EP0014202A1 - Device for study of the alimentary canal - Google Patents

Device for study of the alimentary canal

Info

Publication number
EP0014202A1
EP0014202A1 EP19790900335 EP79900335A EP0014202A1 EP 0014202 A1 EP0014202 A1 EP 0014202A1 EP 19790900335 EP19790900335 EP 19790900335 EP 79900335 A EP79900335 A EP 79900335A EP 0014202 A1 EP0014202 A1 EP 0014202A1
Authority
EP
European Patent Office
Prior art keywords
mass
chamber
fluid
fact
valve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP19790900335
Other languages
German (de)
French (fr)
Inventor
Jerzy Pawelec
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DK133478A external-priority patent/DK133478A/en
Application filed by Individual filed Critical Individual
Publication of EP0014202A1 publication Critical patent/EP0014202A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/073—Intestinal transmitters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B2010/0061—Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions

Definitions

  • This invention relates to sampling devices for automatically obtaining samples of gastric and intestinal fluids in the digestive tracts of humans and animals and for use in determining the presence of free hydrochloric acid and lactic acid in the gastric fluids.
  • clonten s of the different parts of the gastrointestinal tract plays a great role in diagnostic and medical research. Information from these examinations can be of great impor ⁇ tance for diagnosing diseases of stomach, duodenum, gallbladder and pancreas, as well as for diagnosing certain blood diseases.
  • the determination of the presence or absence of free hydrochloric acid and lactic acid in the digestive tract is especially important and useful.
  • the absence of free hydrochloric acid in the gastric fluid is a character ⁇ istic finding of pernicious anemia.
  • the absence of hydro ⁇ chloric acid together with the presence of lactic acid in the gastric fluid indicates for advanced carcinoma of the stomach.
  • Stomach tubes are the normal instruments for col ⁇ lecting samples of the contents of the stomach and duodeum. As is known, these are long, flexible tubes wich are inser ⁇ ted to the digestive tractc through the patient's mouth or nose, and then fluid from the actual part of the digestive tract is aspirated through the tube. The examination normally takes place under x-ray control, to check for proper positioning of the end of the tube in the digestive tract.
  • test results may be inconclusive or erroneous.
  • Intubation of the digestive tract is an expensive examination. It is a very time-consuming examination for the doctor, and demands the help of highly qualified nurses, a suitable place with comfortable beds where the patients can be examined, and access to x-ray apparatus. The examination immobilizes the patient for several hours, and exposes him to the risks of x-ray exposure.
  • the present invention provides a sampling device for automatically obtaining samples of gastric and/or intestinal fluids and for use in determining the presence of free hydrochloric acid and lactic acid in the digestive tracts of humans or animals.
  • the device is similar in size and shape to a conventional pharmaceutical capsule and is thus suitable for ingestion.
  • the capsule defines an inner fluid receiving chamber having an entrance which is normally sealed off from the external environment by way of a blocking mechanism including a mass which, upon contact with a certain fluid present in the digestive tract causes the mechanism to " communicate the opening with the outside of the capsule allowing a sample of the fluid to enter and be retained in the chamber.
  • a cylindrical spring operated valve normally maintained in a flow permit ⁇ ting position by a mass which glues the necessary parts of the valve together in such a way that the parts cannot move, so the action of the strained spring is neutralized. This mass is also responsive to contact with the fluid to permit the valve to operate and seal off the chamber after a predetermined time.
  • the sample is then secured from contami ⁇ nation during its further travel through the rest of the di ⁇ gestive tract, and the capsule is evacuated by a normal defectory process and recovered to be sent to a laboratory for analysis of the sample.
  • the collected samples can be . used for chemical, biochemical, microbiological, parasito- logical and cytological examination.
  • the sampling device of the present invention used in collecting a sample of gastric fluids is equiped with mechanisms, which control the opening and closing of the capsule, and which are blocked by a mass, which can for example comprise gelatin, saccarose or another carbohydrate, which loses its blocking properties after a short time following contact with the gastric fluid.
  • a mass which can for example comprise gelatin, saccarose or another carbohydrate, which loses its blocking properties after a short time following contact with the gastric fluid.
  • the opening of the capsule, the collection of the sample and reclosing of the capsule takes place in the stomach.
  • Capsule D-duodenum With the use of a different mass, which for example comprises celluloseacetatephtalate which will no dissolve until after contact with the alkaline contents o the small intestine, the capsule ( Capsule D-duodenum) ma be used to collect a sample of intestinal fluids.
  • the capsule additionally contains a basic-acid indicator in the chamber, which res ponds to free HC1 in the gastric fluid to cause a color • change in the fluid sample, indicating the presence of fr HC1 in the sample (Capsule A-acidity).
  • a part of the wall the capsule is made of transparent material to permit viewing of the sample contained therein.
  • indicator sesitive to lactic acid may be disposed in the chamber to react with the fluid sample, and provide a cha in color of the sample, indicating the presence of lactic acid in the sample (Capsule LA-lactic acid) .
  • first and second spring achanisms control the ⁇ opening of the capsule and then its closing.
  • the spring mechanisms initially neutralized by a mass that secures parts of the capsule* together, in such a way that the mechanisms canno operate. In this configuration, the entrance to the caps chamber is normally kept closed off.
  • the mass which blocks these mechanism has such properties that after it contacts gastro or intestinal fluid, depending on the application and thus type of mass used, its characteristics are altered in such a way that loses the properties that permit it to secure the parts o the device together and prevent operation of the capsule' mechanisms.
  • a portion of the mass which normally neutral zes the action of the first spring mechanism is disposed externally of the capsule. Accordingly, when the capsule is swallowed by the patient and the portion of the mass contacts the gastro ( or intestinal ) fluid, its properti are altered allowing the first spring mechanism to operat This expands the capsule, enlarging the capacity of its
  • OMPI inner chamber and aspirating a sample of the fluid into the chamber.
  • the expanding of the capsule causes exposure of a place covered by a second portion of the mass, which normally neutralizes the action of the second spring means, to the fluid being sampled.
  • the second mass loses the properties which enable it to neutralize operation of the second spring mechanism. This permits a valve to operate and close the capsule, hermetically sealing it. With the fluid sample enclosed therewithin and isolated from contamination during its way through the rest of the digestive tract.
  • the present invention it is possible to examine the gastric and duodenal fluids without any stress, discomfort and pain of intubation obviates the need for x-ray exposure and x-ray equipment, and immobilization of . the patient for several hours in bed.
  • the examination can be performed independently of the patient's state of health.
  • Examination using the principles of the present invention is so simple to perform, that the patient can do part of the examination (according to doctor's instruc ⁇ tions) himsef -in his own home, with no need for expensive medical care.
  • the examination which can be made by the help of the new invention, open new possibilites for diagnostic and research, and can lead to a better knowledge of the physiology and biochemistry of the digestive process.
  • the fluid sampling device of the present invention can play an especially large role in mass- examinations of the digestive tract for finding cancer alterations because it is inexpensive and easy to use.
  • FIG. 1 is in axial section view of one embodimen of the sampling capsule device in initial position.
  • FIG. 2 is a sectional view taken along lines 2-2 of FIG. 1;
  • FIG. 3 is a sectional view taken along the lines 3-3 of FIG. 1;
  • FIG. 4 is a sectional view taken along the lines 4-4 of FIG. 1;
  • FIG. 5 is a sectional view taken along the lines 5-5 of FIG. 1;
  • FIGS. 6 and 7 are breakaway views showing the capsule of FIG. 1 in two different working positions
  • FIG. 8 is a perspective view of the capsule with the bottom portion of the capsule removed;
  • FIG. 9 is a perspective view of the inner shell member of the capsule of FIG. 1;
  • FIG. 10 is a side elevation view, partially in section of a second embodiment of the capsule.
  • FIG..11 is a breakaway view of a third embodimen of the capsule.
  • FIGS. 12 and 13 are sectional views of a fourth embodiment of the capsule illustrating unoperated and operated configurations, respectively;
  • FIG. 14 is a sectional view of a fifth embodimen of the capsule.
  • FIGS. 15 and 16 are sectional views of a sixth embodiment of" the capsule illustrating unoperated and operated configuration, respectivly;
  • FIG. 17 is a sectional view taken along lines 17-17 of FIG. 15;
