Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
  • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/30—Surgical robots
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00017—Electrical control of surgical instruments
  • A61B2017/00022—Sensing or detecting at the treatment site
  • A61B2017/00075—Motion
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00017—Electrical control of surgical instruments
  • A61B2017/00221—Electrical control of surgical instruments with wireless transmission of data, e.g. by infrared radiation or radiowaves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00743—Type of operation; Specification of treatment sites
  • A61B2017/00818—Treatment of the gastro-intestinal system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/30—Surgical robots
  • A61B2034/303—Surgical robots specifically adapted for manipulations within body lumens, e.g. within lumen of gut, spine, or blood vessels
• • 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
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
  • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
  • A61B5/1107—Measuring contraction of parts of the body, e.g. organ or muscle

Definitions

• the present apparatus and method relate to agent delivery methods and apparatuses and more specifically to agent delivery methods and apparatuses in the intestine.
• the intestine is a site where both local and systemic delivery of drugs can take place. Over the recent years, intestine-specific drug delivery systems have been gaining importance not only for local delivery of drugs but also for the systemic delivery of protein & peptide drugs. The colon, for example, as a site for topical drug delivery, is beneficial for treatments with poorly absorbable drugs and orally delivered vaccines..
• intestinal drug delivery poses a major challenge in the areas of drug development as well as packaging design and overcoming such challenges may be commercially rewarding.
• Conditions of the large intestine and specifically the colon include gastrointestinal hemorrhage, unexplained changes in bowel habit, suspicion of malignancy, an unexplained drop in hematocrit. These conditions are often diagnosed or explored employing colonoscopy, imaging systems such as ultrasound, CT and MRI scans and video/wireless video endoscopy (PillcamTMColon by Given Imaging LTD., Yoqneam, Israel).
• the wall of the digestive tract organs and specifically of the large intestine are characterized by their peristaltic activity effecting almost continuous movement of intestinal content from the direction of the mouth towards the rectum.
• Part of the challenge both in colonic drug delivery and some colonic diagnostic systems stems from the environment in the lumen of the colon and the continuous movement of intestinal content driven by pressure exerted thereupon by the peristaltic waves in the intestinal wall.
• the continuous movement of intestinal content carries with it any ingested treatment agent or apparatus such as the PillcamTMColon thus posing a challenge in releasing the treatment agent at, or acquiring video imaging of, a specific location of the intestinal tract such as a tumor over an extended period of time.
• the present method and apparatus seek to provide a method and apparatus for at least delivering an agent at a specific location in the intestinal tract remaining stationary at the location over an extended period of time.
• an apparatus including one or more expandable portions having at least two expandable compartments or two or more expandable compartments wherein the expandable compartments or portions expand and contract, alternately non-invasively anchoring the apparatus in place by pressing against an organ wall that contracts and relaxes in a peristaltic wave so that to maintain the apparatus stationary at its location within a lumen defined by the wall.
• an apparatus having one or more connecting portions located at least between the expandable portions and including one or more of a main lumen and a secondary lumen.
• the lumina of the expandable portions include fluid transferred from one expandable portion lumen to another via at least one of the connecting portion main lumen and secondary lumen the fluid alternately expanding and contracting the expandable portions.
• the fluid may be driven from one expandable portion to another by at least one of a pump and a force resulting from a difference in the resilience of the walls.
• the apparatus also includes one or more electrically-driven component including one or more of a pump, a fluid agent delivery mechanism, a sensing component, a controller, a telemetry component, a remote controller, an antenna, a timer, a digital camera, a power source and circuitry thereof.
• One or more of the sensing components may be placed at a distance from each other along the longitudinal axis of the apparatus and sense and track the propagation of a peristaltic wave along the longitudinal axis thereof.
• the apparatus also includes a fluid agent delivery mechanism for delivering a fluid agent communicating with the atmosphere and one or more of the expandable portions Jumina and a dedicated reservoir and is capable of delivering content of at least one of the lumina and the reservoir to the atmosphere.
• the fluid reservoir may also include fluid to complement diminishing fluid from the expandable portions.
• the cross-section of at least one of the expandable portions normal to the longitudinal axis of the apparatus is at least one of a ring-shaped and a "C"-shaped cross-section and may also include one or more flaps that have a curved cross-section so that to press against the intestinal wall when the expandable portion is expanded.
• the apparatus may also include one or more connecting portion at least part of which is axially stretchable.
• the apparatus connecting portion may include at least one of a axially stretchable portion and a non-stretchable portion having corresponding lumina the passageway therebetween blocked by a permanent wall.
• the apparatus may also include a secondary lumen external to the primary lumen having one side thereof attached to at least one expandable portion and the other side attached to the non-stretchable portion so as to provide a sealed fluid pathway extending along at least part of the length of the connecting portion.
• one or more of the expandable portions may also include one or more arms or flaps the cross-section of which taken along the longitudinal axis of the apparatus being curved and rotatively attached thereto so that when the expandable portion expands, the arms or flaps spread radially.
