CN102740798A

CN102740798A - Bariatric device and method for recipient with altered anatomy

Info

Publication number: CN102740798A
Application number: CN2011800080439A
Authority: CN
Inventors: R·S·贝克
Original assignee: BFKW LLC
Current assignee: BFKW LLC
Priority date: 2010-02-02
Filing date: 2011-02-01
Publication date: 2012-10-17
Also published as: AU2011213048B2; EP2531137A1; WO2011097209A1; AU2011213048A1

Abstract

A bariatric device and method of causing at least partial satiety in a recipient that either has or is presently undergoing a procedure that alters the anatomy of the recipient includes deploying a bariatric device to the recipient having an altered anatomy. The bariatric device includes a cardiac member having a cardiac surface that is configured to generally conform to the shape and size of a portion of the cardiac region of the stomach of the recipient. The cardiac member stimulates receptors with the cardiac surface in order to influence a neurohormonal mechanism in the recipient sufficient to cause at least partial satiety by augmenting fullness caused by food and simulating fullness in the absence of food.

Description

Be used to have the Bariatric device and the method for receptor of the anatomical structure of change

Technical field

The present invention relates to a kind of Bariatric device and method that causes receptor weight saving.

Background technology

Obesity all is a kind of general, increasingly serious problem in the U.S. and worldwide.In integer, from year period period to 2000 nineteen ninety, the overweight person's of American (BMI is greater than 25) prevalence rate increases to 65% from 56%, and fat adult's (BMI is greater than 30) prevalence rate increases to 30% from 23%.Similarly, the prevalence rate of prevalence of overweight children and teenager (age is 6 to 19 years old) increases to 16% of period in 2000 from 11% of period nineteen ninety.The increase of the prevalence rate of overweight makes that this problem is more serious when they grow to manhood in the middle of child and teenager.This problem is not limited only to the U.S..10% to 20% European male is the overweight people, and 10% to 25% European women is the overweight people.Obesity makes many medical conditions worse, comprises type ii diabetes, apoplexy, gallbladder disease and various forms of cancer.Estimate that in North America and West Europe annual nearly 500,000 people die from the disease relevant with obesity, and estimate that influence surpasses 1,000,000,000 adults to obesity in the whole world.For the needs of the solution of this epidemic disease problem is that urgent Buddhist monk is unsatisfied.

Summary of the invention

The invention provides and a kind ofly cause the Bariatric device and the method for part satiety at least living through or experiencing at present in the receptor of the operation that changes its anatomical structure; According to an aspect of the present invention, said Bariatric device and method comprise: the receptor that Bariatric device is deployed to the anatomical structure with change.Said Bariatric device comprises the cardia element, and said cardia element has the cardia surface, and said cardia surface is configured to the shape and size of the part of the cardia region of the stomach of receptor unanimous on the whole.The cardia element is by cardia surface stimulation sensor, is enough to through increasing the distension that caused by food and causing part satiety at least through simulation distension under the situation that lacks food so that influence the intravital neuro hormone mechanism of receptor.

Said Bariatric device can be deployed to the receptor that has lived through the Bariatric operation; (i) gastric bypass operation for example; (ii) vertically interdict gastroplasty, the shape stomach resecting operation of (iii) tucking inside the sleeve, (iv) duodenum version; Perhaps (v) no matter peritoneoscope stomach band bariatric surgery is through peritoneoscope, carries out operation through endoscope or similar approach.

The cardia element can have the self expandable surface.This self expandable surface can be the form of curl shape, and said curl shape is set for and allowed the self expandable its surface compressed to become reel, for example is used for disposing; And allow the self expandable unfolded surface to engage coat of the stomach.Bariatric device can also comprise esophagus element and the adapter that is connected with said cardia element with said esophagus element, and said esophagus element has the esophagus surface, and said esophagus surface is configured to the shape and size of the part of esophagus unanimous on the whole.

The cardia surface can be adjustable, so that regulate the amount of the stimulation of the cardia part that is applied to stomach.Adjusting can be carried out when disposing or after disposing.Adjusting can be carried out through endoscope via radio link (radio frequency link) or similar fashion.

The anti-migration mechanism (Anti-migration) of cardia element can be provided.Said anti-migration mechanism can comprise providing to have organizes surface attached and/or the tissue ingrowth characteristic.Said anti-migration mechanism can comprise with the size of cardia element set for make the cardia element shape substantially greater than the mouth of making of natural stomach.Said anti-migration mechanism can comprise that mucosa captures.Said anti-migration mechanism can comprise the projection from the cardia element, and said cardia element is configured to extend to esophagus or the small intestinal of receptor to prevent the orientating deviation of Bariatric device.

