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Title:
SURGICAL SUCTION-IRRIGATION SYSTEM ALSO EQUIPPED WITH COAGULATION AND NEUROMUSCULAR STIMULATION ACTIVITY AND A METHOD OF OPERATION
Document Type and Number:
WIPO Patent Application WO/2020/225835
Kind Code:
A1
Abstract:
The present invention relates to a surgical suction-irrigation system also equipped with coagulation and neuromuscular stimulation activity which exploits bipolar energy. In this context,the technical task underlying this invention is to propose a surgical instrument that has the task of aspirating-irrigating and at the same time coagulating the site of bleeding, making the hemostasis easier, or electrically stimulating specific anatomical structures to facilitate their localization.

Inventors:
THOMASSET RAPHAEL (IT)
Application Number:
PCT/IT2020/050074
Publication Date:
November 12, 2020
Filing Date:
March 25, 2020
Export Citation:
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Assignee:
THOMASSET RAPHAEL (IT)
International Classes:
A61B18/14; A61M25/00; A61N1/05
Domestic Patent References:
WO1999048430A11999-09-30
Foreign References:
US20160051322A12016-02-25
US20010025177A12001-09-27
US20150164632A12015-06-18
US20180271596A12018-09-27
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Claims:
Claims

[Claim 1] Surgical suction-irrigation system also equipped with coagulation

activity and neuromuscular stimulation comprising:

- two cannulas with electrical conductivity, one of which (1) inside the other (2) separated by an insulating material that does not conduct electricity (3), where each cannula is missing at the distal end of a semicircle or an approximation to it, for a section of length, the cannulas are oriented so that the two remaining semicircles or an ap proximation to them, are in opposition between them;

- suction and irrigation control means (14) connected to the internal cannula (1) via a communication line (6);

- a suction line (15) and an irrigation line (16);

- an electrical circuit for connecting the cannulas (11) with the means for controlling the coagulation function and the neuromuscular stimulation function (10);

- a bipolar current generator (12);

- a current generator for neuromuscular stimulation (13);

- means of controlling coagulation function and neuromuscular stimulation function (10);

characterized in that the system has the ability to coagulate or determine a neuromuscular stimulation depending on the configuration of the interface of means (10) and the activation of the bipolar generator (12) or of the pulse generator for neuromuscular stimulation

(13).

[Claim 2] Surgical suction-irrigation system also equipped with coagulation

activity and neuromuscular stimulation according to claim 1, char acterized in that the inner cannula (1) and the external cannula (2) are missing at the distal end of a semicircle or of an approximation to it, for a section of length preferably not exceeding 1 cm.

[Claim 3] Surgical suction-irrigation system also equipped with coagulation

activity and neuromuscular stimulation according to claims 1 and 2, characterized in that the insulating material (3) between the inner cannula (1) and the external cannula (2) is present between the cannulas at least along their entire cylindrical structure.

[Claim 4] Surgical suction-irrigation system also equipped with coagulation

activity and neuromuscular stimulation according to any of the previous claims, characterized in that the proximal end of the cannulas (1,2) is incorporated in an insulating material to the electric current (5) where there are the connections (9) of the electric wires (7,8) of the electric circuit for connecting the cannulas (11) with the respective cannulas (1,2).

[Claim 5] Surgical suction-irrigation system also equipped with coagulation

activity and neuromuscular stimulation according to any of the previous claims, characterized in that it comprises:

- a suction line (15) that can be connected to a pump that generates de pression or to a fixed depression circuit present in hospital structures (17).

[Claim 6] Surgical suction-irrigation system also equipped with coagulation

activity and neuromuscular stimulation according to any of the previous claims, characterized in that it comprises:

- an irrigation line (16) connected to a motor pump for fluids or to a container of fluid placed higher than the point of use of the aspirator- irrigator (18).

[Claim 7] Surgical suction-irrigation system also equipped with coagulative

activity and neuromuscular stimulation according to any of the previous claims, characterized in that it comprises:

- suction and irrigation control means (14) near the proximal end of the two cannulas (1,2) of the surgical aspirator-irrigator.