• the arm or flap may anchor the apparatus in place by pressing against the organ wall upon full expansion of the expandable portion.
• a method for maintaining an apparatus stationary at a location within a lumen defined by a wall contracting and relaxing in a peristaltic wave including providing at least two expandable portions and expanding and contracting the portions so that they alternately press against the wall and maintain the apparatus stationary at its location within the lumen.
• the method may also include providing a fluid agent stored in at least one of the expandable portions and a dedicated reservoir and delivering the fluid agent into the lumen of the intestinal tract.
• a method for maintaining an apparatus stationary at a location within a lumen defined by a wall contracting and relaxing in a peristaltic wave including providing one or more expandable portions and two or more sensing components placed at a distance from each other along the longitudinal axis of the apparatus and sensing an approaching peristaltic wave, contracting the expandable portion nearest the approaching peristaltic wave and expanding the expandable portion farthest from the approaching peristaltic wave, sensing the peristaltic wave location between the expandable portions, contracting the expandable portion ahead of the peristaltic wave, and expanding the expandable portion behind the peristaltic wave and maintaining the apparatus stationary at the location.
• the method may also include sensing the peristaltic wave moving away and contracting the expandable portion nearest the approaching peristaltic wave and expanding the expandable portion farthest from the approaching peristaltic wave.
• a method for translating an apparatus within a lumen of an organ defined by a wall including providing at least two expandable portions, providing at least one connecting portion at least part of which is axially stretchable, expanding a first expandable portion so that to press against the wall and maintain the expandable portion stationary at its location within the lumen, expanding the connecting portion so that to axially translate the second expandable portion along the organ lumen and away from the first portion and expanding the second expandable portion so that to press against the wall and maintain the apparatus stationary at its location within the lumen.
• the method may also include contracting the first expandable portion and contracting the connecting portion so that the first expandable portion axially translates towards the second expandable portion.
• a method for translating an apparatus within a lumen of an organ defined by a wall including providing one or more expandable portions including at least one semi-rigid arm or flap rotatively attached to the apparatus, expanding at least one expandable portion so that when the expandable portion expands, the arm or flap rotates spreading radially, applying force to the organ wall in a direction parallel to the longitudinal axis of the apparatus andbringing about axial translation of the apparatus in a direction opposite to the direction of the applied force.
• FIG. 1 is cross-section view simplified illustration of a delivery apparatus in accordance with an example of a delivery apparatus of the current apparatus and method
• FIG. 2 is cross-section view simplified illustration of a delivery apparatus in accordance with another example of the current apparatus and method
• FIG. 3 is cross-section view simplified illustration of a delivery apparatus in accordance with yet another example of the current apparatus and method
• FIGs. 4A, 4B, 4C and 4D are cross-section view simplified illustrations of implementation in the large intestine of a delivery apparatus in accordance with another example of the current apparatus and method;
• FIGS. 5A and 5B are cross-section view simplified illustrations of a delivery apparatus in accordance with yet another example of the current apparatus and method;
• Fig. 6 is a cross-section view simplified illustration of a delivery apparatus in accordance with still another example of the current apparatus and method;
• FIG. 7 is a cross-section view simplified illustration of a delivery apparatus in accordance with another example of the current apparatus and method
• FIG. 8 is a cross-section view simplified illustration of a delivery apparatus in accordance with yet another example of the current apparatus and method
• FIGs. 9A, 9B, 9C and 9D are cross-section view simplified illustrations of a delivery apparatus in accordance with still another example of the current apparatus and method;
• FIG. 10 is a cross-section view simplified illustration of a delivery apparatus in accordance with another example of the current apparatus and method
• FIG. 11 is a cross-section view simplified illustration of a delivery apparatus in accordance with yet another example of the current apparatus and method
• FIG. 12 is a cross-section view simplified illustration of a delivery apparatus in accordance with still another example of the current apparatus and method
• FIG. 13 is a cross-section view simplified illustration of a delivery apparatus in accordance with another example of the current apparatus and method
• Fig. 14 is a flow chart illustrating an example of a method for maintaining an apparatus stationary at a location within a lumen defined by a wall contracting and relaxing in a peristaltic wave in accordance with the current method and apparatus;
• FIGs. 1 A and 15B are cross-section view simplified illustrations of a delivery apparatus in accordance with another example of the current apparatus and method
• FIG. 16 is a cross-section view simplified illustration of another example of a delivery apparatus in accordance with the current apparatus and method
• Figs. 17A, 17B and 17C are cross-section view simplified illustrations of implementation in the intestine of an example of the delivery apparatus of Fig. 16 in accordance with the current apparatus and method;
• Figs. 18A, 18B, 18C, 18D and 18E are cross-section view simplified illustrations of yet another example of a delivery apparatus in accordance with the current apparatus and method;
• Figs. 19A, 19B, 19C, 19D and 19E are cross-section view simplified illustrations of implementation in the intestine of an example of the delivery apparatus of Fig. 18 in accordance with the current apparatus and method; and
• Fig. 20 is a cross-section view simplified illustration of yet another example of a delivery apparatus in accordance with the current apparatus and method.
