WO2019226745A1

WO2019226745A1 - Therapy delivery systems and methods for miniaturized intra-body controllable medical devices

Info

Publication number: WO2019226745A1
Application number: PCT/US2019/033476
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 conveyance includes a host structure and one or more therapy delivery systems. The therapy delivery systems include optical-coherence tomography (OCT) guided laser instruments, radiation discharging sources, chemotherapy deploying devices, pharmaceutical and/or drug deploying devices, and photodynamic therapy devices.

Description

THERAPY DELIVERY SYSTEMS AND METHODS FOR MINIATURIZED INTRABODY CONTROLLABLE MEDICAL DEVICES

FIELD OF THE INVENTION

[0001] The present invention relates generally to miniaturized intra-body controllable medical devices. More specifically, the invention relates to intra-body medical devices having a therapy system. In addition to the therapy system, the intra-body controllable medical devices may have a propulsion system, a deployment system, a control system, a power supply system, an intra- device storage system, an imaging system, a sample and data gathering system, and/or a material dispensing system.

[0002] These devices may be externally controllable or may be fully autonomous. They may communicate via a tether or may communicate wirelessly. The devices may work independently or work together in a group. Further, the invention includes materials and methods for using an intrabody controllable medical device for therapy delivery.

BACKGROUND OF THE INVENTION

[0003] 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.

[0004] 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. [0005] 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 the 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.

[0006] 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.

[0007] Thus, improvements are desirable in this field of technology. It would be beneficial to combine therapy delivery systems using robotic instruments with the footprint, size, and maneuverability of capsule systems or other structures.

SUMMARY

[0008] There is disclosed herein a medical device for intra-body conveyance. The medical device includes a host structure and one or more therapy delivery systems.

[0009] In one embodiment, the therapy delivery system includes optical-coherence tomography (OCT) guided laser instruments, radiation discharging sources, chemotherapy deploying devices, pharmaceutical and drug deploying devices, and/or photodynamic therapy devices.

[00010] In certain 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 a material having physical and/or chemical properties to withstand exposure to bodily fluids for a predetermined period of time.

[00011] In a particular embodiment, the therapy delivery systems are configured to travel through a body lumen to provide therapy.

[00012] In some embodiments, the therapy delivery systems are configured to be discharged from the host structure while in the lumen and deposited in a predetermined location in the lumen for ongoing therapy delivery. [00013] In one embodiment, the therapy delivery systems include a storage medium configured to record a time, a duration and/or a location of a therapy delivery.

[00014] In another aspect of the invention, a method for using the medical device and providing the therapy is disclosed herein. The method 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.

[00015] In another aspect, a method of providing therapy utilizing a medical device for intra- body conveyance is disclosed. The medical device includes a host structure and one or more therapy delivery systems.

[00016] In some embodiments of this aspect, 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] In one embodiment, the therapy delivery system, includes optical-coherence tomography (OCT) guided laser instruments, radiation discharging sources, chemotherapy deploying devices, pharmaceutical and/or drug deploying devices, and photodynamic therapy devices.

[00018] In another embodiment, the therapy delivery systems are configured to travel through a body lumen to provide therapy.

[00019] In some embodiments, the therapy delivery systems are configured to be discharged from the host structure while in the lumen and deposited in a predetermined location in the lumen for ongoing therapy delivery.

[00020] In yet other embodiments, the therapy delivery systems include a storage medium configured to record a time, a duration and/or a location of a therapy delivery.

[00021] In another aspect, a method of providing therapeutic treatment to a patient includes inserting a medical device into a patient’s body lumen; navigating the medical device to a specific site in need of a site-specific therapy and delivering the site-specific therapy in proximity to the site in need of the therapy. [00022] In one embodiment, the site-specific therapy includes optical-coherence tomography (OCT) guided laser instruments, radiation discharging sources, chemotherapy deploying devices, pharmaceutical and drug deploying devices, and/or photodynamic therapy devices.

[00023] In a particular embodiment, the specific site in need of therapy is proximate to the ampulla of Vater, also known as the hepatopancreatic ampulla or the hepatopancreatic duct.

DESCRIPTION OF THE DRAWINGS

[00024] 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:

[00025] FIG. 1 illustrates a representative intra-body controllable therapy delivery device formed in accordance with the present invention;

[00026] FIG. 2 illustrates an alternative representation of an intra-body controllable therapy delivery device formed in accordance with the present invention;

[00027] FIG. 3 A illustrates a medical device with a therapy delivery device therein;

[00028] FIG. 3B illustrates a medical device in communication with therapy delivery device outside of the medical device; and.

