BILL ZURN
Cardiovascular Medical Devices Inventor:
William Harrison Zurn
UPDATED on 5/10/2018
Patent No.: US 9,962,533 B2 issued on May 8, 2018 to William Harrison Zurn
MODULE FOR TREATMENT OF MEDICAL CONDITIONS: SYSTEM FOR MAKING MODULE AND METHODS OF MAKING MODULE
18 Claims, 12 Drawing Sheets
UPDATED on 3/17/2016
Bill Zurn is Founder and Chairman of the Board “Vascular Devices” – LLC, a start-up company chartered to develop his patented, untethered human vessel catheter.
This catheter is the world’s first untethered catheter, a fifth generation device that produces a burst of laser energy to vaporize vessel blockages.
UPDATED on 1/13/2016
Bill Zurn’s Patent Portfolio for selling or licensing:
This one is for sale or licensing.
Modular, Robotic Road Repair Machine – US Patent 6,821,052 B2
This one is for sale or licensing.
Automated Vessel Repair, Devices – US Patent 7,979,108 B2
This one is for sale or licensing.
Automated Vessel Repair, Methods – US Patent 9,049,988 B2 [DIV]
This patent is not for sale or licensing, a start-up company is being formed with respect to commercializing the device.
Vessel Clearing Apparatus – Devices & Methods – US Patent 8,663,209
Pending Patents, will discuss at a later date.
Automated Vessel Repair, Systems – US Application 14/706,237 [DIV]
Mucus Analysis & Clearing Device – US Application 13/569,204
Transhumanism Device – US Application 13/767,671
Drill Bit & Cylinder Body Device, Assemblies, Systems & Methods
US Application 14/806,340
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OVERALL PROJECT SUMMARY
IMPLANTED VESSEL CLEARING MODULE
EXECUTIVE SUMMARY
VISION
Enable a leap in technology, transcending the present methods of clearing human vessel blockage.
MISSION
Construct a master machine and multiple implant modules that will be an affordable, single-operator, non-surgeon (long term) instrument. A complete system that has sufficient and complex computing capabilities for the medical tasks required for the leading edge, computer assisted surgical methods of clearing blocked vessels in the human body. The underlying benefits of this are: cost savings, efficiency and safety.
STRATEGIC GOALS AND OBJECTIVES
Plan to utilize the funds made available from venture capitalists, angel investors or medical foundation grants. Plan to market to US, with a potential user rate of 50% of all surgeons who perform procedures to cure this ailment or ancillary one’s of within 7 years.
STRATEGIES AND TACTICS – COMPLIANCE TO US FEDERAL MEDICAL DEVICE GUIDELINES
FDA 21 DFR Part 820
ISO 13485 Compliance
FDA Class III Medical Device Compliance
FOCUS
The critical component of master machine is the computing operating system technology: the technique of processing the image information (MRI), creating the circulatory system path algorithm, and controlling the movement and operation of the module within the human body.
US market demand (2015) for implantable medical devices – $52 billion
FUNDING
- Phase I: $5 million,
- Phase II: $7 million,
- Phase III: $10 million
MANAGEMENT STAFFING
Hire CEO, hire CTO, first duties; retain MEMS scientist and computer systems scientist. After a prototype is built, tested and verified to function correctly (phase I), start phase II. The critical technical function phase II: develop requirements for communication between master machine and implant modules. Retain CFO, FDA compliance officer, admin manager; main duties – coordination all outsourcing activities: HR outsource services, accounting, legal, IT, facilities. Add personal as required. Production manager and quality control manager as liaison to outsourced factory contractors. Also retain supply-chain manager/materials manager to assess how currency fluctuations are impacting cost of raw materials. Phase III, commercialize master machine and modules.
FACILITIES & EQUIPMENT
Retooling existing medical instrument assembly line (MRI equipment) to manufacture main machine chassis with NMR capability (phase II).
INTELLECTUAL CAPITAL
William Zurn holds title to United States Patent 8,663,209, issued on March 4, 2014. This patent has 18 claims that protect the exclusive design and/or function of the machine/module and method.
MILESTONES
Phase one, put together staff, build and test implant module (one year).
FIRST YEAR STAFFING
President/Chief Financial Officer
Chief Technical Officer
Three Software Engineers
Three Nano-Manufacturering Engineers
Office Manager/Administration/Grant Writer
FIRST YEAR START UP COSTS
Labor $1,200,000
Build Prototype $1,000,000
Facilities/Office $100,000
Miscellaneous $100,000
Out Sourcing $80,000
Phase two, modify currently available MRI machine with NMR capability (one year).
