WO2018083632A1

WO2018083632A1 - Intraluminal device and method with fixation technique

Info

Publication number: WO2018083632A1
Application number: PCT/IB2017/056838
Authority: WO
Inventors: Randal Baker
Original assignee: Bfkw, Llc
Priority date: 2016-11-03
Filing date: 2017-11-02
Publication date: 2018-05-11

Abstract

An intraluminal device and method of fixation of an intraluminal device in a mammalian lumen or hollow organ that experiences peristalsis includes a fixation system that is adapted to resist distal migration of the intraluminal device in the lumen or hollow organ. The intraluminal device has a wall surface configured to the size and shape of a mammalian lumen or hollow organ. A fixation system is adapted to resist distal migration of the body in the lumen or hollow organ. The fixation system includes at least one fastener having portions adapted to engage tissue of the lumen or hollow organ on opposite sides of the connector and join the tissue around the connector.

Description

INTRALUMINAL DEVICE AND METHOD WITH FIXATION TECHNIQUE

BACKGROUND OF THE INVENTION

[001] The present invention is directed to an intraluminal device and fixation

technique for resisting distal migration of the intraluminal device when in a mammalian lumen or hollow organ, especially one that experiences peristalsis. The fixation technique may provide immediate fixation of the intraluminal device while long-term fixation, such as tissue ingrowth or capture, takes hold and may expedite the long-term fixation. It may also provide complete fixation of the intraluminal 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.

SUMMARY OF THE INVENTION

[002] An intraluminal device and method of fixation of an intraluminal device in a mammalian lumen or hollow organ that experiences peristalsis, according to an aspect of the invention, includes a fixation system that is adapted to resist distal migration of the intraluminal device in the lumen or hollow organ. The intraluminal device has a wall defining a surface. The wall surface is configured to the size and shape of a mammalian lumen or hollow organ. The wall defines 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 connected with said esophageal portion and said cardiac portion. The fixation system includes at least one fastener having portions adapted to engage tissue of the lumen or hollow organ on opposite sides of the connector and join the tissue around the connector.

[003] A band may be provided that is adapted to bias the fastener portions and join tissue portions together around the connector. The fastener may be delivered from a channel of an endoscope. The fastener portions may be adapted to be biased together by the channel of the endoscope and move apart from each other outside of the endoscope. The fastener portions may be separate and said band keeps said fastener portions together. The fastener portions may be joined together at a bridge. Surface features of the fastener portions may be provided to retain the band engaged with the fastener portions.

[004] The fixation system may be long-term fixation that bonds the body with the lumen or hollow organ and immediate fixation. The immediate fixation resists distal migration while said long-term fixation forms. The fastener may provide both immediate fixation and promote establishment of the long-term fixation. The long-term fixation may include the tissue portions fusing together around the connector. The long-term fixation may include a tissue ingrowth characteristic on the wall that facilitates tissue ingrowth at the characteristic.

[005] These and other objects, advantages and features of this invention will become apparent upon review of the following specification in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[006] Fig. 1 is a perspective view of an intraluminal device, according to an

embodiment of the invention;

[007] Fig. 2 is a sectional view taken along the lines II- II in Fig. 1 ;

[008] Fig. 3 is a side elevation view of a distal end of an endoscope with a fastener therein;

[009] Fig. 4 is the same view as Fig. 3 with the fastener extending distally from the endoscope;

[010] Fig. 5 is an end elevation view of the endoscope in Fig. 3;

[011] Fig. 6 is an enlarged view of the fixation system showing the portions of the endoscope tool engaging fastener portions with tissue on opposite sides of the connector;

[012] Fig. 7 is the same view as Fig. 6 with the endoscopic tool pulling the tissue and fastener portions around the connector;

[013] Fig. 8 is the same view as Fig. 7 with the endoscopic tool moving away from the fastener after applying a band and severing the fastener portions from a stem;

[014] Fig. 9 is the same view as Fig. 2 of an alternative embodiment thereof;

[015] Fig. 10 is a side elevation view of the distal end of an endoscope with the

fastener shown in Fig. 9 internal to the endoscope; [016] Fig. 11 is the same view as Fig. 10 showing the fastener extending distally from the endoscope;

[017] Fig. 12 is the same view as Fig. 6 of the embodiment in Figs. 9-11;

[018] Fig. 13 is the same view as Fig. 7 of the embodiment in Figs. 9-11;

