Device and method for anchoring a medical device introducer to the human body

Abstract

The fixation device (10) comprises a support (14) to be held on the patient, a connection assembly (18) mounted to the support (14), an introducer (12) to receive a clip (16) attached to the connection assembly (18), 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), and a retention system (20) for holding the introducer (12) in place within the clip (16). The retention system (20) includes at least one reversible locking pad (88) for securing the introducer (12), and the retention system (20) is reversible from a released configuration to a configuration for locking the introducer (12) in place.

Description

[Technical Field]

[0001] The present invention provides a device for anchoring an introducer of a medical device to a human body, comprising: a support intended to be held on or against a patient; a connection assembly mounted to the support; a receiving clip of an introducer attached to the connection assembly for mounting on the support, the receiving clip defining a central passage extending along the longitudinal axis and a longitudinal opening for inserting the introducer into the central passage; a system for holding the introducer in place within the clip; The present invention relates to a device comprising: [Background technology]

[0002] The medical devices introduced into the human body are, for example, implants formed by stents or endovalves, and implant delivery tools.

[0003] Stents are used, for example, to repair and support the wall of a blood vessel when it is partially blocked or to bridge an aneurysm, and endovalves are used to replace diseased or defective native valves.

[0004] To this end, the therapeutic device carrying the implant is preferably introduced by an intraluminal route, thus avoiding surgical opening of the patient's chest, in order to minimize the risks of surgery, especially in elderly or infirm patients.

[0005] When a therapeutic device is introduced to its implantation site through a blood vessel such as the aorta, it is known to introduce it into the bloodstream through an introduction vessel such as the femoral artery by making an incision in the patient's groin.

[0006] Other introducer vessels, such as the carotid artery, arteries and veins of the upper limbs, or the jugular vein, may also be used depending on the final implantation site.

[0007] The introducer is then required to guide the treatment device from outside the body through the introduced blood vessel into another blood vessel of a larger diameter. Depending on the treatment device being introduced, the introducer may have a diameter ranging from, for example, 4F to 26F (i.e., 1.3 mm to 8.7 mm).

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

[0009] During the process of introducing a therapeutic device through an introducer, there is always a risk that the introducer will move out of the introduction vessel, which can occur, for example, when a device such as a stent or catheter is removed from inside the introducer, or when the pressure of the pulsatile blood flow within the introducer is too high.

[0010] This movement of the introducer outside of the blood vessel can result in complete expulsion of the introducer and cause the patient to bleed from the puncture site.

[0011] Additionally, movement of the introducer outside the blood vessel can cause the introducer to bounce, leading to improper positioning of the medical device within the patient.

[0012] Therefore, to minimize risk to the patient, it is necessary to immobilize the introducer to prevent it from moving.

[0013] It is known that an operator typically assists in manually holding the introducer in the desired position throughout the surgical procedure. However, surgical procedures can last several hours, and there is a risk of movement due to operator fatigue. Furthermore, radiological images are taken throughout the procedure to verify the positioning of the medical device within the patient. The operator holding the introducer remains in close proximity to the source of radiation emissions from the x-ray machine, which is harmful to the operator.

[0014] It is also known to fix the introducer to the patient with sutures, however this solution does not allow for adapting the position of the introducer during the procedure and furthermore requires additional sutures on the patient.

[0015] To avoid introducer migration, it is also known, for example in US Pat. No. 5,629,999, to sew the introducer to a patch that is adhered to the patient's skin. However, this solution does not allow the position of the introducer to be adapted during the procedure without changing the patch and moving the entire introducer, which poses additional risks for the patient. [Prior art documents] [Patent documents]

[0016] [Patent Document 1] International Publication No. 2005 / 081882 Summary of the Invention [Problem to be solved by the invention]

[0017] One object of the present invention is to provide a system for fixating an introducer that securely holds the introducer in a desired fixation position and allows for adaptation of this position during a surgical procedure without creating additional risk to the patient. [Means for solving the problem]

[0018] To this end, the present invention has as its object a device for securing an introducer of a medical device to a human body, the fixation system including at least one reversible locking pad for the introducer, the fixation system being characterised in that it can be changed from a release configuration for positioning, displacement and removal of the introducer within the central passage to a configuration for locking the introducer in place within the central passage.

