CONTROLLABLE MEDICAL DEVICES

FIELD OF THE INVENTION

[0001] The present invention relates generally to internal storage systems for a miniaturized intra-body controllable medical device. Additionally, the intra-body medical device may have a propulsion system, a deployment system, a control system, a power supply system, an imaging system, a therapy system, a sample and data gathering system, and/or a material dispensing system. The devices may work independently or work together in a group. Furthermore, the invention details materials and methods for using an intra-body controllable medical device with internal storage systems.

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 to combine internal storage systems for housing one or more power supplies, energy storage devices, medications, imaging systems, computer processor controllers, communications transmitters and receivers, propulsion systems, therapy delivering devices (e.g., radiation sources), process waste, biopsies, blood and tissue samples, medical and surgical instruments, fluids, gases, powders and consumables with the footprint, size, and maneuverability of capsule systems or other structures.

SUMMARY

[0007] There is disclosed herein a medical device for intra-body conveyance that has internal storage systems therein. The medical device includes a host structure defining an interior area and one or more internal storage systems located in the interior area.

[0008] In one embodiment, the internal storage systems include one or more miniaturized compartments.

[0009] In certain embodiments, the host structure has a diameter D of about 25mm and a length L of about 75mm.

[00010] In some embodiments, one or more of the miniaturized compartments are configured for housing a power supply, an energy storage device, a medication, an imaging system, a computer processor controller, a communications transmitters or receiver, a propulsion system, a therapy delivering device, a process waste, a biopsy sample, a blood or tissue samples, a medical or surgical instrument, a fluid, a gas, a powder, and/or a consumable material.

[00011] In other embodiments, 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 a predetermined period of time.

[00012] A method for using any of the medical devices having one or more internal storage systems 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] A method for treating a patient, utilizing a medical device for intra-body conveyance having one or more internal storage systems is disclosed. The medical device includes a host structure defining an interior area and one or more internal storage system located in the interior area.

[00014] In one embodiment, the internal storage systems include one or more miniaturized compartments.

[00015] In some embodiments, the miniaturized compartments are configured for housing a power supply, an energy storage device, a medication, an imaging system, a computer processor controller, a communications transmitters or receiver, a propulsion system, a therapy delivering device, a process waste, a biopsy sample, a blood or tissue samples, a medical or surgical instrument, a fluid, a gas, a powder, and/or a consumable material.

[00016] In some embodiments 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 a

predetermined period of time.

DESCRIPTION OF THE DRAWINGS

[00017] 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:

[00018] FIG. 1 illustrates a representative intra-body controllable medical device formed in accordance with the present invention;

[00019] FIG. 2 illustrates an alternative representation of an intra-body controllable medical device formed in accordance with the present invention; and [00020] FIG. 3 illustrates one embodiment of an internal storage system for intra-body controllable medical devices in accordance with the present invention.

DETATT/ED DESCRIPTION OF THE PREFERRED EMBODIMENT

[00021] FIG. 1 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. The intra-body controllable medical device 5 has a distal end 10, a proximal end 15, and a body 20 connecting the distal end 10 and proximal end 15. An internal storage system is located within the body 20 of the medical device 5, as described herein. Additionally, a control unit, a power supply system, an imaging system, a therapy system, a sample and data gathering system, and a material dispensing system is located within the body 20 of the medical device 5, as described herein. The intra-body controllable medical device 5 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 systems, power supply systems, internal storage systems, imaging systems, therapy systems, sample and data gathering systems, and material dispensing systems are sized to fit within these dimensional guidelines.

[00022] 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. An internal storage system 200 is located within main body 30 and/or appendages 35 of the device or in the interior areas 22 of the host structure. Additionally, a control unit, power supply systems, an imaging system, a therapy system, a sample and data gathering system, and a material dispensing system is located within main body 30 and/or appendages 35 of the device or in the interior areas 22 of the host structure or in one or more of the internal storage systems 200.

[00023] As shown in FIG. 3, the present invention is generally directed to an intra-body medical device having internal storage systems 200, 200’ therein. The internal storage system 200 is shown and marked with five miniaturized compartments A, B, C, D and E for housing one or more power supplies, energy storage devices, medications, imaging systems, computer processor controllers, communications transmitters and receivers, propulsion systems, therapy delivering devices (e.g., radiation sources), process waste, biopsies, blood and tissue samples, medical and surgical instruments, fluids, gases, powders and consumables, generally designated by element number 210. The internal storage systems 200, 200’ and miniaturized compartments A, B, C, D and E are sized to fit within the body 20 and are therefore of smaller length and diameter than the length L and diameter D of the body 20. The miniaturized compartments A, B, C, D and E of the internal storage system 200 are shown removably connected to one another in series. In one embodiment a channel or conduit 202 provides an interconnection and

communication configuration between the miniaturized compartments A, B, C, D and E. The internal storage system 200 is shown secured to the body 20 at the miniaturized compartment E by supports or tethers 203. The miniaturized compartment B is shown in communication with a conduit 204 which extends through an opening or port 201 which is configured to be selectively opened, closed or throttled by a suitable valve, door, screen or the like to transmit fluids, therapy and imaging components, tissue and medication therethrough. The body 20 includes another opening 206 that is also configured to be selectively opened, closed or throttled by a suitable valve, door, screen 205 for receiving or discharging (e.g., in the general direction of the arrow X) one or more of the miniaturized compartments A, B, C, D and E, as shown, for example, by dashed lines for miniaturized compartment C’.

[00024] As shown in FIG. 3, the internal storage system 200’ is secured to an internal wall of the body 20 and includes openings or ports 201’ which are configured to be selectively opened, closed or throttled by a suitable valve, door, screen or the like to transmit fluids, therapy and imaging components, tissue and medication therethrough.

[00025] While each of the internal storage systems 200 and 200’ are shown and described having 5 miniaturized compartments, the present invention is not limited in this regard as less than 5 or more than 5 miniaturized compartments may be employed in each of the internal storage systems 200 and 200’. While the internal storage system 200 is shown and described as being secured to the body 20 at the miniaturized compartment E by supports or tethers 203, the present invention is not limited in this regard as the internal storage system 200 may be secured directly to or be integral with the body 20 or may be secured to the body 20 or other portions of the medical device 5 at one or more of the miniaturized compartment A, B, C, D and E.

[00026] The storage compartments A, B, C, D and E configured with walls, internal and external support structures, inlets, outlets, sensors (e.g., temperature, pressure and chemistry sensors), valves, pumps and ingress/egress apertures. The internal storage system 200 is used to hold nerve blocking and stimulating drugs and devices, may hold devices for cleaning plaque from artery walls or may hold and deploy intestinal restrictive bands.

[00027] The present invention includes materials for manufacture of an intra-body controllable medical devices 5 and the internal storage systems 200, 200’, and in particular to materials 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.

[00028] The intra-body controllable medical devices 5 and internal storage devices 200, 200’ may be disposable, disintegrable and selectively collapsible intra-body controllable medical devices and materials and structures thereof. The intra-body controllable medical devices 5 and/or the internal storage devices 200, 200’ are manufactured of one or more materials 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 and/or and the internal storage devices 200, 200’ 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 5 along with the internal storage devices 200, 200’ are configured to be flattened, extruded, stretched or disassembled in the lumen. Thus, the intra-body controllable medical devices 5 with the internal storage devices 200, 200’ therein 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. [00029] The present invention is directed to methods for using intra-body controllable medical devices 5 with the internal storage devices 200, 200’ therein 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 with the internal storage devices 200, 200’ therein 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 also routine living experiences.

[00030] 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.