Medical device

Abstract

An anoscope (1) is formed by an intervention unit (2) and a control unit (3), which works as a single system by slidably and pivotally inserting the unit (1) into the unit (2). The interface housed by the transparent core body of the cylindrical control unit (3) and the height-adjustable mechanism allow the axial distance between the multi-dimensional access unit aperture (5) and the control unit base (12) to be adjusted. The mechanism is made of an alignment button (9) on the outer wall of the interventional unit (2) designed to engage with an interface and height-adjustable structure on the inner wall of the transparent core body of the control unit (3), formed by a vertical alignment track (14) having three holes (10) for indicating the access points of the access of the interventional unit (2) into the alignment slot (18), the alignment button (9) being designed to engage with the interface and height-adjustable structure on the inner wall of the transparent core body of the control unit (3). The alignment groove extends along the entire circumference on the inner surface of the wall of the control unit (3).

Description

Technical Field

[0001] The invention relates to the field of medical equipment, and in particular to an anoscope for minimally invasive treatment of anorectal diseases. Background Art

[0002] An anoscope is a medical device used primarily by anorectal physicians, general surgeons, or colon and rectal surgeons to access the anal canal and lower rectum for diagnostic and / or therapeutic purposes. It is typically a tubular device that is inserted into the anal canal to dilate the anatomical structures of the lower rectum. It allows the physician to obtain the best possible view of the anatomical structures of the lower rectum and anal canal and facilitates easy access to the instruments needed for the procedure.

[0003] A common application of anoscopy is the treatment of hemorrhoidal disease with minimally invasive non-excisional surgery (first- or second-line treatment) or interventional measures for severe cases that require excision or resection (third-line treatment).

[0004] Hemorrhoids are cushion-like clusters of a network of arteries and veins and elastic connective tissue located beneath the mucosa lining the lowermost part of the rectum and anus. Their physiological role is to protect the anal sphincter muscles, they help maintain continence during bowel movements, and affect the resting pressure of the anal canal. Hemorrhoidal disease, also known as symptomatic hemorrhoids, is a clinical condition when these cushions become enlarged, inflamed, and produce symptoms. Constipation and constant straining during bowel movements can cause the anal cushions to become engorged, weaken their support structure, and eventually lead to prolapsed hemorrhoids.

[0005] Symptomatic hemorrhoids are differentiated by their location relative to the dentate line. Hemorrhoids arising from the superior hemorrhoidal plexus appear above the dentate line and are called internal hemorrhoids. External hemorrhoids arise from the inferior hemorrhoidal plexus and can be seen near the anus.

[0006] Hemorrhoidal disease progresses gradually through multiple stages, leading to vascular and muscular dysfunction, as well as prolapse of anorectal structures.

[0007] Anoscopes are basically tube-like structures that are open at the proximal end (the end closest to the doctor or surgeon) and contain openings at the distal end, in the sidewalls, or both. Commercially available anoscopes are either made of metal or metal alloys, known as durable types, or made of synthetic materials, known as single-use or disposable anoscopes, e.g. Figure 1anoscope as shown. However, this anoscope has some disadvantages, for example, if the surgeon wants to perform mucopexy and arterial ligation along multiple columns (critical for all techniques of second-line treatment) and keep the height of the device the same throughout the entire procedure, this anoscope does not provide optimal conditions because it lacks an adjustable height feature. In addition, it requires hand-held assistance during the procedure, which unnecessarily increases the number of operating room personnel required for the intervention. The geometry of the opening in the side wall of this anoscope does not provide the surgeon with optimal visual conditions for the anatomical structures in the area of ​​interest and may hinder the surgeon from manipulating the needle during suturing. In addition to the above-mentioned disadvantages of the prior art, we cannot ignore the requirements of today's major stakeholder groups (such as healthcare providers, patients, health insurance companies), as well as the challenges associated with the various treatment measures and devices involved in the treatment of symptomatic internal hemorrhoids: patient safety, risks associated with excision techniques, hospitalization and postoperative recovery time, limited clinical application and learning curve - the time required to reach a proficiency stage, especially the time associated with complex equipment such as Doppler guidance systems, and the overall cost of each surgical procedure. Summary of the invention

