Anastomosis device

Abstract

The present invention relates to an anastomosis device, comprising: a first tube (10) having a side surface (11), an upstream opening (13) and a downstream opening (14); at least one second tube (100) extending from the side surface (11) of the first tube (10) to the inlet (101) of the second tube (100) and communicating with the first tube (10); a valve (130) attached to the second tube (100); and a ligation device (150) disposed around the first tube (10) downstream of the communication region (120) between the first tube and the second tube, the ligation device (150) taking a first arrangement or a second arrangement, the first arrangement closing the first tube (10), and the second arrangement leaving the first tube (10) open.

Description

Technical Field

[0001] The technical field of the present invention generally relates to the field of vascular reconstruction surgery, and more particularly to the field of vascular anastomosis devices used in this type of surgery.

[0002] The present invention relates to an anastomosis device.

[0003] The present invention has found use in the treatment of patients suffering from vascular diseases and in the use of heart unloading pumps.

Background Art

[0004] Generally speaking, surgical anastomosis is an artificial connection made by a surgeon between two parts of the same blood vessel, or between two parts of two blood vessels, or between two organs.

[0005] Surgical vascular anastomosis can be used in particular to repair damaged or injured arteries and veins.

[0006] Thus, it is often required for pathologies of the aorta such as aortic aneurysm, lower limb occlusive arteriosclerosis, and aortic occlusive injury. In these pathologies, a part of the blood vessel is occluded or damaged. Therefore, the anastomosis consists of redirecting the blood flow from this part through a prosthesis, for example an artificial tube, which communicates with the blood vessels on both sides of the occluded part.

[0007] In this configuration, the procedure for anastomosing the blood vessels is intended to insert the end of the prosthesis into the blood vessel and connect this prosthesis to the region of this part of the blood vessel.

[0008] Generally, an anastomosis device refers to a prosthesis and the associated intervention device.

[0009] Among vascular anastomosis devices, there are two types of devices depending on the method by which they are handled. For example, there are so-called "fully endovascular" devices that are handled by a completely endovascular route, and vascular prostheses that are handled by conventional open surgery.

[0010] Devices handled by a completely endovascular route do not require open surgery or laparotomy. They are introduced into the blood vessels by puncture through the skin or a very short surgical approach. They are generally called intravascular prostheses or intravascular anastomoses. Theoretically, they result in a reduction in morbidity and mortality. However, they still have a relatively high rate of perioperative complications and reoperations.

[0011] Therefore, anastomosis devices handled by conventional open surgery are still the gold standard. They are formed by approaching the anastomosis from the outside of the blood vessel.

[0012] The problem encountered is that these devices require a temporary interruption of blood circulation within the blood vessel in an area free of vascular disease during the anastomosis procedure. This temporary interruption of blood circulation, also called clamping, has an adverse effect on the patient and makes it impossible to apply treatment to the most vulnerable patients, including the elderly or high-risk patients.

[0013] In the case of treating occlusive arterial disease of the lower extremities with aortic occlusion injury, or treating aneurysms of the thoracic and abdominal aorta or abdominal aorta that have spread to the renal artery, superior mesenteric artery, or celiac artery, the risk of complications is particularly high when the clamp is on the kidney. In fact, since the prosthesis has to be anastomosed over a considerable length, the interruption time is as long as about 40 to 45 minutes. During this period, important organs such as the kidney and liver are not supplied with blood, and the heart is under abnormal pressure. This leads to an increased risk of stroke, renal failure, digestive ischemia, and even myocardial infarction.

[0014] Therefore, there is a need for an anastomosis device for providing an anastomosis within a blood vessel or organ without interrupting blood circulation within the blood vessel or organ while preventing blood loss.

[0015] This need also appears in the specific case of a cardiac circulatory assist device, in particular in the case of an unloading blood pump device as described, for example, in French Patent Application Publication No. 3112579. Such a device would particularly benefit from access to the left atrium of the heart by anastomosis to prevent blood loss.

