Biomedical device, system comprising the same, method of percutaneous peripheral intubation of an in vivo tube and method of adapting an external

Abstract

The invention relates to a biomedical device (101) for percutaneous puncture catheterization of an in-vivo conduit (13), in particular for arterial puncture catheterization, comprising an introducer assembly (1), the invention relates to an introducer assembly (1) having a dilator (2) for dilating an insertion site (131) of a patient (14) for access to an intracorporeal conduit (13), the dilator (2) having a constricted outer section (21) and at least one distal opening (22), a sheath (3) for introduction into the intracorporeal conduit (13), and an inner guide unit (4) for guiding the dilator (2) and / or the sheath (3) into the intracorporeal conduit (13), the guide unit (4) has at least one distal opening (32) and is arranged at least partially concentrically around the guide unit (4), and the sheath tube (3) has at least one distal opening (32) and is arranged at least partially concentrically around the dilator (2), such that the guide unit (4), the dilator (2) and the sheath tube (3) can be moved relative to one another in a longitudinal direction (L) of the guide assembly (1). The dilator (2) can be guided along the guide unit (4) after insertion of the piercing element (41) into the internal conduit (13) without removing the piercing element (41) for piercing the internal conduit (13) at the proximal end (5) of the introducer assembly (1).

Description

Technical Field

[0001] The present invention relates to a biomedical device, a system comprising the biomedical device, a method for percutaneous puncture and catheterization of an in-vivo channel, and a method for matching an in-vivo channel with an external imaging mechanism. Background Art

[0002] In percutaneous catheterization, in order to insert a catheter, it is necessary to pierce a vessel in the body, particularly an arterial vessel in the body. In the prior art, catheterization into the arterial and / or venous system is usually performed using a femoral artery puncture (Seldinger or Seldinger) technique.

[0003] The Seldinger technique involves placing a cannula in a body vessel and introducing a guidewire surrounded by the cannula through the cannula into the body vessel. Subsequently, the cannula is retracted from the proximal end of the guidewire, allowing the dilator and ultimately the catheter sheath to be advanced over the guidewire into the body vessel.

[0004] US 5,7493,71A discloses an automatic guidewire placement device using the Seldinger technique, the device having a hollow cannula with a gripping device at the tip for releasably engaging a guidewire.

[0005] N. Zevallos et al. disclosed a robotic-assisted arterial puncture and catheterization technique using the Seldinger technique in the paper "Toward Robotically Automated Femoral Vascular Access" published at the 2021 International Symposium on Medical Robotics (ISMR).

[0006] A particularly time-consuming and complex step, especially with non-manually automated implementation of the Seldinger technique, is the removal of the cannula by fully retracting the coaxial cannula over the guidewire.

[0007] Generally speaking, the prior art lacks a simple, reliable and time-saving method to achieve percutaneous catheterization of a body channel, especially automated percutaneous catheterization. Summary of the invention

[0008] The present invention is directed to overcoming these and other disadvantages of the prior art. Specifically, the present invention is directed to providing a device and system to reduce and / or optimize the number of steps required for surgical catheterization, particularly catheterization using the Seldinger technique, and to providing a standardized technique for atraumatic catheterization.

[0009] Another object of the present invention is to provide a biomedical device and system with reduced complexity.

[0010] This object is solved by a biomedical device, a system comprising a biomedical device, a method for percutaneous catheterization and a method for coupling to an external imaging mechanism as described in the independent claims. Further embodiments are defined in the dependent claims.

[0011] The biomedical device according to the present invention is used for percutaneous catheterization of a body pipeline, in particular arterial catheterization. The device includes an introducer assembly, which has a dilator, which is used to expand the patient's insertion site to enter the body pipeline. The device also includes a sheath for introducing the body pipeline and an inner guide unit for guiding the dilator and / or the sheath into the body pipeline. The dilator has a narrowed outer section and at least one distal opening, and the dilator is at least partially arranged concentrically around the guide unit or can be arranged concentrically around the guide unit. The sheath has at least one distal opening and is at least partially arranged concentrically around the dilator.

[0012] Once the puncture element is inserted into the body tract, the dilator can be guided along the guide unit without completely pulling the puncture element out of the proximal end of the introducer assembly.

[0013] The proximal end refers to the end of the introducer assembly that may be positioned proximally outside the patient's body relative to the insertable distal end of the introducer felt by the surgeon.

[0014] The introducer assembly may be a consumable introducer assembly having pre-matched movable parts for use with the robotic drive device.

[0015] The guide unit may include or consist of a guide wire, a puncture element and / or an insertion guide.

[0016] The piercing element may be a cannula, optionally a commercially available cannula having a hollow cylindrical cannula shape and a pointed distal end that is sharpened with a bevel grind.

[0017] The dilator and the narrowed outer section of the sheath may be configured to be introduced into a body vessel atraumatically via an introduction unit.

[0018] The guide unit may include an insertion guide for inserting a puncture element or a guide wire. The insertion guide has a distal section and a proximal section. The proximal section has a proximal lumen for at least partially receiving the puncture element or the guide wire. The distal section has a distal lumen for receiving the puncture element or the guide wire. The distal lumen and the proximal lumen are interconnected.

[0019] In this embodiment, the distal section has a lateral opening at the proximal end through which the puncture element can be reversibly inserted into the distal lumen, and has a distal opening from which the puncture element can be inserted into the body duct.

[0020] The distal section of the insertion guide is insertable into the body duct, with the puncture element protruding from the distal opening thereof.

[0021] The puncture element does not need to be fully retracted from the proximal end of the introducer assembly, but can be retracted from the side opening located in the middle position. Therefore, catheter insertion becomes easier. In addition, the insertion guide can be inserted into the body channel at the same time as the puncture element, thereby further simplifying the catheter insertion step.

[0022] The openings of the device, in particular the distal opening, the lateral openings, at least one distal opening of the dilator and / or the sheath may include a hemostatic valve for reducing leakage and / or blood backflow.

[0023] The distal lumen of the insertion guide may extend in a straight line between the lateral opening and the distal opening of the distal section.

[0024] Alternatively, the distal section of the insertion guide may be elastically deformable such that the distal lumen may assume a straight line shape between the lateral opening and the distal opening.

[0025] The distal lumen of the insertion guide extends in a straight line, making it possible to easily insert and remove the puncture element, which may have a straight shape and is not easily bent.

[0026] The length of the distal lumen of the insertion guide in the longitudinal direction is preferably sufficient to reliably guide the puncture element into the body duct, and is short enough to allow rapid insertion and removal of the puncture element, which is usually in the form of a cannula. The length of the distal lumen ranges from 1 cm to 20 cm, preferably from 7 cm to 20 cm.

[0027] The longitudinal axis of the proximal section of the insertion guide may be arranged or arrangeable at an angle of 1° to 125°, preferably 10° to 75°, in particular 20° to 50° relative to the longitudinal axis of the distal section of the insertion guide.

[0028] Such an angle enables reliable insertion of the puncture element while enabling the guidewire to be inserted into the proximal and distal lumens of the insertion guide. The guidewire is flexible enough to accommodate the angle between the distal and proximal sections of the insertion guide.

[0029] The dilator may be arranged or arrangeable coaxially around the insertion guide and configured to be advanced relative to the insertion guide in a longitudinal direction of the insertion guide.

[0030] The expander can also be arranged or can be arranged to coaxially surround the guide wire and be configured to be advanced relative to the guide wire in the longitudinal direction of the guide wire. The outer sleeve portion of the proximal and distal sections can have a release opening extending in the longitudinal direction. The release opening can be permanently open or can be opened. The release opening is configured to radially release the guide wire that is at least partially arranged or can be arranged in the proximal and distal lumens.

[0031] A dilator coaxially arranged around the insertion guide and pushable in the longitudinal direction relative to the insertion guide makes it possible to easily introduce the dilator into the body duct through the proximal and distal sections of the insertion guide.

[0032] The distal and proximal sections of the insertion guide may have a constant cross-sectional dimension along their length so that the dilator may be advanced over the entire insertion guide.

[0033] The insertion guide may extend at least partially, in particular completely, through the lumen of the dilator.

[0034] A dilator coaxially disposed about a guidewire and longitudinally advanceable relative to the guidewire allows the use of existing commercially available dilator, sheath, and guidewire assemblies for performing the Seldinger technique. The guidewire can be radially removed from the introducer guide so that the introducer guide does not have to be removed through the proximal end of the device. Thus, the guidewire can remain in place and the introducer guide can be removed from the patient site before the dilator is advanced over the guidewire to insert the introducer assembly.

[0035] The dilator and / or sheath may include a hydrophobic coating to allow atraumatic insertion into a body vessel.

[0036] The size of the dilator and / or sheath may be between 1 French (Fr) and 34 Fr, in particular between 3 Fr and 16 Fr, wherein 1 Fr is equal to 0.33 mm.

[0037] The dilator and / or sheath may include or consist of a thermoplastic such as silicone, polyethylene, polypropylene, polyetheretherketone, fluoropolymers, polyvinyl chloride, and / or polyurethane.

[0038] The device may include multiple dilators and / or sheaths.

[0039] The guide wire of the guide unit may be pre-matched in the proximal lumen of the proximal section of the insertion guide of the guide unit.

[0040] The guide unit and in particular the insertion guide, the guide wire and / or the puncture element may comprise or consist of metal, preferably stainless steel or a shape memory alloy, in particular Nitinol.

[0041] The puncture element may have the shape of a hollow cylindrical cannula.

[0042] The puncture element may include at least one retaining structure. The retaining structure may have a groove on the outer surface and be radially open outward to receive a guide wire extending at least partially along the longitudinal direction of the puncture element.

[0043] The retaining structure may also have a lumen defined by a wall that is at least partially open or openable for radially releasing a guidewire that is at least partially disposed or displaceable in the lumen.

[0044] The retaining structure may alternatively have an attachment mechanism for attaching the guide wire in parallel to the puncture element.

[0045] The retaining structure may include a retaining state for re-securing the guidewire at the puncture member and a releasing state for radially releasing the guidewire from the lumen or recess of the puncture member.

[0046] The retention structure is capable of being switched, optionally reversibly, from a retention state to a release state, for example by rotational or translational movement of the retention structure and / or the guidewire relative to each other or relative to the introducer assembly.

[0047] The retaining structure may include a spring-loaded tip of the puncture element. The spring-loaded tip may be switched from a retaining state to a releasing state. The spring-loaded tip may be switched to a retaining state when compressed and to a releasing state when decompressed. Thus, the spring-loaded tip may secure the guidewire during introduction through the skin and tissue into the body conduit while being compressed, and may release the guidewire within the body conduit in response to a reduction in the compressive force within the body conduit.

[0048] The retaining structure may include a mechanical coupler element to frictionally engage the puncture element, optionally a bioabsorbable glue or a lumen within the puncture element for applying local suction to secure the guidewire. The guidewire may have a lumen for applying local suction to secure the guidewire.

[0049] The holding structure can be converted by applying local vibration to overcome the frictional engagement of the mechanical coupling elements. The holding structure can also be converted by eliminating the connection provided by the preferably bioabsorbable glue. The holding structure can be converted from a holding state (wherein suction is applied to the lumen of the puncture element or guidewire) to a released state by stopping the local suction force on the lumen.

[0050] Thus, once the guidewire has been inserted into the body duct, the retaining structure can be converted to a released state to release the guidewire.

[0051] The open or openable lumen may comprise at least one, in particular two, jacket parts. The first and second jacket parts may be movable relative to each other. The first and second jacket parts may form a C-shape, in particular a C-shape with different diameters, such that one of the jacket parts may be positioned to be at least partially surrounded by the other jacket part.

[0052] The groove or lumen may be arranged partly in the longitudinal direction of the puncture element and partly in the circumferential direction of the puncture element, in particular along a spiral or curved path. Such a spiral or curved path may hinder the movement of the guide wire relative to the puncture element in the longitudinal direction of the puncture element due to increased friction.

[0053] To increase static friction and / or sliding friction, the groove or lumen of the puncture element may be configured to frictionally engage the guidewire.

[0054] The puncture element can be relatively long and can be 6 cm to 35 cm in length, preferably 8 cm to 30 cm, more preferably 12 cm to 25 cm in length. The proximal end of the puncture element can be connected to the distal end of the guide wire so that the puncture element and the guide wire are substantially flush with each other.

[0055] A relatively long puncture element allows the dilator to be introduced coaxially directly around the puncture element into the body vessel, in particular without the need for a guide wire.

[0056] The puncture element connected to the distal end of the guide wire has the following advantages: the longitudinal length of the puncture element can be shorter than 6 cm, less than 2 cm, preferably less than 1 cm. Since the puncture element is shorter and harder, when the dilator is introduced into the body duct, the dilator can be more reliably advanced along the more flexible guide wire portion.

[0057] The puncture element and the guide wire can each have different elastic properties. For example, the guide wire can have a lower bending stiffness than the puncture element, so that the curvature of the guide wire can be more easily adapted to the in vivo pipeline and / or introducer assembly.

[0058] The guide wire connected to the puncture element can still be used as a push rod, moving longitudinally relative to the introducer assembly to guide the puncture element, and the expander can be coaxially guided around the puncture element connected to the guide wire into the body channel.

[0059] The puncture element connected to the distal tip of the guidewire end allows avoiding the traditional steps of the Seldinger technique, namely, introducing the guidewire separately after the puncture element is introduced, and retracting the puncture element after the guidewire is introduced into the body vessel.

[0060] The puncture element can be connected or connectable to the expander and includes an actuating element, in particular a spring, which can be switched between a retracted state and an extended state. By switching the actuating element, the puncture portion of the puncture element for contacting and puncturing tissue can be retracted behind the non-puncture surface, or the non-puncture surface can be advanced to shield the puncture portion.

[0061] Then, the puncture element can be used to pierce tissue, and in addition makes it atraumatic by the non-puncture surface.In addition, the puncture element with the non-puncture surface of the protection puncture surface can be used to directly introduce the dilator, without the need for guide wire and / or insertion guide.

[0062] The non-piercing surface may be located at the distal end of the dilator or on a separate element of the introducer assembly.

[0063] The non-puncturing surface and / or the actuating element may be arranged concentrically in the lumen of the puncturing element. The puncturing element may in particular be a Veress cannula.

[0064] The puncture element may include an anchor, which is at least partially arranged circumferentially on the puncture element and preferably forms a longitudinal portion of the puncture element. The anchor includes a collapsed configuration and an expanded configuration. The radial dimension of the collapsed configuration is smaller than the radial dimension of the expanded configuration.

[0065] In the deployed configuration, the anchor can prevent the puncture element from advancing into the patient's body, particularly into the body duct, beyond a predetermined longitudinal distance of the puncture element.

[0066] The anchor in the expanded configuration can additionally or alternatively prevent the puncture element from being retracted from the body channel beyond a predetermined longitudinal distance of the puncture element, particularly by contacting the inner wall of the body channel. This can firmly anchor the puncture element in the body channel and prevent the puncture element from being accidentally removed from the body channel.

[0067] This anchor prevents potential damage caused by inserting the puncture element too deep into the patient's skin or a duct in the patient's body. In addition, this puncture element can be used to insert a dilator directly onto the puncture element, thereby eliminating the need for a guide wire and / or insertion guide.

[0068] The predetermined longitudinal distance may be smaller than the width of the internal channel, or larger than the distance from the puncture position of the puncture element on the patient's skin to the internal channel. The anchor may contact the patient's skin or the outer wall of the internal channel in the expanded state.

[0069] The expander may include an anchor actuator such that upon longitudinal movement of the expander relative to the puncturing element, the anchor actuator engages the anchor in the expanded configuration to transition the anchor from the expanded configuration to the collapsed configuration.

[0070] The dilator may include a longitudinal slot disposed adjacent to the distal opening of the dilator. The longitudinal slot is configured to advance through the anchor in a longitudinal direction of the puncture element.

[0071] The anchor actuator may include a radially extending protrusion at least partially circumferentially disposed on the piercing element and spaced a predetermined longitudinal distance from the anchor such that the protrusion is engageable with the expander with the slot advanced over the anchor.

[0072] The anchor may be biased towards the deployed configuration, in particular due to a spring element, in particular by a spring element exerting a restoring force on the anchor. Thus, when the anchor is not secured or engaged by an anchor actuator of the expander, the anchor assumes the deployed configuration as a default state.

[0073] At least a portion of the sheath, dilator and / or guide unit, in particular the puncture element, can be connected to at least one mechanical coupling. Relative longitudinal movement of one of these components (at least a portion of the sheath, dilator and / or guide unit) beyond a predetermined point causes the coupling to longitudinally move another of these components.

[0074] The coupling enables movement of components of the introducer assembly (particularly the dilator, the sheath) and at least a portion of the guide unit (particularly the puncture element) so that they can be coupled to or separated from each other.

[0075] The coupler may be configured to couple the components only one-way, particularly in the distal or proximal direction of the introducer assembly, or to couple the components bidirectionally, in both the proximal and distal directions of the introducer assembly.

[0076] The coupling may comprise at least one, in particular two coupling elements.

[0077] The coupler may include a first coupling element located on one of the sheath, dilator or a portion of the guide unit and a second coupling element located on the other of the sheath, dilator or a portion of the guide unit. The coupling elements may be formed to positively engage each other at a predetermined point.

[0078] The coupling may include at least one groove and / or at least one protrusion extending in the radial direction.

[0079] The grooves and / or protrusions may be arranged at least partially in the circumference of the dilator, the sheath or at least part of the guiding unit (in particular the puncture element).

[0080] In one embodiment of the invention, only a single actuation unit configured to drive the guide unit is required, and a plurality of couplers may be arranged to allow insertion of the sheath through the dilator and guide unit and retraction of the dilator and guide unit. This may be achieved by a dilator comprising two coupling elements for engaging the guide unit, in particular the puncture element, and preferably comprising one coupling element for engaging the sheath.

[0081] The coupling elements of the expander and the guide unit can be arranged so that the advancement of the guide unit in the distal direction beyond the first predetermined position causes the guide unit and the expander to advance in unison. In addition, the coupling elements can be arranged so that the retraction of the guide unit in the proximal direction beyond the second predetermined position causes the guide unit and the expander to retract in unison.

[0082] The dilator may have a coupling element that allows distal movement of the dilator to be coupled to the sheath by engaging a coupling element of the sheath, while retraction of the dilator is independent of movement of the sheath.

[0083] The present invention also relates to a system for percutaneous cannulation of a body conduit, in particular arterial catheter insertion, through an insertion site of a patient's skin using a biomedical device having an introducer assembly, in particular the biomedical device described previously. The introducer assembly has a dilator for enlarging the patient's insertion site to enter the body conduit, a sheath for introducing the body conduit, and an inner guide unit for guiding at least one of the dilator and the sheath into the body conduit. The dilator has a tapered outer section and at least one distal opening, and is at least partially arranged concentrically around the guide unit. The sheath has at least one distal opening, and is at least partially arranged or can be arranged concentrically around the dilator. The guide unit, the dilator and the sheath can be moved relative to each other in the longitudinal direction of the introducer assembly. The system includes at least one actuating unit configured to actuate at least one of the dilator, the sheath and the guide unit in the longitudinal direction, in particular two, preferably all, in particular the puncture element of the guide unit of the device and at least one of the insertion guide and / or guidewire. The system includes a shearing unit that can be actuated to shear an opening at the insertion site, particularly an incision extending from or across the insertion site. As used in this application, shearing refers to any separation of tissue parts by means of a scalpel, scissors, or any other instrument for sharp or blunt dissection.

