The technical field of the invention is that of medical instruments.
In particular, the invention relates to a device and a method allowing to close a perforation in a cavity in a human or animal body.
Furthermore, the invention relates to a catheter introducer in a cavity in a human or animal body comprising such a closing device. Moreover, the invention relates to an injection or sampling cannula for an extracorporeal membrane oxygenation system comprising such a closing device. In addition, the invention relates to an extracorporeal membrane oxygenation system comprising such a cannula.
An extracorporeal membrane oxygenation system, known as ECMO, comprising a set of components allowing to extract, by means of a sampling cannula, a blood volume from a cavity in a human or animal body, to oxygenate it, to decarboxylate it, possibly to heat it, then to reinject it, by means of an injection cannula, into a cavity different from or identical to the sampling cavity.
After using sampling and injection cannulas, it is necessary to ensure the closing of the perforation formed at the insertion point of the cannula in the cavity. Yet, the diameter of the cannulas used in ECMO systems is important, generally between 5 and 8 mm, such that the removal of the cannulas leaves a large opening in the cannulated cavity.
In most cases, the perforation is closed up through open surgery which requires the intervention of a specialist surgeon, access to an operating theatre and a potentially morbid surgical approach (disunity, lymphorrhoea, lymphocele, infection, etc.).
In rarer cases, the perforation is closed up by manual compression. However, if this technique works in 80% of cases, in the remaining 20%, it requires emergency surgery.
In other rarer cases, the perforation is closed up by a percutaneous closing system implemented before the insertion of the cannula or after its removal, which makes it possible to avoid open surgery. However, given the complexity of this technique, only very specialist teams can do it. In addition, these teams must have access to an operating theatre in case of problems.
The invention offers a solution to the problems mentioned above, by proposing a device and a method for closing a perforation which is simple to use and which does not require open surgery and therefore does not require making a surgeon intervene or does not require having access to an operating theatre.
A first aspect of the invention relates to a device for closing a perforation in a wall in a human or animal body, said wall having an internal part and an external part, the closing device having closing means comprising:
In addition, the closing means are made of a shape memory material and have a structure allowing a variation in the relative position of the hooking means with respect to one another according to the state of compression of the central portion such that when the central portion is in a compressed state, the distance between the hooking means increases and that when the central portion passes from a compressed state to a relaxed state, the distance between the hooking means decreases, which leads to the alignment of the borders of the perforation and therefore the closing of the perforation.
By “cavity of the body”, this means an organ, a blood vessel, a lymphatic vessel or also a bronchial structure.
Thanks to the closing device according to the invention, the operation of closing a perforation in a wall of a cavity is simplified. Indeed, it suffices to place the closing means in the cavity, via the perforation, to compress the central portion so as to spread the hooking means such that they can be anchored on the borders of the perforation, at the internal part of the wall of the cavity, then to relax the central portion, in order to reduce the gap between the hooking means which allows to progressively align the borders of the perforation, and therefore to ensure its closing.
Due to its ease of use, the closing device does not require nor perform a surgical intervention and all the more so, the intervention of a specialist surgeon or access to an operating theatre. In addition, the closing means can be left in place in the cavity for a long duration.
Further to the characteristics which have just been mentioned in the preceding paragraph, the closing device according to the first aspect of the invention can have one or more complementary characteristics from among the following, considered individually or according to any technical possible combinations.
According to a non-limiting embodiment, the closing device has a guide channel having an end adapted to be positioned in the cavity, through the perforation, the guide channel being configured to receive the closing means and to ensure the compression of said closing means.
According to a non-limiting embodiment, the closing means are configured to adopt:
Advantageously, when the closing device is integrated in a cannula, the closing means can, when they are in the intermediate position, have an abutment function allowing the positioning of the cannula and an anchoring function allowing the removal of the cannula during its use.
According to a non-limiting embodiment, the closing device has movement means configured to ensure the movement of the closing means inside the guide channel.
According to a non-limiting embodiment, the movement means are removably fixed to the central portion of the closing means.
According to a non-limiting embodiment, the central portion has the form of a loop.
According to a non-limiting embodiment, the first hooking means and the second hooking means each have the form of a hook.