Bariatric device and method can be applied to and live through the bariatrician operation in advance to produce the receptor of the anatomical structure that changes.Perhaps, Bariatric device and method can side by side be used with the anatomical structure that changes receptor.

Of the present invention these will be through with reference to the following description of advantages and more obvious with other purpose, advantage and characteristic.

Description of drawings

Fig. 1 illustrates Bariatric device at the axonometric chart that lives through or experiencing the deployment in the receptor of vertical blocking gastroplasty;

Fig. 2 illustrates Bariatric device at the axonometric chart that lives through or experiencing the deployment in the receptor of sleeve shape gastrectomy;

Fig. 3 illustrates Bariatric device at the axonometric chart that lives through or experiencing the deployment in the receptor of duodenum version;

Fig. 4 illustrates Bariatric device at the axonometric chart that lives through or experiencing the deployment in the receptor of gastric bypass operation;

Fig. 5 is a alternate embodiments that Bariatric device is shown at the axonometric chart that lives through or experiencing the deployment in the receptor of vertical blocking gastroplasty;

Fig. 6 is another alternate embodiments that Bariatric device is shown at the axonometric chart that lives through or experiencing the deployment in the receptor of sleeve shape gastrectomy;

Fig. 7 is another alternate embodiments that Bariatric device is shown at the axonometric chart that lives through or experiencing the deployment in the receptor of duodenum version;

Fig. 8 is another alternate embodiments that Bariatric device is shown at the axonometric chart that lives through or experiencing the deployment in the receptor of gastric bypass operation;

Fig. 9 is the axonometric chart of Bariatric device among Fig. 1; And

Figure 10 is the axonometric chart identical with Fig. 9, shows an alternate embodiments of the Bariatric device of this figure.

The specific embodiment

Referring now to accompanying drawing and the exemplary embodiments described here, the Bariatric device of various embodiments disclosed herein for example can be applied to because the receptor that the Bariatric operation has the anatomical structure of change.This Bariatric device stimulates the sensor in natural stomach at least; Perhaps cryptomere portion is enough to through increasing the distension that caused by food and causing part satiety at least through simulation distension under the situation that lacks food so that influence the intravital neuro hormone mechanism of receptor.But this Bariatric device can be applied to and for example live through Bariatric operation in advance the receptor of the difficulty of the shortage satiety that is now standing to comprise that weight increases.Perhaps, this Bariatric device can be deployed to the present receptor that is experiencing the Bariatric operation to strengthen the effect of performing the operation and to avoid lacking in the future satiety.The anatomical structure that changes can be the result of the operation (for example, being used to treat the stomach operation or the similar operation of cancer) except the Bariatric operation.And the anatomical structure of change can use abdominal, laparoscopic surgery or endoscopic surgery to carry out.

Bariatric device 10 has cardia element 14, and the stomach spare of the anatomical structure that it is configured for changing is to provide tension force, for example outside pressure.Cardia element 14 has wall 20, and said wall 20 is configured to live through the shape and size of a part of cardia region of the stomach of vertical blocking gastroplasty (Fig. 1).The outer surface of wall 20 apply strain to the cardia region of stomach with the excitement receiver; With through increasing the distension that causes by food and causing at least the mode of the part satiety hormone feedback mechanism that affects the nerves through simulation distension under the situation that lacks food; Like United States Patent(USP) No. 7 in co-assigned; Disclosed that kind in 846,174, the disclosure of this patent is contained in this through reference.Cardia element 14 can be partly or entirely is the size of gastric pouch.If cardia element 14 is greater than the mouth of making of gastric pouch, then the cardia element will be avoided through making the distal migration of mouth.

Shown Bariatric device 110 has and cardia element 14 similar cardia elements 114, and the wall that has except cardia element 114 is configured to live through the shape and size (Fig. 2) of cardia region of the stomach of sleeve shape stomach resecting operation.Shown Bariatric device 210 has and cardia element 14,114 similar cardia elements 214, and the wall that has except cardia element 214 is configured to live through the shape and size (Fig. 3) of cardia region of the stomach of duodenum version.Shown Bariatric device 310 has and cardia element 14,114,214 similar cardia elements 314, and the wall that has except cardia element 314 is configured to the shape and size (Fig. 4) unanimous on the whole with the cardia region of the stomach that has lived through the gastric bypass operation that also is known as biliary enteric anastomosis (roux-en-y procedure).Though not shown, principle disclosed herein can be used on the receptor of accepting peritoneoscope stomach band bariatric surgery.Corrode for fear of the position that is organized in band, can make the cardia element of this Bariatric device have soft especially outer surface.

