WO2019226606A1

WO2019226606A1 - Deployment systems and methods for deploying miniaturized intra-body controllable medical devices

Info

Publication number: WO2019226606A1
Application number: PCT/US2019/033236
Authority: WO
Inventors: Christopher J.P. VELIS; Matthew P. PALMER
Original assignee: Velis Christopher J P; Palmer Matthew P
Priority date: 2018-05-21
Filing date: 2019-05-21
Publication date: 2019-11-28

Abstract

A system for deployment of intra-body medical devices. The system includes a docking station for receiving at least one of a tether, a medical scope, and a second medical device.

Description

DEPLOYMENT SYSTEMS AND METHODS FOR DEPLOYING MINIATURIZED INTRA-BODY CONTROLLABLE MEDICAL DEVICES

FIELD OF THE INVENTION

[0001] The present invention relates generally to deployment systems for miniaturized intra- body controllable medical devices. Intra-body controllable medical devices may have a propulsion system, a control 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. Deployment systems for these devices may incorporate medical scopes or needles and are used to deploy an intra-body medical device into the lumen of the body.

Furthermore, the invention includes materials and methods for deploying intra-body controllable medical devices.

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.

[0006] Thus, improvements are desirable in this field of technology. It would be beneficial to have a device for controlling the location and deployment of an intra-body controllable medical device so that it can be navigated to a specific area within a body

SUMMARY

[0007] There is disclosed a system for deploying an intra-body medical device. The system includes a docking station for receiving at least one of a tether, a medical scope; and a second medical device.

[0008] In one embodiment, the medical scope includes at least one of an ENT otoscope, a naso-pharyngoscope, a laparoscope, an esophagoscope, a sinuscope, a bronchoscope, a colonoscope, a resectoscope, a gastroscope, a proctoscope, a sigmoidoscope, and a cystoscope.

[0009] In some embodiments, the docking station includes at least one of a tether, a holding device, a release device, a launch device, a push device, and a pull device.

[00010] In a particular embodiment, the docking station can include any one of a claw or a spring for holding and deploying the intra-body medical device.

[00011] In one embodiment, the intra-body medical device can be released within at least one of the gastrointestinal tract, the pathways of the bronchi in the lungs, the interior of the renal tubules, the urinary collecting ducts, and the pathways of the vagina, uterus, and fallopian tubes.

[00012] In certain embodiments, intra-body medical device includes a host structure, 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.

[00013] The present invention includes methods for using the system described above. In one embodiment, the method is 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 use in radiation treatment.

[00014] In one embodiment a method for using an intra-body medical device includes deploying a docking station into a human body. The docking station can receive at least one of a tether, a medical scope, and a second medical device.

[00015] In one embodiment of this method, the docking station includes any one of a claw or a spring for holding and deploying the intra-body medical device.

[00016] In some embodiments, the medical scope can include at least one of an ENT otoscope, a naso-pharyngoscope, a laparoscope, an esophagoscope, a sinuscope, a bronchoscope, a colonoscope, a resectoscope, a gastroscope, a proctoscope, a sigmoidoscope; and a cystoscope.

[00017] In certain embodiments, the docking station includes at least one of a tether, a holding device, a release device, a launch device, a push device; and a pull device.

[00018] In some embodiments, the intra-body medical device is released within at least one of the gastrointestinal tract, the pathways of the bronchi in the lungs, the interior of the renal tubules and urinary collecting ducts; and the pathways of the vagina, uterus, and fallopian tubes.

[00019] In one embodiment, the intra-body medical device includes a host structure. 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.

[00020] The host structure may include or be manufactured from 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. 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 medical device formed in accordance with the present invention.

[00023] FIG. 2 illustrates an alternative representation of an intra-body controllable medical device formed in accordance with the present invention.

[00024] FIG. 3 A illustrates a deployment device secured to an ENT otoscope;

[00025] FIG. 3B illustrates the deployment device secured to a naso-pharyngoscope;

[00026] FIG. 3C illustrates the deployment device secured to a laparoscope;

[00027] FIG. 3D illustrates the deployment device secured to a sinuscope;

[00028] FIG. 3E illustrates the deployment device secured to a colonoscope;

[00029] FIG. 3F illustrates the deployment device secured to a resectoscope;

[00030] FIG. 3G illustrates the deployment device secured to a cystoscope;

[00031] FIG. 3H illustrates the deployment device secured to a gastroscope;

[00032] FIG. 31 illustrates the deployment device secured to a proctoscope;

[00033] FIG. 4A illustrates the deployment device secured to a general purpose scope;

