IT202000013321A1 - PERMANENTLY IMPLANTABLE INTO A PATIENT HEMODIALYSIS VASCULAR ACCESS DEVICE, VASCULAR ACCESS CICATRIZATION DEVICE, AND STERILE PACKAGING CONTAINING A SINGLE USE BLOOD COLLECTION AND/OR INPUT DEVICE FOR USE IN HEMODIALYSIS - Google Patents

Description

PERMANENTLY IMPLANTABLE INTO A PATIENT HEMODIALYSIS VASCULAR ACCESS DEVICE, VASCULAR ACCESS CICATRIZATION DEVICE, AND STERILE PACKAGING CONTAINING A SINGLE USE BLOOD COLLECTION AND/OR INPUT DEVICE FOR USE IN HEMODIALYSIS

DESCRIPTION OF THE INVENTION

The invention fits into the field of hemodialysis devices. In particular, the invention relates to a vascular access device for hemodialysis that can be permanently implanted in a patient having an arteriovenous fistula and a disposable device for drawing and/or introducing blood from the patient usable in combination with the vascular access device with which ? It is possible to obtain a withdrawal and/or injection system for hemodialysis which comprises both devices and which allows to advantageously carry out the surgical and hemodialysis methods described herein.

Hemodialysis ? a treatment which allows, through the extracorporeal circulation of the blood, to purify it in a special hemodialysis equipment which includes a semi-permeable membrane through which pass only (or at least in greater quantities) the toxic substances to be removed. This treatment is used by patients suffering from severe renal insufficiency. Obviously, to carry out hemodialysis, a vascular access must be created, i.e. two points: one from which the blood to be purified is taken, and the other from where the filtered blood is re-entered into the circulatory system. The most commonly used vascular access? the arteriovenous fistula (also called AVF) which is made with surgery by creating a permanent connection between a vein and an artery which involves the enlargement of the vein portion of the arteriovenous fistula, why? blood pressure? much more higher than the venous one. Therefore, the two aforementioned points of the vascular access in the arteriovenous fistula can be arranged, since? allows the passage of relatively high blood flows, decreasing the time required for haemodialysis. Despite us? hemodialysis? long treatment, in fact, requires from three to four hours and must be performed two/three times a week. Consequently the arteriovenous fistula ? periodically and frequently subjected to trauma due to the insertion of metal needles called ?fistula needles?, which are metal, have diameters of the order of 1.6 mm, a pointed and cutting tip. They must be inserted into the arteriovenous fistula and can create trauma to the portion of the AVF wall opposite the inlet portion, in particular because to central the vein, the fistula needle is inserted with an initial inclination with respect to the skin and to insert it in the AVF, this inclination must then be changed and the needle positioned parallel to the fistula. There? causes stress, pain and trauma to the patient (just think of the hematomas), the risk of passing the AVF from side to side, complications for those with frailty? of the veins and a?high possibility? of infection. In fact, even if a local anesthesia is administered, the patient still feels pain once the effect of the latter has worn off. To work around this?, ? was the ?Buttonhole? which plans to insert needles in the AVF always in the same two points (withdrawal and entry) with the same angle and depth? in order to create a kind of subcutaneous channel of scar tissue extending from the skin surface to the AVF through which the needles are inserted before each hemodialysis session. Special devices have also been created to be inserted into the canal between one session and another to keep it open until the canal closes. stably formed. It is obvious that it is essential to ensure the same angle and the same depth? during each needle insertion. In this regard, initially the aforementioned fistula needles (pointed and cutting needles) must be used for a certain number of dialysis sessions, and only afterwards must one switch to suitable Buttonhole needles which have the same diameter as the fistula needles and a blunt and not sharp. Therefore ? highly specialized personnel is necessary to use this technique, especially in the initial stages of treatment. Furthermore, the Buttonhole technique seems to be related to a higher incidence of infections than the use of sharp needles and is not? indicated in case the subcutaneous tissue is too much or too little and in the case of scarred skin. Recently, hemodialysis vascular access devices have been devised that are permanently implantable in a patient having an arteriovenous fistula. These devices have a fixation surface intended to be fixed to the outer wall of the AVF proximally to the skin and which include a funnel-shaped channel leading into the most? thin in said fastening surface and that once implanted the device remains lodged in the muscle. Also with these devices a fistula needle must be used which is inserted into the skin and muscle trying to center the funnel-shaped channel and as it is inserted it pierces the wall of the AVF in correspondence with the fixing surface of the device. This device does not avert the risk of being able to pass the vein (V) from side to side with the fistula needle: moreover, in virtue of of the funnel channel, does not allow a variety? of inclinations of? needle fistula that therefore you can not? insert deeply, n? allows you to decrease the treatment time that ? limited by the section of the fistula needle like the Buttonhole technique. Documents US 2010/318016 A1 and US 4,822,341 A disclose further permanently implantable hemodialysis vascular access devices in a patient having an arteriovenous fistula. The device according to US 4,822,341 is to be implanted in series with a blood vessel. Once implanted, the device has an inlet hole and an outlet hole, respectively for withdrawing and re-injecting blood. Said device provides a sliding valve to close and or open said holes sliding longitudinally with respect to the blood vessel, once the device has been implanted, said sliding valve ? placed subcutaneously. It is clear that, in order to open and close the holes, the operator must slide said sliding valve inside the patient's body, contrasting the action of the tissues in correspondence with the valve, and that he must use a fistula needle by inserting it into the skin and into the muscle trying to center these holes, once they are open. in virtue of the objective difficulties? to slide the valve implanted in the body, this device has practically never had a practical application. So does the need emerge? to carry out hemodialysis sessions limiting stress, pain, and trauma to the patient, damage to the AVF, the possibility? of infections of the vascular access sites of the AVF, the necessity? of specialized personnel and treatment times. In addition, there emerges the need to reduce the number of operations to be performed on a patient to make him suitable for hemodialysis in order to reduce the risks related to said operations and the disturbance and pain caused to the patient. Furthermore ? the need to reduce the costs and/or times relating to haemodialysis is strongly felt.

The purpose of the present invention ? to solve or limit the inconveniences related to hemodialysis via AVF. In particular, the main purpose of the present invention ? make a hemodialysis treatment possible by limiting stress, pain, and trauma to the patient, damage to the AVF or other blood vessels, the possibility? d? infections of the vascular access sites of the AVF, need? of highly specialized personnel and related costs. In addition, a further object of the present invention ? create a device for vascular access devices that is constructively simple and economical, as well as? reliable in use. A further object of the present invention ? to allow for a reduction in hemodialysis times. The above objects are achieved in accordance with the content of the independent claims 1, 11 and 14. In fact, the vascular access device for hemodialysis in accordance with claim 1 can be permanently implanted in series with the pre-existing AVF, vein or artery or can? hydraulically connect a vein to an artery. The sterile package containing a disposable device for sampling and/or placing blood in an arteriovenous fistula as defined in claim 14 can be opened and used in each hemodialysis session by hydraulically connecting the connection element of said disposable device to a blood inlet tube or to a blood outlet tube of a hemodialysis device, acting on the adjustment device and/or flow interception to allow flow into the cannula and inserting the first end? of the medical cannula (possibly by piercing with a separate needle only the skin of the patient at the second end of the second tubular element of the second duct) through the second and first duct of said vascular access device according to the invention implanted. because the only bodily element that is drilled? the skin, and that it heals easily, in particular if treated with special fistula-pressing pads comprising silver and/or another disinfectant and/or healing agent, the pain caused to the patient during hemodialysis sessions is considerably reduced. It is also evident that, in accordance with the invention, there is never the risk of passing through the vein, the artery or the arteriovenous fistula during the hemodialysis sessions since the insertion of the withdrawal or injection device into the vein is carried out by cannulation and takes place in correspondence with the vascular access device and with the insertion of an extremity free of a medical cannula for cannulation. This end, by definition, is not sharp and ? flexible enough to conform and fit first into the second conduit and then into the first conduit of the hemodialysis vascular access device. Consequently, there is no risk of any damage to the FAV. In addition to this?, the first conduit can? have the same internal diameter as the AVF, vein or artery and the cannula can? have, depending on the relative thickness, a diameter 0.1-0.2 mm smaller than the internal diameter of the first duct, i.e. an internal diameter of 2.0-4.0 mm, therefore, much higher than that of the first duct fistula needle what ? of 1.6mm. This?, allows you to significantly increase the amount? of blood drawn and introduced into the AVF during haemodialysis. Therefore, by suitably sizing the filtering surface of the semipermeable membrane of the hemodialysis equipment on the basis of the blood flow that can flow into the cannula having this internal diameter of 2.0 - 4.0 mm, sar? Is it possible to significantly limit the time and costs of personnel related to a single hemodialysis treatment by increasing productivity? of the staff.

