Invented by Lowell L. Wood, JR., Clarence T. Tegreene, William H. Gates, III, Roderick A. Hyde, Gearbox LLC

The market for injectable controlled-release fluid delivery systems is rapidly expanding, driven by the growing demand for more effective and convenient drug delivery methods. These systems offer numerous advantages over traditional oral medications, including improved patient compliance, reduced side effects, and enhanced therapeutic outcomes. As a result, pharmaceutical companies and medical device manufacturers are investing heavily in the development and commercialization of these innovative technologies. Injectable controlled-release fluid delivery systems are designed to release drugs gradually over an extended period, ensuring a sustained therapeutic effect. This is achieved through the use of specialized formulations and delivery mechanisms that control the release rate of the drug. These systems can be used to administer a wide range of medications, including pain relievers, hormones, antibiotics, and anti-cancer drugs. One of the key drivers of the market for injectable controlled-release fluid delivery systems is the increasing prevalence of chronic diseases. Conditions such as diabetes, cardiovascular diseases, and cancer require long-term medication regimens, often involving multiple daily doses. Injectable controlled-release systems simplify this process by reducing the frequency of drug administration, improving patient adherence, and ultimately enhancing treatment outcomes. Moreover, these systems offer several advantages over traditional oral medications. Firstly, they bypass the gastrointestinal tract, avoiding issues such as poor absorption, degradation by stomach acid, and first-pass metabolism. This allows for a higher bioavailability of the drug, meaning that a greater proportion of the administered dose reaches the target site. Additionally, injectable controlled-release systems can minimize side effects by maintaining drug levels within a therapeutic range, avoiding the peaks and troughs associated with oral medications. The market for injectable controlled-release fluid delivery systems is also benefiting from advancements in technology. Innovations in polymer science, nanotechnology, and microencapsulation techniques have enabled the development of more precise and efficient drug delivery systems. These advancements have resulted in improved control over drug release rates, increased stability of the formulations, and enhanced biocompatibility. Furthermore, the growing interest in personalized medicine is driving the demand for injectable controlled-release fluid delivery systems. These systems can be tailored to individual patient needs, allowing for personalized dosing regimens and targeted drug delivery. This approach maximizes the therapeutic effect while minimizing side effects, leading to improved patient outcomes. In terms of market segmentation, the injectable controlled-release fluid delivery systems market can be categorized based on the type of delivery mechanism, such as implants, microspheres, liposomes, and hydrogels. Each of these mechanisms has its own advantages and limitations, and companies are actively exploring new technologies to overcome these challenges. North America currently dominates the market for injectable controlled-release fluid delivery systems, owing to the presence of a well-established healthcare infrastructure and a large patient population. However, the market is expected to witness significant growth in Asia Pacific and Europe as well, driven by increasing healthcare expenditure, rising awareness about advanced drug delivery systems, and a growing geriatric population. In conclusion, the market for injectable controlled-release fluid delivery systems is experiencing rapid growth, driven by the need for more effective and convenient drug delivery methods. These systems offer numerous advantages over traditional oral medications and are being increasingly adopted for the treatment of chronic diseases. With advancements in technology and a growing focus on personalized medicine, this market is expected to continue expanding in the coming years.

The Gearbox LLC invention works as follows

Embodiments for a material-delivery device, including a reservoir that can be deformed and a controllable output system associated with it, are described. The device is also controlled and used in various ways. In some embodiments, the material delivery device can be placed inside an animal to controllably disperse at least one substance into the animal. The material delivery device can include a programmable system to control the release into the animal. In certain embodiments, the material delivery device can be programmed or controlled using a remote control. “Some embodiments describe the use of a magnetic or electric field as well as an electromagnetic control signal.

Background for Injectable controlled-release fluid delivery system

In vivo drug release is now achieved by a variety of technologies, including actuator pumps and osmotic pump, as well as the release from highly engineered materials. Implantable controlled-release devices have been developed for drug delivery. Certain devices depend on the gradual release of drug from polymeric carriers over time due to degradation. The development of polymer-based drugs release devices that contain a drug within a ferropolymer can be controlled by an external magnetic field to influence the drug release. MEMS-based devices for drug release that have integrated electrical circuitry, as well as MEMS systems to perform chemical reactions, are under development. “Implantable osmotic pumps have been developed to deliver drugs.