The anti-migration mechanism of cardia element 14,114,214 can be provided.With regard to vertical blocking gastroplasty or biliary enteric anastomosis, the cardia element can be arranged to have expanded configuration, and said expanded configuration is greater than the mouth of making of the gastric pouch that soars.By this way, the cardia element will have the trend that remains in the gastric pouch.For the Bariatric device that is applied to for example tuck inside the sleeve shape stomach resecting operation or duodenum version, anti-migration mechanism can be used for resisting the cardia element at gastric pouch to distal migration.This anti-migration mechanism can be the form that the cardia element is sewn onto the wall of gastric pouch.This stitching can pass Bariatric device wall, pass coat of the stomach, return and pass coat of the stomach and return the wall that passes Bariatric device.The surface character of the surface character through selecting suture material and/or the wall of cardia element.Can be through promoting to organize attached and/or tissue ingrowth helps anti-migration mechanism on this device and/or suture.Perhaps, be utilized in the principle of setting forth among the open No.WO 2008/100984A2 of international patent application, the mucosa of gastric pouch wall and/or capturing of flesh layer can be provided, the disclosure of said patent application is contained in this through reference thus.

Shown Bariatric device 410 has esophagus element 412; Said esophagus element 412 has wall; The size and dimension of the part of the esophagus that said wall is configured to be connected with cardia element 414 through adapter 416; Said cardia element 414 has wall, and said wall is configured to live through the shape and size (Fig. 5) of cardia region of the stomach of vertical blocking gastroplasty.Esophagus element 412 can be configured to reduce the narrow of esophagus; Autograph like the James A.Foote that submits on October 1st, 2010 is the U.S. Patent application No.61/388 of the co-assigned of " INTRALUMINAL DEVICE AND METHOD "; Disclosed that kind in 857, the disclosure of this patent is contained in this through reference.Adapter 416 can comprise tension element 424 that passes stomach esophagus junction surface and the tether 426 that applies on the spot; As autograph in for the open No.2010/0030017A1 of the U.S. Patent application of the co-assigned of " BARIATRIC DEVICE AND METHOD " disclosed, the disclosure of this patent is through with reference to being contained in this.

Shown Bariatric device 510 has and esophagus element 412 similar esophagus elements 512; Said esophagus element 512 has wall; The size and dimension of the part of the esophagus that said wall is configured to be connected with cardia element 514 through adapter 516; Said cardia element 514 has wall, and said wall is configured to live through the shape and size (Fig. 6) of cardia region of the stomach of sleeve shape stomach resecting operation.Adapter 516 has tension element 524 and tether 526.

Shown Bariatric device 610 has and esophagus element 412 similar esophagus elements 612; Said esophagus element 612 has wall; The size and dimension of the part of the esophagus that said wall is configured to be connected with cardia element 614 through adapter 616; Said cardia element 614 has wall, and said wall is configured to live through the shape and size (Fig. 7) of cardia region of the stomach of duodenum version.Adapter 616 has tension element 624 and tether 626.

Shown Bariatric device 710 has and esophagus element 412 similar esophagus elements 512; Said esophagus element 712 has wall; The size and dimension of the part of the esophagus that said wall is configured to be connected with cardia element 714 through adapter 716; Said cardia element 714 has wall, and said wall is configured to the shape and size (Fig. 8) unanimous on the whole with the cardia region of the proximal capsule of the receptor that has lived through the gastric bypass operation that also is known as biliary enteric anastomosis.Adapter 716 has tension element 724 and tether 726.Other example will be conspicuous for a person skilled in the art.

Esophagus element 412,512,612 and 712 can be according to the principle setting of in the open NoWO 2008/101048A2 of international patent application, setting forth, and the disclosure of this patent is contained in this through reference.

The neuro hormone feedback mechanism that sensor in the strain costimulatory receptor that is applied by Bariatric device 410-710 is present in esophagus and/or gastric pouch place with influence is to cause weight saving.Influence is present in the strain of neuro hormone feedback mechanism of cardia part of abdominal section and/or the stomach of esophagus and hopes on as far as possible rationally big zone consistent relatively.

For example need the receptor pickuping food so that the restraint device of the hormone feedback mechanism that affects the nerves is compared with previously presented device, each embodiment of Bariatric device disclosed herein is lacking under the situation of food effectively.It has also strengthened the sensation of fullness that is caused by food.