  • FIGS. 18 and 19 are sectional views of a seventh embodiment of the capsule illustrating unoperated and operated configurations, respectively.
  • FIGS. 20 and 21 are sectional views of a eighth embodiment of the capsule illustrating unoperated and operated configurations, respectively.. DESCRIPTION OF PREFERRED EMBODIMENTS
  • the sampling device basically comprises a capsule having an outer shell member' 1 and an inner shell member 2 which is received in telescopic- engagement with the outer shell member defining an enclosed chamber 18.
  • FIG. 1 which illustrates the device in its closed configuration
  • an aperture or- window 17, shown best in FIG. 9, formed in the side.-wall of the inner shell member 2 is normally sealed off or- closed by the inner wall of the outer shell member 1.
  • shell members 1 and 2 are securated together by mass 21 neutralizing the effect of a compressed spring 19, extending axially within compartment 18, and which tends to drive the two shell members apart.
  • the mass 21 loses its effectiveness as a holding agent. This permits the shell members to be driven apart under the force of the spring 19, so that as the walls of the two shell members slide along one another, eventually aperture 17 is communicated with the outside of the capsule, as shown in FIG. 6, allowing fluid, such as intestinal or gastric fluid, to be aspirated into chamber 18.
  • a spring operated valve assembly including valve member 9 and valve operating spring 25, is mounted within the capsule.
  • the valve operates a short time after the capsule expands and the fluid contacts mass 28 changing its characteristics. When operated, the valve closes the capsule by rotating aperture 16 out of alignment with aperture 17, as shown in FIG, 7, hermetically sealing
  • OMPI the capsule with the fluid contained within the chamber thereof.
  • the device in shape of a capsule and size of 8 X 19 mm, is able to collect about 1 ml of intestinal flu Using microanalysis, this is sufficient quantity to perfor many different analysis.
  • the mass that is used depends upon- the ' function application of the capsule. If the capsule is used to collecting gastric fluid, the machanisms that guide the opening and closing of the capsule, hereinafter referred t as capsule G (Gastric) are blocked by a mass which loses i blocking properties after short contact with the gastric fluid.
  • the opening of the capsule, the collection of the sample and the closing takes place in stomach.
  • the mass may be comprised of gelatin, proteins, gum arabic, saccharose or other carbohydrates. hot solutions of these substances after stiffening creates mass, which secures or holds together appropriate parts of the capsule in a way to effectively neutralize the action springs.
  • Such mass loses its properties which enable it t hold these parts together after a short contact with the g tric fluid. For example, depending on the composition of mass, it may become brittle causing it to fracture under force of the spring it normally neutralizes, or the mass m dissolve freeing the parts it normally holds together.
  • the capsule may also be used to collect intestin fluid, in which case the mass is comprised of cellulose- acetate phtalate, shellac, polyvinyl chloride or polymers polyvinylpyridine acril acid.
  • capsule D duodenum
  • the block mass or substance is not submitted to any change in the stomach. Its change occurs only after contact with the al line contents of the small intestine. It is pointed out t capsule D mechanisms can use that same mass as that used f the capsule, that mass being covered with a film or . coating comprising celluloseacetatephtalate, shellac, polyvinyl chloride or polymers of polyvinylpyridineacri acid which resist gastric fluids.
  • the outer shell 1 has a bottom or cover 3 which is connected to the main body portion of the shell 1 for example, by way of screw threads (not shown) and with vacuum grease indicated at 4 providing a seal between the bottom member and the main body portion.
  • Bottom 3 is provided to simplify assembly of the working mechanisms of the capsule during manufacture and to facilitate access to the sample of gastric fluid stores in the chamber 18 after use of the device to enable analysis of the sample.
  • Shell members 1 and 2 are so fit together and tightened by help of vacuum grease or 0-rings, to create a hermetically sealed capsule.
  • the bottom 3 has an opening 5 filled with a plug 6 which allows air to be evacuated from chamber 18 as by iserting a needle probe of suitable vacuum pump or syringe through plug 6, providing an under pressure in chamber 18.
  • the plug 6 is of material having characteristics providing self sealing when the needle is withdrawn.
  • the inner shell 2 has a neck 7 extending per ⁇ pendicular to a horizontal wall 8, hereinafter referred to as the base of the neck. As shown best in FIG. 9, the height of the neck, which is of hollow cylindrical confi ⁇ guration, is differentiated with the circumference of the upper portion of the neck having a stepped configuration defining- stop surfaces 30a and 30b. Under the base of neck
  • valve sleeve 8 is placed the cylindrical valve sleeve 9.
  • valve sleeve 9 and the neck base 8 have central apertures 10 and 11 of the same inner diameters which makes it possible to thread them onto the shank of a pivot pin 12.
  • the valve sleeve 9 is permanently connected to pin 12 in a suitable manner, such as by a layer of epoxy 13.
  • the inner shell 2, which threaded onto the pin 12, can rotate freely around the axis of pin 12.
  • a header 14 which can rotate
  • Header 14 is permanently connected to pin 12 such as by a layer of epoxy 15. In this way, the rotation of the header 14 around neck 7 causes the rotatio of sleeve 9 around the inner ahell 2. Header 14, pin 12, sleeve 9 and torque 25 form the valve mechanism of the capsule.
  • the inner shell 2 has rectangular window 17 form in its side wall and it has the same shape and size as win 16 formed in the side wall of the valve sleeve 9.
  • the winndows- 16 and 17 are disposed so that in the initial condition (FIGS. 1 and 5) the valve is in flow permiting position and the capsule is in its closed and compressed position, with the openings in alignment with one another. In this position, the chamber 18 is out of communication w the external environment because windows 16 and 17 are cov by the inner wall of outer shell 1.
  • the spring 19 which extends within chamber 18 has its bottom end permanently fastened to bottom member 3, for example by layer of epoxy 20. The top end of the spring engages the under surface o valve sleeve 9. When the capsule is in the closed positio the spring 19 is compressed, exerting a force along the longitudinal axis of the capsule tending to separate shell 1 and 2.
  • chamber 18 When the capsule expands, chamber 18 is enlarged to almost twice its initial capacity and is communicated with the environment through the openings 16 and 17 (FIG. 6) which are uncovered as the result of the separating movement of members 1 and 2. As result of the underpressure in chamber 18, the gastric fluid will aspirate into the inner of chamber 18 through the openings 16 and 17.
  • valve sleeve 9 is moved from the opening 17 in the wall of the inner shell 2 (FIG. 7), causing the capsule to be closed to the environment.
  • the sample of gastric fluid in the chamber 18 is thus sealed in and is secured of contamination as the capsule continues its way through the rest of the digestive tract.
  • the turning of valve sleeve 9 around the inner ahell 2 is limited to 180° by a stop member 29 fastened to header 14, and which engages a vertical surface 30a of neck 7 (FIG. l). At its other extreme of travel, stop member 29 engages surface 30b of the neck 7 as shown in FIG. 2.
  • the capsule After the capsule has passed through the digesti tract, it is recovered from the fecies and washed, and the sent to a laboratory for analysis of the sample. In the laboratory, bottom 3 and spring 19 fastened to 3 are remov as shown in FIG. 8, and the rest of the capsule serves as tube which encloses the sample for use by the clinical technician during testing.
  • the outer shell 1 has opening 31, which has the same diameter as an opening 32 formed in header 14 and an opening 33 formed in neck 7.
  • the openings 31, 32, 33 and pin 34 (FIG.5) simplify set-up of the capsule.
  • torque spring 25 is first wound by rotating head 14 180° around neck 7 until the opening 32 and 33 overlap and it is possible to insert peg 34 through the openings.
  • the layer of mass 28 is applied, and when becomes set, the peg 34 is removed.
  • the inner shell is slid along the outer shell 1 until the openings 31 and are aligned, and it is possible to pass peg 34 through the Then the layer of mass 21 is applied and after it becomes set, the peg 34 is removed.
  • the set-up of the capsule is finished by inserting the spring 19 in chamber 18 and the ring spring 23, and securing the bottom 3 on the main body portion of the outer shell 1.
  • the capsule can be used to detect the present of free HC1 in the gastric fluid.
  • Capsule A is constructed identically with capsul G, with the difference that in its inner chamber 18, a container 35, which is secured to or formed integrally wit the bottom of pin 12, holds a small quantity of a basic- acid indicator which upon contact with free HC1 in the fluid sample received in chamber 18 causes a color change of the fluid sample also.
  • a portion of the walls of the shell members 1 and 2 of capsule A is made of transparent material so that the color change is: visible through the
  • OMPI WIPO transparent wall of the capsule On the basis of the color of the sample, a determination can be made as to the normal or unnormal composition of the patient's gastric fluid.
  • indicator of free HCl which can be used is • dimetylaminoazobenzol which may be in powdered form.
