Catheter system for implanting medical implant to form medical bypass connection

Abstract

A catheter system (1) for implanting a medical implant (2) to form a medical bypass connection on a blood vessel or between a first blood vessel and a second blood vessel comprises a medical implant (2) having a first end (20), a second end (21) and a body (22) forming a flow cavity (220). The catheter shaft (11) defines a lumen (110) and has a distal end (111) in which the medical implant (2) in a delivery state is received such that a first end (20) of the medical implant (2) is received near the distal end (111) of the catheter shaft (11) and a second end (21) is arranged proximal to the first end (20), wherein the catheter shaft (11) is configured to move towards a vessel wall (W) to place the first end (20) of the medical implant (2) on the vessel wall (W). An actuation catheter (12) is received in the lumen (110) and has a tip (120) operably connected to the second end (21) of the medical implant (2), where the actuation catheter (12) is movable relative to the catheter shaft (11) to approach the second end (21) of the medical implant (2) towards the first end (20) of the medical implant (2), the tip (120) being configured to penetrate a vessel wall (W), to move the second end (21) of the medical implant (2) through the vessel wall (W).

Description

Technical Field

[0001] The present invention relates to a catheter system for implanting a medical implant to form a medical bypass connection on a blood vessel or between a first blood vessel and a second blood vessel, and to a method for operating a catheter system for implanting a medical implant. Background Art

[0002] The catheter system includes a catheter shaft defining a lumen and having a distal end. A medical implant in a delivery state is received in the lumen such that a first end of the medical implant is received near the distal end of the catheter shaft and a second end of the medical implant is disposed proximally relative to the first end.

[0003] In order to provide treatment for coronary heart disease (CHD for short), it may be necessary to form a bypass on the coronary artery to overcome the blockage in the coronary artery and ensure adequate blood flow through the coronary artery, especially in cases where treatment by angioplasty is not easily achieved. While in angioplasty procedures, stents are placed in the narrowed portion of the coronary artery to improve blood flow in the coronary artery, bypasses on the coronary artery are usually formed by open heart surgery. To form the bypass, a healthy blood vessel is usually obtained from another part of the patient's body (such as the patient's leg) in order to connect the blocked portion of the coronary artery to, for example, the aorta to allow blood to flow in the coronary artery.

[0004] Because open heart surgery is stressful for the patient and requires a considerable recovery time span, it would be desirable to be able to provide a bypass connection on or between different blood vessels in a minimally invasive manner, for example to provide treatment for coronary artery disease.

[0005] Furthermore, it would be desirable to be able to prepare a medical implant for forming a bypass connection prior to the actual surgery, such that a harvesting operation for obtaining a healthy blood vessel from another part of the patient prior to the actual implantation surgery is unnecessary.

[0006] US2016 / 0213462 A1 describes a system and method for performing a transcatheter coronary artery bypass graft procedure, which involves passing a graft from the aorta through the pericardial space to the coronary arteries. To this end, a pullout wire, a coring device, and a device for forming anastomoses at the proximal and distal ends of the vascular graft are used. Summary of the invention

[0007] It is an object of the present invention to provide a catheter system and a method for operating a catheter system which allow the formation of a medical bypass connection using a medical implant in an easy, minimally invasive manner.

[0008] In one aspect, a catheter system for implanting a medical implant to form a medical bypass connection on a blood vessel or between a first blood vessel and a second blood vessel includes a medical implant having a first end, a second end, and a body forming a flow chamber. The catheter system also includes: a catheter shaft, the catheter shaft defining an inner cavity and having a distal end, the medical implant in a delivery state is received in the inner cavity, so that the first end of the medical implant is received near the distal end of the catheter shaft, and the second end is arranged proximally relative to the first end, wherein the catheter shaft is configured to move toward the blood vessel wall to place the first end of the medical implant on the blood vessel wall. In addition, the catheter system includes: an actuating catheter, the actuating catheter is received in the inner cavity and has a tip operably connected to the second end of the medical implant, wherein the actuating catheter can be moved relative to the catheter shaft to approach the second end of the medical implant toward the first end of the medical implant, and the tip is configured to penetrate the blood vessel wall to move the second end of the medical implant through the blood vessel wall.

[0009] The catheter system includes a catheter shaft, a medical implant and an actuating catheter. The medical implant in a delivery state is received in the inner cavity of the catheter shaft. In addition, the actuating catheter is received in the inner cavity of the catheter shaft. In the delivery state, the first end of the medical implant is placed near the distal end of the catheter shaft, and the actuating catheter with a tip is connected to the second end of the medical implant so that the actuating catheter can act on the medical implant at the second end.

[0010] During the implantation process, the catheter shaft is inserted into the patient with its distal end and moved within the patient toward a starting location in a blood vessel, such as within the aortic arch. During delivery toward the starting location, the medical implant is received within the catheter shaft, wherein the first end of the medical implant is placed at or near the distal end of the catheter shaft.

