Elastic ligation device

Abstract

Elastic ligation devices enable a clinician to deploy multiple ligation bands without the assistance of a hand assistant and without the need for an external suction device. The ligation bands can be loaded into the distal end of the ligation device by a detachable loading device, and a pusher can be provided to advance the ligation bands from the loading device onto the ligation device. A loading kit can be provided to enable two, three, or more ligation bands to be loaded consecutively onto the same ligation device in a single procedure. Related methods are also disclosed.

Description

Cross-reference of relevant priority claims

[0001] This application is a continuation-in-part of U.S. Application No. 18 / 395,283, filed December 22, 2023, which claims priority to U.S. Provisional Patent Application No. 63 / 504,367, filed May 25, 2023, the entire contents of each of the above applications are incorporated herein by reference. All applications that, at the time of filing this application, specify in the Application Data Sheet that claim foreign or domestic priority, are hereby incorporated herein by reference. Technical Field

[0002] This disclosure relates to the treatment of hemorrhoids by elastic ligation. More specifically, this disclosure relates to an elastic ligation device equipped with an improved elastic band loading assembly. Background Technology

[0003] Elastic ligation for hemorrhoid treatment typically involves placing an elastic band on the hemorrhoidal tissue below the dentate line (the junction of the sensitive squamous epithelium called the anal membrane and the insensitive inner lining of the rectum called the mucosa), an area with fewer sensory nerves. The tissue encased in the elastic band has its blood supply cut off, gradually degenerates, and sloughs off. The elastic band is then expelled with the sloughed tissue during bowel movements. More importantly, the subsequent healing process stabilizes nearby tissue, minimizing hemorrhoidal prolapse. This tissue stabilization helps eliminate hemorrhoid symptoms.

[0004] O'Regan's U.S. Patent No. 5,741,273 discloses an elastic ligation device for treating hemorrhoids that can be used without direct observation of the ligation site. Therefore, it eliminates the need for a proctoscopy, anoscope, or any other type of endoscopy or observation technique. Because the device can be inserted into the rectum and accurately positioned without simultaneous visualization or any endoscopic assistance, ligation procedures performed in this manner reduce patient discomfort. This technique also allows the elastic band to be placed more proximally, thereby improving treatment effectiveness while reducing discomfort and complications. The device incorporates a suction device that draws hemorrhoidal tissue into the ligation hole, eliminating the need for a second operator or external suction.

[0005] The standard procedure for ligation surgery is as follows: First, the lesion site is examined using a sigmoidoscope, anoscope, rectoscope, or other type of endoscope, and the optimal placement area for the elastic band is mentally noted. Then, the endoscope is removed, and the ligation device is inserted into the rectum. This method is known as the "blind method" or "tactile method."

[0006] Another application method involves observing the lesion area through an anoscope and directly ligating the ligation device through the anoscope's cavity. This method can be used if the operator prefers direct visualization. This method is known as the "transanoscopy" or "direct visualization method."

[0007] Insert the distal end of the device well beyond the ligation site. Then, gently withdraw the device towards the anal canal, minimizing patient discomfort. Upon withdrawal, the operator will feel a palpable bulge on the outer side of the tubular component at the anal verge; this bulge serves as a reference for the optimal placement of the elastic band within the rectum. Next, gently tilt or "aim" the device at the hemorrhoid to be treated. For larger patients, the operator may insert the device 1-2 cm further into the anus before aiming at the hemorrhoid. In all cases, apply ample lubricant to the device with the elastic band to reduce patient discomfort.

