Surgical device comprising a stem having at its distal end a deformable sleeve surrounding said stem

Abstract

The invention relates to a surgical device comprising a rod having at its distal end a deformable sleeve surrounding said rod. The distal annular end of said deformable sleeve is fixed to a peripheral area of ​​said rod, and the proximal annular end of said deformable sleeve is integral with a control element surrounding said rod. This control element is longitudinally movable to move the proximal end of said sleeve between a rest position, where said deformable sleeve has a tubular shape, and an active position, where said sleeve is deformed by bringing its distal and proximal ends closer together. The sleeve forms a filtering envelope. The control element is also rotationally movable around the rod to exert a torsional deformation on said deformable sleeve. Abstract Figure: 6

Description

Title of the invention: Surgical device comprising a rod having at its distal end a deformable sleeve surrounding said rod. Field of invention

[0001] The present invention relates generally to medical devices and more particularly to the field of surgical devices intended to be used in minimally invasive or open surgical procedures for the manipulation of medical instruments in cavities of a living body, in particular in the field of coelioscopy or laparoscopy, such as hooks for implanting suture threads, forceps of any kind for, for example, cutting, removing, etc., an organ or a portion of an organ, electrodes for, for example, incising, cutting, suturing, coagulating, for aspirating fluids and semi-solid debris, aspirating fluids in the presence of large debris without clogging, irrigating the operating field, dissecting and retracting tissues without damaging them.

[0002] Such surgical devices generally consist of a guide tube comprising a through-hole of substantially cylindrical shape of revolution opening respectively at its proximal and distal ends, a cylindrical control rod generally of revolution with an external diameter less than the diameter of the hole and slidably mounted in the guide tube, and means for attaching a medical instrument of any kind, these attachment means being mounted in cooperation with the distal end of the control rod.

[0003] The outer diameter of the control rod is determined so that it is less than the diameter of the through-hole so that there is an annular space between the control rod and the wall of the through-hole, so that it is possible to insufflate a gas under a certain pressure in order to expand the wall of the cavity in which the instrument is to be used, and therefore to facilitate the work of the practitioner by increasing the space around the point on which he is to intervene medically.

[0004] The tube may be rigid, for coelioscopy and laparoscopy applications, or flexible, for endoscopic applications.

[0005] An endoscope comprises a rigid elongated rod or a flexible cord surrounded by a waterproof sheath. The rigid rod or the flexible cord is traversed in a waterproof manner in the longitudinal direction by an operating channel open at the distal end and opening at the proximal end into the body of a handle.

[0006] The working channel is used for the passage of working instruments along the entire length of the endoscope to the intervention zone. The sheath which tightly surrounds the working channel contains in its interior volume the devices necessary for the use of the endoscope, in particular an optical instrument, a lighting device, for example in the form of a conventional optical fiber bundle, or other devices such as electronic devices or endotherapy or microsurgery instruments.

[0007] The operating channel is also used for the circulation of a fluid. For this purpose, a lateral outlet conduit is provided, to which extension flow pipes can be connected.

[0008] As a rule, the proximal end of the working channel can be closed on the handle side by a valve and the outlet conduit can be opened by another valve, so that a cleaning liquid, for example, can be injected through the distal part of the working channel to the intervention area or aspirated from it. The outflow pipe can also, for example, be used for suction or gas intake. State of the art

[0009] Minimally invasive surgery has gained popularity in recent decades because it offers a less traumatic approach for the patient, it allows for a shorter procedure and shorter hospital stay. These procedures generally result in fewer side effects (fewer post-operative infections) and better aesthetic results (much smaller scars). Surgical instruments are introduced into the patient's body through small incisions (usually around 5-10 mm).

[0010] Suction / irrigation devices are part of the surgeon's basic arsenal and are used in almost all surgical operations. Suction is used for the removal of bodily fluids and debris to maintain a clean operating field and a clear view of the surroundings throughout the operation. Irrigation is used to clean the operating field when the operating cavity is contaminated or obscured by blood, biological material and / or debris. They must allow suction or irrigation without disrupting the workflow of the surgeon and / or assistant.

