JP2022541107A - implantable vascular access device - Google Patents

Abstract

The present invention is for hemodialysis, permanently implantable in patients with pre-existing arteriovenous fistulas, or alternatively in veins, arteries, or between veins and arteries, to create artificial arteriovenous fistulas. vascular access device, vascular access healing device, and a sterile package containing a disposable blood collection and/or infusion device usable in conjunction with the vascular access device. [Selection drawing] Fig. 7

Description

The present invention relates to the field of hemodialysis devices. In particular, the present invention provides a vascular access device for hemodialysis and a collection and/or infusion system for hemodialysis that can be permanently implanted in a patient with a pre-existing arteriovenous fistula. a sterile package containing a disposable device for withdrawing blood from and/or infusing blood into a patient, usable in combination with a vascular access device for hemodialysis, the present invention comprising both devices; The surgical and hemodialysis methods described herein are advantageously practicable.

Hemodialysis is a treatment that allows extracorporeal circulation of blood to purify the blood in a special hemodialysis machine, which is equipped with a semi-permeable membrane through which only the toxins to be removed ( or at least most of it) is transparent. Patients with severe renal failure are candidates for this treatment. To perform hemodialysis, of course, it is necessary to create vascular access at two points. On the one hand the blood to be purified is withdrawn and on the other hand the filtered blood is reinfused into the circulatory system. The most commonly used vascular access is an arteriovenous fistula (also known as FAV), which is surgically achieved to create a permanent connection between a vein and an artery. It involves dilating the venous portion of the arteriovenous fistula because arterial pressure is much higher than venous pressure. Thus, the two points of vascular access described above can be pre-arranged in the arteriovenous fistula, allowing a relatively high blood flow through and reducing the time required for hemodialysis. Despite this, hemodialysis is a long treatment, actually requiring 3 to 4 hours and must be performed two or three times a week. As a result, arteriovenous fistulas are periodically and frequently subjected to trauma resulting from the insertion of metal needles, known as fistula needles, made of metal and having a diameter of the order of 1.6 mm and a sharp cutting tip. . These needles are inserted into the arteriovenous fistula and may create trauma to the wall portion of the FAV opposite the ostium. Specifically, for venous insertion, the fistula needle is inserted at a first oblique angle to the skin. In order to insert the fistula needle into the FAV, it is necessary to change this inclination and position the needle parallel to the fistula. This is due to the patient's stress, pain and trauma (the only proof for this is the wound), the danger of completely penetrating the FAV from side to side, the individual complexity incurred from the fragility of the vein, and the high potential for infection. give rise to sex and In fact, even when administering local anesthesia, the patient still feels pain once the anesthetic effect wears off. To obviate this, the "buttonhole" method has been developed. This involves inserting a needle at the FAV always at the same two points (harvest and return) with the same angle and depth, with the goal of creating a sort of subcutaneous channel in the scar tissue that extends from the skin surface to the FAV. including doing Through this subcutaneous channel a needle is inserted prior to every hemodialysis session. Special devices have also been created that are inserted into the channel from dialysis session to dialysis session to keep the channel open until the channel is stably formed. It is clear that it is of fundamental importance to ensure the same angle and same depth during each insertion of the needle. In this regard, first the above-mentioned (sharp-cutting) fistula needle must be used for a certain number of dialysis sessions, and only then can a needle suitable for the buttonhole method be used. These needles have the same diameter as fistula needles and a beveled tip without cutting. Therefore, highly specialized personnel are required to carry out this method, especially in the early stages of treatment. In addition, the buttonhole method is associated with a higher incidence of infection than the use of cutting needles and is not recommended in cases of too much or too little subcutaneous tissue and broken skin. Recently, vascular access devices for hemodialysis have been developed that can be permanently implanted in patients with arteriovenous fistulas. These devices have an anchoring surface defined to be anchored to the outer wall of the FAV near the skin, with a funnel-shaped channel leading into the thinnest portion of the anchoring surface. Once embedded in it, the device remains impaled in the muscle. Even with these devices, a fistula needle inserted into the skin and muscle is used to locate the center of the funnel-shaped channel and, as it is inserted, gradually penetrate the wall of the FAV at the fixation surface of the device. is required. This device cannot eliminate the risk of crossing the fistula needle from side to side of the vein (V), moreover, due to the funnel-shaped channel, it is impossible to change the inclination of the fistula needle, thus Deep insertion is not possible, and like the buttonhole method, the treatment time, which is limited by the cross-section of the fistula needle, cannot be shortened.

U.S. Patent Application Publication No. 2010/318016 and U.S. Patent No. 4,822,341 disclose another vascular access device for hemodialysis that is permanently implantable in patients with pre-existing arteriovenous fistulas. described. A device according to US Pat. No. 4,822,341 is continuously implanted in a blood vessel. Once implanted, the device has entry and exit holes for blood withdrawal and reinfusion, respectively. The device includes a sliding valve for opening and closing the hole by sliding it longitudinally relative to the blood vessel, the sliding valve being placed subcutaneously once the device is implanted. In order to open and close the hole, the operator must slide the sliding valve inside the patient to counteract the action of the tissue on the valve, and the operator must use the fistula needle to penetrate the skin and muscle. It is clear that once the hole is drilled, it is necessary to locate the center of the hole. The objective difficulty of sliding a valve implanted in the body renders the device of virtually no practical application. Thus, while limiting patient stress, pain and trauma, damage to the FAV, the potential for infection at FAV blood access sites, the need for highly specialized personnel and associated costs, The need to perform hemodialysis sessions arises. An additional need arises to reduce the number of surgeries that patients need to undergo in order to prepare them for hemodialysis, with the goal of reducing the risks associated with surgery and the disability and suffering that patients experience. Additionally, there is a recognized need, as well as a need for specialized medical operators, to reduce the cost and/or time for hemodialysis.

U.S. Patent Application Publication No. 2010/318016 U.S. Pat. No. 4,822,341

It is an object of the present invention to obviate or limit the drawbacks associated with hemodialysis using FAV. Specifically, the primary objectives of the present invention are to address patient stress, pain and trauma, damage to FAV or other blood vessels, the potential for infection of FAV blood access sites, and the need for highly specialized personnel. providing hemodialysis treatment while limiting the availability and associated costs. Additionally, another object of the present invention is to achieve a vascular access device that is structurally simple, economical and reliable in use. Another object of the invention is to make it possible to reduce hemodialysis time.

The above objectives are achieved by the content of independent claims 1, 2, 10 and 13. The vascular access device for hemodialysis of claim 1 can be permanently implanted serially to a pre-existing FAV, vein or artery, or hydraulically connect a vein to an artery. A sterile package containing at least one disposable device for withdrawing and/or infusing blood in an arteriovenous fistula as defined in claim 14 is opened and used for each hemodialysis session to provide flow control and/or or inserting a first end of a medical cannula (possibly a first The connecting element of the disposable device is connected to the blood inlet tube of a hemodialyzer or It can be hydraulically connected to a blood outlet tube. The skin is the only body element that can be pierced, so it heals easily. Especially when treated with a suitable fistula pressure pad with silver and/or another antiseptic and/or healing agent, the pain experienced by the patient during a hemodialysis session is greatly reduced. According to the present invention, during a hemodialysis session, the free end of the treatment cannula for cannulation procedures is used when insertion for withdrawal from or return to the vein is accomplished with a cannula and performed with a vascular access device. When inserted, it is also clear that there is no risk of side-to-side penetration of a vein, artery, or arteriovenous fistula during a hemodialysis session. This end is of course non-cutting and flexible enough for conforming insertion first into a second conduit in a vascular access device for hemodialysis and then into the first conduit. . As a result, there is no risk of damaging the FAV. Additionally, the first conduit can have the same internal diameter as the FAV, and the vein or artery and cannula can have an internal diameter of 0.1 to 0.1 to the internal diameter of the first conduit, depending on the thicknesses involved. It can have a diameter less than 2 mm, ie an inner diameter of 2.0 to 4.0 mm. It is therefore significantly larger than the 1.6 mm fistula needle diameter. This makes it possible to greatly increase the volume of blood drawn at the FAV and the volume of blood returned during hemodialysis. Therefore, by appropriately sizing the filtration surface of the semipermeable membrane in the hemodialyzer, the production of personnel is based on the blood flow that can flow through a cannula with an inner diameter of 2.0 to 4.0 mm. Personnel time and costs associated with a single hemodialysis treatment can be greatly limited while increasing efficiency.

