This application claims the benefit of priority under 35 USC § 119(e) of Israel Patent Application No. 267989 filed Jul. 10, 2019, and of Israel Patent Application No. 271738, filed 26 Dec. 2019, the contents of which are incorporated herein by reference in their entirety.
The present invention, in some embodiments thereof, relates to methods and systems for introducing a treatment object into a tumor, more particularly, but not exclusively, to methods and systems for heating the treatment object including remote treatment.
Treatment of cancer in the human or animal body centers around the killing and removal of tumor and tumorous cells. Once identified as malignant, the next stage of treatment is the removal of the tumor. As long as the tumor is accessible and reasonably large and the cancer has not spread, surgery is an option. However, numerous small tumors or tumors that are difficult to access, cannot be treated with surgery, so that other, less invasive options, such as chemotherapy and radiotherapy may be used. Radiotherapy may be aimed precisely at the tumor from outside and takes advantage of the fact that the rapidly dividing tumor cells are more sensitive to the radiation than healthy cells. Chemotherapy also takes advantage of the sensitivity of the rapidly dividing tumor cells but is much harder to direct precisely at the tumor, hence having considerable side effects. Both of radiotherapy and chemotherapy are highly effective with the right kinds of cancers and the earlier the stage of the cancer the better. However some kinds of cancer are resistant to these therapies or it may be too late to apply them. In some cases chemotherapy fails because of the side-effects of the chemotherapy agents on healthy tissue requiring the dose to be limited, and surgery may be difficult if there are large numbers of small tumors or the tumors are hard to access.
Cancer research is thus constantly on the look-out both for means of delivering chemotherapy drugs more precisely to the tumor, thus safely allowing for an increase in the dose. Likewise cancer research is looking for ways of dealing with tumor that has spread to multiple sites around the body.
The disclosures of all references mentioned above and throughout the present specification, as well as the disclosures of all references mentioned in those references, are hereby incorporated herein by reference.
The present invention, in some embodiments thereof, relates to attacking the tumor using heat and/or directly delivered chemotherapy drugs. Embodiments may insert a treatment object into the tumor and heat the body and/or release the drug. Rapidly dividing cells such as tumor cells are generally more sensitive to heat and chemotherapy drugs than healthy cells and hence there is a temperature range in which the tumor cells can be effectively attacked with minimal collateral damage to healthy cells. Such a temperature range is between 39 and 50 degrees, advantageously between 42 and 45 degrees, more advantageously between 43 and 44 degrees, and a particularly recommended temperature is 43.5 degrees. The embodiments relate further to methods and systems for introducing such a treatment object into a patient, and to methods and systems for heating the treatment object, including heating by wire, by laser through an optical fiber, using piped fluid, using a battery or using induction. Embodiments relate to controlling the heating of the treatment object
According to a first aspect of the present invention there is provided a device for treatment of a tumor comprising a treatment object configured for placement about the tumor, the treatment object comprising a heating surface configured to reach a treatment temperature, the treatment temperature being higher than a patient body temperature; and an energy source to provide energy to reach the treatment temperature, the energy source being located externally to the treatment object. The term external may refer to being connected to the treatment object via a wire or pipe or both, or may refer to a wireless connection, so that the treatment object may be powered externally of the patient.
greater than 38 degrees;
greater than 39.5 degrees;
less than 55 degrees;
between 39.5 degrees and 55 degrees;
between 40 degrees and 50 degrees;
between 40 degrees and 48 degrees;
between 41 degrees and 47 degrees;
between 42 degrees and 46 degrees;
between 43 degrees and 45 degrees;
between 43 degrees and 44 degrees;
about 43.5 degrees; and
precisely 43.5 degrees.
In embodiments, the treatment object comprises an outwardly expandable spring.
The spring may expand under temperature control, for example being made of Nitinol.
The spring may make up the heating surface.
Alternatively or additionally, the spring is configured to provide a predetermined outward pressure.
In an embodiment, the container is a hollow element of a wire mesh or spring-like structure.
In an embodiment, the container is openable under external control to dispense the treatment drug.
In an embodiment, the bladder comprises a heating element for heating fluid in the bladder.
Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
As will be appreciated by one skilled in the art, the protocols and timing operations for embodiments of the present invention may be embodied as a system, method or computer program product. Accordingly, some embodiments of the present invention may include control systems which take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “circuit,” “module” or “system.” Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. Implementation of the method and/or system of some embodiments of the invention can involve performing and/or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of some embodiments of the method and/or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware and/or by a combination thereof, e.g., using an operating system.
