WO1994028807A1

WO1994028807A1 - Liquid jet for surgical instrument

Info

Publication number: WO1994028807A1
Application number: PCT/FR1994/000680
Authority: WO
Inventors: Marc Philibert
Original assignee: Saphir Medical S.A.
Priority date: 1993-06-09
Filing date: 1994-06-09
Publication date: 1994-12-22
Also published as: FR2706276A1

Abstract

A liquid jet for a surgical instrument has a two-part structure, is of simple, economic design and is suitable for frequent use in surgery. It consists of a first, entirely sterile, single-use part and a second fixed part. The first, single-use part comprises a hand piece (11) connected by at least one feed pipe (12) to a flexible pouch (13) for physiological serum. The serum is pressurized in a hermetic chamber (14) by means of a pressurized gaz from a reservoir (15), both the chamber and the reservoir being located in the second, fixed part. A control unit (30) controls and regulates the operating parameters of the instrument. Application in surgery.

Description

LIQUID JET SURGICAL APPARATUS

The present invention relates to a liquid jet surgical device comprising a handpiece arranged to generate a controlled jet of this liquid consisting in particular of physiological saline under pressure and a device arranged to put this liquid under pressure.

Equipment of this type is already known, in particular an apparatus described in the journal Surgical Workshop Vol 78 April 1981 under the title "New water-jet dissector: Initial experience in hepatic surgery" and an apparatus called Aqua Jet manufactured by the Japanese company SUGINO MACHINE LTD.

These known devices operate with a high pressure pump which is used to pressurize the physiological saline. Therefore, all equipment must be sterilized after each use. Such sterilization is extremely long, since it lasts about a week to allow the total desorption of the gas in the conduits and the investment corresponding to the acquisition of such a device by a hospital center is too large to allow its immobilization for such a long time. Consequently, these devices are little used today, even if they are well suited to certain surgical procedures.

Other devices as described in US Pat. No. 4,913,698 and Japanese publication JP 63,279,832, include a pressurized gas tank, pressurizing a sealed chamber which contains a flexible serum bag. This pocket is connected by means of an irrigation tube to a handpiece provided with an ejection nozzle. A striker connects one end of the tube to the pocket, the other end of the tube being connected to the handpiece. The striker and the handpiece are generally metal parts, for example stainless steel, having relatively complex shapes, a high manufacturing cost and, for example, Consequently, they are not designed to be disposable parts. Therefore, between two surgical procedures, these parts, and possibly the tubes and the ejection nozzle, must be sterilized to avoid any bacterial contamination. This results in wasted time, fixed assets and a high intervention cost. In addition, it is difficult to guarantee perfect and complete sterility of the device. This compulsory sterilization operation prevents the surgical device from being reliable, flexible, fast and economical to use. Furthermore, no known device is equipped with an electronic device for controlling and regulating the operating parameters of the device, such as the gas supply pressure, the cutting pressure, that is to say say serum pressure.

The present invention proposes to overcome these drawbacks by providing a liquid jet surgical apparatus of simple construction, inexpensive and of practical and reliable use, which can be used at high frequency for surgical interventions, without requiring any intermediate operation of sterilization.

This object is achieved by the surgical device defined in the preamble and characterized in that it comprises a first part which is entirely sterile and for single use, and a second stationary part, said first part for single use comprising said handpiece connected by means of the at least one conduit for supplying a reservoir of physiological saline, this serum being pressurized by means of a pressurized gas originating from a reservoir disposed in said second stationary part and in that it comprises means of control and regulating the pressure of said serum.

In a first embodiment, the physiological saline is contained in a flexible gas-tight pocket, housed in a sealed enclosure, this enclosure being connected to the pressurized gas tank and containing said pressurized gas. According to a second embodiment, the physiological saline is contained in a sealed enclosure also containing gas under pressure and in that said enclosure is connected to an external reservoir of physiological saline.

The surgical device advantageously comprises at least one sterilizing filter interposed between the pressurized gas tank and the sealed enclosure and a flow limiter disposed before said sterilizing filter and arranged to deliver a progressive gas flow.

The handpiece preferably comprises means for controlling the opening and closing of the serum jet, these means being arranged to compress and partially close off said supply conduit. It may include at least one recess arranged to receive said control means and said conduit.

