DEVICE FOR CLOSING A PERFORATION IN THE WALL OF A CAVITY IN THE HUMAN OR ANIMAL BODY

Abstract

TITLE: DEVICE FOR CLOSING A PERFORATION IN THE WALL OF A HUMAN OR ANIMAL BODY CAVITY The invention relates to a device for closing a perforation (21) in a wall (2), the closing device (10) comprising closing means (11) including: a central portion (14), a first end (12) comprising a first attachment means (12') and a second end (13) comprising a second attachment means (13'), the two ends (12, 13) being arranged on either side of the central portion (14), the closing means (11) being made of a shape-memory material and having a structure allowing variation of the relative position of the attachment means (12', 13') with respect to each other as a function of the compression state of the central portion (14). Figure to be published with the abbreviation: Fig. 1

Description

Title of the invention: DEVICE FOR CLOSING A PERFORATION IN THE WALL OF A CAVITY IN THE HUMAN OR ANIMAL BODY. TECHNICAL FIELD OF THE INVENTION

[0001] The technical field of the invention is that of medical instruments.

[0002] In particular, the invention relates to a device for closing a perforation in a cavity of the human or animal body.

[0003] Furthermore, the invention relates to a catheter introducer for a human or animal body cavity comprising such a closure device. Moreover, the invention relates to an injection or sampling cannula for an extracorporeal membrane oxygenation (ECMO) system comprising such a closure device. In addition, the invention relates to an ECMO system comprising such a cannula. TECHNOLOGICAL BACKGROUND OF THE INVENTION

[0004] An extracorporeal membrane oxygenation system, known by the acronym ECMO for "extracorporeal membrane oxygenation", comprises a set of components enabling the extraction, by means of a sampling cannula, of a blood volume from a cavity of the human or animal body, of oxygenating it, of decarboxylating it, possibly of heating it, and then of reinjecting it, by means of an injection cannula, into a cavity different from or identical to the sampling cavity.

[0005] After using the sampling and injection cannulas, it is necessary to ensure the closure of the perforation formed at the point of insertion of the cannula into the cavity. However, the diameter of the cannulas used in ECMO systems is large, generally between 5 and 8 mm, so that removing the cannulas leaves a large opening in the cannulated cavity.

[0006] In the majority of cases, the perforation is closed by open surgery, which requires the intervention of a specialist surgeon, access to an operating room and a potentially morbid surgical approach (disunion, lymphorrhea, lymphocele, infection, etc.).

[0007] In rarer cases, the perforation is closed by manual compression. However, while this technique works in 80% of cases, in the remaining 20%, emergency surgery is required.

[0008] In other, rarer cases, the perforation is closed by a percutaneous closure system placed before the insertion of the cannula or after its removal, thus avoiding open surgery. However, given the complexity of this Technically, only highly specialized teams can perform it. Furthermore, these teams must have access to an operating room in case of problems. Summary of the invention

[0009] The invention offers a solution to the problems mentioned above, by proposing a device for closing a perforation that is simple to use and does not require open surgery and therefore does not require the intervention of a surgeon or access to an operating room.

[0010] A first aspect of the invention relates to a device for closing a perforation in a wall of a cavity of the human or animal body, said wall having an internal part and an external part, the closing device comprising closing means including: • a central portion, • a first end comprising a first hooking means and a second end comprising a second hooking means, the two ends being arranged on either side of the central portion, each hooking means being configured to anchor itself on an edge of the perforation at the level of the internal part of the wall of the cavity.

[0011] Furthermore, the closing means are made of a shape-memory material and have a structure allowing a variation of the relative position of the hooking means with respect to each other depending on the state of compression of the central portion so that when the central portion is in a compressed state, the distance between the hooking means increases and when the central portion goes from a compressed state to a relaxed state, the distance between the hooking means decreases which leads to the approach of the edges of the perforation and therefore the closure of the perforation.

[0012] By “body cavity” is meant an organ, a blood vessel, a lymphatic vessel or a bronchial structure.

[0013] Thanks to the closing device according to the invention, the operation of closing a perforation in a cavity wall is simplified. Indeed, it is sufficient to place the closing means in the cavity, via the perforation, to compress the central portion so as to spread the hooking means apart so that they can anchor themselves on the edges of the perforation, at the level of the internal part of the cavity wall, then to release the central portion in order to reduce the spacing between the hooking means, which allows the edges of the perforation to be brought together progressively and thus ensures its closure.

[0014] Due to its ease of use, the closure device does not require any surgical intervention, and a fortiori, the intervention of a specialist surgeon or access to an operating room. In addition, the closure devices can be left in place in the cavity for a long time.

[0015] In addition to the characteristics mentioned in the preceding paragraph, the closure device according to the first aspect of the invention may have one or more additional characteristics from among the following, considered individually or according to all technically possible combinations.

[0016] According to a non-limiting embodiment, the closure device comprises a guide channel having an end adapted to be positioned in the cavity, through the perforation, the guide channel being configured to receive the closure means and to ensure the compression of said closure means.

