WO2019226743A1

WO2019226743A1 - Imaging systems and methods for miniaturized intra-body controllable medical devices

Info

Publication number: WO2019226743A1
Application number: PCT/US2019/033474
Authority: WO
Inventors: Christopher J.P. VELIS; Matthew P. PALMER
Original assignee: Velis Christopher J P; Palmer Matthew P
Priority date: 2018-05-22
Filing date: 2019-05-22
Publication date: 2019-11-28

Abstract

A medical device for intra-body imaging includes a host structure having an interior area and at least one imaging system. The imaging system can include one or more of the group consisting of X-ray radiography, magnetic resonance imaging, medical ultrasonography or ultrasound, confocal microscopy, elastography, optical-coherence tomography, tactile imaging, thermography and medical digital photography.

Description

IMAGING SYSTEMS AND METHODS FOR MINIATURIZED INTRA-BODY

CONTROLLABLE MEDICAL DEVICES

FIELD OF THE INVENTION

[0001] The present invention relates generally to imaging systems for miniaturized intra-body medical devices. The intra-body medical devices may additionally have a propulsion system, a deployment system, a control system, a power supply system, an intra-device storage system, a therapy system, a sample and data gathering system, and/or a material dispensing system. The imaging system may include X-ray radiography imaging, magnetic resonance imaging, medical ultrasonography or ultrasound, confocal microscopy, elastography, optical-coherence

tomography, tactile imaging, thermography and medical digital photography. Further, the invention also 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 instalment 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. Additionally, pill capsules currently are only capable of taking digital photographs.

[0006] Thus, improvements are desirable in this field of technology. It would be beneficial to combine imaging such as X-ray radiography imaging, magnetic resonance imaging, medical ultrasonography or ultrasound, confocal microscopy, elastography, optical-coherence

tomography, tactile imaging, thermography and medical digital photography within the footprint, size and maneuverability of capsule systems or other structures to obtain medical images from within the body.

SUMMARY

[0007] There is disclosed herein imaging systems for intra-body medical devices. A medical device for intra-body imaging includes a host structure defining an interior area and one or more imaging systems.

[0008] In one embodiment, the imaging systems include X-ray radiography, magnetic resonance imaging, medical ultrasonography or ultrasound, confocal microscopy, elastography, optical-coherence tomography, tactile imaging, thermography and/or medical digital

photography.

[0009] In some embodiments, the at least one imaging system is configured to travel through a body lumen. The imaging system can be housed within the host structure.

[00010] In certain embodiments, the imaging system is configured to be discharged from the medical device while the medical device resides in a body lumen. The imaging system can be deposited in a predetermined location in the body lumen for ongoing monitoring.

[00011] In some embodiments, the host structure can include 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.

[00012] In one aspect of the invention, a method for using any of the medical devices described is disclosed. The method being directed to at least one of use of the devices 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.

[00013] In another aspect of the invention, a method for treating a patient utilizing a medical device for intra-body imaging is disclosed. The medical device can include a host structure defining an interior area and one or more imaging systems.

[00014] In one embodiment, the imaging system includes X-ray radiography, magnetic resonance imaging, medical ultrasonography or ultrasound, confocal microscopy, elastography, optical-coherence tomography, tactile imaging, thermography and/or medical digital

photography.

[00015] 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.

[00016] In a particular embodiment, the at least one imaging system is configured to travel through a body lumen, the imaging system being housed within the host structure.

[00017] In one embodiment, the imaging system is configured to be discharged from the medical device while the medical device resides in a body lumen and to be deposited in a predetermined location in the lumen for ongoing monitoring.

[00018] In one aspect of the invention, a method for treating a patient utilizing a medical device for intra-body imaging includes introducing a medical device into a body lumen. The medical device includes a host structure defining an interior area and an imaging system housed within the interior area. The medical device can be navigated to a treatment area within the body and a diagnostic image of the treatment area can be obtained by using the imaging system. [00019] In one embodiment of this aspect, the host structure is octopus shaped and includes a main body and appendages.

[00020] In some embodiments, the host structure can be controllable.

[00021] In one embodiment, the method can further include the steps of storing the diagnostic image in a storage medium and transmitting the diagnostic image to one or more receivers located in the lumen or outside the lumen.

DESCRIPTION OF THE DRAWINGS

[00022] 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:

[00023] FIG. 1 illustrates a representative intra-body controllable medical device formed in accordance with the present invention;

[00024] FIG. 2 illustrates an alternative representation of an intra-body controllable medical device formed in accordance with the present invention;

[00025] FIG. 3 A illustrates an intra-body controllable medical device with an imaging system disposed therein;

[00026] FIG. 3B illustrates an intra-body controllable medical device with an imaging system connected externally thereto; and

[00027] FIGS. 4 A and 4B illustrate the placement of an intra-body controllable imaging device in a body lumen.