Said control means advantageously comprise a control handle provided with a first part emerging from said handpiece and arranged to be actuated manually, and a second part housed in said recess and arranged to bear on said conduit by means of a organ comes out.

Preferably, the handle is articulated in its middle part around an axis integral with said handpiece.

In said embodiments, the handpiece comprises an endpiece removably mounted on the body of said handpiece, this endpiece comprising at least one lance for ejecting the serum connected to one end of said supply conduit and a cone connected to a suction duct by a suction channel.

The surgical device can include a plurality of interchangeable tips with ejection lances of varying shapes and sizes. In the first embodiment, the supply conduit is connected to the pocket by means of a striker provided at one end of said conduit, and comprises a sealing cone arranged to seal said enclosure in the area of passage of said conduit.

With reference to the embodiments of the invention, the control and regulation means comprise a control unit arranged to centralize and command measurement and control devices placed in said device.

Preferably, the measuring devices comprise at least one pressure gauge mounted on the gas circuit from the tank, a pressure gauge mounted on said enclosure and the control devices comprise at least one solenoid valve mounted on said gas circuit, a solenoid valve and a safety valve mounted on said enclosure.

The control unit may include keys for adjusting the pressure of the serum, this unit being arranged to control said solenoid valves to keep said pressure of serum constant.

The control unit is advantageously arranged to automatically control the measurement devices and readjust them, if necessary, with respect to reference values.

The present invention and its advantages will appear better in the following description of two nonlimiting exemplary embodiments and with reference to the appended drawings, in which:

FIG. 1 represents an overall view of a first embodiment of the present invention,

- Figure 2 is a top view of the handpiece according to the invention,

FIG. 3 is a sectional view along line III— III of the of FIG. 2,

FIG. 4 is a cross-sectional view along the line IV-IV of FIG. 3, and

Figure 5 shows a schematic view of a second embodiment according to the present invention.

Referring to Figure 1, the liquid jet surgical apparatus 10 as shown consists of a first part completely sterile and disposable and a second stationary part. Said first disposable part comprises a handpiece 11 which constitutes the working tool of the surgeon, connected by at least one supply conduit 12 to a reservoir of physiological saline. This serum is pressurized by means of a pressurized gas from a reservoir 15 disposed in said second stationary part. In the example shown, the physiological saline reservoir is in the form of a flexible gas-tight bag 13, housed in a sealed enclosure 14 which constitutes a pressurization chamber. The bag 13 preferably corresponds to the standard serum bags used in the medical field. This enclosure 14 can be metallic or made of a suitable synthetic material. It comprises an access hatch 140 fixed to one of its walls by a fastening device 141 for safety and quick opening and a seal 142, suitable for closing off sealed enclosures. The conduit 12 is connected to the pocket 13 by means of a striker 120 forced into the end piece 130 of the pocket. For practical mounting questions, this duct is split into two parts, a part 121 inside the enclosure and a part 122 outside the enclosure. These two parts are connected by a male / female connector 123 of the type known in the medical field. The seal between the part interior 121 of the conduit 12 and the enclosure 14 is obtained by means of a sealing cone 124 sliding or not mounted on said part 121. The pressurizing of the sealed enclosure 14 is carried out by means of a gas under pressure contained in a reservoir 15 connected to the sealed enclosure 14 by a suitable conduit 16. The handpiece

11 is also connected by a suction pipe 24 to a suction device 25. It will be noted that the suction device 25 can be integrated into a control unit 30 or correspond to an existing suction device, for example of the wall mount type found in hospital operating rooms.

A control unit 30 makes it possible to check and regulate the various operating parameters of the apparatus by means of the measurement and control devices placed on this apparatus. It allows, if necessary, to stop the device and to trigger alarm signals in the event of a malfunction which could be dangerous. It is also arranged to periodically check, for example at each start-up, the operation of said measuring devices and ensure their automatic recalibration, if necessary.

The device is equipped with at least one pressure regulator 17, mounted on its gas supply duct 16, which expands and controls the pressure of the gas leaving the tank 15, with a solenoid valve 18 making it possible to open and close the gas circuit, a flow limiter 19 to ensure a gradual increase in pressure of the enclosure 14 and at least one bacterial filter 20 to make the gas sterile. The enclosure 14 comprises at least one safety valve 21 in the event of overpressure, a regulating solenoid valve 22 for regulating the pressure of the serum, and a manometer 23 for controlling the pressure in the enclosure. Finally, the suction pipe 25 is equipped with a pressure gauge 26 to control the suction pressure.

