BACKGROUND OF THE INVENTION

[0001] The present invention is directed to a method and structure for resisting migration of an intraluminal device in a lumen and in particular to a lumen that experiences peristalsis.

[0002] Resisting migration in a lumen that experiences peristalsis is a difficult problem. In addition to migration distally in the direction of the peristalsis, migration can occur proximally in the opposite direction. For example, in the esophagus, the persistence of peristalsis presents a strong force tending to cause distal migration. Occasionally, proximal migration forces may be produced; for example, when the patient belches or vomits. Various techniques have been proposed to resist migration but were either ineffective, difficult to deploy or potentially injurious to the patient.

SUMMARY OF THE INVENTION

[0003] The gastrointestinal (GI) tract is a lumen that includes a number of sphincters or

pseudo-sphincters, which will be collectively referred to herein as“sphincters”, at various locations. Each sphincter is formed of muscle and is under voluntary and/or involuntary control to close to hold back intraluminal content against the force of peristalsis or open to pass the intraluminal content. Because each sphincter produces at least some narrowing of the lumen, proposals have been made to use the sphincter to resist distal migration of an intraluminal device. However, when the sphincter opens, it is unable to resist distal migration of the intraluminal device which then migrates. Other proposals have been made to use barbs expending outwardly and/or distally from the outer wall of the intraluminal device to resist distal migration of the device in the lumen. However, the distal force created by peristalsis is sufficient to overcome resistance of many types of barbs Also, the lumens of the GI tract are not very thick or strong. There is a serious risk that outwardly-pointed barbs could cause ulceration to the lumen or penetrate it altogether resulting in internal infections to the patient.

[0004] The present invention provides a method of resisting migration of a device and an

intraluminal device that is both robust and straightforward to deploy without the need for an additional deployment device. It can be used alone or in combination with other fixation techniques.

[0005] A method of resisting migration of a device in a lumen, the lumen having muscle

defining an intraluminal sphincter, according to an aspect of the invention, includes a device having a body with a size and shape of a portion of the lumen. The device further includes at least one tine extending distally from the body. The at least one tine is rigid or semi rigid. The device is deployed in the lumen with the body proximal the sphincter with respect to peristaltic movement of the lumen, with the at least one tine penetrating the muscle of the sphincter.

[0006] The at least one tine may include at least two tines that are axially spaced around the body with respect to the lumen. The at least one tine may be configured to penetrate the sphincter muscle sufficiently to avoid detachment from the sphincter from the peristalsis of the lumen. The at least one tine may have a length from approximately 0.5 cm to approximately 2.0 cm.

[0007] The device body may be coupled with another body with a connector, with the other body being positioned distal of the sphincter and the connector passing through the sphincter with the device deployed in the lumen. The device may be deployed by (i) compressing the body and the another body in a deployment device, (ii) positioning the deployment device at least partially distal of the sphincter and deploying the another body from the deployment device distal of the sphincter, (iii) moving the deployment device proximally and deploying the body and the at least one tine proximal the muscle of the sphincter and (iv) further deploying the device from the deployment device wherein the at least one tine subsequently penetrates the sphincter. The connector and/or another device may be sufficiently flexible in order to perform (iii) while maintaining said the other body generally distal to the sphincter.

[0008] The body may be an esophageal member configured to the size and shape of the distal portion of the esophagus. The other body may be a cardiac member that is configured to the size and shape of a portion of the cardiac portion of the stomach and the connector passes through the esophageal-gastric (EG) sphincter.

[0009] The body may be configured to be positioned at the pylorus. The other body may be configured to the size and shape of a portion of the intestine and the connector passes through the pyloric sphincter. The at least one tine penetrates the pyloric sphincter.

[0010] The body may be configured to be positioned at the throat. The other body may be configured to the size and shape of a portion of the esophagus and the connector passes through the upper esophageal sphincter. The at least one tine penetrates the upper esophageal sphincter. [0011] The body may be configured to be proximal the ileocecal valve, the other body may be configured to the size and shape of a portion of the large colon and the connector passes through the ileocecal valve. The at least one tine penetrates the sphincter of the ileocecal valve.