Prior Art Documents

Patent Documents

[0016]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0017] The present invention provides a solution to the aforementioned problems by providing an anastomosis device including a backflow prevention device that limits blood loss and avoids clamping.

Means for Solving the Problems

[0018] For this purpose, it should be noted that one object of the first aspect of the present invention is an anastomosis device, which includes the following.

[0019] - A first tube having a longitudinal axis, a side surface, an upstream opening, and a downstream opening, - At least one second tube extending from the side surface of the first tube to the inlet of the second tube and communicating with the first tube by passing while sealing the side surface, wherein the area of the side surface through which the second tube passes defines a communication area between the first tube and the second tube, - A valve attached to the second tube, and - A ligation device disposed around the first tube downstream of the communication area between the first tube and the second tube, having a first arrangement or a second arrangement, wherein the first arrangement closes the first tube and the second arrangement leaves the first tube open.

[0020] Thus, the device according to the invention includes a prosthesis (first tube) comprising a shunt (second tube) capable of receiving the intervention instruments necessary for performing an anastomosis within a blood vessel or an organ, wherein this anastomosis is then performed at the upstream opening of the first tube.

[0021] More precisely, the device according to the invention makes it possible to receive a medical device used in endovascular surgery, comprising a transverse guide adapted to pierce the wall of a blood vessel or an organ and a holding guide adapted to form a junction between the blood vessel and the organ.

[0022] According to the invention, the anastomosis is performed in a rapid, simple and reproducible manner without blood loss and with greater consideration for the blood vessel wall. In other words, the invention makes it possible to perform minimally invasive anastomosis without blood loss. Thus, the device avoids relying on clamping the blood vessel upstream of the anastomosis site or, alternatively, this clamping is reduced to a very short time of about a few minutes, for example 5 minutes. Thus, the device can be provided to elderly or frail patients for whom conventional surgery is generally contraindicated.

[0023] More precisely, blood loss is avoided by the following.

[0024] - A first seal provided even before the blood vessel wall is transected by simply suturing the prosthesis around the upstream and downstream openings on the blood vessel or organ. - A second seal provided by a valve and the ligation device arranged in its first arrangement, which prevent the backflow of blood from the device when the wall of the blood vessel or organ is transected, i.e., punctured, by the transverse guide. - A third seal provided by a retaining guide at the junction between the blood vessel or organ and the device, the retaining guide enabling an end-to-end anastomosis to be performed.

[0025] Advantageously, the ligating device may be a ligating clip disposed around the first tube, and the ligating clip is provided with a ligating screw.

[0026] Thus, the ligating screw can be used to remotely, rapidly, and simply operate the tightening and loosening of the clip, and the clip can be respectively disposed in a first position and a second position.

[0027] Advantageously, the device may further include a support guide wire extending from the inlet of the second tube through a valve to the upstream opening of the first tube, and the support guide wire forms a guide path.

[0028] The support guide wire enables the intervention instrument to be guided through the device in a simple and reproducible manner.

[0029] Advantageously, the device further includes at least one intervention instrument selected from a set of intervention instruments including a transverse guide adapted to puncture the wall of a blood vessel or organ, the first tube, and a retaining guide adapted to form a junction between the first tube and the area of the blood vessel or organ, and each intervention instrument is configured to follow the guide path.

[0030] Thus, the device enables an anastomosis procedure to be performed using an endovascular instrument for minimally invasive anastomosis.

[0031] Advantageously, the first tube has a first diameter, the second tube has a second diameter, the first diameter can be equal to 9F, 10F, 12F, 14F, 16F, or 18F, and the second diameter can be equal to 6F or 8F.

[0032] Thus, the first tube is adapted to the vascular prosthesis, and the second tube is adapted to the passage of the anastomosis instrument and the attachment of the valve inside it.

[0033] Advantageously, the retaining guide cooperates with the support guide wire and comprises a stent, the stent being covered and having an expanded shape with a diameter larger than the diameter of the first tube, the expanded shape extending from the upstream end of the first tube.