[0008] Therefore, the main object of the present invention is to provide a medical device for accessing the anal canal and lower rectum of a human body to overcome the above-mentioned shortcomings and challenges. According to claim 1, the medical device comprises an intervention unit of cylindrical elongated shape having a first length and a control unit of cylindrical elongated shape having a first distal end and a first proximal open end and having a second length shorter than the first length, the intervention unit and the control unit being separate components and defining a common longitudinal axis, the intervention unit being axially disposed within the control unit and being able to slide relative to the control unit in a direction parallel to the common longitudinal axis and in a pivotal direction about the common longitudinal axis within the control unit, the intervention unit having a second distal end and a second proximal end, wherein the second distal end is closed by a circular top and the second proximal end is open, and a first body located between the second distal end and the second proximal end has an orifice on a transverse wall near the distal end, the orifice being designed to allow selective observation and access to the anatomical structures of the lower rectum and the anal canal, and a fixing mechanism being able to block and unblock longitudinal axial sliding and pivotal circumferential sliding between the intervention unit and the control unit at several axial and angular positions of the intervention unit relative to the control unit.

[0009] Due to these specific features, the anoscope of the present invention enables the surgeon to perform transanal minimally invasive non-resective procedures.The anoscope consists of two distinct parts, defined as an intervention unit and a control unit, which together function as a single system due to their interface functionality.

[0010] The interface and height-adjustable mechanism are housed by the transparent core body of the control unit, which allows the surgeon to adjust the height of the anoscope so as to facilitate the insertion of the interventional unit in the following manner: Figure 2 , 3 , wherein the anatomical structures can be selectively accessed during intervention to overcome anatomical differences due to the physique or nature of the patient. The multi-dimensional design of the interventional port of the interventional unit has dedicated areas for selective arterial ligation by using a portion of the interventional port with a larger opening in a transverse direction of the longitudinal axis, and for mucosal fixation by using a portion of the interventional port with a longer dimension in the longitudinal direction of the anoscope. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Further aspects and advantages of the anoscope according to the present invention will become apparent from the following detailed description of preferred embodiments thereof with reference to the accompanying drawings, in which:

[0012] Figure 1 : shows an anoscope according to the prior art,

[0013] Figure 2 : shows an isometric front view of the anoscope of the invention in its assembled configuration for use, with the intervention unit inserted into the control unit and arranged in a low position,

[0014] Figure 3 : Shows Figure 2 An anoscope assembled for use, wherein the interventional unit is inserted into the control unit and set in a neutral position,

[0015] Figure 4 : Shows Figure 2 An anoscope assembled for use, wherein the interventional unit is inserted into the control unit and arranged in a high position,

[0016] Figure 5 : Shown as Figure 2 An isometric front view of the interventional unit of the first component of the anoscope,

[0017] Figure 6 : Shows Figure 5 An enlarged view of the front bottom of the intervention unit,

[0018] Figure 7 : Shows Figure 5 Axonometric side view of the interventional unit of the anoscope,

[0019] Figure 8 : Shown as Figure 2 An isometric front view of the control unit of the second component of the anoscope,

[0020] Fig. 9: Shows the Figure 8 An axial isometric view of an adjustable height structure on an inner wall of a control unit;

[0021] Fig.10 : Shows the Figure 8 Enlarged cross-sectional view of the control unit in the axial plane.

[0022] The same reference numerals in different drawings refer to the same components. DETAILED DESCRIPTION

[0023] The present invention will be better understood by reading the following description of a preferred embodiment of a medical device (also referred to as an anoscope) according to the present invention. Figure 2 The anoscope in the invention is indicated as a whole by the reference numeral 1, having a generally cylindrical shape with its longitudinal axis parallel to the Y axis of the orthogonal coordinate system X, Y, Z, and is a height-adjustable device comprising two distinct components: a first component is an intervention unit 2 and a second component is a control unit 3. The components 2 and 3 of the anoscope 1 are designed to function as a system centered on their interface capabilities provided by an alignment button 9 located on the outer surface of the wall, which is located in the proximal part of the intervention unit 2 along the generatrix of the cylinder located on the plane YZ, and a height-adjusting structure located on the inner surface of the wall of the control unit 3.