[019] Fig. 14 is the same view as Fig. 8 of the embodiment in Figs. 9-11; and

[020] Fig. 15 is an alternative embodiment of an intraluminal device.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[021] Referring now to the drawings and the illustrative embodiment depicted therein, an intraluminal device, such as a bariatric device or a metabolic disease treatment 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 a mammalian lumen or hollow organ, namely, the cardiac portion of the stomach and a connector 18 connected with esophageal portion 14 and cardiac portion 16 (Figs. 1-5). Such intraluminal device is disclosed in detail in commonly assigned U.S. Pat. Nos. 9, 198,789; 8,801,599; 8,672,831; 8,100,931; 7,846,174; 8,529,431 ; 8,894,670;

9,375,338 and International Publication No. WO 2016/109346 Al, the disclosures of which are hereby incorporated herein by reference in their entirety. While illustrated as a bariatric device, it should be understood that that principles of the invention are applicable to other intraluminal devices that are positioned in a lumen or hollow organ that experiences peristalsis, such as an esophageal stent, an anti-reflux device, a nasal gastric tube, an intestinal sleeve, and the like. Also, the invention may be applied to a metabolic disease treatment device and method as disclosed in commonly assigned International Patent Application Publication No. WO 2015/031077 Al, the disclosure of which is hereby incorporated by reference in its entirety.

[022] As can be seen in Figs. 1 and 2, intraluminal device 10 is positioned at the

gastroesophageal region with the esophageal portion 14 in the esophagus, the cardiac portion 16 at the cardiac portion of the stomach and at least a portion of connector 18 extending through the gastroesophageal (GE) junction. In the illustrated embodiment, connector 18 is made up of two elongated filaments 20a, 20b, which are in tension and may be referred to as struts. A fixation system 22 is configured to resist distal migration of intraluminal device 10 within the lumen or hollow organ in which it is deployed. Resisting distal migration is challenging in the presence of peristalsis which tends to cause such distal migration. Fixation system 22 includes long-term fixation that develops over a length of time and immediate fixation 26 that resists distal migration of the wall 12 at least while the long-term fixation develops. Long-term fixation may be provided by a characteristic of wall 12 that facilitates tissue ingrowth, such as tissue ingrowth openings, tissue capture of connectors 20, or the like. As can be seen in Fig. 1 with device 10 fixed at the gastroesophageal region to cause body mass loss, mucosa (which may include submucosa and even musculara) tissue bridges over at least one of the two struts 20a, 20b after device 10 has been positioned in the GE region for a period of time on the order of weeks. The bridging tissue can thus fuse within the time necessary to achieve significant loss of excess body mass making it difficult to explant intraluminal device 10. Also, as will be discussed in more detail below, tissue bridging of struts 20a, 20b may provide long-term fixation of device 10, alone or in combination with other functions in accordance with the principles set forth in commonly assigned U.S. Pat. No. 8,894,670 B2. In particular, the struts correspond to the bridge in the '670 patent and the spaces between the struts correspond to the openings adjacent the bridge in the '670 patent so that the tissue bridging over the struts implements mucosal capture patented in the '670 patent.

[023] Immediate fixation system 26 is made up of one or more fasteners 28 which can provide fixation immediately upon deployment of device 10 and continue to provide fixation while long-term fixation develops over days, weeks, or months. However, it should be understood that immediate fixation 26 may provide the entire fixation of intraluminal device 10 against distal migration for the duration of the device being deployed to the lumen or hollow organ. Also, immediate fixation system 26 brings tissue portions together over one or both struts 20a, 20b, thus promoting formation of long-term fixation by contact between the tissue portions.

[024] Immediate fixation system 26 includes one or more fasteners 28 having portions

30a, 30b adapted to engage tissue of the lumen or hollow organ on opposite sides of connector filament 20a or 20b and joins the tissue around the connector. Each fastener portion includes barbs 32 so that a force on the fastener portion in the direction of the lumen or hollow organ wall will penetrate the tissue thereof, as best seen in Fig. 6, while a force in the opposite direction will pull tissue portions around the connector filament, as best seen in Fig. 7. A band 34 is adapted to bias fastener portions 30a, 30b together and join tissue portions together around the connector filament. Thus, band 34 brings together the tissue that is engaged by both fastener portions 30 and keeps the connector 18 firmly engaged by fastener 28 and the tissue of the lumen or hollow organ, as seen in Figs. 2 and 8.

[025] Fastener 28 is configured to be delivered from a channel 36 of an endoscope 38.

