Traction devices for biological tissues
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- オスピスシヴィルドゥリヨン
- Filing Date
- 2023-04-25
- Publication Date
- 2026-04-14
AI Technical Summary
Current traction devices for resection of superficial tumors in the digestive tract face challenges in maintaining sufficient exposure of submucosal tissue, as the pulling force exerted by the elastic member becomes insufficient after initial resection, making it difficult to continue the resection surgery effectively.
The traction device incorporates a proximal anchor, a distal anchor, and an elastic member, along with an adjustment member that allows for dynamic adjustment of the maximum proximal and distal distances, ensuring consistent traction force throughout the resection process.
This solution ensures that the submucosal tissue remains adequately exposed, allowing for smooth and effective resection of the tumor mucosa, even after initial resection, by maintaining an optimal traction force.
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Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of endoscopic devices, and more particularly, to a traction device for biological tissues, for example, used for resection of superficial tumors in the digestive tract.
Background Art
[0002] Traction devices used for resection of superficial tumors in the digestive tract are known. Such traction devices generally include a proximal anchor and an elastic member configured to exert a proximal pulling force on the proximal anchor.
[0003] In fact, the technique used for resection of superficial tumors in the digestive tract is submucosal dissection. This is a complex technique that can remove superficial tumors by a minimally invasive method. Submucosal dissection involves separating the tumor mucosa from other parts of the digestive tract wall, particularly the muscle, by using the submucosal tissue as the resection surface. This surgery is said to be less invasive because it respects the organ with a short healing time compared to conventional invasive surgeries.
[0004] The traction device facilitates submucosal dissection by separating the mucosa from the muscle by traction to expose the submucosal tissue. For this purpose, using an endoscopic hemoclip, the proximal anchor is fixed to the proximal part of the tumor mucosa, and the elastic member is fixed to the opposite wall of the digestive tract, thereby exerting a pulling force on the proximal part of the tumor mucosa, and thereby separating the tumor mucosa from other parts of the digestive tract wall.
Summary of the Invention
Problems to be Solved by the Invention
[0005] However, the current traction device is not fully satisfactory. In fact, after removing the first part of the submucosal tissue under the proximal part of the tumor mucosa, the proximal part relaxes, and the pulling force exerted by the elastic member on the proximal anchor is insufficient to properly expose the submucosal tissue. Therefore, it becomes difficult to insert the resection device and continue the resection surgery in a good state.
[0006] In view of this situation, an object of the present invention is to provide a traction device that sufficiently exposes the submucosal tissue and provides appropriate conditions for the resection device to move freely throughout the resection of the tumor mucosa.
Means for Solving the Problems
[0007] The solution of the present invention is a traction device for biological tissue as described in appended claim 1. The present invention also relates to modifications of the dependent claims. Those skilled in the art will understand that the features of the modifications of the dependent claims and the specification can be combined independently of the above features without constituting intermediate generalizations.
Brief Description of the Drawings
[0008] Other features and advantages of the present invention will become apparent from the following description of specific embodiments of the present invention, which is made as a guide with reference to the accompanying drawings.
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DETAILED DESCRIPTION OF THE INVENTION
[0009] Referring to FIGS. [FIG. 1] to [FIG. 8], the present invention relates to a traction device (1) for biological tissue (101). In fact, the biological tissue (101) can be a tumor mucosa as shown in FIGS. [FIG. 4] to [FIG. 8]. The biological tissue is usually located in a cavity of the human body such as the digestive tract.
[0010] The traction device (1) comprises a proximal anchor (3). This can be in the form of a circular loop, triangle, rectangle, or any other shape suitable for those skilled in the art, such as in the embodiment of FIG. 1. This loop can have rigidity, flexibility, or elasticity. For example, the loop can be made of metal, plastic, latex, or any other material suitable for those skilled in the art. Also, the loop can be made of a fil of cotton, silk, polyester, nylon, or any other material suitable for those skilled in the art. Preferably, the proximal anchor (3) is made of at least one hypoallergenic material such as polyglcaprone, polybutester, glycolma, polyglactin, polyglyconate, polydioxanone, polypropylene, etc. Ingeniously, the proximal anchor (3) comprises a surface coating made of at least one hypoallergenic material of the type described above. Preferably, the loop forming the proximal anchor (3) has an opening (31) configured to allow free movement of the jaws of the endoscopic hemoclip (203). In particular, the loop can comprise an opening (31) extending beyond a semi-circle with a diameter of 8 mm. Generally, an endoscopic hemoclip is a clamp having two linear jaws (mors stries). The endoscopic hemoclip is configured to be fixed to biological tissue by sandwiching the biological tissue between its jaws.
