RU2580903C1 - Proctoscope - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to devices for medical examination and therapeutic and diagnostic procedures of inner cavities, namely for rectal by visual examination and using ultrasonic waves. Proctoscope includes translucent body with hole for access to surface of rectum, head case, ultrasonic sensor, light source, and handle. In lower part of housing there is compartment with internal side walls, in which there is plate or panel, in lower part of which along its length there are light-emitting diodes that double as the light source, wherein they are placed so that their light flux is directed mainly perpendicular to inner side walls of compartment, and in upper part of plate or panel there is ultrasonic sensor, having an output on the outer side of housing in its end part between opening and head housing. At that, sensor is mounted with inclination towards hole, final part of plate or panel is arranged in support inside housing.

EFFECT: technical result consists in improvement of accuracy of performed manipulations and quality of device, structure as a whole more durable and reliable, manufacturable.

9 cl, 5 dwg

Description

Technical field

The device relates to devices for medical examination and medical diagnostic procedures of internal cavities, namely for the rectum, by visual inspection and using ultrasonic waves. The device (proctoscope) is used in coloproctology and is intended for the diagnosis and treatment of hemorrhoids and is used in the suture ligation of hemorrhoidal vessels, carried out under the control of ultrasonic dopplerography.

State of the art

The prior art device for the surgical treatment of prolapse, containing a hollow elongated body, extending mainly in the direction along the longitudinal axis, made with the possibility of introducing into the hole and having a through window defining the area of intervention and providing communication between the inner cavity of the elongated body and part of the prolapse, and a movable wall bounding said window together with the elongated body and slidingly connected to the body to provide opening and / or closing the through window between the configurations of its minimum and maximum length, while it contains a locking means that acts between the movable wall and the elongated body to ensure stable maintenance of the through window in the configuration of the minimum length and keep the wall in the closed position while inserting the elongated body into the specified hole (RU 2480138 C2, A61B 1/31, 04/27/2013).

A device for surgical operations in hemorrhoidal prolapse is also known, containing a hollow divaricator, structurally made in the prevailing direction along the longitudinal axis and inserted into the anus, while the divaricator has a window restricting the working area and providing a message between the internal cavity of the divaricator and the hemorrhoidal prolapse section, moreover the device comprises opening and closing means for facilitating changes in the area of operation, said opening and closing means The window opening comprises a movable wall adapted to be moved from a closed position to an open position by sliding movement of said movable wall towards the rear end of the divaricator. The window has a first section extending predominantly across the longitudinal axis, and a second section extending parallel to the longitudinal axis, the movable wall functioning on the second section of the window to open or close it (RU 2408290 C2, A61B 17/00, 20.03.2010). This device has a light source located in the handle or bell of the tube and directed along the tube.

It is also known a disposable device for surgical operations on the arteries of the rectum, containing a retractor tube, closed and rounded at the end, with which it is inserted into the anus, and having at least one window on its side surface through which the mucous membrane of the rectal region appears, on which undergoes an operation for ligation of the artery, a gripping handle made in one piece with the outer neck having a conical section through which you can observe the tissue through the specified window and input to insert into the tube the instruments necessary for the surgical operation, and the illumination means of said window and the mucous membrane that appears through this window, said illumination means containing a light source attached with the possibility of removal inside the indicated handle and at the level of the connection area of this handle with the outer edge the retractor tube contains a means of reflecting light coming from the specified source, with the possibility of lighting the inner portion of the retractor tube and, in particular, the specified lateral in the direction indicated by reflected light, while the retractor tube is aligned with the examination window, and in front of it is a longitudinal, rectilinear inner chamber separated by a partition made integrally with the inner walls of the tube and the rear side of the window, and in general it is designed so that the resulting chamber is open in the direction of the outer neck of the specified tube, moreover, an ultrasonic probe is inserted into the specified chamber with friction, which partially protrudes from the hole made in the longitudinal direction abnormality on the side wall of the retractor tube in such a way that the probe comes into contact with the mucous membrane of the anal region (RU 2308873 C2, A61B 1/31, 10.27.2007). This device also has a light source located in the handle and does not provide sufficient lighting, and an ultrasound probe is placed in the area up to the window for examining the mucosa. An anoscope for ligation of internal hemorrhoidal nodes has an external tubular body with lateral openings for access to the surface of the rectum, coinciding in location with the normal location of internal hemorrhoidal nodes in a person, and a bullet-shaped head covering the distal end of the anoscope. The rotating inner shutter has side openings that coincide with the side openings of the body when the anoscope is open, and intermediate rails that close the side openings when the anoscope is closed (WO 2007032776 A1, A61B 1/00, 03/22/2007). This device does not have an ultrasonic sensor, which reduces its diagnostic value.