The application is concerned with the delivery of materials to animals in general. In particular, the application relates to intelligently-controlled material delivery systems including devices that are capable of being deployed transcutaneously, percutaneously, or subdermally into a natural or an engineered body cavity of an animal. The device can deliver material for a long time in vivo, and it may also be adapted to accept externally provided delivery material. The device can be loaded with delivery material after it is deployed in vivo. The device can be self-powered or contain a processor that is programmable, or it may be activated externally.

Embodiments for a system that includes a remote-controlled material delivery apparatus and controller are described. The device is also controlled and used in various ways. In various embodiments, the material delivery device can be placed into an in vivo animal environment to release or eject a substance. Delivery devices are described that include at the least one deformable container configured to receive, hold and disperse at the least one substance, at the least one outlet where material can exit the deformable container, and at the least one controllable mechanism linked to the outlet for controlling the dispensing at the least a part of the material leaving the deformable vessel. The device can also include a processor, memory or another self-contained mechanism for activating controllable output mechanisms. A system is also described, which includes the device and a controller that can generate and transmit the control signal necessary to activate the material delivery device. The control signal can activate the controllable out put mechanism itself or provide instructions to the device in order to activate the controllable out put mechanism. Other embodiments include methods of delivering a substance into a person or animal. Further embodiments include the percutaneously-deployable material delivery device including sensors that sense environmental conditions and provide a signal that may be used to activate the at least one controllable output mechanism to control the exit of material from the deformable reservoir. Other embodiments contemplate the material delivery device being self-powered. This means that it comprises a power source or a device that harvests power, such as one that generates energy in response an electromagnetic signal or local acceleration. Local accelerations may be caused by the movement of the animal’s environment. In certain embodiments, power may be provided by the subject’s body. Different ‘energy scavenging’ techniques are available. There are many ‘energy harvesting’ There are devices that have been developed or could be developed. Nos. Nos. The device can be powered by devices that use energy captured from the body movements of the subject. The device can also be powered by pressure gradients and chemical gradients in the body. Energy can be captured, for example, from the systolic/diastolic or pulsatile flow of blood of the subject or by a microturbine placed within the subject’s respired airflow. The subject’s surroundings can also be used to scavenge the energy. A material delivery device embodiment includes a structure configured to receive energy or power from the environment. The device can be configured to either store the energy it receives or use that energy to power the device.

Other embodiments contemplate the use of a micropump, or nanopump, to pump material from at least one reservoir. The disclosure envisages the reservoir as a flexible elastomeric substance that can change shape in at lease one dimension after being filled with material and injected into the animal. The reservoir can be a reconfigurable geometric member placed in the lumen of an animal, and loaded with material to deliver it. The method also includes the use of a remotely controlled device that can be placed either inside or outside the animal and transmit a signal to activate a controllable output to release material from the reservoir. The remote controller can be programmed to send a signal in response to a condition sensed either inside or outside the animal, and/or a predetermined time schedule. The remote controller can be programmed to send programmable commands to the device. The rate at which material is ejected from the deformable reservoir can be variable or constant, or it can occur at controlled intervals.

An embodiment” relates to percutaneous deployment using a delivery mechanism. This embodiment could allow for a simpler and quicker deployment using a syringe instead of surgical deployment in some applications. In some cases, the device can be deployed under local anesthesia, or even without anesthesia, at the time the primary procedure is performed, resulting in a puncture rather than an open wound. This type of percutaneous deployment is less painful or less likely to cause complications, such as infection in the wound or damage to tissues around it.

The above summary is intended to be illustrative and not limitative. Additional to the above illustrative features and embodiments, you can refer to the drawings for further details and additional aspects.