It should be noted that the use of the vascular access healing device according to the invention allows, by inserting it into the vascular access point of the body and into the second and/or third second duct, to cause the valve access to heal around the cylinder of the device of scarring. In fact, leaving the healing device in place for a few days, removing it to periodically dress the vascular access (at least 2-3 times a week), and replacing it after each dressing, ? It is possible to obtain, in a relatively short time, permanent vascular access having a permanently open scarred access hole. The latter flows into the second or third second conduit of the vascular access device according to the invention to which it is preferably ? connected, respectively, the first or second valve, which hydraulically close the respective second or third duct. In this way, blood loss can be drastically limited. Note that permanent vascular access having a scarred access hole is traversable by a cannula for cannulation, in particular the one included in the sterile package according to the invention. Therefore, not ? need to use fistula needles to perform dialysis. Consequently, the latter can? then also be performed by an employee not highly specialized in dialysis why? the entrance of the cannula in said permanent vascular access? enormously simplified with respect to the prior art and the connection of the hemodialysis equipment to the patient is further facilitated. Furthermore, by not involving the use of fistula needles, the discomfort and pain caused to the patient is reduced and the probability of being injured is reduced. to cause damage to veins, arteries or the AVF.

Depending on the characteristics of the individual being dialysed, the time required to obtain permanent vascular access with the permanently open scarred access hole can be vary from 4 to 12 weeks, or 8 to 10 weeks. In this period and in any case, in the event that the proposed healing device is not used, until the vascular access device is implanted? reached maturity (that is, it is not ready to be used) is the dialysis not performed or is it performed through a central venous catheter, which will come? then deleted. In addition to the advantages outlined above, the vascular access device for hemodialysis in accordance with the independent claim 1 further and advantageously allows to choose the blood vessel in which to implant it, in fact, it can to be implanted in series with an artery (A) to a vein to a pre-existing arteriovenous fistula or, more preferably, to be implanted between an artery and a vein to itself constitute an artificial arteriovenous fistula. In this case, a single operation creates a permanent vascular access and outlet and an artificial arteriovenous fistula, thus limiting the number of operations to be performed on the patient and the consequent risks of postoperative complications as well as the discomfort caused to the patient.

The characteristics of the invention will be highlighted below in which preferred, but not exclusive, relative embodiments are described, with reference to the attached drawings in which: Figures 1A, 1B, 1C, 1D, and 1E are schematic views, respectively perspective, lateral, top, frontal, and sectional view with respect to the IE-IE plane of figure 1D of a first embodiment of a vascular access device for hemodialysis according to the invention; Figures 2A, 2B, 2C, 2D, and 2E are schematic views, respectively perspective, side, top, front, in section with respect to the plane 2E-2E of Figure 2D of a second embodiment of a vascular access device for hemodialysis according to the invention; figure 3 ? an enlarged view of detail K of Figure 2B; figure 4 ? a schematic perspective view, of a third embodiment of a vascular access device for hemodialysis according to the invention; figure 5A ? a top view of a sterile package according to the invention; figure 5B ? a side view of an embodiment of the disposable blood sampling and/or injecting device according to the invention; figure 5C ? a top view of the disposable device of figure 5B; the 5D figure ? a sectional view along the VD-VD axis of figure 5C of the disposable device of figure 5B; figure 5E ? a front view of the disposable device of figure 5B; figure 5F ? an enlarged view of detail A of figure 5D; the figure 5G ? a perspective view of the disposable device of figure 5B; figure 5I ? an enlarged view of detail B of figure 5G; figure 5H ? an enlarged view of detail C of figure 5G; figure 5L ? a side view of a further embodiment of the disposable blood withdrawal and/or inlet device; the 5M figure ? a top view of the disposable device of figure 5L; figure 5N ? a sectional view along the VN-VN axis of figure 5M of the disposable device of figure 5L; figure 5O ? a front view of the disposable device of Figure 5L; figure 5P ? an enlarged view of detail D of figure 5N; figure 5Q ? a perspective view of the disposable device of Figure 5L; the figure 5R ? an enlarged view of detail E of figure 5G; the 5S figure ? an enlarged view of detail D of figure 5G; figure 6 ? a schematic sectional view of a first embodiment of a portion of a withdrawal and/or injection system for hemodialysis according to the invention coupled to an arteriovenous fistula in a configuration of use; figure 7 ? a schematic sectional view of a second embodiment of a portion of a withdrawal and/or injection system for hemodialysis according to the invention coupled to an arteriovenous fistula in a configuration of use; the figure 8 ? a schematic sectional view of a third embodiment of a portion of a withdrawal and/or injection system for hemodialysis according to the invention coupled to an arteriovenous fistula in a configuration of use; Figure 9A ? a side view of a fourth embodiment of a vascular access device according to the invention; Figure 9B a rear view of the device of Figure 9A, Figure 9C a top view of the device of Figure 9A, Figure 9D a sectional view of the device of Figure 9A according to the IXD-IXD plane of Figure 9C, Figure 9E is a sectional view of the device of Figure 9A according to the IXE-IXE plane of Figure 9B, Figure 9F ? an enlarged view of detail J of Figure 9D, Figure 9G ? a sectional view of the device of Figure 9A according to the IXG-IXG plane of Figure 9D, Figure 9H ? a sectional view of the device of Figure 9A according to the plane IXH-IXH of Figure 9G, Figure 9I ? an enlarged view of detail W of Figure 9H, Figures 9L 9M are perspective views, respectively from below and from above, of the device of Figure 9A, Figure 10A ? an exploded view of the device of Figure 9A , Figure 10B and a rear view of the exploded device of Figure 10A , Figure 10C ? a sectional view of the exploded device of Figure 10A according to the plane XC-XC of Figure 10A, Figure 10D ? a sectional view of the exploded device of Figure 10A according to the plane XD-XD of Figure 10B, Figure 10E ? a perspective view of the exploded device of Figure 10A , Figure 10F ? an enlarged view of detail X of Figure 10D, Figure 11A ? a side view of a fifth embodiment of a hemodialysis vascular access device according to the invention, Figure 11B is shown. a rear view of the device of Figure 11A, Figure 11C ? a top view of the device of Figure 11A, Figure 11D ? a sectional view of the device of Figure 11A according to the XID-XID plane of Figure 11C, Figure 11E ? a sectional view of the device of Figure 11A according to the XIE-XIE plane of Figure 11B, Figure 11F ? an enlarged view of detail U of Figure 11D, Figure 11G ? a sectional view of the device of Figure 11A according to the XIG-XIG plane of Figure 11D, Figures 11L and 11M are perspective views, respectively from below and from above, of the device of Figure 11A, Figure 12A ? an exploded view of the device of Figure 11A, Figure 12B ? a rear view of the exploded device of Figure 12A , Figure 12C ? a sectional view of the exploded device of Figure 12A according to the plane XIIC - XIIC of Figure 12A, Figure 12D ? a sectional view of the exploded device of Figure 12A according to the XIID-XIID plane of Figure 12B, Figure 12E ? a perspective view of the exploded device of Figure 12A , Figure 12F ? an enlarged view of detail V of Figure 12D, Figure 13A is a side view of a sixth embodiment of a vascular access device according to the invention, Figure 13B is shown. a rear view of the device of Figure 13A, Figure 13C ? a top view of the device of Figure 13A, Figure 13D ? a sectional view of the device of Figure 13A according to the XIIID-XIIID plane of Figure 13C, Figure 13E a sectional view of the device of Figure 13A according to the XIIIE-XIIIE plane of Figure 13D, Figure 13F ? an enlarged view of detail K of Figure 13D, Figures 13G and 13H are perspective views, respectively from below and from above, of the device of Figure 13A, Figure 14A? an exploded view of the device of Figure 13A, Figure 14B ? a rear view of the exploded device of Figure 14A , Figure 14C ? a sectional view of the exploded device of Figure 14A according to the XIVC-XIVC plane of Figure 14A, Figure 14D ? a sectional view of the device of Figure 14A according to the XIVD-XIVD plane of Figure 14B, Figure 14E ? an enlarged view of detail Z of Figure 14D, Figure 14F ? a perspective view of the device of Figure 14A , Figures 15A, 15B and 15C are side, and bottom and top perspective views, respectively, of a seventh embodiment of a vascular access device according to the invention Figures 16A 16B and 16C are side, and bottom and top perspective views, respectively, of an eighth embodiment of a vascular access device according to the invention, FIGS. 17A, 17B, 17C and 17D are, respectively, side, longitudinal section, and bottom and top perspective views of a ninth embodiment of a vascular access device according to the invention; Figure 18A ? a side view of a tenth embodiment of a vascular access device according to the invention; Figure 18B ? a rear view of the device of Figure 18A, Figure 18C ? a top view of the device of Figure 18A, Figure 18D ? a sectional view of the device of Figure 18A according to the XIIXD-XIIXD plane of Figure 18B, Figure 18E ? a view of the device of Figure 18A from towards P, Figure 18F ? a sectional view of the device of Figure 18A according to the XIIXF-XIIXF plane of Figure 18A, Figure 18G ? an enlarged view of detail J of Figure 18D, Figure 18H ? a sectional view of the device of Figure 18A according to the XIIXH-XIIXH plane of Figure 18A, Figure 18I ? a sectional view of the device of Figure 18A according to the XIIXI-XIIXI plane of Figure 18H, Figures 18N and 18M are views and perspectives, respectively from below and from above, of the device of Figure 18A, Figure 19A ? a side view of an eleventh embodiment of a vascular access device according to the invention, Figure 19B is shown. a rear view of the device of Figure 19A, Figure 19C ? a top view of the device of Figure 19A, Figure 19D ? a sectional view of the device of Figure 19A according to the XIXD-XIXD plane of Figure 19B, Figure 19F ? an enlarged view of detail B of Figure 19D, Figure 19E ? a sectional view of the device of Figure 19A according to the plane XIXE-XIXE of Figure 19B, Figure 19G ? an enlarged view of detail c of Figure 19E, Figure 19H ? a sectional view of the device of Figure 19A according to the XIXH-XIXH plane of Figure 19A, Figure 19I ? a sectional view of the device of Figure 19A according to the XIXI-XIXI plane of Figure 19H, Figures 19N and 19M are views and perspectives, respectively from below and from above, of the device of Figure 19A; Figures 20A, 20B and 20C are views illustrating the positions in which pu? 21A, 21B, 21C, and 21D are schematic front, side, top, and perspective views, respectively, of a valve access healing device in accordance with the invention in a first related configuration and figures 21E, 21F and 21G are schematic side, front and perspective views, respectively, of the device of Fig. 2A in a second related configuration.

