MEDICAL DEVICES

FIELD OF THE INVENTION

[0001] The present invention relates generally to an interactive groups of miniaturized intra- body controllable medical devices. Each of the intra-body medical devices may have a propulsion system, a deployment system, a control system, a power supply system, an intra- device storage system, an imaging system, a therapy system, a sample and data gathering system, and/or a material dispensing system. Furthermore, the invention details configurations for intra- body controllable medical devices, and methods of using intra-body controllable medical devices. Further, the invention includes materials and methods for using groups of intrabody controllable medical devices.

BACKGROUND OF THE INVENTION

[0002] Many medical procedures require the physician to gain access to regions within the body in order to complete a diagnosis or provide therapy to a patient. Often, physicians access internal regions of the body through the body’s own natural orifices and lumens. Natural orifices include the nostrils, mouth, ear canals, nasolacrimal ducts, anus, urinary meatus, vagina, and nipples. The lumens include the interior of the gastrointestinal tract, the pathways of the bronchi in the lungs, the interior of the renal tubules and urinary collecting ducts, the pathways of the vagina, uterus, and fallopian tubes. From within these orifices and lumens, physicians can create an incision to gain access to almost any region of the body.

[0003] Traditional methods for gaining access to regions within the body include open surgical procedures, laparoscopic procedures and endoscopic procedures. Laparoscopic procedures allow the physician to use a small“key-hole” surgical opening and specially designed instruments to gain access to regions within the body. Initially, laparoscopic instruments were linear in nature, and required a straight obstruction free“line-of-sight” to access regions of the body. Endoscopic procedures allow the physician to access regions of the digestive system by passing flexible instruments through either the mouth or rectum.

[0004] Recently, physicians have begun to control these instruments using robots. These robots are typically connected in master/slave configuration, where the robot translates the physician’s movements into instrument movements. Robotic controls have also allowed for advent of flexible laparoscopic instruments. Medical robots still require a physician to be actively controlling the movements and actions of the devices being controlled and require large expensive capital equipment and dedicated operating room spaces.

[0005] Additionally, pill capsules have been invented that allow for a patient to ingest the capsule and as it passes through the digestive system takes pictures. There are no means for: controlling the motion of these devices, tracking or controlling the orientation, speed or location of these devices, accurately knowing where pictures were taken, and performing any type of surgical procedure or delivering therapy.

[0006] Thus, improvements are desirable in this field of technology. It would be beneficial if two or more intra-body controllable medical devices are configured to cooperate with one another to distribute components such as power supplies, medical devices, storage compartments and auxiliary devices among the intra-body controllable medical devices so that the intra-body controllable medical devices operate together as a group to accomplish the intended functional operations and to enable the use of smaller sized individual intra-body controllable medical devices than those that would otherwise not fit into the lumen.

SUMMARY

[0007] There is disclosed herein an interactive group of medical devices for intra-body conveyance. The interactive group of medical devices includes two or more medical devices. Each of the medical devices includes a host structure that has an interior area and one or more propulsion systems linked to the host structure. The host structure and the propulsion systems are configurable into a peripheral boundary of a size adapted to fit in a lumen of a living organism such as in an organ in a human body. Each of the medical devices includes one or more power supplies in communication with the propulsion systems. A controller such as a computer programed processor is in communication with the propulsion systems and the power supplies. The controller is configured to control propulsion systems to move the host structure and the propulsion systems in the lumen so that the host structure and the propulsion systems are self- maneuverable within the lumen.

[0008] In one embodiment, the interactive group of medical devices are in communication with the controller which is configured to generate signals to cause the medical devices to cooperate with each another to perform one or more predetermined missions.

[0009] In one embodiment, a controller is located in one or more of the medical devices. [00010] In one embodiment, the controller is located externally to the medical device.

[00011] In one embodiment, the host structure includes a clinically inert material, a sterilizable material, an elastomeric material, a chemically reactive material, a chemically inert material, a disintegrable material, a dissolvable material, a collapsible material and/or a material having physical and chemical properties to withstand exposure to bodily fluids for predetermined periods of time.