[0084] The guide unit may include or consist of a guide wire, an insertion guide and / or a puncture element.

[0085] The piercing element may be a cannula, optionally a commercially available cannula having a hollow cylindrical cannula shape and a sharp distal end that is sharpened by bevel grinding.

[0086] The shearing unit allows widening of the insertion site, in particular the cutout of the cutting element of the shearing unit, to allow atraumatic widening / insertion of the dilator and / or sheath into the body vessel of the patient.

[0087] The shearing unit may be arranged at a distal end of the system such that the shearing unit can be arranged adjacent to a distal end of the biomedical device, in particular adjacent to a distal end of the puncture element.

[0088] The shearing unit can be mechanically or functionally coupled to at least a portion of the introducer assembly, in particular a dilator or sheath, and a coupler of an inner guide unit, preferably formed by a puncture element. Such a coupler allows advancement of a portion of the introducer assembly to cause the shearing unit to be activated in a fully automated manner, in particular to perform an incision. The coupler is preferably configured so that after the inner guide unit (in particular the puncture element) is inserted into the insertion site, the incision is sequentially performed by the cutting element of the shearing unit. This facilitates the use of the system for percutaneous catheterization.

[0089] The cutting element of the shearing unit can be configured to be actuatable so that the incision originates from the puncture hole formed by the puncture element at the insertion position. This allows the incision to be made with higher precision when the inner guide unit (eg puncture element) is inserted into the insertion position.

[0090] The system may have at least one placement section. The placement section is suitable for releasably mounting at least one part of a biomedical device, in particular a dilator, a sheath and a guide unit, preferably a puncture element, a guide wire and / or an insertion guide. The placement section may include a shape that is at least partially open in the radial direction of the system, corresponding to a mountable component of the biomedical device.

[0091] The system may have a plurality of placement sections for respectively mounting a plurality (especially all) of sheaths, dilators and inner guide units, which makes it possible to improve the mounting, coupling and individual and collective actuation of these elements by the actuation unit.

[0092] The plurality of placement sections may be configured to receive a sheath, dilator and / or inner guide unit having a specific predetermined position / orientation. This allows positioning of the introducer assembly in an optimized pre-operative orientation to facilitate catheter insertion and achieve improved actuation considerations.

[0093] The plurality of placement sections may include a coupler, optionally including a plurality of coupling elements, so that the movements of the placement sections may be coupled to each other. Similar to the coupler of a biomedical device, this may allow simplified actuation of the introducer assembly by the actuation unit, for example when advancing or retracting one or more of the sheath, dilator, and guide unit.

[0094] The system may have an engagement member that is switchable between an engaged configuration and a disengaged configuration. In the engaged configuration, at least one mountable component of the biomedical device is fixedly held in the seating section relative to the seating section at least with respect to movement in a longitudinal direction, in particular with respect to a radial direction of the biomedical device. In the disengaged configuration, at least one mountable component may be separated from the seating section such that the mountable component may be removed from the system.

[0095] Such an engagement member is capable of securely attaching a biomedical device in a previously defined position, enabling percutaneous procedures to be performed reliably and reproducibly.

[0096] The actuation unit may be adapted to actuate at least one mountable component of the biomedical device, such as a dilator, a sheath and / or an introducing unit, by moving a seating section having an open shape for receiving a mountable component of the introducer assembly.

[0097] The engagement member may be based on a form-fitting mechanism, such as a snap-fitting mechanism, a locking mechanism, such as a closeable bracket or a clamp.

[0098] The engagement member can be integrally formed with the placement section, in particular the open shape of the placement section. This can, for example, allow the engagement member to be manually switched between the engagement configuration and the disengagement configuration.

[0099] Alternatively, the engagement member may be actively switched, for example by a processing unit controlling an actuator. This allows a fully automated process, independent of the skill of the clinician, while minimizing the risk of injury when the system is removed from the mountable component of the introducer assembly.

[0100] The system may include only one actuation unit. A single actuation unit simplifies the design and construction of the system and greatly reduces the associated costs.

[0101] The actuation unit may be configured to actuate one of the dilator, sheath and guide unit while remaining stationary relative to the system. Alternatively, the actuation unit may be configured to actuate one of the dilator, sheath and guide unit by translating itself, in particular in the longitudinal direction of the system.

[0102] The actuation unit may comprise a clutch, in particular a clutch comprising at least two rollers with adjustable spacing. Thus, the actuation of the actuation unit may be switched between at least two, preferably three, particularly preferably all configurations for actuating the dilator, the sheath and the guide unit, in particular the puncture element, the guide wire and / or the insertion guide.

[0103] The system may comprise at least one guide element, in particular at least two guide elements, preferably formed by guide rails, such that at least one of the actuation unit and the at least one seating section is movable along the guide element.

[0104] The actuation unit and / or the seating section may be connected or connectable to at least one guide element, in particular to two guide elements simultaneously. This enables precise and reliable guidance along the guide elements in a desired orientation.

[0105] The guide element can be arranged or can be arranged in the longitudinal direction of the system. At least two, in particular three, preferably four guide elements can be arranged parallel to each other.

[0106] One end of the guide element may be connected or connectable to the system base, while the other free end does not have any connection.

[0107] The shearing unit may be configured to be actuatable by a specific movement of the actuation unit or the placement segment, in particular beyond a specific spatial position, preferably at a distal end of the system.

[0108] The system may comprise a processing unit adapted to control at least one, preferably at least two or all of the shearing unit, the actuation unit and the engagement member.

[0109] Precise coordination of the system for catheterization may be achieved by control of the processing unit, in particular based on coordination of external imaging mechanisms, external guiding mechanisms, or coordination between an actuation unit and a shearing unit.

[0110] According to the present invention, another aspect of a system for performing percutaneous catheterization of a body channel, in particular the system described previously, comprises a shearing unit. The shearing unit comprises at least one, in particular two, cutting elements for performing shearing puncture at the insertion site. The system comprises an actuation unit configured to translate at least one cutting element, in particular to translate at least one cutting element parallel to the longitudinal axis of the shearing unit. The actuation unit is configured to move the shearing unit to perform shearing puncture by (i) rotating at least one cutting element around the longitudinal axis of the shearing unit or (ii) moving the cutting element radially outward relative to the longitudinal axis of the shearing unit.

[0111] This allows performing a spatially precise shear opening or multiple shear openings at the insertion site in the patient's tissue, thereby performing a percutaneous catheterization in a simple and reliable manner.

[0112] The system may further comprise a handling unit adapted to operate the shearing unit via the actuation unit.

[0113] The system may comprise a processing unit configured to operate the actuation unit and the shearing unit by repeated continuous translational movement of the shearing unit in the direction of the distal end of the shearing unit and subsequent rotation of the shearing unit around the longitudinal axis. The rotation of the shearing unit shall not exceed an angle of 360°. Preferably, the rotation of the shearing unit in a first angular direction does not exceed an angle of 180° and the subsequent rotation of the shearing unit in a second angular direction opposite to the first angular direction does not exceed an angle of 180°. At least one cutting element has a non-rotationally symmetrical cross-sectional shape at its distal tip or is arranged radially offset from the rotation axis of the shearing unit. At least one cutting element is further adapted to perform shearing openings by blunt dissection.

[0114] Alternatively, the cutting element may be converted to have a non-rotationally symmetric cross-sectional shape at the distal tip.

[0115] This continuous translational and rotational movement of the shearing unit allows for blunt dissection to be performed for catheterization with greater precision and control based on a central rotational trajectory while minimizing tissue trauma.

[0116] The system may include a blunt insert having a blunt distal tip, in particular a rounded distal tip, and configured to be insertable into the lumen of the shearing cell.

[0117] This blunt insert enhances the stiffness of the shear cell by providing greater structural integrity when performing shear openings.

[0118] The processing unit and the actuation unit may be adapted to advance and retract the blunt insert through the lumen of the shearing unit in a synchronized manner to perform the shearing puncture.

[0119] The system may include an expansion element that can be arranged between the first and second cutting elements. The expansion element can be formed by an expandable expansion element or an expansion element configured to be insertable into the lumen of the shearing cell. The expansion element is configured to move the cutting element radially outward relative to the longitudinal axis of the shearing cell.

[0120] The expansion element allows the cutting element to be selectively radially expanded to form a shear opening at the insertion site.

[0121] The blunt insert may form an expansion element and be configured to move the cutting element (particularly only the distal end of the cutting element) radially outward by translating through the lumen in a proximal or distal direction (e.g., similar to a pin). The blunt insert may include a longitudinally varying cross-sectional dimension (particularly at its distal tip) to facilitate radial movement of the cutting element.

[0122] The cutting element is rotatably connected at at least one fulcrum for relative pivotal movement about the fulcrum. The conversion mechanism of the shearing unit may be configured to convert a translational movement of an actuating portion of the conversion mechanism, in particular a translational movement parallel to the longitudinal axis of the shearing unit, into an outward pivotal movement of the cutting element about at least one fulcrum to perform shearing of the opening.

[0123] The outward pivoting movement of the cutting element enhances the compatibility of the system, as the shear openings can be used to insert, even sequentially, medical instruments in a simple and efficient manner.

[0124] The shearing unit may comprise a plurality of fulcrums, particularly adapted to couple the pivoting movement of the first and second cutting elements.In a preferred embodiment, upon coupling of the pivoting movement, moving the first cutting element results in an equidistant movement of the second cutting element in opposite directions.

[0125] The actuation unit may be configured to actuate the switching mechanism to switch the shearing unit between a closed configuration in which the cutting elements are adjacent to each other and an open configuration in which the cutting elements are rotated outwardly. The actuation unit may be adapted to advance and retract the shearing unit toward and away from the insertion site.

[0126] This enables simple machine control changeover of the shearing unit, in particular in a fully automatic manner.

[0127] The shape of the conversion mechanism can be longitudinally expanded and contracted. The conversion mechanism can be adjusted so that in the open configuration of the cutting element, the conversion mechanism is in a longitudinally contracted position, and in the closed configuration of the cutting element, the conversion mechanism is in a longitudinally expanded position.

[0128] The processing unit and the actuation unit may be adapted to operate the actuation unit and the cutting unit to perform a plurality of cutting openings at the insertion site by repeatedly and continuously advancing the cutting unit in a longitudinal direction of the cutting unit in a closed configuration and then switching to an open configuration.

[0129] This allows to successively perform incisions, preferably blunt dissection shear openings, through the tissue in the distal direction of the shearing unit.

[0130] The system may also be configured to enable advancement, and particularly continuous advancement, of a medical device (eg, a biomedical device as previously described) through a shear opening and into a body channel.

[0131] The system may comprise a biomedical device as previously described, optionally with a dilator, a sheath and / or an inner guide unit, which are movable by the system, in particular by an actuation unit of the previously described system, in the longitudinal direction of the biomedical device.

[0132] The actuation unit adapted to advance / retract the shearing unit may be adapted to advance / retract the shearing unit in a direction parallel to the longitudinal direction, in particular along the longitudinal direction of the biomedical device.

[0133] Alternatively, the actuation unit for advancing / retracting the shearing unit may be adapted to translate the shearing unit in a direction that is angled relative to the longitudinal direction of the biomedical device, e.g., at an angle greater than 5°, 15°, 25°, or 35°, in particular along a guide element (e.g., a guide rail). The angled direction of movement may be aligned to intersect the longitudinal direction at a distal section of the system, which corresponds to the location of the insertion site.

[0134] By inclining the moving direction of the shearing unit in this manner, the shearing unit can be easily moved out of the way after shearing the opening to advance the introducer assembly of the system for catheterization of the insertion site in the longitudinal direction.

[0135] The shearing unit may be adapted to perform shear openings by outward pivoting movement of the cutting elements in a common plane.

[0136] Alternatively, the shearing unit may be adapted to perform shearing apertures by blunt dissection with cutting elements. Blunt dissection can minimize tissue trauma by reducing the risk of damaging nearby body structures, nerves or blood vessels, thereby enhancing wound healing due to less inflammation, complications (e.g., infection), and tissue scarring.

[0137] The first and second cutting elements may have distal ends converging to form at least one distal tip, in particular a sharp distal tip, for insertion into patient tissue at the insertion site when the first and second cutting elements are in the closed configuration.

[0138] This allows precise positioning of the shearing unit and system in the closed configuration on the patient's tissue at the insertion site while performing the outward pivoting movement to the open configuration to perform the shearing opening.

[0139] Alternatively, the first and / or second cutting element may have a T-shaped distal tip, respectively, for performing blunt dissection by expanding the tissue at the insertion site. The T-shaped distal tips of the cutting elements can be laterally parallel to each other, particularly adjacent to each other, and placed on the patient's tissue to perform blunt dissection.

[0140] The shearing unit can be adjusted such that a longitudinal axis of the distal tip is arranged substantially along a longitudinal axis of an introducer assembly of the system.

[0141] The cutting elements may be configured such that respective blunt or cutting edges of the cutting elements are radially outward relative to each other in the closed configuration.

[0142] The outwardly blunted cutting elements of the shearing device can achieve a minimally invasive approach to blunt dissection by reducing tissue trauma.

[0143] The cutting edge of the cutting element allows an incision to be performed outwardly relative to the insertion site prior to catheterization.

[0144] The first and second cutting elements having blunt or cutting edges may be arranged in a common plane for radially outward pivotal movement relative to the longitudinal direction of the shearing unit.

[0145] The system may comprise a biomedical device, in particular a biomedical device as described above.

[0146] The system according to the present invention comprises a biomedical device, preferably the biomedical device described above, for percutaneous cannulation of a body channel, in particular arterial catheter insertion. The biomedical device comprises an introducer assembly having a dilator for enlarging an insertion site of a patient to enter a body channel, a sheath for introducing the body channel, and an inner guide unit for guiding the dilator and / or the sheath.

[0147] The dilator has a tapered outer section, a distal opening, and is at least partially concentrically arranged around the guide unit. The sheath has a distal opening, and is at least partially concentrically arranged around the dilator.

[0148] The guide unit, the dilator and the sheath can be moved relative to each other in the longitudinal direction of the introducer assembly. The system comprises at least one actuating unit configured to actuate the dilator, the sheath and / or the guide unit of the device, in particular the puncture element, the guide wire and / or the insertion introducer. The actuating movement is a movement in the longitudinal direction of the introducer assembly.

[0149] The system may comprise at least one actuation unit, preferably only one actuation unit, comprising a clutch, in particular a clutch comprising at least two rollers with adjustable spacing. The actuation of the actuation unit may be switched between configurations for actuating the dilator, the sheath and / or the guide unit, in particular the puncture element, the guide wire and / or the insertion guide.

[0150] The roller may be configured to frictionally engage the dilator, sheath, and / or guide unit.

[0151] According to another aspect of the invention, a system comprises a biomedical device, preferably a biomedical device as previously described, for percutaneous cannulation of a body conduit, in particular arterial catheter insertion. The device comprises an introducer assembly for puncturing an application site at the patient's skin. The introducer assembly comprises a positionable and actuatable cannula for puncturing the skin at a desired location and in a desired direction.

[0152] The device includes an external imaging mechanism, in particular an ultrasound probe, such as a Doppler ultrasound probe for measuring blood flow in a body channel, or an X-ray imaging probe. The imaging mechanism is configured to perform two-dimensional or three-dimensional imaging of a patient's body channel, in particular an arterial body channel, and optionally perform time period measurement. The external imaging mechanism and the introducer assembly are connected to a common support of the system.

[0153] The external imaging mechanism and the introducer assembly, in particular the guide unit, may be configured to be fixedly pre-oriented relative to each other. The longitudinal axes of the fields of view of the external imaging mechanism and the introducer assembly may be arranged to be pre-oriented at an angle of 1° to 90°, in particular 20° to 60°, particularly preferably 30° to each other.

[0154] to 45°.

[0155] The angle, translational movement and / or rotational movement between the imaging device and the introducer assembly can be adjusted by means of matching elements, in particular at least one clamp or a screw.

[0156] In addition, the imaging mechanism may be configured to image at least one other anatomical feature and generate data based on the other anatomical feature for path planning. The anatomical feature may also be provided by a preoperative scan for this purpose. The anatomical feature may be the location and orientation of nerves, ligaments, bones, fat, muscles, organ tissue, bifurcations, arterial walls, and calcifications.

[0157] The system may include an external guidance mechanism. The external guidance mechanism may include a stereo camera or an RGBD camera, a lidar system and / or an electromagnetic sensor. Based on these guidance mechanisms, the distance between the patient (particularly the internal conduit) and / or the patient's surroundings and the imaging mechanism and / or the guide assembly (particularly the guide unit) can be determined or reconstructed.

[0158] The system may have a marking which comprises or consists of one or more visual identification elements, in particular reference points. The visual identification elements may have a specific shape, in particular a line, a polygon or a circle.

[0159] The plurality of visual identification elements may have a predetermined distance from each other, so that the guide mechanism may be calibrated by measuring the distance of the visual identification elements from the guide mechanism.

[0160] The visual identification element (particularly a patch) can be applied or arranged on a surgical drape or attached to the patient, particularly near the patient's insertion site to access a body duct.

[0161] The guide mechanism may be fixedly connected to an external imaging mechanism, fixedly connected to a patient or a fixed surface, and / or attached to a movable surface that is movable independently of the imaging mechanism.

[0162] The device of the system may include an introducer positioner for positioning the introducer assembly relative to the body channel and / or the common support. The introducer positioner may be configured to position the introducer assembly in two translational degrees of freedom and at least one rotational degree of freedom, or in three translational degrees of freedom and at least one rotational degree of freedom, in particular in two or three rotational degrees of freedom.

[0163] The common support of the system may be a handheld support for manually matching the device, particularly the imaging mechanism, relative to the patient.

[0164] It may also be a spatially fixed support which comprises pre-positioning means, in particular an adhesive, a strip, or a mechanically fixed or fixable carrier.

[0165] Alternatively, it may also be a spatially movable support comprising a device positioner for independent positioning in two or three translational degrees of freedom and at least one rotational degree of freedom, in particular in one, two or three rotational degrees of freedom, relative to the intracorporeal conduit.

[0166] The device positioner and / or introducer positioner allows to adapt the introducer assembly, in particular the guide unit, at the insertion site with translational and rotational freedom, in particular to a predetermined orientation relative to the body duct and / or the at least one visual identification element.

[0167] The device positioner may preferably be configured by the processing unit to align the external imaging mechanism relative to the visual identification element, in particular a visual identification element placed on or near the intracorporeal vessel.

[0168] The external imaging mechanism placed on or near the in vivo channel may preferably be configured by the processing unit to locally image the in vivo channel so that the processing unit can determine the insertion path based on the imaged in vivo channel.

[0169] The introducer assembly is preferably positionable by an introducer positioner based on a determined insertion path relative to the body vessel so as to enable the previously described insertion to be performed.

[0170] The predetermined orientation of the longitudinal direction of the introducer assembly, in particular the guide unit, relative to the body channel may be at an angle of 1° to 80°, in particular 5° to 60°, preferably 10° to 55° to the axial direction of the body channel.

[0171] The introducer positioner and / or the device positioner may comprise at least one actuating element, in particular an electric motor, a hydraulic actuator, a pneumatic actuator and / or a piezoelectric motor.

