest to the distal end of the surgical guide tube, is greater than the distance from the proximal end to the distal end of the clamping part. This allows for a large number of pre-determined clamping positions for the separate clamping parts.

[0029] According to a second aspect of the present disclosure, there is provided a kit including a surgical guide tube as described above, the vascular graft, which can be made, for example, from Dacron, having a proximal end, a distal end configured to secure the vascular graft to a patient's blood vessel, for example by anastomosis, and a graft lumen extending from the proximal end to the distal end of the vascular graft, the graft lumen configured to receive a distal section of the surgical guide tube within the proximal end of the vascular graft.

[0030] Preferably, the surgical guide tube includes one or more circumferential bumps as described above, and the inner diameter of the graft lumen is between 1 and about 1.2 times the outer diameter of the circumferential bumps (particularly the circumferential bump having the largest outer diameter). Specifically, the graft lumen can have an inner diameter of about 10 mm, and the circumferential bump can have an outer diameter of about 9 mm. This facilitates insertion of the surgical guide tube into the vascular graft and provides good sealing and fixation characteristics, for example for additional fixation means described below.

[0031] In a preferred embodiment, the surgical guide tube includes a clamping part as described above, which is configured to fix the vascular graft to the surgical guide tube by clamping the clamping part onto the graft when the surgical guide tube is inserted into the graft, whereby the graft and the surgical guide tube are fixed to each other and a clearance or gap between the graft and the surgical guide tube is closed, sealing the graft against the surgical guide tube and preventing blood from flowing through said clearance. Wherein, the clamping part is preferably configured to reduce the diameter of the guide lumen of the surgical guide tube, i.e. to narrow the cross section of the guide lumen by clamping the clamping part onto the vascular graft when the surgical guide tube is inserted into the graft. The clamping preferably occurs at a predetermined longitudinal position between two adjacent bumps, between the proximal bulge and the bump located closest to the proximal bulge, or between the distal bulge and the bump located closest to the distal bulge of the surgical guide tube. In this way, after inserting the medical device into the guide lumen, the medical device can be held in a fixed position relative to the guide lumen (i.e., the surgical guide tube). In other words, the medical device is prevented from moving inside the guide lumen.

[0032] The kit may further include at least one of at least one suture and at least one fixation clamp, which is configured to fix the vascular graft to the outer periphery of the body of the surgical guide tube when the surgical guide tube is inserted into the graft at a predetermined longitudinal position, in particular between two adjacent bumps, between the proximal bulge and the bump located closest to the proximal bulge, or between the distal bulge and the bump located closest to the distal bulge of the surgical guide tube. Preferably, the suture or fixation clamp is configured to reduce the diameter of the graft, i.e., to narrow the cross-section of the graft lumen to a reduced diameter that is smaller than the outer diameter of the adjacent bump, the outer diameter of the proximal bulge and the bump located closest to the proximal bulge, or the outer diameter of the distal bulge and the bump located closest to the distal bulge, in particular, by applying it to the graft when the surgical guide tube is inserted into the graft. The surgical guide tube inside the graft is thereby secured to the graft and the clearance between the outer surface of the surgical guide tube and the inner wall of the graft is reduced or closed.

[0033] Preferably, the fixation clamp is configured to reduce the diameter of the guide lumen of the vascular graft, i.e., to narrow the cross section of the guide lumen, in particular between two adjacent bumps, between the proximal bulge and the bump located closest to the proximal bulge, or between the distal bulge and the bump located closest to the distal bulge of the surgical guide tube, by applying the fixation clamp to the graft with the surgical guide tube inserted into the graft. In this way, after inserting the medical device into the guide lumen of the surgical guide tube, the medical device can be held in a fixed relative position with respect to the guide lumen (i.e. with respect to the surgical guide tube) by the fixation clamp. In other words, the medical device is prevented from moving inside the guide lumen of the surgical guide tube.

[0034] In a preferred embodiment, the kit can include a medical device (particularly a catheter) configured to insert the medical device into and through the guide lumen of the surgical guide tube, which is preferably slidable on the outer surface of the medical device. Furthermore, the kit can include an intravascular blood pump configured to connect it to the medical device (catheter) and to insert it into the patient's blood vessel through the vascular graft. If the medical device is a catheter, it is preferred that the catheter is made with a catheter shore hardness of about 55D. The surgical guide tube can be made with a hardness of about 60A. The catheter can be made from, for example, polyurethane or Teflon or silicone. Preferably, the catheter has an outer diameter of about 2mm to about 5mm, especially about 3mm, which allows a small skin access port and thus prevents infection.

[0035] According to a third aspect of the present disclosure, a system configured to fix a medical device to a patient's body is provided. The system includes a surgical guide tube configured to be inserted into a vascular graft. The surgical guide tube includes a body portion, which may have a tubular (particularly linear) shape, the body portion having a proximal end, a distal end, and a guide lumen having a longitudinal axis, the guide lumen extending from the proximal end to the distal end, and configured to insert a medical device (particularly a catheter of an intravascular blood pump) through the guide lumen. The surgical guide tube further includes a lateral extension, which extends laterally from the body portion and defines a planar surface, the planar surface being configured to be attached to the patient's fascia between the patient's body vessel, preferably a blood vessel, more preferably at least one of the axillary artery and the subclavian artery, and the patient's skin. The fascia preferably surrounds or extends adjacent to the blood vessel. The system further includes a fixator configured to be secured to the patient's skin and configured to hold the medical device against the patient's body, the fixator having a central body portion and two fixator wings extending in opposite directions from the central body portion, each fixator wing having a planar surface, the planar surfaces facing a common direction.

[0036] This allows one portion of the system to be secured under the skin (i.e., to the patient's deep fascia between the access vessel and the skin) and another portion of the system to be secured above the outer surface of the patient's skin, allowing for secure fixation of the medical device on the patient's body.

[0037] There, the surgical guide tube can include any one of the features described above with reference to the first and second aspects of the present disclosure. For example, in the surgical guide tube according to the first aspect of the present disclosure, the planar surface of the lateral extension of the surgical guide tube is inclined with respect to the longitudinal axis of the guide lumen by an inclination angle of about 30° to 60°, preferably 40° to 50°, more preferably 45°. However, this is not a necessary feature of the surgical guide tube in the system according to this third aspect of the present disclosure and can be omitted from the system without departing from the present disclosure.

[0038] Additionally, the system according to this third aspect of the disclosure may include any one of the features of the kit as described above with reference to the second aspect of the disclosure, for example, the system may include a vascular graft, sutures, fixation clamps, a medical device, and an intravascular blood pump according to the above-mentioned configurations of the kit.

[0039] In a preferred embodiment of the system, each of the two fixator wings includes at least one opening (preferably two or more openings) configured to insert a suture or clamp therethrough for attaching the fixator wings to the outer surface of the patient's skin (e.g., by a suture or clamp).More preferably, the planar surface of the fixator wings is at least partially or completely covered by an adhesive configured to adhere the planar surface to the patient's skin.In this way, attachment of the fixator wings to the patient's skin is facilitated.

[0040] Preferably, the system includes a repositioning unit having a proximal end, a distal end, and a repositioning lumen extending from the proximal end to the distal end of the repositioning unit, the repositioning lumen being configured to insert the medical device therethrough. The repositioning unit includes at least one button or lever accessible from the outside of the repositioning unit, preferably projecting to or extending through the circumferential outer surface of the repositioning unit. The button or lever is configured to hold the medical device in its longitudinal position relative to the repositioning lumen in a first state, and to release the medical device upon actuation of the button or lever in a second state, allowing movement of the medical device inside the repositioning lumen. Such a repositioning unit allows for releasable fixation of the medical device, i.e., the surgeon is able to fix and release the medical device as needed.

[0041] Preferably, the fixator central body portion has a proximal end, a distal end, and a fixator lumen extending from the proximal end to the distal end of the central body portion, the fixator lumen configured for insertion of a medical device therethrough such that the medical device can be guided and held inside the fixator lumen while the fixator is attached to the patient's skin.

[0042] More preferably, a tubular extension having an extension lumen is attached to the central body of the fixator at the distal end thereof, preferably integrally formed therewith, and configured for inserting a medical device through the tubular extension, whereby the medical device can be guided and held inside the extension lumen when the fixator is attached to the patient's skin.

[0043] In particular, the repositioning unit can be attached to the proximal end of the central body portion, where the extension lumen, the fixator lumen, and the repositioning lumen are coaxially aligned and preferably have the same diameter, which facilitates insertion of a medical device through said lumens.

[0044] Preferably, the system further includes a medical device insertable through the extension lumen, the fixator lumen, and the repositioning lumen, and the tubular extension, the fixator, and the repositioning unit are slidable over the medical device when a button or lever on the repositioning unit is actuated, whereby the repositioning unit together with the tubular extension and the fixator can be advanced or retracted to the intended anchoring location.

[0045] In a preferred embodiment, the central body of the fixator forms an arched (i.e., convex) bridge that allows the medical device to pass between the central body of the fixator and the patient's skin. In other words, the medical device can pass under the bridge while the fixator is applied to the patient's skin. The central body of the fixator thereby holds the medical device against the patient's skin, while the fixator wings attach the fixator to the patient's skin.

[0046] More preferably, the system can include an anchoring graft configured to be implanted under the patient's skin and through which the medical device is inserted. The anchoring graft preferably includes velour on its outer surface, the velour configured for the skin (or tissue under the skin) to grow into. In this way, another part of the system (i.e., the anchoring graft) can be fixed under the skin in addition to the surgical guide tube, which is fixed under the patient's skin by the lateral extension, thereby providing an additional means for fixing, sealing and guiding the medical device on the patient's body.

[0047] In a preferred embodiment, a tubular extension having an extension lumen is attached to, and preferably formed integrally with, the surgical guide tube at the proximal end of the surgical guide tube and configured for insertion of a medical device therethrough, whereby the medical device can be guided and held inside the extension lumen.

[0048] Preferably, the system includes a connecting part, the connecting part having a connecting lumen configured to insert the medical device therethrough, the connecting part connecting the proximal end of the tubular extension and the distal end of the repositioning unit, the connecting part having a section with a reduced outer diameter, the section being positioned between the repositioning unit and the tubular extension, such that a waist part is formed between the repositioning unit and the tubular extension. The waist part facilitates attachment of the connecting part to the skin of the patient, thereby also fixing the repositioning unit and the tubular extension to the skin of the patient. In particular, the central body part of the fixator can form an arched (i.e. convex) bridge, such that only the waist part can pass between the central body part and the skin of the patient. In other words, the waist part can pass under the bridge when the fixator is applied to the skin of the patient. There, the waist portion has a proximal end and a distal end, and the waist portion is movable under the bridge along a predetermined direction (which is the direction of the longitudinal length of the connecting lumen) with the movement of the waist portion being stopped at the distal end and the proximal end of the waist portion, respectively, thereby attaching the waist portion to the patient's skin while at the same time providing a range of movement for the connecting portion (within which the connecting portion can be pushed back and forth).

[0049] Preferably, the extension lumen, the connecting lumen, and the repositioning lumen are coaxially aligned and, more preferably, have the same diameter, which facilitates insertion of a medical device therethrough.

[0050] According to a fourth aspect of the present disclosure, a clamping unit is provided and configured for securing a medical device (especially a catheter of an intravascular blood pump) to a patient's body. The clamping unit has a tubular body with a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The lumen is configured for inserting the medical device therethrough (i.e., through the clamping unit). The tubular body includes a surgical guide tube portion at its distal end configured for insertion into a vascular graft, and the tubular body includes a lateral extension defining a planar surface configured for attachment to a patient's fascia between the patient's internal vessel (preferably a blood vessel, more preferably at least one of the axillary artery and the subclavian artery) and the patient's skin. The fascia preferably surrounds or extends adjacent to the blood vessel. The lateral extension of the tubular body is provided proximal to the surgical guide tube portion. The tubular body further includes a handling portion provided proximal to the lateral extension and a rotatable tube configured to insert a medical device therethrough. The rotatable tube is provided inside the lumen of the tubular body and is operably connected to a first lever or a first button accessible from outside the handling portion. The first lever or the first button preferably projects to or extends through an outer surface of the handling portion such that actuation of the first lever or the first button causes rotation of the rotatable tube about its longitudinal axis in a non-twisting manner.Furthermore, the tubular body includes a flexible tubular foil portion configured to insert a medical device therethrough, the tubular foil portion being provided inside the lumen of the tubular body and being fixed to the rotatable tube at its proximal connection portion, such that the tubular foil portion and the rotatable tube are fixed to each other in a non-rotatable manner at the proximal connection portion of the foil portion. Furthermore, the foil portion is fixed to the lumen of the tubular body (more specifically, to the inner wall of the tubular body) at its distal connection portion, such that the foil portion and the tubular body are fixed to each other in a non-rotatable manner at the distal connection portion of the foil portion, such that the foil portion twists about its longitudinal axis when the rotatable tube is rotated in a first direction and untwists when the rotatable tube is rotated in a second direction opposite to the first direction after the rotatable tube is rotated in the first direction. Upon twisting of the foil portion, the inner diameter of the foil portion decreases, and upon untwisting, the inner diameter increases, returning to its original size. The clamping unit thus allows for releasable fixation of a medical device inserted through the lumen of the tubular body portion, i.e., the surgeon can fix and release the medical device as needed.

[0051] More specifically, the handling part may further include a second button or second lever, accessible from the outside of the handling part and preferably projecting to or extending through the circumferential outer surface of the handling part. The second button or second lever is configured to hold the medical device in its longitudinal position relative to the lumen of the tubular body of the clamping unit in a first state, and to release the medical device upon actuation of the second button or second lever, releasing the movement (longitudinal and rotational) of the medical device relative to the lumen of the tubular body of the clamping unit. For example, a torsion spring may additionally be provided in the handling part, and the second button or second lever is biased to the first state by the torsion spring. Thereby, the foil portion can be configured to secure the medical device unless the second button or lever is actively actuated, for example by a surgeon, into the second state against the spring force.

[0052] Furthermore, the handling portion may include a section having a reduced outer diameter along its length to form a waist portion, and the first button or first lever is preferably provided within the waist portion and, more preferably, does not extend radially beyond a portion of the handling portion adjacent the waist portion, thereby avoiding unintentional actuation of the first button or first lever.

[0053] Preferably, the clamping unit further comprises a fixator, the fixator being configured for attachment to the patient's skin and configured to hold the clamping unit on or against the patient's body. The fixator has a central body portion and two fixator wings extending in opposite directions from the central body portion. Each fixator wing has a planar surface, which faces a common direction. The central body portion of the fixator forms an arched (i.e. convex) bridge such that only a waist portion of the handling portion of the tubular body portion of the clamping unit passes between the central body portion of the fixator and the patient's skin. In other words, only the waist portion can pass under the bridge when the fixator is applied to the patient's skin. There, the waist portion has a proximal end and a distal end, and the tubular body of the handling portion of the clamping unit is capable of moving along a longitudinal direction (which corresponds to the longitudinal axis of the lumen of the tubular body portion) under the bridge (until such movement is stopped at the distal and proximal ends of the waist portion, respectively), thereby providing a range of movement for the handling portion of the clamping unit (within which the handling portion can be pushed back and forth) while at the same time being attached to the patient's skin.

[0054] Further preferably, the surgical guide tube portion, the lateral extension, and the fixator of the clamping unit may each include any one of the features of the surgical guide tube, the lateral extension, and the fixator of the system described above with reference to the third aspect of the present disclosure.

[0055] According to a fifth aspect of the present disclosure, there is provided a method of providing vascular access to a patient's body vessel, preferably to a blood vessel, more preferably to at least one of the axillary and subclavian arteries, comprising the steps of providing a surgical guide tube, the surgical guide tube including a tubular (particularly linear) body having a proximal end, a distal end, and a guide lumen having a longitudinal axis, the guide lumen extending from the proximal end to the distal end of the body and configured for inserting a medical device (particularly a catheter of an intravascular blood pump) therethrough, and the further step of anchoring the surgical guide tube to the patient's fascia between the blood vessel and the patient's skin, the fascia preferably surrounding or extending adjacent to the blood vessel.

[0056] The method allows the surgical guide tube to be anchored under the patient's skin such that movement of the patient's shoulder (which can induce skin movement in the shoulder area) poses less risk of dislocating the surgical guide tube.

[0057] Preferably, the surgical guide tube further includes a lateral extension, the lateral extension extending laterally from the body portion and defining a planar surface, and the method further includes attaching the planar surface of the lateral extension to the patient's fascia, preferably by suturing, clamping, or adhering the lateral extension to the fascia. This provides an easy attachment option, where the planar surface attached to the fascia can be the proximal or front planar surface of the lateral extension. Alternatively or additionally, the planar surface attached to the fascia can be the distal or back planar surface of the lateral extension.

[0058] More preferably, the surgical guide tube may include any one of the features of the surgical guide tube of the system described above with reference to the third aspect of the present disclosure.