According to a non-limiting embodiment, the closing means have an antithrombogenic coating in order to prevent the formation of thrombus and/or antiproliferative coating to favour haemostasis at the perforation and to prevent the formation of a hyperplasia of the cavity and/or a prothrombogenic coating to favour haemostasis at the perforation and/or a procoagulant coating.
According to a non-limiting embodiment, the closing means are made of a resorbable material in order to decrease the risk of long-term complications.
According to a non-limiting embodiment, the closing means are made from a nickel-titanium alloy wire.
Furthermore, the invention according to a second aspect relates to an catheter introducer in a cavity of a human or animal body, through a perforation, having a conduit configured for the passage of the catheter, characterised in that it has a closing device according to the first aspect, configured to be positioned inside the conduit and to ensure the closing of the perforation by deploying the closing means of the closing device in the cavity during the removal of the introducer from the perforation.
In addition, the invention according to a third aspect relates to a cannula for injecting or sampling a fluid in a cavity in a human or animal body, through a perforation, having:
Further to the characteristics which have just been mentioned in the preceding paragraph, the cannula according to the third aspect of the invention can have one or more complementary characteristics from among the following, considered individually or according to any technical possible combinations.
According to a non-limiting embodiment, the cannula has:
The presence of two closing devices allows to close the perforation more effectively.
According to a non-limiting embodiment, the first auxiliary lumen and/or the second auxiliary lumen is/are arranged in a peripheral portion of the cannula, which can be the wall of the main lumen.
According to a non-limiting embodiment, the closing means form means for anchoring the cannula in the cavity when the closing means are in an intermediate position.
Thus, the closing means allow to block in position the injection cannula in the cavity such that it does not risk being extracted from the body of the patient even in case of movements of the patient. Thus, the injection cannula can be held in the body of a patient for a long duration.
Moreover, the invention according to a fourth aspect relates to an extracorporeal membrane oxygenation system having:
Furthermore, the invention according to a fifth aspect relates to a method for closing a perforation, by means of the closing device having:
The invention and its different applications will be best understood upon reading the following description and upon examining the figures which accompany it.
The figures are presented for information and not at all limiting of the invention.
The figures are presented for information and not at all limiting of the invention.
The invention relates to a closing device 10 allowing to close a perforation 21 in the wall 2 of a cavity 1 in a human or animal body.
In reference to
As can be seen in
Moreover, the closing means 11 are made of a shape memory material, i.e. that the material has the capacity to keep an initial shape in memory and to return to its initial shape, even after having been deformed. Advantageously, the closing means 11 are made of a nickel-titanium alloy material, as this material has a good elasticity, as well as a certain rigidity. In an embodiment variant, the closing means 11 are made of a resorbable material. In addition, the closing means 11 can have an antithrombogenic and/or antiproliferative and/or procoagulant and/or prothrombogenic coating. In addition, the closing means 11 preferably have a form chosen so as to not cause lesions in the wall 2 of the cavity 1. Also, the closing means 11 have rounded angles, as well as a collected shape. Moreover, the form of the closing means 11 can vary in order to obtain the best resistance with a smaller volume and the least aggression for the wall 2 of the cavity 1.
In addition, the closing means 11 have a structure allowing a variation in the relative position of the hooking means 12′, 13′ with respect to one another according to the state of compression of the central portion 14.
In a rest position illustrated in
In the intermediate position illustrated in
In the compression position illustrated in
In the closing device 10 illustrated in
According to the embodiment illustrated in
Moreover, the movement of the closing 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, an end 31 of which is fixed to the central portion 14 of the closing means 11, while the other end is kept outside of the body of the patient, in order to be able to be controlled by a practitioner from the outside of the cavity 1.
In a step 101 illustrated in
Then, in a step 102 illustrated in
At the outlet of the guide channel 20, the hooking means 12, 13 thus pass from a compressed state to a relaxed state leading to the spreading of the hooking means 12′, 13′ from one another. The distance d between the hooking means 12′, 13′ when the closing means 11 are in the intermediate position is thus greater than the distance d between the hooking means 12′, 13′ when the closing means 11 are in the rest position. Advantageously, the distanced between the hooking means 12′, 13′ in this position is greater than the diameter of the perforation 21.