With reference to the figures, yes? indicated with 1 a vascular access device for hemodialysis, permanently implantable in a patient having an arteriovenous fistula, with 1 a vascular access device usable for hemodialysis, permanently implantable in a patient, with 102 a disposable withdrawal and/or injection device of blood, with 500 a valve access healing device, with 100 a sterile package and with 1000 a withdrawal and/or injection system for hemodialysis in accordance with the invention. How can you? note from the figures, the first to third embodiments relate to a single access vascular access device according to the invention (see Figures 1A-4 and 6-8), while the fourth to fourth embodiments eleventh relate to a double access vascular access device according to the invention because they allow a double vascular access (see Figures 9-19N). This vascular access device according to the invention with double access, in fact, can be used both for withdrawing blood from the patient to be subjected to hemodialysis and for re-introducing blood into the patient undergoing dialysis, for example by withdrawing the blood from the second tubular element 203 and re-introducing it into the third tubular element 303, or vice versa. While single access vascular access devices allow only one access, either incoming or outgoing, and therefore two must be implanted for each patient. The mono-access vascular access device 1 ? a vascular access device 1 which ? made of a biocompatible and sterilizable material, and includes:

- a relative first tubular element 2 having a first and a second relative end? 21, which are longitudinal, and defining a first duct 22 which extends from the first to the second end? 21;

- a related second tubular element 3 having a first and a second related end? 31, 32, which are longitudinal, and defining a second conduit 33 which extends from its first to second end? 31, 32; in which the first extremity? 31 of the second tubular element 3 ? fixed to the first tubular element 2 in an intermediate position between the first and second ends? 21 of the first tubular element 3 (see figures 1A, 1B, 1E, 2A, 2B, 2E, and 4), so that the second duct 33 is in fluid communication with the first duct 22 and that the second end? 32 of the second tubular element 3 is on a first side with respect to the first tubular element 2;

- fixing means 4 comprising a first plurality? of through holes 41 and being fixed to said first and/or second tubular element 3 (preferably they are fixed to the second tubular element 3) with said first plurality? of through holes 41 arranged on said first side, with respect to the first tubular element 2, and at the second end? 32 of the second tubular element 3, wherein said vascular access device 1 ? shaped and sized to be able to be implanted in the arm of a patient having an arteriovenous fistula for hemodialysis with the first duct 22 interposed in series with the arteriovenous fistula, with respect to the flow of blood in the latter, between a first section 51 and a second section 52 of said arteriovenous fistula, with the first extremity? and the second end? 21 of the first tubular element 2 fixed respectively to the first section 51 and to the second section 52 of the arteriovenous fistula, at a relative end of the relative section 51, 52 and with said second end? 32 of the second tubular element 3 and the first plurality? of through holes 41 arranged subcutaneously in an implant skin region 7 to allow the fixing of the first plurality? of through holes 41 to the skin region 7 of the implant by means of a first plurality? of stitches 60, and the consequent fixing of the second extremity? 32 of the second duct 33 to the implant skin portion 7. Note that, in order for the second duct 33 is in fluid communication with the first duct 22 and that the second end? 32 of the second tubular element 3 is on a first side with respect to the first tubular element 2, the first end? 31 of the second tubular element 3 cannot? be fixed to the first tubular element 2 in an intermediate position between the first and second ends? 21 of the second tubular element 3. In fact, the first end? 31 of the second tubular element 3 but ? fixed in an intermediate position between the first and the second extremity? 21 of the first tubular element 2 as visible in figures 1A, 1B, 1E, 2A, 2B, 2E, and 4.

The vascular access device 1 according to the invention, of the double access type, such as those illustrated in figures 9-19, is a vascular access device 1 for hemodialysis permanently implantable in a patient, which ? made of a biocompatible and sterilizable material, and which includes:

- a related first tubular element 202 having a first and a second related end? 221, 223, which are longitudinal, and defining a first conduit 222 which extends from the first to the second end? 221, 223;

- a related second tubular element 203 having a first and a second related end? 231, 232 (see FIG. 10F), which are longitudinal, and defining a second conduit 233 extending from its first to second ends? 231, 232; in which the first extremity? 231 of the second tubular element 203 ? fixed to the first tubular element 202 proximally to the first end? 221 of the first tubular element 202, so that the second duct 233 is in fluid communication with the first duct 222 and that the second end? 232 of the second tubular element 203 is on a first side with respect to the first tubular element 202;

- a related third tubular element 303 having a first and a second related end? 331, 332, which are longitudinal, and defining a third conduit 333 which extends from its first to second end? 331, 332 (see figure 19G); in which the first extremity? 331 of the third tubular element 303 ? fixed to the first tubular element 202 proximally to the second end? 223 of the first tubular element 202, so that the third duct 333 is in fluid communication with the first duct 222 and with the second duct 233 and that the second end? 332 of the third tubular element 303 is on said first side with respect to the first tubular element 202; And

- first fastening means 4 comprising a first plurality? of through holes 41 and being fixed to said first tubular element 202 and/or second tubular element 203 with said first plurality of through holes 41 ? arranged on said first side, with respect to the first tubular element 202, and at the second end? 232 of the second tubular element 203,

- second fastening means 304 comprising a second plurality? of through holes 41 and being fixed to said first tubular element 202 and/or third tubular element 303 with said second plurality? of through holes 41 ? arranged on said first side, with respect to the first tubular element 202, and at the second end? 332 of the third tubular element 303, wherein said vascular access device 1? shaped and sized to be implanted in a patient, preferably in a related arm, in:

- a first position that ? in correspondence with an artery A, a vein V, or a pre-existing arteriovenous fistula F (see figures 20C, 20B and 20A respectively) with the first duct interposed in series with respect to the blood flow, respectively in artery A, in vein V or in the pre-existing arteriovenous fistula F between a first section and a second section, respectively, of said artery A, vein V, or pre-existing arteriovenous fistula F, with the first extremity? and the second end? 221, 223 of the first tubular element 202 fixed, respectively to the first section 51 and to the second section 52, and/or

- in a second position, between said artery A and said vein V (see figure 20D), with the relative first or second end? 231, 232 of the first tubular element 202 fixed to said artery A and with remaining between said relative first or second relative extremity? 231, 232 of the first tubular element 202, which is not fixed to artery A, fixed to vein V in such a way that the first conduit 222 hydraulically connects said artery A to said vein V to form an artificial arteriovenous fistula FA, in which, in said first and second positions, the second end? 232 of the second tubular element 203 and the second end? 332 of the third tubular element 303, the first and second plurality? of through holes 41 arranged subcutaneously in an implant skin region 7 to allow the fixing of the first and second plurality? of through holes 41 to the skin region 7 of the implant by means of a corresponding first and a corresponding second plurality? of stitches 60, and the consequent fixing, respectively, of the second extremity? 232 of the second duct 233 and of the second extremity? 332 of the third tubular element 303 to the implant skin portion 7.