[0059] In a preferred embodiment, the method further includes, among other things, the step of securing the distal end of the vascular graft to the patient's blood vessel (e.g., by anastomosis) prior to securing the surgical guide tube to the fascia. The vascular graft can be made of Teflon or Dacron. It can have a graft lumen extending from the proximal end to the distal end of the vascular graft, the graft lumen configured to receive the distal section of the surgical guide tube within the proximal end of the vascular graft. The vascular graft thereby provides access to the blood vessel into which a medical device is to be inserted.

[0060] In particular, the method may further include the step of introducing an intravascular blood pump including a catheter at its proximal end into and through the vascular graft and, preferably, further into the patient's blood vessel after the vascular graft is secured to the vessel. Preferably, the method may further include the step of advancing the intravascular pump to its intended final location, which may be the left ventricle of the patient's heart. More preferably, the surgical guide tube may be slidably mounted on the outer surface of the catheter, and the method may further include the step of sliding the surgical guide tube over the outer surface of the catheter such that a distal section of the surgical guide tube enters the graft lumen of the vascular graft, which step is preferably performed before securing the surgical guide tube to the fascia. Therein, the inner diameter of the graft lumen can be between 1 and about 1.2 times the outer diameter of the surgical guide tube, and preferably about 1.1 times, which facilitates insertion of the surgical guide tube into the vascular graft and sealing of the vascular graft to the surgical guide tube, as will be described later.

[0061] Preferably, the method may further include the step of fixing the vascular graft to the outer surface of the surgical guide tube after the surgical guide tube is inserted into the graft lumen of the vascular graft. Preferably, the fixation is achieved by clamping or suturing the vascular graft to the outer surface of the surgical guide tube, preferably before fixing the surgical guide tube to the fascia. Thereby, the vascular graft can be fixed to and simultaneously sealed against the surgical guide tube.

[0062] For this purpose, the surgical guide tube may further include a separate clamping part having a proximal end, a distal end and a clamping lumen extending from the proximal end to the distal end of the clamping part, the lateral extensions being attached to the clamping part in a non-removable manner, preferably being integrally formed with the clamping part, the clamping part being configured to clamp onto or around the body of the surgical guide tube, where the method may further include the step of fixing the vascular graft to the body of the surgical guide tube by clamping the clamping part onto the vascular graft inserted therein. This has the further advantage that the lateral extensions can be more individually positioned.

[0063] There, the clamping part can reduce the diameter of the guide lumen (i.e., narrow the cross section of the guide lumen) when the surgical guide tube is clamped onto the vascular graft into which it is inserted. In particular, the clamping part can be clamped onto the vascular graft at a predetermined position of the surgical guide tube between two adjacent bumps that can be provided on the surgical guide tube, between a proximal bulge and a bump located closest to the proximal bulge, or between a distal bulge and a bump located closest to the distal bulge, thereby fixing the medical device inside the guide lumen of the surgical guide tube and preventing longitudinal movement of the medical device inside the guide lumen.

[0064] Alternatively or additionally, the method may further comprise the step of fixing the vascular graft to the body of the surgical guide tube (which has been previously inserted into the graft) by applying at least one of at least one suture and at least one fixation clamp onto the graft into which the surgical guide tube has been inserted. In particular, the vascular graft may be fixed to the body of the surgical guide tube at a longitudinal position of the surgical guide tube between two adjacent bumps provided on the surgical guide tube, between a proximal bulge and a bump located closest to the proximal bulge, or between a distal bulge and a bump located closest to the distal bulge, where the suture or fixation clamp may reduce the diameter of the graft lumen (i.e., narrow the cross-section of the graft lumen) when the surgical guide tube is applied onto the graft into which the surgical guide tube has been inserted. In particular, the diameter of the graft lumen can be narrowed to a reduced diameter that is smaller than the outer diameter of two neighboring bumps provided on the surgical guide tube, the outer diameter of the proximal bulge and the bump located closest to the proximal bulge, or the outer diameter of the distal bulge and the bump located closest to the distal bulge, thereby reducing (preferably preventing) the risk of longitudinal movement of the surgical guide tube inside the graft lumen.

[0065] Preferably, the fixation clamp is capable of reducing the diameter of the guide lumen (i.e. narrowing the cross section of the guide lumen) when the surgical guide tube is clamped onto the vascular graft into which it is inserted. Preferably, the fixation clamp is located at a longitudinal position of the surgical guide tube between two adjacent bumps provided on the surgical guide tube, between a proximal bulge and a bump located closest to the proximal bulge, or between a distal bulge and a bump located closest to the distal bulge, thereby fixing the medical device inside the guide lumen of the surgical guide tube and preventing longitudinal movement of the medical device inside the guide lumen.

[0066] In a preferred embodiment, the method can include a step of fixing the fixator to the patient's skin so that the medical device is held on or against the patient's body. The fixator has a central body portion and two fixator wings extending in opposite directions from the central body portion, each fixator wing having a planar surface, the planar surfaces facing a common direction. This provides additional fixation of the medical device to the patient's body. Therein, each of the two fixator wings can include at least one opening, preferably two or more openings, and the method can include a step of inserting a suture or clamp through said opening so that the fixator wings are attached (i.e., sutured or clamped) to the patient's skin. Alternatively or additionally, the planar surfaces of the fixator wings can be at least partially or completely covered by an adhesive, and the method can further include a step of adhering the planar surfaces to the patient's skin.

[0067] More preferably, the fixator central body portion may have a proximal end, a distal end, and a fixator lumen extending from the proximal end to the distal end of the central body portion, and the method may further include inserting the medical device into and through the fixator lumen. Preferably, the fixator central body portion is slidably mounted over the medical device.

[0068] Preferably, a tubular extension having an extension lumen is attached to the distal end of the fixator central body portion, preferably integrally formed therewith, and the method may further include the step of inserting a medical device into and through the extension lumen. Preferably, the tubular extension is slidably mounted over the medical device.

[0069] In particular, a repositioning unit may be provided having a proximal end, a distal end, and a repositioning lumen extending from the proximal end to the distal end of the repositioning unit, and the method may further include inserting the medical device into and through the repositioning lumen. The repositioning unit may further include at least one button or lever, accessible from the outside of the repositioning unit, and preferably projecting to or extending through the circumferential outer surface of the repositioning unit. The method may further include using a button or lever to hold the medical device in its longitudinal position relative to the repositioning lumen in a first state and to release the medical device upon actuation of the button or lever in a second state, allowing movement of the medical device relative to the repositioning lumen. Preferably, the repositioning unit is attached to the proximal end of the fixator central body portion.

[0070] In a preferred embodiment, the method may further include attaching the fixator to a predetermined location on the outer surface of the patient's skin such that the section of the medical device (which extends from the fixator to the surgical guide tube) may be placed in a C-curve on the patient's skin. This arrangement provides the advantage that movements of the patient's skin (especially in the shoulder area) may be absorbed by the C-curve (i.e., the C-curve section of the medical device may be compressed or stretched). Thus, pulling or pushing forces on the anastomosis, the intravascular blood pump, or both may be prevented.

[0071] More preferably, the central body of the fixator can form an arched (i.e., convex) bridge, and the method can further include applying the fixator over the medical device and over the outer surface of the patient's skin such that the medical device passes between the central body of the fixator and the patient's skin (i.e., under the bridge), which provides further anchoring of the medical device to the patient's body.

[0072] Preferably, the medical device is inserted into and through the anchoring graft, which may include velour (e.g., Dacron, etc.) on its outer surface, the velour configured for skin or tissue to grow into, and the method may include implanting the anchoring graft under the patient's skin such that a section of the medical device between the surgical guide tube and the fixator extends under and along the skin, and such that tissue may grow into the velour. In this manner, further anchoring under the patient's skin may be achieved by the velour in addition to the surgical guide tube being secured to the fascia under the patient's skin, thereby providing a further means for securing the medical device to the patient's body.

[0073] In a preferred embodiment, a tubular extension having an extension lumen can be attached to, and preferably integrally formed with, the surgical guide tube at a proximal end of the surgical guide tube, and the method can include inserting a medical device into and through the extension lumen, the medical device being additionally held and guided by the tubular extension of the surgical guide tube.

[0074] Furthermore, a connecting portion having a connecting lumen can connect the proximal end of the tubular extension with the distal end of the repositioning unit described above, and the medical device can be inserted into and through the connecting lumen, where the connecting portion can have a section with a reduced outer diameter along its length, said section being positioned between the repositioning unit and the tubular extension, so as to form a waist portion between the repositioning unit and the tubular extension, where the central body portion of the fixator can form an arched (i.e., convex) bridge, and the method can include applying the fixator over the connecting portion and onto the patient's skin such that only the waist portion of the connecting portion passes between the arched bridge of the central body portion of the fixator and the outer surface of the patient's skin (i.e., the waist portion of the connecting portion passes under the bridge). Preferably, the waist portion has a proximal end and a distal end, the waist portion is movable under the bridge along a predetermined direction, the predetermined direction being in the direction of the longitudinal length of the connecting lumen, and the movement of the waist portion is stopped at the distal end and the proximal end of the waist portion, respectively, so that the waist portion is attached to the patient's skin while at the same time providing a range of movement for the connecting portion within which the connecting portion can be pushed back and forth.

[0075] In a preferred embodiment, the surgical guide tube including the lateral extension is part of the clamping unit as described above with reference to the fourth aspect of the present disclosure, where the central body of the fixator can form an arched (i.e., convex) bridge, and the method can include applying the fixator onto the patient's skin over the waist portion of the clamping unit such that only the waist portion passes between the central body of the fixator and the outer surface of the patient's skin (i.e., the waist portion passes under the bridge). Preferably, the waist portion has a proximal end and a distal end, and the waist portion can move under the bridge along a predetermined direction, the predetermined direction being in the direction of the longitudinal length of the lumen of the clamping unit, and the movement of the waist portion is stopped at the distal end and at the proximal end of the waist portion, respectively. Thereby, the waist portion is attached to the patient's skin while at the same time providing a range of movement for the handling portion of the clamping unit (within which the handling portion of the clamping unit can be pushed back and forth).

[0076] 1 is an exemplary method of providing vascular access to a patient's body vessel, particularly to a blood vessel, preferably to at least one of the axillary artery and the subclavian artery, inserting an intravascular blood pump including a catheter at its proximal end into the patient's vasculature and attaching the catheter to the patient's body, the method comprising: - suturing the vascular graft to the patient's blood vessel by performing an anastomosis, thereby providing vascular access to the blood vessel; - introducing an intravascular blood pump into and through the vascular graft into a blood vessel and advancing the intravascular blood pump to its intended location inside the patient's body, i.e., across the aortic valve in the left ventricle of the patient's heart; - sliding a surgical guide tube slidably mounted on an outer surface of the catheter along the catheter and into the surgical graft; - fixing the surgical graft to the surgical guide tube inserted therein, for example by sutures or by clamps; - fixing a lateral extension of the surgical guide tube to the patient's deep fascia between the blood vessel and the patient's skin, in particular to the deep fascia extending in the vicinity of the blood vessel; - fixing the catheter directly or indirectly to an outer surface of the patient's skin; Includes.

[0077] In the exemplary method, any of the above-described embodiments of the surgical guide tube, kit, system, and clamping unit can be applied.

[0078] A different method of stabilizing a catheter-based medical device in a patient's blood vessel according to the present disclosure does not require the use of a surgical guide tube. According to this method, the patient's skin is opened to gain access to the vessel, a graft is connected to the vessel by an anastomosis, the medical device is inserted into the vessel through the graft, and the catheter extends through the graft and out of the patient. The graft is then twisted to reduce its inner diameter, thereby clamping the catheter inside the graft. This can be further improved by additional measures, as described below, to prevent twisting forces from being transmitted to the anastomosis.

[0079] Once the graft is twisted, it can be kept in the twisted state, such that it cannot be untwisted. This can be done by temporarily clamping the proximal part of the twisted graft to the catheter using a clamp acting on the graft from outside the graft. Then, or without an additional clamping step, the twisted graft can be sutured to keep it always in the twisted state, i.e., the twisted graft is sutured to itself to preserve the twisted structure. In addition, the twisted graft can be shortened to the desired length, either before suturing it or, preferably, after suturing it.

[0080] The step of connecting the graft to the blood vessel by an anastomosis may include suturing the graft to the blood vessel, thereby creating a seam between the graft and the blood vessel, the seam preferably being reinforced with glue.

[0081] As stated, the medical device can be an intravascular blood pump. In such a case, introducing the medical device into the blood vessel includes advancing the intravascular blood pump into the patient's blood vessel (e.g., the axillary or subclavian artery) until a pumping device of the intravascular blood pump reaches into the patient's heart.

[0082] Preferably, the medical device includes a plug that is slidable along the catheter. When the medical device is placed at the target location inside the patient, the slidable plug is placed on the catheter inside the graft so that it is in close proximity to the blood vessel. One purpose of the plug is to seal the graft against the catheter to provide hemostasis. Due to the plug being slidable on the catheter, it can be placed loosely on the catheter so that the plug slides back on the catheter when the medical device is introduced through the graft into the blood vessel towards its final position. The slidable plug preferably has a closed configuration. The closed configuration can be a closed cylindrical configuration, preferably the outer configuration of the slidable plug corresponds to a cylinder, thereby stabilizing the position of the plug inside the graft. Furthermore, the slidable plug can have a through hole, through which the catheter extends, said through hole having a hexagonal shape in cross section, preferably having the shape of a hexagonal prism. The hexagonal shape can help to reduce friction while the plug slides along the catheter. The slidable plug can be made from silicone rubber. The slidable plug can have a strength of 50 Shore A.

[0083] Preferably, prior to placing the plug inside the graft, a slotted shim is placed around the graft at a location distal to where the slidable plug is intended to be placed inside the graft. The slotted shim is inelastic and includes a central through-hole, with slots extending radially outward from the central through-hole to form radial openings in the shim. With a catheter inserted therein, the graft can be threaded through the slots into the central through-hole of the shim to place the shim around the graft. The inner diameter of the central through-hole is smaller than the outer diameter of the slidable plug, such that the plug cannot be pushed past the shim into the vessel and abuts against the shim when pushed distally. The slotted shim can further include eyelets located on its radially outer periphery. The eyelets serve as fixation means for fixing the shim to the patient's fascia (e.g., by suturing). The slotted shim can be easily grasped and held by the surgeon as the graft is being twisted. During the twisting movement, the shim and plug act as a twisting stop so that the torsional forces generated by the twisting do not reach the anastomosis and therefore cannot adversely affect the anastomotic joint. In other words, the step of twisting the graft to reduce its inner diameter preferably includes holding a slotted shim, thereby facilitating the twisting step. The shim is preferably made of polyetheretherketone (PEEK).

[0084] Preferably, just before the twisting step, the position of the medical device inside the patient's body is corrected or finalized. This is beneficial because sliding the plug inside the graft to its intended position may lead to an undesired displacement of the medical device, so that after the plug is properly placed, the position of the medical device requires a small correction. Due to the clamping force generated by the twisted graft, when the graft is properly fixed to the catheter, the medical device can no longer move forward or backward inside the vessel. Thus, the twisted graft can finally be pushed into the patient's body with the catheter extending out of the patient's body through the twisted graft, and then the open skin can be closed around the catheter.

[0085] To prevent tissue ingrowth into the graft, a sleeve (e.g., a tubular part made of polytetrafluoroethylene (PTFE)) can be provided around the twisted graft, i.e., the graft is usually made of Dacron® or a similar material, and it must be ensured that the graft can be untwisted without effort when the medical device is to be removed from the vessel. Tissue ingrowth into the graft would prevent untwisting.

[0086] According to another aspect of the present disclosure, a kit for stabilizing a medical device including a catheter is provided. The kit includes a vascular graft, through which the medical device can be introduced and through which the catheter can extend. The graft can be twistable to reduce its inner diameter to clamp the catheter inside the graft. The kit further includes a plug, configured to be slidable along the catheter, which can be inserted into the graft, preferably with the plug placed on the catheter. The graft can be sutured to itself, especially in its twisted state. Preferably, the graft is a knitted, warp knitted, knotted, woven, or nonwoven fabric, which facilitates suturing the graft.

[0087] The plug can have a closed configuration, preferably a closed cylindrical configuration. For example, the outer configuration of the slidable plug corresponds to a cylinder. Furthermore, the plug can have a through hole, through which the catheter can extend. Such a through hole preferably has a hexagonal shape in cross section, in particular in the form of a hexagonal prism. The plug can be made of silicone rubber and can have a strength of 50 Shore A.

[0088] In particular, the kit further includes a slotted shim configured to be placed around the graft with the catheter inserted therein, the slotted shim can be made from PEEK. The slotted shim is preferably inelastic. The slotted shim preferably includes radially extending slots through which the graft can be threaded toward the center of the shim with the catheter extending through the graft. Additionally, the shim can be provided with eyelets by which the shim can be secured to the patient's fascia.