[0008] A problem with the aforementioned types of devices is the loading of the elastic band onto the ligation device. The optimal loading time is in the clinical setting, as pre-loading the elastic band during manufacturing can cause it to lose its elasticity after stretching. In the clinical setting, the small elastic band of the O'Regan device must be manually pushed upwards along the conical loading device by a gloved physician or assistant until it reaches the distal end of the ligation device. This operation expands the elastic band to the required diameter to fit the end of the O'Regan device. However, due to the lubricant coating on the device surface, the operating environment is slippery, making the manual pushing of the small elastic band along the loading cone difficult and time-consuming. Summary of the Invention

[0009] This disclosure provides a single-operated elastic ligation device, which is an integral (self-contained) device containing all the necessary components for ligating internal hemorrhoids, including a suction function for drawing hemorrhoidal tissue into a cylindrical body and a ligation function for placing an elastic band around the hemorrhoidal tissue. The elastic band is expanded and positioned around the front end of an inner tubular component. By advancing an outer sleeve along the inner tubular component, the elastic band can be released and looped over the hemorrhoidal tissue drawn into the inner tubular component.

[0010] In one embodiment, the ligation device is a single-use device that can be discarded after use.

[0011] In one embodiment of the invention, a pusher is provided for loading an elastic band onto a ligation device. The pusher includes: a base; at least two arms extending proximally from the base, the arms being radially inwardly inclined in a proximal direction and defining a proximal opening; the arms being movable between a first position defining a first diameter of the opening, and a second position being a radially outwardly deflected position that defines a second opening of a larger diameter in response to distal advancement of the loading device within the pusher.

[0012] The pusher may also include an elastic band carried by the arm for biasing the arm to the first position.

[0013] In some embodiments, the arm of the pusher may have a predetermined and variable stiffness to apply a biasing force that radially compresses the arm to the first position.

[0014] In some embodiments, the arm of the pusher may be provided with a feature that engages the elastic band, which causes the elastic band to expand radially as the loading device advances axially.

[0015] In some embodiments, the engagement structure prevents the elastic band from rolling and twisting, and enables true radial expansion before the elastic band is released.

[0016] The pusher may include two, three, four, or more arms. The base may include radially outwardly extending protrusions, such as annular flanges. The arms may be integrally formed with the base. The distal end of each arm may be provided with a ligature engagement structure for rolling the ligature along the loading device. The ligature engagement structure may include a ramp facing the distal side.

[0017] The base may be provided with a hole communicating with a proximal opening through a central cavity defined by the arm. The hole may be provided with a rotary alignment structure configured to engage with a complementary alignment structure on the loading device. The alignment structure may include a keyway, such as a radially inwardly extending protrusion or a radially outwardly extending groove formed in the base near the hole.

[0018] This disclosure also provides a loading device configured to load an elastic band onto a ligation device. The loading device includes: a body having a proximal end and a distal end, the diameter of the body gradually increasing from the distal end to the proximal end; an engagement structure carried by the proximal end and configured to releasably engage with the distal end of the ligation device; and an axially extending guide disposed along a surface of the body for rotational engagement with an elastic band pusher, while allowing axial relative movement between the loading device and the pusher.

[0019] The engagement structure may include a proximal protrusion configured to be removably received within a distal aperture of the ligation device. The loading device may also include a ligation band carried near the distal end of the loading device.

[0020] This disclosure also provides a ligation device loading kit, which includes a pusher, a loading device, and at least one ligation strap. The ligation strap can be pre-loaded onto the loading device. The ligation device loading kit may further include a ligation device configured to be detachably connected to the loading device. The kit may include at least three loading devices and at least three ligation straps.

[0021] This disclosure also provides a method for loading a ligation band onto a ligation device. The method includes the steps of: removably connecting a proximal end of a loading device to a distal end of the ligation device, the loading device carrying the ligation band; positioning the distal end of the loading device within the proximal end of a pusher; and advancing the ligation device distally relative to the pusher, causing the pusher to advance the ligation band proximally along the loading device and load it onto the ligation device. The proximal end of the pusher may be provided with a ligation band engagement structure that causes the ligation band to roll along the loading device during the advancement step. The pusher may also be configured to prevent the ligation band from rolling, allowing only radial expansion.

[0022] In some embodiments, the system may include multiple loading devices to facilitate use when the device is contaminated or coated with lubricant.