The closest analogue to the claimed device is a device for ligation of arteries in the body cavity, which includes a handle and a tube that is installed in the rectum. The device has a near, proximal section where the handle is located, and a distal, distal section in which an ultrasound probe is located to localize the artery, as well as an opening for access to the surface of the rectum. The device is equipped with a backlight, consisting of a fiber, which directs the light from the proximal to the distal portion of the device. The tube is made of polycarbonate or polysulfone (EP 1234539 A2, A61B 1/31, 08/28/2002). An analog ultrasonic device is placed in front of the flashing zone, i.e. when viewed from the side of the surgeon - in front of the window to access the surface of the rectum, and the illumination is directed from the surgeon to the side of the window, it may not be effective due to the remoteness of the light sources, which affects the quality of the manipulations.

Disclosure of invention

The objective of this technical solution is to increase the usability, reliability of the device and increase the stability of ultrasonic research while providing greater strength, manufacturability of its manufacture.

The problem is solved due to the fact that the proctoscope, including a translucent body with an opening for access to the surface of the rectum, the head of the body, an ultrasonic sensor, a light source, a handle, according to the technical solution, has a compartment with internal side walls in which the side wall is located a plate or panel, in the lower part of which along its length there are LEDs that act as a light source, and they are placed in such a way that their luminous flux is oriented mainly perpendicular larly inner sidewalls of the compartment, and in the upper part of the plate or panel is placed an ultrasonic sensor having an output on the outer side of the housing in its end portion between the hole and the head body, wherein the sensor is arranged with a slope toward the opening.

The plate or panel may be configured to provide a sunshade function from a portion of the light output of the LEDs.

The end of the housing can be separated from the rest of the housing by a wall. The wall in the upper part may have a thickening, which on one side of the wall serves as a support for the ultrasonic sensor, and on the other side of the wall in the area of the thickening there are recesses for supporting the medical instrument.

Two rounded recesses can be made in the wall, interconnected by a groove for supporting the medical instrument.

The head of the housing can be made removable and provided with protruding guides with latches for fixing in the housing of the device.

The housing head in the upper part can be provided with protruding stops for fixing the ultrasonic sensor.

The proctoscope may include a removable insert provided with runners and snap-locks, mounted motionless with partial overlapping of the holes in the housing.

The final part of the plate or panel can be placed in abutment inside the head of the housing.

The technical result consists in increasing the accuracy of the manipulations and the quality of the device by improving the illumination of the manipulation zone with a light source consisting of a plurality of LEDs placed along the axis of the device housing close to the manipulation zone, distributing the light flux through the inner side walls inside the translucent device’s case and not creating Thus, a pronounced shadow, providing the possibility of manipulation under constant visual and ultrasonic control it to give a clear, stable and reliable signal from the vessel into the zone in manipulitsy-line due to the oblique arrangement of the ultrasonic probe aperture, wherein the ligation is performed hemorrhoidal vessels and vascular location field approximation ultrasonic sensor to the area of ligation. Moreover, the design as a whole is more durable and reliable, technologically advanced in manufacturing, since it is possible to separately manufacture and modularly connect the device parts to each other, especially when installing light sources and an ultrasonic sensor inside the case.

The current level of safety in medicine during medical diagnostic procedures, especially during surgical procedures, requires the maximum possible use of disposable products, especially made of polymeric materials.