[0089] Preferably, the inner diameter of the slotted shim is smaller than the outer diameter of the plug, such that the plug cannot pass through the shim, and preferably, the inner diameter of the slotted shim is larger than the outer diameter of the medical device, such that the medical device can be passed through the shim.

[0090] The kit may further include an intravascular blood pump as a medical device. Additionally, the kit may include a clamp configured to clamp the proximal part of the twisted graft to the catheter.

[0091] Although the above disclosure is described in the context of a blood pump positioned in the heart (particularly the left ventricle), other applications are possible and are not excluded from the scope of the present disclosure. For example, the entire disclosure can be applied to stabilizing the position of a blood pump for right side support (right ventricle) or other parts of the vasculature (e.g., near the kidney in cases where the blood pump is positioned to drive renal perfusion). Furthermore, the entire disclosure (at least its aspects) can be applied to any type of catheter-based device other than a blood pump (which may need to be positioned at a specific location in the vasculature). Moreover, although it is described that a medical device can be introduced into the aorta via the subclavian or axillary arteries, the present disclosure is not limited to access via the subclavian or axillary arteries. It is also within the present disclosure to provide access for a medical device directly via the aorta or to provide suprasternal access. Furthermore, the femoral vessels can be accessed as well. The entire disclosure can also be applied in pediatrics. [Brief description of the drawings]

[0092] The present disclosure will hereinafter be described by way of example only with reference to the accompanying drawings, in which: [Figure 1] 1 is a side view of a surgical guide tube and a vascular graft according to a first embodiment of the present disclosure attached to a patient's body. [Diagram 2] 2(a) to (d) are diagrams showing different embodiments of the fixing clamp. [Diagram 3] FIG. 13 is a perspective view of a surgical guide tube according to a second embodiment of the present disclosure. [Figure 4] FIG. [Diagram 5] 1 is a side view of a surgical guide tube and a vascular graft according to a second embodiment of the present disclosure attached to a patient's body. [Figure 6]FIG. 1 is a plan view of a system for fastening a medical device to a patient's body according to a first embodiment of the present disclosure. [Figure 7] FIG. 13 is a plan view of a system for fastening a medical device to a patient's body according to a second embodiment of the present disclosure. [Figure 8] FIG. 2 is a cross-sectional view of a system according to a second embodiment of the present disclosure. [Figure 9] FIG. 13 is a plan view of a system for fastening a medical device to a patient's body according to a third embodiment of the present disclosure, attached to the patient's body. [Figure 10] FIG. 10 is an enlarged side view of section X in FIG. [Figure 11] FIG. 2 is a partial cross-sectional plan view of a clamping unit in a first state. [Figure 12] 12 is a partial cross-sectional plan view of the clamping unit of FIG. 11 in a second state. [Figure 13] FIG. 1 shows a vascular graft twisted over a catheter. [Figure 14A] FIG. 2 is a plan view of a resilient open ring. [Figure 14B] 14B is a cross-sectional view of the elastic open ring of FIG. 14A taken along line XIV. [Figure 15A] A three-dimensional view of the plug. [Figure 15B] FIG. 15B is a cross-sectional view of the plug of FIG. 15A.

[0093] The drawings are not to scale and are not to be construed as limiting the disclosure in any way. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0094] 1 shows a side view of a surgical guide tube 1 according to a first embodiment of the surgical guide tube. The surgical guide tube 1 includes a tubular body 2 having a proximal end 4, a distal end 6, and a guide lumen extending from the proximal end 4 to the distal end 6, the guide lumen having a longitudinal axis 8. The surgical guide tube 1 includes a lateral extension 10 extending laterally from the tubular body 2 and defining planar surfaces 12a, 12b, where planar surface 12a is a proximal or front planar surface and planar surface 12b is a distal or back planar surface. The lateral extension 10 forms a wing extending radially relative to the longitudinal axis 8 of the guide lumen. Further wings forming further lateral extensions (not shown in FIG. 1) are provided on the tubular body 2 radially opposite to the lateral extension 10 shown in FIG. 1. The two wings thus extend in opposite radial directions. The planar surfaces 12a, 12b of the lateral extension 10 are parallel to each other and inclined by an inclination angle of about 45° with respect to the longitudinal axis 8 of the guide lumen. Each planar surface 12a, 12b includes an axis which extends perpendicularly through the longitudinal axis 8 of the guide lumen and serves as a virtual axis of rotation A about which the planar surfaces 12a, 12b are rotated to said inclination angle.

[0095] The lateral extension 10 (as well as the radially opposite lateral extension of the tubular body 2) is integrally formed with the tubular body 2 and is located at the proximal end 4 of the tubular body 2. The lateral extension 10 (as well as the radially opposite lateral extension of the tubular body 2) includes an opening 14 having a D-shaped transverse cross-section and has a longitudinal axis extending substantially perpendicular to the planar surface 12a, as shown, for example, in the embodiment of FIG.

[0096] Distal to the lateral extension 10, a circumferential bump 16 is provided on the tubular body 2. The circumferential bump 16 extends radially from the tubular body 2 and has a cross section in the shape of a circular ring. The cross-sectional plane of the circumferential bump 16 extends perpendicular to the longitudinal axis 8 of the guide lumen. The distal end 6 of the tubular body 2 is provided with a distal bulge 18, which surrounds the tubular body 2 and has a cross section in the shape of a circular ring. The periphery of the distal end 6 of the surgical guide tube 1 (i.e. the distal end of the distal bulge 18) lies in a plane that is inclined by about 45° to the longitudinal axis 8 of the guide lumen. This plane is inclined in the same direction and by the same inclination angle as the planar surfaces 12a, 12b, i.e. said plane and the planar surfaces 12a, 12b are parallel to each other. The tubular body 2 has a constant inner diameter, i.e. its guide lumen has a constant diameter.

[0097] The arrangement is shown with the distal end portion of the surgical guide tube 1 inserted into the vascular graft 20. Specifically, the surgical guide tube 1 is inserted into the graft 20 up to and including the circumferential bump 16. At the distal end 22 of the graft 20, the graft 20 is attached (e.g., by anastomosis) to the patient's blood vessel 24. The graft 20 thereby provides access to the blood vessel 24, which may be, for example, a vessel such as the axillary or subclavian artery. With the surgical guide tube 1 inserted into the graft 20, the circumferential bump 16 and distal bulge 18 provide a light seal to reduce, and ideally prevent, blood loss through the gap between the tubular body portion 2 and the inner wall of the graft 20. The inner wall of the graft 20 is then completely sealed to the tubular body 2, i.e., the gap between the inner wall of the graft 20 and the tubular body 2 is completely closed by the two sutures 28 that secure the graft 20 to the surgical guide tube 1. Alternatively, the inner wall of the graft 20 can be completely sealed to the tubular body 2 by more or fewer sutures or by a fixation clamp, which will be described later.

[0098] The lateral extension 10 is fixed on the deep fascia 26 of the patient, which extends between the access vessel 24 and the patient's skin (not shown). Preferably, the deep fascia is chosen as a fixation point lying near the accessed vessel 24. For this purpose, the lateral extension 10 is sutured to the deep fascia 26 with the distal planar surface 12b in contact with the deep fascia 26 by means of sutures 29, which pass through the opening 14, through or around the deep fascia 26 and further around the lateral extension 10. Alternatively, the lateral extension 10 can be clamped or glued to the deep fascia 26. In the same manner, it is equally possible to fix the fascia 26 to the lateral extension 10 with the proximal planar surface 12a in contact with the deep fascia 26.

[0099] Through the guide lumen, a catheter 30 (e.g., a catheter attached to the proximal end of an intravascular blood pump (not shown)) is inserted into the accessed blood vessel 24. The surgical guide tube 1 is slidable over the catheter 30, i.e., the catheter 30 and the surgical guide tube 1 are able to move longitudinally relative to each other. After the surgical guide tube 1 is secured to the vascular graft 20 by the sutures 28, the catheter 30 is still able to move longitudinally back and forth inside the guide lumen of the surgical guide tube 1. This allows for a later exchange of the intravascular blood pump.

[0100] Instead of the sutures 28, the graft 20 can be fixed to the surgical guide tube 1 by a fixation clamp 32 as shown by the embodiments (a) to (d) depicted in FIG. 2, where embodiment (a) is a fixation clamp in the form of a cable tie, embodiment (b) is a clip or a spring, embodiment (c) is a fixation clamp with a flap lock, and embodiment (d) is a tubing clip. When the surgical guide tube 1 is inserted into the vascular graft 20 with the catheter 30 inserted through the guide lumen of the surgical guide tube 1, the fixation clamp 32 is clamped onto the graft 20, which reduces the diameter of the guide lumen so that the catheter 30 is fixed inside the guide lumen. This means that the fixation clamp 32 clamped onto the vascular graft 20 prevents the catheter 30 from moving longitudinally inside the surgical guide tube 1. The relative longitudinal movement of the surgical guide tube 1 and the vascular graft 20 is likewise prevented by the fixation clamp 32. Thus, the catheter 30 can be held fixedly in the intended position and dislocation of the intravascular blood pump is avoided.

[0101] 3 shows a perspective view of a second embodiment of the surgical guide tube 1. The surgical guide tube 1 of the second embodiment differs from the surgical guide tube 1 of the first embodiment in the following features: The lateral extension 10 is provided on a separate clamping part 34, which can be clamped onto the tubular body 2 of the surgical guide tube 1. The clamping part 34 includes a proximal end 36, a distal end 38 and a clamping lumen extending from the proximal end 36 to the distal end 38. The lateral extension 10 is integrally formed with the clamping part 34.

[0102] The planar surfaces 12a, 12b of the lateral extension 10 are inclined at an inclination angle of about 45° to the longitudinal axis of the clamping lumen. When the clamping part 34 is clamped onto the tubular body 2, the planar surfaces 12a, 12b are also inclined at an inclination angle of about 45° to the longitudinal axis of the guide lumen, i.e. the longitudinal axis of the clamping lumen and the longitudinal axis of the guide lumen 8 are parallel and can even coincide when the clamping part 34 is clamped onto the surgical guide tube 1.

[0103] The proximal bulge 40 surrounds the tubular body 2 and forms the proximal end of the surgical guide tube 2. The proximal bulge 40 has a cross section in the shape of a circular ring. Distal to the proximal bulge 40, two circumferential bumps 16 and a distal bulge 18 are provided. The proximal bulge 40, the circumferential bump 16 and the distal bulge 18 are aligned parallel to each other, and the circumferential bumps 16 and the distal bulge 18 have the same outer diameter, which is larger than the outer diameter of the proximal bulge 40.

[0104] The proximal bulge 40, the circumferential bump 16 and the distal bulge 18 are positioned along the longitudinal axis 8 of the guide lumen at a mutual distance greater than the distance from the proximal end 36 of the clamping part 34 to the distal end 38 of the clamping part 34. Thereby, the clamping position of the clamping part 34 on the tubular body 2 is variable. To be precise, the clamping part 34 can be clamped on the tubular body 2 between neighboring bumps or between a bump of the tubular body 2 and a neighboring bulge, i.e. between the proximal bulge 40 and the nearest circumferential bump 16, between two circumferential bumps 16 or between the distal bulge 18 and the nearest circumferential bump 16.

[0105] FIG. 4 shows a plan view of the clamping part 34. The lateral extension 10 is formed by two wings and includes a D-shaped opening 14, which extends substantially perpendicularly to the planar surfaces 12a, 12b. The clamping part 34 includes two arms 42 extending in opposite circumferential directions. The arms 42 are each provided with an interlocking profile 44 and are arranged such that when the arms 42 are moved towards each other and pass each other in opposite circumferential directions, the cross section of the clamping lumen of the clamping part is narrowed. When moved towards each other and past each other, the arms 42 interlock with each other via the interlocking profile 44. The interlocking profile 44 forms a ratchet mechanism.

[0106] FIG. 5 shows a side view of the surgical guide tube 1 according to the second embodiment in place, where it is inserted into and fixed to the vascular graft 20, which is attached to the accessed blood vessel 24 of the patient. In contrast to the surgical guide tube 1 of the first embodiment, the tubular body 2 of the surgical guide tube 1 of the second embodiment is inserted into the vascular graft 20 up to and including the proximal bulge 40 (i.e. up to and including the proximal end 4 of the tubular body 2 of the surgical guide tube). After the tubular body 2 is inserted into the graft 20, with the catheter 30 inserted into the accessed blood vessel 24 through the guide lumen of the tubular body 2, the clamping part 34 is clamped onto the vascular graft 20 at a position between the proximal bulge 40 and the nearest circumferential bump 16. It is also possible to clamp the clamping part 34 at one of the other clamping positions mentioned above.

[0107] When the tubular body 2 is inserted into the graft 20 with the catheter 30 inserted through the guide lumen and the clamping part 34 is clamped onto the graft 20, the clamping part 34 reduces the diameter of the guide lumen, so that the catheter 30 is fixed inside the guide lumen of the surgical guide tube 1. This means that the longitudinal movement of the catheter 30 inside the tubular body 2 is prevented by the clamping part 34 clamped onto the vascular graft 20. The longitudinal movement of the tubular body 2 inside the vascular graft 20 is also prevented by the clamping part 34. Thus, the catheter 30 can be fixedly held in the intended position and the displacement of the intravascular blood pump can be avoided. The lateral extension 10 can be attached to the deep fascia 26 in the same manner as described above with reference to the surgical guide tube 1 of the first embodiment.

[0108] FIG. 6 shows a plan view of a system for fixing a medical device (e.g., a catheter) in a patient's body according to a first embodiment of the system. The system includes a surgical guide tube 1, which can be the surgical guide tube 1 already described above. However, the surgical guide tube 1 of this system for fixing a medical device can also have a different configuration (e.g., a different number of circumferential bumps 16). In particular, the surgical guide tube 1 of this system for fixing a medical device has a lateral extension 10 with planar surfaces 12a, 12b, which can be inclined by about 45° with respect to the longitudinal axis of the guide lumen. However, this is not a necessary feature of this system for fixing a medical device and can be omitted without departing from the present disclosure. In particular, the planar surfaces 12a, 12b can have a different inclination angle or may not have any inclination at all. Similar to the surgical guide tube 1 described above, the lateral extension 10 is configured to secure the surgical guide tube 1 to the patient's deep fascia (not shown in FIG. 6).

[0109] The system for fixing a medical device includes a fixator 46 with a central body portion 48 and fixator wings 50 extending in opposite directions from the central body portion 48. Each fixator wing 50 has a planar surface, and the planar surfaces of the two fixator wings 50 face a common direction. The fixator wings 50 are configured to fix the fixator 46 to the outer surface of the patient's skin and are configured to hold the catheter 30 against the patient's body. For this purpose, the fixator wings 50 each include two openings 52 through which a suture can be passed to suture the fixator wings 50 to the patient's skin. There can be more or less than two openings 52 provided in the fixator wings 50.

[0110] The system for securing a medical device includes a repositioning unit 54 having a proximal end 56, a distal end 58, and a repositioning lumen extending from the proximal end 56 to the distal end 58. The repositioning unit 54 includes two buttons 60 that are accessible from the exterior of the repositioning unit 54. The two buttons 60 are designed to hold the catheter 30 in its longitudinal position relative to the repositioning lumen 54 in a first state and to release the catheter 30 upon actuation of the buttons 60 in a second state, allowing movement of the catheter 30 relative to the repositioning lumen 54.

[0111] The central body portion 48 of the fixator 46 has a proximal end 62, a distal end 64, and a fixator lumen extending from the proximal end 62 to the distal end 64 of the central body portion 48. A tubular extension 66 having an extension lumen is joined to the central body portion 48 at the distal end 64 of the central body portion 48. The repositioning unit 54 is attached to the proximal end 62 of the central body portion 48.

[0112] In use, the catheter 30 extends through the repositioning lumen, the fixator lumen, the extension lumen and the guide lumen into the accessed blood vessel 24 of the patient, with the catheter 30 penetrating the patient's skin. The vascular graft 20 (not shown in FIG. 6 ), the surgical guide tube 1 and the catheter 30 are secured by the fixation clamp 32 in the manner described above, and the lateral extension 10 is secured above the deep fascia 26 of the patient. It is also possible to apply the above-mentioned second embodiment of the surgical guide tube 1 including a separate clamping part 34, in which the clamping part 34 is used to secure the vascular graft 20, the tubular body 2 and the catheter 30. Thereby, the catheter 30 can be prevented from moving inside the blood vessel 24.

[0113] The tubular extension 66, the fixator 46 and the repositioning unit 54 are positioned proximal to the lateral extension 10, where the tubular extension 66 is positioned at a predetermined distance relative to the lateral extension 10. The tubular extension 66 is placed so that it penetrates the patient's skin to reduce skin irritation. The catheter 30 has a maximum stiffness of about 55D and should be as flexible as possible to reduce force transmission. The tubular extension 66 should have a stiffness of about 60A and should be configured as thin as possible to obtain a small diameter to reduce infection. The catheter 30 can be positioned to form a C-curve between the tubular extension 66 and the lateral extension 10. The C-curve of the catheter 30 can then absorb the movement of the patient's body part to which the fixator 46 is attached (especially the movement of the skin in the shoulder area) and pulling forces on the anastomosis can be prevented.

