CN103002839B - Regulate the system that body fluid distributes - Google Patents

Regulate the system that body fluid distributes Download PDF

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Publication number
CN103002839B
CN103002839B CN201080068040.XA CN201080068040A CN103002839B CN 103002839 B CN103002839 B CN 103002839B CN 201080068040 A CN201080068040 A CN 201080068040A CN 103002839 B CN103002839 B CN 103002839B
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bile
control signal
valve
food
control
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CN103002839A (en
Inventor
M·弗雷德
F·比洛蒂
M·加尔瓦奥内托
M·S·奥尔蒂茨
A·帕斯托雷利
T·E·亚尔布雷彻特
C·J·赫斯
M·J·斯托克斯
M·S·齐纳
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Ethicon Endo Surgery Inc
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/0076Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves

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  • Health & Medical Sciences (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

The invention discloses a kind of system (11) for regulating body fluid to distribute, described system (11) comprises control valve (12) and physiological property sensing apparatus (13), described control valve (12) can be placed in the flow channel of body fluid, described physiological property sensing apparatus (13) and described control valve (12) signal communication and can generate control signal (14) according to described physiological property, wherein said control valve (12) can respond the flow velocity that described control signal (14) changes described body fluid.

Description

Regulate the system that body fluid distributes
Technical field
The present invention relates generally to following apparatus and method, described apparatus and method are used for surgical ground and change organ and blood vessel to affect the digestion of patient, treat metabolic disease such as morbid obesity and relevant comorbidities thus, such as diabetes, heart disease, apoplexy, lung disease and accidental disease.
Background technology
Many non-operative treatment in fact without permanent successful treatment morbid obesity were attempted.
The surgical method for the treatment of morbid obesity, such as, obtained increasingly extensive application for bad open, the abdominal cavity mirror of persistency food absorption and intracavity gastric bypass operation and obtained comparatively ten-strike.But the method at present for performing gastric bypass relates to consuming time with the dependent surgery operating technology of high sensitivity and the gastrointestinal anatomical structure of patient remarkable and usual worthless amendment.
In order to avoid gastric bypass operation shortcoming and affect the digestion of patient in more specifically and targetedly mode, the present invention emphatically research is used for major effect and amendment intestinal-hepatic bile circulation but not gastral method and apparatus.For this reason, the following possibility method acting on intestinal-hepatic bile circulation and mechanism should be susceptible to:
-amendment intestinal-hepatic bile cycle frequency, especially biliary cycle acceleration;
-revise by the contact of the food of bile and enteral and interaction and contact by bile and intestinal wall the physiological signal triggered;
-revise food absorption ability by the attaching space between the food of amendment bile and enteral or chyme and time of contact and by making bile be separated targetedly from food.
Specific objective of the present invention is for providing following method and apparatus, and described method and apparatus is for regulating body fluid, and the especially distribution of gallbladder pancreatic juice, such as, affect targetedly in the mode of especially Wicresoft and regulate digestion.
Clinical experiment shows, food is introduced the time in jejunum and gallbladder pancreatic juice is introduced the time in jejunum and make their mixing and interactional time can cause the loss in weight and/or allow to control diabetes.Therefore, need mixing of bile and chyme delay to the comparatively low spot in gastrointestinal tract or stop bile to interact with gastrointestinal tract until reach comparatively distal position and just discharge bile and allow to mix.
Distad transfer to enteral known devices and method at US2009/0062717 and US7,314 for secretions (such as, bile and pancreas secretions) will be digested, discuss to some extent in 489.Be disclosed in US7,314, the device in 489 comprises support, and described support has the duodenal near-end in far-end and joint ampulla of vater region and between near-end and far-end, can collect the diameter parts of the reduction of the annular volume of bile with generation.The device be disclosed in US2009/0062717 comprises bearing support and conduit, and described bearing support has lateral opening, and described conduit extends between the near-end be connected with lateral opening and distal open end, and the near-end of wherein said conduit can form reservoir.
Bile is collected for the known devices of shift and assimilation secretions and method, but their distribution time of bile of not responding specific physiological property and regulating on one's own initiative.
Therefore, another target of the present invention is revise according to the physiological property through gastrointestinal food intake patient's body relevant with passage of food the time be incorporated into by gallbladder pancreatic juice in gastrointestinal tract.
Summary of the invention
These targets are realized by the system for regulating body fluid to distribute, described system comprises can be placed on the control valve in the flow channel of body fluid and the physiological property sensing apparatus with control valve signal communication, and the signal wherein deriving from physiological property sensing apparatus can cause valve to change the flow velocity of body fluid.Body fluid can be bile or pancreatic juice and physiological property can be pH value or the pH value change of the fluid such as gastric content in a part for health.
