Devices for treating hemorrhoids

Abstract

The present invention relates to a device, the device comprising an elongated hollow member, a rigid member and an actuating mechanism; the elongated hollow member having a window for receiving tissue inside the hollow member; the rigid member being slidably coupled to the hollow member; the actuating mechanism being configured to move the rigid member longitudinally along a longitudinal axis through at least a portion of the window. When a ligature is adjacent to the window and the rigid member moves relative to the hollow member, the rigid member deforms the ligature from an open position to a closed position around the tissue received in the window.

Description

[0001] Inventors: Daniel KEENAN, Briana Jean MORETTI, and Jacqueline Nicole MAGAHA

[0002] Priority claim

[0003] This disclosure claims priority to U.S. Provisional Patent Application Serial No. 62 / 877,960, filed on July 24, 2019; the disclosure of that provisional patent application is incorporated herein by reference. Technical Field

[0004] The present invention relates to a device and method for treating hemorrhoids, and in particular to a fully anoscope-compatible band ligation procedure. Background of the Invention

[0006] 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 inner wall of the anus or lower rectum. Ligation is a common method for treating hemorrhoids. In ligation, a band or other device is placed around the base of the hemorrhoid, thereby blocking its blood flow, reducing inflammation and eventually eliminating the hemorrhoid. The band can be, for example, rubber or metal.

[0007] Commercially available anoscopes allow physicians to visualize and access the anal cavity while treating the patient. Summary of the invention

[0008] The present disclosure relates to a device, which includes an elongated hollow member, a rigid member, and an actuation mechanism; the elongated hollow member has a window for receiving tissue inside the hollow member; the rigid member is slidably coupled to the hollow member; the actuation mechanism is configured to move the rigid member longitudinally along a longitudinal axis through at least a portion of the window. When the ligature is adjacent to the window and the rigid member moves relative to the hollow member, the rigid member deforms the ligature around the tissue received in the window from an open position to a closed position.

[0009] In one embodiment, the device further comprises a dilator configured to be inserted into the hollow member.

[0010] In one embodiment, the device further comprises a light source directed towards the window.

[0011] In one embodiment, the ligature is made of metal.

[0012] In one embodiment, the ligature is bent into a C-shape with open sides.

[0013] In one embodiment, the ligature is loaded with the open side of a C-shape facing distally toward the window, the C-shape being formed by a transverse side and two longitudinal sides extending from either end of the transverse side.

[0014] In one embodiment, the ligature is loaded with the open side of a C-shape pointing laterally relative to the longitudinal axis, the C-shape being formed by a longitudinal side portion and two lateral sides extending from either end of the longitudinal side portion.

[0015] In one embodiment, the hollow member includes a tapered distal portion, a flared proximal base, and an elongated mid-portion.

[0016] In one embodiment, the hollow member comprises an inner cylinder and an outer cylinder separated by an annular space.

[0017] In one embodiment, the device further comprises a crimp plate channel extending from a proximal end of the window to a distal end of the window.

[0018] In one embodiment, the device further comprises a ligature band channel extending from a proximal end of the intermediate portion to a proximal end of the window, opening into the window.

[0019] In one embodiment, the rigid member includes an annular crimp plate received in the crimp plate channel.

[0020] In one embodiment, the device further comprises a notch in the crimping plate configured to deform the ligature into a predetermined pattern.

[0021] In one embodiment, the tie channel is configured to accommodate a plurality of tie ties.

[0022] In one embodiment, the device further comprises a safety stop located on the actuation mechanism to prevent deformation of the ligature during loading and prior to deployment.

[0023] The present disclosure also relates to a method, the method comprising inserting a device into an anal cavity, the device comprising an elongated hollow member, the hollow member comprising a window for receiving tissue within the interior of the hollow member; and an actuation mechanism for actuating the device, the actuation mechanism being configured to move a rigid member longitudinally through at least a portion of the window, the rigid member being slidably coupled to the hollow member. When the ligature is adjacent to the window and the rigid member moves relative to the hollow member, the rigid member deforms the ligature around the tissue received in the window from an open position to a closed position.

