DEVICE FOR ATTACHING AN INTRODUCER OF A MEDICAL DEVICE IN THE HUMAN BODY

Description

[0001] The present invention relates to a device for securing a medical device introducer into the human body, comprising: a support intended to be held on or in relation to the patient; a linkage assembly mounted on the support; an introducer receiving bracket attached to the linkage assembly to be mounted on the support, the bracket defining a central passage extending along a longitudinal axis and a longitudinal opening for insertion of the introducer into the central passage; and a system for holding the introducer in position in the bracket.

[0002] The medical device to be introduced into the human body is, for example, an implant consisting of an endoprosthesis or an endovalve, and an implant delivery tool.

[0003] Endoprostheses are used, for example, to repair and support the wall of the duct when it is partially blocked, or to bypass an aneurysm. Endovalves are used to replace a diseased or defective native valve.

[0004] For this purpose, the treatment device carrying the implant is preferably introduced endoluminally, in order to avoid surgically opening the patient's chest and thus minimize operative risks, particularly for elderly or frail patients.

[0005] In cases where the treatment device needs to be delivered to its implantation site through a blood vessel such as the aorta, it is known to introduce it into the bloodstream through an introducer vessel such as the femoral artery, by making an incision in the patient's groin.

[0006] Other introducing vessels such as the carotid artery, the arteries and veins of the upper limb, or the jugular vein, are also used depending on the final implantation site.

[0007] An introducer is then required to guide the treatment device from outside the body, through the delivery vessel, to another, larger-diameter blood vessel. Depending on the treatment device being introduced, the introducer can have a diameter varying, for example, between 4F and 26F (i.e., between 1.3 mm and 8.7 mm).

[0008] The introducer has a sealing valve which prevents blood from flowing back out of the patient under pressure by creating a seal around the treatment device.

[0009] During the procedure of introducing the treatment device via the introducer, there is always a risk of the introducer being dislodged from the blood vessel into which it is inserted. This risk can occur when removing a device from inside the introducer, such as a stent or a catheter, or when the pressure of the pulsed blood flow in the introducer is too high.

[0010] This mobilization of the introducer outside the vessel can lead to the complete expulsion of the introducer and cause bleeding from the patient at the puncture site.

[0011] Furthermore, mobilizing the introducer outside the vessel can cause the introducer to retract, leading to incorrect positioning of the medical device in the patient.

[0012] In order to minimize risks to the patient, it is therefore necessary to fix the introducer to prevent its mobilization.

[0013] Typically, an operator is used to manually hold the introducer in the desired position throughout the surgical procedure. However, the procedure can last several hours, and there is a risk that the operator will move due to fatigue. Furthermore, X-ray images are taken throughout the procedure to verify the placement of the medical device in the patient. The operator holding the introducer remains close to the radiation source of the X-ray equipment, which is harmful to the operator.

[0014] It is also known to fix the introducer to the patient using sutures. However, this method does not allow for adjusting the introducer's position during the procedure. Furthermore, this method necessitates placing additional sutures on the patient.

[0015] To avoid dislodging the introducer, it is also known, for example from WO 2005 081882 A2, to suture the introducer to a patch adhered to the patient's skin. However, this solution does not allow for adjusting the introducer's position during the procedure without changing the patch and dislodging the entire introducer, which poses additional risks to the patient. Document WO 01 / 68180 A1 discloses a catheter fixation device.

[0016] One aim of the invention is to provide an introducer fixation system capable of reliably maintaining the introducer in a desired fixed position and allowing adaptation of this position during the surgical procedure, without generating additional risk to the patient.

[0017] These objectives are achieved by means of a device for fixing a medical device introducer according to claim 1, as well as by means of a method for fixing a medical device fixing device according to claim 16. Dependent claims 2-15 define the preferred alternatives.

