WO2018073752A1

WO2018073752A1 - Intraluminal device and fixation technique

Info

Publication number: WO2018073752A1
Application number: PCT/IB2017/056455
Authority: WO
Inventors: James Foote
Original assignee: Bfkw, Llc
Priority date: 2016-10-17
Filing date: 2017-10-17
Publication date: 2018-04-26

Abstract

An intraluminal device and method of fixation of an intraluminal device having a body in a mammalian lumen or hollow organ that experiences peristalsis includes a fixation system that is adapted to resist distal migration of the body in the lumen or hollow organ. The intraluminal device body has a wall defining a surface, the wall surface is configured to the size and shape of the lumen or hollow organ. The fixation system includes at least one fastener joined with the wall and having a tissue-capturing state and a non-tissue-capturing state and at least one filament. The at least one filament changing the fastener between the tissue-capturing state and the non-tissue- capturing state.

Description

INTRALUMINAL DEVICE AND 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 inttaluminal 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. 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 configured to the size and shape of the lumen or hollow organ. The fixation system includes at least one fastener joined with the wall having a tissue-capturing state, a non-tissue-capturing state and at least one filament. The at least one filament is adapted to change said fastener between the tissue-capturing state and the non-tissue-capturing state.

[003] The at least one filament may be sized to extend outside of the lumen or hollow organ. The tissue may be captured by applying a force to the at least one filament to engage the fastener with tissue of the lumen or hollow organ and releasing the force from the at least one filament to capture the engaged tissue. The at least one filament may be at least two filaments and the tissue may be captured by applying a force to one of the filaments to engage the fastener with tissue of the lumen or hollow organ and applying a force to the other of the filaments to capturing the engaged tissue. [004] The fastener may be biased to the tissue-capturing state and the filament(s) change the fastener from the tissue-capturing state to the non-tissue-capturing state by overcoming the bias. The fastener may be made up of a plurality of jaw portions and teeth on the jaw portions that engage in the tissue-capturing state. The jaw portions may be biased together with the filament(s) separating the jaw portions.

[005] The fastener may be defined by a generally spiral-shaped spring having jaw portions along the spring with the tissue penetrating teeth along the spring. The filament extends the spring in length to separate the jaw portions and the teeth to the non-tissue-capturing state. The spring is biased to retract the jaw portions and teeth together to the tissue-capturing state when force is released from the filament.

[006] The at least one filament may be two filaments, one filament for changing the fastener to the tissue-capturing state and another filament for changing said fastener to the non-tissue-engaging state. The fastener may have opposing jaw portions with teeth that are spread apart in the non-tissue-engaging state and intermeshed when in the tissue-engaging state. The jaw portions may be biased together and the fastener includes an actuator piece that forces said jaw portions apart in a non-tissue-engaging state and allows said jaw portions to return together in a tissue-engaging state.

[007] The wall may be configured to the size and shape of the gastro-intestinal tract and the at least one filament sized to extend outside the mouth or anus. The wall may have an esophageal member that is configured to the size and shape of a portion of the esophagus and a cardiac member that is configured to the size and shape of the cardiac portion of the stomach and a connector connecting the esophageal portion and cardiac portion. The fastener may be at a proximal portion of the esophageal member.

[008] The at least one fastener may be a plurality of fasteners distributed around said wall. The fixation system may include long-term fixation that develops over a length of time and short-term fixation that resists distal migration of the wall at least while the long-term fixation develops, with the fastener(s) being the short-term fixation. The long-term fixation may be a characteristic of the wall that facilitates tissue ingrowth.

[009] 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

[010] Fig. 1 is an environmental view of an intraluminal device with a fixation system disposed within an esophagus and stomach of a human;

[011] Fig. 1 A is an enlarged view of the intraluminal device and fixation system

shown in Fig. 1 at section IA;

[012] Fig. 2 is an enlarged perspective view of the fixation system of Fig. 1;

[013] Fig. 2A is a cross-sectional elevation view of the fixation system of Fig. 2, taken at the section line ΠΑ-ΠΑ of Fig. 2;

[014] Fig. 3 is a cross-sectional perspective view of the fixation system of Fig. 2, shown disposed in a lumen and moved to an expanded state;

[015] Fig. 3 A is an elevational view of the fixation system shown in Fig. 3;

[016] Fig. 4 is a cross-sectional perspective view of the fixation system of Fig. 3, shown engaged with tissue of the lumen wall in a tissue-capturing state;

[017] Fig. 4A is an elevational view of the fixation system shown in Fig. 4;

[018] Fig. 5 is an enlarged perspective view of an alternative embodiment of the

fixation system;