[0114] FIG. 7 shows a plan view of a system for fixing a medical device to a patient's body according to a second embodiment of the system. The second embodiment of the system for fixing a medical device includes a surgical guide tube 1, which can include any one of the features of the first embodiment of the surgical guide tube 1 described above. However, the surgical guide tube 1 of this second embodiment of the system for fixing a medical device can also have a different configuration, for example a different number of circumferential bumps 16, which in this case is two. In particular, the surgical guide tube 1 of this second embodiment of the system for fixing a medical device has a lateral extension 10 with planar surfaces 12a, 12b, which can be inclined by about 45° with respect to the longitudinal axis of the guide lumen. However, this is not a necessary feature and can be omitted from the system without departing from the present disclosure. The planar surfaces 12a, 12b can also have a different inclination angle or no inclination at all. Similar to the first embodiment of the surgical guide tube 1 described above, the lateral extension 10 is configured to anchor the surgical guide tube 1 to the patient's deep fascia.

[0115] Similar to the first embodiment of the system for fixing a medical device, this second embodiment of the system also includes a fixator 46 with a central body portion 48 and fixator wings 50 extending in opposite directions from the central body portion 48. Each fixator wing 50 has a planar surface, and the planar surfaces of the two fixator wings 48 face a common direction. The fixator wings 50 are configured to fix the central body portion 48 to the outer surface of the patient's skin and are configured to hold the catheter 30 against the patient's body. For this purpose, the planar surfaces of the fixator wings 50 are each covered with an adhesive (such as, for example, a plaster or adhesive tape) to adhere the fixator wings 50 to the patient's skin.

[0116] This second embodiment of the system for fixating a medical device also includes a repositioning unit 54 having a proximal end 56, a distal end 58, and a repositioning lumen extending from the proximal end 56 to the distal end 58. In contrast to the repositioning unit 54 of the first embodiment of the system for fixating a medical device, the repositioning unit 54 of this second embodiment of the system for fixating a medical device includes only one button 60 for holding the catheter 30 in its longitudinal position relative to the repositioning lumen 54 in a first state and for releasing the catheter 30 upon actuation of the button 60 in a second state, allowing movement of the catheter 30 relative to the repositioning lumen 54.

[0117] The surgical guide tube 1 includes a tubular extension 66 provided proximal to the lateral extension 10, both of which are integrally formed with the tubular body portion 2. At its proximal end, the tubular extension 66 includes a sleeve portion 68 having an enlarged diameter compared to the distal end of the tubular extension 66, which is joined to the lateral extension 10. A distal portion 70 of the tubular extension 66, which has a constant diameter corresponding to the diameter at the distal end of the tubular extension 66, merges into a tapered portion 72, which connects the distal portion 70 of the tubular extension 66 with the sleeve portion 68.

[0118] A connecting portion 74 connects the sleeve portion 68 with the repositioning unit 54. The distal end 58 of the repositioning unit 54 and the proximal end of the sleeve portion 68 have substantially the same diameter, but the outermost diameter of the connecting portion 74 is smaller. The connecting portion 74 includes a waist portion 76, the diameter of which is further reduced within the waist portion 76. At the distal end of the waist portion 76 and at the proximal end of the waist portion 76, the waist portion 76 tapers to a central region 78 having a constant diameter, which is the smallest diameter of the waist portion 76.

[0119] The fixator 46 has a central body portion 48 in the form of an arched bridge 80 (or bracket) that connects the two fixator wings 50. The width of the bridge 80 is small compared to the width of the fixator wings 50, and the bridge 80 is adapted to pass over the waist portion 76 so that the waist portion 76 can move longitudinally underneath the bridge 80. The length of the central region 78 corresponds to approximately twice the width of the bridge 80, and the proximal end of the waist portion 76 and the distal end of the waist portion 76 limit the span d of the longitudinal movement of the waist portion 76 underneath the bridge 80 (see FIG. 8).

[0120] As can be seen in the cross-sectional view of FIG. 8, the repositioning unit 54, the connecting part 74 and the tubular extension 66 are connected via a plug connection. For this purpose, the repositioning unit 54 provides a radially outer guide sleeve 82 and a sealing 84, which is positioned inside the guide sleeve 82. The connecting part 74 has a proximal sleeve 86, which is adapted to fit radially between the guide sleeve 82 and the sealing 84 in order to engage the sealing 84 in a non-removable manner. The distal part 88 of the connecting part 74 is provided with a radially outer engagement structure 90 and the sleeve part 68 of the tubular extension 66 is provided with a radially inner engagement structure 92. When the connecting part 74 is inserted into the sleeve part 68, the engagement structures 90, 92 engage in a non-removable manner. A guide tube 94 is provided which is connected with the sealing 84. The guide tube 94 extends through the waist portion 76 and the distal portion 88 of the connecting portion 74 to form a connecting lumen through which a medical device can be inserted. When the connecting portion 74 is inserted into the sleeve portion 68 of the tubular extension 66, the guide tube 94 of the connecting portion 74 abuts distally against the tapered portion 72 of the tubular extension 66, such that the distal end of the guide tube 94 provides a sealing function between the sleeve portion 68 and the distal portion 88 of the connecting portion 74.

[0121] In use, the catheter 30 (not shown in Figs. 7 and 8) extends through the repositioning lumen, the connecting lumen, and the guide lumen into the accessed blood vessel 24 of the patient. The vascular graft 20 (not shown in Figs. 7 and 8) and the surgical guide tube 1 are connected by sutures 28 (not shown in Figs. 7 and 8) in the manner described above (with reference to the first embodiment of the surgical guide tube 1), and the lateral extension 10 is anchored above the deep fascia 26 of the patient. The tubular extension 66 penetrates the skin of the patient. Due to this configuration, the catheter 30 is fixedly positioned by the repositioning unit 54, preventing unintended relocation of the catheter 30 and the intravascular blood pump inside the patient's vasculature, while the pump is still replaceable. Furthermore, movement of the skin in the application area of ​​the fixator wings 50 (e.g., shoulder area) is permitted within the span d of longitudinal movement of the waist portion 76, i.e., pushing or pulling forces on the anastomosis may be reduced.

[0122] FIG. 9 shows a third embodiment of a system for fixing a medical device to a patient's body. Like the first embodiment of the system for fixing a medical device, this third embodiment of the system includes a surgical guide tube 1, which may include any one of the features of the first or second embodiment of the surgical guide tube 1 described above. However, the surgical guide tube 1 of this third embodiment of the system for fixing a medical device may have a different configuration. The surgical guide tube 1 of this third embodiment of the system for fixing a medical device has a lateral extension 10 with planar surfaces 12a, 12b, which are inclined by about 45° with respect to the longitudinal axis of the guide lumen. However, this is not a necessary feature and may be omitted from the system without departing from the present disclosure. The planar surfaces 12a, 12b may have a different inclination angle or may not have any inclination at all. Similar to the first and second embodiments of the surgical guide tube 1 described above, the lateral extension 10 is configured to anchor the surgical guide tube 1 to the patient's deep fascia.

[0123] Similar to the second embodiment of the system for fixing a medical device, this third embodiment of the system also includes a fixator 46 with a central body portion 48 and fixator wings 50 extending in opposite directions from the central body portion 48. Each fixator wing 50 has a planar surface, and the planar surfaces of the two fixator wings 50 face a common direction. The fixator wings 50 are configured to fix the central body portion 48 of the fixator 46 to the outer surface of the patient's skin and are configured to hold the catheter 30 against the patient's body. For this purpose, the planar surfaces of the fixator wings 50 are each covered with an adhesive (such as, for example, a plaster or adhesive tape) to adhere the fixator wings 50 to the patient's skin.

[0124] A third embodiment of a system for fixing a medical device includes an anchoring graft 96 for implantation under the skin of a patient and for inserting a medical device therethrough. On its outer surface, the anchoring graft 96 is provided with velour to enhance ingrowth of the fixator graft 96 into the tissue beneath the skin.

[0125] In use, the catheter 30 penetrates the patient's skin at a point of skin access 98 located proximal to the proximal end of the anchoring graft 96, extends through the anchoring graft 96 under the patient's skin, and further extends through the surgical guide tube 1 into the blood vessel 24. The vascular graft 20 (shown in the enlarged view of section X in FIG. 10), the surgical guide tube 1, and the catheter 30 are secured by the fixation clamps 32 in the manner described above (see, for example, FIG. 2), and the lateral extension 10 is secured above the deep fascia 24 of the patient. It is also possible to apply a second embodiment of the surgical guide tube 1 including a separate clamping part 34, in which the clamping part 34 is used to secure the graft 20, the tubular body 2, and the catheter 30. Due to this configuration, longitudinal movement of the catheter 30 inside the blood vessel 24 is prevented, and displacement of the intravascular blood pump is avoided.

[0126] The fixator 46 has a central body portion 48 in the form of an arched bridge 80 (or bracket) that connects the two fixator wings 50. The bridge 80 is adapted to pass over the catheter 30 above the outer surface of the skin such that the portion of the catheter 30 that extends above the outer surface of the skin proximal to the point of skin access 98 can move longitudinally underneath the bridge 80.

[0127] The third embodiment of the system for fixing a medical device is particularly suitable for long-term fixation of a medical device, which in this case is a catheter 30 and an intravascular blood pump. When the medical device is to be removed from the patient's body, the vascular graft 20 and the fixation clamp 32 (or in the case of the second embodiment of the surgical guide tube 1, the separate clamping part 34) are exposed in the patient's armpit, and the catheter 30 is then cut off in the armpit and at the point of skin access 98. The part of the catheter 30 between the cut point in the armpit and the point of skin access 98 remains in the patient's body. The vascular graft 20 and the fixation clamp 32 (or in the case of the second embodiment of the surgical guide tube 1, the separate clamping part 34) are removed from the patient's body.

[0128] 11 shows a partial cross-sectional view of a clamping unit 100 for fastening a medical device to a patient's body in a first state. The clamping unit 100 has a tubular body 102 with a proximal end 104, a distal end 106 and a lumen for inserting a medical device therethrough, the lumen extending from the proximal end 104 to the distal end 106. The tubular body 102 includes a surgical guide tube portion 108 at the distal end 106 of the tubular body 102 and two lateral extensions 110 provided proximally of the surgical guide tube portion 108. Each lateral extension 110 defines a proximal planar surface 112a and a distal planar surface 112b (not shown). The tubular body 102 further includes a handling portion 114 provided proximally of the lateral extensions 110 and a rotatable tube 116 configured to insert a medical device therethrough. A rotatable tube 116 is provided inside the inner lumen of the tubular body 102 and is operatively connected to a lever 118 that is accessible from outside the handling portion 114. The lever 118 protrudes through an outer surface of the handling portion 114, and actuation of the lever 118 causes the rotatable tube 116 to rotate in a non-twisting manner about its longitudinal axis.

[0129] Furthermore, the tubular body 102 comprises a flexible tubular foil portion 120, which is configured for inserting a medical device therethrough. The tubular foil portion 120 is provided inside the inner lumen and is fixed to the rotatable tube 116 at a proximal connection portion 122, such that the tubular foil portion 120 and the rotatable tube 116 are fixed to each other in a non-rotatable manner at the proximal connection portion 122. The tubular foil portion 120 is further fixed to the inner wall of the tubular body 102 (inside the lumen of the tubular body) at a distal connection portion 124, such that the tubular foil portion 120 and the tubular body 102 are fixed to each other in a non-rotatable manner at the distal connection portion 124.

[0130] Due to this configuration, the tubular foil portion 120 is twisted about its longitudinal axis when the rotatable tube 116 is rotated in a first direction, and is untwisted when the rotatable tube 116 is rotated in a second direction opposite to the first direction after the rotatable tube 116 has been rotated in the first direction. Figure 11 shows the tubular foil portion 120 in an untwisted state, and Figure 12 shows the tubular foil portion 120 in a twisted state. To transition the tubular foil portion 120 from an untwisted state to a twisted state, i.e. to cause the rotatable tube 116 to rotate in a first direction, the lever 118 (which is connected to the rotatable tube 116) is moved from a first position shown in Figure 11 (the lever 118 is turned up) to a second position shown in Figure 12 (the lever 118 is turned down). In the same manner, by moving the lever 118 from the second position (lever 118 rotated down) back to the first position (lever 118 rotated up), the tubular foil portion 120 is transitioned from a twisted state to an untwisted state, i.e., the rotatable tube 116 is rotated in a second direction.

[0131] The handling portion 114 further includes a button 126 that is accessible from the exterior of the handling portion 114, the button 126 extending through a circumferential outer surface of the handling portion 114. The button 126 is configured to hold the medical device in position relative to the lumen of the tubular body 102 in a first state and to release the medical device upon actuation of the button 126 in a second state to allow longitudinal and rotational movement of the medical device relative to the inner lumen. However, the button 126 is not a required feature and can be omitted from the clamping unit 114 without departing from this disclosure.

[0132] The handling portion 114 includes a section along its length having a reduced outer diameter to form a waist portion 128. At the distal end of the waist portion 128, and at the proximal end of the waist portion 128, the waist portion 128 tapers to a central region 130 having a constant diameter that is the smallest diameter of the waist portion 128. The lever 118 is provided in the central region 130 of the waist portion 128 and does not extend radially beyond the portion of the handling portion 114 adjacent the waist portion 128.

[0133] The clamping unit 100 can be combined with the above-mentioned fixator 46 of the second embodiment of the system for fixing a medical device, where the fixator wings 50 (which are covered by adhesive) can fixate the central body part 48 of the fixator to the patient's skin and hold the handling part 114 against the patient's body. The central body part 48 in the form of an arched bridge 80 can pass over a waist part 128 of the handling part 114 so that the waist part 128 can move longitudinally under the bridge 80. The longitudinal length of the central region 130 corresponds to approximately twice the width of the bridge 80, and the proximal end of the waist part 128 and the distal end of the waist part 128 limit the span of the longitudinal movement of the waist part 128 under the bridge 80.

[0134] In use, the catheter 30 is inserted into the lumen of the tubular body 102 with the lever 118 in the first position (the lever 118 is turned up), i.e. with the tubular foil portion 120 untwisted, and extends through the entirety of the handling portion 114 and the surgical guide tube portion 108. That is, the catheter 30 also extends through the lumen of the rotatable tube 116 and the tubular foil portion 120 into the accessed blood vessel 24 of the patient. The vascular graft 20 (not shown in FIGS. 11 and 12) and the surgical guide tube portion 108 are connected by sutures 28 (not shown in FIGS. 11 and 12) in the manner described above (with reference to the first embodiment of the surgical guide tube 1), and the lateral extension 110 is secured to the deep fascia 26 of the patient. The handling portion 114 penetrates the skin of the patient. Due to this configuration, the catheter 30 can be fixedly positioned inside the clamping unit 100 by moving the lever 118 to the second position (turning the lever 118 down), thereby twisting the tubular foil portion 120, which results in a reduction in the inner diameter of the tubular foil portion 120 and clamping the catheter 30. Thereby, unintended repositioning of the catheter 30 and the intravascular blood pump inside the patient's vasculature can be prevented. Furthermore, the catheter 30 can be released from the clamping by moving the lever 118 back to the first position (turning the lever 118 up), thereby untwisting the tubular foil portion 120, which results in an expansion of the inner diameter of the tubular foil portion 120 and unclamping the catheter 30. Thereby, the catheter 30 and the intravascular blood pump can be repositioned or exchanged. Additionally, movement of the skin in the area where fixator wings 50 are applied (eg, the shoulder area) is permitted within the span of longitudinal movement of waist portion 128 .In this way, the pushing or pulling force on the anastomosis can be reduced even when the catheter 30 is clamped inside the tubular foil portion 120, i.e., when the lever 118 is in the second position (lever 118 is turned down).

[0135] The different method stabilizes a catheter-based medical device in a patient's blood vessel so that it cannot move forward or backward inside the vessel when the patient moves, and does not require the use of a surgical guide tube. The first method step is the same as in the previously described embodiment. That is, in the first step, the patient's skin is opened to gain access to the vessel, then a vascular graft is connected to the vessel by anastomosis, the seam generated by suturing the graft to the vessel can be reinforced by glue, and then the medical device is inserted into the vessel through the graft, such that the catheter extends out of the patient through the graft with its proximal end. However, according to this different method, instead of using a surgical guide tube to stabilize the catheter, the graft is twisted to reduce its inner diameter, thereby clamping the catheter inside the graft, which is fixed to the vessel.