[0011] To achieve the actual implantation, the catheter shaft in which the medical implant is received is placed with its distal end on the vessel wall, for example the aorta wall in the aortic arch. By placing the distal end of the catheter shaft on the vessel wall, the first end of the implant is arranged on the vessel wall and is held on the vessel wall during the subsequent placement of the medical implant.

[0012] In order to form a bypass, now, the actuating catheter is actuated so that the actuating catheter moves within the lumen of the catheter shaft so that the actuating catheter acts on the medical implant at the second end of the medical implant. The second end in the delivery state is placed proximally relative to the first end of the medical implant. By actuating the actuating catheter, the second end is brought close to the first end of the medical implant, and thereby the tip of the actuating catheter is brought close to and penetrates the vessel wall, so that the second end of the medical implant moves through the vessel wall, for example, into the pericardial space beyond the aortic wall.

[0013] By guiding the actuation catheter toward the target location and by arranging the second end of the medical implant at the target location, for example at a different location in the same blood vessel or on another blood vessel, the medical implant and its body are extended between the starting location and the target location, so that a medical bypass connection is formed between the starting location and the target location.

[0014] The implantation procedure can be performed in a minimally invasive manner, for example, by inserting a catheter system into an artery in the patient's groin to gain vascular access. The implantation procedure can be performed while the heart is beating and during regular cardiac activity, thereby minimizing stress on the patient and significantly reducing the patient's recovery time.

[0015] The catheter system can be prepared in advance and can be delivered to a healthcare facility in a prefabricated state. Thus, it is no longer necessary to obtain a bypass from a patient's healthy blood vessel prior to surgery, but the medical implant can be prefabricated and delivered with the catheter system.

[0016] In order to be able to control the movement of the actuating catheter, the actuating catheter can be implemented by a steerable catheter. In particular, with the help of a steerable catheter, the target location can be reached by guiding the actuating catheter through the space outside the blood vessel wall in a controlled manner, for example under X-ray guidance and / or by using a sensor on the tip of the actuating catheter.

[0017] Instead of using a steerable catheter, an auxiliary catheter may be inserted into the blood vessel at the target location, the auxiliary catheter providing a marker of the target location.

[0018] When a medical implant is implanted using a catheter system, the first end of the medical implant is placed on the vessel wall at a starting position, and when the medical implant is moved toward a target position, the first end of the medical implant should remain on the vessel wall. To this end, in one embodiment, the medical implant includes a first fixture arranged at the first end for anchoring the first end to the vessel wall. By means of the first fixture, a fixed connection between the medical implant and the vessel wall can be established at the first end, so that after the first end of the medical implant is placed on the vessel wall, the second end of the medical implant can be moved through the vessel wall and can be approached toward the target position to form a bypass connection. In particular, the fixture is configured to permanently fix the first end of the medical implant to the vessel wall.

[0019] In one embodiment, the first fixture comprises one or more tines arranged at the first end. The one or more tines may be made, for example, of a shape memory alloy, such as a nickel-titanium alloy, in particular nitinol, a nickel-titanium-copper alloy, a copper-zinc alloy, a copper-zinc-aluminum alloy, a copper-aluminum-nickel alloy, an iron-nickel-aluminum alloy, an iron-manganese-silicon alloy, or a zinc-gold-copper alloy. When the distal end of the catheter shaft is placed on the vessel wall, the first fixture at the first end of the medical implant is engaged with tissue at the vessel wall, and the one or more tines, for example, pierce the vessel wall, so that a fixed connection is formed between the medical implant and the vessel wall at the first end of the medical implant.

[0020] In one embodiment, the catheter system includes a sheath configured to sheath the first fixture in a delivery state. By means of the sheath, the first fixture, for example formed by one or more tines, is prevented from engaging with tissue when the catheter system is moved toward a starting position within the patient's vascular system. The sheath provides coverage of the first fixture during delivery, wherein by moving the sheath relative to the catheter shaft, the first fixture is unsheathed so that the first fixture can engage with tissue at the starting position.

[0021] In the sheathed position, the first fixation means is held within the sheath, for example in a deformed position. By moving the sheath relative to the catheter shaft, the first fixation means is released so that the first fixation means, for example formed by one or more tines, can be reset to a non-deformed state and thereby can engage with tissue and can form a fixed connection with the tissue at a starting position on the vessel wall.

[0022] The sheath may in particular be formed by an outer shaft extending outside the catheter shaft.The sheath may be longitudinally movable along the catheter shaft in order to disengage the first fixation means of the medical implant.

[0023] In one embodiment, the medical implant comprises a sealing device arranged at the first end to establish a seal between the first end and the vessel wall. The seal can be, for example, made of an elastic plastic material and / or can be configured to expand during implantation. By sealing, a substantially fluid-tight connection should be formed between the first end of the medical implant and the vessel wall so that during the implantation process, the fluid does not leave the vessel through the through hole punched into the vessel wall by the tip of the actuating catheter.