Use of a vascular access healing device according to the present invention allows valve access of the healing device around the cylinder of the healing device by insertion into a second and/or third conduit at a vascular access point in the body. Note that the In fact, by leaving the healing device at this site for several days, removing it for periodic vascular access treatments (at least 2-3 times a week), and reinstalling after each treatment, healing can be achieved in a relatively short time. It is possible to obtain permanent vascular access with a permanently open vascular access hole. The vascular access holes lead to the second and/or third conduits in the vascular access device of the present invention, to which are preferably connected first and second valves, respectively, which valves are connected to the second or third conduits. The third conduits are each closed hydraulically. This dramatically limits blood loss. A permanent vascular access with a healed access hole is penetrated by a cannula for cannulation, particularly a cannula contained in the sterile packaging of the present invention. Therefore, there is no need to use fistula needles to perform dialysis. As a result, dialysis can be performed by operators who are not highly specialized in dialysis. This is because the cannula entry in permanent vascular access is greatly simplified relative to the prior art, making it easier to connect the hemodialysis machine to the patient. Additionally, the absence of fistula needles reduces patient discomfort and pain that can damage veins, arteries, or FAVs.

Depending on the characteristics of the person receiving dialysis, the time required to obtain permanent vascular access with a healed and permanently open vascular access hole may vary from 4-12 weeks, or 8-10 weeks. There is During this period, and in any case, if the healing device of the present invention is not used, dialysis will not be performed or a central venous catheter will be used until the vascular access device implantation is acclimated (i.e., ready for use). , which will then be eliminated. In addition to the advantages mentioned above, the vascular access device for hemodialysis according to claim 1 advantageously also allows selection of the vessel for implantation. In fact, it can be implanted sequentially in an artery (A), a vein, a pre-existing arteriovenous fistula. Or, more preferably, the vascular access device itself can be implanted between an artery and a vein to create an artificial arteriovenous fistula. In this case, a single operation creates a permanent vascular access and exit as well as an artificial arteriovenous fistula. It thereby limits the number of surgeries a patient needs to undergo, as well as the consequent risk of post-operative complications and discomfort suffered by the patient.

Features of the present invention are presented below and related preferred but non-exclusive embodiments are described with reference to the accompanying figures.

1 is a schematic perspective view of a first embodiment of a vascular access device for hemodialysis according to the present invention; FIG. 1 is a schematic side view of a first embodiment of a vascular access device for hemodialysis according to the present invention; FIG. 1 is a schematic top view of a first embodiment of a vascular access device for hemodialysis according to the invention; FIG. 1 is a schematic front view of a first embodiment of a vascular access device for hemodialysis according to the present invention; FIG. 1D is a schematic cross-sectional view of the first embodiment of a vascular access device for hemodialysis according to the present invention, taken along the IE-IE plane of FIG. 1D; FIG. Fig. 2 is a schematic perspective view of a second embodiment of a vascular access device for hemodialysis according to the invention; Fig. 2 is a schematic side view of a second embodiment of a vascular access device for hemodialysis according to the invention; Fig. 2 is a schematic top view of a second embodiment of a vascular access device for hemodialysis according to the invention; Fig. 2 is a schematic front view of a second embodiment of a vascular access device for hemodialysis according to the present invention; 2D is a schematic cross-sectional view of a second embodiment of a vascular access device for hemodialysis according to the present invention, taken along plane 2E-2E of FIG. 2D; FIG. Figure 2C is an enlarged view of detail K of Figure 2B; FIG. 3 is a schematic perspective view of a third embodiment of the vascular access device for hemodialysis of the present invention; 1 is a top view of an aseptic package according to the invention; FIG. FIG. 4 is a side view of another embodiment of a disposable device for withdrawing and/or infusing blood according to the present invention; 5B is a top view of the disposable device of FIG. 5B; FIG. FIG. 5B is a cross-sectional view of the disposable device of FIG. 5B taken along the V _D -V _D axis of FIG. 5C; 5B is a front view of the disposable device of FIG. 5B; FIG. 5D is an enlarged view of detail A of FIG. 5D; FIG. 5B is a perspective view of the disposable device of FIG. 5B; FIG. Figure 5G is an enlarged view of detail C of Figure 5G; Figure 5G is an enlarged view of detail B of Figure 5G; FIG. 11 is a side view of another embodiment of a disposable device for drawing and/or infusing blood; Figure 5L is a top view of the disposable device of Figure 5L; FIG. 5L is a cross-sectional view of the disposable device of FIG. 5L along the VN _{- VN} axis of FIG. 5M; Figure 5L is a front view of the disposable device of Figure 5L; Figure 5N is an enlarged view of detail D of Figure 5N; Figure 5L is a perspective view of the disposable device of Figure 5L; Figure 5G is an enlarged view of detail D of Figure 5G; Figure 5G is an enlarged view of detail D of Figure 5G; 1 is a schematic cross-sectional view of a first embodiment of part of a collection and/or infusion system for hemodialysis according to the invention, connected to an arteriovenous fistula in a use configuration; FIG. Fig. 2 is a schematic cross-sectional view of a second embodiment of part of a collection and/or infusion system for hemodialysis according to the invention, connected to an arteriovenous fistula in a use configuration; FIG. 11 is a schematic cross-sectional view of a third embodiment of part of a collection and/or infusion system for hemodialysis according to the invention, connected to an arteriovenous fistula in a use configuration; FIG. 11 is a side view of a fourth embodiment of a vascular access device according to the present invention; Figure 9B is a rear view of the device of Figure 9A; Figure 9B is a top view of the device of Figure 9A; Figure 9C is a cross-sectional view of the device of Figure 9A along plane _IXD - _IXD of Figure 9C; FIG. 9C is a cross-sectional view of the device of FIG. 9 along plane _IXE - _IXE of FIG. 9B; Figure 9C is an enlarged view of detail J of Figure 9D; FIG. 9D is a cross-sectional view of the device of FIG. 9A in plane _IXG - _IXG of FIG. 9D; FIG. 9G is a cross-sectional view of the device of FIG. 9A in plane _IXH - _IXH of FIG. 9G; Figure 9H is an enlarged view of detail K of Figure 9H; Figure 9B is a schematic perspective view from below of the device of Figure 9A; Figure 9B is a schematic perspective view from above of the device of Figure 9A; Figure 9B is an exploded top view of the device of Figure 9A; 10B is a rear view of the exploded device of FIG. 10A; FIG. FIG. 10B is a cross-sectional view of the exploded device of FIG. 10A taken along the X _C -X _C plane of FIG. 10A; FIG. 10B is a cross-sectional view of the exploded device of FIG. 10A along the plane X _D -X _D of FIG. 10B; 10B is a perspective view of the exploded device of FIG. 10A; FIG. 10D is an enlarged view of detail X of FIG. 10D; FIG. FIG. 5 is a side view of a fifth embodiment of a vascular access device for hemodialysis according to the invention; 11B is a rear view of the device of FIG. 11A. FIG. FIG. 11B is a top view of the device of FIG. 11A; FIG. 11C is a cross-sectional view of the device of FIG. 11A in plane XI _D -XI _D of FIG. 11C; FIG. 11B is a cross-sectional view of the device of FIG. 11A in plane XI _E -XI _E of FIG. 11B; FIG. 11D is an enlarged view of detail K of FIG. 11D; FIG. 11D is a cross-sectional view of the device of FIG. 11A in the plane XI _G -XI _G of FIG. 11D; FIG. 11B is a schematic perspective view of FIG. 11A viewed from below; FIG. 11B is a schematic perspective view of FIG. 11A viewed from above; 11B is an exploded view of the device of FIG. 11A; FIG. Figure 12B is a rear view of the exploded device of Figure 12A; FIG. 12B is a cross-sectional view of the exploded device of FIG. 12A taken along plane XII _C -XII _C of FIG. 12A; FIG. 12B is a cross-sectional view of the exploded device of FIG. 12A taken along plane XII _D -XII _D of FIG. 12B; Figure 12B is a perspective view of the exploded device of Figure 12A; Figure 12D is an enlarged view of detail K of Figure 12D; FIG. 11 is a side view of a sixth embodiment of a vascular access device according to the present invention; 13B is a rear view of the device of FIG. 13A; FIG. 13B is a top view of the device of FIG. 13A; FIG. FIG. 13C is a cross-sectional view of the device of FIG. 13A in plane XIII _D -XIII _D of FIG. 13C; Figure 13D is a cross-sectional view of the device of Figure 13A along plane _XIIIE - _XIIIE of Figure 13D; Figure 13D is an enlarged view of detail K of Figure 13D; Figure 13B is a bottom perspective view of the device of Figure 13A; Figure 13B is a top perspective view of the device of Figure 13A; Figure 13B is an exploded view of the device of Figure 13A; Figure 14B is a rear view of the exploded device of Figure 14A; Figure 14B is a cross-sectional view of the exploded device of Figure 14A taken along the XIV _C -XIV _C plane of Figure 14A; FIG. 14B is a cross-sectional view of the device of FIG. 14A in plane XIV _D -XIV _D of FIG. 14B; Figure 14D is an enlarged view of detail Z of Figure 14D; Figure 14B is a perspective view of the device of Figure 14A; FIG. 11 is a side view of a seventh embodiment of a vascular access device according to the present invention; FIG. 11 is a bottom perspective view of a seventh embodiment of a vascular access device according to the present invention; FIG. 11 is a top perspective view of a seventh embodiment of a vascular access device according to the present invention; FIG. 11 is a side view of an eighth embodiment of a vascular access device according to the present invention; FIG. 12 is a bottom perspective view of an eighth embodiment of a vascular access device according to the present invention; FIG. 11 is a top perspective view of an eighth embodiment of a vascular access device according to the present invention; FIG. 11 is a side view of a ninth embodiment of a vascular access device according to the present invention; FIG. 11 is a longitudinal cross-sectional view of a ninth embodiment of a vascular access device according to the present invention; FIG. 12 is a bottom perspective view of a ninth embodiment of a vascular access device according to the present invention; FIG. 11 is a top perspective view of a ninth embodiment of a vascular access device according to the present invention; FIG. 12A is a side view of a tenth embodiment of a vascular access device according to the present invention; Figure 18B is a rear view of the device of Figure 18A; Figure 18B is a top view of the device of Figure 18A; FIG. 18B is a cross-sectional view of the device of FIG. 18A in plane _XIIXD - _XIIXD of FIG. 18B; Figure 18B is a P-side view of the device of Figure 18A; FIG. 18B is a cross-sectional view of the device of FIG. 18A in plane XIIX _F -XIIX _F of FIG. 18A; Figure 18D is an enlarged view of detail J of Figure 18D; Figure 18B is a cross-sectional view of the device of Figure 18A in the _XIIXH - _XIIXH plane of Figure 18A; FIG. 18H is a cross-sectional view of the device of FIG. 18A along plane XIIX _I -XIIX _I of FIG. 18H; Figure 18B is a bottom perspective view of the device of Figure 18A; Figure 18B is a top perspective view of the device of Figure 18A; FIG. 11 is a side view of an eleventh embodiment of a vascular access device according to the present invention; Figure 19B is a rear view of the device of Figure 19A; 19B is a top view of the device of FIG. 19A; FIG. FIG. 19B is a cross-sectional view of the device of FIG. 19A in plane _XIXD - _XIXD of FIG. 19B; Figure 19B is a cross-sectional view of the device of Figure 19A taken along the _XIXE - _XIXE plane of Figure 19B; Figure 19D is an enlarged view of detail B of Figure 19D; Figure 19E is an enlarged view of detail C of Figure 19E; Figure 19B is a cross-sectional view of the device of Figure 19A taken along the _XIXH - _XIXH plane of Figure 19A; FIG. 19H is a cross-sectional view of the device of FIG. 19A along plane XIIX _I -XIIX _I of FIG. 19H; Figure 19B is a bottom perspective view of the device of Figure 19A; Figure 19B is a top perspective view of the device of Figure 19A; 1A-1D illustrate locations in which a vascular access device according to the present invention can be implanted. 1A-1D illustrate locations in which a vascular access device according to the present invention can be implanted. 1A-1D illustrate locations in which a vascular access device according to the present invention can be implanted. 1 is a schematic front view of a healing device for valve access according to the invention, in a first relevant configuration; FIG. 1 is a schematic side view of a healing device for valve access according to the invention in a first relevant configuration; FIG. 1 is a schematic top view of a healing device for valve access according to the invention in a first relevant configuration; FIG. 1 is a schematic perspective view of a healing device for valve access according to the invention, in a first relevant configuration; FIG. Figure 2B is a schematic side view of the device of Figure 2A in a related second configuration; Figure 2B is a schematic front view of the device of Figure 2A in a related second configuration; Figure 2B is a schematic perspective view of the device of Figure 2A in a related second configuration;

