Classifications

• • 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
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0082—Catheter tip comprising a tool
  • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
• • 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
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0082—Catheter tip comprising a tool
  • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
  • A61M2025/0089—Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip

Definitions

• the present invention relates to an improved catheter with retractable tip tool for puncture or puncture work.
• an active agent for example a medicament, a product useful for surgical intervention or a diagnostic product, directly in contact with the diseased or to be treated area, which is located most of the time inside the human body, in an organ, or in its tissue.
• an injection catheter is used for this, which is inserted and pushed along a vessel inside the patient's body until its distal end, pierced with one or more orifices, is as close as possible to the area to be treated. Then the active agent is injected into the area to be treated through the opening (s) of the end of the injection catheter.
• the active product For the treatment to be effective, the active product must be applied for a long period or several times, which lengthens the patient's hospital stay and increases the risk. infections or complications related to the procedure. In addition, since the active product is often relatively expensive, the cost of treatment is considerably increased. In addition, the active product which is useful and beneficial in the targeted area can be harmful or even toxic if it is applied to other organs of the patient not affected by the treatment. This is particularly the case with the increasing development of gene therapies, during which it is possible, for example, to administer genes, cells, nucleic acids or genetically modified proteins to the target organ, applied in isolation or by means of 'a vector for example a virus. It is therefore very important that the administered product, developed for a specific application, remain localized at the site of its injection. However, with the conventional device described above, the active agent is carried away from the treatment site by the flow of the blood circulation and can therefore inadvertently lead to other organs not targeted.
• catheters comprising at their distal end an injection needle device have been developed.
• the needle enters the targeted tissue and the active agent is injected through this needle directly into the heart of the tissue to be treated.
• the active agent is much more effective. Indeed, all of the agent injected can act and is much less likely to be involuntarily trained towards other non-target organs. In addition the fabric is treated in depth and no longer just on the surface.
• injection catheters comprising at their distal end a retractable needle have been proposed in the prior art.
• the exit of the needle prior to injection and then the re-entry of the latter inside the catheter are controlled manually by the user.
• One of the objectives of the invention is to meet this need.
• the catheter according to the invention is of the injection catheter type, that is to say a flexible adjustable conduit intended to inject into an organ or into the tissue of an organ an active product. It has at its distal end a retractable puncture or puncture tool making it possible to perform a puncture work and to inject a product directly into the tissue of an organ.
• the catheter device provides greatly improved security by eliminating the risk previously mentioned.
• the position of the retractable end tool is controlled automatically, its output only taking place when a liquid under sufficient pressure is sent to be delivered by the catheter.
• the tool In the absence of liquid or if the pressure thereof is below a threshold value, the tool is automatically returned to the retracted safety position inside the catheter. Before and after injection, the tool is therefore in the retracted position without the user having to intervene. Any risk of involuntary damage is thus avoided.
• the work of the pressurized jet makes it possible to produce a conduit in the tissue or the organ to be treated, into which an active, treatment, growth or other liquid is injected or introduced.
• the working liquid is also the active liquid or a mixture.
• the active product sent inside the conduit dug by the working liquid under pressure is thus administered to the heart of the tissue to be treated.
• the end of the conduit being open the active agent tends to come out of the conduit and to be quickly evacuated from the treatment site. We then find us in the disadvantageous situation previously mentioned.
• the pressure jet working longitudinally, the concentration of the liquid takes place at the blind end of the duct.
• the area of the open end and the walls of the beginning of the conduit receive very little active liquid when this end also needs it.
• the inventive solution described below overcomes this drawback.
• the device according to the invention makes it possible to combine the benefits of the jet of liquid under pressure with those of needle catheters.
• the invention enables the first part of an injection pipe to be produced mechanically by a perforating or puncturing tool, while diffusing the active product in a layer located near the surface.
• the catheter according to the invention has a retractable end tool, preferably a retractable needle, which can be used as an outlet nozzle for a pressurized liquid, the work of which consists in digging a conduit in the layer of tissue against which the front wall catheter is affixed.
• the active liquid or a part of it is also used as working liquid for the diffusion of the liquid along the conduit.
• the catheter according to the invention is in the form of a flexible conduit with a steerable end by known means, comprising a retractable end tool of the puncturing or pricking type, movable between a working out position and a retracted safety position. inside the catheter, allowing the injection of a liquid under pressure.