[0017] According to a non-limiting embodiment, the closing means are configured to adopt: • a compression position in which the central portion and the attachment means are in the guide channel and in a compressed state, • a rest position in which the central portion and the attachment means are outside the guide channel and in a relaxed state, • an intermediate position in which the central portion is in the guide channel, in a compressed state, while the hooking means are outside the guide channel, in a relaxed state, the distance between the hooking means in the intermediate position being greater than the distance between the hooking means in the rest position.

[0018] Advantageously, when the closure device is integrated into a cannula, the closure means can, when in the intermediate position, have a stop function allowing the positioning of the cannula and an anchoring function allowing the cannula to be withdrawn during its use.

[0019] According to a non-limiting embodiment, the closing device includes movement means configured to ensure the movement of the closing means inside the guide channel.

[0020] According to a non-limiting embodiment, the means of movement are removably fixed to the central portion of the closing means.

[0021] According to a non-limiting embodiment, the central portion has the shape of a loop.

[0022] According to a non-limiting embodiment, the first attachment means and the second attachment means each have the shape of a hook.

[0023] According to a non-limiting embodiment, the closure means have an anti-thrombotic coating to prevent thrombus formation and / or an anti-proliferative coating to promote hemostasis at the perforation site and to prevent the formation of cavity hyperplasia and / or a pro-thrombotic coating to to promote hemostasis at the perforation site and / or a procoagulant coating.

[0024] According to a non-limiting embodiment, the closure means are made of a resorbable material in order to reduce the risk of long-term complications.

[0025] According to a non-limiting embodiment, the closure means are made from a nickel-titanium alloy wire.

[0026] Furthermore, the invention according to a second aspect relates to a catheter introducer in a cavity of the human or animal body, through a perforation, comprising a conduit configured for the passage of the catheter, characterized in that it comprises a closure device according to the first aspect, configured to be positioned inside the conduit and to ensure the closure of the perforation by deploying the closure means of the closure device in the cavity when the introducer is withdrawn from the perforation.

[0027] Furthermore, the invention according to a third aspect relates to a cannula for injecting or withdrawing a fluid into a cavity of the human or animal body, through a perforation, comprising: • a main lumen defining a first space in the cannula for fluid circulation • a first auxiliary lumen defining a second space of the cannula and comprising an outlet opening into the cavity, • a first closure device according to the first aspect configured to be positioned inside the first auxiliary lumen and to ensure closure of the perforation by deploying the closure means of the first closure device in the cavity when the cannula is withdrawn from the perforation.

[0028] In addition to the characteristics just mentioned in the preceding paragraph, the cannula according to the third aspect of the invention may have one or more complementary characteristics from among the following, considered individually or according to all technically possible combinations.

[0029] According to a non-limiting embodiment, the cannula comprises: • a second auxiliary lumen defining a third space of the cannula and comprising an outlet opening into the cavity, • a second closing device according to the first aspect configured to be positioned inside the second auxiliary light.

[0030] The presence of two closing devices allows the perforation to be closed more effectively.

[0031] According to a non-limiting embodiment, the first auxiliary lumen and / or the second auxiliary lumen is / are provided in a peripheral portion of the cannula, which may be the wall of the main lumen

[0032] According to a non-limiting embodiment, the closure means form anchoring means for the cannula in the cavity when the closure means are in an intermediate position.

[0033] Thus, the locking means make it possible to secure the injection cannula in position within the cavity so that it cannot be withdrawn from the patient's body even if the patient moves. Therefore, the injection cannula can remain in the patient's body for an extended period.

[0034] Furthermore, the invention according to a fourth aspect relates to an extracorporeal membrane oxygenation system comprising: • a sampling cannula to receive a low-oxygen fluid; • a pump to ensure the pumping of the oxygen-depleted fluid from of the sampling cannula; • an oxygenator to ensure oxygenation of the oxygen-poor fluid coming from an outlet of the pump; • an injection cannula to inject the oxygenated fluid into the cavity, • the sampling cannula and / or the injection cannula being formed by the cannula according to the second aspect.

[0035] The invention and its various applications will be better understood by reading the following description and examining the accompanying figures. BRIEF DESCRIPTION OF THE FIGURES

[0036] The figures are presented for illustrative purposes only and are in no way limiting of the invention.

[0037] [fig. 1] illustrates the closing device according to one embodiment of the invention.

[0038] [fig.2a] is an enlargement of the closing means of the closing device re shown in Figure 1.

[0039] [fig.2b] illustrates the closing means of the closing device shown in figure 1, in an intermediate position.

[0040] [fig.2c] illustrates the closing means of the closing device shown in figure 1, in a compression position.

[0041] [fig.3] is a block diagram illustrating the method of closing a perforation in using the closing device shown in Figure 1.

[0042] [fig.4] illustrates the closing device shown in figure 1, when it is po positioned in the perforation and that the closing means are in the compression position.

[0043] [fig.5] illustrates the closing device shown in figure 4, when the means The closing mechanisms are in the intermediate position and are anchored on the edges of the perforation.

[0044] [fig.6] illustrates the transition from the compression position shown in figure 4 to the intermediate position shown in figure 5.

[0045] [fig.7] illustrates the transition from the intermediate position shown in figure 5 to the resting position and at the closing of the perforation.

[0046] [fig.8] is a schematic representation of an ECMO system according to a mode of resuscitation implementation of the invention.