Additionally by the method for regulating body fluid to distribute to realize above-mentioned target, said method comprising the steps of:
-control valve is placed on first position in the flow channel of the body fluid in patient body;
-by sensing apparatus placement second position in vivo; And
The physiological property of-sensing the second position; And generate control signal according to the physiological property of sensing; And
-control signal is provided to valve to regulate the flow velocity of body fluid.
According to an aspect of the present invention, providing the method for the flow velocity for regulating gallbladder pancreatic juice, said method comprising the steps of:
-active adjustment valve is placed in the flow channel of gallbladder pancreatic juice; And
-pH sensor is placed under one's belt; And
The pH of-sensing gastric content; And
-generate control signal according to the pH of sensing; And
-control signal is sent to valve and utilizes the information deriving from control signal to regulate the flow velocity of gallbladder pancreatic juice.
This makes to affect metabolism mechanism when the anatomical structure without the need to invasive surgical operation or remarkable change patient becomes possibility.
According to another aspect of the present invention, providing the surgical method of the digestion for changing patient, said method comprising the steps of:
-support per os is placed to is communicated with the active adjustment valve fluid of the first position on the flow channel being positioned at gallbladder pancreatic juice;
-pH sensor is connected to the position of gastric; And
-support is anchored in a gastrointestinal part, thus increase the resistance of support for the peristaltic forces acted on support.
Accompanying drawing explanation
By accompanying drawing and explanation thereof, these and other objects of the present invention and advantage will become obvious, described accompanying drawing and explanation thereof show embodiments of the invention, and together with the detailed description of the invention of the whole description of the present invention provided above and the embodiment hereafter provided for explaining principle of the present invention.
-Fig. 1 shows the method and apparatus of the flow velocity for regulating the gallbladder pancreatic juice in patient body according to the first embodiment of the present invention;
-Fig. 2 is the schematic cross sectional views for the bile gathering-device in the method for Fig. 1;
-Fig. 3 shows the method and apparatus of the flow velocity for regulating the gallbladder pancreatic juice in patient body according to a second embodiment of the present invention;
-Fig. 4 show according to the third embodiment of the invention for by bile gathering-device anchoring apparatus and method in the gastrointestinal tract;
-Fig. 5 show according to a fourth embodiment of the invention for by bile gathering-device anchoring apparatus and method in the gastrointestinal tract;
-Fig. 6 show according to a fifth embodiment of the invention for by bile gathering-device anchoring apparatus and method in the gastrointestinal tract;
-Fig. 7 show according to a sixth embodiment of the invention for by bile gathering-device anchoring apparatus and method in the gastrointestinal tract;
-Fig. 8 and 8A show according to a seventh embodiment of the invention for by bile gathering-device anchoring apparatus and method in the gastrointestinal tract;
-Fig. 9,9A to 9C show according to the eighth embodiment of the present invention for by bile gathering-device anchoring apparatus and method step in the gastrointestinal tract;
-Figure 10 shows the body fluid reservoir bag according to an embodiment of the invention with ACTIVE CONTROL valve;
-Figure 11 and 12 is the schematic diagram of the control system of regulating system according to an embodiment of the invention;
-Figure 13 and 14 is the schematic cross sectional views of control valve device according to an embodiment of the invention;
Detailed description of the invention
See accompanying drawing, the anatomical structure that wherein similar in some views digitized representation is similar and parts, Fig. 1 is the partial view in the abdominal cavity of patient, show have esophagus 1, stomach 2, duodenum 3, jejunum 4, ileum 5, colon 6 gastrointestinal tract and there is liver, comprise the major duodenal papilla 10 of the biliary system 7 of gallbladder 8, ductus pancreaticus 9 and the ampulla of vater liver and gall of (bile and pancreatic juice normally enter duodenum 3 through it) and the system 11 for regulating body fluid to distribute.
According to embodiment, system 11 comprises flow rate regulating valve 12 and physiological property sensing apparatus 13, described flow rate regulating valve 12 can be placed in the flow channel of body fluid, described physiological property sensing apparatus 13 is with control valve 12 signal communication and can generate control signal 14 according to physiological property, and wherein control valve 12 responsive control signal 14 changes the flow velocity of body fluid.
According to an aspect of the present invention, body fluid can be bile and or pancreatic juice, and physiological property can be the pH value of the fluid (such as gastric content) in a part for health or pH changing value and/or temperature value or temperature change value.
the detailed description of the embodiment of physiological property sensing apparatus
In the exemplary embodiment, physiological property sensing apparatus 13 can comprise pH sensor 18, described pH sensor 18 can be placed and be anchored in patient body, especially in stomach 2, and pH control signal 14 can be generated according to the pH value of gastric content or pH changing value and pH control signal 14 is directly transferred to control valve 12 with set controller 15 or be transferred to remote control unit 16 alternatively.