[Claim 8] Surgical suction-irrigation system also equipped with coagulation

activity and neuromuscular stimulation according to any of the previous claims, characterized in that it comprises:

- a bipolar current generator (12) and a pulse generator for neuro muscular stimulation (13) which, through an interface of means (10), controlled by a pedal or a manual command, allows to exchange the connection of the two connected wires respectively to the two cannulas of the aspirator-irrigator from one generator to another as needs change.

[Claim 9] Method of operation of a surgical suction-irrigation system also

equipped with coagulation activity and neuromuscular stimulation including the ability to:

-generate depression along the suction line (15) by means of suction means (17);

- connecting the inner cannula (1) with the suction line (15) through the connection (6) and the control means (14);

- determine a strength of the tissues in contact with the two ends of the cannulas (4) of the aspirator-irrigator, on these latter, reducing the impedance between them;

-coagulate the tissues in contact with the distal end of the two cannulas (1,2) when the bipolar current generator (12) is activated and the interface of means (10) which manages the connection of the wires to the two cannulas is connected with the bipolar energy generator (12).

[Claim 10] Method according to claim 9, characterized in that:

- if the interface of means (10) which manages the connection of the wires to the two cannulas (1,2) is connected with the neuromuscular stimulator (13) and the latter is activated, there is the electrical stimulation of the tissues in contact with the distal end of the two cannulas and not their coagulation.

[Claim 11] Method according to claims 9 and 10, characterized in that the co agulation or neuromuscular stimulation can also occur by simply placing the distal end of the two cannulas on the tissues without ac tivating the depression.

[Claim 12] Method according to claims 9, 10 and 11 characterized in that:

- if the means of control of the suction-irrigation connect the irrigation line (16) with the internal cannula (1) through the connection (9) there will be the exit of fluid at the distal end of the latter.

Description:
Description

Title of Invention: Surgical suction-irrigation system also equipped with coagulation and neuromuscular stimulation activity and a method of operation

[0001] The present invention relates to a surgical suction-irrigation system also equipped with coagulation and neuromuscular stimulation activity which exploits bipolar energy. The instruments that are currently available on the market have the ability to execute suction, irrigation and only in given situations coagulate in monopolar mode but not in bipolar mode, without neuromuscular stimulation activity.

[0002] The system is not only connected to a circuit for washing-suction as in the common commercially available devices, but is connected through two electric wires to an apparatus which allows to exchange the connection between the bipolar energy generator for coagulating tissues and the pulse generator for neuromuscular

stimulation. The system can be used simply with suction-irrigation functionality, as the current devices available on the market, but in case of need it can coagulate in bipolar mode or determinate a neuromuscular stimulus. During use, the operator can place the distal end of said system, as shown in Figure 1, in correspondence either of organic fluids that are needed to be sucked or tissues that need to be coagulated, coagulating then the site of bleeding. The surgical suction-irrigation system also equipped with co agulation and neuromuscular stimulation activity can be also used to stimulate elec trically determined anatomical structures (for example muscles, nerves, or specific structures such as the ureter) allowing their recognition directly, visualizing the movement or indirectly, looking for distant structures activation when there is the necessity to locate a precise nerve. Normally the surgical suction-irrigation systems available on the market do not allow to coagulate the origin site of hemorrhage neces sitating the use of another instrument as a forceps with coagulative function connected to a generator of monopolar-bipolar energy. Only some suction-irrigation systems on the market can also coagulate but in a monopolar mode. The use of bipolar energy makes this new surgical instrument object of invention safer than other instruments available on the market, since the closure of the electric circuit occurs between the inner cannula and the external cannula of the instrument and not through the patient or the ground as it occurs in the monopolar coagulation mode.