[0024] In one embodiment, the method further comprises inserting a dilator through the hollow member into the device prior to inserting the device into the anal cavity; and removing the dilator after the device is inserted into the desired position.

[0025] In one embodiment, the method further comprises illuminating the first target area via a light source to align the window of the hollow member with the first target portion of the tissue.

[0026] In one embodiment, the method further includes releasing a safety stop on the actuation mechanism to allow the rigid member to move longitudinally through at least a portion of the window.

[0027] In one embodiment, the method further includes observing a second target area; rotating the hollow member independently of the actuation mechanism; aligning the window with the second target area; pulling a second target portion of tissue through the window into the device; and actuating the actuation mechanism to deform the ligature from an open position to a closed position around the second target portion of tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 A first exemplary embodiment according to the present disclosure shows a perspective view of an anoscope device for ligating hemorrhoids.

[0030] Figure 2 Shown with the dilator removed Figure 1 A perspective view of the device.

[0031] Figure 3 Shows Figure 1 Front view of the device.

[0032] Figure 4 Shows Figure 1 Transparent perspective view of the device.

[0033] Figure 5 Shows Figure 1 Transparent top view of device.

[0034] Figure 6 Shows Figure 1 A cross-sectional view of a device including a band channel portion and a crimping ring channel portion.

[0035] Figure 7 Shows Figure 1 A transparent perspective view of a device including a belt channel portion and a crimp ring channel portion.

[0036] Figure 8 Shows Figure 1 A perspective view of the ligation window in the top of the device when the device is not actuated.

[0037] Fig. 9 Shows Figure 1 A transparent side view of the device when the device is not actuated.

[0038] Fig.10 Shows Figure 1A stereoscopic view of the ligation window in the top of the device when the device is actuated.

[0039] Fig.11 Shows Figure 1 A transparent side view of the device when it is actuated.

[0040] Fig.12 Shows Figure 1 An alternative embodiment of a ligature for a device in which the device is not activated.

[0041] Fig.13 Shows Figure 1 An alternative embodiment of a ligature of the device, when the device is activated.

[0042] Fig.14 Shows the use of Figure 1 A method of anoscopy for ligating hemorrhoids. DETAILED DESCRIPTION

[0043] 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 an anoscope device having a metal band ligation mechanism for ligating one or more hemorrhoids. An exemplary device may enter the anal cavity, observe the hemorrhoid treatment area, and crimp the metal ligation band around the base of one or more hemorrhoids. It should be noted that the terms "proximal" and "distal" (as used herein) refer to directions toward (proximal) and away from (distal) a user of the device.

[0044] Figure 1 An anoscope device 100 for performing a metal band ligation procedure is shown. The anoscope device 100 includes an elongated body 102 having a tapered distal portion 104, a flared proximal base 108, and an elongated middle portion 106 therebetween. In the present embodiment, a handle 110 extends orthogonally from the body 102 along with a trigger 112 for actuating a crimping mechanism during a ligation procedure, as explained in more detail below. The body 102 has a hollow interior defined by an inner cylinder 114 extending through the middle portion 106 and the distal portion 104 of the body 102. The middle portion 106 has an outer cylinder 116 surrounding the exterior of the inner cylinder 114 and concentric therewith; and defining an annular space therebetween, wherein components of the crimping mechanism are housed in the annular space. A window 118 extends through the middle portion 106 adjacent to the distal portion 104 and opens into the interior of the device 100. During the ligation procedure, a hemorrhoid may be received in the window 118 and a ligation band 150 may then be applied thereto.