Physiological property sensing apparatus 13 also can comprise temperature sensor 19 (it can mechanically be separated with pH sensor 18 or mechanically connect), described temperature sensor 19 can be placed and be anchored in patient body, especially in stomach 2, and temperature control signals can be generated according to the temperature of gastric content or variations in temperature and temperature control signals 14 is directly transferred to control valve 12 with set controller 15 or be transferred to remote control unit 16 alternatively.
Can on physiological property sensing apparatus 13, provide radio-signal transmitter 20 for wireless transmission control signal 14.
According to embodiment, physiological property sensing apparatus 13 comprises for providing the chargeable with live pond 21 of energy to sensing function and control signal production and transfer, and comprise wireless with live electrolytic battery charger 22, such as, ultrasound wave or magnetic field impulse are converted to electric energy with the ultrasonic or induction electricity charger recharged battery 21.
As limiting examples, physiological property sensing apparatus 13 can comprise the Bravo that can derive from MedtronicFunctionalDiagnostics (Minneapolis, Minnesota, USA) wireless pH capsule sensor.
Physiological property sensing apparatus 13 is preferably attached in single per os or per nasal plug-in type capsule, described capsule be connected to distal esophagus or coat of the stomach and pH data are transferred to remote control unit 16 by radiotelemetry or be directly transferred to control valve 12 with set controller 15.
Sensing apparatus 13 capsule can be connected to delivery catheter end and through mouth or nose until it arrives desired locations, such as, above the Z line measured in endoscope about 6cm place.After location, sensing apparatus 13 permanently or is temporarily connected to esophagus or coat of the stomach.Then delivery catheter is removed.When patient is calm during splanchnoscopy or when patient is clear-headed after esophageal manometry, oral inserting can be performed.
With regard to such as by draw to sensing apparatus 13 provisional fixing with regard to, it is similar to the fixing of above-mentioned BRAVOpH probe, but the latter does not need with live electrolytic battery charger and will decline within the time period of 7 to 14 days scopes and be sent in feces.Sensing apparatus 13 maybe can cannot reclaim and re-use.
In addition, can be attached in capsule by physiological property sensing apparatus 13, described capsule can carry out according to the mode being similar to pill swallowing and have the mating interface for being automatically docked to the capsule acquisition equipment previously implanted.Disclosed in the possible embodiment of mating interface and capsule acquisition equipment has in such as U.S. Patent application US2010/0063486, US2010/0056874, US2010/0049120, US2010/0049012, US2009/0306632, these patent applications relate to diagnostic pill capture systems and their full content is all incorporated herein by reference.
With regard to sensing apparatus 13 permanent fixing with regard to, should be with live pond can wireless recharging.
In one embodiment, physiological property sensing apparatus 13 can be constructed to dental implants and the pH value that can sense in the oral cavity of patient or pH changing value.This example provides the simple implantation of sensing apparatus, maintenance and replacing, and without the need to any surgical operation or endoscopic surgery.
the detailed description of the embodiment of control valve
Control valve 12 can comprise electromechanics or electromagnetic valve actuator 26, fluid passage 27 and component of the strobe 28, described electromechanics or electromagnetic valve actuator 26 control by with carrying formula valve control 15, described component of the strobe 28 to act on fluid passage 27 from inner (Figure 13) or outside (Figure 14) and moves between open and closed positions by valve actuator 26, component of the strobe 28 can freely flow through passage 27 at described open position release fluids passage 27 to make body fluid, component of the strobe 28 at described closed position engaging fluid passage 27, thus is closed.
In the exemplary embodiment of Figure 13, control valve 12 is globe valve, and described globe valve has the inside component of the strobe 28 that can discharge respectively with obstruct fluid flow passage 27.
Figure 14 shows alternative embodiment, and wherein control valve 12 comprises elastic flow channel pipe 27 and can discharge the external gate component 29 with the elastic part of compression fluid passage 27 respectively.
These two illustrated embodiment of control valve 12 all allow body fluid to open in configuration at it to flow substantially without resistance, and this controlled discharge for bile and pancreatic juice is required, because their natural secretions produces when there is not remarkable pressure.
the detailed description of the embodiment of system controller
According to embodiment, remote control unit 16 have sensor control signal receptor 23, program control signal resolution unit 24 (as, microprocessor) and valve control signal emitter 25, and can from pH sensor 13 reception control signal 14 and valve control signal 17 can be generated according to the valve control sequence the control signal 14 received and the memorizer being loaded into signal resolution unit 24 and valve control signal 14 can be transferred to control valve 12 with set controller 15.
Remote control unit 16 can match with battery charger 22, especially can generate and convert electric energy to the ultrasound wave recharged battery 21 or magnetic field impulse by battery charger 22.