[0024] The height adjustment structure is formed by longitudinal alignment rails 14 located on the inner surface of the wall of the control unit 3 along generatrixes located on plane YZ, which allow insertion of the intervention unit 2 into the control unit 3 and axial movement of said intervention unit 2 inside the control unit 3 .

[0025] The control unit 3 is also provided with three holes 10 made in its wall, which are aligned along the alignment tracks 14 and indicate the access points of the interventional unit 2 into three alignment slots 18 extending along the entire circumference 360° on the inner surface of the wall of the control unit 3. The alignment slots 18 allow clockwise and counterclockwise pivoting movements around the longitudinal axis of the interventional unit 2 inside the control unit 3 and have a guiding function for the button 9 in the three positioning heights of the anoscope (low, middle, high).

[0026] Figure 2 The anoscope 1 shown in its assembled configuration for use has the intervention unit 2 fixed in a lower position, while Figure 3 and Figure 4 The anoscope 1 assembled for use is shown in a mid-position and a high-position, respectively.

[0027] The intervention unit 2 has a generally cylindrical shape, is axially elongated, and has a closed top 4 at its distal end, which is dome-shaped and connected to the body of the intervention unit 2 by a hyperboloid 6. When considering a cross section of this surface 6 lying on an axial plane, this surface 6 has an angular rate of change such that a tangent to said surface changes from positive to negative when moving along the surface. The top 4 is also defined as an anatomical tip, allowing easy insertion into the anal canal and smooth lifting of the prolapsed anatomical structure.

[0028] In the distal part of the wall of the interventional unit 2, immediately below the dissecting tip 4, a multidimensional interventional orifice 5 is provided, which constitutes a dedicated area through which the surgeon can selectively perform arterial ligation and mucopexy. Arterial ligation can be performed through a first portion 5', which is shaped as a wider opening extending along the wall of the interventional unit 2, with its longer dimension extending in the circumferential direction of the interventional unit 2. Mucopexy can be performed through a second portion 5" of the interventional orifice 5, which is generally rectangular in shape, with its larger dimension extending in the direction of the longitudinal axis Y of the interventional unit 2.

[0029] Two pressure relief slits 11 are advantageously located on the front wall of the proximal portion of the intervention unit 2, and are located to the left and to the right of the alignment button 9 with respect to the longitudinal axis of the intervention unit 2. These slits 11 are provided to enhance the elasticity and biasing capacity of the wall of the intervention unit 2 in the portion 8 defined between the pressure relief slits 11, since this area is not fixed to the base 15 of the intervention unit, as shown in FIG. Figure 6 Thus, the portion 8 of the wall between the two slits 11 has the form of a flexible biasing rod 8, enabling the surgeon to easily lock and unlock the alignment button 9 during the intervention. By unlocking the alignment button 9 to perform a longitudinal movement of the intervention unit 2 along the alignment track 14 of the control unit 3, the surgeon can select the most suitable water height, such as low, medium or high, taking into account the anatomical features of the patient, as shown in FIG. Figure 2 , 3 4 to correctly locate the position of the interventional orifice 5 relative to the dentate line which is usually used as an anatomical reference point. The core body of the control unit 3 is transparent and thus provides the surgeon with optimal visual conditions to locate the anatomical reference points.

[0030] However, as an alternative, the number of holes 10 foreseen in the control unit 3 may be greater than three, if better adapted to the patient's needs, taking into account the patient's anatomy, to allow a greater number of axial positions between the interventional unit 2 and the control unit 3 .

[0031] The surgeon performs the same locking and unlocking actions to allow changing the angular orientation of the interventional orifice 5 by applying slight pressure to the wall portion 8 to more flexibly unlock the button 9 and sliding the button 9 circumferentially in the alignment slot 18 of interest until the interventional unit 1 reaches the desired angular position relative to the control unit 2 and the patient's body.