Then, in a step 103 illustrated in
Subsequently, in a step 104, the guide channel 20 is fully removed from the cavity 1, which leads to the deployment of the central portion 14. Indeed, insofar as the hooking means 12, 13 are hooked to the borders of the perforation 21, at the internal part 3 of the wall 2 of the cavity 1, the hooking means 12, 13 form an abutment preventing the closing means 11 from being extracted from the cavity 1. This is the rest position described in reference to
As can be seen in
Moreover, the invention relates to a catheter introducer (not illustrated) in a cavity in a human or animal body, through a perforation. The introducer has a conduit for the passage of the catheter, as well as a closing device identical to the closing device 10 described in reference to
The invention also relates to a cannula comprising at least one closing 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 as ECMO.
In a known manner and as represented schematically in
Below in the description, it will be recognised that the closing device 10 is integrated with an injection cannula 50 of an ECMO system. Naturally, the closing device 10 can be integrated with any cannula intended to be inserted into a cavity of a human or animal body, such as a sampling cannula of the ECMO system.
Below in the description, it will be recognised that the fluid to be injected into a cavity of the body is blood. In addition, the physiological flow direction S of blood in a vessel, an organ, is called “anterograde flow direction” of a fluid. Furthermore, the opposite physiological flow direction S of blood in a vessel or an organ is called “retrograde flow direction” of a fluid. The baseline is therefore taken with respect to the physiology of the human or animal body. By extension of language and for clarity of the description of the embodiment, the flow direction of the main lumen LP will be called: the “retrograde direction”, and the flow direction of the reperfusion ancillary lumen LA will be called: the “anterograde direction”, each being considered at the outlet of the injection cannula when their direction is mentioned.
Moreover, the terms “upstream” and “downstream” are defined in the present text with respect to the practitioner who handles the injection cannula 50.
Finally, “F2” and “F2′” mean, a treated blood flow, i.e. oxygenated and decarboxylated.
As can be seen in
Advantageously, the injection cannula 50 is made from a deformable material, for example, polyurethane, possibly heparinised. Thus, the injection cannula 50 can be deformed during its introduction into the cavity 1 so as to be able to be inserted transversally into the wall 2 of the cavity 1 to avoid causing lesions in the wall 2 of the cavity 1. Furthermore, as can be seen in
Furthermore, according to the embodiment of
The main lumen LP ensures the injection of the blood flow F2 coming 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 from the inlet 51 of the injection cannula 50, in order to receive the blood flow F2. The blood flow F2 is then discharged through the outlet 51′ of the injection cannula 50.
Moreover, the main lumen LP has a circular cross-section and has a diameter which varies between its inlet 52 and its outlet 51′. Furthermore, the diameter of the main lumen LP at its outlet 51′ is smaller than at its inlet 52 such that the part 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 the main lumen LP. Furthermore, the main lumen LP could absolutely have a cross-section other than circular, for example, an oval, elliptic cross-section.
The reperfusion ancillary lumen LA ensures the injection of some of the blood flow F2′ into the cavity 1, in a second direction, here an anterograde direction. To this end, the reperfusion ancillary lumen LA has an inlet 53 in fluid communication with the main lumen LP. In particular, the inlet 53 of the reperfusion ancillary lumen LA is arranged downstream from the inlet 52 of the main lumen LP, in order to capture some of the blood flow F2′ coming from the main lumen LP. In an embodiment variant, the inlet 53 of the reperfusion ancillary lumen LA is not in fluid communication with the main lumen LP. In this case, the reperfusion ancillary lumen LA captures some of the blood flow F2′ directly from the inlet 51 of the injection cannula 50. Furthermore, as can be seen in
Moreover, the reperfusion ancillary lumen LA has a curved portion 53 allowing to modify the retrograde flow direction of the blood flow F2′ captured by the reperfusion ancillary lumen LA. The curved portion 54 allows the blood flow F2′ captured to flow in an anterograde direction. The curved portion 54 forms a circular arc, even a semi-circle allowing to modify the orientation of the fluid F2′ in an anterograde direction, i.e. in a direction opposite the ejection direction of the blood flow F2 into the outlet 51′ of the main lumen LP.
