Systems, devices and methods for treating hemorrhoids
By designing a device for internal hemorrhoids, using the elongated shell and gripping arm combined with a negative fluid pressure source, the problem of difficult treatment of internal hemorrhoids is solved, achieving a more comfortable and effective therapeutic effect.
Patent Information
- Application Number
- CN202080053002.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-07-22
- Filing Date
- 2020-07-21
- Publication Date
- 2024-12-17
- Estimated Expiration
- 2040-07-21
AI Technical Summary
Internal hemorrhoids are difficult to treat, and existing treatments may cause discomfort in patients.
A device including an elongated shell, a handle and an internal elongated member is designed, equipped with a tissue gripping and ligation mechanism to restrain hemorrhoid tissue by inserting into the target part of the rectum, using a gripping arm and a ligation tie to combine with negative fluid pressure The source is to pull and restrain hemorrhoids, reducing discomfort during healing.
Effective treatment of internal hemorrhoids reduces the discomfort of patients during the treatment process and improves the comfort and effectiveness of treatment.
Smart Images

Figure CN114144127B_ABST
Abstract
Description
[0001] Priority claim
[0002] This disclosure claims priority to U.S. Provisional Patent Application No. 62 / 876,846, filed on July 22, 2019; the disclosure of which is hereby incorporated by reference. Technical Field
[0003] The present disclosure generally relates to devices and methods for treating hemorrhoids, and more particularly, for treating internal hemorrhoids. Background Art
[0004] Hemorrhoids are swollen and inflamed veins around the anus or in the lower rectum. Hemorrhoids can be external, forming under the skin around the anus, or internal, forming in the lining of the anus and lower rectum.
[0005] Internal hemorrhoids are often difficult to treat, and some treatments can cause discomfort to the patient. Summary of the invention
[0006] The present disclosure relates to a device for treating internal hemorrhoids. The device comprises an elongated shell, a handle, and an internal elongated member; the elongated shell extends from a proximal end to a distal end, the size and shape of the elongated shell are set for insertion into a living body, and the distal end of the shell is configured for insertion into a target site in the rectum; the handle extends from a distal end connected to the proximal end of the shell to a proximal end, and the handle is configured to remain outside the body when the distal end of the shell is inserted into the rectum; the internal elongated member is received in the shell, and the shell and the elongated member are coupled to each other so that the shell and the elongated member can move longitudinally relative to each other. The device also includes a tissue grasping and ligating mechanism connected to the distal end of the slender member, the grasping and ligating mechanism includes a plurality of tissue grasping arms that can move between a tissue receiving configuration and a tissue grasping configuration, the distal ends of the grasping arms are separated from each other by a first distance in the tissue receiving configuration, the distal ends of the grasping arms are pulled together in the tissue grasping configuration so that they are separated from each other by a second distance that is less than the first distance to grasp the tissue received between the grasping arms, the grasping and ligating mechanism also includes a ligating band received around the grasping arms, the ligating band can be moved distally away from the grasping arms to be constrained around the tissue grasped by the grasping arms.
[0007] In one embodiment, the device further comprises a tissue engaging structure that draws tissue proximally toward the distal end of the elongated member and away from surrounding tissue between the distal ends of the grasping arms.
[0008] In one embodiment, the elongate member defines a lumen extending therethrough and the tissue engaging structure comprises one of a clamp, a cork screw, a hook, and a grasper.
[0009] In one embodiment, the elongate member defines a lumen extending therethrough, and the tissue engaging structure includes a negative fluid pressure source fluidly coupled to a proximal end of the lumen to apply suction to a distal end of the elongate member.
[0010] In one embodiment, the negative fluid pressure source includes a piston slidably mounted within a vacuum chamber formed in the handle, the vacuum chamber being fluidly coupled to the lumen.
[0011] In one embodiment, the grasping arms are circumferentially distributed around the longitudinal axis of the slender member, the proximal ends of the grasping arms are separated from the longitudinal axis by a first radial distance, and each grasping arm extends from its proximal end gradually away from the longitudinal axis to a maximum separation point from the longitudinal axis and bends back toward the longitudinal axis from the maximum separation point to its distal end.
[0012] In one embodiment, the points of maximum separation of the gripping arms are generally aligned along the longitudinal axis.
[0013] In one embodiment, a first and a second of the grasping arms include a ligature retaining structure formed thereon at a location where the ligature is retained until deployed.
