Multiple band ligation

Abstract

The device includes a housing having a first opening for receiving tissue therein; and a distal head at least partially disposed within the housing. The distal head is configured to rotate about a longitudinal axis of the distal head. The device also includes a first retaining member coupled to the housing and a second retaining member coupled to the distal head. The first retaining member and the second retaining member are configured such that rotating the distal head stretches a first ligature coupled to the first retaining member and the second retaining member, thereby allowing tissue drawn into the first opening to pass through the opening of the first ligature.

Description

[0001] Priority declaration

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 871,348, filed on July 8, 2019; the disclosure of which is incorporated herein by reference. Technical Field

[0003] The present invention relates to the treatment of hemorrhoids, and in particular to a device for ligating hemorrhoids using a plurality of ligatures and a retaining member to draw in hemorrhoidal tissue. Background Art

[0004] Hemorrhoids, swollen and inflamed veins around the anus or in the lower rectum, can form externally, under the skin around the anus, or internally, in the lining of the anus and lower rectum. In the United States, about 50% of adults over the age of 50 experience symptoms caused by hemorrhoids, including bleeding, irritation, or pain.

[0005] Sometimes cases of hemorrhoids are treated non-surgically. Some common methods include rubber band ligation (RBL), infrared light coagulation (IRC), HETTM bipolar or topical therapy. The RBL system works by placing a rubber band at the base of the hemorrhoid, constricting blood flow to reduce inflammation and eventually eliminate the hemorrhoid.

[0006] Many adults have more than one hemorrhoid. For example, in adult men, there are three common locations for internal hemorrhoids: the right front, left side, and right back of the rectum. It is desirable to treat multiple internal hemorrhoids in a single minimally invasive procedure. Summary of the invention

[0007] The present invention relates to a device, which includes a housing having a first opening for receiving tissue therein; and a distal head, which is at least partially disposed within the housing. The distal head is configured to rotate around a longitudinal axis of the distal head. The device includes a first retaining member coupled to the housing and a second retaining member coupled to the distal head. The first retaining member and the second retaining member are configured so that rotating the distal head stretches a first ligature coupled to the first retaining member and the second retaining member, thereby allowing tissue sucked into the first opening to pass through the opening of the first ligature.

[0008] In one embodiment, the shell has a second opening and a third retaining member connected to the shell and a fourth retaining member connected to the head adjacent to the second opening, and the third retaining member and the fourth retaining member are configured so that rotating the distal head stretches the second ligature connected to the third retaining member and the fourth retaining member to allow tissue sucked into the second opening to pass through the opening of the second ligature.

[0009] In one embodiment, the shell has a third opening and a fifth retaining member connected to the shell and a sixth retaining member connected to the head adjacent to the third opening, and the fifth retaining member and the sixth retaining member are configured so that rotating the distal head stretches the third ligature connected to the fifth retaining member and the sixth retaining member to allow tissue sucked into the third opening to pass through the opening of the third ligature.

[0010] In one embodiment, the first, second, and third openings are spaced apart around a circumference of the conical distal portion of the housing and rotating the distal head stretches the first, second, and third ligature ties substantially simultaneously.

[0011] In one embodiment, at least one of the first retention member and the second retention member is configured to break when the distal head is rotated a predetermined amount to release a ligature coupled thereto from the device.

[0012] In one embodiment, one of the shell and the distal head includes an interference member that contacts one of the first retaining member and the second retaining member during rotation of the head relative to the shell, so that further rotation of the head relative to the shell causes one of the first retaining member and the second retaining member to break.

[0013] One embodiment further includes a rotation mechanism for rotating the distal head relative to the housing; and an actuator maintained accessible to a user, the actuator coupled to the rotation mechanism such that operation of the actuator rotates the housing relative to the head.

[0014] One embodiment further includes a vacuum port extending from the proximal end of the housing, the vacuum port configured to be attached to a vacuum source, wherein external actuation of the vacuum source creates a vacuum at the distal head to draw tissue into the first opening.

