EP1164946A1 - Apparatus for dissection with pressurised liquid and injection by pressurised jet of a treating product - Google Patents
Apparatus for dissection with pressurised liquid and injection by pressurised jet of a treating productInfo
- Publication number
- EP1164946A1 EP1164946A1 EP00912724A EP00912724A EP1164946A1 EP 1164946 A1 EP1164946 A1 EP 1164946A1 EP 00912724 A EP00912724 A EP 00912724A EP 00912724 A EP00912724 A EP 00912724A EP 1164946 A1 EP1164946 A1 EP 1164946A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- surgical
- liquid
- work device
- medical work
- jet
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3203—Fluid jet cutting instruments
- A61B17/32037—Fluid jet cutting instruments for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
- A61B2018/00392—Transmyocardial revascularisation
Definitions
- Apparatus for dissection by pressurized liquid and injection by spraying with pressure of a treatment product Apparatus for dissection by pressurized liquid and injection by spraying with pressure of a treatment product.
- the present invention relates to an apparatus for dissection by pressurized liquid allowing the simultaneous projection under pressure of a treatment product.
- the pressurized liquid jet surgical devices make it possible to advantageously replace for certain delicate medical or surgical interventions the traditional mechanical cutting tools such as scalpels whose precision is conditioned by the human factor and particularly traumatic or lasers which perform a particularly cutting fine and precise but by means of a burn leading to necrosis of the adjacent tissues, unwanted and difficult to heal, as well as the ultrasonic scalpels having less effectiveness and requiring frequent and precise adjustments.
- the traditional mechanical cutting tools such as scalpels whose precision is conditioned by the human factor and particularly traumatic or lasers which perform a particularly cutting fine and precise but by means of a burn leading to necrosis of the adjacent tissues, unwanted and difficult to heal, as well as the ultrasonic scalpels having less effectiveness and requiring frequent and precise adjustments.
- pressurized liquid jet devices allow a clean and precise cut to be made without damaging the tissues adjacent to the target. They are moreover of a modest cost, in any case considerably lower for example than that of the apparatuses with laser or ultrasound rays, and are particularly flexible to use.
- Many operating parameters such as the pressure of the working liquid, the power of the suction or the frequency and duration of the pulses if a pulsed jet is used, can be modified in order to optimize the effect obtained. Depending on the value of these parameters, it is possible to obtain a work of more or less incisive cutting of the tissues and a more or less large dissection effect, leading for example to a cutting of the softest tissues and leaving the others intact.
- Pressurized liquid jet surgical devices are therefore particularly suitable for removing soft tissue, for example, because they are capable of emulsifying these tissue without damaging adjacent tissue.
- the emulsified tissues are then easily drawn out of the intervention site by means of suction.
- This product may have any therapeutic activity related to the patient's pathology or to the course of the intervention. It can for example be a preparatory agent for the intervention, useful for its progress, increasing its beneficial effects, limiting the risks of post-operative complications or combating side effects linked to the operative trauma. It can also be any therapeutic agent useful in the treatment of the patient's problem or illness.
- the application must be carried out with an instrument different from the dissection instrument which implies a loss of time and concentration for the surgeon who must change the instrument during the intervention. This is all the more complicated when the intervention is non-invasive, that is to say takes place percutaneously by means of instruments carried by or integrated in a catheter slid to the site of the intervention.
- the object of the invention is to allow the application of a treatment product directly on the site of the surgical or medical intervention and simultaneously with its realization and this with the same device.
- the apparatus for dissection by pressurized liquid according to the invention comprises means for switching or mixing a treatment product with the working liquid or means for multiplexing during a pulse regime of jets drawn under pressure.
- the surgeon can thus, by means of the apparatus according to the invention, carry out the cutting directly with the treatment product by using it as sterile working liquid.
- the therapeutic agent is generally quite expensive, it is also possible to use a sterile mixture of conventional working liquid, preferably physiological saline, and of treatment product.
- This can for example include a control means allowing the person practicing the intervention to trigger, stop and / or modify the parameters, according to his needs, of the jet of pressurized working liquid and that of the treatment product, the two liquids being able to open from the device through two different orifices or through a single outlet orifice communicating via a switching or mixing device with two separate reserves or with a mixture reserve placed ( s) under pressure.