[0023] In some embodiments, the pusher and loading frame may be provided with a structure to prevent reuse.

[0024] In some embodiments, the elastic band may contain latex or be a latex-free elastic band.

[0025] In some embodiments, the elastic band may be specifically configured and stored on the loading device to maximize its shelf-life stability. The pre-expansion range may be 5%-50%, with an optimal stretch of 25%.

[0026] In some embodiments, the device may be packaged and delivered in a sterile or non-sterile configuration.

[0027] In some embodiments, the elastic band and loading device may be configured for single use, while the conveying device may be packaged separately.

[0028] In some embodiments, the elastic band and components may be color-coded to identify whether they contain latex.

[0029] In some embodiments, the expanded elastic band may be packaged using a moisture-proof packaging system to prevent degradation of the elastic band.

[0030] In some embodiments, the expanded elastic band may be packaged in UV-resistant packaging to prevent the elastic band from being exposed to ultraviolet light and degrading.

[0031] In some embodiments, the expanded elastic band may be packaged using vacuum-sealed, inert gas-purged packaging to prevent oxidation and degradation of the elastic band.

[0032] This disclosure also provides a method for treating a patient. The method includes the following steps: providing a ligation device with a first ligation band deployed into the patient; connecting a loading device to a distal end of the ligation device; advancing a second ligation band distally along the loading device relative to a pusher, thereby causing the pusher to advance the second ligation band along the loading device and load it onto the ligation device; removing the loading device from the ligation device; and deploying the second ligation band into the patient.

[0033] The disposable elastic ligation device can be used in a doctor's office and typically does not require any form of anesthesia. One to three elastic bands are usually placed during each patient visit; in more severe cases, up to six elastic bands may be required in total. In one embodiment, the ligation device is made of plastic and is for single use only, thus it can be discarded after use without sterilization. In another embodiment, the ligation device is made of metal and can be sterilized after each use for reuse. Brief description of the attached figures

[0034] The following description will be made in conjunction with the accompanying drawings, which are intended to illustrate certain embodiments of the present disclosure and not to limit the scope of the disclosure.

[0035] Figure 1 This is a cross-sectional front view of an elastic ligation device according to an embodiment of the present disclosure;

[0036] Figure 2 yes Figure 1 End view of the ligation device shown;

[0037] Figure 3 This is a partial cross-sectional front view of a conical loading device used to expand an elastic band when it is loaded onto a ligation device.

[0038] Figure 4 Is with Figure 1 A cross-sectional front view of a similar flexible ligation device, which includes an occluder;

[0039] Figure 5 This is a partial front view of the inner tubular component of the flexible ligation device, which has an inclined front end;

[0040] Figure 6 This is a perspective view of one embodiment of the ligation device;

[0041] Figure 7 It is used to load elastic bands into Figure 6 A perspective view of one embodiment of the loading device on the ligation device shown;

[0042] Figures 8A-8B It is a 3D diagram of an elastic band pusher;

[0043] Figure 9A and 9B yes Figures 8A-8B The pusher shown is positioned above the far end of the loading device in a 3D view.

[0044] Figure 10 A kit is schematically shown, which includes a pusher and multiple loading devices, each of which can be preloaded with a small-diameter configured elastic band;

[0045] Figure 11 This is a perspective view of an elastic ligation device according to another embodiment of the present disclosure;

[0046] Figure 12 yes Figure 11 A three-dimensional cross-sectional view of the elastic ligation device shown.

[0047] Figure 13 This is a perspective view of an elastic ligation device according to another embodiment of the present disclosure;

[0048] Figure 14 yes Figure 13 A three-dimensional cross-sectional view of the elastic ligation device shown.

[0049] Figure 15 This is a partial exploded perspective view of an elastic ligation device according to another embodiment of the present disclosure;

[0050] Figure 16 This is another perspective view of an elastic ligation device according to another embodiment of the present disclosure;

[0051] Figure 17 yes Figure 16 Cross-sectional view of the elastic ligation device shown.