Each fastener portion 30a, 30b has a surface feature 40, such as a bead, bend, or the like, to retain band 40 firmly engaged with fastener portions 30a, 30b. Each fastener portion 30a, 30b is joined with a respective stem 42a, 42b that extends out the opposite proximal end of channel 36. Stem 42a, 42b is joined with fastener portion 30a, 30b by a frangible connection so that the fastener portion may be separated from the stem in situ, such as by rotation of the stem where it exits channel 36 proximally, or the like, to place stress on the frangible connection to separate the connection. Also, once the fastener portions are deployed and the stems 42a, 42b are withdrawn, the physician can reload the endoscope with a new fastener 28 at the proximal end of channel 36 without withdrawing the endoscope from the recipient of the endoscopic device.

[026] A band dispenser 44 is at the distal end of endoscope 38. Band dispenser 44 may have a number of bands 34 stored in grooves 46 with each band separately dispensed by proximal movement of dispenser filaments 48. By supporting a number of bands, band dispenser 44 can deploy bands for a number of fasteners 28 without needing to be removed from the recipient. Such band dispensers are well known in the art, such as marketed by Ovesco Endoscopy and as disclosed in commonly assigned U.S. Pat. Application Publication No. 2015/0182239 Al, the disclosure of which is hereby incorporated herein by reference in its entirety.

[027] An alternative fixation system 122 includes an immediate fixation system 126 having one or more fasteners 128 (Figs. 9-14). Fasteners 128 are dispensed from a channel 36 or endoscope 38 and has fastener portions 130a, 130b that are joined by a bridge 50. Faster portions 130a, 130b have barbs 132 and are biased away from each other. When in channel 36, the fastener portions may be compressed together as illustrated in Fig. 10, but, when dispensed distally, the fastener portions are allowed to expand away from each other as seen in Fig. 11. Force placed on the fastener 128 causes portions 130a, 130b into engagement of tissue of the lumen or hollow organ as seen in Fig. 12. Once engaged with the tissue, the fastener portions 130a, 130b are pulled away from the wall of the lumen or hollow organ and a band 34 applied around the fastener portions, as best seen in Fig. 13. A band 34 is then dispensed as shown in Fig. 14. While it may be possible to deploy fastener 128 without the use of a band because of bridge 50 capturing the connector filament, the band both biases the fastener portions 130a, 130b to bring engaged tissue portions together as well as provides additional outward force of the fastener portions and their engaged tissue against the connector filament. Fastener 128 has surface feature 140 to retain the band 34 engaged with fastener portions 130a, 130b. A stem 142 allows the physician to dispense the fastener from the endoscope and is connected with bridge 50 by a frangible connection so it can be disconnected by turning, or the like. Also, fastener 128 can be reloaded in the manner previously described.

[028] Thus, it is seen that fixation system 126 is capable of providing both immediate fixation and promoting long-term fixation. The immediate fixation resists distal migration while the long-term fixation occurs and that long-term fixation is promoted by bringing tissue portions together around the connector so that they can fuse together around the connector. Such long-term fixation may also include a characteristic on wall 12 of esophageal portion 14 and/or cardiac portion 16 such as tissue ingrowth openings (not shown) that facilitates tissue ingrowth at such characteristic. Fastener 28 and 128 may be made by a variety of biocompatible materials, including a bioabsorbable material.

[029] In an alternative embodiment, an intraluminal device 210 includes an

esophageal portion, or member, 214 that is sized and shaped to the distal esophagus, a cardiac portion, or member 216 that is sized and shaped to a portion of the cardiac portion of the stomach and a connector 218 connected with the esophageal and cardiac portions. Connector 218 includes elongated filaments 220a, 220b, which are sized to be positioned at the GE junction and are slightly bowed outwardly as seen in Fig. 15. The outward bow in the filament, which is semi-rigid or rigid, applies outward pressure to the tissue of the GE junction which tends to increase mucosal capture of the connector by tissue at the GE junction in order to further expedite formation of long-term fixation. Also, such outward stress on the GE junction will assist in the placement of immediate fixation by causing mucosa to bulge outwardly where it can be more readily engaged by the fastener 28, 128.

[030] Also, struts or filaments 20a, 20b, 220a, 220b may include a therapeutic agent eluting coating that applies a therapeutic agent, such as an anesthesia, or the like. This coating may elute the agent for a limited period, such as two weeks, after deployment, to ensure pain-free embedding of the struts in the recipient. Alternatively, an agent- dispensing reservoir could be at a distal portion of esophageal portion 14 to dispense a controlled amount of a therapeutic agent, such as an anesthesia to the tissue engaging the struts. A different type of agent, such as to encourage tissue fibrosis and ingrowth, may be eluted to encourage earlier and stronger long-term fixation.