For example, hardware for performing selected tasks according to some embodiments of the invention could be implemented as a chip or a circuit. As software, selected tasks according to some embodiments of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In an exemplary embodiment of the invention, one or more tasks according to some exemplary embodiments of method and/or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a magnetic hard-disk and/or removable media, for storing instructions and/or data. Optionally, a network connection is provided as well. A display and/or a user input device such as a keyboard or mouse are optionally provided as well.
Any combination of one or more computer readable medium(s) may be utilized for some embodiments of the invention. The computer readable medium may be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium would include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.
A computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electro-magnetic, optical, or any suitable combination thereof. A computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.
Program code embodied on a computer readable medium and/or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.
Computer program code for carrying out operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including an object oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the “C” programming language or similar programming languages. The program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).
Some embodiments of the present invention may be described below with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.
These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or block diagram block or blocks.
The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.
Some of the methods described herein are generally designed only for use by a computer, and may not be feasible or practical for performing purely manually, by a human expert. A human expert who wanted to manually perform similar tasks, such as controlling heating of a remote body, might be expected to use completely different methods, e.g., making use of expert knowledge and/or the pattern recognition capabilities of the human brain, which would be vastly more efficient than manually going through the steps of the methods described herein.
Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.
In the drawings:
The present invention, in some embodiments thereof, relates to methods and systems for introducing such a treatment object into a patient, more particularly, but not exclusively, to methods and systems for remotely heating the treatment object, more particularly, but not exclusively, to methods and systems for controlling the heating of the treatment object, and, more particularly, but not exclusively, to methods and systems for treatment in a patient's body.
A device for treatment of a tumor comprises a treatment object for placement in or around the tumor. The treatment object has a heating surface and/or a chemotherapy drug release opening which is placed against tumor tissue and which achieves a controlled treatment temperature that is higher than a patient body temperature or a controlled release of the drug into the tumor. An energy source is external to the treatment object and provides energy to reach the treatment temperature or power the release of the drug. The energy source may be contactless.
Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings and/or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.
Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details set forth in the following description or exemplified by the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.
Introduction
The term “treatment object” is used herein to refer to a device which is intended to be used inside a patient's body.
The term “patient” is used herein to refer to an entity which the treatment device is used to treat, by way of examples: human, animal and plant.
The term “magnetic” is used herein to refer to materials which can be attracted or repulsed or otherwise mechanically affected by magnetic fields. Such materials include, by way of some non-limiting examples, ferromagnetic materials, such as, by way of a non-limiting example, iron; additional materials which react to a magnetic field, such as paramagnetic materials; and composite materials including some component(s) which can be affected by a magnetic field, optionally together with some components which are not affected by a magnetic field.
Overview
As explained in the background, treatment of cancer in the human or animal body centers around the killing and removal of tumor and tumorous cells. Once identified as malignant, the next stage of treatment is the removal of the tumor. As long as the tumor is accessible and reasonably large and the cancer has not spread, surgery is an option. However, numerous small tumors or tumors that are difficult to access, cannot be treated with surgery, so that other, less invasive options, such as chemotherapy and radiotherapy may be used. Radiotherapy may be aimed precisely at the tumor from outside and takes advantage of the fact that the rapidly dividing tumor cells are more sensitive to the radiation than healthy cells. Chemotherapy also takes advantage of the sensitivity of the rapidly dividing tumor cells but is much harder to direct precisely at the tumor, hence having considerable side effects. Cancer cells are also differentially sensitive to heat, and the present invention, in some embodiments thereof, relates to attacking the tumor using heat, or using directly inserted chemotherapy agents. Embodiments may insert a treatment object into the tumor and heat the body. Rapidly dividing cells such as tumor cells are generally more sensitive to heat than healthy cells and hence there is a temperature range in which the tumor cells can be effectively attacked with minimal collateral damage to healthy cells. Such a temperature range is between 39 and 50 degrees, advantageously between 42 and 45 degrees, more advantageously between 43 and 44 degrees, and a particularly recommended temperature is 43.5 degrees. The embodiments relate further to methods and systems for introducing such a treatment object into a patient, and to methods and systems for heating the treatment object, including heating by wire, by laser through an optical fiber, using piped fluid, using a battery or using induction. Embodiments relate to controlling the heating of the treatment object
System for Guiding
As will be discussed in greater detail below, the body may be inserted into the tumor directly using a syringe and needle or other placement device. The tumor may have been detected in a body scan and in embodiments, markers may have been inserted. In embodiments the markers inserted into the tumors during the scan are in fact bodies that can be heated.