[0018] The fastening device disclosed below may include one or more of the following features, in isolation or in any technically feasible combination: The blocking cushion has a sleeve split along a generatrix. The blocking cushion is formed from a block of deformable material, or from a pocket containing deformable material. The retention system includes a cushion inflation system that controls the inflation and deflation of the cushion. The linkage assembly between the yoke and the support includes a ball joint and a ball joint support that receives the ball joint. The support includes a bar, with the receiving yoke being mounted to the support bar by the linkage assembly. The receiving yoke is mounted to slide along the support bar. The bar is extendable, and its length is adjustable. The support includes at least one additional piece attached to the bar to increase the support height. The support includes a spreader. The support includes a patch. The receiving yoke includes a deformable sleeve between an open and a closed position.The receiving bracket includes a mechanism for tightening and / or loosening the deformable sleeve. The deformable sleeve tightening mechanism includes a ratchet system, a toggle system, or a clamp system. It includes a guide fastening system offset from the receiving bracket and the support, and advantageously a flexible link connecting the guide fastening system to the support or the receiving bracket. The guide fastening system includes a retaining block fixed to a patch defining a guide receiving slot.

[0019] The method for attaching a medical device introducer outside the human body, disclosed below, comprises the following steps: provision of a fixation device comprising a support previously fixed to the patient and an introducer receiving sling mounted on the support, the sling defining a central passage extending along a longitudinal axis and a longitudinal opening for insertion of the introducer into the central passage, the fixation device comprising a system for holding the introducer in position in the sling, the holding system comprising at least one reversible locking cushion for the introducer; placement of the introducer in the central passage through the longitudinal opening, and reversible change of the locking cushion from a relaxed configuration when placing the introducer in the central passage to a locking configuration in position of the introducer in the central passage.

[0020] The invention will be better understood upon reading the following description, given solely by way of example, and made with reference to the attached drawings, in which: [ Fig 1 ] there figure 1 is a perspective view of an initial device for securing a medical device introducer into the human body. Fig 2 ] there figure 2 is a perspective view of the receiving bracket, the connecting assembly, and the retention system of the fastening device. figure 1 . [ Fig 3 ] there figure 3 is a perspective view of the support and connecting assembly of the fastening device figure 1 . [ Fig 4 ] there figure 4 is a perspective view of a second fastening device according to the invention. Fig 5 ] there figure 5 is a perspective view of the support bar, the receiving bracket, the connecting assembly, and the retention system of the fastening device. figure 4 . [ Fig 6 ] there figure 6 is a perspective view of the receiving bracket, the connecting assembly, and a retention system for a third fastening device according to the invention. Fig 7 ] there figure 7 is a perspective view of the receiving bracket, the connecting assembly, and a retention system for a fourth fastening device according to the invention. Fig 8 ] there figure 8 is a perspective view of the receiving bracket, the connecting assembly, and a retention system for a fifth fastening device according to the invention. Fig 9 ] there figure 9 is a perspective view of a variant of an intermediate part located between the connecting assembly and the support for the fastening device. Fig 10 ] there figure 10 is a perspective view of a variant of the fourth fastening device of the figure 7 . [ Fig 11 ] ] Fig 12 ] ] Fig 13 ] ] Fig 14 ] ] Fig 15 ] ] Fig 16 ] THE figures 11 à 16 are perspective views of fastening devices according to other embodiments of the invention.

[0021] There figure 1 illustrates a fixation device 10 of a medical device introducer 12 into the human body.

[0022] As seen on the figure 1 The fixation device 10 includes a support 14, a receiving bracket 16 for the introducer 12, a connecting assembly 18 connecting the support 14 to the receiving bracket 16 and a releaseable system 20 for holding the introducer 12 in position in the bracket 16. The fixation device 10 advantageously includes a fixation system 22 for a surgical guide 24.

[0023] By "releasable" we mean that the retaining system 20 is capable of moving from a locking configuration of the introducer 12, in which it firmly holds the introducer 12 in position, to a released configuration in which it allows the introducer 12 to move at least in translation along an axis.

[0024] The introducer 12 includes a hollow tip 26 for introduction and a substantially rigid tube 28 for guiding the medical device into the introducing vessel.

[0025] The tip 26 comprises a rigid tubular body 30 for handling and a sealing valve 32 disposed in the body 30. The valve 32 is suitable for opening to introduce the surgical guide 24 into the introducer 12 and then the medical device mounted on the surgical guide 24. It is suitable for closing to create a seal around the guide 24.