In contrast to the statement in WO 2004064624 (RU 2308873), which states that “the presence of an ultrasonic probe and the placement of a light source at the closed end of this device (proctoscope) increases its cost so much that it is not possible to offer it as a disposable product with all the consequences out of this with drawbacks and limitations, ”the proposed developed device, containing both an integrated ultrasonic sensor and an integrated light source, eliminated this drawback.

The design of the developed device greatly simplifies (due to improved manufacturability) the process of its manufacture and, thus, makes this device available for single use and more convenient to use.

Brief Description of the Drawings

The claimed technical solution is illustrated by the drawings below, not covering the entire scope of the claims of this decision, but only being its special case.

In FIG. 1 shows a proctoscope in isometry;

in FIG. 2 - an unassembled proctoscope, an isometric view;

in FIG. 3 - proctoscope, sectional view along the longitudinal axis;

in FIG. 4 is a proctoscope, a sectional view perpendicular to the longitudinal axis of the wall toward the head of the housing;

in FIG. 5 is a proctoscope, view from the side of the head of the body (the head of the body is removed, the extension and handle are not shown).

The proctoscope consists of the main part, which is a body 1 in the form of a rounded tube, in the proximal part it is gradually expanding and passing into a flat handle 2, equipped with an opening 3 for access to the surface of the rectum, the head of the body, an ultrasonic sensor, a light source.

The lateral surface of the body on one side is truncated by a plane parallel to the longitudinal axis of the body, as a result of which an opening 3 is formed for access to the surface of the rectum, which is deaf in the final (distal) part, expanding and open in the proximal part. Closer to the final (distal) part, the body 2 has a blind perpendicular wall 4 with two rounded recesses 5 located on it closer to the truncated side surface of the body (hole 3), connected by a groove 6 and designed to support the surgical instrument, priority needle holder.

The use of recesses for supporting a medical instrument connected by a groove reduces the risk of injuring the mucous membrane with a needle when suturing, as allows you to firmly fix (rest) the needle holder in the left (right) stop when you first pierce the mucous membrane with the needle, and smoothly, controllably move the needle holder nose in the groove at the same time as the needle holder is rotated to withdraw the needle tip from the mucosa, which already occurs when the needle holder nose is in the other, right (left) emphasis. Distant to the blank wall 4, the lateral surface of the housing 1 is truncated by a plane facing the proximal part of the proctoscope, in which a hole 7 for installing the ultrasonic sensor 8 is made, conjugated and passing into the hollow cylinder 9 with through grooves 10, designed to fix the ultrasonic (US) sensor 8 A flattened through cavity (or cable channel) 11, elongated from the distal part of the housing 1 to its proximal expansion, is formed in the side wall wall opposite from the truncated part of the housing and designed to accommodate the light source 12 of the proctoscope and the cable 13 of the proctoscope. On the inner surface of the housing in its distal part, protruding guides are formed in the form of stoppers-latches 14 latches 15 for fixing the head 16 of the proctoscope, which is a blind dome-shaped in the distal part, open in the proximal part, which is a separate part when manufacturing from the body (main part of the proctoscope). The proctoscope body is preferably made of a transparent material. In the proximal part of the head (16), latches 15 are made in the side walls, which act as locks for reliable fixation of the head 16 and the housing 1 when they are coaxially connected.

Proximally directed rods 17 adjacent to the axis of symmetry of the head 16 are adjacent to the inner surface of the head, fixing the ultrasonic sensor 8 in the housing 1 when the head 16 is connected to the housing 1 and when entering the through grooves 10 of the hollow cylinder and grooves 18 of the ultrasonic sensor.

The ultrasound sensor 8 is installed in the hollow cylinder 9 of the housing 1 and has grooves 18 in the lateral surface, coupled with the corresponding grooves 10 in the wall of the hollow cylinder for the input of the head rods 17 when assembling the proctoscope. Moreover, the external surface of the ultrasonic sensor during assembly becomes part of the external surface of the housing. The ultrasonic sensor is inclined toward the hole and has a connector 19 for connection with the connector 20 of the light source 12.