  • the _ powder is covered with a film of gelatin to delay exposure of the indicator to the fluid until after the valve operates to close the chamber.
  • the capsule may be used to determine the presence of lactic acid in the gastric juice.
  • Tis cap ⁇ sule referred as capsule LA lactic acid
  • capsule LA lactic acid
  • the indicator when contacting lactic acid in the sample of gastric fluid, causes coloring of the sample characteristic of the presence of lactic acid.
  • Such indicator is covered this same film as capsule A.
  • the color of the sample may be viewed through the transparent wall of the capsule to determine the existence or non-existence of lactic acid in the gastric fluid of the patient.
  • an indicator of la ⁇ tic acid which can be used is Fe Cl ⁇ .
  • a paper or other sorbent which contains or is saturated with suit ⁇ able chemicals may be used.
  • FIG. 11 there is shown a further embodiment of the capsule having two separate fluid storage chambers 18a and 18b each having an associated valve mechanism simi ⁇ lar- to that used in capsule G, for example.
  • Each section of the capsule is similar to that described with reference to the embodiment of FIG. 1 with the mass 21 and 28 that neut ⁇ ralizes the spring 19, embodied as a flat power spring, and valve member 9, respectively, for one of the chambers 18a, being the type responds to gastric fluid, and the mass associated with the other chamber 18b being the type that responds to intestinal fluids.
  • the stop member 29 wich limits rotation of valve sleeve 9 extends from the side wall of the header 14.
  • this capsule may be used to obtain samples of both gastric fluid and intestinal fluid, or may use the same mass but different indicators forming a combination capsule A and LA.
  • the operation and construct of the sampling device is apparent from foregoing descrip ⁇ tion. It is apparent that one or both of the chambers may be provided with an indicator, as in capsule A or LA, the mass for each section of the device being selected in accordance with its intended use.
  • capsule chamber 18 is defined in part by a container 38 of an elastic material, which is normally folded up and contained, along with a valve mechanism within a capsule shaped container 46 of a material that is isoluable in fluids of the alimentary canal.
  • the valve mechanism is similar to that employed in the capsule G shown and described above with reference to FIG. 1.
  • the container 38 is hermetically sealed to the bas of the inner shell member at points 49. ⁇ he opening to the chamber 18, is defined by window 16 in valve sleeve 9 and window 17 in the side wall of the inner shell member 2A.
  • the envelope 46 which can be made of material insoluble i alimentary canal's fluids, consists of at least two parts 46a and 46b which are glued together by means of mass 21 which after contact with a suitable fluid of alimentary ca loses the properties that glued the parts 46a and 46b together. Consequently, the envelope breaks apart, allowi the elastic- container 38 to expand as shown in FIG. 13.
  • the valve is normally maintaine in fluid permitting condition so that when the capsule bre away, and the container expands, fluid is aspirated into chamber 18 due to the vaccum created as the container 38 expands.
  • the cover 46 can also be made of material that is soluable in suitable fluids of the alimentary canal. It is pointed out that the container 38 may be of other configurations
  • O P such as a bellows-shaped, normally compressed and expandible coaxially of the capsule.
  • FIG. 14 there is shown a further embodiment in which the mass 21 is employed to seal the entrance way 65 to the openings 53 and 54 of the inner cham ⁇ ber 18.
  • mass 21 changes its properties, fluid is permitted to flow into the chamber through openings 53 and 54 and when received within the chamber 18 will cause mass 28 and 64 to changes its properties and allow the valve mechanism to rotate and close the openind 54.
  • a hollow shell member 50 is permanently connected to a flange 55 at the base of a header 6 " by a layer of epoxy 57, applied circumferentially, which also seals the shell and the header at the connection.
  • the inner chamber 18 is communicated with the external environment through openings 53 and 54 formed in the side walls of the valve sleeve 58 and the header 56, respectively, and a channel 65 provided by spacing between the capsule 50 and the valve sleeve 56. Channel 65 is normally blocked by mass 21.
  • valve sleeve 58 is secured to the header 5o " by mass 28, with openings 53 and 54 being in register, and the action of valve spring 60, which is wound up, being neutralized.
  • the spring 60 tends to rotate the sleeve 58 around a pivot pin 61, the shank of which is fixedly received in an aperture 62 formed in the underside of the header 56.
  • a further mass 64 secures the valve sleeve to the pin 61, which is permanently connected to the head 56 by means of a layer of epoxy 62.
  • One end of spring 60 is secured to the pin 61 and other end is secured to the valve sleeve 58 so that when the spring is torqued, the spring tends to rotate the sleeve to move opening 53 out of register with opening 54.
  • the spring action is effectively neutra ⁇ lized by the mass 28 and the mass 64.
  • a suitable stop means limits rotational movement of the valve member in the manner of stop means 29 shown in FIG. 1.
  • This- device does not use the expansion principle
  • OMPI employed in the device of FIG. 1 and may- be evacuated to establish an under pressure in the chamber 18 prior to use employing a syringe the needle of which is insertable throu suitable self sealing plug 66.
  • Notches 70 in the side of the container 50 provid break away points for removing the valve assembly and the rest of the capsule serves as a tube which contains the sample for use by the clinical technician during testing.
  • mass 21 changes i properties which otherwise permit it to block the entrance channel 65 to the chamber 18, and a sample of the fluid is aspirated into the chamber 18.
  • the fluid contacts mas 28 and mass 64 they lose their properties which permitted them to neutralize the operation of the valve.
  • the valve sleeve then rotates under the force of spring 60 to move opening 53 out of register with opening 54 to seal off the chamber 18 with the fluid sample retained therewith.
  • FIGS. 15-17 there is shown a further embodimen of the capsule.
  • the capsule has the inner chamber 18 which is communicated with the external environment through openings 17a and 17b formed in the side wall of the capsule
  • the chamber there are two discs 91 and 93 made of such material as metal or plastic.
  • the disc 91 is permanently connected to the seal 92 and the disc 93 is per nently connected to tne sea l 94.
  • the discs 91 and 93 divide the chamber 18 into three portions, 18a, 18b and 18c.
  • an underpressure is establishe through self-sealing plug 6a and in the chamber 18c an overpressure is established through the plug 6b.
  • the seal 92 tends to aspirate a sample of the fluid from the environment and the seal 94 tends to close the openings 17a and 17 " b.
  • the suction effect of the underpres ⁇ sure is blocked by a mass 21b which glues together the wall of the capsule and the disc 91. in such a way that the seal 92 cannot move.
  • the effect of the overpressure is blocked by a mass 28 which blocks the movement of the seal 94.
  • the openings 17a and 17b are covered by a mass 21a.
  • mass 21a changes its properties which otherwise permit it to block the openings 17a and 17b, and sample of the fluid is permitted to flow into the chamber 18b and when received within the chamber 18b will cause mass 21b and 28 to change its properties which blocked the movement of the the seals 92 and 94.
  • the layer of the mass 28 is much more thick than the layer of the mass 21b causing that the mass 21b is removed as the first one. This permits the under ⁇ pressure to move the seal 92 and to collect the sample of the fluid, and then the overpressure in the chamber 18c is able to move the seal 94 and close the capsule, herm ⁇ etically sealing it as shown in FIG. 16.
  • FIGSv- 18 and 19 a modification of the capsule in wich the capsule chamber 18 is defined in part by bellows-shaped container 95.
  • the closing means is similar to that employed in the capsule shown and described above with reference to FIGS. 15-17, but the overpressure is replaced by the compressed spring 97, and the underpressure is replaced by the spring means 96 and said bellows-shaped container.
  • the envelope 21 is similar to that employed in the capsule shown and described above with reference to FIG. 12.
  • the envelope 21 breaks apart, allowing the bellows-shaped . ' container 95 to expand as shown in FIG. 19.
  • the sample of fluid is aspirated into the chamber 18a due to the under ⁇ pressure created as the container expands.
  • the mass 28 which blocks operation of the spring 97, it changes its properties, allowing the seal 94 to close the openings 17a and 17b as shown in FIG. 19.
  • FIGS. 20 and 21 a modification of the device similar to the device shown in FIGS. 18 and 19.
  • the compressed spring 106 tends to close the opening 104 through which the inner chamber is communicable with the exterior of the device.
  • the round block 109 situated between the seal 1 and the O-ring 108 blocks the action of the compressed spri 106 and keeps the opening 104 in the open position.
  • the block 109 is permanently connected with the bottom of the bellows-shaped container 102 by means of the thread 110.
  • the length of the thread 110 is shorter than the length of the expanded device.
  • the envelope 21 which covers the opening 104 and keeps the spri 105 i the compressed state and keeps the container 102 in i tense position breaks apart and provokes the expansion of the container 102, suction of the body fluid, removal of th block 109 and closing of the opening 104, as shown in FIG.2