[0011] In addition, the traction device (1) comprises a distal anchor (4). This can be in the form of a circular loop, triangle, rectangle, or any other shape suitable to those skilled in the art, such as in the embodiment of FIG. 1. This loop can have rigidity, flexibility, or elasticity. For example, the loop can be made of metal, plastic, latex, or any other material suitable to those skilled in the art. Also, the loop can be made of a thread made of cotton, polyester, nylon, or any other material suitable to those skilled in the art. Preferably, the distal anchor (4) is made of at least one of the low-irritant materials described above. Ingeniously, the distal anchor (4) comprises a surface coating made of at least one of the low-irritant materials described above. Preferably, the loop forming the distal anchor (4) has an opening (41) configured to allow free movement of the jaws of the endoscopic hemoclip (204). In particular, the loop can comprise an opening (41) extending beyond a semi-circle with a diameter of 5 mm.
[0012] Furthermore, the traction device (1) comprises an elastic member (2). The elastic member comprises at least one elastic part having a length (L) and a Young's modulus (E). It should be understood that the "at least one elastic part" means that the elastic member (2) can have elasticity as a whole or can comprise at least one elastic part. In the embodiments shown in FIGS. 1 to 8, the elastic part can be made of an elastic material having a Young's modulus (E). In practice, the elastic part can be made of an elastomer such as rubber, thermoplastic elastomer (TPE), polyethylene terephthalate (PET), etc. Ingeniously, the elastic part is made of a latex-based elastomer. Preferably, the elastic part is made of one low-irritant material such as a silicone-based elastomer. If the material of the elastic part has a risk of allergy, the elastic part can comprise a coating made of a low-irritant material with a Young's modulus (Er) less than or equal to the Young's modulus (E) and of the type of silicone-based elastomer. The elastic part can be in the shape of a ring as in the embodiments of FIGS. [FIG. 1] to [FIG. 3]. The ring can have a diameter of 3 mm to 10 mm and a cross-sectional diameter of 0.5 mm to 3 mm. In some embodiments, the elastic part can be in the form of a strip, a cylinder, or any other shape suitable for those skilled in the art. In other embodiments, the elastic part has a spring shape.
[0013] The Young's modulus (E) is less than 0.1 GPa. It is advantageous for the Young's modulus (E) to be between 0.001 GPa and 0.05 GPa. Preferably, the Young's modulus (E) is between 0.008 GPa and 0.03 GPa.
[0014] The elastic member (2) can comprise an opening configured to enable free movement of the jaws of the endoscopic hemoclip (202). The passageway can be an opening passing through the elastic member (2). In some embodiments, the passageway can be in the form of a cylindrical or annular insert shape, or any other shape suitable for those skilled in the art. In particular, the passageway can extend beyond a semi-circle with a diameter of 5 mm. When the elastic part of the elastic member (2) is ring-shaped, the opening of the ring can serve as the passageway.
[0015] The elastic part is configured to apply a pulling force to the distal anchor (4) and the proximal anchor (3) when the length (L) extends beyond the contraction length (Lc).
[0016] The proximal anchor (3) is attached so as to move between a minimum proximal distance and a maximum proximal distance with respect to the elastic member (2). The minimum proximal distance is preferably between 0 mm and 10 mm. The maximum proximal distance is preferably between 10 mm and 50 mm. As in the embodiment shown in FIG. 1, the proximal anchor (3) can be attached to move with respect to the elastic member (2) by a proximal thread (32). This can be made of cotton, polyester, nylon, or any other material suitable for those skilled in the art. The proximal thread can have a length between 10 mm and 50 mm. In some embodiments, the proximal anchor (3) can be attached to move with respect to the elastic member (2) by a flexible strip or a flexible rod.
[0017] The traction device (1) includes an adjustment member (6). This is configured to adjust the maximum proximal distance between an initial maximum proximal distance and a final maximum proximal distance less than the initial maximum proximal distance.
[0018] In the first embodiment of the adjustment member as shown in FIG. 1, the adjustment member (6) may comprise a clamp (61). The latter comprises a body (62) and a cage (63). The body (62) may have a cylindrical or parallelepiped outer shape, or any other shape outer shape suitable for those skilled in the art. The body (62) preferably has a diameter or thickness between 0.2 mm and 5 mm. The body (62) may have a length between 5 cm and 20 cm. The cage (63) is configured such that the body (62) can move freely and forms a closed curve with a variable circumference. The body (62) can have one or several visual marks, and each of these visual marks can indicate a predetermined circumferential length when the visual mark is located at the level of the cage (63). In particular, the visual mark can be a colored line along the body (62). In one embodiment, the visual mark can be a colored area along the body (62). Preferably, the clamp (61) has from 2 to 6 visual marks. The end of the body (62) opposite to the cage (63) may comprise a traction loop (64). This traction loop (64) is preferably configured to enable clamping fixation for endoscopic surgery (210). In particular, the traction loop (64) can have a diameter between 5 mm and 20 mm. The clamp (61) can be made of a plastic material, a composite material, or any other material suitable for those skilled in the art. The clamp (61) is preferably made of the low-irritation material described above. Ingeniously, the clamp (61) can be made of a shape memory material such as nitinol.