[0172] The system may comprise a force sensor configured to convert an external force, in particular an external torque, applied to at least a sub-portion of the system, in particular the distal tip of the guide unit, preferably the distal end of the puncture element of the guide unit, into an electrical signal indicative of the external force.

[0173] Such a force sensor can verify the position and / or orientation of a sub-part of the system, in particular the puncture element, relative to the patient or the internal vessel.

[0174] The system may include a processing unit for processing data of an image of the in vivo vessel measured by an external imaging mechanism, in particular a plurality of images.

[0175] Alternatively or additionally, the processing unit can process a determined or reconstructed distance, in particular a plurality of distances, of the guide means.

[0176] It may also process an electrical signal, in particular a plurality of electrical signals, of the force sensor.The processing unit may process the data to calculate at least one electrical signal for operating the introducer positioner and / or the device positioner.

[0177] Information derived from the electrical signals processed by the processing unit may alternatively or additionally be displayed on a display unit of the system.

[0178] Data of the imaging mechanism relative to at least one other anatomical feature may be processed by the processing unit to determine at least one signal for operating the introducer positioner and / or the device positioner.

[0179] The processing unit may be configured to operate the introducer positioner in a partially or fully automatic manner, in particular requiring only partial or no manual operating input from a user.

[0180] The system may include a storage unit connected or connectable to the processing unit for storing data of the in vivo channel measurement images, in particular a plurality of images, of the external imaging mechanism. Additionally or alternatively, the storage unit may be configured to store data of the determined or reconstructed distances, in particular a plurality of distances, of the guiding mechanism.

[0181] It may also be configured to save data of an electrical signal of the force sensor, in particular data of a plurality of electrical signals.

[0182] The data may be saved at an initial point in time. The processing unit may also be configured to retrieve the saved data from the storage unit at a later point in time for use in operating or supporting the operation of the introducer positioner and / or the device positioner.

[0183] The storage unit may be configured to store pre-operative scan or reconstruction data, in particular CT, MRI or ultrasound scan or reconstruction data.

[0184] The processing unit may be configured to match a pre-operative or intra-operative scan or reconstruction, in particular a CT, MRI or ultrasound scan or reconstruction, optionally stored on the storage unit, to an image generated by an external imaging modality.

[0185] The processing unit may be configured to use the stored and / or processed data to reconstruct an occupancy distribution map of the free space without obstacles being detected.

[0186] The processing unit may be configured to determine the location of the insertion site and / or the orientation of the introducer assembly, in particular the guide unit, to avoid or minimize interference with calcifications within the body vessel. Calcifications may be detected by imaging means or preoperative scans, in particular CT scans.

[0187] The processing unit may be configured to process the stored and / or processed data using artificial intelligence, in particular by means of unsupervised, supervised or reinforcement machine learning.

[0188] The guide unit of any of the aforementioned systems may include a puncture element having a length of 6 cm to 35 cm, particularly 8 cm to 30 cm, preferably 12 cm to 25 cm. This allows the puncture element, which is at least partially surrounded by the dilator, to guide the dilator into the body conduit for catheter insertion without having to advance the guide wire and / or retract the puncture element in advance. The puncture element and the dilator can be uniformly introduced into the body conduit in a predetermined spatial relationship relative to each other. The puncture element can be adapted to receive the guide wire through the inner cavity formed by the puncture element.

[0189] The aforementioned system may include an external imaging mechanism for two-dimensional or three-dimensional imaging of the patient's internal conduit, in particular the aforementioned imaging mechanism, which is preferably connected to a processing unit of the system for controlling the actuation unit. The processing unit may be adapted to control the actuation unit based on the image of the external imaging mechanism.

[0190] The previously described system may be adapted to detect temporal variations of pressure in a vessel of a body conduit. The previously described system may comprise a cardiac cycle detector, in particular by means of an external imaging means, preferably by means of an ultrasound probe, for detecting temporal variations of pressure in a vessel of a body conduit.

[0191] The processing unit may be adapted to predict the temporal variation of the blood vessel pressure of the internal conduit based on the data collected by the cardiac cycle detector. The processing unit may be adapted to control the actuation unit so that when the predicted blood vessel pressure reaches a maximum value (e.g., at a time point when the blood vessel has a maximum stiffness and a maximum cross-sectional diameter during systole), the puncture element of the guiding unit is advanced into the internal conduit. This makes it easier to insert the puncture element into the internal conduit, thereby minimizing the risk of missing the internal conduit when advancing the puncture element.

[0192] The aforementioned system may have a non-sterile component formed by at least a first transmission unit of the actuation unit, in particular a motor of the actuation unit for driving the actuation. The system may have a sterile component formed by at least a biomedical device, preferably a shearing unit, and a second transmission unit of the actuation unit. The sterile component and the non-sterile component are detachably connected to each other, so that the first and second transmission units are functionally connected to each other for actuating the biomedical device. The sterile and / or non-sterile components may have a connecting element. The connecting element may be a protruding, recessed and / or magnetic connecting element.

[0193] In this way, sterilized components including biomedical devices can be installed for a one-time operation without risking the sterile environment required for the operation. In addition, this allows the use of a simple system to mount and couple the biomedical device so that the actuation unit can actuate at least a portion of the biomedical device, such as a sheath, a dilator, a guide unit and / or a shearing unit, via the transmission unit while maintaining a sterile environment.

[0194] Protruding, recessed and / or magnetic connection elements can simplify the connection steps and ensure that the connection elements can be placed in a specific spatial orientation, for example, in order to establish electrical contact or actuate a transmission. If both the sterilized component and the non-sterile component have connection elements, the connection elements can be shaped accordingly relative to each other.

[0195] The second transmission unit may include at least one transmission shaft, such as a main shaft, in particular a plurality of transmission shafts, for moving the placement section in the longitudinal direction to move a part of the biomedical device.

[0196] The aforementioned system may have a retaining element, which is suitable for fixing the sterilized component and the non-sterile component in a state connected to each other. The retaining element includes at least one connecting element, in particular a bayonet connection element, for connecting to the sterilized component and / or the non-sterile component so that the sterilized component and the non-sterile component are fixed in a connected state.

[0197] Thus, during percutaneous cannulation, the sterile and non-sterile components can be fixedly connected to each other during the entire process of actuating the biomedical device. The retaining element can have an annular shape. The retaining element can have a plurality of connecting elements arranged along the annular shape, preferably a bayonet connection element. The plurality of retaining elements can be adjusted so that the connecting elements, in particular the bayonet connection elements, can be simultaneously closed by rotating the annular retaining element relative to the sterile and / or non-sterile components.

[0198] The aforementioned system may include a pressure sensor adapted to detect the pressure of the intraluminal fluid connected or connectable to the lumen of the guide unit, in particular the lumen of the puncture element. The pressure sensor may be arranged on a sterile component, in particular a biomedical device.

[0199] At least one hemostatic valve may also be arranged in the biomedical device. The pressure sensor may be arranged at the distal end of the hemostatic valve or in the hemostatic valve of the biomedical device.

[0200] The pressure sensor allows detection of whether the guide unit has been inserted into the body channel, so that once the guide unit (particularly the puncture element) is advanced into the body channel, preferably the distal tip of the puncture element is located at the center of the body channel, the driving by the actuation unit can be stopped. The hemostatic valve can allow reliable detection of the pressure in the inner cavity of the guide unit by the pressure sensor, while introducing surgical instruments (such as guide wires) or drugs into the inner cavity through at least one hemostatic valve.

[0201] The pressure sensor may be connected to a processing unit of a system that may be adapted to control the actuation unit. The processing unit may be adapted to control the actuation of the guide unit, in particular the actuation of the puncture element, by actuating the guide unit in the longitudinal direction of the introducer assembly until the distal tip of the guide unit is detected by the pressure sensor to have been advanced into the body duct.

[0202] This allows safe catheter insertion in a partially or fully automated manner. Furthermore, this allows avoiding the need to completely puncture the intracorporeal conduit through both sides of the intracorporeal conduit using the guiding unit / puncture element, or only to perform a less forceful but atraumatic puncture which would only damage the outer vessel wall without introducing the distal tip into the lumen.

[0203] The second transmission unit may be at least partially formed to be extendable parallel to the longitudinal direction. The second transmission unit may be extendable parallel to the longitudinal direction by comprising a plurality of transmission elements at least partially nested.

[0204] This enables the second transmission unit to extend synchronously with the movement of a placement section of the system, which is adapted to releasably mount at least a part of the introducer assembly, in particular a dilator, a sheath and a guide unit, preferably a puncture element, a guidewire and / or an insertion guide.

[0205] The plurality of partially nested transmission elements may have a non-circular cross-sectional shape.The transmission elements may preferably be formed such that rotation of the proximal-most transmission element results in rotation of the distal-most transmission element.

[0206] The actuation unit may comprise a third transmission unit. The third transmission unit may be arranged at the distal end of the second transmission unit, in particular attached to the placement section, for releasably mounting at least a part of the introducer assembly. The third transmission unit may be adapted to convert a rotational movement of the second transmission unit into a longitudinal movement of the dilator, sheath and / or guide unit, in particular a puncture element, a guide wire and / or an insertion guide, while the third transmission unit is fixed in translation.

[0207] In a preferred embodiment, the third transmission unit is used to advance / retract the guidewire in the longitudinal direction.

[0208] The third transmission unit may allow actuation of at least a portion of the introducer assembly by a rotational movement without the third transmission unit having to be moved in the longitudinal direction.

[0209] The previously described system, in particular the biomedical device, may include an external guide unit, for example, formed in a shape similar to a cannula needle. The external guide unit may include a tubular member. The tubular member may have an inner cavity with a proximal and a distal opening, which has a cross-sectional size suitable for receiving, in particular in a coaxial manner, components of the biomedical device, in particular a sheath, a dilator and / or a puncture element, within the external guide unit.

[0210] The system, in particular a system comprising a shearing unit, may be adapted to advance the outer guiding unit in the longitudinal direction of the introducer assembly through the insertion site, optionally by actuation of the outer guiding unit having a sharp distal tip, for example by the previously described actuation unit.

[0211] The outer guide unit may have a sealing element adapted to seal the lumen, in particular at the distal end of the lumen. The sealing element may be formed by a balloon, a septum, in particular a silicone septum, or a check valve, in particular a ball check valve.

[0212] This allows for selective sealing and opening of the lumen of the outer guide unit, such that the outer guide unit may be sealed when inserted into a patient and opened when a component of the introducer assembly (eg, a sheath) is advanced.

[0213] Alternatively, the outer guiding unit may comprise an inner tubular member without a lumen, such that the inner tubular member is adapted to occlude / seal the lumen of the outer tubular member of the guiding unit.

[0214] The distal inner tubular member may have a blunt tip so that it protrudes from the outer tubular member, making insertion of the outer guide unit easier. The inner tubular member may have a sharp distal tip for insertion into the outer tubular member. This may allow the sharp distal tip to be removed by removing the inner tubular member after placement of the outer tubular member, to reduce the risk of injury when inserting the medical device.

[0215] The actuation unit may be adapted to move the outer tubular member and the inner tubular member independently of each other, so that the tubular members can be advanced together into the patient's body, and the inner tubular member can be subsequently retracted without removing the outer tubular member to clear the lumen. The tubular member can be translated by the actuation unit along the guide element, in particular the guide rail, preferably in the longitudinal direction of the introducer assembly.

[0216] The outer tubular member can be more rigid than the inner tubular member so that the inner tubular member can be removed from the outer tubular member in a curved trajectory of the inner tubular member. This allows the inner tubular member to be removed without blocking the longitudinal advancement direction of the introducer assembly, so that, for example, once the inner tubular member is removed in a curved trajectory, the sheath / dilator / puncture element can be directly inserted into the lumen.

[0217] The outer guide unit, in particular the outer tubular member, can have a sufficient length so that the proximal opening can remain outside the patient's body, while the distal opening can remain inside the patient's body but outside the body conduit to be catheterized. Specifically, the length of the outer guide unit can be between 3 cm and 15 cm, in particular between 3.5 cm and 11 cm, preferably between 4 cm and 8 cm.

[0218] The length of the inner tubular member may be greater than the length of the outer tubular member, so that the inner tubular member can be easily retracted from the lumen, especially in a curved trajectory.

[0219] The outer tubular member of the outer guide unit may have a slit, in particular two slits arranged on opposite sides of the guide unit, formed in the longitudinal direction of the guide unit. The slits may allow easy removal of the inner tubular member. The actuation unit may be adapted to rotate the outer tubular member to match the slits so that the inner tubular member can be removed more easily.

[0220] The two slits may extend through most or the entire longitudinal length of the outer tubular member such that the outer tubular member is or can be split by advancing components of the introducer assembly into the outer tubular member.

[0221] The two slits on opposite sides further allow the shearing unit to be advanced synchronously / in unison with the external guide unit to facilitate catheter insertion.

[0222] In a preferred embodiment, the previously described system comprises a rotary actuator, in particular comprised by the actuation unit, adapted to rotationally move at least one, in particular all, of a guide unit, a dilator and / or a sheath of a biomedical device in their angular direction.

[0223] This rotational motion facilitates insertion of the biomedical device or component thereof through the insertion site by reducing static friction with the patient's tissue.

[0224] The rotary actuator may be operated by a processing unit of the system. The processing unit and the rotary actuator may be configured to perform the rotation in a continuous rotary motion. Alternatively, the processing unit and the rotary actuator may be configured to perform an oscillating rotary motion in two opposite angular directions within a defined angular range, preferably less than a complete continuous rotation, in particular less than 90°.

[0225] This oscillatory rotational motion also reduces static friction, and the rapid oscillatory rotation imparts less unidirectional force to the rotating tissue than unidirectional rotation, making it less traumatic.

[0226] The oscillatory rotational movement may have a frequency between 5 Hertz (Hz) and 300 Hz, in particular between 10 Hz and 200 Hz, preferably 20 Hz-100 Hz.

[0227] The processing unit and the rotary actuator may be configured to have an angular range of the oscillating rotary movement between 0.01° and 90°, in particular between 0.01° and 30°, preferably between 0.01° and 10°.

[0228] According to another aspect of the present invention, the object is also solved by a method for percutaneous catheterization of a body channel, the method preferably using the biomedical device with an introducer assembly as described previously. The method comprises the following steps:

[0229] - inserting the inner guide unit through the patient's skin into the internal duct using the puncture element,

[0230] - optionally inserting the guide wire of the inner guide unit into the body channel through the insertion guide,

[0231] - guiding the dilator along the guide unit without completely removing the puncture element at the proximal end of the introducer assembly,

[0232] -Advance the sheath over the dilator into the body tract,

[0233] - Optionally retracting the dilator, the inner guide unit, in particular the insertion guide and / or the guide wire.

[0234] The method may include the step of releasing the guidewire from a retaining structure of a puncture element of the introducer assembly.

[0235] The method may comprise the step of measuring the blood flow through a guide unit, in particular an insertion guide, introduced into the body channel.

[0236] The method may include the step of replacing the guidewire used for insertion with a more flexible guidewire for navigation within the body conduit.

[0237] The object is also solved by a method for matching an external imaging device to a vessel in the body, preferably using a system as described above. The method comprises the following steps:

[0238] - Use external imaging devices to image the plane of the internal vessels,

[0239] - matching the external imaging device in translational and / or rotational degrees of freedom of the imaging device, preferably using a device positioner, such that the intracorporeal channel is located in the center of the field of view of the imaging device and is positioned along an orthogonal direction to the imaging plane or within a range of 30°, in particular 15°, relative to the orthogonal direction,

[0240] - Matching the external imaging mechanism in translational and / or rotational degrees of freedom so that the intracorporeal vessel is kept in the center of the field of view, preferably using a device positioner, and the imaging plane is in a direction parallel to the longitudinal axis of the intracorporeal vessel.

[0241] Furthermore, the longitudinal direction of the imaging plane may also be positioned orthogonal to the longitudinal axis of the in vivo vessel.

[0242] The method may further comprise the step of matching pre-operative scan data based on another anatomical feature, in particular calcification, with the in vivo vessel imaged by the external imaging mechanism.

[0243] The method may further comprise the step of matching the external imaging mechanism in translational and / or rotational degrees of freedom, preferably using a device positioner, such that an insertion path inserted through the introducer assembly avoids the matching anatomical features. BRIEF DESCRIPTION OF THE DRAWINGS

[0244] The invention will now be described with reference to certain embodiments and the accompanying drawings, which show:

[0245] Figure 1A and 1B : longitudinal cross-sectional views of first and second embodiments of the biomedical device,

[0246] Figure 2A : A longitudinal cross-sectional view of a third embodiment of a biomedical device comprising an insertion guide,

[0247] Figure 2B : Schematic arrangement of an actuation unit of a system comprising a biomedical device,

[0248] Figure 2C :Including according to Figure 2A A third embodiment of a biomedical device and according to Figure 2B A longitudinal sectional view of a system of actuating units,

[0249] Figures 3A to 3F : Based on the introduction through the patient's skin Figure 2A A longitudinal cross-sectional view of a third embodiment of a biomedical device,

[0250] Figure 4 : A longitudinal cross-sectional view of a fourth embodiment of a biomedical device comprising an insertion guide,

[0251] Figure 5A and 5B : A schematic side view of a fifth embodiment of a biomedical device having an attachment mechanism,

[0252] Figure 5C : a cross-sectional view of a sixth embodiment of a biomedical device having a retaining structure,

[0253] Figures 5D to 5F :according to Figure 5C A cross-sectional view of a first and a second embodiment of a retaining structure for a puncture element,

[0254] Figures 6A to 6D : longitudinal cross-sectional views of first and second embodiments of a dilator connected to a puncture element comprising an actuation element in different states,

[0255] Figure 7 : A longitudinal cross-sectional view of an embodiment of a biomedical device including a mechanical coupling,

[0256] Figures 8A to 8C : A longitudinal cross-sectional view of an embodiment of a puncture element with an anchor,

[0257] Figures 8D to 8F : Based on Figures 8A to 8C A longitudinal cross-sectional view of an embodiment of a puncture element is shown with its anchor disposed within a dilator configured as a switching anchor,

[0258] Figure 8G and 8H : Based on Figures 8A to 8C A front view of a first and a second embodiment of a piercing element of an anchor is shown,

[0259] Figures 9A to 9C : Patients with biomedical devices inserted into the femoral artery,

[0260] Fig.10 : A first embodiment of a system comprising a biomedical device for insertion into a channel in a patient, the biomedical device having an imaging mechanism and a guiding mechanism,

[0261] Fig.11A and 11B : schematic side views of first and second embodiments of a system including a biomedical device having an imaging mechanism secured to and movable relative to an introducer assembly,

[0262] Figures 12A to 12C : Schematic side view of an introducer positioner for positioning an introducer assembly with five, four and three degrees of freedom,

[0263] Figures 13A to 13D : A schematic side view of an embodiment of an imaging mechanism relative to a body channel and a method of positioning an imaging mechanism relative to a body channel,

[0264] Figures 14A to 14C : A top view and two perspective side views of an embodiment of a system having a cutting element with a biomedical device mounted thereon,

[0265] Fig.15A and 15B :according to Figures 14A to 14C A top view of a system and a method of advancing and retracting an introducer assembly by an actuation unit of the system,

[0266] Figures 15C to 15H : A perspective side view of a system for performing percutaneous catheterization, the system having a shearing unit at the distal tip for performing shearing puncture,