System for Heating
The present embodiments may allow for the body to be heated in a number of ways, including heating by wire, by laser through an optical fiber, using piped fluid, using a battery or using induction or radio frequency. In one embodiment, the patient sits within a coil that generates a large electromagnetic field that can heat many small heating bodies each inserted into a different tumor of a cancer that has already begun to spread. Embodiments relate to controlling the heating of the treatment object, as will be discussed in greater detail below.
Treatment Object Features
The body may be constructed of any material with a suitable heat capacity to allow it to be heated reasonably easily and quickly and which may allow for dissipation of the heat into the surroundings. The material may differ depending on the mode of supplying heat, thus metal or metal powder in a carrier may be needed for inductive heating, but any conductive material may be useful in the case of using a piped fluid. Metal may include iron, a combination of two or more metals as different portions of the treatment object or alloyed together to obtain particular properties. The device may use a binding agent of polymer and metal particles, and in an embodiment, a part of the device may be heatable by radio and another part may not-necessarily heatable by radio. Embodiments may be designed by constructing alloys with a specific thermal capacity by mixing two or more materials with different thermal capacities.
Method for Controlling the Heating
Any kind of heating rests on a balance between heat provided and heat dissipated. The heat provided may be estimated based on tables associating one or more of antenna parameters, treatment object parameters, tumor parameters, body-part parameters, heating pulse duration, and non-heating duration. A device may be custom made for a particular tumor, based on say the size, location and type of tumor treatment object.
The present section relates to guidance of a treatment object and, more particularly, but not exclusively, to a treatment object that may be guided towards a treatment site and then activated.
Some embodiments may provide a treatment object that is reactive to magnetic or other guidance, and guide the treatment object to a treatment site, where it may optionally be activated to apply treatment. The treatment object may for example be heated, by way of a non-limiting example by using magnetic waves, in order to destroy a tumor or gallstone or the like, or cause a blood clot to form, for example to stop a hemorrhage, or to destroy a blood clot. In some embodiments the treatment object may include radioactive material. In some embodiments the treatment object may be a container containing treatment material. In the case of a container, when the target is reached, the treatment object may optionally be caused by applied energy to open and release material at the treatment target. The treatment object may alternatively destroy the target by heating, say caused externally by induction. In an embodiment, the treatment object may enter the target at successive locations and apply heating at each location. The treatment object may travel or rotate around the outside of a tumor and separate the tumor from its blood supply, potentially inducing tumor necrosis.
The treatment object may be moved in pulses. The size and weight of the treatment object are known and it is possible to set the size of a magnetic pulse so as to define a given step size. The treatment object may be moved at different rates through different media and movement may be monitored using X-ray or CT scanning or even MRI, so that the treatment object can be delivered precisely at a target. In some embodiments the treatment object may contain a radioactive source which can be located and/or traced, for example using triangulation. A further optional method of location and/or tracing includes using ultrasound to locate and/or trace the treatment object. In some embodiments the treatment object may be moved and activated using electro-magnetic radiation of any suitable kind. A magnetic field may provide propulsion and/or guide the treatment object. In some embodiments, activation may use the same magnetic field to induce currents in the object and thus heat the treatment object.
In some embodiments, heating may be achieved using infra-red, radio-frequency or even X-ray radiation and all references herein to induction and heat activation are to be construed accordingly. The radiation wavelengths may be selected in accordance with the size of the treatment object and the material that the treatment object is made of. The material may be an alloy that has specific properties in terms of heat capacity and/or heat absorption from radiated energy.
When the target area is in bone, say in the case of bone tumors, the treatment object may be pulsed to carry out repeatable knocks on the bone and thereby to make a precise hole.
According to an aspect of some embodiments of the present invention there is provided a treatment object including or consisting of magnetic material, and a magnetic field source, the magnetic field source configured to provide pulses to move the treatment object in steps through a viscous medium, thereby to locate the treatment object at a desired location in the viscous medium. As an alternative to pulses, continuous movement may be used.
