The present invention is directed to an intraluminal device and method of fixation of an intraluminal device and, in particular, a technique that enhances both fixation and removeability of the device. While the invention is illustrated for use with a bariatric device and/or a metabolic device, it may be applied to other intraluminal devices positioned in a mammalian lumen or hollow organ that is subject to peristalsis, such as an esophageal stent, an anti-reflux device, a nasal gastric tube, an intestinal sleeve, and the like, including devices positioned in the fallopian tubes, vas deferens, and the like.
An intraluminal device and method of providing satiety and/or treating a metabolic disease in a recipient is disclosed in U.S. Pat. Nos. 7,846,174; 8,100,931; 8,372,087; 8,529,431; 8,672,831; 8,801,599 and 8,894,670 and published PCT Application No. WO 2015/031077 A1, the disclosures of which are hereby incorporated herein by reference in their entirety. Such devices and methods apply stress to the gastro-intestinal tract in general and in particular to the cardiac portion of the stomach of the recipient to produce satiety in the absence of food to produce satiety, and to augment fullness caused by food, and/or to treat a metabolic disease. A challenge with such devices and methods is fixation of a portion of the device against a surface of the GI tract, such as the cardiac portion of the stomach in the presence of peristalsis tending to cause distal migration of the device.
While the use of tissue ingrowth patented in the above-identified patents has been found to provide a satisfactory solution for fixation to resist distal migration, aspects of the present invention includes providing short-term fixation of the device until the tissue ingrowth providing long-term fixation is in place. Such short-term fixation is easy to carry out and capable of complete fixation over the days or weeks that it takes for the long-term fixation to occur.
Aspects of the present invention provide techniques for explantation of an intraluminal device having a wall defining first and second wall portions configured to be positioned in a lumen. The first wall portion may be an esophageal portion that is configured to the size and shape of a portion of the esophagus. The second wall portion may be a cardiac portion that is configured to the size and shape of the cardiac portion of the stomach. A connector connecting the esophageal and cardiac portions is positioned against lumen tissue, such as in the gastroesophageal (GE) junctions wherein lumen tissue bridges or encases the connector during deployment of the device. Explantation of the device should not substantially damage the GE junction of the recipient. Aspects of the present invention facilitate such explantation and provide techniques that may beneficially utilize such tissue bridging the connector for long-term fixation of an intraluminal device.
An intraluminal device adapted to be positioned in a lumen, according to an aspect of the invention, includes a wall having a first wall portion configured to the size and shape of a first portion of the lumen and a second wall portion configured to the size and shape of a second portion of the lumen. A connector connects the first wall portion with the second wall portion. The connector is configured to be positioned against the lumen and wherein the connector is separably connected with one or both of the first and second wall portions. This allows the device to be explanted by disconnecting the connector and axially withdrawing the connector from tissue that encases the connector without substantial damage to the tissue.
The wall portions may be joined with the connector prior to deployment in the lumen. The connector may include at least one filament that is coated with a bio-compatible material that extends around the at least one filament from one of the wall portions to the other of the wall portions. A removable attachment may connect the connector with at least one of the wall portions and wherein the connector is separable by removing the removable attachment. The removable attachment may include a severable filament.
The device may include a fixation system that is configured to resist distal migration of the wall in the lumen. The fixation system may include the connector having a configuration to facilitate tissue of the lumen growing around the connector. The fixation system may include a tissue penetrating fastener configured to engage the connector with tissue of the lumen. The connector may include at least one elongated member including irregular portions thereof.
The fixation system may include a long-term fixation system including a characteristic of the wall that is configured to facilitate tissue adhesion to the wall and a temporary fixation system that at least initially resists distal migration of the wall, wherein the temporary fixation system includes a tissue penetrating fastener. The temporary fixation system may include a looped filament extending from that at least one of the wall portions and is configured to be captured with the fastener. The looped filament may be at least partially elastic and may be at least partially bioabsorbable.
The intraluminal device may be an esophageal stent, an anti-reflux device, a nasal gastric tube, an intestinal sleeve, a bariatric device or a metabolic disease treatment device.
An intraluminal device adapted to be positioned at the gastro-esophageal (GE) region of a recipient, according to an aspect of the invention, includes a wall defining an esophageal portion that is configured to the size and shape of a portion of the esophagus, a cardiac portion that is configured to the size and shape of the cardiac portion of the stomach and a connector connecting the esophageal and cardiac portions. The connector is configured to be positioned at the GE junction. The connector is separably connected with the esophageal portion and/or the cardiac portion.