[0047] [fig.9] illustrates an injection cannula according to a first embodiment of the invention, used in the ECMO system shown in Figure 8.

[0048] [fig.10] is seen in cross-section of an injection cannula according to a second method of implementation.

[0049] [fig.l 1] shows a side view of a portion of the injection cannula shown in figure 10, when the closure means are in the compression position.

[0050] [fig.12] mounts a lateral view of a portion of the injection cannula shown in the figure 10, when the closing means are in the intermediate position.

[0051] The figures are presented for illustrative purposes only and are in no way limiting of the invention. DETAILED DESCRIPTION

[0052] The invention relates to a closure device 10 for closing a perforation 21 in the wall 2 of a cavity 1 of the human or animal body.

[0053] Figure 1 illustrates the closure device 10 according to one embodiment of the invention.

[0054] With reference to Figure 1, the closing device 10 includes closing means 11 configured to ensure the closure of the perforation 21.

[0055] As can be seen in Figure 1, the closure means 11 comprise a central portion 14 arranged between a first end 12 and a second end 13. The central portion 14 is in the form of a loop. The first end 12 comprises a first attachment means 12' and the second end 13 comprises a second attachment means 13'. Advantageously, the hooking means 12', 13' are arranged symmetrically on either side of the central portion 14. Each hooking means 12', 13' has the form of a hook oriented towards the central portion 14, which is intended to anchor itself on an edge of the perforation 21 at the level of the internal part 3 of the wall 2 of the cavity 1. In addition, each end 12, 13 of the closing means 11 forms an elbow between each hooking means 12', 13' and the central portion 14.Advantageously, the fastening means 11 are formed from the same wire so that the loop is formed by crossing the two strands of said wire.

[0056] Furthermore, the closing means 11 are made of a shape-memory material, meaning that the material has the ability to retain an initial shape and return to its original shape even after being deformed. Advantage Preferably, the closure devices 11 are made from a nickel-titanium alloy material because this material offers good elasticity and rigidity. In an alternative embodiment, the closure devices 11 are made from a resorbable material. Furthermore, the closure devices 11 may have an anti-thrombotic and / or anti-proliferative and / or procoagulant and / or pro-thrombotic coating. In addition, the closure devices 11 preferably have a shape designed to avoid damaging the wall 2 of cavity 1. Therefore, the closure devices 11 have rounded corners and a compact shape. Moreover, the shape of the closure devices 11 may vary to achieve the best resistance with the smallest possible size and minimal impact on the wall 2 of cavity 1.

[0057] Furthermore, the closure means 11 have a structure allowing a variation of the relative position of the hooking means 12', 13' with respect to each other depending on the state of compression of the central portion 14.

[0058] Figures 2a, 2b and 2c illustrate the closing means 11 in different positions.

[0059] In a rest position illustrated in Figures 1 and 2a, the central portion 14 and the ends 12, 13 of the fastening means 11 undergo no deformation. The fastening means 11 are then in a relaxed state, i.e., at rest. In this position, the width 1 of the loop is, for example, between 2 and 5 mm. Furthermore, the distance d between the fastening means 12', 13' is, for example, between 1 and 2 mm.

[0060] In the intermediate position illustrated in Figure 2b, the central portion 14 is in a compressed state. In particular, the central portion 14 is laterally compressed, which here results in an elongation of the loop and therefore a decrease in its width 1. In other words, the width 1 of the loop in the intermediate position is less than the width 1 of the loop in the rest position. The width 1 of the loop in the intermediate position is, for example, between 0.1 and 2 mm. Furthermore, the compression of the central portion 14 causes the ends 12, 13 of the fastening means 11 to expand, extending on either side of the central portion 14. The expansion of the ends 12, 13 of the fastening means 11 results in an increase in the distance d between the fastening means 12', 13'.Thus, in the intermediate position, the distance d between the attachment means 12', 13' is greater than the distance d between the attachment means 12', 13' when they are in the rest position. The distance d between the attachment means 12', 13' in the intermediate position is, for example, between 1 and 10 mm.

[0061] In the compression position illustrated in Figure 2c, the central portion 14 and the ends 12, 13 of the closure means 11 are in a compressed state. In particular, the central portion 14 and the ends 12, 13 of the fastening means 11 are compressed laterally. As explained previously, the lateral compression of the central portion 14 causes the loop to elongate and therefore reduces its width 1. In other words, the width 1 of the loop in the compression position is less than the width 1 of the loop in the rest position. The width 1 of the loop in the compression position is, for example, between 0.1 and 2 mm. Furthermore, the lateral compression of the ends 12, 13 of the fastening means 11 causes a deformation of the ends 12, 13 of the fastening means 11, which fold against the loop strands. Thus, the distance d between the fastening means 12', 13' in the compression position is less than the distance d between the fastening means 12', 13' in the rest position.The distance d between the attachment means 12', 13' in the compression position is, for example, between 0.1 and 2 mm.

[0062] In the closure device 10 illustrated in figures 1, 3 to 9, the compression of the closure means 11 is ensured by a guide channel 20 which also allows the closure means 11 to be guided into the cavity 1, through the perforation 21.