[0024] In one embodiment, the medical implant comprises a second fixing device arranged at the second end for anchoring the second end to tissue at the target location.Thus, by means of the second fixing device, the medical implant is fixedly connected to the target location beyond the obstacle on the same or another blood vessel.

[0025] The second fixing means may for example be formed by a magnetic element for magnetically interacting with a counter element at the target location. In another embodiment, the second fixing means may comprise an arrangement of tines or the like. Alternatively, the fixing means may comprise a screw or a screw.

[0026] The magnet element and / or the counter element can be formed, for example, by an annular magnet. For example, the counter element can be moved to the target position by using an auxiliary catheter, which can also help guide the actuating catheter toward the target position and establish a connection between the second end of the medical implant and the blood vessel portion at the target position.

[0027] By moving the actuating catheter through the blood vessel wall at the starting position and through the space beyond the blood vessel wall toward the target position, the medical implant is inserted into the space beyond the blood vessel wall and guided toward the target position to form a medical bypass connection between the starting position and the target position. Here, in the implanted state, in one embodiment, the body of the medical implant extends between the blood vessel wall at the starting position and the target position on the same blood vessel or another blood vessel to form the medical bypass connection. By means of the body and the flow cavity formed in the body, a fluid connection is established between the blood vessel at the starting position and the blood vessel at the target position, and the fluid can flow through the body in the implanted state of the medical implant.

[0028] In one embodiment, the main body is configured to flip from inside to outside when the actuating catheter is moved relative to the catheter shaft so that the second end of the medical implant approaches the first end of the medical implant and the second end of the medical implant moves through the blood vessel wall. In the delivery state, when the catheter system is moved through the patient's vascular system toward the starting position, the medical implant is received in the lumen of the catheter shaft so that the first end of the medical implant is placed at the distal end of the catheter shaft, and the second end of the medical implant is received at the proximal side relative to the first end. The actuating catheter herein is operably connected to the medical implant at its second end so that the medical implant is approached to the first end with its second end by actuating the actuating catheter. By means of the tip of the actuating catheter, the blood vessel wall is penetrated, and by moving the actuating catheter through the blood vessel wall, the second end of the medical implant also moves through the blood vessel wall, and the first end of the medical implant remains on the blood vessel wall, particularly on the side of the blood vessel wall facing the inside of the corresponding blood vessel (e.g., aorta). During the actuation movement of the actuation catheter, the medical implant is turned inside out, and the second end of the medical implant is moved toward the first end and beyond the first end through the vessel wall toward the target location into the space beyond the vessel wall.

[0029] By this movement, the implantation operation becomes easy and reliable. That is, during the implantation operation, the first end of the medical implant is fixed to the vessel wall, which can be achieved simply by placing the distal end of the catheter shaft on the vessel wall and by disengaging the fixing device arranged on the first end of the medical implant. Therefore, first, the first end of the medical implant is fixed to the vessel wall at the starting position and remains fixed during the further operation, wherein, after the first end of the medical implant is fixed to the vessel wall, the second end is brought close to the target position and in this way the medical implant is turned from the inside out. Therefore, by actuating the actuating catheter, the medical implant moves toward the target position with the second end and is fixed at the target position with the second end so that the body of the medical implant extends between the starting position and the target position.

[0030] When the actuating catheter is actuated, the tip of the actuating catheter approaches the distal end of the catheter shaft and causes it to penetrate the vessel wall at the starting position. To achieve easy penetration, herein, in one embodiment, the actuating catheter includes a cutting edge at the tip for cutting into the vessel wall and forming a through hole through the vessel wall at the starting position.

[0031] In one embodiment, the body of the medical implant is made of pericardial material. For example, the medical implant can be formed by a tubular member formed from pericardial material. The pericardial material can, for example, be rolled up to form a tubular member, wherein the pericardial material can be fixed by means of gluing, suturing or cross-linking to form a tubular structure. Particularly suitable pericardial materials and methods for making the same are disclosed in PCT / EP2021 / 080039 filed on October 28, 2021.

[0032] Generally, all of the above-mentioned suitable pericardial tissue must be thoroughly cleaned and prepared before implantation. As much as possible, the tissue is modified in such a way that it is not recognized as foreign tissue by the body, has as little calcification as possible, and has as long a service life as possible. Basically, this method of preparing tissue includes several steps:

[0033] A possible preparation step is so-called tissue decellularization. In this step, cell membranes, intracellular proteins, cell nuclei and other cell components are almost completely removed from the tissue to obtain a roughly pure extracellular matrix. The cells and cell components retained in the tissue represent the possible causes of the undesirable calcification of the bioimplant material in particular. Decellularization should be carried out so gently that the structure of the extracellular matrix, in particular the collagen fibers in the extracellular matrix remain as unaffected as possible, and on the other hand, all cells and cell components contained therein are removed from the tissue as completely as possible.

[0034] Preferably, the tissue is subjected to a pretreatment comprising optional decellularization with a suitable detergent, preferably with a solution containing surfactin and deoxycholic acid. Decellularization can also be performed in other ways, for example, by cell lysis or by osmotic digestion.