In some embodiments, the magnetic field source is further configured to induce heating in the treatment object. In some embodiments, microwave or radio waves may be used.
In some embodiments, the treatment object contains a therapeutic substance.
In some embodiments, the treatment object includes a shell of material, the shell being dissolvable or melt-able, optionally melt-able by heating, to release the therapeutic substance.
In some embodiments, the shell is optionally dissolvable and/or melt-able by receipt of a signal from the magnetic field source, potentially causing release of material such as medication to take place at a desired location.
In embodiments, the shell of the treatment object is dissolvable and/or melt-able by induction from the magnetic field source causing heating, thereby to ensure that the release takes place at the desired location.
Some embodiments of the treatment object optionally include a magnetized core, a hollow volume containing a therapeutic substance and an outer shell.
Some embodiments of the treatment object may include a central hollow space for a therapeutic substance, a magnetized shell and a dissolvable shell.
Some embodiments of the treatment object may include a central hollow, the hollow being openable, when the of the treatment object reaches a desired location, and the magnetic field source is configured to provide a pulse to move the opened hollow through the medium so that the hollow in the of the treatment object potentially collects a sample of the medium at the target location.
According to an aspect of the invention there is provided a method of targeting a location in a human or animal for treatment including:
Inserting a treatment object into the human or animal;
Using a magnetic field to pulse the treatment object in incremental steps towards the target;
Using x-ray based imaging to trace progress of the treatment object through the body; and
When the treatment object is at the location then activating the treatment object to apply a treatment.
In this way, in some embodiments, the treatment object is able to deliver substances to locations that cannot be approached using a needle, or that are too small to be approached by a needle. There are certain tumors that can be very clear under scanning, say under MRI or PET/CT scanning, but are too small for the surgeon to see when operating. Some of the embodiments provide a way for such tumors to be approached.
Activating may include heating the treatment object and/or or releasing a therapeutic substance contained in the treatment object.
In some embodiments, the method may involve repeatedly approaching the target from different sides and applying treatment at some or all of the approaches. In some embodiments, using 3D imaging, a program of attacking the tumor from different sides may be provided and followed.
Reference is now made to
Reference is now made to
Reference is now made to
Reference is now made to
The magnetic field source may induce heating in the treatment object 401. The source may be electro-magnetic and bring about induction. The source may be RF or may be micro-waves or any source of radiation that may cause heating. The treatment object 401 may be plastic and include magnetic particles within the plastic.
Reference is now made to
Reference is now made to
Reference is now made to
Reference is now made to
The shell 532 may be dissolved by receipt of a signal from a magnetic field source, thereby to ensure that release takes place at the target.
For example the shell 532 may be dissolved after a certain time has passed or by induction from the magnetic field source causing heating.
Reference is now made to
Reference is now made to
In some embodiments, the hollow shell 553 may be surrounded by an outer shell 554, which may optionally control release of a therapeutic material, optionally through optional hole(s) 555, similarly to the description above.
Reference is now made to
Reference is now made to
Reference is now made to
Reference is now made to
Reference is now made to
In various embodiments, magnetic coils may be flat, cylindrical, conical, and various additional shapes as known in the art.
In some embodiments, a method of targeting a location in a human or animal for treatment may include:
Inserting a treatment object into a human or animal;
Using a magnetic field to pulse the treatment object in incremental steps towards a treatment target;
Using x-ray based or other imaging to trace progress of the treatment object through the body; and
When the treatment object is at a desired location, activating the treatment object to apply a treatment.
Activating may involve heating, or dissolving or otherwise removing a cover to release a therapeutic substance.
An approach toward a treatment target may involve repeatedly approaching the target from different sides and applying the treatment at one or more or all of the approaches. In some embodiments, the treatment may be to remove tumors. In some embodiments, the tumor may be approached from various sides to destroy the tumor blood supply, thus inducing necrosis of the tumor. In case of a bone tumor the treatment object may be pulsed against the tumor multiple times. In the case of a blood clot the device may arrive at the blood clot and dissolve the clot. In the case of blood not clotting, the object may be delivered to a location to induce clotting. The device may be delivered to the location of gallstones and the like to destroy the stones.
As a further option, the treatment object may comprise a radioactive material, and be left at the target for a preset amount of time to provide a particular radiation dose. The treatment object may then be removed after the dose is completed.