Referring to the drawings, reference number (1) relates to a vascular access device for hemodialysis, permanently implantable in patients with arteriovenous fistulas. (1) shows a vascular access device for hemodialysis (with both single and double vascular access) permanently implantable in a patient and (102) a disposable device for blood collection and/or infusion. , (500) indicates a healing device for valve access, (100) indicates a sterile package, and (1000) indicates a collection and/or infusion system for hemodialysis according to the present invention. As can be seen, the first to third embodiments relate to a vascular access device according to the single access invention (see FIGS. 1A-4 and 6-8), while the fourth to eleventh embodiments Embodiments relate to the double access vascular access device of the present invention, which allows for double vascular access (see Figures 9-19N). The double-access vascular access device in the invention actually serves to withdraw blood from the patient to undergo dialysis and to reinfuse the dialyzed blood into the patient, e.g. withdrawing blood from the second tubular element (203). and reinfusing the third tubular element (303) with blood, or vice versa. However, single-access vascular access devices only allow either entry or exit access, and therefore two of them must be implanted in each patient.

According to the present invention, a single-access vascular access device (1) is a vascular access device (1) made of biocompatible and sterile material:
- an associated first conduit (22) having longitudinally associated first and second ends (21) and defining a first conduit (22) extending from the first to the second end (21); 1 tubular element (2);
- a second conduit (33) having longitudinally associated first and second ends (31,32) and extending from the associated first to second ends (31,32); Defining an associated second tubular element (3), the first end (31) of the second tubular element (3) is connected to the second conduit (33) by the first conduit (22). ) and such that the second end (32) of the second tubular element (3) is on the first side with respect to the first tubular element (2). It is fixed to the first tubular element (2) at an intermediate position between the first and second ends (21) at (3) (Figs. 1A, 1B, 1E, 2A , FIGS. 2B, 2E and 4), with the associated second tubular element (3);
- comprising a first plurality of through-holes (41), fixed to the first tubular element (202) and/or the second tubular element (3) (preferably they are the second tubular element (3) ) and the first plurality of through holes (41) are located at the second end (32 ), wherein the vascular access device (1) is positioned between the first portion (51) and the second portion (52) of the arteriovenous fistula, adapted and dimensioned for implantation in the arm of a patient having an arteriovenous fistula for hemodialysis with a first conduit (22) in series with the arteriovenous fistula for blood flow; The first end (21) and the second end (21) of the first tubular element (2) are connected to the first part (51) and the second part (52) of the arteriovenous fistula, respectively; Fixed at the associated ends of the associated portions (51, 52) and the second end (32) in the second tubular element (3), the first plurality of through holes (41) are connected to the first implanted skin area (7) by securing with a plurality of suture stitches (60) thereby securing the second end (32) of the second conduit (33) to the implanted skin area (7); a first fixing means (4) in which the first plurality of through-holes (41) are subcutaneously placed at the implanted skin area (7) for fixing to the skin. For the second conduit (33) to be in fluid communication with the first conduit (22) and the second end (32) at the second tubular element (3) ), the first end (31) of the second tubular element (3) is connected to the first end and the second end of the second tubular element (3) Note that it is not possible to fix to the first tubular element (2) in an intermediate position between (21). Indeed, the first end (31) of the second tubular element (3) is the first end (31), as can be seen in Figures 1A, 1B, 1E, 2A, 2B, 2E and 4 . is fixed at an intermediate position between the first and second ends (21) of the tubular element (2).

The double-access type vascular access device (1) of the present invention, as shown in FIGS. Made of materials and sterilized materials:
- defining a first conduit (222) having longitudinally associated first and second ends (221, 223) and extending from the first to the second ends (221, 223); , with the associated first tubular element (202);
a second longitudinally associated first and second end (231, 232) (see FIG. 10F) and extending from the associated first to second end (231, 232); An associated second tubular element (203) defining a conduit (233), wherein a first end (231) of the second tubular element (203) connects the second conduit (233) to the second tubular element (233). in fluid communication with one conduit (222) and such that the second end (232) of the second tubular element (203) is on the first side with respect to the first tubular element (202). , an associated second tubular element (203) secured to the first tubular element (202) adjacent the first end (221) of the first tubular element (202);
- a third conduit having longitudinal associated first and second ends (331, 332) and extending from the associated first end to the second end (331, 332); 333) (see FIG. 19G), the first end (331) of the third tubular element (303) being connected to the third conduit (333 ) is in fluid communication with the first conduit (222) and the second conduit (233), and the second end (332) of the third tubular element (303) is connected to the first tubular element (202). ), and an associated third tubular element (303) secured adjacent to the second end (223) of the first tubular element (202) so as to be on the first side with respect to the first tubular element (303);
- a first fixing means (4) comprising a first plurality of through-holes (41) and fixed to the first tubular element (202) and/or the second tubular element (203), A first plurality of through holes (41) are positioned on a first side relative to the first tubular element (202) and at a second end (232) in the second tubular element (203). and a first securing means (4);
- a second fixing means (304) comprising a second plurality of through holes (41) and fixed to the first tubular element (202) and/or the third tubular element (303), A second plurality of through holes (41) is located on a first side relative to the first tubular element (202) and at a second end (332) in the third tubular element (303). a second securing means (304);
wherein the vascular access device (1):
- in a first location in an artery (A), a vein (V), or a pre-existing arteriovenous fistula (F) (see Figures 20C, 20B and 20A respectively), wherein the first conduit is , an artery (A), a vein (V), or a pre-existing arteriovenous fistula (F), respectively, between a first portion and a second portion, respectively, for blood flow. V), or contiguously sandwiched by a pre-existing arteriovenous fistula (F), the first and second ends (221, 223) of the first tubular element (202) are respectively connected to the first a first position fixed to the portion (51) and the second portion (52) of
- in a second position (see Fig. 20D) between the artery (A) and the vein (V), the associated first or second end (231, 232) is fixed to the artery (A), and the rest of the associated first or second ends (231, 232) of the first tubular element (202) not fixed to the artery (A) are a second location, where the first conduit (222) is secured to the vein (V) so as to hydraulically connect the artery (A) to the vein (V) to create an artificial arteriovenous fistula (FA); ,
is adapted and dimensioned for implantation in a patient, preferably in the patient's arm. wherein the second end (232) on the second tubular element (203) and the second end (332) on the third tubular element (303) in the first and second positions; of the first and second pluralities of through-holes (41) can be secured to the implanted skin area (7) by corresponding first and corresponding second pluralities of suture stitches (60), and so that the second end (232) of the second conduit (233) and the second end (332) of the third tubular element (303) can be secured to the implanted skin area (7) by The first and second plurality of through-holes (41) are positioned subcutaneously in the implanted skin area (7).