[0136] More specifically, the medical device includes a plug, which is mounted on a catheter such that the plug is slidable along the catheter. The slidable plug can have a closed configuration (e.g., a closed cylindrical configuration, among other external configurations corresponding to a cylinder) and can be made of silicone rubber. When the medical device (e.g., an intravascular blood pump, etc.) is placed at its target location inside the patient, the slidable plug, which is located on the catheter, is pushed into the graft to a position close to the anastomosis. By additional means described below, the slidable plug is held in close proximity to the blood vessel and in front of the blood vessel. To facilitate the insertion of the plug into the graft, the outer diameter of the plug can be smaller than the inner diameter of the graft. Additionally or alternatively, the graft can have elastic properties such that a plug whose outer diameter is equal to or even exceeds the inner diameter of the graft can still be pushed into the graft. In the latter case, tension is applied to the graft in the radial and circumferential directions of the graft where the plug is positioned. Due to this tension and the elastic properties of the graft, a clamping force is generated that stabilizes the position of the plug inside the graft.

[0137] Prior to inserting the plug into the graft, a slotted shim (which is preferably not elastic and can be made of PEEK) is placed around the graft at a location distal to where the slidable plug is intended to be placed inside the graft, thereby forming a stop for the distally slidable plug. The slotted shim is placed as close to the anastomosis as possible. The purpose of the slotted shim, in addition to serving as a sliding stop for the plug, is that it can be easily grasped and held by the surgeon when the graft is being twisted. Furthermore, the shim can be provided with eyelets, which protrude radially outward, and the shim can be secured (e.g., sutured) to the patient's fascia by the eyelets for enhanced stability. Preferably, the shim is secured to the fascia by the eyelets before the plug is inserted into the graft. To place the shim around the graft, the shim includes radially extending slots and is guided radially over the graft at the location of the slots. To this end, the slot has a width at least equal to, and preferably greater than, the outer diameter of the graft with the catheter inserted therein, and the inner diameter of the shim is smaller than the outer diameter of the plug, such that the plug is prevented from sliding through the shim and into the vessel.

[0138] Once the shim is brought to the desired position around the graft and the plug is pushed into the graft to its final position, the position of the medical device in the patient is finalized. The graft is then twisted to reduce its inner diameter, whereby a clamping force is exerted on the catheter inside the graft, and the slidable plug is pressed against the shim and tightly compressed onto the catheter. The plug and shim act as a twisting stopper for the graft, whereby the anastomosis can be protected from exerting tension forces when the graft is twisted to secure the catheter to the graft. In other words, the torsional and tension forces generated by the twisting action do not reach the anastomosis and therefore cannot adversely affect the anastomotic joint.

[0139] Once the graft is twisted, it is held in the twisted state, for example by using clamps, which act on the graft from the outside of the graft so that it cannot be untwisted again. The twisted graft is then sutured to itself, preserving the twisted structure and thus always holding it in the twisted state. The resulting seam can be collinear with the longitudinal extension of the twisted graft. The clamps can then be removed. The twisted graft can then be shortened to the desired length, preferably without compromising the sutures of the graft.

[0140] Due to the clamping force generated by the twisted graft, when the graft is properly secured to the catheter, the medical device can no longer move forwards or backwards inside the vessel. Thus, the twisted graft is pushed into the patient's body while the catheter extends out of the patient's body through the twisted graft, and the open skin can then be closed around the catheter.

[0141] The graft is usually made of Dacron or similar material. The graft is a knitted, warp knitted, knotted, woven, or nonwoven fabric that facilitates suturing. To ensure that the graft can be untwisted without effort when the medical device is to be removed from the vessel, tissue ingrowth into the graft should be prevented, since this would prevent untwisting. Therefore, a sleeve can be provided around the twisted graft to prevent any ingrowth of tissue into the graft. The sleeve can be tubular or can be wrapped around the twisted portion of the graft. The sleeve can be made of polytetrafluoroethylene (PTFE) (e.g., Teflon).

[0142] The advantage of this method is that the medical device can be easily removed without cutting the patient. More specifically, when the medical device has to be removed, the sutures on the graft that hold the graft in a twisted state are removed first. Then the graft is untwisted and loses its clamping force on the catheter. The medical device is pulled out of the vessel and the graft, which also pulls the slidable plug out of the graft. This is because the typically wider part (referring to the outer diameter) of the medical device (such as the pumping device of a catheter-based intravascular blood pump) that is located at the distal end of the catheter pushes the slidable plug out of the graft. Since the inner diameter of the shim exceeds the outer diameter of the medical device, it is possible to remove the medical device without first removing the shim from the graft. The shim can be left inside the patient.

[0143] FIG. 13 shows the vascular graft 20 on the catheter 30 with the slotted shim 33, the clamp 32, and the seam 20b, the slotted shim 33 being placed on the distal end 22 of the graft, the surgeon holds the proximal end 21 of the graft against the catheter 30 with the clamp 32 to prevent untwisting of the graft 20, the seam 20b extending along the length of the twisted portion 20a of the graft, preserving the twisted structure of the graft 20, while the proximal end of the catheter extends out of the patient's body through the skin 200. It is also possible to twist the graft 20 and secure the twisted structure without the clamp 32 by first manually twisting the graft 20 and then providing a ligature to prevent untwisting. The distance between the patient's skin 200 and the blood vessel 24 can vary. It is preferred that the plug 31 is positioned completely below the skin 200.

[0144] The graft 20 can have an inner diameter of 6 mm to 10 mm, preferably an inner diameter of 8 mm, or an inner diameter of 8 mm to 10 mm. Inside the graft 20, proximal to the shim 33, a plug 31 (shown in dashed lines) is provided. With the plug 31 inserted into the graft 20, the graft 20 is sealed against the catheter and provides hemostasis. The plug 31 is made of, among other things, silicone rubber and has a strength of 40 to 60 Shore A, preferably 50 Shore A. The outer diameter of the plug 31 is smaller than the inner diameter of the graft 20. Alternatively, the graft 20 can be elastic, such that the plug 31 can have an outer diameter equal to or greater than the inner diameter of the graft 20. The plug 31 and shim 33 protect the anastomosis from tensile and torsional forces caused by the twisting movement of the graft. The graft 20 may be a knit, warp knit, knotted fabric, woven, or nonwoven. The situation shown in Figure 13 corresponds to a moment in the procedure prior to removing the clamps 32, severing the proximal end 21 of the graft 20, pushing the graft 20 into the patient's body, and closing the opening in the patient's skin 200.

[0145] FIG. 14A shows a plan view of the slotted shim 33, as it may be used, for example, for a vascular graft twisted onto a catheter as shown in FIG. 13. The slotted shim 33 has a flat main body portion 1133 in the form of an open ring. A flat radial protrusion 1133A extends radially outward from the open ring and forms an eyelet for fixing the shim 33 to the fascia. Spaced apart from the eyelet in the circumferential direction of the open ring, the shim 33 further includes a slot 1033 extending in the radial direction of the ring 33. The two ends of the open ring form respective end surfaces 1233, which define the slot 1033 and run parallel to each other. The distance a between the end surfaces 1233 (i.e. the width of the slot 1033) is between 4 mm and 8 mm, preferably 6 mm. The inside diameter b of the open ring is between 5 mm and 9 mm, preferably 7 mm. The outside diameter c of the open ring is between 15 mm and 25 mm, preferably 20 mm. As can be seen in Fig. 14B (Fig. 14B shows a cross-section of the slotted shim 33 of Fig. 14A along line XIV), the flat main body part 1133 has a thickness d of 1 mm to 2 mm, preferably 1.5 mm. In general, the width of the slot 1033 is dimensioned such that the graft into which the catheter is inserted fits through the slot 1033. This means that the width of the slot 1033 corresponds at least to the outside diameter of the catheter plus twice the wall thickness of the graft. Furthermore, the inside diameter b is dimensioned such that a medical device (e.g., a pump head) wider than the catheter can be guided through the shim 33. This means that the inside diameter b corresponds at least to the outside diameter of the medical device plus twice the wall thickness of the graft.

[0146] FIG. 15A shows a three-dimensional view of the plug 31, as it can be used for example for a vascular graft twisted onto a catheter as shown in FIG. 13. The outer form of the plug 31 corresponds to a cylinder. The plug 31 has a length of 15 mm to 25 mm, preferably 20 mm. As can be seen in FIG. 15B (FIG. 15B shows a cross-sectional view of the plug of FIG. 15A), the plug 31 comprises a central through-hole 1031 in the form of a hexagonal prism. The outer diameter e of the plug 31 is 7 mm to 11 mm, preferably 9 mm. The respective opposing surfaces of the hexagonally shaped through-hole 1031 are provided at a distance f of 2.5 mm to 3.5 mm, preferably 3 mm, while the respective opposing edges are provided at a distance g of preferably 3.46 mm. The adjacent surfaces are angled at 120°. The plug 31 is made of silicone rubber and has a strength of 50 Shore A.

[0147] Preferred embodiments of the present disclosure 1. A surgical guide tube 1 configured for insertion into a vascular graft 20, the surgical guide tube 1 comprising: a body 2 having a proximal end 4, a distal end 6, and a guide lumen having a longitudinal axis 8, the guide lumen extending from the proximal end 4 to the distal end 6 of the body 2 and configured for insertion of a medical device therethrough, in particular a catheter 30 of an intravascular blood pump; a lateral extension 10 extending laterally from a body portion 2 and defining planar surfaces 12a, 12b, the planar surfaces 12a, 12b configured to be attached to a patient's fascia 26 between a patient's body vessel 24, preferably a blood vessel, and more preferably at least one of the axillary artery and the subclavian artery, and the patient's skin; Including, A surgical guide tube 1, characterized in that the planar surfaces 12a, 12b of the lateral extension 10 are inclined with respect to the longitudinal axis 8 of the guide lumen by an inclination angle of approximately 30° to 60°, preferably 45°.

[0148] 2. A surgical guide tube 1 as described in paragraph 1, characterized in that the lateral extension 10 is arranged such that its planar surfaces 12a, 12b include an axis extending perpendicularly through the longitudinal axis 8 of the guide lumen.

[0149] 3. A surgical guide tube 1 as described in paragraphs 1 or 2, characterized in that the lateral extension 10 is attached to the main body portion 2 in a non-detachable manner, preferably integrally formed with the main body portion 2.

[0150] 4. The surgical guide tube 1 according to paragraph 1 or 2, further comprising a separate clamping part 34 having a proximal end 36, a distal end 38 and a clamping lumen extending from the proximal end 36 to the distal end 38 of the clamping part 34, the lateral extension 10 being attached to the clamping part 34 in a non-detachable manner and preferably being integrally formed with the clamping part 34, the clamping part 34 being configured to clamp onto the main body part 2, and the planar surfaces 12a, 12b of the lateral extension 10 being inclined by said inclination angle with respect to the longitudinal axis 8 of the guide lumen.

[0151] 5. A surgical guide tube 1 as described in paragraph 4, characterized in that the clamping part 34 is configured to clamp onto the main body part 2 so that the longitudinal axis of the clamping lumen is parallel to the longitudinal axis 8 of the guide lumen.

[0152] 6. A surgical guide tube 1 as described in paragraphs 4 or 5, characterized in that the clamping part 34 is configured to reduce the diameter of the guide lumen when clamped onto the main body part 2, in particular when the surgical guide tube 1 is provided with two or more bumps 16 or with at least one bump 16 and at least one bulge 18, 40, when the clamping part 34 is located at a longitudinal position of the surgical guide tube 1 between the bumps 16 or between at least one bump 16 and at least one bulge 18, 40.

[0153] 7. A surgical guide tube 1 as described in any one of paragraphs 4 to 6, characterized in that the clamping part 34 includes at least two arms 42 extending in substantially opposite circumferential directions, each provided with an interlocking profile 44, and arranged such that when the arms 42 are moved past each other, the cross-section of the clamping lumen is narrowed, and interlocked with each other via the interlocking profiles 44.

[0154] 8. A surgical guide tube 1 according to paragraph 7, characterized in that the interlocking profiles 44 of at least two arms 42 form a ratchet mechanism.

[0155] 9. A surgical guide tube 1 according to any one of paragraphs 1 to 8, characterized in that two of the lateral extensions 10 are provided, which are preferably arranged in mirror symmetry with respect to one another, each forming a wing, the two wings extending in opposite radial directions relative to the longitudinal axis 8 of the guide lumen of the main body portion 2.

[0156] 10. A surgical guide tube 1 as described in paragraph 9, characterized in that the distance between the longitudinal axis 8 of the guide lumen and the radially outermost edge of each of the lateral extensions 10 is between about 5 mm and about 19 mm, preferably between about 8 mm and about 16 mm, and more preferably about 12 mm.

[0157] 11. A surgical guide tube 1 as described in any one of paragraphs 1 to 10, characterized in that the lateral extension 10 includes a protrusion, recess or opening 14, more preferably two or more of said openings 14, which are configured to insert a suture 28 or a clamp 32 through the lateral extension 10.

[0158] 12. A surgical guide tube 1 according to paragraph 11, characterized in that the longitudinal axis of the opening 14 extends substantially perpendicular to the planar surfaces 12a, 12b.

[0159] 13. A surgical guide tube 1 according to paragraph 11 or 12, characterized in that the opening 14 is substantially D-shaped in transverse cross section.

[0160] 14. A surgical guide tube 1 as described in any one of paragraphs 1 to 13, characterized in that the lateral extension 10 is arranged at the proximal end 4 of the surgical guide tube 1.

[0161] 15. A surgical guide tube 1 as described in any one of paragraphs 1 to 13, characterized in that the proximal bulge 40 surrounds the main body portion 2 and forms the proximal end of the surgical guide tube 1, and the proximal bulge 40 is preferably annular, and more preferably has the shape of a circular ring.

[0162] 16. A surgical guide tube 1 as described in any one of paragraphs 1 to 15, characterized in that the surgical guide tube 1 is provided with one or more circumferential bumps 16 extending radially from the main body portion 2, each of the one or more circumferential bumps 16 surrounding the main body portion 2 and preferably being annular, and more preferably having the shape of a circular ring, and the one or more circumferential bumps 16 are arranged in a spaced-apart relationship along the longitudinal axis 8 of the guide lumen.

[0163] 17. The surgical guide tube 1 described in paragraph 16, wherein at least two of the one or more circumferential bumps 16 are present, and the at least two circumferential bumps 16 include at least one of the following characteristics: (a) being aligned parallel to one another along the longitudinal axis 8 of the guide lumen; and (b) having the same outer diameter.

[0164] 18. A surgical guide tube 1 as described in paragraph 16, wherein some or all of the one or more circumferential bumps 16 are positioned distal to the lateral extension 10, and preferably there are at least two of the distally positioned circumferential bumps, and wherein the at least two distally positioned circumferential bumps include at least one of the following characteristics: (a) they are aligned parallel to each other along the longitudinal axis 8 of the guide lumen, and (b) they have the same outer diameter.

[0165] 19. A surgical guide tube 1 as described in any one of paragraphs 1 to 18, characterized in that a distal bulge 18 surrounds the main body portion 2 and forms the distal end of the surgical guide tube 1, the distal bulge 18 being preferably annular, and more preferably having the shape of a circular ring.

[0166] 20. A surgical guide tube 1 as described in any one of paragraphs 16 to 18, wherein a distal bulge 18 surrounds the main body portion 2 and forms the distal end of the surgical guide tube 1, the distal bulge 18 is preferably annular, and more preferably has the shape of a circular ring, and all of the one or more circumferential bumps 16 positioned proximally of the distal bulge 18 have at least one of the following characteristics: (a) they are aligned parallel to each other along the longitudinal axis 8 of the guide lumen, and (b) they have the same outer diameter.

[0167] 21. A surgical guide tube 1 as described in paragraph 18, characterized in that the distal bulge 18 surrounds the main body portion 2 and forms the distal end of the surgical guide tube 1, the distal bulge 18 is preferably annular, more preferably having the shape of a circular ring, and all of the one or more circumferential bumps 16 positioned between the lateral extension 10 and the distal bulge 18 include at least one of the following features: they are aligned parallel to each other along the longitudinal axis 8 of the guide lumen, and they have the same outer diameter.

[0168] 22. A surgical guide tube 1 as described in any one of paragraphs 1 to 21, characterized in that the peripheral portion of the distal end of the surgical guide tube 1 lies in a plane that is inclined by approximately 30° to 60°, preferably 45°, relative to the longitudinal axis 8 of the guide lumen.

[0169] 23. A surgical guide tube 1 according to paragraph 22, characterized in that the plane is inclined relative to the longitudinal axis 8 of the guide lumen in the same direction and preferably by the same inclination angle as the planar surfaces 12a, 12b of the lateral extension 10.

[0170] 24. A surgical guide tube 1 described in any one of paragraphs 16 to 23, characterized in that one or more circumferential bumps 16 are concentrically arranged around the longitudinal axis 8 of the guide lumen, and the outer diameter of each of the bumps relative to the longitudinal axis 8 of the guide lumen is approximately 0.8 to approximately 1.8 times larger than the outer diameter of the main body portion 2, preferably approximately 1 to approximately 1.6 times larger, and more preferably approximately 1.3 times larger.