[0026] The surgical guide 24, designed to navigate the bloodstream, was inserted along the generatrix of the tube 28 from a proximal point on the tip 26 located outside the human body to a distal point on the tip 26 located inside the human body. The surgical guide 24 is made of a thin-diameter wire, for example, between 0.1 mm and 3 mm.

[0027] As illustrated on the figure 1 The support 14 includes a fixation patch 34 and a bar 36 fixed transversely to the patch 34. The support 14 is intended to be fixed to the patient near the incision in order to define a fixed point on the patient's body throughout the surgical procedure.

[0028] The fixation patch 34 is a flat, horseshoe-shaped adhesive element. The patch 34 defines a first non-adherent upper surface 40 and a second adhesive lower surface 42 suitable for sticking to the patient's skin.

[0029] As depicted on the figure 3 The bar 36 is a straight piece with a rectangular cross-section extending along a longitudinal axis A. The bar 36 defines a top face 44, a bottom face 46 and two lateral faces 48. The bottom face 46 of the bar 36 is fixed to the top surface 40 of the patch 34.

[0030] Bar 36 is preferably a single-use metal or plastic bar.

[0031] The linkage assembly 18 includes a fastener 52 connected to the bar 36 and a ball joint support 54 connected to the caliper 16.

[0032] The fastener 52 is a U-shaped bracket capable of being attached to the bar 36. The fastener 52 is mounted on the bar 36 and can move in translation along the longitudinal axis A along the bar 36.

[0033] The fastener 52 also includes a threaded hole 56 on one of its lateral faces capable of receiving a fixing screw 58 or other fixing system.

[0034] Tightening the fixing screw 58 in the hole 56 fixes the position of the fastener 52 along the bar 36.

[0035] The fixing screw 58 is advantageously linked to the fastener 52 by means of a wire link 59, for example made of plastic, so as not to be lost in case of detachment.

[0036] As depicted on the figure 2 , the receiving stirrup 16 defines a central passage 60 extending along a longitudinal axis B and a longitudinal opening 62 for insertion of the introducer 12 into the central passage 60, in the form of a longitudinal slot which opens at its longitudinal ends.

[0037] On the figure 1 , the longitudinal axis A of the bar 36 and the longitudinal axis B of the central passage 60 are substantially perpendicular.

[0038] The receiving bracket 16 includes a ball joint 64 received in the linkage assembly 18, a deformable sleeve 66 and a release mechanism 68 for the deformable sleeve 66.

[0039] The ball joint 64 is fixed in the ball joint support 54 of the link assembly 18, thus linking the stirrup 16 and the support 14 in a ball joint connection. This ball joint connection offers the possibility of orienting the stirrup 16, and therefore the introducer 12, relative to the support 14 fixed on the patient's body.

[0040] The sleeve 66 extends around the central passage 60 and defines a first longitudinal edge 70 and a second longitudinal edge 72 on either side of the longitudinal opening 62.

[0041] The 66 shirt is deformable between an open position and a closed position.

[0042] In the closed position, the first edge 70 and the second edge 72 of the sleeve 66 are in the vicinity and / or in contact with each other, causing the longitudinal opening 62 to narrow and therefore making it impossible to insert the introducer 12 into the central passage 60 or to remove the introducer 12 from the central passage 60. In this example, the closed position is the rest position.

[0043] In the open position, the first edge 70 and the second edge 72 of the sleeve 66 are apart from each other, causing the longitudinal opening 62 to open and thus making it possible to insert and move the introducer 12 into the central passage 60 or to withdraw the introducer 12 from the central passage 60 through the longitudinal opening 62.

[0044] The loosening mechanism 68 can be operated by a practitioner to move the sleeve 66 from the closed position to the open position.

[0045] In this example, the loosening mechanism 68 includes a first clamp 74 rotatably mounted on the first edge 70 of the sleeve 66 and a second clamp 76 rotatably mounted on the second edge 72 of the sleeve 66.