By means of an appropriate internal regulation electronic card, the control unit makes it possible to centralize and process the information from the manometers 17, 23 and 26, as well as the control of the solenoid valves 18, 22 and of the safety valve 21. This unit comprises on its front face a synoptic table of control and command of the apparatus. This panel is provided with control means comprising at least one on / off switch 31 which connects its electronic equipment to the sector, a start button 32 controlling the solenoid valve 18 for pressurizing the device, a button 'stop 33 controlling the solenoid valve 22 and the valve 21 for rapid depressurization of the apparatus and control keys 35' controlling the two solenoid valves 18, 22 to increase or decrease the cutting pressure. These control keys 35 ′ can, for example, be replaced by one or two control pedals (not shown) actuated by the surgeon. The synoptic table is also provided with visual control means, comprising at least one graduated indicator 34 connected to the pressure regulator 17 and indicating the pressure of the gas leaving the reservoir 15, a graduated indicator 38 connected to the pressure gauge 26 and indicating the suction pressure. and a screen 35 with liquid crystal or with digital display connected to the pressure gauge 23. This screen 35 indicates the pressure of the serum, which corresponds to that of the enclosure, and which is assimilated to the cutting pressure, namely the pressure of the jet of serum at the outlet of the handpiece 11. The control means additionally comprise an indicator light 36 which lights up during the pressure build-up of the device and goes out as soon as the cutting pressure is reached and an indicator light 37 which lights up as soon as a malfunction occurs, this light can possibly be coupled to an audible alarm.

The control unit 30 also makes it possible, by means of its electronic regulation card, to maintain a constant pressure in the sealed enclosure 14, equivalent to that requested by the surgeon and defined by the keys 35 '. Therefore, the cutting pressure is kept constant.

The handpiece 11, illustrated in more detail in FIGS. 2 to 4, comprises a substantially cylindrical body 40 and a nozzle 41 removably fixed to one end of this body by screwing, interlocking or any other suitable means. The external shape of said body can vary to best adapt to the hand of the surgeon. This body 40 is preferably made of a molded synthetic material and comprises, in its upper part close to the end piece, a lumen 40 'from which emerges a control handle 45. This body 40 also comprises, in its upper half, a recess 42 inside through, intended to receive the control handle 45. It comprises, in its lower half, a longitudinal groove 43 intended to receive the conduit 12 of serum under pressure and a channel 44 parallel to this groove intended to be connected to the conduit suction 24, in particular by gluing in a notch 44 'provided for this purpose. The control handle 45 has a form of lever, articulated in its middle around an axis.

46 secured to said body and defining an outer arm 45a and an inner arm 45b. The inner arm 45b has a conical end 48 arranged to compress the serum conduit 12 disposed in the groove 43, by means of a return spring 47 housed between this end and a lug 49 provided inside said recess

42. The outer arm 45a, which serves as an actuating member, has a flat end arranged to allow the support of a finger from the hand of a surgeon. In the rest position, when the control handle 45 is released, it compresses the conduit 12, under the effect of the spring, preventing the passage of the serum. In the working position, when the control handle 45 is actuated by a surgeon, it compresses the spring and releases the pressure on the conduit 12 allowing the serum jet to pass. The end piece 41 has a funnel shape comprising a flared part 50 removably fixed to said body and a narrow elongated hollow part defining a suction cone 51 and comprising an ejection lance 53 emerging from said cone through an orifice. suction 55. This ejection lance 53 is removably connected to the serum conduit 12 by fitting or any other means in a notch 53 'provided for this purpose. The suction cone 51 is connected to the suction channel 44 of said body 40 by a channel 54 provided in said flared part 50.

This end piece 41 could, if necessary, be connected definitively to said body 40, for example by gluing. However, a removable attachment, making it possible to replace the end piece with other interchangeable end pieces during surgical intervention, constitutes a preferred solution. These interchangeable tips preferably include ejection lances of different diameters or different shapes. During the intervention, and depending on the nature of the tissues or organs to be cut, the surgeon can easily change the tip in order to work with jets of serum of different diameters. In this way, it creates the best conditions for carrying out a quality intervention in complete safety.