[0035] After decellularization, as many cellular components as possible are removed from the tissue and the biomaterial consists only of the extracellular matrix. In pericardial tissue, the extracellular matrix is ​​mainly formed by collagen fibers. In order to achieve a biomaterial with the best possible mechanical properties and to prevent defense reactions of the receiving body, in the prior art, these collagen fibers are crosslinked by bonding chemical bonds with the aid of suitable crosslinking agents.

[0036] In one embodiment, the body of the medical implant is made of ultrathin pericardial tissue. The term "ultrathin tissue" means that the processed tissue has a thickness uniformity characterized by a substantially constant thickness of the tissue, preferably less than 40% of the starting tissue thickness (with a tolerance range of ±5 μm for measurement error), or a thickness of the tissue less than 80 μm, preferably between 80 and 20 μm or between 25 μm and 20 μm.

[0037] Typically, the normal remaining thickness of pericardial tissue is 120%-40% of the initial thickness. In the case of free crosslinking on the mesh (the pericardium thickens during free crosslinking with glutaraldehyde), the thickness increases even by 120%. For a standard UTT patch, the thickness reduction is already 40%. However, any mark below this is a very thin patch, where 10% of the initial thickness would be the absolute lower limit. The absolute minimum for porcine pericardial tissue is, for example, 20 μm thickness.

[0038] The above-mentioned adjustment of tissue properties (such as thickness in particular, but also shape and / or flexibility) is achieved by chemical crosslinking and optionally forming using a permeable material layer (preferably made of industrial fabric), optionally in combination with a (continuous) pressure load on the tissue, and using an added pressure compensation layer (e.g., also a permeable compressible foam, or an impermeable elastomer pad / silicone pad). Therefore, the pressure compensation layer can be permeable, but not necessarily permeable. It is essential for the crosslinking solution to enter the tissue and for the drainage of tissue water to add a permeable material layer, for example, actually only one or at least two or even more permeable material layers, preferably made of industrial fabric. At least one, preferably two permeable material layers can be an organic polymer layer, preferably a polyester layer. At least one, preferably two permeable material layers have a mesh size or aperture that enables the crosslinking solution to pass through the permeable material layer. This enables the tissue to be fully in contact with the crosslinking solution that passes through the permeable material layer. At least one, preferably two permeable material layers can have a mesh size or aperture that is less than 60 μm, preferably in the range of 10 μm to 60 μm. Mesh sizes or pore sizes less than 60 μm result in a uniform tissue surface. Mesh sizes or pore sizes greater than 60 μm result in a non-uniform tissue surface, so that the imprinted structure on the biological tissue surface can be visible to the naked eye. However, if necessary, i.e. whenever it is desired to imprint a technically functional surface on the tissue to be treated, such as a roughening of the surface or a specific depression in the surface, etc., a mesh size or pore size greater than 60 μm can be used to imprint a structure on the surface of the biological tissue. At least one, preferably two, permeable material layers can have a thickness of 40 μm to 70 μm. Preferably, the tissue is sandwiched between two permeable material layers.

[0039] Further details on the properties and methods of manufacturing ultrathin tissues can be found in PCT / EP2021 / 080039, in particular page 28, line 1 to page 32, line 9.

[0040] In one embodiment, the body of the medical implant is made of pericardial tissue, which is formed by using at least one, in particular a single, rigid molded body in combination with a suitable crosslinking agent (e.g. glutaraldehyde) and particles. The rigid molded body serves only as a support surface and, if necessary, for shaping the tissue / tissue components, while the particles mechanically fix the tissue to be formed to the molded body during a chemical crosslinking process and can be penetrated by the crosslinking solution (e.g. glutaraldehyde). Further details of the properties and manufacturing methods can be found in particular in PCT / EP2021 / 080039, in particular on page 68, line 20 to page 73, line 25.

[0041] In one embodiment, the body of the medical implant is made by seamlessly connecting pericardial tissue. For this process, the starting tissue must be introduced into a process that is essentially non-crosslinked at least in the overlapping area (i.e., the tissue area to be joined / connected, but preferably in its entirety); that is, if possible, no substantial pre-crosslinking occurs, for example by a glutaraldehyde solution. Throughout the application, essentially non-crosslinked tissue refers to a tissue to be treated with a proportion of crosslinkable groups (compared to non-crosslinkable groups) greater than 50%, preferably greater than 60%, even more preferably greater than 80%, and most preferably greater than 90%. However, this also means that slightly or only slightly pre-crosslinked or partially crosslinked tissue is suitable for the method of the first aspect of the present invention. However, this also means that slightly or only slightly pre-crosslinked or partially crosslinked tissue is suitable for this process.

[0042] The process particularly involves chemically crosslinking tissue joining partners containing crosslinkable groups (e.g. free amino groups) in defined overlapping areas by suitable crosslinking agents under static, quasi-static and periodic pulse pressure loads, respectively, for seamless, dense and strong material closure. As a result, a seamless, uniform and at the same time mechanically stable connection / joining of tissues / tissue components is achieved. Further details of the above method can be found in particular in PCT / EP2021 / 080039, in particular on page 129, line 11 to page 132, line 14. Advantageously, the tissues described therein can be seamlessly joined so as to form the body of the medical device by crosslinking (e.g. with glutaraldehyde, etc.).