[0011] Generally, suction / irrigation devices consist of an elongated cannula attached to a handle, which is itself connected to the suction and irrigation devices. This tube is generally made of metal or plastic. The tube terminates in a hole at its distal end and has perforations near its distal end through which fluid is supplied (irrigation mode) and / or evacuated (suction mode) from the field operative. Suction and / or irrigation mode is generally activated by push buttons on the handle. Suction and irrigation controls are generally located in the handle.

[0012] The problem which arises more particularly is that of the risk of clogging of the suction duct by tissues or clots sucked into the suction duct.

[0013] In particular, a solution described by patent US5836953 is known in the state of the art. This patent describes an endoscopic device comprising an elongate outer member, an elongate inner member housed within the outer member, and a distal loop portion connected between the outer and inner members. The loop portion is movable from outside the body from an undeployed position to a deployed position to form a loop structure. The loop portion can be moved from outside the body by squeezing to express sampled substances from the loop portion into a bag forming part of a collection system before removing the loop portion from the body. The bag is movable between an undeployed position that facilitates its introduction into the body and a deployed position within the body that allows the loop portion to be positioned within the bag and then removed by squeezing.

[0014] Also known is US5456667 describing an intravascular catheter with an expandable region formed of a tubular material that extends the distal end of the catheter body in a one-piece configuration and is radially expanded and contracted by means of a control wire. The interior of the expandable region is in fluid communication with a lumen in the catheter body to allow delivery of fluid to the artery via openings in the surface of the expandable region. The catheter is adapted to maintain an artery open after a vascular procedure, such as a balloon or other type of angioplasty, and optionally introduce a therapeutic drug or other fluid to the site of the vascular procedure. Disadvantages of the prior art

[0015] The solutions of the prior art are not entirely satisfactory.

[0016] The solution described in patent US5836953 proposes a sleeve deployable by a longitudinal guide, to form a collection bag to recover elements which could obstruct the cannula. The solid debris trapped in the bag is wrung out before it is removed from the patient. The prior recovery of the debris prevents the cannula from becoming blocked, but an additional step must be carried out during the surgical procedure: the evacuation of the waste collected in the collection bag. This can cause an extension of the procedure time. Solution provided by the invention

[0017] In order to overcome these drawbacks, the invention relates, in its most general sense, to a surgical device comprising a rod or a flexible cord having at its distal end a deformable sleeve surrounding said rod or said flexible cord, the distal annular end of said flexible sleeve being fixed to a peripheral zone of said rod or said flexible cord and the annular end of said deformable sleeve is integral with a control element surrounding said rod or said flexible cord, said control element being movable longitudinally to move the proximal end of said sleeve between a rest position where said deformable sleeve has a tubular shape, and an active position where said sleeve is deformed by bringing its distal and proximal ends together.

[0018] Characterized in that • Said sleeve forms a filtering envelope and in that said control element is also movable in rotation around said rod or said flexible cord to exert a deformation by torsion of said deformable sleeve.

[0019] Advantageously, said control element is formed by a tube surrounding said rod or said flexible cord.

[0020] According to a first variant, said deformable sleeve is formed by a porous film.

[0021] According to a second variant, said deformable sleeve is constituted by a mesh of wires.

[0022] According to a third variant, said deformable sleeve is made up of a lattice of steel metal wires.

[0023] According to a fourth variant, said deformable sleeve is made up of a mesh of stainless steel wires with a section between 150 and 300 micrometers.

[0024] Preferably, said deformable sleeve forms a filter having lights with a section of less than 2 millimeters.

[0025] Advantageously, the device comprises a handle comprising a control button movable along a linear travel, for moving the proximal end of the sleeve between a rest position and a folded position, and an angular travel when said control button has reached said folded position. Detailed description of the invention

[0026] The present invention will be better understood on reading the following description, referring to a non-limiting example of embodiment of the invention illustrated by the appended figures where:

[0027] [Fig.l] [Fig.l] represents a perspective view of a device according to the invention

[0028] [Fig.2] [Fig.2] represents a partial cutaway view of the guide of the device according to the invention

[0029] [Fig.3] [Fig.3] represents a perspective view of the handle of the device according to the invention

[0030] [Fig.4] [Fig.4] represents a ¾ front perspective view of the distal end in the open position

[0031] [Fig.5] [Fig.5] represents a sectional view along a longitudinal plane of the distal end in the open position.