Abstract

Capsule a avaler pour obtenir des echantillons de fluides gastriques et/ou intestinaux, la capsule definissant une chambre de reception (18) d'un fluide ayant un orifice d'entree (17) qui est normalement ferme et isole de l'exterieur de la capsule avec des moyens d'obstruction consistant en une masse (21) dont les proprietes changent au contact des fluides appropries presents dans l'appareil digestif, ce qui provoque la communication a travers l'orifice d'entree (17) entre l'exterieur de la capsule et la chambre de reception (18) ou un echantillon de fluide est aspire. Dans la chambre se trouvent des moyens de fermeture (9, 12, 14) normalement maintenus en position permettant l'ecoulement par une masse (28) qui colle les parties necessaires des moyens de fermeture ensemble de telle maniere qu'elles ne puissent pas bouger, de sorte que l'action des moyens de fermeture soit neutralisee. Cette masse (28) est sensible au contact des fluides appropries du tube digestif pour permettre aux moyens de fermeture (9, 12, 14) de fermer la chambre (18) de maniere a ce que l'echantillon soit protege contre la contamination pendant la suite de son parcours a travers le reste de l'appareil digestif. En utilisant une masse differente (21, 28) qui se dissoudra dans le suc gastrique ou qui ne se dissoudra qu'apres contact avec le contenue alcalin du grale intestin, la capsule peut etre utilisee pour obtenir un echantillon de suc gastrique ou de suc intestinal. Un indicateur d'HC1 libre, ou alternativement d'acide lactique, peut etre contenu dans la chambre (18) de la capsule; cet indicateur reagit en presence d'HC1 libre, ou d'acide lactique dans l'echantillon pour changer la couleur de l'echantillon, ce qui permet de le voir a travers une partie transparente de la paroi de la capsule.Capsule to be swallowed to obtain samples of gastric and / or intestinal fluids, the capsule defining a chamber for receiving (18) a fluid having an inlet (17) which is normally closed and isolated from the outside of the capsule with obstructing means consisting of a mass (21) whose properties change in contact with the appropriate fluids present in the digestive system, which causes communication through the entry orifice (17) between the exterior from the capsule and the receiving chamber (18) where a sample of fluid is aspirated. In the chamber there are closing means (9, 12, 14) normally held in position allowing the flow by a mass (28) which sticks the necessary parts of the closing means together in such a way that they cannot move. , so that the action of the closing means is neutralized. This mass (28) is sensitive to contact with the appropriate fluids of the digestive tract to allow the closure means (9, 12, 14) to close the chamber (18) so that the sample is protected against contamination during the following its journey through the rest of the digestive system. By using a different mass (21, 28) which will dissolve in the gastric juice or which will only dissolve after contact with the alkaline content of the intestinal tract, the capsule can be used to obtain a sample of gastric juice or intestinal juice . An indicator of free HC1, or alternatively of lactic acid, may be contained in the chamber (18) of the capsule; this indicator reacts in the presence of free HC1, or lactic acid in the sample to change the color of the sample, which allows it to be seen through a transparent part of the wall of the capsule.