[0012] The at least one tine may be directed distally and outwardly but more distally than

outwardly. The at least one tine may have a length of between approximately 0.5 cm and 2.0 cm. The angle between each tine and the central axis of the body may be between 5 degrees and approximately 45 degrees. An enlarged tip may be provided on the at least one tine to resist catching on a deployment device or other surface. The at least one tine may be configured to be retained entirely within the lumen and not penetrate the lumen.

[0013] An intraluminal device that is adapted to be deployed in a lumen that experiences

peristaltic waves and has muscle defining an intraluminal sphincter, according to an aspect of the invention, includes a body having a size and shape of a portion of the lumen proximal of the sphincter and at least one tine extending distally from a distal portion of the body. The at least one tine is rigid or semi rigid. The at least one tine extends distally from the body with respect to peristaltic movement of the lumen and is adapted to penetrate the muscle of the sphincter when the body is deployed in the lumen proximal to the sphincter.

[0014] The at least one tine may be at least two tines that are axially spaced around with

respect to the body. The at least one tine may have a length of at least a wavelength of a peristaltic wave of the lumen. The body may be coupled with another body using a connector. The other body has a size and shape to be deployed downstream of the sphincter and the connector being configured to pass through the sphincter.

[0015] The body may be an esophageal member that is configured to the size and shape of the distal portion of the esophagus and the other body a cardiac member that is configured to the size and shape of a portion of the cardiac portion of the stomach. The connector is adapted to pass through the esophageal-gastric (EG) sphincter and the at least one tine adapted to penetrate the EG sphincter..

[0016] The body may be configured to the size and shape of a portion of the pylorus and the other body configured to the size and shape of a portion of the intestine. The connector is adapted to pass through the pyloric sphincter and the at least one tine adapted to penetrate the pyloric sphincter. [0017] The body may be configured to be positioned proximal the upper esophageal sphincter and the other body configured to the size and shape of a portion of the esophagus. The connector is adapted to pass through the upper esophageal sphincter and the at least one tine adapted to penetrate the upper esophageal sphincter.

[0018] The body may be configured to be positioned proximal the ileocecal valve and the other body configured to the size and shape of a portion of the large intestine. The connector is adapted to pass through the ileocecal valve and the at least one tine adapted to penetrate the sphincter of the ileocecal valve.

[0019] The at least one tine may be directed distally and outwardly but more distally than

outwardly. The angle between each tine and the central axis of the body may be between 5 degrees and 45 degrees, such as between approximately 5 and approximately 30 degrees such as approximately 10 degrees. The at least one tine may have a length of between

approximately 0.5 cm and approximately 2.0 cm.

[0020] An enlarged tip of the at least one tine to resist catching on a surface such as a

deployment device. The at least one tine may be configured to be retained entirely within the lumen.

[0021] An intraluminal device that is adapted to be deployed in a lumen that experiences

peristaltic waves and has muscle defining an intraluminal sphincter, according to an aspect of the invention, includes an esophageal member having a size and shape of a distal portion of the esophagus and at least one tine extending distally from a distal portion of the esophageal member. The at least one tine is rigid or semi-rigid. The at least one tine is adapted to penetrate the muscle of the EG sphincter when the esophageal member is deployed in the esophagus proximal to the gastro-esophageal sphincter. A cardiac member is coupled with said esophageal member with a connector. The connector is configured to cause the cardiac member to apply stress to the cardiac portion of the stomach when the connector passes through the gastro-esophageal sphincter and the cardiac member is in the stomach.

[0022] The at least one tine may be at least two tines that are axially spaced around the

esophageal member. The at least one tine may be configured to penetrate the sphincter sufficiently to avoid separating from the sphincter by peristaltic effect on the device.. The at least one tine may have a length of between approximately 0.5 cm and approximately 2.0 cm. The angle between each tine and the central axis of the esophageal member may be between approximately 5 degrees and approximately 45 degrees outwardly.