Cardia element 14 (any among the embodiment of cardia element perhaps disclosed herein) can be limited on wall 20, and said wall 20 has the end sections 20a and the 20b (Fig. 9) of crossover.Wall 20 limits outer surface 21, and this outer surface applies strain on coat of the stomach.Wall 20 also limits opening 22, and said opening 22 is configured to be engaged on the stomach esophagus junction surface and passes between coat of the stomach and surface 21 with erstricted diet.The wall 20 that can be as general as cylindrical in form is a self expandable, so that make

end sections

20a and 20b form curly form, said curly form trends towards outwards launching to be expanded to the shape of gastric

pouch.End sections

20a and 20b may be compressed to the reel form of further crossover, so that dispose orally.The crossover degree of

end sections

20a and 20b is configured to the cardia size of component size of gastric pouch.Wall 20 can form cross cutting Nitinol plate or the analog that perhaps covers with silicone by nitinol wire.

Wall 20 can have the ability of the amount of the strain of regulating the cardia region be applied to stomach or power.This can be for example through being provided with bladder or realizing through in addition bladder being covered in the wall 20 on outer surface 21.After can or disposing during cardia element 14 is disposed, bladder for example fills with saline through use endoscope pin.And, the electronics/hydraulic controller can be connected to bladder and via radio link from regulating in patient's controller outside.The adjusting of the bladder of arbitrary mode can be as disclosed during WO 2008/101048 announces.

The controllability of wall 20 can alternately for example provide through ratchet mechanism, and said ratchet mechanism flocks together

end sections

20a and 20b or makes their spread aparts.This ratchet mechanism can be installed to wall 20 and when disposing or after disposing, visit through endoscope when disposing or before disposing.Perhaps, can in

end sections

20a and 20b, form foraminous pattern, said foraminous pattern can engage through ratchet mechanism, and said ratchet mechanism has the parts such as foot of coupling opening.This ratchet mechanism can be regulated through endoscope after endoscope disposes and for example disposing.

With regard to Bariatric device 410-710, can controllability be provided through regulating adapter 416-716, said adjusting adapter 416-716 comprises any tension element, for example, forms the tether of the part of adapter.

It is to help Bariatric device to remove from receptor that the advantage of controllability of the amount of the strain that applied by wall 20 or power is provided.For example, because receptor has experienced the minimizing of too much body fat, the amount of strain or power can reduce so that receptor adapts to the satiety that reduces by Bariatric device provided.Certainly, if patient experience is too many or insufficient satiety, then controllability allows the amount of setting satiety perhaps when disposing or after disposing, to regulate the amount of satiety.

In the alternative embodiment shown in Figure 10; Bariatric device 10 ' comprises and cardia element 14 similar cardia elements 14 '; Except wall 20 comprises projection 30, said projection 30 be configured to remote extension in the intestinal or to proximal extension in esophagus.Projection 30 can for example be captured through stitching, bookbinding, mucosa or similar approach is attached.Projection 30 is guaranteed the suitable orientation of cardia element 10 ', make the opening at

end sections

20a and 20b place with aim in the respective openings at GE junction surface and pylorus place.

But Bariatric device disclosed herein can entirely or partly be processed by the material of bio-absorbable or the material that can not absorb.Some embodiment that, tissue ingrowth attached by organizing of causing of tissue and/or mucosa are captured basically at least in part Bariatric device covers in the anatomical structure of receptor; Resistance for the formation of bacterial biof iotalm can be provided, and reduce thus to infect, the probability of stink etc.The technique for fixing of the anti-migration of described herein all can use with other technique for fixing in combination.These anchorage technologies can be used for promoting long-term the deployment through the health that Bariatric device is covered receptor.

Thereby, can find out that the disclosed embodiments provide a kind of newtype of weight saving technology.This embodiment advantageously utilizes those mechanoreceptors of the pars cardiaca office of the stomach that is positioned at receptor, and for example tension receptor, stretch receptor and/or pressure receptor are to cause weight saving.The disclosed embodiments are convenient to have the hiccups and vomit, and do not interfere false sphincteral other function in GE junction surface basically.With using in the past or with receptor that the embodiment that receives Bariatric device disclosed herein side by side carries out the Bariatric operation; Strengthened the effect of Bariatric operation, said Bariatric operation can utilize the existence of food to produce satiety.

Can in specifically described embodiment, change under the situation that does not break away from principle of the present invention and revise, principle of the present invention should be only limited the scope of accompanying claims, understands according to the regulation of the Patent Law of the principle that comprises equivalent.

Claims

1. Bariatric device, it comprises:

The cardia element, said cardia element has the cardia surface, and said cardia surface is configured to the shape and size of a part of the cardia region of the stomach of the receptor of the anatomical structure with change unanimous on the whole; And

Said cardia element is in order to the excitement receiver, is enough to through increasing the distension that caused by food and causing part satiety at least through simulation distension under the situation that lacks food so that influence the intravital neuro hormone mechanism of said receptor.