[0019] The fixation device according to the invention may comprise one or more of the following features, alone or in any technically feasible combination: The locking pad includes a sleeve that is split along a generatrix. The locking pad is formed from a block of deformable material or a bag containing deformable material. The retention system comprises an inflation system for the pad that controls the inflation and deflation of the pad. The connection assembly between the clip and the support includes a ball and a ball joint that receives the ball. The clip comprises a bar, the receiving clip of which is attached to the support bar by means of a connecting assembly. The receiving clip is slidably mounted along the bar of the support. -The bar is extendable and the length of the bar is adjustable. The support includes at least one additional part attached to the bar to increase the height of the support. The support comprises a spacer. The support comprises a patch. The receiving clip includes a sleeve that is deformable between an open position and a closed position. The receiving clip includes a mechanism for clamping and / or unclamping the deformable sleeve. The clamping mechanism of the deformable sleeve comprises a notch system, a toggle system or a clamp system. It comprises a guide fastening system separate from the receiving clip and the support, and advantageously a flexible link connecting the guide fastening system to the support or the receiving clip. The guide fastening system comprises a retaining block attached to the patch that defines a slot for receiving the guide.

[0020] The present invention also has as its object a method for anchoring an introducer of a medical device performed outside the human body, the method comprising: - providing a fixation device comprising a support pre-fixed to a patient and a clip for receiving an introducer attached to the support, the clip defining a central passage extending along a longitudinal axis and a longitudinal opening for inserting the introducer into the central passage, the fixation device including a system for holding the introducer in place within the clip, the holding system including at least one reversible locking pad for the introducer; - positioning an introducer within a central passageway through the longitudinal opening; - reversibly shifting the locking pad from a release configuration to a configuration that locks the introducer in place within the central passage while placing the introducer within the central passage; Includes:

[0021] The invention will be better understood from the following description, given by way of example only and made with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 is a perspective view of a first device for anchoring an introducer of a medical device to a human body. [Figure 2] 2 is a perspective view of a receiving clip, a connecting assembly, and a retention system of the fixation device of FIG. 1. FIG. [Figure 3] FIG. 2 is a perspective view of a support and connection assembly of the fixation device of FIG. 1. [Figure 4] FIG. 2 is a perspective view of a second fixation device according to the present invention. [Figure 5] FIG. 5 is a perspective view of the support bar, receiving clip, connection assembly and retention system of the fixation device of FIG. 4. [Figure 6] 10 is a perspective view of a receiving clip, a connecting assembly, and a retention system of a third fixation device according to the present invention. FIG. [Figure 7] 10 is a perspective view of a receiving clip, a connecting assembly, and a retention system of a fourth fixation device according to the present invention. FIG. [Figure 8]FIG. 10 is a perspective view of a receiving clip, a connecting assembly, and a retention system of a fifth fixation device according to the present invention. [Figure 9] 10 is a perspective view of an alternative intermediate piece provided between the connection assembly of the fixation device and the support; FIG. [Figure 10] FIG. 8 is a perspective view of the alternative fourth fixation device of FIG. 7. [Figure 11] FIG. 10 is a perspective view of a fixation device according to another embodiment of the present invention. [Figure 12] FIG. 10 is a perspective view of a fixation device according to another embodiment of the present invention. [Figure 13] FIG. 10 is a perspective view of a fixation device according to another embodiment of the present invention. [Figure 14] FIG. 10 is a perspective view of a fixation device according to another embodiment of the present invention. [Figure 15] FIG. 10 is a perspective view of a fixation device according to another embodiment of the present invention. [Figure 16] FIG. 10 is a perspective view of a fixation device according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0023] FIG. 1 shows a fixation device 10 for an introducer 12 of a medical device into the human body.

[0024] 1, fixation device 10 includes a support 14, a clip 16 for receiving introducer 12, a connection assembly 18 connecting support 14 to receiving clip 16, and a releasable retention system 20 for holding introducer 12 in place within clip 16. Advantageously, fixation device 10 includes a system 22 for securing a surgical guide 24.

