Apparatus and method for creating a channel in soft tissue

Abstract

Medical devices and methods are described for removing a predetermined shape of soft tissue from a target tissue layer, leaving a matching passage having a predetermined geometry and orientation in the target tissue layer. The medical devices include coaxial outer and inner elongate members extending along an axis X; the outer member includes an open distal end and a first distal portion configured for piercing the target tissue layer during forward axial movement; the inner member includes a second distal portion configured to rotate and protrude distally through the open distal end to cut the predetermined shape of soft tissue from the target tissue layer and create the passage, which forms a hole across the target tissue layer.

Description

[0001] This application is a divisional application of PCT international patent application No. 201880020473.4, filed on April 9, 2018, entitled "Apparatus and method for generating channels in soft tissue". Technical Field

[0002] This invention belongs to the medical field, and specifically relates to surgical devices, and more particularly to miniature surgical cutting tools. Background Technology

[0003] In various situations (including for diagnostic or therapeutic purposes), there is a request to remove tissue from the body. For example, during a biopsy, a tissue specimen small enough to be examined outside the body is obtained. Often, the shape of the specimen or the cavity left at the site of tissue removal is of little or no importance, and the body heals from the injury without leaving a noticeable scar. In another instance, such as in glaucoma (where intraocular pressure is too high), tissue is removed to create a pathway for draining excess fluid.

[0004] Several surgical procedures are performed to treat glaucoma and / or elevated intraocular pressure (IOP). Filtering surgery involves accessing the inner layer of the eye to create a drainage channel under the conjunctiva from the anterior chamber to the outer surface of the eye, allowing aqueous humor to seep into the filtering bleb and be slowly absorbed therefrom. Depending on whether intraoperative entry into the anterior chamber occurs, filtration surgery is classified as penetrating or non-penetrating. Scar formation at the surgical site can obstruct aqueous humor circulation. Surgical adjunctive therapies can be used to promote the regeneration of healthy tissue and maintain the function of the created drainage channel.

[0005] The trephine technique for producing an internal scleral stoma was reported by Brown et al. (Brown RH, Lynch MG, Denham DB et al. Internal sclerectomy with an automated trephine for advanced glaucoma. Ophthalmology 1988; 95:728–734) and by Shihadeh et al. (Wisam A. Shihadeh, MD, Robert Ritch, MD, Jeffrey M. Liebmann, MD. Rescue of failed filtering blebs with an interno trephination. Cataract Refract Surg 2006; 32:918–922) as a method to perform filtering surgery while maintaining the integrity of the overlying conjunctiva at the treatment site after other surgical failures due to obstruction. Summary of the Invention

[0006] This invention provides a new technique for removing tissue from the body. The technique is particularly effective and useful for the controlled removal of soft tissue, for example, by creating well-defined, timely controlled channels within the tissue. The technique also provides the ability to verify the creation and size of the channels by retrieving and preserving the shape of the removed tissue without the use of external verification techniques (such as imaging). It should be noted that, as used herein, “channel” refers to a pathway created in the tissue after the removal of a corresponding tissue block from the body. No components (such as one or more implants) remain in the body, thus creating or maintaining the integrity of the channel. Other expressions used interchangeably herein are “pore,” “void,” and “pathway.” Specifically, the unique technique allows for the controllable creation of channels in one or more adjacent target tissue layers that are part of a multi-layered tissue structure, while preserving one or more tissue layers covering / before and / or after the target tissue layer. Additionally, the unique technique provides online feedback to the user by verifying the volume and shape of the removed tissue, which relates to the success of the channel creation process. The length and / or diameter of the removed tissue (e.g., having a cylindrical shape) matches / approximates the length and / or diameter of the created channel. Minimize the deformation applied to the removed tissue to make it as close as possible to its original length and / or diameter, thereby providing improved and better real-time feedback.

[0007] It should be noted that, as used herein, the term "tissue layer" can refer to a single tissue layer or a group of layers, such as adjacent stacked layers (multiple layers) or a group of different layers. However, typically, a single tissue layer is the default meaning. Moreover, "tissue layer" usually refers to a tissue wall with a specific thickness and two sides (outer and inner, or proximal and distal), such that the channels / pores created therein extend between the two sides of the tissue wall.

[0008] For example, a channel could be a channel in the sclera-cornea junction of a subject's eye, which could be used to treat glaucoma by reducing intraocular pressure through providing fluid communication between the anterior chamber of the eye and the interface between the outer layer of the sclera and the conjunctival tissue.

[0009] In the literature described above (Brown et al. and Shihadeh et al.), the internal trephine technique involves invasively introducing a surgical device into the anterior chamber of the eye through an incision formed in the cornea opposite to the site of channel creation. This procedure is highly demanding, relying heavily on the surgeon's expertise and the ability to accurately visualize the surgical device's path within the anterior chamber, parallel to the iris, as a filtering angle. Unless an additional gonioscope is used, this procedure carries risks to vital organs such as the iris and lens, as well as angular structures that cannot be directly observed. Even glaucoma surgeons rarely use this intraoperative gonioscope.

[0010] In contrast, this invention provides a safe, minimally invasive (external approach) and extremely fast (approximately a few seconds) and highly efficient technique. Therefore, this invention offers the possibility of performing combined surgeries by combining several surgical procedures (e.g., combining high intraocular pressure treatment according to the invention with cataract surgery), thereby saving time and effort for both surgeons and patients.

[0011] Although the invention is advantageous in its external applications as described above, the device of the invention can also be safely and effectively used in internal processes because, as will be further detailed below, the device includes an external portion that acts as a protector, which, when used in an internal configuration, is configured to protect organs of the eye, including internal organs (such as the iris).

[0012] At different locations in the body, the target tissue in which the channel must be created must be located beneath or before one or more other tissues. In such cases, the challenge is even greater, as damage to one or more surrounding or adjacent tissues must be avoided. One example is creating a channel in the sclera while preserving the integrity of the conjunctiva. In external applications, the medical device of the present invention is configured to optimize long-range penetration through an external first tissue (e.g., the conjunctiva) and then cut through an internal second tissue (e.g., the sclera) to create a channel, while applying the minimum possible force so that the hole formed in the superior tissue (conjunctiva) heals almost immediately without scarring. On the other hand, in internal applications, the device, when actually inserted into the anterior chamber of the eye, is constructed and modulated to ensure no damage to other organs, including the external conjunctiva, while creating a channel from within the scleral tissue.

[0013] Furthermore, the medical device of the present invention is configured for easy automatic or semi-automatic operation, reducing the burden on the surgeon and providing continuous feedback throughout the surgical procedure. The technology of the present invention helps the surgeon safely position the device within the tissue to be cut, while still allowing him / her to control the three-dimensional orientation of the channel.

[0014] Furthermore, the device of the present invention can incorporate authentication or verification features by retaining the form / sample of tissue removed from the body during channel generation. The shape of the cutting tool of the device also provides enhanced capture of the removed tissue within the cutting tool and prevents or minimizes the possibility of leaving the removed tissue within tissue walls (such as the eye wall).

[0015] For example, the channel created by the technique of this invention is advantageous compared to other techniques that leave one or more implants within the tissue to ensure fluid drainage, because nothing remains in the tissue except for the created void / hole / channel extending between two sidewalls of a specific target tissue layer or multiple layers (as the case may be). In other words, the created channel is a hole through the tissue, with no artificial tube / shunt remaining within the target tissue. Therefore, the created channel can be dynamically used as a pressure regulator, i.e., its drainage capacity can be adjusted by changing its size based on the pressure acting on its two ends. When the pressure gradient increases, the channel opens / increases its size accordingly, and when the pressure gradient decreases, the channel closes / decreases its size accordingly.

[0016] The size range of the channel can be controlled by the geometry and size of the device that generates the channel. In specific instances of generating a channel in the eye wall to treat elevated IOP, for example, the present invention is advantageous for achieving channel generation and verification at a microscale, since the desired size of the discharge channel is typically a diameter of about 0.1 mm to 0.2 mm and a length of 1 mm to 1.5 mm, assuming the channel and the matching removed tissue are substantially cylindrical. The present invention achieves the above-mentioned objective at the microscale while overcoming the limitations of currently available techniques. Available techniques are particularly suitable for producing tools with a tissue receiving cavity having a length of at most about 0.5 mm and the required diameter mentioned above. However, this is not suitable for forming a substantially cylindrical channel with a length of 1.5 mm within the eye wall. The technique of the present invention enables the generation of cutting tools with the desired microscale dimensions in diameter and length, thereby allowing the shape of the removed tissue to be preserved for verification of channel generation.

[0017] Typically, the medical device of the present invention is configured to operate in three distinct phases: a positioning phase, characterized by the device advancing substantially linearly along its linear longitudinal axis through one or more tissue layers until reaching the target tissue and being stabilized within the target tissue by an anchoring / insertion portion of the device's external portion; a penetration phase, during which an internal rotatable cutting tool of the device rotates about its linear longitudinal axis of rotation and then advances to protrude from the external portion of the device and advance within the target tissue to cut the tissue of the target tissue and create a channel with desired dimensions (diameter, cross-sectional area, length, etc.); and an extraction phase, during which the internal rotatable cutting tool is extracted from the target tissue into the external portion of the device and the entire device is retracted from the body. The extraction phase can be performed with or without rotation of the internal rotatable cutting tool, depending particularly on tissue characteristics (type, stiffness, in vivo region), operating time, and desired channel shape. Typically, the external portion does not rotate during any of the phases; it moves only straight forward and backward along the linear longitudinal axis of the device. Typically, the outer portion acts as a protective shaft, protecting the surrounding tissue during device advancement until reaching the target tissue, and also acts as a stabilizing portion, allowing its front (distal) portion to insert / anchor / pierce into the target tissue during the penetration phase to achieve stable activation and performance of the internal rotatable cutting tool.