[0171] 25. A surgical guide tube 1 as described in any one of paragraphs 1 to 24, characterized in that the main body portion 2 has a constant outer diameter relative to the longitudinal axis of the guide lumen.

[0172] 26. A surgical guide tube 1 described in any one of paragraphs 1 to 25, including any one of paragraphs 16 to 18, 20, 22, 23, and 25 and any one of paragraphs 4 to 8, characterized in that all of the at least two circumferential bumps 16 are positioned along the longitudinal axis 8 of the guide lumen at a mutual distance greater than the distance from the proximal end 36 to the distal end 38 of the clamping part 34.

[0173] 27. A surgical guide tube 1 as described in any one of paragraphs 1 to 26, including any one of paragraphs 16, 17, 18, 20, 22, 23, 25, and 26 and any one of paragraphs 4 to 8, characterized in that at least one of (a) the distance between the proximal end of the surgical guide tube 1 and one of the one or more circumferential bumps 16 positioned closest to the proximal end of the surgical guide tube 1, and (b) the distance between the distal end of the surgical guide tube 1 and one of the one or more circumferential bumps 16 positioned closest to the distal end of the surgical guide tube 1, is greater than the distance from the proximal end 36 to the distal end 38 of the clamping part 34.

[0174] 28. A kit comprising a surgical guide tube 1 described in any one of paragraphs 1 to 27 and a vascular graft 20, the vascular graft 20 having a proximal end configured to insert the distal end of the surgical guide tube 1 therein, a distal end 22 configured to fix the vascular graft 20 to a patient's blood vessel 24, and a graft lumen extending from the proximal end of the graft 20 to the distal end 22 of the graft 20, the graft lumen being configured to accommodate a distal section of the surgical guide tube 1.

[0175] 29. A kit according to paragraph 28, characterized in that the surgical guide tube 1 comprises one or more circumferential bumps 16 as defined in paragraph 16, and the diameter of the graft lumen is between 1 and about 1.2 times, preferably about 1.1 times, the outer diameter of the one or more circumferential bumps 16, in particular the maximum outer diameter of the one or more circumferential bumps 16.

[0176] 30. A kit according to paragraph 28 or 29, characterized in that the surgical guide tube 1 includes a clamping part 34 as defined in any one of paragraphs 4 to 8, and the clamping part 34 is configured to fix the graft 20 to the surgical guide tube 1 by clamping the clamping part 34 onto the graft 20 when the surgical guide tube 1 is inserted into the graft 20.

[0177] 31. A kit as described in paragraph 30, characterized in that the clamping part 34 is configured to reduce the diameter of the guide lumen of the surgical guide tube 1 by clamping the clamping part 34 onto the graft 20 while the surgical guide tube 1 is inserted into the graft 20.

[0178] 32. A kit according to any one of paragraphs 28 to 31, characterized in that the kit further comprises at least one of (a) at least one suture 28 and (b) at least one fixation clamp 32 configured to fix the graft 20 to the outer periphery of the main body portion 2 with the surgical guide tube 1 inserted into the graft 20.

[0179] 33. A kit as described in paragraph 32, characterized in that at least one suture 28 or at least one fixation clamp 32 is configured to reduce the diameter of the graft 20 by applying it to the graft 20 while the surgical guide tube 1 is inserted into the graft 20.

[0180] 34. A kit according to any one of paragraphs 32 or 33, characterized in that the fixation clamp 32 is configured to reduce the diameter of the guide lumen of the graft 20 by applying the fixation clamp 32 to the graft 20 with a surgical guide tube inserted into the graft 20.

[0181] 35. A kit according to any one of paragraphs 28 to 34, characterized in that the kit further comprises a medical device, in particular a catheter 30, configured for inserting the medical device into and through the guide lumen of the surgical guide tube 1, the surgical guide tube 1 being preferably slidable over an outer surface of the medical device.

[0182] 36. A kit according to paragraph 35, characterized in that the kit further comprises an intravascular blood pump, the intravascular blood pump being configured to connect it to the medical device and configured to insert it into the patient's blood vessel 24 through the graft 20.

[0183] 37. A system configured to secure a medical device to a patient's body, the system comprising: (a) a surgical guide tube 1 configured for insertion into a vascular graft 20; The surgical guide tube 1 a body 2 having a proximal end 4, a distal end 6, and a guide lumen having a longitudinal axis 8, the guide lumen extending from the proximal end 4 to the distal end 6 of the body 2 and configured for insertion of a medical device therethrough, in particular a catheter 30 of an intravascular blood pump; a lateral extension 10 extending laterally from a body portion 2 and defining planar surfaces 12a, 12b, the planar surfaces 12a, 12b being configured to be attached to a patient's fascia 26 between a patient's body vessel, preferably a blood vessel, more preferably at least one of the axillary artery and the subclavian artery, and the patient's skin; Including, The system also: (b) a system comprising a fixator 46 configured to secure the fixator 46 to a patient's skin and to hold a medical device to the patient's body, the fixator 46 having a central body portion 48 and two fixator wings 50 extending in opposite directions from the central body portion 48, each fixator wing 50 having a planar surface facing a common direction.

[0184] 38. The system according to paragraph 37, characterized in that the planar surface of the lateral extension 10 is inclined with respect to the longitudinal axis 8 of the guide lumen by an inclination angle of approximately 30° to 60°, preferably 45°.

[0185] 39. A system according to paragraph 37 or 38, characterized in that the lateral extension 10 is arranged such that its planar surfaces 12a, 12b include an axis extending perpendicularly through the longitudinal axis 8 of the guide lumen.

[0186] 40. A system according to any one of paragraphs 37 to 39, characterized in that the lateral extension 10 is attached to the main body part 2 in a non-detachable manner, preferably integrally formed with the main body part 2.

[0187] 41. A system according to any one of paragraphs 37 to 40, characterized in that the surgical guide tube 1 further comprises a separate clamping part 34 having a proximal end 36, a distal end 38 and a clamping lumen extending from the proximal end 36 to the distal end 38 of the clamping part 34, the lateral extension 10 being attached to the clamping part 34 in a non-detachable manner and preferably being integrally formed with the clamping part 34, the clamping part 34 being configured to clamp onto or around the main body part 2, and preferably such that the planar surfaces 12a, 12b of the lateral extension 10 are inclined by said inclination angle with respect to the longitudinal axis 8 of the guide lumen.

[0188] 42. The system described in paragraph 41, characterized in that the clamping part 34 is configured to clamp onto or around the main body part 2 so that the longitudinal axis of the clamping lumen is parallel to the longitudinal axis 8 of the guide lumen.

[0189] 43. A system according to paragraph 41 or 42, characterized in that the clamping part 34 is configured to reduce the diameter of the guide lumen when clamped onto the main body part 2, in particular when the surgical guide tube 1 is provided with two or more bumps 16 or with at least one bump 16 and at least one bulge 18, 40, when the clamping part 34 is located at a longitudinal position of the surgical guide tube 1 between the bumps 16 or between at least one bump 16 and at least one bulge 18, 40.

[0190] 44. A system according to any one of paragraphs 41 to 43, characterized in that the clamping part 34 comprises at least two arms 42 extending in substantially opposite circumferential directions, each provided with an interlocking profile 44, and arranged such that when the arms 42 are moved past each other, the cross-section of the clamping lumen is narrowed, and interlocked with each other via the interlocking profiles 44.

[0191] 45. A system according to paragraph 44, characterized in that the interlocking profiles 44 of at least two arms 42 form a ratchet mechanism.

[0192] 46. ​​A system according to any one of paragraphs 37 to 45, characterized in that there are two of the lateral extensions 10, each forming a wing, the two wings extending in opposite radial directions relative to the longitudinal axis 8 of the guide lumen of the main body portion 2.

[0193] 47. The system described in paragraph 46, characterized in that the distance between the longitudinal axis 8 of the guide lumen and the radially outermost edge of each of the lateral extensions 10 is between about 5 mm and about 19 mm, preferably between about 8 mm and about 16 mm, and more preferably about 12 mm.

[0194] 48. A system according to any one of paragraphs 37 to 47, characterized in that the lateral extension 10 comprises an opening 14, more preferably two or more of said openings 14, which are configured to insert a suture 28 or a clamp 32 through the lateral extension 10.

[0195] 49. The system according to paragraph 48, characterized in that the longitudinal axis of the opening 14 extends substantially perpendicular to the planar surfaces 12a, 12b.

[0196] 50. The system according to paragraph 48 or 49, characterized in that the opening 14 is substantially D-shaped in transverse cross section.

[0197] 51. A system according to any one of paragraphs 37 to 50, characterized in that the lateral extension 10 is arranged at the proximal end of the surgical guide tube 1.

[0198] 52. A system according to any one of paragraphs 37 to 50, characterized in that the proximal bulge 40 surrounds the main body 2 and forms the proximal end of the surgical guide tube 1, the proximal bulge 40 being preferably annular, and more preferably having the shape of a circular ring.

[0199] 53. A system according to any one of paragraphs 37 to 52, characterized in that the surgical guide tube 1 is provided with one or more circumferential bumps 16 extending radially from the main body portion, each of the one or more circumferential bumps 16 surrounding the main body portion 2 and preferably being annular, more preferably having the shape of a circular ring, and the one or more circumferential bumps 16 are arranged in a spaced apart relationship along the longitudinal axis 8 of the guide lumen.

[0200] 54. The system described in paragraph 53, wherein at least two of the one or more circumferential bumps 16 are present, and the at least two circumferential bumps 16 include at least one of the following characteristics: (a) being aligned parallel to one another along the longitudinal axis 8 of the guide lumen; and (b) having the same outer diameter.

[0201] 55. The system described in paragraph 53, wherein some or all of the one or more circumferential bumps 16 are positioned distally of the lateral extension 10, and preferably there are at least two of the distally positioned circumferential bumps, and wherein the at least two distally positioned circumferential bumps include at least one of the following characteristics: (a) they are aligned parallel to one another along the longitudinal axis 8 of the guide lumen, and (b) they have the same outer diameter.

[0202] 56. A system according to any one of paragraphs 37 to 55, characterized in that the distal bulge 18 surrounds the main body 2 and forms the distal end of the surgical guide tube 1, the distal bulge 18 being preferably annular, and more preferably having the shape of a circular ring.

[0203] 57. A system as described in any one of paragraphs 37 to 55, wherein a distal bulge 18 surrounds the main body 2 and forms the distal end of the surgical guide tube 1, the distal bulge 18 is preferably annular, more preferably having the shape of a circular ring, and all of the one or more circumferential bumps 16 positioned proximally of the distal bulge 18 include at least one of the following features: (a) they are aligned parallel to each other along the longitudinal axis 8 of the guide lumen, and (b) they have the same outer diameter.

[0204] 58. The system described in paragraph 55, wherein the distal bulge 18 surrounds the main body 2 and forms the distal end of the surgical guide tube 1, the distal bulge 18 is preferably annular, more preferably having the shape of a circular ring, and all of the one or more circumferential bumps 16 positioned between the lateral extension 10 and the distal bulge 18 have at least one of the following characteristics: (a) they are aligned parallel to each other along the longitudinal axis 8 of the guide lumen, and (b) they have the same outer diameter.

[0205] 59. A system according to any one of paragraphs 41 to 66, characterized in that the periphery of the distal end of the surgical guide tube 1 lies in a plane inclined by approximately 30° to 60°, preferably 45°, relative to the longitudinal axis 8 of the guide lumen.

[0206] 60. The system according to paragraph 59, characterized in that the plane is inclined relative to the longitudinal axis 8 of the guide lumen in the same direction and preferably by the same inclination angle as the planar surfaces 12a, 12b of the lateral extension 10.

[0207] 61. A system described in any one of paragraphs 53 to 60, wherein one or more circumferential bumps 16 are concentrically arranged around the longitudinal axis 8 of the guide lumen, and the outer diameter of each of the bumps 16 relative to the longitudinal axis 8 of the guide lumen is from about 0.8 to about 1.8 times greater than the outer diameter of the main body portion 2, preferably from 1 to about 1.6 times greater, and more preferably about 1.3 times greater.

[0208] 62. A system according to any one of paragraphs 37 to 61, characterized in that the main body portion 2 has a constant outer diameter relative to the longitudinal axis of the guide lumen.

[0209] 63. A system described in any one of paragraphs 53 to 62, including any one of paragraphs 41 to 45 and any one of paragraphs 53 to 55, 58, 61, characterized in that all of the at least two circumferential bumps 16 are positioned along the longitudinal axis 8 of the guide lumen at a mutual distance greater than the distance from the proximal end 36 to the distal end 38 of the clamping part 34.

[0210] 64. A system described in any one of paragraphs 53 to 63, including any one of paragraphs 41 to 45 and any one of paragraphs 53 to 55, 58, 61, characterized in that at least one of (a) the distance between the proximal end of the surgical guide tube 1 and one of the one or more circumferential bumps 16 positioned closest to the proximal end of the surgical guide tube 1, and (b) the distance between the distal end of the surgical guide tube 1 and one of the one or more circumferential bumps 16 positioned closest to the distal end of the surgical guide tube 1, is greater than the distance from the proximal end 36 to the distal end 38 of the clamping part 34.

[0211] 65. A system as described in any one of paragraphs 37 to 64, further comprising a vascular graft 20 having a proximal end configured for insertion therein of the distal end of the surgical guide tube 1, a distal end 22 configured for fixing the graft 20 to the patient's blood vessel 24, and a graft lumen extending from the proximal end of the graft 20 to the distal end 22 of the graft 20, the graft lumen being configured to accommodate the distal section of the surgical guide tube 1.

[0212] 66. The system according to paragraph 65, wherein the surgical guide tube 1 comprises one or more circumferential bumps 16 as defined in paragraph 53, and wherein the diameter of the graft lumen is between 1 and about 1.2 times, preferably about 1.1 times, the outer diameter of the one or more circumferential bumps 16, in particular the maximum outer diameter of the one or more circumferential bumps 16.

[0213] 67. A system as described in paragraph 65 or 66, characterized in that the surgical guide tube 1 includes a clamping part 34 as defined in any one of paragraphs 41 to 45, and the clamping part 34 is configured to fix the graft 20 to the surgical guide tube 1 by clamping the clamping part 34 onto the graft 20 when the surgical guide tube 1 is inserted into the graft 20.

[0214] 68. The system described in paragraph 67, characterized in that the clamping part 34 is configured to reduce the diameter of the guide lumen of the surgical guide tube 1 by clamping the clamping part 34 onto the graft 20 while the surgical guide tube 1 is inserted into the graft 20.

[0215] 69. The system of any one of paragraphs 65 to 68, further comprising at least one of (a) at least one suture 28 and (b) at least one fixation clamp 32 configured to fix the graft 20 to the outer periphery of the main body portion 2 when the surgical guide tube 1 is inserted into the graft 20.

[0216] 70. The system described in paragraph 69, characterized in that at least one suture 28 or at least one fixation clamp 32 is configured to reduce the diameter of the graft 20 by applying it to the graft 20 while the surgical guide tube 1 is inserted into the graft 20.

[0217] 71. The system described in paragraph 69 or 70, characterized in that the fixation clamp 32 is configured to reduce the diameter of the guide lumen of the graft 20 by applying the fixation clamp 32 to the graft 20 with a surgical guide tube inserted into the graft 20.

[0218] 72. A system according to any one of paragraphs 65 to 72, characterized in that the system further comprises a medical device, in particular a catheter 30, configured for inserting the medical device into and through the guide lumen of the surgical guide tube 1, the surgical guide tube 1 being preferably slidable over an outer surface of the medical device.

[0219] 73. The system according to paragraph 72, characterized in that the system further comprises an intravascular blood pump, the intravascular blood pump being configured to connect it to the medical device and configured to insert it through the graft 20 into the patient's blood vessel 24.

[0220] 74. A system according to any one of paragraphs 37 to 73, characterized in that each of the two fixator wings 50 includes at least one opening, preferably two or more openings, configured to insert a suture or a clamp therethrough, for attaching the fixator wings 50 to the patient's skin.

[0221] 75. A system according to any one of paragraphs 37 to 74, characterized in that the planar surface of the fixator wing 50 is at least partially covered by an adhesive configured to adhere the planar surface to the patient's skin.

[0222] 76. The system according to any one of paragraphs 37 to 75, further comprising a repositioning unit 54, the repositioning unit 54 having a proximal end 56, a distal end 58 and a repositioning lumen extending from the proximal end 56 to the distal end 58 of the repositioning unit 54, the repositioning lumen being configured to insert a medical device through the repositioning unit 54, the repositioning unit 54 including at least one button 60 or lever accessible from outside the repositioning unit 54 and preferably protruding to or extending through a circumferential outer surface of the repositioning unit 54, the button 60 or lever being configured to hold the medical device in a proper position relative to the repositioning lumen in a first state and to release the medical device upon actuation of the button 60 or lever in a second state to allow movement of the medical device relative to the repositioning lumen.

