Parenteral Administration of Drugs, Fluids, and Nutrients

Abstract

The present invention relates to the delivery of therapeutic agents to interstitial fluids and is designed to replace other forms of parenteral administration of fluids and drugs when appropriate. The invention features an expandable reservoir and stylet guide catheter made from mesh. The proposed catheter innovation includes a catheter for administering fluids and drugs and a mechanism for safely securing the catheter inside the reservoir to prevent accidental removal of the catheter. One method of securing the catheter is to place a self-inflating balloon on the catheter's proximal end.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Nonprovisional Patent Application No. 17,698,337, entitled “PARENTERAL ADMINSTRATION OF MEDICATIONS, FLUIDS, AND NUTRITION,” filed March 18, 2022, the entire contents of which are incorporated by reference herein.

[0002] The present invention relates generally to the parenteral administration of fluids and drugs, as well as to new methods of administering drugs via medical implant (pump) devices. [Background technology]

[0003] Currently, there are multiple methods for parenteral administration of drugs and fluids, the most common being subcutaneous (S / C), intravenous (IV), and intramuscular (IM). IV drug and fluid administration can be further subdivided into peripheral and central venous administration. Each method has its own advantages and disadvantages. The novel interstitial fluid administration via expandable reservoirs that we describe in this patent has advantages over current methods for parenteral administration of drugs and fluids in some applications.

[0004] The IV route is the most frequently used parenteral route of fluid administration. However, IV administration requires highly qualified medical personnel. Locate the vein, ensure the vein is not perforated, etc., and requires a lot of skill. Qualified medical personnel also need to maintain IV access for the duration of the infusion. Prolonged use of a vein for administration of drugs usually results in venous sclerosis. As a result, patients who require long-term IV administration of fluids or drugs often require a central venous placement or central venous catheter (CVC) that is inserted into a large vein. CVCs are often performed by radiologists under ultrasound guidance. Risks faced with peripherally inserted CVCs include damage to local structures, phlebitis at the insertion site, air embolism, hematoma, arrhythmia, and catheter failure. Late complications may also include infection, thrombosis, and catheter failure.

[0005] Due to the risks involved, an additional parenteral route for administration of fluids and drugs would be beneficial and preferred for many patients. The use of expandable reservoirs for administration of fluids and drugs would require much less time to install and minimal maintenance after installation. Interstitial fluid-filled reservoirs would also be highly beneficial in the event of a mass casualty incident (MCI) where multiple patients require treatment simultaneously and there are not enough medical personnel to provide the necessary medical care.

[0006] In cases of MCI, a significant number of patients die from hypovolemic shock, and survival rates improve significantly with timely administration of fluids and analgesics. Similar scenarios occur in developed countries when there is an epidemic of diarrheal disease and children die from dehydration. Expandable reservoirs take much less time to install and maintain, solving the problem of mismatch between the number of patients needing emergency care and the number of medical personnel available to provide it. Expandable reservoirs can replace central venous or umbilical venous catheters for administration of parenteral nutrition and medications in babies born prematurely.

[0007] Parenteral drug administration via an expandable reservoir can often replace IV administration. For example, when a patient requires long-term IV antibiotic treatment for urosepsis, or long-term IV administration of other drugs. In some cases, the use of an expandable reservoir will allow patients to receive medical care at home instead of in a hospital or skilled nursing facility. This technology will reduce medical costs and can save lives.

[0008] Another important application of expandable or non-expandable reservoirs may be with implantable, reloadable drug delivery systems and pumps. These medical devices will help address treatment compliance in patients with mental and cognitive deficiencies. The most important application of implantable and reloadable drug pumps is the treatment of substance use disorders (SUD) or drug abuse. In the case of SUD, it is the disease itself that prevents the patient from complying with treatment; the drug is not effective if the patient fails to take it.

[0009] Reloadable and implantable drug pumps are already used in medical practice. Reloadable devices store and deliver drugs to the intrathecal space (intracecal delivery systems) for the treatment of chronic pain and spasms. An example of this technology is the baclofen pump, or an opioid analgesic pump that delivers drugs intrathecally for pain management. One of the examples is the Synchromed™ intrathecal pump. In these cases, the drug is delivered directly to the cerebrospinal fluid (CSF). As a result, the formation of scar tissue around the catheter is avoided. Unfortunately, reloadable implantable medical pumps that deliver drugs outside the CSF are not widely used in medical practice. The formation of a "capsule" of scar tissue around any kind of implant "foreign body" is a normal part of the healing process. The body automatically reacts to any foreign body it detects and tries to isolate it by creating a barrier of scar tissue around it. The scar tissue prevents the administration of a precise dose, which is the main requirement of these medical devices. The problem of scar formation and precise dosing would be addressed by attaching a drug-eluting expandable or non-expandable reservoir to a reloadable implant delivery system. The drug-eluting reservoir slowly releases the drug to prevent scar formation. The implantable drug pump administers the drug into the open space created by the reservoir. Even if some scar tissue forms around the device, it would be difficult to seal the large surface of the reservoir compared to the small opening of the implantable device itself. Summary of the Invention

[0010] This Summary is provided to introduce various concepts in a simplified form that are further disclosed in the Detailed Description of the Embodiments. This Summary is not intended to identify key or essential inventive concepts of the claimed subject matter, nor is it intended to determine the scope of the claimed subject matter.