When control signal 14 is directly transferred to control valve 12 from sensing apparatus 13, valve 12 can have control signal receptor 30 and program control signal resolution unit 31 with set controller 15, such as microprocessor, and also can carry out starter gate valve actuator 26 according to the control signal 14 received and the valve control sequence be loaded into the memorizer of signal resolution unit 31 from pH sensor 13 reception control signal 14.
Usually, can from providing physiological property (such as with year formula valve control 15 or remote control unit 16, the pH of the content of the stomach 2 of patient and/or temperature) sensing apparatus 13 reception control signal 14, and operable valve actuator 26 is to adjust the flow section of fluid passage 27.
In one exemplary embodiment, be constructed with the signal resolution unit carrying formula valve control 15 or remote control unit 16 and compare for by measured physiological property value and predetermined desired value with program control.Such as, if sensor device comprises pH sensor or temperature sensor, then signal resolution unit 24,31 pH that sensor device 13 can be detected or temperature and predetermined target pH or temperature compare.
In order to be conducive to comparing, can be constructed to the signal resolution unit carrying formula valve control 15 or remote control unit 16 receive the input signal representing desired value.Except comparing numerical value, can by the program control change for calculating physiological property according to a series of control signal 14 of receiving subsequently and temporal information with the signal resolution unit carrying formula valve control 15 or remote control unit 16.
Also can by fluid passage 27 flow section of the program control expectation for calculating control valve 12 to realize the target flow velocity of body fluid with the signal resolution unit carrying formula valve control 15 or remote control unit 16.
Outside program control device 32 also can be comprised for regulating the system 11 of the distribution of body fluid and flow velocity, described outside program control device 32 is communicated with the signal resolution unit 24,31 carrying formula valve control 15 or remote control unit 16 and can be incorporated in external remote control unit 16.
Usually, program control device 32 can comprise user interface, and described user interface allows operator to input one or more instruction to be sent to the signal resolution unit 24,31 with carrying formula valve control 15 or remote control unit 16.Such as, outside program control device 32 by the signal of the predetermined target value of the pH change or temperature that represent the gastric content of patient and can represent relative to the bile hang-over delay of the expectation flow through for gastrointestinal food or the Signal transmissions of bile release pre-set time to signal resolution unit 24,31.Outside program control device 32 can comprise the display element for information being sent (such as predetermined body fluid distributes parameter, the physiological property of measurement, the low battery alert of regulation scheme) to user.
As previously mentioned, according to exemplary embodiment, implanted physiological property sensing apparatus 13, valve control 15, remote control unit 16 (if providing) and outside program control device 32 can be constructed to be communicated by radio frequency (RF).For this purpose, sensing apparatus 13, valve control 15, remote control unit 16 (if providing) and outside program control device 32 can comprise and can be constructed to sending to each other and/or the signal projector of Received signal strength and receptor or antenna.This communication allows the Noninvasive of governor valve actuator 26 to control.Antenna can have multiple structure, and can be arranged on the multiple positions in system 11.Such as, in one exemplary embodiment, controller 15 and relative antenna all can be arranged on implanted control valve 12.In another embodiment, controller 15 can be included in implanted control valve 12, and antenna can be disposed in independent implant.In another exemplary embodiment, external control unit outside 16 and relative antenna all can be arranged to and be separated with control valve 12.
In one embodiment, valve control 15 or remote control unit 16 are constructed and carry out operating valve actuator 26 to close control valve 12 with program control to respond pH change control signal 14, described pH changes control signal instruction food and is introduced in stomach 2, thus bile and/or pancreatic juice is accumulated in flow channel and do not flow into digestive tract (now little enteral distad walked by food).
In another embodiment, valve control 15 or remote control unit 16 can be constructed and carry out operating valve actuator 26 to open control valve 12 with program control to respond pH change control signal 14, described pH changes control signal instruction food and has left stomach 2 and be sent to gastral more distally further, thus bile and/or pancreatic juice is assigned in digestive tract after to walk the specific time delay small intestinal from stomach relative to food.
In another exemplary embodiment, valve control 15 or remote control unit 16 can be constructed and enter to compare the reference value of pH and/or temperature control signals 14 or signal 14 sequence and storage to identify food enteral walked by time point in stomach 2 and food time point from stomach 2 with program control.
In addition, valve control 15 or remote control unit 16 can be constructed and enter the time point of intestinal and the time reference curve of storage or reference value with the time point and food that enter stomach according to food to extrapolate food or chyme stream position in the gastrointestinal tract with program control.
With carry formula valve control 15 or remote control unit 16 can by program control be sent to according to food position in the gastrointestinal tract and food as in jejunum and distribute between gallbladder pancreatic juice preset pre-set time interval and/or delay time lag activate to open and/or close and/or regulate the flow section of control valve 12.