• peripheral wave and “peristaltic activity” are used interchangeably and mean: radial contractions and relaxations of organ muscles which propagate in a wave moving in a forward direction (e.g., from the mouth towards the rectum) down a muscular tube such as, for example, the intestine.
• FIGs. 1, 2 and 3 are cross-section view simplified illustrations of a delivery apparatus in accordance with an example of the current apparatus and method.
• an apparatus 100 includes one or more expandable portions 102 and 112 connected to each other by a connecting portion 130.
• Connecting portion 130 may be a resilient, semi-rigid and/or flexible tubular sleeve and may include a main lumen 132.
• Expandable portions 102/112 may each include corresponding lumina 104 and 114 communicating with each other via at least one of main lumen 132 and openings 140 in a secondary lumen 106 inside main lumen 132, [0046] Expandable portions 102/112 lumina 104/114 may contain fluid so that when the fluid is transferred from one expandable portion 102/112 lumen 104/114 to another via one or more of the connecting portion 130 main lumen 132 and secondary lumen 106 the fluid may alternately expand and contract expandable portions 102/112.
• One or both expandable portions 102/112 may include resilient stretchable walls 144, stretched by increasing content volume inside lumina 104/114 and capable of easily and rapidly returning to an original deflated state once the content has been removed.
• Walls 144 may be made of a resilient biocompatible material such as elastic polymers and optionally may be covered with an elastic mesh made of a Shape-Memory Alloy (SMA) such as for example, Nitinol.
• SMA Shape-Memory Alloy
• the resilience of walls 144 may be uniform throughout or have variable levels of resilience at variable locations.
• the resilience of walls 144 of expandable portions 102 and 112 may be the same.
• each of expandable portions 102 and 112 walls 144 may be different, the difference in resilience of the walls may result in fluid flow between expandable portions 102/112.
• the transfer of fluid from an expandable portion having higher resilience to an expandable portion having lower resilience may be slower. Transferring of fluid from an expandable portion having lower resilience to an expandable portion having higher resilience may be faster as will be explained in greater detail below.
• an apparatus 200 may include a secondary lumen 106 external to lumen 132, fixedly and sealingly attached thereto as by a suitable adhesive, so as to provide a sealed fluid pathway extending along at least part of the length of portion 130.
• Portion 130 may extend beyond one or more expandable portions 102 and 112 to form front end 202 and back end 204.
• apparatus 300 expandable portions 102/112 lumina 104/114 may communicate with each other via an opening 302 in a common wall 304 shared by expandable portions 102/112, obviating the need for a connecting portion such as portion 130 between expandable portions 102/112 lumina 104/114 (Figs. 1 and 2).
• Expandable portions 102/112 Lumina 104/114 when expanded may act as temporary anchoring elements anchoring apparatus 100 in place by pressing against a wall of an organ characterized by having peristaltic activity, such as the intestine, maintaining apparatus 100 stationary at a location in the lumen of the intestine overcoming the peristaltic activity of the wall as well as continuous movement of intestinal content as will be described in greater detail below.
• the temporary anchoring is characterized by temporary application of pressure against the organ wall without disruption of the integrity thereof.
• expandable portions 102/112 Lumina 104/114 may contract enabling expandable portions 102/112 to float freely within the intestinal lumen evading the intestinal wall contracting in a peristaltic wave as will be explained in detail below.
• Lumina 104/114 may serve as reservoirs storing various fluid agents such as pharmaceuticals, drugs, vitamins, vaccines or any other fluid-form material such as, for example, a medication, a nutrient or a food additive, as will be explained in greater detail below.
• Any one of apparatuses 100/200/300 may also include electrically-driven components including at least one of one or more uni-directional or bi-directional pump 160 communicating with and controlling flow through secondary lumen 106 or main lumen 130, fluid agent delivery mechanismll6, controller 118 that may include a timer 1 6, telemetry component 120 communicating with a remote controller 150 via antenna 122, a sensing component 124 and power source 126.
• antenna 122 may be external to apparatus 100/200/300 and be adhered to an external surface 138 of connecting portion 130 or external surfaces 142/152 of respective expandable portions 102 and 112, as seen in Fig. 2.
• Sensing component 124 may be at least one of a pressure sensor, a proximity sensor (e.g. capacitance sensor, impedance sensor and or sonic sensor), a temperature sensor, a pH sensor, an electro-optical muscle contraction sensor, electro-mechanical sensor, an electric potential sensor, a magnetic field sensor and a motion sensor.
• Remote controller 1 0 may also include a telemetry antenna and an electrical induction coil (not shown) and receive data from one or more of the aforementioned electrically-driven components as well as control the activation thereof.
• Power source 126 may electrically power the aforementioned electrically-driven components and be rechargeable employing an induction coil (not shown) for receiving inductive energy from remote controller 150 induction coil.
