WO2019226867A1

WO2019226867A1 - Control and communications systems for miniaturized intra-body controllable medical devices

Info

Publication number: WO2019226867A1
Application number: PCT/US2019/033697
Authority: WO
Inventors: Christopher J.P. VELIS; Matthew P. PALMER
Original assignee: Velis Christopher J P; Palmer Matthew P
Priority date: 2018-05-24
Filing date: 2019-05-23
Publication date: 2019-11-28

Abstract

A medical device for intra-body conveyance, the medical device includes a host structure defining an interior area, and a control unit and or a communications system located in or remotely from the host structure. One or more propulsion systems are in communication with the propulsion systems. The control unit includes a computer process controller configured to communicate with and control the propulsion systems to move the host structure and the propulsion systems in a body lumen so that the host structure and the propulsion systems are self-maneuverable within the lumen.

Description

CONTROL AND COMMUNICATIONS SYSTEMS FOR MINIATURIZED INTRABODY CONTROLLABLE MEDICAL DEVICES

FIELD OF THE INVENTION

[0001] The present invention relates generally to control and communication systems for miniaturized intra-body controllable medical devices. The intra-body medical device may have a propulsion system, a deployment 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. The devices may work independently or work together in a group.

Furthermore, the invention includes materials and methods for using an intrabody controllable medical device.

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 control and communications systems with robotic instruments that fit within the footprint, size, and maneuverability of capsule systems or other structures.

SUMMARY

[0007] There is disclosed herein a medical device for intra-body conveyance. The medical device includes a host structure defining an interior area, and a control unit and or a

communications system, disposed in or remotely from the host structure.

[0008] In one embodiment, the device further includes one or more propulsion systems and one or more power supplies in communication with the propulsion systems. The control unit includes a computer process controller configured to communicate with and control the propulsion systems to move the host structure and the propulsion systems in a body lumen so that the host structure and the propulsion systems are self-maneuverable within the lumen.

[0009] In some embodiments, the device includes a tracking device, a signal transmitter and/or a signal receiver in communication with the control unit for tracking and guiding the medical device within the lumen. The tracking device, signal transmitter and/or signal receiver can include GPS, radiation emitting sources/radiation monitoring devices, ultra sound devices, near field communication devices, Wi-Fi devices, and Bluetooth devices, that are configured to determine the position of medical device in the lumen.

[00010] In certain embodiments, the device includes a control unit having hard wired and/or wireless communication devices linking an external command and monitor center with a computerized process controller in the medical device which is in communication with and controls the operation of the propulsion systems and the orientation systems based upon real time position information of the device in a body. [00011] 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.

[00012] A method for using the medical devices 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 providing therapy using a medical device for intra-body conveyance is disclosed. The medical device includes a host structure defining an interior area, and a control unit.

[00014] In one embodiment, the control unit is configured to communicate with and control the propulsion systems and the power supplies. The control unit includes a computer process controller configured to control the propulsion systems to move the host structure and the propulsion systems in a body lumen so that the host structure and the propulsion systems are self- maneuverable within the lumen.

[00015] In another embodiment the device can include a tracking device, a signal transmitter and/or a signal receiver in communication with the control unit for tracking and guiding the medical device within the lumen.

[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.

[00017] The medical devices described herein include a host structure that has an interior area and one or more control and communications systems. In one embodiment, the control systems and/or the communications systems are disposed in the host structure. In one embodiment, the control systems and/or the communications systems are positioned remotely to the host structure. The host structure is sized to fit into a peripheral boundary of a size adapted to fit in a lumen or cavity of a living organism such as a human being or animal. Additionally, the medical device may contain a propulsion system, a deployment 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.

[00018] In one embodiment, the medical device includes a tracking device, a signal transmitter, and/or a signal receiver in communication with the control unit for tracking and guiding the medical device within the lumen. Additionally, the medical device may have a signal transmitter and/or a signal receiver in communication with the control unit for taking and sending images and/or other data.

DESCRIPTION OF THE DRAWINGS

[00019] 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:

[00020] FIG. 1 A illustrates a representative intra-body controllable medical device having control and communication systems formed in accordance with the present invention;

[00021] FIG. 1B illustrates a representative intra-body controllable medical device formed having control and communication systems in accordance with the present invention;

[00022] FIG. 2 illustrates an alternative representation of an intra-body controllable medical device having control and communication systems formed in accordance with the present invention;

[00023] FIG. 3 A illustrates an intra-body controllable medical device including a hardwire communication system formed in accordance with the present invention; and

[00024] FIG. 3B illustrates an intra-body controllable medical device featuring various systems for communication.