[0015] In one embodiment, the distal head defines a first recessed portion sized to receive a portion of tissue prior to rotating the distal head and a first passage portion adjacent the first recessed portion sized to receive a larger portion of tissue after rotating the distal head.

[0016] In one embodiment, the first passage portion is angled such that when the device is drawn proximally, received tissue exits the first opening.

[0017] The present invention also relates to a method, which includes receiving tissue through a first opening in a housing of a device, the device having a distal head, the distal head being at least partially disposed within the housing and being configured to rotate about a longitudinal axis of the distal head. The device includes a first retaining member coupled to the housing and a second retaining member coupled to the distal head. The method includes rotating the distal head so that a first ligature coupled to the first retaining member and the second retaining member is stretched to allow the tissue drawn into the first opening to pass through the opening of the first ligature.

[0018] In one embodiment, the shell has a second opening and a third retaining member connected to the shell and a fourth retaining member connected to the head adjacent to the second opening, and the third retaining member and the fourth retaining member are configured so that rotating the distal head stretches the second ligature connected to the third retaining member and the fourth retaining member to allow tissue sucked into the second opening to pass through the opening of the second ligature.

[0019] In one embodiment, the shell has a third opening and a fifth retaining member connected to the shell and a sixth retaining member connected to the head adjacent to the third opening, and the fifth retaining member and the sixth retaining member are configured so that rotating the distal head stretches the third ligature connected to the fifth retaining member and the sixth retaining member to allow tissue sucked into the third opening to pass through the opening of the third ligature.

[0020] In one embodiment, the first, second, and third openings are spaced apart around a circumference of the conical distal portion of the housing and rotating the distal head stretches the first, second, and third ligature ties substantially simultaneously.

[0021] In one embodiment, at least one of the first retention member and the second retention member is configured to break when the distal head is rotated a predetermined amount to release a ligature coupled thereto from the device.

[0022] In one embodiment, one of the shell and the distal head includes an interference member that contacts one of the first retaining member and the second retaining member during rotation of the head relative to the shell, so that further rotation of the head relative to the shell causes one of the first retaining member and the second retaining member to break.

[0023] In one embodiment, the device has a rotation mechanism for rotating the distal head relative to the housing; and an actuator coupled to the rotation mechanism such that operation of the actuator rotates the housing relative to the head.

[0024] One embodiment further comprises externally actuating a vacuum source attached to a vacuum port extending from the proximal end of the housing, wherein external actuation of the vacuum source creates a vacuum at the distal head to draw tissue into the first opening.

[0025] In one embodiment, the distal head defines a first recessed portion sized to receive a portion of tissue prior to rotating the distal head and a first passage portion adjacent the first recessed portion sized to receive a larger portion of tissue after rotating the distal head.

[0026] In one embodiment, the first passage portion is angled such that when the device is drawn proximally, received tissue exits the first opening. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 A perspective view showing a device for ligating hemorrhoids according to an exemplary embodiment of the present invention.

[0028] Figure 2 Show Figure 1 A stereoscopic view of the head of the device.

[0029] Figure 3 Show Figure 1 Front view of the cavity of the head of the device.

[0030] Figure 4 Show Figure 1 A stereoscopic view of the head of the device with the cavity of the device closed.

[0031] FIG. 5A to FIG. 5D Show use Figure 1 Ligation surgery of the device.

[0032] Figure 6 Shown for execution using Figure 1 The method of ligation of the device.

[0033] Figure 7 Shown for Figure 1 Surgery to remove the device. DETAILED DESCRIPTION

[0034] The present invention may be further understood with reference to the following description and accompanying drawings, in which like elements are indicated by like reference numerals. The present invention relates to a multi-band ligation device for ligating one or more hemorrhoids at the same time. An exemplary embodiment of the present invention describes a gun-shaped device comprising a handle and a conical portion, the conical portion comprising a distal head defining a plurality of hemorrhoid receiving cavities. The device applies a ligation band to each hemorrhoid received in one of the cavities and releases the hemorrhoids to release the device for repositioning or removal from the body. It should be noted that the exemplary embodiment is described herein as a device with three hemorrhoid receiving cavities for ligating up to three hemorrhoids simultaneously or continuously without reloading the device. However, as will be appreciated by those skilled in the art, the principles described herein may be applied to devices with more or less than three cavities. It should also be noted that the terms proximal and distal as used herein are intended to refer to the direction of the user toward (proximal) and away from (distal) the device.