[0019] The clamp (61) can comprise a return prevention mechanism, which is configured to prevent the body (62) from sliding in the direction in which its circumferential length increases. The return prevention mechanism can be of any type suitable for those skilled in the art.
[0020] In particular, the return prevention mechanism is - such that the part of the body to which the return prevention hair or return prevention strip is fixed approaches the body (62) when it moves in the direction in which the circumferential length decreases within the cage (63). - When the part of the body with the anti-return hair or anti-return strip fixed thereto tends to move in the direction of increasing the circumferential length within the cage, it is to contact the cage (63) away from the body (62). It can be a flexible anti-return hair or anti-return strip arranged on the body (62) of the clamp (61).
[0021] In one embodiment, the anti-return mechanism can be a stop arranged along the body (62) and at least one flexible strip arranged within the cage (63), and at least one strip - When the body moves in the direction of decreasing the circumferential length within the cage (63), it moves away from the body (62) to pass through the stop. - When the body moves in the direction of increasing the circumferential length within the cage (63), it is configured to approach the body (62) to prevent passing through the stop.
[0022] In other embodiments, the anti-return mechanism includes a toothed part that moves within a cone formed by the cage (63), and the toothed part - When the body (62) moves in the direction of decreasing the circumferential length within the cage (63), they move away from each other so that the body (62) can move freely. - When the body tends to move in the direction of increasing the circumferential length within the cage (63), they move closer to each other so that the body cannot move freely within the cage, and pressure is applied to the body (62).
[0023] Referring to the embodiments shown in [Figures 1 to 3], the adjustment member (6) may also include a central guide (65) arranged on the elastic member (2). The central guide (65) is configured such that the body (62) of the clamp (61) can move freely. Some embodiments do not include a central guide, but the presence of the central guide (65) improves the adjustment function of the adjustment member (6).
[0024] As shown in FIGS. [FIGS. 1 to 3], the central guide (65) can be a ring attached to the elastic member (2). The central guide (65) can be an opening passing through the elastic member (2). In some embodiments, the central guide (65) can have the shape of a cylindrical or annular insert, or any other shape suitable for those skilled in the art. The central guide (65) can include a passage having a dimension greater than at least 0.2 mm, preferably greater than 0.5 mm, in the diameter or thickness of the body (62) of the clamp (61).
[0025] Also, the adjustment member (6) can include a proximal guide (66) configured such that the body (62) of the clamp (61) can move freely. The proximal guide (66) can be disposed on the proximal anchor (3). The proximal guide (66) can be of any type suitable for those skilled in the art.
[0026] In particular, when the proximal anchor (3) is formed of a thread, the proximal guide (66) can be in the form of a cylindrical or annular insert, or any other shape suitable for those skilled in the art.
[0027] Similarly, when the proximal anchor (3) is formed of a rigid material, the proximal guide (66) can be integrally formed with the body of the proximal anchor. And the proximal guide (66) can be in the shape of an opening located in the body of the proximal anchor (3), or can be in the form of a cylindrical, ring-shaped, or any other shape protruding from the body of the proximal anchor (3) towards the inside or outside of the proximal anchor.
[0028] In a particular embodiment, the opening (31) of the proximal anchor (3) functions as the proximal guide (66).
[0029] Alternatively, the proximal guide (66) can be arranged on the proximal thread (32). In particular, the proximal guide (66) can be arranged at the end of the proximal thread (32). As in the embodiments shown in FIGS. [FIG. 1] to [FIG. 8], the proximal guide (66) can also be arranged between two portions of the proximal thread (32). It is advantageous for the proximal guide (66) to be arranged near the proximal anchor (3). The proximal guide (66) can be in the form of a cylindrical or annular insert, or any other shape suitable for those skilled in the art. When the proximal anchor (3) is a strip, the proximal guide (66) can be in the form of an eyelet.
[0030] The proximal guide (66) can comprise a passage having a dimension that is at least greater than 0.2 mm, preferably greater than 0.5 mm, in the diameter or thickness of the body (62) of the clamp (61).
[0031] And in a first embodiment of this adjustment member (6), the clamp (61) is configured to reduce the maximum proximal distance when the circumferential length thereof is reduced.
[0032] In a second embodiment of the adjustment member (6) not shown, this can comprise a proximal coil, which is configured to wind up the proximal thread (32) when the pulling force acting on the proximal thread is less than the return force. The return force is preferably between 0.2 N and 1.8 N. In one embodiment, the proximal coil comprises a drum configured to receive the wound proximal thread (32). Also, the proximal coil comprises a casing to which the drum is attached so as to be rotatable freely. Finally, the proximal coil comprises a return spring, which is configured to start the wound proximal thread (32) around the drum when the pulling force acting on the proximal thread is less than the return force. The casing can be fixed to the elastic member (2). Ingeniously, in one embodiment, the return spring functions as the elastic member (2).