[0023] The connector and/or cardiac member may be sufficiently flexible in order to allow the esophageal member to be displaced proximally sufficiently to allow the at least one tine to engage the muscle of the gastro-esophageal sphincter. An enlarged tip may be provided on the least one tine to resist catching on a deployment device. The at least one tine is configured to be retained entirely within the lumen.

[0024] A method of resisting migration of a device in a lumen having muscle defining an

intraluminal sphincter, according to an aspect of the invention, includes the device having a body with a size and shape of a portion of the lumen. The device further includes at least one tine extending outwardly and distally from the body. The at least one tine is rigid or semi rigid. The device is deployed in the lumen with the body proximal the sphincter with respect to peristaltic movement of the lumen with the at least one tine penetrating the muscle of the sphincter. The device is explanted by moving the at least one tine to not extend outwardly from the body.

[0025] The device may include a removal ring at a proximal end portion of the body and a retraction ring at a distal end portion of the body that is connected with the removal ring.

Proximal force applied to the removal ring causes the retraction ring to move the at least one tine inwardly. The traction ring may move the at least one tine inwardly by a (i) reducing a diameter of the distal end portion of the body (ii), pulling inwardly on the at least one tine, and/or (iii) retracting the at least one tine into a pouch.

[0026] These and other objects, advantages, purposes and features of this invention will

become apparent upon review of the following specification in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] FIG. 1 is a side elevation of an intraluminal device according to an embodiment of the invention;

[0028] FIG. 2 is a view of the intraluminal device in FIG. 1 deployed to the GI tract of a

recipient an positioned at the esophageal-gastric sphincter (ESP) of the recipient;

[0029] FIG. 3 is the save view as FIG. 2 of an alternative embodiment of an intraluminal

device having a body, another body and a connector connecting the bodies position at the esophageal-gastric sphincter of the recipient; [0030] FIG. 4 is a sectional view taken along the lines IV-IV in FIG 3;

[0031] FIG. 5 is a side elevation of an alternative embodiment of an intraluminal device

positioned at the pyloric sphincter of the recipient;

[0032] FIG.6 is a side elevation of an alternative embodiment of an intraluminal device

positioned at the upper esophageal sphincter of the recipient;

[0033] FIG. 7 is a flattened view of the body in FIG, 3 illustrating interview details thereof;

[0034] FIG. 8 is a side elevation of an alternative embodiment of an intraluminal device

adapted to be positioned at the esophageal-gastric sphincter of the recipient; and

[0035] FIG. 9 is a sectional view taken along the lines IX-IX in FIG. 8.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] The present invention will now be described with reference to the accompanying

figures, wherein the numbered elements in the following written description correspond to like- numbered elements in the figures.

[0037] Referring now to the drawings and the illustrative embodiments depicted therein, an intraluminal device 10 is adapted to be deployed in a lumen 12 that experiences peristaltic waves and has muscle defining an intraluminal sphincter or pseudo-sphincter, hereafter “sphincter”. An example of such a lumen is a portion of the gastro-intestinal (GI) tract having sphincters including the upper esophageal sphincter (UES), the esophageal-gastric sphincter (EGS), the pyloric sphincter (PS) and the ileocecal valve (IV) that separates the large intestine from the small intestine. Intraluminal device 10 has a body 14 having a size and shape of a portion of the lumen proximal of the sphincter with respect to peristaltic movement of the lumen and a through opening 15 that allows movement of intraluminal content through the body. The through opening may be a central passage through the body or a shape of the body that allows intraluminal content to bypass the body.