[0046] The two clamps 74, 76 are articulated in rotation relative to the sleeve 66 around axes parallel to the axis B. When the clamps 74, 76 press against each other, they separate the first edge 72 from the second edge 74 and allow the retaining system 20 to open to release the introducer 12, as described below.

[0047] The holding system 20 in position of the introducer 12 in the yoke 16 is fixedly mounted inside the sleeve 66 of the receiving yoke 16. It is applied to an inner surface of the sleeve 66. It extends inside the central passage 60.

[0048] The retaining system 20 defines a central passage 82 extending along the longitudinal axis B of the central passage 60 and with a diameter smaller than the central passage 60 of the stirrup 16. The retaining system 20 also defines a longitudinal opening 86 for insertion of the introducer 12 into the central passage 82 in continuity with the longitudinal opening 62 of the stirrup 16.

[0049] In this example, the retaining system 20 includes a blocking cushion 88 which has a cylindrical sleeve shape split along a generatrix.

[0050] The locking cushion 88 is designed to receive the introducer 12, clamping it within the central passage 82 and holding it in position. It is also designed to deform, partially releasing the introducer 12, particularly through translation along the axis of the central passage 82.

[0051] The retaining system 20 thus has a locking configuration in which the locking cushion 88 is compressed between the introducer 12 and the inside of the sleeve 66 and a relaxed configuration, in which the introducer 12 is mobile at least in translation in the central passage 82.

[0052] Advantageously, the surface texture of the blocking cushion 88 is rough to prevent slippage of the introducer 12 in the central passage 82 and to combat the hydrophilic treatment of introducers which is usually associated to allow the best glide in the arteries.

[0053] The blocking cushion 88 is for example made in one piece from an elastomeric material such as silicone, rubber, PVC or is made using a pouch, for example made of plastic, containing a deformable material, for example water, oil, gelatin or liquid silicone.

[0054] As depicted on the figure 1 , the fixing system 22 of guide 24 includes a retaining block 90 fixed on an adhesive patch 92 and a flexible link 94 for its connection to the support 14.

[0055] The retaining block 90 defines a slot 96 for receiving the guide 24. The slot 96 has a diameter between 0.1 mm and 3 mm depending on the diameter of the corresponding guide 24.

[0056] Advantageously, the 90 support block is made of foam.

[0057] The adhesive patch 92 is a flat adhesive element, here circular in shape, defining a non-adhesive upper surface 98 and an adhesive lower surface 100. The retention block 90 is attached to the upper surface 98 of the adhesive patch 92, for example, by gluing. The lower surface 100 of the adhesive patch 92 is adhered to the patient.

[0058] The fixation system 22 is fixed on the patient offset from the support 14, so that the receiving slot 96 of the guide 24 extends substantially along the longitudinal axis B of the receiving splint 16.

[0059] The flexible link 94 is advantageously a ball collar fixed at one end to a ring 102 on the bar 36 and at the other end to a ring 104 on the retaining block 96.

[0060] A method for fixing a medical device introducer 12 into the fixing device 10 described previously will now be described.

[0061] With reference to the figure 1 , the surgical guide 24 is first inserted into the patient until it reaches its desired position.

[0062] Then, the introducer 12 is put in place by engaging it on the surgical guide 24. The tube 28 is partially inserted into the patient, the tip 26 remaining outside the patient.

[0063] The part of the surgical guide 24 protruding out of the introducer 12 is then introduced into the slot 96 of the retaining block 90, thus defining the desired centering axis of the introducer 12.

[0064] The support 14 on which the receiving stirrup 16 is mounted by means of the linkage assembly 18 is then fixed on the patient by sticking the lower adhesive surface 42 of the patch 34 onto a surface of the patient's skin close to the insertion incision without hindering the practitioners' working space.

[0065] The introducer 12 is then inserted into the central passage 82 through the longitudinal openings 62 and 86. As it passes through the openings 62 and 86, the introducer 12 separates the first edge 70 from the second edge 72, moving the sleeve 66 into the open position and the cushion 88 into its relaxed configuration. When the introducer 12 reaches the passage 60, the sleeve 66 spontaneously returns to its closed position, and the cushion 88 moves into its locking configuration, in which it clamps the introducer 12.