The reperfusion ancillary lumen LA furthermore has an outlet 53′ leading into a side opening 55 arranged in the injection cannula 50 so as to discharge the blood flow F2′ flowing in an anterograde direction into the cavity 1.
The reperfusion ancillary lumen LA, also with a circular cross-section, has, different from the main lumen LP, a constant diameter over the whole of its length. According to an embodiment example, the diameter of the reperfusion ancillary lumen LA has a diameter between 20G, i.e. 0.8 mm, and 6F, i.e. 2 mm. Naturally, the diameter of the reperfusion ancillary lumen LA could vary between the inlet 53 and the outlet 53′ of the reperfusion ancillary lumen LA. It is noted that it is possible to make the ratio of the cross-sections of the lumens LA and LP vary, in order to control the speed and the ejection rate of the blood flow F2, F2′ in the cavity 1 in both directions, i.e. anterograde and retrograde. Furthermore, the reperfusion ancillary lumen LA could have a cross-section other than circular, for example, oval, elliptic.
In an embodiment variant not illustrated, the reperfusion ancillary lumen LA is arranged inside the main lumen LP such as described in patent application FR3058642. In this case, the outlet 53′ of the reperfusion ancillary lumen LA also leads into the side opening 55 arranged in the injection cannula 50. In an embodiment variant not illustrated, the outlet 53′ of the reperfusion ancillary lumen LA is equipped with an electromechanical device for measuring the flow connected to an electronic display located at the handle, i.e. at the inlet 51, of the injection cannula 50.
Moreover, as can be seen in
The drain valve 58 allows the opening of two ways and the closing of the third way, simultaneously. Thus, when the outlet 581 of the drain valve 58 is closed, the blood flow F2′ circulating in the reperfusion ancillary lumen LA can pass from the inlet 53 of the reperfusion ancillary lumen LA to the outlet 53′ of the reperfusion ancillary lumen LA. Furthermore, when the outlet 581 of the drain valve 58 is open, the blood flow F2′ cannot pass from the inlet 53 of the reperfusion ancillary lumen LA to the outlet 53′ of the reperfusion ancillary lumen LA.
In a first position of the drain valve 58, called anterograde or control drain of the flow, the blood flow F2′ circulates in the reperfusion ancillary lumen LA, upstream to downstream, i.e. from the inlet 53 of the reperfusion ancillary lumen LA to the outlet 281 of the drain valve 58.
In a second position of the drain valve 58, called retrograde or control drain of the backflow, the blood flow F2′ circulates in the reperfusion ancillary lumen LA from downstream to upstream, i.e. from the outlet 53′ of the reperfusion ancillary lumen LA to the outlet 581 of the drain valve 58. It is noted that the blood flow F2′ circulating in the reperfusion ancillary lumen LA from downstream to upstream can be generated during the introduction of the injection cannula 50 into the cavity 1.
Advantageously, the drain valve 58 allows to ensure that the outlet 53′ of the reperfusion ancillary lumen LA is correctly positioned in the cavity 1. To do this, the flow and the backflow between the outlet 53′ of the reperfusion ancillary lumen LA and the outlet 581 of the drain valve 58 are tested by using a syringe connected to the outlet 581 of the drain valve 58, in order to respectively inject or suction a fluid between the outlet 53′ of the ancillary lumen LA and the outlet 581 of the drain valve 58.
Advantageously, the injection cannula 50 comprises a first closing device 60, allowing to ensure the closing of the perforation 21 corresponding to the insertion point of the injection cannula 50, when the injection cannula 50 is removed from the cavity 1.
The first closing device 60 comprises closing means 61 identical to the closing means 11 described in reference to
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 arranged in a peripheral portion of the injection cannula 50, which can be the wall of the main lumen LP. Furthermore, the outlet 56′ of the first auxiliary lumen LX1, arranged upstream from the outlet 53′ of the reperfusion ancillary lumen LA leads into the side opening 55 arranged in the injection cannula 50. In an embodiment variant, the outlet 56′ of the first auxiliary lumen LX1 and the outlet 53′ of the reperfusion ancillary lumen LA do not lead into the same opening of the injection cannula 50.