[0033] The distal anchor (4) can be attached so as to move between a minimum distal distance and a maximum distal distance relative to the elastic member (2). The minimum distal distance is preferably between 0 mm and 10 mm. The maximum distal distance is preferably between 10 mm and 50 mm. In a preferred embodiment of the distal anchor (4), the maximum distal distance is less than or equal to 1 / 3 of the maximum proximal distance. As shown in the embodiments illustrated in FIGS. 1 to 8, the distal anchor (4) can be attached so as to move relative to the elastic member (2) by a distal thread (42). This can be made of cotton, polyester, nylon, or any other material suitable for those skilled in the art. The distal thread (42) can have a length between 10 mm and 50 mm. In some embodiments, the distal anchor (4) can be attached so as to move relative to the elastic member (2) by a flexible strip or a flexible rod.
[0034] The adjustment member (6) can be configured to adjust the maximum distal distance between an initial maximum distal distance and a final maximum distal distance less than the initial maximum distal distance.
[0035] In a first embodiment of the adjustment member (6), it can include a distal guide (67) configured such that the body (62) of the clamp (61) can move freely. The distal guide (67) can be disposed on the distal anchor (4).
[0036] The distal guide (67) can be of any type suitable for those skilled in the art.
[0037] In particular, when the distal anchor (4) is formed of a thread, the distal guide (67) can be in the form of a cylindrical or annular insert, or any other shape suitable for those skilled in the art.
[0038] Similarly, when the distal anchor (4) is formed of a rigid material, the distal guide (67) can be formed integrally with the body of the distal anchor. The distal guide (67) can then be in the shape of an opening located on the body of the distal anchor (4), or can be cylindrical, ring-shaped, or any other arbitrary shape protruding from the body of the distal anchor (4) towards the inside or outside of the distal anchor.
[0039] In a particular embodiment, the opening (41) of the distal anchor (4) functions as the distal guide (67).
[0040] Alternatively, the distal guide (67) can be arranged on the distal thread (42). In particular, the distal guide (67) can be arranged at the end of the distal thread (42). The distal guide (67) can also be arranged between two portions of the distal thread (42), as in the embodiments shown in FIGS. [FIG. 1] - [FIG. 8]. In this case, it is advantageous for the distal guide (67) to be arranged near the distal anchor (4). The distal guide (67) can be in the form of a cylindrical or annular insert, or any other shape suitable for a person skilled in the art. When the distal anchor (4) is a strip, the distal guide (67) can be in the shape of an eyelet.
[0041] The distal guide (67) can comprise a passage having a dimension that is at least greater than 0.2 mm, preferably greater than 0.5 mm, in the diameter or thickness of the body (62) of the clamp (61).
[0042] In a first embodiment of this adjustment member (6), the clamp (61) can be configured to reduce the maximum distal distance as the circumferential length thereof decreases.
[0043] In a second embodiment of the adjustment member (6), not shown, this can comprise a distal coil which is configured to wind up the distal thread (42) when the traction force acting on the distal thread is less than the return force. The return force is preferably between 0.2 N and 1.8 N. In one embodiment, the distal coil comprises a drum configured to receive the wound distal thread (42). The distal coil also comprises a casing to which the drum is mounted so as to be able to rotate freely. Finally, the distal coil comprises a return spring which is configured to return the wound distal thread (42) around the drum when the traction force acting on the distal thread is less than the return force. The casing can be fixed to the elastic member (2). Advantageously, in one embodiment, the return spring functions as the elastic member (2). The elastic member (2) comprises several elastic parts, namely a return spring for the proximal coil and a return spring for the distal coil. Advantageously, the casing of the proximal coil and the casing of the distal coil form a single casing.
[0044] The proximal anchor (3) can be attached so as to move between a minimum spacing distance and a maximum spacing distance relative to the elastic member (4). The minimum spacing distance is preferably between 0 mm and 10 mm. The maximum spacing distance is preferably between 10 mm and 50 mm. In fact, according to all the embodiments described above for the distal anchor (4) and the proximal anchor (3), the proximal anchor (3) can move relative to the distal anchor (4).
[0045] And the adjustment member (6) can be configured to decrease the maximum spacing distance between an initial maximum spacing distance and a final maximum spacing distance which is shorter than the initial maximum spacing distance. In fact, according to all the embodiments described above for the adjustment member (6), the maximum spacing distance can be decreased.
[0046] As shown in FIGS. [FIG. 1] to [FIG. 10], the adjustment member (6) may comprise a clamping link (lien de serrage) (70) configured to maintain the cage (63) at a specific clamping distance from the distal anchor (4). The clamping distance is preferably between 0 mm and 20 mm. The clamping distance is preferably less than 5 mm. This clamping link (70) may be a thread between the cage (63) of the clamp (61) and the distal anchor (4). The thread can be made of cotton, polyester, nylon, or any other material suitable for those skilled in the art. Alternatively, the clamping link (70) may be a strip, rod, ring, or any other mechanical link suitable for those skilled in the art. And the clamping link (70) can be made of tissue, plastic, metal, or any other material suitable for those skilled in the art. The material of the clamping link (70) is hypoallergenic, and if not, the clamping link (70) preferably has a hypoallergenic coating.