[0035] like Figure 1 As shown in FIG. 5 , the device 100 for ligating hemorrhoids includes a proximal handle portion 102 and a conical distal portion 110. The handle 102 includes a handle housing 104, a trigger 106 extending outward from the handle housing 104 through an opening in the handle housing 104, and an accessory 108 for connecting the device 100 to a vacuum source (not shown) at the proximal end of the handle 102. The accessory 108 can be, for example, a Luer connector, but as will be appreciated by those skilled in the art, any other suitable accessory can be used. The vacuum source can be, for example, a dedicated automatic device, such as a pump, or can be a manual device, such as a syringe or any other suitable source. The vacuum source is actuated separately from the actuation mechanism (i.e., the trigger 106) of the device 100. The trigger 106 is actuated to advance the device 100 from a first configuration to a second configuration via an internal rotation mechanism (not shown). The exemplary arrangement of the trigger 106 on the side of the device 100 is for illustrative purposes only, and the trigger 106 can be disposed on any face of the handle housing 104.

[0036] The conical distal portion 110 includes a distal housing 112 having a distal opening 114. In a first configuration, the distal opening 114 provides access to a cavity 120 defined by a distal head 116. Each of the distal openings 114 may have a protrusion 136 extending partially radially inward from the distal housing 112 into the cavity 120 on one side, as seen in the cross-sectional view of FIG. 5, and a housing retaining ring 124 on the other side for retaining the ligature 122 until the band 122 is deployed on the hemorrhoid. The distal head 116 extends longitudinally from a proximal end coupled to a rotation mechanism to a distal end terminating in a rounded distal tip 118. The rotation mechanism may be, for example, any mechanical linkage configured to convert the motion of a trigger into a rotational motion to rotate the distal head 116 relative to the distal housing 112. For example, the rotation mechanism may be gear- or pulley-based.

[0037] The distal head 116 is configured to rotate within the distal housing 112 while the distal housing 112 remains fixed. In one embodiment, the device 100 may include three cavities 120, and the distal head 116 may rotate approximately 60° to advance from the first configuration to the second configuration. However, the degree of rotation may be greater than or less than 60°. In the first configuration, the distal head 116 and the distal housing 112 are attached by a flexible ligature 122 through each of the distal openings 114. The ligature 122 may be any flexible band having a natural (unstretched) state of relatively small diameter and capable of withstanding stretching to a diameter several times its unstretched diameter. For example, the ligature 122 may be a rubber band. When the device 100 is in the first configuration, the ligature 122 extends from a housing retaining ring 124 on the distal housing 112 to one or more head retaining rings 126 on the distal head 116. As distal head 116 rotates, ligature 122 stretches until device 100 reaches the second configuration, then the retaining loop breaks and the stretched ligature 122 contracts toward its natural state around the base of the hemorrhoid under its natural bias, as will be discussed further below.

[0038] The present invention describes a specific embodiment of the device 100 in which the ligature 122 is retained by the retaining rings 124, 126 until the second configuration is achieved, and the retaining rings 124, 126 break by interference with the device components to release the ligature 122. However, the present invention is not limited to this specific release mechanism. For example, the ligature 122 can be held in place by structures other than retaining rings, such as a protrusion at the open end. In this example, the band 122 can slide off the protrusion through the device components. In yet another example, a device similar to the device 100 may include a shaped similar to the device 100. FIG. 5A to FIG. 5DThe movable retaining clamps or hooks of the retaining rings 124, 126 shown in the drawings are different from those in that the hooks of this device are movable to release the ligature. Specifically, the hooks holding the ligature in this device do not break to release the ligature, but are moved away from the ligature via an actuation mechanism (or simply released to move under the force applied by the ligature).