- a preferred embodiment of the apparatus according to the invention provides a pulsed jet of pressurized liquid. It can then include a multiplexer 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 apparatus according to the invention provides very significant advantages over known systems. Thanks to him, the sterile treatment liquid can be sprayed directly under pressure on the site of the operation. The product thus arrives directly at its site of action with maximum efficiency. The risks of touching and damaging organs or tissues not affected by the application are greatly reduced.
- the application is made from the cut and simultaneously with the course of the intervention, at the most appropriate time to ensure maximum effectiveness of the treatment product.
- the strength of The pressure of the liquid jet also allows better penetration of the treatment product into the heart of the tissues where it diffuses rapidly and widely, which further reinforces its effectiveness.
- the application of the therapeutic agent is simple, rapid and is done without changing the device and without distracting the surgeon.
- the medical or surgical device according to the invention makes it possible to perform on the body of a living being or in ex situ surgery an operative and therapeutic act in a single intervention and with the same device.
- the treatment product is preferably in liquid form.
- the apparatus according to the invention may be suitable for a wide variety of medical or surgical interventions on all the organs of the body of a living being or in ex situ surgery, which will not be described below and in the body of the description, just a few examples.
- the surgical device according to the invention is, for example, particularly suitable for performing interventions of the transmyocardial or myocardial revascularization type, because it allows the application of angiogenic substances simultaneously with the realization of the revascularization conduits in the ischemic zone of the myocardium.
- Another example of application of the apparatus according to the invention and of the method implemented by it is the treatment of vascular diseases such as thromboses.
- this device is also particularly advantageous for interventions on soft tissues such as for example those of the liver. It can advantageously be used to remove cancerous tumors on this organ or to perform transplants, the device according to the invention allowing the simultaneous application of anti-rejection substances.
- FIG. 1 is a simplified explanatory diagram of a dissection apparatus with continuous jets of pressurized liquid, comprising two independent circuits for the circulation and ejection of the working liquid and of the treatment product;
- FIG. 2 is a simplified explanatory diagram of a dissection apparatus with jets drawn from pressurized liquid, comprising two independent circuits for the circulation and ejection of the working liquid and of the treatment product;
- FIG. 3 is a simplified explanatory diagram of a dissection apparatus with a jet of pressurized liquid, comprising a single circuit allowing the circulation and the ejection of a mixture of working liquid and of treatment product, mixture produced before pressurizing the liquid; .
- FIG. 4 is a simplified explanatory diagram of a dissection apparatus with a jet drawn from a pressurized liquid extended by a hose and comprising a single circuit allowing the circulation and the ejection of a mixture of working liquid and treatment product, mixture produced after the pressurization of its constituents; .
- FIG. 3 is a simplified explanatory diagram of a dissection apparatus with a jet of pressurized liquid, comprising a single circuit allowing the circulation and the ejection of a mixture of working liquid and treatment product, mixture produced after the pressurization of its constituents; .
- FIG. 5 is a simplified explanatory diagram of a dissection apparatus with a jet of pressurized liquid, comprising a single circuit allowing alternately the circulation and the ejection of a working liquid or of a treatment product, the switching member being arranged before pressurizing the liquid;
- FIG. 6 is a simplified explanatory diagram of a dissection apparatus with a pulsed jet of pressurized liquid, comprising a single circuit allowing alternately the circulation and the ejection of a working liquid or of a treatment product, the switching member being arranged after the pressurization of the liquids;
- FIG. 7 is a simplified explanatory diagram of a dissection apparatus according to the invention allowing the emission of a pulsed jet of pressurized liquid formed of elementary pulses of working liquid and of a treatment product according to an order and according to parameters which can be modified and programmed as required.
- the pressurized liquid dissection apparatus will now be described in detail with reference to Figures 1 to 7.
- the equivalent elements shown in the different figures will bear the same numerical references.
- the portions of circuits in which the working liquid circulates have been shown in thick gray lines.
- the portions of circuits intended for the treatment product have been shown in thick black lines.
- the thick continuous lines represent a continuous jet of liquid and the thick dotted lines represent a pulsed jet.
- the surgical apparatus according to the present invention has been schematically represented in FIGS. 1 to 7. It is an apparatus 1 capable of sending one or more jets of sterile liquid under pressure, for example against a tissue to be cut or a material to be disaggregated.