[0047] In a variant of the embodiment in the clamping link, the adjustment member (6) can also comprise a clamping guide (guide de serrage), which is configured such that the body (62) of the clamp (61) can move freely and the cage (63) of the clamp remains between the distal guide (67) and the clamping guide.
[0048] The clamping guide can be arranged on the distal anchor (4). The clamping guide can be of any type suitable for those skilled in the art.
[0049] In particular, when the distal anchor (4) is made of a thread, the clamping guide can be in the form of a cylindrical or annular insert, or any other shape suitable for those skilled in the art.
[0050] Also, when the distal anchor (4) is made of a rigid material, the tightening guide can be made integrally with the body of the distal anchor (4). And the tightening guide can be in the shape of an opening located in the body of the distal anchor (4), or can be in a cylindrical, ring-shaped, or any other arbitrary shape protruding from the body of the distal anchor (4) towards the inside or outside of the distal anchor.
[0051] Alternatively, the tightening guide can be arranged on the distal thread (42). In this case, it is advantageous to arrange the tightening guide near the distal anchor (4). The tightening guide can be in the shape of a cylindrical or annular insert, or any other arbitrary shape suitable for those skilled in the art. When the distal anchor (4) is a strip, the tightening guide can be in the shape of an eyelet.
[0052] The tightening guide can also be arranged on the tightening thread (fil de serrage). This is fixed to the distal anchor (4). The tightening thread can be made of cotton, polyester, nylon, or any other material suitable for those skilled in the art. The tightening thread can have a length of 5 mm to 20 mm. In some variations of the embodiments, the tightening thread can be replaced with a flexible strip or a flexible rod. It is advantageous to arrange the tightening guide near the distal anchor (4). The tightening guide can be in the form of a cylindrical or annular insert, or any other arbitrary shape suitable for those skilled in the art.
[0053] The tightening guide can have a passage with a dimension that is at least greater than 0.2 mm, preferably greater than 0.5 mm, in the diameter or thickness of the body (62) of the clamp (61).
[0054] As in the embodiment shown in [Figure 2], the traction device (1) may include a second proximal anchor (3') of the same type as the above-described proximal anchor (3). This means that the second proximal anchor (3') has the same characteristics as the above-described proximal anchor (3), particularly in terms of shape, material, mobility, distance from other components, etc. In particular, the second proximal anchor (3') is provided with an opening (31'), and can be attached by a second proximal thread (32') so as to be able to move freely with respect to the elastic member. As described above, the elastic part of the elastic member (2) is configured to apply a traction force to the second proximal anchor (3') when its length (L) extends beyond the contraction length (Lc). Furthermore, the second proximal anchor (3') can be attached so as to move between a minimum front distance and a maximum front distance with respect to the above-described proximal anchor (3).
[0055] Similarly, the adjustment member (6) may be configured to adjust the second maximum proximal distance between a second initial maximum proximal distance and a second final maximum proximal distance less than the second initial maximum proximal distance. For this reason, in the selected embodiment, the adjustment member (6) may include a second proximal guide (66') or a second proximal coil. Also, the adjustment member (6) may be configured to adjust the maximum front distance between an initial maximum front distance and a final maximum front distance less than the initial maximum front distance.
[0056] Referring to the embodiment shown in FIG. 2, the adjustment member (6) may also comprise a second central guide (65') arranged on the elastic member (2). The second central guide (65') is of the same type as the central guide (65). This means that the second central guide (65') has the same characteristics as the central guide (65), particularly in terms of shape, material, position with respect to the elastic member (2), etc. For this reason, the second central guide (65') is configured such that the body (62) of the clamp (61) can move freely. The body (62) of the clamp (61) advantageously moves through the distal guide (67), then through the central guide (65), then through the proximal guide (66), then through the second proximal guide (66'), and then through the second central guide (65'). Alternatively, as shown in FIG. 2, the body (62) of the clamp (61) moves through the distal guide (67), then through the second central guide (65'), then through the second proximal guide (66'), then through the proximal guide (66), and then through the central guide (65).
[0057] As in the embodiment shown in FIG. [FIG. 3], the traction device (1) may further comprise one or more lateral anchors (5, 5'). The traction device (1) preferably comprises an even number of lateral anchors (5, 5'). For each pair of lateral anchors (5, 5'), one of the lateral anchors (5, 5') is located on one side of the traction device (1), and the other lateral anchor is located on the other side of the traction device.
[0058] The transverse anchors (5, 5') can be in the form of a circular loop, triangle, rectangle, or any shape suitable for one skilled in the art. This loop can be rigid, flexible or elastic. For example, the loop can be made of metal, plastic, latex, or any other material suitable for one skilled in the art. The loop can also be made of a thread made of cotton, polyester, nylon, or any other material suitable for one skilled in the art. The transverse anchors (5, 5') are preferably made of at least one of the low-irritancy materials described above. Ingeniously, the transverse anchors (5, 5') are provided with a low-irritancy coating made of at least one of the low-irritancy materials described above. The loop preferably has an opening (51, 51') configured to allow free movement of the jaws of the endoscopic hemoclip. In particular, the loop can be provided with an opening (51, 51') extending beyond a semi-circle with a diameter of 8 mm.