[0043] In one embodiment, the body of the medical implant is made from stabilized, dried pericardial tissue, particularly involving treatment of the tissue with a moisture-absorbing exchange material and subsequent controlled drying.

[0044] In order to achieve that the structure of the tissue remains dry, i.e. maintains / stabilizes, a hygroscopic exchange material is used (e.g. glycerol and / or polyethylene glycol, if necessary, as a mixture), which stabilizes the collagen structure when water is removed. In this way, rehydration makes it possible to restore the tissue to its original state.

[0045] Further details of the method for producing stable dried pericardial tissue can be found in PCT / EP2021 / 080039, in particular on page 171, line 28 to page 172, line 23 and page 178, lines 1 to 180.

[0046] The fixation means, such as tines or magnetic elements, may be fixed to the body of the medical implant at the first end and the second end by suturing, gluing or by a press-fit connection.

[0047] Medical implants may be coated with pharmaceutical substances, for example to counteract the risk of thrombosis.

[0048] The medical implant may include a reinforcement structure, such as a stent-like wire structure, for example made of a nickel-titanium alloy material (eg, Nitinol), or made of an electrically braided plastic fabric.

[0049] The catheter system can be used to provide a bypass connection to establish blood flow through the coronary arteries. Likewise, the catheter system can be suitable for establishing a bypass connection between blood vessels in another body region, such as in the urinary tract region.

[0050] On the other hand, a method for operating a catheter system for implanting a medical implant to form a medical bypass connection on a blood vessel or between a first blood vessel and a second blood vessel includes: providing a medical implant, the medical implant having a first end, a second end, and a body forming a flow chamber; providing a catheter shaft, the catheter shaft defining an inner cavity and having a distal end, the medical implant in an initial state being received in the inner cavity so that the first end of the medical implant is received near the distal end of the catheter shaft and the second end is arranged proximally relative to the first end; moving the catheter shaft toward the blood vessel wall to place the first end of the medical implant on the blood vessel wall; and moving an actuating catheter relative to the catheter shaft, the actuating catheter including a tip operably connected to the second end of the medical implant, wherein by moving the actuating catheter, the second end of the medical implant approaches the first end of the medical implant, the tip penetrates the blood vessel wall, and the second end of the medical implant moves through the blood vessel wall.

[0051] The advantages and advantageous embodiments as described above for the catheter system also apply to the method, so that in this respect reference is made to the above description.

[0052] In particular, in one embodiment, in the method, when the actuating catheter is moved relative to the catheter shaft to approach the second end of the medical implant toward the first end of the medical implant and the second end of the medical implant is moved through the blood vessel wall, the body of the medical implant is turned inside out. When the actuating catheter is actuated to approach the medical implant with the second end toward the target position, the first end is maintained on the blood vessel wall at the starting position, so that in the implanted state, the body of the medical implant extends between the starting position and the target position, and thus a flow connection is established between the starting position and the target position. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] The basic idea of ​​the invention will be described in more detail below with reference to the embodiments shown in the accompanying drawings, in which:

[0054] Figure 1 A schematic diagram of a patient's heart is shown;

[0055] Figure 2 A schematic diagram showing an embodiment of a catheter system for establishing a bypass connection;

[0056] Figure 3AThe catheter system is shown in a delivery state;

[0057] Figure 3B The catheter system is shown when the distal end of the catheter shaft is placed on the wall of a blood vessel;

[0058] Figure 3C The catheter system is shown while moving an actuating catheter toward a target location;

[0059] Figure 3D shows the catheter system after reaching a target location and after securing a medical implant at the target location;

[0060] Figure 3E shows a medical implant in an implanted state; and

[0061] Figure 4 Shows Figure 3E An enlarged view of the accompanying drawing. DETAILED DESCRIPTION

[0062] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the accompanying drawings, the same reference numerals denote the same structural elements.

[0063] It should be noted that the embodiments do not limit the present invention but merely represent illustrative examples.

[0064] refer to Figure 1 In coronary heart disease (CHD), there may be a blockage in a coronary artery C of a patient's heart H that prevents adequate blood flow through the patient's heart H's coronary artery system.

[0065] To overcome obstruction in the context of coronary artery disease, it may be desirable to establish a bypass connection B, for example between a starting location (before obstruction) and a target location (beyond obstruction) on coronary artery C, or between aorta A and obstructed coronary artery C, for example within the aortic arch, so that blood can flow between the aorta and coronary artery C.

[0066] Although bypass B is currently typically implanted during an open heart surgery procedure by, for example, harvesting a portion of a healthy blood vessel from the patient's leg and implanting it into the healthy blood vessel to form bypass B, it is desirable to be able to form bypass connection B between different blood vessels or on a single blood vessel to bridge the blockage via minimally invasive surgery, thereby avoiding the undue stress and lengthy recovery time associated with open heart surgery.