Double-access vascular access devices are not only continuously implantable in blood vessels (veins, arteries, and pre-existing arteriovenous fistulas), but are also advantageous in performing the following surgical methods for implanting the device. to enable. It includes the following steps:
prepositioning the double access vascular access device of the present invention; performing a surgical incision in the wall of the vein (V) at the implantation site; making a surgical incision in the wall of the artery (A) at the implantation site. hydraulically connecting a vein and an artery via a first conduit (222) hydraulically connected at relevant ends to a second conduit (233) and a third conduit (333), respectively; connecting the associated first or second end (231, 232) of the first tubular element (202) anchored to the artery (A) at the associated surgical incision; With the remainder of the associated first or second end (231, 232) of one tubular element (202) not fixed to the artery (A) at the associated surgical incision, the first A conduit (222) hydraulically connects the artery (A) to the vein (V) to construct an artificial arteriovenous fistula (FA), the second end (222) in the second tubular element (203). 232) and the second end (332) of the third tubular element (303) so that the first and second plurality of through-holes (41) are subcutaneously in the implanted skin area (7). and filling the first and second pluralities of through-holes (41) by corresponding first and corresponding second pluralities of suture stitches (60). fixing to the embedded skin area (7);

With the goal of obtaining permanent vascular access with a healed, permanently open vascular access hole, Applicants have also developed a vascular access healing device (500):
- a cylinder (505) insertable inside the vascular access and having an associated longitudinal axis of development; longitudinally associated first and second ends, at the first end of the cylinder (505); and an associated insert (502) with a fixed (preferably coaxial with the cylinder) distally tapered tip (503), which insert extends through the first valve (50 ) and the first plate (4) or between the second valve (50) and the second plate (304), respectively, a second conduit (33, 233) or a third any one of claims 4, 7, 8, 9 and 10 from the associated second end (32, 232, 332) so as to exclusively occlude a portion of the conduit (333) of the an associated insert (502) insertable into a second conduit (33, 233) or a third conduit (333) in a vascular access device (1) for hemodialysis according to;
- an associated connection (504) fixed to the second end of the cylinder (505);
- an associated first and associated second gripping tab (501), wherein the first and second gripping tabs (501) are substantially coplanar (Fig. 21A) 21D), and a second configuration (FIGS. 21E-21F) in which these tabs face each other, both of their connections (504) and on both sides with respect to the cylinder axis. and has the possibility of relative motion with respect to the connection (504), and in both the first and second configurations the first and second gripping tabs (501) are connected to the second conduit (33, 233) or the associated first and associated second gripping tabs (501) that cannot be inserted into the third conduit (333).

In a preferred associated embodiment of the vascular access healing device, the associated cylinder is angled (FIGS. 21B, 21D, and FIG. 21G respectively), at which angle the second tubular element (3, 203) or the third tubular element (303) is positioned relative to the first plate (4) or the second plate (304) respectively. to tilt.

Referring to FIGS. 21A-21G, the length L3 of the insert (502) is configured to be 2 mm or 2.5-5 mm, preferably 1-3 mm to avoid contacting the valve (50). . The gripping tab (501) can have the following dimensions. L4 is comprised between 3 and 6 mm, preferably 4.5 mm, and L5 is comprised between 4.5 and 6 mm, preferably 5 mm. The diameter θ of the cylinder is, of course, dependent on the dimensions of the second and third conduits, but is advantageously between 1.5 and 2 mm, preferably 1.75 mm. The width L6 of the vascular access healing device (500) can be 10-15 mm, preferably about 12.5 mm, while the length L7 can be 7-10 mm, preferably about 8.5 mm.

The sterile package (100) of the present invention comprises at least one disposable device (102) for drawing and/or infusing blood in an arteriovenous fistula, which:
- a therapeutic cannula (103) for cannulation, having an associated first end (108) and an associated second end (109), wherein the first end (108) is free; , to a pre-existing arteriovenous fistula (F), artery (A), or vein (V) of the patient, via a second conduit (33, 233) and a first conduit (22, 222), or a second a treatment cannula (103), which is cannulaable with both double and single access devices via the third conduit (333) and the first conduit (222);
- a pre-arranged flow control and/or blocking device (104) for controlling and/or blocking the flow of liquid in the treatment cannula (103);
- a connecting element (106) fixed to the second end (109) of the treatment cannula (108), which allows a hydraulic connection to the blood inlet line or the blood outlet line of the hemodialysis machine; ;
- an access channel (181) located between the cannula first end (108) and the control and/or blocking device (104) and hydraulically connected to the cannula first end (108); (see FIGS. 5F and 5P); and permits the injection of fluid into access channel (181) and into the first end of treatment cannula (103). reversible closure means (180) for reversibly closing the access channel (181) at the distal end of the access element for flow towards (108);
- an optional first gripping element (120) and/or close to the connecting element (106) arranged between the first end (108) and the control and/or blocking device (104); a second gripping element (130) arranged as a . Naturally, the package also has an associated wrapping (101), sealed and made of a suitable material to allow sterility of the contents. For example, the wrapping (101) can be made using a sheet material that is permeable to ultraviolet light and/or ionizing radiation (gamma and/or beta radiation) and/or microwaves. By appropriate selection of both the relevant configuration and dimensions of the vascular access device (1) and the collection and/or infusion disposable device (102) contained in the sterile package (100), the vascular access device (1) ) and a collection and/or infusion disposable device (102) for hemodialysis, opening the package at each hemodialysis session. is sufficient. The first free end (108) of the treatment cannula (103) is free to connect to the patient's arteriovenous fistula, vein or artery to the second conduit (33, 233) and the first conduit (33, 233) of the vascular access device (1). A cannula can be used via the first conduit (22, 222) and/or via the third conduit (333) and the first conduit (22, 222). System 1000 makes it possible to achieve the above objectives over the prior art.

Thus, the collection and/or infusion system (1000) for hemodialysis according to the invention can be double-access or single-access, the vascular access device (1) for hemodialysis according to the invention and an arteriovenous at least one disposable device (102) for withdrawing and/or infusing blood in a fistula (F), vein (V), or artery (A), wherein the disposable device (102):
- a therapeutic cannula (103) for cannulation, having an associated first end (108) and an associated second end (109), wherein the first end (108) is free; , the second conduit (33, 203) and the first conduit (22, 222) of the vascular access device (1) to a pre-existing arteriovenous fistula (F), artery (A), or vein (V) of the patient. ) or via the third conduit (333) and the first conduit (22, 222), the treatment cannula (103);
- a pre-arranged flow control and/or blocking device (104) for controlling and/or blocking the flow of liquid in the treatment cannula (103);
- a connecting element (106) fixed to the second end (109) of the treatment cannula (108), which allows a hydraulic connection to the blood inlet line or the blood outlet line of the hemodialysis machine; ;
- an access channel (181) located between the cannula first end (108) and the control and/or blocking device (104) and hydraulically connected to the cannula first end (108); (see FIGS. 5F and 5P); and permits the injection of fluid into access channel (181) and into the first end of treatment cannula (103). reversible closure means (180) for reversibly closing the access channel (181) at the distal end of the access element for flow towards (108);
- an optional first gripping element (120) and/or close to the connecting element (106) arranged between the first end (108) and the control and/or blocking device (104); a second gripping element (130) arranged as a
- wherein the collection and/or injection system (1000) optionally comprises at least one healing device (500) of the vascular access of the invention, preferably a plurality, advantageously 8 to 30 healing devices (500) , can be provided.

In the case of a double access vascular access device, the system preferably has two single access devices (102) for collection and/or injection.

Note that the access element and closure means are capable of aspirating any thrombus present in both single and double access access devices. Additionally, the access element and closure means allow the injection of an anticoagulant into the first conduit (22, 222). The anticoagulant can be, for example, heparin, such as heparin lock, sodium citrate, urokinase, and mixtures thereof.