[0038] Intraluminal device 10 further includes at least one tine 16. The at least one tine 16 extends distally from a distal portion of body 14 and is rigid or semi rigid. In this manner, with body 14 deployed in the lumen proximal the sphincter, the at least one tine 16 penetrates the muscle that defines the sphincter as peristalsis causes distal motion of the body thrusting the at least one tine distally. The penetration of the at least one tine in the sphincter is sufficient to resist action of peristalsis of lumen 12 separating the at least one tine from the sphincter. In this manner distal migration of body 14 is resisted even as the sphincter opens and closes. Thus the orientation of the at least one tine penetrating the sphincter resists distal migration of the body without placing excessive sheer force on the at least one tine, while the bulk and thickness of the sphincter resists penetration of the wall of lumen 12 with the tine(s) where intraluminal content could escape outside of the lumen where infection could ensue. This may be accomplished by the angle a between each tine 16 and the central axis of body 14 being between approximately 5 degrees and approximately 45 degrees, such as between

approximately 5 degrees and approximately 30 degrees and illustrated as approximately 10 degrees outwardly.

[0039] While one tine 16 may be sufficient to resist distal migration of body 14, at least two tines 16 that are axially spaced around body 14 with respect to lumen 12 enhances and more evenly distributes the forces resisting peristalsis. In the illustrated embodiment, each tine 16 is between approximately 0.5 cm and approximately 2.0 cm. In this manner, even with proximate/distal movement of body 14 in response to peristalsis of lumen 12, any

commensurate movement of the tine(s) 16 within the sphincter, will not cause the tine(s) to disengage from the sphincter. If a plurality of tines 16 are used they may be of different lengths to provide a variety of engagements with the sphincter.

[0040] In the illustrated embodiment in FIG. 3, device 110 body 114 is coupled with another body 18 with a connector 20. With intraluminal device 110 deployed at lumen 12 with body 114 proximal the sphincter and tine(s) 16 penetrating the EG sphincter, another body 18 is distal of the sphincter and connector 20 connecting body 114 with another body 18 passing through the EG sphincter. Connector 20 is configured to not substantially interfere with operation of the sphincter while passing through the sphincter. FIG 4 illustrates a possible arrangement of a plurality of tines 16 disposed angularly around the distal end of body 114. As can be seen, two tines 16 angle radially away from each connector 20 and two tines angle radially away from each other offset from the connectors. Other arrangements are possible.

[0041] Intraluminal device 110 may be deployed with a deployment device of the type

disclosed in commonly assigned US patent number 9,545,326, the disclosure of which is hereby incorporated herein by reference. Deployment begins by compressing body 114 and another body 18 and positioning them in the deployment device along with connector 20. The deployment device is deployed in the lumen 12 at least partially distal of the EG sphincter using techniques disclosed in the‘326 patent. Another body 18 is deployed from the deployment device distal of the EG sphincter. The deployment device is then pulled proximally and body 114 and at least one tine 16 is deployed from the deployment device in a position that is proximal the muscle of the EG sphincter. After body 114 is deployed from the deployment device, distal movement of the body will result in the at least one tine 116 penetrating the muscle of the EG sphincter.

[0042] Intraluminal device 110 may be explan ted with an endoscopic grasper or hook pulling proximally on a removal ring 30. In the illustrated embodiment, ring 30 is made of a suture or other material weaving between proximal ends 32 of the support mesh of body 114 (FIG. 7). This distributes the proximal force evenly around the perimeter of body 114 and pulls the wall inward from the esophagus thus reducing any tendency to injure the esophagus. One or more force transfer sutures 34 transfers the movement of removal ring 30 to a retraction ring 36. Retraction ring 36 retracts tines 16 inwardly in order to reduce any scratching of the tine tips along the esophagus as body 114 is removed. Retraction ring 36 functions by applying an inward force on a distal end of body 114, by applying an inward force directly on the tines 16 or by retracting the tines into pockets provided in body 114. Other methods will be apparent to the skilled artisan.

