Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
  • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
  • A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
  • A61B17/12013—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot for use in minimally invasive surgery, e.g. endoscopic surgery
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00017—Electrical control of surgical instruments
  • A61B2017/00022—Sensing or detecting at the treatment site
  • A61B2017/00039—Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
  • A61B2090/3966—Radiopaque markers visible in an X-ray image

Definitions

• the present invention relates to a hydraulic implant for an arteriovenous fistula of a hemodialysis patient, comprising at least one inflatable balloon.
• the document US2004138684 describes an implant consisting of a rigid sleeve in two parts articulated together by means of a hinge, arranged around the vessel. It includes one or more inflatable membranes. When swollen, the membranes help to constrict the vein and flatten it to serve as a venous valve. A nearby reservoir allows the membranes to be inflated and deflated by hydraulic pressure. To serve as a valve, the membranes are inflated and deflated as needed. The vessel is pinched by the membranes to fulfill the role of venous valve.
• the system has certain imperfections. For example, the side walls of the ring made of rigid material are liable to damage the surrounding tissues.
• the junction of the two parts of the ring creates an uninflated area when the ring is closed. This area creates an irregularity in the tightening which can generate an undesirable flattening or crushing of the vessel.
• the inflation tube arranged perpendicular to the wall of the ring creates an excess thickness liable to damage the tissues. This device was not designed to reduce an arteriovenous fistula flow rate of the dialysis patient and is incompatible with subcutaneous implantation at the risk of ulcerating the skin with infectious complications.
• Document EP1830905 describes a process for creating an arteriovenous fistula and for controlling the flow.
• the flow is controlled by an inflatable sleeve implanted around the vein, near the fistula. When the cuff is inflated, it helps compress the vessel around which it is placed. The flow is controlled according to the degree of inflation of the sleeve.
• the sleeve is secured around the vein with a suture. The suture closure creates a non-inflating area that can flatten the vessel.
• the lack of lateral protection poses a risk to the tissues on both sides of the ring.
• the inflation tube arranged perpendicular to the wall of the ring is liable to damage the surrounding tissue.
• Document JPS6173668 describes a ring comprising an inflatable element.
• the ring is placed around the vessel and closed with a bead located at each end.
• the closure is implemented by attaching the beads to each other.
• the inflatable member is inflated in order to crush the vessel to increase the pressure of the flow.
• Preferably, several rooms are provided.
• the inflation tube arranged perpendicular to the wall of the ring creates an area of excess thickness liable to damage the surrounding tissues. Closing the ring against the vessel by joining two separate chambers creates an interruption of the swollen area which may affect, or even block, the flow of the vessel. The lack of lateral protection presents a risk for the tissues on either side of the ring.
• Document WO98 / 08466 describes an apparatus for regulating blood flow through a graft comprising a balloon placed against the exterior surface of the graft by a rigid sheath. When the balloon is inflated, it causes constriction of blood flow through the transplant. The balloon is arranged laterally against the vessel and exerts lateral pressure against the latter. Such a crash of the vessel is likely to affect, or even block, the flow of the vessel.
• the invention provides various technical means.
• a first objective of the invention is to provide a hydraulic implant for an arteriovenous fistula of a hemodialysis patient making it possible to control the blood flow in a precise and reproducible manner in order to reduce or even eliminate everything for the patient. risk of complication linked to an initially vascular hyper flow, or to vascular theft.
• Another objective of the invention is to be able to modify the flow rate in the arteriovenous fistula at will in a simple manner according to the needs of the patient and while limiting the risks, in particular of infection.
• Another objective of the invention is to provide a hydraulic implant making it possible to retain its functional characteristics as long as the arteriovenous fistula is functioning.
• Yet another object of the invention is to provide a removable and non-decaying hydraulic implant.
• Yet another object of the invention is to provide a hydraulic implant making it possible to contain the expansion of the vein on which it is positioned.
• Another objective of the invention is to provide a hydraulic implant not being in direct contact with the blood in order to limit the various complications such as thrombosis, infection or the like of the vascular access.