Description

DEVICE FOR STUDY Off THE ALIMENTARY CANAL
BACKGROUND OP THE INVENTION
Field of the Invention. This invention relates to sampling devices for automatically obtaining samples of gastric and intestinal fluids in the digestive tracts of humans and animals and for use in determining the presence of free hydrochloric acid and lactic acid in the gastric fluids.
Description of the Prior Art. Examination of the
"clonten s of the different parts of the gastrointestinal tract plays a great role in diagnostic and medical research. Information from these examinations can be of great impor¬ tance for diagnosing diseases of stomach, duodenum, gallbladder and pancreas, as well as for diagnosing certain blood diseases.
The determination of the presence or absence of free hydrochloric acid and lactic acid in the digestive tract is especially important and useful. The absence of free hydrochloric acid in the gastric fluid is a character¬ istic finding of pernicious anemia. The absence of hydro¬ chloric acid together with the presence of lactic acid in the gastric fluid indicates for advanced carcinoma of the stomach. -
Stomach tubes are the normal instruments for col¬ lecting samples of the contents of the stomach and duodeum.. As is known, these are long, flexible tubes wich are inser¬ ted to the digestive tractc through the patient's mouth or nose, and then fluid from the actual part of the digestive tract is aspirated through the tube. The examination normally takes place under x-ray control, to check for proper positioning of the end of the tube in the digestive tract.
Intubation of the digestive tract using these methods is difficult, and for patient a very unpleasant . intervention. It is a burden for the patient, both physically and psychologically, and it is often impossible to examine patients who are especially sensitive, physicall weak or who have heart disease.
The stress to which the patient is subjected during intubation of the stomach or duodenum can have a disturbing influence on the function of the digestive organ and consequently, in some instances the test results may be inconclusive or erroneous.
Intubation of the digestive tract is an expensive examination. It is a very time-consuming examination for the doctor, and demands the help of highly qualified nurses, a suitable place with comfortable beds where the patients can be examined, and access to x-ray apparatus. The examination immobilizes the patient for several hours, and exposes him to the risks of x-ray exposure.
The above mentioned difficulties and hazards associated with the collection of intestinal fluid preclude the use of conventional technique for mass-examinations, which are especially important to reveal cases of gastric cancer.
In recent years an application of swallowable capsules for the purpose of collecting samples of gastric fluids has been suggested. Examples of such devices are described in U.S. Patent 3,118,439 issued to J. Perrenond on January 21, 1964 and in U.S. Patent 3*485,235 issued to R. Felson on December 23, 1969. In using these patented devices, the opening of the swallowed capsule in the aliment tary canal and the intake of the sample of fluid is exter¬ nally controlled by placing the patient in the high- frequency electromagnetic field. This examination however requires highly skilled medical personnel, the use of an x-ray device, to observe the passage of the capsule through the alimentary canal, and this procedure itself is likely to induce psychological stress in the patient.
O SUMMARY OF THE INVENTION
The present invention provides a sampling device for automatically obtaining samples of gastric and/or intestinal fluids and for use in determining the presence of free hydrochloric acid and lactic acid in the digestive tracts of humans or animals.
The device is similar in size and shape to a conventional pharmaceutical capsule and is thus suitable for ingestion. The capsule defines an inner fluid receiving chamber having an entrance which is normally sealed off from the external environment by way of a blocking mechanism including a mass which, upon contact with a certain fluid present in the digestive tract causes the mechanism to" communicate the opening with the outside of the capsule allowing a sample of the fluid to enter and be retained in the chamber. Located within the chamber is a cylindrical spring operated valve normally maintained in a flow permit¬ ting position by a mass which glues the necessary parts of the valve together in such a way that the parts cannot move, so the action of the strained spring is neutralized. This mass is also responsive to contact with the fluid to permit the valve to operate and seal off the chamber after a predetermined time. The sample is then secured from contami¬ nation during its further travel through the rest of the di¬ gestive tract, and the capsule is evacuated by a normal defectory process and recovered to be sent to a laboratory for analysis of the sample. The collected samples can be . used for chemical, biochemical, microbiological, parasito- logical and cytological examination.
The sampling device of the present invention used in collecting a sample of gastric fluids (Capsule G-gastric) is equiped with mechanisms, which control the opening and closing of the capsule, and which are blocked by a mass, which can for example comprise gelatin, saccarose or another carbohydrate, which loses its blocking properties after a short time following contact with the gastric fluid. The opening of the capsule, the collection of the sample and reclosing of the capsule takes place in the stomach.
With the use of a different mass, which for example comprises celluloseacetatephtalate which will no dissolve until after contact with the alkaline contents o the small intestine, the capsule ( Capsule D-duodenum) ma be used to collect a sample of intestinal fluids.
In another embodiment, the capsule additionally contains a basic-acid indicator in the chamber, which res ponds to free HC1 in the gastric fluid to cause a color • change in the fluid sample, indicating the presence of fr HC1 in the sample (Capsule A-acidity). A part of the wall the capsule is made of transparent material to permit viewing of the sample contained therein. Alternatively, indicator sesitive to lactic acid may be disposed in the chamber to react with the fluid sample, and provide a cha in color of the sample, indicating the presence of lactic acid in the sample (Capsule LA-lactic acid) .
In accordance with one aspect of the invention, first and second spring achanisms control the ^opening of the capsule and then its closing. The spring mechanisms initially neutralized by a mass that secures parts of the capsule* together, in such a way that the mechanisms canno operate. In this configuration, the entrance to the caps chamber is normally kept closed off.
The mass which blocks these mechanism has such properties that after it contacts gastro or intestinal fluid, depending on the application and thus type of mass used, its characteristics are altered in such a way that loses the properties that permit it to secure the parts o the device together and prevent operation of the capsule' mechanisms. A portion of the mass which normally neutral zes the action of the first spring mechanism is disposed externally of the capsule. Accordingly, when the capsule is swallowed by the patient and the portion of the mass contacts the gastro ( or intestinal ) fluid, its properti are altered allowing the first spring mechanism to operat This expands the capsule, enlarging the capacity of its
OMPI inner chamber and aspirating a sample of the fluid into the chamber. The expanding of the capsule causes exposure of a place covered by a second portion of the mass, which normally neutralizes the action of the second spring means, to the fluid being sampled. As result, the second mass loses the properties which enable it to neutralize operation of the second spring mechanism. This permits a valve to operate and close the capsule, hermetically sealing it. With the fluid sample enclosed therewithin and isolated from contamination during its way through the rest of the digestive tract.
Through the present invention it is possible to examine the gastric and duodenal fluids without any stress, discomfort and pain of intubation obviates the need for x-ray exposure and x-ray equipment, and immobilization of . the patient for several hours in bed. The examination can be performed independently of the patient's state of health.
Examination using the principles of the present invention is so simple to perform, that the patient can do part of the examination (according to doctor's instruc¬ tions) himsef -in his own home, with no need for expensive medical care. The examination, which can be made by the help of the new invention, open new possibilites for diagnostic and research, and can lead to a better knowledge of the physiology and biochemistry of the digestive process. In particular, the fluid sampling device of the present invention can play an especially large role in mass- examinations of the digestive tract for finding cancer alterations because it is inexpensive and easy to use. DESCRIPTION OF THE DRAWINGS
The construction of the subject invention will b understood clearly from reference to the accompanying drawings in which:
FIG. 1 is in axial section view of one embodimen of the sampling capsule device in initial position.
FIG. 2 is a sectional view taken along lines 2-2 of FIG. 1;
FIG. 3 is a sectional view taken along the lines 3-3 of FIG. 1;
FIG. 4 is a sectional view taken along the lines 4-4 of FIG. 1;
FIG. 5 is a sectional view taken along the lines 5-5 of FIG. 1;
FIGS. 6 and 7 are breakaway views showing the capsule of FIG. 1 in two different working positions;
FIG. 8 is a perspective view of the capsule with the bottom portion of the capsule removed;
FIG. 9 is a perspective view of the inner shell member of the capsule of FIG. 1;
FIG. 10 is a side elevation view, partially in section of a second embodiment of the capsule;
FIG..11 is a breakaway view of a third embodimen of the capsule;
FIGS. 12 and 13 are sectional views of a fourth embodiment of the capsule illustrating unoperated and operated configurations, respectively;
FIG. 14 is a sectional view of a fifth embodimen of the capsule;
FIGS. 15 and 16 are sectional views of a sixth embodiment of" the capsule illustrating unoperated and operated configuration, respectivly;
FIG. 17 is a sectional view taken along lines 17-17 of FIG. 15;
FIGS. 18 and 19 are sectional views of a seventh embodiment of the capsule illustrating unoperated and operated configurations, respectively; and,
O PI fø IPO FIGS. 20 and 21 are sectional views of a eighth embodiment of the capsule illustrating unoperated and operated configurations, respectively.. DESCRIPTION OF PREFERRED EMBODIMENTS