[0267] Fig.15I : A perspective view of an embodiment of an outer guide unit having at least one sealing member,

[0268] Figures 15J to 15L: A perspective side view of a first embodiment of a shearing cell having a non-rotationally symmetrical cross section at a blunt distal tip and a second embodiment of a shearing cell having two cutting elements that are radially movable relative to each other to perform shear openings,

[0269] Figure 15J.1 : A perspective view of an embodiment of a blunt insert having a rounded distal tip,

[0270] Figure 15M and 15N : A schematic side view of a system for sequentially advancing a biomedical device and a shearing unit through the skin of a patient to a vessel in the body and repeatedly performing shearing openings using the shearing unit,

[0271] Figures 15O to 15R : A schematic side view of inserting and placing an external guide unit from an insertion site to almost reach a body duct, and then performing catheterization using a biomedical device,

[0272] Fig.16 : A longitudinal cross-sectional view of an embodiment of a biomedical device comprising two mechanical couplings,

[0273] Fig.17A and 17B : A top view of an embodiment of a biomedical device including an introducer assembly having a guidewire, a puncture element, a dilator, a sheath, and a side port that are separated and nested from each other,

[0274] Fig.18A and 18B : A perspective view and a top view of an embodiment of non-sterile components of a system for percutaneous catheterization including a first transmission unit of an actuation unit,

[0275] Fig. 18C : A top view of an embodiment of a sterilization component of a second transmission unit including an actuation unit,

[0276] Fig.18D :Suitable for Fig.18A Sterilized parts and Fig.18B A perspective side view of an embodiment of a holding element with a non-sterile component fixed in a connected state,

[0277] Fig.19A : A perspective side view of an embodiment of a placement section of a dilator of a system for percutaneous catheterization,

[0278] Fig.19B and 19C : A perspective side view of an embodiment of a sheath placement section of a system for percutaneous catheterization having an engagement member that can be switched between an engaged configuration and a disengaged configuration,

[0279] Fig. 20Aand 20B : A perspective side view of an embodiment of an extendable portion of a second transmission unit of an actuation unit of a system for percutaneous cannulation, the extendable portion being extendable in a longitudinal direction,

[0280] Figures 21A to 21C : A perspective side view and a side view of an embodiment of a third transmission unit of an actuation unit of a system for percutaneous cannulation, and a placement section attached to a guide unit Fig.21A and 21B A perspective side view of the third transmission unit,

[0281] Fig.21D : A perspective side view of an embodiment of a sterilization component 54 of a system for performing percutaneous catheterization in an at least partially automated manner,

[0282] Figures 22A to 22J :include Fig.21D A top view of an embodiment of a system of sterilized and non-sterilized components for performing percutaneous catheterization steps using a biomedical device. DETAILED DESCRIPTION

[0283] The introducer assembly 1 has an outer sheath 3, a dilator 2 and an inner guide unit 4 which are arranged concentrically inside each other along the longitudinal direction L of the introducer assembly 1. The sheath 3 circumferentially surrounds the dilator 2 along its longitudinal length. It has a distal opening 32 at its distal side. The sheath 3 has a narrowing section 31 on the outer surface near the distal side, and has a wing 33 for guiding the sheath 3 at the proximal side. The sheath 3 has a proximal opening 34 at its proximal end.

[0284] The dilator 2 extends through the distal opening 32 and the proximal opening 34 of the sheath 3 .

[0285] The dilator 2 also has a distal opening 22 at its distal side. The distal side has a narrowed outer section 21 for insertion through the skin and tissue into a patient's body duct over the guide unit 4. The dilator also has a proximal opening 25 at its proximal end. The dilator 2 circumferentially surrounds the guide unit 4 along its length.

[0286] Figure 1A and 1B The guide unit 4 in the introducer assembly 1 protrudes from the first opening 22 and the second opening 25 of the dilator 2. The sheath tube 3, the dilator 2 and the guide unit 4 are all movable relative to each other along the longitudinal direction of the introducer assembly 1.

[0287] Figure 1A The guide unit 4 in the embodiment includes a puncture element 41 formed by a continuous stainless steel cannula, which circumferentially surrounds a cylindrical lumen 413 and has a puncture portion 417 at its distal end. The lumen 413 extends from the distal opening formed by the puncture portion 417 to a proximal end 416 at the proximal end 5 of the introducer assembly 1.

[0288] The length of the cannula 41 ranges from 6 cm to 35 cm, in particular 15 cm. Figure 1A The cannula 41 in the embodiment is sufficiently rigid so that the narrowed outer section 21 of the dilator 2 can be introduced along the cannula 41 without a separate guide wire. The cannula 41 can optionally be a Veress cannula (see Figure 6B ) is used to protect the puncture portion 417 during the introduction of the dilator 2 and / or the sheath 3 to protect the tissue wall of the tube in the patient's body.

[0289] Figure 1B The guide unit 4 in the embodiment includes a puncture element formed by a continuous cylindrical stainless steel cannula 41 and an additional guide wire 43. The length of the cannula 41 is Figure 1A The shortest in the range is 0.1 cm to 6 cm, particularly 0.5 cm. The cannula 41 has a distal opening formed by a puncture portion 417 at its distal end, and circumferentially surrounds a cylindrical lumen 413. The proximal end 416 of the cannula 41 forms a smooth transition with the distal end 431 of the guide wire 43. Therefore, the cannula 41 connected to the guide wire 43 can be used as a kind of push rod to move back and forth relative to the rest of the introducer assembly 1 by means of the guide wire 43. The bending rigidity of the guide wire 43 is lower than that of the cannula 41 so that the guide wire 43 can more easily fit the turn in the introducer assembly 1 and / or the body pipeline. The guide wire 43 is hard enough so that the narrowed outer section 21 of the dilator 2 can be introduced into the body pipeline along the guide wire 43.

[0290] Figure 2A A longitudinal cross-sectional view of a third embodiment of a biomedical device 101 comprising an introducer assembly 1 with an insertion guide 42 is shown. The introducer assembly 1 comprises a portion of a sheath 3, a dilator 2 and a guide unit 4 arranged coaxially with each other along a longitudinal direction L of the introducer assembly 1. The outer surface of the sheath 3 near its distal end has a distal opening 32 and a narrowed outer section 31. The outer surface of the dilator 2 near its distal end also has a distal opening 22 and a narrowed outer section 21.

[0291] The insertion guide 42 of the guide unit 4 has a proximal section 421 and a distal section 422. The proximal section 421 of the insertion guide 42 is circumferentially surrounded by the dilator 2 and has a proximal lumen 423 in which a guide wire 43 is arranged. The distal section 422 of the insertion guide 42 has a distal lumen 424, the distal end of which has a distal opening 427 and the proximal end 426 has a lateral opening 425.

[0292] The distal lumen 424 extends in a straight line between the openings 425, 427. A puncture element formed by the cannula 41 is arranged within the lumen 424 and is movable relative to the insertion guide 42 in the longitudinal direction L4 of the cannula 41.

[0293] The cannula may be a commercially available standardized stainless steel cannula 41 which is not necessarily part of the device. The distal section 422 is arranged at an angle α of 30° relative to the proximal section 421 so that the cannula 41 can be inserted and retracted from the lateral opening 425 of the distal section 422 along the longitudinal direction L4 to introduce the guidewire 43.

[0294] Therefore, the step of introducing the guide wire 43 can be performed faster, because the cannula 41 only needs to be retracted a short distance from the lateral opening 425 to introduce the guide wire 43 into the body channel. The cannula 41 is not arranged concentrically around the guide wire 43, so that after the cannula 41 is inserted, it is not necessary to remove the cannula 41 from the proximal end of the introducer assembly 1.

[0295] The insertion guide 42 can be passed through the patient's skin and tissue in parallel with the cannula 41 having the puncture portion 417 protruding from the distal opening 427, or can be advanced around the cannula 41 introduced into the body channel. The distal opening 427 of the insertion guide 42 is instead formed into a blunt edge, so that the insertion guide 42 is configured not to damage the tissue wall of the body channel.

[0296] Figure 2B A schematic arrangement of an actuation unit 9 of a system including the above-mentioned biomedical device is shown. The actuation unit 9 has a clutch 91 which can be switched between different configurations 95, 96, 97, 98, 99 to grasp one of the components of the introducer assembly 1. In a first configuration 95, the actuation unit 9 or an additional actuation unit 9 is configured to grasp the cannula and move the cannula relative to the rest of the introducer assembly in the longitudinal direction L4.

[0297] In the second configuration 96 , the drive unit 9 is configured to grasp the sheath.

[0298] In a third configuration 97 , the drive unit 9 is designed to grasp a spreader.

[0299] In the fourth configuration 98 , the drive unit 9 is configured to grasp an insertion guide, and in the fifth configuration 99 it is configured to grasp a guide wire.

[0300] In one of these configurations 96 , 97 , 98 , 99 , the clutch 91 enables the correspondingly grasped component of the introducer assembly to be moved in the longitudinal direction L relative to the rest of the introducer assembly.

[0301] As Figure 2B Instead of the actuation unit 9 , at least some (in particular all) of the different components of the introducer assembly 1 may have a separate actuation unit which is configured to actuate only the corresponding component in the longitudinal direction L, L4.

[0302] Figure 2C A longitudinal cross-sectional view of a system 102 is shown, the system comprising Figure 2A A third embodiment of the biomedical device 101 and according to Figure 2B The actuating unit 9 has a clutch 91 which comprises two rollers 92 which are adjustable to a plurality of different spacings 93 and are arranged radially outwards on opposite sides of the introducer assembly 1 .

[0303] In this embodiment, the spacing 93 between the rollers 92 is substantially perpendicular to the longitudinal direction L of the introducer assembly 1. The sheath 3, the dilator 2, the insertion guide 42 of the guide unit 4 and the guide wire 43 have at least partially exposed portions that are spaced apart from each other at the proximal end 5 of the introducer assembly 1. The actuation unit 9 includes a longitudinal actuator 902 so that the clutch 91 can move in the longitudinal direction L of the introducer assembly 1, preferably along a track parallel to the introducer assembly 1.

[0304] The longitudinal actuator 902 can be used to move the clutch to the partially exposed portion of the sheath 3, dilator 2, insertion guide 42 and guidewire 43. The spacing 93 between the rollers 92 can then be adjusted to engage the partially exposed portion. Therefore, the configurations 96, 97, 98 and 99 of the actuation unit 9 can be selected to actuate the sheath 3, dilator 2, insertion guide 42 or guidewire 43 in the longitudinal direction L by rotating the rollers 92 that frictionally engage the corresponding exposed portion.

[0305] exist Figure 2C In the embodiment, the cannula 41 arranged in the distal section 427 of the insertion guide 42 can be moved by the second actuation unit 901 along the longitudinal direction L4 at a certain angle relative to the longitudinal direction L of the introducer assembly 1.

[0306] Figures 3A to 3F Shown according to Figure 2A 1 is a longitudinal cross-sectional view of a third embodiment of a biomedical device 101 which is introduced through the patient's skin 91 at an insertion site 131 in several steps.

[0307] exist Figure 3A , the cannula 41 is arranged in the distal lumen 424 of the distal section 422 of the insertion guide 42. The insertion guide 42 together with the puncture portion 417 of the cannula 41 protruding from the distal opening 427 is introduced through the skin 91 along the longitudinal direction L4 of the cannula 41. The longitudinal direction L4 is arranged at an angle α of 30° relative to the longitudinal direction L (see Figure 2A and Figure 2C ). The distal segment 422 has a longitudinal length such that it can be inserted into the body tube through the distal opening 427, while the lateral opening 425 of the distal segment 422 is located outside the patient's skin 91. The longitudinal direction L4 of the distal segment 422 can be arranged at a selected angle relative to the longitudinal axis of the body tube.

[0308] The guide wire 43 is arranged in the proximal section 423 of the insertion guide 42. The proximal section 423 is circumferentially surrounded by the dilator 2 and the sheath 3. The inner diameter of the dilator 2 corresponds to the outer diameters of the proximal section 421 and the distal section 422 of the insertion guide 42.

[0309] Figure 3B The cannula 41 is shown retracted from the lateral opening 425 of the distal section 422 , leaving the distal lumen 424 unobstructed for insertion of the guidewire 43 .

[0310] Figure 3C The distal end 431 of the guide wire 43 is shown to be introduced into the patient's internal duct through the distal lumen 424 of the insertion guide 42 (see Fig. 9B and 9C ).

[0311] Figure 3D The dilator 2 is shown introduced through the patient's skin 91, with its distal end having a narrowed outer section 21. To this end, the distal opening 22 of the dilator is advanced along the insertion guide 42. The narrowed outer section 21 of the dilator widens the insertion site 131 so that the dilator can be advanced.

[0312] Figure 3E It is shown that a sheath 3 with a narrowed outer section 31 is introduced through the patient's skin and the distal opening 32 is advanced over the dilator 2 into the body tract.

[0313] Figure 3F The dilator 2 and insertion guide 42 are shown retracted from the lumen 34 of the sheath 3, while the guidewire 43 remains in place to perform the surgical procedure.

[0314] Figure 4 A longitudinal cross-sectional view of a fourth embodiment of a biomedical device 101 comprising an insertion assembly 1 having an insertion guide 42 is shown. The device 101 and Figure 2A The device in is generally similar and reference is made to the features described previously. Figure 2A compared to, Figure 4 The biomedical device 101 in the embodiment has a dilator 2 which is coaxially arranged to surround a guide wire 43 instead of an insertion guide 42. Therefore, the inner diameter of the lumen of the dilator 2 corresponds to the diameter of the guide wire 43. Therefore, the sheath 3, the dilator 2 and the guide wire 43 can be a commercially available assembly or kit for performing the Seldinger technique. In addition, the guide wire 43 can be inserted through a similar Figures 3A to 3F The insertion assembly 1 is introduced into a vessel in the body.

[0315] The insertion guide 42 can be inserted using the puncture surface 417 of the cannula 41 protruding from the distal opening 427 of the insertion guide 42. The cannula 41 can be pushed forward and retracted from the distal section 422 of the insertion guide 42 at an angle α relative to the longitudinal direction L of the introducer assembly 1. After the cannula 41 is retracted along the longitudinal direction L4 of the cannula 41, the guide wire 43 can be advanced from the distal opening 427 into the body duct.

[0316] Figure 4 The outer sleeve portion 428 of the insertion guide 42 is shown, which is partially open in the circumferential region of the insertion guide 42, so that the guide wire 43 can be released from the proximal and distal lumens 423, 424 of the proximal and distal segments 421, 422 along the radial direction R of the insertion guide 42. The partially open circumferential region extends to the entire length of the insertion guide 42.

[0317] Therefore, by retracting the insertion guide 42 relative to the guide wire 43, the insertion guide 42 can be separated from the guide wire 43, so that the guide wire 43 is radially released through the opening of the outer cover 428. The insertion guide 42 is retracted along the additional translation path L3. Retracting the insertion guide 42 will not move the guide wire 43, so that the distal end 431 of the guide wire 43 can remain in the body channel.

[0318] Figure 5A and 5B A schematic side view of a fifth embodiment of a biomedical device 101 is shown, which includes an introducer assembly 1 having a guide wire 43 connected to a distal end 431 of a puncture element 41. The distal end 431 includes a spring-type attachment mechanism that connects the guide wire 43 to the distal end 431 so that a longitudinal portion 432 of the guide wire 43 extends substantially parallel to the longitudinal direction L of the puncture element 41. However, the guide wire 43 is arranged outside the lumen of the puncture element 41. The spring-type attachment mechanism is configured to hold the guide wire 43 during insertion of the puncture element 41 and release the guide wire when passing through the tissue wall 132 of the body conduit 13. Therefore, the guide wire 43 can be introduced into the body conduit 13 without removing the puncture element 41 at the proximal end 5 of the introducer assembly 1. The dilator 2 and the sheath 3 can be directly introduced into the body conduit 13 after or simultaneously with the removal of the puncture element 41.

[0319] Figure 5C A cross-sectional view of a sixth embodiment of a biomedical device 101 is shown having an introducer assembly 1 having a puncture element 41 having a retaining structure 411 circumferentially surrounding a guide wire 43 at least partially in a lumen 413 along a longitudinal portion 432 of the guide wire 43 (see Figure 5D and Figure 5E ). Figure 5C The guide wire 43 is pre-installed in the lumen 413.

[0320] Figure 5D and 5E Shown according to Figure 5C A first embodiment of a retaining structure 411 of a puncture element 41 . Figure 5D The retaining structure 411 in the embodiment has a first C-shaped outer sleeve surface 4111 and a second C-shaped outer sleeve surface 4112, which surround the lumen 413 of the puncture element 41 in the retaining state 418 so that the longitudinal portion 432 of the guide wire 43 (see Figure 5C ) can be retained in the lumen 413. The C-shaped outer sleeve surfaces 4111 and 4112 can rotate relative to each other along the circumferential direction C of the puncture element 41 to convert the retaining structure 411 from the retaining state 418 to the radially opened release state 419. The C-shaped outer sleeve surfaces 4111 and 4112 have different diameters, so that Figure 4 The outer outer surface 4112 in E surrounds the inner outer surface 4111. Therefore, in the released state 419, the longitudinal portion 432 of the guide wire 43 can be released radially outward from the puncture element 41.

[0321] Fig. 5F Shown according to Figure 5C The second embodiment of the retaining structure 411 of the puncture element 41 of the present invention. The retaining structure 411 has a single outer surface 4111, which only partially surrounds the lumen 413 of the puncture element 41 in the circumferential direction C of the puncture element 41. The diameter of the guide wire can be greater than or approximately equal to the circumferential dimension 4113 of the groove in the outer surface (4111). When the puncture element 41 is retracted relative to the guide wire, it can be retracted by applying a predetermined amount of force. Figure 5C A longitudinal portion of the guidewire 43 is released radially outward from the lumen 413 .

[0322] Figures 6A to 6D 1 shows a longitudinal cross-sectional view of a first and a second embodiment of a dilator 2 connected to a piercing element 41 comprising an actuating element 6. The actuating element 6 is formed by a spring which can be moved in a Figure 6B and Fig.6D The compression state 61 in Fig. 6A and Figure 6C Switch between the expanded states 62 in.

[0323] Fig. 6A and 6BA puncture element in the form of a cannula tip 41 is shown, which is connected to the dilator 2 via an actuating element 6. The cannula tip 41 is arranged in the lumen 25 formed by the dilator 2. In the expanded state 62 of the actuating element 6, the puncture surface 417 of the cannula tip 41 is retracted behind a non-puncture surface 63 formed at the distal side of the dilator 2. In the compressed state 61 of the actuating element 6, the puncture surface 417 is advanced in the longitudinal direction of the dilator 2, so that the puncture portion 417 protrudes from the non-puncture surface 63 of the dilator 2.

[0324] Figure 6C and 6D A puncture element in the form of a cannula tip 41 is shown, which is directly connected to the dilator 2 within the lumen 25 of the dilator 2. The actuation element 6 is arranged within the lumen 413 of the cannula tip 41. Figure 6C In the embodiment, the spring of the actuator 6 is in the expanded state 61, so that the non-puncturing surface 63 concentrically located in the cannula is pushed forward to protect the puncturing portion 417 of the cannula tip 41, similar to the Veress cannula. Therefore, the cannula tip 41 will not damage the wall of the internal tube in the expanded state 61. Fig.6D In the retracted state 61 of the spring, the non-puncture surface 63 located in the lumen 413 of the cannula tip 41 is retracted behind the puncture surface 417, so that the cannula tip 41 can be introduced into the body channel through the patient's skin.