• the invention provides a hydraulic implant for arteriovenous fistula intended to be wound around a blood vessel of known PV perimeter and linked to the fistula, said implant comprising:
• a non-inflatable and non-elastic retaining outer membrane that can be wound around an axis A-A corresponding to the axis of a blood vessel to be surrounded with the implant;
• the outer membrane extends to form an elongated fin coaxial with the balloon;
• the width of the fins being at least equal to 0.5 times the width of the balloon and more preferably at least once the width of the balloon;
• the flexible and non-elastic outer membrane provides support for the balloon (s), and forms an outer envelope allowing, after winding the implant around a vessel, to maintain the outer diameter of the implant and to ensure expansion of the balloons towards the vessel, to reduce its diameter uniformly over the entire perimeter.
• the fins perform a similar function on either side of the balloons, to prevent any overflow of a balloon or part of a balloon out of the clamping zone of the vessel.
• One-piece, or continuous, balloons provide consistent inflation and tightening around the entire perimeter of the vessel.
• the implant is available in a plurality of LG lengths standardized as a function of a plurality of standardized values of PV perimeters of blood vessels capable of being surrounded with an implant.
• the implant is preferably designed to provide an adjusted winding around the vessel.
• a dimension measurement or evaluation can be carried out, for example by means of a pre-surgical ultrasound (or any other visualization means) making it possible to evaluate the diameter, and therefore the perimeter of the affected vessel.
• An implant of suitable length is then chosen from among the standard lengths available. The available lengths range from a few millimeters (eg 3 mm or more) to a few centimeters (eg 1, or 2 or 3 or more cm).
• This architecture provides protection zones on each side of the balloon and prevents the latter, by inflating, can come into contact with a vessel or another part of the body and thus cause a possible injury.
• the fins make it possible to separate the balloon from the surrounding tissues and avoid the risk of trauma on these tissues.
• These fins also make it possible, by extending covering each side of the vein, to prevent the balloon once inflated from being able to extend on either side of the membrane, leading to a loss of pressure in contact with the vein. vein, no longer making it possible to maintain a satisfactory circumferential pressure in order to reduce the flow and making the device inoperative and uncontrollable.
• the fins are of the same width or of different widths.
• the length of the balloon and of the fins corresponds at least to the perimeter of a vessel to be surrounded.
• the fins are preferably, but not necessarily, the same length as the balloon. This feature helps to ensure that the implant surrounds the whole well, with no area of interruption, no obstacle, and thus avoids flattening the vessel.
• the balloon helps to control blood flow. The regularity of the tightening avoids creating areas of irritation.
• the preferably one-piece, seamless balloon helps distribute the tightening force well.
• the filling tunnel is parallel to the A-A axis.
• This arrangement so that the tunnel and the vessel surrounded by the implant are parallel, facilitates the implantation of the device in a small volume and avoids affecting organs in the vicinity of the implant.
• This configuration also avoids any area of excess thickness in the patient's epidermis.
• the balloon and the fins define a plane B-B, the filling tunnel being coplanar with the plane B-B and perpendicular to the axis B-B.
• This architecture makes it possible to align the supply tube in the main plane of the implant, and to avoid creating any extra thicknesses in an area of the body where the available space is minimal. Any extra thickness could raise or even pierce the skin of the implant wearer. This characteristic makes it possible to obtain an ergonomic device.
• the absence of an elbow and / or protuberance at the level of the branches between the different parts of the implant makes it possible to avoid tissue damage and any risk of perforation of the epidermis.
• the axial fixing lugs arranged in the extension of the fins on the side opposite the tunnel are adapted to cooperate with transverse slots arranged in the fins, in the vicinity of the tunnel.
• the implant comprises one or more blood flow sensors, arranged to allow measurement of the blood flow through a vessel around which the implant is surrounded.
• the presence of one or more blood flow sensors makes it possible to monitor the level of blood flow in the vessel when the balloon is inflated, thus allowing the level of inflation to be adjusted according to the level of blood flow desired.
• the balloon is one-piece. Tightening is performed circumferentially all around the vessel, without discontinuity or pressure variation. This characteristic makes it possible to avoid any crushing of all or part of the vessel.
• the balloon is a main balloon
• the implant comprises at least one secondary balloon disposed between the main balloon and a fin.
• the secondary balloon or balloons may be in fluid communication with the main balloon, to allow inflation of the latter to a pressure identical to that of the main balloon.
• the secondary balloons can be connected to an inflation system separate from that of the main balloon.
• This embodiment further provides an additional level of precision in the control of blood flow.
• This architecture makes it possible, for example, to provide a progressive level of tightening between the balloon main, with higher tightening and moving towards the secondary balloons, lower tightening, then to the fins, without tightening other than that given at the time of installation.