[0066] The receiving bracket 16 is then translated along the longitudinal axis A along the bar 36 and oriented via the ball joint 64 linked to the linkage assembly 18, so that the longitudinal axis B of the receiving bracket 16 coincides with the desired centering axis of the introducer 12.

[0067] The lower adhesive surface 100 of the patch 92 is then glued to the patient's skin in such a way that the flexible link 94 fixed on one side to the support 14 and on the other to the retaining block 90 is taut and that the receiving slot 96 of the guide 24 extends in a direction parallel to the longitudinal axis B of the central passage 60.

[0068] In this configuration, the locking cushion 88 is in a locking position. The locking cushion 88 is compressed between the introducer 12 and the inside of the sleeve 66 and thus holds the introducer 12 in position in the central passage 60 of the stirrup 16.

[0069] The introducer 12 is now fixed in the desired position. The medical device is then inserted into the introducer 12.

[0070] During the procedure, it is possible, if necessary, to adjust the position of the introducer 12 in the central passage 60 while remaining centered with respect to the surgical guide 24.

[0071] The practitioner presses the two clamps 74 and 76 against each other. This deforms the sheath 66, separating the first edge 70 from the second edge 72 and moving it into the open position. The locking cushion 88 is therefore no longer compressed between the introducer 12 and the inside of the sheath 66. The locking cushion 88 is now in its relaxed configuration. The introducer 12 can thus be moved into the central passage 60. By releasing the two clamps 74 and 76, the sheath 66 returns to its closed position, and the locking cushion 88 is again compressed between the introducer 12 and the inside of the sheath 66, thus fixing the introducer 12 in a new position.

[0072] Once the setup is complete, the introducer 12 is removed from the splint 16 and from the patient's body. The adhesive patches 34 and 92 are then peeled off the patient's skin.

[0073] The fixation device 10 according to the invention therefore maintains the introducer 12 in a desired fixed position, while minimizing risks to the patient and to medical personnel.

[0074] Furthermore, the position of the introducer 12 in the fixation device 10 is easily adaptable during the surgical procedure, without generating additional risk for the patient, while remaining centered on the centering axis defined by the surgical guide 24.

[0075] The device 10 according to the invention is also very versatile since the fixing device 10 can be used for different diameters of introducer 12.

[0076] Thanks to the use of adhesive patches 34, 92, the method of fixing an introducer 12 leaves only minimal and temporary traces on the patient's body, unlike stitches for example.

[0077] In one variant, the fixation device 10 includes a plurality of fixation systems 22 for the surgical guide 24, in order to fix the guide 24 at several points.

[0078] In an illustrated variant on the figure 4 The support 14 includes a spacer 106. The bar 36 is fixed to the spacer 106 instead of being glued to the patch 34.

[0079] The retractor 106 comprises two arms 108 facing each other, each designed to separate one of the walls of the insertion incision on the patient's body. Each arm 108 has a retraction paddle 110 designed to be positioned against one of the edges of the incision.

[0080] As depicted on the figure 5 , the bar 36 has at each of its ends a hook 112 capable of attaching to the arms 108 of the spreader 106.

[0081] The 36 bar is extendable and the length of the 36 bar is adjustable.

[0082] Advantageously, the bar 36 comprises two parts 111, 113 mounted telescopically one inside the other. The length of the bar 36 is thus adjustable, allowing the size of the bar 36 to be adapted to the spacing of the arms 108 of the spreader 106.

[0083] In the embodiment with a spreader 106, the fixation method differs from that of the previous embodiment only for the step of fixing the support 14 to the patient's body.

[0084] Indeed, after the arms 108 have been spread apart, each of the spreading paddles 110 is fixed against one of the edges of the incision. The retractor 106 thus defines a fixed position on the patient's body.

[0085] The length of the bar 36 is then adjusted according to the spacing of the arms 108 of the spacer 106 by moving the two parts 111, 113 relative to each other. The hooks 112 are then clipped onto the arms 108 of the spacer 106. The bar 36 is thus fixed to the spacer 106, defining the support 14.

[0086] Advantageously, the 36 bar is chosen to be metallic when a surgical femoral retractor is put in place to maintain the previously opened route.