[0018] Therefore, according to a broad aspect of the invention, a medical device is provided for removing soft tissue of a predetermined shape from a target tissue layer, thereby leaving a matching channel with a predetermined geometry and orientation between two sidewalls of the target tissue layer, the device comprising a coaxial outer elongated member and an inner elongated member extending along an axis X.

[0019] The external member includes an open distal portion and a first distal portion, the first distal portion being configured to penetrate the target tissue layer (or multiple layers) during forward axial movement;

[0020] The internal component includes a second distal portion configured to rotate and protrude distally through the open distal portion to create the channel from the target tissue layer of soft tissue of a predetermined shape, the channel being formed as a hole through the target tissue layer or multiple layers.

[0021] In some embodiments, the first distal portion is configured to penetrate at least one other tissue layer prior to the target tissue layer during the forward axial movement.

[0022] In some embodiments, the first distal portion includes: a tissue puncture tip at its distal end, the tissue puncture tip being configured and operable to penetrate the at least one other tissue layer and the target tissue layer; and a proximal portion at its proximal end, the proximal portion being configured and operable to penetrate the at least one other tissue layer and stop at the target tissue layer, thereby inserting the external member into the target tissue layer.

[0023] In some embodiments, the first distal portion has an intermediate portion between the tip and the proximal portion, the intermediate portion having a shape and orientation complementary to the shape and orientation of the second tissue layer.

[0024] In some implementations, the first distal portion has a predefined length such that the tip does not extend distally from the target tissue layer.

[0025] In some embodiments, the proximal portion is the edge of the outer member, formed by cutting segments of the wall of the outer member along the axis X.

[0026] In some embodiments, the inner member is fixedly attached to and housed within the outer member during the forward axial movement of the outer member.

[0027] In some embodiments, the external member is manually moved during the forward axial movement until it penetrates the second tissue layer.

[0028] In some implementations, the internal component is manually moved along the axis X during rotation to create the channel.

[0029] In some embodiments, the device includes a constant force movement mechanism configured and operable to move the internal member along the axis X under the action of a constant force during rotation. In some embodiments, the device includes a constant rate movement mechanism configured and operable to move the internal member along the axis X at a constant rate during rotation.

[0030] In some embodiments, the device includes an electric motor configured and operable to cause axial movement and / or rotation of the internal components.

[0031] In some embodiments, the device includes a cavity for collecting tissue cut from the target tissue layer during the creation of the channel. In some embodiments, the cavity is located within the inner member. In some embodiments, the cavity is located within the space between the inner member and the outer member.

[0032] In some embodiments, the second distal portion of the internal member is open at its distal end and includes a circular cutting edge configured to attach to and cut soft tissue upon rotation. The internal member may include a chamber for preserving the intact shape of the tissue cut from the second tissue layer during the creation of the channel.

[0033] In some implementations, the internal component includes:

[0034] - An elongated circular body, which extends along a longitudinal axis and has a uniform outer diameter near its proximal side.

[0035] - A cutting portion, located distal to the elongated body, comprising a circular cutting edge at its distal end with a first diameter smaller than the outer diameter, and including an outer diameter that decreases distally.

[0036] A cavity extending from the cutting portion within the cutting tool along the longitudinal axis, the cavity having dimensions that match the shape of the soft tissue.

[0037] The tissue is cylindrical and has a length of about 1.5 mm and a diameter between about 0.1 mm and about 0.2 mm.

[0038] In some implementations, the internal component includes:

[0039] - An elongated circular body, which extends along a longitudinal axis and has a uniform outer diameter near its proximal side.

[0040] - A cutting portion, located distal to the elongated body, comprising a circular cutting edge at its distal end with a first diameter smaller than the outer diameter, and including an outer diameter that decreases distally.

[0041] A cavity extending from the cutting portion within the cutting tool along the longitudinal axis, the cavity having a length at least the length of the tissue being removed.

[0042] The cavity has a diameter that is smaller at the distal end of the cavity than the first diameter and increases toward the proximal end of the cavity.

[0043] In some implementations, the internal component includes:

[0044] - An elongated circular body, which extends along a longitudinal axis and has a uniform outer diameter near its proximal side.

[0045] - A cutting portion, located distal to the elongated body, comprising a circular cutting edge at its distal end with a first diameter smaller than the outer diameter, and including a diameter that decreases distally.

[0046] A cavity extending from the cutting portion within the cutting tool along the longitudinal axis, the cavity having a length at least the length of the tissue being removed.

[0047] The cavity has a constant cavity diameter equal to the first diameter, and the first diameter is between about 0.1 mm and about 0.2 mm.

[0048] In some embodiments, the internal member includes a tissue trap comprising a slit formed in the wall of the body of the internal member along at least a portion of the cavity. In some embodiments, the slit is formed by tangentially cutting the wall of the body of the internal member, and the device therefore also includes an outer cavity located between the internal member and the outer member. In some embodiments, the slit is formed by radially cutting the wall of the internal member.

[0049] In some embodiments, the second distal portion of the internal member is configured as a drill bit for removing soft tissue.

[0050] In some implementations, the rotation of the second distal portion includes clockwise and counterclockwise reciprocating movements.

[0051] In some implementations, the tissue puncture tip is configured as a lancet.

[0052] In some embodiments, the first distal portion of the external member is formed by cutting the external member along a curve in the direction of the axis X, the curve being selected to provide smooth penetration at the distal segment of the first distal portion and increased forward resistance at the proximal segment of the first distal portion.

[0053] In some embodiments, the at least one other tissue layer includes the conjunctiva and / or tendons, and the target tissue layer is the outer sclera and / or sclera and / or cornea of ​​the eye.

[0054] In some implementations, the predetermined geometry of the channel is selected to enable pressure modulation of the treated eye over a predetermined time period.

[0055] According to another broad aspect of the invention, a method is provided for producing a cutting tool for cutting soft tissue, the cutting tool comprising: a distal cutting portion having a circular cutting edge of a first diameter at its distal end; and a cavity extending from the cutting portion along a longitudinal axis of the cutting tool for a predetermined length and including a cavity diameter that is constant along the predetermined length or increases proximally, the method comprising:

[0056] – A tool is provided, the tool comprising, at its distal end, a hollow cylinder having a uniform outer diameter and an inner diameter and extending along at least the predetermined length, wherein the inner diameter is larger than the first diameter.

[0057] – The distal portion of the hollow cylinder is shaped into a predetermined pattern, such that both the inner and outer diameters decrease towards the distal end of the hollow cylinder, and that at the distal end, the first diameter is larger than the inner diameter and smaller than the outer diameter.

[0058] – Remove a slice of the hollow cylinder along the distal portion such that the inner diameter at the distal end is substantially equal to the first diameter, and the inner diameter at the proximal end of the distal portion is substantially equal to the cavity diameter.

[0059] In some embodiments, the forming of the distal portion is performed by forging and / or spinning techniques.

[0060] In some implementations, the shaping of the distal portion is performed using a tapered technique.

[0061] In some implementations, the predetermined pattern is linear.

[0062] In some implementations, the predetermined pattern is non-linear.

[0063] In some implementations, the cavity diameter is equal to the first diameter.

[0064] In some embodiments, the method further includes sharpening the circular cutting edge from the inside of the cut portion, such that the cavity diameter at the proximal end of the cut portion is smaller than the first diameter. In some embodiments, the cavity diameter increases proximally.

[0065] In some embodiments, the method further includes using the inner surface of the cavity with a friction-reducing composition.

[0066] In some implementations, the predetermined length is at least 1.5 mm.

[0067] In some embodiments, the diameter of the cavity near the proximal side is between 0.1 mm and 0.2 mm.

[0068] In some embodiments, the uniform outer diameter and inner diameter of the hollow cylinder are approximately 0.3 mm and 0.16 mm, respectively.

[0069] In some embodiments, after forming, the outer diameter and inner diameter of the hollow cylinder at the distal end are approximately 0.27 mm and 0.13 mm, respectively.

[0070] In some embodiments, the distal portion of the hollow cylinder has a length along the longitudinal axis between about 1 mm and about 2 mm.

[0071] According to another broad aspect of the invention, a cutting tool is provided for removing soft tissue of a predetermined shape during rotation and forward movement, thereby leaving a matching channel between two walls of the soft tissue, the cutting tool being manufactured according to the method described above.

[0072] According to another broad aspect of the invention, a method is provided for creating a channel having a predetermined geometry in a target tissue layer, the channel being formed as a hole extending between two sidewalls of the tissue layer, the method comprising:

[0073] A device is provided that includes a coaxial outer member and an inner member, the outer member including a first distal portion configured to penetrate the tissue layer during forward axial movement, and the inner member including a second distal portion configured to cut and remove tissue to thereby create the channel;

[0074] The device is positioned at the target tissue layer by advancing the device along axis X until it reaches the target tissue layer while the inner member is inside the outer member, wherein the first distal portion of the outer member is pushed into the target tissue such that at least the distal portion of the distal portion penetrates into the target tissue layer.

[0075] The channel is created by rotating the second distal portion and causing it to protrude from the external member, thereby cutting and removing tissue from the target tissue layer and storing the removed tissue in the device.