PET ATT ED DESCRIPTION OF THE PREFERRED EMBODIMENT

[00025] 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. A control unit and/or

communication system is located within body 20 of the medical device 5. While the control unit and/or communication systems is described as being located within body 20, the present invention is not limited in this regard as the control unit and/or communication systems may be located remotely from the body 20.

[00026] Additionally, 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 may be 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 Lis 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.

[00027] As shown in FIG. 1B, the medical device 5 includes the body 20 (FIG. 1 A) which is a host structure 320 that has an interior area 20A. 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 40A 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. Additionally, 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. A control unit and a communications system are located within main body 30 and/or appendages 35 of the device or in the interior areas 22 of the host structure 20. Additionally, 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 main body 30 and/or appendages 35 of the device or in the interior areas 22 of the host structure 20.

[00029] As shown in FIG. 3 A and FIG. 3B, the present invention is generally directed to an intra-body controllable medical device 5 and more particularly to control and communications systems and methods for controlling and communicating with the intra-body controllable medical device in a lumen. In particular, the control and communications systems are configured to identify and track the location and orientation of the device relative to predetermined locations in the lumen and to control the device propulsion and orientation systems to guide the device to, from and around the predetermined position.

[00030] As shown in FIGS. 1B and 3A and 3B, the control unit 350 includes hard wired 160 (FIG. 3 A) and/or wireless 165 (FIG. 3B) communication devices (e.g., transmitters 352 and receivers 353) linking an external command and monitor center with a computerized process controller 355 (FIG. 1B) in the medical device 10 which is in communication with and controls the operation of the propulsion and orientation systems based upon real time position

information of the device in the body. The control unit 350 includes a software algorithm on a computer readable medium that is operable with the computerized process controller to effectuate the identification, tracking and control of the intra-body controllable medical device within the lumen.

[00031] The control unit 350 includes tracking devices 351, transmitters 352 and receivers 353, see FIG.1B, FIG. 3 A and FIG. 3B including GPS, radiation emitting source s/radiati on monitoring devices, ultra sound devices, near field communication devices, Wi-Fi devices, and Bluetooth devices, that are configured to determine the position of the intra-body controllable medical device in the lumen, similar to those shown and described with reference to element numbers 351, 352 and 353 in FIG. 1B.

[00032] 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.

[00033] 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.

[00034] The present invention is directed to methods for using intra-body controllable medical devices 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 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.

[00035] 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.

Claims

What is claimed is:

1. A medical device for intra-body conveyance, the medical device comprising: a host structure defining an interior area, and at least one of:

(a) a control unit disposed in or in remotely from the host structure; and

(b) a communication system disposed in or remotely from the host structure.

2. The medical device of claim 1, further including at least one propulsion system and at least one power supply in communication with the at least one propulsion system, wherein the control unit includes a computer process controller configured to communicate with and control the at least one propulsion system to move the host structure and the at least one propulsion system in a body lumen so that the host structure and the at least one propulsion system are self-maneuverable within the lumen.

3. The medical device of claim 2, further comprising at least one of a tracking device, a signal transmitter and a signal receiver in communication with the control unit for tracking and guiding the medical device within the lumen.

4. The medical device of claim 3, wherein the at least one of a tracking device, a signal transmitter and a signal receiver include GPS, radiation emitting sources/radiation monitoring devices, ultra sound devices, near field communication devices, Wi-Fi devices, and Bluetooth devices, are configured to determine the position of medical device in the lumen.

5. The medical device of claim 1, wherein the control unit includes hard wired and/or wireless communication devices linking an external command and monitor center with a computerized process controller in the medical device which is in communication with and controls the operation of at least one propulsion and at least one orientation system based upon real time position information of the device in a body.

6. The medical device of claim 1, wherein the host structure comprises at least one of 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 a material having physical and chemical properties to withstand exposure to bodily fluids for a predetermined period of time.

7. A method for using the medical device of any one of the preceding claims, the method being directed to at least one of 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 radiation treatment.

8. A method for providing therapy using a medical device for intra-body conveyance, the medical device comprising: a host structure defining an interior area, and a control unit.

9. The method of claim 8, wherein the control unit is configured to communicate with and control at least one propulsion system and at least one power supply, wherein the control unit includes a computer process controller configured to control the at least one propulsion system to move the host structure and the at least one propulsion system in a body lumen so that the host structure and the at least one propulsion system are self- maneuverable within the lumen.

10. The method of claim 9, further comprising at least one of a tracking device, a signal transmitter and a signal receiver in communication with the control unit for tracking and guiding the medical device within the lumen.

11. The method of claim 8, wherein the host structure comprises at least one of 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 a material having physical and chemical properties to withstand exposure to bodily fluids for predetermined periods of time.