[0059] And the elastic part of the elastic member (2) can be configured to apply a pulling force to the transverse anchors (5, 5') when its length (L) extends beyond the contracted length (Lc).
[0060] The transverse anchors (5, 5') can be attached so as to move between a minimum transverse distance and a maximum transverse distance with respect to the elastic member (2). The minimum transverse distance is preferably between 0 mm and 10 mm. The maximum transverse distance is preferably between 10 mm and 50 mm. The transverse anchors (5, 5') can be attached so as to move with respect to the elastic member (2) by transverse threads (52, 52'). This can be made of cotton, polyester, nylon, or any other material suitable for one skilled in the art. The transverse threads (52, 52') can have a length between 10 mm and 50 mm. In a variation of some embodiments, the transverse anchors (5, 5') can be attached so as to move with respect to the elastic member (2) by a flexible strip or a flexible rod.
[0061] The adjustment member (6) can be configured to adjust the maximum lateral distance between the initial maximum lateral distance and the last maximum lateral distance less than the initial maximum lateral distance.
[0062] In its first embodiment, the adjustment member (6) can include lateral guides (68, 68') for each lateral anchor (5, 5'), and the lateral guides are configured such that the body (62) of the clamp (61) can move freely. The lateral guides (68, 68') can be arranged on the lateral anchors (5, 5'). The lateral guides can be of any type suitable for those skilled in the art.
[0063] In particular, when the lateral anchors (5, 5') are formed of a thread, the lateral guides (68, 68') can be in the form of a cylindrical or annular insert, or any other shape suitable for those skilled in the art.
[0064] Similarly, when the lateral anchors (5, 5') are formed of a rigid material, the lateral guides (68, 68') can be formed integrally with the lateral anchor body. And the lateral guides (68, 68') can be in the shape of an opening located in the body of the lateral anchor (5, 5'), or can be in a cylindrical, ring-shaped, or any other arbitrary shape protruding from the body of the lateral anchor (5, 5') towards the inside or outside of the lateral anchor.
[0065] In a specific embodiment, the openings (51, 51') of the lateral anchors (5, 5') function as the lateral guides (68, 68').
[0066] Alternatively, the lateral guides (68, 68') can be arranged on the lateral threads (52, 52'). Specifically, the lateral guides (68, 68') can be arranged at the ends of the lateral threads (52, 52'). The lateral guides (68, 68') can also be arranged between two portions of the lateral threads (52, 52'), as in the embodiment shown in [Figure 3]. In this case, it is advantageous for the lateral guides (68, 68') to be arranged near the lateral anchors (5, 5'). The lateral guides (68, 68') can be in the form of a cylindrical or annular insert, or any other shape suitable for those skilled in the art. When the lateral anchors (5, 5') are strips, the lateral guides (68, 68') can be in the form of eyelets.
[0067] The lateral guides (68, 68') can have a passage with a dimension that is at least greater than 0.2 mm, preferably greater than 0.5 mm, in the diameter or thickness of the body (62) of the clamp (61).
[0068] Referring to the embodiment shown in [Figure 3], the adjustment member (6) can also include a second central guide (65') arranged on the elastic member (2). The second central guide (65') is of the same type as the central guide (65). This means that the second central guide (65') has the same characteristics as the central guide (65) described above, particularly in terms of shape, material, position relative to the elastic member (2), etc. For this reason, the second central guide (65') is configured such that the body (62) of the clamp (61) can move freely. As shown in Figure 3, it is advantageous for the body (62) of the clamp (61) to pass through the distal guide (67), then through the central guide (65), then through the first lateral guide (68), through the proximal guide (66), then through the second lateral guide (68'), and then through the second central guide (65'). Alternatively, the body (62) of the clamp (61) can pass through the distal guide (67), then through the second central guide (65'), then through the second lateral guide (66'), through the proximal guide (66), then through the first lateral guide (66), and then through the central guide (65).
[0069] In the first embodiment of this adjustment member (6), the clamp (61) is configured to reduce the maximum lateral distance when the circumferential length thereof decreases.
[0070] In the second embodiment of the adjustment member (6), it can include a lateral coil, and the lateral coil is configured to wind up the lateral threads when the traction force acting on the lateral threads (52, 52') is smaller than the return force. The return force is preferably between 0.2 N and 1.8 N. In one embodiment, the lateral coil includes a drum configured to receive the wound lateral threads (52, 52'). The lateral coil also includes a casing to which the drum is attached so as to be rotatable freely. Finally, the lateral coil includes a return spring, and the return spring is configured to return the wound lateral threads (52, 52') around the drum when the traction force acting on the lateral threads is smaller than the return force. The casing can be fixed to the elastic member (2). Ingeniously, in one embodiment, the return spring functions as the elastic member (2). And the elastic member includes several elastic components, namely, a return spring for the proximal coil, a return spring for the distal coil, and a return spring for the lateral coil. Ingeniously, the casings of the proximal coil, the distal coil, and the lateral coil constitute a single casing.