[0076] The second distal portion is retracted proximally from the target tissue layer and into the interior of the external member; and

[0077] The first distal portion is pulled proximally from the target tissue layer, and the device is extracted from the body substantially along the axis X. Attached Figure Description

[0078] To better understand the subject matter disclosed herein, and to illustrate how the subject matter can be implemented in practice, embodiments will now be described with reference to the accompanying drawings, using only non-limiting examples, in which:

[0079] Figures 1A to 1B Non-limiting exemplary embodiments of the device according to the invention are shown;

[0080] Figures 2A to 2B Another non-limiting exemplary embodiment of the device according to the invention is shown;

[0081] Figures 3A to 3E Examples of non-limiting techniques for creating channels in soft tissue according to the present invention;

[0082] Figures 3F to 3I Another non-limiting technique according to the invention for creating channels in soft tissue is illustrated;

[0083] Figures 4A to 4D The following is a non-limiting example of a device according to an exemplary embodiment of the present invention;

[0084] Figures 5A to 5D3 A non-limiting example of a device according to the invention is shown;

[0085] Figures 5E1 to 5E7 This illustrates a non-limiting case in which a channel is created in soft tissue, and specifically in the eye wall;

[0086] Figures 5F to 5G4 Non-limiting examples of apparatus and methods for producing said apparatus according to exemplary embodiments of the present invention are shown;

[0087] Figures 6A to 6D A non-limiting example of a manually operated mechanism according to the invention is shown;

[0088] Figures 7A to 7D Another non-limiting example of the manual movement mechanism according to the invention is shown;

[0089] Figures 8A to 8D Another non-limiting example of a manual moving mechanism according to the invention is shown;

[0090] Figures 9A to 9E Non-limiting examples of the automatic movement mechanism according to the invention are shown; and

[0091] Figures 10A to 10D Another non-limiting example of an automated moving mechanism according to the invention is shown. Detailed Implementation

[0092] This invention provides a technique for creating well-defined channels in soft tissue. In one aspect, a medical device is provided for removing soft tissue of a predetermined shape from a target tissue layer (or a first set of target tissue layers) thereby leaving a matching / corresponding channel with a predetermined geometry and / or orientation between the two sidewalls of the target tissue layer. In some embodiments, such a device is particularly useful for creating drainage channels along the outer sclera and / or sclera and / or corneal tissue (for simplicity, this is generally referred to herein as the sclera) to treat hyperintraocular pressure. The sclera is covered by conjunctiva and tendon tissue, such that access to the sclera from the outside requires penetration of the conjunctiva and tendons. Therefore, the device can also be configured to penetrate the conjunctiva / tendon before reaching the sclera.

[0093] refer to Figure 1A and Figure 1B This illustrates specific, non-limiting examples of a medical device 100 according to some embodiments of the present invention.

[0094] Medical device 100 is configured to and capable of creating a channel with a predetermined geometry that penetrates one or more first upper tissue layers and passes through a successive second lower target tissue layer. Device 100 includes a coaxial outer member 110 and an inner member 120, each extending along an axis X, for creating a channel in the target tissue and potentially penetrating one or more tissue layers preceding the target tissue layer. The axis X is generally a longitudinally straight axis. The coaxial outer member 110 and inner member 120 are generally made of a rigid, tough material, and are therefore rigid and do not bend when pushed / inserted / advanced through at least soft tissue. The coaxial outer member 110 and inner member 120 are mounted on a handle / grip unit 150 at their proximal side 114P, through which a user grips / grabs and operates device 100.

[0095] The external member 110 includes an open distal side 112D, a first distal portion 112, and a first proximal elongated portion 114. It should be noted that the relative expressions “proximal” and “distal” as used herein define relative orientations with respect to the user, such that “proximal” refers to the side closer to the user, and “distal” refers to the side farther from the user. The external member 110 is configured to move axially along the X-axis, thereby penetrating soft tissue through its first distal portion 112. Axial movement of the external member 110 is achieved by manual operation by the user. When the external member 110 is manually operated by the user, it may be fixedly / securely attached to the handle 150 at the proximal side 114P. Alternatively, the external member 110 may be configured to be manually slid by the user along the X-axis without being securely attached to the handle 150. Details regarding the movement mechanism are further described below.

[0096] The first distal portion 112 is configured to penetrate and pass through one or more tissue layers (if any) preceding the target tissue layer during forward axial movement, and therefore includes a tissue puncture tip 116 at the distal end of the first distal portion 112, which achieves penetration. It should be noted that since the forward axial movement is manually controlled, penetration of the preceding one or more tissue layers (such as a relatively thin conjunctiva) is achieved by a manual thrust applied by the user and can be further facilitated by manually lifting / pulling the conjunctiva outward toward the user. The first distal portion 112 is also configured to pierce and penetrate the target (typically thicker) tissue layer in order to position the device within the target tissue in which a channel is to be created and to provide the user with key points defining the three-dimensional orientation of the channel. In addition to its common name, the first distal portion 112 may be interchangeably referred to herein as the “piercing portion,” “stabilizing portion,” or “anchoring portion.” It should be understood that when the first distal portion 112 enters and penetrates / anchors within the target tissue, it can be withdrawn posteriorly with minimal force without damaging the surrounding tissue. As used herein, penetration and / or anchoring do not imply a permanent position of the first distal portion, but rather a temporary transitional state that provides the user with a stable point of action.

[0097] The tissue puncture tip 116 formed at the most distal portion of the first distal portion 112 can be configured according to those known in the art, for example, as is done in the case of a conventional medical needle. Therefore, the tissue puncture tip 116 may include, for example, a beveled lancet structure. However, the tissue puncture tip 116 may have other configurations, as will be referred to below. Figures 4A to 4D Further description.

[0098] The first proximal elongated portion 114 is hollow, for example, a hollow tube, thereby enclosing and housing the internal member 120 therein. Typically, the first proximal elongated portion 114 has a cylindrical shape with a circular or substantially circular lateral outer cross-section. The first proximal elongated portion 114 is configured to smoothly and easily penetrate soft tissue with minimal force, therefore it may have a circular outer cross-section and be provided with a smooth (polished) outer surface to minimize friction during penetration into the tissue. The inner cross-section of the first proximal elongated portion 114 is circular or has other shapes that match the outer surface of the internal member 120 enclosing it.

[0099] The internal component 120 includes a second distal portion 122 and a second proximal elongated portion 124. The second distal portion 122 is configured to project distally through an open distal portion 112D, thereby approaching the target tissue during rotation, thereby cutting the target tissue of a predetermined shape and creating a channel with a predetermined geometry and orientation within the target tissue, while the first distal portion 112 is substantially positioned within the target tissue, as described above and referred to below. Figures 3A to 3I As further illustrated, generally, the second distal portion 122 is configured at its distal end to provide effective adhesion to the target tissue and to cut the target tissue during rotation. For this purpose, the distal end of the second distal portion 122 may be provided with a cutting edge, a punching mechanism, etc., as will be further described below.

[0100] Generally, the device 100 includes a cavity / chamber 126 configured to collect and remove tissue therein, such that no tissue remains in the body. In some embodiments, the cavity / chamber is located within a second proximal elongation 124, as in... Figure 1B As illustrated in the illustration. In some other embodiments, the cavity / chamber 126 may be located in the space between the outer member 110 and the inner member 120.

[0101] Device 100 (including handle 150) can be configured for single-use, disposable applications, thus enhancing and maintaining the safety and sterility of the device. Handle 150 can be configured as described in PCT / IL2016 / 051063 assigned to the assignee of this invention.

[0102] The moving mechanism 140 is configured to achieve both forward (distal) and backward (proximal) axial movement of the outer member 110, and axial and rotational movement of the inner member 120. The moving mechanism 140 may have manual (by user) and / or automatic (using mechanical and / or electrical devices, such as springs and / or motors) operating modes for each of its capable movements. The rotational movement of the inner member 120 may be performed in a full or partial circle or rotation, and may be clockwise and / or counterclockwise and / or reciprocating.

[0103] The construction and size of the device can be customized to match the application, tissue properties, and the anatomy and morphology of the body part in which the channel is created.

[0104] For example, if used to create an drainage channel in the human eye, the dimensions of the device could be as follows:

[0105] The outer diameter of the external component is selected to allow for smooth and safe penetration into and withdrawal from the tissue, while maintaining minimal strength so that the external component remains continuously within the tissue during operation. The outer diameter can be approximately 0.4 mm to 1.2 mm.

[0106] The overall length of the external component is selected to allow for easy and safe access to the surgical site. The overall length can be approximately 8mm-30mm.

[0107] The length of the first distal portion of the external member can be selected to allow the first distal portion to be inserted / pierced / anchored into the second tissue (i.e., in this case, the sclera), while ensuring that the first distal portion does not protrude distally from the sclera, thus minimizing or eliminating invasive entry into the anterior chamber of the eye. The length can be approximately 0.5 mm to 3 mm.

[0108] The outer diameter of the internal component is selected to create a predetermined geometry of the channel while maintaining minimum strength, ensuring that the internal component remains continuously within the tissue during operation. The outer diameter can be approximately 0.2 mm to 0.5 mm.

[0109] The overall length of the internal components is selected such that they can be connected to the moving mechanism proximally, while providing sufficient forward distance to produce the desired channel length. The overall length can be approximately 15mm-40mm.

[0110] The length of the second distal portion of the internal component depends on the specific construction of the second distal portion, which ensures the generation of the channel.

[0111] During channel formation, the internal component protrudes / projects from the external component by approximately 1mm-4mm.

[0112] The internal components can rotate in the range of approximately 1 rpm to 10,000 rpm. Furthermore, the penetrating force is approximately 0.2 Newtons to 10 Newtons.

[0113] The diameter of the resulting channel will be approximately 0.1mm-0.5mm.