[00034] FIG. 4B is an enlarged view of the deployment device shown in detail 13 of FIGS. 3A-3I;

[00035] FIG. 4C is an enlarged view of another embodiment of the deployment device shown in detail 13 of FIGS. 3A-3I;

[00036] FIG. 5A illustrates an intra-body controllable medical device being deployed into the stomach via a general purpose scope;

[00037] FIG. 5B is an enlarged view of the deployment device shown in detail 5 of FIG. 5 A; and

[00038] FIG. 6 illustrates an intra-body controllable medical device being deployed into the stomach by a tube. DETATT/ED DESCRIPTION OF THE PREFERRED EMBODIMENT

[00039] 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/or a material dispensing system are located within body 20 of the medical device 5, as described herein. The intra-body controllable medical device is 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 of about 25mm and a length of about 75mm. More preferably, the device may have a diameter of about 15 mm and a length of about 50mm. Most preferably, the diameter is less than about l5mm and a length of less than about 50mm. Overall dimensions for an intra- body controllable device that is delivered using a scope may have a diameter of about 20mm in diameter and a length of about 75mm. More preferably, the diameter is about l5mm and the length is about 50mm. Most preferably, the diameter is less than l5mm and the length 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.

[00040] 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 are located within main body 30 and/or appendages 35 of the device or in the interior areas 22 of the host structure 20

[00041] As shown in FIGS. 3A-I through FIG. 5, the present invention is generally directed to an intra-body controllable medical device 5 and more particularly to deployment devices and methods for deploying an intra-body medical device into a lumen of the body. In particular, scopes for medical applications having rigid shafts or flexible conduits are configured with one or more device storage compartments, channels, actuation devices, tethers and discharge ports for deployment from one or more portions of the probe portion of the scope while positioned in a lumen. Referring to FIGS. 3A-3I, the deployment device 154 is configured to be integrated with various medical scopes. As shown in FIG. 3 A the deployment device 154 is secured to an end of an ENT otoscope 115. As shown in FIG. 3B the deployment device 154 is secured to an end of a naso-pharyngoscope 120. As shown in FIG. 3C the deployment device 154 is secured to an end of a laparoscope 125. As shown in FIG. 3D the deployment device 154 is secured to an end of a sinuscope 130. As shown in FIG. 3E the deployment device 154 is secured to an end of a colonoscope 135. As shown in FIG. 3F the deployment device 154 is secured to an end of a resectoscope 140. As shown in FIG. 3G the deployment device 154 is secured to an end of a cystoscope 145. As shown in FIG. 3H the deployment device 154 is secured to an end of a gastroscope 160. As shown in FIG. 31 the deployment device 154 is secured to an end of a proctoscope 165. While the deployment devices 154 are shown and described as being secured to an end of the respective scopes, the present invention is not limited in this regard as one or more additional deployment devices 154 may be employed at the end of the respective scope and/or at one or more intermediate locations along the scope as shown in FIGS. 3B and 3E, for example.

[00042] In one embodiment, the deployment devices 154 include a docking station 151 (FIG. 4B and FIG. 4C.) The docking station 151 may utilize a claw 152 (FIG. 4B) or a spring 153 (FIG. 4C) to hold and/or deploy the medical device 5. While the claw 152 and the spring 153 are described as being employed to hold and/or deploy the medical device 5, the present invention is not limited in this regard as other deployment devices may be employed, including but not limited to an anchor and tether system, a push rod, a pull mechanism to pull the medical device from the scope and magnets or magnetic field systems.

[00043] As shown in FIG. 4A the deployment device 154 is secured to a general purpose scope 110. As shown in FIGS. 5A and 5B, the medical device 5 is deployed through the general purpose scope 110. As shown in FIG. 6, the medical device 5 is deployed through a tube 110’ instead of a scope. While the medical device 5 is shown and described as being deployed through various scopes and tubes, the present invention is not limited in this regard as the medical device 5 may also be deployed via a catheter into a blood vessel or may be surgically placed (e.g. after heart surgery); the medical device 5 may be deployed through an appropriately sized needle (e.g. to gain access bone marrow); may also be deployed generally to any area within the body (e.g. muscle, fat, and tissue) or on the skin; and the medical device 5 may be deployed on the skin at the site of a wound and provide therapy (e.g. discharge clotting material like zeolite or antibacterial medication).