[0003] In this context, the technical task underlying the present invention is to propose a surgical instrument that has the task of sucking-irrigating and at the same time co agulating the site of bleeding or electrically stimulating precise anatomical structures. Another aim of this invention is to propose an aspirator that facilitate the execution of surgical hemostasis in the sites of bleeding since the operator does not have to lift the instrument from the above mentioned sites, the operating field that needs hemostasis does not have time to become coated of hemorrhagic blood, making the procedure simpler and accurate. To the function just described is added the one to get easier the location of particular anatomic structures evaluating the response to the electrical stimuli (such as the ureteral movements) avoiding structural damages during surgical dissection. The mentioned technical tasks and the aims specified are substantially achieved by a surgical suction-irrigation system also equipped with coagulation and neuromuscular stimulation activity, comprising the technical features described in one or more of the appended claims. Further characteristics and advantages of the present invention shall become readily apparent from the indicative, and thus non limiting de scription of a preferred but not exclusive embodiment of a surgical suction-irrigation system also equipped with coagulation and neuromuscular stimulation activity as shown in the accompanying drawings in which figures 1-2-3-4-5-6 showing a schematic view of a constructive solution according to the present invention. In the figures 1 -2-3-4 are indicated the inner and the outer cannula which make up the surgical suction-irrigation system also equipped with coagulation and neuromuscular stimulation activity. The cannula (1) is located inside the cannula (2), these latter preferably of biocompatible metallic material, are electrically insulated for their path of an insulating material of various kinds (for example a plastic biocompatible material) (3). At the distal end of said surgical suction-irrigation system also equipped with co agulation and neuromuscular stimulation activity, each single cannula is missing from a length of not higher than 1 cm of its semicircle or an approximation to it. The two cannulas are oriented so that the two semicircles are in opposition as shown in figure 1 and 2. The two ends of the cannula (1) and (2) as shown in figure 1 and 2 are insulated in their distal portion with gas (air or C0 2 as in laparoscopic interventions), the distance between the edges of the two semicircles that are nearer will vary as a function of the thickness of the insulation between the two cannulas. The proximal portion of the two cannulas has the connection points (9) of these latter to the electric wires of connection (7 and 8) with the control means (10) which exchange the circuit of the cannulas (11) with the bipolar generator (12) (coagulation) or with the neuro muscular stimulator (13) (stimulation). Of the two electric wires of the circuit connected to the two cannulas, electrical wire (8) will be connected to the internal cannula and the other (7) to the outer cannula as shown in the figure 5. The electrical connections to the cannulas (9) and the connection of the connecting tube (6) of the inner cannula (1) to the control means of the surgical suction-irrigation system are included in an insulating material (for example epoxy resin) that makes up the handpiece (5) of the surgical suction-irrigation system. In the proximal part of the two cannula of the surgical suction-irrigation system we find also the connection of the inner cannula with a tube (6) that connects the latter to the means of control of the suction-irrigation (14) that may be at a variable distance. The means to control the suction-irrigation (14) are connected to a vacuum pump or to a fixed vacuum circuit we can find in hospitals (17) through a suction line (15). Furthermore, the means of control of the suction-irrigation (14) are also connected to a motor pump for fluids or to a fluid container (18) located in a higher point than the surgical suction-irrigation system through an irrigation line (16). By actuating the means of control of the vacuum (14) connected to the suction line (15), as in the common surgical aspirators there will be a lower pressure to the distal end of the two cannulas allowing the instruments to suck gases or fluids (for example blood). In the case in which the distal end of the cannulas is placed directly on the tissues and the means of control of the vacuum (14) are activated and connected to the vacuum line (15) there will be a force which pushes the tissues against the contact surface of the distal end of the two cannulas (4), thus reducing the electrical impedance between the two cannulas and facilitating the electric current flow. By operating the control means (10) that connect the circuit of the cannulas of the surgical suction-irrigation system with the bipolar energy generator and at the same time by activating the bipolar generator (12) the result will be the tissue co agulation. In the same manner if the control means that connect the circuit of the cannulas of the surgical suction-irrigation system are operated in order to connect the cannulas with the neurostimulator (13) and the neurostimulator is activated to generate an electric impulse, the result will be a stimulation of an anatomical structure and not the coagulation of it. With vacuum is meant a pressure lower than the atmospheric one. The flow of current between the two cannulas can also be achieved without the ac tivation of the vacuum at the end of the cannulas, but only by placing them on anatomical structures; greater will be the mechanical pressure exerted on the tissue, lower impedance will be measured between the two cannulas. When the control means of the irrigation (14) are activated to connect the irrigation line (16) to the inner cannula, such as in the common surgical washing- suction devices, there will be the exit of fluid at the distal end (Figure 1) of the inner cannula (1) of the surgical suction-ir rigation system. The invention thus conceived can be susceptible of numerous modi fications and variations, without thereby departing from the scope of the inventive concept. All the details may further be replaced with other technically equivalent elements. In practice, all materials used, as well as the dimensions, may be any, according to requirements.