Described flow adjustment method and apparatus can carry out correcting according to unique physiological condition of patient and can obtain the advantageous effects of weight saving and control diabetes.
According to embodiment, system 11 can comprise bile gathering-device 33 or support, described bile gathering-device 33 and support can be anchored in small intestinal, especially the gallbladder pancreatic juice in duodenum 3 enters papilla of Vater 10 place of intestinal usually, and can trap gallbladder pancreatic juice and be directed in the fluid passage 27 of control valve 12.
the detailed description of the embodiment of bile gathering-device
In the exemplary embodiment, bile gathering-device 33 comprises tubulose passage of food groove 34 and the open bile collecting chamber 37 of side direction, described tubulose passage of food groove 34 has the preferred infundibulate proximal open end 35 that can be received through the food stream that enterokinesia transmits and the preferred infundibulate distal open end 36 that food distad can be discharged into enteral from groove 34, and the open bile collecting chamber 37 of described side direction is isolated with passage of food groove 34 and can limit the bile collecting chamber 38 substantially sealed together with the adjacent part of intestinal wall.
Exemplary, non-limiting example according to Fig. 1 and 2, bile collecting chamber 37 comprises radially outer annular chamber, and described radially outer annular chamber to be formed and the nearside tube chamber hermetic unit 39 given prominence to by radial direction in the axial direction and distally tube chamber hermetic unit 40 set boundary around passage of food groove 34.
Tube chamber hermetic unit 39,40 preferably can expand from the less configuration of initial flexible radial direction, to allow the selected duodenal segment at papilla of Vater 10 place is introduced and be sent to bile gathering-device 33 through chamber (such as per os) and completes its subsequent deployment by expansion tube cavity hermetic unit 39,40.
For this reason, tube chamber hermetic unit 39,40 can comprise inflatable sacculus sections, and described inflatable sacculus sections permanently expands by injection expansion fluid (such as saline solution) or setting expansion agent (such as hardening polymer foam or paste).
According to embodiment, nearside tube chamber hermetic unit 39 also can limit bile access opening 41, described bile access opening 41 passes into bile collecting chamber 37 and leads to bile duct 42, such as conduit, described bile duct 42 can be connected isolates and the bile flow passage of also isolating with intestinal wall with food and chyme for generation.
In the exemplary embodiment, bile duct 42 is included in the flexible pipe extended between proximal open end and distal open end, wherein proximal open end is connected with the internal flow of bile collecting chamber 37, and distal open end can be positioned in the enteral in bile gathering-device 33 more distally, as illustrated in fig. 1 and 2.
Control valve 12 can be connected to control the bile flow velocity extended there through with bile gathering-device 33 or bile duct 42 fluid.
In the exemplary embodiment, control valve 12 can be placed near the distal open end of bile duct 42, thus provides the extra bile accumulation space being positioned at bile duct 42.In alternative exemplary embodiment, near the proximal open end that control valve 12 can be placed on bile duct 42 or in its center.
In view of the above-mentioned feature of bile gathering-device 33, to make when there is not chyme contact and when not with catheter contact extremely meticulous biliary system 7 collect gallbladder pancreatic juice and become possibility.
The embodiment seen figures.1.and.2, bile collecting chamber 38 is produced by following manner: endoscope auxiliary under by bile gathering-device 33 (being still in its initially flexible configuration) and the position of bile duct 42 (if providing) oral delivery be connected to the ampulla of vater 10, bile gathering-device 33 is disposed subsequently by its tube chamber hermetic unit 39,40 that expands.
In another exemplary embodiment, the support of type described in the U.S. Patent application 2009/0062717 that bile gathering-device can comprise Laufer, the content of this patent application is incorporated herein by reference.
Alternative embodiment according to Figure 10, reservoir bag 59 can be comprised for regulating the system of the distribution of body fluid 11, biliary drainage catheter 60, and bile distribution ducts 61, described reservoir bag 59 is for building up and keeping gallbladder pancreatic juice, described biliary drainage catheter 60 can be the pin of introducing common bile duct 7 and extends between the proximal open end that can be fixed in biliary system 7 and the distal open end be connected with the proximal inlet port hole of reservoir bag 59, to make bile directly drain into reservoir bag 59 from biliary system, the distal outlet port hole of reservoir bag 59 is connected with control valve 12 and (if providing) body fluid pumping system by described bile distribution ducts 61.
According to exemplary embodiment, reservoir bag 59 can comprise inflatable sacculus, bile can be entered in it and make it expand for storage until when needing (that is, until by pH control valve start distribute time).Sacculus self can be processed by PET.
According to another embodiment again, reservoir bag 59 can comprise rigid exterior wall 62 to serve as the protector of the inflatable inwall 63 of the flexibility for limiting bile storage area.