[0034] In other words, the stent is expanded at the upstream opening from inside the first tube, so that its expanded shape is arranged as an extension of the first tube by adjoining the upstream opening. Thus, the stent provides a stable, sealed, long-term connection between the prosthesis and the blood vessel or organ. This is particularly advantageous when the device is applied to organs such as the heart because the retention is stable and has good properties regardless of the movements associated with the heart's contractions.

[0035] Furthermore, the retaining guide is easily, reproducibly and rapidly positioned by the support guide wire.

[0036] One advantage of the covered stent is that it enables sealing of the junction between the prosthesis and the blood vessel, and as a result, blood loss can be prevented.

[0037] Advantageously, the stent may also be a covered balloon stent.

[0038] The balloon enables the stent to be expanded.

[0039] In the first embodiment, the first tube is a single tube without branches (or bifurcations or shunts).

[0040] According to one development of this first embodiment, a third tube passes through the device following a guide path and the stent further comprises an attachment device.

[0041] Advantageously, the attachment device may be another stent.

[0042] This development is particularly advantageous when applied to the atrial septum of the patient's heart and used with a circulatory assist device to reduce the burden on the left side of the heart and reduce heart failure. In fact, the third tube allows the circulation of blood from the left atrium of the heart to the assist device and avoids peripheral access to the left atrium through the myocardium. The advantage is that the surgical approach is much less invasive since thoracotomy is no longer necessary.

[0043] Furthermore, the attachment device makes it possible to improve the retention of the anastomosis, particularly with respect to the movement of the heart.

[0044] In a second embodiment, the first tube includes a branch into two tubes, the branch forming a straight portion and a branch portion on the first tube, the branch being arranged downstream of the ligation device such that the straight portion of the first tube is upstream of the ligation device and the branch portion is downstream of the ligation device.

[0045] The branching of the prosthesis into two downstream tributaries is particularly advantageous when an anastomosis is made to the abdominal aorta. In fact, downstream, the prosthesis can be directly anastomosed to the two iliac arteries by two branches. Thus, the anastomosis is rapid and faster than conventional prostheses where the anastomosis is end-to-end, i.e., along the aorta and the prosthesis, and made laterally along the entire length of the prosthesis. The advantage of the first branch tube is to avoid relying on long-term clamping and to result in an easier surgery.

[0046] According to a first development of this second embodiment, the branch portion of the first tube communicates with at least one fourth tube, the fourth tube extending between the side of the branch portion of the first tube and the inlet of the fourth tube.

[0047] The fourth tube constitutes an additional branch of the prosthesis to be anastomosed onto a blood vessel or an organ. Particular advantages are found when the device is applied to the abdominal aorta. In fact, the fourth tube can be anastomosed to one of the main arteries (renal and mesenteric arteries) supplied by the aorta. Thus, the third tube makes it possible to shorten the time necessary to perform the anastomosis.

[0048] Advantageously, the branching portion of the first tube may communicate with the fifth, sixth and seventh tubes, which are spaced apart on the side surface of the branching portion of the first tube, the spacing being in the longitudinal or circumferential direction.

[0049] Thus, the third, fifth, sixth and seventh tubes are arranged so as to be easily anastomosed to the main visceral artery, the right renal artery, the left renal artery, the celiac artery and the superior mesenteric artery.

[0050] The present invention and its various applications will be better understood by reading the following description and examining the accompanying drawings.

[0051] The drawings are described for purposes of suggesting the object of the present invention and are in no way limiting.

Brief Description of the Drawings

[0052]

Figure 1

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Figure 15

DETAILED DESCRIPTION OF THE INVENTION

[0053] The present invention relates to an anastomosis device for preventing blood loss.

[0054] As used herein, the term "anastomosis" means the surgical connection of an artificial prosthesis having a tubular structure to a natural structure, which may be a blood vessel or an organ, for the purpose of connecting the prosthesis to a region of the blood vessel or the organ.