In the detailed description that follows, the drawings are referred to. They form part of this document. In the drawings, symbols that are similar to one another usually identify similar components unless context dictates something else. The detailed description, drawings and claims do not limit the illustrative examples. Other embodiments can be used, and changes made without departing the spirit or scope presented here.

The term “percutaneously deployable” is used in this context. The term “percutaneously deployable” and other similar terms, such as “percutaneous deployment”, “percutaneous deployment”, or “transcutaneously deployable”, refer to the deployment of a material delivery device through the skin or hide layer of an animal. The deployment of a device for material delivery through the hide or skin of an animal is what we mean by this term. The material delivery device can be deployed percutaneously into any body lumen, such as the peritoneal, thoracic, sinus, nasal, or other cavities. It may also be placed subdermally, e.g. in an ad-hoc cavity. The term “animal” is used here. As used in this document, the term?animal? includes vertebrates such as mammals and birds. Further, the term “mammal” is used. As used in this article, mammals are warm-blooded vertebrates that have a higher body temperature (such as placentals or marsupials) and whose young are fed with milk from mammary glands. They also include humans. “Other mammals include livestock and pets, but are not limited to them.

The embodiments described herein include a material-delivery device that can be deployed in an animal. This includes at the least, a deformable storage reservoir configured to receive and retain at the least, one material. It also includes at the least, a controllable output system operably connected to the outlet for controlling the dispensing at the least, a portion, of the material. At least One Material Delivery System, which includes at one material device that can be deployed in an animal and has at one deformable device configured to receive, hold and disperse at one material. The system also includes at one deformable outlet, through which at one material may leave the deformable device. At least one kit for a material delivery system is described, which includes a deployment mechanism, at lease one material delivery device that can be deployed in an animal and has atleast one deformable storage configured to receive, hold and release material with control. The atleast one deformable storage also includes atleast one outlet, through which atleast one material can be released. “Further described are embodiments of a method for delivering atleast one material to an animals, which includes deploying atleast one material delivery devices into an in-vivo environment, where the deformable device is configured to receive, hold and controllably dispense the material. The atleast one material device also includes atleast one outlet and atleast one controllable out put mechanism that can

FIG. The figure 1 shows an embodiment of the material delivery system. Delivery?materials? are defined as follows: A substance can be in the form a liquid, solid or material that fluidises, or gas. Delivery materials can be a variety of materials including single materials, mixtures, two or three distinct materials or combinations of materials. A delivery material can be a compound with a physiological effect or a drug or its pharmaceutically accepted salt, adduct, or derivative. It could also be a chemical compound or peptide nucleotide, glycopeptide, lipopeptide. A delivery material can be a biologically-active material such as a cell or cell component, a virus, a provirus, a microscopic organism, or a virus. In certain embodiments, the delivery material can include at least one of a nutrient or hormone, growth-factor, medication, therapeutic compound or enzyme, genetic material for a vaccine, vitamin or neurotransmitter or cytokine. It may also contain a labeling agent or diagnostic compound or material. In some embodiments the delivery material can be a component of biologically active materials; for instance, it may include at least a precursor or component of: a nutrient or hormone, growth-factor, medication, therapeutic compounds, enzyme, genetic material or vaccine, vitamin neurotransmitter or cytokine cell-signaling agent, pro-or anti-apoptotic agents, imaging agent or labeling agent diagnostic compound nanomaterial inhibitor or blocker. These precursors may include prodrugs. (See, e.g. “Liver-Targeted drug delivery using HepDirect1Prodrugs”). Erion, et. al. Journal of Pharmacology and Experimental Therapeutics, Fast Forward, JPET 312, 554-560, 2005, (stating that the first publication date was August 31, 2004), and ‘LEAPT: Lectin directed enzyme-activated drug therapy?, Robinson, et. al. PNAS, Oct. 5, 2004, vol. 101, No. 40, 14527-14532, stating published online before print Sep. 24, 2004 (, both of which are incorporated herein by reference. “Beneficial materials can be produced by converting prodrug into drug through an enzymatic reaction in the bloodstream, tissue, or organ (CYP450).