[019] Fig. 6 is a perspective view of an another alternative embodiment of the fixation system, shown moved toward an expanded state;

[020] Fig. 6A is a cross-sectional elevation view of the fixation system shown in

Fig. 6, with the fixation system disposed in a lumen;

[021] Fig. 7 is a cross-sectional perspective view of the fixation system of Fig. 6, shown engaged with tissue of the lumen wall in a tissue-capturing state;

[022] Fig. 7A is an elevational view of the fixation system shown in Fig. 7;

[023] Fig. 8 is a perspective view of an another alternative embodiment of the fixation system;

[024] Fig. 8A is a cross-sectional elevation view of the fixation system shown in

Fig. 8, with the fixation system disposed in a lumen in a contracted state;

[025] Fig. 9 is a cross-sectional perspective view of the fixation system of Fig. 8, shown engaged with tissue of the lumen wall in a tissue-capturing state; and

[026] Fig. 9A is an elevational view of the fixation system shown in Fig. 9. DESCRIPTION OF THE PREFERRED EMBODIMENT

[027] Referring now to the drawings and the illustrative embodiments depicted

therein, an intraluminal device 10 is configured to be deployed to a mammalian lumen or hollow organ that experiences peristalsis, such as the gastro-esophageal (GI) tract of a human (Fig. 1). Intraluminal device 10 has a body 11 defined by a wall 12 having a surface 13 (Fig. 1A). Surface 13 is configured to the size and shape of a mammalian lumen or hollow organ. In the illustrated embodiment, the intraluminal device includes an esophageal member 16 that is configured to the size and shape of a portion of the esophagus of the recipient and a cardiac member 18 that is configured to the size and shape of the cardiac portion of the stomach with a connector 24 connecting the esophageal portion and the cardiac portion. 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 Application 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 the 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.

[028] A fixation system is configured to resist distal migration of body 11 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. The fixation system may include long-term fixation that develops over a length of time and immediate fixation 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 the wall 12 that facilitates tissue ingrowth, such as tissue ingrowth openings, tissue capture of connectors 20, or the like. Also or alternatively, long-term fixation may be provided at the connector 24 extending between and connecting the esophageal portion and the cardiac portion 18, such as with mucosa (which may include submucosa and even musculara) tissue bridging over at least one of the two filaments or struts of the connector 24 after device 10 has been positioned in the gastroesophageal (GE) junction for a period of time on the order of weeks. An 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 the immediate fixation system 26 may provide the entire fixation of body 11 against distal migration for the duration of the device being deployed to the lumen or hollow organ.

[029] Fastener 28 has a plurality of jaw portions 30 with tissue-capturing teeth 32 distributed along the jaw portions. Jaw portions 30 are moveable between a contracted or tissue-capturing state and an expanded non-tissue-capturing state. To operate the jaw portions 30 of the device 10 between these states, one or more filaments 34 may be adapted to extend outside of the body lumen or hollow organ with device 10 in the lumen or hollow organ. Filament 34 is configured to move jaw portions 30 between the contracted or tissue-capturing state, such as shown in Figs. 2-2A and 4-4A, and the non- tissue-capturing state in which jaw portions 30 are spaced apart, such as shown in Figs. 3 and 3A. As illustrated in Figs. 1 and I A, fasteners 28 are connected with a proximal portion of esophageal member 16, and filaments 34 extend transorally out of the mouth of the recipient of the intraluminal device.

[030] In the embodiments illustrated in Figs. 1-5, a generally spiral-shaped spring 36 defines jaw portions 30 with tissue-capturing teeth 32 defined by the shape of the jaw portions. Such configuration could be produced from a small diameter tube, such as Nitinol and spiral cut in a sawtooth pattern. Filament 34 extends spring 36 in length from a contracted or tissue-capturing state (Figs. 2 and 2A) to the non-tissue-capturing state (Figs. 3 and 3 A) with an extension force F applied to filament 34. This causes jaw portions 30 and teeth 32 to separate forming gaps into which tissue, such as mucosa, submucosa and muscularis, enters. Spring 36 is biased to retract in length to or toward the tissue-capturing state with force reduced to or eliminated from filament 34 due to the spring force of the spring 36. This will cause jaw portions 30 to move toward each other and teeth 32 to capture the tissue of the esophagus. In the illustrated embodiment, fastener 28 is configured so that the force applied to filament 34 to separate jaw portions 30 is less than a force that would reposition body 11 in the lumen or hollow organ. However, if desired, a greater force could be applied to the filament to reposition body 11 such as moving esophageal member 16 proximally to increase the pressure of the cardiac member against the cardiac portion of the stomach. When this additional force is applied to the filament, the fastener 28 moves to a non-tissue- capturing state to release its grasp of the tissue and, when released after repositioning the esophageal member, the fastener again captures the tissue to provide fixation.