[0055] The anastomosis of the aorta and the left atrium of the heart is mainly discussed. Naturally, the present invention can alternatively be used for connecting other natural structures.

[0056] The term "internal anastomosis" is used more particularly when the anastomosis is made from the inside of a natural structure.

[0057] Furthermore, the terms "upstream" and "downstream" refer to the circulation of blood flow, and the terms "distal" and "proximal" refer to the "upstream" position and the "downstream" position, respectively.

[0058] Figure 1 shows a schematic view of a first embodiment of the device according to the present invention.

[0059] The device 1 first comprises a first tube 10 having a side surface 11, a longitudinal axis X1, an internal flow path 12 extending along the axis X1, and an upstream opening 13 and a downstream opening 14 at its ends. The first tube also has a diameter that can take the following values: 9F (3 mm), 10F (3.33 mm), 12F (4 mm), 14F (4.67 mm), 16F (5.33 mm), or 18F (6 mm). The length unit F is called French ("F"), and 1F is equal to 1 / 3 of 1 millimeter.

[0060] The first tube 10 is made of a material such as expanded polytetrafluoroethylene (ePTFE) in a microporous form or polyethylene terephthalate (PET) in a woven form. For example, the first tube 10 may be made of Gore-Tex® or Dacron®.

[0061] The device then comprises a second tube 100 extending between the inlet 101 of the second tube 100 and the side surface 11 of the first tube 10. The second tube 100 communicates with the first tube 10 through the side surface 11 of the first tube 10, that is, the internal flow path 102 of the second tube 100 is connected to the internal flow path 12 of the first tube 10. This connection of the two internal flow paths 12 and 102 defines a communication area 120 between the first tube 10 and the second tube 100. In other words, the second tube 100 is a shunt of the first tube 10 at its side surface 11.

[0062] The second tube 100 has a diameter smaller than that of the first tube 10. For example, the diameter of the second tube is 2 mm (or 6F) or 2.67 mm (or 8F).

[0063] The second tube 100 may be made of the same material as the first tube.

[0064] The second tube 100 includes a valve 130 inserted into the internal flow path 102. The valve 130 includes, within its internal region, a duct for passing a support guide wire 141 and a set of intervention instruments introduced through the inlet 101. The valve 130 also includes a sealing device for preventing the passage of the flow of fluid coming from the first tube 10 and circulating within the second tube 100.

[0065] The support guide wire 141 is introduced through the inlet 101 of the second tube 100, then passes through the valve 130, and is carried through the communication area 120 to the upstream opening 13 of the first tube 10. At the upstream opening 13, the support guide wire 141 is preferably placed substantially at the center of the upstream opening 13. Once inserted into the device, the support guide wire 141 cannot be moved anymore. It forms a guide path for the set of intervention instruments.

[0066] Generally speaking, a guide wire includes a central core of steel or nitinol, a sheath and / or turns covering the central core, a lubricant coating covering the sheath and / or turns, and a distal end. The guide wire further includes a radiopaque marker at the core or at the end. Preferably, the support guide wire 141 is rigid or super-rigid and has a distal end that is more flexible and untapered. Its length is preferably 180 cm and its diameter is 0.889 mm (0.035 inches), but other lengths and diameters are possible, such as a length of 300 cm, a diameter of 0.4572 mm (0.018 inches) or 0.3556 (0.014 inches).

[0067] An intervention device means a medical device used in endovascular surgery. Such a device generally comprises a tubular structure, with or without a lumen, having a diameter generally in the range of 0.2 (0.008 inches) to 3.33 mm (10F) and a relatively large length, for example exceeding 40 cm.

[0068] A set of intervention devices means a set of medical devices useful for performing anastomosis within a blood vessel or an organ. Such a set comprises a transverse device, also called a transverse guide, and a holding device, also called a holding guide.

[0069] The transverse guide is, for example, a transverse guide wire 140, preferably flexible, having a tapered distal end (a "floppy") configured to pierce the wall of a blood vessel or an organ.

