Medical devices

Abstract

The anoscope (1) is formed by an intervention unit (2) and a control unit (3), and functions as a single system by slidably and rotatably inserting unit 1 into unit (2). The interface and height adjustment mechanism accommodated by the transparent core of the cylindrical control unit (3) enables adjustment of the axial distance between the opening (5) of the multidimensional intervention unit and the base (12) of the control unit. The mechanism is created by an alignment button (9) located on the outer wall of the intervention unit (2) and designed to engage with an interface and height adjustment structure located on the inner wall of the transparent core of the control unit (3). The inner wall of the transparent core of the control unit (3) is formed by a vertical alignment track (14) having three holes (10), and the holes indicate access points to alignment grooves (18) that extend circumferentially over the entire inner surface of the wall of the control unit (3) of the intervention unit (2).

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and more particularly to an anoscope for minimally invasive management of anorectal diseases.

Background Art

[0002] An anoscope is a medical instrument mainly used by anorectal surgeons, general surgeons or colorectal surgeons to access the anal canal and lower rectum for diagnostic and / or therapeutic purposes. It is generally a tubular device inserted into the anal canal that expands the anatomical structure up to the lower rectum. This allows the clinician to obtain the best possible view of the anatomical structure of the lower rectum and anal canal and facilitates easy access to the instruments required for treatment procedures.

[0003] One common use of an anoscope is the management of hemorrhoid disease by either minimally invasive non-excision procedures (primary or secondary treatment), or secure intervention (tertiary treatment) in severe cases requiring partial resection or excision.

[0004] Hemorrhoids are cushion-like clusters of arteriovenous networks and elastic connective tissues located under the mucosa covering the inner most part of the rectum and anus. Their physiological role is to protect the anal sphincter, and they maintain the suppression of the urge to defecate and affect the static pressure of the anal canal. Hemorrhoid disease, also called symptomatic hemorrhoids, is a clinical condition in which these cushion-like clusters swell, become inflamed, and cause symptoms. Constipation and persistent straining during defecation cause congestion of the anal cushions, weaken their supporting structures, and ultimately result in hemorrhoid prolapse.

[0005] Symptomatic hemorrhoids are distinguished by their position relative to the dentate line. Those originating from the superior hemorrhoidal venous plexus occur above the dentate line and are called internal hemorrhoids. External hemorrhoids originate from the inferior hemorrhoidal venous plexus that can be seen adjacent to the anus.

[0006] Hemorrhoid disease develops gradually through several stages, resulting in a dysfunction of the coordinated functions of blood vessels and muscles and prolapse of the anorectal structure.

[0007] An anoscope is essentially a tubular structure with an opening at the proximal end (the tip proximally to the physician or surgeon) and openings at the distal end, the lateral wall, or both. Commercially available anoscopes are made of metal or metal alloy, sometimes called durable versions, or of synthetic materials, known as disposable or disposable anoscopes, such as the anoscope shown in Figure 1. However, such anoscopes have several drawbacks, such as not providing optimal conditions for surgeons who wish to perform mucosal fixation and arterial ligation along multiple rows (essential for all secondary treatment techniques), and lacking height adjustment, requiring the instrument to remain at a constant height throughout the procedure. Furthermore, they require hand support during the procedure, unnecessarily increasing the number of OR personnel required for the intervention. The geometric shape of the lateral wall opening of this anoscope does not provide surgeons with optimal anatomical visual conditions for the area of ​​interest, which can make it difficult for surgeons to manipulate the needle during suturing.