[0032] By changing the angular orientation of the access opening 5, the surgeon can selectively access the quadrant of interest as required by the sequence of the surgical procedure. When the access unit is pivotally moved in the control unit, the alignment button 9 can engage one of a plurality of (preferably but not limited to six) alignment cavities 19, which are 60° apart from each other along the circumference. In this way, the two units 2 and 3 maintain their constant and secure relative angular orientation and the direction of the access opening 5 in the position selected by the surgeon. Advantageously, the wire support 16 (such as Figure 6 ) is integrated into the front part of the base 15 of the intervention unit 2 , where it forms a bridge 15 ′ on the wall 8 of the intervention unit 2 between the pressure relief slits 11 .

[0033] The wire support 16 helps the surgeon to keep the proximal end of the wire out of his / her field of vision when it is not needed or in order to tighten the wire, as desired by the surgeon, to perform suturing under optimal conditions.

[0034] Advantageously, the surface of the outer wall of the distal portion of the intervention unit 2 is designed with a sharkskin-like 7 pattern in the wall portion located behind the intervention orifice.

[0035] The control unit 3 has a transparent core body of cylindrical shape, a frustoconical distal end portion 3 ′, a base 12 forming a ring-like structure, and advantageously has a handle 21 extending radially from the base 12 for better gripping of the control unit 3 .

[0036] Three holes 17 are provided on the base 12, preferably but not necessarily oval, for fixing the control unit 3 to the patient's body by suturing to prevent accidental movement during the intervention and to enable the surgeon to perform the surgical procedure autonomously.

[0037] The six orientation marks 20 on the bottom of the base 12 are an orientation aid for the surgeon, indicating the position where the alignment button 9 of the interventional unit 2 meets the alignment cavity 19 evenly distributed along each of the three alignment slots 18 .

[0038] Advantageously, the two handles 13 and 14 are fixed to the sides of a base 15 of the interventional unit 2 and are oriented at an angle slightly away from the rear of the patient.

[0039] As mentioned above, the unique features of the anoscope 1 of the present invention provide several advantages over other known anoscopes, in addition to the advantages explained above:

[0040] - The dissecting tip 4 with a double curved design and closed top provides optimal visualization of the area in which the intervention is to be performed by preventing tissue or feces from entering the anoscope internal space. It also helps to physically lift the prolapsed tissue smoothly during the insertion of the anoscope 1 and provides a support platform for the anatomical structures around the distal part of the interventional unit 2 during surgical or medical interventions;

[0041] - The multidimensional interventional orifice 5 on the anoscope's anterior wall constitutes areas 5' and 5", through which the clinician can selectively perform arterial ligation and / or mucosal fixation, and provides the surgeon with optimal conditions for manipulating the instruments used during the intervention, thus improving the quality of suturing along each column when performing superficial and / or deep passages with the needle;

[0042] - a surface with a sharkskin-like 7 pattern enhances support and contributes to the uniform distribution of the prolapsed tissue in direct contact with the wall of the interventional unit 2 in the corresponding area;

[0043] - two handles 13 , 14 allow the surgeon to easily grasp and hold the interventional unit 2 when manipulating the anoscope during a surgical procedure;

[0044] - the frustoconical distal portion 3 ′ of the control unit 3 fits like a cannula over the dissecting tip 4 of the interventional unit and provides stability during the insertion of the control unit 3 into the anal canal;

[0045] - The positioning and alignment structure allows the surgeon to easily choose the positioning height of the intervention orifice 5 and its angular position, giving the anoscope a wider field of use when performing an intervention.

[0046] - The height adjustability of the anoscope 1 allows the clinician to overcome anatomical differences caused by the size or nature of the patient and facilitates providing minimally invasive treatment of anorectal diseases under optimal conditions when performing non-resective treatment options;

[0047] - The transparent body of the control unit 3 allows the clinician to see the dentate line and use it as an anatomical reference point to determine the appropriate height for interventions above the dentate line;

[0048] - a dissecting tip 4 formed by a double-curved closed top is provided, which enables smooth physical lifting of the prolapsed tissue during insertion of the device and provides a support platform for the anatomical structures around the distal end of the interventional unit 2 during intervention;

[0049] - two pressure relief slits 11 in the interventional unit 2 enhance the elasticity of the walls of the device and enable the clinician to safely and easily navigate the adjustable height structure within the control unit 3 by actuating the alignment button 9 of the interventional unit 2;

[0050] - The feature 16 acting as a wire support enables the surgeon to keep the lower end of the wire out of view when not needed, or to tighten the wire as desired by the surgeon to perform the suturing under optimal conditions.