[0070] The holding guide is, for example, a balloon stent catheter 146 as shown in FIG. 6. Such a guide includes a stent 142 preloaded in an introducer device 143 that cooperates with a support guide wire 141.

[0071] The stent 142 corresponds to a spring having a tubular shape with open ends and can be expanded when pressure / tension is applied thereto. The "expanded shape" means the shape taken by the stent 142 when it is expanded. Preferably, the diameter of the stent, i.e., the diameter of the stent in its expanded shape, is 1 mm larger than the diameter selected for the first tube 10. For example, if the first tube 10 has a diameter equal to 10F (3.33 mm), the stent has a diameter of 4.33 mm.

[0072] In this expanded shape, the stent 142 is a tube that extends from the first tube 10 at the upstream opening 13, i.e., extends from the first tube 10 adjacent to the upstream opening 13.

[0073] The stent 142 is a covered stent, i.e., its surface does not allow blood to pass through.

[0074] The stent 142 is made of laser-cut metal or from pre-welded modules. The metal is preferably a chromium-cobalt alloy, but may also be steel or a nickel-titanium alloy. Thus, the stent 142 has good visibility under fluoroscopic examination (X-ray), good deformation resistance, strong radial force, and good elongation accuracy.

[0075] The stent 142 is pre-loaded at the distal end of an introducer 143 such as a catheter. The catheter is a tubular structure inserted over a support guide wire 141. In this way, the tubular structure and the support guide wire 141 are coaxially arranged, i.e., the fixed support guide wire 141 serves as a guide or rail for guiding the catheter 143 that is movable along the support guide wire 142.

[0076] Furthermore, the stent 142 is expanded using a release device. Referring to FIG. 7 showing the distal portion of the holding guide 146, this release device is, for example, a balloon 144 attached inside the stent and connected via a small tube incorporated in an introducer (not shown), the small tube being connected to an air injector (not shown) on the opposite side of the balloon. The balloon 144 is inflated to expand the stent 142 and keep the stent in its expanded shape. The balloon 144 is then contracted and removed together with the introducer 143. Another release device may be a self-expanding stent 145 as shown in FIG. 8.

[0077] Each intervention instrument is introduced through the inlet 101 of the second tube 100 and carried through the device along the guide path formed by the support guide wire 141.

[0078] The intervention instrument is movable through the device. In other words, it can slide within the device based on the actions of the operator. The instrument may also extend axially beyond the opening 13, i.e., along the longitudinal axis X1 of the first tube 10.

[0079] Preferably, only one intervention instrument is used at a time. Thus, the catheter 143 is slid over the holding guide 146, after which the holding guide 146 is removed and the stent 142 remains in its expanded shape after removal of the introducer 143 and the balloon 144.

[0080] The device 1 further comprises a ligation device 150 disposed around the first tube 10 downstream of the communication area between the first tube and the second tube 120. This ligation device comprises a ligation element 151 that cooperates with a tightening mechanism 152 that enables the ligation element to be tightened or released. The ligation element is, for example, a ligation clip 151 disposed around the first tube 10, and the tightening mechanism is, for example, a ligation screw 152 that acts on the ligation clip. By means of the tightening mechanism, the ligation device takes two positions, namely, a first tightened position shown in FIG. 2 in which the first tube is 100% ligated and closed with a clip, or a second loose position (FIG. 1) in which the first tube 10 remains open.

[0081] Here, the device 1 will be described from a functional perspective.

[0082] The anastomosis is performed at the upstream opening 13 of the first tube 10 of the device 1, which is in contact with the wall of a blood vessel or an organ.

[0083] Thus, the first tube 10 is inserted into a prosthesis, i.e., a synthetic / artificial substitute that functions as a duct or extension of this blood vessel or organ and becomes a component of the prosthesis.