In some embodiments, a processor may be used to obtain information from an imaging system and may optionally maneuver the treatment object. Alternatively or additionally a joystick may be used to guide the treatment object, where the movement of the joystick is optionally translated into electromagnetic pulses to navigate.
In some embodiments, under activation, the size and thermal capacity of the treatment object is known so the amount of heat to be applied can be precisely defined according to a desire to achieve specific damage to the treatment target.
Precise temperature levels can be achieved by changing the magnetic fields around the object, so as to cause local damage to a target without damaging the surrounding tissues. That is to say, the damage may be precisely targeted.
Additional example embodiments include:
inserting a treatment object into said human or animal;
using a magnetic field to pulse the treatment object in incremental steps towards the target location;
using x-ray based imaging to trace progress of the treatment object through the body;
and
when the treatment object is at the target location then activating said treatment object to apply a treatment.
As explained in the background, a major part of the treatment of cancer in the human or animal body involves the killing and removal of tumors. However once a cancer has started to spread around the body, the surgeon is faced with numerous tumors, some of which may be quite inaccessible and some of which may be quite small, say of millimeter scale diameter. In such cases surgery may be impractical, leaving radiotherapy and chemotherapy as the two common options. Radiotherapy may be aimed very precisely at the tumor and may take advantage of the fact that tumor cells, because they are always dividing, are more sensitive than normal cells. Chemotherapy also takes advantage of the fact that tumor cells are constantly dividing, but cannot currently be aimed very precisely at the tumor and hence has side effects which are particularly noticeable in healthy body cells that divide more often.
An aspect of some embodiments provides a treatment object for treatment of a tumor that can be placed precisely into or next to the tumor and may deliver a precisely measured dose of treatment. An injector may be used to place a treatment object into the tumor in accordance with a tumor location obtained, optionally using some form of imaging. The treatment object then delivers the treatment from within, or right next to, the tumor. In some embodiments, the amount of treatment is optionally set according to the size of the tumor to kill the tumor while doing minimal damage to surrounding healthy cells.
In some embodiments the treatment object is already in place in the tumor as a result of being used in an imaging process.
The treatment object may contain a measured amount of therapeutic substance which may be released. According to embodiments the rate of release may be preset and/or may be controllable.
In some embodiments the object may heat itself to a preset or controllable specific temperature to kill the tumor cells. Tumor cells which are constantly dividing are more susceptible to raised temperature than healthy cells.
In some embodiments, the treatment object is optionally connected via wires to an external power source. The wires may also include a connection for temperature measurement so that the temperature of the treatment object may be monitored and controlled.
In some embodiments, no wires are used. Instead the treatment object includes an antenna to pick up radiation for heating by induction.
In some embodiments, no wires are used. Instead the treatment object itself picks up radiation for heating by induction.
In some embodiments, the treatment object may decompose after a while in the body into harmless substances. In some embodiments, the treatment object is removed after use by means of minor surgery.
An aspect of some embodiments may thus relate to devices for the treatment of a tumor.
An aspect of some embodiments may thus relate to a treatment object.
An aspect of some embodiments may thus relate to an injector for the treatment object.
An aspect of some embodiments may relate to a system that is a combination of the injector and the treatment object.
An aspect of some embodiments may relate to a power and/or control source.
An aspect of some embodiments may relate to a method of treatment of a tumor in humans and animals or may relate explicitly to treatment of a non-human animal.
According to an aspect of some embodiments of the present invention there is provided a treatment object that is placeable within a tumor, and activatable when within the tumor to deliver a dose of treatment. In other embodiments there is provided a system and a method.
An aspect of some embodiment provides a treatment object that can be placed within a tumor, and is then activated when within the tumor to deliver a dose of treatment. The treatment object may be injected via needle into the tumor and may be powered via wire or by induction to deliver a controlled dose of a tumor treatment drug or of heat into the body of the tumor. In some embodiments, feedback may be provided on the treatment, and the feedback may be used to assess the treatment and/or determine the continuation of the treatment. Reference is now made to
As shown, the treatment bodies 1214 are for placing in the injector 10, from which they can be ejected via an injector 10 needle to be placed precisely where intended, that is within a tumor of interest.