[0025] By "releasable" it is meant that the retention system 20 can be moved from a locked configuration of the introducer 12, which holds the introducer 12 securely in place, to a released configuration in which the introducer 12 can be translated at least along its axis.

[0026] Introducer 12 comprises a hollow introducer tip 26 and a substantially rigid tube 28 for guiding a medical device into the introducer vessel.

[0027] Tip 26 comprises a rigid tubular handling body 30 and a sealing valve 32 disposed within body 30. Valve 32 can be opened to introduce surgical guide 24 into introducer 12 and then introduce a medical device attached to surgical guide 24. It can be closed to seal around guide 24.

[0028] A surgical guide 24 intended to navigate within a blood vessel is introduced following the generatrix of a vessel 28 from a proximal point of the tip 26 located outside the body to a distal point of the tip 26 located inside the body. The surgical guide 24 is made of a small diameter wire, for example between 0.1 mm and 3 mm.

[0029] 1, the support 14 comprises an adhesive 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 to define a fixation point on the patient's body throughout the surgical procedure.

[0030] The adhesive patch 34 is a flat, horseshoe-shaped adhesive element that defines a first, non-adhesive upper surface 40 and a second, adhesive lower surface 42 suitable for adhesion to the patient's skin.

[0031] 3, the bar 36 is a straight piece of rectangular cross section extending along a longitudinal axis A. The bar 36 defines an upper surface 44, a lower surface 46, and two side surfaces 48. The lower surface 46 of the bar 36 is secured to the upper surface 40 of the patch 34.

[0032] The bar 36 is preferably a disposable metal or plastic bar.

[0033] The connection assembly 18 includes a clamp 52 connected to the bar 36 and a ball joint 54 connected to the clip 16 .

[0034] The clamp 52 is a U-shaped jumper that can be secured to the bar 36. The clamp 52 is attached to the bar 36 and is translatable along the bar 36 along a longitudinal axis A.

[0035] The clamp 52 also includes a threaded hole 56 on one of its sides that can receive a fastening screw 58 or other fastening system.

[0036] Tightening the fastening screws 58 into the threaded holes 56 fixes the position of the clamp 52 along the bar 36 .

[0037] Advantageously, the fastening screw 58 is connected to the clamp 52 by a threaded connection 59, for example made of plastic, so that it cannot be lost in the event of removal.

[0038] As shown in FIG. 2, the receiving clip 16 defines a central passage 60 extending along the longitudinal axis B and a longitudinal opening 62 for inserting the introducer 12 into the central passage 60 in the form of a longitudinal slot opening at its longitudinal end.

[0039] In FIG. 1, the longitudinal axis A of the bar 36 and the longitudinal axis B of the central passage 60 are substantially perpendicular.

[0040] The receiving clip 16 includes a ball 64 received within the connecting assembly 18 , a deformable sleeve 66 , and a mechanism 68 for releasing the deformable sleeve 66 .

[0041] The ball 64 is secured within the ball joint 54 of the connection assembly 18, thus connecting the clip 16 and the support 14 in a ball-and-socket connection that allows the clip 16, and therefore the introducer 12, to be oriented relative to the support 14, which is secured to the patient's body.

[0042] Sleeve 66 extends around central passageway 60 and defines first and second longitudinal edges 70 and 72 on either side of longitudinal opening 62 .

[0043] The sleeve 66 is deformable between an open position and a closed position.

[0044] In the closed position, the first edge 70 and the second edge 72 of the sleeve 66 are adjacent and / or in contact with one another, narrowing the longitudinal opening 62 and thus preventing the introduction of the introducer 12 into or removal of the introducer 12 from the central passage 60. In this example, the closed position is the rest position.

[0045] In the open position, the first edge 70 and second edge 72 of the sleeve 66 are spaced apart, thereby opening the longitudinal opening 62 and thus allowing the introducer 12 to be inserted and moved into the central passage 60 or to be withdrawn from the central passage 60 through the longitudinal opening 62.

