Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/06—Body-piercing guide needles or the like
  • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
  • A61B17/3496—Protecting sleeves or inner probes; Retractable tips
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
  • A61B2017/00238—Type of minimally invasive operation
  • A61B2017/00243—Type of minimally invasive operation cardiac
  • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
  • A61B2017/00252—Making holes in the wall of the heart, e.g. laser Myocardial revascularization for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
  • A61B2017/22065—Functions of balloons
  • A61B2017/22067—Blocking; Occlusion
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22072—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
  • A61B2017/22074—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
  • A61B2017/22077—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel with a part piercing the tissue
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/28—Surgical forceps
  • A61B17/29—Forceps for use in minimally invasive surgery
  • A61B2017/2926—Details of heads or jaws
  • A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
  • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
  • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
  • A61B2017/3486—Balloon
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
  • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
  • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
  • A61B2017/3488—Fixation to inner organ or inner body tissue
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M25/104—Balloon catheters used for angioplasty

Definitions

• the present invention relates to a device for single use, intended to be used in surgery whenever a vascular approach by cannulation or catheterization (extracorporeal circulation, anesthesia, emergencies, resuscitation) proves essential, particularly in heart surgery. or in interventional cardiology.
• This new device allows penetration of blood vessels and / or heart chambers more efficient and much more secure than those currently obtained.
• ECC cardiopulmonary bypass
• a CEC console consists of an arterial head pump (centrifugal or peristaltic) and four other peristaltic pumps for the aspiration of cardiotomy and cardiac chambers and the administration of cardioplegia.
• the set is supplemented by an emergency pump as well as biocompatible material, tubules, arterial and venous cannulas, venous reservoir, oxygenator, arterial filter, etc.
• the arterial line of the CEC is connected to an aortic or femoral cannula
• the venous blood arrives by one or two cannulas, introduced into the superior, inferior or right atrium vena cava;
• a left ventricular discharge cannula is introduced through the tip of the heart, left atrium or pulmonary artery;
• a catheter for the injection of cardioplegia is slipped into the root of the aorta upstream of the aortic cannula, or through the right atrium into the coronary sinus or directly into the coronary ostia;
• additional catheters allow haemodynamic measurements to be taken: systemic and pulmonary artery pressure line, venous lines including a central lane, pressure line in the left atrium, etc.
• Surgical procedures involving the heart and the vessels use delicate techniques, especially in pediatric cardiac surgery, with high bleeding and traumatic risks.
• Aortic cannula for example, which must, once in place, benefit from perfect security, requires "purse” stitches kept on zippers before piercing the aorta using a scalpel , and to push the cannula very quickly to avoid a cataclysmic haemorrhage.
• This cannula will then be carefully connected to the arterial line of the CEC to prevent any risk of air embolism in the circuit. The same procedure will then be repeated to set up the cardioplegia catheter or cannula.
• An aortic clamp will be placed downstream of the cardioplegia catheter at the start of the cardiopulmonary bypass (the heart will stop after cardioplegia injection).
• the inventors propose a more effective solution that must respond step by step to each problem posed by vascular cannulation. It consists in grouping together within a single device all the tools that make it possible to obtain a more efficient, faster, safer and less costly cardiovascular approach.
• the medical device for cannulation or vascular catheterization of single use of the present invention is usable as:
• a fixation system which will replace stock sutures and their drawbars
• a blood flow blocking system which will replace the metal aortic clamp which always causes vascular trauma on the endothelial part of the vessel and which can lead to rupture of the atheroma plaques in the elderly
• a guided perfusion system which will replace the cardioplegia cannula, and separately direct blood and cardioplegic perfusion accurately and efficiently.
• the device of the present invention allows the realization of complex surgical procedures usually requiring the intervention of an experienced team, by a single operator, safely.
• a further advantage of the invention is that the surgical space concerned, such as the peri-aortic space in the case of intervention targeting the aortic trunk, is less crowded and allows a better approach to the heart thus cleared.