[0067] In order to implant a medical implant 2 to form a bypass connection between a starting location and a target location on a blocked blood vessel or between different blood vessels to overcome the blockage, it is proposed herein to use a catheter system 1, such as Figure 2As shown in the embodiment of FIG. 4 , the catheter system 1 can be prefabricated and delivered to a healthcare facility, wherein the medical implant 2 to be implanted is received within the catheter system 1 .

[0068] exist Figure 2 In the embodiment of the present invention, the catheter system 1 includes a catheter shaft 11 forming an inner cavity 110, and in the delivery state, the medical implant 2 is received in the inner cavity 110. The medical implant 2 herein is placed near the distal end 111 of the catheter shaft 11 with a first end 20, and the second end 21 of the medical implant 2 in the delivery state is placed proximally relative to the first end 20.

[0069] At the first end 20 of the medical implant 2, a fixation device 200 is arranged together with a sealing device 201. In the delivery state, the fixation device 200 (realized by an arrangement of flexible tines made of a shape memory alloy, preferably a nickel-titanium alloy, such as Nitinol) is received within a sheath 10, which is arranged outside the catheter shaft 11 and extends circumferentially around the catheter shaft 11.

[0070] The sheath 10 in the delivery state holds the fixation device 200 in a deformed state so that the tines of the fixation device 200 point forward. The sheath 10 is slidably movable relative to the catheter shaft 11 so that the fixation device 200 can be disengaged by retracting the sheath 10 in the proximal direction so that the tines of the fixation device 200 relax toward the non-deformed state to provide fixation of the medical implant 2 on the tissue at the desired position.

[0071] The catheter system 1 further comprises an actuation catheter 12 which is operatively connected to the second end 21 of the medical implant 2 at a tip 120. By actuating the actuation catheter 12, the medical implant 2 may be moved so as to establish a bypass connection between a starting location and a target location.

[0072] The medical implant 2 comprises a body 22 having a tubular shape and defining a flow lumen therein for establishing a bypass connection between a starting location and a target location.

[0073] The medical implant 2 may be made, for example, of pericardial material, which may be rolled up and fixed by gluing or suturing to present a tubular shape, which defines therein (in the implanted state, see Figure 3A and Figure 4 ) flow cavity 220. The fixing device 200 can be fixed to the first end 20 of the medical implant 2, for example, by gluing, suturing or by a press-fit connection. Similarly, the sealing device 201 can be fixed to the first end 20 of the medical implant 2 by gluing, suturing or by a press-fit connection.

[0074] The connection of the actuating catheter 12 to the second end 21 of the medical implant 2 is releasable, the actuating catheter 12 being particularly used to push the second end 21 of the medical implant 2 forward in the distal direction, as will be described later with reference to FIG. 3A to FIG. 3E The order is described in more detail.

[0075] The medical implant 2 may be closed at the first end 20 by a septum 202 which is pierced by the tip 120 of the actuation catheter 12 during the implantation procedure such that a flow path through the medical implant 2 is opened.

[0076] Reference now Figure 3A The catheter system 1 can be prefabricated and delivered to a healthcare facility in a ready-to-use state, for example, to be inserted into a patient's body at the femoral artery to gain vascular access. Figure 3A The catheter system 1 in the state shown is advanced toward a starting position for forming a bypass connection, for example at the aortic arch of a patient's heart H, in order to establish a flow connection between the aorta A and the coronary arteries C, as shown in FIG. Figure 1 Shown schematically.

[0077] At the beginning of the actual implantation procedure, the catheter system 1 is approached in the movement direction M1 towards the vessel wall W, for example the wall of the aorta A at the aortic arch. FIG. 3A to FIG. 3B As can be seen from the transition, by retracting the sheath 10 relative to the catheter shaft 11 in the direction M2 opposite to the direction M1, the fixing device 200 at the first end 20 of the medical implant 2 is disengaged and engaged with the blood vessel wall W, so that the medical implant 2 is anchored on the blood vessel wall W at its first end 20, as shown in FIG. Figure 3B In particular, the fixing device 200 is configured to permanently anchor the medical implant 2 at the first end 20 thereof to the vessel wall W.

[0078] As from Figure 3A It can be seen that in the delivery state, the tines of the fixing device 200 remain in a deformed state within the sheath 10. By retracting the sheath 10 in the direction M2, the tines are relaxed toward a relaxed, non-deformed state. Since the tines of the fixing device 200 are arcuate outward and their free ends point proximally (in the direction M2), the tines engage with the vessel wall W, thereby causing the medical implant 2 to be tensioned toward the vessel wall W and pulling the first end 20 of the medical implant 2 into close proximity with the vessel wall W.

[0079] By placing the medical implant 2 with its first end 20 on the vessel wall W, the sealing device 201 also rests on the vessel wall W in order to provide a seal between the medical implant 2 and the vessel wall W at the first end 20 .