[0087] In one variant, the chosen spacer 106 is a single-use spacer with a bar 36 already mounted between the two arms 108 of the spacer 106. The single-use spacer therefore defines the support 14 by itself.

[0088] According to another embodiment illustrated on the figure 6 The blocking cushion 88 of the support system 20 includes at least one balloon 114 capable of being inflated by fluid injection. On the figure 6 , four balloons 114 are represented.

[0089] Advantageously, the outer texture of the 114 balloons is rough to prevent slippage.

[0090] The support system 20 includes an inflation system 116 for the balloons 114, including for example a syringe 118 suitable for injecting fluid into the balloons 114 through a valve 120.

[0091] Advantageously, the fluid injected into the balloons 114 is water, oil, gelatin, or liquid silicone.

[0092] The 114 balloons have a compression behavior identical to the cushion described previously.

[0093] The inflation system 116 is controlled by a push button 122. Pressing the push button 122 opens the valve 120 and injects the liquid from the pump 118 into the balloons 114, causing the balloons 114 to inflate.

[0094] In one variant (not shown), the mechanism 68 is a clamping mechanism for the sleeve 66. The sleeve 66 is not held at rest in the closed position.

[0095] The first clamp 74 has a notch, and the second clamp 76 has a stop designed to engage in the notch.

[0096] To move the sheath 66 into the closed position, the practitioner pivots the first clamp 74 upwards and simultaneously pivots the second clamp 76 upwards. This brings the two clamps 74 and 76 into contact. The stop of the second clamp 76 then engages in the notch of the first clamp 74, ensuring the sheath 66 moves from the open to the closed position.

[0097] In one embodiment shown on the figure 7 , the clamping mechanism 68 of the shirt 66 does not include clips 74, 76 but defines a notched system comprising a first part 124 and a second part 126.

[0098] The first part 124 of the clamping mechanism 68 extends over the first edge 70 of the sleeve 66 and defines a notch 128 having internal teeth.

[0099] The second part 126 of the clamping mechanism 68 extends along the second edge 72 of the sleeve 66 and defines a tab 130 having external teeth. The tab 130 extends opposite the notch 128 of the first part 124 and is designed to fit into the notch 128.

[0100] Inserting the tab 130 into the notch 128 by pressing the first part 124 towards the second part 126 of the clamping mechanism 68 causes the first edge 70 to contact the second edge 72 of the sleeve 66, thus moving the sleeve 66 into the closed position. The external teeth on the tab 130 engage with the internal teeth of the notch 128 to lock it in position.

[0101] The sleeve 66 includes a hinge 131 extending in a direction parallel to the longitudinal axis of the sleeve 66. Advantageously, the hinge 131 extends diametrically opposite the longitudinal opening 62.

[0102] In a variant of this embodiment shown on the figure 10 , the receiving bracket 16 is suitable for receiving the hollow tip 26 of the introducer 12.

[0103] Advantageously, the sleeve 66 has a notch 152 suitable for allowing passage of a fluid introduction pipe 154 connected to the sealing valve 32 located inside the tubular body 30 of the hollow end 26.

[0104] According to another embodiment illustrated on the figure 8 , the clamping mechanism 68 of the sleeve 66 defines a toggle system comprising a first part 132 and a second part 134.

[0105] The first part 132 defines a toggle and includes an articulated lever 136 mounted rotatably parallel to the axis B on the first edge 70 of the sleeve 66 and a connecting rod 138 articulated on the lever 136 around an axis parallel to the axis B. The connecting rod 138 has at its end a closing link 140 in the form of a crossbar extending parallel to the axis B.

[0106] The second part 134 is fixedly mounted on the second edge 72 of the shirt 66 and defines a hook 144 capable of receiving the closure link 140.

[0107] The first part 132 defines a first free position where it extends loosely over the first edge 70 of the shirt 66, a second position engaged in the second part, represented on the figure 8 where the closure link 140 is locked in the hook 144 and where the lever 136 is in the high position and a third position where the closure link 140 is locked in the hook 144 and where the lever 136 is in the low position.