[0051] Additionally, the device of the present invention has the advantage of maximizing patient safety, providing an opportunity to reduce the overall cost of the surgical procedure compared to using Doppler guidance techniques, and minimizing the surgeon's reliance on operating room assistance.

[0052] The anoscope of the present invention also improves the clinical effectiveness of treatment measures for high-risk patients (e.g., patients receiving anticoagulant therapy, patients with comorbidities) or patients who require repair surgery when third-line treatment techniques fail to achieve the desired results.

[0053] The present invention has been described in detail as a medical device for use in human treatment procedures. It will be readily apparent to those skilled in the art that it may also be applied to veterinary procedures. Although the anoscope has been disclosed as a single-use device, and in this case it is made of a synthetic resin, it will be apparent that it may be made of a more durable material, such as metal or other suitable material that may be resterilized for multiple uses, without departing from the scope of the present invention.

Claims

1. A medical device (1) designed to be inserted into the anal canal and lower rectum of a human body, comprising: an intervening unit (2) having a cylindrical elongated shape of a first length, and a control unit (3) having a first distal end and a first proximal open end and having a cylindrical elongated shape with a second length shorter than the first length, wherein the intervention unit (2) and the control unit (3) are separate components and define a common longitudinal axis Y, wherein the intervention unit (2) is axially placed in the control unit (3) and is able to slide in the control unit (3) relative to the control unit (3) in a direction parallel to the common longitudinal axis Y and in a pivoting direction around the common longitudinal axis Y, Wherein, the intervention unit (2) comprises: a second distal end and a second proximal end, wherein the second distal end is closed by a circular top (4) and the second proximal end is open, a first body intermediate the second distal end and the second proximal end, a multi-dimensional aperture (5) located laterally in a wall adjacent to said second distal end (4) and designed to allow selective visualization and access to the anatomy of said lower rectum and anal canal, A fixing mechanism (9, 10) capable of preventing and releasing the sliding between the intervention unit (2) and the control unit (3), in a plurality of axial and angular positions of the intervention unit (2) relative to the control unit (3), in a direction parallel to the common longitudinal axis Y and in a pivoting direction around the common longitudinal axis Y.

2. The medical device according to the preceding claim, wherein the circular top (4) is connected to the first body of the interventional unit (2) by a surface (6) having a double curvature of opposite sign.

3. The medical device according to any of the preceding claims, wherein the control unit (3) is at least partially made of a transparent material.

4. Medical device according to any of the preceding claims, wherein the orifice (5) is constituted by two areas (5', 5") having different perimeters and shapes.

5. A medical device according to any of the preceding claims, wherein the fixing mechanism comprises a button (9) placed on a flexible portion (8) of the outer surface of the first body of the interventional unit (2), entering into one of a plurality of holes (10) made on the control unit (3) and aligned at a certain distance from each other along a vertical alignment track (14).

6. Medical device according to any of the preceding claims, wherein the height-adjustable mechanism comprises a plurality of circumferential grooves (18) in the inner surface of the control unit (3).

7. The medical device according to any of the preceding claims, wherein the intervention unit (2) has a pair of slits (11) in one wall, thereby forming a flexible rod (8).

8. The medical device according to any of the preceding claims, wherein a support (16) for sutures is fixed to the base (15) of the interventional unit (2).

9. The medical device according to any of the preceding claims, wherein at least a portion of the surface (7) of the body of the interventional unit (2) adopts a sharkskin-like pattern.

10. Medical device according to any of the preceding claims, wherein the control unit (3) has a base (12) with holes (17) to allow suturing the anoscope to the posterior of the patient.

11. The medical device according to any of the preceding claims, wherein the medical device is an anoscope.

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