[0046] The release mechanism 68 is operable by the practitioner to move the sleeve 66 from a closed position to an open position.

[0047] In this example, the release mechanism 68 comprises a first jaw 74 rotatably mounted to a first edge 70 of the sleeve 66 and a second jaw 76 rotatably mounted to a second edge 72 of the sleeve 66.

[0048] The two jaws 74, 76 are hinged for rotation relative to the sleeve 66 about an axis parallel to the B axis. When the jaws 74, 76 are forced together, they can move the first edge 72 away from the second edge 74, opening the retention system 20 and releasing the introducer 12, as described below.

[0049] The retention system 20 for retaining the introducer 12 within the clip 16 is fixedly mounted within the sleeve 66 of the receiving clip 16 and is affixed to the inner surface of the sleeve 66. It extends into the central passage 60.

[0050] Retention system 20 defines a central passageway 82 that extends along longitudinal axis B of central passageway 60 and is of a smaller diameter than central passageway 60 of clip 16. Retention system 20 also defines a longitudinal opening 86, contiguous with longitudinal opening 62 of clip 16, for inserting introducer 12 into central passageway 82.

[0051] In this example, the retention system 20 comprises a locking pad 88 in the form of a cylindrical sleeve split along a generatrix.

[0052] The locking pad 88 can receive the introducer 12 and clamp it within the central passageway 82, holding it in place. It can be deformed to partially release the introducer 12, particularly in translation along the axis of the central passageway 82.

[0053] Thus, the retention system 20 has a locked configuration in which the locking pad 88 is compressed between the introducer 12 and the inside of the sleeve 66, and a released configuration in which the introducer 12 is translatable at least within the central passageway 82.

[0054] Advantageously, the locking pad 88 has a rough surface texture to prevent the introducer 12 from slipping within the central passageway 82 and to counteract the hydrophilic treatment of the introducer that is typically associated with better gliding within the artery.

[0055] The lock pad 88 may be made integrally from an elastomeric material, such as silicone, rubber, PVC, or may be made from a pouch, such as a plastic, containing a deformable material, such as water, oil, gelatin, or liquid silicone.

[0056] As shown in FIG. 1, the fastening system 22 of the guide 24 comprises a retaining block 90 secured to an adhesive patch 92 and a flexible link 94 for connection to the support 14 .

[0057] 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.

[0058] Advantageously, the retaining block 90 is made of foam.

[0059] Adhesive patch 92 is here a circular, flat adhesive element defining a non-adhesive upper surface 98 and an adhesive lower surface 100. Retaining block 90 is secured, for example, adhesively, to upper surface 98 of adhesive patch 92. Lower surface 100 of adhesive patch 92 is adhered to the patient.

[0060] The fixation system 22 is fixed to the patient and displaced relative to the support 14 so that the slot 96 for receiving the guide 24 extends substantially along the longitudinal axis B of the receiving clip 16 .

[0061] 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 90 .

[0062] A method for securing medical device introducer 12 to the aforementioned securement device 10 will now be described.

[0063] Referring to FIG. 1, a surgical guide 24 is first inserted into the patient at the desired location.

[0064] The introducer 12 is then positioned by engaging it onto the surgical guide 24. The tube 28 is partially inserted into the patient with the tip 26 remaining outside the patient.

[0065] The portion of the surgical guide 24 protruding from the introducer 12 is then inserted into the slot 96 in the retention block 90 , thus defining the desired central axis of the introducer 12 .

[0066] The support 14, to which the receiving clip 16 is attached by the connecting assembly 18, is then secured to the patient by adhering the adhesive underside 42 of the patch 34 to the surface of the patient's skin near the insertion incision, without interfering with the practitioner's workspace.

[0067] The introducer 12 is then inserted through the longitudinal openings 62, 86 into the central passage 82. While passing through the openings 62, 86, the introducer 12 pushes the first edge 70 away from the second edge 72, passing the sleeve 66 to its open position and the pad 88 to its relaxed configuration. When the introducer 12 reaches the passage 60, the sleeve 66 spontaneously returns to its closed position and the pad 88 transitions to its locked configuration, clamping the introducer 12.