In some embodiments, the injector 10 may come pre-fabricated with the treatment object 1214 inside, ready for injection. In some embodiments, the injector 10 may be provided with different needle lengths according to the depth of the tumor. In some embodiments, the injector 10 may be provided with different needle diameters according to a diameter of the treatment object 1214.
In some embodiments, a needle tip 16 of the injector 10 may be breakable or otherwise detachable, so that a treatment object, be it a treatment object such as treatment bodies 1214 shown herein, or the needle tip 16 itself, is optionally placed in the tumor by detaching from the injector 10.
In some embodiments, an endoscope is optionally provided with or attached to the injector 10, to help with precise location on the tumor.
In some embodiments, a treatment object may be inserted into an empty injector and an endoscope may be supplied together with or separately from the treatment object and/or injector.
Reference is now made to
In some embodiments, the injector 1306 is optionally withdrawn from a patient's body, leaving the treatment object 1302 within the patient's body, and the wires 1304 leading from the treatment object 1302 to outside the patient's body.
In some embodiments, the treatment object may receive power via the wires.
The treatment object may release a predetermined treatment dose into the tumor by activation via the wires. That is to say a controller sends a signal to activate the treatment at the treatment object.
The treatment object may release a particular treatment into the tumor following activation via the wires and may send feedback regarding the dose via the wires. A controller may thus be able to monitor efficacy of the treatment and also direct the way in which the treatment is to continue.
The treatment object may controllably release a treatment into the tumor in response to signaling via the wires and may send feedback regarding the dose via the wires.
The treatment may involve releasing a substance for killing the tumor. As discussed elsewhere the substance may be released by opening a cover. In some embodiments, controlled release may be achieved by using a semi-permeable membrane.
The treatment may involve heat. The heat may be applied to the tumor. For example the treatment may involve heating the tumor such that boundaries of the tumor reach a predetermined temperature selected to cause tumor death with minimal effect on surrounding cells. In some embodiments, the heating may be for a set amount of time, optionally selected on the basis of the properties of the tumor to effectively kill the tumor.
The treatment of tumors using heat is known in the art as hyper-thermal treatment and is generally carried out from outside the body. As typically practiced, the heat is not well directed at the tumor, especially if it is deep within the tissues, and considerable amounts of energy miss the tumor and cause damage to surrounding tissue.
Some embodiments potentially alleviate the problem of damage to surrounding tissue by applying heat from within the tumor. In some embodiments, the heat is applied at amounts calculated for specific properties of a specific tumor. The properties of the tumor include one or more of mass, tissue type, level of hydration, density, proximity to blood vessels (which may dissipate heat), extent of necrosis in the tumor and/or adjacent tissue and processes induced by necrosis, quantity or percentage of fat in the tumor, level of salinity and size of the tumor.
In some embodiments, suitable temperatures may be, for example 42, 43, 44 and 45 degrees Celsius and a particular temperature of interest is 43.5 degrees Celsius.
In some embodiments, tumor temperatures, named herein Ttemp, are controlled so as to damage the tumor.
In some embodiments, the temperatures are selected as temperatures to be reached at extremities or periphery of the tumor, named herein TPtemp.
In some embodiments, the treatment object reaches a temperature, named herein Tbody, used so that at least a portion of the tumor reaches Ttemp, and/or so that the extremities or periphery of the tumor reach TPtemp.
In some embodiments, TPtemp is controlled not to exceed a specific maximal temperature, so as to alleviate or prevent damage to surrounding tissues.
Reference is now made to
In some embodiments, the antenna 200 may be built into an outer skin of the treatment bodies to optionally form an outside of the treatment bodies, as shown in
In some embodiments, the treatment bodies may be hollow inside.
Reference is now made to
The treatment object may thus be powered by induction. The induction powered treatment object may contain a predetermined amount of a substance for killing the tumor, in some embodiments optionally placed in a hollow in the treatment object, and may be inductively powered to release the substance into the tumor. An amount of the substance may be selected according to a size of the tumor. That is to say, the tumor is identified, and a treatment object is optionally filled with an amount in accordance with the specific tumor the treatment object is intended for.
In some embodiments, the treatment object may be heated by induction.
Reference is now made to
In some embodiments, when the antenna 1604 receives transmitted energy, the antenna heats up, potentially heating the treatment object 1602, causing the treatment object 1602 to affect a tumor.