[0080] After the medical implant 2 is placed with its first end 20 on the vessel wall W, the actuating catheter 12 is actuated so that the actuating catheter 12 moves toward the vessel wall W along the direction M3 to pierce and penetrate the vessel wall W, as shown in FIG. FIG. 3B to FIG. 3C To this end, the actuating catheter 12 includes a cutting edge at its tip 120, so that the tip 120 can easily cut a through hole in the blood vessel wall W. Because the actuating catheter 12 is operably connected to the second end 21 of the medical implant 2 at its tip 120, when the actuating catheter 12 is moved along the direction M3, the second end 21 of the medical implant 2 is carried, so that the second end 21 of the medical implant 2 approaches the first end 20 and moves through the blood vessel wall W into the space beyond the blood vessel wall W, such as from Figure 3B and Figure 3C The transition between them is visible.

[0081] During the movement of the actuating catheter 12, the medical implant 2 is turned inside out with its body 22. That is, the first end 20 of the medical implant 2 remains on the vessel wall W due to the fixation of the fixation device 200. The second end 21 moves through the first end 20 and through the vessel wall W, and is guided by the actuating catheter 12 toward a target position on another vessel or a different position on the same vessel, such as Figure 3C Visible in.

[0082] During the movement of the actuation catheter 12, the septum 202 (if present at the first end 20 of the medical implant 2) is also pierced, such as from FIG. 3B to FIG. 3C The transition is visible.

[0083] The actuating catheter 12 may be a steerable catheter that can be controlled to approach a target location, for example, by using a sensor. Figure 3C As shown, the auxiliary catheter 3 can be inserted into a corresponding blood vessel at the target location to help guide the actuating catheter 12 toward the target location.

[0084] The auxiliary catheter 3 can, for example, carry a counter element 300 formed by an annular magnet to interact with a fixing device 210 arranged at the second end 21 of the medical implant 2 for providing fixation of the medical implant 2 to the vessel wall of the corresponding blood vessel at the target location, such as Figure 3D shown.

[0085] In particular, the fixing device 210 formed by the annular magnet arranged on the second end 21 of the medical implant 2 can interact magnetically with the opposing element 300, so that the blood vessel wall at the target position is clamped between the magnetic element 210 and the opposing element 300. By further advancing the actuating catheter 12, the blood vessel wall at the target position is penetrated, and a through hole is established at the target position, so that a flow path through the body 22 of the medical implant 2 is opened, and a fluid connection is established between the starting position at the blood vessel wall W and the target position.

[0086] When the catheter shaft 11 is now removed together with the actuation catheter 12 and the sheath 10 , the medical implant 2 remains in place and forms a bypass connection between a starting location and a target location over an occluded vessel or between two different vessels.

[0087] Figure 4 The enlarged view shows Figure 3B In the implanted state, the medical implant 2 is fixed at its first end 20 to the vessel wall W, for example at the aorta A, for example within the range of the aortic arch of the patient's heart H. The first end 20 herein rests on the inner side of the aortic vessel wall W. At the second end 21, the medical implant 2 is fixed to a target position, for example a target position of the coronary artery C. The fixation at the starting position is provided by the tines of the first fixing device 200 at the first end 20 of the medical implant 2, while the fixation at the second end 21 is established by the magnetic element of the fixing device 210, which interacts with the counter element 300 to establish a clamping connection at the target position C.

[0088] The sealing device 201 may be placed at either end 20, 21 of the medical implant 2. The sealing device 201 is particularly used to establish a sealed connection during the implantation surgery and during subsequent operations to avoid leakage of blood through the vessel wall into the pericardial space.

[0089] The basic idea of ​​the invention is not limited to the above-described embodiments, but can be implemented in completely different ways.

[0090] By using the catheter system, a bypass connection can be established between the aortic arch and the coronary arteries or between different locations of a blocked coronary artery. Likewise, the catheter system can be used to establish a bypass connection, for example, in the patient's urethra or in another body region.

[0091] Turning the medical implant inside out during the implantation procedure may be forced by the actuation catheter, wherein the movement of the medical implant may be hydraulically supported, for example by causing a flow of, for example, a saline solution within the catheter system.

[0092] Reference numerals list

[0093] 1. Catheter system

[0094] 10 Sheath

[0095] 11 Catheter shaft

[0096] 110 Inner cavity

[0097] 111 Remote

[0098] 12 Actuation catheter

[0099] 120 Tip

[0100] 2 Implantation Device

[0101] 20 First End

[0102] 200 Fixtures

[0103] 201 Sealing device

[0104] 202 Diaphragm

[0105] 21 Second End

[0106] 210 Fixtures

[0107] 22 Main Body

[0108] 220 flow chamber

[0109] 3 Auxiliary catheter

[0110] 30 End

[0111] 300 Opposed Components

[0112] AAortic arch

[0113] B bypass

[0114] Coronary arteries

[0115] H Heart

[0116] M1-M3 moving direction

[0117] W blood vessel wall.