[00029] FIG. 3C illustrates the therapy delivery device delivering therapy in a body lumen.

PET ATT ED DESCRIPTION OF THE PREFERRED EMBODIMENT

[00030] 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 control unit, 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 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. 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 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.

[00031] 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, power supply systems, 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 main body 30 and/or appendages 35 of the device or in the interior areas 22 of the host structure 20.

[00032] As shown in FIG. 3A, FIG. 3B, and FIG. 3C, the present invention is generally directed to an intra-body controllable medical device having one or more therapy delivery systems 215 within (FIG. 3 A) or remote (FIG. 3B) to the intra-body controllable medical device. The therapy delivery systems 215 include optical-coherence tomography (OCT) guided laser instruments, radiation discharging sources, chemotherapy deploying devices, pharmaceutical and drug deploying devices, ablation devices and photodynamic therapy devices. The therapy delivery systems 215 are configured to travel through the lumen in the intra-body controllable medical device and provide therapy. The therapy delivery systems 215 may further be configured to be discharged from the device while in the lumen 100 and deposited in a predetermined location in the lumen 100 for ongoing therapy delivery (FIG. 3C). The therapy delivery systems 215 are configured with a storage medium 216 to record time, duration and application location of the therapy. The therapy device systems 215 are further configured with a transmitting device 217 to transmit real time data 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. The medical device 5 of FIG. 3 A and FIG. 3B may travel through the small intestine and deposit therapy delivery system 215 adjacent to the ampulla of Vater, also known as the hepatopancreatic ampulla or the hepatopancreatic duct 210 (FIG. 3C). The medical device 5 may then continue to travel through the small intestine without the imaging system.

[00033] 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.

[00034] 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.

[00035] 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. [00036] 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 and at least one therapy delivery system in communication therewith.

2. The medical device of claim 1. wherein the therapy delivery system is selected from the group consisting of optical-coherence tomography (OCT) guided laser instruments, radiation discharging sources, chemotherapy deploying devices, pharmaceutical and drug deploying devices, and photodynamic therapy devices.

3. 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.

4. The medical device of claim 1, wherein the at least one therapy delivery system is configured to travel through a body lumen to provide therapy.

5. The medical device of claim 1, wherein the at least one therapy delivery system is configured to be discharged from the host structure while in the lumen and deposited in a predetermined location in the lumen for ongoing therapy delivery.

6. The medical device of claim 1, wherein the at least one therapy delivery system includes a storage medium configured to record at least one of a time, a duration and a location of a therapy delivery.

7. The medical device of claim 1, wherein the therapy delivery system is disposed in the host structure.

8. The medical device of claim 1, wherein the therapy delivery system is positioned remotely from the host structure.

9. 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.

10. A method of providing therapy, utilizing a medical device for intra-body conveyance, the medical device comprising: a host structure and at least one therapy delivery system.

11. The method of claim 10, 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.

12. The method of claim 10, wherein the therapy delivery system, is selected from the group consisting of optical-coherence tomography (OCT) guided laser instruments, radiation discharging sources, chemotherapy deploying devices, pharmaceutical and drug deploying devices, and photodynamic therapy devices.

13. The method of claim 10, wherein the at least one therapy delivery system is configured to travel through a body lumen to provide therapy.

14. The method of claim 10, wherein the at least one therapy delivery system is configured to be discharged from the host structure while in the lumen and deposited in a predetermined location in the lumen for ongoing therapy delivery.

15. The method of claim 10, wherein the at least one therapy delivery system includes a storage medium configured to record at least one of a time, a duration and a location of a therapy delivery.

16. A method of providing therapeutic treatment to a patient comprising: inserting a medical device into a patient’s body lumen; navigating the medical device to a specific site in need of a site-specific therapy; and delivering the site-specific therapy in proximity to the site in need of the therapy.

17. The method of claim 16, wherein the site-specific therapy is selected from the group consisting of optical-coherence tomography (OCT) guided laser instruments, radiation discharging sources, chemotherapy deploying devices, pharmaceutical and drug deploying devices, and photodynamic therapy devices.

18. The method of claim 14, wherein the specific site in need of therapy is proximate to the ampulla of Vater.