[0325] Figure 7 A longitudinal cross-sectional view of an embodiment of a biomedical device 101 is shown comprising an introducer assembly 1 having a sheath 3, a dilator 2, a cannula tip 41 and first and second mechanical couplers 8, 83. Such mechanical couplers 8, 83 may be arranged in any of the above-described first to fifth embodiments of the biomedical device 101.

[0326] The first coupler 8 has a first coupling piece 81 formed by an annular protrusion protruding radially inward of the sheath tube 3 and a second coupling piece 82 formed by an annular protrusion protruding radially outward of the dilator 2. Therefore, before these coupling pieces 81, 82 block each other, only a predetermined portion 86 of the dilator 2 can be inserted into the lumen 34 of the sheath tube 3. The coupling pieces 81, 82 can also be arranged inversely so that only a predetermined portion 86 of the dilator 2 can be introduced from the lumen 34.

[0327] The second coupler 83 has a first coupling member 84 formed by an annular protrusion protruding radially inwardly of the dilator 2 and a second coupling member 85 formed by an annular protrusion protruding radially outwardly of the cannula tip 41. Therefore, before the coupling members 84, 85 block each other, only a predetermined portion 87 of the dilator 2 can be inserted into the lumen 25 of the dilator 2. The coupling members 84, 85 can also be arranged inversely so that only a predetermined portion 87 of the puncture member 41 can be introduced from the lumen 25.

[0328] Figures 8A to 8C A longitudinal cross-sectional view of an embodiment of a puncture element 41 with an anchor 7 is shown. The anchor 7 is formed by a longitudinal portion 75 of the puncture element 41 and is partially arranged circumferentially around the puncture element 41 . Fig. 8A The anchor 7 is shown in a collapsed configuration 71 having a collapsed radial dimension 73. The anchor 7 is formed by three rows of longitudinally spaced circumferential joints 77 that allow the anchor 7 to be converted from the collapsed configuration 71 to the expanded configuration 72 ( Figure 8B ).exist Figure 8C In the expanded configuration 72, the anchor 7 forms a star shape with a protrusion formed by a central joint 77 at the outermost radial top of the anchor 7 (see Figure 8G and Figure 8H ). Between the projections of the anchor 7 , the anchor 7 has a longitudinal groove, the diameter of which is substantially the reduced radial dimension 73 .

[0329] Figure 8B It is further shown that the anchor 7 is biased to transform from the contracted configuration 71 to the expanded configuration 72. The anchor 7 is biased to transform from the contracted configuration 71 to the expanded configuration 72. The anchor 7 is biased to transform from the contracted configuration 71 to the expanded configuration 72. FIG. 8A to FIG. 8F The anchor 7 is held in the retracted configuration 71 only by the static holding of the expander 2 (see Fig.8D ).

[0330] By advancing the dilator 2 onto the anchor 7, the anchor 71 can be transformed from the default expanded configuration 72 to the collapsed configuration 71 (see Figures 8D to 8F ). The joint 77 of the anchor 7 allows radial expansion due to the longitudinal compression 80 due to the force of the return spring.

[0331] Figure 8C The anchor 7 is shown in a fully deployed configuration 72 having a maximum deployed radial dimension 74 .

[0332] Figures 8D to 8F A longitudinal cross-sectional view of an embodiment of a piercing element 41 is shown, wherein Figures 8A to 8C The anchor member 7 is arranged in the lumen 25 of the expander 2. The expander 2 has a longitudinal groove 24 at its distal end and is configured to convert the anchor 7 from the contracted configuration 71 to the expanded configuration 72 and vice versa. The longitudinal groove 24 allows the expander 2 to be advanced on the protrusion 78 of the anchor 7 to convert the anchor 7 from the default expanded configuration 72 to the contracted configuration 71 (see Figure 8G and Figure 8H ).

[0333] The anchor 7 has an anchor actuator ( Figures 8D to 8F), so that by retracting the dilator 2 on the puncture element 41 or advancing the puncture element 41 relative to the dilator 2, the anchor 7 can be removed from Fig.8D The contraction pattern 71 in is converted to Fig.8F The anchor actuator of the expander 2 can engage the anchor 7 so that the anchor 72 can be transformed from the expanded configuration 72 to the collapsed configuration 71 by applying a force outward in the longitudinal direction to push the groove 24 on the anchor 7.

[0334] Figure 8G and 8H A front view of a first and a second embodiment of a piercing element 41 is shown, wherein Figures 8A to 8C The anchor 7 is in the expanded configuration 72. The anchor 7 in the expanded configuration 72 comprises a protrusion 78 formed by a longitudinal portion 75 (see Fig. 8A ), and has an expanded radial dimension 74. Each projection 78 is formed by a joint 77, which is arranged on the distal tip of the projection 77 and on the distal and proximal ends of the longitudinal portion 75 (see Figures 8A to 8C Between adjacent protrusions 78, the puncture element 41 forms a slit 79 in its longitudinal direction, so that the longitudinal groove 24 of the dilator 2 (see Figures 8D to 8F ) can be advanced on the protrusion 78. The width of the slit 79 in the radial direction R of the puncture element 41 is smaller than the width of the protrusion 78 in the radial direction of the anchor 7. Figure 8G and 8H The slit 79 in the puncture element 41 has substantially the same radial dimension as the inner cavity 413 of the puncture element 41 .

[0335] The projections 77 of the anchor 7 can be arranged spaced apart from each other along the circumferential direction C of the puncture element 41 or arranged directly adjacent to each other, such as Figure 8G and Figure 8H shown.

[0336] Fig. 9A A patient 14 and a channel 13 in the body of the patient 14 into which the biomedical device 101 may be introduced are shown. Fig. 9B and Fig. 9C , a cross section of the femoral artery 134 of the patient 14 in which the biomedical device 101 is implanted is shown in an enlarged view.

[0337] Fig. 9B The intracorporeal conduit 13 of the femoral artery 134 is shown surrounded by the tissue wall 132 and skin 141 of the patient 14 .

[0338] Fig. 9C The sheath 3 of the device 101 is shown introduced into the body duct 13, so that the catheterization is complete and the subsequent medical procedure can be performed.

[0339] Fig.10A schematic diagram of a first embodiment of a system 102 including a biomedical device 101 for insertion into a body duct 13 of a patient 14 is shown. The biomedical device 101 has an ultrasound probe 11 as an imaging mechanism. The system 102 has a camera 1121 used as a guide mechanism 112. The device 101 includes an ultrasound probe 11 and an introducer assembly 1, which are connected by a base plate as a common support 121. The device 101 is arranged to be connected to a robotic arm 123 of the system 102.

[0340] The system 102 also has a processing unit 125 operably connected to the actuators of the robotic arm 123, the imaging mechanism 11, and the camera 1121. The processing unit 125 is configured to operate the robotic arm 123 based on the images provided by the ultrasound probe 11 and the camera 1121.

[0341] The processing unit 125 is also connected to the storage unit 126, which is used to store the images of the ultrasound probe 11 and the camera 1121 and the data processed by the processing unit 125 based on these images. In addition, the storage unit 126 also stores the CT data of the internal pipe 13 before the operation, so that the processing unit 125 can align the image provided by the ultrasound probe 11 with the CT data.

[0342] The robotic arm 123 is located on a fixed surface 1232 and has a plurality of joints 1231 so that the device 101 can be positioned relative to the body channel 13 at the insertion site 131 .

[0343] The camera 1121 provides an image to the processing unit 125. The processing unit 125 is configured to visually detect feature points 1122 in the form of known geometric shapes (particularly rectangular shapes) within the provided image. The feature points 1122 are placed on the surgical drape 15 and frame a target site 131 for catheterization of the internal body pipe 13, so that the processing unit 125 can identify the target site 13 based on the feature points 1122. The surgical drape 15 covers the portion of the patient 4 other than the insertion site 131 to reduce unnecessary visual input from the camera 1121. Based on the input from the processing unit 125, the robotic arm 123 can position the device 101 so that the ultrasound probe 11 can be placed near the internal body pipe 13. To this end, the robotic arm 123 has three translational degrees of freedom t and two rotational degrees of freedom f (see Fig.13A and 13B ). In addition, the robot arm 123 is configured to rotate the device 101 along the circumferential direction of the ultrasound probe 11 (see Figures 13C to 13D ).

[0344] The processing unit 125 is also configured to detect calcification within the body vessel 13. Based on the images provided to the processing unit 125 by the ultrasound probe 11 and the preoperative CT scan, the position of the device 101 can be adjusted to a different position using the robotic arm 123 if the predicted introduction path will pass through the detected calcification.

[0345] Fig.11A and 11B Schematic side views of first and second embodiments of a system 102 are shown including a biomedical device 101 having an ultrasound probe 11 fixedly connected to a base plate 121 and an introducer assembly 121. Fig.11A and 11B In the embodiment, the longitudinal axis of the ultrasonic probe 11 is substantially perpendicular to the longitudinal axis of the internal tube (see Figures 13A to 13D ). The field of view 113 of the ultrasound probe is located in a section of the internal tube 13, wherein the puncture element 41 of the introducer assembly 1 can be introduced into the internal tube 13 through the insertion site 131, the patient's skin 141 and the tissue wall 132 of the internal tube 13.

[0346] exist Fig.11A In the embodiment, the angle α between the longitudinal direction L4 of the puncture element 41 and the longitudinal direction of the body tube is fixed to 30°.

[0347] exist Fig. 11B The angle α can be adjusted by the motor 1227 of the introducer positioner 122 (see Figures 12B to 12C ). The introducer assembly 1 is positioned and the longitudinal direction L4 of the puncture element 41 is adjusted in particular without moving the probe 11. The dilator 2 and the sheath 3 of the introducer assembly 1 can be moved as before. Figure 1A It is introduced into the body channel 13 as described in .

[0348] Figures 12A to 12C It shows a structure with five ( Fig. 12A ), four ( Fig. 12B ) and three ( Fig. 12C ) is a schematic side view of an introducer positioner 122 for positioning the introducer assembly 1 with degrees of freedom T, F. The introducer positioner 122 is fixedly connected to a common support 121, which connects the introducer positioner 122 to the imaging mechanism (see Fig.11A and 11B ).

[0349] Fig. 12AAn introducer positioner 122 is shown having three translational degrees of freedom T and two rotational degrees of freedom F of the introducer assembly 1 relative to the common support 121. Arms 1228, 1229 each have a joint 1230 at one end connected to the introducer assembly 1, so that the introducer assembly 1 can rotate relative to the common support 121. The introducer assembly 1 with the puncture element 41 has three translational degrees of freedom T and two rotational degrees of freedom F.

[0350] Fig. 12B An introducer positioner 122 having three translational degrees of freedom T and one rotational degree of freedom F is shown.

[0351] Fig. 12C An introducer positioner 122 is shown, which is substantially similar to Fig. 12B The introducer positioner 122, but Fig. 12C The introducer assembly 1 in has only two translational degrees of freedom T instead of three.

[0352] Figures 13A to 13D A schematic side view of an embodiment of an ultrasonic probe 11 relative to a body pipe 13 and a method of positioning the ultrasonic probe 11 relative to the body pipe 13 are shown. Fig.13A In the embodiment, the ultrasonic probe 11 is positioned by the device positioner 123 to image the internal vessel 13 (see Fig.10 ). The ultrasound probe 11 is preferably configured to retrieve three-dimensional spatial information with a minimum delay of more than 10 frames per second, with a total data delay of less than 100 milliseconds.

[0353] exist Fig.13A In the first step, the field of view 113 of the ultrasound probe 11 is roughly matched with the in vivo pipe 13, so that the field of view 113 captures the cross section of the in vivo pipe 13 within the imaging plane I of the ultrasound probe 11.

[0354] exist Fig. 13B In the second step of the method, the ultrasound probe 11 is aligned so that the cross section of the in-vivo pipe 13 is located at the center of the field of view 113 in the imaging plane I. Therefore, the ultrasound probe 11 is adjusted in at least one translational degree of freedom t by the device positioner so that the imaging plane I is substantially orthogonal to the longitudinal direction of the in-vivo pipe 13. Alternatively, the imaging plane I can be arranged so that the cross section of the in-vivo pipe 13 is at least completely contained in the field of view 113 of the ultrasound probe 11.

[0355] exist Fig. 13C In the third step, the translational freedom t and the rotational freedom f of the ultrasound probe 11 are adjusted until the longitudinal direction of the internal pipe 13 is substantially parallel to the imaging plane I, as shown in FIG. Fig.13D As shown. Fig.13D In the embodiment, the longitudinal direction of the in-vivo tube 13 is substantially orthogonal to the longitudinal direction L2 of the ultrasonic probe 11. Fig. 13C During the alignment, the translational and / or rotational degrees of freedom f, t are continuously adjusted so that the intracorporeal channel 13 is kept substantially at the center of the field of view 113 .

[0356] Figures 14A to 14C A device having a cutting element 16 formed by a scalpel (see Fig. 14B ) and a top view and two perspective side views of an embodiment of a system 104 of a shearing unit and a mounted biomedical device 101. The biomedical device 101 has an introducer assembly 1, which includes a dilator 2, a sheath 3 and an inner guide unit 4 formed by a puncture element 41.

[0357] The system 104 has an actuation unit 9 with two rollers 92 driven by a gearbox for advancing and retracting the introducer assembly 1, i.e., the dilator 2, sheath 3 and guide unit 4. The top of the actuation unit 9 is shown semi-transparent so that the rollers 92 can be better seen.

[0358] The system 104 has three receiving sections 181, 182, 183 having an open shape 184 to form proximal sections for respectively receiving the sheath 3, the dilator 2, and the guide unit 4 of the biomedical device 101. The sheath 3, the dilator 2, and the guide unit 4 can be installed in the corresponding receiving sections 181, 182, 183 forming a snap-fit ​​mechanism, so that the sheath 3, the dilator 2, and the guide unit 4 can be arranged in a specific predetermined position relative to each other.

[0359] The system 104 also has four guide elements 211, 212, 213, 214 formed by metal rails, which are arranged parallel to the longitudinal direction L of the system 104. The first guide element 211 is arranged in the center of the other three guide elements 212, 213, 214. The other three guide elements 212, 213, 214 are respectively connected to a base 215 on the proximal side of the system 104, while the distal side forms a free part.

[0360] The three seating sections 181, 182, 183 are movably attached to the central guide element 211 and one of the other three guide elements 212, 213, 214. The three seating sections 181, 182, 183 can be moved along the guide elements 211, 212, 213, 214 by the actuation unit 9.

[0361] The rollers 92 are driven by gears in a common driven gearbox 921 of the actuating unit 9, so that the two rollers 92 can perform rotational movement at the same speed and power.

[0362] Fig.15A and 15B Shown according to Figures 14A to 14CA top view of the system 104 and a method of advancing and retracting the introducer assembly 1 by the actuation unit 9 of the system 104.

[0363] The actuation unit 9 is configured to translate along the centrally located guide element 211 in the proximal direction P and the distal direction D of the system 104 (see for example Fig.15A and 15B ).exist Figures 14A-14C , the actuating unit 9 is configured to engage and move the third seating section 183 connected to the guide unit 4 by engaging the guide elements 212, 214 via the roller 92. Since the seating sections 181, 182, 183 are sequentially movably arranged along the central guide element 211, the actuating unit 9 is configured to move all three seating sections 181, 182, 183 in unison along the distal direction D, as shown in FIG. Fig.15A As shown. This allows the sheath 3, dilator 2 and guide unit 4 to move in unison while being arranged in a predetermined position relative to each other. The sheath 3, dilator 2 and guide unit 4 are arranged in a predetermined position so that the distal tip 44 of the guide unit 4 extends from the distal opening 22 of the dilator 2, and the distal tip of the dilator 2 extends from the distal opening 32 of the sheath 3. The predetermined position is a direct result of the design (particularly the longitudinal length) of the respective placement sections 181, 182, 183.

[0364] like Fig.15A As shown, the introducer assembly 1 is pushed to a predetermined position by the actuating unit 9, so that the introducer assembly 1 can be inserted into the body channel through the patient's skin.

[0365] When the third seating section 183 is engaged with the second seating section 182, the hollow cylindrical element of the expander 2 and the cylindrical element of the guide unit 4 form a mechanical coupling 8, which engage with each other and couple the movements of the expander 2 and the guide unit 4. However, the mechanical coupling 8 can also be alternatively arranged on the seating sections 181, 182, 183 to achieve the same effect.

[0366] Fig. 14B The cutting element 16 can be arranged in a retracted state to avoid accidental injury. Fig. 14C The extended state is shown, in which the cutting element 16 projects in the distal direction in order to make an incision at the insertion site through the guide unit 4. The cutting element 16 may be automatically extended in response to advancement of the guide unit 4, or independently operated by the processing unit.

[0367] The cutting element 16 is configured to make an incision by placing its cutting edge at the insertion site of the guide unit 4 and cutting therefrom. The incision of the cutting element 16 has sufficient dimensions to allow atraumatic widening / insertion of the dilator 2 and subsequently the sheath 3.

[0368] Fig. 15B It is shown that once the sheath 3 is fully advanced, for example into a body duct, the dilator 2 and the guide unit 4 can be retracted by the actuation unit 9, since they are coupled together with the mechanical coupling 8. However, the sheath 3 remains in place so that a percutaneous surgical procedure can be performed after the system 104 is removed. This design of the system 104 allows for atraumatic, preferably fully automated, catheterization using only a single actuation unit 9.

[0369] To disconnect the biomedical device 101 from the system 104 after successful percutaneous catheterization, the processing unit ( Figures 14A-15B The engaging member 19 is converted from the engaging mode to the disengaging mode (not shown). All three placement sections 181, 182, 183 are equipped with corresponding engaging members 19. Figures 14A-15B The engagement member 19 in the embodiment is formed by a latch which can be extended to release the sheath 3 , the dilator 2 and the guide unit 4 from the snap-fit ​​mechanism of the seating sections 181 , 182 , 183 .

[0370] Subsequently, after releasing the sheath 3, dilator 2, and guide unit 4 via the engagement member 19, the system 104 can be removed, allowing the clinician to perform a surgical intervention after the catheterization.

[0371] Figures 14A-15B The entire process of catheter insertion in the apparatus may be controlled by a processing unit which operates the actuation unit 9 , the shearing unit (particularly the cutting element 16 ) and the optional engagement member 19 .

[0372] Figures 15C-15H A perspective side view of a system 106 for performing percutaneous catheterization is shown, having a shearing unit 16 at the distal tip of the system 106 for performing shearing openings. The shearing unit 16 has two cutting elements 161, 162, each formed by two blades with outwardly directed cutting edges 165, 166. The cutting elements 161, 162 are attached to a common fulcrum 163 by a rod extending through the common fulcrum 163.

[0373] Figures 15C-15H The cutting elements 161, 162 are shown arranged at an angle between 15° and 60° relative to the rod to optimize the pivoting movement of the cutting elements 161, 162. Therefore, the longitudinal axes of the cutting elements 161, 162 are further arranged at an angle relative to each other in the closed configuration 169 (see Fig. 15C This allows the cutting elements 161, 162 to be converted into the open configuration 168 (see Fig.15D ) has a smaller distal component and a radially outward component.