[0043] For intraluminal device 110, body 114 is an esophageal member 22 configured to the size and shape of the distal portion of the esophagus and another body 18 is a cardiac member 24 that is configured to the size and shape of a portion of the cardiac portion of the stomach as illustrated in FIG 3. Connector 20 passes through the esophageal-gastric (EG) sphincter. Such embodiment is useful as a bariatric device and method as disclosed in commonly assigned international application publication WO 2016/109346 or a metabolic disease treatment device and method as disclosed in commonly assigned international application publication WO 2015/031077 the disclosures of which are hereby incorporated herein by reference. In order to function as a bariatric device or a metabolic disease treatment device, cardiac member 24 applies pressure to the cardiac portion of the stomach at least part of the time via connector 20 being under tension. In order to do so, while allowing esophageal member 22 to be initially deployed sufficiently proximal of the EG sphincter to allow the distal tip of tine(s) 16 to engage the muscle of the EG sphincter, connector 20 and/or cardiac member 24 may be sufficiently flexible in order to accommodate temporary further spacing between the esophageal member and the cardiac member while maintaining position of the cardiac member 24 generally distal of the EG sphincter. This may be accomplished by connector 20 being elastic and/or by cardiac member 24 being flexible. In that manner, the connector and/or cardiac member can flex to allow tine(s) 16 to engage the EG sphincter then relax sufficiently to place pressure on the cardiac portion of the stomach

[0044] In an alternative embodiment illustrated in FIG. 5, a device 210 has a body 214 that is configured to be positioned at the pyloric and another body 118 that is configured to the size and shape of a portion of the small or large intestine. A connector 120 passes through the pyloric sphincter in a manner that does not interfere with operation of the sphincter. Tines 16 extending distally from body 214 penetrate the pyloric sphincter (PS) in a manner that resists distal migration of device 210.

[0045] In another alternative embodiment illustrated in FIG. 6, a device 310 has a body 314 that is configured to be positioned proximate the upper esophageal sphincter and another body 218 that is configured to the size and shape of a portion of the esophagus. A connector 220 passes through the upper esophageal sphincter in a manner that does not interfere with operation of the sphincter. Tines 16 extending from body 314 penetrate the upper esophageal sphincter sufficiently to resist distal migration of device 310.

[0046] A device embodying the invention may use the sphincter of the ileocecal valve in order to position another body in the large colon in a manner that will be apparent to the skilled artisan.

[0047] In another embodiment illustrated in FIG. 8 an intraluminal device 410 has a body 414 that is configured to be positioned at a distal portion of the esophagus, another body 418 that is configured to be positioned against the cardiac portion of the stomach and a connector 320 that passes through the esophageal-gastric sphincter in a manner that does not interfere with operation of the EG sphincter. Body 414 is ring-shaped in order to pass intraluminal content through the esophagus and, as can best be seen in FIG. 9, body 414 has a curvilineal cross section in order to minimize any potential irritation of the esophagus.

[0048] Tine(s) 16 can be made of nitinol wire, stainless steel, titanium, carbon fiber, or the like, covered with a biocompatible material such as a silicone coating. This makes the tine(s) stiff yet flexible. Each tine is directed generally distally but with an outward slant. This ensures that the tine engages the sphincter. Each tine is directed more distally than outwardly so that shear forces on the tine are minimal. Also this minimizes possibility of the tine penetrating the wall of lumen 12. For example, the angle between each tine and the central axis of body 314 may be between approximately 5 degrees and approximately 45 degrees but a greater or lesser amount may be used such as between approximately 5 degrees and approximately 30 degrees or approximately 10 degrees. An enlarged tip 26 of tine(s) 16 may be provided to resist catching on a deployment device or other surface. Although two tines 16 are shown, one on each side of body 414, more than two tines may be used. A plurality of additional distally directed tines may be deployed, each between one of the ones shown and body 418.

[0049] While the foregoing description describes several embodiments of the present

invention, it will be understood by those skilled in the art that variations and modifications to these embodiments may be made without departing from the spirit and scope of the invention, as defined in the claims below. The present invention encompasses all combinations of various embodiments or aspects of the invention described herein. It is understood that any and all embodiments of the present invention may be taken in conjunction with any other embodiment to describe additional embodiments of the present invention. Furthermore, any elements of an embodiment may be combined with any and all other elements of any of the embodiments to describe additional embodiments.