Medical device

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. This is generally a tubular device inserted into the anal canal, which expands the anatomical structure up to the lower rectum. This enables the clinician to obtain the best possible view of the anatomical structures 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-excisional procedures (primary or secondary treatment), or secured intervention (tertiary treatment) in severe cases that require partial or total resection.

[0004] Hemorrhoids are cushion-like clusters of arteriovenous networks and elastic connective tissue located under the mucosa covering the innermost 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 resting pressure of the anal canal. Hemorrhoid disease, also known as 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 lead to 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 function of blood vessels and muscles and prolapse of the anorectal structure.

[0007] An anoscope is basically a tubular structure that opens at the proximal end (the tip that is proximal to the physician or surgeon) and includes openings at the distal end, on the sidewalls, or both. Commercially available anoscopes are made of metal or metal alloy, called the durable version, or of synthetic materials, known as disposable or disposable anoscopes, such as the anoscope shown in FIG. 1. However, such anoscopes do not provide optimal conditions when the surgeon wants to perform mucosal fixation and arterial ligation along multiple rows (which are essential for all techniques of secondary treatment), and have several drawbacks such as no height adjustment function, so that the height of the device has to be kept much more constant during the procedure. Furthermore, it requires hand assistance during the procedure, unnecessarily increasing the number of OR personnel required for the intervention. The geometric shape of the openings on the sidewalls of this anoscope does not provide optimal visual conditions for the anatomical structure of the area of interest to the surgeon, and it may be difficult for the surgeon to manipulate the needle during suturing.

[0008] In addition to the above drawbacks of the state-of-the-art, the current needs of the major stakeholder groups (such as healthcare providers, patients, health insurance companies), and the issues related to the various treatment means and devices involved in the management of symptomatic internal hemorrhoids (patient safety, risks related to resection techniques, hospitalization period and postoperative recovery period, limited clinical application and learning curve (the time required to reach the proficiency stage, especially related to complex devices such as Doppler-guided systems), the total cost of each treatment) cannot be ignored. SUMMARY OF THE INVENTION

[0009] Accordingly, a 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 eliminate the above-mentioned drawbacks and solve the problems according to claim 1. The medical device includes an elongated cylindrical intervention unit having a first length, and an elongated cylindrical control unit 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 and the control unit are separate components, define a common longitudinal axis, and the intervention unit is axially disposed inside the control unit and is slidable with respect to the control unit in a direction parallel to the common longitudinal axis and in a rotational direction about the common longitudinal axis inside the control unit. The intervention unit has a second distal end and a second proximal end, the second distal end being closed by a rounded top and the second proximal end being open, a first body intermediate the distal end and the proximal end, an aperture located in a transverse wall close to the distal end, and a fixing mechanism between the intervention unit and the control unit capable of preventing and releasing longitudinal axial sliding and rotational circumferential sliding at several axial and angular positions of the intervention unit with respect to the control unit.

[0010] The anoscope of the present invention, by virtue of certain features, enables a surgeon to perform transanal minimally invasive non-excisional 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 by virtue of their interface connection capabilities.

[0011] The interface and height adjustment mechanism are housed by the transparent core body of the control unit, thereby enabling the surgeon to adjust the height of the anoscope to eliminate anatomical differences due to the patient's build or nature by facilitating smooth alignment at three levels (low, medium, high) as shown in Figures 2, 3, and 4 between the intervention unit and the anatomical structures selectively accessed during the intervention. The multi-dimensional design of the intervention opening of the intervention unit has dedicated fields for selectively performing arterial ligation using a section of the intervention opening having a wide opening along a transverse direction with respect to the longitudinal axis, and for performing submucosal fixation using a section of the intervention opening having a longer dimension in the direction of the longitudinal axis of the anoscope.

Brief Description of the Drawings

[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

Figure 2

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Figure 4

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Figure 8

Figure 9

Figure 10

[0014] The same reference numerals in different figures refer to the same components.