[0052] Figure 18 This is a perspective view of an elastic band pusher according to another embodiment of the present disclosure;

[0053] Figure 19 A ligature loading cone according to an embodiment of the present disclosure is shown;

[0054] Figure 20 A ligature loading rack according to one embodiment of the present disclosure is shown;

[0055] Figure 21 The ligature loading process and interface according to one embodiment of the present disclosure are illustrated;

[0056] Figure 22 A cross-section and details of a ligature loading process and interface according to an embodiment of the present disclosure are shown;

[0057] Figure 23 This is another perspective view of an elastic ligation device according to another embodiment of the present disclosure;

[0058] Figure 24 This is another perspective view of an elastic ligation device assembly according to another embodiment of the present disclosure;

[0059] Figure 25 This is another perspective view of a complete flexible ligation device system according to another embodiment of the present disclosure;

[0060] Figure 26 This is another perspective view of a complete flexible ligation device system according to another embodiment of the present disclosure;

[0061] Figure 27 This is another perspective view of a partially exploded elastic ligation device system according to another embodiment of the present disclosure;

[0062] Figure 28 This is another perspective view of a fully disassembled elastic ligation device system according to another embodiment of the present disclosure;

[0063] Figure 29 This is a side view of an elastic ligation device according to another embodiment of the present disclosure, with the cross-sectional cutting positions marked in the figure;

[0064] Figure 30 yes Figure 29 A cross-sectional view;

[0065] Figure 31 yes Figure 30 A close-up view of the cross-section. Detailed Implementation

[0066] In one embodiment, the flexible ligation device of this disclosure is made of plastic, which may be transparent or opaque, and is for single use. In another embodiment, the ligation device is made of stainless steel and can be sterilized after each use. Figure 1As shown, the ligation device 10 has an inner tubular component 12, the front end 14 of which is circular, obliquely cut, or rounded, and the diameter of its opening 15 is slightly smaller than the diameter of the inner tubular component 12. The inner tubular component 12 may be slightly tapered, with its diameter gradually increasing as it extends rearward from the front end 14. In another embodiment, the inner tubular component 12 may be cylindrical without a tapered structure. The length of the inner tubular component 12 is sufficient to be inserted into the patient's rectum to treat hemorrhoidal tissue. The inner tubular component 12 is integrally formed with a plunger housing 16, within which a plunger 18 is disposed, so that when the plunger 18 moves rearward within the plunger housing 16, a suction force is generated at the opening 15 of the front end 14. In another embodiment, the plunger housing 16 and the inner tubular component 12 may be separate components connected together.

[0067] A stretched elastic band 20 (also referred to as a rubber band in some cases) is positioned on the inner tubular component 12 near the front end 14. An outer tubular push sleeve 22 is fitted onto the inner tubular component 12 and forms a limited frictional engagement with it. When the outer tubular push sleeve 22 is pushed forward toward the front end 14 of the inner tubular component 12, the elastic band is pushed away from the front end 14 of the inner tubular component 12 and fits onto the hemorrhoidal tissue sucked into the opening 15 at the front end of the inner tubular component 12.

[0068] like Figure 2 As shown, the outer tubular push sleeve 22 is provided with a longitudinal slit 24, so the sleeve is actually a clamp structure wrapped around the inner tubular component 12. In another embodiment, the push sleeve 22 is a tubular structure that can be slidably fitted onto the inner tubular component 12. A partial push flange 26 extending from the end of the push sleeve 22 is provided on one side of the outer tubular push sleeve 22. The push flange 26 facilitates the operator to push the push sleeve 22 with their thumb, thereby releasing the elastic band 20 from the front end 14 of the inner tubular component 12. A first raised step 28 and a second raised step 30 are provided on the side of the push sleeve 22 near the push flange 26. These steps allow the operator to locate the ligation device 10 by sight or touch. In one embodiment, longitudinal ribs (not shown) are provided on the inner side of the push sleeve 22 to increase friction and ensure that the push sleeve does not slide freely on the inner tubular component 12, but only moves when pushed by the operator.