• the exit from the end tool is automatic and caused by the pressure of the liquid escaping from the catheter.
• the end tool is automatically retracted inside the catheter in the absence of liquid or if the pressure of the latter is below a threshold value.
• Figure 1 is a sectional view of the end of an embodiment of the catheter according to the invention, the needle-nozzle being in the retracted position of rest; .
• Figure 2 is a sectional view of the end of an embodiment of the catheter according to the invention, the needle-nozzle being in the out position for injecting liquid; .
• Figure 3 is a sectional perspective view of the end of a variant of the catheter according to the invention comprising a suction means, the needle-nozzle being in the retracted position; .
• Figure 4 is a schematic sectional view of the end of the suction variant of the catheter according to the invention, positioned in contact with the wall of an organ, the needle-nozzle being in the retracted position; .
• FIG. 5 is a schematic sectional view of the end of the suction variant of the catheter according to the invention, positioned in contact with the wall of an organ, the needle-nozzle being in the outgoing injection position for liquid ; .
• FIG. 6 is a more general simplified explanatory diagram, illustrating a possible application of the catheter according to the invention to a dissection apparatus with jets pulsed with liquid under pressure.
• the catheter according to the present invention will now be described in detail with reference to Figures 1 to 6.
• the equivalent elements shown in the different figures will have the same reference numerals.
• the catheter 1 is conventionally in the form of a flexible conduit 2 in which an active liquid 3 can flow, for example a working liquid, a therapeutic, surgical or diagnostic product. It comprises a proximal end 4 manipulated by the surgeon and a distal end 5 introduced inside the patient's body.
• the distal end 5 includes known navigation and orientation means which have not been shown in the figures because they are not part of the invention.
• the catheter ends at its distal end with a front end wall 6 pierced with an orifice 7, preferably central, through which the active liquid 3 can flow or be ejected.
• this end 5 of the catheter can optionally be protected by a removable closure piece, for example a screw cap. In this case, it has an external thread 8.
• the distal end of the catheter according to the invention contains a retractable end tool 9 movable between a retracted safety position inside the catheter, illustrated in FIGS. 1, 3, 4 and 6, and an extended position. work, illustrated in Figures 2 and 5.
• the end tool 9 makes it possible to carry out perforating or puncturing work.
• it comprises a slide 10 and a base 11 carrying a needle-nozzle 12.
• the slide 10 is preferably in the form of a substantially cylindrical hollow part or pierced with a through channel 13. Its outside diameter is slightly smaller than the inside diameter of the pipe 2 so that it can slide inside the latter. However, the clearance between the duct 2 and the slide 10 remains minimal in order to ensure sealing despite this freedom of sliding.
• the internal wall 14 of the conduit 2 and the parts of the slide in contact with the latter are lined with a Teflon-based coating ensuring sealing even at high pressure, while promoting sliding.
• all the sliding parts of the end tool 9 in contact with the internal wall 14 of the conduit 2 are preferably provided with a coating based on Teflon.
• the slide 10 is integral or capable of pushing the needle holder base 11 in order to drive it in its sliding movement. According to an alternative embodiment shown in Figures 4 and 5, the slide 10 and the base 11 can be made in one piece.
• the needle holder base 11 comprises a plate 15 preferably substantially circular and with a diameter less than the internal diameter of the conduit 2 so as to be able to slide inside the latter.
• the parts of the needle holder base 11 in contact with the internal wall 14 of the conduit 2 are also provided with a coating based on Teflon.
• the needle 12 is connected to the plate 15 by a base 16 and ends with a tip 17 capable perform perforation or puncture work.
• the internal channel 18 of the needle has a substantially conical shape narrowing in the direction of the ejection orifice 19 so as to be able to act as a nozzle.
• the needle 12 also has a substantially conical external shape. This form is not, however, limiting. Indeed, the length and the shape of the needle 12 can be optimized according to the application envisaged for the catheter according to the invention. Thus, the needle 12 can for example be pointed, rounded or bevelled.
• the outer surface of the needle is not necessarily smooth. It may include reliefs, such as for example one or more twist (s), notches, hooks or retaining pins, in order to improve the anchoring and the attachment of the needle into the fabric.
• reliefs such as for example one or more twist (s), notches, hooks or retaining pins, in order to improve the anchoring and the attachment of the needle into the fabric.