• antenna 122 may also serve as an induction coil to receive inductive energy from remote controller 150 induction coil.
• apparatus 100/200/300 may also include a digital video camera 206 (Fig. 2) placed at any suitable location on apparatus 100/200/300 and capable of transmitting digital images via telemetry component 120 to remote controller 150.
• a fluid source 306 may communicate via a supply tube 308 and a valve 310 with portion 130 lumen 132.
• portion 130 lumen 132 may include an opening 312 communicating with one of lumina 104/114 so that fluid supplied by source 306 may flow through lumen 132 and opening 312 into one or both of lumina 104/114.
• the electrically-driven components and circuitry may be enclosed within a sealed capsule 128 (Fig. 2) accommodated inside any one or more of expandable portions 102, 112 and/or portion 130 main lumen 132 to allow fluids, for example, supplied by source 306 via supply tube 308 and valve 310 to flow freely through main lumen 132.
• Supply tube 308 may be detachable from valve 310.
• the electrically-driven components and circuitry and optionally antenna 122 may be embedded or molded (not shown) within wall 134 of portion 130.
• Fluid agent delivery mechanism 116 may be controlled by controller 118 or remote controller 150 via antenna 122 and communicate with a fluid agent reservoir such as main lumen 132 or a dedicated reservoir such as, for example, reservoir 1106 (Fig. 11) located elsewhere in apparatus 100, and the atmosphere delivering the content of the reservoir to the atmosphere.
• a fluid agent reservoir such as main lumen 132 or a dedicated reservoir such as, for example, reservoir 1106 (Fig. 11) located elsewhere in apparatus 100, and the atmosphere delivering the content of the reservoir to the atmosphere.
• a fluid agent reservoir such as main lumen 132 or a dedicated reservoir such as, for example, reservoir 1106 (Fig. 11) located elsewhere in apparatus 100, and the atmosphere delivering the content of the reservoir to the atmosphere.
• a fluid agent reservoir such as main lumen 132 or a dedicated reservoir such as, for example, reservoir 1106 (Fig. 11) located elsewhere in apparatus 100, and the atmosphere delivering the content of the reservoir to the atmosphere.
• one or more expandable portions 102/112 Lumina 104/114 may
• Apparatus 100 may be coated with or encased within a protective capsule 350 made of a biocompatible dissolvable material.
• the protective capsule wall may be rigid or semi-rigid and have a smooth external surface to allow comfortable introduction of apparatus 100 into the intestine and dissolve once exposed to the intestinal environment.
• Figs. 4 A, 4B, 4C and 4D are cross-section view simplified illustrations of implementation in the intestine of an example of a delivery apparatus in accordance with example the current apparatus and method transit time of a peristaltic wave 406 along the length of apparatus 400 may be much shorter than the period of time between consecutive peristaltic waves. This dictates a rapid phase of transferring of fluid from one lumen 404/414 to the other during the transit time period of a peristaltic wave 406 along the length of apparatus 400 whereas the longer period of time between consecutive peristaltic waves enables a slow phase of fluid transferring from one lumen 404/414 to the other as will be explained in greater detail below.
• An apparatus 400 of a type similar to anyone of the examples of Figs. 1 and 2, is placed at a desired location in a lumen 402 defined by an intestinal wall 404 employing an introducing device such as, for example, an endoscope.
• the location of apparatus 400 throughout the introduction process and at the desired final placement location may be tracked and verified by one or more of the following methods: identifying the location of the endoscope tip employing CT, MRI or Ultrasound imaging, visually measuring the distance travelled from the anal sphincter along the intestine using markings on the body of the endoscope, visually identifying the desired location by received images from digital video camera 206 (Fig. 2) or employing telemetry signals received by remote controller 150 from apparatus 00.
• Apparatus 400 may be filled with a fluid material. As described above, transferring fluid from one expandable portion lumen to another, for example, from expandable portion 412 lumen 414 to expandable portion 402 lumen 404 and back may bring expandable portions 412/402 to expand and contract, alternately pressing against an organ wall so that the system remains stationary at its location within the lumen defined by the wall.
• apparatus 400 may include, among other components such as those described in Figs. 1, 2 and 3, two or more sensing components 124-1, 124-2 and 124-3 that may be, for example, a proximity sensor or pressure sensor placed at a distance from each other along the longitudinal axis of apparatus 400and sense and track the propagation of a peristaltic wave along the longitudinal axis of apparatus 400.
• Sensing components 124-1, 124-2 and 124-3 are capable of communicating to remote controller 150 via a telemetry component 120 information regarding propagation of a peristaltic wave along the longitudinal axis of the apparatus.
• Wall 404 is characterized by peristaltic waves, such as a peristaltic wave 406 propagating in a forward direction indicated by arrows designated reference numeral 450.
• peristaltic waves such as a peristaltic wave 406 propagating in a forward direction indicated by arrows designated reference numeral 450.