[0069] The plunger housing 16 is generally cylindrical, without a tapered structure, and its outer shoulder 32 facilitates the operator's grip on the housing 16 when pulling the plunger 18 backward. The plunger 18 is connected to a rod 34, the cross-section of which is shown below. Figure 1 As shown, its shoulder 36 can be used as a grip to pull the plunger 18 out of the housing 16, thereby generating suction through the opening 15 of the front end 14 of the inner tubular member 12.

[0070] The first shoulder ring 37, located near the end of the housing 16, acts as a locking system. When the plunger 18 is pulled back and passes the first shoulder ring 37, it is held in that position, thus maintaining a vacuum within the housing 16 and the inner tubular component 12. Without this locking system, the plunger 18 would immediately return to its initial position, making it impossible to maintain a vacuum to draw hemorrhoidal tissue into the inner tubular component 12. The second shoulder ring 38, located outside the first shoulder ring 37, acts as a limiter, preventing the plunger 18 from being completely pulled out of the housing 16.

[0071] Although the figure shows shoulder rings 37, 38 for locking the plunger 18 within the housing 16, those skilled in the art will understand that other types of clamping systems may also be used to prevent the plunger 18 from retracting within the housing 16.

[0072] The procedure is as follows: After examining the patient's rectum and determining the location of the hemorrhoids, the doctor removes the endoscope used for preliminary examination, remembers the location of the hemorrhoids, and then inserts... Figure 1 The ligation device is shown. Positioning the opening 15 of the inner tubular component 12's front end 14 as close as possible to the hemorrhoidal tissue, the operator holds the housing 16 and pulls the plunger 18 backward past the first shoulder ring 37, creating a vacuum within the housing 16. The hemorrhoidal tissue is then drawn into the inner tubular component 12 through the opening 15. After completing these steps, the doctor releases the shoulder 36 of the plunger 18 and pushes the outer plastic push sleeve 22 forward, causing the stretched elastic band 20 to be pushed away from the front end 14 of the inner tubular component 12, thus encasing the hemorrhoidal tissue. The ligation device can then be removed. This procedure can be performed at least three times during a single patient visit. This ligation device does not require connection to a suction device or other equipment; its built-in plunger mechanism draws the hemorrhoidal tissue into the inner tubular component 12 and holds it in position, facilitating the doctor's placement of the elastic band.

[0073] Figure 3 A conical loading device 40 is shown, which has a thin sleeve 42 that overlaps with the front end 14 of an inner tubular member 12. An elastic band 20 is pushed across the loading device 40 and expanded during movement until it is pushed off the sleeve 42 and onto the front end 14 of the inner tubular member 12. The loading device 40 is then removed, and the elastic band is moved to… Figure 1 The location shown.

[0074] The thin sleeve 42 of the loading device 40 can prevent the elastic band from getting stuck at the connection between the loading device 40 and the inner tubular component 12.

[0075] In another embodiment, a blocker 44 is provided, which is as follows: Figure 4As shown, it can be fitted inside the inner tubular component 12. The occluder 44 has a button-shaped front end 46 that protrudes slightly from the opening 15 of the front end 14 of the inner tubular component 12. The function of the occluder 44 is to improve the passage of the ligation device 10 when it is inserted into the rectum. It prevents the edge of the opening 15 of the front end 14 from catching on the hemorrhoidal tissue, thereby reducing patient discomfort. The plunger 18 abuts against the outer end of the occluder 44 and applies a pushing force to it, keeping the occluder 44 in place during the insertion of the device into the rectum. After the ligation device 10 is positioned, the doctor pulls the plunger 18 backward, and the occluder 44 moves backward with the plunger 18, exposing the opening 15 of the front end 14 of the inner tubular component 12. The hemorrhoidal tissue is then drawn into the inner tubular component 12 through the opening 15.