[0045] The device 100 includes a removable dilator 120 that is sized to extend through the interior of the body 102 and extend out of the distal end of the distal portion 104. The dilator 120 has a conical distal end, an elongated shaft, and an enlarged proximal end. The elongated shaft of the dilator 120 has an outer diameter that generally corresponds to the inner diameter of the inner cylinder 114 so that the shaft slides therein. The enlarged proximal end of the dilator 120 cannot extend through the flared base 108 of the body 102 due to its size. The enlarged proximal end of the dilator 120 is positioned so that when the enlarged proximal end of the dilator 120 abuts the flared base 108, only the conical distal end of the dilator 120 extends out of the distal end of the distal portion 104.

[0046] During the metal band ligation process, the dilator 120 is used to expand the patient's anus, thereby facilitating the device 100 to enter the anal cavity. In addition, during insertion into the anal cavity, the dilator 120 prevents access to the interior of the body 102 of the device 100 via the window 118, that is, the dilator 120 blocks the window 118. In this way, the surgeon will not capture non-target tissue in the window 118 before the anoscope 100 is properly arranged relative to the anatomical structure and the target site. After the dilator 120 has been removed, the interior of the body 102 can lead to the anal cavity and the open end of the tapered distal portion 104 via the window 118. The body 102 can be rotated independently of the handle 110 so that the window 118 can be properly aligned with the target portion of the tissue at the target site. The light source 122 arranged in the proximal end of the device 100 is directed to the window 118. During the ligation procedure, light source 122 illuminates the anal cavity and treatment area surrounding the hemorrhoid to help the physician visualize the treatment area through flared proximal base 108, thereby facilitating placement of device 100 and window 118 in a desired location and orientation relative to the hemorrhoidal tissue.

[0047] Two channels are defined in a portion of the space between the outer cylinder 116 and the inner cylinder 114. The remainder of the space may be open or may include structures for securing the inner cylinder 114 and the outer cylinder 116. The ligature channel 124 (e.g., Figure 6 The belt channel 124 is sized to accommodate a plurality of ligatures 150. For example, Figures 4 to 5 The present embodiment of the body 102 shown is loaded with five ligature ties 150, however, any number of ties may be used, as will be appreciated by those skilled in the art. The ties 150 are preferably metal (eg, 304SS), however, any material having comparable strength and deformation properties may be used.

[0048] In one embodiment, the ligature band 150 is a C-shape with two longitudinal sides extending away from the lateral sides. When the band 150 is loaded in the passage 124, the lateral sides of the C-shape are arcuate to rest on the outside of the inner cylinder 114. The two longitudinal sides of the C-shape are generally straight. The band 150 is loaded in the passage 124, wherein the open side of the C-shape faces the window 118 toward the distal side. Utilizing a removable plug-in or another type of pushing element, a plurality of bands 150 can be loaded in the passage 124. The passage 124 provides a gap for inserting the band 150 so that the band 150 can slide. The alignment of the band 150 and the crimping mechanism is described in detail below.

[0049] The crimping plate channel 126 is defined as the annular space between the inner cylinder 114 and the outer cylinder 116, which extends from the proximal end of the window 118 to the distal end of the window 118. In other words, the crimping plate channel 126 is the portion of the space radially adjacent to the window 118. A cross-section of the channel 126 is shown in Figure 6 A transparent view of the ligature 124 and crimping plate channel 126 is shown in FIG. Figure 7 The passage 126 accommodates an annular crimping plate 128. When the device 100 is in an unactuated state, the crimping plate 128 rests at the distal end of the passage 126 adjacent the tapered distal end 104 of the body 102. The crimping mechanism actuates the trigger 112 to move the plate 128 proximally through the passage 126, and release of the trigger 112 returns the plate 128 to its distal position. The crimping plate 128 may have a notch 130 (e.g., Figure 8 ), to orient the deformation of the ligature 150 (to be described below).