[0063] According to the embodiment illustrated in Figures 1, 3 to 9, the guide channel 20 is formed by a tube whose diameter D is adapted to the dimensions of the perforation 21 so as to ensure its insertion into said perforation 21. Advantageously, the guide channel 20 is made from a deformable material, for example polyurethane, so that it can be inserted in a deformed state into the cavity 1 and thus avoid causing damage to the wall 2 of the cavity 1. In addition, the diameter D of the guide channel 20 is chosen so as to ensure the compression of the closing means 11 when the latter are housed in the guide channel 20. The diameter D of the guide channel 20 is, for example, between 0.1 and 50 mm.

[0064] Furthermore, the movement of the closure means 11 in the guide channel 20 is ensured by movement means 30. Advantageously, the movement means 30 are formed by a wire, for example made of polypropylene, one end 31 of which is fixed to the central portion 14 of the closure means 11 while the other end is kept outside the patient's body so that it can be controlled by a practitioner from outside the cavity 1.

[0065] Figure 3 is a schematic block representation illustrating the steps of a method for closing 100 a perforation 21, using the closing device 10 of Figure 1. To improve its understanding, the closing method 100 will be described with reference to Figures 4 to 9.

[0066] In a step 101 illustrated in Figure 4, the end 22 of the guide channel 20 is inserted into the cavity 1 through the perforation 21. As can be seen in Figure 4, during the insertion step 101, the closing means 11 are compressed to inside the guide channel 20. This is the compression position described previously with reference to Figure 2c. Advantageously, during the insertion step 101, the closing means 11 are positioned near the end 22 of the guide channel 20 by means of the displacement means 30.

[0067] Next, in a step 102 illustrated in Figure 5, the closure means 11 are partially deployed in the cavity 1. Indeed, in this step 102, the ends 12, 13 of the closure means 11 are deployed outside the guide channel 20 while the central portion 14 of the closure means 11 is maintained in a compressed state inside the guide channel 20. The closure means 11 are then in the intermediate position described previously with reference to Figure 2b. To achieve this, the ends 12, 13 of the closure means 11 are moved towards the cavity 1.

[0068] Upon exiting the guide channel 20, the gripping means 12, 13 then transition from a compressed state to a relaxed state, causing the gripping means 12', 13' to separate from each other. The distance d between the gripping means 12', 13' when the closing means 11 are in the intermediate position is then greater than the distance d between the gripping means 12', 13' when the closing means 11 are in the rest position. Advantageously, the distance d between the gripping means 12', 13' in this position is greater than the diameter of the perforation 21.

[0069] Next, in a step 103 illustrated in figure 6, the displacement means 30 and the guide channel 20 are partially withdrawn from the cavity 1, through the perforation 21, until the hooking means 12', 13' hook onto the edges of the perforation 21, at the level of the internal part 3 of the wall 2 of the cavity 1. In this step 103, the central portion 14 of the closing means 11 is kept compressed in the guide channel 20.

[0070] Subsequently, in step 104, the guide channel 20 is completely withdrawn from the cavity 1, resulting in the deployment of the central portion 14. Indeed, since the gripping means 12, 13 are hooked to the edges of the perforation 21, at the level of the inner part 3 of the wall 2 of the cavity 1, the gripping means 12, 13 form a stop preventing the closing means 11 from being extracted from the cavity 1. This is the rest position described with reference to Figure 2a. The central portion 14 is then positioned in the perforation 21, straddling the cavity 1 and the outside of the cavity 1.

[0071] As can be seen in Figure 7, which illustrates the transition from the intermediate position to the rest position during the withdrawal of the guide channel 20, the central portion 14 transitions from a compressed state to a relaxed state, i.e., to rest. The transition from the compressed state to the relaxed state results in an increase in the width 1 of the loop and a decrease in the distance d between the attachment means 12', 13'. The decrease The distance d between the attachment means 12', 13' causes the banks surrounding the perforation 21 to move closer together because the attachment means 12', 13' are anchored to the banks of the perforation 21. The banks then come together, resulting in the closure of the perforation 21. During the closure of the perforation 11, the central portion 14 of the closure means 11 is held outside the cavity 11, while the attachment means 12, 13 are held inside the cavity 11, anchored to the inner wall 3 of the wall 2 of the cavity 1. Advantageously, the displacement means 30 are then detached from the central portion 14. When the displacement means 30 are formed by a wire attached to the central portion 14, said wire is, for example, cut by means of scissors or a wire cutter, flush with the central portion 14.

[0072] Furthermore, the invention relates to a catheter introducer (not illustrated) inserted into a cavity of the human or animal body through a perforation. The introducer comprises a conduit for the passage of the catheter and a closure device identical to the closure device 10 described with reference to Figure 1. Advantageously, the guide channel for the closure device is formed by the conduit of the introducer. In one embodiment, the closure device includes a guide channel positioned inside the conduit of the introducer to ensure the guidance of the closure means.

[0073] The invention also relates to a cannula comprising at least one closure device 10 according to the invention. Advantageously, the cannula according to the invention is an injection cannula or a sampling cannula used in an extracorporeal membrane oxygenation system, known by the acronym ECMO.