Alternatively, fastener 28 could be moved to a non-tissue-engaging state by holding body 11 in its deployed position, such as using an endoscope, or the like, and applying a force to filament 34.

[031] As seen in Fig. 5, a plurality of fasteners 28 can be evenly distributed about the perimeter of esophageal member 16. A common actuator, such as a ring 40, may actuate fasteners 28 together with filaments 34 applying a force to ring 40 to extend the fasteners to a non-tissue-capturing state. When filaments 34 are released, ring 40 and fasteners 28 return to a tissue-capturing state. Fasteners 28 can be separate devices that are fastened onto the esophageal member or may be formed out of the same Nitinol strand or piece forming the mesh of the esophageal member. Additional filaments (not shown) could be connected directly to esophageal member 16 to place proximal force on device 10 with filament 34 used just to operate fastener 28. Fastener 28 will have jaw portions 30 and teeth 32 together in its resting state thereby allowing the fastener to pass through the Gl tract should it become detached from esophageal member 16.

[032] In an alternative embodiment, such as shown in Figs. 6-7 A, an intraluminal device 110 has a body 111 and an immediate fixation system 126 that is defined by a fastener 128 that may be made from a single piece of material, such as a Nitinol wire 44, or the like. Jaw portions 130 have teeth 132 that may also or alternatively be formed of the Nitinol wire 44. The wire may be coiled at 42 so that jaw portions 130 are biased together. Jaw portions 130 are spaced apart in the expanded or non-tissue- engaging state (Figs. 6 and 6A) and moved toward each other under biasing force of the coil 42 with teeth 132 intermeshed when in the contracted or tissue-capturing state (Figs. 7 and 7A). Wire 44 may be formed into a narrowed region or waist 46, such that an actuator or separator, such as a ball or cylinder 48, may be disposed adjacent the waist and between opposing portions of the wire. A pair of filaments 134a, 134b are attached to ball or cylinder 48, such as at a central portion of the ball or cylinder that is aligned with the wire. Thus, a force F applied to filament 134a may move ball 48 into waist 46 to separate or move jaw portions 130 apart to the non-tissue-capturing state. The other filament 134b may pass through an opening at upper edge of the body 111, such that a force applied to the other filament 134b may then move ball 48 downward and out of waist 46 to allow the spring force of wires 44 to move to or toward the tissue-capturing state (Figs. 7 and 7A). As with fastener 28, with jaw portions 130 biased together with teeth 132 together, fastener 138 can safely pass through the GI tract if it were to become detached from the esophageal member.

[033] In yet another alternative embodiment, such as shown in Figs. 8-9 A, an

intraluminal device 210 has a body 211 and an immediate fixation system 226 that is defined by a fastener 228 having jaw portions 230 made up of a pair of cogs defining tissue capturing teeth 232. Jaw portions 232 are mounted to a base wire 50 with a spring 52 that may be an integral section of the base wire. The base wire 50 may attach at an upper edge portion of the body 211 , such as with filament sutures, heat bonding, integral formation, or the like. A filament 234 is attached to each of the cogs, such as at a lower radial portion of the respective cog, so that a force F applied to the filament 234 rotates and disengages cogs 230 to the expanded or non-tissue-capturing state. The cogs 230 are biased to rotate and engage to the tissue-capturing state by springs 52 when force F to filaments 234 is released or lessened. Since the teeth 232 on jaw portions 230 are engaged with each other, it is possible that one filament can rotate both cogs like a gear pair.

[034] Fasteners 28, 128, 228 may be made from a durable material, such as Nitinol or a bioabsorbable material. The bioabsorbable material will allow the immediate fixation to dissolve as long-term fixation takes hold.

[035] 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 of a recipient; and

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

said fixation system comprises at least one fastener joined with the wall, said fastener having a tissue-capturing state and a non-tissue-capturing state and said at least one filament configured to change said fastener between the tissue-capturing state and the non-tissue-capturing state.

2. The intraluminal device as claimed in claim 1 wherein said at least one filament is sized to extend outside of the recipient with the body deployed to the lumen or hollow organ.

3. The intraluminal device as claimed in claim 1 or claim 2 wherein said fastener is adapted to capture tissue by applying a force to said at least one filament to engage said fastener with tissue of the lumen or hollow organ and is adapted to capture the engaged tissue by releasing the force from the at least one filament.

