WO2019226866A1

WO2019226866A1 - Sample and data gathering systems and methods for using miniaturized intra-body controllable medical devices

Info

Publication number: WO2019226866A1
Application number: PCT/US2019/033696
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 includes a host structure that has an interior area and one or more sample gathering system and/or a data gathering system. The sample gathering system is configured to obtain at least one of tissue biopsies, bone samples, cell samples, bone marrow samples, blood samples, urine samples, DNA samples and fecal samples. The data gathering system includes at least one of pH probes, accelerometers, pressure transducers, thermometers, and dimensional measurement systems.

Description

SAMPLE AND DATA GATHERING SYSTEMS AND METHODS FOR USING MINIATURIZED INTRA-BODY CONTROLLABLE MEDICAL DEVICES

FIELD OF THE INVENTION

[0001] The present invention relates generally to a miniaturized intra-body controllable medical device. More specifically, the invention relates to the intra-body medical device having sample and data gathering systems. In addition, the intra-body controllable medical device 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, 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 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-sighf’ 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 the ability to sample and gather data using robotic instruments with the footprint, size, and maneuverability of capsule systems or other structures utilized in the present invention.

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 sample gathering system.

[0008] In one embodiment, the medical device further includes a data gathering system.

[0009] In certain embodiments, the sample gathering system is configured to obtain tissue biopsies, bone samples, cell samples, bone marrow samples, blood samples, urine samples, DNA samples and/or fecal samples.

[00010] In some embodiments, the data gathering system includes pH probes, accelerometers, pressure transducers, thermometers, and/or dimensional measurement systems.

[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] As disclosed herein, a method for using the medical devices described with sample and/or data gathering system 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] In another aspect of the invention, a method of 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 sample gathering system.

[00014] In one embodiment of this aspect, the medical device further includes a data gathering system.

[00015] In one embodiment, the sample gathering system is configured to obtain tissue biopsies, bone samples, cell samples, bone marrow samples, blood samples, urine samples, DNA samples and/or fecal samples.

[00016] In certain embodiments, the data gathering system includes pH probes,

accelerometers, pressure transducers, thermometers, and/or dimensional measurement systems.

[00017] 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.

[00018] In a particular embodiment, the sample gathering system includes snares, forceps, and/or needles.

[00019] In some embodiments, the sample and data gathering systems are configured to obtain, record, and transmit a dimensional, an angular, a velocity and/or a volumetric measurement.

[00020] In one embodiment, the dimensional, angular, velocity and volumetric measurement are acquired by one or more miniaturized devices deployed from the medical device using an ultrasound system or a laser imaging system.

DESCRIPTION OF THE DRAWINGS

[00021] 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:

[00022] FIG. 1 illustrates a representative intra-body controllable sample and/or data gathering medical device formed in accordance with the present invention;

[00023] FIG. 2 illustrates an alternative representation of an intra-body controllable sample and data gathering medical device formed in accordance with the present invention; [00024] FIG. 3 A illustrates a snare type tissue sampling devices employed by the intra-body controllable medical device;

[00025] FIG. 3B illustrates a forceps type tissue sampling device employed by the intra-body controllable medical device;

[00026] FIG. 3C illustrates a needle type tissue and fluid sampling device employed by the intra-body controllable medical device; and

[00027] FIG. 3D illustrates another needle and fluid sampling device employed by the intra- body controllable medical device.

DETATEED 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. A sample and data gathering system is located within body 20. Additionally, a control unit, a power supply system, an intra- device storage system, an imaging system, a therapy 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.

[00029] 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 sample and data gathering system is located within main body 30 and/or appendages 35 of the device or in the interior areas of the host structure. Additionally, a control unit, power supply systems, an intra-device storage system, an imaging system, a therapy system, and a material dispensing system is located within main body 30 and/or appendages 35 of the device or in the interior areas of the host structure 20.

[00030] As shown in FIGS. 3A-3D, the present invention is generally directed to an intra-body controllable medical device having one or more sample and data gathering systems. The sample gathering systems are configured to obtain tissue biopsies and blood, bone, cells, bone marrow, blood, urine, DNA and fecal samples. The sample gathering devices include miniaturized snares 220 (FIG. 3A), forceps 225 (FIG. 3B), and needles 230 (FIG. 3C and 3D). The data gathering devices may include pH probes, accelerometers, pressure transducers, thermometers, and dimensional measurement systems. The sample and data gathering systems are configured to perform localized testing such as complete blood counts, bone density measurements, acidity testing and turbidity testing. The sample and data gathering systems are configured to take, record and transmit dimensional, angular, velocity and volumetric measurements. The intra- body controllable medical devices contain miniaturized devices for performing the tests and obtaining the data, including miniaturized needle aspiration devices 230, and suction devices 235. The dimensional, angular, velocity and volumetric measurements are acquired by miniaturized devices deployed from the intra-body controllable medical device including ultrasound systems and laser imaging.

[00031] 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.

[00032] 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.

[00033] 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 other non-procedural environments such as a home treatment.

[00034] 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 a sample gathering system in communication therewith.

2. The medical device of claim 1, further including a data gathering system.

3. The medical device of claim 1, wherein the sample gathering system is configured to obtain at least one of tissue biopsies, bone samples, cell samples, bone marrow samples, blood samples, urine samples, DNA samples and fecal samples.

4. The medical device of claim 2, wherein the data gathering system includes at least one of pH probes, accelerometers, pressure transducers, thermometers, and dimensional measurement systems.

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. 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.

7. A method of providing therapy using a medical device for intra-body conveyance, the medical device comprising: a host structure defining an interior area and a sample gathering system.

8. The method of claim 7, wherein the medical device further includes a data gathering system.

9. The method of claim 7, wherein the sample gathering system is configured to obtain at least one of tissue biopsies, bone samples, cell samples, bone marrow samples, blood samples, urine samples, DNA samples and fecal samples.

10. The method of claim 8, wherein the data gathering system includes at least one of pH probes, accelerometers, pressure transducers, thermometers, and dimensional measurement systems.

11. The method of claim 7, 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 7, wherein the sample gathering system includes snares, forceps, or needles.

13. The method of claim 8, wherein the sample and data gathering systems are configured to obtain, record, and transmit at least one of a dimensional, an angular, a velocity and a volumetric measurement.

14. The method of claim 13, wherein the dimensional, angular, velocity and volumetric measurement are acquired by one or more miniaturized devices deployed from the medical device using an ultrasound system or a laser imaging system.