[0068] The receiving clip 16 is then translated along the longitudinal axis A along the bar 36 and oriented by the ball joint 64 connected to the connecting assembly 18 so that the longitudinal axis B of the receiving clip 16 is aligned with the desired central axis of the introducer 12.

[0069] The flexible link 94, which is attached to the support 14 on one side and to the retaining block 90 on the other side, is then tensioned and the adhesive underside 100 of the patch 92 is adhered to the patient's skin so that the receiving slot 96 of the guide 24 extends in a direction parallel to the longitudinal axis B of the central passage 60.

[0070] In this configuration, the locking pad 88 is in a locked configuration. The locking pad 88 is compressed between the introducer 12 and the inside of the sleeve 66, thereby holding the introducer 12 in place within the central passage 60 of the clip 16.

[0071] The introducer 12 is now fixed in the desired position. Placement of the medical device within the introducer 12 is then performed.

[0072] During the procedure, the position of the introducer 12 within the central passage 60 can be adjusted as needed while remaining centered relative to the surgical guide 24 .

[0073] The practitioner presses the two jaws 74, 76 together. Thus, the sleeve 66 is deformed to move the first edge 70 away from the second edge 72 to the open position. Thus, the locking pad 88 is no longer compressed between the introducer 12 and the inside of the sleeve 66. The locking pad 88 is in the released configuration. Thus, the introducer 12 can be moved into the central passage 60. Once both jaws 74, 76 are released, the sleeve 66 returns to its closed position and the locking pad 88 is again compressed between the introducer 12 and the inside of the sleeve 66, whereby the introducer 12 is in its new position.

[0074] Once placement is complete, the introducer 12 is removed from the clip 16 and the patient's body. The adhesive patches 34, 92 are then peeled from the patient's skin.

[0075] Thus, the fixation device 10 according to the present invention holds the introducer 12 in a desired fixation position while minimizing risk to the patient and medical personnel.

[0076] Furthermore, the retention position of the introducer 12 within the fixation device 10 remains centered on the central axis defined by the surgical guide 24 and can be easily adapted during the surgical procedure without creating additional risk to the patient.

[0077] The device 10 according to the present invention is also extremely versatile, as the fixation device 10 can be used with different diameters of introducer 12.

[0078] The use of adhesive patches 34, 92 allows the method of securing introducer 12 to leave minimal, temporary marks on the patient's body, as opposed to, for example, suturing.

[0079] In one alternative, the fixation device 10 includes multiple fixation systems 22 for the surgical guide 24 to fixate the guide 24 at multiple points.

[0080] 4, the support 14 includes a retractor 106. The bar 36 is attached to the retractor 106 instead of being glued to the patch 34.

[0081] The retractor 106 includes two opposing legs 108 for spreading one of the walls of the insertion incision against the patient's body. Each leg 108 includes a retractor paddle 110 intended to be placed against one of the edges of the incision.

[0082] As shown in FIG. 5, the bar 36 includes a hook 112 at each end that can be attached to the legs 108 of the retractor 106 .

[0083] The bar 36 is extendable and the length of the bar 36 is adjustable.

[0084] Advantageously, the bar 36 comprises two parts 111, 113 that are telescopically mounted one inside the other. The length of the bar 36 is therefore adjustable, allowing the size of the bar 36 to be adapted to the spacing of the legs 108 of the retractor 106.

[0085] In the embodiment having the retractor 106, the fixation method differs from the fixation method of the previous embodiment only in the step of fixing the support 14 to the patient's body.

[0086] Indeed, after spreading the legs 108, each of the retractor paddles 110 is fixed relative to one of the edges of the incision, so that the retractor 106 makes it possible to define a fixed position on the patient's body.

[0087] The length of the bar 36 is then adjusted according to the spacing of the legs 108 of the retractor 106 by moving the two parts 111, 113 relative to each other. The hooks 112 are then clipped onto the legs 108 of the retractor 106. The bar 36 is thus fixed to the retractor 106, which defines the support 14.

[0088] Advantageously, the bar 36 is selected to be metallic when the surgical femoral retractor is positioned to maintain a previously opened pathway.