[0223] 77. A system as described in any one of paragraphs 37 to 76, characterized in that the central body portion 48 of the fixator 46 has a proximal end 62, a distal end 64, and a fixator lumen extending from the proximal end 62 to the distal end 64 of the central body portion 48, the fixator lumen being configured to insert a medical device through the central body portion 48.

[0224] 78. A system according to any one of paragraphs 37 to 77, characterized in that a tubular extension 66 having an extension lumen is attached to the central body portion 48 at the distal end 64 of the central body portion 48, preferably integrally formed with the central body portion 48, and the extension lumen is configured for inserting a medical device through the tubular extension 66.

[0225] 79. A system according to any one of paragraphs 76 to 78, characterized in that the repositioning unit 54 is attached to the proximal end of the central body portion 48.

[0226] 80. The system according to paragraph 79, wherein the extension lumen, the fixator lumen, and the repositioning lumen are coaxially aligned with respect to each other.

[0227] 81. A system according to any one of paragraphs 78 to 80, including paragraph 76, wherein the system further comprises a medical device insertable through the extension lumen, the fixator lumen and the repositioning lumen, and wherein the tubular extension 66, the fixator 46 and the repositioning unit 54 are slidable over the medical device when the button 60 or lever of the repositioning unit 54 is actuated.

[0228] 82. A system as described in any one of paragraphs 37 to 76, characterized in that the central body portion 48 forms an arched bridge 80 such that a medical device can pass between the central body portion 48 and the patient's skin when the fixator 46 is applied to the patient's skin.

[0229] 83. The system of paragraph 82, further comprising an anchoring graft 96 configured to implant the anchoring graft 96 under the patient's skin and configured to insert a medical device through the anchoring graft 96, the anchoring graft 96 preferably comprising velour on an outer surface of the anchoring graft 96, the velour configured to allow skin to grow into it.

[0230] 84. A system according to any one of paragraphs 37 to 76, characterized in that a tubular extension 66 having an extension lumen is attached to the surgical guide tube 1 at the proximal end of the surgical guide tube 1, preferably integrally formed with the surgical guide tube 1, and the extension lumen is configured for inserting a medical device through the tubular extension 66.

[0231] 85. The system according to paragraph 84 including paragraph 76, wherein the system further comprises a connecting portion 74, the connecting portion 74 having a connecting lumen configured to insert a medical device therethrough, the connecting portion 74 connecting the tubular extension 66 to the repositioning unit 54, the connecting portion 74 having a section with a reduced outer diameter, the section being positioned between the repositioning unit 54 and the tubular extension 66, such that a waist portion 76 is formed between the repositioning unit 54 and the tubular extension 66.

[0232] 86. The system described in paragraph 85, characterized in that the central body portion 48 of the fixator 46 forms an arched bridge 80 such that the waist portion 76 can pass between the central body portion 48 and the patient's skin when the fixator 46 is applied to the patient's skin.

[0233] 87. The system described in paragraph 86, wherein the waist portion 76 has a proximal end and a distal end, the waist portion 76 is movable under the bridge 80 along a longitudinal direction, and the movement of the waist portion 76 along the longitudinal direction is stopped at the distal end and the proximal end of the waist portion 76, respectively.

[0234] 88. The system according to paragraph 85, wherein the extension lumen, the connecting lumen, and the repositioning lumen are coaxially aligned with respect to each other.

[0235] 89. A clamping unit 100 configured to secure a medical device, particularly a catheter 30 of an intravascular blood pump, to a patient's body, the clamping unit 100 having a tubular body 102 with a proximal end 104, a distal end 106, and a lumen extending from the proximal end 104 to the distal end 106 of the tubular body 102, configured for inserting a medical device through the tubular body 102, the tubular body 102 having a a surgical guide tube portion 108 at a distal end 106 of the tubular body portion 102, the surgical guide tube portion 108 configured to insert the surgical guide tube portion 108 into the vascular graft 20; A lateral extension 110, the lateral extension 110 defining planar surfaces 112a, 112b, the planar surfaces 112a, 112b configured to be attached to a patient's fascia 26 between a patient's body vessel 24, preferably a blood vessel, more preferably at least one of the axillary artery and the subclavian artery, and the patient's skin, the lateral extension 110 being provided proximal to the surgical guide tube portion 108. a handling portion 114 provided proximally of the lateral extension 110; a rotatable tube 116 configured for inserting a medical device therethrough, the rotatable tube 116 being provided inside the lumen of the tubular body 102 and operably connected to a first lever 118 or a first button, the first lever 118 or the first button being accessible from outside the handling portion 114 and preferably protruding to or extending through an outer surface of the handling portion 114, such that actuation of the first lever 118 or the first button causes rotation of the rotatable tube 116 about a longitudinal axis of the rotatable tube 116 in a non-twisting manner; a flexible tubular foil portion 120 configured for inserting a medical device therethrough, the foil portion 120 being provided inside a lumen of the tubular body portion 102 and being fixed in a non-rotatable manner to the rotatable tube 116 at a proximal connecting portion 122 of the foil portion 120, the foil portion 120 being further fixed in a non-rotatable manner to the inner lumen of the tubular body portion 102 at a distal connecting portion 124 of the foil portion 120, thereby causing the foil portion 120 to twist when the rotatable tube 116 is rotated in a first direction and causing the rotatable tube 116 to untwist when the rotatable tube 116 is rotated in a second direction opposite to the first direction after the rotatable tube 116 has been rotated in the first direction; The clamping unit 100 comprises:

[0236] 90. The clamping unit 100 according to paragraph 89, characterized in that the handling portion 114 further includes a second button 126 or a second lever, which is accessible from outside the handling portion 114 and preferably protrudes to or extends through the circumferential outer surface of the handling portion 114, and which is configured to hold the medical device in a suitable position relative to the lumen of the tubular body portion 102 in a first state and to release the medical device upon actuation of the second button 126 or the second lever, thereby releasing movement of the medical device relative to the inner lumen.

[0237] 91. The clamping unit 100 according to paragraph 89 or 90, characterized in that the handling portion 114 includes a section having a reduced outer diameter, forming a waist portion 128, and the first lever 118 or first button is preferably provided in the waist portion 128 and more preferably does not extend radially beyond the portion of the handling portion 114 adjacent to the waist portion 128.

[0238] 92. The clamping unit 100 according to any one of paragraphs 89 to 91, further comprising a fixator 46 configured for attachment to the patient's skin and configured to hold the clamping unit 100 against the patient's body, the fixator 46 having a central body portion 48 and two fixator wings 50 extending in opposite directions from the central body portion 48, each fixator wing 50 having a planar surface facing a common direction, the central body portion 48 of the fixator 46 forming an arched bridge 80 such that a waist portion 128 of the handling portion 114 of the tubular body portion 102 can pass between the central body portion 48 of the fixator 46 and the patient's skin when the fixator 46 is applied to the patient's skin.

[0239] 93. The clamping unit 100 as described in paragraph 92, characterized in that the waist portion 128 has a proximal end and a distal end, the waist portion 128 is movable under the bridge 80 along the longitudinal direction, and the movement of the waist portion 80 along the longitudinal direction is stopped at the distal end and the proximal end of the waist portion 128, respectively.

[0240] 94. A clamping unit 100 as described in any one of paragraphs 89 to 93, characterized in that at least one of the surgical guide tube portion 108, the lateral extension 110 and the fixator 46 have the same configuration as the surgical guide tube 1, the lateral extension 10 and the fixator 46, respectively, of the system as described in any one of paragraphs 37 to 88.

[0241] 95. A method of providing vascular access to a patient's body vessel, preferably a blood vessel, and more preferably to at least one of the axillary artery and the subclavian artery, the method comprising the steps of: providing a surgical guide tube, the surgical guide tube including a body portion having a proximal end, a distal end, and a guide lumen having a longitudinal axis, the guide lumen extending from the proximal end to the distal end, the guide lumen configured to insert a medical device, in particular a catheter of an intravascular blood pump, through the surgical guide tube; and securing the surgical guide tube to the patient's fascia between the patient's blood vessel and the skin.

[0242] 96. The method of paragraph 95, wherein the surgical guide tube further includes a lateral extension, the lateral extension extending laterally from the body portion and defining a planar surface, the method further comprising the step of attaching the planar surface of the lateral extension to the patient's fascia, preferably by suturing, clamping or adhering the lateral extension to the fascia.

[0243] 97. The method of paragraph 96, wherein the lateral extension includes a proximal planar surface and a distal planar surface, and wherein the lateral extension is attached to the fascia by the proximal planar surface.

[0244] 98. The method of paragraph 96, wherein the lateral extension includes a proximal planar surface and a distal planar surface, and wherein the lateral extension is attached to the fascia by the distal planar surface of the lateral extension.

[0245] 99. The method according to any one of paragraphs 95 to 98, characterized in that the surgical guide tube has the same configuration as the surgical guide tube of the system according to any one of paragraphs 37 to 64.

[0246] 100. The method of any one of paragraphs 95 to 99, characterized in that the method further comprises the step of fixing, preferably by anastomosis, a distal end of the vascular graft to a patient's blood vessel, the vascular graft having a graft lumen extending from a proximal end to a distal end of the graft, the graft lumen being configured to accommodate a distal section of a surgical guide tube within the proximal end of the vascular graft.

[0247] 101. A method as described in paragraph 100, the method further comprising the step of inserting an intravascular blood pump including a catheter at its proximal end into and through the vascular graft and further into the patient's blood vessel, the method preferably including the additional step of advancing the intravascular pump to its intended final location, the final location preferably being the left ventricle of the patient's heart, the surgical guide tube being slidably mounted over an outer surface of the catheter, the method further comprising the step of sliding the surgical guide tube over the outer surface of the catheter such that a distal section of the surgical guide tube is received within the graft lumen at the proximal end of the vascular graft.

[0248] 102. The method of paragraph 101, wherein the diameter of the graft lumen is between 1 and about 1.2 times the outer diameter of the surgical guide tube, preferably about 1.1 times.

[0249] 103. The method according to paragraph 101 or 102, characterized in that the method further comprises the step of fixing the vascular graft to the outer surface of the surgical guide tube, preferably by clamping or suturing the vascular graft to the outer surface of the surgical guide tube, after the surgical guide tube is received within the graft lumen of the vascular graft.

[0250] 104. A method according to paragraph 103, wherein the surgical guide tube further comprises a separate clamping part, the separate clamping part having a proximal end, a distal end and a clamping lumen extending from the proximal end to the distal end of the clamping part, the lateral extension is attached to the clamping part in a non-removable manner and is preferably integrally formed with the clamping part, the clamping part being configured to clamp onto or around the body of the surgical guide tube, and the method comprises the step of fixing the graft to the body of the surgical guide tube by clamping the clamping part onto the vascular graft in which the distal section of the surgical guide tube is housed.

[0251] 105. The method according to paragraph 104, characterized in that the clamping part reduces the diameter of the guide lumen when the distal section of the surgical guide tube is clamped onto the vascular graft housed therein, in particular when the surgical guide tube is provided with two or more bumps or at least one bump and at least one bulge, at a longitudinal position of the surgical guide tube between the bumps or between at least one bump and at least one bulge, thereby fixing the medical device inside the guide lumen and preventing migration of the medical device along the guide lumen.

[0252] 106. The method according to paragraph 103, characterized in that the method further comprises, in particular when the surgical guide tube is provided with two or more bumps or at least one bump and at least one bulge, a step of fixing the vascular graft to the body of the surgical guide tube by applying at least one of at least one suture and at least one fixation clamp at appropriate positions of the surgical guide tube between the bumps or between the at least one bump and the at least one bulge over the graft in which the distal section of the surgical guide tube is housed, the distal section of the surgical guide tube being housed within the vascular graft.

[0253] 107. The method according to paragraph 106, characterized in that at least one suture or at least one fixation clamp, when applied to the vascular graft in which the proximal section of the surgical guide tube is housed, reduces the diameter of the graft lumen, inter alia, to a reduced diameter that is smaller than the outer diameter of the bump or at least one bump and at least one bulge, thereby reducing, and preferably preventing, migration of the surgical guide tube along the graft lumen.

[0254] 108. A method according to paragraphs 106 or 107, characterized in that the fixation clamp reduces the diameter of the guide lumen when the distal section of the surgical guide tube is clamped onto the vascular graft into which it is inserted, in particular between the bumps or between at least one bump and at least one bulge, when the fixation clamp is installed at an appropriate position on the surgical guide tube, thereby fixing the medical device inside the guide lumen and preventing migration of the medical device along the guide lumen.

[0255] 109. The method of any one of paragraphs 95 to 108, further comprising the step of fixing a fixator to the patient's skin so that the medical device is held on the patient's body, the fixator having a central body portion and two fixator wings extending in opposite directions from the central body portion, each fixator wing having a planar surface facing a common direction.

[0256] 110. The method according to paragraph 109, wherein each of the two fixator wings comprises at least one opening, preferably two or more openings, and the method comprises the step of inserting a suture or a clamp through said at least one opening so that the fixator wings are attached to the patient's skin.

[0257] 111. The method of paragraphs 109 or 110, wherein the planar surface of the fixator wing is at least partially covered by an adhesive, and the method further comprises the step of adhering the planar surface to the patient's skin.

[0258] 112. The method of any one of paragraphs 109 to 111, wherein the fixator central body portion has a proximal end, a distal end, and a fixator lumen extending from the proximal end to the distal end of the central body portion, the method further comprising the step of inserting a medical device into and through the fixator lumen, the fixator central body portion preferably being slidably mounted over the medical device.

[0259] 113. A method according to any one of paragraphs 109 to 112, wherein a tubular extension having an extension lumen is attached to the central body of the fixator at a distal end of the central body, preferably integrally formed with the central body of the fixator, the method further comprising the step of inserting a medical device into and through the extension lumen, the tubular extension preferably being slidably mounted on the catheter.

[0260] 114. The method of any one of paragraphs 109 to 113, the method comprising the step of providing a repositioning unit, the repositioning unit having a proximal end, a distal end, and a repositioning lumen extending from the proximal end to the distal end of the repositioning unit, the method further comprising the step of inserting a medical device into and through the repositioning lumen, the repositioning unit comprising at least one button or lever accessible from outside the repositioning unit and preferably protruding to or extending through a circumferential outer surface of the repositioning unit, the button or lever adapted in a first state to hold the medical device in its longitudinal position relative to the repositioning lumen and in a second state to release the medical device upon actuation of the button or lever and allow movement of the medical device relative to the repositioning lumen, the repositioning unit preferably being attached to the proximal end of the central body portion of the fixator.

[0261] 115. The method of any one of paragraphs 109 to 114, characterized in that the method further comprises the step of attaching the fixator to a predetermined location on the patient's skin such that the section of the medical device extending from the fixator to the surgical guide tube is placed in a C-curve on the patient's skin.

[0262] 116. The method of any one of paragraphs 109 to 115, wherein the central body portion of the fixator forms an arched bridge, the method comprising the step of applying the fixator over the medical device onto the patient's skin such that the medical device passes between the central body portion of the fixator and the patient's skin.

[0263] 117. The method of any one of paragraphs 109 to 116, the method including the step of inserting a medical device into and through the fixation graft, the fixation graft preferably including velour on an outer surface of the fixation graft, the velour being configured for skin to grow into, and the method further including the step of implanting the fixation graft under the patient's skin such that a portion of the medical device between the surgical guide tube and the fixator extends under the skin.

[0264] 118. A method according to any one of paragraphs 95 to 111, wherein a tubular extension having an extension lumen is attached to the surgical guide tube at a proximal end of the surgical guide tube, preferably integrally formed therewith, and wherein the method further comprises the step of inserting a medical device into and through the extension lumen.

[0265] 119. The method of paragraph 118 inclusive of paragraph 114, wherein a connecting portion having a connecting lumen connects a tubular extension to a repositioning unit, the method comprising the step of inserting a medical device into and through the connecting lumen, the connecting portion having a section having a reduced outer diameter, the section of reduced diameter being positioned between the repositioning unit and the tubular extension so as to form a waist portion between the repositioning unit and the tubular extension.

[0266] 120. The method of paragraph 119, wherein the central body portion of the fixator forms an arched bridge, the method comprising the step of applying the arched bridge of the fixator over the waist portion of the connection portion onto the patient's skin such that the waist portion passes between the central body portion of the fixator and the patient's skin.

[0267] 121. The method of paragraph 120, wherein the waist portion of the connecting part has a proximal end and a distal end, the waist portion is movable along a longitudinal direction under the arched bridge of the fixator, and movement of the waist portion along the longitudinal direction is stopped at the distal end and the proximal end of the waist portion, respectively.

[0268] 122. The method according to any one of paragraphs 95 to 112, characterized in that the surgical guide tube and the lateral extension form part of a clamping unit according to any one of paragraphs 89 to 91.

[0269] 123. The method of paragraph 122, inclusive of paragraph 109, wherein the central body portion of the fixator forms an arched bridge, and the method includes the step of applying the fixator over a waist portion of the clamping unit onto the patient's skin such that the waist portion passes between the central body portion of the fixator and the patient's skin.