- This device comprises a pressurized liquid generator 2 connected to a reserve 3 of working liquid.
- This reserve can be, for example, a plastic bag containing the working liquid enclosed in an enclosure which is filled with a neutral gas in order to compress the bag and put the liquid under pressure.
- the pressure of the jet of liquid generated can be adjustable in order to adapt it to the needs.
- the pressure inside the enclosure is preferably between 0.3 and 200 bars and preferably between 0.3 and 100 bars.
- the enclosure can also be thermostatically heated to a temperature close to or slightly above 37 ° C so that the working liquid reaching the intervention site is approximately the same temperature as the patient's body.
- a suitable working liquid pressure value cited here only by way of example for a dissection application is approximately 30 bars.
- the working liquid used is preferably sterile physiological saline used at a suitable pressure which depends on the application. Therefore the cut is completely sterile and not aggressive for the tissues. This limits the problems of sterilization of needles and conventional surgical devices and reduces the risk of complications.
- sterile liquids can obviously be used as a sterile working fluid such as for example a saline solution, a glucose solution, Ringer-lactate, hydroxyethyl starch or a mixture of these solutions.
- the sterile working liquid is brought to a handpiece 4 allowing the surgeon performing the intervention to control the triggering of the working liquid jet and to direct it.
- the handpiece 4 comprises an ergonomic body 5, allowing easy gripping and handling and may have control members such as for example a push button 6, as well as an active end 7 for example a tube 8 delivering the jet sterile liquid under pressure.
- the end tube 8, for example of cylindrical shape, comprises a conduit 9 inside which the working liquid passes to an end orifice 10 through which the jet of pressurized liquid 11 gushes out in order to produce a surgical work of cutting, dissection or disintegration.
- the surgical device 1 preferably comprises a suction system 12 connected to a vacuum source 13, for example the general vacuum circuit of the hospital.
- a vacuum source 13 for example the general vacuum circuit of the hospital.
- the suction system is terminated by a 'suction duct 14, for example of generally cylindrical shape, located at the end of level 7 and concentric or surrounding the conduit 9.
- the suction conduit 14, opening ' close to the intervention zone makes it possible to aspirate the working liquid and the small debris during the dissection work, thereby improving the cutting efficiency and the visibility of the intervention area for the surgeon.
- the surgical device is preferably a pulsed jet device sending the liquid under pressure by a shot in the form of a discontinuous train of pulses constituting jets. of pressurized liquid.
- a shot can also consist of a single pulse.
- the surgical apparatus further comprises a sequencer 15 allowing the formation of the pulsed jet and controlling its parameters.
- the conduit for passing the pressurized liquid is put at certain times, as a function of the characteristics of the pulsed jet, in communication with the suction system in order to improve the shape of the train of pulses of pressurized liquid and according to an originality patented elsewhere.
- the active end 7 of the device according to the invention may have a different shape depending on the nature of the intervention to be carried out.
- the end tube 8 can thus be relatively short in the case of interventions concerning surface parts of the body or largely exposed tissue.
- the tube 8 may have a greater length when, for example, it has to pass through a trocar in order to reach deeper tissues, the intervention thus requiring only incisions of reduced size that are less traumatic for the patient.
- the apparatus according to the invention is extended by a hose 16, comprising the fluid circulation circuit (s) and which can be introduced and guided in a catheter slid to the site of the intervention, to perform non-invasive percutaneous interventions.
- the active end 7 can also be articulated and orientable and include a locating system in order to be able to position itself at the appropriate place and at a preferential inclination, the assembly being controlled from the handpiece 4. It can also include an anchoring system in order to ensure immobilization of the active end during the firing of liquid under pressure, thus improving the precision of the interventions. It may for example be any mechanical means of anchoring or a means using the suction system of the instrument such as for example the skirt 17 illustrated in FIG. 4.
- the dissection apparatus further comprises a reserve 18 of treatment product.
- the treatment product constitutes the working liquid and is stored in the reserve 3 previously described.
- the treatment product is preferably in a liquid form or sufficiently fluid to be applied by means of the device according to the invention. It may be a single therapeutic agent or a mixture of several of them, in a form for example fluid and preferably liquid, in solution or suspension in any solvent or in the form of an emulsion , foam or gel.