The delivery device described in this invention may use therapeutic agents known to those skilled in the art. The therapeutic agents can include agents that treat autoimmune diseases, osteoporosis or cancer, Type I and Type II diabetes or mental disorders like schizophrenia, depression or bipolar disorder.

Depending on intended use or application environment of the delivery device, delivery material can include at least one antibacterial, microbicides, antivirals, fungicides, transfection agents, or nanomaterial. In certain embodiments, delivery material can include a targeting molecule or tissue-specific marker, such as a tissue specific endothelial protein. “A tissue-specific targeting molecule or marker may help to target the delivery material at a specific tissue or location within an animal’s body.

The material delivery device described in this invention can be used to deliver medication with control, aimed at the treatment or prevention of diseases that are common in Third World countries. One skilled in the art would be familiar with such diseases, which include but are not restricted to those described herein. The embodiments of the material-delivery device can include programming the device to deliver at lease one material into the in-vivo environment, such as prior to deployment or after deployment. Programming may include steps to implement a long-term material delivery regimen, such as daily delivery over a period of weeks, months, or days. The device described in this application can be programmed to deliver a material on a regular basis, allowing for consistent blood levels. In order to maintain the desired blood concentration, some delivery regiments can take into consideration the pharmacokinetic characteristics of the substance. As described in this document, certain embodiments of a material delivery device can include sensors configured to sense an environmental parameter or a biological condition. The device can be programmed to react to the sensed parameter or condition. In order to avoid a recurrence or create immunity to a vaccine, some diseases or infections require the delivery of therapeutic materials over a period of months. One of ordinary skill in this art will readily recognize that the material-delivery device described in this application allows for a wide range of variations when delivering materials to animals, including humans. The user can program any aspect of the device’s function, including but not limited the quantity and concentration of material delivered, or control it remotely. “For example, the vaccine can be delivered using the material delivery device at a time interval that is pulsed or widely spaced.

Vaccines against HIV-1, which are widely known by those with expertise in the field, may contain a fragment or a portion of the HIV-1 membrane protein gp120. This includes the portion of gp120 bound to antibody b12. Immune system modulators or vaccine adjuvants may be used as other delivery materials. “A vaccine adjuvant can potentiate the immune response to an antigen or modulate it in the direction of the desired immune response.

The list of adjuvants includes mineral salts such as aluminum hydroxide, calcium phosphate, and aluminum salts. Other examples include oil emulsions such as MF59, ISCOMS, and Mont Phlei cell wall skeleton), RC-529 (synthetic acylated polysaccharide), DC_Chol, OM-174, CpG motifs, OM-174,

Other embodiments include delivery materials that can be delivered as needed and/or in the amount required, such as insulin or pain medications.

One or more material delivery devices described in this invention may be used to control therapeutic delivery of controlled substances materials in vivo, and/or to prevent abuse or addiction by the patient. Prescription pain medication or other potentially addictive material can be delivered according to a time-program or schedule that minimizes or avoids the possibility of abuse or addiction. Opioids, or narcotic painkillers, are some of the most commonly abused controlled substances. Opioids are commonly abused prescription medications that treat pain. Oxycodone (oxycodone), Vicodin(hydrocodone), Demerol(meperidine) are all opioids. Central nervous system depressants are also controlled substances that are used to treat anxiety disorders, panic attacks and sleep disorders. Examples include Nembutal, Valium, and Xanax. Other controlled substances include central nervous system stimulants that are commonly used to treat the sleeping disorder narcolepsy and attention-deficit/hyperactivity disorder. Ritalin, Dexedrine and methylphenidate are examples. These drugs can be addictive and enhance brain activity, increasing alertness and energy. The same means can be used to prevent or minimize the risk of overdosing. This is especially true when it comes to a subject’s individual characteristics or the current state of the drug.

The schedules that can be used with the material delivery devices described and claimed in this document are those that have been pre-established by a doctor, or the patient, according to a preset model or guidelines. A schedule can also be created based on a specific measurement, such as a physiological sensor described in this document.

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