• the object of the present invention is a cardiovascular device for surgical intervention allowing a single operator to achieve penetration of blood vessels and / or heart chambers. It consists of a proximal part intended to penetrate said blood vessels and cardiac cavities, an intermediate portion constituted by the body of said device and a distal portion capable of accommodating at least one catheter and / or a connection system.
• the device, object of the present invention is characterized in that it comprises:
• a body 5 having a longitudinal axis XX 'and making it possible to house and guide the lines, catheters, vascular tubes and connectors necessary for said surgical operation,
• a sealing system consisting of two inflatable disks 4, which extend substantially perpendicularly to the longitudinal axis XX 'of the body 5, axially separated from each other by a few millimeters, a proximal diskette 4a being intended for be positioned on the inner wall of a vascular lumen or heart chamber, a distal diskette 4b being intended to be positioned on the outer wall of a vascular lumen or a heart chamber.
• the two inflated disks provide tightness by compression of the vascular wall, the position of said two disks on the longitudinal axis of said device being adjustable by the operator to modify the depth of the vascular penetration and the two disks being housed in the body of the device so as to avoid any enlargement of the incision at the time of the ablation of said device,
• a control connector for inflating and deflating said inflatable disks constituting the sealing system housed in the body of the device,
• a flexible guide 1 movable relatively to the inside of the body 5 of the device, the proximal portion of which has a tip located near the proximal portion of the body of the device and which allows a vascular or cardiac incision, the displacement of said guide in the body 5 being controllable by its distal portion housed in said lateral tubular block 6.
• the device according to the present invention further comprises in its proximal part intended to penetrate the blood vessels or heart cavities:
• an inflatable occlusive balloon 2 whose position is modifiable by digital guidance of the surgeon or by remote control with respect to the longitudinal axis XX 'of the device, said inflatable occlusive balloon being placed at the proximal end and integrated into the body of the device; to prevent any enlargement of the incision at the time of removal of said device, inflation and deflation of said inflatable occlusive balloon being controlled by a connector 10 integrated in the outer wall of the device and which has a rod, provided with a system of nonreturn valves 8 located in the lateral tubular block 6,
• At least one lateral hole 3 in the body of the device axially located between the inflatable occlusive balloon 2 and the two inflatable floppies 4 of the sealing system, allowing cardioplegic injections, said at least one hole 3 being connected to a system of infusion of the cardioplegia by a connector 9 integrated on the outer wall of the device and which has a rod, provided with a system of non-return valves 8 located in the lateral tubular block 6.
• the device of the present invention when used as a ventricular discharge cannula, for example non-limiting, is characterized in that the distal disk 4b, among the two inflatable diskettes constituting the sealing system, takes a suction cup shape during its inflation to adapt to the shape of the end of the heart.
• the device according to the present invention is characterized in that the proximal diskette 4a, among the two inflatable disks constituting the sealing system, has at least one irrigation hole forming a system anti-thrombotic safety.
• the cardiovascular device may have a hinge elbow 13 allowing inclination of the device relative to the inner vascular or cardiac wall 12.
• the cardiovascular device is used for the implementation of aortic or cardiac cannulations, vascular catheterization or cavity drainage.
• body 5 of the device is meant a tube having a longitudinal axis XX 'made of a material suitable for the field of surgery, grouping or supporting the various mechanisms, systems and accessories constituting the device according to the present invention.
• the body 5 may have lengths and diameters that vary according to the surgical applications of the device according to the present invention, in particular as a function of the cardiac and periacial morphologies.
• the body 5 of the device may have at least one articulation elbow 13 to make vascular catheterization less complicated and to reduce the traumatic risks.
• the articulation of the device can be done manually or in a controlled manner, assisted by a pneumatic, electrical or other system.
• the proximal portion of the device of the present invention intended to penetrate the lumen of the vessels and / or the cardiac cavities may present a curvature adapted to the physiology of the vascular and / or cardiac light concerned, allowing a favored flow of blood between the device and the target organ.