[0089] In one alternative, the retractor 106 selected is a disposable retractor that has the bar 36 already attached between two legs 108 of the retractor 106. Thus, the disposable retractor itself defines the support 14.

[0090] According to another embodiment shown in Figure 6, the lock pad 88 of the retention system 20 includes at least one balloon 114 that can be inflated by injection of a fluid. Four balloons 114 are shown in Figure 6.

[0091] Advantageously, the outer texture of the balloon 114 is rough to prevent slippage. The retention system 20 comprises an inflation system 116 for the balloon 114, for example comprising a syringe 118 suitable for injecting a fluid into the balloon 114 through a valve 120.

[0092] Advantageously, the fluid injected into the balloon 114 is water, oil, gelatin or liquid silicone.

[0093] The balloon 114 has the same compression behavior as the pads described above.

[0094] Inflation system 116 is controlled by a pressure button 122. Pressing button 122 opens valve 120, allowing pump 118 to inject fluid into balloon 114, causing it to inflate.

[0095] In one alternative (not shown), mechanism 68 is a clamping mechanism for sleeve 66. Sleeve 66 is not held in a rest position in the closed position.

[0096] The first jaw 74 has a notch and the second jaw 76 includes a stop adapted to engage the notch.

[0097] To move the sleeve 66 to the closed position, the practitioner pivots the first jaw 74 upward and simultaneously pivots the second jaw 76 upward. The practitioner brings the two jaws 74, 76 into contact. Thus, the stop on the second jaw 76 engages the notch on the first jaw 74, positively moving the sleeve 66 from the open position to the closed position.

[0098] In one embodiment shown in FIG. 7, the clamping mechanism 68 of the sleeve 66 does not include jaws 74 , 76 but defines a notch system comprising a first portion 124 and a second portion 126 .

[0099] A first portion 124 of the clamping mechanism 68 extends beyond the first edge 70 of the sleeve 66 and defines a notch 128 having internal teeth therein.

[0100] The second portion 126 of the clamping mechanism 68 extends over the second edge 72 of the sleeve 66 and defines an externally toothed tab 130. The tab 130 extends facing the notch 128 in the first portion 124 and is adapted to be inserted into the notch 128.

[0101] Inserting tab 130 into notch 128 by pressing first portion 124 toward second portion 126 of clamping mechanism 68 causes first edge 70 to contact second edge 72 of sleeve 66, thus moving sleeve 66 to the closed position. External teeth of tab 130 engage internal teeth of notch 128, locking it in place.

[0102] The sleeve 66 comprises a hinge 131 extending according to a direction parallel to the longitudinal axis of the sleeve 66. Advantageously, the hinge 131 extends diametrically opposite the longitudinal opening 62.

[0103] In an alternative to this embodiment shown in FIG. 10, the receiving clip 16 can receive the hollow tip 26 of the introducer 12 .

[0104] Advantageously, the sleeve 66 presents a notch 152 suitable for the passage of a pipe 154 for introducing a fluid, connected to a sealing valve 32 arranged inside the tubular body 30 of the hollow tip 26.

[0105] According to another embodiment shown in FIG. 8, the clamping mechanism 68 of the sleeve 66 defines a toggle system comprising a first portion 132 and a second portion 134 .

[0106] The first part 132 defines a toggle and comprises an articulated lever 136 mounted for rotation parallel to axis B on the first edge 70 of the sleeve 66, and a connecting rod 138 articulated to the lever 136 about an axis parallel to axis B. The connecting rod 138 includes at its end a closure link 140 in the form of a crosspiece extending parallel to axis B.

[0107] The second portion 134 is fixedly attached to the second edge 72 of the sleeve 66 and defines a hook 144 that may receive the closure link 140 .

[0108] The first portion 132 defines a first free position in which it extends loosely over the first edge 70 of the sleeve 66, a second engaged position with the second portion in which the closure link 140 is locked within the hook 144 and the lever 136 is in an upper position as shown in FIG. 8, and a third position in which the closure link 140 is locked within the hook 144 and the lever 136 is in a lower position.