To improve sterilization and mechanical resistance of the vascular access device (1), it is preferably made of metal, more preferably titanium. However, the present invention can also include construction using biocompatible and sterile plastic materials to prevent resorption by the body as described below. a second end (32, 232) at the second tubular element (3, 203) and a second end (332) at the third tubular element (303) in a vascular access device for hemodialysis; If present, the first and second plurality of through-holes (41) are separated by two through-holes (41) for the purpose of improving fixation to the skin area (7) for their implantation. , preferably on opposite sides, arranged in the second conduit (33, 232) and conduit (333) respectively. When constructed with three through-holes, they are preferably spaced at an angle of 120° around the second conduit (33, 233) and the third conduit (333). If a greater number of through holes (41) are included, they surround the second conduit (33, 233) at the second end (32, 232) in the second tubular element (3, 203). It can be arranged along a closed loop (see Figures 1C and 2C). It may even be preferred that they are equiangular. The through holes (41) are preferably at least six. The same applies to the hole at the second end (332) in the third tubular element (303), if present. Advantageously, the treatment cannula (103) is positioned in the second conduit (33) and the first conduit (22, 222) and/or in the first conduit (222) and the third conduit (333). At least one, preferably both, of the cannula and the conduit have an associated elliptical internal cross-section, or more preferably a circular internal cross-section, for ease of insertion into the cannula. The conduits (22, 33) advantageously have cylindrical inner walls.

Naturally, the first tubular element (2, 202) and the second tubular element (3, 203) have associated longitudinal deployment axes (24, 34) that are incident with respect to each other. , define two angles of incidence, one complementary to the other. This also applies to the first and third tubular elements in the case of double access vascular access devices. A preferred embodiment of a vascular access device (1) for hemodialysis is that the first tubular element (2) and the second tubular element (3) are incident on each other at a minimum angle (α) that is acute. with an associated longitudinal deployment axis. This angle may preferably consist of 25-60°, more preferably 25-50°, more preferably 28-30° or 43-48°, 25° and 45° and/or (preferably ) where, if there is an associated third tubular element (303), the first tubular element (202) and the third tubular element (303) are configured at 25-50°, preferably 25°. have associated longitudinal development axes that are incident on each other at a minimum angle (α). The minimum angle (α) can advantageously be 25°, 35° or 45°. Of course, depending on the angle (α), the measured length (L2) of the second tubular element (3) is reduced by fixing the first tubular element (2) to the FAV. Appropriately dimensioned along the associated longitudinal deployment axis to dimension the vascular access device (1) such that the second end (32) of the element (3) is below the skin (7). need to decide. However, based on the patient's physical characteristics (gender, diagonal, muscle mass, fat mass), the surgeon may select the first tubular element (2) of interest to be the FAV in series, and the second tubular element ( It is perfectly possible to choose a vascular access device (1) suitable for implanting the patient with the second end (32) at 3) under the skin (7).

In an embodiment of the vascular access device (1) for hemodialysis of the present invention, the first securing means (4) is located at the second end (32, 232) of the second tubular element (3, 203). and/or (preferably) if present, the second securing means (304) originate from the second end (332) of the third tubular element (303) be able to. For example, the first and/or second fixing means (4) may be constructed by a plurality of arm braces, not shown, arranged in spokes to the second conduit (33), each arm band , one or more of the first plurality of through holes (41).

It is particularly preferred that the first fixing means (4) comprise a plate (4) having an associated main through-hole (44). Here the first plurality of through-holes (41) are arranged around the main through-hole (44) and the plate (4) is aligned with the second tubular element (3, 203) on the associated first side. is secured to the second end (32) of the so that the second conduit (33, 233) is accessible from the associated main through hole. And/or (preferably) if present, it is particularly preferred that the second fixing means comprise a second plate (304) having an associated main through hole. Here a second plurality of through-holes (41) are peripherally arranged with respect to the associated main through-hole and another second plate (304) is a third tubular plate on the associated first side. Affixed to the second end (332) of the element (303) so that the third conduit (333) is accessible from the associated main through hole (44). This simplifies the implementation of the vascular access device (1). The main throughbore (44) advantageously has the same cross-section as the second conduit (33) at the second end and they are coincident to allow the treatment cannula (103) to pass through the first conduit (22). to facilitate insertion into

In an advantageous embodiment of the invention, the plate (4) is positioned with the second side of association towards the second end (45) opposite to the first side of association with the second tubular element ( 3) and positioned along a plane parallel to the longitudinal unfolding axis (24) of the first tubular element (2, 202). and/or (preferably) if present, the second plate (304) is connected to the third tubular element (303) by a second side of association (45) opposite to the first side of association. and positioned along a plane parallel to the longitudinal deployment axis (24, 224) of the first tubular element (2, 202). As shown in the embodiment of Figures 9-19, the second and third tubular elements (203, 303) preferably have their associated longitudinal deployment axes aligned with the first tubular element (202). placed across from the side of This is because it facilitates drawing blood for dialysis and returning the dialyzed blood to the patient. The second side (44) is defined to face the inside of the skin (7) and comprises a first tubular element (2, 202) of 5-10 mm, preferably 6.5-8.0 mm. relative distance (D2) to the longitudinal deployment axis (24). This distance (D2) is of course also dependent on the minimum angle (α) and the above considerations are valid for vascular access device (1) sizing and surgeon selection.

For the purpose of facile fixation of vascular access devices (1) for hemodialysis, both single and double access, the vascular access is continuous to the pre-existing FAV and artery (A) or vein (V). When permanently implanted, the first end and the second end (21, 221, 223) of the first tubular element (2, 202) each advantageously comprise a third plurality of through holes. (28) (see FIGS. 1A-1C, 6, and 16A-17D). They are arranged along the relevant transverse fixation sector and represent the first and second ends (21, 221, 223) of the first tubular element (2, 202), respectively, in the third direction visible in FIG. A plurality of suture stitches (80) allow anchoring to the ends of the first (51) and second (52) portions of the arteriovenous fistula. The suture may be placed outside (see FIG. 6) or inside the first and/or second ends of the first tubular portion through an artery (A), vein (V), or pre-existing arteriovenous fistula. (F) can be performed using the ends of the first and second portions. In the latter case, the end of each of the first (51) and second (52) portions of the artery (A), vein (V) or pre-existing arteriovenous fistula (F) and the artery (A) a terminal annular surface at the end of each of the first (51) and second (52) portions of the arteriovenous fistula (see FIGS. 7 and 20A) of the arteriovenous fistula (see FIG. 20C) or vein (see FIG. 20B); at least one, preferably both (shown in FIG. 1E) between the first and second ends (21, 221, 223) of the first tubular element (2, 202) when adapted ) is defined by the first conduit (22, 222) and has an associated inner housing with an associated inner annular abutment surface (27) for (preferably across) abutment. Good to have. Not only does this improve fixation, but once the treatment cannula ( 103) is inserted into the second conduit (33) and the first conduit (22), it prevents the cannula from striking against the terminal annular surfaces of the ends. Of course, if the housing (25) is present only on one side between the first and second ends (21, 221, 223) of the first tubular element (2, 202), this is the end opposite the minimum angle (α).

Preferably, the third plurality of through-holes (28) is at least four, preferably at least six, more preferably at least eight. They are advantageously arranged equiangularly. The through-holes (41, 28) in the first, second and third plurality of through-holes must, of course, be sized and configured to be traversable by a surgical needle. For each of the first and second plurality of through-holes (28), the skin (7) incised by the surgeon and two pre-existing FAVs (F), veins (V), or arteries (A). During the suturing operation on the two parts, the surgeon will pass each suture stitch through a different through hole.

the first and second ends (21) of the first tubular element (2, 202) to two pre-existing FAVs (F), veins (V), or dissected arteries (A); In another fixation mode, the ends are attached to the ends of the first (51) and second (52) portions of the pre-existing arteriovenous fistula of the vein (V) or artery (A), respectively. Adhesive (not shown) can be used to secure.

For the purpose of improving fixation of the first and/or second ends of the first tubular element (2, 202) with surgical glue, each may, for example, comprise a plurality of concave surfaces, slots, Or it can have an associated transverse fixed sector with a relatively irregular outer surface with grooves. In a preferred embodiment of the invention, the associated transverse fixation section comprises a plurality of associated external annular grooves (29) (Figs. 2E and 3) of the first and second ends (21) of the first tubular element (2, 202) by surgical glue, venous (F) or arterial (A). Improving fixation to respective first and second portions of a pre-existing arteriovenous fistula.