Phase three, prove the device can be implanted in a live pig, fire the laser and safely remove the module from the pig.
Phase four, prove the device can be implanted in a live human, fire the laser, and safely remove the module from the human.
STRATEGIC RELATIONSHIPS Develop relationships with university hospital systems, medical foundations and federal health agencies. Build alliances with adjacent technologies and applications: utilize (outside of the company) digital destructive techniques. Build incentives for hospitals to develop relationships with firm. Build incentives for medical foundations and federal health agencies for working with the firm. Construct synergies with other technologies/vendors and between company/solutions offered and hospital systems, medical foundations and federal health agencies. Allow the company to drive the evolution of this technology and benefits to the medical community.
CRITICAL SUCCESS FACTORS The software technology interfacing to the sub-sections of the master machine and communication to the implant module.
IMPLANT DEVICE SUMMARY
The purpose of the invention is to clear blockages (i.e. caused by blood clot formation, atherosclerotic plaque) of human vessels, that is, customarily human arteries, capillaries or other difficult-to-reach vessels within the human cardiovascular system. This device and prescribed method of employing the device can also be used to clear other types of human vessels. The vessels are cleared by application and treatment of a biocompatible module apparatus (BCM), constructed by the use of nanotechnology and/or semiconductor materials. The use of nanotechnology and/or semiconductor material provides for the construction of multiple sizes of BCM devices or modules. Larger sized modules can be used to clear arteries and also very small devices; modules 100 nanometers by 50 nanometers, could be utilized to clear blocked capillaries and other difficult-to-reach vessels in locations, such as the brain and its’ very complex and vessel-dense circulatory system.
The BCM is comprised of multiple sub-sections; each section is manufactured by the use of a combination of nanotechnology and integrated circuit (semiconductor) manufacturing. The sub-sections include: wireless communication unit, RF receiving section, RF to electronic conversion section and laser transmitting section. Several other small components are included to direct, position, buffer and guide the BCM within the human cardiovascular system.
The method of clearing vessels commences with a MRI map of the entire cardiovascular system, locating the blockages in the circulatory system and/or vessel system and recording the precise location of the blockages on a diagram. Once the diagram has been completed and the blockages are located, an algorithm of the procedure of removing the blockage/s is programmed into the master computer. The scan and analysis may be conducted on a single vessel only on any number of vessels, up to and including any or all vessels and/or ducts in the patient’s body. The results of the scan are analyzed by the administrator of the scanning and repair procedure, in addition to the consulting physicians, in order to determine the superlative course of action to remove the vessel blockages.
The exact coordinates of the blockage(s) of the artery (ies) or vein(s) or other vessel(s) in need of restoration are determined, in order to provide a course of action, thereof for reference of NMR (nuclear magnetic resonance) control during performance of the delivery and implementation of the module(s). The size of the module(s) is determined by the vessel dimensions and various sizes would be available. The module is inserted into the body and controlled by use of NMR technology into and within the body.
The module uses laser energy to remove the blockage; the laser energy is generated by converting non-destructive x-ray energy to electrical energy, and in turn, converting the electrical energy to therapeutic laser energy (i.e. without causing surrounding tissue damage/vessel damage).
The operator controlling the procedure at the control panel can visually monitor (e.g., on one or more computer monitors, the locations of the modules), as well as the surgical target locations, and other related structures and landmarks within the patient (displayed on the diagram), including, but not limited to the vessel that the module is traveling through the body. Thus, the operator can continuously (or intermittently) view the locational relationship of each module and the vessel it is currently traveling through, as well as its positional relationship relative to the vessel and surgical target site that it is intended to treat, in real time. The operator can stop or pause the procedure at any time needed via control of the NMR instrument.
Movement of the module is tracked in relation to the roadmap, guided by a predetermined path to the surgical target area. Also, the operator is aware of the location of the module(s) at all times. After executing a clearing event on a surgical target (blockage or other obstruction), a scan (e.g., CAT Scan or other visualization) of the target surgical area may be performed to confirm that the module has successfully cleared the blockage/obstruction. After it is determined that the blockage/obstructions has been satisfactorily cleared, the procedure is successfully completed and the module is removed from the patient.
IMPLANT DEVICE PROTOTYPE BUILD SUMMARY
Three companies have been contacted with respect to building a prototype medical device; all have experience regarding building the type of device I have patented. One firm indicated the device would cost $750-800 thousand to build and test. This company also indicates the device could be built with existing technology available today.
The three companies are:
Gilero is a privately-held biomedical devices development company. Gilero was founded in 2002 and is headquartered in Durham, NC.