[0050] The crimping mechanism includes a crimping plate 128 and a link 132 in the trigger 112 to actuate the crimping plate 128 in the channel 126 via a pulling member 134. The link 132 includes a safety stop button 138 that ensures that the ligature 150 cannot be deployed prematurely during loading and other process steps. The pulling member 134 extends from the link 132 in the handle 110 to the bottommost portion of the crimping plate 128. The pulling member 134 and the crimping plate 128 are connected so that they can only move forward and backward. When the safety button 138 is released, the trigger 112 can be moved inwardly toward the handle 110 by the user. When the trigger 112 is actuated, it pulls the link 132, which in turn pulls the pulling member 134 and pulls the crimping plate 128 toward the proximal side. The pulling member 134 is rigid to ensure that there is enough force to translate to the crimping plate 128 to crimp the band 150. Once the user releases the trigger 112, the crimping band 150 will be attached to the hemorrhoid and the crimping mechanism will return to its initial state, as shown in FIG. Fig. 9 The crimping mechanism may be spring loaded to return to its initial state.

[0051] The middle portion 106 of the body 102 has a step 136 between the ligature passage 124 and the window 118 so that the ligature 150 pushed distally into the window 118 moves radially (inwardly toward the longitudinal axis of the device) a short distance into the window 118 and rests on the cut-away portion 115 of the inner cylinder 114, as shown in FIG. Figures 8 to 9 When the band 150 is located in the window 118 and the crimping plate 128 is in the distal position, the device 100 is ready to deploy the band 150. Actuation of the trigger 112 retracts the crimping plate 128 and deforms the band 150 against the step 136. Thus, it can be seen that the step 136 acts as an abutment surface against which the movable crimping plate 128 (acting as an anvil) crimps the band 150.

[0052] In this particular embodiment, the deformed shape of the strap 150 of this embodiment is a result of the curvature of the lateral sides of the strap 150 and the interaction between the ends of the longitudinal sides of the strap 150 and the notches 130 in the crimping plate. Fig.10 In the illustrated embodiment, as the crimping plate 128 moves proximally, the ends of the longitudinal sides of the band 150 are inserted into the notches 130. The notches 130 provide a temporary fixed lateral position for the ends of the longitudinal sides, and the curvature of the band 150 causes the band 150 to initially bend outward. As the crimping plate 128 continues to move proximally, the longitudinal sides of the band 150 bend inwardly into Fig.10 The crimping plate 128 has a limited travel that will not close within the entire window. The limited travel allows for the treatment of advanced hemorrhoids so that tying the stem of the hemorrhoid and crimping the band 150 into the deformed shape collapses these structures and prevents puncture of the hemorrhoid. However, it is important to note that the shape formed by the band 150 may not be completely deformed when tissue is within the cavity of the band 150.

[0053] The foregoing configuration of the band 150 and crimping plate 128 is one embodiment of the present disclosure. In other embodiments, the band 150 may be deformed into different shapes as a function of modifying the parameters of the device 100. For example, the crimping plate 128 may not have the notch 130, the longitudinal sides of the band 150 may be longer or shorter, the crimping plate 128 may be limited in its degree of proximal movement, etc.

[0054] Once the band 150 is deformed, the release of the trigger 112 unties the band 150 from the window 118. When the tied hemorrhoid is no longer in the window 118, a second ligating band 150 can be pushed into the window 118 to reload the device 100. The device 100 can then be positioned to receive the second hemorrhoid in the window 118.

[0055] In the second embodiment, the ligature 150 is configured to be loaded into the ligature channel 124 with the open side of the C-shape pointing to the side, such as Fig.12 . In other words, the ligature band 150 of the second embodiment is rotated 90° in any direction relative to the ligature band 150 of the first embodiment. The ligature band 150 of the second embodiment has two lateral sides that extend away from the longitudinal sides, similar to the first embodiment. However, unlike the first embodiment, the two lateral sides have an arcuate shape and the longitudinal side is generally straight, so that when the band 150 is loaded in the channel 124, the side C shape can be placed on the outside of the inner cylinder 114. The second embodiment of the ligature band 150 can be used to produce different crimping shapes, such as Fig.13 The crimping shape of the second embodiment is a longitudinal flattened C-shape, wherein the longitudinal sides of the C-shape are bent inwardly. The bending of the C-shape is controlled by the same limiting stroke as the first embodiment.

