IT202100006617A1 - GUIDE FOR A MINIMALLY INVASIVE SURGICAL OPERATION - Google Patents

Description

Title "Guide for a minimally invasive surgery"

DESCRIPTION

Technical field

The present invention ? relating to a guide for a minimally invasive surgical operation. The guide ? usable, for example, for a surgical operation to remove stones that have accumulated in a patient's kidney calices.

State of the art

? known in the state of the art a guide which can be used for a minimally invasive surgical operation for the removal of kidney stones. Such a guide? commonly known as the ureteral sheath. In detail, this guide comprises a body which extends between a first and a second end.

In addition, the body of the guide comprises a channel passing between a first opening located at the first end, and a second opening located at the second end.

During the surgical operation this guide is inserted through the patient's ureter to reach the kidney and position the second end? of the guide body at the renal calices.

AND? otherwise? I know a surgical instrument that can be used to remove kidney stones. In detail, this surgical instrument comprises an operating element having a terminal tip. This terminal tip ? equipped with an optical instrument configured to acquire video signals and to transmit the acquired video signals to a video control unit external to the surgical instrument.

In addition, the surgical instrument comprises a control instrument operably connected to the working element and provided with driving means configured to move the terminal tip of the working element. This control tool? challenged by an operator, such as the surgeon who performs the operation to remove kidney stones.

After inserting the working element into the guideway through channel so as to position the terminal tip beyond the second opening of the guideway through channel, the surgeon positions the guidewire and working element into the patient. By moving the terminal tip by means of the movement means and monitoring the video signals acquired by the optical element of the terminal tip, the surgeon checks the position of the stones inside the renal calices.

The end tip is then moved to a position where the end tip ? facing the stones positioned in the renal calices.

Problem of the prior art

During the operation to remove kidney stones can? it may be necessary to extract the operating element from the guide and then reinsert this operating element into the through channel of the guide positioned in the patient.

Whenever the working element of the surgical instrument is removed from the through channel of the aiming device, the location of the stones within the renal calices is lost.

Consequently, after the reinsertion of the operating element of the surgical instrument into the through channel of the guide, ? necessary to move the terminal tip to seek again the position of the stones.

The movements of the terminal tip lead the guide and the terminal tip itself to hit the patient's renal and ureteral tissue. Each bump can lead to edema and inflammation with consequent problems of post-operative pain.

In addition, in the event of a violent impact on the patient's renal and ureteral tissue, serious injury to these tissues may occur. In such an event? It is necessary to interrupt the minimally invasive surgery, remove the guide and the surgical instrument from the patient and proceed with the removal of the kidney stones and the repair of the injured tissue by means of a highly invasive surgery.

Summary of the invention

In this context, the technical task underlying the present invention ? that of providing a guide for a minimally invasive surgical operation which overcomes the problems of the prior art.

In particular, ? The object of the present invention is to propose a guide for a minimally invasive surgical operation which allows to avoid excessive shocks and possible lesions of the patient's tissue during the minimally invasive surgical operation.

The technical task specified and the aims specified are substantially achieved by a guide for a minimally invasive surgical operation comprising the technical characteristics set forth in one or more of the joint claims.

Advantages of the invention

Thanks to the guide described ? It is possible to reduce shock and injury to the patient's tissue during minimally invasive surgery, such as kidney stone removal surgery.

Thanks to the guide described ? It is also possible to reduce the times of the minimally invasive surgery, allowing a more effective and rapid removal of calculi from the kidneys.

BRIEF DESCRIPTION OF THE DRAWINGS

Further characteristics and advantages of the present invention will appear more clearly from the indicative, and therefore non-limiting, description of a preferred but not exclusive embodiment of a guide for a minimally invasive surgical operation with reference to the attached figures in which:

- Figure 1 ? a sectional view of a guide in accordance with the present invention; -Figure 2 ? a sectional view of the guide of Figure 1 and of a surgical instrument inserted in the guide;

- Figure 3 ? a schematic view of the guide of Figure 1 inserted into the ureter of a patient;

- Figure 4 ? a view of a detail of Figure 3;

- Figure 5 ? a perspective view of the guide of Figure 1;

- Figure 6 ? a perspective view of a detail of the guide of Figure 5;

- Figure 7 ? a perspective view of a surgical instrument;

- Figure 8 ? a perspective view of a detail of the surgical instrument of Figure 7;

- Figure 9 ? a perspective view of the guide of Figure 1 and of the surgical instrument of Figure 7 inserted in the guide;

- Figure 10 ? a perspective view of a detail of Figure 9;

- Figure 11 ? a sectional view of a portion of the guide of Figure 1 and of a surgical instrument inserted in the guide.