• intestinal content such as for example, fecal matter, has been removed.
• apparatus 400 has been introduced into the intestinal tract and is now located at a desired final placement location.
• expandable portion 402 is in a contracted state whereas expandable portion 412 is in an expanded state.
• Expandable portion 412 is not fully expanded so that to enable advancing apparatus 400 along the intestine during introduction.
• apparatus 400 may be encased within a protective capsule 350 during the introduction process.
• apparatus 400 may be introduced with both expandable portions 402/412 fully contracted and have expandable portions 402/412 lumina 404/414 once placed at a desired final placement location filled as desired with fluids supplied by source 306 via supply tube 308 and valve 310 (Fig. 3).
• Supply tube 308 may be later detached and removed from the intestine.
• peristaltic wave 406 is shown to be advancing forward in a direction indicated by arrows 450 towards apparatus 400.
• Sensing component 124-1 may sense advancing peristaltic wave 406 and signal controller 118 of the approaching peristaltic wave.
• sensing component 124-2 may send a signal to controller 118 (Figs. 1, 2 and 3) which, in turn initiates a rapid phase by activating transferring of fluid from expandable portion 412 lumen 414 via connecting portion 430 into portion 402 lumen 404 in a direction indicated by an arrow designated reference numeral 470.
• sensing component 124-2 may sense peristaltic wave 406 moving away while sensing component 124-3 may sense approaching peristaltic wave 406 and send a signal to controller 118 (Figs. 1, 2 and 3) which, in turn initiates a slow phase by activating transferring fluid from portion 402 lumen 404 via connecting portion 430 into portion 412 lumen 414 in the direction indicated by an arrow designated reference numeral 490.
• expandable portion 412 may be fully expanded pressing against wall 404 temporarily and non-invasively anchoring apparatus 400 in place as indicated by broken line of reference (K), while portion 402 contracts evading contact with and clearing wall 404 peristaltic wave 406 as it passes the location of portion 402.
• sensing component 124-1 may sense peristaltic wave 406 beginning to move away and sensing component 124-2 senses approaching peristaltic wave 406, sensing component 124-2 may send a signal to controller 118 (Figs. 1, 2 and 3) which again initiates the rapid phase by activating transferring of fluid from expandable portion 412 lumen 414 via connecting portion 430 into portion 402 lumen 404 in the direction indicated by arrow designated reference numeral 472 repeating the process described above.
• apparatus 400 expandable portions 402 and 412 alternately expand and contract, pressing against peristaltically-contracting wall 404 maintaining apparatus 400 stationary at its location within intestinal lumen 402 as indicated by broken line of reference (K) overcoming peristaltic wave 406 activity and continuous movement of intestinal content.
• fluid agent delivery mechanism 116 may communicate with connecting portion 130 as well as with one or more expandable portions 102/112 lumina 104/114 that may function as fluid agent reservoirs. Fluid agent delivery mechanism 116 may release predetermined fluid agents of a fluid agent stored in lumina 104/114 out of apparatus 100 into the intestinal lumen resulting in a diminished volume of the fluid agent in reservoir lumina 104/114 over a predetermined period of time.
• expandable portions 102/112 may lose their anchoring property
• apparatus 100 loses its ability to press against the organ wall and maintain its location within a lumen.
• apparatus 100 may be freely carried by the peristaltic activity of wall 404 and the moving intestinal content and be expelled from the intestinal tract together with the intestinal content.
• fluid may be discharged or released from lumina 404/414 either automatically by a timing device such as timer 146, by full discharging or emptying of power source 26 diminishing the power supply therefrom or by a signal received from remote controller 150 by telemetry component 120.
• a timing device such as timer 146
• full discharging or emptying of power source 26 diminishing the power supply therefrom or by a signal received from remote controller 150 by telemetry component 120.
• FIGS. 5A and 5B are cross-section view simplified illustrations of a delivery apparatus in accordance with another example of a delivery apparatus of the current apparatus and method.
• 544 may be more resilient than expandable portion 12 wall 546, represented in Figs. 5 A and 5B by a thicker wall 546.
• a connecting portion 530 may include a secondary lumen 506 and a tertiary lumen 508 having a valve 510.
• an optional unidirectional or bidirectional pump 560 may be employed to transfer fluid during the slow phase such as that described in Fig.4C from portion 502 lumen 504 via secondary lumen 506 to portion 512 lumen 514 in a direction indicated by an arrow designated reference numeral 540.
• the transferred fluid exerts pressure represented in Fig. 5A by outwardly pointing arrows 550 bringing about the stretching of wall 546 and the expansion of expandable portion 532 as in situations such as described in Figs. 4C and 4D resulting in elastic potential energy stored in wall 546.
• valve 510 may be opened initiating a rapid phase as described in Figs. 4B and 4D.
• the elastic potential energy stored in wall 546 may exert pressure inwards in a direction indicated by inwardly pointing arrows 570 driving the fluid content of expandable portion 512 lumen 514 via tertiary lumen 508 valve 510 in a direction indicated by an arrow designated reference numeral 590 back into portion 502 lumen 504.