With reference t'o FIGS. 1-9 of the drawings, the sampling device according to one embodiment basically comprises a capsule having an outer shell member' 1 and an inner shell member 2 which is received in telescopic- engagement with the outer shell member defining an enclosed chamber 18. As shown best in FIG. 1, which illustrates the device in its closed configuration, an aperture or- window 17, shown best in FIG. 9, formed in the side.-wall of the inner shell member 2 is normally sealed off or- closed by the inner wall of the outer shell member 1. In the closed configuration, shell members 1 and 2 are securated together by mass 21 neutralizing the effect of a compressed spring 19, extending axially within compartment 18, and which tends to drive the two shell members apart. As will be described, upon contact with a certain fluid normally present in the alimentary canal, the mass 21 loses its effectiveness as a holding agent. This permits the shell members to be driven apart under the force of the spring 19, so that as the walls of the two shell members slide along one another, eventually aperture 17 is communicated with the outside of the capsule, as shown in FIG. 6, allowing fluid, such as intestinal or gastric fluid, to be aspirated into chamber 18.
A spring operated valve assembly, including valve member 9 and valve operating spring 25, is mounted within the capsule. A further mass 28, having the same charac¬ teristics as mass 21, normally maintains the valve in flow permitting position, that is with aperture 16, (FIG. 3) formed in the side wall of the valve member 9 being in alignment with aperture 17. The valve operates a short time after the capsule expands and the fluid contacts mass 28 changing its characteristics. When operated, the valve closes the capsule by rotating aperture 16 out of alignment with aperture 17, as shown in FIG, 7, hermetically sealing
OMPI the capsule with the fluid contained within the chamber thereof. The device in shape of a capsule and size of 8 X 19 mm, is able to collect about 1 ml of intestinal flu Using microanalysis, this is sufficient quantity to perfor many different analysis.
The mass that is used depends upon- the'function application of the capsule. If the capsule is used to collecting gastric fluid, the machanisms that guide the opening and closing of the capsule, hereinafter referred t as capsule G (Gastric) are blocked by a mass which loses i blocking properties after short contact with the gastric fluid. The opening of the capsule, the collection of the sample and the closing takes place in stomach. For blocki the mechanism, the mass may be comprised of gelatin, proteins, gum arabic, saccharose or other carbohydrates. hot solutions of these substances after stiffening creates mass, which secures or holds together appropriate parts of the capsule in a way to effectively neutralize the action springs. Such mass loses its properties which enable it t hold these parts together after a short contact with the g tric fluid. For example, depending on the composition of mass, it may become brittle causing it to fracture under force of the spring it normally neutralizes, or the mass m dissolve freeing the parts it normally holds together.
The capsule may also be used to collect intestin fluid, in which case the mass is comprised of cellulose- acetate phtalate, shellac, polyvinyl chloride or polymers polyvinylpyridine acril acid. In use of this capsule, hereinafter referred to as capsule D (duodenum), the block mass or substance is not submitted to any change in the stomach. Its change occurs only after contact with the al line contents of the small intestine. It is pointed out t capsule D mechanisms can use that same mass as that used f the capsule, that mass being covered with a film or . coating comprising celluloseacetatephtalate, shellac, polyvinyl chloride or polymers of polyvinylpyridineacri acid which resist gastric fluids. Considering the construction of the sample device in more detail, with reference to FIG. 1, the outer shell 1 has a bottom or cover 3 which is connected to the main body portion of the shell 1 for example, by way of screw threads (not shown) and with vacuum grease indicated at 4 providing a seal between the bottom member and the main body portion. Bottom 3 is provided to simplify assembly of the working mechanisms of the capsule during manufacture and to facilitate access to the sample of gastric fluid stores in the chamber 18 after use of the device to enable analysis of the sample. Shell members 1 and 2 are so fit together and tightened by help of vacuum grease or 0-rings, to create a hermetically sealed capsule. All the parts of the capsule, except the mass are made of" materials, such as teflon or an acid resistant steel which are resistant to fluids normally present in the alimentary canal. The bottom 3 has an opening 5 filled with a plug 6 which allows air to be evacuated from chamber 18 as by iserting a needle probe of suitable vacuum pump or syringe through plug 6, providing an under pressure in chamber 18. The plug 6 is of material having characteristics providing self sealing when the needle is withdrawn.
The inner shell 2 has a neck 7 extending per¬ pendicular to a horizontal wall 8, hereinafter referred to as the base of the neck. As shown best in FIG. 9, the height of the neck, which is of hollow cylindrical confi¬ guration, is differentiated with the circumference of the upper portion of the neck having a stepped configuration defining- stop surfaces 30a and 30b. Under the base of neck
8 is placed the cylindrical valve sleeve 9. The valve sleeve
9 and the neck base 8 have central apertures 10 and 11 of the same inner diameters which makes it possible to thread them onto the shank of a pivot pin 12. The valve sleeve 9 is permanently connected to pin 12 in a suitable manner, such as by a layer of epoxy 13. The inner shell 2, which threaded onto the pin 12, can rotate freely around the axis of pin 12. On neck 7 is placed a header 14 which can rotate
IPO around the neck 7. Header 14 is permanently connected to pin 12 such as by a layer of epoxy 15. In this way, the rotation of the header 14 around neck 7 causes the rotatio of sleeve 9 around the inner ahell 2. Header 14, pin 12, sleeve 9 and torque 25 form the valve mechanism of the capsule.
The inner shell 2 has rectangular window 17 form in its side wall and it has the same shape and size as win 16 formed in the side wall of the valve sleeve 9. The winndows- 16 and 17 are disposed so that in the initial condition (FIGS. 1 and 5) the valve is in flow permiting position and the capsule is in its closed and compressed position, with the openings in alignment with one another. In this position, the chamber 18 is out of communication w the external environment because windows 16 and 17 are cov by the inner wall of outer shell 1. The spring 19 which extends within chamber 18 has its bottom end permanently fastened to bottom member 3, for example by layer of epoxy 20. The top end of the spring engages the under surface o valve sleeve 9. When the capsule is in the closed positio the spring 19 is compressed, exerting a force along the longitudinal axis of the capsule tending to separate shell 1 and 2.
This movement is prevented by the layer of mass 21 disposed in a space between a groove 22 formed in the outer shell 1 and head 14. The mass 21 secures header 14 to the shell 1 and in this way effectively neutralizes the action of the spring 19, and prevents the capsule from expanding.
When in use the capsule- G comes into contact wit the gastric- fluid, mass 21 reacts and loses the properties that enables it to hold the two shells together and thus retard the action of the spring 19. This permits the spri 19 to move the inner shell and the outer shell 1 apart and the capsule assumes its open configuration to the con¬ figuration shown in FIG. 6. Complete separation of the tw shells 1 and 2 of the capsule is prevented by an expansion spring 23, normally compressed as shown in FIG. 4, and which expands into a groove 24 formed in the inner wall of outer member 1 as the shells 1 and 2 are moving apart as shown in FIG. 6.
When the capsule expands, chamber 18 is enlarged to almost twice its initial capacity and is communicated with the environment through the openings 16 and 17 (FIG. 6) which are uncovered as the result of the separating movement of members 1 and 2. As result of the underpressure in chamber 18, the gastric fluid will aspirate into the inner of chamber 18 through the openings 16 and 17.
Referring to the valve assembly, the torque spring
25 is located in the neck of inner shell 2 with its lower end
26 fastened to the neck base 8 and its upper end 27 fastened to header 14. In the closed position of the capsule, the . spring 25 is wound up so it tends to rotate header 14, and together with it, the rest of the valve mechanism around neck 7. But the action of spring 25 is neutralized by the layer of mass 28 placed in a space between neck 7 and header 14. The mass 28 secures the head 14 to the neck 7 and prevents movement of the valve mechanism as long as the mass 28 is intact. After the capsule has expanded (FIG-. 6), the space where mass 28 disposed is exposed to the gastric fluid and as result, it loses the properties that permited it to hold head 14 to the neck 7 and thus prevent the movement of the valve mechanism. This allows spring 25 to rotate the assembly including header 14, pin 12 and sleeve 9 through 180°. In this way, the opening 16 in sleeve 9 is moved from the opening 17 in the wall of the inner shell 2 (FIG. 7), causing the capsule to be closed to the environment. The sample of gastric fluid in the chamber 18 is thus sealed in and is secured of contamination as the capsule continues its way through the rest of the digestive tract. The turning of valve sleeve 9 around the inner ahell 2 is limited to 180° by a stop member 29 fastened to header 14, and which engages a vertical surface 30a of neck 7 (FIG. l). At its other extreme of travel, stop member 29 engages surface 30b of the neck 7 as shown in FIG. 2.
After the capsule has passed through the digesti tract, it is recovered from the fecies and washed, and the sent to a laboratory for analysis of the sample. In the laboratory, bottom 3 and spring 19 fastened to 3 are remov as shown in FIG. 8, and the rest of the capsule serves as tube which encloses the sample for use by the clinical technician during testing.
Referring to FIGS. 2 and 5, for the purpose of providing for pre-biasing of springs 19 and 25 during asse bly of the device, the outer shell 1 has opening 31, which has the same diameter as an opening 32 formed in header 14 and an opening 33 formed in neck 7. The openings 31, 32, 33 and pin 34 (FIG.5) simplify set-up of the capsule. During set-up, torque spring 25 is first wound by rotating head 14 180° around neck 7 until the opening 32 and 33 overlap and it is possible to insert peg 34 through the openings. Next the layer of mass 28 is applied, and when becomes set, the peg 34 is removed. Then the inner shell is slid along the outer shell 1 until the openings 31 and are aligned, and it is possible to pass peg 34 through the Then the layer of mass 21 is applied and after it becomes set, the peg 34 is removed. The set-up of the capsule is finished by inserting the spring 19 in chamber 18 and the ring spring 23, and securing the bottom 3 on the main body portion of the outer shell 1.
Referring to FIG. 10, the capsule can be used to detect the present of free HC1 in the gastric fluid.
Capsule A is constructed identically with capsul G, with the difference that in its inner chamber 18, a container 35, which is secured to or formed integrally wit the bottom of pin 12, holds a small quantity of a basic- acid indicator which upon contact with free HC1 in the fluid sample received in chamber 18 causes a color change of the fluid sample also. A portion of the walls of the shell members 1 and 2 of capsule A is made of transparent material so that the color change is: visible through the
