WO2019226872A1

WO2019226872A1 - Material dispensing systems and methods for use with miniaturized intra-body controllable medical devices

Info

Publication number: WO2019226872A1
Application number: PCT/US2019/033702
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 includes a host structure defining an interior area and one or more material dispensing systems. The host structure can include the material dispensing system. The material dispensing systems can include one or more storage compartments. The storage compartments can be configured for storing a payload therein and/or dispensing a payload therefrom.

Description

MATERIAL DISPENSING SYSTEMS AND METHODS FOR USE WITH

MINIATURIZED INTRA-BODY CONTROLLABLE MEDICAL DEVICES

FIELD OF THE INVENTION

[0001] The present invention relates generally to material dispensing systems for miniaturized intra-body controllable medical devices. Additionally, 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, a sample and/or data gathering 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 material dispensing 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 material dispensing systems with the footprint, size, and maneuverability of capsule systems or other structures.

SUMMARY

[0007] There is disclosed herein material dispensing systems for a medical device for intra- body conveyance. The medical device includes a host structure defining an interior area and at least one material dispensing system in communication therewith.

[0008] In one embodiment, the host structure includes the at least one material dispensing system. The at least one material dispensing system has at least one storage compartment.

[0009] In another embodiment, the at least one storage compartment is configured for at least one of storing a payload and dispensing a payload. The payload can include at least one of a medication, a liquid, a powder, a chemically reactive agent and a radiation emitting sources.

[00010] In certain embodiments, the at least one material dispensing system includes at least one of an actuator, a pump, a compressor, a nozzle, a flow control device, an injection device, a piercing device, a dose measuring device and a recording device.

[00011] In some embodiments, 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.

[00012] A method for using the medical devices having the material dispensing systems is disclosed herein. The method is directed to use of the medical device with the material dispensing systems 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] A method for treating a patient using a medical device for intra-body conveyance and having the material dispensing systems, is disclosed. The medical device includes a host structure defining an interior area and a material dispensing system in communication therewith.

[00014] In one embodiment of this aspect, the material dispensing system includes one or more storage compartments configured for storing a payload and/or dispensing a payload. The payload can include medication, liquids, powders, chemically reactive agents and/or radiation emitting sources.

[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] The present invention includes an interactive group of two or more of the foregoing medical devices having the material dispensing systems. The interactive group of the medical devices are in communication with at least one of an external computer-based control system and each other and are configured to cooperate with each other to perform at least one predetermined mission.

[00017] The present invention includes a method for using the foregoing medical devices and in particular, the material dispensing systems, for administering medications, administering therapy, deploying medical devices, imaging and/or surgery.

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 illustrates a representative intra-body controllable dispensing system for a medical device formed in accordance with the present invention;

[00020] FIG. 2 illustrates an alternative representation of an intra-body controllable dispensing system for a medical device formed in accordance with the present invention; and [00021] FIG. 3 illustrates example of a material dispensing system including a piercing device in accordance with the present invention.

DETATT/ED DESCRIPTION OF THE PREFERRED EMBODIMENT

[00022] 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 body 20 connecting the distal end 10 and proximal end 15. The medical device 5 has a material dispensing system located within body 20 of medical device 5, as described herein. Additionally, the medical device 5 may have a control unit, a power supply system, an intra- device storage system, an imaging system, a therapy system, a sample and data gathering system, located within 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 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. The material dispensing systems 240 are sized and configured to fit within the medical device 5 and/or extend partially therefrom.

[00023] 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 5 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 medical device 5 has a material dispensing system 240 located partially within main body 30 and/or appendages 35 of the medical device 5 or in the interior areas of the host structure 20. Additionally, the medical device 5 may have a control unit, power supply systems, an intra-device storage system, an imaging system, a therapy system, a sample and data gathering system, located within main body 30 and/or appendages 35 of the device or in the interior areas of the host structure 20.

[00024] As shown in FIGS 2 and 3, the present invention is generally directed to an intra-body controllable medical device having one or more material dispensing systems 240. As shown in FIG. 3, the material dispensing systems 240 are equipped with storage compartments 245 for storing and dispensing payloads including medication, liquids, powders, chemically reactive agents and radiation emitting sources and recording and tracking the location of the payloads before and after the dispensing operation. The material dispensing systems 240 include actuators, pumps, compressors, nozzles, flow control devices 250 including valves and orifices, injection and piercing devices 255 and dose measuring and recording devices 260.

[00025] The present invention includes materials for manufacture of an intra-body controllable medical device and the material dispensing systems 240, and in particular to materials for such devices and systems 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.

[00026] The intra-body controllable medical devices 5 and/or the material dispensing systems 240 may be disposable, disintegrable and selectively collapsible. The intra-body controllable medical devices 5 and the material dispensing systems 240 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 5 and/or the material dispensing systems 240 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 and/or the material dispensing systems 240 are configured to be flattened, extruded, stretched or disassembled in the lumen. Thus, the intra-body controllable medical devices 5 and the material dispensing systems 240 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.

[00027] The present invention is directed to methods for using intra-body controllable medical devices 5 with the material dispensing systems 240 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 the intra-body controllable medical devices 5 with the material dispensing systems 240 include use in procedural environments, operatory/surgical procedures, ambulatory/out-patient procedures and unobtrusive normal routine living.

[00028] 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 material dispensing system at least partially disposed therein.

2. The medical device of claim 1, wherein the host structure includes the at least one material dispensing system, the at least one material dispensing system having at least one storage compartment.

3. The medical device if claim 2, wherein the at least one storage compartment is configured for at least one of storing a payload and dispensing a payload.

4. The medical device of claim 3, wherein the payload includes at least one of a medication, a liquid, a powder, a chemically reactive agent and a radiation emitting sources.

5. The medical device of claim 1, wherein the at least one material dispensing system includes at least one of an actuator, a pump, a compressor, a nozzle, a flow control device, an injection device, a piercing device, a dose measuring device and a recording device.

6. 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.

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 treating a patient using a medical device for intra-body conveyance, the method comprising:

providing the medical device comprising a host structure defining an interior area and a material dispensing system; and

storing in or dispensing a material from, the material dispensing system.

9. The method of claim 8, wherein the method comprises:

providing at least one storage compartment in the medical device;

storing a payload in or dispensing a payload from, the storage compartment.

10. The method of claim 9, wherein the payload includes at least one of medication, liquids, powders, chemically reactive agents and radiation emitting sources.

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 a predetermined period of time.