[0076] like Figure 1 As shown, the distal end 14 of the inner tubular component 12 has rounded or chamfered corners, allowing the physician to insert the ligation device 10 at any angle without snagging tissue or causing discomfort to the patient. The ligation device 10 can be made in different sizes, with the inner diameter of the inner tubular component 12 preferably being 8 mm, 10 mm, or 12 mm. The opening 15 is typically about 0.5 to 1 mm smaller than the inner diameter of the inner tubular component to form a rounded edge at the distal end 14. The occluder 44 is typically used in larger ligation devices but can also be included in devices of all sizes.

[0077] In another embodiment, such as Figure 4 As shown, the front end 14 of the inner tubular component is inclined and not perpendicular to the axis of the inner tubular component 12. This inclined front end 14 and opening 12 facilitate the placement of the ligation device on the rectal sidewall to encircle the hemorrhoidal tissue.

[0078] The following will combine Figures 6 to 10 The ligature loading device of the present invention will be described in detail. Loading device 40 ( Figure 7 The loading device 40 is configured to be removably connected to the distal (front end) 14 of the ligation device 10. The loading device 40 includes an elongated, ramp-shaped or tapered body 50, the outer diameter of which gradually increases from the distal end 52 to the proximal end 54. The proximal end 54 may be provided with a ligation device engagement structure 56, such as an axially proximal protrusion 58, for removable insertion into the distal opening 15 on the ligation device 10. The loading device 40 is configured to allow the elastic band to advance proximally along the ramp surface, causing the elastic band to gradually expand radially until it advances proximally past the proximal end 54 of the loading cone 40 and reaches the placement area of ​​the distal end of the inner tubular member 12.

[0079] To facilitate the proximal advancement of the elastic band 20 along the cone 40 and its loading onto the inner tubular component 12, a pusher 62 is provided, one embodiment of which is as follows: Figures 8A-8BAs shown. The pusher 62 includes a base 64 that supports a loading frame 66 extending between a distal end 70 and a proximal end 68 connected to the base 64. The loading frame 66 includes at least one, preferably two, three, four or more arms 72 that are radially inwardly inclined in a proximal direction. The arms 72 surround to form a central cavity that extends through the entire length of the loading frame 66 to a proximal opening 74. The proximal ends of the arms 72 may be... Figure 8A and 8B The small-diameter configuration shown is radially outwardly movable between the radially expanded large-diameter configuration discussed below. Arm 72 is pivotally fixed to base 64 and / or made of a flexible material, such as various medical-grade polymers. Preferably, arm 72 is biased to the small-diameter configuration and may carry an elastic retaining band 76 to provide greater radially inward biasing force.

[0080] In use, the loading device 40 is connected to the distal end of the ligation device 10, for example by pushing the axial proximal extension 58 into the opening 15 on the ligation device 10 (see...). Figure 9A and 9B The elastic ligature 20 is supported on the distal end of the conical body 50 of the loading device 40.

[0081] Position the distal end 52 of the loading device 40 within the proximal end 68 of the pusher 62 such that the elastic band 20 carried by the conical body 50 contacts the proximal end 68 of the loading frame 66.

[0082] Subsequently, the loading device 40 is axially advanced into the loading frame 66, causing the arm 72 to deflect radially outward to accommodate the gradually increasing diameter of the tapered body 50 extending therein. This can be achieved by abutting the base 64 against a table or other surface and pushing the ligation device distally. The distal surface of the arm 72 pushes the elastic band proximally along the sloping surface of the tapered body 50 until the elastic band is positioned on the outer surface of the inner tubular component 12. Afterward, the pusher 62 and the loading device 40 can be detached from the ligation device 10, at which point the ligation device is ready for ligation surgery.