This vascular access device for dual access hemodialysis, in addition to being implantable in series with a blood vessel (vein, artery A and pre-existing arteriovenous fistula), advantageously allows the following surgical method to be performed for implanting said device which comprises the following steps: preparing said dual access hemodialysis vascular access device in accordance with the invention; make a surgical hole in a wall of a vein V at an implant site; performing a surgical hole in a wall of an artery A disposed in said implantation site; hydraulically connect said vein to said artery through a first conduit 222, which ? hydraulically connected at the relative ends, respectively to a second duct 233 and to a third duct 333; fix the relative first or the second extremity? 231, 232 of the first tubular element 202 to said artery A at the relative surgical hole; and fix, the remainder between said relative first or second relative extremity? 231, 232 of the first tubular element 202, which is not fixed to the artery A in correspondence with the relative surgical hole, to the vein V in such a way that the first conduit 222 hydraulically connects said artery A to said vein V to form an artificial arteriovenous fistula FA, arranging the second end? 232 of the second tubular element 203, the second end? 332 of the third tubular element 303, the first and second plurality? of through holes 41 arranged subcutaneously in an implant skin region 7; and fix the first and second plurality? of through holes 41 to the skin region 7 of the implant by means of a corresponding first and a corresponding second plurality? of stitches 60.

In order to obtain a permanent vascular access having a permanently open scarred access hole the Applicant has also devised a vascular access scarring device 500 comprising:

- a relative insertion portion 502 which ? that can be inserted inside a vascular access and which comprises: a cylinder 505 having a relative longitudinal axis of development: a first and a second relative end? which are longitudinal; and a distally tapered tip 503 (preferably coaxial with the barrel) attached to the first end? of cylinder 505; in which said portion of insertion ? insertable in the second conduit 33, 233 or in the third conduit 33 of a vascular access device 1 for hemodialysis according to any claim 4, 7, 8, 9 and 10 from the relative second end? 32, 232, 332 to occlude only a portion of said second duct 33, 233 or said third duct 33 between, respectively, the first valve 50 and the first plate 4 or between the second valve 50 and the second plate 304;

- a relative connection portion 504 fixed to the second end? of cylinder 505; And

- a relative first and a relative second gripping lug 501, fixed to the connecting portion 504 on opposite sides of the latter and on opposite sides with respect to the axis of the cylinder and with the possibility of relative movement with respect to the connecting portion 504 in order to be able to assume: a first relative configuration in which the first and second gripping lugs 501 are substantially coplanar (see figures 21A-21D); and a second configuration in which the fins are mutually opposite (See figures 21E-21F), in which both in the first and in the second configuration said first and said second gripping fin 501 cannot be inserted into said second duct 33, 233 or third conduit 33.

In accordance with a related embodiment preferably of the vascular access healing device, the related cylinder ? inclined to the connecting portion of an angle ? (See figures 21B, 21D and 21G) equal to the angle ? (see figure 1A) with which the second tubular element 3, 203 or the third tubular element 303 ? inclined with respect to the first plate 4 or the second plate 304, respectively.

With reference to figures 21A-21G, preferably the length L3 of the insertable portion 502 is between 2 or 2.5 mm and 5 mm to avoid contacting the valve 50 and preferably ? of 1-3 mm. The gripping wings 501 can have the following dimensions: L4 comprised between 3 and 6 mm, preferably 4.5 mm and L5 comprised between 4.5 mm and 6 mm, preferably 5 mm. The diameter? of the cylinder, obviously depends on the size of the second and third duct, but can? be advantageously 1.5-2 mm, preferably 1.75 mm. The width L6 of the vascular access scar device 500 can be 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 according to the invention contains a disposable device 102 for drawing and/or introducing blood into an arteriovenous fistula consisting of:

- a medical cannula 103 for cannulation having a relative first end? 108 and a relative second extremity? 109 in which the first end? 108 ? free and cannulable in a pre-existing arteriovenous fistula F, in an artery A, or in a vein V of a patient through said second conduit 33, 233 and said first conduit 22, 222 or through the third conduit 333 and the first conduit 222 of both a dual- and single-access device;

- a flow regulation and/or interception device 104 arranged to regulate and/or interrupt a flow of a liquid in the medical cannula 103; and - a connection element 106, fixed at the second end? 109 of the medical cannula 108 for enabling hydraulic connection to a blood inlet tubing or a blood outlet tubing of a hemodialysis apparatus;

- optionally an access element disposed between the first extremity? 108 of the cannula and the adjustment and/or shut-off device 104 and defining a hydraulically access channel 181 (see figures 5F and 5P) connected to the first end? 108 of the cannula; and reversible closing means 180 for reversibly closing said access channel at one end of the gate. distal end of the access element to allow fluid to be injected into the access channel and flow to the first end. 108 of the medical cannula 103. - optionally a first gripping element 120, arranged between the first end? 108 and the adjustment and/or shut-off device 104, and/or a second gripping element 130 arranged proximal to the connection element 106. Obviously, the package also comprises a relative sealed casing 101 and made of a suitable material which allows the sterilization of its content, for example said envelope 101 can? be made with a sheet of a material permeable to ultraviolet rays and/or ionizing radiations (gamma rays and/or beta rays) and/or microwaves. By suitably choosing both the relative shapes and dimensions of the vascular access device 1 and of the disposable withdrawal and/or injection device 102, contained in said sterile package 100, ? it is sufficient to open said package at each hemodialysis session to easily obtain a withdrawal and/or injection system 1000 for hemodialysis which comprises both the vascular access device 1 and said disposable withdrawal and/or injection device 102 in which the first end? 108 free of the medical cannula 103 ? free and cannulable in an arteriovenous fistula, a vein or an artery of a patient, through said second conduit 33, 233 and said first conduit 22, 222 and/or through the third conduit 333 and said first conduit 22, 222 of said device 1 of vascular access. This system 1000 allows to achieve the aforesaid objects and advantages with respect to the prior art.

This withdrawal and/or injection system 1000 for hemodialysis, in accordance with the invention therefore comprises a vascular access device 1 for hemodialysis in accordance with the invention which can be double or single-access and at least one disposable device 102 for drawing and/or placing blood in an arteriovenous fistula F, a vein V or an artery a consisting of:

- a medical cannula 103 for cannulation having a relative first end? 108 and a relative second extremity? 109 in which the first end? 108 ? free and can be cannulated in a pre-existing arteriovenous fistula F, in an artery A, or in a vein V of a patient, through said second duct 33, 203 and said first duct 22, 222 or through said third duct 333 and said first duct 22 , 222 of said vascular access device 1;

- a flow regulation and/or interception device 104 arranged to regulate and/or interrupt a flow of a liquid in the medical cannula 103; and - a connection element 106, fixed at the second end? 109 of the medical cannula 108 medical 103 for enabling hydraulic connection to a blood inlet tubing or a blood outlet tubing of a hemodialysis apparatus;

- optionally an access element disposed between the first extremity? 108 of the cannula and the adjustment and/or shut-off device 104 and defining an access channel 181 (see figures 5F and 5P) hydraulically connected to the first end? 108 of the cannula; and reversible closing means 180 for reversibly closing said access channel 181 at one end of the gate; distal of the access member to allow liquid to be injected into the access channel 181 and flow to the first end? 108 of the medical cannula 103; And

- optionally a first gripping element 120, arranged between the first end? 108 and the adjustment and/or shut-off device 104, and/or a second gripping element 130 arranged proximal to the connection element 106; and - optionally at least one vascular access healing device 500 in accordance with the invention, preferably a plurality of of such scarring devices 500, and advantageously from eight to thirty.

In the case of dual port vascular access device ? it is preferable that the system comprises two disposable withdrawal and/or injection devices 102. It should be noted that the access element and the closing means allow to aspirate any blood clots present in the access device, single and double access. In addition, they allow an anticoagulant to be injected into the first duct 22, 222. This anticoagulant can be heparin, e.g. heparin in lock, sodium citrate, urokinase and mixtures thereof.

To improve the sterilization and mechanical strength of the vascular access device 1, it ? preferably metallic, pi? preferably ? titanium, even if the? invention pu? provide that it is also made of biocompatible plastic materials that can be sterilized and not reabsorbed by the body, such as those described below. In order to improve the fixing of the second end? 32, 232 of the second tubular element 3, 203 and of the second end? 332 of the third tubular element 303, when present in the vascular access device, to the portion of skin 7 for implantation, called first and second plurality? of through holes 41 pu? be made up of two through holes 41, preferably arranged on the opposite side with respect to the second duct 33, 232 and the duct 333, respectively. If it is made up of three through holes, it would instead be preferable to arrange them around the second duct 33, 233 and to the third conduit 333 at an angular distance 120?, if ? If a greater number of through holes 41 is provided, they can be arranged along a closed ring which surrounds the second duct 33, 233 at the second end? 32, 232, of the second tubular element 3, 203 (see Figs. 1C and 2C). They can preferably also be angularly equidistant. Preferably there are at least six through holes 41. The same also applies to the holes related to the second end? 332 of the third tubular element 303, when the latter? present. Advantageously, to facilitate the insertion of said medical cannula 103 in the second 33 and in the first duct 22, 222, and/or in the first duct 222 and in the third duct 333, at least one of the two, between cannula and duct, and preferably both, have relative internal sections oval or more? preferably circular. Advantageously, these channels 22, 33 have cylindrical internal walls.