• the plate 15 is also pierced with a through channel 20, the ends of which are in fluid communication for one with the end of the channel 13 of the slide 10 and for the other with the internal channel 18 of the needle 12.
• the tip 17 of the needle 12 is located opposite the orifice 7 of the front wall 6 of the catheter end, so as to be able to project out of the catheter through this orifice when the needle 12 is in the out position. job ( Figures 2 and 5).
• an elastic restoring force recalls the slide-needle assembly in the retracted position of rest, that is to say in the retracted safety position inside the catheter.
• This restoring force can be exerted by a spring 21, preferably disposed between the plate 15 of the needle holder base 11 and the end end wall 6 of the catheter.
• the spring 21 exerts an elastic return force on the needle holder base 11, which keeps the needle 12 in the retracted position of rest.
• the slider 10 slides inside the conduit 2 in the direction of the distal end 5 of the catheter, driving with it the needle holder base 11 and compressing the return spring 21.
• the movement of the base 11 causes the tip 17 of the needle 12 to exit the catheter through the orifice 7 of the front end wall 6.
• the needle 12 is then in the working output position ( Figures 2 and 5).
• the fluid is ejected from the catheter 1 through the orifice 19 of the needle-nozzle 12 in the form of a jet 24.
• the return spring 21 decompresses and pushes the plate 15 which causes the sliding of the needle holder base 11 as well as that of the slide 10 in the direction of the proximal end 4 of the catheter.
• the needle 12 then returns to its retracted rest position.
• the exit and re-entry of the needle take place automatically and without direct intervention by the user, depending on the pressure of the fluid flowing into the catheter.
• the surgeon controls only the start and / or stop of the flow of liquid, the position of the needle being automatically and almost immediately adapted to the situation.
• the fluid To bring out the needle 12, the fluid must have sufficient pressure to succeed in compressing the spring 21. There therefore exists for the fluid a limit pressure or threshold pressure, corresponding to the equilibrium pressure with the elastic force of reminder, below which the needle exit does not take place.
• This threshold pressure is, in this embodiment, fixed by construction and depends on the stiffness constant of the return spring 21. It is preferably close to five bars.
• the catheter according to the invention makes it possible to achieve this objective satisfactorily.
• the catheter according to the present invention may further comprise a suction means opening out near the intervention zone, which makes it possible to aspirate the working fluid, body fluids and small debris, thus improving the efficiency of the 'intervention and visibility of the treated area for the surgeon.
• a suction means opening out near the intervention zone which makes it possible to aspirate the working fluid, body fluids and small debris, thus improving the efficiency of the 'intervention and visibility of the treated area for the surgeon.
• FIGS. 3 to 6 A variant of this type has been shown in FIGS. 3 to 6.
• the catheter 1 comprises a suction duct 25, for example of generally cylindrical shape and surrounding the duct 2 preferably concentrically.
• the suction duct 25 widens at the distal end 5 of the catheter until it forms a skirt 26.
• the catheter according to the invention may include an additional anchoring system in order to ensure immobilization of its active end during the firing of liquid under pressure, thus improving the precision of the interventions.
• FIGS. 4 and 5 An example of use of the catheter according to the invention has been shown diagrammatically in FIGS. 4 and 5.
• the surgeon introduces the distal end of the catheter into the body of the patient and guides it along an appropriate vessel until it comes close to an organ or tissue 27 to be treated.
• a wall area 28 suitable for treatment After having identified, by means of location not shown, a wall area 28 suitable for treatment, it positions the front end wall 6 of the catheter as close as possible to the targeted area of the wall 28 by means of means of orientation and articulation also not represented.
• the point 17 of the needle passes through the wall 28 and penetrates into the tissue 27.
• the maximum depth of penetration into the fabric 27 depends on the maximum length of the stroke of the slide 10 and therefore on the possible compression of the spring 21. It is preferably about 2 mm.
• the pressurized liquid passes through the channel 13 of the slide 10, the channel 20 of the base 11 and the channel 18 of the needle 12 which acts as a nozzle. It is then ejected at high speed through the orifice 19 of the needle into the tissue 27 where it digs a conduit 29.
• the needle 12 which, by its mechanical penetration, initiates the digging work of the duct 29.
• This advantageous characteristic makes it possible to reduce the pressure of the working liquid and / or the number of shots necessary to dig the duct 29.
• This characteristic is particularly interesting when the target organ is surrounded by a membrane or an external wall more resistant than its internal tissue.