• the material of the balloon (s) is inelastic.
• the material of the fins and of the membrane covering the balloon on its external face is inelastic in order to concentrate the pressure during inflation on the internal side of the implant, in contact with the vein .
• This characteristic of the material of the two elements makes it possible to avoid any loss of the force exerted in tightening during the inflation of the balloon. The control of the tightening level is thus particularly precise.
• the implant also comprises at least one localization band, visible by an external detection means (for example during radiology examinations).
• the invention also provides a hydraulic implant system comprising a hydraulic implant as previously described, and an inflation module comprising an implantable chamber comprising an inflation fluid reservoir and an injection membrane designed to allow filling. tank with needles passing through the membrane. Inflating the balloon with an incompressible fluid ensures that constant pressure is exerted at the periphery of the vessel.
• This architecture makes it possible to provide a completely closed balloon inflation circuit, without contact of the filling liquid with the tissues of the recipient of the implant.
• the system with implant and inflation module can be set up with the reservoir deflated, then inflated after installation, by introducing the correct amount of inflation fluid required. The risk of infection is very limited thanks to the closed-circuit system and the absence of direct contact with the patient's blood.
• neutral fluid provides additional safety in the event of a leak.
• neutral fluid is meant a fluid that is harmless to the body.
• the implementation of the implant is preferably carried out several days after the surgery in order to allow perfect skin healing.
• the balloon is inflated by injecting liquid through the implantable chamber using a needle. The volume injected depends on the reduction of the desired flow in the fistula. Once the appropriate flow rate has been obtained, the needle is withdrawn from the implantable chamber which guarantees the seal and the maintenance of pressure in the system.
• Figure 1 illustrates an embodiment of a hydraulic implant
• Figure 2 illustrates another embodiment of a hydraulic implant
• Figure 3 schematically illustrates an example of implantation of an implant system with the hydraulic implant in the open position
• Figure 4 schematically illustrates an example of implantation of an implant system with the hydraulic implant in the closed position
• Figures 5 to 7 illustrate an example of the placement of an implant, with axial sections in uninflated and inflated mode in Figures 5 and 6, and in cross section in Figure 7.
• Figures 8 and 9 illustrate an example of placement of a wingless implant, in axial section and uninflated mode in Figure 8, and axial section in inflated mode in Figure 9.
• FIG. 1 and 2 illustrate embodiments of hydraulic implants 1 for arteriovenous fistula.
• the hydraulic implant 1 comprises at least one elongated inflatable balloon 2, oriented in a plane BB. Before installation, flat, the balloon 2 defines a plane BB. At least one fin 5 is provided on one side of the balloon. Flat, before installation, the fin is coplanar with the balloon. As illustrated, there is preferably a fin 5 on each side of the balloon 2.
• the length of the balloon, and also preferably that of the fins, are provided in order to correspond with the perimeter of the vessel on which the implant will be fixed. A slight excess length producing an overlap is preferably chosen rather than a too short length which would not allow the vessel to be well surrounded. In the example illustrated in FIG.
• the axial fins 5 extend parallel to the plane BB.
• the width La of the fins 5 is preferably at least equal to 0.5 times the width Lb of the balloon 2 and more preferably at least once the width Lb of the balloon as illustrated in FIG. 1.
• the fins 5 and the balloon 2 are of substantially equal length. This length corresponds at least to the perimeter of the vessel to be surrounded.
• the fins 5 form an envelope around the balloon 2 in order to maintain and concentrate the pressure exerted by the balloon 2, when it is inflated, essentially around the vessel. The pressure on the vessel is thus exerted in a circumferential, continuous and uniform manner.
• the balloon is advantageously one-piece.
• one-piece balloon is meant a balloon forming a continuous chamber over its entire length, to avoid forming discontinuities against the blood vessel during inflation.
• the fins are integral with the balloon (s).
• the material (s) used for the balloon (s) and the fins are non-elastic.
• the balloon 2 is a main balloon, and two secondary balloons 10 are arranged between the main balloon 2 and the fins 5. There are preferably two secondary balloons, one on each side of the main balloon. . To ensure inflation of the main balloon 2 and of the secondary balloons 10, two variants are possible.
• the secondary balloon or balloons 10 are in fluid communication with the main balloon. All the balloons 2 and 10 are then at iso pressure.