Obviously the first 2, 202 and the second tubular element 3, 203 have relative longitudinal development axes 24, 34 which are mutually incident and define two angles of incidence, one supplementary to the other. There? it also applies for the first and third tubular members, in the case of the dual port vascular access device. Preferred are the embodiments of the vascular access device 1 for hemodialysis in which said first 2 and said second tubular element 3 have a relative longitudinal axis of development incident with each other at a minimum angle ?, which ? acute. Preferably the latter can? be between 25? and 60?, more? preferably in 25? and 50? and even more preferably between 28?-30? or 43?-48? 25? and 45? and/or (preferably e) in which, when present, said third tubular element 303, said first tubular element 202 and said third tubular element 303 have a relative axis of longitudinal development incident with each other at a minimum angle ? between 25? and 50?, preferably 25?. Advantageously said minimum angle ? can? be 25, 35? or 45?. Obviously, as a function of the?minimum angle ? you will have to suitably dimension the length L2 of the second tubular element 3 obviously measured along the relative longitudinal development axis to suitably dimension the vascular access device 1 in such a way that, by fixing the first tubular element 2 to the AVF, the second end? 32 of the second tubular element 3 is found under the skin 7. However, the surgeon based on the physical characteristics of the patient (gender, age, build, muscle mass and fat mass) will be? perfectly able to choose a vascular access device 1 suitable for being implanted in a patient with the relative first tubular element 2 in series with the AVF and the second end? 32 of the second tubular element 3 under the skin 7.

In accordance with an embodiment of the proposed vascular access device 1 for hemodialysis, the first fastening means 4 can originate from the second end? 32,232 of the second tubular element 3, 203 and/or (preferably e), when present, the second fastening means 304 can originate from the second end? 332 of the third tubular element 303, for example, said first and/or second fastening means 4 can consist of a plurality of of arms not illustrated arranged radially with respect to the second duct 33 in which each arm comprises one or more? of said through holes of the first plurality? of through holes 41.

It is particularly preferable that the first fastening means 4 comprise a plate 4 having a relative main through hole 44, in which said first plurality? of through holes 41 ? arranged peripherally with respect to the main through hole 44, in which the plate 4 is fixed, in correspondence of a relative first facade, to the second extremity? 32 of the second tubular element 3, 203 so that the second duct 33, 233 is accessible from said through hole and/or (preferably e) that, when present, the second fastening means comprise a second plate 304 having a relative hole main loop, in which said second plurality? of through holes 41 ? arranged peripherally with respect to the relative main through hole and in which said second further plate 304 ? fixed, in correspondence of a relative first facade, to the second extremity? 332 of the third tubular element 303 so that the third duct 333 is accessible from the relative main through hole 44. What? simplifies the manufacture of the vascular access device 1. Advantageously, the main through hole 44 has the same section as the second duct 33 at the second end? and are coincident, there? facilitates the insertion of the medical cannula 103 into the first duct 22.

According to an advantageous aspect of the invention, plate 4 is fixed to the second tubular element 3 with a relative second face 45 opposite the relative first face and arranged along a plane parallel to the longitudinal development axis 24 of the first tubular element 2, 202 and/or (preferably e), when present, the second plate 304 ? fixed to the third tubular element 303 with a relative second face 45 opposite the relative first face and arranged along a plane parallel to the longitudinal development axis 24, 224 of the first tubular element 2, 202. As illustrated in the embodiments of Figures 9- 19 ? it is preferable that the second and third tubular element 203, 303 are arranged in such a way that the relative longitudinal development axes cross each other from said first side of the first tubular element 202 since There? facilitates the withdrawal of blood for dialysis and the return of dialysed blood to the patient. Said second facade 44 ? intended to internally counterfeit the skin 7 and preferably ? arranged at a relative distance D2, with respect therefrom to the axis of longitudinal development 24, of the first tubular element 2, 202 comprised between 5 and 10 mm, preferably between 6.5 and 8.0 mm. Also said distance D2 obviously depends on said minimum angle ? and the above considerations regarding the sizing and choice of the surgeon relating to the vascular access device 1 apply.

In order to be able to easily fix the vascular access device 1 for both single and double access hemodialysis, when the latter must be implanted in series with the pre-existing AVF, artery A or vein V, the first and second extremities ? 21, 221, 223 of the first tubular element 2, 202 can advantageously each comprise a third plurality of through holes 28 (see figures 1A-1C, 6 and 16A-17D), arranged along a relative transversal fixing sector to allow the fixing of the first and second ends? 21, 221, 223 of the first tubular element 2, 202 at one end, respectively, of the first section 51 and of the second section 52 of the arteriovenous fistula by means of a third plurality of stitches 80 visible in Figure 6. This suture pu? be performed with the end of the first of the second section of artery A, vein V or of the pre-existing arteriovenous fistula F placed externally (as in Figure 6) or internally at the first and/or second end? of the first tubular portion. In the latter case, ? preferable at least one between the first and the second extremity? 21, 221, 223 of the first tubular element 2, 202 preferably both (as illustrated in Figure 1E) each comprise a relative internal housing defined by the first duct 22, 222 and comprising a relative annular internal abutment surface 27 for, when fitted on the end, respectively, of the first section 51 and of the second section 52 of the artery A, of the vein V or of the pre-existing arteriovenous fistula F, to find (preferably entirely) a terminal annular surface of the end, respectively, of the first section 51 and of the second arteriovenous fistula tract 52 (see Figures 7 and 20A) of artery A (see Figure 20C) or vein V (see Figure 20B). There? in addition to improving the fixing, it prevents that, once the extremity has been inserted? free 108 of the medical cannula 103 in the second duct 33 and in the first duct 22, during the cannulation in a section of the artery A, of the vein V or of the pre-existing arteriovenous fistula F of this extremity? free 108, the latter can hit the annular end surface of the extreme section. Obviously if this housing 25 ? present only in one of the first and the second extremity? 21, 221, 223 of the first tubular element 2, 202 this will be? the end? opposite to the mentioned minimum angle ?.

Preferably, the second third of through holes 28 comprises at least 4, preferably at least 6 and more? preferably at least 8. Advantageously they are arranged angularly equidistant. The through holes 41 28, of the first and second and third plurality? of through holes must obviously have a size and shape such as to allow them to be crossed by a surgical needle for sutures. During the operation of suture of the first plurality? and of the second plurality? of through holes 28, respectively, to the skin 7 and to the two sections of the pre-existing AVF F, of the vein F or of the artery A severed by the surgeon, the latter will so that each of the sutures passes through a different through hole.

According to another modality? fastening of the first and second extremity? 21 of the first tubular element 2, 202 to the two sections of the pre-existing AVF F, of the severed vein F or artery A, these ends? they can be fixed to one end, respectively, of the first 51 and of the second section 52 of the pre-existing arteriovenous fistula F, of the vein F or of the artery A by means of surgical glue (not shown). In order to improve the fixation with surgical glue, the first and/or the second extremity? of the first tubular element 2, 202 can each comprise a relative transversal fastening sector having a relative irregular external surface, for example comprising a plurality? of concavity?, grooves or furrows. According to a preferred aspect of the invention, this relative transversal fastening sector has a relative plurality of of external annular grooves 29 (see figures 2A-2E and 3) coaxial to the longitudinal development axis 24 of the first tubular element 2, 202 to improve the fixing by means of surgical glue of the first and second ends? 21 of the first tubular element 2, 202 at one end, respectively, of the first and second section of the pre-existing arteriovenous fistula F, of the vein F or of the artery A.