2. Bariatric device according to claim 1; Wherein, Said cardia element is configured to live through the gastric bypass operation from (i); (ii) vertically interdict gastroplasty, (iii) tuck inside the sleeve the shape stomach resecting operation and the size and dimension of the cardia region of the receptor of at least a operation (iv) selected in the duodenum version.

3. Bariatric device according to claim 1, wherein, said cardia element has the self expandable surface.

4. Bariatric device according to claim 3, wherein, said self expandable surface is curl shape and becomes reel to allow said self expandable its surface compressed.

5. Bariatric device according to claim 1 comprises: the esophagus element, and it has the esophagus surface, and said esophagus surface is configured to the shape and size of the part of said esophagus unanimous on the whole; And adapter, it is connected with said cardia element with said esophagus element.

6. Bariatric device according to claim 5; Wherein, Said cardia element is configured to live through the gastric bypass operation from (i); (ii) vertically interdict gastroplasty, (iii) tuck inside the sleeve the shape stomach resecting operation and the size and dimension of the cardia region of the receptor of at least a operation (iv) selected in the duodenum version.

7. according to each described Bariatric device in the above claim, comprise anti-migration mechanism.

8. Bariatric device according to claim 7, wherein, said anti-migration mechanism comprise from (i) tissue attachment surface and (ii) select the tissue ingrowth surface at least one.

9. Bariatric device according to claim 7, wherein, said anti-migration mechanism comprises: the shape cardinal principle of said cardia element is greater than the shape of making mouth of natural stomach.

10. Bariatric device according to claim 7, wherein, said anti-migration mechanism comprises: the structure that is used for capturing at least the mucosa of said coat of the stomach.

11. Bariatric device according to claim 7; Wherein, Said anti-migration mechanism comprises: from the projection of said cardia element, said projection is configured to extend to said esophagus or the intestinal of said receptor to prevent the orientating deviation of said Bariatric device.

12. one kind causes the method for part satiety at least in receptor, it comprises:

Bariatric device is deployed to the receptor of anatomical structure with change; Said Bariatric device comprises the cardia element; Said cardia element has the cardia surface, and said cardia surface is configured to the shape and size of the part of the cardia region of the stomach of said receptor unanimous on the whole; And

By said cardia surface stimulation sensor, be enough to through increasing the distension that causes by food and causing part satiety at least through simulation distension under the situation that lacks food so that influence the intravital neuro hormone mechanism of said receptor.

13. method according to claim 12; Comprise: said Bariatric device is deployed to lives through gastric bypass operation from (i); (ii) vertically interdict gastroplasty, (iii) tuck inside the sleeve the shape stomach resecting operation and the receptor of at least a operation (iv) selected in the duodenum version.

14. method according to claim 10, wherein, said cardia element has the self expandable surface.

15. method according to claim 14, wherein, said self expandable surface is curl shape and becomes reel to allow said self expandable its surface compressed.

16. method according to claim 12, wherein, said Bariatric device has: the esophagus element, and it is unanimous on the whole that it comprises that esophagus surface, said esophagus surface are configured to the shape and size of the part of said esophagus; And adapter, it is connected with said cardia element with said esophagus element.

17. method according to claim 16; Comprise: said Bariatric device is deployed to lives through gastric bypass operation from (i); (ii) vertically interdict gastroplasty, (iii) tuck inside the sleeve the shape stomach resecting operation and the receptor of at least a operation (iv) selected in the duodenum version.

18. according to each the described method in the claim 12 to 17, wherein, said Bariatric device comprises anti-migration mechanism.

19. method according to claim 18, wherein, said anti-migration mechanism comprises: provide from (i) tissue attachment surface and (ii) select the tissue ingrowth surface at least one.

20. method according to claim 18, wherein, said anti-migration mechanism comprises: the shape cardinal principle of said cardia element is greater than the shape of making mouth of natural stomach.

21. method according to claim 18, wherein, said anti-migration mechanism comprises: the mucosa of capturing said coat of the stomach at least.

22. method according to claim 18, wherein, said anti-migration mechanism comprises: from the projection of said cardia element, said projection is configured to extend to said esophagus or the intestinal of said receptor to prevent the orientating deviation of said Bariatric device.

23. method according to claim 12 is applied to and has lived through the receptor of bariatrician operation with mutagenic anatomical structure in advance.

24. method according to claim 12 is side by side carried out with the anatomical structure that changes said receptor.

25. method according to claim 12 comprises the amount that stimulates by said cardia surface modulation.

26. Bariatric device according to claim 1, wherein, said Bariatric device is adjustable.