[0374] The ends of the rods are attached to two separate rods leading to a second fulcrum 164 connected to the actuation portion 167. The cutting elements 161, 162 are attached to the actuation portion 167 to form a conversion mechanism configured to allow the cutting elements 161, 162 to pivot when the actuation portion 167 is advanced / retracted in translation (see Fig. 15C and 15D ). This allows the shearing unit 16 to be switched between the closed configuration 169 and the open configuration 168.

[0375] exist Fig. 15C In the closed configuration 169, the distal ends of the cutting elements 161, 162 merge to form a sharp distal tip 1601 that is suitable for piercing an insertion site of the patient's skin.

[0376] In various embodiments, the cutting elements 161 , 162 may have distal ends formed by a T-shape, for example, and be adapted to perform blunt dissection by rotational and / or translational movement of the cutting elements 161 , 162 .

[0377] The shearing unit 16 is mounted on a guide element formed by the guide rail 216 of the system 106. The shearing unit 16 can be actuated by the actuation unit 9 (see e.g. Figures 14A-15B ), the shearing unit 16 is retracted / advanced by rotating the threaded surface of the guide rail 216. This allows the shearing unit 16 to be advanced to perform a shearing opening, particularly an incision at the insertion site, and to be retracted after performing the shearing opening.

[0378] exist Figures 15A to 15H , the shearing unit 16 can be advanced along the longitudinal axis L of the system 106. The system 106 is configured such that the distal tip 1601 of the shearing unit 16 can be arranged at a spatial position of an insertion site where components of an introducer assembly, such as a catheter, a dilator, a puncture element, and an external guide unit, can be inserted into the insertion site. Thus, the shearing unit 16 can facilitate the insertion of the introducer assembly during the catheter insertion process.

[0379] Fig.15E It is shown that the puncture element 41 , the dilator 2 and the sheath 3 can be advanced to the insertion site along the longitudinal axis L by the actuation unit simultaneously with, before or after the shear opening is performed by the shear unit 16 .

[0380] Fig.15F The outer guide unit 1602 is shown to be able to advance the insertion site until it is close to the proximal end of the body channel to be inserted with the catheter (see Figure 15N-15Q The outer guide unit 1602 includes an outer tubular member 1603 and an inner tubular member 1604, which can be advanced / retracted independently of each other by the actuation unit 9 (see, e.g. Figures 14A-15B). The outer tubular member 1603 is formed of a harder material than the inner tubular member 1604 and has an inner lumen for receiving the inner tubular member 1604 and a medical instrument (particularly the biomedical device described previously).

[0381] The inner tubular member 1604 is formed to seal the lumen of the outer tubular member 1603 during advancement of the outer guide unit 1602 through the insertion site. Subsequently, the inner tubular member 1604 can be retracted by the actuation unit to clear the lumen while the outer tubular member 1603 remains in the patient's body. This allows reliable access to the vascular body channel even during or after catheterization is completed, because the medical / surgical instrument can be replaced or reintroduced while the outer tubular member 1603 remains in the patient's body.

[0382] Figure 15G and 15H The system 106 of an embodiment of an outer guide unit is shown, which has an outer tubular member 1603 having a longitudinal length between 4 cm and 8 cm and a lumen having a proximal opening 1605 and a distal opening 1606. The more flexible inner tubular member 1604 of the outer guide unit 1602 is partially arranged in the lumen for sealing the lumen during insertion into the insertion site. The proximal section of the inner tubular member 1604 protrudes from the proximal end 1605 of the outer tubular member in a curved manner so that the longitudinal direction of the components for inserting the introducer assembly is not blocked by the inner tubular member 1604.

[0383] After the guide unit 1602 is inserted, the inner tubular member 1604 can be inserted into the lumen at the proximal end 1605, for example, through the actuation unit, along the Figure 15G The curved space trajectory shown is retracted, as Fig.15H This allows the components of the introducer assembly to be introduced through the lumen of the outer guide unit 1602 through the insertion site into the patient's body for catheter insertion. Fig.15H It is shown that the sheath 3 of the biomedical device 101 , the dilator 2 can be introduced through the outer tubular member 1603 along the common longitudinal axis L of the biomedical device 101 and the outer tubular member 1603 .

[0384] Fig.15I A perspective view of an embodiment of a guide unit 1602 formed by an outer tubular member 1603 is shown, which has at least one sealing element, in particular two inner sealing elements, which are formed by an inflatable balloon or diaphragm made of silicon to allow the insertion of medical / surgical instruments and prevent the outflow of patient blood.

[0385] Figures 15J-15LA perspective side view of a first embodiment of a shearing unit 16 is shown, the shearing unit 16 having a non-rotationally symmetrical cross-section at its blunt distal tip 1612, and a second embodiment of a shearing unit 16 is shown, the shearing unit 16 comprising two cutting elements 161, 162 which are radially movable relative to each other to perform shear openings.

[0386] Fig.15J A first embodiment of a shearing unit 16 is shown, which is formed by a tubular cutting element 161 having two longitudinal slits 1611 extending longitudinally from a blunt distal tip 1612 of the tubular cutting element 161 to a middle portion of the tubular cutting element 161. The longitudinal slits 1611 are arranged on opposite sides of the cutting element 161. The blunt distal tip 1612 of the cutting element 161 has a non-rotationally symmetrical elliptical cross-sectional shape, so that by the actuation unit ( Fig.15J Rotation of the insert (not shown) generates a shearing force, thereby shearing the opening by blunt dissection at the insertion site.

[0387] use Fig.15J The system of the shearing unit 16 may also include a blunt insert 1615 (see Figure 15J.1 ), which can be inserted into the inner cavity 1613 of the cutting element 161 to enhance the structural integrity of the shearing unit 16 during rotation.

[0388] Fig.15J The actuation unit and the processing unit of the system for actuating the rotation of the shearing unit 16 are preferably configured to translate the shearing unit 16 in the distal direction and to rotate the shearing unit 16 in a continuous or simultaneous manner. In a preferred embodiment, the rotation of the shearing unit 16 is performed by sequentially rotating around the longitudinal axis of the shearing unit 16 in a first angular direction and then rotating in a second angular direction opposite to the first angular direction. The rotation range of one continuous step preferably does not exceed 360° of a full rotation, in particular does not exceed 180° in one angular direction, or even does not exceed 90° in one angular direction. Rapidly switching the angular direction of orientation further enhances the applied shearing force and facilitates shearing opening by blunt dissection.

[0389] Figure 15K and 15L A second embodiment of a shearing unit 16 is shown having two semi-cylindrical cutting elements 161 , 162 which are separated from each other by a longitudinal slit 1611 on opposite sides which extends over the entire length of the shearing unit 16 .

[0390] Figure 15K The cutting elements 161, 162 are shown enclosing the inner cavity 1613 in the closed configuration of the shearing unit 16, and Figure 15LThe cutting elements 161, 162 are shown to be movable radially outward relative to each other to convert the shearing cell 16 to the open configuration. The lumen 1613 of the shearing cell 16 has a smaller cross-sectional dimension, for example less than 20% of the maximum cross-sectional dimension of the shearing cell 16, so that the lumen 1613 can be used as a biomedical device or blunt insert 1615 (see Figure 15J.1 )'s entry point for the component. This allows Figure 15K and 15L The shear unit 16 in Figure 15K The closed configuration shown in is introduced through the insertion site. Subsequently, the shearing unit 16 may be radially expanded, for example by inserting a blunt insert 1615 to convert the shearing unit 16 to the open configuration.

[0391] include Figure 15K and 15L The actuation unit and the processing unit of the system of the shearing unit 16 are preferably configured to sequentially advance and transform the shearing unit 16 by advancing the shearing unit 16 in the closed configuration and then advancing the blunt insert 1615 or even the biomedical device in the lumen 1613 to transform the shearing unit 16 into the open configuration and perform blunt dissection. Subsequently, the shearing unit 16 can be transformed into the closed configuration again so as to be advanced deeper into the tissue by retracting the blunt insert 1615 or the biomedical device.

[0392] The processing unit may be configured to repeat this process multiple times in a fully automated manner to perform multiple blunt dissections by repeatedly advancing the shearing unit 16 deeper into the tissue until intracorporeal duct catheterization can be performed.

[0393] This expandable nature of the shearing unit 16 further enables medical / surgical instruments having different cross-sectional sizes to be inserted into the body passage through the insertion site, as the cutting elements 161 , 162 expand accordingly.

[0394] Figure 15J.1 A blunt insert 1615 having a rounded distal tip is shown. A system for performing shear opening may include Figure 15J.1 The blunt insert 1615 is provided to enhance the structural integrity of the rotatable shearing element 16, especially when the angular direction of rotation of the rotatable shearing element is changed rapidly (see Fig.15J Alternatively, the system may include a blunt insert 1615 for converting the shearing unit 16 from the closed configuration to the open configuration by repeatedly advancing or retracting the blunt insert 1615 (see Figure 15J.1 ).

[0395] Figure 15M and 15NA schematic side view of a system 106 is shown for sequentially advancing a biomedical device 101 and a shearing unit 16 through an insertion site 131 into a patient's skin 141 to a body duct 13 , and repeatedly shearing and opening a hole using the shearing unit 16 .

[0396] The system 106 has an actuation unit and a processing unit ( Figure 15M and 15N 16 (not shown), which is suitable for operating the translational movement of the biomedical device 101 and the shearing unit 16. The biomedical device 101 has an outer sheath 3, a dilator 2 and an inner guide unit 4 nested in each other. The actuation unit and the processing unit are also suitable for placing the shearing unit 16 in a closed state 169 (see Figure 15M ) and open pattern 168 (see Fig.15N ). The introduction of the biomedical device 101 is performed by a processing unit and an actuation unit, which are adapted to sequentially advance the shearing unit 16 in a closed configuration 169 and subsequently convert the shearing unit 16 into an open configuration 168. The shearing unit 16 has at least two cutting elements 161, 162, which merge to form at least one distal tip in a closed configuration 169, so that it can be sequentially advanced through tissue along the longitudinal direction of the shearing unit 16.

[0397] Figure 15M and 15N The cutting elements 161, 162 of the shearing unit 16 in the embodiment also have two blunt edges facing outwards, so that the shearing unit 16 is suitable for forming a shearing opening of the tissue by performing blunt dissection when switching from the closed configuration 169 to the open configuration 168. The processing unit and the actuation unit are also suitable for sequentially advancing the biomedical device 101 after performing further distal shearing openings. The process can be repeated, in particular in a fully automatic manner controlled by the processing unit, until the biomedical device 101 is introduced into the body conduit 13, in particular into the femoral artery of the patient.

[0398] This enables the biomedical device 101 to be introduced via a more non-invasive vascular catheterization procedure.

[0399] Figure 15M and 15N The shearing cell 16 is shown arranged at an angle relative to the longitudinal direction of the biomedical device 101 for better viewing. However, in a preferred embodiment, the system 106 may be adapted to advance the shearing cell 16 and the biomedical device 101 in a common longitudinal direction.

[0400] Figure 15M and 15N The system 106 in the embodiment may alternatively or additionally be used for advancement and in vivo positioning of the external guide unit 1602 (see Figures 15O-15R ).

[0401] Figures 15O-15R A schematic side view of inserting and placing an outer guide unit 1602 through an insertion site 131 almost to the body conduit 13 formed by the femoral artery and subsequently catheterizing the biomedical device 101 is shown. The outer guide unit 1602 can be positioned at the insertion site 131 through the patient's skin 141, as previously described with respect to the biomedical device 101. Figure 15M and 15N As described in.

[0402] The outer guide unit 1602 can be based on Figures 15I-15L One of the three embodiments is formed to inhibit blood outflow while facilitating the insertion of medical / surgical instruments, such as biomedical device 101. This allows the outer guide unit to simplify the introduction and exchange of medical / surgical instruments during surgery.

[0403] Figure 15Q and 15R It is shown that the biomedical device 101 can be advanced through the outer guide unit 1602. The procedure is preferably performed by the previously described system, for example by an actuation unit of a processing unit controlling the system to perform the insertion of the outer guide unit 1602 and the biomedical device 101 in a fully automated manner.

[0404] Figure 15Q and 15R Biomedical Devices 101 in Fig.17A and 17B Described in more detail in .

[0405] Fig.16 A longitudinal cross-sectional view of an embodiment of a biomedical device 101 having an introducer assembly 1 including a sheath 3, a dilator 2, a puncture element 41 and two mechanical couplers 8, 83 is shown. The first coupler 8 is formed by first and second annular coupling elements 81, 82 between the sheath 3 and the dilator 2 of the introducer assembly 1. The second coupler 83 is formed by three coupling elements 84, 85, 86 arranged on the dilator and the puncture element 41. The coupling elements 81, 82, 84, 85, 86 are substantially formed as Figure 7 The connecting elements previously described in.

[0406] The first and second coupling elements 84, 85 of the second coupling 83 are arranged so that they engage with each other at a specific position when the puncture element 41 moves in the distal direction. This allows limiting the length of the puncture element 41 extending from the distal end of the dilator, and at the same time allows the puncture element 41 and the dilator 2 to move in unison after the first and second coupling elements 84, 85 engage with each other. In addition, the first and second coupling elements 81, 82 of the first coupling 8 allow the dilator 2 and the sheath 3 to move in unison after engaging with each other. Therefore, the puncture element 41, the dilator 2 and the sheath 3 can be simultaneously advanced only by actively actuating the puncture element 41 (for example, by an actuation unit).

[0407] In addition, when the puncture element 41 is retracted, the puncture element 41 and the second and third coupling elements 85, 86 of the dilator 2 are engaged with each other, so that the puncture element 41 and the dilator 2 can be retracted in unison. However, at the same time, no coupling element is provided for realizing the motion coupling of the dilator 2 and the sheath 3, so that the dilator 2 and the puncture element 41 can be retracted and removed, while the sheath 3 remains stationary, for example, in the patient's internal duct.

[0408] Fig.17A and 17B A top view of an embodiment of a biomedical device 101 including an introducer assembly 1 is shown. The introducer assembly 1 has a guide wire 43, a puncture element 41 formed by a cannula, a dilator 2, a sheath 3, and a side port 45, which are separated from each other and nested with each other. The puncture element 41 can have sufficient longitudinal extension so that the dilator can be directly advanced into a body conduit for catheter insertion, preferably with a longitudinal extension of at least 6 cm, 8 cm, or 12 cm. The puncture element 41, the dilator 2, the sheath 3, and / or the side port can have proximal joints 46, 47, 48, 49, respectively. Fig. 17B The embodiment shows that the guide wire 43 can be nested in the puncture element 41, the puncture element 41 can be nested in the dilator 2, and the dilator 2 can be nested in the sheath 3. Fig. 17B As shown, the proximal connector 46 of the side port 45 can be attached to the proximal end of the connector 49 of the puncture element 41. The connector 49 of the puncture element 41 can be attached to the proximal end of the connector 48 of the dilator 2. The connector 48 of the dilator 2 can be attached to the proximal end of the connector 47 of the sheath 3. If the proximal connector 49 of the dilator 2 and the proximal connector 48 of the puncture element 41 are connected, the puncture element 41 can protrude from the distal opening of the dilator, which can allow the puncture element 41 and the dilator to be uniformly advanced in the longitudinal direction.

[0409] The lumen surrounded by the side port 45 can be connected in fluid communication with the lumen of the puncture element 41. A hemostatic valve 52 can be disposed in the lumen of the side port 45. Fig.17A and 17BIt is shown that the hemostatic valve 52 can be arranged at the outer end of the side branch of the side port 45. The hemostatic valve 52 arranged laterally in the side port 45 can allow the administration of drugs simultaneously with the movement of the guide wire 43. The proximal connector 46 of the side port 45 can have a second hemostatic valve 521, which allows the guide wire 43 to be advanced / retracted while maintaining the pressure in the lumen of the side port 45 and the lumen of the puncture element 41. In addition, a pressure sensor 51 for detecting the intracavitary pressure can be arranged in the hemostatic valves 52, 521. Fig.17A and 17B In the embodiment, the pressure sensor 51 is arranged in the hemostasis valve 52 arranged laterally.

[0410] The proximal connectors 46, 47, 48, 49 may be formed to have a shape corresponding to the shape of the placement section, for example, corresponding to the open shape of the placement section of the sterilized components of the percutaneous catheterization system including the biomedical device 101. At least two proximal connectors may include a coupler, which in particular includes a plurality of coupling elements, so that the movements of the connectors 46, 47, 48, 49 can be coupled to each other.

[0411] Fig.18A and 18B 1 shows a perspective view and a top view of an embodiment of a non-sterile component 55 of a percutaneous catheter placement system, the system comprising a first transmission unit 902 of an actuation unit. When the first transmission unit 902 is engaged by at least one engagement structure 906 (e.g., by Fig.18A and 18B The six engagement structures 906 of the first transmission unit 902 are connected to the second transmission unit 903 (see Fig.18C ), the first transmission unit 902 may be adapted to form a plurality of connections for transmitting the rotational motion. The non-sterile component 55 may have a plurality of recesses, protrusions and / or magnetic connection elements, for example, Fig.18A and 18B The six magnetic connection elements 905 are shown. The engagement structure 906 of the non-sterile component 55 can be formed to releasably engage the engagement structure 907 of the sterilized component 54 (see Fig.18C ) to transmit rotational motion, such as for use in components of an introducer assembly / placement section of an actuation system.

[0412] The non-sterile component 55 may include a plurality of actuators of an actuation unit for driving the rotational movement. The non-sterile component 55 may include a processing unit for controlling the actuation unit, in particular for controlling the actuation unit in a fully automatic manner ( Fig.18A and 18B not shown).

[0413] Fig.18CA top view of an embodiment of a sterilized component 54 including a second transmission unit 903 of an actuating unit is shown. The second transmission unit 903 may have a plurality of engagement structures 907 that are correspondingly formed and positioned to engage engagement structures 906 of the non-sterilized component 55 (see Fig.18A and 18B ) to transmit rotational motion. Fig.18C It is shown that the sterilized component 54 can include connecting elements 908 that are formed and positioned corresponding to the connecting elements 905 of the non-sterilized component 55. Fig.18C In the embodiment, the connection element 908 of the sterilized component 54 is magnetic, so that the sterilized component and the non-sterilized component 54, 55 can be firmly connected to each other. The magnetic connection elements 905, 908 can be embedded in the surface of the sterilized component 54 and the non-sterilized component 55.

[0414] The engagement structures 906, 907 and / or the connecting elements 905, 908 of the sterile and non-sterile components 55 can be arranged asymmetrically so that the sterile and non-sterile components 54, 55 can only be connected in a specific orientation relative to each other. This ensures that the actuation unit can connect a specific actuator to actuate a specific part of the introducer unit / placement section of the system.

[0415] Fig.18D A perspective view of an embodiment of a retaining element 53 is shown, which is suitable for Fig.18C Sterilization parts 54 and Fig.18A and 18B The non-sterile components 55 are held in a connected state. The holding element 53 may have a Fig.18D The retaining element 53 may have a contact surface 532 for engaging the sterilization component 54. The retaining element 53 may have a plurality of connecting elements. Fig.18D It is shown that the connection elements can be formed by bayonet connection elements 531, which can be arranged at different circumferential positions of the holding element 53. This can allow the holding element 53 to be rotated relative to the sterile and / or non-sterile components 54, 55 to be connected to the sterile or non-sterile components 54, 55 by locking all bayonet connection elements 531 at the same time.