OMPI WIPO transparent wall of the capsule. On the basis of the color of the sample, a determination can be made as to the normal or unnormal composition of the patient's gastric fluid. On example of indicator of free HCl which can be used is • dimetylaminoazobenzol which may be in powdered form. The _ powder is covered with a film of gelatin to delay exposure of the indicator to the fluid until after the valve operates to close the chamber.
Alternatively the capsule may be used to determine the presence of lactic acid in the gastric juice. Tis cap¬ sule referred as capsule LA (lactic acid) is constructed * exactly as capsule A, with the difference that the indicator, when contacting lactic acid in the sample of gastric fluid, causes coloring of the sample characteristic of the presence of lactic acid. Such indicator is covered this same film as capsule A. Again, the color of the sample may be viewed through the transparent wall of the capsule to determine the existence or non-existence of lactic acid in the gastric fluid of the patient. One example of an indicator of laαtic acid which can be used is Fe Cl^. As an indicator, a paper or other sorbent which contains or is saturated with suit¬ able chemicals may be used.
In FIG. 11 there is shown a further embodiment of the capsule having two separate fluid storage chambers 18a and 18b each having an associated valve mechanism simi¬ lar- to that used in capsule G, for example. Each section of the capsule is similar to that described with reference to the embodiment of FIG. 1 with the mass 21 and 28 that neut¬ ralizes the spring 19, embodied as a flat power spring, and valve member 9, respectively, for one of the chambers 18a, being the type responds to gastric fluid, and the mass associated with the other chamber 18b being the type that responds to intestinal fluids. The stop member 29 wich limits rotation of valve sleeve 9 extends from the side wall of the header 14. Thus, this capsule may be used to obtain samples of both gastric fluid and intestinal fluid, or may use the same mass but different indicators forming a combination capsule A and LA. The operation and construct of the sampling device is apparent from foregoing descrip¬ tion. It is apparent that one or both of the chambers may be provided with an indicator, as in capsule A or LA, the mass for each section of the device being selected in accordance with its intended use.
Referring to FIGS. 12 and 13, there is shown a modification of the capsule in which capsule chamber 18 is defined in part by a container 38 of an elastic material, which is normally folded up and contained, along with a valve mechanism within a capsule shaped container 46 of a material that is isoluable in fluids of the alimentary canal. The valve mechanism is similar to that employed in the capsule G shown and described above with reference to FIG. 1. The container 38 is hermetically sealed to the bas of the inner shell member at points 49. ϊhe opening to the chamber 18, is defined by window 16 in valve sleeve 9 and window 17 in the side wall of the inner shell member 2A. The envelope 46, which can be made of material insoluble i alimentary canal's fluids, consists of at least two parts 46a and 46b which are glued together by means of mass 21 which after contact with a suitable fluid of alimentary ca loses the properties that glued the parts 46a and 46b together. Consequently, the envelope breaks apart, allowi the elastic- container 38 to expand as shown in FIG. 13. Referring again to FIG. 12, the valve is normally maintaine in fluid permitting condition so that when the capsule bre away, and the container expands, fluid is aspirated into chamber 18 due to the vaccum created as the container 38 expands. After the fluid in the alimentary canal contacts the mass 28 which neutralizes the valve operation, it chan ges its properties, allowing the valve to close the entranc to the container to seal the fluid within by rotating slee 9 to move window 16 out of alignment with window 17. The cover 46 can also be made of material that is soluable in suitable fluids of the alimentary canal. It is pointed out that the container 38 may be of other configurations
O P such as a bellows-shaped, normally compressed and expandible coaxially of the capsule.
Referring to FIG. 14, there is shown a further embodiment in which the mass 21 is employed to seal the entrance way 65 to the openings 53 and 54 of the inner cham¬ ber 18. When the mass 21 changes its properties, fluid is permitted to flow into the chamber through openings 53 and 54 and when received within the chamber 18 will cause mass 28 and 64 to changes its properties and allow the valve mechanism to rotate and close the openind 54.
More specifically, a hollow shell member 50 is permanently connected to a flange 55 at the base of a header 6 "by a layer of epoxy 57, applied circumferentially, which also seals the shell and the header at the connection. The inner chamber 18 is communicated with the external environment through openings 53 and 54 formed in the side walls of the valve sleeve 58 and the header 56, respectively, and a channel 65 provided by spacing between the capsule 50 and the valve sleeve 56. Channel 65 is normally blocked by mass 21.
The valve sleeve 58 is secured to the header 5o" by mass 28, with openings 53 and 54 being in register, and the action of valve spring 60, which is wound up, being neutralized. The spring 60 tends to rotate the sleeve 58 around a pivot pin 61, the shank of which is fixedly received in an aperture 62 formed in the underside of the header 56. A further mass 64 secures the valve sleeve to the pin 61, which is permanently connected to the head 56 by means of a layer of epoxy 62. One end of spring 60 is secured to the pin 61 and other end is secured to the valve sleeve 58 so that when the spring is torqued, the spring tends to rotate the sleeve to move opening 53 out of register with opening 54. As indicated, the spring action is effectively neutra¬ lized by the mass 28 and the mass 64. A suitable stop means, not shown, limits rotational movement of the valve member in the manner of stop means 29 shown in FIG. 1.
This- device does not use the expansion principle
OMPI employed in the device of FIG. 1 and may- be evacuated to establish an under pressure in the chamber 18 prior to use employing a syringe the needle of which is insertable throu suitable self sealing plug 66.
Notches 70 in the side of the container 50 provid break away points for removing the valve assembly and the rest of the capsule serves as a tube which contains the sample for use by the clinical technician during testing.
In use, after the capsule is swallowed by the patient and comes into contact with certain fluids in the alimentary tract, such as gastric fluids, mass 21 changes i properties which otherwise permit it to block the entrance channel 65 to the chamber 18, and a sample of the fluid is aspirated into the chamber 18. When the fluid contacts mas 28 and mass 64, they lose their properties which permitted them to neutralize the operation of the valve. The valve sleeve then rotates under the force of spring 60 to move opening 53 out of register with opening 54 to seal off the chamber 18 with the fluid sample retained therewith.
In FIGS. 15-17 there is shown a further embodimen of the capsule. The capsule has the inner chamber 18 which is communicated with the external environment through openings 17a and 17b formed in the side wall of the capsule In the chamber there are two discs 91 and 93 made of such material as metal or plastic. The disc 91 is permanently connected to the seal 92 and the disc 93 is per nently connected to tne seal 94. The discs 91 and 93 divide the chamber 18 into three portions, 18a, 18b and 18c.
In the chamber 18a an underpressure is establishe through self-sealing plug 6a and in the chamber 18c an overpressure is established through the plug 6b. In this manner the seal 92 tends to aspirate a sample of the fluid from the environment and the seal 94 tends to close the openings 17a and 17"b. The suction effect of the underpres¬ sure is blocked by a mass 21b which glues together the wall of the capsule and the disc 91. in such a way that the seal 92 cannot move. The effect of the overpressure is blocked by a mass 28 which blocks the movement of the seal 94.
The openings 17a and 17b are covered by a mass 21a. In use, after the capsule is swallowed by the patient and comes into contact with suitable fluids in the alimen¬ tary tract, mass 21a changes its properties which otherwise permit it to block the openings 17a and 17b, and sample of the fluid is permitted to flow into the chamber 18b and when received within the chamber 18b will cause mass 21b and 28 to change its properties which blocked the movement of the the seals 92 and 94. The layer of the mass 28 is much more thick than the layer of the mass 21b causing that the mass 21b is removed as the first one. This permits the under¬ pressure to move the seal 92 and to collect the sample of the fluid, and then the overpressure in the chamber 18c is able to move the seal 94 and close the capsule, herm¬ etically sealing it as shown in FIG. 16.
In FIGSv- 18 and 19 is shown a modification of the capsule in wich the capsule chamber 18 is defined in part by bellows-shaped container 95. The closing means is similar to that employed in the capsule shown and described above with reference to FIGS. 15-17, but the overpressure is replaced by the compressed spring 97, and the underpressure is replaced by the spring means 96 and said bellows-shaped container. The envelope 21 is similar to that employed in the capsule shown and described above with reference to FIG. 12.
After contact with suitable body fluid, the envelope 21 breaks apart, allowing the bellows-shaped . ' container 95 to expand as shown in FIG. 19. The sample of fluid is aspirated into the chamber 18a due to the under¬ pressure created as the container expands. After the fluid contacts the mass 28 which blocks operation of the spring 97, it changes its properties, allowing the seal 94 to close the openings 17a and 17b as shown in FIG. 19.
In FIGS. 20 and 21 is shown a modification of the device similar to the device shown in FIGS. 18 and 19. The compressed spring 106 tends to close the opening 104 through which the inner chamber is communicable with the exterior of the device. The round block 109 situated between the seal 1 and the O-ring 108 blocks the action of the compressed spri 106 and keeps the opening 104 in the open position. The block 109 is permanently connected with the bottom of the bellows-shaped container 102 by means of the thread 110. The length of the thread 110 is shorter than the length of the expanded device.
After contact with suitable body/ fluid, the envelope 21 which covers the opening 104 and keeps the spri 105 i the compressed state and keeps the container 102 in i tense position breaks apart and provokes the expansion of the container 102, suction of the body fluid, removal of th block 109 and closing of the opening 104, as shown in FIG.2
Having thus disclosed in detail preferred embodiments of my invention, persons skilled in the art wil be able to modify certain of the structures which have been disclosed and to substitute equivalent elements for those which have been illustrated; and it is, therefore, intended that all such modifications and substitutions be covered a they are embraced within the spirit and scope of the append claims..