• the elastic potential energy stored in wall 546 may be sufficient to drive the fluid content from lumen 514 to lumen 504.
• pump 560 may assist by transferring a portion of the fluid content from lumen 514 to lumen 504 via secondary lumen 506.
• employing pump 560 may shorten fluid transfer time from lumen 514 to lumen 504 via secondary lumen 506. Additionally, this configuration requires less electrical energy and may enable employing a smaller pump 560.
• Pump 560 may be unidirectional and be employed during the slow phase only.
• apparatus 600 may include double-lumen expandable portions 602/612.
• a pair of lumina 604/614 may be within lumina 624 and 634 and may be connected by a main lumen 630
• Lumina 624 and 634 may be connected by a secondary lumen 608.
• Lumina 604/61 may be arranged within lumina 624 and 634 concentrically or eccentrically.
• Lumina 604/614 may include an inert biocompatible fluid such as water or a saline solution transferred between lumina 604/614 by a pump 660 and lumina 624/634 may include a fluid agent fluid agent into the intestinal lumen by fluid agent delivery mechanism 616 or vice versa.
• the operation and implementation of apparatus 600 may be similar to any of the operations and implementations described above.
• FIG. 7 illustrates an expandable portion 702/712 attached to a connecting portion 730 similar to connecting portion 130 of Fig. 1.
• Expandable portion 702/712 may be ring-shaped and attached to connecting portion 730 and may include a passageway 706 to allow intestinal content to flow therethrough when expandable portion 702/712 is expanded, pressing against wall 404 (Fig. 4) anchoring apparatus 700 at the desired final placement location as explained above.
• Fig. 7 illustrates an expandable portion 702/712 attached to a connecting portion 730 similar to connecting portion 130 of Fig. 1.
• Expandable portion 702/712 may be ring-shaped and attached to connecting portion 730 and may include a passageway 706 to allow intestinal content to flow therethrough when expandable portion 702/712 is expanded, pressing against wall 404 (Fig. 4) anchoring apparatus 700 at the desired final placement location as explained above.
• Fig. 7 illustrates an expandable portion 702/712 attached to a connecting portion 730 similar to connecting portion 130 of Fig. 1.
• expandable portion 802/812 attached to a connecting portion 830 similar to connecting portion 130 of Fig. 1 may be shaped in a form of the letter "C" having a passageway 806 to allow intestinal content to flow therethrough when expandable portion 802/812 is expanded, pressing against wall 404 (Fig. 4) anchoring apparatus 800 at the desired final placement location as explained above.
• one or more resilient retention bands 810 may be attached to borders 808 of expandable portion 802/812.
• FIGs. 9A, 9B, 9C and 9D are cross-section view simplified illustrations of a delivery apparatus in accordance with yet another example of the current apparatus and method.
• any one or both of apparatus 900 expandable portions 902 or 912 may be "C"-shaped , similar to expandable portion 802/812 of Fig. 8 and one or more flaps 950.
• Flaps 950 may be flat and have a curved cross-section (Figs. 9B and 9C).
• Expandable portion 902/912 is "C"-shaped and includes one or more flaps 950 attached to expandable portion 902/912 wall 906. Flaps 950 may be rigid or semirigid, have a curved cross-section and a flat surface 910 to press against intestinal wall 404 (Figs. 4A, 4B, 4C and 4D) when expandable portion 902/912 is expanded. Additionally, a segment of expandable portion 902/912 wall 906 may be less resilient than the remainder of wall 906 represented in Figs. 9B-9D by a thicker segment 908.
• Fig. 9B illustrates expandable portion 902/912 in a folded configuration as would be when apparatus 900 is introduced into or expelled from the intestine.
• the fluid volume in lumen 904/914 may be relatively small.
• fluid is transferred via connecting portion 930 main lumen 932, as explained above, and fills lumen 904/914.
• the fluid filling lumen 904/914 exerts pressure on lumen wall 942/952 in the directions indicated by arrows 960, inflating expandable portion 902/912. Segment 908, being less resilient than the remainder of wall 942/952 applies a force attempting to pull flaps 950 towards connecting portion 930 as indicated by arrows 970.
• the remaining more resilient segments of wall 942/952 create one or more lobes 954 that expand as lumen 904/914 fills with fluid pushing flaps 950 in directions indicated by arrows 990 bringing expandable portion 902/912 to be fully expanded, as shown in Fig. 9D, so that apparatus 900 is capable to press against wall 404 (Fig. 4) temporarily non-invasively anchoring apparatus 900 in place.
• FIG. 10 illustrates a side tube 1002 fixedly and sealingly attached to connecting portion 1030 as by a suitable adhesive, so as to provide a sealed fluid pathway extending along the length of portion 1030.
• a fluid source 1006, supplying irrigation or lubricating fluid, may communicate with side tube 1002 lumen 1004 via a supply tube 1008 and a valve 1010 located at a back end 1012 of tube 1002.