The connector may be separably connected with the cardiac portion. The connector may be separably connected with the cardiac portion with a removable attachment. A distal portion of the connector may extend along the cardiac portion and the removable attachment being a chain stitch between the distal portion of the connector and the cardiac portion of the wall. The cardiac portion may include a structural mesh defining intersections and covered with a biocompatible coating and the distal portion of the connector having openings that align with some intersections of the mesh. The chain stitch includes a filament extending between the openings and at least some of the intersections.
The cardiac portion may include a structural mesh defining intersections and covered with a biocompatible coating. The distal portion of the connector may extend proximally over some of the intersections and distally under other ones of the intersections at the cardiac portion. The removable attachment is between the distal portion of the connector and the cardiac portion. The removeable attachment keeps the distal portion of the connector from sliding with respect to the intersections. The removable attachment may be a filament between the distal portion of the connector and the cardiac portion of the wall. A bead may be provided on the filament to provide access to sever the filament.
An intraluminal device that is adapted to be deployed at the gastroesophageal (GE) region of a recipient, according to an aspect of the invention, includes a wall defining a cardiac portion that is configured to the size and shape of the cardiac portion of the stomach, an esophageal portion that is configured to the size and shape of a portion of the esophagus and a connector connecting the esophageal portion and the cardiac portion. A fixation system is configured to resist distal migration of the wall. The fixation system includes short-term fixation and long-term fixation. The short-term fixation is configured to at least temporarily resist distal migration of the wall. The long-term fixation includes a wall characteristic of the connector that is configured to facilitate tissue ingrowth.
The wall characteristic may be the connector being an elongated filament. The wall characteristic may be a tissue ingrowth promotion surface configuration. The ingrowth promotion surface configuration may face away from the GE junction. The short-term fixation may include a fastener that is adapted to fix the device at the GE junction. The short-term fixation fastener may be a tissue penetrating fastener that is adapted to fasten the connector with tissue at the GE junction. The tissue penetrating fastener may be configured to engage the GE junction as a function of deployment of the device at the GE region of the recipient. The tissue penetrating fastener may be adapted to be applied to tissue at the connector after deployment of the device at the GE region of the recipient. The tissue penetrating fastener may be made at least in part from a bio-absorbable material. The tissue penetrating fastener may face outwardly toward the GE junction and the connector may include a wall characteristic that faces inwardly away from the GE junction that is configured to facilitate tissue ingrowth.
The short-term fixation may include one or more sutures. The short-term fixation may include a looped filament extending proximally from the esophageal portion and a tissue penetrating fastener configured to capture the looped filament. The looped filament may be at least partially elastic and/or at least partially bioabsorbable. The looped filament may include an enlarged portion wherein the fastener penetrates tissue and the enlarged portion. A retainer filament may be provided that is temporarily connected with the looped filament, the retainer filament extending from the esophagus for use with positioning the wall at the GE junction of the recipient and with deployment of short-term fixation. The retainer filament is removed after deployment of the device.
The connector may be separably connected with the esophageal portion and/or the cardiac portion. The intraluminal device may be a bariatric device used to treat excess body mass or a metabolic device used to treat metabolic disease.
An intraluminal device adapted to be deployed at the gastroesophageal (GE) region of a recipient, according to an aspect of the invention, includes a wall defining a cardiac portion that is configured to the size and shape of the cardiac portion of the stomach. A fastener temporarily fixes the wall to the recipient to resist distal migration. A wall characteristic fixes the wall to the GE region through growth of tissue causing long-term fixing of the wall to the GE region to resist distal migrations. The wall characteristic facilitates tissue ingrowth. The temporarily fixing fixes the device at the GE region while the tissue grows at the characteristics to provide the long-term fixation.
The fastener may be a tissue penetrating fastener. The tissue penetrating fastener may include barbs joined with the wall and facing the GE region. The barbs may be formed on the wall and engage the tissue of the GE region upon deployment of the device. The barbs may be formed on a separate fastener attached with the wall. The fastener may be at least partially made with a bio-absorbable material wherein the temporary fixing diminishing resistance of distal migration after long-term fixing of the wall to the GE region has at least partially occurred.
The wall characteristic may facilitate tissue ingrowth openings in the wall. The device may include an esophageal portion that is configured to the size and shape of a portion of the esophagus and a connector connecting the esophageal portion and the cardiac portion wherein the tissue ingrowth openings are at the esophageal portion. The wall characteristic may include the connector being an elongated member that is configured to be positioned at the GE junction wherein tissue at least partially envelopes the connector to provide long-term fixation.