Considering the average body size of patients, it is preferred that the single or double access vascular access device (1) for hemodialysis in the present invention has the following features, alone or in combination:
- the first conduit (22, 222) has an associated minimum inner diameter comprised between 2 and 5 mm, preferably between 2.5 and 4.0 mm, and/or between 3 and 7 mm, between 4 and 6.0 mm, preferably 4 and/or
- if the second conduit (33, 233) and/or the third conduit (333) are present, the associated minimum internal diameter is comprised between 2.0 and 5.0 mm, preferably between 2.5 and 4 mm; / or have an associated outer diameter comprised between 3.0 and 6.0 mm, preferably between 3.5 and 5.0 mm, and/or
- 5 from the longitudinal development axis (24) of the first tubular element (2, 202), if the first plurality of through holes (41) and/or the second plurality of through holes (41) are present; arranged at a distance comprised between 9 mm, preferably 6.5-8 mm and depending on the angle between the longitudinal development axes, and/or
- the holes (41) in the first and/or second plurality of through holes (41) have dimensions of 1.1 to 2 mm, preferably 1.6 x 0.9, and/or
- the holes in the third plurality of through-holes (28) have dimensions of 0.6-0.9 mm, preferably 0.7 x 0.85, preferably 0.8;

Especially for double access vascular access devices, it is particularly preferred if the length of the first tubular element is 3-10 cm, more preferably 4-12 cm, 8-12 cm, or advantageously 4-6 cm. Because it can thus be implanted between a vein and an artery, especially in the patient's arm or leg, and in an artificial conduit of this length, the same anatomy that exists naturally inside the vein and artery. It is both to allow the anatomical structure to be replicated in the internal structure of the conduit. This greatly reduces the risk of thrombi and blockages in the first conduit (22, 222). Furthermore, the length of the first tubular element (2, 202) of at least 4 cm, preferably 5-6 cm ensures that the blood withdrawn during dialysis does not contain blood that has just returned during dialysis. . If the vascular access device for hemodialysis is of the double access type and is used to obtain an artificial arteriovenous fistula, the length is preferably at least 8-12 cm, which of course depends on the patient's anatomy. do. Additionally, it is highly preferred if the device or at least the inner walls of the first, second and third conduits (22, 222, 33, 233, 333) are made of metal or biocompatible plastic material. In the second case, the device can be made by molding or 3D printing. Preferred materials, especially for making double-access devices, are silicone, polydimethylsiloxane PDMS, PTFE, preferably ePTFE, DACRON, preferably silicone and/or polydimethylsiloxane, and ePTFE, more preferably ePTFE. because they are less prone to thrombus formation and allow better endothelinization of the associated primary conduit (22, 220), which prevents the access device from becoming blocked. and rejection is reduced.

The vascular access device (1) for hemodialysis according to the invention preferably further comprises a first valve (50). A first valve (50) is connected to a second conduit (33, 233) and hydraulically closes the second conduit (33, 233) in an associated closed configuration and hydraulically closes the second conduit (33, 233) in an associated open configuration. to open the second conduit (33, 233). Particularly in the case of a double access vascular access device, and thus with an associated third tubular element (303), it is advantageous to further include a second valve (50). A second valve (50) is connected to a third conduit (333) and hydraulically closes the third conduit (333) in an associated closed configuration and hydraulically closes the third conduit (333) in an associated open configuration. It is configured to open the conduit (333). In particular, the presence of the first valve (50) in the case of a single-access vascular access device, and the presence of the first and second valves (50) in the case of double-access, is critical once hemodialysis is complete. It advantageously allows to limit the blood loss of the drug and improves its tolerability by the patient. The valve (50) permits blood flow as soon as the cannula of the blood withdrawal and/or infusion disposable device (102) according to the invention is withdrawn from the first conduit or from the second conduit at the end of dialysis. stop to advantage. Thus, in particular the patient may be treated with EMODIAL S. et al. r. l. facilitates minimizing blood loss from patients undergoing dialysis when treated with a fistula pressure pad in a silver-laden blood access, marketed as .

The first and/or second valve (50) is preferably located distal to the second end of the second conduit (3, 33) and/or the third conduit (333), respectively. be. Use of the vascular access healing device according to the present invention is performed by inserting the vascular access healing device into the second and/or third conduit at the vascular access point of the body, as described above, to open the valve access around the cylinder of the healing device. allow to heal.

The first and/or second valve (50) is connected to the associated tubular element (2, 203) at the first end (108) of the treatment cannula (103) of the sampling and/or infusion disposable device (102). , 303) via the associated second end (21, 232) into the associated conduit (3, 233, 33).

In an alternative preferred embodiment of the single and double access vascular access device for hemodialysis, the first valve (50) is located at the second end (21, 203) of the second tubular element (2, 203). 232) and the first plate (4). The first plate (4) has, on the first side of association, the second ends (21, 232) of the second tubular element (203) and/or the third tubular element (303) If present, it comprises a first engagement means (41) engaged with the second plate (304) and the second valve (50). A second valve (50) is disposed between a second end (332) of the third tubular element (303) and a second plate (304), the second plate (304) , on a first side of association, a second engagement means (41) for engaging the second end (21, 232) of the third tubular element (303) (FIGS. 9A- See Figure 10F).

In the preferred embodiment of the vascular access device for hemodialysis, both single and double access, the first valve (50) is located on the first plate (4), opposite to the first side of association. ) and pre-arranged on the second end (21, 232) on the second tubular element (203) and/or on the first plate (4). A third engagement means (54) is provided for frictionally engaging the engagement means (55). If a third tubular element (303), a second plate (304) and a second valve (50) are present, the second valve (50) is opposite to the associated first face. on the second side of the second plate (304) and pre-arranged on the second end (332) of the third tubular element (303) and/or the second plate (304) a fifth engaging means (54) for frictionally engaging the sixth engaging means (55) (see FIGS. 11A-14E). The first means of engagement (41) and/or the second means of engagement (41) and/or the third means of engagement (54) and/or the fifth means of engagement (54) are There may be a plurality of associated engagement elements (41, 54) projecting from the first face in frictional engagement with the second end (21, 232).

However, if there is a first valve (50) and/or a second valve (50), as shown in the single and double access vascular access device drawings for hemodialysis, the two operating edges It is preferable to have an associated through slot (56) which equates the parts. In the associated closed configuration of the first and/or second valves (50), the working edges meet to prevent passage of fluid through the valves (50). The first and/or second valves (50) are elastically deformable to provide an associated open configuration in which the working edges move away from each other to allow passage of fluid through the slots (50). (See FIGS. 18A-18N, especially 18F). In a preferred embodiment of the present invention in a vascular access device for hemodialysis, both single and double access, the first valve (50) and/or the second valve (50) are elastically deformable element can be provided. It intercepts the associated second conduit (33, 233) and/or the associated third conduit (333) without deformation in the associated closed configuration, and is compressed in the associated open configuration, compressing the associated third conduit (33, 233) and/or the associated third conduit (333). 2 conduit (33, 233) and/or the associated third conduit (333).

In an alternative preferred embodiment of the single and double access vascular access device for hemodialysis, the first valve (50) has an associated perimeter and a second valve in the second tubular element (3, 203). a first portion (151) at one end (31, 231) disposed in a second conduit (33, 233) and at an associated perimeter fixed to the second conduit (33, 233); and With the second portion (152) free at the rest of the perimeter of the association. In the closed configuration it faces the second conduit (3, 233), the second conduit and/or (preferably) if present the third tubular element (303), the second plate (304), and contact the second conduit (3, 233) to hydraulically close the second valve (50). The second valve (50) has an associated perimeter and is located in the third conduit (333) at the first end (332) in the third tubular element (303) and With the first portion (151) at the perimeter of association fixed at (333) and the second portion (152) remaining free at the perimeter of association. It faces the second conduit (233) in the closed configuration and contacts the second conduit (233) to hydraulically close the second conduit (233). The first and/or second valve (50) is elastically deformable such that the associated second portion at the associated perimeter extends through the second conduit (3, 233) and/or the third conduit (333). 19A-19M, particularly FIG. and FIG. 19G).

In a particularly preferred embodiment of the present invention, a vascular access device for hemodialysis comprising a third tubular element (303) according to the invention for double access comprises first and second tubular elements (202) of the first tubular element (202). It further comprises first and second contact surfaces (401, 402) (see Figures 18D, 18N, 19E and 19N) originating from the ends (221, 223) of the . Each of the first and second contact surfaces (401, 402) is configured to partially face a transverse section of the outer wall of the vessel (A, V). A surgical incision is made in a transverse section of the outer wall of the blood vessel (A, V) and the wall of each of the first and second ends (221, 223) of the first tubular element (202). surrounds the surgical incision for the purpose of hydraulically connecting the associated surgical incision to the first conduit (222) to facilitate fixation to the first conduit (222). In this case, in the surgical method described above, the step of pre-positioning the vascular access device (1) for hemodialysis is such that the double-access vascular access device (1) contacts the first and second contact surfaces (401, 402). Securing the first and second ends (231, 232) of the first tubular element (202) to the vein and the artery includes connecting the first and second contact surfaces (401, 402) to the associated Advantageously, positioning at the transverse section of each of the vein and artery facing the transverse section and completely surrounding the relevant surgical incision can be included. Further in this case, according to a particularly preferred aspect of the invention, each of the first and second contact surfaces (401, 402) is provided with a fourth plurality of through-holes (48) (FIGS. 19E and 1M). The fourth plurality of through-holes (48) includes an associated plurality of through-holes (see FIGS. 18D, 18N, 19E, and 19N) in the first and second contact surfaces (401, 402) and a blood vessel. Predisposed around the surgical incision to facilitate fixation by corresponding suture stitches penetrating the walls of (A, V). Alternatively, each of the first and second contact surfaces (401, 402) (see FIGS. 18D, 18N, 19E, and 19N) is a continuous surface, smooth and/or jagged, and is surgically graded. Preferably, an adhesive is used to improve fixation to the wall of the vessel (A, V). In this case, in the surgical method described above and the step of anchoring the first or second end (231, 232) of the first tubular element (202) to the vein and the artery, the first and second contact Using surgical adhesive, the first and second contact surfaces (401, 402) face the transverse section of the vein and artery, respectively, and completely surround the relevant surgical incision. 402) to the transverse section of each vein and artery.