[0008] In addition to the aforementioned drawbacks of cutting-edge technology, the current needs of key stakeholders (e.g., healthcare providers, patients, and health insurance companies), and the challenges associated with various treatments and devices involved in the management of symptomatic internal hemorrhoids (patient safety, risks associated with resection techniques, length of hospital stay and postoperative recovery period, limited clinical application and learning curve (especially with complex devices such as Doppler induction systems, the time required to reach a mastery level), and the total cost of each procedure) cannot be ignored. [Overview of the project]

[0009] Therefore, the main object of the present invention is to provide a medical device designed to access the human anal canal and lower rectum in order to overcome the above-mentioned drawbacks and solve the problems, in accordance with claim 1. The medical device includes an elongated cylindrical intervention unit having a first length, and an elongated cylindrical control unit having a second length shorter than the first length, having a first distal open end and a first proximal open end, wherein the intervention unit and the control unit are separate components, define a common longitudinal axis, the intervention unit is axially positioned inside the control unit, and is slidable within the control unit in a direction parallel to the common longitudinal axis and in a rotational direction about the common longitudinal axis, the intervention unit has a second distal end and a second proximal end, the second distal end is closed by a rounded apex and the second proximal end is open, a first body located midway between the distal end and the proximal end, and an opening located in the lateral wall near the distal end, designed to allow selective observation and access to the anatomical structures of the lower rectum and anal canal. The device includes a aperture and a fixing mechanism that can prevent and release longitudinal axial sliding and rotational 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.

[0010] The anoscope of the present invention, through specific features, enables surgeons to perform minimally invasive, non-resectable transanal procedures. The anoscope is formed by two separate parts, defined as an intervention unit and a control unit, which function together as a single system through their interface connectivity capabilities.

[0011] The interface and height-adjustable mechanism are housed within a transparent core body of the control unit, allowing the surgeon to adjust the height of the anoscope to compensate for anatomical differences due to patient size or characteristics by facilitating smooth alignment of the intervention unit and the anatomical structures selectively accessed during the intervention at three levels (low, medium, and high), as shown in Figures 2, 3, and 4. The multidimensional design of the intervention opening of the intervention unit has dedicated fields for selectively performing arterial ligation using sections of the intervention opening with wider openings along the transverse direction relative to the longitudinal axis, and for performing mucosal fixation using sections of the intervention opening with longer dimensions in the direction of the longitudinal axis of the anoscope. [Brief explanation of the drawing]

[0012] Further aspects and advantages of the anoscope according to the present invention will become apparent from the following detailed description of its preferred embodiments with reference to the accompanying drawings.

[0013] [Figure 1] This shows an anoscope using state-of-the-art technology. [Figure 2] The image shows an asymmetrical front view of the anoscope of the present invention in an assembled form for use, with the intervention unit inserted into the control unit and set to a low level. [Figure 3] Figure 2 shows an anoscope assembled for use, with the intervention unit inserted into the control unit and set to a medium level. [Figure 4] Figure 2 shows the anoscope assembled for use, with the intervention unit inserted into the control unit and set to a high level. [Figure 5] Figure 2 shows an asymmetrical projection front view of the intervention unit, which is the first component of the anoscope. [Figure 6] Figure 5 shows a magnified view of the front bottom of the intervention unit. [Figure 7] Figure 5 shows an asymmetrical projection side view of the anoscope intervention unit. [Figure 8]Figure 2 shows an asymmetrical projection front view of the control unit, which is the second component of the anoscope. [Figure 9] Figure 8 shows an axial unequal projection view of the height-adjustable structure located on the inner wall of the control unit. [Figure 10] Figure 8 shows an enlarged cross-sectional view of the control unit on the axial plane.

[0014] The same reference numeral in different diagrams refers to the same component. [Modes for carrying out the invention]

[0015] The present invention will be better understood by reading the following description of preferred embodiments of the medical device, also defined as an anoscope, according to the present invention. Referring to the drawings, the anoscope of Figure 2, generally indicated by reference numeral 1, which is substantially cylindrical and whose longitudinal axis is parallel to the Y axis of the X, Y, Z Cartesian coordinate system, is a height-adjustable device comprising two distinct components, the first of which is an intervention unit 2, and the second of which is a control unit 3. Components 2 and 3 of the anoscope 1 are designed to function as a system centered on their interface connectivity capabilities provided by an alignment button 9 located on the outer surface of the wall of the proximal part of the intervention unit 2 along the generatrix of the cylinder in the plane YZ, and a height adjustment structure located on the inner surface of the wall of the control unit 3.