Gilero develops biomedical devices, specializing in high-volume disposables such as drug and fluid delivery systems.
Website: gilero.com
Proven Process Medical Device
CIRTEC Medical
COMMERCILIZATION OF THE MEDICAL IMPLANT DEVICE
Due to the fact the medical implant device is an improvement over existing technology, and is able to resolve procedural issues not attempted before, the product will take market share away from existing products from existing companies. The commercialization will include multiple product lines of medical devices of various sizes, shapes and complexities.
THE FINANCIAL FORECAST
Estimated US Market demand for implantable medical devices by 2015
US demand for implantable medical devices – $52 billion *
US demand for medical devices – 120.4 billion **
Estimated Market Penetration: Ten years after introduction
2.0% – 5.0%
Annual Growth:
20%
Estimated Selling Price of the overall machine, plus implant devices:
$7,000,000 for Vessel Repair/Clearing System
*Source: The Freedonia Group, Inc
**Source: Espicom
VASCULAR MEDICAL DOCTOR COMMENTS
I received the following letter from Dr. Julian Javier
Dear Mr. Zurn:
After carefully reading about your invention it is fascinating to think what it could do and where we could use it. During the last 10 years endovascular device industries are dedicating incredible amount of finances and resources to developing devices that can work on totally occluded arteries and veins. Prevention for leg amputation due to closure of small vessels of the lower extremity and treatments of totally occluded veins of the pelvis are two of the field that are undergoing significant amount of research. There is tremendous need of newer and better percutaneous devices to treat those conditions, your can be one of those.
Your device could work ideally not only on those vessels, but also and those very difficult to reach arteries and veins. I am co-founder of a company called Vascular Device Partners http://www.vasculardevicepartners.com and we are dedicated to study new devices for those specific conditions.
We assist with animal studies to First in Man, if you need any further help, please let us know.
Cordially,
Julian J Javier, MD, FACC, FSCAI, FCCP
Vol Asst Professor of Medicine Univ of Miami School of Medicine Adj Professor of Medicine NOVA Southeastern University.
1168 Goodlette Frank rd.
Naples, FL 34102
Dr Javier indicated in a phone discussion the trials for the implant device could be held out of the US, speeding up the process of proving the device works. He has done this in the past.
- Medical device implant
US Patent (Patent 8,663,209)
http://www.google.com/patents/US8663209
Drawings
(US Patent 8,663,209) is similar to the device in this article:
Fantastic voyage through the cardiovascular system
http://ehjcimaging.oxfordjournals.org/content/5/1/8.full
VESSEL CLEARING APPARATUS – DEVICES & METHODS
US Patent 8,663,209
SUMMARY OF THE INVENTION
The purpose of the invention is to clear blockages (i.e. caused by blood clot formation, atherosclerotic plaque) of human vessels, that is, customarily human arteries, capillaries or other difficult-to-reach vessels within the human cardiovascular system. This device and prescribed method of employing the device can also be used to clear other types of human vessels. The vessels are cleared by application and treatment of a biocompatible module apparatus (BCM), constructed by the use of nanotechnology and/or semiconductor materials. The use of nanotechnology and/or semiconductor material provides for the construction of multiple sizes of BCM devices or modules. Larger sized modules can be used to clear arteries and also very small devices; modules 100 nanometers by 50 nanometers, could be utilized to clear blocked capillaries and other difficult-to-reach vessels in locations, such as, the brain and it’s very complex and vessel-dense circulatory system.
The BCM is comprised of multiple sub-sections; each section is manufactured by the use of a combination of nanotechnology and integrated circuit (semiconductor) manufacturing. The sub-sections include: wireless communication unit, RF receiving section, RF to electronic conversion section and laser transmitting section. Several other small components are included to direct, position, buffer and guide the BCM within the human cardiovascular system.
Detailed explanations are specified in the patent. Nanotechnology (sometimes shortened to “nanotech”) is the study of manipulating matter on an atomic and molecular scale. Another technology utilized would be the application of Micro-Electro-Mechanical Systems (MEMS), is the integration of mechanical elements, sensors, actuators, and electronics on a common silicon substrate through microfabrication technology.
While the electronics are fabricated using integrated circuit (IC) process sequences (e.g., CMOS, Bipolar, or BICMOS processes), the micromechanical components are fabricated using compatible “micromachining” MEMS processes that selectively etch away parts of the silicon wafer or add new structural layers to form the mechanical and electromechanical devices.