[0032] [Fig.6] [Fig.6] represents a ¾ front perspective view of the distal end in the closed position

[0033] [Fig.7] [Fig.7] represents a sectional view along a longitudinal plane of the distal end in the closed position. Hardware description of the device

[0034] By convention, in this patent, the parts furthest from the handle will be designated as "distal", and those closest to the operator will be designated as "proximal".

[0035] The surgical device comprises, in a known manner, a tubular rod (10) whose proximal end (11) is engaged in a handle (20) comprising the control valves for the suction and injection conduits, the connections with complementary equipment and the control buttons.

[0036] The handle (20) is composed of: - A suction channel connected to a suction device - From an irrigation canal connected to an irrigation device - The two channels join into one at the proximal end of the two concentric tubes so that suction and irrigation are done through the same orifice at the distal end of the cannula - A button to activate the suction - A button to activate the irrigation - A button to activate the deployment of the anti-obstruction device which can be any type of button like push button, wheel, slider, trigger...

[0037] The rod (10) is attached by its proximal end to the handle (20) and allows the administration of irrigation fluids and the removal of bodily fluids and debris.

[0038] The distal end of the rod (10) is surrounded by a deformable sleeve (30) of tubular shape, and of an inner section corresponding substantially to the outer section of the rod (10).

[0039] The distal annular edge (31) of the sleeve (30) is secured to the distal end of the rod (10) by a sealing ring (32) which connects both in longitudinal translation and in rotation the distal end (31) of the sleeve (30) with the distal end of the rod (10).

[0040] The proximal end (33) is integral, in translation and in rotation, with a sheath (40) having a rigidity allowing it to deform as much as the rod (10), and sufficient to transmit a longitudinal displacement and / or axial rotation force exerted at the level of the handle, to the sleeve (30).

[0041] This sheath (40) is coaxial with the rod (10). It is for example made of a sheath made of a metal profile, for example aluminum. It extends from the proximal end (33) of the sleeve (30) to the handle (20). This handle comprises a mechanism for actuating the sleeve (30) formed by a control button (21) extending a transmission lever (22) sliding in a grid having a first longitudinal segment (23), opening at its distal end onto an arcuate segment (24).

[0042] The user can move the button (21) with his finger by first sliding the lever (22) in the distal direction, then, when the lever comes into abutment against the bottom of the longitudinal segment (23), pivoting axially in the groove (22) to exert a torsional torque on the sheath (40). Sleeve Description

[0043] The sleeve (30) is formed by a mesh of metal wires, for example stainless steel wires with a section between 150 and 300 micrometers forming meshes with openings with a section of 2 millimeters or less. Functional description

[0044] When the user pushes the sheath (40) distally, it pushes back the rear (proximal) end of the sleeve (30) which will be subjected to a stress deforming it, by "curling" it on itself, then causing a torus-shaped expansion (35) when the proximal end (33) of the sleeve approaches its distal end (31). Figures 4 and 5 illustrate this situation which occurs when the sleeve exerts a solely longitudinal force, without rotation. The torus (35) which is formed is open with a central well (36), and allows the passage of flows and debris into the conduit without any obstruction.

[0045] When an angular force is applied to the sheath (40), the sleeve (30) twists, which causes the formation of a double torus (37, 38) with a closed intersection (39) forming a constriction closing the inlet vein of the rod (10). Figures 6 and 7 illustrate this situation.

[0046] This device makes it possible to easily switch from an open cannula to a cannula closed by the sleeve (30) thanks to the deployment button (21) present on the handle (20) and to avoid the surgeon having to take the aspirator out of the patient if he wants to switch from an open to a closed cannula.

[0047] The filter sleeve (30) can therefore be in three different states:

[0048] - Retracted = around and along the rod (10) for insertion through a trocar

[0049] - Deployed by translation leaving the orifice of the distal end open for suction of small debris (open deployed position)

[0050] - Deployed by translation / rotation which allows closure of the end orifice distal to prevent obstruction of the device (closed deployed position). Use of the device

[0051] The device according to the invention makes it possible to control from the handle a modification of the inlet configuration of the rod to allow the entire flow to pass into the suction duct, or to selectively filter the components according to their size and / or their viscosity. The device according to the invention allows easy switching between the filtration mode where the distal end is permeable only to liquids and the suction mode for blood clots, debris or solids.