Claims

1. A swallowable device for use in the examination of fluids of the alimentary canal, said device comprising: a container having an inner chamber and at least one opening through which said chamber is communicable the exterior of the device, a suction means situated in said chamber and tending to aspirate a sample of the fluid into said chamber, a closing-means situated in said chamber and operable to close said opening after aspiration of a body fluid into said chamber,c h a r a c t e r i z e d by the fact that in the initial condition said opening is normally sealed off from the exterior of said container by way of a blocking means including a mass having properties such that following contact with a predetermined body fluid, its properties are altered to cause said opening to be communicated with the exterior of the device; the action of said suction means is blocked by a mass which blocks the necessary parts of said suction means in such a way that the parts cannot move and a sample of fluid can not be aspirated, said mass is responsive to contact* with the suitable fluids of the alimentary canal to permit the suction means to operate and to aspirate a sample of the fluid into said chamber; the action of said closing means is blocked by a mass which blocks its action in such a way that the necessary parts of said closing means can not move, said mass which blocks said closing means has properties such that following contact with a predetermined body fluids its properties are altered to permit a closing means to operate and close the device.
2. A device according to claim 1 comprising: a generally cylindrical member enclosing means assembled on said first and cooperating member therewith to define an enclosed chamber, and for normally covering an opening in said first member through which said chamber is communicable the exterior of the device, c h a r a c t e r i z e d by the fact, that the closing means consists of a valve means enclosed within said device for controlling fluid flow
O PI WIPO through said opening, first retaining means including a firs mass normally maintaining- said valve means in a flow permit¬ ting position in which said chamber is communicated with sai opening, and said valve means being operable under the • control of said first retaining means to prevent fluid flow into said chamber through said opening; said enclosing means including second retaining means including a second mass having properties such that following contact with predeter¬ mined fluid normally present in the alimentary canal, its properties are altered to cause said opening to be communica ted with the exterior of the device permitting a sample of the fluid to be aspirated into said chamber, said mass of said first retaining means being responsive to said predeter mined fluid to permit said valve means to be operated to flo preventing position to thereby retain the sample of fluid within said chamber.
3. A device according to claim 1 comprising: a first generally cylindrical member: a second member assembled on said first member and cooperating therewith to define an enclosed chamber;said first member having an aperture formed through a wall thereof defining an inlet port for said chamber and enclosing means, c h a r a c t e r i z e d by the fact, that said enclosing means includes a mass for nor¬ mally maintaining said inlet port out of communication with exterior of said device; said mass having properties such that following contact with a predetermined fluid normally present in the alimentary canal, its properties are altered to cause said inlet port to be communicated with the exterio of the device permitting a sample of fluid to be aspirated * into said chamber.
4. A device as defined in claim 3, c h a r a c t e r i ¬ z e d by the fact, that said device further comprises valve means enclosed within said device to control fluid flow thro ugh said inlet port, retaining means including a second mass normally maintaining said valve means in a flow permitting position in which said chamber is communicated with said . inlet port, and said valve means being operable under the
°MPI control of said retaining means to close said inlet port to prevent fluid flow into said chamber through said inlet port, said second mass being responsive to said predetermined fluid to permit said valve means to operate to said flow preventing position to thereby retain the sample of fluid within said chamber.
5. A device as defined in claim 4 c h a r a c t e r - i z e d by the fact, that said first mass covers said inlet port of said device to normally prevent fluid through an opening of valve means to the chamber which is normally maintained at an under pressure, said first mass dissolving in predetermined fluid to thereby communicate the exterior of said device with the interior of said device through said openings.
6. A device as defined in claim 4 c h a r a c t e r ¬ i z e d by the fact, that said second member comprises an open ended container of an elastic material having its open end disposes around and hermetically sealed to a generally cylindrical wall of said first member at its open end, and wherein said enclosing means comprises at least a two piece envelope enclosing said first member, said second member which is in a compressed condition, and said valve means, said envelope pieces being joined together by said first- mentioned mass to thereby permit said envelope pieces to separate upon said predetermined fluid contacting said first mass and altering its properties causing said container to expand, aspirating a sample of the predetermined fluid into the chamber and exposing the second mass to the predetermined fluid to permit said valve means to operate and close the inlet port of the chamber.
7. A device as defined in claim 6 c h a r a c t e r ¬ i z e d by the fact, that said enclosing means is made of material that is soluable in predetermined fluid of the alimentary canal.
8. A device as defined in claim 4 c h a r a c t e r ¬ i ze d by the fact, that said chamber is normally mainta¬ ined at an underpressure, said first mass being disposed in
OMPI IPO and blocking a channel through which said inlet port, and thus said chamber are communicable to the exterior of said device to normally prevent fluid flow through said channel to said inlet port, said first mass dissolving in said predetermined fluid to thereby communicate said inlet port and thus said chamber with the exterior of said device through said chanel, aspirating a sample of the predeter¬ mined fluid into the chamber.
9. A device as defined in claim 8 c h a r a c t e r ¬ i z e d by the fact, that said second mass is disposed within said chamber to be responsive to said fluid sample to-' cause said valve means to operate.
10. A device as define in claim 4 wherein one of said first and second members is assembled on the other one of said members in telescoping engagement with at least a portion of the wall of said second member covering said inlet port defining a closed position* for said device; bia means extending within said chamber for driving said first and second members apart to communicate said inlet port wi the exterior of the device defining an open position for s device c h r a c t e r i z e d by the fact, that said first mass normally neutralizes the action of the bias me to normally maintain said device in its closed position, a said first mass is responsive to said predetermined fluid to lose its properties that permited it to neutralize the action of said bias means whereby said first and second _ members are driven apart, communicating said inlet port wi the exterior of the device.
11. A device as defined in claim 10 c h r a c t e r ¬ i z e d by the fact, that an underpressure is established in said chamber, prior to said device being swallowed.
12. A device as defined in claim 10 c h a r a c t e r ¬ i z e d by the fact, that includes means to limit the tra of said first and second members as they are driven apart said bias means.
13. A device as defined in claim 10 c h a r a c t e r i z e d by the fact, that said bias means comprises a sp ng extending axially within said chamber and being compressed between said first and second members when said device is in its closed position.
14. A device as define in claim 10 c h a r a c t e r ¬ i z e d by the fact, that includes means dividing said chamber into first and second portion, one of said portion communicating with said inlet port and other portion of said chamber communicating with a further inlet port formed in said first member, and said valve means including first and second individually operable valve assemblies each associated with a different one of said inlet port for controlling fluid flow through the associated inlet port.
15. A device as defined in claim 4 c h a r a c t e r ¬ i z e d by the fact, that said valve comprises a valve element, means movably mounting said valve element on said first member for operation between a first position in which said valve element opens said inlet port and a second position in which said valve element closes said inlet port, bias means normally biasing said element to said second position; said second mass normally neutralizing the action of said bias means to normally retain said valve element at said first position and said second mass having properties such that after contact with said predetermined fluid it loses the properties that permitted it to neutralize the action of said bias means whereby said bias means moves said valve element to said second position thereby closing said . inlet port.
16. A device as defined in claim 15 c h a r a c t e r ¬ i z e by the fact, that said means for mounting comprises a pivot assembly including a pivot pin secured to said valve element and pivotally mounted on said first member, said bias means comprising a spring member disposed to rotate said pivot assembly and thus said valve element on said first * member, said second mass normally securing said pivot assembly to said first member to normally prevent rotation of said pivot assembly.
17. A device as define in claim 16 c h a r a c t e r ¬ i z e d by the fact, that said valve means further comp¬ rises means for limiting the rotational movement of said pivot assembly relative to said first member.
18. A device as defined in claim 1 c h a r a c t e r ¬ i z e d by the fact, that said mass comprises gelatin or carbohydrates or gum arabic or proteins, or cellulose- acetate phtalate or shellac or polyacryl or its mixtures.
19. device as defined in claim 2, wherein said mass is covered by celluloseacetate phtalate or shellac or polyvinyl chloride or polymers of acryl acid.
20. A device as defined in claim 1 c h a r a ς t e r - i z e d by the fact, that at least a portion of the wall of said container is made of transparent material, and which includes indicator means in said chamber which reacts upon contact with the fluid sample to change the color of the fluid sample or said indicator means.
21. A device as defined in claim 20 c h a r a c t e r ¬ i z e d by the fact, that said indicator means comprises a basic-acid indicator or Fe Cl, or dimethylaminoazobenzol.
22. A device as defined in claim 20 c h a r a c t e r ¬ i z e d by the fact, that said indicator means is covered by a film which protects it from dissolution in the fluid sample when the device is open, and said film is dissolvable in the fluid sample when the device is closed.
23. A device as defined in claim 3 c h a r a c t e r ¬ i z e d by the fact, that an underpressure is establshed in said chamber prior to said inlet port being communicated to the exterior of the device.
24. A valve assembly for use with a container for cont¬ rolling fluid flow through an inlet port formed in said container, said valve assembly comprising: a valve member, means mounting said valve member on said container for operation between a first position in which said valve membe opens said inlet port and a second position in which said valve member closes said inlet port; bias means normally biasing said rsralve -member to said second position; and
OMP retaining means, ' c h a r a c t e r i z e d by the fact, that said retaining means includes a mass normally neutral¬ izing the action of said bias means to normally retain said valve member at said first position; said mass having properties such that after contact with a predetermined fluid it loses the properties that permitted it to neutralize the action of said bias means whereby said bias means moves said valve member to said second position thereby closing said inlet port.
25. A valve assembly as defined in claim 24 wherein said means for mounting comprises a pivot assembly including a pivot pin secured to said valve member and pivotally mounted on said container, said bias means comprising a spring member disposed to rotate said pivot assembly and thus said valve member relative to a wall of said container in which said inlet port is formed, c h a r a c t e r i z e d by the fact, that said mass normally secures said pivot assembly to said container to normally prevent rotation of said pivot assembly.
26. A valve assembly as defined in claim 25 c h a r a c ¬ t e r i z e d by the fact, that said valve means further comprises means for limiting the rotational movement of said pivot assembly.
27. A device as defined in claim 6 c h a r a c t e r ¬ i z e d by the fact, that said elastic container is made of transparent material and which includes indicator means in said chamber which reacts upon contact with the fluid sample changes the colour of the fluid sample pr said indicator means.
28. A device according to claim 1, c h a r a c t e r ¬ i z e d by the fact, that said suction means consists of an underpressure operated seal the movement of" which is preven¬ ted by means of a mass which has properties such that following contact with a predetermined body fluids its properties are altered to permit said seal to operate and to aspirate the samples of the fluid.
- θRE OMP A WIP
29. A device according to claim 28 c h a r a c t e r ¬ i z e d by the fact, that said closing means consists of a overpressure operated seal the movement of which is prevent by means of a mass which has properties such that following contact with a predetermined body fluids its properties are altered to permit said seal to operate and close the device. '
30. A device according to claim 1, c h a r a c t e r ¬ i z e d by the fact, that said closing means consists of a spring operated seal the movement of which is prevented by means of a mass which has properties such that following contact with a predetermined body fluids its properties are altered to permit said seal to operate and close the device.
31. A device according to claim 1," c h a r a c t e r ¬ i z e d by the fact, that the closing means consists of a spring operated seal which tends to close the opening through which the inner chamber is communicable the exterio of the device; the action of said spring is neutralized by means of the block which keeps said opening in the open posi tion; said block is permanenly connected with the wall of t resilientable container in such a manner that the expansion of said resilientable container removes the block and per¬ mits the spring operated seal to operate and to close the device.
32. A device according to claim 30, c h a r a c t e r ¬ is e d by the fact, that said suction means consists of a resilientable container which is covered by a mass which keeps said container in its tense position, said mass has such properties that after contact with a suitable body flui loses the property which kept the container in its tense position and provokes the expansion- of* the resilientable container and suction of the body fluid.
EP19790900335 1978-03-22 1979-10-23 Device for study of the alimentary canal Withdrawn EP0014202A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DK133478A DK133478A (en) 1976-12-08 1978-03-22 INSTRUMENT FOR EXAMINATION OF THE DIGESTIVE CHANNEL AND PROCEDURE FOR USING THE INSTRUMENT
DK1334/78 1978-03-22
US91037078A 1978-05-30 1978-05-30
US910370 1997-08-13

Publications (1)

Publication Number Publication Date
EP0014202A1 true EP0014202A1 (en) 1980-08-20

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EP19790900335 Withdrawn EP0014202A1 (en) 1978-03-22 1979-10-23 Device for study of the alimentary canal

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GB (1) GB2039219B (en)
WO (1) WO1979000811A1 (en)

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WO2013120184A1 (en) 2012-02-17 2013-08-22 Micropharma Limited Ingestible medical device
CN102920418B (en) * 2012-10-24 2014-07-30 刘思德 Self-stable patency capsule of alimentary canal
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WO1979000811A1 (en) 1979-10-18
GB2039219B (en) 1982-10-06

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