[0074] In a known manner and as schematically represented in Figure 8, an ECMO system comprises various components including a CP sampling cannula, a PMP pump, an OXY oxygenator, and a CL injection cannula. Thus, the oxygen-poor blood flow Fl is drawn from a CV1 cavity by the CP sampling cannula, then conveyed to the OXY oxygenator by means of the PMP pump, and finally reinjected into a CV2 cavity by means of the CL injection cannula. The CV2 injection cavity may be identical to, or a different from, or identical to the CV1 sampling cavity.

[0075] In the following description, it will be assumed that the closure device 10 is integrated into an injection cannula 50 of an ECMO system. Naturally, the closure device 10 can be integrated into any cannula intended to be inserted into a cavity of the human or animal body, such as a sampling cannula of the ECMO system.

[0076] In the following description, it will be assumed that the fluid to be injected into a body cavity is blood. Furthermore, the physiological flow direction S of blood in a vessel or organ is called the "anterograde flow direction" of a fluid. Furthermore, the "retrograde flow direction" of a fluid is defined as the opposite direction to the physiological flow S of blood in a vessel or organ. The reference frame is therefore based on the physiology of the human or animal body. For the sake of clarity in describing this implementation, the flow direction of the main lumen (LP) will be referred to as the "retrograde direction," and the flow direction of the accessory reperfusion lumen (LA) as the "anterograde direction," each being considered at the exit of the injection cannula when referring to their direction.

[0077] Furthermore, the terms "upstream" and "downstream" are defined in this text in relation to the practitioner who manipulates the injection cannula 50.

[0078] Finally, "F2" and "F2'" are designated as a treated blood flow, i.e. oxygenated and decarboxylated.

[0079] Figure 9 illustrates a perspective view of an injection cannula 50 according to a first embodiment of the invention, when inserted into a perforation 21. The perforation 21 corresponds to the point of insertion of the injection cannula 50 into the cavity 1.

[0080] As can be seen in Figure 9, the injection cannula 50 has an inlet 51 adapted to cooperate with a connecting mouthpiece (not shown) from an ECMO component in order to receive the treated blood flow. Furthermore, the injection cannula 50 has an outlet 51' for insertion into cavity 1.

[0081] Advantageously, the injection cannula 50 is made of a deformable material, for example polyurethane, optionally heparinized. Thus, the injection cannula 50 can be deformed during its insertion into the cavity 1 so as to be inserted transversely into the wall 2 of the cavity 1 to avoid causing damage to the wall 2 of the cavity 1. Furthermore, as can be seen in Figure 9, the injection cannula 50 is partially inserted into the cavity 1 so that a portion of the injection cannula 50 remains outside the patient's body and can thus be manipulated by a practitioner.

[0082] In addition, according to the embodiment of figure 9, the injection cannula 50 comprises a main lumen LP, an accessory reperfusion lumen LA and a first auxiliary lumen LX1 delimiting three spaces of the injection cannula 50.

[0083] The main lumen LP ensures the injection of the blood flow F2 from the inlet 51 of the injection cannula 50 into the cavity 1, in a first direction, here a retrograde direction. To this end, the main lumen LP extends along the injection cannula 50 between an inlet 52 and the outlet 51' of the injection cannula 50, which forms the outlet of the main lumen LP. The inlet 52 of the main lumen LP is arranged downstream of the inlet 51 of the injection cannula 50 in order to receive the flow F2 blood flow. The F2 blood flow is then evacuated through outlet 51' of injection cannula 50.

[0084] Furthermore, the main lumen LP has a circular cross-section and a diameter that varies between its inlet 52 and its outlet 51'. In addition, the diameter of the main lumen LP at its outlet 51' is smaller than at its inlet 52 so that the portion of the injection cannula 50 intended to be inserted into the cavity 1 is adapted to the dimensions of said cavity 1. Advantageously, the diameter of the main lumen LP is between 10F and 21F, i.e., between 3.3 and 7 mm. Naturally, the diameter of the main lumen LP can be constant along its entire length. Moreover, the main lumen LP could very well have a cross-section other than circular, for example, an oval or elliptical cross-section.

[0085] The accessory reperfusion lumen LA ensures the injection of a portion of the blood flow F2' into cavity 1, in a second direction, here an anterograde direction. For this purpose, the accessory reperfusion lumen LA has an inlet 53 in fluidic communication with the main lumen LP. In particular, the inlet 53 of the accessory reperfusion lumen LA is arranged downstream of the inlet 52 of the main lumen LP in order to capture a portion of the blood flow F2' from the main lumen LP. In an alternative embodiment, the inlet 53 of the accessory reperfusion lumen LA is not in fluidic communication with the main lumen LP. In this case, the accessory reperfusion lumen LA captures a portion of the blood flow F2' directly from the inlet 51 of the injection cannula 50. Furthermore, as can be seen in Figure 9, a portion of the accessory reperfusion lumen LA extends parallel to the main lumen LP.

[0086] Furthermore, the accessory reperfusion lumen LA includes an angled portion 54 that allows the retrograde flow direction of the blood flow F2' captured by the accessory reperfusion lumen LA to be modified. The angled portion 54 allows the captured blood flow F2' to flow in an anterograde direction. The angled portion 54 forms an arc, or even a semicircle, allowing the orientation of the fluid F2' to be modified in an anterograde direction, that is, in a direction opposite to the ejection direction of the blood flow F2 at the outlet 51' of the main lumen LP.