• the various systems arranged in the outer wall of the device such as balloons or automatic suture systems, they are integrated into the wall so as to avoid any enlargement or tearing of the vascular or cardiac incision at the time of penetration and / or ablation of the device.
• sealing system is meant a system for compression squeezing the vascular or cardiac wall on its inner and outer faces around the incision made by the device of the present invention, said sealing system based on the presence of two inflatable disks 4, one termed proximal 4a and the other distal 4b with respect to their provisions on the longitudinal axis XX 'of the device, these two inflatable disks being housed in the wall of the body of the device to avoid any enlargement or tearing of the vascular or cardiac incision at the time of penetration and / or ablation of the device.
• the housings that can accommodate said inflatable disks 4 may be in the form of tunnels whose diameters are smaller than the diameter of the body 5 of the device.
• the proximal floppy disk 4a enters the vascular or cardiac lumen while the distal floppy disk 4b remains outside.
• Inflatable disks are two disk-shaped balloons whose surface after inflation is compatible with a compression of the vascular wall, the diskette surface after inflation and the compression force to be perfect to ensure a tightness of the area of incision without damaging the vascular or cardiac wall, without the need for zippers or stitches.
• the position of these inflatable disks, spaced a few millimeters apart, is modifiable along the longitudinal axis of the device in order to adapt it to the thickness of the vascular or cardiac wall concerned, at the location of the incision and to be able to modify the depth of vascular penetration of the device.
• This positioning can be manual, directly or not by the operator or ordered, assisted by a pneumatic, electrical or other.
• the distal floppy disk 4b can take a so-called "suction cup" shape when it is inflated, making it possible to adapt to a compression of the outer wall of the tip of the heart.
• the proximal floppy disk 4a may be equipped with an irrigation system to prevent the local formation of micro-clots between the inflatable balloon and the vascular wall; particularly, the proximal diskette 4a may be equipped with at least one irrigation hole, and preferably several, to allow the flow of a heparinized serum, for example.
• This particular embodiment preferably extends to all applications requiring prolonged maintenance of the cannula on the vascular or cardiac wall.
• Inflation and deflation of said disks constituting the sealing system are triggered directly by the operator via a connector 11 housed in the wall the body of the device, connected to the rod of said connector 11 located in the tubular block 6 of the device according to the present invention.
• inflatable occlusive balloon 2 is meant primarily a balloon of aortic obstruction, positioned a few millimeters from the proximal end of the device.
• the position of said inflatable occlusive balloon 2 is modifiable by manual guidance of the surgeon or by remote control relative to the longitudinal axis XX 'of the device, preferably intraoperatively.
• modifying the position of said balloon is meant an inclination on its axis of said balloon in order to position it relative to the morphology of the arteries or other lights concerned.
• This inclination refers to the longitudinal axis XX 'of the device according to the present invention; after inflation, the axis of said balloon being substantially perpendicular to the axis XX 'of the body of the device, this angle may be modified according to the morphology of the arteries to ensure complete occlusion of the vessels and cavities concerned.
• This possibility of intraoperative guidance by the surgeon's finger of the inflatable occlusive balloon allows, unlike current catheter systems, an obstruction of the blood flow in the ascending aorta, without blocking the circulation in the vessels of the aortic arch. that infuse the brain and upper limbs.
• Inflation and deflation of said inflatable occlusive balloon are triggered via a connector 10 housed in the wall of the body of the device, connected to the rod of said connector 10 located in the tubular block 6 of said device, directly by the operator.
• By hole or lateral orifice means at least one, preferably two orifices 3 in the wall of the device, allowing cardioplegic injections. These orifices are located between the inflatable occlusive balloon 2 and floppy disks 4 of the sealing system, ideally directed towards the coronary ostia. These lateral holes 3 replace the traditional system of cardioplegic injection by separate catheter and avoid associated risks and complications such as vascular complications, crowding of the aorta, etc.