[0014] In one embodiment, the ligature retaining structure is located at the point of maximum separation of the first and second grasping arms.
[0015] In one embodiment, the housing includes a distal tip having a diameter that gradually increases from a first diameter at a proximal end of the distal tip to a maximum diameter at a distal end of the distal tip.
[0016] In one embodiment, the ligature retaining structure is formed as a recess in the radially outer surface of the first and second grasping arms, facing away from the longitudinal axis.
[0017] In one embodiment, the ligature retention structure includes at least one of a groove, a protrusion, a textured surface, a retainer, a lock, and an adhesive.
[0018] The present disclosure also relates to a system for treating internal hemorrhoids. The system includes an introducer extending from a proximal end to a distal end, the size and shape of the introducer are set to be inserted into the anus, the introducer is transparent to observe the anatomical structure of the anus, the diameter of the introducer increases from the proximal end to the distal end, and the introducer includes a narrow groove configured to be aligned with a target tissue portion. The system also includes a device, the device having a slender shell, a handle, and an internal slender member; the slender shell extends from the proximal end to the distal end, the size and shape of the slender shell are set to be inserted into a living body through the introducer, and the distal end of the shell is configured to be inserted into a target site in the rectum; the handle extends from the distal end connected to the proximal end of the shell to the proximal end, and the handle is configured to remain outside the body when the distal end of the shell is inserted into the rectum; the internal slender member is received in the shell, and the shell and the slender member are connected to each other so that the shell and the slender member can move longitudinally relative to each other. In addition, the device includes a tissue grasping and ligating mechanism connected to the distal end of the slender member, the size and shape of the grasping and ligating mechanism being set to be inserted into the narrow slot of the guide and including a plurality of tissue grasping arms, which can be moved between a tissue receiving configuration and a tissue grasping configuration, the distal ends of the grasping arms being separated from each other by a first distance in the tissue receiving configuration, the distal ends of the grasping arms being pulled together in the tissue grasping configuration so that they are separated from each other by a second distance less than the first distance to grasp the tissue received between the grasping arms, the grasping and ligating mechanism also including a ligating band received around the grasping arms, the ligating band being movable distally away from the grasping arms to be constrained around the tissue grasped by the grasping arms.
[0019] In one embodiment, the system further includes a handle extending radially outward from the proximal end of the introducer.
[0020] In one embodiment, the system further comprises a tissue engaging structure that draws tissue proximally toward the distal end of the elongated member and away from surrounding tissue between the distal ends of the grasping arms.
[0021] In one embodiment, the elongate member defines a lumen extending therethrough and the tissue engaging structure comprises one of a clamp, a cork screw, a hook, and a grasper.
[0022] In one embodiment, the housing includes a distal tip having a diameter that gradually increases from a first diameter at a proximal end of the distal tip to a maximum diameter at a distal end of the distal tip.
[0023] In addition, the present disclosure includes a method for treating internal hemorrhoids. The method includes inserting a device into a target site in the rectum, the device including a slender housing extending from a proximal end to a distal end, a handle coupled to the proximal end of the housing, an internal slender member received in the housing, and a tissue grasping and ligating mechanism of the device coupled to the distal end of the slender member for moving a plurality of tissue grasping arms from a tissue receiving configuration to a tissue grasping configuration; receiving a target tissue portion in the tissue grasping and ligating mechanism; actuating the tissue grasping and ligating mechanism from the tissue receiving configuration to the tissue grasping configuration; and actuating the slender housing to push the ligating band out of the device onto the target tissue portion.
[0024] In one embodiment, the method further includes inserting an introducer into the target site before inserting the device into the target site, wherein the introducer extends from a proximal end to a distal end and includes a narrow slot configured to align with the target tissue portion; inserting the device proximally through the distal end of the introducer; and inserting a grasping and ligating mechanism proximally through the narrow slot of the introducer to engage the target tissue portion.
[0025] In one embodiment, the device includes a source of negative fluid pressure, thereby further comprising drawing tissue proximally away from surrounding tissue into the tissue grasping and ligating mechanism.