DETAILED DESCRIPTION

With particular reference to the attached figures, with the number 1 ? indicated a guide for a minimally invasive surgical operation. This guide 1 ? configured to be inserted into human tissue. For example, guide 1 ? that can be inserted into the ureter of a patient during a minimally invasive surgical operation, commonly known as ureterorenoscopy, (identified by the acronym RIRS or ECIRS) for the removal of stones accumulated in the renal calices.

The guide 1 comprises a body 2. This body 2 extends between a first 21 and a second end? 22.

In addition, the body 2 comprises a channel 23 passing between a first opening 24 located at the first end? 21, and a second opening 25, located at the second end? 22.

The body 2 also has a first portion 28, arranged along a first direction of development X-X, and a second portion 26, placed close to the? of the second end? 22 and arranged along a second development direction Y-Y. Preferably, the first portion 28 ? mail near? of the first end? 21 of body 2.

This second portion 26 ? reversibly deformable between a rest position, in which the second direction of development Y-Y coincides with the first direction of development X-X, and a deformation position, in which the second direction of development Y-Y defines a respective bending angle greater than zero with respect to the first development direction X-X.

In other words, in the rest position, both the first portion 28 and the second portion 26 are both arranged along the first development direction X-X, the second development direction Y-Y being coincident with the first development direction X-X.

Conversely, in each deformation position, does the second direction of development Y-Y not coincide with the first direction of development X-X and this second direction of development Y-Y ? curvilinear.

In addition, the second portion 26 ? configured to maintain the deformation position assumed until an external action brings the second portion 26 back to the rest position. Advantageously, how will it be? more clear in the following of the present description, it is avoided that, after having deformed the second portion 26 up to a desired deformation position, the second portion 26 returns automatically, by elastic return, to the rest position even without an external action acting on the second portion 26. In other words, even when the cause of deformation of the second portion 26 ceases to go from the rest position to a deformation position, this second portion 26 remains in the assumed deformation position, as long as an external action it does not return it to the rest position.

In accordance with the preferred embodiment of the invention, the second portion 26 is made at least in part of shape memory material. For example, the second portion 26 comprises a frame made of shape memory metal. Since the second portion 26 is made at least in part of shape memory material, this second portion 26? then configured to maintain the assumed deformation position until an external action brings the second portion 26 back to the rest position. The shape memory materials, as well as? their operation are per se? known to those skilled in the art and will not be described further here for this reason.

According to one aspect, the second portion 26 extends between a first area 261 and an opposite second edge 262 along the second direction of development Y-Y. This second border 262 ? placed at the second end? 22 of the body 2. The first zone 261?, instead, distanced from the second end? 22 of block 2 along the second development direction Y-Y.

Preferably, the first portion 28 of the body 2 is contiguous to the second portion 26. Still preferably, the first portion 28 of the body 2 extends from the first end? 21 of the body 2 to the first area 261 of the second portion 26 of the body 2.

In accordance with the preferred embodiment of the invention, the second portion 26 has an internal surface 263 connecting the first area 261 and the second edge 262 and facing the through channel 23 of the body 2 of the guide 1. Preferably, the internal surface 263 has at least one corrugated portion. Pi? preferably, the inner surface 263 ? fully corrugated.

It should be emphasized that the corrugated portion of the entire surface 263 helps to avoid that, when the cause of the deformation of the second portion 26 from the rest position to a deformation position ceases, this second portion 26 automatically returns to the rest position even without a? external action acting on the second portion 26.

According to a further aspect, the flexible portion 26 has an external surface 264 opposite the internal surface 263 along a further development direction (not indicated in the accompanying figures) of the body 2 transversal to the first X-X and to the second Y-Y development direction. In use, i.e. when guide 1 ? inserted, for example, in the ureter of a patient, the external surface 264 ? in contact with human tissue. Preferably, the outer surface 264 of the flexible portion 26 is therefore substantially smooth to facilitate interaction with the patient's tissue and avoid injury to this tissue.

In accordance with the preferred embodiment of the invention, the second portion 26 is deformable to assume and maintain a deformation position up to a position of maximum deformation. The bending angle defined by the second direction of development Y-Y with respect to the first direction of development X-X increases from the rest position, in which this bending angle ? equal to 0?, at the position of maximum deformation.

Preferably, the curvature angle defined by the second development direction Y-Y with respect to the first development direction X-X in correspondence with the position of maximum deformation of the second portion 26? equal to 270?.

In accordance with the preferred embodiment of the invention, the body 2 comprises an input channel 27 located near the? of the first end? 21. This input channel 27 ? in fluid communication with the through channel 23 of the body 2 and ? connectable to a vacuum source configured to generate a vacuum inside the through channel 23 of the body 2.