• Supply tube 1008 may be detachable from valve 1010.
• a nozzle 1014 may be placed at a front end 1016 of side tube 1002 capable of providing directional irrigation of fluid supplied by fluid source 1006 to lubricate and/or irrigate the intestinal wall during the insertion of apparatus 1000 into the intestine or to clear the intestinal lumen from luminal content in the vicinity of apparatus 1000.
• an apparatus may include a fluid agent reservoir 1106 to complement diminishing fluid agent from one or more expandable portions 1102/1104, being delivered to the intestinal lumen by fluid agent delivery mechanism 1108.
• an expandable portion 1104 may include a double lumen.
• a lumen 1 1 12 may be inside a lumen 1 114 and may communicate with reservoir 1106.
• Portion 1104 lumen 1114 may contain a biocompatible inert fluid such as water or a saline solution and communicate with a portion 1102 lumen 1116 via a connecting portion 1130.
• a pump 1110 may be employed to transfer the fluid agent from reservoir 1106 to lumen 1112 and a pump 1118 may be employed to transfer the inert fluid between expandable portions 1102/1104 lumina 1114/1116.
• Fig. 12 illustrates another embodiment, which provides a biocompatible inert fluid such as water or a saline solution reservoir 1206 to compensate for diminishing fluid agent from one or more expandable portions 1202/1204, being delivered to the intestinal lumen by fluid agent delivery mechanism 1208.
• expandable portions 1202 and 1204 may include a double lumen.
• a lumen 1212 may be inside a lumen 1214 and a lumen 1222 may be inside a lumen 1224 and may communicate with lumen 1212 and reservoir 1206.
• Portion 1202 lumen 1214 may contain a fluid agent and communicate with a portion 1204 lumen 1224 via a connecting portion 1230.
• a pump 1210 may be employed to transfer the inert fluid agent from reservoir 1206 to lumen 1222 and a pump 1218 may be employed to transfer the inert fluid between expandable portions 1202/1204 lumina 1212/1222.
• Connecting portion 1330 may be semi-rigid or flexible and having a degree of resilience allowing relative mainly but not limited to lateral movement between expandable portions 1302 and 1304 in directions indicated by an arrow designated reference numeral 1350.
• Fig. 14 is a flow chart illustrating an example of a method for maintaining an apparatus stationary at a location within a lumen defined by a wall contracting and relaxing in a peristaltic wave in accordance with the current method and apparatus.
• the method may include providing at least two expandable portions 102/112 (Figs. 1, 2 and 3) and at least two sensing components 124-1, 124-2 and 124-3 (Figs. 4A, 4B, 4C and 4D) placed at a distance from each other along the longitudinal axis of an apparatus 100.
• the method is carried out employing the following steps:
• Controller 118 initiates transfer of content from the expandable portion 102/112 nearest to the approaching peristaltic wave to the expandable portion 102/112 farthest from the approaching peristaltic wave resulting in contracting the expandable portion 102/112 nearest to the peristaltic wave and expanding the expandable portion 102/112 farthest from the peristaltic wave so that to anchor apparatus 100 (Figs. 1, 2 and 3) in place.
• Controller 118 initiates transfer of content from the expandable portion 102/112 ahead of the propagating peristaltic wave to the expandable portion 102/112 behind the propagating peristaltic wave resulting in contracting the expandable portion ahead of the propagating peristaltic wave and expanding the expandable portion behind the propagating peristaltic wave so that to anchor apparatus 100 in place and maintaining apparatus 100 stationary at the desired location.
• the delivery apparatus may be repositioned as desired at any location along the intestinal tract such as, for example, the small intestine and/or the large intestine. Some examples may enable repositioning the delivery apparatus upon demand transmitted to controller 118 (Figs. 1, 2 and 3) from remote controller 150 via telemetry component 120.
• apparatus 1500 may include a connecting portion 1530 that may be consist of a axially stretchable portion 1532 and a non-stretchable portion 1534 having corresponding lumina 1508 and 1510 the passageway therebetween blocked by a permanent wall 1512.
• [0091] may be loose and not adhesively connected to connecting portion 1530, having one side thereof attached to expandable portion 1502 and the other side attached to non- stretchable portion 1534 or expandable portion 1512 so as to provide a sealed fluid pathway extending along at least part of the length of portion 1530.
• the passageway between lumina 1508 and 1510 may be blocked by a permanent wall.
• lumina 1 08 and 1510 may communicate via one or more valves.
• Content of expandable portion 1512 lumen 1 14 may be transferred to expandable portion 1502 lumen 1504, for example, by a pump 1560, via secondary lumen 1506.
• the content may enter lumen 1504 in a direction indicated by arrows designated together reference numeral 1550, filling and expanding both lumen 1504 and axially stretchabie portion 1532 lumen 1 08, thus bringing about axial movement of expandable portion 1502 relative to expandable portion 1512 in a direction indicated by arrow designated reference numeral 1570.