[0026] In one embodiment, the device includes a tab located on the proximal end of the grasping and ligating mechanism and a narrow slot located on the distal end of the slender member, thereby also including disengaging the grasping and ligating mechanism from the slender member by holding the grasping and ligating mechanism while rotating the device, wherein the tab slides away from the narrow slot, thereby releasing the grasping and ligating mechanism from the device. BRIEF DESCRIPTION OF THE DRAWINGS
[0027] Figure 1 is a perspective view of a device for treating hemorrhoids according to a first exemplary embodiment;
[0028] Figure 2 yes Figure 1 A perspective view of a distal end of the device in a first configuration;
[0029] Figure 3 yes Figure 1 A perspective view of the distal end of the device in a second configuration;
[0030] Figure 4 yes Figure 1 A partial cross-sectional view of the handle of the device in FIG. 1 , showing the piston mechanism;
[0031] Figure 5 Yes Figure 1 A perspective view of a system of devices in which the device is used in a first step of an exemplary method for treating hemorrhoids; and
[0032] Figure 6 Yes Figure 1 A perspective view of a system of devices in which the device is used in the second step of an exemplary method for treating hemorrhoids. DETAILED DESCRIPTION
[0033] The present disclosure may be further understood with reference to the following description and accompanying drawings, in which similar elements are referred to by the same reference numerals. The present disclosure relates to a device and method for treating internal hemorrhoids. It should be noted that the terms proximal and distal (as used herein) refer to directions toward (proximal) and away from (distal) the user of the device. Although the embodiments described herein are particularly configured for treating internal hemorrhoids, it will be appreciated by those skilled in the art that the embodiments described herein may also be used to treat similar lesions, such as polyps palpable in the anus.
[0034] like Figure 1-3 As shown, the device 10 for treating internal hemorrhoids includes a shell 12 having a distal portion 14, which is sized and shaped to be inserted into the anus. In the present embodiment, the shell 12 includes a handle 16, which remains outside the body during use and is available to the user. The distal portion 14 includes a generally cylindrical outer shell 18 with a flared distal tip 20. Those skilled in the art will recognize that the outer shell 18 can have any suitable atraumatic shape. For example, the outer shell 18 can have any suitable smooth non-cylindrical outer profile (oval, etc.), and the flared distal tip 20 of the outer shell 18 can have any shape, as long as the diameter of the outer shell 18 gradually increases toward its distal end so that the distal tip 20 can smoothly engage the grasping arm 32 of the device 10 (see Figure 2 ), as described in more detail below. The diameter of the distal tip 20 of the outer housing 18 gradually increases from the proximal end 22 of the distal tip 20 to the distal end 24 of the distal tip 20 .
[0035] The inner elongated member 26 extends from the handle 16 within the outer housing 18 and extends distally out of the outer housing 18, thereby extending distally beyond the distal tip 20. The elongated member 26 is connected to the actuator 28 on the handle 16 via a mechanism; when the actuator moves distally and proximally relative to the handle 16, the mechanism causes the elongated member 26 to move longitudinally within the outer housing 18. The grasping and ligating mechanism 30 is releasably coupled to the distal end of the elongated member 26. The grasping and ligating mechanism 30 includes a plurality of tissue grasping arms 32, which are coupled to the radial inner surface of the ring member 34 and are arranged around the circumference of the ring member 34. The grasping arms 32 are biased to radially open away from each other from the longitudinal axis L of the grasping and ligating mechanism 30 into a tissue receiving configuration. Although the present embodiment shows four grasping arms 32, it should be understood by those skilled in the art that any desired number of arms 32 may be used, wherein at least three arms 32 are preferably used.
[0036] like Figure 1-3As shown, the grasping arms 32 in this embodiment are curved, wherein the proximal end of each grasping arm 32 is radially received within the ring member 34. This maintains the proximal end 32' of the grasping arms 32 in a state where the diameter is substantially equal to the diameter of the distal end of the slender member 26. From the proximal end 32' toward the distal side, each arm 32 extends away from the axis L to a maximum diameter adjacent the recess 38. From the recess 38 toward the distal side, the grasping arms 32 bend back toward the axis L to a minimum diameter at their distal ends 32". In this embodiment, each grasping arm 32 is a rigid section that follows an arc that is a portion of a circle, so that the grasping arms 32 collectively define a portion of a sphere when in the open tissue receiving configuration.