Best Mode for Carrying Out the Invention

[0015] The present invention will be better understood by reading the following description of the preferred embodiments of the medical device, which is also defined as an anoscope according to the present invention. Referring to the drawings, the anoscope of FIG. 2, generally designated by reference numeral 1, is substantially cylindrical and has a longitudinal axis parallel to the Y-axis of the X, Y, Z orthogonal coordinate system, and is a height-adjustable device including two different components. The first component is the intervention unit 2, and the second component is the control unit 3. The components 2 and 3 of the anoscope 1 function as a system centered around their interface connection ability provided by an alignment button 9 located on the outer surface of the wall at the proximal portion 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 the generatrix in the plane YZ, which enables the insertion of the intervention unit 2 into the control unit 3 and the 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 by 360° 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 buttons 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 domed 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 positive-to-negative change in the rate of change of the angle at which the tangent to the curve rotates when moving along the curve. 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 during withdrawal.

[0020] At the distal portion of the wall of the intervention unit 2, directly below the anatomical tip 4, a multi-dimensional intervention opening 5 is provided that 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 access unit 2 and are positioned on the left and right sides of the alignment button 9 with respect to the longitudinal axis of the access unit 2. These slits 11 are provided to enhance the elasticity and biasing capacity of the wall of the access unit 2 in the defined portion 8 between the pressure relief slits 11, since this region is not fixed to the base 15 of the access 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 access unit 2 along the alignment track 14 of the control unit 3, the surgeon can, taking into account the patient's anatomical characteristics, select the most appropriate level, for example, a low level, a medium level, or a high level, as shown in FIGS. 2, 3, and 4 respectively, in order to accurately position the access opening 5 relative to the dentate line, which usually functions as an anatomical reference point. Since the core body of the control unit 3 is transparent, it provides 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 taking into account the patient's anatomical structure, thereby enabling more axial positions between the access unit 2 and the control unit 3.

[0023] To enable angular orientation changes of the access opening 5, the surgeon performs the same locking and unlocking action, 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 access 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 access opening 5, the surgeon can selectively access the abdomen of interest as required by the treatment sequence. In the pivoting movement within the control unit of the intervention unit, the alignment button 9 can engage one of a plurality of, preferably six but not limited to this, 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 their relative angular direction and the direction of the access opening 5 constant and reliably at the position selected by the surgeon. Advantageously, the thread support 16 shown in the enlarged detail view of FIG. 6 is incorporated into the front section of the base 15 of the intervention unit 2, and the front section forms a bridge 15' on the wall 8 of the intervention unit 2 between the pressure relief slits 11.

[0025] The thread support 16 helps the surgeon keep the proximal end of the thread out of his / her field of vision when not needed or to tighten the thread as desired by the surgeon to perform suturing under optimal conditions.

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

[0027] The control unit 3 has 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 to better grip the control unit 3. Three preferably elliptical holes 17, although not essential, are provided in the base 12 to fix the control unit 3 to the patient's body by sutures to prevent accidental movement during the intervention and to enable the surgeon to perform the treatment autonomously.

[0028] The six orientation marks 20 at the bottom of the base 12 are orientation aids for the surgeon, indicating the positions where the alignment buttons 9 of the intervention unit 2 contact the alignment cavities 19 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 are oriented at an angle slightly away from the rear of the patient.

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

[0031] The anatomical tip 4 with the complex-curved design and the closed top provides optimal visualization over the area where the intervention is performed by preventing tissue or feces from accessing the internal space of the anoscope. It also facilitates the smooth physical lifting of prolapsed tissue during the insertion of the anoscope 1 and provides a support platform due to the anatomical structure surrounding the distal part of the intervention unit 2 during surgical or medical intervention. The multi-dimensional intervention opening 5 on the front wall of the anoscope frames the areas 5' and 5'' where the clinician selectively performs arterial ligation and / or mucosal fixation, providing optimized conditions for the surgeon to manipulate the instruments used during the intervention, improving the quality of the suture along each row while performing shallow and / or deep passages with a needle. The patterned surface such as the sharkskin 7 enhances the support and promotes the uniform distribution of the prolapsed tissue that comes into direct contact with the wall of the intervention unit 2 in each area. The two handles 13, 14 enable the surgeon to easily grasp and hold the intervention unit 2 while operating the anoscope during the procedure. The frustum-shaped distal section 3' of the control unit 3 is attached like a sleeve over the anatomical tip 4 of the intervention unit, providing stability while inserting the control unit 3 into the anal canal. The positioning and alignment structure enables the surgeon to easily select the height and angular position of the access opening 5, and provides a wider field of use for the anoscope when performing the intervention.