[0087] The accessory reperfusion lumen LA further comprises an outlet 53' opening into a lateral opening 55 provided in the injection cannula 50 so as to evacuate the blood flow F2' flowing in an anterograde direction into the cavity 1.

[0088] The accessory reperfusion lumen LA, also circular in cross-section, unlike the main lumen LP, has a constant diameter along its entire length. In one embodiment, the diameter of the accessory reperfusion lumen LA is between 20G, i.e., 0.8 mm, and 6F, i.e., 2 mm. Natu- Therefore, the diameter of the LA reperfusion accessory lumen could vary between the inlet 53 and the outlet 53' of the LA reperfusion accessory lumen. It is noted that it is possible to vary the ratio of the cross-sectional areas of the LA and LP lumens in order to control the velocity and flow rate of blood flow F2, F2' into cavity 1 in both directions, i.e., anterograde and retrograde. Furthermore, the LA reperfusion accessory lumen could have a cross-section other than circular, for example, oval or elliptical.

[0089] In an embodiment not shown, the accessory reperfusion lumen LA is arranged inside the main lumen LP as described in patent application FR3058642. In this case, the outlet 53' of the accessory reperfusion lumen LA also opens into the lateral opening 55 provided in the injection cannula 50. In another embodiment not shown, the outlet 53' of the accessory reperfusion lumen LA is equipped with an electromechanical flow-measuring device connected to an electronic display located at the handle, i.e., at the inlet 51, of the injection cannula 50.

[0090] Furthermore, as can be seen in Figure 9, a purge valve 58 is connected to the reperfusion accessory lumen LA to ensure its purging. In particular, the purge valve 58 is a three-way valve in which two ports are connected to two portions LAI, LA2 of the reperfusion accessory lumen LA, while one port forms an outlet 581. It should be noted that the portion of the injection cannula 50 containing the purge valve 58 is intended to be kept outside the human or animal body.

[0091] The purge valve 58 allows two channels to be opened and the third channel to be closed simultaneously. Thus, when the outlet 581 of the purge valve 58 is closed, the blood flow F2' circulating in the accessory reperfusion lumen LA can pass from the inlet 53 of the accessory reperfusion lumen LA to the outlet 53' of the accessory reperfusion lumen LA. Furthermore, when the outlet 581 of the purge valve 58 is open, the blood flow F2' cannot pass from the inlet 53 of the accessory reperfusion lumen LA to the outlet 53' of the accessory reperfusion lumen LA.

[0092] In a first position of the purge valve 58, called antegrade purge or flow control, the blood flow F2' circulates in the accessory reperfusion lumen LA from upstream to downstream, i.e. from the inlet 53 of the accessory reperfusion lumen LA to the outlet 281 of the purge valve 58.

[0093] In a second position of the purge valve 58, called the retrograde purge or reflux control position, the blood flow F2' circulates in the accessory reperfusion lumen LA from downstream to upstream, i.e., from the outlet 53' of the accessory reperfusion lumen LA to the outlet 581 of the purge valve 58. It should be noted that the blood flow F2' circulating in the accessory reperfusion lumen LA from downstream to upstream can be generated during the introduction of the injection cannula 50 into cavity 1.

[0094] Advantageously, the purge valve 58 makes it possible to ensure that the outlet 53' of the accessory reperfusion lumen LA is correctly positioned in the cavity 1. To do this, the flow and reflux between the outlet 53' of the accessory reperfusion lumen LA and the outlet 581 of the purge valve 58 are tested using a syringe connected to the outlet 581 of the purge valve 58 in order, respectively, to inject or aspirate a fluid between the outlet 53' of the accessory lumen LA and the outlet 581 of the purge valve 58.

[0095] Advantageously, the injection cannula 50 includes a first closure device 60 to ensure the closure of the perforation 21 corresponding to the point of insertion of the injection cannula 50, when the injection cannula 50 is withdrawn from the cavity 1.

[0096] The first closure device 60 comprises closure means 61 identical to the closure means 11 described with reference to Figures 2a, 2b, and 2c. To ensure the guidance of the closure means 61 of the first closure device 60, the closure means 61 are housed in the first auxiliary light LX1. In other words, the guidance and compression of the closure means 61 are ensured here by the first auxiliary light LX1. In an alternative embodiment not shown, the first closure device 60 comprises a guide channel located inside the first auxiliary light LX1 to ensure the guidance and compression of the closure means 61.

[0097] The first auxiliary lumen LX1 extends parallel to the main lumen LP and has an inlet 56 and an outlet 56'. Advantageously, the first auxiliary lumen LX1 is provided in a peripheral portion of the injection cannula 50, which may be the wall of the main lumen LP. Furthermore, the outlet 56' of the first auxiliary lumen LX1, arranged upstream of the outlet 53' of the reperfusion accessory lumen LA, opens into the lateral opening 55 provided in the injection cannula 50. In an alternative embodiment, the outlet 56' of the first auxiliary lumen LX1 and the outlet 53' of the reperfusion accessory lumen LA do not open into the same opening of the injection cannula 50.