Advantageously, how will it be? more clear in the following of the present description, during a surgical operation for the removal of stones in the renal calices, after the connection of the inlet channel 27 to a vacuum source and the actuation of this vacuum source, they are aspirated through the through channel 23 of guide 1, calculations, suitably fragmented, to extract them from the patient. The appropriate aspiration of the stones, through the through channel 23 of the guide 1, avoids the introduction inside this through channel 23 of specific instruments for the removal of the stones, thus reducing the time of the minimally invasive surgical operation and avoiding actions which could lead to damage to the patient's kidney tissue.

Also described here is a kit for a minimally invasive surgical operation, such as for example an operation to remove stones which have accumulated in the renal calices. This kit includes the guide 1 as described in the present description.

In addition, the kit comprises a surgical instrument 3. The surgical instrument 3 comprises an operating element 4 having a terminal tip 41. Preferably, the operating element 4 is? arranged substantially along a longitudinal direction Z-Z.

This operational element 4 ? insertable and sliding inside the through channel 23 of the body 2 of the guide 1 so as to position the terminal tip 41 in correspondence with the second portion 26 of the body 2 of the guide 1.

It should be emphasized that the operating element 4 ? also sliding inside the through channel 23 of the body 2 of the guide 1 to position the end tip 41 beyond the second opening 25 of the through channel 23 of the guide 1. In other words, it? It is possible to position the operating element 4 inside the through channel 23 of the guide 1 in such a way that the terminal tip 41 is placed beyond the second opening 25 of the through channel 23 of the guide 1 and is, therefore, spaced from the second opening 25 of the through channel 23 of guide 1 along the second development direction Y-Y.

In addition, the surgical instrument 3 comprises a control element 5 comprising a movement device 51 operatively connected to the terminal tip 41 of the operating element 4 to move this terminal tip 41. For example, this control element 5 corresponds to a gripable knob by a user such as, for example, a surgeon, and the movement means 51 comprise a lever 511 which can be operated to move the terminal tip 41 of the operating element 4.

The movement of the end tip 41, when the end tip 41 is placed in correspondence with the second portion 26 of the body 2 of the guide 1, it determines the deformation of the second portion 26 from the rest position to a deformation position and the external action which returns the second portion 26 to the rest position. In other words, through the handling means 51 ? It is possible to actuate the terminal tip 41 to deform the second portion 26 of the body 2 of the guide 1 in a deforming position and to return this second portion 26 of the body 2 of the guide 1 to the rest position. Preferably, the terminal tip 41 acts on the internal surface 263 of the second portion 26 to deform this second portion 26 from the rest position to a deformation position and to return this second portion 26 to the rest position.

In the event that the kit is used for a surgical operation to remove kidney stones, after having inserted the operating element 4 inside the through channel 23 of the body 2 of the guide 1 and reversibly locked this operating element 4 inside of the through channel 23 of the body 2 of the guide 1, this guide 1 is positioned inside the ureter of a patient in such a way that the second portion 26 of the body 2 of the guide 1 is positioned in correspondence with the renal calices. The surgeon, by means of the movement device 5, controls the movement of the terminal tip 41 to deform the second portion 26 of the body 2 of the guide 1 in a deformation position in which the second end? 22 of the body 2 of the guide 1 ? facing the position of the stones inside the renal calices. In the event that it is necessary to extract the operating element 4 from the guide 1, the second portion 26 remains in the assumed deformation position. Consequently, in case of subsequent reinsertion of the operating element 4 in the guide 1, it does not? It is necessary to look again for the location of the calculi in the kidneys. At the end of the operation, by means of the terminal tip 41, the second portion 26 of the body 2 of the guide 1 is returned to the rest position to be able to extract the guide 1 from the patient.

In accordance with the preferred embodiment, the surgical instrument 3 comprises an operating channel 42 which extends between a terminal opening 421 located at the terminal tip 41 and an insertion opening 422 located at the control element 5.

Again in accordance with the preferred embodiment of the invention, the kit comprises at least one operating instrument which can be inserted and slidable inside the operating channel 42 of the surgical instrument 3. Preferably, such at least one operating instrument ? selected from the group comprising: probe for stone fragmentation, forceps and/or baskets for extracting stones, forceps for performing biopsies, laser probe for tissue biopsy and/or fragmentation of stones. These operating instruments, which can be used in an operation to remove kidney stones, are in themselves? known to those skilled in the art and will not be further described for this reason.