[0052] The filter sleeve (30) in the retracted position is of such a thickness that it allows for effortless and safe penetration into incision sizes typically present during minimally invasive surgical procedures. Once in the body cavity, the filter sleeve (30) can be easily and quickly deployed by the action of a dedicated button on the handle. When deployed, the filter sleeve (30) partially or completely covers the suction hole, thereby preventing debris and solids from obstructing the passage of fluids. The porous nature of the filter allows for unhindered suction of bodily fluids.

[0053] A major disadvantage of known devices is that organs and soft tissues (small intestine, fatty tissue, mesentery, omentum) or large clots can easily be sucked into the lumen of the cannula. In minimally invasive surgery, the surgeon must then stop the suction and use another tool to unclog the aspirator, and if this is not successful, the aspirator must be removed to clean it outside the patient. It may be necessary to unclog the suction device several times during a single surgical operation, with the following consequences:

[0054] • to disrupt the work of the surgeon and the rest of the staff,

[0055] • and to extend the duration of interventions

[0056] • and therefore to increase

[0057] o the risks for the patient

[0058] o the fatigue of the surgical team

[0059] o and the total cost of the operation.

[0060] Untimely interruption of suction is a major problem presented by available vacuum irrigators.

[0061] Most existing solutions having a device that prevents the cannula from clogging do not allow the aspiration of semi-solid debris.

[0062] It also provides new functionalities, namely the aspiration of fluids and / or semi-solid debris, the filtration of solid debris, the dissection of tissues and the safe retraction of organs. The deployable filter sleeve (30) makes it possible to filter solid debris and to carry out blunt dissection safely, while retaining the possibility of aspirating fluids and semi-solid debris when the filter is in the retracted position.

[0063] Surgeons have become accustomed to using suction-irrigation devices for purposes other than suctioning and irrigating, and in particular for dissecting tissues and moving organs. Known suction devices are generally made of an unprotected metal cannula at the distal end. There is therefore a possibility of causing tissue damage when using these devices for purposes not originally intended.

[0064] Collateral uses include gentle tissue retraction: while the filter sleeve (30) is deployed, it is sufficiently rigid to allow gentle dissection and retraction of tissue.

[0065] • To move tissues and organs safely thanks to the anti-slip device obstruction that extends beyond the distal end of the rod (10)

[0066] • To prevent contact between the tip of the cannula and the tissues during suction by deploying the anti-obstruction device beyond the distal end of the rod (10).

Claims

Claims

1. - Surgical device comprising a rod (10) having at its distal end a deformable sleeve (30) surrounding said rod (10), the distal annular end of said deformable sleeve (30) being fixed to a peripheral zone of said rod (10) and the proximal annular end of said deformable sleeve (30) is integral with a control element surrounding said rod, said control element (21, 22, 40) being movable longitudinally to move the proximal end of said sleeve (30) between a rest position where said deformable sleeve (30) has a tubular shape, and an active position where said sleeve (30) is deformed by bringing its distal and proximal ends together. Characterized in that • said control element (21, 22,40) is also rotatable around said rod (10) or said flexible cord to exert a torsional deformation of said deformable sleeve (30) • Said sleeve (30) forms a filtering envelope; • The distal annular edge (31) of said sleeve (30) being secured to the distal end of the rod (10) by a sealing ring (32) connecting both in longitudinal translation and in rotation the distal end (31) of the sleeve (30) with the distal end of the rod (10). • The proximal end (33) is secured, in translation and in rotation, to a sheath (40) coaxial with the rod (10).,

2. - Surgical device according to claim 1 characterized in that said deformable sleeve (30) is formed by a porous film.

3. - Surgical device according to claim 1 characterized in that said deformable sleeve (30) is constituted by a mesh of wires.

4. - Surgical device according to claim 1 characterized in that said deformable sleeve (30) is constituted by a lattice of steel metal wires.

5. - Surgical device according to claim 1 characterized in that said deformable sleeve (30) is constituted by a mesh of stainless steel wires with a section between 150 and 300 micrometers.

6. - Surgical device according to claim 1 characterized in that said deformable sleeve (30) forms a filter having lumens with a section of less than 2 millimeters.

7. - Surgical device according to claim 1 characterized in that it comprises a handle (20) comprising a movable control button (21, 22) along a linear stroke, for moving the proximal end of the sleeve (30) between a rest position and a folded position, and an angular stroke when said control button has reached said folded position.

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