According to another embodiment, body fluid is discharged overflow valve or is discharged flood pump and can be provided and be integrated into possibly in control valve 12, and a part for built up body fluid can be allowed to be discharged to enteral when reaching maximum body fluid storage volume.
for the detailed description of the embodiment of the anchor of bile gathering-device and control valve
According to another aspect of the present invention, system 11 can be included in the first sleeve pipe 43 (shown in Figure 1) extended between infundibulate proximal open end 44 and distal open end 45, described infundibulate proximal open end 44 can such as by being anchored in stomach 2 with pylorus conformal connection, and described distal open end 45 is connected to the proximal aperture 35 of bile gathering-device 33.First sleeve pipe 43 can anchoring bile gathering-device 33 to resist peristaltic forces preferably, and the food that is contained in stomach 2 can be collected and be directed in passage of food groove 34 and do not contact intestinal wall.
In exemplary non-limiting example, second sleeve pipe 64 distad can extend from the distal open end 36 of bile gathering-device 33, chyme or partial digested food and intestinal wall to be isolated, and gallbladder pancreatic juice can be isolated (contrasting Fig. 2) with intestinal wall and chyme by bile duct 42 conduit simultaneously.
Alternatively or in addition, in order to resistant function is at device 33,42, the peristaltic forces of 12, can such as be anchored in gastrointestinal tract by stomach coil 46 by these devices, described stomach coil 46 can from extended configuration (its per os or per nasal can be sent in stomach 2) elastic deformation for screwing arc or circular in configuration (can conformably engage stomach 2 to provide anchoring to the anchor line of the near-end being connected to bile gathering-device 33) (Fig. 3).
In one embodiment, physiological property sensing apparatus 13 can be contained in stomach coil 46 or be connected to stomach coil 46, can reliably be fixed in stomach 2 thus.
In another exemplary embodiment shown in Fig. 4, such as anchor line 47 can be connected to by T-shaped hoop the folding folds in a garment 48 previously formed in coat of the stomach.
In another exemplary embodiment shown in Fig. 5, by being with 49 under mucosa, bile gathering-device 33 is anchored to intestinal wall, 49 are with to be inserted in wall of the lumen under described mucosa and Perfect Ring extends around it, such as form anchoring ring to produce bottleneck portion in intestinal wall, described bottleneck portion can engage the tube chamber hermetic unit 39 being formed at bile gathering-device 33, the corresponding ring-type Anchoring recess 50 at least one in 40.
Fig. 6 shows and another exemplary embodiment, wherein by rami gastrici frame 51 be connected elastic expansion formula (possibly shape memory) 52 can be bent by bile gathering-device 33 anchoring in the gastrointestinal tract, described bow 52 can form conformal connection with stomach 2.
Fig. 7 shows another exemplary embodiment, and wherein by T-shaped hoop 53 by bile gathering-device 33 anchoring in the gastrointestinal tract, described T-shaped hoop 53 hits from enteral to be delivered to intestinal wall, thus forms fixing point and be connected with the near-end of bile gathering-device 33.
Fig. 8 and 8A shows another exemplary embodiment, wherein by there is the ring-type anchor part 54 of multiple anchoring barb 55 by bile gathering-device 33 anchoring in the gastrointestinal tract, described barb 55 can move from resting position (as, rotate) to operating position, barb 55 is contained in the scope of anchorage part 54 in described resting position to allow the unobstructed intracavity transmission of device 33, barb 55 radially outward protrudes in described operating position, thus pierces through wall of the lumen and thus device 33 anchored to wall of the lumen.
In another exemplary embodiment shown in Fig. 9-9C, by there is the tubulose anchorage part 56 of one or more anchor hole 57 by bile gathering-device 33 anchoring in the gastrointestinal tract, described anchor hole 57 is intended to towards intestinal wall part, and can to allow these intestinal wall parts to be pulled in hole 57 and to fix with it.Suction lumen wall portion in tubulose anchorage part 56 can be provided for and the intracavity aspirator 58 be pulled in anchor hole 57 and permanent (mushroom-head) for generation of wall of the lumen part swelling, with the apparatus and method preventing it from exiting from anchor hole 57.Can comprise will to be injected under extender or sclerosing agent mucosa or by plasticity pearl, such as poly-(methyl methacrylate) (PMMA) is inserted into and had previously been drawn through in the tissue part of anchor hole 57 for generation of the permanent swelling such device of wall of the lumen part and method.
Although describe the preferred embodiments of the present invention in detail, the object of applicant is not that the scope of claim is limited to these specific embodiments, but all modifications form covering within the scope of the invention and alternative constructions.