[0071] The lateral anchors (5, 5') can be attached so as to move between a minimum lateral spacing distance and a maximum lateral spacing distance with respect to the distal anchor (4) and / or the proximal anchor (3). The minimum lateral spacing distance is preferably between 0 mm and 10 mm. The maximum lateral spacing distance is preferably between 10 mm and 50 mm. In fact, according to all the embodiments described above for the distal anchor (4), the proximal anchor (3), and the lateral anchors (5, 5'), the anchors can move relative to each other.
[0072] Next, the adjustment member (6) can be configured to make the maximum lateral spacing distance between the initial maximum lateral spacing distance and the final maximum lateral spacing distance smaller than the initial maximum lateral spacing distance. In practice, all the embodiments described above for the adjustment member (6) enable the reduction of the maximum lateral spacing distance.
[0073] Another aspect of the present invention relates to a method of traction of biological tissue (101) in a cavity by the traction device (1) according to the present invention. This method is usually performed in the resection surgery of mucosal biological tissue (101) having a tumor (102). The biological tissue (101) is usually located on the wall of the digestive tract (100). In this surgery, the boundary of the biological tissue (101) to be resected is cut off by an endoscopic resection device. FIG. [FIG. 4] shows the biological tissue (101) after its boundary (103) is cut. Then, the biological tissue (101) must be separated from the remaining wall of the digestive tract (100). For this purpose, a traction force needs to be applied to the biological tissue (101) to remove it from the remaining wall of the digestive tract (100). The submucosal tissue (104) composed of fibers can be stretched and exposed and can be resected with an endoscopic resection device (220). The traction process can apply a traction force to the biological tissue (101). The traction process includes the following steps. a) Fixing the proximal anchor (3) to the proximal part of the biological tissue (101) using the first endoscopic hemoclip (203); b) Fixing the distal anchor (4) to the distal part of the biological tissue (101) using the second endoscopic hemoclip (204); c) Fixing the elastic member (2) to the wall (105) of the cavity in front of the biological tissue (101) using the third endoscopic hemoclip (202), so that the elastic part of the elastic member (2) extends beyond the contraction length (Lc) and applies a traction force to the distal anchor (4) and the proximal anchor (3). And it includes.
[0074] When the biological tissue (101) has a proximal region exceeding 3 cm in width, this traction process also includes the following steps. d) It may include the step of using a hemostatic clip of another endoscope to separate the second proximal anchor (3') from the proximal anchor (3) fixed in step a) and fixing it to the proximal part of the biological tissue (101).
[0075] When the biological tissue (101) extends more than 8 cm in length and 5 cm in width, this traction process further includes the following steps according to the number of lateral anchors of the traction device: e) The step of using a hemostatic clip of another endoscope to fix the lateral anchors (5, 5') to the lateral part of the biological tissue (101) can be included at least once.
[0076] As shown in FIG. [FIG. 5], when the first step of the traction process is performed, the submucosal tissue (104) of the biological tissue (101) is sufficiently exposed. Then, the proximal part of the submucosal tissue (104) is resected by the resection device (220). However, as shown in FIG. [FIG. 6], when the proximal part of the submucosal tissue (104) is resected, the proximal part of the biological tissue (101) is no longer constrained by the submucosal tissue and relaxes. Therefore, the traction force applied to the biological tissue becomes insufficient to expose the submucosal tissue and allow the resection device (220) to pass through.
[0077] To solve this problem, the traction process includes the following steps: d) When the traction force applied to the proximal anchor (3) is less than the threshold value (Ts), it includes the step of reducing the maximum proximal distance by the adjustment member (6).
[0078] In the selected embodiment for the traction device (1), this process may also independently or in combination include the following steps: e) When the traction force applied to the distal anchor (4) is less than the threshold value (Ts), the step of reducing the maximum distal distance by the adjustment member (6); f) When the traction force applied to the second proximal anchor (3') is less than the threshold value (Ts), the step of reducing the second maximum proximal distance by the adjustment member (6); g) When the traction force applied to the lateral anchors (5, 5') is less than the threshold value (Ts), reducing the maximum lateral distance by the adjustment member (6); e) When the traction force applied to the proximal anchor (3) and / or the distal anchor (4) is less than the threshold value (Ts), reducing the maximum spacing distance by the adjustment member (6); f) When the traction force applied to one of the proximal anchor (3), and / or the distal anchor (4), and / or the lateral anchors (5, 5') is less than the threshold value (Ts), reducing the maximum spacing distance by the adjustment member (6); may be included.