[0037] However, it will be appreciated by those skilled in the art that the specific shape of the gripping arm 32 is not limited to this shape, and the gripping arm may take any desired shape, so long as the gripping arm 32 extends from the proximal end 32' gradually away from the axis L to a point at or slightly distal to the band retention structure described in more detail below. This allows the inner member 26 to be drawn proximally into the outer housing 18, so that the gripping arm 32 gradually moves from an open tissue receiving configuration to a closed tissue grasping configuration as the outer housing 18 slides distally over the proximal portion of the gripping arm 32. Distal to the band retention structure, the gripping arm 32 curves back toward the axis L, so that when the ligating band 36 leaves the retention structure (as described below), the deflection of the ligating band 36 will interact with the ramp formed by the diameter reduction defined by the progressive distal portion of the gripping arm 32, so that the ligating band 36 can move distally on the gripping arm 32 and slide off the distal end 32" of the gripping arm 32, so that it can be constrained around tissue just distal to the tissue portion grasped by the gripping arm 32.
[0038] As indicated above, the ligature 36 is received around the gripping arm 32 so that when the gripping arm 32 is in the position shown in FIG. Figure 2 When the tissue receiving configuration is shown, the ligature 36 is stretched beyond the resting diameter; when not constrained by the gripping arm 32, the ligature 36 returns to the resting diameter. As will be appreciated by those skilled in the art, any known ligature 36 of suitable size may be employed, and any ligature 36 used with these embodiments may include any known therapeutic agent, such as a drug for treating the ligated tissue and / or for reducing discomfort during the healing process. As indicated above, each of the gripping arms 32 of the present embodiment includes a band retaining structure to hold the ligature 36 at a desired position on the gripping arm 32 until the user operates the actuator 28 to deploy the ligature 36. In the present embodiment, the band retaining structure is a series of notches 38 formed on the gripping arm 32. The notches 38 are sized and shaped to receive the ligature 36 therein so that the ligature 36 does not inadvertently slip off the gripping arm 32 before the user intends to deploy it.
[0039] In the present embodiment, the notch 38 is located at the maximum diameter point of the circle of the circumscribed gripping arm 32. It will be appreciated by those skilled in the art that any number of features may be substituted for or used in conjunction with the notch 38 to keep the ligature 36 in place until deployment. For example, the ligature 36 may be held in place by one or more grooves, one or more protrusions, a textured surface, a locking feature, an adhesive, etc., and the band retaining structure may be on all or only a subset of the gripping arms 32. In addition, it will be appreciated by those skilled in the art that while the present embodiment shows the handle 16, the outer shell, and the elongated member 26 longitudinally arranged along the common axis L, the distal portion of the device may be tilted to any desired degree relative to the handle 16, for example to facilitate reaching hemorrhoids at different locations in the body.
[0040] The grasping and ligating mechanism 30 of the present embodiment is releasably coupled to the distal end of the elongated member 26 via two slots 40 formed in the elongated member 26, each of the slots 40 being sized and shaped to receive a tab 42 extending radially inwardly from the proximal end of the first and second of the grasping arms 32 toward the axis L. Each slot 40 is generally L-shaped and includes a first portion 44 extending circumferentially around a portion of the elongated member 26 and leading to a second portion 46 extending distally from the first portion 44 to an open distal end. When the grasping and ligating mechanism 30 is coupled to the elongated member 26, the tab 42 is received in the first portion 44 of the slot 40 and rotated away from the second portion 46 so that the tab 42 is retained in the slot 40, whereupon the grasping and ligating mechanism 30 remains coupled to the elongated member 26. Those skilled in the art will appreciate that this allows a user of the device 10 to select one of a variety of types and / or sizes of grasping and fastening mechanisms 30 depending on the characteristics of the anatomy being treated.
[0041] like Figure 1 As shown, the handle 16 also includes a piston 48 that can slide in a vacuum chamber 50 formed in the handle 16, so that when the piston 48 (e.g., plunger) is pulled proximally through the vacuum chamber 50, a vacuum is drawn in the vacuum chamber 50. The piston 48 is connected to a pull rod 49, which extends proximally from the handle 16 so that it can be used by the user. The proximal end of the elongated member 26 is in fluid communication with the vacuum chamber 50, so that when a vacuum is drawn in the vacuum chamber 50, suction is applied to the distal end of the elongated member 26 via a lumen 52 extending through the elongated member 26. Those skilled in the art will recognize that any negative fluid pressure source can replace the disclosed piston mechanism or add to it, including, for example, a syringe, a spherical body, a pump, or a tube extending to a negative fluid pressure auxiliary source. In addition, in addition to using suction to pull tissue into the device 10 or as an alternative, any known mechanical tissue grasping mechanism (such as a clamp, a spiral, a cork screw member, a hook, a gripper, etc.) can be used to suck tissue as needed.