Affecting the tumor, in various embodiments, may be achieved by one or more of:
Heating the tumor;
Melting an envelope surrounding the treatment object, enabling the treatment object to release medication to treat the tumor; and
Causing a door or flap in the treatment object to open or melt, enabling the treatment object to release medication to treat the tumor.
Operation of the treatment object 1612 may be similar to the operation described above with reference to the treatment object 1602 shown in
Operation of the treatment object 1622 may be similar to the operation described above with reference to the treatment object 1602 shown in
Operation of the treatment object 1632 may be similar to the operation described above with reference to the treatment object 1602 shown in
Reference is now made to
The covers 17151716 may optionally be made of two materials 400, 410 having different heating coefficients so that they expand at different rates causing a cover to bend and thus open and release a substance contained within the treatment object 1702.
In some embodiments, the treatment object 1702 may act as a heating element within a tumor to deliver a dose of heating to kill the tumor from within. The temperature is selected as discussed herein.
In some embodiments, delivery of substance and acting as a heating element may be combined into a single device.
In some embodiments, the temperature may be altered by changing a frequency of induction.
In some embodiments, the temperature of the treatment object may be regulated by setting intervals at which heating is applied and intervals at which heating is not applied, that is to say by providing a duty cycle.
In some embodiments, an amount of energy needed to kill the tumor may be set according to the nature of the tumor, by way of a non-limiting example by estimating an amount of hydration and size of the tumor.
In some embodiments, the amount of heat is optionally determined based on heat dissipation of the tissue. By way of a non-limiting example, one tumor may be more rapidly cooled due to being close to a blood supply, whereas another tumor may not have much in the way of large blood vessels or a large number of blood vessels in the vicinity of the tumor.
Opening of the cover 1728 of the opening of the hollow 1725 treatment object 1722 may be as described above with reference to
In some embodiments, the hollow 1735 with the treatment object 1732 optionally has a hole at one end. Such a hole is optionally covered and closed by a cover 1738.
Opening of the cover 1738 of the opening of the hollow 1735 treatment object 1732 may be as described above with reference to
In some embodiments, the hollow 1735 within the treatment object 1732 has a hole at one end. Such a hole is optionally plugged by a plug 1739.
In some embodiments, the plug 1739 is optionally configured to be heated, by way of a non-limiting example by receiving RF radiation. In some embodiments, the plug 1739 separates from the treatment object 1732 when heated, by way of a non-limiting example by melting glue attaching the plug to the treatment object 1735, or by melting the substance of the treatment device 1735. In some embodiments, separating the plug 1739 from the treatment device 1735 enables a substance stored within the treatment object 1735 to exit the treatment object 1735 and affect a tumor.
In some embodiments, one or more of the plug 1739 and the treatment object are optionally soluble in a patient body.
In some embodiments, one or more of the plug 1739 and the treatment object are optionally insoluble in a patient body.
In some embodiments, the hollow treatment object 1802 has a hole 1806 at one end. Such a hole 1806 is optionally covered and closed by the cover 1804.
Reference is now made to
In some embodiments, a treatment object includes an antenna, configured to be inserted into a body via a tube such as a syringe, needle, or injector as described herein or as are known in the art.
In some embodiments, the treatment object is an antenna, configured to be inserted into a body via a tube such as a syringe, needle, or injector as described herein or as are known in the art.
In some embodiments, the antenna is optionally a wire which, when released from an injector, assumes a specific shape.
In some embodiments, the wire is a tensioned wire, which, when released from the injector, assumes a specific shape. In some embodiments, the wire is a pre-tensioned wire, which, when released from the injector, assumes a specific shape.
In some embodiments, the wire is made of shape-memory material, which, when released from the injector, assumes a specific shape.
Reference is now made to
In some embodiments, advantage is taken of markers that may have been left in a body, possibly in a tumor, by previous imaging or other diagnosis procedures. An example embodiment method of treating a tumor is provided that includes ascertaining that a previous imaging process has left a marker, possibly a metal marker, in a tumor. In some embodiments, it is ascertained how much energy is needed to kill the tumor based on the properties of the tumor to absorb heat and on properties of the marker to be susceptible to induction and a heating effect. Some embodiments may use induction to heat the marker, and apply the required amount of energy needed to kill the tumor.
In some embodiments, markers which are conducive to heating by absorption of radiated energy are optionally provided for imaging or other diagnosis procedures, for potential eventual use in heating and affecting a tumor.