Claims

1. A catheter system (1) for implanting a medical implant (2) to form a medical bypass connection on a blood vessel or between a first blood vessel and a second blood vessel, comprising: A medical implant (2) having a first end (20), a second end (21) and a body (22) forming a flow cavity (220), a catheter shaft (11) defining an inner cavity (110) and having a distal end (111), wherein the medical implant (2) in a delivery state is received in the inner cavity (110) so that the first end (20) of the medical implant (2) is received near the distal end (111) of the catheter shaft (11) and the second end (21) is arranged proximally relative to the first end (20), wherein the catheter shaft (11) is configured to move toward a blood vessel wall (W) to place the first end (20) of the medical implant (2) on the blood vessel wall (W), and An actuating catheter (12) is received in the inner cavity (110) and has a tip (120) operably connected to the second end (21) of the medical implant (2), wherein the actuating catheter (12) is movable relative to the catheter shaft (11) to move the second end (21) of the medical implant (2) toward the first end (20) of the medical implant (2), and the tip (120) is configured to penetrate the blood vessel wall (W) to move the second end (21) of the medical implant (2) through the blood vessel wall (W).

2. The catheter system (1) according to claim 1, characterized in that The medical implant (2) comprises a first fixing device (200) arranged at the first end (20) for anchoring the first end (20) to the vessel wall (W).

3. The catheter system (1) according to claim 2, characterized in that The first fixation device (200) is formed by at least one tine arranged at the first end (20) and configured to engage with tissue of the vessel wall (W).

4. The catheter system (1) according to claim 2 or 3, characterized in that A sheath (10) is configured to sheath the first fixing device (200) in the delivery state and is movable relative to the catheter shaft (11) to disengage the first fixing device (200), so that the first fixing device (200) engages with the tissue of the blood vessel wall (W).

5. The catheter system (1) according to any one of the preceding claims, characterized in that The medical implant (2) comprises a sealing device (201) arranged at the first end (20) to establish a seal between the first end (20) and the blood vessel wall (W).

6. The catheter system (1) according to claim 5, characterized in that The sealing device (201) is made of a resilient plastic material and / or is configured to expand during implantation.

7. The catheter system (1) according to any one of the preceding claims, characterized in that The medical implant (2) comprises a second fixing device (200) arranged at the second end (21) for anchoring the second end (21) to tissue at a target location.

8. The catheter system (1) according to claim 7, characterized in that The second fixing device (200) comprises a magnetic element for magnetically interacting with a counter element (300) at the target position.

9. The catheter system (1) according to claim 8, characterized in that An auxiliary catheter (3) is capable of approaching the target location and is used to deliver the opposing element (300) to the target location.

10. The catheter system (1) according to any one of claims 7 to 9, characterized in that In an implanted state, the body (22) of the medical implant (2) is configured to extend between the blood vessel wall (W) and the target location to form the medical bypass connection.

11. The catheter system (1) according to any one of the preceding claims, characterized in that The body (22) is configured to flip from the inside out when the actuating catheter (12) is moved relative to the catheter shaft (11) so that the second end (21) of the medical implant (2) approaches the first end (20) of the medical implant (2) and moves the second end (21) of the medical implant (2) through the blood vessel wall (W).

12. The catheter system (1) according to any one of the preceding claims, characterized in that The actuation catheter (12) comprises a cutting edge at the tip (120) for penetrating the vessel wall (W).

13. The catheter system (1) according to any one of the preceding claims, characterized in that The body (22) of the medical implant (2) is made of pericardial material.

14. A method for operating a catheter system (1) for implanting a medical implant (2) to form a medical bypass connection on a blood vessel or between a first blood vessel and a second blood vessel, the method comprising: A medical implant (2) is provided, wherein the medical implant (2) has a first end (20), a second end (21), and a body (22) forming a flow cavity (220); Providing a catheter shaft (11), the catheter shaft defining an inner cavity (110) and having a distal end (111), the medical implant (2) in an initial state being received in the inner cavity (110), such that the first end (20) of the medical implant (2) is received near the distal end (111) of the catheter shaft (11), and the second end (21) is arranged proximally relative to the first end (20); moving the catheter shaft (11) toward a blood vessel wall (W) to place the first end (20) of the medical implant (2) on the blood vessel wall (W); and An actuating catheter (12) is moved relative to the catheter shaft (11), the actuating catheter (12) comprising a tip (120) operably connected to the second end (21) of the medical implant (2), wherein, by moving the actuating catheter (12), the second end (21) of the medical implant (2) approaches the first end (20) of the medical implant (2), the tip (120) penetrates the blood vessel wall (W), and the second end (21) of the medical implant (2) moves through the blood vessel wall (W).

15. The method according to claim 14, characterized in that When the actuating catheter (12) is moved relative to the catheter shaft (11), the main body (22) is rotated from the inside to the outside so that the second end (21) of the medical implant (2) approaches the first end (20) of the medical implant (2) and the second end (21) of the medical implant (2) moves through the blood vessel wall (W).

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