[0084] The second tube 100 serves to carry the intervention instruments, which enables the execution of an anastomosis procedure 300 including anastomosis treatments 301 to 306 shown in the diagram of FIG. 3. Treatments 302, 303, 304 and 306 are shown in FIGS. 4, 5, 6 and 9 in particular. In these figures, the device is anastomosed within the blood vessel shown by its wall 401 and its internal region 402.

[0085] These treatments relate to positioning the device 1, puncturing the wall of the blood vessel or organ, expanding the puncture, and holding the device 1 in communication with the blood vessel or organ. The holding treatment includes holding the dimensions of the opening in the wall, holding the seal of the connection, and holding both structures (the blood vessel or organ and the device 1) together.

[0086] In the first treatment 301, the device 1 is carried by a surgical approach to the peripheral wall 401a of the blood vessel or organ. The support guide wire 141 enables the device 1 to be accurately positioned at the anastomosis site by microscopic control. For this purpose, the support guide wire 141 is pre-introduced through the inlet 101 of the second tube 100 and carried through the device 1 until it contacts the peripheral wall 401a of the blood vessel or organ.

[0087] In the second treatment 302 shown in FIG. 4, the first tube 10 is sutured to the wall 401 of the blood vessel 402 by the thread 400. More precisely, the first tube 10 is sutured around its upstream opening 13. Thus, a first seal is achieved between the device 1 and the blood vessel without forming an opening in the wall of said blood vessel 401.

[0088] In the third procedure 303 shown in FIG. 5, the transverse guide wire 140 is introduced into the device through the inlet 101 of the second tube 100 and carried along the support guide wire 141 onto the wall 401a of the blood vessel through the upstream opening 13 of the first tube 10. An opening having a diameter of less than 0.3 mm is formed through the wall 401 of the blood vessel by a screw (not shown) and the tapered end of the transverse guide wire 140. Then, the blood from the blood vessel is carried to the first tube 10 and the second tube 100. However, thanks to the valve 120, the blood does not flow back from the second tube 100, and thanks to the ligation device 140 pre - arranged in the first arrangement at the clamping position, the blood does not flow out from the first tube 10 either. Therefore, the valve 120 and the clamping device 140 make it possible to prevent blood loss without the need to stop the blood circulation in the blood vessel or organ upstream of the anastomosis site.

[0089] In the fourth procedure 304, the transverse guide wire is withdrawn from the device 1 through the inlet 101 of the second tube 100, and the stent 142 is expanded within the wall opening under the guidance of the support guide wire 141. More precisely, referring to FIG. 6, the stent 142 is expanded at the junction 500 between the first tube 10 and the blood vessel or organ within the wall 401. The stent 142 thus expanded abuts against a part of the wall 401 of the blood vessel or organ, leaving a cylindrical circulation lumen without turbulent flow and thus non - thrombogenic. Further, after being withdrawn from the introducer 143, the opening diameter is maintained at a predetermined opening equal to the diameter of the first tube 10 plus 1 mm. In other words, the stent 142 forms a sealed duct between the blood vessel or organ and the device 1, and this duct also has good stability and retention force regardless of the movement of the human body or the movement associated with the handling of the device 1.

[0090] Therefore, the stent 142 makes it possible to further reduce the risk of blood leakage. Furthermore, it makes the anastomosis quick, accurate, reliable and reproducible.

[0091] The stent 142 enables internal anastomosis to be performed within a blood vessel. In fact, the connection is made from the inside of the blood vessel 402.

[0092] In the fifth procedure 305, the downstream opening 14 of the first tube 10 is anastomosed in the same manner as in procedures 301 to 304. Thus, both the upstream opening 13 and the downstream opening 14 of the first tube 10 are anastomosed within the blood vessels 402 and 502, respectively. The downstream opening 14 of the first tube may be connected to a circulatory device, such as a blood pump.

[0093] In the sixth procedure 306 shown in FIG. 9, the ligation device is in the second arrangement and blood is circulating freely within the first tube 10.

[0094] Procedures 301 to 306 are carried out rapidly in about a few minutes. Thus, the device 1 avoids relying on clamps.