The method of clearing vessels commences with a MRI map of the (entire) cardiovascular system, locating the blockages in the circulatory system and/or vessel system, recording the precise location of the blockages on a diagram. Once the diagram has been completed and the blockages are located, an algorithm of the procedure of removing the blockage/s is programmed into the master computer. The scan and analysis may be conducted on a single vessel only or any number of vessels, up to and including any or all vessels and/or ducts in the patient’s body. The results of the scan are analyzed by the administrator of the scanning and repair procedure, in addition to the consulting physicians, in order to determine the superlative course of action to remove the vessel blockages.
The exact coordinates of the blockage(s) of the artery (ies) or vein(s) or other vessel(s) in need of restoration are determined, in order to provide a course of action, thereof for reference of NMR (nuclear magnetic resonance) control during performance of the delivery and implementation of the module(s).
In the case of multiple modules being needed, an established priority of order in which multiple surgical target locations are treated is necessary. This may be accomplished by a surgeon, a medical team, or any other entity with the surgical expertise and sufficient knowledge of these surgical techniques qualifying them to do so. An algorithm used by the controlling computer will use the priority list to ascertain a sequence in which the modules are manufactured and arranged in the module container. The module container lies outside of the body and allows insertion of the modules into the body.
The size of the module(s) is determined by the vessel dimensions and various sizes would be available. The module is inserted into the body and controlled by use of NMR technology into and within the body.
The module uses laser energy to remove the blockage, the laser energy is generated by converting non-destructive x-ray energy to electrical energy, and in turn, converting the electrical energy to a therapeutic laser energy (i.e. without causing surrounding tissue damage/vessel damage).
The module includes multiple sub-sections/units. The X-ray receiving sub-section/unit receives non-destructive X-ray energy from the X-ray transmitting module (outside of the body), which transmits the X-ray energy emitted by X-ray generation unit by the master machine.
X-ray energy conversion unit converts the X-rays received by X-ray receiving unit to (by intermediate steps) laser energy. As the X-rays from receiving unit are sent through the electronic interface of X-ray energy conversion unit through electronic buffer and to semiconductor photon generator which generates photons as a result. X-ray energy conversion unit then outputs the photons to an intermediate laser beam transmission unit. The X-rays must be converted to an electronic signal by the electronic interface that is buffered and sent as an input to the photon generator. The X-ray energy conversion unit converts the non-destructive X-ray energy received by the X-ray energy receiving unit to laser-focused energy that is transmitted by use of the intermediate beam transmission unit.
During the interventional procedure one or more modules are or can be delivered into the patient through one or more vessels or ducts in which one or more conduits have been inserted; transported to locations adjacent to surgical target locations in the body of the patient, respectively. The master system NMR (nuclear magnetic resonance) technology directs and controls the modules based on the locations of the modules and the targeted locations of the abnormal, damaged, blocked or diseased vessels, i.e., defined and targeted as the surgical target sites.
The operator (controlling the procedure) at the control panel can visually monitor (e.g., on one or more computer monitors, the locations of the modules), as well as the surgical target locations, and other related structures and landmarks within the patient (displayed on the diagram), including, but not limited to the vessel that the module is traveling through the body. Thus, the operator can continuously (or intermittently) view the locational relationship of each module and the vessel it is currently traveling through, as well as its positional relationship relative to the vessel and surgical target site that it is intended to treat, in real time. The operator can stop or pause the procedure at any time needed via control of the NMR instrument.
Upon reaching a surgical target site and proper positioning of module adjacent to the surgical target site, X-ray energy is sent from module to X-ray receiving unit, X-ray energy is transferred from unit to X-ray conversion unit, X-ray energy is converted to photons by X-ray energy conversion unit and sent to the intermediate laser beam transmission unit, where the photons are condensed into a laser beam and transmitted to multiple final beam transmitters in beam length and intensity unit. Elements emit laser energy to the surgical target site to destroy (e.g., vaporize or ablate) the material at the surgical target site, e.g., plaque or blood-clot obstructing a vessel or other obstruction, growth, diseased tissue, or other unwanted material. The length of the laser beams emitted is up to, but not exceeding, about ten percent of the overall length of the module. Very small devices; modules 100 nanometers by 50 nanometers may be used to clear blockages in the brain.
The amount of energy in the laser beam in terms of Watts depends upon the length of the beam, but is on the order of nano Watts. The intensity, length duration, power and all other variable features of the laser beams emitted by elements are algorithmically controlled by the circuits between the electronic interface and the final beam transmitters, as instructed by instructions received from the wireless instruction receiving unit, and ultimately by controller and instructions transmission module of system. The control may be by an algorithmic voltage oscillator where an electrical signal controls the frequency of the oscillator. The frequency of oscillation can be varied by the applied DC voltage, while modulating signals may also be fed into the voltage controlled oscillator to cause frequency modulation (FM) or phase modulation (PM). A voltage controlled oscillator (with digital pulse output may similarly have its repetition rate) or pulse width modulated. The laser energy is typically applied in bursts.