• FIG. 16 which is a cross-section view simplified illustration of yet another example of a delivery apparatus in accordance with the current apparatus and method, illustrates an apparatus 1600 similar to apparatus 1500 of Figs. 15A and 15B, in which connecting portion 1630 may consist of a axially stretchabie portion 1632 and a non- stretchable portion 1634 having corresponding lumina 1608 and 1610 that communicate via one or more valves 1 50 and 1652.
• FIGs. 17A, 17B and 17C are cross-section view simplified illustrations of implementation in the intestine of an example of the delivery apparatus of Fig. 16 in accordance with the current apparatus and method.
• both valves 1750 and 1752 are closed and apparatus 1700 is anchored by expandable portion 1712 pressing against wall 1744 at a location indicated by a broken line of reference marked with the letter (R).
• both valves 1750 and 1752 are open and content is transferred from expandable portion 1712 lumen 1714 via connecting portion 1730 axially stretchabie portion 1732 and a non-stretchable portion 1734 corresponding lumina 1708 and 1710, in a direction indicated by an arrow designated reference numeral 1780, filling and expanding both lumen 1704 and axially stretchable portion 1732 lumen 1708, thus bringing about axial movement of expandable portion 1702 relative to expandable portion 1712 in a direction indicated by arrow designated reference numeral 1770.
• FIGs. 8A, 18B, 18C, 18D and 18E are cross-section view simplified illustrations of yet another example of a delivery apparatus in accordance with the current apparatus and method.
• apparatus 1800 expandable portions 1802/1812 may include one or more semi-rigid arms or flaps 1806 the cross- section of which taken along the longitudinal axis of apparatus 1800 being curved.
• organ e.g., intestine
• FIG. 18D which is a cross-section of an example of a delivery apparatus 1800 of Fig. 18C taken along axis (J- J) and viewed in the direction indicated by arrow (G)
• one or more arms or flaps 1806 may spread out radially in a geometric pattern such as, for example but not necessarily, in a radial fashion resembling flower petals around connecting portion 1830.
• FIG. 18E which is a cross-section of an example of a delivery apparatus 1800 of Fig. 18C taken along axis (J- J) and viewed in the direction indicated by arrow (G), illustrates an apparatus 1800 having only two flaps 1806.
• FIGs. 19A, 19B, 19C, 19D and 19E are cross-section view simplified illustrations of implementation in the intestine of an example of the delivery apparatus of Fig. 18 in accordance with the current apparatus and method.
• apparatus 1900 is anchored at a location indicated by broken line of reference marked with the letter (L) by fully expanded expandable portion 1 12 pressing against wall 1944.
• FIG. 19B content is transferred from expandable portion 1 12 lumen 1914 via connecting portion 1930, in a direction indicated by an arrow designated reference numeral 1960, filling and expanding lumen 1904, outwardly spreading of arms or flaps 1906, in a direction indicated by arrows designated reference numeral 1980.
• arms or flaps 1906 press and push against intestinal wall 1944, bringing about axial movement of apparatus 1 00 in a direction indicated by arrow designated reference numeral 1970.
• apparatus 1900 is anchored by expandable portion 1902 pressing against wall 1944, repositioning apparatus 1900 at a new location indicated by a broken line of reference marked with the letter (S).
• both expandable portions 2002/2012 of apparatus 2000 may include one or more semi-rigid arms or flaps 2006 similar to arms or flaps 1806 of Figs. 18A, 18B, 18C, 18D and 18E enabling apparatus 2000 to be axially repositioned in any direction along the intestinal tract as indicated by an arrow designated reference numeral 2050 in accordance with the method described in Figs. 19A-1 E.
• any one of the delivery devices described in Figs. 15 A, 15B, 16, 18A-18D and 20, may be introduced into the intestinal tract independently without an introducing device such as, for example, an endoscope.
• Any one of delivery apparatuses 1500, 1800 and 2000 may be manually introduced into the intestinal tract and activated in the methods described above to be positioned at any desired location along the intestinal tract.
• any one of delivery apparatuses 1500, 1800 and 2000 may be tracked throughout the introduction process and the desired final placement location verified by one or more of the following methods: CT, MRI or Ultrasound imaging, visually identifying the desired location by received images from digital video camera 206 (Fig. 2) or employing telemetry signals received by remote controller 1 0 from apparatuses 1500, 1800 and 2000.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Public Health (AREA)
• Surgery (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Molecular Biology (AREA)
• Medical Informatics (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Robotics (AREA)
• Medicinal Chemistry (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Chemical & Material Sciences (AREA)
• Physics & Mathematics (AREA)
• Biophysics (AREA)
• Pathology (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=48781098

Family Applications (1)

Country Status (1)

Cited By (2)

Citations (5)

• 2013
  • 2013-01-13 WO PCT/IL2013/000003 patent/WO2013105083A1/fr not_active Ceased

Patent Citations (5)

Similar Documents

Legal Events