[0098] Furthermore, the first auxiliary light LX1 has a circular cross-section and a constant diameter along its entire length, for example, a diameter between 0.1 and 5 mm. In one embodiment, the diameter of the first auxiliary light LX1 varies between the inlet 56 and the outlet 56' of the first auxiliary light LX1. It should also be noted that the first auxiliary light LX1 may have a cross-section other than circular, for example, elliptical.

[0099] The movement of the closure means 61 inside the first auxiliary lumen LX1 and then its deployment in the cavity 1 are remotely controlled by Movement means 65. In particular, the movement means 65 according to the embodiment shown in Figure 9 comprise a connecting element 66 fixed to the central portion 14 and a push button 63 adapted to slide along a longitudinal groove 64 formed in the injection cannula 50. The upstream to downstream movement of the push button 63 in the longitudinal groove 64 causes the connecting element 66, and therefore the closure means 61, to move in the same direction. In particular, during the upstream to downstream movement of the push button 63, it comes into contact with one end of the connecting element 66 and then pushes the connecting element 66, and therefore the closure means 61, towards the cavity 1. At the exit 56' of the first auxiliary lumen LX1, the closure means 61 are deployed, at least partially, into the cavity 1.In one embodiment, the deployment of the closing means 61 is carried out by means of an electric motor located at the handle of the injection cannula 50, under the control of a switch also located at said handle.

[0100] The method of closing the perforation 21 using the first closing device 60 of the injection cannula 50 is similar to the closing method 100 described previously.

[0101] Thus, when the injection cannula 50 is withdrawn from the cavity 1, the closure means 61, housed in the first auxiliary lumen LX1 in a compressed position, are pushed towards the cavity 1 by the displacement means 30 so that only the ends 611, 612 of the closure means 61 are deployed in the cavity 1, in a relaxed state. The closure means 61 are then in the intermediate position. Advantageously, the position of the closure means 61 relative to the injection cannula 50 is blocked by the push button 63 so that when the injection cannula 50 is withdrawn a few centimeters, the hooking means 611', 612' of the ends 611, 612 come to anchor themselves on the edges of the perforation 21, at the level of the internal part 3 of the wall 2 of the cavity 1. In this position, the closure means 61 form anchoring means allowing the injection cannula 50 to be locked in position in the cavity 1.Thus, in the intermediate position, the hooking means 611,612 prevent the withdrawal of the injection cannula 50 from cavity 1.

[0102] Once the anchoring means 611, 612 are secured in the edges of the perforation 21, the injection cannula 50 is withdrawn so that the central portion 613 of the closure means 61 extends outside the first auxiliary lumen LX1 to return to its resting position. The extension of the central portion 613 causes the anchoring means 611', 612' to move closer together, and thus the edges of the perforation 21 to move closer together until it is closed.

[0103] Advantageously, the closing means 61 have radio- marking An opaque or echo-opaque material is suitable for identifying the closure means 61 by radiography or ultrasound. In another embodiment, the identification marking is made on the outlet 56' of the auxiliary lumen LX. In yet another embodiment, both the closure means 61 and the outlet 56' of the auxiliary lumen LX are marked.

[0104] Furthermore, in order to ensure effective reperfusion of cavity 1, it is essential that the outlet 53' of the accessory reperfusion lumen LA be positioned in cavity 1 so that the blood flow F2' flowing in an anterograde direction is ejected into the full lumen of cavity 1. In other words, the outlet 53' of the accessory reperfusion lumen LA must not be positioned so as to face a wall 2 of cavity 1.

[0105] Also, the outlet 56' of the auxiliary lumen LX is positioned at a predetermined distance d from the outlet 53' of the reperfusion accessory lumen LA so that, when the injection cannula 50 is locked in position in cavity 1 by the attachment means 611, 612, the blood flow F2' circulating in the reperfusion accessory lumen LA is correctly evacuated into cavity 50, i.e., in the anterograde direction. Advantageously, the predetermined distance between the outlet 56' of the auxiliary lumen LX and the outlet 53' of the reperfusion accessory lumen LA is between 0.1 and 500 mm.

[0106] Figures 10, 11 and 12 illustrate an injection cannula 70 according to a second embodiment.

[0107] The injection cannula 70 is overall identical to the injection cannula 50 according to the first embodiment, with the sole difference that it includes, in addition to a first auxiliary lumen LX1 and a first closure device 71, a second auxiliary lumen LX2 and a second closure device 72.

[0108] The first closure device 71, positioned inside the first auxiliary lumen LX1, comprises closure means 710 and a connecting element 81 fixed to the central (non-visible) portion of the closure means 710 of the first closure device 71. The second closure device 72, positioned inside the second auxiliary lumen LX2, comprises, in the same manner as the first closure device 71, closure means 720 and a connecting element 82 fixed to the central (non-visible) portion of the closure means 720 of the second closure device 72. Advantageously, the second auxiliary lumen LX2 is identical to the first auxiliary lumen LX1 and is arranged in a peripheral portion of the injection cannula 70 opposite to the peripheral portion in which the first auxiliary lumen LX1 is provided.The outlet 73 of the first auxiliary lumen LX1 and the outlet of the second auxiliary lumen LX2 are preferably arranged at the same level of the injection cannula 70.