For the purpose of maximizing blood collection and infusion rates during hemodialysis, both the sterile package of the present invention and the hemodialysis collection and/or infusion system (1000) are particularly preferred. The first conduit (22) and the second conduit (33) have associated minimum internal diameters, the cannula having the minimum internal diameter of the first conduit (22) and the minimum internal diameter of the second conduit (33). has an associated outer diameter that is 0.2-0.3 mm smaller than between This in fact allows more blood flow to be drawn and/or infused.

For the purpose of maintaining sterility, in both the sterile package of the present invention and the hemodialysis collection and/or infusion system of the present invention, it is preferred that the access elements have associated connecting ends. This connecting end is distal to the first end (108) of the treatment cannula (103) and is engageable with a needleless syringe. The access element comprises an elastically deformable element arranged in the access channel (181). The access channel (181) and the elastically deformable element are configured such that the elastically deformable element does not deform and opens the access channel (181) when the connecting ends are disengaged to prevent the passage of liquids and aerosols. elastic to block and to hydraulically connect the syringe to the first end (108) of the treatment cannula (103) when the connecting end is engaged with the needleless syringe. The deformable elements are configured and arranged together such that they are compressed by a needleless syringe and do not block the access cannula (181). In this package and system, the access element, once implanted, allows any anticoagulant to be inserted into the access device while constructing the closure means (180); or preferably with a friction-coupled cap or lid or valve. If a first gripping means is present, the access element should be positioned on the first gripping means (120) between the first gripping means (120) and the control and/or blocking device (104). (see FIG. 5C). The first and/or second gripping means may be constructed by typical 'butterfly' elements normally applied to treatment cannulas.

To the correct side of the first conduit (2, 202), the vascular access device (1), via the second conduit (33, 203) and the first conduit (22, 222), or the third First conduit (22, 222) for facilitating insertion of first end (108) of treatment cannula (103) through conduit (333) and first conduit (22, 222) may comprise first and/or second protrusions (250). The first and/or second projections (250) are respectively between the second conduit (33, 202) and the first end (221) of the first tubular element (2, 202), and between the third conduit (333) and the second end (223) of the first tubular element (202) opposite the second conduit (33, 203) and the third conduit ( 333) to allow the first end (108) of the treatment cannula (103) to pass over the projection, and the first and second ends of the first tubular element (202). It is adapted to proceed towards each part (221, 223). To achieve the projection (250), the first tubular element (202) is deformed from the outside and correspondingly opposite to the second and/or third tubular element (3, 202, 303). It is possible to obtain a concave surface (251) (see Figures 17A-17C).

The system preferably also comprises a syringe, more preferably packaged in a syringe, advantageously without a needle, containing the liquid injectable anticoagulant composition.

It should be understood that the foregoing has been described as a non-limiting example, and that any variation in the nature of the actual application falls within the protection scope of the present invention, as in the foregoing description and the claims below. want to be

Claims (14)