The embodiment of the apparatus described above is designed so that all the parts in contact with the physiological saline are disposable parts, therefore disposable after each intervention, in order to avoid any risk of bacterial contamination. This characteristic which is the basic principle on which the present invention is based makes it possible to save the sterilization operation and to avoid the drawbacks mentioned in the state of the prior art. Single-use parts, called consumable parts, are pre-assembled and packaged in separate sterile packages. A first package includes the pocket perforation assembly, comprising in particular the striker 120, the part 121 of the supply conduit 12, the sealing cone 124 and the female connector 123. A second package comprises the body 40 of the handpiece 11, the part 122 of the supply conduit 12, the male connector 123 and the suction conduit 24. A third package includes a set of interchangeable tips 41 provided with lances 41 of different shapes and diameters. The serum bag 13 which is naturally part of the consumables is supplied in the usual way.

To prepare the surgical device which is the subject of the invention, the operator takes a pocket 13 and the first sterile package from the stock of consumables. He inserts the striker 120 into the tip 130 of the pocket 13, installs the pocket and the perforation assembly in the enclosure 14 by the access hatch 140, for example suspended on a bracket 143. The operator blocks then the sealing cone 124 in the corresponding orifice of the enclosure to ensure its sealing. It closes the hatch 140. It takes the second sterile package and connects the body 40 of the handpiece 11 to the striker assembly by means of the connector 123. From the third sterile package, it takes an end piece 41 comprising a lance 52 of shape and of appropriate diameter and fixes it to said body 40. The device can be started by pressing the start button 32. The solenoid valve 18 then opens the pressurized gas circuit filling the enclosure 14 at a rate of controlled gas. Indeed, the gas flow is progressive thanks to the flow limiter 19 to avoid damaging the bacterial filter 20.

When the pressure of the serum reaches the value displayed by the operator by means of the keys 35 ', the indicator light 36 goes out. An audible warning beep can also be provided in parallel with this indicator. The surgery can then start. The surgeon controls the jet of serum by acting on the control handle 45, which will, at first, expel the air from the serum circuit, that is to say from the supply duct 12 and the part hand 11. At any time during the intervention, the surgeon can change the tip of the handpiece, for example, by a tip with a lance with a smaller diameter. The pressure regulation provided by the control unit 30 makes it possible to maintain a constant pressure in the enclosure, therefore a constant cutting pressure. It can also increase or decrease this cutting pressure by acting directly on the keys 35 ′ or by means of control pedals (not shown). To decrease the pressure, the control unit 30 controls the opening of the solenoid valve 22 and the closing of the solenoid valve 18. To increase the pressure, the control unit 30 controls the opening of the solenoid valve 18 and maintains the solenoid valve 22 in the closed position. At the end of the intervention, the enclosure can be depressurized quickly by pressing the button 33 which controls the closing of the solenoid valve 18 and the opening of the solenoid valve 22 and of the valve 21.

To prepare the device for a new surgical intervention, the operator removes and discards the consumable parts and replaces them with new ones which are packaged in sterile packages. The preparation is therefore carried out very quickly and without any loss of time.

FIG. 5 schematically represents a variant 60 of the liquid jet surgical device of FIG. 1. In this embodiment, the handpiece 11 is connected by the conduit 12 to a reserve 61 of physiological saline contained in a sealed enclosure 62 This enclosure 62 is connected on the one hand to an external reservoir of serum

63 and on the other hand to the pressurized gas tank 15 respectively by means of the conduits 64 and 16.

What distinguishes this embodiment from the previous one is that the serum is free at the bottom of the enclosure 62 and surmounted by an atmosphere of pressurized gas also free in this enclosure.

To avoid contamination of the serum by the gas with which it is directly in contact inside the sealed enclosure 62, at least one bacterial filter 65 of the sterilizing type must be interposed on the pressurized gas supply circuit , that is to say, preferably on the conduit 16.

The gas used for pressurizing the serum must be chosen from gases immiscible with water to avoid its dissolution in the serum.