[0114] refer to Figure 2A and Figure 2B Throughout this text, functional parts with the same functionality are designated by the same reference numerals, with copies differing by 100. For example, reference numeral 210 indicates an external component and reference numeral 220 indicates an internal component, both configured to have at least the features described above with respect to external component 110 and internal component 120, and possibly additional features. Various non-limiting embodiments of the device, including its external and internal components and their moving mechanisms, will be illustrated below. It should be understood that any combination of an external component, an internal component, and a moving mechanism is equally possible. The specific examples shown or described should not limit the broad aspects of the invention.

[0115] Figure 2A and Figure 2BA non-limiting example of the device 200 of the present invention is illustrated. In the figures, an external member 210 and an internal member 220 of the device 200 are shown. The external member 210 and the internal member 220 are configured and operable at least as described above for the external member 110 and the internal member 120. Figure 2A (as well as Figure 1A The diagram illustrates the device during the positioning phase (i.e., during insertion of the device through the first and second (target) consecutive tissues), wherein the outer member 210 guides the device into its position within the second tissue to be penetrated, and the inner member 220 (and...) Figure 1A 110) is completely contained within the outer component 210. Figure 2B (as well as Figure 1B The diagram illustrates the apparatus during the penetration phase (i.e., during the creation of a channel by one or more rotations and forward movements of the inner member 220). As shown, the first distal portion 212 of the outer member 210 includes a puncture portion / tip 216 at its distal end, which is configured and operable as described above to puncture and penetrate one or more tissue layers preceding the target tissue, and to puncture but not completely penetrate the target tissue layer. Furthermore, the first distal portion 212 includes a portion 212P at its proximal end, which is configured and operable to puncture and penetrate one or more tissue layers preceding the target tissue, and stops at a second (target) tissue layer, i.e., portion 212P prevents the outer member 210 from over-penetrating the second (target) tissue in which the channel is created, thereby inserting the outer member 210 into the target tissue layer through its distal puncture portion 216. Portion 212P may be interchangeably referred to herein as a "stop portion" or "stop".

[0116] In the described example, the stop 212P is an integral part of the outer member 210, formed by cutting a segment of the wall of the outer member 210 substantially along axis X from the edge of a cross-section of the transverse circle of the outer member 210. Specifically, the cut segment is the wall of the cylinder of the outer member 210, for example, half of the cylinder of the outer member at its most distal end and at most to the proximal point along the outer member. The length of the wall segment cut along axis X defines the length of the first distal portion 212, which in turn defines the extent to which the outer member 210 penetrates the target tissue, such that the distal end of the puncture tip 216 does not protrude / extend distally from the target tissue layer.

[0117] refer to Figures 3A to 3IThis illustrates a non-limiting technique for creating channels in soft tissue using the medical device of the present invention. The described example relates to creating channels in the scleral tissue of the eye. However, as already stated, the invention is not limited to this application and can be practiced in other areas of the body where controlled channels need to be created in tissue layers located before / below one or more other tissue layers. Specifically, the invention enables the creation of channels in areas of the body that require clear and defined stopping / positioning / stabilizing features of the device therein, because such areas do not provide these features; such areas are soft tissue. Figures 3A to 3E The example described involves an external approach process, where the device approaches the scleral tissue from the outside. A human eye 360 ​​is shown, where a channel should be created in the region of the sclerocorneal junction 362. The created channel will controllably connect the anterior chamber 364 of the eye with the space / area beneath the conjunctiva, and thus allow excess fluid accumulating in the anterior chamber to exit and thereby reduce intraocular pressure. As previously described, the channel size can be controlled by providing a device with specific geometry. Moreover, when used to treat excessive pressure, the size of the created channel is determined based on the magnitude of the excessive pressure to be treated. Higher pressure requires a larger channel, and vice versa. The created channel ensures effective pressure regulation such that it expands or contracts within a controlled size based on the pressure gradient across the channel (i.e., the pressure difference between the inside and outside of the eye).

[0118] like Figure 3A As shown, the device 300 approaches the eye from the outside via the external member 310, and more precisely, via the first distal portion 312 of the external member 310, wherein the device 300 encounters an external tissue layer comprising the conjunctiva and / or tendon tissue. Figure 3B (366 in the text). When the surgeon (usually manually) advances the external member 310 forward, it punctures and penetrates the conjunctiva and / or tendon.

[0119] like Figure 3B As shown, after or while the device has passed through the conjunctiva and tendon 366, the surgeon can retract the conjunctiva 366 (and possibly the tendon) outward with the aid of a suitable tool held in his other hand. The conjunctival tissue (and possibly the tendon) now wraps around the outer member 310 at the first proximal elongated portion 314. This protects the conjunctiva and / or tendon from contact with the inner member, which will be rotated and advanced to cut and remove the scleral tissue. The tissue puncture tip 316 of the outer member 310 now contacts the scleral tissue 368.

[0120] like Figure 3CAs shown and described above, the outer member 310 is further manually advanced so that the tissue puncture tip 316 penetrates the scleral tissue 368. The device is temporarily inserted (anchored) and stabilized in the scleral tissue 368 via the first distal portion 312 of its outer member 310. During advancement within the scleral tissue 368, the advancing resistance increases as the surgeon manually advances the device, providing feedback to him / her. In cases where the device is configured with a stop 312P, as shown in this particular example, the device 300 reaches a hard stop because the stop 312P provides significantly increased advancing resistance to the outer member 310 and prevents further penetration / advancement within the scleral tissue 368.

[0121] It should be understood that Figures 3A to 3C The positioning phase of device 300 is shown as preparation for the penetration phase. It should also be understood that no relative movement occurs between the outer and inner components during the positioning phase. Generally, during axial movement of the outer component, the inner component is concealed within and fixedly attached to the outer component, regardless of how the axial movement of the outer component is performed, whether the axial movement includes manual displacement of the outer component relative to the handle performed by the surgeon, or whether the outer component is fixedly attached to the handle such that the axial movement of the outer component is generated by manual axial movement of the handle performed by the surgeon.

[0122] At this time, as Figure 3D As shown, while the outer member 310 protects the conjunctival tissue, the inner member 320 is rotated mechanically or electrically by a dedicated motor (as described above and further illustrated below), and advanced forward by an applied moving mechanism, causing it to contact and attach to the scleral tissue 368 and begin drilling and creating a channel. The advancing distance of the rotating inner member can be configured by the moving mechanism such that the distal end of the inner member 320 does not protrude significantly into the anterior chamber of the eye to avoid damage to the medial side of the eye. The inner member 320 is then retracted (not shown), whether rotated or not, depending on its configuration, as will be further described below, until it returns to its fixed position within the outer member 310, and the surgeon pulls the latter out of the scleral and conjunctival tissues. The conjunctival tissue recovers almost immediately, and the hole formed solely by the outer member closes. Furthermore, because the surgeon pulls the conjunctiva outward during the positioning phase, the hole in the conjunctiva will be displaced relative to the channel in the sclera after the conjunctiva is released. When the conjunctiva reattaches to the sclera, it prevents the risk of eye collapse due to excessive fluid leaving the eye.

[0123] Figure 3EThe channel 370 created after the device is pulled out of the eye is shown. Aqueous humor (fluid in the anterior chamber) begins to leave the anterior chamber into the space under the conjunctiva, causing a filtering vacuole 372 to form under the conjunctiva and above the sclera, and the fluid is reabsorbed in the nearby blood vessels.

[0124] Now for reference Figures 3F to 3I This illustrates a non-limiting technique for creating channels in soft tissue using the medical device of the present invention. The described examples relate to creating channels in the sclera of the eye during an intraocular procedure by approaching the sclera from within the eye. As mentioned above, the advantage of the device of the present invention is that it can be used for both external and intraocular procedures. For simplicity of presentation, it is assumed that each feature not mentioned in the figures is related to… Figures 3A to 3E The same as in [the text]. It shows the human eye, where a channel should be created in the region of the sclera-cornea junction 362, as [the text is incomplete]. Figure 3F As described above, the resulting channel will controllably connect the anterior chamber of the eye with the space / area beneath the conjunctiva, thus allowing excess fluid accumulating in the anterior chamber to exit and thereby reducing intraocular pressure. The properties of the channel, including its size and geometry, can be referenced as previously stated. Figures 3A to 3E As already described. (e.g.) Figure 3F As shown, the device 300 approaches the eye from the outside and is inserted through an opening 374 into the anterior chamber 364 of the eye, which is pre-formed in the clear cornea on the side opposite to where the channel is to be created. The opening 374 can be implemented using conventional devices known in the art, such as probe blades. Relative to the eye in relation to… Figures 3A to 3E The device is inserted in an orientation opposite to that described in the external approach procedure. In other words, the sharp tip of the external component is now closer to the inner side of the eye, whereas during the external approach procedure, the tip is further away (e.g., ...). Figure 3A (As shown). In view of this, the slope shape and orientation of the first distal portion will be complementary to the shape and orientation of the sclera at the contact area 362.

[0125] The device is inserted into the anterior chamber and manually pushed by the surgeon, passing over the iris 376 until it contacts the scleral tissue at the scleral-corneal junction 362 from the inside.

[0126] Depend on Figure 3GAs can be seen, after the surgeon feels contact, they manually apply another thrust in the forward direction, causing the outer member 310 to pierce and penetrate the sclera (from the inside). The device is temporarily inserted (anchored) and stabilized in the scleral tissue via the first distal portion 312 of its outer member 310. As described above, during advancement within the scleral tissue, the forward resistance increases as the surgeon manually advances the device, providing feedback to him / her. In the case where the device is configured with a stop 312P, as shown in this particular example, the device reaches a hard stop because the stop provides significantly increased forward resistance to the outer member and prevents further penetration / advancement within the scleral tissue. Also as described above, the pre-configured length of the first distal portion of the outer member ensures that the puncture tip does not leave the sclera from the other (here, the outer) side, preventing the conjunctiva or other covering tissue from being torn or punctured by the outer member.