[0016] The height adjustment structure is formed by a longitudinal alignment track 14 located on the inner surface of the wall of the control unit 3 along a generatrix in the plane YZ, which allows insertion of the intervention unit 2 into the control unit 3 and axial movement of the intervention unit 2 within the control unit 3.

[0017] In addition, the control unit 3 is provided with three holes 10 formed in its wall, and these holes are aligned along the alignment track 14, indicating access points to three alignment grooves 18 that extend along the entire inner surface of the wall of the control unit 3 in a 360° full circumference for the intervention unit 2. The alignment grooves 18 enable clockwise and counterclockwise rotational movement of the intervention unit 2 around the longitudinal axis within the control unit 3 and have a guiding function for the button 9 at three positioning levels of low, medium, and high levels of the anoscope.

[0018] The anoscope 1 in the assembled form for use shown in FIG. 2 has an intervention unit 2 fixed at a low level, while FIGS. 3 and 4 show the anoscope 1 assembled for use at medium and high levels, respectively.

[0019] The intervention unit 2 has a generally cylindrical shape, is axially elongated, has a dome-shaped closed top 4 at its distal end, and is joined to the body of the intervention unit 2 on a double curved surface 6. Considering its cross-section in the axial plane, the double curved surface 6 has a change rate of the angle at which the tangent to the curve rotates when moving along the curve, changing from a positive value to a negative value. The top 4, which is also defined as the anatomical tip, enables easy insertion into the anal canal and smooth lifting of the anatomical structure for withdrawal.

[0020] At the distal part of the wall of the intervention unit 2, directly below the anatomical tip 4, a multi-dimensional intervention opening 5 is provided, which constitutes a dedicated field where the surgeon can selectively perform arterial ligation and mucosal fixation. Arterial ligation can be performed through the first section 5', which is shaped as a wider opening extending along the wall of the intervention unit 2, and its longer dimension extends in the circumferential direction of the intervention unit 2. Mucosal fixation can be performed through the second section 5'' of the intervention opening 5, which is generally rectangular, and its larger dimension extends in the direction of the longitudinal axis Y of the intervention unit 2.

[0021] The two pressure relief slits 11 are preferably located on the front wall of the proximal part of the intervention unit 2, on the left and right sides 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 defined portion 8 between the pressure relief slits 11, since this area is not fixed to the base 15 of the intervention unit, as shown in the enlarged view of FIG. 6. Thus, the wall portion 8 between the two slits 11 has the form of a flexible biasing bar 8 that enables the surgeon to easily lock and unlock the alignment button 9 during the intervention. By unlocking the alignment button 9 to effect longitudinal movement of the intervention unit 2 along the alignment track 14 of the control unit 3, the surgeon can select the most appropriate level, e.g., a low level, a medium level, or a high level, as shown in FIGS. 2, 3, and 4 respectively, to accurately position the intervention opening 5 relative to the dentate line, which normally functions as an anatomical reference point, taking into account the patient's anatomical characteristics. The core body of the control unit 3 is transparent, thus providing the surgeon with optimal visual conditions for identifying the position of the anatomical reference point.

[0022] However, as an alternative form, the number of holes 10 anticipated in the control unit 3 may be three or more if it is more appropriate for the patient's needs considering the patient's anatomical structure, thereby enabling more axial positions between the intervention unit 2 and the control unit 3.

[0023] To enable angular direction changes of the intervention opening 5, the surgeon performs the same locking and unlocking operation, applies slight pressure to the wall portion 8 to unblock the button 9, and slides the button 9 circumferentially within the alignment groove 18 of interest until the intervention unit 1 reaches the desired angular position relative to the control unit 2 and the patient's body.