[0095] FIGS. 10 and 11 show two applications of the anastomosis device 1.

[0096] Referring to FIG. 10, the first application consists of a bypass, for example a bypass of the aorta 402, aimed at replacing the diseased section 403 with the first tube 10 of the device 1. The diseased section 403 is, for example, an aortic aneurysm.

[0097] Referring to FIG. 11, the second application consists of an anastomosis of the left atrium 602 of the heart to improve the unloading blood pump device 4 for treating heart failure. The device 1 is then used as an alternative to the suction cannula, making access to the heart much less risky.

[0098] More precisely, the unloading blood pump device 4 is attached to unload blood from the left atrium 602 to the left subclavian artery 3.

[0099] In addition to the device 1, the unloading blood pump device 4 includes a reinfusion cannula 41 and an unloading blood pump 40, and in this example, a ligation member, in this case a second clip 42 that can be replaced with a wire rope. The blood pump 40 includes an inlet port 43 connected to the downstream opening 14 (see FIG. 1 for example) of the device 1, and an outlet port 44 connected to the inlet end 45 of the reinfusion cannula 41. The upstream opening 13 of the device 1 is located in the left atrium 602, and the reinfusion cannula 43 includes a reflux end 46 on the opposite side of the inlet end 45 located in the left subclavian artery 3 in this example. The second clip 42 is clipped to the left subclavian artery upstream of the reflux end 46 to ligate the artery. The second clip 42 or the wire rope can be adapted to ligate 85% to 100% of the left subclavian artery.

[0100] Therefore, the unloading blood pump 40 enables blood to be sucked from the left atrium 602 through the upstream opening 13 of the device 1 and discharged into the subclavian artery 3 through the reflux end 46 of the reinfusion cannula 41.

[0101] In a further development of the first embodiment shown in FIG. 14, the device 1 includes a stent 142 including a mounting device 147, and a third tube 160 called an "inner tube" since it is inserted inside the device 1. This third tube 160 is introduced through the inlet 101 of the second tube 100 and follows the guide path formed by the support guide wire 141 to be carried inside a blood vessel or an organ.

[0102] In this development, the diameter of the first tube (10) is preferably 6F (2 mm), 8F (2.67 mm), 10F (3.33 mm), 12F (4 mm), 14F (4.67 mm), 16F (5.33 mm), the diameter of the second tube is preferably 6F or 8F, and the diameter of the stent is preferably 1 mm larger than the diameter of the first tube (10).

[0103] This development also finds a particularly advantageous application in the atrial septum 601, which is the wall separating the left atrium 601 from the right atrium 601 of the heart.

[0104] Figure 15 shows an apparatus 1 used for such an application. The third tube 160 enables blood from the left atrium 602 to be circulated to the unloading blood pump 4 via the right atrium 603. The mounting device 147 provides a mounting point for the apparatus 1 on the wall of the atrial septum 601 and enables improvement of the holding stability even in the presence of heart movements.

[0105] According to the present invention, an unloading blood pump can be introduced into the body of a patient under the collarbone. This approach is much less invasive than the thoracotomy required to directly implant the unloading pump into the left atrium of the heart.

[0106] In the second embodiment shown in FIG. 12, the first tube 10 includes a straight portion 10a and a branch portion 10b, and the branch is arranged downstream of the clamping device 150. In other words, the first tube 10 is divided into two tubes 15, 16 having equal diameters at the branch portion 10b, and in this case, the diameter is equal to half of the diameter of the first tube 10 in its straight portion 10a.

[0107] In a development of this second embodiment shown in FIG. 13, the first tube further comprises four side branches 17, 18, 19, 20 in the form of four tubes with a diameter of 6F (2 mm) or 8F (2.67 mm) extending from the side surface 11 to the tributary inlets 21, 22, 23 and 24. The tributaries are spaced axially or circumferentially at the side surface 11 of the first tube 10. Preferably, three tributaries 17, 18, 19 are spaced along the axial direction, and one tributary 20 is spaced circumferentially so as to face the three tributaries.