The location of the ultrasound transducer behind the hole for access to the surface of the rectum (beyond the ligation zone) frees up more work space for manipulating a medical instrument in the internal cavity of the proctoscope body.

The light source 12 has at least two LEDs 21 and is installed in the lower part of the housing 1 in a flattened through compartment 11 with inner side walls 22. In the compartment 11 there is a plate or panel 23, in the lower part of which along its length there are LEDs 21 installed along the axis the specified compartment 11 so that the light is emitted perpendicularly to the side walls 22 for its further distribution inside the walls of the housing and lighting, thus, the space inside the entire housing and the window 3 of access to the surface of the rectum ki. The plate or panel 23 is at the same time a protective visor to minimize direct light propagation inside the proctoscope body and, thus, the possible blinding of the surgeon. The final part of the plate or panel 23 is placed in abutment inside the head of the housing.

Using the proposed embodiment of the light source, it is possible to obtain distributed light propagating within the walls of the entire proctoscope body from several LEDs, which provides significantly better illumination of the operation area.

The proctoscope may include a removable insert 24. The insert is installed from the proximal part of the housing 1 by means of U-shaped runners 25, mating with the guides 26 of the side surface of the housing. After installation, the removable insert 24 of the housing is securely and motionlessly fixed in the housing 1 by locks-latches formed by the grooves 27 in the guides 26 and the reciprocal protrusion in the runners 25 of the housing partially overlapping the opening 3 in the housing.

If a removable insert is installed, then it limits the prolapse of hemorrhoidal nodes into the hole to access the surface of the rectum. A removable insert is primarily used in the arterial ligation operation step.

If the removable insert is not installed, then the device provides free access to the prolapsing mucosa and hemorrhoid, which allows the stage of mucopexy surgery (suturing of the mucosa) after the ligation stage.

The stops-latches 14 and latches 15 with spacer rings (not shown in the drawings) and connectors 19, 20 of the ultrasonic sensor and light source make it possible to quickly and technologically assemble the proctoscope as a modular design.

The head 16 and the ultrasonic sensor 8 can be connected to the housing 1 by gluing, i.e. without locks.

The ultrasonic sensor 8 can be connected to the light source 12 and without a connector 20.

The implementation of the invention

Anatomical studies have established that the main causative factors of hemorrhoids are pathological arterial inflow along the distal branches of the superior rectal artery (a. Rectalis superior), as well as degeneration and weakening of the ligamentous apparatus. This leads to hypertrophy of the cavernous tissue, bleeding and prolapse of the hemorrhoids from the anus.

The developed device is used in a minimally invasive method for the treatment of hemorrhoids, based on the identification of hemorrhoidal arteries using ultrasound dopplerography and subsequent transanal desarterization of internal hemorrhoids under the control of ultrasound dopplerography in order to stop or reduce the flow of arterial blood to the hemorrhoid with further mucopexia of the mucous membrane and cavernous tissue channel.

When carrying out the above procedure, the device is introduced into the anal canal, holding it by the handle and the expanding part of the body. The initial position of the device in the anal canal is, as a rule, the handle down (the hole for access to the surface of the rectum of the surface of the intestine is located at 12 o’clock on the dial).

By translationally rotating the device, a search is made for the branches of the superior rectal artery to be ligated. The search is conducted at a depth of 3-4 cm above the gear line, priority - in the directions 1, 3, 5, 7, 9, 11 hours of the conditional dial using an ultrasonic sensor installed in the device and connected to the device of the electronic unit, where signals are displayed and voiced from the sensor.

Next, a medical instrument (needle holder) with a 5/8 rounded needle is inserted into the device. In the case of a device with recesses for a medical instrument, the needle holder nose is installed in one of the recesses inside the wall of the end part of the device body.

An 8-shaped flashing of the mucosa and the hemorrhoidal artery found during the search is carried out by injecting the needle, turning it, moving the needle holder nose in the device groove to another recess and continuing to turn until the needle tip leaves the mucosa.