[0032] The height adjustability of the anoscope 1 enables the clinician to eliminate anatomical differences caused by the patient's physique or nature, promotes minimally invasive management of anorectal diseases under optimal conditions while implementing non-excision treatment strategies, The transparent body of the control unit 3 enables the clinician to use the dentate line as an anatomical reference point when viewing the dentate line and determining the appropriate level above the dentate line where the intervention is to be performed. By providing the anatomical tip 4 formed by the complexly curved closed top, it enables smooth physical lifting of the prolapsed tissue during insertion of the device, and provides a support platform for the anatomical structure surrounding the distal end of the intervention unit 2 during the intervention. The two pressure relief slits 11 in the intervention unit 2 enhance the elasticity of the wall of the device, enabling the clinician to safely and easily manipulate the height adjustment structure in the control unit 3 by actuating the alignment button 9 of the intervention unit 2. The feature 16 used as a thread support enables the surgeon to keep the lower end of the thread out of the field of view when not needed, or to tighten the thread as desired by the surgeon, enabling suturing to be performed under optimal conditions.

[0033] Furthermore, other advantages of the device according to the present invention are to maximize patient safety, provide an opportunity to reduce the overall cost of the treatment compared to the use of Doppler-guided techniques, and minimize the surgeon's dependence on OR support.

[0034] The anoscope of the present invention also enhances the clinical effectiveness of the treatment means for high-risk patients (e.g., patients undergoing anticoagulant therapy, patients with coexisting diseases) or patients who require corrective treatment when the expected results of the tertiary treatment technique could not be achieved.

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

Claims

1. A medical device (1) designed to access the human anal canal and lower rectum, comprising 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, wherein 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 disposed inside the control unit (3) and is slidable with respect to 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 inside the control unit (3), the intervention unit (2) has a second distal end and a second proximal end, wherein the second distal end is closed by a rounded top (4) and the second proximal end is open, a first body intermediate the second distal end and the second proximal end, is designed to selectively observe and access the anatomical structure of the lower rectum and anal canal, and has a multidimensional opening (5) laterally located in a wall close to the distal end (4), and a fixing mechanism (9, 10) capable of blocking and unblocking the sliding of the intervention unit (2) with respect to 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) with respect to the control unit (3). A medical device (1).

2. The medical device according to claim 1, wherein the rounded top (4) is joined to the first body of the intervention unit (2) by a surface (6) having a double curvature of 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 any one of claims 1 to 3, wherein the opening (5) is constituted by two regions (5', 5'') having different circumferences and shapes.

5. The medical device according to any one of claims 1 to 4, wherein the fixing mechanism is disposed on a flexible portion (8) on the outer surface of the first body of the intervention unit (2) and includes a button (9) that enters one of a plurality of holes (10), and the holes are formed in the control unit (3) and are aligned along a vertical alignment track (14) spaced apart from each other. **Claim 6** The height-adjustable mechanism includes a plurality of circumferential grooves (18) located on the inner surface of the control unit (3), and the medical device according to any one of claims 1 to 5. **Claim 7** The intervention unit (2) has a pair of slits (11) in the wall, whereby a flexible bar (8) is created, and the medical device according to any one of claims 1 to 6. **Claim 8** A support (16) for sutures is fixed to the base (15) of the intervention unit (2), and the medical device according to any one of claims 1 to 7. **Claim 9** At least a part of the surface (7) of the body of the intervention unit (2) is patterned as sharkskin, and the medical device according to any one of claims 1 to 8. **Claim 10** The control unit (3) has a base (12) having a hole (17) through which an anoscope can be sutured to the patient's posterior part, and the medical device according to any one of claims 1 to 9. **Claim 11** The medical device is an anoscope, and the medical device according to any one of claims 1 to 10.

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