[00012] There is also disclosed herein a method for using the interactive group of medical devices. The method is directed to use in a gastro/intestinal tract, use in urology applications, use in a lung, use in a bladder, use in a nasal system, use in a reproductive system, use in performing Transurethral Resection of Bladder Tumors (TURBT), use in Transurethral

Resection of the Prostate (TURP), use in trans rectal prostate ultrasound, biopsy, and/or radiation treatment.

[00013] There is further disclosed herein a method of treating a patient using an interactive group of medical devices for intra-body conveyance. The method includes providing two or more interactive medical devices. Each of the medical devices has a host structure which defines an interior area. One or more one propulsion systems are linked to the host structure. The host structure and the propulsion systems are configurable into a peripheral boundary of a size adapted to fit in a lumen of a living organism. The power supplies are in communication with the propulsion systems. A controller is in communication with the propulsion systems and the power supplies. The method includes controlling one or more of the medical devices with the controller and conveying the medical devices within the body.

[00014] In one embodiment, the medical devices are in communication with the controller the method includes generating signals via the controller to cause the medical devices to cooperate with each another to perform at least one predetermined mission.

[00015] In one embodiment, the method includes controlling the propulsion systems via the controller, to move the host structure and the propulsion systems in the lumen so that the host structure and/or the propulsion systems are self-maneuverable within the lumen.

[00016] In one embodiment, the method includes controlling the power supplies via the controller and controlling transmission of power the propulsion systems to move the host structure and the propulsion systems in the lumen so that the host structure and the propulsion system are self-maneuverable within the lumen. [00017] In one embodiment, the method includes providing the host structure which is made from a clinically inert material, a sterilizable material, an elastomeric material, a chemically reactive material, a chemically inert material, a disintegrable material, a dissolvable material, a collapsible material and/or a material having physical and chemical properties to withstand exposure to bodily fluids for predetermined periods of time.

DESCRIPTION OF THE DRAWINGS

[00018] The drawings show embodiments of the disclosed subject matter for the purpose of illustrating the invention. However, it should be understood that the present application is not limited to the precise arrangements and instrumentalities shown in the drawings, wherein:

[00019] FIG. 1 A illustrates a representative intra-body controllable medical device formed in accordance with the present invention;

[00020] FIG. 1B illustrates a representative intra-body controllable medical device formed in accordance with the present invention;

[00021] FIG. 2 illustrates an alternative representation of an intra-body controllable medical device formed in accordance with the present invention;

[00022] FIG. 3 illustrates an interactive group of intra-body medical devices with controllers located in the medical device formed in accordance with the present invention; and

[00023] FIG. 4 illustrates an interactive group of intra-body medical devices with controllers located outside of the medical device formed in accordance with the present invention

PET ATT ED DESCRIPTION OF THE PREFERRED EMBODIMENT

[00024] FIG. 1 A illustrates an exemplary intra-body controllable medical device (hereinafter “the medical devices”). In one embodiment, the intra-body controllable medical device 5 is capsule shaped. Intra-body controllable medical device 5 has a distal end 10, a proximal end 15, and body 20 connecting the distal end 10 and proximal end 15. The intra-body controllable medical device may have a control unit or controller, a power supply system, an intra-device storage system, an imaging system, a therapy system, a sample and data gathering system, and a material dispensing system is located within body 20 of the medical device 5, as described herein. The intra-body controllable medical device may be sized according to the anatomy that it will need to navigate, and the method used to deliver it. As an example, overall dimensions for an intra-body controllable device operating within the gastrointestinal track may have a diameter D of about 25mm and a length L of about 75mm. More preferably, the device may have a diameter D of about 15 mm and a length L of about 50mm. Most preferably, the diameter D is less than about l5mm and a length L of less than about 50mm. Overall dimensions for an intra- body controllable device that is delivered using a scope may have a diameter D of about 20mm in diameter D and a length L of about 75mm. More preferably, the diameter D is about l5mm and the length L is about 50mm. Most preferably, the diameter D is less than l5mm and the length L less than 50mm. Control system, power supply system, intra-device storage system, imaging system, therapy system, sample and data gathering system, and material dispensing systems are sized to fit within these dimensional guidelines.