[0108] This second embodiment has found application for the anastomosis of the aorta in supra-renal pathologies. Indeed, this configuration advantageously enables rapid anastomosis with the four main aortas (renal arteries and mesenteric arteries) supplying the kidneys and the liver at the inlets of the side branches. The apparatus 1 avoids clamps or shortens the time to a few minutes (i.e., about 5 minutes), makes the procedure easier, and is thus applicable to elderly or frail patients.

[0109] Regardless of the embodiment, the anastomosis device 1 is implanted in the patient by means of a so-called "hybrid" route, based on conventional surgery and combining the advantages of internal anastomosis without clamps. In other words, the device 1 makes it possible to take maximum care with respect to the vessel wall without clamps while ensuring a better seal at the end of the prosthesis. The purpose of the device 1 is to achieve a less invasive surgical procedure adapted to fragile patients, which is also safer, provides better intraoperative results and, in the longer term, results in a shorter length of stay in intensive care, less pain and faster recovery compared to state-of-the-art anastomosis devices.

Claims

1. An anastomosis device (1), wherein the device is - A first tube (10) having a longitudinal axis (X1), a side surface (11), an upstream opening (13), and a downstream opening (14), - At least one second tube (10) extending from the side surface (11) of the first tube (10) to the inlet (101) of the second tube (100), and communicating with the first tube (10) by passing through while sealing the side surface (11), wherein the area of ​​the side surface (11) through which the second tube (100) passes defines a communication area (120) between the first tube and the second tube. - A valve (130) attached to the second tube (100), and - A ligation device (150) positioned around the first tube (10) downstream of the communication area (120) between the first tube (10) and the second tube (100), wherein the ligation device (150) has a first arrangement or a second arrangement, the first arrangement closing the first tube (10) and the second arrangement leaving the first tube (10) open. An anastomosis device (1) characterized by comprising:

2. The apparatus (1) according to claim 1, comprising a support guide wire (141) that extends from the inlet (101) of the second tube (10) to the upstream opening (13) of the first tube (10) by passing through a valve (130), wherein the support guide wire (141) forms a guide path.

3. The apparatus (1) according to claim 2, further comprising at least one interventional instrument selected from a set of interventional instruments comprising a transverse guide (140) adapted for puncturing the wall of a blood vessel or organ and a retaining guide (146) adapted for forming a junction between a first tube (10) and a region of a blood vessel or organ, wherein each interventional instrument is configured to follow a guide path.

4. The apparatus (1) according to claim 3, wherein the retaining guide (146) cooperates with a support guide wire (141) and comprises a stent (142), the stent (142) being covered and having an expanded shape having a diameter greater than the diameter of the first tube (10), the expanded shape extending from the upstream end (13) of the first tube (10).

5. The apparatus (1) according to claim 4, wherein the stent (142) is a covered balloon stent.

6. The apparatus (1) according to claim 4, characterized in that a third tube (160) follows a guide path and passes through the apparatus (1), and a stent (142) further comprises an attachment device (147).

7. The apparatus (1) according to claim 6, wherein the mounting device (147) is another stent.

8. Apparatus (1) according to any one of claims 1 to 7, wherein the first tube (10) includes a branch to two tubes (15, 16), the branch forming a straight portion (10a) and a branch portion (10b) on the first tube (10), the branch being positioned downstream of the ligation device (150) such that the straight portion (10a) of the first tube is upstream of the ligation device (150) and the branch portion (10b) is downstream of the ligation device (150).

9. The apparatus (1) according to claim 8, wherein the branch portion (10b) of the first tube (10) communicates with at least one fourth tube (17), and the fourth tube (17) extends between the side surface (11) of the branch portion (10b) of the first tube and the inlet (21) of the fourth tube.

10. The ligation device (1) according to any one of claims 1 to 7, wherein the ligation device (150) is a ligation clip (151) arranged around the first tube (10), and the ligation clip (151) is provided with a ligation screw (152).

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