[0127] It should be understood that Figure 3F and Figure 3G The positioning phase of device 300 is shown as preparation for the penetration phase. It should also be understood that no relative movement occurs between the outer and inner components during the positioning phase. Generally, during axial movement of the outer component, the inner component is concealed within and fixedly attached to the outer component, regardless of how the axial movement of the outer component is performed, whether the axial movement includes manual displacement of the outer component relative to the handle performed by the surgeon, or whether the outer component is fixedly attached to the handle such that the axial movement of the outer component is generated by manual axial movement of the handle performed by the surgeon.

[0128] like Figure 3HAs shown, while or after the external member is anchored into the scleral tissue, the surgeon, aided by a suitable tool held in his other hand, can retract and elevate the conjunctiva 366 (and possibly the tendon) outward in direction 378. This protects the conjunctiva and / or tendon from contact with the internal member, which will be rotated and advanced to cut and remove the scleral tissue. The internal member is rotated mechanically or electrically by a dedicated motor (as described above) and advanced forward by an applied locating mechanism, causing it to contact and attach to the scleral tissue and initiating drilling and creating a channel. The advancement distance of the rotated internal member can be configured by the locating mechanism such that the distal end of the internal member does not protrude significantly beyond the scleral tissue to avoid damage to the conjunctiva and / or tendon tissue. While the inner member rotates to cut and remove tissue from the sclera, the outer member, stabilized by anchoring to the scleral tissue, remains stationary, moving little or no, thus protecting internal organs such as the iris from any damage that could be caused by the rotating inner member. Furthermore, the anchoring of the outer member to the sclera minimizes any accidental pull of the rotating inner member from the sclera, which could otherwise have adverse consequences for the internal organs of the eye. After the channel is created, the inner member is retracted (not shown), with or without rotation depending on its configuration, as will be further described below, until it returns to its fixed position within the outer member, and the device is pulled posteriorly from the anterior chamber and through opening 374 out of the eye, which can be treated with appropriate medication to heal and close almost immediately.

[0129] Figure 3I The diagram shows the channel created after the device is pulled out of the eye. Aqueous humor (fluid in the anterior chamber) begins to leave the anterior chamber into the space beneath the conjunctiva, causing a filtering bleb 372B to form beneath the conjunctiva and above the sclera, and the fluid is reabsorbed in nearby blood vessels.

[0130] refer to Figures 4A to 4D The figures illustrate various non-limiting examples of external components of a device according to some non-limiting embodiments of the invention. These figures are merely illustrative and not presented at full scale. Specifically, these figures show different non-limiting configurations of the first distal portion of the external component. Generally, the shape and / or orientation of the first distal portion can be selected to be complementary to the shape and / or orientation of the target tissue, thereby enabling better coupling / attachment / adhesion / anchoring between the external component and the target tissue.

[0131] Figure 4A This illustrates a cannula end of a known shape used in medical needles. This is a common tip cannula end known as a flat bevel tip. This configuration can be used as the first distal portion 412A of the outer member 410A.

[0132] Figure 4B Also shown is a cannula tip of a known shape used in medical needles. This is a common tip cannula tip known as a lancet bevel tip. This configuration can be used as the first distal portion 412B of the outer member 410B.

[0133] Figure 4C A particular, non-limiting example of the first distal portion 412C of the external member 410C according to the invention is shown. Figure 2A and Figure 2B It also shows the relationship with Figure 4C A similar configuration. The first distal portion 412C includes a tissue puncture tip 416C configured as a lancet bevel tip and a stop portion 412PC formed by the edge of the outer member 410C, the stop portion 412PC being obtained by cutting a segment of the wall of the outer member 410C along its longitudinal axis. In some exemplary, non-limiting embodiments, half of the wall (e.g., half of a cylinder) is cut.

[0134] Figure 4D A particular, non-limiting example of a first distal portion 412D of the outer member 410D according to the invention is shown. The first distal portion 412D includes a tissue puncture tip 416D and a stop portion 412PD, both obtained by cutting the outer member 410D along a curve in the direction of the longitudinal axis. The curve may be selected to provide a smooth transition along the first distal portion, thereby achieving smooth penetration with increased forward resistance. The curve is generally configured as a smooth, continuous line with a constant or variable slope (whose derivative tends to always be positive or always negative, but not necessarily constant), although other discontinuous behaviors may be used. For example, the curve may be a combination of two or more line segments, some of which are curved and / or straight. Specifically, for example, in the direction of the cross-section of the inner member, the puncture portion may be configured as a curve, while the stop portion may be configured as a straight line. In some embodiments, such a smooth curve may follow a circular, elliptical, semi-circular, or semi-elliptical path, for example, it may be a circumference of a circle or a portion of the circumference of an ellipse. In the example shown, an elliptical curve is presented such that the major axis of the ellipse lies in the direction of the longitudinal axis of the outer member, and the minor axis of the ellipse lies in an orthogonal direction (across the outer member). In this case, the major axis defines the length of the first distal portion, and the minor axis (or more specifically, the relationship between the major and minor axes) defines the level of forward resistance of the stop portion 412PD. It should be understood that the example described above involves forming a curve to form the puncture tip / stop from a single direction (2D forming) along the longitudinal axis direction, while any other 3D forming combination is also possible.

[0135] As explained above, any configuration of the external components can be used in conjunction with any configuration of the internal components. Furthermore, it should be noted that all examples presented herein are by no means limiting, and the invention can be practiced with other specific and suitable configurations.

[0136] As described above, the internal member is configured to effectively attach to the second tissue (in which the channel is formed) and to cut the well-defined geometry of the tissue during rotation and distal advancement. In some embodiments, the internal member is configured to store the cut tissue in its complete form, thereby providing verification and authentication of the resulting channel. Furthermore, storing the cut tissue within the internal member (in the second proximal elongation) protects the eye from sudden collapse by preventing the outflow of aqueous humor from the anterior chamber during channel formation and / or when the device is pulled outward from the eye.

[0137] refer to Figure 5A Figure 5D illustrates non-limiting examples of internal components of a device according to some non-limiting exemplary embodiments of the invention. Different examples can be distinguished by the specific channel-generating application, including the specific size of the channel, which is influenced by its purpose and its location in the body. Specifically, some of the described examples may be more suitable than others for applications that generate channels in the eyewall for treating elevated IOP.

[0138] Figure 5A An internal member 520A with a second distal portion 522A is shown. The second distal portion 522A is configured to attach to and cut tissue upon rotation and distal advancement, and is configured to guide the internal member through tissue, for example, toward the anterior chamber of the eye. The internal member also includes a second proximal elongated portion 524A, which includes an elongated chamber / cavity (not shown) configured to receive the tissue being removed therein. The outer diameter of the internal member should preferably match the inner diameter of the external member, leaving no space between them. The shape of the chamber / cavity is preferably matched to the shape of the tissue being cut. During operation, the internal member (at least the second distal portion) approaches the tissue upon rotation, thus rotation creates the desired attachment of the internal member to the tissue and enables puncture and cutting to begin. Typically, the second distal portion 522A has a circular cutting edge 522EA at its distal end, which is typically circular in shape and has one of the following configurations:

[0139] - The diameter of the circular cutting edge 522EA is equal to the diameter of the elongated cavity, so that the cutting edge is produced by sharpening (grinding) in the direction from the outer diameter of the inner component toward the diameter of the elongated cavity;

[0140] - The diameter of the circular cutting edge 522EA is equal to the outer diameter of the internal component, such that the cutting edge is produced by sharpening in a direction from the diameter of the elongated cavity toward the outer diameter of the internal component; and

[0141] - The diameter of the circular cutting edge 522EA is larger than the diameter of the elongated cavity and smaller than the outer diameter of the inner component, so that the cutting edge is produced by sharpening in two directions (from the outer diameter of the inner component to the diameter of the elongated cavity and from the diameter of the elongated cavity to the outer diameter of the inner component).

[0142] The inventors discovered that the degree of sharpening (i.e., the angle of inclination) plays an important role in providing effective tissue puncture and / or attachment.

[0143] Figure 5B Another non-limiting example of the internal component 520B is shown. In this example, the internal component is configured as an integral, non-hollow, elongated member having a second distal portion 522B, which is configured as a drill bit with a chip flute, enabling the creation of a desired channel in the soft tissue during rotation. The length, helix, tip angle, and lip angle of the drill bit can be adjusted for optimal removal of soft tissue. In this case, the internal component 522B rotates a full turn clockwise or counterclockwise depending on the helix direction, causing the removed tissue to be conveyed rearward from the target tissue and toward the collection cavity located between the internal and external components of the device.