[0109] Moving the first part 132 from the second position to the third position by pushing the lever 136 moves the connecting rod 138 to the lower position, which drives the second edge 72 of the sleeve 66 toward the first edge 70, thus driving the sleeve 66 through to the closed position.

[0110] Moving the first portion 132 from the third position to the second position by lifting the lever 136 returns the sleeve 66 to the open position to adjust the position of the introducer 12 during the surgical procedure.

[0111] In one alternative shown in FIG. 9, the support 14 comprises at least one additional part 146 attached to the bar 36 so as to increase the height of the support 14 .

[0112] Additional components 146, or stacks of components 146, increase the height of support 14, thereby positioning introducer 12 at a desired height, for example, to maintain the angle of the introducer at the exit of the incision.

[0113] The part 146 comprises a first part 148 defining a hollow cavity intended to receive the bar 36 and a second part 150 of the same size as the bar 36 and intended to receive the connection assembly 18.

[0114] The part 146 is attached to the bar 36 by clipping a first portion 148 of the part 146 to the bar 36. The connection assembly 18 is attached to a second portion 180 of the part 146.

[0115] A first part 146 may be stacked to a second part 146 by clipping a first portion 148 of the first part 146 to a second portion 150 of the second part 146. This action may be performed as many times as necessary to build the stack of parts 146 to the desired height.

[0116] The stack of parts 146 is secured to the bar 36 by clipping a first portion 148 of the part 146 located at the bottom of the stack onto the bar 36, and the connection assembly 18 is attached to a second portion 150 of the part 146 located at the top of the stack.

[0117] Alternatively, instead of a stack of parts 146, another lifting system is used, such as a screw system.

[0118] 11, the support 14 includes a disposable retractor 106 having the bar 36 already mounted between two legs 108 of the retractor 106. Such a disposable retractor 106 may be made, for example, from a plastic material.

[0119] In the embodiment of the invention shown in Figure 12, the support 14 includes a sterile field consisting of an adhesive film 158 that defines a sterile barrier between its underside, which is applied to the patient's skin, and its upper surface. The adhesive film 158 has a central window.

[0120] In this embodiment, each end of the bar 36 is mounted between two metal retention tabs 160 attached to an adhesive film 158 .

[0121] In an alternative embodiment shown in FIG. 13, each end of the bar 36 is attached to a single metal retaining tab 160 attached to an adhesive film 158 .

[0122] In an alternative embodiment shown in Figure 14, the bar 36 is adhered directly to an adhesive film in the sterile field.

[0123] In an alternative form of the invention shown in Figures 15 and 16, the support 14 is not held directly on the patient, but is held in a fixed manner relative to the patient.

[0124] "Held fixedly relative to the patient" means in particular that the patient is fixed to the surface of, for example, an operating table, with the support 14 being held fixedly relative to the table and therefore relative to the patient.

[0125] In the embodiment shown in Figure 15, the support 14 includes an articulated arm that is attached at one end to an operating table on which a patient lies. A bar 36 is attached to the other end of the articulated arm and can be positioned and held in a desired position relative to the patient by the articulated arm. The articulated arm is preferably radiolucent.

[0126] 16, the support 14 comprises a rigid shell with two movable side walls 162. The rigid shell with the side walls 162 is preferably radiolucent.

[0127] The patient is received on the rigid shell between two side walls 162 that are moved toward the patient to abut the patient on either side. The bar 36 extends between the two side walls 162 and forms a belt over the patient. The bar 36 is slidably mounted, for example, on rails defined in each side wall 162. Optionally, the bar 36 is also attached at each end to the patient's skin by adhesive patches.