[0042] The user operates the actuator 28 to move the grasping and ligating mechanism 30 from the open tissue receiving configuration (position 28A) to the tissue grasping configuration (actuator position 28B), wherein the distal ends of the grasping arms 32 are drawn together toward the axis L by drawing the elongated member 26 proximally into the outer housing 18 (as the user advances the handle 16 and the outer member 18 distally, respectively, over the elongated member 26). This allows the grasping arms 32 and grasped tissue to remain stationary as the outer housing 18 slides distally over the elongated member 26. As the actuator 28 is advanced from position 28A to position 28B, the flared distal tip 20 of the outer housing 18 slides over the curved proximal ends of the grasping arms 32. As the distal tip 20 slides over the grasping arms 32 and the more proximal, decreasing diameter portions of the distal tip 20 approach and slide over the increasing diameter circles formed by the grasping arms 32, the grasping arms 32 are squeezed together, forcing the distal ends of the grasping arms 32 toward each other to grasp the tissue received therebetween.
[0043] In the present embodiment, under the tissue grasping configuration, it is desirable that the distal ends of the grasping arms 32 remain separated from each other by a certain interval, which corresponds to the diameter of the tissue portion surrounded by the ligature band 36. For example, the interval may be between about 3 mm and 15 mm, depending on the size of the targeted hemorrhoid. It will be appreciated by those skilled in the art that the interval may be any desired size or may eliminate the distal ends of the arms 32 from contacting each other when in the tissue grasping configuration. When the grasping arms 32 move to the closed tissue grasping configuration and the user confirms that the desired tissue portion has been grasped by the grasping arms 32 (e.g., the appropriate margin of the target hemorrhoid and the surrounding healthy tissue), the user may deploy the ligature band 36 by moving the actuator 28 to position 28C. This further pulls the elongated member 26 into the outer housing 18 proximally until the distal end 20 of the outer housing 18 slides through the notch 38 distally, causing the ligature band to move away from the notch 38 beyond the maximum diameter point of the grasping arms 32. As described above, the ligature 36 then constrains and moves distally under its own bias over the distal portion of the grasping arm 32 until the ligature 36 slides off the distal end 32" of the grasping arm 32 and constrains around the target tissue.
[0044] The user can disengage the grasping and ligating mechanism 30 from the elongated member 26 by rotating the device 10 in the direction of arrow R while holding the grasping and ligating mechanism 30. While the grasping and ligating mechanism 30 is held in place, the tab 42 slides through the first portion 44 of the slot 40 to the second portion 46. The tab 42 can then slide away from the slot 40 via the second portion 46, thereby releasing the grasping and ligating mechanism 30 from the device 10. The user can then attach a different grasping and ligating mechanism 30 (e.g., a mechanism 30 of a different size setting, a mechanism 30 with a different drug on the ligating band 36, etc.) to the device 10 by reversing the process.
[0045] Alternatively, the user can use the detachment feature to replace the grasping and ligating mechanism 30 with a new grasping and ligating mechanism 30 from which the ligating band 36 has been deployed, so that the user can repeat the above process and treat another hemorrhoid using the same device 10. In a single-use device or to provide a grasping and ligating mechanism 30 in a different size setting or configuration, the grasping and ligating mechanism 30 can be permanently coupled to the elongated member 26. In the present embodiment, the device 10 is a single-use device (e.g., used on a single patient during a single procedure, even if the device 10 is used to deploy multiple ligating bands 36 during this single procedure).