[0108] Moving the first part 132 from the second to the third position by pressing the lever 136 forces the connecting rod 138 into its lower position. The connecting rod 138 then moves the second edge 72 of the sleeve 66 towards the first edge 70, thus closing the sleeve 66.

[0109] Moving the first part 132 from the third position to the second position by lifting the lever 136 returns the shirt 66 to the open position to adjust the position of the introducer 12 during the surgical procedure.

[0110] In an illustrated variant on the figure 9 , the support 14 includes at least one additional part 146 which attaches to the bar 36 in order to increase the height of the support 14.

[0111] The additional piece 146 or the stack of pieces 146 increases the height of the support 14 and thus positions the introducer 12 at a desired height in order, for example, to maintain the angle of the introducer at the exit of the incision.

[0112] Part 146 includes a first part 148 defining a hollow imprint intended to receive the bar 36 and a second part 150 of identical dimensions to the bar 36 and intended to receive the connecting assembly 18.

[0113] Part 146 is mounted on bar 36 by clipping the first part 148 of part 146 onto bar 36. The connecting assembly 18 is mounted on the second part 180 of part 146.

[0114] A first piece 146 can be stacked on a second piece 146 by clipping the first part 148 of the first piece 146 onto the second part 150 of the second piece 146. This operation can be carried out as many times as necessary to obtain a stack of pieces 146 with the desired height.

[0115] The stack of parts 146 is fixed on the bar 36 by clipping the first part 148 of part 146 located at the bottom of the stack onto the bar 36 and the connecting assembly 18 is mounted on the second part 150 of part 146 located at the top of the stack.

[0116] Alternatively, another riser system is used instead of stacking parts 146, for example a screw system.

[0117] In the variant of the invention illustrated on the figure 11 , the support 14 includes a single-use spacer 106 with a bar 36 already mounted between the two arms 108 of the spacer 106. Such a single-use spacer 106 is for example made of a plastic material.

[0118] In the embodiment of the invention illustrated in the figure 12 The support 14 comprises a sterile field consisting of an adhesive film 158 defining a sterile barrier between its lower surface, which is adhered to the patient's skin, and its surface. The adhesive film 158 has a central transect window.

[0119] In this embodiment, each end of the bar 36 is mounted between two metal retaining tabs 160 which are fixed to the adhesive film 158.

[0120] In the variant of this embodiment illustrated on the figure 13 , each end of the bar 36 is mounted on a single metal retaining tab 160 fixed to the adhesive film 158.

[0121] In the variant illustrated on the figure 14 , bar 36 is directly glued onto the adhesive film of the sterile field.

[0122] As an alternative to the invention illustrated on the figures 15 And 16 , support 14 is not held directly on the patient, but is held fixed relative to the patient.

[0123] By "maintained in a fixed manner relative to the patient", we mean in particular that the patient is immobilized on a surface, for example of an operating table, the support 16 being maintained fixed relative to the table and consequently, relative to the patient.

[0124] In the embodiment illustrated on the figure 15 The support 14 comprises an articulated arm fixed at one end to the operating table on which the patient lies. The bar 36 is fixed to the other end of the articulated arm and is able to be positioned and held by means of the articulated arm in a desired position relative to the patient. The articulated arm is preferably radiolucent.

[0125] In the embodiment illustrated on the figure 16 The support 14 comprises a rigid shell including two movable side walls 162. The rigid shell including the side walls 162 is preferably radio-transparent.

[0126] The patient is received on the rigid shell between the two side walls 162, which are moved towards the patient to butt against them on either side. The bar 36 extends between the two side walls 162 and forms a belt above the patient. The bar 36 is, for example, mounted to slide on rails defined on each of the side walls 162. Optionally, the bar 36 is also fixed at each end to the patient's skin by an adhesive patch.

[0127] In one embodiment of the invention, the fixation device 10 comprises a plurality of guide fixation systems 22. Each of the guide fixation systems 22 is adapted for fixing a specific type and / or diameter of surgical guide 24. The guide fixation systems 22 differ from one another in their color and / or texture, so that they are easy to differentiate and identify.