[0109] The invention also relates to an ECMO system comprising the injection cannula 50 according to the first embodiment or the injection cannula 70 according to the second embodiment of the invention.

Claims

Demands

1. A closure device (10) for a perforation (21) in a wall (2) of a cavity (1) of the human or animal body, said wall (2) having an internal part (3) and an external part (4), characterized in that the closure device (10) comprises closure means (11) including: - a central portion (14), - a first end (12) comprising a first attachment means (12') and a second end (13) comprising a second attachment means (13'), the two ends (12, 13) being arranged on either side of the central portion (14), each attachment means (12', 13') being configured to anchor to an edge of the perforation (21) at the level of the internal part (2) of the wall (2) of the cavity (1), the closure means (11) being made of a shape-memory material and having a structure allowing variation in the relative position of the means of attachment (12',13') relative to each other depending on the compression state of the central portion (14) such that when the central portion (14) is in a compressed state, the distance (d) between the hooking means (12', 13') increases and when the central portion (14) passes from a compressed state to a relaxed state, the distance (d) between the ends (12', 13') of the hooking means (11) decreases, which leads to the approach of the edges of the perforation (21) and therefore the closure of the perforation (21).

2. A closure device (10) according to the preceding claim, characterized in that it comprises a guide channel (20) having an end (22) adapted to be positioned in the cavity through the perforation (21), the guide channel (20) being configured to receive the closure means (11) and to ensure the compression of said closure means (11).

3. A closing device (10) according to the preceding claim, characterized in that the closing means (11) are configured to adopt: a compression position in which the central portion (14) and the fastening means (12, 13) are in a state compressed in the guide channel (20), - a rest position in which the central portion (14) and the hooking means (12, 13) are outside the guide channel (20) and in a relaxed state, - an intermediate position in which the central portion (14) is in a compressed state in the guide channel (20) while the hooking means (12, 13) are outside the guide channel (20) in a relaxed state, the distance (d) between the hooking means (12', 13') in the intermediate position being greater than the distance (d) between the hooking means (12', 13') in the rest position.

4. A closing device (10) according to any one of claims 2 to 3, characterized in that it comprises movement means (30) configured to ensure the movement of the closing means (11) inside the guide channel (20).

5. A closing device (10) according to the preceding claim, characterized in that the displacement means (30) are removably fixed to the central portion (14) of the closing means (H).

6. A closure device (10) according to any one of the preceding claims, characterized in that the central portion (14) has the shape of a loop.

7. A closure device (10) according to any one of the preceding claims, characterized in that the first hooking means (12) and the second hooking means (13) each have the shape of a hook.

8. Closure device (10) according to any one of the preceding claims, characterized in that the closure means (11) are made of a resorbable material.

9. A closure device (10) according to any one of claims 1 to 7, characterized in that the closure means (11) are made from a nickel-titanium alloy wire.

10. A catheter introducer for a cavity (1) of the human or animal body, through a perforation, comprising a conduit configured for the passage of the catheter, characterized in that it comprises a closure device (10) according to any one of the preceding claims, configured to be positioned inside the conduit and to ensure closure of the perforation by deploying the closing means (11) of the closing device (10) in the cavity when the perforation introducer is removed.

11. A cannula (50, 70) for injecting or withdrawing fluid from a perforation (21) in a wall (2) of a cavity (1) of the human or animal body, comprising a main lumen (LP) defining a first space in the cannula (50) for fluid circulation, characterized in that the cannula (50) further comprises: - a first auxiliary lumen (LX1) defining a second space in the cannula (50) and comprising an outlet (56') opening into the cavity (50), - a first closure device (10, 71) according to any one of claims 1 to 9, configured to be positioned inside the first auxiliary lumen (LX1) and to ensure closure of the perforation (21) by deploying the closure means (61, 710) of the first closure device (10, 70) into the cavity (1) when the cannula (50) is withdrawn from the perforation (21).

12. Cannula (50, 70) according to the preceding claim, characterized in that it comprises: - a second auxiliary lumen (LX2) defining a third space of the cannula (50, 70) and comprising an outlet opening into the cavity (1), - a second closure device (72) according to any one of claims 1 to 10, configured to be positioned inside the second auxiliary lumen (LX2).

13. Cannula (50, 70) according to any one of claims 11 to 12, characterized in that the first auxiliary lumen (LX1) and / or the second auxiliary lumen (LX2) is / are provided in a peripheral portion of the cannula (50, 70).

14. Cannula (50, 70) according to any one of claims 11 to 13, characterized in that the closure means (61, 71, 72) form anchoring means for the cannula (50) in the cavity (1) when the closure means (61,71, 72) are in an intermediate position.

15. Extracorporeal membrane oxygenation system comprising: - a sampling cannula (CP) to receive an oxygen-poor fluid; - a pump (PMP) to ensure the pumping of oxygen-poor fluid from the sampling cannula; - an oxygenator (OXY) to ensure oxygenation of the oxygen-poor fluid coming from a pump outlet (PMP) - an injection cannula (IC) for injecting the oxygenated fluid into the cavity (1); characterized in that the sampling cannula (CP) and / or the injection cannula (CI) of the system is / are formed by the cannula (50) according to any one of claims 11 to 14.

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