Considering the average size of the patients, it is preferable that the vascular access device 1 for hemodialysis according to the invention, with single or double access, has the following characteristics, taken individually or in combination with each other:

- said first duct 22, 222 has a relative minimum internal radius between 2 and 5 mm, preferably 2.5-4.0 mm, and/or a relative external radius between 3 and 7 mm, 4 mm and 6.0 mm, preferably 4mm and 6.0mm, and/or

- said second duct 33, 233 and/or said third duct 333, when present, has a relative internal radius between 2.0 and 5.0 mm, preferably 2.5-4 mm, and/or a relative external radius between 3 .0 mm and 6.0 mm, preferably 3.5 mm and 5.0 mm, and/or

- said first plurality? of through holes 41 and/or said second plurality? of through holes 41, when present it is arranged at a distance between 5-9 mm, from the axis of longitudinal development 24 of the first tubular element 2, 202 preferably 6.5-8 mm and also depends on the angle between the axes of longitudinal development, and/or

- the holes 41 of said first and/or second plurality? of through holes 41 have dimensions of 1.1-2 mm, preferably 1.6 x 0.9, and/or

- the holes of said third plurality? of through holes 28 have dimensions of 0.6 - 0.9 mm, preferably 0.7 ? 0.85 and preferably ? by 0.8.

It is particularly preferable, above all in the case of the double access vascular access device, for the length of the first tubular element to be 3-10 cm, more than preferably of 4-12 cm, 8-12 cm or advantageously of 4-6 cm, both because? thereby ? possible to implant it between a vein and an? artery, in particular in an arm or a leg of a patient, both because? in artificial ducts of this length ? It is possible that the same anatomical structure naturally present inside the veins and arteries is recreated on the internal surface of the duct. There? considerably decreases the risk of thrombi and blockages of the first duct 22, 222. Furthermore, a length of the first tubular element 2, 202 of at least 4 cm, preferably 5-6 cm ensures that the blood taken during dialysis does not contain freshly recovered blood. entered during dialysis. In the event that the hemodialysis vascular access device is dual access, and must be used to obtain an artificial arteriovenous fistula, ? preferably that this length is at least 8-12 cm, obviously there? depends on the physical structure of the patient. In addition, ? highly preferable that the device, or at least the internal walls of the first second and third ducts 22, 222, 33, 233, 333, be made of metal or biocompatible plastic materials. In the second case can? be made by molding or 3D printing. The preferred materials in which ? this device is made especially if with double access, they are silicones, polymethylsiloxanes PDMSs, PTFE preferably ePTFE, DACRON, preferably silicones and/or polymethylsiloxanes and ePTFE, more? preferably ePTFE why? they have a reduced propensity for thrombogenesis and allow for better endothelialization of the related first duct, 22, 220 which prevents the access device from occluding and also decreases the risk of rejection.

Preferred is a hemodialysis vascular access device 1 in accordance with the invention further comprising a first valve 50 connected to the second conduit 33, 233 and configured to, in a relative closed configuration, hydraulically close the second conduit 33, 233 and to , in a relative opening configuration, hydraulically open the second duct 33, 233. In particular, in the case of a double access vascular access device, which therefore includes said relative third tubular element 303, it is advantageous for it to also comprise a second valve 50 connected to the third conduit 333 and configured to, in a relative closed configuration, hydraulically close the third conduit 333 and to, in a relative open configuration, hydraulically open the third conduit 333. The presence of the first valve 50, in particular in the single-access vascular access device, and of the first and second valves 50, in the double-access one, advantageously allow blood loss to be limited once the hemodialysis has ended, improving tolerability? of the latter by the patient. The valve 50 advantageously stops the flow of blood as soon as the cannula of the disposable device 102 for drawing and/or injecting blood according to the invention is extracted from the first duct or from the second duct at the end of dialysis. Thereby ? possible to minimize the blood loss of the patient undergoing dialysis, especially when the vascular access is medicated with a fistula plug containing silver as described in the patent documents EP2296717 and ITBO20080303, marketed by EMODIAL S.r.l..

Preferably this first and/or second valve 50 ? disposed, respectively, in the second duct 3, 33 and/or in the third duct 333 distal to the second end? of these ducts. There? allows the vascular access healing device according to the invention to be used by inserting it into the vascular access point of the body and into the second and/or third second conduit to heal the valve access around the cylinder of the healing device as previously reported .

Advantageously, the first and/or second valve 50 ? configured to allow entry into the relative duct 3, 233, 33 through the relative second end? 21, 232 of the relative tubular element 2, 203, 303 of said first end? 108 of said medical cannula 103 of the disposable withdrawal and/or injection device 102.

According to preferred embodiments of the single and double access vascular access device for hemodialysis, said first valve 50? disposed between the second extremity? 21, 232 of the second tubular element 2, 203 and the first plate 4 in which the latter comprises, in correspondence with the relative first face, first engagement means 41 engaged with said second end? 21, 232 of the second tubular element 203 and/or and, when present, the third tubular element 303, the second plate 304 and the second valve 50, the latter ? disposed between the second extremity? 332 of the third tubular element 303 and the second plate 304 with the latter comprising, at the relative first face, second engagement means 41 for engaging with the second end? 21, 232 of the third tubular element 303 (See Figures 9A-10F ).

In accordance with preferred embodiments of the single and double access vascular access device for hemodialysis, said first valve 50? arranged on the second side of the first plate 4, opposite the relative first side and comprises third engagement means 54 for engaging by interference with fourth engagement means 55 arranged in said second end? 21, 232 of the second tubular element 203 and/or in said first plate 4, and, when there is the third tubular element 303, the second plate 304 and the second valve 50, the latter? arranged on the second side of the second plate 304, opposite the relative first side and comprises, fifth engagement means 54 for engaging by interference with sixth engagement means 55 arranged in said second end? 332 of the third tubular element 303 and/or in said second plate 304. (See Figures 11A-14E). The first engagement means 41 and/or the second engagement means 41 and/or the third engagement means 54 and/or the fifth engagement means 54 can comprise a relative plurality? of engagement elements 41, 54 protruding from the first face to engage by interference with said second end? (21, 232).

However, it is preferable that, as shown in the figures of the vascular access device for hemodialysis, with single and double access, said first valve 50 and/or said second valve 50, when present, comprises a relative through slot 56 which identifies two operating edges, wherein, in the relative closed configuration, the first and/or second valve 50, such operating edges are in contact to prevent the passage of fluids through the valve 50, and wherein said first and/or second valve 50 ? elastically deformable to obtain the relative opening configuration in which said operating edges are separated from each other to allow the passage of a fluid through the slit 50 (see figures 18A-18N, in particular 18F). According to a preferred aspect of the invention in the vascular access device for both single and double access hemodialysis, said first valve 50 and/or said second valve 50, when present, can? include an elastically deformable element which, in its closed configuration, is not ? deformed and obstructs, respectively, the related second duct 33, 233 and/or the related third duct 333 and what related opening configuration? compressed and unblocks its second conduit 33, 233 and/or its third conduit 333.

In alternative preferred embodiments of the vascular access device for hemodialysis, with single and double access, said first valve 50 has a relative perimeter and ? arranged in the second duct 33, 233 at the first end? 31, 231 of the second tubular element 3, 203 with a first portion 151 of the relative perimeter fixed to said second duct 33, 233 and with a remaining second portion 152 of the relative perimeter which ? free, and which in its closing configuration, counterfeits the ed ? in contact with said second duct 3, 233 to close it hydraulically and/or (preferably e), when present the third tubular element 303, the second plate 304 and the second valve 50, the latter has a relative perimeter and ? arranged in the third duct 333 at the first end? 332 of the third tubular element 303 with a first portion 151 of the relative perimeter fixed to said third duct 333 and with a remaining second portion 152 of the relative perimeter which ? free, and which in its closing configuration, counterfeits the ed ? in contact with the second conduit 233 to close it hydraulically; and wherein said first and/or second valve 50 ? elastically deformable to obtain the relative opening configuration in which the relative second portion of the relative perimeter is not? in contact with, respectively, the second conduit 3, 233 and/or with the third conduit 333 to open it hydraulically (see figures 19A-19M in particular 19F and 19G).

According to a particularly preferred aspect, the double access vascular access device for hemodialysis in accordance with the invention, which therefore comprises said third tubular element 303, further comprises: a first and a second contact surface 401, 402 (See figure 18D. 18N 19E and 19N) that originate, respectively, from the first and second ends? 221, 223 of the first tubular element 2, wherein each of said first and said second contact surfaces 401, 402 ? configured to partially simulate a cross section of an external blood vessel wall A,V in which ? Has a surgical hole been obtained completely surrounding this surgical hole, to facilitate the fixing, respectively, of the first and second ends? 221, 223 of the first tubular element 2 to this wall in order to hydraulically connect the surgical hole to the first duct 222. In this case, in the aforementioned surgical method, the phase for preparing said vascular access device 1 for hemodialysis provides for said device 1 of dual access vascular access has said first and second contact surfaces (401, 402) and the steps of attaching said first or second end? (231, 232) of the first tubular element (202) to said vein and said artery can advantageously comprise the positioning of said first and said second contact surfaces (401, 402) at a cross section, respectively of said vein and of said artery by counterfeiting the relative transversal sections and completely surrounding the relative surgical hole. Furthermore, in this case, according to a particularly preferred aspect of the invention, each of said first and second contact surfaces 401, 402 comprise a fourth plurality of contact surfaces. of through holes 48 (See Figures 19E and 1M) arranged to surround said surgical hole to allow said fixing by means of corresponding stitches passing through the relative plurality of through holes of said first and second contact surfaces 401, 402 (See Fig. 18D. 18N 19E and 19N) and for said blood vessel wall A,V. Alternatively, ? it is preferable that said first and second contact surfaces 401, 402 (See figure 18D. 18N 19E and 19N) are continuous surfaces, smooth and/or knurled, to facilitate said fixing by means of surgical glue to the wall of the blood vessel A,V. In this case, in the aforementioned surgical method, is the step of fixing said first or second extremity? 231, 232 of the first tubular element 202 to said vein and said artery can? advantageously comprising gluing, by means of surgical glue, the first and second contact surfaces 401, 402, respectively, to the cross section, respectively of said vein and said artery while of the first and second contact surfaces 401, 402 they counterfeit them and completely surround the relative surgical hole.