• the secondary balloons 10 can be connected to an inflation system separate from that of the main balloon. We can then inflate the secondary balloons with a different pressure than the main balloon. Still in variants, other balloons are still added in order to increase the adjustment possibilities.
• the balloon or balloons are preferably made using fabrics made from stretched polytetrafluoroethylene (PTFE) fibers, such as for example a fabric marketed under the trademark goretex.
• PTFE stretched polytetrafluoroethylene
• the fins are made of flexible material, woven or not. All materials used are biocompatible for implant function.
• the implant advantageously comprises lateral perforations 16 facilitating attachment to the surrounding tissues.
• the implant can be provided with one or more localization bands 17, visible with an external detector. These bands make it possible, for example, to correctly locate the implant during a radiology examination.
• two localization bands are provided on both edges of the implant so as to clearly identify the precise area where the latter is implanted.
• inflation is meant an action allowing the volume of one or more balloons to be increased by injecting a fluid or a gas.
• the implant 1 further comprises an inflation tunnel 3, to which an inflation module 4 can be connected, in order to ensure the inflation of the balloon.
• the tunnel 3 is advantageously parallel to the axis AA of the vessel to be surrounded, in the same plane BB as the balloon 2 and the fins 5.
• the inflation pressure of the balloon or balls can vary between 0 and 150 mmHg, and more preferably from 50 to 90 mmHg.
• the tunnel 3 is arranged at one end of the balloon (s) and the fins. At least one fluid communication is provided between the balloon and the tunnel to allow circulation of the inflation fluid. This fluid communication is provided for example by a micro tube or a micro-opening connecting the tunnel to the balloon. As a variant, the tunnel is not arranged at the end, but separates the balloon 2 and the fins in two parts, equal or not. This embodiment can facilitate the placement of the implant in certain cases. Such an embodiment makes it possible for example to achieve uniform inflation. The ends are used only for locking / closing the system and the supply tunnel is placed in a less restrictive place that does not interfere with closing.
• Figures 8 and 9 illustrate an example of a wingless implant, in an uninflated situation in Figure 8 and inflated in Figure 9. It is observed that the balloon, subjected to the stresses of the outer shell of a side and the vessel on the other hand, tends to swell outside the surface of the outer shell. Such an arrangement does not make it possible to guarantee good implantation. The flow of the ship is not well controlled. The balloon can also affect organs in the vicinity of the implant.
• Figures 5 to 7 illustrate an example of favorable implantation, with an implant according to the invention, provided with an outer membrane 18 of non-elastic material retaining material forming fins 5 on either side of the balloon 2
• Figure 5 illustrates the implant 1 before inflation.
• Figures 6 and 7 illustrate the inflated implant. It is observed that the holding membrane 18 and the fins 5 ensure that the balloon is held in the internal region of the outer membrane. The distribution of forces against the vessel is thus very uniform both along the A-A axis of the vessel and circumferentially, over the entire perimeter of the vessel.
• Figure 7 illustrates the maintenance of the two ends of the implant by the tabs 6 inserted in the slots 7, ensuring contact between the two ends of the balloon, so as to surround the vessel well and exert a uniform force on the whole of its periphery.
• the implant may include a sensor 14 of blood flow, arranged to allow a measurement of blood flow through a vessel around which the implant is surrounded
• This measurement of flow can be automated by coupling the sensor to an automated or semi-automated electronic system making it possible to vary the pressure in the balloon in order to adapt the blood flow in the fistula to the desired values according to the circumstances.
• This system can be controlled remotely.
• This or these sensors of known type is designed to transmit a signal to a flow reading device arranged near the patient during implantation.
• the real-time monitoring of the level of the flow during inflation of the balloon is particularly advantageous, and thus makes it possible to adjust the level of inflation according to the level of the desired blood flow.
• the attachment of the hydraulic implant 1 contiguously when it is disposed on the vessel is provided by a set of axial fixing lugs 6 coupled to transverse slots 7.
• three axial fixing lugs 6 are arranged in the extension of the fins 5 and of the balloon 2, on the side opposite to the tunnel 3.
• Three transverse slots 7 complementary to the axial fixing lugs 6 are arranged in the fins 5 and the balloon 2 near the tunnel 3.
• the slot 7 and the axial fixing tab 6 at the level of the balloon 2 are arranged in such a way that they in no way alter the technical characteristics of the balloon 2.