[0083] Although this disclosure has been described in the context of specific embodiments and examples, those skilled in the art will understand that the scope of this disclosure is not limited to the specific embodiments disclosed above, but also covers other alternative embodiments, uses, and obvious modifications and equivalents. Furthermore, while various variations of this disclosure have been shown and described in detail, those skilled in the art will understand that other modifications are also within the scope of this disclosure. It should also be considered that various combinations or sub-combinations of specific features and aspects of the embodiments can be made, and these combinations are still within the scope of this disclosure. For example, a feature described above in conjunction with one embodiment can be used in conjunction with another embodiment described herein, and such combination is still within the scope of this disclosure. It should be understood that various features and aspects of the disclosed embodiments can be combined or substituted with each other to form different forms of embodiments of this disclosure. Therefore, the scope of this disclosure should not be limited to the specific embodiments described above. Therefore, unless otherwise stated or obviously contradicted, each embodiment of the invention may include one or more features of each of the other embodiments disclosed herein, in addition to the essential features described herein.

[0084] Features, materials, characteristics, or groups described in connection with a particular aspect, embodiment, or example should be understood to be applicable to any other aspect, embodiment, or example described in this section or elsewhere in this specification, unless incompatible with them. All features disclosed in this specification (including any appended claims, abstracts, and drawings) and / or all steps of any disclosed method or process may be combined in any combination, unless at least some of these features and / or steps are mutually exclusive. The scope of this disclosure is not limited to the details of any of the foregoing embodiments. The scope of this disclosure extends to any new feature or any new combination of features disclosed in this specification (including any appended claims, abstracts, and drawings), or to any new step or any new combination of steps of any disclosed method or process.

[0085] Furthermore, certain features described in this disclosure in the context of individual embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments. Moreover, although features may be described in the foregoing description as functioning in a particular combination, in some cases, one or more features may be deleted from the claimed combination, and the claimed combination may refer to a sub-combination or a variation of a sub-combination.

[0086] Furthermore, although operations may be shown in the accompanying drawings or described in a specific order in the specification, these operations need not be performed in the specific order or sequence shown, nor need all operations be performed to achieve the desired result. Other operations not shown in the drawings or described in the specification may be incorporated into exemplary methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any described operations. Furthermore, in other embodiments, operations may be rearranged or reordered. Those skilled in the art will understand that in some embodiments, the actual steps in the processes shown in the drawings and / or described in the specification may differ from the steps shown. According to embodiments, some steps described above may be deleted, and others may be added. Moreover, the features and properties of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of this disclosure. Similarly, the separation of various system components in the above embodiments should not be construed as requiring such separation in all embodiments; it should be understood that the described components and systems can generally be integrated in a single product or packaged into multiple products.

[0087] For the purposes of this disclosure, certain aspects, advantages, and novel features have been described herein. However, not all of these advantages need to be achieved in any particular embodiment. Therefore, for example, those skilled in the art will recognize that this disclosure may be implemented or performed in a manner that achieves one or a set of advantages taught herein, without necessarily achieving other advantages that may be taught or implied herein.

[0088] Unless otherwise expressly stated, or understood in the context of use, conditional language such as “may,” “possibly,” “perhaps,” or “can” is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Therefore, such conditional language is not generally intended to imply that one or more embodiments necessarily require these features, elements, and / or steps, or that one or more embodiments must include logic for determining whether such features, elements, and / or steps are included in any particular embodiment or whether they are to be performed, with or without user input or prompting.

[0089] Unless otherwise explicitly stated, connective language such as “at least one of X, Y, and Z” is generally understood to convey, in the context of use, that an item, term, etc., may be X, Y, or Z. Therefore, such connective language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0090] The degree terms used herein, such as “approximately,” “around,” “usually,” and “substantially,” indicate values, quantities, or characteristics that are close to the stated value, quantity, or characteristic but still achieve the desired function or result. For example, the terms “approximately,” “around,” “usually,” and “substantially” may refer to a range of less than 10%, less than 5%, less than 1%, less than 0.1%, or less than 0.01% of the stated quantity. As another example, in some embodiments, the terms “generally parallel” and “substantially parallel” refer to deviations from perfect parallelism of less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degrees, or other values. Furthermore, the term “gradual” as used herein has its usual meaning (e.g., distinct from discontinuous changes, such as step changes).