[0039] Those skilled in the art will appreciate that such a device can then be sterilized, reloaded with ligatures, and reused. In this example, the band 122 can be deployed by an independent actuator (such as an external button or trigger) connected to the clamp or hook via a pull line or another actuation mechanism. Even when the retaining rings 124, 126 are implemented in the device 100, the rings 124, 126 may also break by means other than interference of the device components. For example, the mechanism can be actuated from the outside by the user of the device separately from the actuation of the rotating mechanism to break the retaining ring.

[0040] From FIG. 5A to FIG. 5D As can be seen in the figure, the distal head 116 includes a plurality of recessed portions 128 separated by passage portions 130. When the device 100 is in the first configuration, each of the recessed portions substantially defines a limit into which a hemorrhoid can be drawn into the cavity 120 for ligation. The cavity 120 can be defined as a region substantially bounded by the recessed portions 128 and extending longitudinally from the proximal point of the distal opening 114 to the distal tip 118, except that the entire boundary of the cavity 120 is a gap 132 that opens into an interior 134 of the device 100.

[0041] The interior 134 of the device 100 is in direct air communication with a vacuum source. In one embodiment, tubing extends from the proximal fitting 108 to the distal head 116 within the interior of the device 100 to minimize the mass of air to be displaced. In another embodiment, the proximal fitting 108 leads to a substantially airtight interior of the device 100 and applies a vacuum to the entire volume of air within the device. In the first configuration, the gap 132 is minimal and the ligature 122 surrounds the gap. As the device 100 is advanced from the first configuration toward the second configuration and suction is applied, the gap 132 widens, allowing a hemorrhoid positioned adjacent the gap to be drawn into the interior 134 of the device 100 by the suction.

[0042] FIG. 5A to FIG. 5D The transition of the device 100 from the first configuration to the second configuration is shown. Figure 5A The first configuration is shown prior to actuation of the trigger 106. The vacuum has been drawn and a small portion of the hemorrhoid has been drawn by suction into the gap 132 through the center of the opening in the ligature 122 at the minimum stretch level. FIG. 5B to FIG. 5CThe device 100 is shown when the distal head 116 is rotated. During this rotation, the ligating band 122 stretches between the distal head 116 and the housing retaining ring 124, allowing more of the hemorrhoid to be drawn through the band 122 and extend further into the interior 134 of the device 100. Figure 5D The second configuration is shown in which the distal head 116 has been fully rotated. The retaining rings 124, 126 can then be broken at the locations marked by X, and, as shown Figure 5D As shown, ligature band 122 is released to contract around the bottom of hemorrhoids, thereby cutting off the blood flow to hemorrhoids. Once blood flow is cut off, hemorrhoids may die, and tissue and band may be separated and passed from the patient.

[0043] Figure 6 Shown for execution using Figure 1 An exemplary method 600 of a ligation procedure using a device 100 is provided. In this embodiment, the device 100 has three lumens 120 for treating three hemorrhoids simultaneously. At 605, the device 100 is introduced into the patient's body in a first configuration, i.e., prior to actuation of the device 100. Upon insertion of the device 100, the lumen 120 of the device 100 is aligned with the target hemorrhoid to be treated. The location of the hemorrhoid may be known, for example, from a previous examination, or may be determined by any known method. When the patient has three hemorrhoids, all three lumens 120 are used simultaneously in the procedure, with each of the hemorrhoids being roughly aligned with a corresponding one of the lumens 120. When the patient has less than three total hemorrhoids or less than three hemorrhoids that can be aligned with the lumens 120, a cavity cover 138 may be used, as shown in FIG. Figure 4 As shown, to prevent non-hemorrhoidal tissue from being pulled by vacuum and causing damage. The chamber cover 138 in this embodiment also prevents unused belts from jumping out of the device and entering the patient's body when the belts are released from their respective retaining rings.