[00025] As shown in FIG.1B, the medical device 5 includes the body 20 which is a host structure 320 that has an interior area 20A. The device may have a first propulsion system 30A and a second propulsion system 30B that are linked to the host structure 320. While the first propulsion system 30A and the second propulsion system 30B are shown the present invention is not limited in this regard as only one propulsion system or more than two propulsion systems may be employed. The device may have a first power supply 40A and a second power supply 40B in communication (e.g., via power supply conductors or transmission lines or channels generally designated by the dashed lines marked 11P) with the first propulsion system 30A and the second propulsion system 30B. While the first power supply 40A and the second power supply 40B are shown and described as being in communication with the first propulsion system 30A and the second propulsion system 30B, the present invention is not limited in this regard as only one power supply or more than two power supplies may be employed and any of the power supplies (e.g., 30A or 30B) are in communication with one or more propulsion systems (e.g.,

40A or 40B).

[00026] As shown in FIG. 1B, a control unit 350 is in communication (e.g., via signal transmitting lines, wires or wireless channels, generally designated by dashed lines marked 11S) with the first propulsion system 30A, the second propulsion system 30B, the first power supply 40 A and the second power supply 40B. The control unit 350 includes a computer process controller 355 that is configured to control the first propulsion system 30A, the second propulsion system 30B to move the host structure 320, the first propulsion system 30A and the second propulsion system 30B in the lumen 300 so that the host structure 320, the first propulsion system 30A, the second propulsion system 30B and the control unit 350 are self- maneuverable within the lumen 300. [00027] As shown in FIG. 1B, a tracking device 351, a signal transmitter 352 and a signal receiver 353 are in communication with the control unit 350 via signal lines 11S for tracking and guiding the medical device 5 within the lumen 300.

[00028] As shown in the exemplary embodiment of FIG. 2, the intra-body controllable medical device 5 is octopus shaped. The intra-body controllable medical device has a main body 30, and appendages 35. Appendages 35 are used for propulsion, covering or wrapping the host structure 20, forming a portion of the host structure 20 or to perform a therapeutic or diagnostic task. The device may contain a control unit, power supply systems, an intra-device storage system, an imaging system, a therapy system, a sample and data gathering system, and a material dispensing system similar to those shown and described with reference to FIG. 1B and is located within main body 30 and/or appendages 35 of the device or in the interior areas of the host structure 20.

[00029] As shown in FIG. 3, the present invention is generally directed to an interactive group of intra-body controllable medical devices 5 including a first subgroup Gl and a second subgroup G2. The first subgroup Gl includes three of the medical devices 5 located inside of the body 190 (e.g., human body) with one of the medical devices having a controller 280’ therein. The second subgroup G2 includes four medical devices 5 with three of the medical devices 5 located inside of the body 190 (e.g., human body) and one medical device 5 located outside of the body 190 and having a controller 280 therein. In one embodiment, the controller 280 is configured (e.g., programed) to control the medical devices 5 in the first subgroup Gl and/or the second subgroup G2. In one embodiment, the controller 280’ is configured (e.g., programed) to control the medical devices 5 in the first subgroup Gl and/or the second subgroup G2. In one embodiment, the first subgroup Gl interacts and communicates with the second subgroup G2. While the first subgroup Gl is described as having three medical devices 5 therein and the second subgroup is described as having four medical devices therein, the present invention is not limited in this regard, as any number of medical devices may be employed in any number of subgroups.

[00030] As shown in FIG. 4, the present invention is generally directed to an interactive group of intra-body controllable medical devices 5 including a first subgroup Gl and a second subgroup G3. The first subgroup Gl includes three of the medical devices 5 located inside of the body 190 (e.g., human body) with one of the medical devices having a controller 280’ therein. The second subgroup G3 includes three medical devices 5 located inside of the body 190 (e.g., human body) that are controlled by a controller 280 located outside the body 190. In one embodiment, another controller 280” is located inside the body 190 and is configured (e.g., programed) to control the first subgroup Gl and/or the second subgroup G3. In one

embodiment, the controller 280 is configured (e.g., programed) to control the first subgroup Gl and/or the second subgroup G3. In one embodiment, the controller 280’ controls the medical devices 5 in the first subgroup Gl and/or the second subgroup G3. In one embodiment, the first subgroup Gl interacts and communicates with the second subgroup G3. While the first subgroup Gl is described as having three medical devices 5 therein and the second subgroup G3 is described as having three medical devices 5 therein, the present invention is not limited in this regard, as any number of medical devices 5 may be employed in any number of subgroups.