[0091] The scope of this disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or specification, but is defined by the claims set forth in this section or specification or by any future claims. The language of the claims should be interpreted broadly based on the language used in the claims and is not limited to the examples described in this specification or discussed during the examination of the application; these examples should be interpreted as non-exclusive.

Claims

1. A pusher for loading an elastic band onto a ligation device, comprising: Base; At least two arms extending proximally from the base, the arms being radially inwardly inclined in the proximal direction and defining a proximal opening; as well as The arm is movable between a first position and a second position, the first position defining a first diameter of the opening, and the second position being a radially outwardly deflected position that defines a second opening of a larger diameter in response to the loading device within the pusher being advanced distally.

2. The pusher according to claim 1, further comprising an elastic band carried by the arm for biasing the arm toward the first position.

3. The pusher according to claim 1, comprising three arms.

4. The pusher according to claim 1, wherein, The base includes a radially outwardly extending flange.

5. The pusher according to claim 4, wherein, The arm is integrally formed with the base.

6. The pusher of claim 3, further comprising a hole in the base, the hole communicating with the proximal opening through a central cavity defined by the arm.

7. The pusher of claim 6, further comprising a rotational alignment feature configured to engage with a complementary alignment feature on the loading device.

8. The pusher according to claim 7, wherein, The alignment feature includes a keyway formed in the base near the hole.

9. The pusher according to claim 7, wherein, The alignment feature includes a protrusion formed in the base near the hole.

10. The pusher of claim 3, further comprising a ligature engagement structure at the distal end of the arm for rolling the ligature along the loading device.

11. The pusher according to claim 10, wherein, The ligature joint structure includes a slope facing the distal side.

12. A loading device for loading an elastic band onto a ligation device, comprising: A body having a proximal end and a distal end, the diameter of the body gradually increasing from the distal end to the proximal end; A coupling structure, the coupling structure being carried by the proximal end, configured to releasably engage with the distal end of the ligation device; An axially extending guide, disposed along a surface of the body, is configured for rotational engagement with an elastic band pusher, while allowing axial relative movement between the loading device and the pusher; and The loading device described herein is capable of precisely controlling the radial expansion of the elastic band to a specified percentage; The loading device described herein can have a larger radial dimension in the axial direction; The loading device described therein is capable of being isolated from environmental conditions.

13. The loading device according to claim 12, wherein, The engagement structure includes a proximal protrusion configured to be removably received within a distal aperture of the ligation device.

14. The loading device of claim 12, further comprising a ligature strap carried near the distal end.

15. A ligation device loading kit, comprising the pusher of claim 1, the loading device of claim 12, and at least one ligation strap.

16. The ligation device loading kit according to claim 15, wherein, The ligature is carried by the loading device.

17. The ligation device loading kit of claim 15, further comprising a ligation device configured to be detachably connected to the loading device.

18. The ligation device loading kit of claim 15, comprising at least three loading devices and at least three ligation straps.

19. A method for loading a ligation band onto a ligation device, comprising the following steps: The proximal end of the loading device is removably connected to the distal end of the ligation device, the loading device carrying the ligation strap; Positioning the distal end of the loading device within the proximal end of the pusher; and The ligation device is advanced distally relative to the pusher, causing the pusher to advance the ligation band proximally along the loading device and load it onto the ligation device.

20. The method of loading a ligature according to claim 19, wherein, The ligature engagement structure on the proximal end of the pusher causes the ligature to roll along the loading device during the propulsion step.

21. A method of treating a patient, comprising the following steps: Provides a ligation device with a first ligature already deployed inside the patient; Connect the loading device to the distal end of the ligation device; By advancing the loading device distally relative to the pusher, the second ligation band is advanced distally along the loading device, thereby causing the pusher to advance the second ligation band along the loading device and load it onto the ligation device; Remove the loading device from the ligation device; as well as The second ligature is deployed inside the patient's body.

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