The needle is released, the needle holder nose is pulled out of the recess, the needle holder is gripped by the beginning of the needle and, resting the needle holder nose in the nearest recess, they complete the turn and tighten the thread.

A second injection is carried out with an offset and a similar circular rotation of the needle.

For successful ligation, make sure that the pulsation of the artery has disappeared or significantly decreased, after which a knot is tied up, holding it with a special thread holder.

When prolapse of the hemorrhoidal tissue into the opening for access to the surface of the rectum (the so-called ligature window) of the device after ligation of the artery, mucopexy is performed with a continuous suture with the capture of cavernous tissue to the dentate line, followed by pulling and tying the knot.

Continue the search for branches of the upper rectal artery to be ligated around the circumference of the rectum and repeat the manipulations.

An ultrasound sensor is a transceiver component of the device, the principle of which is based on the Doppler effect, in which the low-frequency component of the Doppler shift linearly depends on the mutual speed of objects (in our case, this is a stationary sensor and blood particles in the vessel). If the angle between the direction of blood flow in the vessel and the direction of the ultrasound beam axis (sensor axis) is non-zero, the velocity vector is decomposed into orthogonal projections and, accordingly, at the angle indicated above close to 90 degrees, the projection of the velocity vector on the sensor axis is very small, t. e. the differential frequency of the Doppler shift is close to zero. In a medical electronic device, there is always a high-pass filter that cuts off the low-frequency Doppler signals of the oscillating walls of blood vessels, mucous membranes and other tissues, the level of which is thousands of times higher than the level of the signal reflected from blood particles. Therefore, a “useful” Doppler signal in the range less than the cutoff frequency of the specified filter is very difficult to register and process. Because in our case, the angle is anatomically close to 90 degrees, it is necessary to reduce the angle between the axis of the sensor and the vessel, which is done by tilting the sensor.

When the sensor is tilted towards the opening for access to the surface of the rectum (to the ligation zone and to the plane in which the lunate needle moves, grabbing the vessel and pulling it with a thread, which, after tying, completely compresses the vessel), we bring the vessel location zone with the sensor to the ligation zone and thereby increase the accuracy of determining the location of the vessel and the reliability of the termination or significant decrease in blood flow.

Claims (9)

1. A proctoscope, including a translucent case with an opening for access to the surface of the rectum, a head of the case, an ultrasonic sensor, a light source, a handle, characterized in that in the lower part of the case there is a compartment with internal side walls in which a plate or panel is placed, in the lower part of which along its length are LEDs that act as a light source, and they are placed in such a way that their light flux is oriented mainly perpendicular to the inner side walls of the compartment, and in the upper part of the plate or panel is placed an ultrasonic sensor having an output on the outer side of the housing in its end portion between the hole and the head body, wherein the sensor is arranged with a slope toward the opening. 2. The proctoscope according to claim 1, characterized in that the plate or panel is configured to provide a sunshade function from a part of the light flux of the LEDs. 3. The proctoscope according to claim 1, characterized in that the final part of the body is separated from the rest of the body by a wall. 4. The proctoscope according to claim 3, characterized in that the wall in the upper part has a thickening, which on one side of the wall serves as a support for the ultrasonic sensor, and on the other side of the wall in the area of the thickening, recesses are made for supporting the medical instrument. 5. The proctoscope according to claim 3, characterized in that two rounded recesses are made in the wall, interconnected by a groove for supporting the medical instrument. 6. The proctoscope according to claim 1, characterized in that the head of the housing is removable and provided with protruding guides with latches for fixing in the housing of the device. 7. The proctoscope according to claim 1, characterized in that the housing head in the upper part is provided with protruding stops for fixing the ultrasonic sensor. 8. The proctoscope according to claim 1, characterized in that it comprises a removable insert provided with skids and snap locks, mounted motionless with partial overlapping of the opening in the housing. 9. The proctoscope according to claim 1, characterized in that the final part of the plate or panel is placed in abutment inside the head of the housing.

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