The intraluminal device may be a bariatric device that is used to reduce excess body mass or a metabolic device that is used to treat metabolic disease.
A method of fixation of an intraluminal device to resist distal migration in a mammalian lumen or hollow organ that is subject to peristalsis, according to an aspect of the invention, includes spaced apart wall portions connected with a connector. The wall portions are configured to the size and shape of a portion of the lumen or hollow organ and the connector is configured to be positioned against a wall of the lumen or hollow organ. The intraluminal device is positioned in a mammalian lumen or hollow organ that is subject to peristalsis. The device is fixed in the lumen or hollow organ against distal migration, wherein tissue lining the lumen or hollow organ bridges over the connector. The device is explanted after tissue bridges over the connector including separating the connector from one or both of the wall portions and withdrawing the connector axially from the tissue bridging over the connector.
A method of fixation of an intraluminal device at the gastroesophageal (GE) region of the recipient to resist distal migration, according to an aspect of the invention, includes the device having a wall defining an esophageal portion that is configured to the size and shape of a portion of the esophagus, a cardiac portion that is configured to the size and shape of the cardiac portion of the stomach and a connector connecting the esophageal and cardiac portions. The device is positioned at the GE region with the esophageal portion in the esophagus, the cardiac portion at the cardiac portion of the stomach and at least a portion of the connector at the gastroesophageal (GE) junction, wherein tissue at the GE junction at least partially encompasses the connector. The device is explanted after tissue has encompassed the connector including separating the connector from the esophageal portion and/or the cardiac portion and withdrawing the connector axially from the tissue encompassing the portion of the connector at the gastroesophageal junction.
A method of fixation of an intraluminal device at the gastroesophageal (GE) region of the recipient to resist distal migration, according to an aspect of the invention, includes the device having a wall defining a cardiac portion that is configured to the size and shape of the cardiac portion of the stomach, an esophageal portion that is configured to the size and shape of a portion of the esophagus and a connector connecting the esophageal portion and the cardiac portion. The intraluminal device is positioned at the GE region wherein tissue will grow to a wall characteristic of the connector at the GE junction to provide long-term fixation to resist distal migration. The device is temporarily fixed at the GE region while tissue grows to the wall characteristic of the connector.
A method of fixation of an intraluminal device at the gastroesophageal (GE) region of a recipient to resist distal migration, according to an aspect of the invention, the device having a wall defining a cardiac portion that is configured to the size and shape of the cardiac portion of the stomach includes positioning the device at the GE region with the cardiac portion engaging the cardiac portion of the stomach wherein tissue will grow to a wall characteristic of the wall to provide long-term fixation to resist distal migration of the wall and temporarily fixing the device at the GE region to resist distal migration while tissue grows at the wall characteristic. The temporally fixing including connecting the wall with the lumen using a tissue-penetrating fastener.
A method of fixation of an intraluminal device at the gastroesophageal (GE) region of a recipient to resist distal migration, according to an aspect of the invention, the device having a wall defining a cardiac portion that is configured to the size and shape of the cardiac portion of the stomach, an esophageal portion that is configured to the size and shape of a portion of the esophagus and a connector connecting the esophageal portion and the cardiac portion includes positioning the device at the GE region wherein tissue will grow to the wall to provide long-term fixation of the wall to the GE region of the recipient to resist distal migration and temporarily fixing the device at the GE region to resist distal migration while tissue grows to the wall. The temporarily fixing and the long-term fixation both at least partially occur at the connector.
These and other objects, advantages, purposes and features of the present invention will become apparent upon review of the following specification in conjunction with the drawings.
Referring now to the drawings and the illustrative embodiment depicted therein, an intraluminal device, such as a bariatric device 10, has a wall 12 defining an esophageal portion 14 that is configured to the size and shape of a portion of a mammalian lumen or hollow organ, namely, the esophagus, a cardiac portion 16 that is configured to the size and shape of a separated portion of mammalian lumen or hollow organ, namely, the cardiac portion of the stomach and a connector 18 connecting esophageal portion 14 and cardiac portion 16 (
As can be seen in
Fixation of bariatric device 10 against distal migration includes a fixation technique 22 that fastens esophageal portion 14 with the esophagus with a fastener such as a tissue penetrating fastener 24. A looped filament 26 extending proximally from esophageal portion 14 is captured with fastener 24 engaging the wall of the esophagus by the fastener. The loops in the looped filament are positively engaged by the fastener so that the esophageal portion 14 is firmly fixed to the esophagus by the fastener. The number of loops can vary from one to many and can be any size or shape as long as they are a closed polygon. In the illustrated embodiment, fastener 24 is an endoscopically deployed clip marketed by Ovesco and described in detail in U.S. Pat. No. 8,721,528 for an ENDOSCOPE CAP, the disclosure of which is hereby incorporated herein by reference. Also, although two loops and penetrating fasteners are illustrated, one or more than two may be used.