[0079] In fact, the threshold value (Ts) is a value at which the cutting device (220) cannot move without touching the biological tissue (101). The threshold value (Ts) is usually between 0.2 N and 1.8 N.
[0080] Referring to Fig. [Fig. 7], the maximum proximal distance is reduced by pulling on the body (62) of the clamp (61), as a result of which the circumference length of the clamp is reduced. The pulling is performed by a clamp for endoscopic surgery (210).
[0081] Therefore, as shown in Fig. [Fig. 7], when the maximum proximal distance is reduced, the traction force applied to the biological tissue (101) becomes sufficient again to expose the submucosal tissue (104) and allow the cutting device (220) to pass through. Then, the exposed portion of the submucosal tissue (104) is excised. As described above, after excision, the biological tissue (101) relaxes and the traction force is not sufficient to continue the excision. And, as shown in Fig. [Fig. 8], step d) is repeated the required number of times.
[0082] Another aspect of the present invention relates to a placement device (300) for the traction device (1) of the present invention. Advantageously, the placement device (300) enables the traction device (1) to be placed on and pulled on the biological tissue (101), while preventing the risk of interference with the wall of the digestive tract (100), thereby preventing the risk of various movable anchors getting entangled.
[0083] Referring to FIGS. [FIG. 9] and [FIG. 10], the placement device (300) comprises a single tube (301). This tube comprises an internal space (302) configured to receive the traction device (1). The tube (301) may comprise a circular, rectangular, hexagonal or any other outer shape portion. The diameter, length or width of this portion may be between 30 mm and 70 mm. The tube (301) can be made of plastic, metal, or any other material suitable for those skilled in the art.
[0084] As shown in FIG. [FIG. 10], the placement device (300) also comprises a piston (303), which is configured to slide inside the tube (301) to push the traction device (1) out of the tube. This piston (303) can operate mechanically or by a pressure difference. The piston (303) can be made of plastic, metal, or any other material suitable for those skilled in the art.
Claims
1. A traction device (1) for biological tissue, - Proximal anchor (3), - Distal anchor (4), - An elastic member (2) having a length (L) and at least one elastic portion having a Young's modulus (E) of less than 0.1 GPa, wherein the elastic member is configured to apply a tensile force to the distal anchor (4) and the proximal anchor (3) when the length (L) is elongated beyond the contraction length (Lc), The proximal anchor (3) is attached to the elastic member (2) so as to move between a minimum proximal distance and a maximum proximal distance. The traction device is characterized by comprising an adjustment member (6) configured to adjust the maximum proximal distance between an initial maximum proximal distance and a final maximum proximal distance less than the initial maximum proximal distance. Traction device (1).
2. The distal anchor (4) is attached to the elastic member (2) so as to move between a minimum distal distance and a maximum distal distance. The traction device according to claim 1, characterized in that the adjusting member (6) is configured to adjust the maximum distal distance between the initial maximum distal distance and the last maximum distal distance which is less than the initial maximum distal distance.
3. The proximal anchor (3) is attached to the distal anchor (4) so as to move between a minimum distance and a maximum distance. The traction device according to claim 1 or 2, characterized in that the adjusting member (6) is configured to reduce the maximum spacing distance between an initial maximum spacing distance and a final maximum spacing distance that is less than the initial maximum spacing distance.
4. The traction device according to claim 1 or 2, characterized in that the elastic portion of the elastic member (2) has a Young's modulus between 0.001 GPa and 0.05 GPa.
5. The traction device according to claim 1 or 2, characterized in that the proximal anchor (3) is attached to the elastic member (2) by the proximal thread (32) so as to move.
6. The adjustment member (6) is - A clamp (61) comprising a body (62) and a cage (63), wherein the body is configured to move freely so as to form a closed curve having a circumference of variable length, - A central guide (65) is attached to the elastic member (2) and configured to allow the main body (62) of the clamp (61) to move freely, - A proximal guide (66) is attached to the proximal anchor (3) or the proximal thread (32), and is configured so that the main body (62) of the clamp (61) can move freely, - The traction device according to claim 5, characterized in that the clamp (61) is configured such that the maximum proximal distance decreases when the length of its circumference decreases.
7. The traction device according to claim 6, characterized in that the distal anchor (4) is attached to the elastic member (2) by the distal thread (42) so as to move.
8. The adjustment member (6) is a distal guide (67) attached to the distal anchor (4) or the distal thread (42), and comprises a distal guide (67) configured so that the main body (62) of the clamp (61) can move freely. The traction device according to claim 7, characterized in that the clamp is configured such that the maximum distal distance decreases when the length of its circumference decreases.
9. The traction device according to claim 8, characterized in that the adjusting member (6) comprises a tightening link (70) configured to maintain the cage (63) at a predetermined tightening distance from the distal anchor (4).
10. The traction device according to claim 6, characterized in that the clamp (61) is equipped with a return prevention mechanism configured to prevent the main body (62) from sliding in a direction that increases the length of its circumference.