4. The intraluminal device as claimed in any of the preceding claims wherein said fastener is biased to the tissue-capturing state and wherein said at least one filament changing said fastener from the tissue-capturing state to the non-tissue-capturing state by overcoming the bias.

5. The intraluminal device as claimed in claim 1 or claim 2 wherein said at least one filament comprises at least two filaments and wherein said fastener is adapted to capture tissue by applying a force to one of said filaments to engage said fastener with tissue of the lumen or hollow organ and is adapted to capture the engaged tissue by applying a force to the other of the filaments.

6. The intraluminal device as claimed in any of the preceding claims wherein said fastener is made up of a plurality of jaw portions and teeth on the jaw portions that separate in the non-tissue-capturing state and come together in the tissue-capturing state.

7. The intraluminal device as claimed in claim 6 wherein said jaw portions are biased together with the at least one filament separating the jaw portions.

8. The intraluminal device as claimed in any of the preceding claims wherein said fastener comprises a generally spiral-shaped spring defining jaw portions with tissue penetrating teeth along the jaw portions and wherein said at least one filament extends said spring in length to separate the jaw portions and teeth to the non-tissue-capturing state and said spring is biased to join the jaw portions and teeth to the tissue-capturing state.

9. The intraluminal device as claimed in claim 8 wherein said spring is biased so that said jaw portions return together when force is removed from the at least one filament.

10. The intraluminal device as claimed in any of claims 1 through 7 wherein said fastener comprises opposing jaw portions and teeth that are spaced apart in the non- tissue-engaging state and the teeth intermeshed when in the tissue-capturing state.

11. The intraluminal device as claimed in claim 10 wherein said jaw portions are biased together and including an actuator piece that forces said jaw portions apart in a non-tissue-engaging state and allows said jaw portions to return together in a tissue- engaging state.

12. The intraluminal device as claimed in any of the preceding claims wherein said wall is configured to the size and shape of the gastro-intestinal tract and wherein said at least one filament is sized to extend outside the mouth or anus.

13. The intraluminal device as claimed in any of the preceding claims wherein said wall has an esophageal member that is configured to the size and shape of a portion of the esophagus and a cardiac member that is configured to the size and shape of the cardiac portion of the stomach and a connector connecting said esophageal portion and said cardiac portion.

14. The intraluminal device as claimed in claim 11 wherein said fastener is at a proximal portion of the esophageal member.

15. The intraluminal device as claimed in any of the preceding claims wherein said at least one fastener comprises a plurality of fasteners distributed around said wall.

16. The intraluminal device as claimed in any of the preceding claims wherein said fixation system comprises long-term fixation that develops over a length of time and short-term fixation that resists distal migration of the wall at least while the long-term fixation develops, wherein said at least one fastener comprises said short-term fixation.

17. The intraluminal device as claimed in claim 14 wherein said long-term fixation comprises a characteristic of said wall that facilitates tissue ingrowth.

18. A method of fixation of an intraluminal device in a mammalian lumen or hollow organ of a recipient 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 lumen or hollow organ, said method comprising:

deploying the body 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 lumen or hollow organ, said fixation comprises at least one fastener joined with the wall and at least one filament, said at least one fastener having a tissue-capturing state and a non-tissue-capturing state; and

changing said fastener between the tissue-capturing state and the non-tissue- capturing state by applying a force to said at least one filament.

19. The method as claimed in claim 18 wherein said at least one filament sized to extend out of the recipient with the body deployed to the lumen or hollow organ.

20. The method as claimed in claim 18 or claim 19 wherein said capturing tissue comprises applying a force to said at least one filament to engage said fastener with the tissue of the lumen or hollow organ and capturing the engaged tissue by releasing the force from the at least one filament.

21. The method as claimed in claims 18 or 19 wherein said at least one filament comprises at least two filaments and wherein said capturing tissue comprises applying a force to one of said filaments to engage said fastener with tissue of the lumen or hollow organ and capturing the engaged tissue by applying a force to the other of the filaments.

22. The method as claimed in any of claims 18 through 21 wherein said fixation system comprises long-term fixation that develops over a length of time and immediate fixation that resists distal migration of the wall while the long-term fixation develops, wherein said immediate fixation comprises capturing the tissue of the lumen or hollow organ with said fastener.

23. The method as claimed in claim 22 wherein said long-term fixation comprises a characteristic of said wall that facilitates tissue ingrowth and including said intraluminal device deployed to the lumen or hollow organ a sufficient length of time for tissue to grow in said characteristic of said wall.