[0270] 124. A method as described in paragraph 123, characterized in that the waist portion of the clamping unit has a proximal end and a distal end and is movable along a longitudinal direction under the arched bridge of the fixator, and movement of the waist portion along the longitudinal direction is stopped at the distal and proximal ends of the waist portion, respectively.

[0271] 125. A method for stabilizing a medical device, including a catheter, in a blood vessel of a patient, the method comprising: - opening the patient's skin to gain access to a blood vessel; - connecting the vascular graft to the blood vessel by an anastomosis; - introducing a medical device through the graft and into the blood vessel such that the catheter extends through the graft; - twisting the graft to reduce its internal diameter, thereby clamping the catheter inside the graft; A method comprising:

[0272] 126. The method of paragraph 125, further comprising the step of maintaining the twisted graft in a twisted state such that the twisted graft cannot untwist.

[0273] 127. The method according to paragraph 126, characterized in that the method includes a step of clamping a proximal part of the twisted graft to the catheter using a clamp.

[0274] 128. A method according to paragraph 126 or 127, characterized in that the method preferably includes a step of suturing the twisted graft to hold it in a twisted state after the proximal part of the twisted graft has been clamped to the catheter.

[0275] 129. The method of paragraph 128, further comprising the step of shortening the twisted graft before or after suturing the twisted graft.

[0276] 130. The method of paragraph 125, wherein the step of connecting the graft to the blood vessel by an anastomosis includes the step of suturing the graft to the blood vessel to create a seam between the graft and the blood vessel.

[0277] 131. The method of paragraph 130, characterized in that the method further comprises the step of reinforcing the seam with glue.

[0278] 132. The method of paragraph 125, wherein the medical device is an intravascular blood pump, and the step of introducing the medical device into the blood vessel includes the step of advancing the intravascular blood pump into the patient's axillary artery or subclavian artery until a pumping device of the intravascular blood pump reaches into the patient's heart.

[0279] 133. The method of paragraph 125, wherein the medical device includes a plug that is slidable along the catheter, and the step of introducing the medical device into the blood vessel includes the step of positioning the slidable plug over the catheter inside the graft so that the slidable plug abuts or is in close proximity to the blood vessel.

[0280] 134. The method according to paragraph 133, characterized in that the slidable plug has a closed form, preferably a closed cylindrical form, and particularly preferably, the outer form of the slidable plug corresponds to a cylinder.

[0281] 135. The method according to paragraph 134, wherein the slidable plug has a through hole through which the catheter can extend, the through hole having a hexagonal shape in cross section, preferably in the form of a hexagonal prism.

[0282] 136. The method according to paragraph 133, characterized in that the slidable plug is made of silicone rubber.

[0283] 137. The method of paragraph 133, wherein the slidable plug has a strength of 50 Shore A.

[0284] 138. The method of paragraph 133, the method preferably further comprising the step of placing a slotted shim around the graft at a location distal to the intended location of the slidable plug inside the graft prior to placing the plug inside the graft, the shim preferably including an eyelet, and the method further comprising the step of securing the eyelet to the patient's fascia.

[0285] 139. The method of paragraph 138, wherein the step of twisting the graft to reduce its inner diameter includes the step of holding a slotted shim, thereby generating an opposing force against the torsional forces caused by the twisting step.

[0286] 140. The method according to paragraph 138, characterized in that the slotted shim is not elastic and is preferably made of PEEK.

[0287] 141. The method of paragraph 125, further comprising the steps of pushing the twisted graft into the patient's body with the catheter extending through the twisted graft, and closing the open skin around the catheter.

[0288] 142. The method of paragraph 125, wherein a sleeve is provided around the twisted graft, the sleeve preventing tissue ingrowth into the graft.

[0289] 143. A kit for stabilizing a medical device including a catheter 30, the kit comprising: A vascular graft 20, through which a medical device can be introduced and through which a catheter 30 can extend; a plug 31, the plug 31 being configured to be slidable along the catheter 30, the plug 31 being insertable into the graft 20, preferably while installed on the catheter 30; and A kit comprising:

[0290] 144. The kit according to paragraph 143, wherein the graft 20 is a knitted fabric, a warp knitted fabric, a knotted fabric, a woven fabric, or a nonwoven fabric.

[0291] 145. A kit according to paragraph 143 or 144, characterized in that the graft 20 is configured to be twistable to reduce its inner diameter, thereby clamping the catheter 30 inside the graft 20.

[0292] 146. A kit according to any one of paragraphs 143 to 145, characterized in that the graft 20 is suturable, preferably suturable in a twisted state.

[0293] 147. A kit according to any one of paragraphs 143 to 146, characterized in that the plug 31 has a closed form, preferably a closed cylindrical form, and particularly preferably, the outer form of the slidable plug 31 corresponds to a cylinder.

[0294] 148. A kit according to any one of paragraphs 143 to 146, characterized in that the plug 31 has a through hole and the catheter 30 is capable of extending through the through hole.

[0295] 149. The kit according to paragraph 148, characterized in that the through hole has a hexagonal shape in cross section, preferably in the form of a hexagonal prism.

[0296] 150. A kit according to any one of paragraphs 143 to 149, characterized in that the plug 31 is made of silicone rubber.

[0297] 151. A kit according to any one of paragraphs 143 to 150, characterized in that the plug 31 has a strength of 50 Shore A.

[0298] 152. A kit according to any one of paragraphs 143 to 151, characterized in that the kit further comprises a slotted shim 33 configured to be placed around the graft 20.

[0299] 153. The kit according to paragraph 152, characterized in that the slotted shim 33 is not elastic and is preferably made of PEEK.

[0300] 154. A kit as described in any one of paragraphs 152 or 153, wherein the slotted shim 33 includes radially extending slots, and the graft can be passed through the radially extending slots with the catheter extending through the graft.

[0301] 155. A kit according to any one of paragraphs 152 to 154, characterized in that the shim 33 is provided with an eyelet 1133A, the eyelet 1133A being configured to be fixed to the patient's fascia.

[0302] 156. A kit according to any one of paragraphs 152 to 155, characterized in that the inner diameter of the slotted shim 33 is smaller than the outer diameter of the plug 31.

[0303] 156. A kit according to any one of paragraphs 152 to 155, characterized in that the inner diameter of the slotted shim 33 is greater than the outer diameter of the medical device.

[0304] 157. A kit according to any one of paragraphs 143 to 156, characterized in that the kit further comprises an intravascular blood pump as a medical device.

[0305] 158. A kit according to any one of paragraphs 145 to 157, characterized in that the kit further comprises a clamp 32, the clamp 32 being configured to clamp the proximal part of the twisted graft 20 to the catheter 30. [Explanation of symbols]

[0306] 1 surgical guide tube, 2 tubular body, 4 proximal end of tubular body, 6 distal end of tubular body, 8 longitudinal axis of guide lumen, 10 lateral extension, 12a proximal planar surface, 12b distal planar surface, 14 opening, 16 circumferential bump, 18 distal bulge, 20 vascular graft / graft, 20a twisted portion of graft, 20b sutures on twisted portion of graft, 21 proximal end of graft, 22 distal end of graft, 24 blood vessel, 26 fascia, 28 sutures for fixing surgical guide tube to graft, 29 sutures for fixing lateral extension to fascia, 30 catheter, 31 plug, 32 fixation clamp, 33 slotted shim, 34 clamping part, 36 proximal end of separate clamping part, 38 Distal end of proximal clamping part, 40 Proximal bulge, 42 Arm of clamping part, 44 Interlocking profile, 46 Fixator, 48 Central body part of fixator, 50 Fixator wing, 52 Opening of fixator wing, 54 Repositioning unit, 56 Proximal end of repositioning unit, 58 Distal end of repositioning unit, 60 Button of repositioning unit, 62 Proximal end of central body part, 64 Distal end of central body part, 66 Tubular extension, 68 Sleeve portion, 70 Distal portion of tubular extension, 72 Tapered portion, 74 Connecting portion, 76 Waist portion, 78 Central region, 80 Bridge, 82 Guide sleeve, 84 Sealing, 86 Proximal sleeve, 88 Distal portion of connecting portion, 90 Engagement structure of connecting portion, 92 Engagement structure of tubular extension, 94 Guide tube, 96; anchoring graft, 98; skin access, 100; clamping unit, 102; tubular body portion, 104; proximal end of tubular body portion, 106; distal end of tubular body portion, 108; surgical guide tube portion, 110; lateral extension, 112a; proximal planar surface, 112b; distal planar surface, 114; handling portion, 116; rotatable tube, 118; lever, 120; tubular foil portion, 122; proximal connecting portion, 124; distal connecting portion, 126button, 128 waist portion, 130 central region, 200 skin, 1031 through hole, 1033 slot, 1133 main body portion, 1133A eyelet, 1233 end surface, a distance, b inner diameter, c outer diameter, d span of longitudinal movement, t thickness, e outer diameter, f distance, g distance, A imaginary axis of rotation.

Claims

1. A surgical guide tube (1) configured for insertion into a vascular graft (20), said surgical guide tube (1) comprising: a body (2) having a proximal end (4), a distal end (6), and a guide lumen having a longitudinal axis (8), the guide lumen extending from the proximal end (4) to the distal end (6) of the body (2) and configured for insertion of a medical device, particularly a catheter (30) of an intravascular blood pump, through the body (2); a lateral extension (10) extending laterally from the main body portion (2) and defining planar surfaces (12a, 12b), the planar surfaces (12a, 12b) configured to be attached to the patient's fascia (26) between the patient's body vessel (24), preferably a blood vessel, more preferably at least one of the axillary artery and the subclavian artery, and the patient's skin; Including, The planar surfaces (12a, 12b) of the lateral extension (10) are inclined at an angle of about 30° to 60°, preferably 45°, relative to the longitudinal axis (8) of the guide lumen.

2. 2. The surgical guide tube according to claim 1, further comprising a separate clamping part having a proximal end, a distal end, and a clamping lumen extending from the proximal end to the distal end of the clamping part, wherein the lateral extension is non-detachably attached to the clamping part and preferably integrally formed with the clamping part, the clamping part being configured to clamp onto the main body such that the planar surfaces of the lateral extension are inclined by the inclination angle relative to the longitudinal axis of the guide lumen.

3. 3. A surgical guide tube (1) according to claim 2, characterized in that the clamping part (34) comprises at least two arms (42) extending in substantially opposite circumferential directions and each provided with an interlocking profile (44), arranged such that when the arms (42) are moved past each other the cross section of the clamping lumen is narrowed and interlocked with each other via the interlocking profiles (44).

4. 2. A surgical guide tube (1) according to claim 1, characterized in that the periphery of the distal end of the surgical guide tube (1) lies in a plane inclined by approximately 30° to 60°, preferably 45°, relative to the longitudinal axis (8) of the guide lumen.

5. 5. A kit comprising the surgical guide tube (1) of any one of claims 1 to 4 and a vascular graft (20), wherein the vascular graft (20) has a proximal end configured to insert the distal end of the surgical guide tube (1) therein, a distal end (22) configured to fix the vascular graft (20) to a patient's blood vessel (24), and a graft lumen extending from the proximal end of the graft (20) to the distal end (22) of the graft (20), the graft lumen configured to accommodate a distal section of the surgical guide tube (1).

6. 6. A kit according to claim 5, characterized in that the surgical guide tube (1) includes the clamping part (34) as defined in claim 2, and the clamping part (34) is configured to fix the graft (20) to the surgical guide tube (1) by clamping the clamping part (34) onto the graft (20) when the surgical guide tube (1) is inserted into the graft (20).

7. 6. A kit according to claim 5, further comprising a medical device, in particular a catheter (30), configured for insertion into and through the guide lumen of the surgical guide tube (1), characterized in that the surgical guide tube (1) is preferably slidable over the outer surface of the medical device.

8. 1. A system configured to secure a medical device to a patient's body, the system comprising: (a) a surgical guide tube (1) configured for insertion into a vascular graft (20); The surgical guide tube (1) comprises: a body (2) having a proximal end (4), a distal end (6), and a guide lumen having a longitudinal axis (8), the guide lumen extending from the proximal end (4) to the distal end (6) of the body (2) and configured for insertion of a medical device, particularly a catheter (30) of an intravascular blood pump, through the body (2); a lateral extension (10) extending laterally from the main body portion (2) and defining planar surfaces (12a, 12b), the planar surfaces (12a, 12b) configured to be attached to the patient's fascia (26) between the patient's body vessel (24), preferably a blood vessel, more preferably at least one of the axillary artery and the subclavian artery, and the patient's skin; Including, The system also includes: (b) a fixator (46) configured to secure the fixator (46) to the patient's skin and to hold the medical device to the patient's body, the fixator (46) having a central body portion (48) and two fixator wings (50) extending in opposite directions from the central body portion (48), each fixator wing (50) having a planar surface facing a common direction.

9. 10. The system of claim 8, further comprising a repositioning unit (54), the repositioning unit (54) having a proximal end (56), a distal end (58), and a repositioning lumen extending from the proximal end (56) to the distal end (58) of the repositioning unit (54), the repositioning lumen configured to insert the medical device through the repositioning unit (54), the repositioning unit (54) including at least one button (60) or lever operable from outside the repositioning unit (54). a button or lever that is accessible and preferably projects to or extends through a circumferential outer surface of the repositioning unit (54), the button or lever being configured to, in a first state, hold the medical device in its longitudinal position relative to the repositioning lumen, and to, in a second state, release the medical device upon actuation of the button or lever, allowing movement of the medical device relative to the repositioning lumen.

10. 10. The system of claim 8 or 9, wherein the central body portion (48) forms an arched bridge (80) that allows the medical device to pass between the central body portion (48) and the patient's skin when the fixator (46) is applied to the patient's skin.

11. 11. The system of claim 10, further comprising an anchoring graft (96) configured to implant the anchoring graft (96) under the patient's skin and configured to insert the medical device through the anchoring graft (96), the anchoring graft (96) preferably comprising velour on an outer surface thereof, the velour configured to allow tissue under the skin to grow into it.

12. 10. The system according to claim 8 or 9, characterized in that a tubular extension (66) having an extension lumen is attached to the surgical guide tube (1) at the proximal end of the surgical guide tube (1), preferably integrally formed with the surgical guide tube (1), the extension lumen being configured to insert the medical device through the tubular extension (66).

13. 13. The system of claim 12, including claim 9, further comprising a connecting portion (74) having a connecting lumen configured to insert the medical device therethrough, the connecting portion (74) connecting the tubular extension (66) to the repositioning unit (54), the connecting portion (74) having a section with a reduced outer diameter positioned between the repositioning unit (54) and the tubular extension (66) to form a waist portion (76) between the repositioning unit (54) and the tubular extension (66).

14. 14. The system of claim 13, wherein the central body portion (48) of the fixator (46) forms an arched bridge (80) that allows the waist portion (76) to pass between the central body portion (48) and the patient's skin when the fixator (46) is applied to the patient's skin.

15. A clamping unit (100) configured to secure a medical device, particularly a catheter (30) of an intravascular blood pump, to a patient's body, the clamping unit (100) having a tubular body (102) with a proximal end (104), a distal end (106), and a lumen extending from the proximal end (104) to the distal end (106) of the tubular body (102), the lumen configured to allow insertion of the medical device through the tubular body (102), the tubular body (102) comprising: a surgical guide tube portion (108) at the distal end (106) of the tubular body portion (102), the surgical guide tube portion (108) configured for insertion of the surgical guide tube portion (108) into a vascular graft (20); and a lateral extension (110) defining planar surfaces (112a, 112b) configured to be attached to a patient's fascia (26) between a patient's body vessel (24), preferably a blood vessel, more preferably at least one of the axillary artery and the subclavian artery, and the patient's skin, the lateral extension (110) being provided proximal to the surgical guide tube portion (108); a handling portion (114) provided proximally of said lateral extension (110); a rotatable tube (116) configured for insertion of the medical device therethrough, the rotatable tube (116) being provided inside the lumen of the tubular body (102) and operably connected to a first lever (118) or first button accessible from outside the handling portion (114) and preferably protruding to or extending through an outer surface of the handling portion (114), wherein actuation of the first lever (118) or first button causes rotation of the rotatable tube (116) about a longitudinal axis of the rotatable tube (116) in a non-twisting manner; a flexible tubular foil portion (120) configured for insertion of the medical device therethrough, the foil portion (120) being provided inside the lumen of the tubular body portion (102) and fixed in a non-rotatable manner to the rotatable tube (116) at a proximal connection portion (122) of the foil portion (120), and the foil portion (120) being fixed to the tubular body (102) at a distal connection portion (124) of the foil portion (120); a flexible tubular foil portion (120) further fixed in a non-rotatable manner to the lumen of the portion (102), thereby causing the foil portion (120) to twist when the rotatable tube (116) is rotated in a first direction, and causing the rotatable tube (116) to untwist when the rotatable tube (116) is rotated in a second direction opposite to the first direction after being rotated in the first direction; A clamping unit (100) comprising:

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