Claims (22)

1. the system (11) for regulating body fluid to distribute, described system (11) comprises control valve (12) and physiological property sensing apparatus (13), described control valve (12) can be placed in the flow channel of body fluid, described physiological property sensing apparatus (13) and described control valve (12) signal communication and control signal (14) can be generated according to physiological property, wherein said control valve (12) can respond the flow velocity that described control signal (14) changes described body fluid, wherein said control valve (12) comprises with carrying formula valve control (15), the valve actuator (26) controlled by described valve control (15), fluid passage (27), with component of the strobe (28), described component of the strobe (28) is acted on described fluid passage (27) and goes up and can be moved between open and closed positions by described valve actuator (26), described component of the strobe (28) discharges described fluid passage (27) at described open position, make body fluid freely can flow through described fluid passage (27), described component of the strobe (28) engages described fluid passage (27) in described closed position, thus described fluid passage (27) are closed.
2. system according to claim 1 (11), wherein said physiological property sensing apparatus (13) comprises pH sensor (18), described pH sensor (18) can be placed and be anchored in the stomach (2) of patient, and pH control signal (14) can be generated according to the pH value of gastric content, and described pH control signal (14) is transferred to the controller (15 of described control valve (12); 16).
3. system according to claim 1 and 2 (11), wherein said physiological property sensing apparatus (13) comprises temperature sensor (19), described temperature sensor (19) can be placed and be anchored in stomach (2), and temperature control signals can be generated according to the temperature of gastric content, and described temperature control signals is directly transferred to the controller (15 of described control valve (12); 16).
4. system according to claim 1 and 2 (11), comprise radio-signal transmitter (20), described radio-signal transmitter (20) can be arranged on described physiological property sensing apparatus (13), for the wireless transmission of described control signal (14).
5. system according to claim 1 (11), wherein said physiological property sensing apparatus (13) comprising:
-for providing the chargeable with live pond (21) of energy to described sensing function and described control signal production and transfer,
-wireless with live electrolytic battery charger (22).
6. system according to claim 1 (11), wherein said physiological property sensing apparatus (13) is bonded in single per os plug-in type capsule.
7. system according to claim 6 (11), comprise capsule acquisition equipment, described capsule acquisition equipment can be anchored in esophageal-gastric tube chamber and to have capsule catches interface, and interface caught by described capsule optionally can catch, keeps and discharge described sensing apparatus (13) capsule.
8. system according to claim 1 (11), wherein said physiological property sensing apparatus (13) is constructed to dental implants and can senses the intraoral pH value of patient.
9. system according to claim 1 (11), comprising with set controller (15) of wherein said control valve (12):
-control signal receptor (30), described control signal receptor (30) can receive described control signal (14) from described sensing apparatus (13);
-there is the program control signal resolution unit (31) of memorizer and microprocessor, described program control signal resolution unit (31) can start described valve actuator (26) according to received control signal (14) and the valve control sequence be loaded in described memorizer.
10. system according to claim 1 (11), comprises remote control unit (16), and described remote control unit (16) has:
-control signal receptor (23), described control signal receptor (23) can receive described control signal (14) from described sensing apparatus (13);
-there is the program control signal resolution unit (24) of memorizer and microprocessor, described program control signal resolution unit (24) can generate valve control signal (17) according to received control signal (14) and the valve control sequence be loaded in described memorizer;
-valve control signal emitter (25), described valve control signal emitter (25) described valve control signal (14) can be transferred to described control valve (12) with set controller (15).
11. described systems (11) according to claim 9 or 10, wherein said signal resolution unit (15; 16) be constructed and by program control for:
-measured physiological property value and predetermined target value are compared;
-change of described physiological property is calculated according to a series of control signal (14) of receiving subsequently and temporal information.
12. systems (11) according to claim 9 or 10, wherein valve control (15; 16) be constructed and by program control for:
-response pH changes control signal (14) and carrys out operating valve actuator (26) to close described control valve (12), and described pH changes control signal instruction food and is introduced in stomach (2),
-response pH changes control signal (14) and carrys out operating valve actuator (26) to open described control valve (12) after the time delay of setting, and described pH changes control signal instruction food and left stomach (2) and be sent to gastral more distally.
13. systems (11) according to claim 9 or 10, wherein valve control (15; 16) be constructed and by program control for:
-compare the reference value of physiological property control signal (14) sequence and storage to calculate food to have entered enteral walked by the time point of stomach (2) and food time point from stomach (2);
-the temporal reference value that enters the time point and storage that the time point of stomach (2) and food enter intestinal according to food is extrapolated food or chyme stream position in the gastrointestinal tract;
-to distribute according to the food position in gastrointestinal tract and food transmission and gallbladder pancreatic juice between preset pre-set time interval and delay time lag start the valve actuator (26) of described control valve (12), to regulate flow section.