[0056] Fig.14 Shows the use of Figure 1 A method 200 for ligating a patient's hemorrhoids using an anoscope device 100. At step 205, at least one ligature band 150 is loaded into the ligature band channel 124 of the body 102. The band 150 is preferably loaded before the device 100 is inserted into the patient's anal cavity, however, the band 150 may be loaded at any time before the crimping mechanism is actuated.

[0057] At 210, the anoscope device 100 (with the dilator 120 inserted into the interior of the body 102) is inserted into the patient's anus to dilate the anal cavity. At 215, the dilator 120 is removed from the body 102, thereby opening the window 118 and the distal end 104 to visualize the hemorrhoid treatment area.

[0058] At 220, the surgeon views the treatment area and positions the device 100 to receive the hemorrhoid in the window 118. Once properly positioned, at 225, the trigger 112 is actuated to pull the crimping plate 128 proximally in the crimping plate channel 126 and deform the loading band 150 around the base of the hemorrhoid.

[0059] At 230, the trigger 112 is released to release the crimping plate 128 to its distal position and untie the band 150 from the window 118. If no more hemorrhoids need to be treated, the device can be removed. If other hemorrhoids need to be treated, the window 118 can be loaded with a second ligature band 150 at 235, and steps 220 to 230 can be repeated. The device 100 is repositioned, and the second hemorrhoid can be treated with the second band. These steps can be repeated until no more hemorrhoids need to be treated.

[0060] It will be apparent to those skilled in the art that various modifications can be made to the present disclosure without departing from the scope of the disclosure.

Claims

1. A device for treating hemorrhoids, comprising: an elongated hollow member having a window for receiving tissue within the interior of the hollow member; a crimping plate channel extending from a proximal end of the window to a distal end of the window; a rigid member slidably coupled to the hollow member; and an actuation mechanism configured to move the rigid member longitudinally along the longitudinal axis through at least a portion of the window, wherein the rigid member comprises an annular crimping plate received in the crimping plate channel, and The rigid member is configured such that, when the ligature is adjacent to the window and the rigid member moves relative to the hollow member, the rigid member is configured to deform the ligature around tissue received in the window from an open position to a closed position.

2. The apparatus according to claim 1, further comprising: A dilator is configured to be inserted into the hollow member.

3. The device according to any one of claims 1 to 2, further comprising: A light source is directed toward the window.

4. The device according to any one of claims 1 to 2, wherein the ligature is made of metal.

5. The device according to any one of claims 1 to 2, wherein the ligature is bent into a C-shape with open sides.

6. The device of claim 5, wherein the ligature is loaded with the open side of the C-shape facing distally toward the window, the C-shape being formed by a lateral side and two longitudinal sides extending from either end of the lateral side.

7. The device of claim 5, wherein the ligature is loaded with the open side of the C-shape pointing transversely relative to the longitudinal axis, the C-shape being formed by a longitudinal side and two transverse sides extending from either end of the longitudinal side.

8. The device of any one of claims 1 to 2, wherein the hollow member comprises a tapered distal portion, a flared proximal base, and an elongated mid-portion.

9. The device of claim 8, wherein the hollow member comprises an inner cylinder and an outer cylinder separated from each other by an annular space.

10. The apparatus according to claim 9, further comprising: A ligature band channel extends from the proximal end of the middle portion to the proximal end of the window and leads to the window.

11. The apparatus according to claim 1, further comprising: A notch is located in the crimping plate and is configured to deform the ligature into a predetermined pattern.

12. The device of claim 10, wherein the tie channel is configured to accommodate a plurality of tie ties.

13. The device according to any one of claims 1 to 2, further comprising: A safety stop is located on the actuation mechanism to prevent deformation of the ligature during loading and prior to deployment.

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