[031] 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.

Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. An intraluminal device, comprising:

a body having a wall defining a surface, said wall surface configured to the size and shape of a mammalian lumen or hollow organ; and

a fixation system that is adapted to resist distal migration of the body in the lumen or hollow organ;

said wall defining a cardiac portion that is configured to the size and shape of a cardiac portion of a stomach, an esophageal portion that is configured to the size and shape of a portion of a esophagus, and a connector connected with said esophageal portion and said cardiac portion;

said fixation system comprising at least one fastener having portions adapted to engage tissue of the lumen or hollow organ on opposite sides of the connector and joins the engaged tissue around the connector.

2. The intraluminal device as claimed in claim 1 , including a band that is adapted to bias said portions of the fastener and join the engaged tissue together around the connector.

3. The intraluminal device as claimed in claim 1, wherein said fastener is adapted to be delivered from a channel of an endoscope.

4. The intraluminal device as claimed in claim 3, wherein the portions of the fastener are adapted to be biased together by the channel of the endoscope and move apart from each other outside of the endoscope.

5. The intraluminal device as claimed in claim 2, wherein said portions of the fastener are separate and said band keeps said portions of the fastener together.

6. The intraluminal device as claimed in claim 5, wherein said portions of the fastener are joined together at a bridge of the fastener.

7. The intraluminal device as claimed in claim 6, including surface features of said portions of the fastener that retain said band engaged with the portions of the fastener.

8. The intraluminal device as claimed in any of the preceding claims, wherein said fixation system comprises long-term fixation that bonds said body with the lumen or hollow organ and immediate fixation, and wherein said immediate fixation resists distal migration while said long-term fixation forms.

9. The intraluminal device as claimed in claim 8, wherein said fastener is adapted to provide both said immediate fixation and said long-term fixation.

10. The intraluminal device as claimed in claim 9, wherein said long-term fixation comprises the tissue portions fusing together around the connector.

11. The intraluminal device as claimed in claim 8, wherein said long-term fixation comprises a tissue ingrowth characteristic on said wall that facilitates tissue ingrowth at said characteristic.

12. The intraluminal device as claimed in claim 8, wherein said fastener is made at least in part from a bioabsorbable material.

13. A method of fixation of an intraluminal device in a mammalian lumen or hollow organ that experiences peristalsis, the intraluminal device having a body with a wall defining a surface, said wall surface configured to the size and shape of the mammalian lumen or hollow organ, said 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 connected with said esophageal portion and said cardiac portion, said method comprising:

deploying the intraluminal device to the lumen or hollow organ and capturing tissue of the lumen or hollow organ with a fixation system to resist distal migration of the wall in the body lumen or hollow organ;

said fixation system having at least one fastener with fastener portions engaging tissue of the lumen or hollow organ on opposite sides of the connector and with the faster portions joining the engaged tissue around the connector.

14. The method as claimed in claim 13, including biasing said fastener portions toward each other.

15. The method as claimed in claims 13, including biasing the engaged tissue portions together with a band.

16. The method as claimed in claim 15, wherein said fastener portions are separate and biased together with said band.

17. The method as claimed in claim 13, including delivering said fastener from a channel of an endoscope.

18. The method as claimed in claim 17, wherein the fastener portions are biased together by a channel of the endoscope and moved apart from each other outside of the endoscope.

19. The method as claimed in claim 13, wherein said fastener portions are joined together at a bridge.

20. The method as claimed in claim 13, including surface features of said fastener portions and retaining said band engaged with the fastener portions.

21. The method as claimed in any of claims 13 through 20, wherein said fixation system comprises long-term fixation that bonds said body with the lumen or hollow organ and immediate fixation and including immediately fixing said body against distal migration with said immediate fixation and forming said long-term fixation while said immediate fixation resists distal migration.

22. The method as claimed in claim 21, including immediately fixing and forming long-term fixation with said fastener.

23. The method as claimed in claim 22, wherein said long-term fixation comprises the tissue portions fusing together around the connector.

24. The method as claimed in claim 21, wherein said long-term fixation comprises a tissue ingrowth characteristic on said wall and facilitating tissue ingrowth at said characteristic.

25. The method as claimed in claim 21, wherein said fastener is made at least in part from a bioabsorbable material.