[0044] At 610, a vacuum source is remotely actuated from the device. The vacuum source may be an automatic device or a manual device. Figure 5A As shown, the partial vacuum caused by activation of the vacuum source will draw the hemorrhoid tissue adjacent to each of the uncovered cavities 120 partially through the corresponding gaps 132 toward the interior 134 of the device 100. The remaining portion of the hemorrhoid (not yet drawn into the interior 134) is located on the recessed portion 128 of the distal head 116 in the cavity 120.

[0045] At 615, the trigger 106 is actuated, thereby rotating the distal head 116 toward the second configuration. The recessed portion 128 in the first configuration is aligned with the distal opening 114 of the distal housing 112, thereby forming the cavity 120, such that rotation of the recessed portion 128 away from the distal opening 114 widens the gap 132 leading to the interior of the distal head 116. FIG. 5B to FIG. 5CAs shown, the gap 132 is gradually contained in the distal end of the passage portion 130, which leads directly to the interior 134 of the device. Throughout the rotation process, the vacuum pressure draws the hemorrhoidal tissue further into the interior 134 of the device 100.

[0046] At 620, the distal head 116 completes rotation to the second configuration and multiple actions occur substantially simultaneously. First, the completion of the rotation allows the hemorrhoids to be drawn as completely as possible into the interior 134 of the device 100, so that the base of each hemorrhoid or the portion of each hemorrhoid near its base is drawn flush with the distal opening 114 of the distal housing 112. The vacuum source pulls the hemorrhoids proximally and the passage portion 130 naturally tilts toward the proximal end of the device 100. The relatively small gap 132 in the first configuration becomes a direct, open path into the interior of the device 100 in the second configuration.

[0047] The second action that occurs after the rotation is complete is the breaking of the retaining rings, namely the housing retaining ring 124 (attached to the distal housing 112) and the head retaining ring 126 (attached to the distal head 116). Figure 5D As shown, a protrusion 136 extending radially inward from the distal housing 112 interferes with the rotation of the head retaining ring 126. The protrusion 136 is structurally stronger than the head retaining ring 126, so that further rotation of the head retaining ring 126 against the protrusion 136 will cause the head retaining ring 126 to break. In a similar manner, the housing retaining ring 124 interferes with the rotation of a portion of the recessed portion 128 to form an adjacent cavity. Because the recessed portion 128 is structurally stronger than the housing retaining ring 124, further rotation of the recessed portion 128 against the housing retaining ring 124 will cause the housing retaining ring 124 to break.

[0048] The breaking of the retaining rings 124, 126 releases the ligature 122 so that it contracts around the base of each of the hemorrhoids (i.e., the portion of the hemorrhoid that is currently within the diameter of each of the bands 122). Thus, blood flow to the hemorrhoids is effectively cut off. In the event that one or more of the cavities 120 are covered by the cavity cover 138, the breaking of the retaining rings 124, 126 releases the corresponding ligature 122 that is subsequently drawn into the interior 134 of the device 100 so that the band 122 is not released into the patient's body. Figure 5D As shown, the band 122' is released by rupturing the retaining rings 124, 126, but because the corresponding cavity 120 is covered by the cavity cover 138, the band 122' is retained in the device 100 and is not released into the body.

[0049] At 625, the vacuum source is deactivated and the device 100 is removed from the patient. Deactivation of the vacuum source allows the hemorrhoid to be partially sucked back out of the interior 134 of the device 100. When the device 100 is removed from the patient, the hemorrhoid is sucked along the passage portion 130, as shown in FIG. Figure 7 As shown, thereby allowing smooth removal of hemorrhoids from the device 100. Figure 7 As shown, those skilled in the art will appreciate that in some cases, not all of the hemorrhoidal tissue may be drawn into the device 100, and thus some hemorrhoidal tissue may remain after the ligation procedure.

[0050] Based on the foregoing it can be seen that device 100 is intended as a single use disposable device. The components of device 100 can be machined metal or molded plastic, except for retaining rings 124, 126, which need to be breakable and are preferably made of a relatively low strength material, such as plastic.