[0144] Figures 5C1 to 5C3 Another non-limiting example of internal component 520C is shown. Figure 5C1 This is an isometric view of internal component 520C. Figure 5C2 These are isometric views of the coaxial exterior and components 510C and 520C, in which half of the wall of the exterior component at the far side is removed for illustration. Figure 5C3 Show along Figure 5C2 The cross-sections of the outer and inner components are obtained from line CC. In this example, the inner component is configured to... Figure 5A The example in the figure is partially similar, in that, as shown, the internal member 520C has a second distal portion 522C, which is configured to attach to and cut tissue via its cutting edge 522EC during rotation and distal advance, and is configured to guide the internal member through the tissue. The internal member 520C also includes a second proximal elongated portion 524C, which includes an elongated chamber / cavity 526C (within the second proximal elongated portion 524C, in...) Figure 5C3As shown in the figure, the elongated chamber / cavity 526C is configured to receive the tissue being removed therein. Also as shown, the second proximal elongated portion 524C of the internal member 520C includes a tissue trap 524TC at the distal segment 524DC of the second proximal elongated portion 524C, the tissue trap 524TC being positioned substantially parallel to the elongated cavity 526C. The tissue trap / tissue trap enhancer 524TC enhances and facilitates the trapping of the removed tissue during tissue removal, such that it allows / ensures the removal of the tissue from the body. Furthermore, the tissue trap 524TC can facilitate the flow of removed tissue into the cavity 526C by minimizing clogging issues. In some embodiments, additionally or alternatively, the cavity in the internal member of the device may be designed to trap tissue therein or facilitate the trapping of tissue therein. In this example, the tissue trap 524TC includes a slit 524SC positioned in the longitudinal direction (i.e., along at least a portion of the cavity 526C). Slit 524SC is obtained by tangentially cutting the circular wall of the inner member along the distal segment 524DC (i.e., by cutting the wall / circumference of the inner member in the tangential direction). It should be noted that tissue trap 524TC may typically include more than one slit along the circumference of the inner member, each slit being formed by tangentially cutting along the longitudinal axis. Figure 5C2 The device is shown during the positioning phase or after it has been pulled out of the body, in both cases the internal components (and, in the case of post-operation, tissue removal) are securely located within the external components. Figure 5C2 and Figure 5C3 As shown, in addition to the slit 524SC, the tangential cutting of the wall of the inner member also forms a recess 524D along the distal segment 524DC of the inner member. The recess 524D causes a second outer cavity 528C to be formed between the inner and outer members, which enhances the traction of removed tissue toward the cavity 526C and / or the interior of the outer member 510C. In other words, the recess 524D caused by the tangential cutting forms part of the tissue trap 524TC.

[0145] Figures 5D1 to 5D3 Another non-limiting example of an internal component 520D including a tissue trap / tissue trap enhancer 524TD is shown. Figure 5D1 It is an isometric view of the internal component 520D. Figure 5D2 It is an isometric view of the coaxial exterior and components 510D and 520D, wherein half of the wall of the exterior component at the far side is removed for illustration. Figure 5D3 Show along Figure 5D2 The cross-sections of the external and internal components are obtained from line CC. As can be understood, Figures 5D1 to 5D3 Various features and components in Figures 5C1 to 5C3The various features and components are similar. Specifically, such as Figure 5D1 As shown, the internal member 520D has a second distal portion 522D, which is configured to attach to and cut tissue via its cutting edge 522ED during rotation and distal advance, and is configured to guide the internal member through the tissue. The internal member 520D also includes a second proximal elongated portion 524D, which includes an elongated chamber / cavity 526D (within the second elongated portion 524D, such as...). Figure 5D3 As shown, the elongated chamber / cavity 526D is configured to receive tissue being removed therein. A second proximal elongated portion 524D of the internal member 520D includes a tissue trap 524TD at a distal segment 524DD of the second proximal elongated portion 524D, the tissue trap 524TD being positioned substantially parallel to the elongated cavity 526D. As already illustrated, the tissue trap 524TD enhances and facilitates the trapping of removed tissue during tissue removal, allowing / ensuring that the removed tissue is pulled out of the body. Furthermore, the tissue trap 524TD facilitates the flow of removed tissue into the cavity 526D by minimizing clogging issues. In some embodiments, additionally or alternatively, the cavity in the internal member of the device may be designed to trap tissue therein or facilitate trapping tissue therein. In this example, the tissue trap 524TD includes a slit 524SD positioned in the longitudinal direction (i.e., along at least a portion of the cavity 526D). The slit 524SD is obtained by radially cutting the circular wall of the inner member along the distal segment 524DD (i.e., by cutting the inner member in the radial direction). It should be noted that the tissue trap 524TD may typically include more than one slit along the circumference of the inner member, each slit being formed by radial cutting in the radial direction and along the longitudinal axis. Figure 5D2 The device is shown during the positioning phase or after it has been pulled out of the body, in both cases the internal components (and in the case of post-operation, tissue removal) are securely located within the external components.

[0146] Turn now Figures 5E1 to 5E7 These figures illustrate a non-limiting scenario of removing soft tissue from layers of tissue in the body. Specifically, they illustrate the undesirable effects of soft tissue tearing, rather than cutting, when a cutting tool rotates within the tissue.

[0147] Ideally, the channels created within an organization are expected to appear as... Figure 5E1 As shown, it should have a cylindrical shape, such as when the internal components are like Figure 5AAs described herein, channel 5003 connects the outer scleral surface 5002 and the inner scleral surface 5001. A cutting tool 520E (e.g., an internal component) rotates clockwise or counterclockwise, or reciprocates in both directions, about its longitudinal axis in direction 503E, and approaches the sclera at a feed rate 502E. In a preferred embodiment, the channel should have the required dimensions, with its diameter similar to that of the cutting edge 522EE. The removed tissue 5004 is expected to be captured within the cutting tool 520E, as... Figure 5E2 As shown.

[0148] It should be understood that tissue cutting is limited by the behavior and characteristics of the tissue. When the cutting tool 520E cuts, it rotates / turns within the tissue. While the cutting tool 520E rotates / turns, the organ being treated (e.g., the eye) is stationary. The cutting tool 520E compresses the tissue through its outer surface 504E (outer diameter) and inner diameter 505E. The diameter of the cylindrical tissue 5004 is defined by the cutting edge 522EE; however, the inner diameter 505E may be slightly smaller, resulting in compression of the tissue (within the cavity of the cutting tool). Another reason for the compression of the tissue within the cavity of the cutting tool may be the relatively high frictional force between the tissue and the inner surface of the cavity. Another reason for the compression of the tissue within the cavity of the cutting tool may be the limited length of the cavity, such as… Figure 5E3 As shown, Figure 5E3 This is a magnified image of the cutting tool captured by a microscope. Current technology enables the creation of cavities with small diameters, as required in ocular treatment, with a length of up to about 0.5 mm, as shown in the figure by ladder 508E. However, the required length of the channel may be longer than 0.5 mm; for example, when creating a channel in the sclera within the eye wall, it may be about three times larger (1.5 mm).

[0149] Because the cutting tool 1 (e.g., an internal tool) rotates and the tissue (e.g., an eye) is stationary, tissue 5004 is expected to remain stationary until the cutting process is complete. In fact, during the cutting process, as... Figure 5E4 and Figure 5E5 As shown, tissue 5004 is defined by two segments: tissue segment 5041, which is compressed into the cavity of the cutting tool, and tissue segment 5042, which has not yet been compressed. Due to high friction or insufficient cavity length, the adhesion of tissue segment 5041 to the inner surface of the cavity may cause tissue segment 5041 to begin to rotate with the cutting tool and tear apart from tissue segment 5042. In this case, the separation of tissue 5004 is not caused by cutting, but by torsional tearing. Therefore, the channel created in the eye wall may appear as... Figure 5E6 or Figure 5E7 As shown. This can lead to insufficient or ineffective drainage, or even no drainage at all.

[0150] Minimizing radial adhesion of the removed tissue to the inner surface of the cavity in the cutting tool allows for continued cutting rather than tearing. Reducing the radial adhesion between the removed tissue (e.g., tissue 5041) and the inner surface of the cavity (e.g., surface 505E) can be achieved by lowering the coefficient of friction between the tissue and the inner surface of the cavity (e.g., by applying a low-friction coating to the inner surface). Alternatively or additionally, reducing radial adhesion between the removed tissue and the inner surface of the cavity can be achieved by creating a specific geometry for the cutting tool (e.g., by making the diameter of the inner surface of the cavity larger than the diameter of the cutting edge of the cutting tool).

[0151] Now go to Figure 5F Figure 5G illustrates a non-limiting exemplary embodiment of a tissue cutting tool and its manufacturing and / or optimization methods. The cutting tool is optimized for cutting soft tissue and for creating channels of predetermined size and geometry within a specific, given tissue, while minimizing the effects of tearing. In some embodiments, the internal components of the device of the present invention may be configured to… Figure 5F And the cutting tool described in Figure 5G. Therefore, the reference numerals used in the following figures follow the same numbering used so far; for example, 520E indicates a tissue cutting tool that can be used as an internal component of the device of the present invention. However, this should not be construed as limiting the invention.

[0152] Figure 5F This figure illustrates a first non-limiting example of a cutting tool configured according to some embodiments of the invention. The figure depicts a cutting tool 520E that minimizes radial adhesion between the removed tissue and the inner surface of the cavity, thereby minimizing the effects of tissue tearing. This is achieved by shaping the cutting tool. As shown, the distal portion 504F of the cutting tool is shaped and extruded toward the axis of rotation of the tool (which, if the tool is symmetrical and isotropic, passes through the center of the tool). Extrusion and shaping can be performed using known techniques such as forging and spinning. In this case, the diameter of the cutting edge 522EF at the distal end of the cutting tool is smaller than the inner diameter 505F of the cavity within the cutting tool. Because the diameter of the cutting edge determines the diameter of the removed tissue, the cutting tool 520F is expected to provide minimal or no adhesion to the removed tissue within the tool, thereby improving the capture of the removed tissue while minimizing the risk of tearing and preserving the intact shape of the removed tissue, which matches the complete open channel within the tissue wall.