• FIG. 1 Three axial fixing lugs 6 are arranged in the extension of the fins 5 and of the balloon 2, on the side opposite to the tunnel 3.
• Three transverse slots 7 complementary to the axial fixing lugs 6 are arranged in the fins 5 and the balloon 2 near the tunnel 3.
• the slot 7 and the axial fixing tab 6 at the level of the balloon 2 are arranged in such a way that they in no way alter the technical characteristics of the
• FIG. 2 illustrates another example of a type of fixing at the level of the axial fixing lugs 6.
• the axial legs 6 have at least one groove 9, here four in number, allowing several levels of positioning around the vessel, in order to adapt to various cases of implantation.
• fixing elements are provided which are arranged only on the fins, thereby to release the balloon (s).
• a single fixing element or tab is used for greater ease of installation.
• FIG. 7 illustrates an example of an implant placed around a vessel so as to surround it well.
• the figure shows a tab 6 secured through a slot 7 to keep the implant tightly wrapped around the vessel.
• the length LG of the implant is observed, adapted to allow an adjusted winding around a vessel 31 of perimeter PV.
• Figure 1 also shows an inflation module 4.
• the inflation module 4 and the previously described implant together form a hydraulic implant system.
• the balloon 2 inflation module 4 is in fluid communication with the balloon 2 via the tunnel 3.
• the inflation module 4 comprises an implantable chamber 12.
• the implantable chamber 12 is preferably made of titanium in order to promote biocompatibility and durability.
• the implantable chamber 12 comprises a reservoir 15 of inflation fluid and an injection membrane 13.
• the injection membrane 13 is preferably made of a waterproof, elastic material, ensuring tightness despite repeated introductions and withdrawals of needles through it.
• the inflation fluid reservoir 15 is in fluid communication with the filling tunnel 3 via an inflation tube 11, connectable to the inflation tunnel 3.
• the capacity of the implantable chamber reservoir is a few milliliters.
• the reservoir serves as the interface between the balloon and the inflation syringe initially filled with liquid. This liquid is injected into the chamber using a needle.
• the syringe is coupled to a pressure manometer.
• the inflation is carried out by a gas, preferably inert, or air, for example using a pump connectable to chamber 12.
• FIG. 3 illustrates an example of implantation of an implant system as previously described with the aim of optimizing and perpetuating the dialysis treatments of a patient.
• An implant 1 is placed (FIG. 3) then wound around a venous vessel (FIG. 4) at the level of the arteriovenous anastomosis of the fistula 32 making it possible to connect the artery 30 and the vein 31 of the patient.
• the implant is closed around the vein 31 using the fixing lugs. It can be fixed to the vein or to the artery by any suitable surgical means which can use not exclusively the lateral perforations of the fins.
• An inflation tube 11 is connected to the inflation tunnel 3 and placed up to an inflation module 4.
• the module 4 is implanted for example in the retracted position of the arm, in an area little subject to bumps likely to damage the module, and to benefit from an area with more available space.
• the balloon (s) are inflated by injecting an inflation fluid through the module 4.
• the needle of a filling syringe is inserted into the membrane 13, and the fluid injected. gradually.
• a measurement of the blood flow is advantageously carried out using the flow sensor 14 provided on the implant. The practitioner can thus carry out an inflation exactly targeted on the blood flow that he wishes to be able to maintain in the vein, at the level of the fistula.
• the dialysis machine 20 When a dialysis treatment is performed, conventionally, the dialysis machine 20 is connected to the patient by two needles planted in the vein 31 of the patient's fistula.
• the blood to be treated is taken by means of the venous needle connected to a tubing 21 up to the dialysis machine 20 and the purified blood is returned to the patient by means of the tubing 22 and the needle 23 to return.
• the implant system in place then makes it possible, if necessary, to regulate the flow of blood in the fistula, if necessary, for example to provide an optimal flow during a dialysis phase.
• the implant allows, outside the dialysis phases, to limit the blood flow of the fistula to avoid complications related to hyper flow such as heart failure, for example, and to be increased during the dialysis phase to allow better dialysis quality.
• the implant would also make it possible, by regulating the flow in the fistula, to limit or eliminate any theft syndrome by redistributing part of the blood flow in the patient's artery downstream of the anastomosis of the fistula. These settings can be made manually or automatically.

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• 2019
  • 2019-02-13 FR FR1901465A patent/FR3092486B1/fr active Active
• 2020
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