• This or these lateral holes 3 are connected to an infusion system of the cardioplegia by a connector 9 integrated on the outer wall of the device and which has a rod provided with a system of non-return valves 8, located in the lateral tabular block 6.
• flexible guide 1 or guide is meant a flexible rod which is relatively movable within the body of the device, along the longitudinal axis XX 'and whose proximal portion is a point which makes it possible to make an incision in the wall. a vessel and / or a heart chamber.
• the movement of said guide is controlled manually or by remote control of the surgeon, by his distal portion housed in the lateral tabular block 6.
• the material of said guide is a material compatible with a surgical practice and can be variable, plastic, metallic, etc.
• the material of the tip of said guide may be similar or different from that of the guide.
• the length and diameter of said guide may be adapted according to the use of the device according to the present invention and depending on the shape of said device which is related to the morphology of the vessel to which it is addressed.
• the shape of the tip of said guide is also adapted according to the incision to be made; it may take the form of a more or less thick blade, a conical tip or a more or less thick needle, etc.
• the incision means of the device of the present invention can be a laser beam.
• This flexible guide 1 makes it possible to eliminate the traditional steps encountered during the practice of an incision, most often performed by two operators, one incising with a scalpel blade, the other which ensures blood flow in order to prevent any risk of bleeding.
• the control of the introduction of said flexible guide 1 in an artery can be manual, directly or indirectly by the operator or controlled, assisted by a pneumatic, electrical or other.
• a simple pressure allows the introduction of the tip of said guide 1 in the artery, immediately followed by the body of the device, which avoids the risk of vascular tears. Once the pressure is released by the operator, the cutting tip of the guide 1 enters inside the body of said device, which allows an introduction of the body of the device into the vascular cavity safely.
• tabular block 6 is meant a compartment attached to the outer wall of the body of the device according to the present invention and containing the rods of the control connectors of the lateral orifices, the sealing system, the occlusive balloon inflatable, and also the distal portion of the flexible guide, and the non-return valves of each of the connectors.
• Figure 1 longitudinal longitudinal section showing the device according to the present invention in its catheter version or non-aortic cannula.
• Figure 2 Longitudinal profile section showing the proximal end of the device according to the present invention in its catheter version or non-aortic cannula.
• Figure 3 longitudinal longitudinal section showing the device according to the present invention in its version of aortic cannula.
• Figure 4 Longitudinal profile section showing the proximal end of the device according to the present invention in its catheter or non-aortic cannula version.
• Figure 5 Longitudinal frontal section showing inflation (Figure 5a) and deflation (Figure 5b) of the inflatable occlusive balloon and floppy disks constituting the sealing system;
• Figure 5c Longitudinal section of the face representing the suction-shaped inflation of the distal floppy disk 4b.
• Figure 6 longitudinal longitudinal section showing the device according to the present invention equipped with a hinge bend.
• Figure 7 longitudinal longitudinal section showing the incision of a vessel by the metal guide of the device of the present invention (Figure 7a) and its retraction ( Figure 7b).

Applications Claiming Priority (2)

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• 2010
  • 2010-01-22 FR FR1050428A patent/FR2955500B1/fr not_active Expired - Fee Related
• 2011
  • 2011-01-19 JP JP2012549348A patent/JP2013517814A/ja active Pending
  • 2011-01-19 WO PCT/EP2011/050703 patent/WO2011089162A1/fr active Application Filing
  • 2011-01-19 BR BR112012018191A patent/BR112012018191A2/pt not_active IP Right Cessation
  • 2011-01-19 EP EP11700843A patent/EP2525728A1/fr not_active Withdrawn
  • 2011-01-19 CN CN2011800145255A patent/CN102811674A/zh active Pending
  • 2011-01-19 US US13/574,607 patent/US20130018302A1/en not_active Abandoned

Non-Patent Citations (1)

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