[0153] Figures 5G1 to 5G4 An exemplary non-limiting cutting tool 520G1 (in accordance with some embodiments of the present invention) is shown. Figure 5G3 (in China) and 520G2 (in Figure 5G4 (in China) and tools used for producing cutting tools (in China) Figure 5G1 and Figure 5G2 An example process.

[0154] exist Figure 5G1 In the side view (section) of tool 520G, a hollow cylinder 506G is included at the distal end 501G. The hollow cylinder 506G has cavities 507G between a uniform outer diameter 504G and an inner diameter 505G, which extend along the longitudinal (rotational) axis X1. Figure 5G2 The image shows a close-up view of cylinder 206G. The distal portion 504G is formed, for example, by extrusion, with a predetermined pattern such that both the inner and outer diameters decrease towards the distal end 509G of the hollow cylinder. As shown on the proximal end 511G of the hollow cylinder, the original inner and outer diameters are approximately 0.17 mm and 0.3 mm, respectively, and the modified inner and outer diameters at the distal end 509G are approximately 0.13 mm and 0.27 mm, respectively. The forming of the distal portion can be accomplished, for example, but not limited to, forging and / or spinning techniques. The formed pattern can be linear, for example, by gradually tapering the distal portion to provide a substantially cylindrical truncated shape; or non-linear, for example, by following a curve such as a parabola or other similar pattern.

[0155] In the next step, starting from the distal end 509G, slices of the sidewall of the hollow cylinder are removed along the longitudinal axis in the proximal direction (to the right in the diagram). The thickness of the slice is determined based on the slice depth. Figure 5G3 and Figure 5G4 Two exemplary cutting tools, 520G1 and 520G2, are shown. The cutting edge 522EG is formed at the distal end, and its inner and outer diameters become nearly equal, such as... Figure 5G3 0.18mm and Figure 5G4 The inner diameter is 0.16 mm. Further sharpening of the cutting edge in both the inner and outer directions results in a cavity with a diameter slightly smaller than the cutting edge diameter at its distal end. The cavity's inner diameter then increases continuously in the proximal direction (to the right in the figure) until it reaches a higher value of 505G for the proximal side of the hollow cylinder. Alternatively, planing the inner surface of the cavity can provide a substantially constant cavity inner diameter. Due to this planing step, there are no steps (such as...) Figure 5E3 The cavity (508E) has a length in the longitudinal axis direction that is at least equal to the cavity length of the original hollow cylinder, thus providing a receiving cavity that is longer and wider than the limit of 0.5 mm, thereby minimizing the adhesion of tissue entering the cavity to the inner surface of the cavity. All of this is at the microscopic level required for applications such as creating a sufficiently safe channel in the eye wall.

[0156] Other non-limiting examples of internal components include the devices described in WO2013186779 and WO2015145444, both of which are assigned to the assignee of this invention.

[0157] As described above, various movements of the external and internal components of the device can be performed manually and / or by means of moving / movement mechanisms. The external components are configured for axial movement only, while the internal components are configured for both rotational and axial movement. Typically, the rotation of the internal components is controlled by an electric motor connected to the proximal side of the internal components. This is not specifically described herein, but examples can be found in the aforementioned patent application PCT / IL2016 / 051063, assigned to the assignee of this invention. Various moving mechanisms are described below.

[0158] refer to Figures 6A to 6D This illustrates a non-limiting example of a moving mechanism configured for manually moving the device during operation. As shown, the device 600 includes an outer member 610 and an inner member 620 mounted on a handle 650 via a moving mechanism 640. Figure 6A and Figure 6C The device is shown during the positioning phase (i.e., when the external component moves forward (by the surgeon manually pushing the handle) to pierce the first (previously) and second (target) tissue layers or approach and directly pierce the target tissue layer (such as during an internal approach). Figure 6B and Figure 6D The apparatus is shown during the penetration phase (i.e., when the internal component is rotated by an electric motor (not shown) and advanced distally to cut and remove tissue, thereby leaving a channel in the target tissue layer).

[0159] The moving mechanism 640 includes a latch 642, a spring 644, and a housing 646. For example... Figure 6C As shown, the latch is movable to both sides, as indicated by arrow A. The external member 610 is axially locked by being securely attached to the housing at B and supported by the latch 642 at C. The spring 644 is slightly pre-compressed / relaxed during the positioning phase.

[0160] After using handle 650 to push the device within the tissue until the first distal portion of the outer member is temporarily inserted / anchored within the target tissue layer (e.g., in the sclera, as described above), the surgeon turns the latch 642 to the left (or right), thereby releasing the outer member 610 at point C, thus allowing the outer member 610 to retract proximally. The surgeon then switches the electric motor to rotate the inner member and uses handle 650 to push it distally to expose the inner member 620, as described above. Figure 6DAs shown. The outer member 610 retracts, and the spring 644 is compressed. A channel is created once the surgeon pushes the device distally. Although the compressed spring 644 tends to push the outer member 610 distally, the spring constant is chosen to be low enough that the outer member cannot penetrate further into the sclera. Ergonomically, the surgeon can control all features with a single finger while holding the handle.

[0161] refer to Figures 7A to 7D This illustrates a non-limiting example of a movement mechanism configured for manually moving a device (specifically, an internal component) during operation. As shown, device 700 includes an external component 710 and an internal component 720 mounted on a handle 750 via a movement mechanism 740. Figure 7A and Figure 7C The device is shown during the positioning phase (i.e., when the external component is moved forward (by the surgeon manually pushing the handle) to pierce one or more tissue layers and / or until it is inserted and anchored in the target tissue layer). Figure 7B and Figure 7D The apparatus is shown during the penetration phase (i.e., when the internal components are rotated by an electric motor and pushed distally to create a channel in the second tissue layer).

[0162] The moving mechanism 740 is configured to controllably advance the internal component (towards the distal end) by manually pushing the moving mechanism. Figure 7C As shown, the moving mechanism 740 includes a knob 742, a spring 744, and a housing 746. The external member 710 is axially locked by being fixedly attached at point D to the housing and thus also to the handle 750, such that when the surgeon pushes the handle 750 toward the tissue, the external member moves axially and penetrates the tissue until it pierces the sclera. The spring 744 is relaxed during the positioning phase.

[0163] Knob 742 is attached proximally to the internal member 720 at point E, allowing them to move together in both distal and proximal directions. During the penetration phase, the surgeon can controllably push knob 742 against spring 744 in the distal direction, as indicated by arrow R, causing spring 744 to compress. The internal member moves distally at the same rate as the surgeon pushes knob 742. Upon releasing knob 742, a retraction movement occurs, spring 744 relaxes, and pulls knob 742 and internal member 720 proximally to a closed position, as shown below. Figure 7C As shown. Furthermore, although not specifically shown, the moving mechanism may include a latch configured to lock the knob 742 in a forward position, and retraction occurs only when the surgical surgeon releases the latch. As mentioned, the rotational movement of the internal components is controlled by a motor, which is not specifically described herein.

[0164] refer to Figures 8A to 8D This illustrates a non-limiting example of a movement mechanism configured for manually moving a device (specifically, an internal component) during operation. As shown, device 800 includes an external component 810 and an internal component 820 mounted on a handle 850 via a movement mechanism 840. Figure 8A and Figure 8C The device is shown in the positioning phase (i.e., when the external component is moved forward (by the surgeon manually pushing the handle) to pierce one or more tissue layers and / or until it is inserted and anchored in the target tissue layer). Figure 8B and Figure 8D The apparatus is shown during the penetration phase (i.e., when the internal components are rotated by an electric motor (not shown) and advanced distally to create a channel in the target tissue layer).

[0165] The moving mechanism 840 is configured to controllably advance the internal component (towards the distal end) by manual pulling. For example... Figure 8C As shown, the moving mechanism 840 includes a knob 842, a spring 844, and a housing 846. The external member 810 is axially locked by being fixedly attached to the housing at point F and thus also to the handle 850, such that when the surgeon pushes the handle 850 toward the tissue, the external member moves axially and penetrates the tissue until it pierces the sclera. The spring 844 is relaxed during the positioning phase.

[0166] Knob 842 is attached proximally to the internal member 820 at point G, causing them to move together in both the proximal and distal directions. During the perforation phase, the surgeon controllably pulls knob 842 proximally, as indicated by arrow W, causing G to move distally against spring 844, thereby compressing spring 844. The internal member moves distally at the same rate as the surgeon pulls knob 842. Upon releasing knob 842, its distal movement relaxes spring 844, pushing G and the internal member 820 proximally to the closed position, as... Figure 8C As shown. Furthermore, although not specifically shown, the moving mechanism may include a latch configured to lock knob 842 in a rearward position, and the retraction movement of the internal component occurs only when the surgical surgeon releases the latch. As mentioned, the rotational movement of the internal component is controlled by a motor, which is not specifically described herein.

[0167] refer to Figures 9A to 9E It shows a non-limiting example of a moving mechanism configured to propel an internal component under the action of a constant or substantially constant force (e.g., 5N–6N (with a tolerance of about 1N)). Figure 9A and Figure 9BThe entire device 900 is shown. As shown, the device 900 includes an external member 910 and an internal member 920 mounted on a handle 950 via a moving mechanism 940. Figure 9A , Figure 9C and Figure 9D The device is shown during the positioning phase (i.e., when the external member moves forward to pierce one or more tissue layers and / or until it is inserted and anchored in the target tissue layer (both by the surgeon manually pushing the handle)). Figure 9B and Figure 9E The apparatus is shown during the penetration phase (i.e., when the internal member 920 is rotated by an electric motor and advanced distally to create a channel in the target tissue layer).