Additional example embodiments include:
injecting into a tumor the device of any one of examples 1 to 29; and
activating the device to apply said treatment to kill the tumor.
ascertaining that a previous imaging process has left a metal marker in a tumor;
ascertaining an amount of energy needed according to properties of said tumor and said marker; and
using induction to heat said marker, thereby to apply said amount of energy needed to kill said tumor.
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In general, tumor cells are fast growing cells and are more sensitive to heat than non-tumor cells and thus the device at its preferred temperature may effectively have a differential killing rate that kills tumor cells and leaves other cells unaffected.
In use, the treatment body 3300 is threaded to the treatment point in the same way that a stent is guided to the treatment point to align windows with tumors. In an embodiment, accurate placement may be guided on the basis of metallic markers placed in the tumors during a scan. During the scan, each tumor is marked with such a marker and then subsequently a device according to the embodiments is injected onto each marker.
As explained, using a suitable antenna, the object may be heated inductively using an external field. This is particularly useful for multiple tumors, where separate objects may be injected into each tumor and then the patient may be placed in an electric field, say induced by a coil, and all the devices may be powered together. Reference is now made to
An embodiment is operated by pulsing the power, and this gives more accurate control of the temperature. This is because the pulse is for a clearly defined amount of time, thus providing a defined amount of energy at the given frequency and ensuring that the object is kept at the design temperature for a desired amount of time. General heating for an undefined amount of time may lead to excess heating of the object and cause injury to the patient. In addition to the pulsing that gives the defined amount of energy, the object may be heated for defined intervals and left for defined intervals so that the design temperature is not exceeded. For example the object may be heated for a minute to reach the design temperature. The heating process is stopped for say 30 seconds as the stored energy in the object dissipates to the tumor, and then the cycle is repeated to give a total exposure time of the tumor tissue to a specific energy in Joules. Given the heat capacity of the object, the relationship between the temperature and the energy can be determined so as to know how much energy is flowing into the tumor. The above-defined process may be continuous for an hour, and then may be repeated a day later as the tumor attempts to recover, which is a time at which the tumor is particularly vulnerable.
Reference is now made to
In the above embodiments, the object has been an expandable spring-like construction or even a wire net, placed over a bladder. The object may be delivered inside an outer envelope and released at or in proximity to the tumor, where the wire net then expands to a preset extent. The spring-like structure comprises an electrical resistor that heats under the influence of electrical current. As the tumor is destroyed layer by layer the balloon is expanded so that the wire net is in contact with the remainder of the tumor. As an alternative to wire the material may comprise a polymer with metallic particles. In order not to reduce concentration as the device expands, the material may be in folded layers, say of Milar sheet coated with metal which then unfolds.
Referring now to
Reference is now made to
The object according to some of the above embodiments, is particularly useful for destroying colon tumors which are today only treatable by surgical excision. Due to peristaltic action of the colon wall, the tumor cells have a tendency to be shed and to spread to other places. The object presses against the inner wall, preventing cells from breaking free, and also acts relatively fast in killing the exposed cells first, thus reducing the chances of the cancer spreading.
Reference is now made to
It is expected that during the life of a patent maturing from this application many relevant treatment bodies will be developed and the scope of the term treatment object is intended to include all such new technologies a priori.
It is expected that during the life of a patent maturing from this application many relevant medications and therapeutic materials will be developed and the scope of the terms medication and therapeutic material are intended to include all such new technologies a priori.
The terms “comprising”, “including”, “having” and their conjugates mean “including but not limited to”.
The term “consisting of” is intended to mean “including and limited to”.
The term “consisting essentially of” means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a unit” or “at least one unit” may include a plurality of units, including combinations thereof.
The words “example” and “exemplary” are used herein to mean “serving as an example, instance or illustration”. Any embodiment described as an “example or “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments.
The word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments”. Any particular embodiment of the invention may include a plurality of “optional” features unless such features conflict.
Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range/ranging/ranges between” a first indicate number and a second indicate number and “range/ranging/ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.
Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.
As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.
As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.
In addition, any priority document(s) of this application is/are hereby incorporated herein by reference in its/their entirety.
Number | Date | Country | Kind |
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267989 | Jul 2019 | IL | national |
271738 | Dec 2019 | IL | national |
Filing Document | Filing Date | Country | Kind |
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PCT/IL2020/050776 | 7/9/2020 | WO |