14. systems according to claim 1 (11), comprise bile gathering-device (33), described bile gathering-device (33) can be anchored at weary Te Shi nipple (10) place in small intestinal and can to trap gallbladder pancreatic juice and be directed in the fluid passage (27) of described control valve (12).
15. systems according to claim 14 (11), wherein said bile gathering-device (33) comprising:
-tubulose passage of food groove (34), described tubulose passage of food groove (34) has the distal open end (36) can received the proximal open end of food stream (35) and food distad can be discharged into enteral from groove (34);
The open bile collecting chamber (37) of-side direction, described side direction open bile collecting chamber (37) is isolated with described passage of food groove (34) and can limit the bile collecting chamber (38) of sealing together with the adjacent part of intestinal wall
Described control valve (12) is connected with described bile collecting chamber (37) fluid.
16. systems according to claim 15 (11), wherein said bile gathering-device (33) comprises the nearside tube chamber hermetic unit (39) and distally tube chamber hermetic unit (40) that can expand from the less configuration of the radial direction of initial contraction, and described nearside tube chamber hermetic unit (39) and distally tube chamber hermetic unit (40) comprise the inflatable sacculus sections that can pass through injection expansion fluid or setting expansion agent and permanent expansion.
17. systems according to claim 15 (11), comprise bile duct (42), the flexible pipe that described bile duct (42) has proximal open end and distal open end and extends between, wherein said proximal open end is connected with the internal flow of the bile collecting chamber (37) of described bile gathering-device (33) and described distal open end can be positioned at the enteral of described bile gathering-device (33) compared with distally, and described control valve (12) is arranged in described bile duct (42) to control the bile flow velocity extended there through.
18. systems according to claim 1 (11), comprising:
-for building up and keep the reservoir bag (59) of gallbladder pancreatic juice;
-biliary drainage catheter (60), described biliary drainage catheter (60) is the pin introduced in biliary system (7) and extends between the proximal open end that can be fixed in described biliary system (11) and the distal open end be connected with the proximal inlet port hole of described reservoir bag (59);
-bile distribution ducts (61), the distal outlet port hole of described reservoir bag (59) is connected with described control valve (12) by described bile distribution ducts (61).
19. systems according to claim 18 (11), wherein said reservoir bag (59) comprises inflatable sacculus, bile can be discharged in described sacculus and make described inflation for storage.
20. systems according to claim 14 (11), comprise the first sleeve pipe (43), described first sleeve pipe (43) extends between infundibulate proximal open end (44) and distal open end (45), described infundibulate proximal open end (44) can be anchored in stomach (2), described distal open end (45) is connected to the proximal aperture (35) of described bile gathering-device (33), described first sleeve pipe (43) can by the anchoring of described bile gathering-device (33) in the gastrointestinal tract and can collect the food that is contained in stomach (2) and be directed in described passage of food groove (34) and not contact with described intestinal wall.
21. systems (11) according to claim 14 or 20, comprise the second sleeve pipe (64), described second sleeve pipe (64) distad extends from the distal open end (36) of described bile gathering-device (33), partial digested food and described intestinal wall to be isolated.
22. systems according to claim 14 (11), comprise for by described bile gathering-device (33) anchoring anchor in the gastrointestinal tract, described anchor is selected from:
-stomach coil (46), described stomach coil (46) can from the extended configuration elastic deformation its per os or per nasal are sent in stomach (2) for can with stomach (2) conformal be connected screw arcuate configuration;
-anchor line (47), described anchor line (47) has T-shaped hoop connector for the folding folds in a garment (48) be fixed in coat of the stomach;
(49) and ring-type Anchoring recess (50) is with under-mucosa, be with (49) can insert to form anchoring ring in intestinal wall under described mucosa, described ring-type Anchoring recess (50) to be formed in described bile gathering-device (33) and can to engage described anchoring ring;
-T-shaped hoop anchoring body (53), described T-shaped hoop anchoring body (53) can be hit from enteral and be delivered to form fixing point intestinal wall, and described T-shaped hoop anchoring body (53) can be connected with the near-end of described bile gathering-device (33);
-ring-type anchorage part (54), described ring-type anchorage part (54) has multiple anchoring barb (55), described barb (55) can move to operating position from resting position, be contained in the scope of described anchorage part (54) at barb (55) described in described resting position, described in described operating position, barb (55) radially outward protrudes;
-tubulose anchorage part (56) and swollen thus prevent the device that it exits from anchor hole (57) for generation of the permanent mushroom head swollen body of wall of the lumen part, described tubulose anchorage part (56) has anchor hole described in one or more (57), and anchor hole described in one or more (57) is intended to towards intestinal wall part and can allows these intestinal wall parts to be pulled in described hole (57) and to fix with it.
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