[0046] In use, such as Figure 5 and Figure 6 As shown, the device 10 is inserted into the anus via a previously inserted introducer 60. The introducer 60 includes a generally tapered distal portion 62 formed of transparent plastic, wherein an open slot 64 extends to an open distal end 66. A lip 68 extends radially outward from the proximal end of the tapered distal portion 62 to define a maximum insertion point of the introducer 60 into the body. The introducer 60 also includes a handle 70 that extends proximally from the lip 68 and radially outward from the tapered distal portion 62 to facilitate positioning and rotation of the introducer 60 within the anus as desired. In this case, the introducer 60 is positioned so that the slot 64 is aligned with the hemorrhoid H to be treated, and the device 10 is inserted through the introducer 60 until the grasping and ligating mechanism 30 is adjacent to the hemorrhoid H, as shown in FIG. Figure 5 As shown. When pulled toward the hemorrhoid H, the grasping and ligating mechanism 30 is maintained in an open tissue receiving configuration; and the device 10 is positioned so that the distal ends of the grasping arms 32 abut against the tissue surrounding the hemorrhoid H.
[0047] The user then pulls the pull rod 49 proximally away from the handle 16 to pull the piston 48 proximally through the vacuum chamber 50, which in turn applies suction to the distal end of the elongated member 26 to pull the hemorrhoid H through the grasping and ligating mechanism 30 into the distal end of the elongated member 26. The user can continue to apply suction until the entire hemorrhoid and the edges of the surrounding healthy tissue are drawn between the grasping arms 32. In one embodiment, an anoscope can be used for visualization of the anus, wherein the device 10 is inserted through the working channel of the anoscope into the anus.
[0048] The user then pushes the outer housing 18 distally on the elongated member 26 and the grasping and ligating mechanism 30 to push the grasping arms 32 toward each other, thereby pulling the tissue surrounding the hemorrhoid H further into the device 10. The user can then position the grasping arms 32 so that they are over the tissue surrounding the hemorrhoid H, and continue to push the outer housing 18 distally on the grasping arms 32 until the inner surface of the distal tip 20 contacts the ligating band 36 and pushes the ligating band 36 distally out of the notch 38, thereby allowing the ligating band 36 to freely contract and roll off the grasping arms 32 to be constrained around the tissue just distal to the distal end of the grasping arms 32. The combination of the vacuum applied via the piston 48 and the pulling through the grasping arms 32 enables the user of the present device to preferably pull the entire hemorrhoid H into the grasping and ligating mechanism 30, so that the ligating band 36 is constrained around the healthy tissue surrounding the hemorrhoid H, but not on the tissue of the hemorrhoid H itself. This can reduce discomfort to the patient during healing.
[0049] Those skilled in the art will appreciate that various modifications may be made to the described embodiments without departing from the teachings of the present application. For example, although the embodiments are described with respect to the treatment of internal hemorrhoids, those skilled in the art will appreciate that the embodiments described herein may also be used to treat similar lesions, such as polyps.
Claims
1. A device for treating internal hemorrhoids, comprising: an elongated housing extending from a proximal end to a distal end, the housing being sized and shaped for insertion into a living subject, the distal end of the housing being configured for insertion into a target site within a rectum; a handle extending from a distal end coupled to the proximal end of the housing to the proximal end, the handle being configured to remain external to the body when the distal end of the housing is inserted into the rectum; an internal elongated member received within the housing, the housing and the elongated member being coupled to one another such that the housing and the elongated member are longitudinally movable relative to one another; and a tissue grasping and ligating mechanism coupled to the distal end of the elongated member, the tissue grasping and ligating mechanism comprising a plurality of tissue grasping arms movable between a tissue receiving configuration and a tissue grasping configuration, wherein the distal ends of the grasping arms are separated from each other by a first distance in the tissue receiving configuration, and wherein the distal ends of the grasping arms are pulled together so that they are separated from each other by a second distance less than the first distance to grasp tissue received between the grasping arms, the grasping and ligating mechanism further comprising a ligating band received around the grasping arms at a first position on the grasping arms, the ligating band being movable distally away from the grasping arms to be constrained around tissue grasped by the grasping arms; wherein the housing is slidable distally over the elongated member and the proximal end of the gripping arm so that the distal end of the housing contacts the ligature and pushes the ligature distally away from the first position; wherein the grasping arms are circumferentially distributed around the longitudinal axis of the elongated member, the proximal ends of the grasping arms are separated from the longitudinal axis by a first radial distance, each of the grasping arms extends from its proximal end gradually away from the longitudinal axis to a point of maximum separation from the longitudinal axis and curves back toward the longitudinal axis from the point of maximum separation to its distal end; and The first and second of the grasping arms include a ligature retaining structure formed thereon at the first position, and the ligature retains at the first position until deployed.