In order to maximize the speed? for blood withdrawal and injection during hemodialysis both sterile packages and the withdrawal and/or injection systems 1000 for hemodialysis in accordance with the invention are particularly preferred, in which the first conduit 22, 22 and the second conduit 33 have a relative minimum internal diameter and said cannula has a relative external diameter smaller than 0.2-0.3 mm of the smaller between the minimum internal diameters of the first duct 22 and of the second duct 33. What? in fact, it allows the collection and/or introduction of a greater blood flow.

In order to maintain sterility? ? preferably, both in the sterile package according to the invention and in the withdrawal and/or introduction system according to the invention, the access element has a relative connection end which is: distal to the first end? 108 of the medical 103 and ? engageable with a needle free syringe, wherein said access member further comprises a resiliently deformable member disposed in said access channel 181, and wherein said access channel 181 and the resiliently deformable member are configured and mutually disposed such that, when said connection extreme ? disengaged, the elastically deformable element is not? deformed and obstructs the access channel 181, to prevent the passage of liquids and gaseous substances, and in such a way that, when the connection end ? engaged with said nedlee free syringe, the elastically deformable element ? compressed by said needle free syringe and unblocks the access channel 181 for hydraulically connecting the syringe to the first end? 108 of the medicine 103. In said package and in said system, the access element allows the insertion of any anticoagulants in the access device, once implanted, while the closing means 180 can consist of or include a cap or lid, preferably interference or a valve. The access element, when present the first gripping means, can? be arranged in correspondence with the first gripping means 120 between the latter and the adjustment and/or shut-off device 104 (see Figure 5C). The first and/or second gripping means can consist of a typical ?butterfly? which usually applies to medical cannulas.

To facilitate insertion from the right side of the first duct 2, 202, the first end? 108 of the medical cannula 103 through said second conduit 33, 203 and said first conduit 22, 222 or through said third conduit 333 and said first conduit 22, 222 of said vascular access device 1, the first conduit 22, 222 can comprising a first and/or a second protuberance 250 disposed, respectively, on the side opposite the second 33, 203 and the third duct 333, between, respectively, the second duct 33, 202 and the first end? 221 of the first tubular element 2, 202 and the third duct 333, and the second end? 223 of the first tubular element 202 and shaped to allow said first end? 108 of the medical cannula 103 to pass over the protuberance and continue towards, respectively, the first and second ends? 221, 223 of the first tubular element 202. To obtain said protuberances 250 ? possible, deform the first tubular element 202 from the outside obtaining corresponding concavities? 251 on the opposite side to said second and/or third tubular element, 3, 202, 303 (see Figures 17A-17C).

Preferably said system also comprises a syringe containing a pharmaceutically injectable anticoagulant liquid composition, and more preferably packaged in a syringe, advantageously a needle free syringe.

It is understood that the above ? been described by way of non-limiting example, so that any variants of a practical-applicative nature are understood to fall within the protective scope of the invention as described above and claimed below.

Claims (15)