[0168] The moving mechanism 940 includes a knob 942, a spring 944, a floating disk 948, and a housing 946, the housing 946 including three spaced-apart pins 946P that are securely housed therein, mating with the teeth of the floating disk. An external member is permanently attached to the housing 946 such that it does not move relative to the handle 950, and axial movement of the external member is produced only by the surgical surgeon pushing the handle forward and pulling it backward.

[0169] During the positioning phase, such as Figure 9C As shown, spring 944 is compressed, thereby applying a distal thrust to floating disk 948. However, when knob 942 engages with floating disk 948, thus preventing movement, floating disk remains stationary.

[0170] like Figure 9D As shown, after the external component is inserted and anchored in the sclera, the surgeon turns on the electric motor to cause the internal component to rotate, then turns the knob to the right or left to release the floating disc 948. Once the floating disc is released, it rotates and is pushed distally by the beginning to relax the spring 944, engaging the floating disc with pin 946P, as... Figure 9E As shown. The floating disk 948 is also axially attached to the base of the internal component, such that distal movement of the floating disk under the constant relaxation force of the spring 944 causes the rotating internal component to move distally under a constant force until the floating disk reaches the distal side of the housing 946 and the axial movement stops. Furthermore, although not specifically shown, the movement mechanism may include a latch configured to lock the knob 942, and retraction of the internal component occurs only when the surgical surgeon releases the latch.

[0171] refer to Figures 10A to 10D This illustrates a non-limiting example of a moving mechanism configured to propel internal components at a constant rate. Figure 10A and Figure 10BThe entire device 1000 is shown. As shown, the device 1000 includes an external component 1010 and an internal component 1020 mounted on a handle 1050 via a moving mechanism 1040. Figure 10A and Figure 10A The device is shown during the positioning phase (i.e., when the external member moves forward to pierce one or more tissue layers and / or until it is inserted and anchored in the target tissue layer (both by the surgeon manually pushing the handle)). Figure 10B and Figure 10D The apparatus is shown during the penetration phase (i.e., when the internal member 1020 is rotated by an electric motor and advanced distally to create a channel in the target tissue layer).

[0172] The moving mechanism 1040 is configured to automatically rotate and propel internal components. The rotation and propulsion movements can be performed by the same or different motors. Furthermore, regardless of whether one motor or two separate motors are used, the rates of rotation and propulsion movements can be the same or different.

[0173] like Figure 10C and Figure 10D As shown, the moving mechanism 1040 includes two gears, G1 and G2. Gear G1 receives rotational power transmitted by a motor (not shown) at a first rate (e.g., 100-500 revolutions per minute (RPM)). Gear G1 rotates together with an inlet shaft 1062 that is constantly connected to gear G1 and is responsible for the rotational movement of the internal component 1020. The internal component is connected to the inlet shaft 1062 via an outlet shaft 1064 that rotates together with the inlet shaft 1062 and is axially movable relative to the inlet shaft 1062. Gear G1 engages with gear G2, causing it to rotate according to a predetermined ratio between G1 and G2. Gear G2 is responsible for the axial movement of the internal component, such as... Figure 10D As shown, gear G2 is constantly connected to parallel shaft 1066, which has a built-in drive thread, as illustrated, such that the rotational movement of gear G2 and parallel shaft 1066 is converted into axial movement of drive nut 1072 via the built-in drive thread. The axial movement of the internal components is controlled by the axial length of housing 1046. The rotation of parallel shaft 1066 via the built-in thread drives drive nut 1072, causing it to move distally and forcing outlet shaft 1064 to move distally along with it. Bearing 1074 between drive nut 1072 and outlet shaft 1064 allows outlet shaft to rotate during axial movement, while fork shaft 1076 allows outlet shaft to continue rotating along the distal axial stroke.

Claims

1. A medical device configured and operable for insertion into an anterior chamber of an eye for removing a predetermined shape of soft tissue from a target tissue layer engaging the anterior chamber of the eye, thereby creating a corresponding passage between an inner side and an outer side of the target tissue layer to enable drainage of excess fluid from inside the anterior chamber, the device having dimensions enabling said insertion into the anterior chamber and comprising coaxial outer and inner elongated members extending along an axis X; the outer elongated member being configured for manual linear movement along the X axis forward and backward and comprising an open distal side and a first distal portion comprising a stop that brings the outer elongated member to a hard stop against the inner wall of the target tissue layer when the outer elongated member is manually linearly advanced along the X axis until the open distal side penetrates the inner wall of the target tissue layer; the inner elongated member comprising: - a second distal portion configured to rotate and protrude distally through the open distal side of the outer elongated member, the second distal portion being open at its distal end and comprising a cutting edge configured to adhere to and cut the shape of the soft tissue from the target tissue layer when rotating and advancing distally, and then retract backward into the outer elongated member, and - a chamber extending along the X axis from the open distal end of the second distal portion for a predetermined length, the chamber having dimensions enabling storage of the removed soft tissue within the chamber, thereby creating the passage formed as a hole across the target tissue layer.

2. The apparatus of claim 1, wherein, The inner elongated member is manually moved along the X axis during creation of the passage and retraction when rotating.

3. The device of claim 1, comprising a constant force movement mechanism configured and operable to move the inner elongated member along the axis X under the action of a constant force when rotating.

4. The device of claim 1, comprising a constant rate movement mechanism configured and operable to move the inner elongated member along the axis X at a constant rate when rotating.

5. The apparatus of any of claims 1-4, wherein, The inner elongated member comprises an elongated circular body extending along the axis X and having a uniform outer diameter at its proximal side, the cutting edge having a first diameter smaller than the outer diameter, and the second distal portion having an outer diameter that continuously decreases towards the distal end.

6. The apparatus of any one of claims 1-4, wherein, The chamber has dimensions matching the shape of the soft tissue, thereby providing authentication to the created passage.

7. A cutting tool configured for insertion into an anterior chamber of an eye for removing a predetermined shape of soft tissue from a target tissue layer engaging the anterior chamber of the eye when rotated and advanced, thereby creating a corresponding passage between an inner wall and an outer wall of the target tissue layer to enable drainage of excess fluid from inside the anterior chamber, the cutting tool comprising: - an elongated circular body extending along a longitudinal axis and having a uniform outer diameter at its proximal side, - a cutting portion at a distal side of the elongated circular body, the cutting portion comprising at its distal end a circular cutting edge having a first diameter, the first diameter being smaller than the uniform outer diameter, and comprising a distally and constantly decreasing outer diameter, and - a chamber configured for storing the removed soft tissue in its intact form, thereby providing authentication of the corresponding passage, the chamber extending within the cutting tool along the longitudinal axis from the distal end of the cutting portion, and the chamber having a size matching the shape of the removed soft tissue, wherein the chamber is cylindrical and has a length of 1.5 mm from the distal end of the cutting portion.

8. The cutting tool of claim 7, wherein, The first diameter of the cutting edge is between 0.1 mm and 0.2 mm.

9. A cutting tool configured for insertion into an anterior chamber of an eye for removing a predetermined shape of soft tissue from a target tissue layer of the anterior chamber of the eye when rotated and advanced, thereby creating a corresponding passage between an inner and an outer side wall of the target tissue layer to enable drainage of excess fluid from inside the anterior chamber, the cutting tool comprising: - an elongated circular body extending along a longitudinal axis and having a uniform outer diameter at its proximal side, - a cutting portion at a distal side of the elongated circular body, the cutting portion comprising at its distal end a circular cutting edge having a first diameter, the first diameter being smaller than the uniform outer diameter, and comprising a distally and constantly decreasing outer diameter, and - a chamber configured for storing the removed soft tissue in its intact form, thereby providing authentication of the corresponding passage, the chamber extending within the cutting tool along the longitudinal axis from the distal end of the cutting portion, and the chamber having a length of at least the length of the removed tissue, wherein the chamber has a chamber diameter at its distal side smaller than the first diameter of the cutting edge, the chamber diameter constantly increasing in a proximal direction.

10. The cutting tool of claim 9, wherein, The first diameter of the cutting edge is between 0.1 mm and 0.2 mm.

11. A cutting tool configured for insertion into an anterior chamber of an eye for removing a predetermined shape of soft tissue from a target tissue layer of the anterior chamber of the eye when rotated and advanced, thereby creating a corresponding passage between an inner and an outer side wall of the target tissue layer to enable drainage of excess fluid from inside the anterior chamber, the cutting tool comprising: - an elongated circular body extending along a longitudinal axis and having a uniform outer diameter at its proximal side, - a cutting portion at a distal side of the elongated circular body, the cutting portion comprising at its distal end a circular cutting edge having a first diameter, the first diameter being smaller than the uniform outer diameter, and comprising a distally and constantly decreasing diameter, and - a chamber configured for storing the removed soft tissue in its intact form, thereby providing authentication of the corresponding passage, the chamber extending within the cutting tool along the longitudinal axis from the distal end of the cutting portion, and the chamber having a size matching the shape of the removed soft tissue, wherein the chamber is cylindrical and has a length of 1.5 mm from the distal end of the cutting portion. - a chamber configured for storing the removed soft tissue in its intact form, thereby providing authentication to the corresponding channel, the chamber extending within the cutting tool from the distal end of the cutting portion along the longitudinal axis, and having a length of up to 1.5 mm, wherein the chamber has a constant chamber diameter equal to the first diameter.

12. The cutting tool of claim 11, wherein, The first diameter of the cutting edge is between 0.1 mm and 0.2 mm. The first diameter of the cutting edge is between 0.1 mm and 0.2 mm.

Images