Fixation technique 22 is intended to provide at least temporary fixation to maintain device 10 in position at the GE region of the recipient with cardiac portion 16 engaging the cardiac region of the stomach while permanent fixation develops. Looped filament 26 may be at least partially elastic in order to be slightly stretched when fastener 24 is deployed to maintain upward pressure on cardiac portion 16 after deployment. Looped filament 26 may be at least partially bioabsorbable, or resorbable, so that it, along with fastener 24, may fall away after permanent fixation occurs as seen in
A retainer filament 30 may be temporarily connected with the looped filament 26 and extending external the recipient of the device from the esophagus. Retainer filament 30 allows the physician or other healthcare worker the ability to position bariatric device 10 properly at the GE region and to apply tension to looped filament 26 until fastener 24 is applied. As retainer filament 30 is merely looped proximally to looped filament 26, it can be easily retraced by pulling on one side of the loop. Looped filament 26 is connected directly with the mesh 32 that provides a structure to bariatric device 10. This allows the looped filament to apply proximal axial force to mesh which force is then distributed over wall 12 without causing a narrowing of esophageal portion 14 as may occur if the looped filament were to be connected with a removal suture (not shown) that encircles esophageal portion 14 proximally and is used to remove device 10. If a proximal force were to be applied to such removal suture, the diameter of esophageal portion 14 may be reduced upon fixation thus counteracting mucosal capture and/or tissue ingrowth of the wall of the esophageal portion to the esophageal wall. While the application of proximal axial force to such removal suture, or ring, may be a useful action to explant bariatric device 10, it would not be useful in providing fixation.
Thus, the direct connection of looped filament 26 to mesh 32 allows proximal axial force to be applied to esophageal portion 14 without inducing a radially inward force tending to pull wall 12 away from the esophagus wall. While looped filament 26 is shown in
In an alternative technique illustrated in
Fixation of bariatric device 10 against distal migration includes temporary fixing, such as using fixation 22, and long-term fixing from wall characteristics that fixes the wall to the GE region through growth of tissue, such as using tissue ingrowth zones 34 formed in wall 12, as disclosed in U.S. Pat. No. 7,846,174 discussed above.
Tissue ingrowth zones 34 are openings in the cover 33 of biocompatible material, such as silicone, over mesh 32, which openings allow tissue to bridge over members of the mesh as disclosed in U.S. Pat. No. 8,894,670 discussed above. As shown in
Tissue at or adjacent the GE junction, which includes tissue immediately above and below the sphincter, may bridge over one or both struts 20a, 20b of connector portion 18 at the GE junction as seen in
Struts 20a, 20b may be each formed from a single continuous metallic filament 38, such as Nitinol or stainless steel that is twisted from distally to proximally as shown in
In one embodiment, removable attachment 42 includes a distal portion of struts 20a, 20b extending along the distal surface of cardiac portion 16 as seen in
In an alternative embodiment, a bariatric device 110 includes a wall defining an esophageal portion 114 configured to the size and shape of a portion of the esophagus, a cardiac portion 116 configured to the size and shape of a portion of the cardiac portion of the stomach and a connector 118 (
It should be understood that the tissue bridging over struts 20a, 20b, which are elongated filaments that provide a wall characteristic that fixes the wall of struts 20a, 20b to the GE region through growth of tissue, can be useful as all or part of long-term fixation of device 10. Such long-term fixation may be enhanced by adding length to struts 220a, 220b shown in
Also, short-term and/or long-term fixation using the struts can be enhanced by applying tissue penetrative fasteners in the form of retainers 54 to the bridging mucosa (
Other forms of tissue penetrating fasteners can be used, such as EZ clip or a quick-clip, both available from Olympus. In addition to promotion of tissue bridging over the strut(s) 20a and/or 20b, the retainers 54, 154 may provide resistance to distal migration of esophageal member 14. This helps to provide tension on struts 20a, 20b, thus ensuring cardiac member 16 is in contact with the cardiac portion of the stomach. Thus, clip 54, 154 may provide both immediate short-term fixation of the bariatric device and promote long-term fixation via fusion of tissue bridging struts 20a, 20b.