[00044] As shown in FIG. 4A, the intra-body controllable medical device 5 can be deployed through the working channel 150 of the endoscope 110. The end of the working channel 150 is shown having a docking station 151 (FIG. 4B and FIG. 4C.) Docking station 151 may utilize a claw 152 (FIG. 4B) or a spring 153 (FIG. 4C) to hold and deploy medical device 5. While the

[00045] Furthermore, and referring to FIG. 5A and FIG. 5B this method for deployment of the intra-body controllable medical device in the lumen 100 further includes the use of a general purpose scope 110 to deliver the device directly to the stomach 155. Alternatively, the scope 110 may be used to deliver the device directly to various organs, for example, the bladder. The method for deployment of the intra-body medical device in a lumen further includes digestion through the oral cavity, inhalation of one or more nano-sized versions of such devices for introduction to the respiratory system of a human, including the nose, pharynx, larynx, trachea, bronchi and lungs.

[00046] While FIG. 5 A illustrates the use of the general purpose scope 110 to deliver the medical device 5 directly to the stomach 155, the present invention is not limited in this regard as other deployment devices may be employed including but not limited to the use of a tube 110’, as shown in FIG. 6. The medical device 5 is introduced, in the general direction of the arrow Rl, into the tube 110’ through an inlet deployment device 11 G that is in communication (e.g., connected to) the tube 110’. The medical device 5 travels through the inlet deployment device 11 G and tube 110’ and is discharged into the stomach 155. In one embodiment a push rod 5’ is employed to urge the medical device 5 through the tube 110’. In one embodiment, the inlet deployment device 11 G is configured similar to the deployment devices 154 disclosed herein.

[00047] The present invention includes materials for manufacture of an intra-body controllable medical devices, and in particular to materials for such devices that are clinically inert, sterilizable, elastomeric (e.g., contractible and expandable), chemically reactive, or 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, gelatin or collagen.

[00048] The intra-body controllable medical devices may be disposable, disintegrable and selectively collapsible. The intra-body controllable medical devices can be manufactured using materials such as elastomers (e.g., nitrile) that can expand and contract, for example, by inflating and deflating them. The intra-body controllable medical devices can be manufactured from biodegradable, disintegrable or dissolvable materials, including paper, starches, or biodegradable materials such as gelatin or collagen and/or synthetic natural polymers. The collapsible intra- body controllable medical devices may be configured to be flattened, extruded, stretched or disassembled in the lumen. Thus, the intra-body controllable medical devices can be 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.

[00049] The present invention is directed to structures and 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, obtaining images, and performing 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), transrectal prostate ultrasound, biopsy, and radiation treatment. The methods for using intrabody controllable medical devices include use in procedural environments such asoperatory/surgical procedures, ambulatory/out-patient procedures and also non-procedural environments such as the home.

[00050] 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 system for deploying an intra-body medical device comprising: a docking station for receiving at least one of a tether, a medical scope; and a second medical device.

2. The system of claim 1, wherein the medical scope is at least one of an ENT otoscope, a naso-pharyngoscope, a laparoscope, an esophagoscope, a sinuscope, a bronchoscope, a colposcope, a resectoscope, a gastroscope, a proctoscope, a sigmoidoscope, and a cystoscope.

3. The system of claim 1, wherein the docking station includes at least one of a tether, a holding device, a release device, a launch device, a push device; and a pull device.

4. The system of claim 1, wherein the docking station includes any one of a claw or a spring for holding and deploying the intra-body medical device.

5. The system of claim 1, wherein the intra-body medical device is released within at least one 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.

6. The system of claim 1, wherein the intra-body medical device includes a host structure, the host structure including 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 system 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 use in radiation treatment.

8. A method for using an intra-body medical device, the method comprising deploying a docking station into a human body, wherein the docking station receives at least one of a tether, a medical scope, and a second medical device.

9. The method of claim 8, wherein the docking station includes any one of a claw or a spring for holding and deploying the intra-body medical device.

10. The method of claim 8, wherein the medical scope is at least one of an ENT otoscope, a naso-pharyngoscope, a laparoscope, an esophagoscope, a sinuscope, a bronchoscope, a colonoscope, a resectoscope, a gastroscope, a proctoscope, a sigmoidoscope; and a cystoscope.

11. The method of claim 8, wherein the docking station includes at least one of a tether, a holding device, a release device, a launch device, a push device; and a pull device.

12. The method of claim 8, wherein the intra-body medical device is released within at least one of the gastrointestinal tract, the pathways of the bronchi in the lungs, the interior of the renal tubules and urinary collecting ducts; and the pathways of the vagina, uterus, and fallopian tubes.

13. The method of claim 8, wherein the intra-body medical device includes a host structure, the host structure including 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.