[0024] By changing the angular direction of the intervention opening 5, the surgeon can selectively access the abdominal area of ​​interest as required by the procedure sequence. During pivoting movement of the intervention unit within the control unit, the alignment button 9 can engage with one of several, preferably six but not limited to, alignment cavities 19 arranged at a distance of 60° from each other along the circumference. In this way, the two units 2 and 3 maintain a constant and reliable relative angular direction and the direction of the intervention opening 5 at the position selected by the surgeon. Advantageously, the suture support 16 shown in the enlarged detail view of Figure 6 is incorporated into the front section of the base 15 of the intervention unit 2, which forms a bridge 15' over the wall 8 of the intervention unit 2 between the pressure relief slits 11.

[0025] The suture support 16 helps the surgeon perform the suture under optimal conditions by keeping the proximal end of the suture out of his / her field of view when not needed, or by tightening the suture as desired by the surgeon.

[0026] Advantageously, the outer wall surface of the distal portion of intervention unit 2 is patterned like sharkskin 7 in the wall section behind the intervention opening.

[0027] The control unit 3 comprises a cylindrical transparent core, a frustoconical distal section 3', and a base 12 formed like a ring structure, and advantageously has a handle 21 extending radially from the base 12 for better gripping of the control unit 3. Three elliptical holes 17 are provided in the base 12, which are not mandatory but preferably to secure the control unit 3 to the patient's body with sutures to prevent accidental movement during intervention and to allow the surgeon to perform the procedure autonomously.

[0028] The six orientation marks 20 at the bottom of the base 12 are an orientation aid for surgeons, indicating the position where the alignment buttons 9 of the intervention unit 2 should contact the alignment cavities 19, which are evenly distributed along each of the three alignment grooves 18.

[0029] Advantageously, the two handles 13 and 14 are fixed to both sides of the base 15 of the intervention unit 2 and oriented at an angle slightly away from the rear of the patient.

[0030] The unique features of the anoscope 1 of the present invention described above offer several advantages over other known anoscopes, in addition to the advantages already mentioned above.

[0031] The anatomical tip 4, with its double-curved design and closed apex, provides optimal visibility over the area where the intervention is performed by preventing access of tissue or feces to the internal space of the anoscope. It also facilitates the smooth physical lifting of prolapsed tissue during insertion of the anoscope 1 and provides a support platform for anatomical structures surrounding the distal portion of the intervention unit 2 during surgical or medical interventions. The multidimensional intervention opening 5 on the anterior wall of the anoscope frames areas 5' and 5'' where clinicians can selectively perform arterial ligation and / or mucosal fixation, providing surgeons with optimized conditions for manipulating instruments used during interventions, improving suture quality along each row while performing superficial and / or deep passages with needles. Patterned surfaces like Sharkskin 7 enhance support and promote the uniform distribution of extruded tissue that makes direct contact with the wall of intervention unit 2 in each region. The two handles 13 and 14 allow the surgeon to easily grasp and hold the intervention unit 2 while manipulating the anoscope during the procedure. The frustoconical distal section 3' of the control unit 3 is attached like a sleeve over the anatomical tip 4 of the intervention unit, providing stability during insertion of the control unit 3 into the anal canal. The positioning and alignment structure allows surgeons to easily select the height and angular position of the intervention opening 5, giving the anoscope a wider field of use when performing interventions.

[0032] The height-adjustable capability of the anoscope 1 allows clinicians to compensate for anatomical differences arising from the patient's physique or characteristics, promoting minimally invasive management of anorectal diseases under optimal conditions while implementing non-resectable treatment strategies. The transparent body of control unit 3 allows clinicians to view the dentate line and use it as an anatomical reference point when determining the appropriate level on the dentate line where intervention should be performed. By providing an anatomical tip 4 formed by a double-curved closing apex, it is possible to smoothly lift the protruding tissue during device insertion and to provide a support platform for the anatomical structures surrounding the distal end of the intervention unit 2 during the intervention. The two pressure relief slits 11 within the intervention unit 2 enhance the elasticity of the device walls, allowing the clinician to safely and easily operate the height-adjustable structure within the control unit 3 by activating the alignment button 9 on the intervention unit 2. The feature 16 used as a suture support allows the surgeon to keep the lower end of the suture out of sight when not needed, or to tighten the suture as desired by the surgeon, enabling the suturing to be performed under optimal conditions.