In this embodiment, the consumable parts, which constitute said first entire sterile and disposable part, comprise the handpiece 11, the conduit 12, the sealed enclosure 62, the reservoir serum 63, the part of the duct 16 for supplying the pressurized gas going to the sterilizing filter 65, the filter 65 and the suction duct 24.

The stationary part, which can be reused during each intervention and to which the consumable parts are connected, is essentially constituted by the pressurizing device comprising, depending on the embodiments, the reservoir 15 and the enclosure 14 or only the reservoir 15 , ^'as well as the control unit 30.

The present invention is not limited to the embodiments described above, but may extend to various variants obvious to those skilled in the art.

Claims

claims

1. A liquid jet surgical apparatus comprising a handpiece arranged to generate a controlled jet of this liquid consisting in particular of physiological saline under pressure, and a device arranged to put this liquid under pressure, characterized in that it comprises a first entirely sterile and disposable part, and a second stationary part, said first disposable part comprising said handpiece (11) connected by at least one supply conduit (12) to a reservoir of physiological saline, this serum being pressurized by means of a pressurized gas from a reservoir (15) disposed in said second stationary part and in that it comprises means for controlling and regulating the pressure of said serum.

2. Surgical apparatus according to claim 1, characterized in that the physiological saline is contained in a flexible gas-tight pocket (13), housed in a sealed enclosure (14), this enclosure being connected to the gas reservoir (15) under pressure and containing said gas under pressure.

3. Surgical apparatus according to claim 1, characterized in that said physiological saline is contained in a sealed enclosure (62) also containing gas under pressure and in that said enclosure is connected to an external reservoir (63) of physiological saline.

4. Surgical apparatus according to one of the preceding claims, characterized in that it comprises at least one sterilizing filter (20, 65) interposed between the reservoir (15) of pressurized gas and the sealed enclosure (14, 62) and in that it comprises a flow limiter (19) disposed before said sterilizing filter and arranged to deliver a progressive gas flow.

5. Surgical apparatus according to any one of the claims above, characterized in that said handpiece (11) comprises means for controlling the opening and closing of the serum jet, these means being arranged to compress and partially close off said supply conduit (12).

6. Surgical apparatus according to claim 5, characterized in that the handpiece (11) comprises at least one recess arranged to receive said control means and said conduit (12).

7- Surgical apparatus according to claim 6, characterized in that said control means comprise a control handle (45) provided with a first part (45a) emerging from said handpiece and arranged to be actuated manually, and a second part (45b) housed in said recess and arranged to bear on said conduit (12) by means of a spring member.

8. Surgical apparatus according to claim 7, characterized in that the handle is articulated in its middle part around an axis (46) integral with said handpiece.

9. Surgical apparatus according to one of the preceding claims, characterized in that the handpiece (11) comprises an endpiece (50) removably mounted on the body (40) of said handpiece, this endpiece comprising at least a serum ejection lance (53) connected to one end of said supply duct (12), and a suction cone (51) connected to a suction duct (24) by a suction channel (44 , 54).

10. Surgical apparatus according to claim 9, characterized in that it comprises a plurality of interchangeable tips (50) comprising ejection lances of variable shapes and dimensions.

11. Surgical apparatus according to claim 2, characterized in that the supply duct (12) is connected to the pocket (13) by means a striker (120) provided at one end of said conduit (12), and comprises a sealing cone (124) arranged to seal said enclosure (14) in the passage area of said conduit.

12. Surgical apparatus according to claim 1, characterized in that the control and regulation means comprise a control unit 30 arranged to centralize and control measurement and control devices placed in said apparatus.

13. Surgical apparatus according to claim 12, characterized in that the measuring devices comprise at least one pressure gauge (17) mounted on the gas circuit (16) coming from the reservoir (15), a pressure gauge (23) mounted on said enclosure (14), and in that the control devices comprise at least one solenoid valve (18) mounted on said gas circuit (16), one solenoid valve (22) and a safety valve (21) mounted on said enclosure (14 ).

14. Surgical apparatus according to claim 13, characterized in that the control unit (30) comprises keys (35 ') for adjusting the pressure of the serum, this unit being arranged to control said solenoid valves (18, 23) for keep said serum pressure constant.

15. Surgical apparatus according to claim 12, characterized in that the control unit (30) is arranged to automatically control the measuring devices (17, 23) and readjust them if necessary, with respect to reference values .