[0416] Fig.18D It is shown that the circumferential positions of the bayonet connection elements can be arranged equidistantly along the annular shape of the retaining element 53. The bayonet connection element 531 can be as follows Fig.18D A male bayonet connection element 531 is shown which is suitable for connecting to a female bayonet connection element of a sterile and / or non-sterile component 54 , 55 .

[0417] The retaining element 53 can be positioned so that the contact surface 532 contacts the sterilized component 54 while engaging a plurality of female bayonet connection elements on the non-sterilized component 55 (see Fig. 22B and 22C ). This allows a secure and simple fixed arrangement of the sterile and non-sterile components 54, 55.

[0418] Fig.19A A dilator 2 is shown for use in a system for installing a percutaneous catheter (see, e.g. Fig.17A and 17B ) is a perspective side view of an embodiment of a placement section 182 of the introducer assembly. The placement section 182 may have a partially open shape 184 in the radial direction to receive the proximal joint 48 of the dilator 2 so as to actuate the dilator 2 in the longitudinal direction of the introducer assembly.

[0419] The receiving section 182 may further include a guide region 185. The guide region 185 may be formed by Fig.19A The longitudinal through passage shown is formed and can be connected to receive a guide structure, such as a guide rail 56 (see Figures 22A-22J ). The guide region 185 may be adapted to guide the seating segment 182 parallel to the longitudinal direction. The guide region 185 may be formed to receive a non-circular guide structure, for example having a rectangular cross-section, in a specific spatial orientation so that the seating segment 182 cannot rotate in an orthogonal plane relative to the longitudinal direction when moving along the guide structure.

[0420] The seating section 182 may also have a transmission region 186, which may be suitable for transmitting the rotational actuation (eg, via the torque shafts 9031, 9032, 9033 of the second transmission unit (see Figures 22A-22J )) is converted into movement of the placement section 182 along the longitudinal direction. Fig.19A The transmission region 186 shown can include a threaded channel parallel to the longitudinal direction, which can be driven, for example, by a threaded spindle of a second transmission unit in order to longitudinally actuate the seating section 182 .

[0421] Fig.19B and 19C A perspective side view of an embodiment of a placement section 181 of a sheath for a percutaneous catheter placement system is shown. The placement section 181 may have an engagement member 19 that may be engaged in an engagement configuration (see Fig.19B ) and disconnection type (see Fig.19C ). In the engagement configuration, the engagement member 19 can surround the radial portion opening portion 184 of the placement section 181, so that the sheath, in particular the proximal joint of the sheath, can be surrounded. Fig.19B In the disengagement configuration of the engagement member 19 shown, the sheath can be radially released from the placement section 181, for example after percutaneous catheterization. The engagement member 19 can be converted by a second transmission unit, for example, by a torque shaft 9034 (see FIG. 221 ) of the second transmission unit 903, for converting the engagement member 19 by rotation driven by the actuating unit.

[0422] Fig.19B and 19C The guide area 185 of the receiving section 181 can be connected to the Fig.19A The guide structure described in the embodiment is preferably a common guide structure, such as a guide rail 56 (see Fig.21D ), which also guides the placement section 182 of the expander.

[0423] The transmission region 186 of the seating section 181 may also be adapted to convert a rotational actuation (eg, via a second transmission unit) into a longitudinal movement of the seating section 181. Fig.19B and 19C The illustrated receiving section 181 can be formed such that the transmission region 186 is arranged at a position corresponding to the guide region 185. Fig.19A Different angular orientations / spatial positions of the placement segments 182 of the expander in the embodiment of the present invention. This allows the placement segments 181, 182 to be actuated independently. Fig.19B and 19C The transmission area 186 in the transmission unit 186 may include a threaded channel parallel to the longitudinal direction. The threaded channel may be suitable for receiving the main shaft 9032 (see Fig.21D ), rather than the placement section 182 of the expander. This can allow the placement sections 181, 182 to be actuated in the longitudinal direction by the rotation of different main shafts 9031, 9032 independently of each other by an actuation unit including a second transmission unit.

[0424] Fig. 20A and 20B A perspective side view of an embodiment of an extendable portion 9035 of a second transmission unit 903 of an actuation unit of a system for percutaneous puncture cannulation that can extend longitudinally is shown. The extendable portion 9035 of the second transmission unit 903 can be formed by a plurality of transmission elements 904 that can be nested with each other. This allows the second transmission unit 903 to be extended longitudinally. Fig. 20A and 20B The distal end of the extendable portion 9035 of the second transmission unit 903 can be connected to the placement section 183 of the guide unit, in particular the placement section 183 of the puncture element (see Fig.21A and 21B The extendable portion 9035 of the second transmission unit 903 is adapted to be switched between an extended state and a retracted state by moving the placement section 183 of the guide unit (eg, guide wire) in the longitudinal direction of the introducer assembly. Fig. 20A and 20B ) may have a bonding structure 907 (see Fig.18C), the engagement structure 906 of the first transmission unit 902 for engaging the non-sterile component 55 (see Fig.18A and 18B This may allow for the inclusion of first and second transmission units 902, 903 (see Fig.21D ) of the actuating unit rotatably actuates the extendable portion 9035 of the second transmission unit. To this end, the transmission element 904 may have an interlocking non-circular cross-sectional shape, such as Fig. 20B Thus, rotation of the proximal-most transmission element 904 may result in rotation of the distal-most transmission element 904 regardless of the extended state.

[0425] Figures 21A-21C A perspective side view and a side view of an embodiment of a third transmission unit 909 of the actuation unit of the percutaneous catheterization system and a mounting section 183 attached to the guide unit are shown. Fig.21A and 21B A perspective side view of the third transmission unit 909 .

[0426] The third transmission unit 909 may have a gear system 9091 adapted to be connected to the extendable portion 9035 of the second transmission unit 903 (see Fig. 20A and 20B ). The gear system 9091 is suitable for connecting the second transmission unit 903 to the actuator connected to the first transmission unit 902 (see Fig.18A and 18B ) is converted into a longitudinal actuation of the guide unit of the system, in particular the longitudinal actuation of the guide wire 43 of the guide unit (see Fig.22F ). Fig.21A and 21B 9091 can include a rotatably mounted threaded spindle 9092, which is suitable for driving two gears 9093. The gears 9093 can mesh with each other in a drivable manner, in particular by splines. The interlocked gears 9093 can be suitable for driving the guide wire of the guide unit along the longitudinal direction L. Therefore, the third transmission unit 909 can convert the rotational movement of the second transmission unit 903 into the longitudinal movement of the guide wire. Fig.21A and 21B As shown, the third transmission unit 909 may further include a guide member 9094 for guiding the guide wire, such as an elastic tube, to prevent the guide wire from bending or kinking when being advanced / retracted through the third transmission unit 909 .

[0427] Fig. 21C It is shown that the seating section 183 can have an open shape 184 for receiving a guide unit (in particular a puncture element). The open shape 184 can be formed to receive the proximal connector 49 of the puncture element (see Fig.17A and 17B). In addition, the open shape 184 can be adapted to further receive the side port 45, in particular as Fig. 21C A proximal connector 46 of the side port 45 is shown. Fig. 21C It is also shown that the threaded spindle 9092 of the gear system 9091 can be connected to the distal end of the extendable portion 9035 of the second transmission unit 903 to drive the guide wire in the longitudinal direction through the guide member 9094. In addition, the third transmission unit 909 can move in unison with the placement section 183, while the extendable portion 9035 of the second transmission unit 903 extends accordingly. The placement section 183 can have a transmission area 186 and a guide area ( Figures 21A-21C The guide region may be formed similarly to the guide region 185 described previously and adapted to guide the placement section 183 in the longitudinal direction, for example along a guide rail (see Figures 19A-19C ). The transmission area 186 may include a threaded channel parallel to the longitudinal direction L. The transmission area 186 may be adapted to receive the main shaft 9093 of the second transmission unit 903 so as to move the placement section 183 along the longitudinal direction L. In a preferred embodiment, the placement sections 181, 182, 182 (see Figures 19A-19C ) can be independently moved in the longitudinal direction L by actuating the separate main shafts 9031, 9032, and 9033 of the second transmission unit 903.

[0428] Fig.21D A perspective side view of an embodiment of a sterilization component 54 of a system 104 for performing percutaneous catheterization in an at least partially automated manner is shown. The sterilization component 54 can have three seating sections 181, 182, 183. The first seating section 181 can be adapted to mount a sheath in an open shape and has a configuration that can be adapted to switch between an engagement configuration that engages and locks the sheath and a disengagement configuration that radially releases the sheath (see Fig.19B and 19C ) of the engagement member 19. The engagement member 19 can be converted by rotational actuation of the torque shaft 9034 of the second transmission unit 903 of the actuator which can be connected to the actuation unit. The actuator can be arranged in the non-sterile component 55 (see Figures 22A-22J The second mounting section 182 may be adapted to mount the expander in an open shape 184 (see Fig.19A The third receiving section 183 can be adapted to receive a guide unit, in particular a puncture element formed by a cannula, in an open shape 184 and preferably a lateral port (see Fig. 21C ).

[0429] The placement sections 181, 182, 183 can be placed along the guide structure (eg Fig.21D The guide rail 56 shown in FIG. Fig.21DIt is shown that all the seating sections 181, 182, 183 are arranged in series and are guided along a common guide rail 56 of the sterilization component 54 when moving in the longitudinal direction L of the sterilization component 54. The seating sections 181, 182, 183 may include a guide area for receiving a guide structure. Fig.21D As shown, the guide region may include a through hole which is correspondingly formed to receive the guide rail 56 so that the seating sections 181 , 182 , 183 are non-rotatably movable in the longitudinal direction L along the guide rail 56 .

[0430] Fig.21D It is shown that the placement sections 181, 182, 183 can be connected to the individual torque shafts 9031, 9032, 9033 (e.g., screw shafts) of the second transmission unit 903 at their transmission regions 186. The transmission region 186 can have threaded through holes parallel to the longitudinal direction for receiving the torque shafts 9031, 9032, 9033 (e.g., screw shafts). Fig.21D ). The torque shafts 9031, 9032, 9033 can rotate independently of each other. This allows the three placement sections 181, 182, 183 to be actuated independently of each other, for example by driving a separate actuator of the actuation unit of the second transmission unit. In a preferred embodiment, the actuator of the actuation unit is arranged in the non-sterile component ( Fig.21D not shown).

[0431] Fig.21D It is shown that the sterilization component 54 can have a third transmission unit 909 (see Fig.21A --21C). The third transmission unit 909 can be connected or connectable to the third placement section 183, so that the third transmission unit 909 and the third placement section 183 for mounting the guide unit (such as the puncture unit) can move together in the longitudinal direction in unison. The third transmission unit 909 can also be connected to the extendable portion 9035 of the second transmission unit 903. Fig.21D , the extendable portion 9035 is formed by nested elements having a rectangular cross-section. The extendable portion 9035 can be adapted to actuate the third transmission unit 909 by rotation similar to a torque shaft (but with multiple nested transmission elements 904) that interlock with each other when rotated (see Fig. 20A and 20B ). This enables the gear system 9091 of the third transmission unit 909 to convert the rotational motion into the motion of the drive guide wire in the longitudinal direction L through the extendable portion 9035.

[0432] The sheath, dilator and / or guide unit may have a proximal connector 47, 48, 49, which may be mounted in the receiving section 181, 182, 183 (see Fig.17A and 17BThe opening shape 184 of the seating sections 181 , 182 , 183 may be formed to correspond to the proximal connectors 47 , 48 , 49 of the sheath, dilator, and guide unit. The opening shape of the third mounting section 183 may be further formed to receive the proximal connector 47 of the lateral port 45 .

[0433] Figures 22A-22J A top view of an embodiment of system 104 is shown, which includes Fig.21D The sterilized component 54 and the non-sterile component 55 are used to perform the steps of percutaneous catheterization using the biomedical device 101. The first, second and third placement sections 181, 182, 183 can be movably attached to the torque shafts 9031, 9032, 9033 at their transmission areas, so that they can be moved in the longitudinal direction L by an actuation unit, which includes first and second transmission units 902, 903 independent of each other. The first transmission unit 902 of the non-sterile component 55 can have a plurality of engagement structures 906, which are suitable for engaging with the engagement structures 907 of the second transmission unit 903 of the sterilized component 54 to transmit an actuation motion, such as a rotational actuation motion (see Figures 18A-18C ). In addition, the plurality of connection elements 905, 908 of the sterile and non-sterile components 54, 55 may be connectable. The third transmission unit 909 may be arranged to be attached to the extendable portion 9035 of the second transmission unit 903, as previously described in Fig.21D As described in.

[0434] Fig.22A and 22B It is shown that the sterile and non-sterile components 54, 55 can be connected and fixed in a connected state by means of an annular retaining element 53, wherein the annular retaining element 53 can have a plurality of bayonet connection elements 531. An actuator for driving the actuation unit can be arranged in the non-sterile component 55.

[0435] Fig. 22C It shows that Fig.17A and 17B The biomedical device 101 shown can be installed in the placement sections 181, 182, and 183. The biomedical device 101 can be composed of sterilized components 54. The biomedical device 101 has a sheath 3, a dilator 2, and a guide unit formed by a puncture element 41. The biomedical device 101 can also include a side port 45, which can have a hemostatic valve 54 in a branch portion of the side port 45, such as Fig. 22CAs shown. The pressure sensor 51 can be arranged in the hemostatic valve 52 to detect the intraluminal pressure in the body pipeline by being connected to the lumen fluid of the puncture element 41. The sheath tube 3, the dilator 3, the puncture element 41 and the side port 45 can have proximal joints 47, 48, 49, 46, which can be installed in the opening shape 184 of the corresponding placement sections 181, 182, 183.

[0436] Fig.22D The first transmission unit of the actuation unit arranged in the non-sterile component 55 can be actuated to move the first and second placement sections 182, 183 distally along the longitudinal direction L. The first transmission unit can transmit the rotational movement to the transmission unit 903 via the engagement portion to control the rotational movement of the torque shafts 9032, 9033 of the second transmission unit 903. This allows the first and second placement sections 182, 183 to be advanced so that the puncture element 41 and the dilator 2 protrude from the distal tip. Fig.22D As shown, the puncture element 41 can protrude a predetermined distance from the expander 2. The extendable portion 9035 of the second transmission unit 903 connected to the third placement section 183 can extend parallel to the longitudinal direction L by the distance that the third placement section 183 moves. Fig.22D shown.

[0437] Fig.22E It is shown that the actuation unit can be actuated to control the torque shafts 9031, 9032, 9033 to advance the puncture element 41, the dilator 2 and the sheath 3 to advance into the body channel ( Fig.22E Before or after the introduction of the puncture element, an incision extending from or through the puncture site / future puncture site may be made. The incision may be made by the clinician or by a shearing unit controlled by the processing unit. The shearing unit may be a cutting element 16, as previously described. Figures 14A-15B The system, in particular Fig.21D The non-sterile components 54 in the embodiment may include the cutting element 16 as previously described.

[0438] Since the seating sections 181 , 182 , 183 can be arranged on a common guide rail 56 , the movements can be coupled so that, for example, actuation of the third seating section 183 moves the other seating sections 181 , 182 in the distal direction L. The introduction into the body channel can be guided by an imaging device, in particular an ultrasound probe.

[0439] Fig.22FIt is shown that once the puncture element 41 is introduced into the body pipeline, the guide wire 43 can be introduced through the lumen of the puncture element 41. The guide wire 43 can be advanced in the distal direction L by rotating the extendable portion 9035 of the second transmission unit 903. The rotation of the extendable portion 9035 can drive the gear system 9091 to convert, thereby converting the rotational motion into the translational motion of the guide wire 43. The gear system 9091 may include a rotatably mounted threaded spindle 9092, which can be coupled to the extendable portion 9035 to drive the gear 9093 to actuate the guide wire 43 (see 21A-21C). This allows the guide wire 43 to move independently of the position of the third placement section 183 without translating the third transmission unit 909 / the third placement section 183.

[0440] Figure 22G It is shown that the puncture element 41 can be retracted by retracting the third placement section 183 , so that only the guide wire 43 , the dilator 2 , and the sheath 3 remain in the body channel.

[0441] Fig.22H It is shown that the dilator 2 can be retracted by retracting the second placement section 182 so that only the sheath 3 and the guide wire 43 remain in the body tube.

[0442] Fig.22I The fourth torque shaft 9034 of the second transmission unit 903 can be rotated to convert the engagement member of the first placement section 181 from the engagement state of fixing the sheath 3 to the release configuration for radially releasing the sheath 3 and the proximal joint 47 of the sheath 3 (see Fig.17A and 17B as well as Fig.19A and 19B ). The guide wire 43 can be fixed in the lumen of the sheath tube 3.

[0443] Fig.22J It is shown that the guidewire 43, sheath 3 and hub 47 can be radially released from the sterilization component 54. This allows the catheterization to be completed using the guidewire 43 and sheath 3 within a body conduit separate from the biomedical device 101 and allows the clinician to perform a subsequent surgical procedure.

[0444] Fig.22A --The system 104 in 22J may include a processing unit for controlling the actuation unit 9. The processing unit may also be adapted to independently drive the third transmission unit 909 through the second transmission unit 903 to perform the above steps, in particular in a partially or fully automated manner. The processing unit may also be connected to an external imaging mechanism, preferably an ultrasound probe, for controlling the system with the aid of image data of the in vivo channel and in particular the distal tip of the biomedical device detected by the external imaging mechanism.

[0445] The system may also have a cardiac cycle detector for detecting the temporal changes in the blood vessel pressure in the body pipeline ( Figures 22A-22J (not shown in the figure) The cardiac cycle detector may be connected to the processing unit for controlling the actuation unit so that the puncture element can be introduced into the body channel at a specific blood vessel pressure in the body channel.

[0446] The pressure sensor 51 can be arranged in the hemostasis valve 52, in particular by being connected to the processing unit, for detecting whether the puncture element 41 is introduced into the body channel. Once the pressure sensor 51 detects a pressure change corresponding to a successful puncture of the body channel, the processing unit can control the actuation unit to prevent the puncture element 41 from being further advanced.

Claims

1. A biomedical device (101) for percutaneous puncture and cannulation of a body tube (13), in particular arterial puncture and cannulation, the device (101) comprising an introducer assembly (1), the introducer assembly having - a dilator (2) for dilating an insertion site (131) of a patient (14) to access a body duct (13), - a sheath (3) for introducing into a vessel (13) in the body, and - an inner guiding unit (4) for guiding at least one of the dilator (2) and the sheath (3) into the internal duct (13), The dilator (2) has a narrowed outer section (21) and at least one distal opening (22), and is arranged at least partially concentrically around the guide unit (4), and The sheath (3) has at least one distal opening (32) and is arranged or can be arranged at least partially concentrically around the dilator (2) so that the guide unit (4), the dilator (2) and the sheath (3) can move relative to each other in the longitudinal direction (L) of the introducer assembly (1), It is characterized in that Once the puncture element (41) is inserted into the body duct (13), the dilator (2) can be guided along the guide unit (4) without completely withdrawing the puncture element (41) from the proximal end (5) of the introducer assembly (1).