A vascular access device for hemodialysis permanently implantable in a patient with an arteriovenous fistula and made of biocompatible and sterile materials, comprising:
A first conduit (22) having longitudinally associated first and second ends (21) and extending from said first end (2) to said second end (21). an associated first tubular element (2) defining
a second conduit having longitudinally associated first and second ends (31,32) and extending from said associated first ends to said second ends (31,32); an associated second tubular element (3) defining (33), said first end (31) of said second tubular element (3) being connected to said second conduit (33); is in fluid communication with said first conduit (22), and said second end (32) of said second tubular element (3) is positioned relative to said first tubular element (2). said first tubular element (2) at an intermediate position between said first end and said second end (21) of said first tubular element (2) so as to be on one side; an associated second tubular element (3) secured to
comprising a first plurality of through holes (41) and secured to said first tubular element (2) and/or said second tubular element (3), said first plurality of through holes (41) being , a first fixing means (4) arranged at a second end (32) of said second tubular element (3), on a first side with respect to said first tubular element (2). wherein the vascular access device (1) is continuous to the arteriovenous fistula for blood flow therein between the first portion (51) and the second portion (52) of the arteriovenous fistula. said first tubular element (2) adapted and dimensioned for implantation in the arm of a patient having an arteriovenous fistula for hemodialysis, with said first conduit (22) sandwiched between the The first end (21) and the second end (21) of the arteriovenous fistula are connected to the first part (51) and the second part (52), respectively, of the arteriovenous fistula. (51, 52) and fixed at the second end (32) of the second tubular element (3) to connect the first plurality of through holes (41) to the first said implanted skin area by securing with a plurality of suture stitches (60) thereby securing said second end (32) of said second conduit (33) to said implanted skin area (7); a first fixation means (4), wherein said first plurality of through-holes (41) are subcutaneously positioned at said implanted skin area (7) for fixation to (7); Vascular access device. A vascular access device for hemodialysis permanently implantable in a patient and made of biocompatible and sterile materials, comprising:
a first end (221, 223) having longitudinally associated first and second ends (221, 223) and extending from said first end (2) to said second end (221, 223); an associated first tubular element (202) defining a conduit (222);
a second conduit having longitudinally associated first and second ends (231, 232) and extending from said associated first end to said second end (231, 232); an associated second tubular element (203) defining (233), said first end (231) in said second tubular element (203) being connected to said second conduit (233); is in fluid communication with the first conduit (222), and the second end (232) of the second tubular element (203) is positioned relative to the first tubular element (202). The associated second tubular element (202) fixed to the first tubular element (202) adjacent to the first end (221) of the first tubular element (202) so as to be one side. an element (203);
a third conduit having longitudinally associated first and second ends (331, 332) and extending from said associated first end to said second end (331, 332); A third tubular element (303) defining (333), wherein said first end (331) of said third tubular element (303) is connected to said third conduit (333). In fluid communication with a first conduit (222) and said second conduit (33, 233) and said second end (332) of said third tubular element (303) is connected to said first affixed to said first tubular element (202) proximate said second end (223) of said first tubular element (202) so as to be on a first side with respect to said tubular element (202); an associated third tubular element (303),
a first securing means (4) comprising a first plurality of through holes (41) and secured to said first tubular element (202) and/or said second tubular element (203); , said first plurality of through holes (41) are on a first side with respect to said first tubular element (202) and said second end of said second tubular element (203) ( 32, 232), a first fastening means (4) located at;
a second securing means (304) comprising a second plurality of through holes (41) and secured to said first tubular element (202) and/or said third tubular element (303); , said second plurality of through holes (41) are on a first side with respect to said first tubular element (202) and said second end of said third tubular element (303) ( 332), a second securing means (304) located at the
Said vascular access device (1) comprises:
A first location in an artery (A), a vein (V), or a pre-existing arteriovenous fistula (F), wherein said first conduit is an artery (A), a vein (V), or a pre-existing Between the first part (51) and the second part (52) of each of the arteriovenous fistulas (F), the arterial (A), venous (V), or pre-existing arterial (V), respectively, to the blood flow. The first and second ends (21, 221, 223) of the first tubular element (202) are respectively sandwiched between the venous fistula (F) and the first portion ( 51) and a first patient position fixed to said second part (52);
At a second location between an artery (A) and a vein (V), the associated first or second end (31, 32, 231, 232) of the first tubular element (202). ) is anchored to artery (A) and said first conduit (222) hydraulically connects artery (A) to vein (V) to form an artificial arteriovenous fistula (FA). Of the associated first or second ends (31, 32, 231, 232) of one tubular element (202), the remainder not fixed to the artery (A) are fixed to the vein (V) , a second position of the patient; and
conforming and dimensioned to be embedded in the
said first and second ends (32, 232) of said second tubular element (203) and said second end (332) of said third tubular element (303); A plurality of through-holes (41) are secured to the implanted skin area (7) by a corresponding first and a corresponding second plurality of suture stitches (60) and thereby allow said second conduit ( 233) and said second ends (33, 332) of said third tubular element (303) can be secured to said implanted skin area (7). , said first and second plurality of through-holes (41) are positioned subcutaneously in said implanted skin area (7) for implantation at said first location and said second location. . Said first fixing means (4) originate from said second end (32, 232) of said second tubular element (3, 203) and/or, if present, said second fixing means The means (304) originate from the second end (32, 332) of said third tubular element (3, 303) and said first fixing means (4) extend through the associated main through hole ( 44), said first plurality of through holes (41) being arranged around said main through hole (44), said plate (4) being connected to said second conduit (33, 233) on said second end (32, 232) of said second tubular element (3, 203) at a first side of association so as to be accessible from said main through hole of association. When fixed and/or present, said second fixing means comprises a second plate (304) having associated said main through-holes, said second plurality of through-holes (41) being: Peripherally to the associated main through hole, another second plate (304) is arranged such that the third conduit (333) is accessible from the associated main through hole (44). , secured to the second end (332) of the third tubular element (303) in a first plane of association. Said plate (4) is arranged with said second tubular element (3, 203) facing said second end (45) opposite said first face of association with said second face of association. ) and arranged along a plane parallel to said longitudinal unfolding axis (24) of said first tubular element (2, 202) and/or if present, said second plate (304) is fixed to said third tubular element (303) by means of a second surface of association (45) opposite said first surface of association and said first tubular element (2 4. The vascular access device of claim 3, arranged along a plane parallel to the longitudinal deployment axis (24, 224) of 202). connected to said second conduit (33, 233) and, in an associated closed configuration, hydraulically closing said second conduit (33, 233); in an associated open configuration, said second conduit (33, 233); , 233) and/or connected to said third conduit (333), if present, and/or said third tubular element (303). and a second valve (50) configured to hydraulically close said third conduit (333) in an associated closed configuration and to open said third conduit (333) in an associated open configuration. ), the vascular access device of any one of claims 1-4. Said first valve (50) and/or said second valve (50) comprises an associated through slot (56) equating two working edges, said first and/or said second In the associated closed configuration of two valves (50), said working edges contact to prevent passage of fluid through said valves (50), said first and/or said second valves (50) 6. The vascular access of claim 5, wherein are elastically deformable to provide an associated open configuration in which said working edges move away from each other to allow passage of fluid through said slot (50). device. Said first valve (50) has an associated perimeter and is arranged in a second conduit (33, 233) at said first end (31, 231) of said second tubular element (203). said first portion (151) in said perimeter of association fixed to said second conduit (33, 233) and the remaining second portion (152) of said perimeter of free association. with it facing and in contact with and/or present in said closed position of interest to said second conduit (33, 233) to hydraulically close said second conduit (33, 233) , said second valve (50) has an associated perimeter and is disposed in said third conduit (333) at a first end (332) in said third tubular element (303). , with a first portion (151) at the perimeter of association fixed to the third conduit (333), and a remaining second portion (152) at the perimeter of free association, which is associated with facing and contacting said second conduit (33, 233) to hydraulically close said second conduit (33, 233), said first and/or second The valve (50) is elastically deformable to hydraulically open the second conduit (3, 233) and/or the third conduit (33), respectively, at the associated perimeter. 6. The vascular access device of claim 5, wherein two portions implement an open configuration of association, not in contact with said second conduit (3, 233) and/or said third conduit (333), respectively. further comprising first and second contact surfaces (401, 402) originating from said first and second ends (221, 223), respectively, of said first tubular element (202); and second contact surfaces (401, 402) each configured to partially face a transverse section of the outer wall of the blood vessel (A, V) in which a surgical incision has been made, said To facilitate fixation of each of said first and second ends (221, 223) of first tubular element (202) to said wall, an associated surgical incision is made through said first conduit. The vascular access device of any one of claims 2-7, which completely surrounds a surgical incision for the purpose of hydraulically connecting to (222). Each of said first and second contact surfaces (401, 402) comprises a fourth plurality of through holes (48), said fourth plurality of through holes (48) comprising said first and second contact surfaces (401, 402). associated plurality of said through-holes in the contact surfaces (401, 402) of the , as well as corresponding suture stitches through the wall of the vessel (A, V) to allow for fixation by a surgical incision. 9. The vascular access device of claim 8, pre-disposed surrounding. A vascular access healing device comprising:
A cylinder (505) insertable within a vascular access and having an associated longitudinal axis of development, first and second associated longitudinal ends, and at said first end of said cylinder (505). an associated insert (502) with a fixed distally tapered tip (503) between the first valve (50) and the first plate (4); or to exclusively occlude a portion of the second conduit (33, 233) or the third conduit (333) configured between the second valve (50) and the second plate (304), respectively. 2) said second conduit (33, 233) or said third conduit (333) in the vascular access device (1) for hemodialysis according to any one of claims 5-9, associated with an associated insert (502) insertable from said second end (32, 232, 332);
an associated connection (504) secured to said second end of said cylinder (505);
First and associated second gripping tabs (501) secured to said connecting portion (504) on either side of said connecting portion (504) and on both sides of said cylinder axis, said first and second gripping tabs (501) relative to said connection (504) to assume a first configuration of association, in which gripping tabs (501) are substantially coplanar, and a second configuration, in which said tabs are opposite each other. Possibly of movement, in both said first and second configurations said first and second gripping tabs (501) are attached to said second conduit (33, 233) or said third conduit. an associated first and associated second grasping tab (501) not insertable into (333). The associated cylinder is inclined with respect to the connection by an angle (λ) that is identical to the angle (β), at which angle the second tubular element (3, 203) or the third 11. The vascular access healing device of claim 10, wherein the tubular element (303) is angled relative to the first plate (4) or the second plate (304), respectively. A collection and/or infusion system (1000) for hemodialysis, comprising:
Vascular access device for hemodialysis according to any one of claims 1 to 9 and for drawing and/or infusing blood in an arteriovenous fistula (F), a vein (V) or an artery (A) comprising at least one disposable device (102) for
Said disposable device (102) comprises:
A treatment cannula (103) for cannulation procedures having an associated first end (108) and an associated second end (109), said first end (108) being free , the second conduit (33, 203) and the first conduit (22, 222) of the vascular access device (1) to a pre-existing arteriovenous fistula (F), artery (A), or vein (V) of the patient. ) or via a third conduit (333) and said first conduit (22, 222), a treatment cannula (103);
a pre-arranged flow control and/or blockage device (104) for controlling and/or blocking fluid flow in said treatment cannula (103);
A connecting element (106) secured to said second end (109) of said treatment cannula (108) for enabling hydraulic connection to a blood inlet line or a blood outlet line of a hemodialysis machine. )When,
positioned between the first end (108) of the cannula and the control and/or isolation device (104) and hydraulically connected to the first end (108) of the cannula an optional access element defining an access channel (181); and allowing injection of a liquid into said access channel (181) and directing this liquid to said first end of said treatment cannula (103). reversible closure means (180) for reversibly closing said access channel (181) at the distal end of said access element for flow towards portion (108);
Optionally, a first gripping element (120) and/or said connecting element (106) arranged between said first end (108) and said control and/or blocking device (104) ), a second gripping element (130) positioned proximate to the
built by
A collection and/or injection system (1000) optionally comprising at least one healing device (500) in a vascular access according to claim 10 or 11. A sterile package comprising at least one disposable device (102) for drawing and/or infusing blood in an arteriovenous fistula,
A treatment cannula (103) for cannulation procedures having an associated first end (108) and an associated second end (109), said first end (108) being free , into a pre-existing arteriovenous fistula (F), artery (A) or vein (V) of the patient, the second conduit (33 , 233) and the first conduit (22, 222) or via the third conduit (333) and said first conduit (22, 222), the treatment cannula (103). )When,
a pre-arranged flow control and/or blockage device (104) for controlling and/or blocking fluid flow in said treatment cannula (103);
A connecting element (106) secured to said second end (109) of said treatment cannula (108) for enabling hydraulic connection to a blood inlet line or a blood outlet line of a hemodialysis machine. )When,
positioned between the first end (108) of the cannula and the control and/or isolation device (104) and hydraulically connected to the first end (108) of the cannula an optional access element defining an access channel (181); and allowing injection of a liquid into said access channel (181) and directing this liquid to said first end of said treatment cannula (103). reversible closure means (180) for reversibly closing said access channel (181) at the distal end of said access element for flow towards portion (108);
Optionally, a first gripping element (120) and/or said connecting element (106) arranged between said first end (108) and said control and/or blocking device (104) ), and a second gripping element (130) positioned proximate to the sterile package. The access element has an associated connecting end distal to the first end (108) of the treatment cannula (103) and engageable with a needleless syringe. and said access element further comprises an elastically deformable element arranged in said access channel (181), said access channel (181) and said elastically deformable element preventing the passage of liquids and aerosols so that when the connecting end is disengaged, the elastically deformable element does not deform and blocks the access channel (181); When engaged, the elastically deformable element is compressed by the needleless syringe to hydraulically connect the syringe to the first end (108) of the treatment cannula (103). 14. The aseptic package of claim 13, configured and co-located so as to not obstruct said access cannula (181).

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