- the cost price of the treatment product being generally much higher than that of a working liquid, the apparatus according to the invention preferably comprises at least two separate reserves, one 3 for the working liquid and the 'other 18 for the treatment product.
- the reserve 18 of treatment product can also be a plastic bag placed in the same pressurization enclosure as the reserve of working liquid or in another similar enclosure so as to be able to adjust the pressure of the treatment fluid independently of that of the working liquid.
- the treatment product is then brought to the handpiece 4 through which it passes. It passes through a conduit 19 similar to the conduit 9 taken by the working liquid and emerges in the form of a jet of fluid 20 under pressure through an end orifice 21 similar to the end orifice 10. Triggering and stopping the jet of pressurized treatment fluid are controlled by the surgeon performing the intervention by means of a control member such as for example a push button 22.
- the dissection apparatus according to the invention may also comprise only a single duct 9 and a single end orifice 10 serving for the working liquid as for the treatment product, as shown in FIGS. 3 to 7.
- the dissection apparatus can then comprise, for example, upstream of this conduit 9, a switching member 23 allowing the surgeon performing the intervention to trigger, as desired, the shot from the orifice 10 of a jet of working liquid or of a jet of treatment product.
- a shot of working liquid symbolized by a thick black line, has been represented.
- the switching member 23 the surgeon can in the same way choose to carry out a shot of treatment product.
- This switching member can be located either upstream ( Figure 5) or downstream ( Figure 6) of the generator 2 allowing the pressurization of the liquid (s).
- the device may also include, in place of the switching member 23, a mixing member 24 allowing the surgeon to produce, at the appropriate time, a mixture of working liquid and treatment product.
- the mixing member 24 is adjusted, manually or automatically, so as to make a mixture whose respective proportions of the various constituents have been previously chosen.
- the mixing member 24 is placed upstream of the orifice 10 and of the conduit 9 leading to it, at any level of the apparatus according to the invention which can be located before (FIG. 3) or after (FIG. 4) the setting under pressure of the liquid (s).
- the reserves of working liquid 3 and of treatment product 18 can be replaced by a single reserve 25 of sterile premixed liquid.
- the apparatus makes it possible to send a pulsed jet of pressurized liquid
- it may also comprise a multiplexer 26 making it possible to combine pulses of working liquid and of product processing 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.
- This preferred mode of the apparatus according to the invention has been shown in FIG. 7.
- the invention is obviously not limited to an apparatus which can inject only one treatment product. It is possible to imagine, in accordance with the invention, a dissection apparatus allowing the application of various treatment products of different nature, alternatively, simultaneously or in mixture, by means of independent conduits and orifices, organs switching, mixing components, a multiplexer alternating within a single shot drawn from liquid under pressure of the elementary pulses of working liquid and / or the different treatment products, or a combination of these different means.
- a device according to the invention first injecting an agent preparatory to the intervention, then the working liquid in order to carry out the dissection and simultaneously or just after a second treatment product this time having a therapeutic action.
- the surgical apparatus according to the invention is for example 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.
- the device according to the invention provides a great improvement compared to known revascularization apparatuses, because it makes it possible to inject a therapeutic liquid, directly at the level of the conduits in the myocardium and simultaneously with their production.
- the application of the treating liquid can also be carried out before or after the perforations have been made.
- the treating agent can thus, for example, but not limited to, be an agent preparing the muscle for the formation of conduits, promoting the development of new vessels, limiting the filling of perforations, avoiding post-operative complications, or any other useful agent in case of surgery OR in the treatment of cardiovascular diseases.
- VEGF vascular endothelial growth factor
- a liquid containing the copies of this gene, the virus or any other vector thereof can be applied when the perforations are made or immediately after.
- This application can trigger, accelerate or increase the angiogenesis that one seeks to generate by the intervention of transmyocardial or myocardial revascularization.
- Any other angiogenic substance can also be applied in the same way. It may be, for example, other growth factors, such as fibroblast growth factors (FGF) and mitogenic endothelial growth factors, or else, for example, estrogens such as estradiol, estriol or 17- ⁇ -estradiol.
- FGF fibroblast growth factors
- mitogenic endothelial growth factors or else, for example, estrogens such as estradiol, estriol or 17- ⁇ -estradiol.