A device 210 is shown in
An alternative issue penetrating fastener 256 around each strut 220a, 220b includes a series of tissue penetrating barbs 257 that are capable of penetrating mucosa, submucosa, and/or musculara at the GE junction when pressed against the tissue. Penetrating barb 257 may have fishhook, or arrowhead, features to avoid withdrawal of the barbs once inserted. Fastener 256 may be formed around the strut as part of manufacture or may be a separate device as shown in
In addition to the dimensions of each strut providing a wall characteristic that causes tissue to grow around the strut, each fastener 256 may have a wall characteristic 259 facing away from the tissue of the GE junction that enhances long-term fixation of wall 212 to the GE region through promoting growth of tissue around the respective strut. Wall characteristic 259 may be a roughened or fenestrated surface, a surface impregnated with a tissue growth agent, or the like. Fastener 256 may be made in whole or in part from a bioabsorbable material to resorb after tissue grows around the strut to provide long-term fixation of device 210. The resorption of the fastener 256 avoids fastener 256 from impeding axial withdrawal of the struts for device explantation.
Another tissue penetrating fastener 258 having tissue penetrating barbs 257 may be at a portion of esophageal member 214, such as at its distal rim, in order to provide additional temporary fixing of device 210 at the GE region. Fastener 256 is shown clipped or formed to a distal rim of esophageal portion 214 but could be located at any portion of esophageal portion 214. Fastener 258 only provides temporary fixing of device 210 and therefore does not include a wall characteristic 259 that enhances long-term fixing of wall 212 to the GE region. Fastener 258 is made in whole or in part from bioabsorbable material in order to resorb after long-term fixation is in place to avoid interference with explantation of device 240.
As seen in
An alternative retainer 354 shown in
Thus, it is seen that aspects of the present invention encompass short-term and long-term fixation of an intraluminal device, such as a bariatric device, in a lumen, such as the gastro-esophageal region of the recipient. The long-term fixation uses the body's response to the presence of the device to provide long-term fixation. Short-term fixation, such as one or more tissue penetrating fasteners, provide fixation of the device while long-term fixation develops. Once long-term fixation develops, the short-term fixation may slough off or be absorbed as it is no longer needed. Even multiple different types of long-term fixation may be provided in order to provide optimal fixation at different times after deployment. For an example,
It should be understood that
It may also be possible to eliminate tissue ingrown TI and rely exclusively on mucosal capture MC in order to provide long-term fixation. Such alternative may include using one of the illustrated retainers around one or both struts in order to provide short-term fixation while long-term fixation develops, such as by mucosal capture MC around each of the struts. By providing both short-term and long-term fixation at the struts, the intraluminal device should be simpler to deploy and explant. Deployment may occur by the insertion of a retainer clip at one or both struts or even by a self-deploying retainer that penetrates tissue at the GE junction upon positioning of the device in the lumen of the recipient. With long-term fixation provided at the struts alone, the device can be explanted by separating the separable struts and axially retracting the struts from the GE junction by proximally withdrawing the esophageal member from the esophagus. The cardiac member can then easily be retrieved from the stomach. Because tissue ingrowth is not employed in such embodiment, there is no need to remove tissue from the tissue ingrown zones.
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.
The present application is a continuation of U.S. patent application Ser. No. 15/534,891, filed Jun. 9, 2017, which claims the priority benefits of International Patent Application No. PCT/US2015/067407, filed Dec. 22, 2015, which claims priority from U.S. patent application Ser. No. 62/234,335, filed on Sep. 29, 2015, and U.S. patent application Ser. No. 62/151,150, filed on Apr. 22, 2015, and U.S. patent application Ser. No. 62/115,689, filed on Feb. 13, 2015, and U.S. patent application Ser. No. 62/097,295, filed on Dec. 29, 2014, which are all hereby incorporated by reference herein in their entireties.
Number | Date | Country | |
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62234335 | Sep 2015 | US | |
62151150 | Apr 2015 | US | |
62115689 | Feb 2015 | US | |
62097295 | Dec 2014 | US |
Number | Date | Country | |
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Parent | 15534891 | Jun 2017 | US |
Child | 15974054 | US |