In accordance with the preferred embodiment of the invention, the kit comprises a source of fluid (not shown in the accompanying figures) and the control element 5 comprises an inlet channel 52 in fluid communication with the operating channel 42 of the surgical instrument 3 .

This input channel 52 ? connectable to the fluid source to receive and introduce fluid into the operating channel 42 of the surgical instrument 3.

Preferably, the control element 5 comprises a tap 53 positioned in correspondence with the inlet channel 52. When the inlet channel 52 is? connected to the fluid source, the activation of the cock 53 allows the fluid to reach the inlet channel 52 and, therefore, the operating channel 42 of the surgical instrument 3.

Again in accordance with the preferred embodiment of the invention, the kit comprises a vacuum source. Such a source of depression ? connectable continuously? of fluid with the inlet channel 27 of the body 2 of the guide 1 so as to generate a vacuum inside the through channel 23 of the body 2 of the guide 1.

In one aspect, the terminal tip 41 of the operating element 4 comprises an optical element 43 configured to acquire video signals. For example, the optical element 43 corresponds to a video camera.

In addition, the kit comprises a video connection cable 6, connected to the optical element 43 to power said optical element 43, and a video control unit (not shown in the accompanying figures). The video center? in signal communication with the optical element 43 of the terminal tip 41 via the video connection cable 6 to receive the video signals acquired by the optical element 43.

The kit also comprises a power cable (not shown in the accompanying figures) which can be connected to the control unit and to an electric power supply source to power said control unit.

Preferably, the kit comprises a monitor (not shown in the accompanying figures) which can be connected to the video control unit for displaying the video signals acquired by the optical element 43.

It should be emphasized that, during an operation to remove kidney stones, the surgeon, by monitoring the video signals acquired by the optical element 43, on the monitor connected to the video control unit, is able to verify the position of the stones in the kidney calices.

According to a further aspect, the terminal tip 41 of the operating element comprises at least one LED 44 configured to illuminate human tissue. Preferably, the terminal tip 41 comprises a pair of LEDs 44.

The video connection cable6 ? connected to the at least one LED 44 to power this at least one LED 44.

In the case of a surgical operation to remove kidney stones, the illumination of the kidney tissue makes it possible to facilitate the visualization of the stones in the kidney calices by means of the optical element 43.

Claims (8)

1. Guide (1) for a minimally invasive surgical operation, said guide (1) being configured to be inserted inside a human tissue and comprising a body (2), said body (2) extending between a first (21 ) and a second end? (22), in which: - the body (2) comprises a through channel (23) which extends between a first opening (24), located at the first end? (21), and a second opening (25), located at the second end? (22), said guide (1) being characterized by the fact that: - the body (2) has a first portion (28), arranged along a first direction of development (X-X), and a second portion (26), placed near the? of the second end? (21) and arranged along a second development direction (Y-Y), - the second portion (26) ? reversibly deformable between a rest position, in which the second development direction (Y-Y) coincides with the first development direction (X-X), and a deformation position, in which the second development direction (Y-Y) defines a respective angle of curvature greater than zero with respect to the first development direction (X-X); - the second portion (26) ? configured to maintain the assumed deformation position until an external action brings the second portion (26) back to the rest position. The guide (1) according to claim 1, wherein the second portion (26) is made at least in part of shape memory material. 3. Guide (1) according to claim 1 or 2, wherein the second portion (26) extends between a first zone (261) and an opposite second edge (262) along the second development direction (Y-Y), said second edge (262) being placed at the second end? (22) of the body (2). 4. Guide (1) according to claim 3, wherein the second portion (26) has an internal surface (263) connecting the first zone (261) and the second edge (262) and facing the through channel (23) of the body (2) of the guide (1), said inner surface (263) having at least one corrugated portion. 5. Guide (1) according to any one of claims 1 to 4, wherein the second portion (26) is? deformable to assume and maintain a respective deformation position up to a position of maximum deformation, the curvature angle defined by the second development direction (Y-Y) with respect to the first development direction (X-X) increasing from the rest position to the maximum position deformation. 6. Guide (1) according to claim 5, wherein the curvature angle defined by the second development direction (Y-Y) with respect to the first development direction (X-X) in correspondence with the position of maximum deformation of the second portion (26 ) ? equal to 270?. 7. Guide (1) in accordance with any one of claims from 1 to 6, wherein said body (2) comprises an input channel (27) located near the? of the first end? (21), said inlet channel (27) being in fluid communication with the through channel (23) of the body (2) and being connectable to a vacuum source configured to generate a vacuum inside the through channel (23) of the body (2). 8. Guide (1) according to any one of claims 1 to 7, wherein the first portion (28) of the body (2) is? contiguous to the second portion (26).