2. The apparatus according to claim 1, further comprising: A tissue engaging structure is configured to draw tissue proximally toward the distal end of the elongated member and away from surrounding tissue between the distal ends of the grasping arms.
3. The device of claim 2, wherein the elongated member defines a lumen extending therethrough, and the tissue engaging structure comprises one of a clamp, a cork screw, a hook, and a grasper.
4. The device of claim 2, wherein the elongated member defines a lumen extending therethrough, the tissue engaging structure comprising a negative fluid pressure source fluidly coupled to a proximal end of the lumen to apply suction to a distal end of the elongated member.
5. The device of claim 4, wherein the negative fluid pressure source comprises a piston slidably mounted within a vacuum chamber formed within the handle, the vacuum chamber being fluidly coupled to the lumen.
6. The device of claim 1, wherein the points of maximum separation of the gripping arms are aligned along the longitudinal axis.
7. The device of claim 1, wherein the ligature retention structure is located at a point of maximum separation of the first and second grasping arms.
8. The device of claim 1, wherein the housing comprises a distal tip having a diameter that gradually increases from a first diameter at a proximal end of the distal tip to a maximum diameter at a distal end of the distal tip.
9. The device of claim 1, wherein the ligature retaining structure is formed as a notch in a radially outer surface of the first and second gripping arms, the notch facing away from the longitudinal axis.
10. The device of claim 1, wherein the ligature is held in place via the ligature retention structure, the ligature retention structure comprising at least one of a groove, a protrusion, a textured surface, a lock, and an adhesive.
11. The device of claim 1 , wherein the first position on the grasping arm constitutes the maximum separation point, and when the distal end of the housing pushes the ligature distally away from the first position, the ligature is configured to contract the grasping arm and move distally away from the grasping arm, thereby constraining around tissue grasped by the grasping arm.
12. A system for treating internal hemorrhoids, comprising: an introducer extending from a proximal end to a distal end, the introducer being sized and shaped for insertion into the anus, the introducer being transparent to allow viewing of an anal anatomy, the introducer including a slot configured for alignment with a target tissue portion; and Device, the device comprising: an elongated housing extending from a proximal end to a distal end, the housing being sized and shaped for insertion into a living body through the introducer, the distal end of the housing being configured for insertion into a target site within a rectum; a handle extending from a distal end coupled to the proximal end of the housing to the proximal end, the handle being configured to remain external to the body when the distal end of the housing is inserted into the rectum; an inner elongated member received within the housing, the housing and the elongated member being coupled to one another such that the housing and the elongated member are longitudinally movable relative to one another; and A tissue grasping and ligating mechanism connected to the distal end of the slender member, the tissue grasping and ligating mechanism is sized and shaped to be inserted through the narrow slot of the introducer and includes a plurality of tissue grasping arms that can be moved between a tissue receiving configuration and a tissue grasping configuration, the distal ends of the grasping arms being separated from each other by a first distance in the tissue receiving configuration, the distal ends of the grasping arms being pulled together in the tissue grasping configuration so that they are separated from each other by a second distance less than the first distance to grasp tissue received between the grasping arms, the grasping and ligating mechanism also including a ligating band received around the grasping arms at a first position on the grasping arms, the ligating band being movable distally away from the grasping arms to be constrained around tissue grasped by the grasping arms, wherein the housing is slidable distally over the elongated member and the proximal end of the gripping arm so that the distal end of the housing contacts the ligature and pushes the ligature distally away from the first position; wherein the grasping arms are circumferentially distributed around the longitudinal axis of the elongated member, the proximal ends of the grasping arms are separated from the longitudinal axis by a first radial distance, each of the grasping arms extends from its proximal end gradually away from the longitudinal axis to a maximum separation point from the longitudinal axis and bends back toward the longitudinal axis from the maximum separation point to its distal end; and The first and second of the grasping arms include a ligature retaining structure formed thereon at the first position, and the ligature retains at the first position until deployed.
13. The system of claim 12, further comprising: A tissue engaging structure is configured to draw tissue proximally toward the distal end of the elongated member and away from surrounding tissue between the distal ends of the grasping arms.
14. The system of claim 13, wherein the housing includes a distal tip having a diameter that gradually increases from a first diameter at a proximal end of the distal tip to a maximum diameter at a distal end of the distal tip.
15. The system of claim 12, wherein a diameter of the introducer increases from the proximal end to the distal end.