The module is tracked on the diagram of the patient’s cardiovascular system during the procedure. Once the module has completed the ablation and eliminated the obstruction, having moved to the distal end of where the obstruction was previously located, the operator visually observes and notes the movement and execution of the ablation process. Optionally one or more CMOS cameras may be provided in the module to provide real-time video ( of the obstructions as well as to provide visual feedback of the emitting laser beams and their effect on the obstruction.
Otherwise, movement of the module is tracked in relation to the roadmap, guided by a predetermined path to the surgical target area. Also, the operator is aware of the location of the module(s) at all times. After executing a clearing event on a surgical target (blockage or other obstruction), a scan (e.g., CAT Scan or other visualization) of the target surgical area may be performed to confirm that the module has successfully cleared the blockage/obstruction.
If it is determined that the blockage/obstruction has been satisfactorily cleared, then the module is removed from the patient. If instead, the blockage/obstruction has not been sufficiently or satisfactorily cleared, then processing repeat application of energy to the blockage/obstruction is used to effect additional clearing. This procedure will continue until the blockage/obstruction has been satisfactorily cleared, at which time, the module can be removed from the patient
After performance of clearing all blockages (or otherwise interrogating all surgical target sites, such as removing partial obstructions or other unwanted materials), a post-clear scan may be optionally performed to confirm successful completion of the procedures or to inform the operator if one or more modules need to be used to rework a clearing procedure on one or more surgical target areas. If a particular module is needed for a particular surgical target site, but that module has already been previously removed from the patient, the appropriate module can be reinserted to perform the procedure again.
The module is driven and guided via NMR (nuclear magnetic resonance) machine (i.e., using magnetic forces applied to module) to guide the module along a pathway identified by provision and analysis of the CT or MRI scan described above. The NMR machine utilizes the positioning devices and guide bars (within the module) to guide the module to the surgical target location. Positioning devices/elements (on the module) ensure the module is aligned with the vessel wall, as they are located at four corners of the module and their positions relative to the vessel wall can be monitored by the master machine. Positioning elements may be magnetic, or include a radioactive tracing element, and/or be radiopaque and/or have some other feature that allows its position to be traced from outside the patient’s body.
The NMR machine tracks the movement of the module along the programmed roadmap so the module is maintained in a predetermined position, relative to the vessel walls, along the route to the surgical target area at all times. Safe distances from the vessel walls are predetermined by the algorithm/roadmap and will vary depending upon the size of the module and the inside diameter and conformation (e.g., straight, or relative degree of curvature and tortuosity) of the vessel it is traveling through. In one non-limiting example, a safe distance for a module having a width of 100 nanometers, was in the range of about 10 to about 20 nanometers from the vessel wall. As noted, this can vary considerable depending on the inside diameter of the vessel, the conformation of the vessel, and the width and length of the module. In general, safe distances are typically within the range of about ten to about twenty percent of the width of the module, although these safe distances may vary (depending on what factors?). Feedback (feedback on what specifically?) information is provided by the buffer transducer within guide bars (may want to define guide bars) as to the proximity of the bars to the vessel walls. This feedback is continuously transmitted to the NMR machine, and NMR machine uses the feedback to maintain the module at a safe distance from the vessel wall at all times. The buffer transducer(s) may be in the form of ultrasound emitter and receiver, for example.
Once it has been confirmed (by the operator of the control station visually observing, on monitor, the module adjacent the surgical target location) that the module has been accurately placed in a position immediately adjacent the surgical target location and oriented to as to apply energy directly to the surgical target, the position and orientation of the module are then accurately maintained using magnetic forces applied by NMR machine, as controlled by continuous feedback provided by positioning elements/devices and bars and destructive energy is applied to the material to be removed at the surgical target location.
After it is determined that the blockage/obstructions has been satisfactorily cleared, the procedure is successfully completed and the module is removed from the patient.
- Automated Vessel Repair System, Devices
US Patent (Patent 7,979,108 B2)
http://www.google.com/patents/US7979108
- Automated Vessel Repair System, Methods
US Application Number 12/912,383
- Mucus Analysis & Clearing Device –
US Application Number 13/569,204
- Transhumanism Device –
US Application Number 13/767,671
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