[0128] In one alternative embodiment of the present invention, the fixation device 10 includes multiple guide fixation systems 22. Each of the guide fixation systems 22 is adapted to fix one type and / or diameter of surgical guide 24. The guide fixation systems 22 differ from one another in color and / or texture so that they are easily distinguished and identified. [Explanation of symbols]

[0129] 10 fixation device, 12 introducer, 14 support, 16 receiving clip, 18 connection assembly, 20 releasable retention system, 22 fixation system, 24 surgical guide, 26 hollow introducer tip, 28 substantially rigid tube, 30 rigid tubular treatment body, 32 sealing valve, 34 adhesive patch, 36 bar, 40 first non-adhesive upper surface, 42 second adhesive lower surface, 44 upper surface, 46 lower surface, 48 side, 52 clamp, 54 ball joint, 56 threaded hole, 58 fastening screw, 59 threaded connection, 60 central passage, 62 longitudinal opening, 64 ball, 66 deformable sleeve, 68 mechanism, 70 first longitudinal edge, 72 second longitudinal edge, 74 first jaw, 76 second jaw, 82 central passage, 86 longitudinal opening, 88 Locking pad, 90, Retaining block, 92, Adhesive patch, 94, Flexible link, 96, Slot, 98, Non-adhesive upper surface, 100, Adhesive lower surface, 102, Ring, 104, Ring, 106, Retractor spacer, 108, Leg, 110, Retractor paddle, 111, Component, 112, Hook, 113, Component, 114, Balloon, 116, Inflation system, 118, Syringe, 120, Valve, 122, Pressure button, 124, First part, 126, Second part, 128, Notch, 130, Tab, 131, Hinge, 132, First part, 134, Second part, 136, Articulating lever, 138, Connecting rod, 140, Closure link, 144, Hook, 146, Component, 148, First part, 150, Second part, 152, Notch, 154 Pipe, 158 adhesive film, 160 metal retaining tab, 162 movable side wall, 180 second portion

Claims

1. A fixation device (10) for fixating an introducer (12) of a medical device to a human body, comprising: a support (14) intended to be held on or against the patient; a connection assembly (18) attached to said support (14); a receiving clip (16) of the introducer (12) attached to the connection 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 inserting the introducer (12) into the central passage (60); a retention system (20) for holding said introducer (12) in place within said clip (16); Equipped with the retention system (20) includes at least one reversible locking pad (88) for the introducer (12), such that the retention system (20) can be changed from a release configuration for positioning, displacement, and removal of the introducer (12) within the central passage (60) to a configuration for locking the introducer (12) in place within the central passage (60); the support (14) includes a bar (36), the receiving clip (16) is attached to the bar (36) of the support (14) by the connection assembly (18), The receiving clip (16) is slidably mounted along the bar (36) of the support (14); Fixed device.

2. The fixation device of claim 1 , wherein the locking pad (88) comprises a sleeve split along a generatrix.

3. 3. The fixation device of claim 1, wherein the locking pad (88) is formed from a block of deformable material or a bag containing deformable material.

4. The fixation device of claim 1 or 2, wherein the retention system (20) comprises an inflation system (116) for the pad (88) that controls the inflation and deflation of the pad (88).

5. 5. The fixation device according to claim 1, wherein the connection assembly (18) between the clip (16) and the support (14) includes a ball (64) and a ball joint (54) that receives the ball (64).

6. 6. The fixation device according to any one of claims 1 to 5, wherein the bar (36) is extensible and the length of the bar (36) is adjustable.

7. 7. The fixing device according to any one of claims 1 to 6, wherein the support (14) comprises at least one additional part (146) attached to the bar (36) for increasing the height of the support (14).

8. The fixation device according to any one of claims 1 to 7, wherein the support (14) comprises a spacer (106).

9. The fixation device according to any one of claims 1 to 8, wherein the support (14) comprises a patch (34).

10. 10. The fixation device according to any one of claims 1 to 9, wherein the receiving clip (16) includes a sleeve (66) that is deformable between an open position and a closed position.

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

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

13. 13. The fixation device according to any one of claims 1 to 12, comprising a guide fastening system (22) remote from the receiving clip (16) and the support (14), and advantageously a flexible link (94) connecting the guide fastening system (22) to the support (14) or the receiving clip (16).

14. The fixation device of claim 13, wherein the guide fixation system (22) comprises a retaining block (90) attached to a patch (92) defining a slot (96) for receiving the guide (24).

15. The fixation device of any one of claims 1 to 14, wherein the support (14) comprises a sterile field, an articulated arm, or a rigid shell.

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