- Another example of application of the apparatus according to the invention is the treatment of vascular obstructions such as thromboses.
- the application in recanalization of the arteries obstructed by a thrombus will be carried out using the apparatus according to the invention in its catheter version which can for example project as a preparative a thrombolytic agent of high efficiency of the streptokinase or urokinase type.
- the work of fragmentation or disintegration of the thrombus can be carried out using the same liquid agent under pressure combining its biochemical action with that of the pressure force of the jet.
- Another dissipating thrombolytic agent slow may be projected or diffused on the site after the evacuation of the thrombus by the suction system of the apparatus, to neutralize the usual well-known tendency to the formation of a new thrombus.
- the apparatus according to the invention in its catheter version makes it possible to envisage cleaning and surfacing of the wall of the arteries with a view to recalibrating the vessels.
- the first phase consists of cleaning by the mechanical effect of pressure and by the effect of an agent promoting the detachment of deposits and atheroma plaques.
- the raw flesh can then be smoothed and surfaced by the deposition of an agent promoting the endothelialization of the abraded wall which temporarily becomes very thro bogenic. Again, this may be direct cell therapy with injection of autologous or allogenic endothelial cells from cultures or catalysts for the formation of new autologous cells.
- the apparatus according to the invention because of its dissection work of adjustable intensity, is also particularly advantageous for interventions on soft tissues such as for example those of the liver. It can advantageously be used to carry out hepatic resections, for example partial or total grafts, allowing in addition the simultaneous application of anti-rejection substances.
- Intervention on a cancerous liver will rid it of all its cancerous tumors by the combined action of a cytolytic agent and the high pressure of the working fluid.
- a preparation agent can be projected onto the site. Then, using the high pressure jet, the surgical work, which essentially consists of cleaning the liver of its tumors, will be carried out.
- the cutting and scraping work by the mechanical effect of the high-pressure jet shaped as a sheet allows an effective cleaning practically free bleeding due to the incisive effect of the jet and the softness of the tissue.
- the arterioles and veins, as well as the bile elements are all preserved.
- the locally projected cytolytic agent aids in the scaling of tumors and their dissociation from healthy tissue.
- the projection of a chemotherapy agent can avoid taking tires tiring the body in the immediate post-operative phase.
- an internal cavity will persist within the hepatic parenchyma whose spontaneous re-habitation may be accelerated by the injection of '' an emulsion, foam or gel combining a filling effect and, depending on their composition, healing adjuvants.
- myocardial revascularization multiple sequential perforations according to a precise or random protocol, through the sclerotic parenchyma and regeneration nodules characteristic of cirrhosis could contribute to stabilizing the sclerogenic involution, or even to stimulate the regeneration of healthy elements, especially by combining the injection of hepatotrophic factors.
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Surgical Instruments (AREA)
Abstract
Description
Claims
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19912844A DE19912844A1 (en) | 1999-03-22 | 1999-03-22 | Use of a cutting device, which uses a fluid as cutting medium, for surgical treatment |
DE19912844 | 1999-03-22 | ||
PCT/FR2000/000715 WO2000056232A1 (en) | 1999-03-22 | 2000-03-22 | Apparatus for dissection with pressurised liquid and injection by pressurised jet of a treating product |
Publications (1)
Publication Number | Publication Date |
---|---|
EP1164946A1 true EP1164946A1 (en) | 2002-01-02 |
Family
ID=7901931
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP00912724A Withdrawn EP1164946A1 (en) | 1999-03-22 | 2000-03-22 | Apparatus for dissection with pressurised liquid and injection by pressurised jet of a treating product |
Country Status (6)
Country | Link |
---|---|
US (1) | US6423027B1 (en) |
EP (1) | EP1164946A1 (en) |
JP (1) | JP2002538929A (en) |
AU (1) | AU3438100A (en) |
DE (1) | DE19912844A1 (en) |
WO (1) | WO2000056232A1 (en) |
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- 1999-03-22 DE DE19912844A patent/DE19912844A1/en not_active Ceased
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- 2000-03-22 EP EP00912724A patent/EP1164946A1/en not_active Withdrawn
- 2000-03-22 US US09/532,904 patent/US6423027B1/en not_active Expired - Fee Related
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JP2002538929A (en) | 2002-11-19 |
DE19912844A1 (en) | 2000-09-28 |
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