[0033] Furthermore, other advantages of the apparatus according to the present invention include maximizing patient safety, providing an opportunity to reduce the overall cost of the procedure compared to the use of Doppler induction technology, and minimizing the surgeon's reliance on OR assistance.

[0034] The anoscope of the present invention also enhances the clinical effectiveness of treatment means for high-risk patients (e.g., patients receiving anticoagulant therapy, patients with comorbidities) or patients requiring corrective treatment when tertiary treatment techniques have failed to produce the expected results.

[0035] The present invention is described in detail as a medical device for therapeutic procedures on humans. It will be readily apparent to those skilled in the art that it can also be applied to veterinary procedures. The anoscope is disclosed as a disposable device, in this case manufactured from a synthetic resin, but it will be apparent that it can be manufactured from a more durable material, such as a metal or other suitable material that can be re-sterilized for several uses, without departing from the scope of the present invention.

Claims

1. A medical device (1) designed to access the human anal canal and lower rectum, It includes an elongated cylindrical intervention unit (2) having a first length, and an elongated cylindrical control unit (3) having a first distal open end and a first proximal open end, and having a second length shorter than the first length, The intervention unit (2) and the control unit (3) are separate components, and define a common longitudinal axis Y. The intervention unit (2) is axially positioned inside the control unit (3) and is slidable within the control unit (3) in a direction parallel to the common longitudinal axis Y and in a rotational direction about the common longitudinal axis Y. The intervention unit (2) is A second distal end and a second proximal end, wherein the second distal end is closed by a rounded apex (4) and the second proximal end is open, A first body located midway between the second distal end and the second proximal end, Designed to allow selective observation and access to the anatomical structures of the lower rectum and anal canal, the multidimensional opening (5) is located in the wall of the first body near the second distal end (4) and extends in a direction perpendicular to the common longitudinal axis Y, wherein the multidimensional opening (5) includes a first section (5') having a wider opening in the transverse direction with respect to the common longitudinal axis Y, and a second section (5'') having a longer dimension in the direction of the common longitudinal axis Y. The medical device has a fixing mechanism (8, 9, 10, 11, 19) which is characterized in that it can prevent and release sliding between the intervention unit (2) and the control unit (3) in a direction parallel to the common longitudinal axis Y and in a rotational direction about the common longitudinal axis Y at several axial and angular positions of the intervention unit (2) relative to the control unit (3). The fixing mechanism is a height-adjustable mechanism and includes a button (9) positioned on a flexible bar (8) on the outer surface of the first body of the intervention unit (2), the button entering into one of a plurality of holes (10) provided in the control unit (3), these holes being spaced apart from each other along an alignment track (14) extending along a plane YZ, and including a plurality of circumferential grooves (18) located on the inner surface of the control unit (3), the medical device (1).

2. The medical device according to claim 1, wherein the rounded top portion (4) is joined to the first body of the intervention unit (2) by a surface (6) having double curvature with opposite signs.

3. The medical device according to claim 1 or 2, wherein the control unit (3) is made of at least partially transparent material.

4. The medical device according to claim 1 or 2, wherein the multidimensional opening (5) is composed of a first section (5') and a second section (5''), and the first section (5') and the second section (5'') have different perimeters and shapes from each other.

5. The medical device according to claim 1 or 2, wherein the intervention unit (2) has a pair of slits (11) in the wall, thereby creating the flexible bar (8).

6. A support (16) for sutures is fixed to the base (15) of the intervention unit (2) according to claim 1 or 2.

7. The medical device according to claim 1 or 2, wherein the control unit (3) has a base (12) having a hole (17) that can be sutured to the rear of the patient.

8. The medical device according to claim 1 or 2, wherein the medical device is a height-adjustable anoscope.

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