Claims

1. A device for anchoring (10) an introducer (12) of a medical device in the human body comprising: - a support (14) intended to be held on the patient or relative to the patient ; - a connecting assembly (18) mounted on the support (14); and - a receiving clip (16) of the introducer (12) attached to the connecting assembly (18) for mounting on the support (14), the clip (16) defining a central passage (60) extending along a longitudinal axis (B) and a longitudinal opening (62) for insertion of the introducer (12) into the central passage (60); - a holding system (20) for holding the introducer (12) in position in the clip (16); the holding system (20) including at least one reversible locking pad (88) for the introducer (12), the holding system (20) being able to change from a released configuration for the positioning, the displacement and the removal of the introducer (12) in the central passage (60) to a configuration for locking the introducer (12) in position in the central passage (60), the support (14) including a bar (36), the receiving clip (16) being mounted on the bar (36) of the support (14) by the connecting assembly (18), the receiving clip (16) being slidably mounted along the bar (36) of the support (14).

2. The anchoring device (10) according to claim 1, wherein the locking pad (88) includes a sleeve split along a generatrix.

3. The anchoring device (10) according to claim 1 or 2, wherein the locking pad (88) is formed of a block of deformable material, or a bag containing deformable material.

4. The anchoring device (10) according to claim 1 or 2, wherein the holding system (20) comprises an inflation system (116) for the pad (88) controlling the inflation and deflation of the pad (88).

5. The anchoring device (10) according to any one of the preceding claims, wherein the connecting assembly (18) between the clip (16) and the support (14) includes a ball (64) and a ball joint (54) receiving the ball (64).

6. The anchoring device (10) according to any one of the preceding claims, wherein the bar (36) is extendable and the length of the bar (36) is adjustable.

7. The anchoring device (10) according to any one of the preceding claims, wherein the support (14) includes at least one additional piece (146) attached to the bar (36) to increase the height of the support (14).

8. The anchoring device (10) according to any one of the preceding claims, wherein the support (14) includes a spacer (106).

9. The anchoring device (10) according to any one of the preceding claims, wherein the support (14) includes a patch (34).

10. The anchoring device (10) according to any one of the preceding claims, wherein the receiving clip (16) includes a sleeve (66) deformable between an open position and a closed position.

11. The anchoring device (10) according to claim 10, wherein the receiving clip (16) includes a mechanism (68) for clamping and / or unclamping the deformable sleeve (66).

12. The anchoring device (10) according to claim 11, wherein the clamping mechanism (68) of the deformable sleeve (66) comprises a notch system, a toggle system or a clamp system.

13. The anchoring device (10) according to any one of the preceding claims, comprising a guide fixing system (22) remote from the receiving clip (16) and the support (14), and advantageously a flexible link (94) connecting the guide fixing system (22) to the support (14) or to the receiving clip (16).

14. The anchoring device (10) according to claim 13, wherein the guide fixing system (22) comprises a holding block (90) attached to a patch (92) defining a slot (96) for receiving the guide (24).

15. The anchoring device (10) according to any one of the preceding claims, wherein the support (14) includes a sterile field, an articulated arm, or a rigid shell.

16. A method for anchoring an introducer (12) of a medical device, implemented outside the human body, comprising the following steps: - providing a anchoring device (10) including a support (14) previously fixed to the patient or relative to the patient and a clip (16) for receiving the introducer (12) mounted on the support (14), the clip (16) defining a central passage (60) extending along a longitudinal axis (B) and a longitudinal opening (62) for inserting the introducer (12) into the central passage (60), the anchoring device (10) including a holding system (20) for holding the introducer (12) in position in the clip (16), the holding system (20) including at least one reversible locking pad (88) for the introducer (12), the support (14) including a bar (36), the receiving clip (16) being mounted on the bar (36) of the support (14) by the connecting assembly (18), the receiving clip (16) being slidably mounted along the bar (36) of the support (14); - positioning the introducer (12) in the central passage (60) through the longitudinal opening (62), - reversibly moving the locking pad (88) from a released configuration upon placement of the introducer (12) in the central passage (60) to a configuration locking the introducer (12) in position in the central passage (60).