[0051] Device 100

[0052] Proximal handle 102

[0053] Handle housing 104

[0054] Trigger 106

[0055] Accessories 108

[0056] Distal portion 110

[0057] Distal housing 112

[0058] Distal opening 114

[0059] Distal head 116

[0060] Distal tip 118

[0061] Cavity 120

[0062] Ligature 122

[0063] Housing retaining ring 124

[0064] Head retaining ring 126

[0065] Concave portion 128

[0066] Passage portion 130

[0067] Gap 132

[0068] Interior of the device134

[0069] Protrusion 136

[0070] Cavity cover 138

[0071] Those skilled in the art will appreciate that the above-described embodiments may be modified without departing from the concept of the present invention. It should also be understood that structural features and methods associated with one of the embodiments may be incorporated into other embodiments. Therefore, it should be understood that the present invention is not limited to the specific embodiments disclosed, but modifications are also encompassed within the scope of the present invention as defined by the appended claims.

Claims

1. An apparatus comprising: a housing having a first opening and a second opening for receiving tissue therein; a distal head disposed at least partially within the housing and configured to rotate about a longitudinal axis of the distal head; a first retaining member coupled to the housing and a second retaining member coupled to the distal head, the first retaining member and the second retaining member being configured to enable a first ligature to extend in response to rotation of the distal head relative to the housing, the first ligature being coupled to the first retaining member and the second retaining member; A third retaining member connected to the shell and a fourth retaining member connected to the distal head are adjacent to the second opening, and the third retaining member and the fourth retaining member are configured so that rotating the distal head stretches the second ligature connected to the third retaining member and the fourth retaining member to allow tissue sucked into the second opening to pass through the opening of the second ligature.

2. The device of claim 1, wherein the first ligature is positioned and oriented relative to the first opening to allow tissue drawn into the first opening to pass through the opening of the first ligature when the first ligature is extended.

3. The device according to claim 1, wherein the shell has a third opening and a fifth retaining member connected to the shell and a sixth retaining member connected to the distal head adjacent to the third opening, and the fifth retaining member and the sixth retaining member are configured so that rotating the distal head relative to the shell stretches the third ligature connected to the fifth retaining member and the sixth retaining member to allow tissue sucked into the third opening to pass through the opening of the third ligature.

4. The device of claim 3, wherein the first, second, and third openings are spaced apart around the circumference of the conical distal portion of the housing and rotating the distal head relative to the housing simultaneously stretches the first, second, and third ligatures.

5. The device of claim 1, wherein at least one of the first and second retaining members is configured to break when the distal head is rotated a predetermined amount relative to the housing to release a ligature coupled thereto from the device.

6. A device according to claim 5, wherein the shell and one of the distal head include an interference member, and during the rotation of the distal head relative to the shell, the interference member contacts at least one of the first retaining member and the second retaining member, so that further rotation of the distal head relative to the shell causes one of the first retaining member and the second retaining member to break.

7. The device according to claim 1, further comprising: a rotation mechanism for rotating the distal head relative to the housing; as well as An actuator is maintained accessible to a user, the actuator being coupled to the rotation mechanism such that operation of the actuator rotates the distal head relative to the housing.

8. The device according to claim 1, further comprising: A vacuum port extends from the proximal end of the housing, the vacuum port being configured to be attached to a vacuum source, wherein external actuation of the vacuum source creates a vacuum at the distal head to draw the tissue into the first opening.

9. A device according to claim 1, wherein the distal head defines a first recessed portion, the size of which is configured to receive a portion of the tissue before rotating the distal head; and a first passage portion adjacent to the first recessed portion, the size of which is configured to receive a larger portion of the tissue after rotating the distal head.

10. The device of claim 9, wherein the first passage portion is angled such that when the device is drawn proximally, the received tissue exits the first opening.

11. The device of claim 1 , wherein at least one of the first retaining member and the second retaining member is configured to move out of engagement with the first ligature when the distal head is rotated a predetermined amount relative to the housing to release the first ligature from the device.

12. The device of claim 1, wherein at least one of the first and second retaining members is configured to move out of engagement with the first ligature when the corresponding ligature release actuator is actuated to release the first ligature from the device.

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