• the needle 12 passes through the external wall and the pressurized liquid can then easily dig into the softer internal tissue.
• the surgeon can then initiate the injection into line 29 of an active, treatment, growth, diagnostic or other agent.
• the working liquid is also the active liquid or a mixture containing the active agent.
• the active product sent inside the conduit 29 hollowed out by the working liquid under pressure is thus administered to the heart of the tissue to be treated.
• the dissection apparatus 31 makes it possible to send one or more jets 24 of sterile liquid under pressure for example against a fabric to be cut or a material to be disaggregated.
• This device comprises a generator of pressurized liquid 32 connected to a reserve 33 of working liquid.
• the pressure of the jet of liquid generated can be adjustable in order to adapt it to the needs.
• the working liquid used is preferably sterile physiological serum.
• other sterile liquids can obviously be used as working fluid, for example a saline solution, a glucose solution, a Ringer-lactate solution, a hydroxy-ethyl starch solution or a mixture of these solutions.
• the sterile working liquid is brought to a handpiece 34 allowing the surgeon performing the intervention to control the triggering of the working liquid jet and to direct it.
• the handpiece 34 comprises an ergonomic body 35, allowing easy gripping and handling and which may have control members such as, for example, push buttons 36.
• the handpiece 34 is extended by the catheter 1 according to the invention delivering the jet of sterile liquid under pressure in order to perform surgical work of cutting, dissection or disintegration.
• the surgical device 31 preferably comprises a suction system 37 connected to a vacuum source 38, for example the general vacuum circuit of the hospital.
• the suction system ends with the suction duct 25, concentric with the duct 2 and emerging at the level of the skirt 26.
• the surgical device 31 is preferably a pulsed jet device sending the liquid under pressure by a shot in the form of a discontinuous train of pulses constituting elementary jets of liquid under pressure.
• the surgical apparatus 31 includes a sequencer 39 allowing the formation of the pulsed jet and controlling its parameters.
• the dissection apparatus further comprises a reserve 40 of treatment product.
• the treatment product is preferably in a liquid form or sufficiently fluid to be applied by means of the surgical device 31. It may be a single active agent or a mixture of several of them, in a form, for example fluid and preferably liquid, pure or in solution or suspension in any solvent or in the form of an emulsion, a foam or a gel.
• FIG. 6 the working liquid has been symbolized by a thick black line and the treatment fluid by a thick gray line.
• the dissection apparatus may include, for example, upstream of the catheter 1, a switching allowing the surgeon practicing the intervention to trigger the choice of firing a jet of working liquid or a jet of treatment product.
• the device may also include, in place of the switching member, a mixing member allowing the surgeon to produce, at the appropriate time, a mixture of working liquid and treatment product.
• the surgical device 31 delivers a pulsed jet of pressurized liquid, it may further comprise a multiplexer 41 making it possible to combine pulses of working liquid and treatment product within the discontinuous train of pulses constituting the pulsed jet.
• the parameters of the different pulses, their nature and their succession can be modified and programmed according to the needs of the surgeon, the patient and the type of intervention performed, in order to optimize the result of the intervention.
• the catheter according to the invention is obviously not limited to an application on a surgical device as previously described. It is possible to imagine many other surgical, therapeutic or diagnostic devices to which it can be adapted.
• the catheter according to the invention is particularly suitable for performing interventions of the type of transmyocardial or myocardial revascularization, consisting in digging a plurality of revascularization conduits in an ischemic zone of the wall of the myocardium.
• its use is not limited to cardiac intervention. It is possible to imagine multiple applications of the catheter according to the invention for procedures on any type of organ or tissue of the human or animal body.

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• 2001
  • 2001-10-09 FR FR0112992A patent/FR2830455B1/fr not_active Expired - Fee Related
• 2002
  • 2002-10-07 US US10/266,017 patent/US20030069547A1/en not_active Abandoned
  • 2002-10-08 WO PCT/FR2002/003418 patent/WO2003030980A2/fr not_active Application Discontinuation
  • 2002-10-08 EP EP02800639A patent/EP1434617A2/de not_active Withdrawn
• 2005
  • 2005-02-11 US US11/055,077 patent/US20050148951A1/en not_active Abandoned
  • 2005-02-11 US US11/055,087 patent/US20050148952A1/en not_active Abandoned

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