Furthermore, the first auxiliary lumen LX1 has a circular cross-section and has a constant diameter above the whole of its length, for example, a diameter between 0.1 and 5 mm. In an embodiment variant, the diameter of the first auxiliary lumen LX1 varies between the inlet 56 and the outlet 56′ of the first auxiliary lumen LX1. It is furthermore noted, that the first auxiliary lumen LX1 can have a cross-section other than circular, for example, elliptic.
The movement of the closing means 61 inside the first auxiliary lumen LX1, then its deployment into the cavity 1 are remotely controlled by movement means 65. In particular, the movement means 65 according to the embodiment of
The method for closing the perforation 21 by means of the first closing device 60 of the injection cannula 50 is similar to the closing method 100 described above.
Thus, when the injection cannula 50 is removed from the cavity 1, the closing means 61 housed in the first auxiliary lumen LX1 in a compression position, are pushed in the direction of the cavity 1 by the movement means 30 such that only the ends 611, 612 of the closing means 61 are deployed in the cavity 1, in a relaxed state. The closing means 61 are thus in the intermediate position. Advantageously, the position of the closing means 61 with respect to the injection cannula 50 is blocked by the pushbutton 63 such that when the injection cannula 50 is removed by a few centimetres, the hooking means 611′, 612′ of the ends 611, 612 are anchored on the borders of the perforation 21, at the internal part 3 of the wall 2 of the cavity 1. In this position, the closing means 61 form anchoring means allowing to block in position the injection cannula 50 in the cavity 1. Thus, in the intermediate position, the hooking means 611, 612 prevent the removal of the injection cannula 50 from the cavity 1.
Once the hooking means 611, 612 are anchored in the borders of the perforation 21, the injection cannula 50 is removed such that the central portion 613 of the closing means 61 is deployed outside of the first auxiliary lumen LX1 to return to its rest position. The deployment of the central portion 613 leads to the alignment of the hooking means 611′, 612′, and thus the alignment of the borders of the perforation 21 until it is closed.
Advantageously, the closing means 61 have a radiopaque or echo-opaque marking adapted to ensure an identification of the closing means 61 by radiography or echography. According to another embodiment, the identification marking is made on the outlet 56′ of the auxiliary lumen LX. In another embodiment variant, the closing means 61 and the outlet 56′ of the auxiliary lumen LX are marked.
Moreover, in order to ensure an effective reperfusion of the cavity 1, it is essential that the outlet 53′ of the reperfusion ancillary lumen LA is positioned in the cavity 1 such that the blood flow F2′ flowing in an anterograde direction is ejected right in full light of the cavity 1. In other words, the outlet 53′ of the reperfusion ancillary lumen LA must not be positioned so as to face a wall 2 of the cavity 1.
Also, the outlet 56′ of the auxiliary lumen LX is positioned at a predetermined distance d from the outlet 53′ of the reperfusion ancillary lumen LA such that, when the injection cannula 50 is blocked in position in the cavity 1 by the hooking means 611, 612, the blood flow F2′ which circulates in the reperfusion ancillary lumen LA is discharged correctly into the 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 ancillary lumen LA is between 0.1 and 500 mm.
The injection cannula 70 is broadly identical to the injection cannula 50 according to the first embodiment, the only difference being that it comprises, in addition to a first auxiliary lumen LX1 and a first closing device 71, a second auxiliary lumen LX2 and a second closing device 72.
The first closing device 71, positioned inside the first auxiliary lumen LX1, comprises closing means 710, as well as a connecting element 81 fixed to the central portion (which cannot be seen) of the closing means 710 of the first closing device 71. The second closing device 72, positioned inside the second auxiliary lumen LX2, comprises, in the same way as the first closing device 71, closing means 720, as well as a connecting element 82 fixed to the central portion (which cannot be seen) of the closing means 720 of the second closing 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 the peripheral portion in which the first auxiliary lumen LX1 is arranged. 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.
The invention also relates to an ECMO system having the injection cannula 50 according to the first embodiment of the injection cannula 70 according to the second embodiment of the invention.
Number | Date | Country | Kind |
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1912333 | Nov 2019 | FR | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2020/080373 | 10/29/2020 | WO |