[00031] The controller 280, 280’ and 280” include but are not limited to a computer-based control system or processor.

[00032] The two or more intra-body controllable medical devices 5 are configured to cooperate with one another to distribute components such as power supplies, medical devices, storage compartments and auxiliary devices among the intra-body controllable medical devices 5 so that the intra-body controllable medical devices 5 operate together as a group or subgroups Gl, G2, G3 to accomplish predetermined functional operations and to enable the use of smaller sized individual intra-body controllable medical devices 5 than those that would otherwise not fit into the lumen. The interactive group of intra-body controllable medical devices is configured to operate collectively as a swarm of a plurality of intra-body controllable medical devices that if deployed individually would not be as effective in undertaking the intended medical procedure or other functional operation. The interactive group of intra-body controllable medical devices includes tethering 270 or towing devices (e.g., winches) between intra-body controllable medical devices to assist in propulsion of the intra-body controllable medical devices through the lumens. Additionally, the intra-body medical devices may communicate wirelessly 265 between devices. Intra-body medical devices may communicate with a receiver or the controllers 280, 280’ and 280”. The intra-body medical devices 5 may operate like a drone, communicating and being controlled by an operator in the same room or in a different location from the patient.

Furthermore, when contemplating a swarm of devices, two or more intra-body controllable medical devices 5 are deployed. A first intra-body medical device 5 may leave the swarm group and navigate to a region of interest. This device may perform a first task and communicate back to the other devices in the swarm and direct a second device 5 to navigate to the first device 5. Second device 5 is selected from a number of devices in the swarm because of its particular capabilities (e.g., second device 5 may have an additional battery, an imaging system, a therapy system, a sample and data gathering system, and/or a material dispensing system). Second device 5 may transfer capabilities to first device 5 or second device 5 may perform a task related to its specific capabilities. This serial communication and deployment of devices from the swarm may continue until the desired procedure is completed.

[00033] The present invention includes materials for manufacture of an intrabody controllable medical devices, and in particular to materials for such devices that are clinically inert, sterilizable, elastomeric (e.g., contractible and expandable), chemically reactive, chemically inert, dissolvable, collapsible and have physical and chemical properties to withstand exposure to bodily fluids for precise predetermined periods of time. Such materials include polymers, metallic alloys, shape memory polymers, shape memory metal alloys, shape memory ceramics, composites, silicones, thermoplastic polyurethane-based materials, excipients, zeolite adsorbents and styrene-butadiene rubbers (SBR). Materials may further include biodegradable materials such as paper, starches, biodegradable material such as gelatin or collagen.

[00034] The intra-body controllable medical devices may be disposable, disintegrable and selectively collapsible intra-body controllable medical devices and materials and structures thereof. The intra-body controllable medical devices are manufactured of a material such as an elastomer (e.g., nitrile) that can expand and contract, for example, by inflating and deflating them. The intra-body controllable medical devices are manufactured from a biodegradable, disintegrable or dissolvable material, including paper, starches, biodegradable material such as gelatin or collagen and/or synthetic natural polymers. The collapsible intra-body controllable medical devices are configured to be flattened, extruded, stretched or disassembled in the lumen. Thus, the intra-body controllable medical devices are disposed of in the lumen or via discharge therefrom without the need to recover the intra-body controllable medical devices for analysis, inspection or future use.

[00035] The present invention is directed to methods for using interactive groups and/or subgroups of the intra-body controllable medical devices 5 in the medical field and in particular for use in administering medications and therapy, deploying medical devices, imaging, and surgery. The methods for using intra-body controllable medical devices 5 includes applications in the gastro/intestinal tract (e.g. colonoscopy), urology applications, in the lungs, bladder, nasal and reproductive systems, in performing Transurethral Resection of Bladder Tumors (TURBT), Transurethral Resection of the Prostate (TURP) and transrectal prostate ultrasound, biopsy, and radiation treatment. The methods for using intrabody controllable medical devices include use in procedural environments, operatory/surgical procedures, ambulatory/out-patient procedures and unobtrusive normal routine living.

[00036] Although the present invention has been disclosed and described with reference to certain embodiments thereof, it should be noted that other variations and modifications may be made, and it is intended that the following claims cover the variations and modifications within the true scope of the invention.