A hemodialysis vascular access device permanently implantable in a patient, the vascular access device being made of a biocompatible and sterilizable material, and comprising: - a related first tubular element (202) having a first and a second related end? (221, 223), which are longitudinal, and defining a first duct (222) extending from the first to the second end? (221, 223); - a related second tubular element (203) having a first and a second related end? (231, 232), which are longitudinal, and defining a second conduit (233) extending from its first to second end? 231, (232); in which the first extremity? (231) of the second tubular element (203) ? fixed to the first tubular element (202) proximally to the first end? (221) of the first tubular element (202), so that the second conduit (233) is in fluid communication with the first conduit (222) and that the second end? (232) of the second tubular element (203) is on a first side with respect to the first tubular element (202); - a related third tubular element (303) having a first and a second related end? (331, 332), which are longitudinal, and defining a third duct (333) extending from its first to second end? (331, 332); in which the first extremity? (331) of the third tubular element (303) ? fixed to the first tubular element (202) proximally to the second end? (223) of the first tubular element (202), so that the third duct (333) is in fluid communication with the first duct (222) and with the second duct (233) and that the second end? (332) of the third tubular element (303) is on said first side, with respect to the first tubular element (202); And - first fastening means (4) comprising a first plurality? of through holes (41) and being fixed to said first tubular element (202) and/or second tubular element (203) with said first plurality? of through holes (41) ? arranged on said first side, with respect to the first tubular element (202), and at the second end? (232) of the second tubular element (203), - second fastening means (304) comprising a second plurality? of through holes (41) and being fixed to said first tubular element (202) and/or third tubular element (303) with said second plurality? of through holes (41) ? arranged on said first side, with respect to the first tubular element (202), and at the second end? (332) of the third tubular element (303), wherein said vascular access device (1) ? shaped and sized to be implanted in a patient in: - a first position that ? in correspondence with an artery (A), a vein (V), or a pre-existing arteriovenous fistula (F) with the first duct interposed in series with respect to the blood flow, respectively in the artery A), in the vein (V ) or in the pre-existing arteriovenous fistula (F) between a first section (51) and a second section (52), respectively, of said artery (A), vein (V), or pre-existing arteriovenous fistula (F), with the first end ? and the second end? (221, 223) of the first tubular element (202) fixed, respectively to the first section (51) and to the second section (52), and/or - in a second position, between said artery (A) and said vein V), with the relative first or second end? (231, 232) of the first tubular element (202) fixed to said artery (A) and with remaining between said relative first or second relative end? (231, 232) of the first tubular element (202), which is not fixed to the artery A), fixed to the vein (V) in such a way that the first conduit (222) hydraulically connects said artery (A) to said vein (V) to form an artificial arteriovenous fistula (FA), in which, in said first and second position, the second extremity? (232) of the second tubular element (203) and the second end? (332) of the third tubular element (303), the first and second plurality? of through holes (41) arranged subcutaneously in an implant skin region (7) to allow the fixing of the first and second plurality? of through holes (41) to the skin region (7) of the implant by means of a corresponding first and a corresponding second plurality? of stitches (60), and the consequent fixing, respectively, of the second extremity? (232) of the second duct (233) and of the second extremity? (332) of the third tubular element (303) to the skin portion (7) of the implant. 2. Vascular access device for hemodialysis according to the preceding claim wherein the first fixing means (4) originate from the second end? (32, 232) of the second tubular element (3, 203) and/or in which second fastening means (304) originate from the second end? (332) of the third tubular member (303); wherein the first fastening means (4) comprise: a plate (4) having a relative main through hole (44), in which said first plurality? of through holes (41) ? arranged peripherally with respect to the main through hole (44), in which the plate (4) is fixed, in correspondence of a relative first facade, to the second extremity? (32, 232) of the second tubular element (3, 203) so that the second duct (33, 233) is accessible from the relative main through hole (44); and/or in which the second fastening means comprise a second plate (304) having a relative main through hole, in which said second plurality? of through holes (41) ? arranged peripherally with respect to the relative main through hole and in which said second further plate (304) is fixed, in correspondence of a relative first facade, to the second extremity? (332) of the third tubular element (303) so that the third duct (333) is accessible from the relative main through hole (44). The hemodialysis vascular access device according to the preceding claim, wherein the plate (4) is fixed to the second tubular element (3) with a relative second face (45) opposite the relative first face and arranged along a plane parallel to the longitudinal development axis (24) of the first tubular element (2, 202) and/or in which the second plate 304) ? fixed to the third tubular element (303) with a relative second face (45) opposite the relative first face and arranged along a plane parallel to the longitudinal development axis 24, 224) of the first tubular element (2, 202). The hemodialysis vascular access device according to any one of claims 1 to 3, further comprising a first valve (50) connected to the second conduit (233) and configured to, in a relative closing configuration, hydraulically close the second duct (233) and for, in a relative opening configuration, hydraulically open the second duct (233) and/or, when present said relative third tubular element (303), and a second valve (50) connected to the third duct (333 ) and configured to, in a related closed configuration, hydraulically close the third conduit (333) and to, in a related open configuration, hydraulically open the third conduit (333). The hemodialysis vascular access device according to the preceding claim, wherein said first valve (50) is disposed between the second extremity? (232) of the second tubular element (203) and the first plate (4) with the latter comprising, in correspondence with the relative first face, first engagement means (41) engaged with said second end? (21, 232) of the second tubular element (203) and/or and wherein the second valve (50), a ? disposed between the second extremity? (332) of the third tubular element (303) and the second plate (304) with the latter comprising, at the relative first face, second engagement means (41) for engaging with the second end? (21, 232) of the third tubular member (303). The hemodialysis vascular access device according to claim 4, wherein said first valve (50) is arranged on the second side of the first plate (4), opposite the relative first side and comprises, third engagement means (54) for engaging by interference with fourth engagement means (55) arranged in said second end? (232) of the second tubular element (203) and/or in said first plate (4), and in which the second valve 50), ? disposed on the second side of the second plate (304), opposite the relative first side and comprises, fifth engagement means (54) for engaging by interference with sixth engagement means (55) arranged in said second end? (332) of the third tubular element (303) and/or in said second plate (304). 7. Vascular access device for hemodialysis in accordance with any one of claims 4 to 6, wherein said first valve (50) and/or said second valve (50) comprises a related through slot (56) which identifies two operating edges , in which, in the relative closed configuration, the first and/or the second valve (50), these operating edges are in contact to prevent the passage of fluids through the valve (50), and in which said first and/or second valve (50) ? elastically deformable to obtain the relative opening configuration in which said operating edges are separated from each other to allow the passage of a fluid through the slit (50). 8. Vascular access device for hemodialysis according to claim 4, wherein said first valve (50) has a relative perimeter and ? arranged in the second duct (233) at the first end? (31, 231) of the second tubular element (203) with a first portion (151) of the relative perimeter fixed to said second duct (233) and with a remaining second portion (152) of the relative perimeter which ? free, and which in its closing configuration, counterfeits the ed ? in contact with said second duct (233) to close it hydraulically and/or in which the second valve (50) has a relative perimeter and ? arranged in the third duct (333) at the first end? (332) of the third tubular element (303) with a first portion (151) of the relative perimeter fixed to said third duct (333) and with a remaining second portion (152) of the relative perimeter which ? free, and which in its closing configuration, counterfeits the ed ? in contact with the second conduit (233) to close it hydraulically; and wherein said first and/or second valve (50) ? elastically deformable to obtain the relative opening configuration in which the relative second portion of the relative perimeter is not? in contact with, respectively, the second conduit (3, 233) and/or with the third conduit (333) to open it hydraulically. A hemodialysis vascular access device according to any one of the preceding claims, further comprising: first and second contact surfaces (401, 402) originating from the first and second ends, respectively; (221, 223) of the first tubular element (2), wherein each of said first and said second contact surfaces (401, 402) ? configured to partially simulate a cross section of an external blood vessel wall (A), (V) in which ? Has a surgical hole been obtained completely surrounding this surgical hole, to facilitate the fixing, respectively, of the first and second ends? (221, 223) of the first tubular element (2) to this wall in order to hydraulically connect the surgical hole to the first duct (222). The hemodialysis vascular access device according to the preceding claim, wherein each of said first and second contact surfaces (401, 402) comprise a fourth plurality of of through holes (48) arranged to surround said surgical hole to allow said fixing by means of corresponding stitches passing through the relative plurality of through holes of said first and second contact surfaces (401, 402) and for said wall of the blood vessel (A, V). 11. A vascular access healing device comprising: - a relative insertion portion (502) which ? insertable inside a vascular access and comprising: a cylinder (505) having a relative longitudinal development axis: a first and a second relative end? which are longitudinal; and a distally tapered tip (503) attached to the first end? of the cylinder (505); in which said portion of insertion ? insertable in the second conduit (33, 233) or in the third conduit (333) of a vascular access device (1) for hemodialysis according to any claim 4, 7, 8, 9 and 10 from the relative second end? (32, 232, 332) to exclusively occlude a portion of said second duct (33, 233) or said third duct (33) between, respectively, the first valve (50) and the first plate (4) or between the second valve (50) and the second plate (304); - a relative connection portion (504) fixed to the second end? of the cylinder (505); And - a relative first and a relative second gripping lug (501), fixed to the connecting portion (504) on opposite sides of the latter and on opposite sides with respect to the axis of the cylinder and with the possibility of of relative movement with respect to the connecting portion (504) in order to be able to assume: a first relative configuration in which the first and second gripping tab (501) are substantially coplanar; and a second configuration in which the flaps are mutually opposite, in which both in the first and in the second configuration said first and said second gripping flap (501) cannot be inserted into said second duct (33,233) or third duct (33). 12. A vascular access scarring device according to the preceding claim wherein the related cylinder is inclined with respect to the connecting portion by an angle (?) equal to the angle (?) with which the second tubular element (3, 203) or the third tubular element (303) is? inclined with respect to the first plate (4) or the second plate (304), respectively. 13. Withdrawal and/or injection system (1000) for hemodialysis comprising: - a vascular access device for hemodialysis in accordance with any one of claims 1 to 11 and at least one disposable device (102) for withdrawing and/or injecting blood into an arteriovenous fistula (F), a vein (V) or an artery (A) consisting of: - a medical cannula (103) for cannulation having a relative first end? (108) and a relative second end? (109) in which the first end? (108) ? free and cannlable in a pre-existing arteriovenous fistula (F), in an artery (A), or in a vein (V) of a patient, through said second duct (33, 203) and said first duct (22, 222) or through said third conduit (333) and said first conduit (22, 222) of said vascular access device (1); - a flow regulation and/or shut-off device (104) arranged to regulate and/or interrupt a flow of a liquid in the medical cannula (103); - a connection element (106), fixed at the second end? (109) of the medical cannula (108) of the medical (103) for enabling hydraulic connection to a blood inlet tubing or a blood outlet tubing of a hemodialysis equipment; - optionally an access element disposed between the first extremity? (108) of the cannula and the adjustment and/or shut-off device (104) and defining an access channel (181) hydraulically connected to the first end? (108) cannula; and reversible closing means (180) for reversibly closing said access channel at one end of the access channel. distal end of the access member to allow liquid to be injected into the access channel (181) and flow to the first end? (108) of the medical cannula (103); And - optionally a first gripping element (120), arranged between the first end? (108) and the adjustment and/or shut-off device (104), and/or a second gripping element (130) arranged proximal to the connection element (106); - optionally at least one vascular access healing device (500) according to claim 11 or 12. 14. Sterile package containing at least one disposable device (102) for sampling and/or injecting blood into an arteriovenous fistula consisting of: - a medical cannula (103) for cannulation having a relative first end? (108) and a relative second end? (109) in which the first end? (108) ? free and cannlable in a pre-existing arteriovenous fistula (F), an artery (A), or a vein (V) of a patient through said second conduit (33, 233) and said first conduit (22, 222) or through the third conduit (333) and the first conduit (22, 222) of a vascular access device according to any one of claims 1 to 10; - a flow regulation and/or shut-off device (104) arranged to regulate and/or interrupt a flow of a liquid in the medical cannula (103); And - a connection element (106), fixed at the second end? (109) of the medical cannula (108) for enabling hydraulic connection to a blood inlet tubing or a blood outlet tubing of a hemodialysis equipment; - optionally an access element disposed between the first extremity? (108) of the cannula and the adjustment and/or shut-off device (104) and defining an access channel hydraulically connected to the first end? (108) cannula; and reversible closing means (180) for reversibly closing said access channel (181) at one end of the gate; distal end of the access member to allow liquid to be injected into the access channel (181) and flow to the first end? (108) of the medical cannula (103); - optionally a first gripping element (120), arranged between the first end? (108) and the adjustment and/or shut-off device (104), and/or a second gripping element (130) arranged proximal to the connection element (106). 15. Sterile package according to the previous claim, wherein said access element has a related connection end which is: distal to the first end? (108) of the medical (103) and ? engageable with a needle free syringe, wherein said access element further comprises a resiliently deformable member disposed in said access channel (181), and wherein said access channel (181) and the resiliently deformable member are configured and mutually disposed in so that, when said extreme connection ? disengaged, the elastically deformable element is not? deformed and obstructs the access channel (181), to prevent the passage of liquids and gaseous substances, and in such a way that, when the? connection extreme? engaged with said nedlee free syringe, the elastically deformable element ? compressed by said needle free syringe and unblocks the access channel (181) to hydraulically connect the syringe to the first end? (108) of the medical (103).