PET ATT ED DESCRIPTION OF THE PREFERRED EMBODIMENT

[00028] 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. 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. An imaging 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.

[00029] For 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 may be 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.

[00030] 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 imaging system may be located within main body 30 and/or appendages 35 of the device or in the interior area of the host structure 20.

[00031] As shown in FIG. 3 A, FIG. 3B and FIG. 4A and FIG. 4B the present invention is generally directed to an intra-body controllable medical device having one or more imaging systems 205 within (FIG. 3 A) or remote 205’ (FIG. 3B) to the intra-body controllable medical device. In one embodiment, the remotely located imaging system 205’ is connected to and/or in communication with the medical device 5 via a connector or communication configuration 205T (e.g., a tether, a communications line, a signal line, a wireless communication path or a conduit such as a tube). The imaging systems 205, 205’ include X-ray radiography, magnetic resonance imaging, medical ultrasonography or ultrasound, confocal microscopy, elastography, optical- coherence tomography, tactile imaging, thermography and medical digital photography. In one embodiment, the imaging systems 205, 205’ are configured to travel through the lumen in the intra-body controllable medical device (FIGS 4A and 4B). In an alternative embodiment and referring to FIG. 4A and FIG. 4B, the imaging systems 205 are further configured to be discharged from the intra-body controllable medical device while in the lumen and deposited in a predetermined location in the lumen for ongoing monitoring. As an example, and referring to FIG. 4A, the medical device 5 is equipped with imaging system 205. The medical device 5 may travel through the small intestine and deposit the imaging system 205 adjacent to the ampulla of Vater, also known as the hepatopancreatic ampulla or the hepatopancreatic duct 210 (FIG. 4B). The medical device 5 may then continue to travel through the small intestine without the imaging system. The imaging systems 205 are configured with a storage medium 206 to store images.

The imaging systems 205 may further be configured with a transmitting device 207 to transmit real time images to one or more receivers located in other positions in the lumen and those located in other locations and organs in the body (e.g., a human body) and outside of the body.

[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 also 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 imaging, the medical device comprising: a host structure defining an interior area and at least one imaging system.

2. The medical device of claim 1, wherein the at least one imaging system is selected from the group consisting of X-ray radiography, magnetic resonance imaging, medical ultrasonography or ultrasound, confocal microscopy, elastography, optical-coherence tomography, tactile imaging, thermography and medical digital photography.

3. The medical device of claim 1, wherein the at least one imaging system is configured to travel through a body lumen, the imaging system being housed within the host structure.

4. The medical device of claim 1, wherein the at least one imaging system is configured to be discharged from the medical device while the medical device resides in a body lumen and to be deposited in a predetermined location in the body lumen for ongoing monitoring.

5. The medical device of claim 1, wherein the host structure includes 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.

6. The medical device of claim 1, wherein the imaging system is remote to the medical device.

7. The medical device of claim 6, wherein the imaging system is in connected to the medical device or in communication therewith.

8. 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.

9. A method of treating a patient utilizing a medical device for intra-body imaging, the medical device comprising: a host structure defining an interior area and at least one imaging system.

10. The method of claim 9, wherein the at least one imaging system is selected from the group consisting of X-ray radiography, magnetic resonance imaging, medical

ultrasonography or ultrasound, confocal microscopy, elastography, optical-coherence tomography, tactile imaging, thermography and medical digital photography.

11. The method of claim 9, wherein the host structure includes 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.

12. The method of claim 9, wherein the at least one imaging system is configured to travel through a body lumen, the imaging system being housed within the host structure.

13. The method of claim 9, wherein the at least one imaging system is configured to be discharged from the medical device while the medical device resides in a body lumen and to be deposited in a predetermined location in the lumen for ongoing monitoring.

14. A method for treating a patient utilizing a medical device for intra-body imaging comprising: introducing a medical device into a body lumen, the medical device including a host structure defining an interior area and an imaging system housed within the interior area;

navigating the medical device to a treatment area within the body; and obtaining a diagnostic image of the treatment area using the imaging system.

15. The method of claim 14, wherein the host structure is octopus shaped, the host structure having a main body and appendages.

16. The method of claim 14, wherein the host structure is controllable.

17. The method of claim 14 further including the steps of storing the diagnostic image in a storage medium and transmitting the diagnostic image to one or more receivers located in the lumen or outside the lumen.