2. The device (101) according to claim 1, wherein the guide unit (4) comprises an insertion guide for inserting at least one of the puncture element (41) and the guide wire (43), The insertion guide (42) has a distal section (422), wherein the proximal section (421) has a proximal lumen (423) for at least partially receiving at least one of the puncture element (41) and the guide wire (43), and The distal section (422) has a distal lumen (424) for receiving at least one of the puncture element (41) and the guide wire (43). The distal lumen (424) and the proximal lumen (423) are connected to each other. The distal section (422) has a lateral opening (425) at the proximal end (426) through which the puncture element (41) can be bidirectionally inserted into the distal lumen (424), and A distal opening (427) through which the puncture element (41) can be inserted into the body duct (13) by means of the puncture element (41).

3. The device (101) according to claim 2, wherein the distal lumen (424) extends in a straight line between the lateral opening (425) and the distal opening (427) of the distal section (422).

4. A device (101) according to claim 2 or 3, wherein the longitudinal axis of the proximal segment (421) of the insertion guide (42) is arranged or can be arranged at an angle of 1° to 125° relative to the longitudinal axis of the distal segment (422) of the insertion guide (42), preferably at an angle of 10° to 75°, and more preferably at an angle of 20° to 50°.

5. The device (101) according to any one of claims 2 to 4, wherein the dilator (2) has one of the following features: - is coaxially arranged or can be coaxially arranged around the insertion guide (42) and is configured to be moved forward relative to the insertion guide (42) in the longitudinal direction of the insertion guide (42); and - Coaxially arranged or capable of being coaxially arranged around a guide wire (43) and constructed to be advanced relative to the guide wire (43) in the longitudinal direction of the guide wire (43), wherein the outer sleeve portion (428) of the proximal segment and the distal segment (421, 422) has a release opening extending in the longitudinal direction, which is permanently opened or can be opened and is constructed to radially release the guide wire (43) at least partially arranged or capable of being arranged in the proximal tubular cavity and the distal tubular cavity (423, 424).

6. The device (101) according to any of the preceding claims, wherein the guide unit (4) comprises or consists of a puncture element (41) and optionally an insertion guide (42) or a guide wire (43).

7. The device (101) according to claim 6, wherein the piercing element (41) comprises at least one retaining structure (411) having at least one of the following: a groove (412) arranged on the outer surface and opening radially outwards (41) for receiving a guide wire (43) extending at least partially in the longitudinal direction (L4) of the puncture element (41), a lumen (413) defined by an at least partially open or openable wall for radially releasing a guide wire (43) at least partially arranged or arrangeable in the lumen (413), and - Attachment means for parallel attachment of the guide wire (43) to the puncture element (41).

8. The device (101) according to claim 6 or 7, wherein the piercing element (41) is relatively long and has - a longitudinal length (415) of 6 to 35 cm, preferably 8 to 30 cm, in particular 12 to 25 cm, and / or - A connection between the proximal end (416) and the distal end (431) of the guide wire (43) such that the puncture element (41) and the guide wire (43) are substantially flush with each other.

9. A device (101) according to any one of claims 6 to 8, wherein the puncture element (41) is connected or can be connected to the dilator (2) and includes an actuating element (6), in particular a spring, which can be switched between a retracted state (61) and an extended state (62), wherein by switching the actuating element (6), the puncture part (417) of the puncture element (41) for contacting and puncturing tissue can be retracted behind a non-puncture surface (63), or the non-puncture surface (63) can be moved forward to protect the puncture part (417).

10. The device (101) according to any one of claims 6 to 9, wherein the puncture element (41) comprises an anchor (7) which is at least partially arranged circumferentially on the puncture element (41) and preferably forms a longitudinal portion (75) of the puncture element (41), The anchor (7) includes a contracted state (71) and an expanded state (72). In the collapsed configuration (71), the anchor (7) has a radial dimension (73) that is smaller than the radial dimension (74) in the expanded configuration (72), such that The anchor (7) in the expanded state (72) prevents the puncture element (41) from being advanced into the patient (14), in particular into the body tube (13), beyond a predetermined longitudinal distance of the puncture element (41) and / or prevents the puncture element (41) from being retracted from the patient (14), in particular from being retracted from the body tube (13), beyond a predetermined longitudinal distance of the puncture element (41).

11. The device (101) according to claim 10, wherein the expander (2) includes an anchor actuator, so that when the expander (2) moves longitudinally relative to the puncture element (41), the anchor actuator engages the anchor (7) in the expanded state (72) to convert the anchor (7) from the expanded state (72) to the contracted state (71).

12. The device (101) according to claim 11, wherein the dilator (2) comprises a longitudinal groove (24) arranged at the distal opening (22) of the dilator (2), wherein the longitudinal groove (24) is configured to advance through the anchor (7) along the longitudinal direction (L4) of the puncture element (41).

13. The device (101) according to any of the preceding claims, wherein at least two, optionally three, of the sheath (3), the dilator (2) and at least a part of the guide unit (4), in particular the puncture element (41), are connected to at least one mechanical coupling (8), So that at least one of the sheath (3), dilator (2) or at least a portion of the guide unit (4) moves relative longitudinally beyond a predetermined point relative to the other of the sheath (3), dilator (2) and / or a portion of the guide unit (4), causing the connector (8) to move at least another of the sheath (3), dilator (2) or a portion of the guide unit (4) along the longitudinal direction (L) of the introducer assembly (1).

14. A system (104) for percutaneous cannulation, in particular arterial cannulation, of a body channel (13) through an insertion site (131, 141) of a patient's skin using a biomedical device (101) having an introducer assembly (1), in particular a biomedical device (101) according to any one of the preceding claims, in, The introducer assembly (1) has - a dilator (2) for enlarging an insertion site (131) of a patient (14) to access a body duct (13), - a sheath (3) for introduction into a vessel (13) in the body, and - an inner guiding unit (4) for guiding at least one of the dilator (2) and the sheath (3) into the internal duct (13), The dilator (2) has a narrowed outer section (21) and at least one distal opening (22) and is arranged at least partially concentrically around the guide unit (4), and The sheath (3) has at least one distal opening (32) and is arranged or can be arranged at least partially concentrically around the dilator (2) so that the guide unit (4), the dilator (2) and the sheath (3) can move relative to each other in the longitudinal direction (L) of the introducer assembly (1). The system (104) comprises at least one actuation unit (9) configured to actuate at least one, in particular two, preferably all, of a dilator (2), a sheath (3) and in particular a puncture element (41), an insertion guide (42) and / or a guide wire (43) of a longitudinal actuation device (101) of an introducer assembly (1), of a guide unit (4), It is characterized in that the system (104) includes a shearing unit (16) which is actuatable to shear an opening at the insertion site (131, 141), in particular an incision extending from or across the insertion site (131, 141).

15. A system (104) according to claim 14, wherein the system (104) has at least one placement section (181, 182, 183), which is suitable for releasably placing at least a part of the introducer assembly (1), in particular a dilator (2), a sheath (3) and a guide unit (4), preferably a puncture element (41), a guide wire (43) and / or an insertion guide (42), wherein the placement section (181, 182, 183) preferably includes an at least partially open shape (184) corresponding to a mountable part of the introducer assembly (1) in a radial direction of the system (104).

16. The system (104) of claim 15, wherein the system (104) comprises an engagement member (19) that is switchable between an engaged configuration and a disengaged configuration, wherein in the engaged state, at least one mountable component of the introducer assembly (1) is securely held within the seating section (181, 182, 183) at least with respect to movement of the seating section (181, 182, 183) in a longitudinal direction (L), in particular with respect to radial movement of the biomedical device (101), and In the decoupled configuration, at least one mountable component is disengaged from the seating section (181, 182, 183) such that the mountable component can be removed from the system (104).

17. The system (104) according to claim 14 or 15, wherein the actuating unit (9), preferably exactly one actuating unit (9), comprises a clutch (91), in particular a clutch (91) comprising at least two rollers (92) with an adjustable inner spacing (93), The actuation of the actuating unit (9) can be switched between different modes (95, 96, 97, 98, 99) to actuate at least two, preferably three, and particularly preferably all of the dilator (2), the sheath (3) and, in particular, the puncture element (41), the guide wire (43) and / or the guide unit (4) of the insertion guide (42).

18. A system (104) according to any one of claims 14 to 17, wherein the system (104) comprises at least one guide element (211, 212, 213, 214), in particular at least two guide elements (211, 212, 213, 214), preferably formed by guide rails, so that at least one of the actuating unit (9) and at least one placement section (181, 182, 183) can move along the guide element (211, 212, 213, 214).

19. The system (104) according to any one of claims 14 to 18, wherein the system (104) comprises at least one, preferably at least two, processing units (225) adapted to control the shearing unit (16), the actuation unit (9) and the engaging member (19).

20. The system (104) according to any one of claims 14 to 19, wherein the system (104) comprises a biomedical device (101).

21. A system (106) for percutaneous cannulation of a body channel (13), in particular a system according to any one of claims 14 to 19, comprising a shearing unit (16), wherein the shearing unit (16) comprises - at least one, in particular two, shearing elements (161, 162) for shearing the opening at the insertion site, and an actuating unit (9) configured to translate at least one shearing element (161, 162), in particular to translate at least one shearing element (161, 162) parallel to a longitudinal axis of the shearing unit (16), The actuating unit (9) is configured to move the shearing unit (16) to perform shearing and opening in at least one of the following ways: - (i) rotating at least one shearing element (161, 162) about the longitudinal axis of the shearing unit (16), - (ii) moving the shearing elements (161, 162) radially outwardly relative to the longitudinal axis of the shearing unit (16).

22. A system according to claim 21, wherein the system (106) includes a processing unit (125), which is constructed to operate the actuation unit (9) and the shearing unit (16) by causing the shearing unit (16) to repeat successive translational movements in the distal direction of the shearing unit (16) and then rotate the shearing unit (16) around the longitudinal axis, in particular to rotate the shearing unit (16) by an angle not exceeding 360°, preferably to rotate the shearing unit (16) by an angle not exceeding 180° in a first angular direction and then to rotate the shearing unit (16) by an angle not exceeding 180° in a second angular direction opposite to the first angular direction, wherein at least one shearing element (161, 162) has a non-rotationally symmetrical cross-sectional shape at its distal tip or is arranged to be radially offset from the rotation axis of the shearing unit (16), and at least one shearing element (161, 162) is suitable for shearing a hole by blunt dissection.

23. A system according to claim 21 or 22, wherein the system comprises a blunt insert (1615) having a blunt distal tip, in particular a rounded distal tip, and configured to be insertable into the inner cavity of the shearing unit (16).

24. A system according to any one of claims 21 to 23, wherein the system comprises an expansion element (1615) arranged between the first shearing element and the second shearing element (161, 162), in particular formed by an expandable expansion element or an expansion element (1615) configured to be inserted into an inner cavity (1613) of a shearing unit (16), wherein the expansion element is configured to move the shearing elements (161, 162) radially outward relative to the longitudinal axis of the shearing unit (16).

25. A system according to claim 21, wherein the shearing elements (161, 162) are pivotally connected at at least one fulcrum (163, 164) for relative pivotal movement thereabout, and the conversion mechanism of the shearing unit (16) is constructed to convert the translational movement of the actuating part (167) of the conversion mechanism, in particular the translational movement parallel to the longitudinal axis (L) of the shearing unit (16), into an outward pivotal movement of the shearing elements (161, 162) around at least one fulcrum (163, 164) to perform shear opening.

26. The system of claim 25, wherein the actuation unit (9) is configured to actuate the conversion mechanism to convert the shearing elements (161, 162) between a closed configuration (169) in which the shearing elements (161, 162) are adjacent to each other and an open configuration (168) in which the shearing elements (162, 162) are pivoted outwardly, wherein The actuation unit (9) is particularly adapted to advance the shearing unit (16) towards the insertion site (131, 141) and retract it away from the insertion site (131, 141).

27. A system according to claim 26, wherein the system (106) includes a processing unit (125) adapted to operate the actuating unit (9) and the shearing unit (16) by repeatedly and successively moving the shearing unit (16) in a distal direction in a closed state (169) and subsequently converting the shearing unit (16) into an open state (168) to form a plurality of shearing openings at the insertion site (131, 141).

28. A system according to any one of claims 21 to 27, wherein the first shearing element and the second shearing element (161, 162) have distal ends which merge to form at least one distal tip (1601), in particular a sharp distal tip, for insertion into the patient's tissue at the insertion site (131, 141) when the first shearing element and the second shearing element (161, 162) are in a closed state (169).

29. The system of any one of claims 21 to 28, wherein the shearing elements (161, 162) are configured such that respective blunt or cutting edges (165, 166) of the shearing elements (161, 162) face radially outward in the closed configuration (169).

30. A system (102) for percutaneous cannulation, especially arterial cannulation, of a body tube (13), comprising a biomedical device (101), preferably a biomedical device (101) according to any one of claims 1 to 13, wherein the device (101) comprises an introducer assembly (1), the introducer assembly (1) comprising - a dilator (2) for enlarging an insertion site (131) of a patient (14) to access a body duct (13), - a sheath (3) for introduction into a vessel (13) in the body, and - an inner guide unit (4) for guiding at least one of the dilator (2) and the sheath (3), The dilator (2) has a narrowed outer section (21), a distal opening (22), and is arranged at least partially concentrically around the guide unit (4), and The sheath (3) has a distal opening (32) and is at least partially concentrically arranged around the guide unit (4) so ​​that the guide unit (4), the dilator (2) and the sheath (3) can move relative to each other in the longitudinal direction (L) of the introducer assembly (1). The system (102) includes at least one actuating unit (9) which is configured to actuate at least one, in particular two, and preferably all of the dilator (2), sheath (3), guide unit (4), puncture element (41), guide wire (43) and insertion guide (42) of the device (101) in the longitudinal direction of the introducer assembly (1).

31. The system (102) according to claim 30, wherein the system (102) comprises an actuating unit (9), preferably exactly one actuating unit (9), comprising a clutch (91), in particular comprising at least two rollers (92) with an adjustable inner spacing (93), The actuation of the actuation unit (9) can be switched between different modes (95, 96, 97, 98, 99) to actuate at least two, preferably three, and particularly preferably all of the dilator (2), the sheath (3) and the guide unit (4), in particular the puncture element (41), the guide wire (43) and / or the insertion guide (42).

32. A system (103) for percutaneous cannulation of a body channel (13), in particular arterial cannulation, comprising a biomedical device (101), in particular the biomedical device (101) according to any one of claims 1 to 13, The device (101) comprises an introducer assembly (1) which can be positioned at an application site for puncturing the patient's skin and an external imaging mechanism (11), which is in particular one of the following: - an ultrasound probe, in particular a Doppler ultrasound probe (111) for measuring blood flow, and -X-ray imaging probe, Used for performing two-dimensional or three-dimensional imaging of a vessel (13) in the body of a patient (14), in particular an arterial vessel (13) in the body, and optionally performing time period measurement, in The external imaging mechanism (11) and the introducer assembly (1) are connected to a common support (121) of the system (103).

33. The system (103) of claim 32, wherein the system (103) comprises an external guiding mechanism (112), wherein the guiding mechanism (112) has at least one of the following: - a stereo camera (1121) or an RGBD camera, - LiDAR systems, and - Electromagnetic sensors, The method enables determination or reconstruction of the distance between the patient (14), in particular the in vivo channel (13), and / or the surroundings of the patient (14) and the imaging device (11) and / or the introducer assembly (1), in particular the guide unit (4).

34. The system (103) of claim 32, wherein the guiding mechanism (112) is one of: - is immovably connected to an external imaging device (11), - is immovably connected to a patient (14) or a fixed surface (1123), - Attached to a movable surface (1124) that can move independently of the imaging mechanism (11).

35. The system (103) according to claim 32 or 33, wherein the device (101) comprises an introducer positioner (122) for positioning the introducer assembly (1) relative to the body duct (13) and / or the common support (121), The introducer positioner (122) is configured to position the introducer assembly (1) as one of the following: - two translational degrees of freedom (t) and at least one rotational degree of freedom (f), - three translational degrees of freedom (t) and at least one rotational degree of freedom (f), in particular two or three rotational degrees of freedom (f).

36. A system according to any one of claims 32 to 35, wherein the common support (121) is a handheld support (121) for manually adjusting the device (101), in particular the imaging device (11), relative to the patient, - a spatially fixed support (121) comprising pre-positioning means, in particular adhesive, tape, or a mechanically fixed or fixable bracket, or - A spatially movable support (121), comprising a device positioner (123), which is used to independently position the device (101) relative to the body channel (13) in two or three translational degrees of freedom (t) and at least one rotational degree of freedom (f), in particular one, two or three rotational degrees of freedom (f).

37. A system (103) according to any one of claims 32 to 36, wherein the system (103) includes a force sensor (124) configured to convert an external force, in particular an external torque, applied to at least one sub-portion of the system (103), in particular the distal tip of the guide unit (4), preferably the distal end (431) of the puncture element (41) of the guide unit (4), into an electrical signal indicating the external force.

38. The system (103) according to any one of claims 32 to 37, wherein the system (103) comprises a processing unit (125) for processing data related to at least one of: - measured images of the internal vessel (13), in particular a plurality of images of an external imaging device, a distance, in particular a plurality of distances, determined or reconstructed by the guiding device (112), and an electrical signal, in particular a plurality of electrical signals, of a force sensor (124), to calculate at least one electrical signal based on the data, for - Operating at least one of the introducer positioner (122) and the device positioner (123).

39. The system (103) according to claim 38, wherein the system comprises a storage unit (126) connected or connectable to the processing unit (125) for storing data related to at least one of: - measurement images of the internal vessel (13), in particular a plurality of images of an external imaging device (11), - a determined or reconstructed distance, in particular a plurality of distances, of the guide means (112), and - an electrical signal, in particular a plurality of electrical signals, from a force sensor (124).

40. A method for percutaneous catheterization of a body channel (13) using a biomedical device (101) having an introducer assembly (1), preferably a biomedical device (101) according to any one of claims 1 to 13, comprising the following steps: - inserting the inner guide unit (4) through the skin of the patient (14) into the internal duct (13) using the puncture element (41), - optionally inserting the guide wire (43) of the inner guide unit (4) into the body duct (13) through the insertion guide (42), - guiding the dilator (2) along the inner guide unit (4) without completely removing the puncture element (41) at the proximal end (5) of the introducer assembly (1), - Push the sheath tube (3) forward over the dilator (2) and into the internal tube (13), - optionally retracting at least one of the dilator (2), the inner guide unit (4) and the guide wire (43).

41. A method of matching an external imaging device (11) relative to a body channel (13), preferably using a system (103) according to any one of claims 32 to 39, comprising the steps of: - using an external imaging device (11) to image a plane (I) of a vessel (13) in the body, - preferably using a device positioner (123) to match the external imaging mechanism (11) in the translational degree of freedom (t) and / or the rotational degree of freedom (f) of the imaging mechanism (11) so that the internal tube (13) is located in the center of the field of view (113) of the imaging mechanism (11) and is positioned along the orthogonal direction of the imaging plane (I) or within a range of 30°, in particular 15°, relative to the orthogonal direction, -Preferably, the external imaging mechanism (11) is matched in rotational and / or translational degrees of freedom (t) using a device positioner (123) so that the in vivo channel (13) remains in the center of the field of view (113) and the imaging plane (I) is located in a direction parallel to the longitudinal axis of the in vivo channel (13).

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