[0011] The embodiments provided herein relate to delivering therapeutic agents to interstitial fluids and are designed to replace other forms of parenteral administration of fluids and drugs, where appropriate. The invention features an expandable reservoir (1) made from mesh and a stylet guide catheter (2). The proposed catheter innovation includes a) a catheter for administration of fluids and drugs, and 2) a mechanism for safely securing the catheter inside the reservoir to prevent accidental removal of the catheter. One of the ways to secure the catheter is to place a self-inflating balloon on the catheter at its proximal end.

[0012] An advantage of the proposed system is that the catheter can be connected not only to its own infusion system, but also to any currently available infusion system. One of the examples is a patient-controlled anesthesia (PCA) pump. Depending on different applications, duration of treatment, and other factors, the mesh of the expandable reservoir can be made from different materials. For example, it can be made from synthetic or natural materials, as well as metals. In some embodiments, the reservoir can be composed of expandable metal Nitinol. The application and duration of treatment are the determining factors as to whether the mesh should be made from a biodegradable material. Depending on the application, the mesh can also be drug-eluted. Drug-eluted meshes can be used to increase absorption, prevent the growth of fibrotic tissue around the reservoir, or prevent infection.

[0013] Another part of the invention is the attachment of a drug-eluting mesh reservoir to an implantable drug delivery pump to combat the formation of scar and fibrotic tissue around the pump, which prevents accurate dosing, which is critical to the effectiveness of disease treatment.

[0014] Drug delivery is a very important area in providing medical care to patients. As a result, there are multiple prior arts related to this field. Most of the prior art medical devices are designed to work with proprietary infusion systems that are also part of each specific patent. An advantage of the proposed invention is its ability to work with commercially available drug infusion systems and PCAs. Another main difference is the expandable reservoir made from mesh with a port located at the proximal end of the reservoir. A catheter that is inserted into and removed from the reservoir as needed reduces the risk of infection due to constant exposure to the outside world.

[0015] (blank) [Brief description of the drawings]

[0016] A more complete understanding of the embodiments, and their attendant advantages and features, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings.

[0017] [Figure 1A] 1 illustrates a folded reservoir with a balloon inflation device, according to some embodiments.

[0018] [Figure 1B] 1 illustrates an expanded reservoir with a balloon expansion device, according to some embodiments.

[0019] [Figure 2A] 1 illustrates a mesh in a folded and expanded configuration according to some embodiments.

[0020] [Figure 2B] 1 illustrates an expanded reservoir, according to some embodiments.

[0021] [Figure 3A]1 illustrates a stylet having a catheter and a hub having two ports in addition to an inflatable balloon port and a port for administering fluids or medication, according to some embodiments.

[0022] [Figure 3B] 1 illustrates a catheter having a hub for administration of fluids or drugs with an inflated balloon, according to some embodiments.

[0023] [Figure 3C] 1 illustrates a catheter with an inflated balloon inside an expanded reservoir, according to some embodiments.

[0024] [Figure 4A] 1 illustrates an expanded reservoir with a catheter attached to an infusion system, according to some embodiments.

[0025] [Figure 4B] 1 illustrates an expanded reservoir with a catheter attached to an infusion system attached to a human body, according to some embodiments.

[0026] [Diagram 5] 1 illustrates an expanded catheter attached to a patient-controlled anesthesia (PCA) pump, according to some embodiments.

[0027] [Figure 6A] 1 illustrates a drug pump, according to some embodiments.

[0028] [Figure 6B] 1 illustrates a drug pump, according to some embodiments.

[0029] [Figure 6C] 1 illustrates a drug pump having an attached mesh reservoir, according to some embodiments.

[0030] [Figure 7] 1 illustrates a drug pump under the abdominal skin according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] Specific details of a single embodiment or various embodiments described herein are described in this application. Any specific details of the embodiments are used for illustrative purposes only, and no unnecessary limitations or inferences should be understood therefrom.

[0032] Before describing the exemplary embodiments in detail, it should be noted that the embodiments reside primarily in combinations of system-related components. Accordingly, device components have been represented where appropriate by conventional symbols in the drawings, and only those specific details relevant to an understanding of the embodiments of the present disclosure are shown, so as not to obscure the present disclosure with details other than those readily apparent to one of ordinary skill in the art having the benefit of the description herein.

[0033] As used herein, the term "mesh" refers to an interlaced structure created by a network of wires or threads.

[0034] As used herein, the term "reservoir" refers to a receptacle or portion of a medical device designed to hold interstitial fluid.

[0035] As used herein, the term "expandable reservoir" refers to a device having a permeable wall that is inserted into the human body when in a small, collapsed form and then expanded after insertion.

[0036] As used herein, the term "balloon technology" refers to an inflatable balloon inside a patient's body that expands when air is pumped into the balloon.

[0037] As used herein, the term "biodegradable material" refers to a material inserted into the human body that dissolves / disappears over time, thereby not requiring a separate procedure to remove the device made from it.

[0038] The expandable reservoir can be inserted in several parts of the body, for example, the arms, legs, or abdomen. The expandable reservoir is inserted in a folded form (as shown in FIG. 1A) under local anesthesia in different regions of the body. After insertion, the reservoir is expanded (as shown in FIG. IB) using balloon techniques or other methods. After the reservoir expansion is completed, the balloon will be deflated and removed. The reservoir is expanded to create an open space inside the reservoir. Once the reservoir is expanded, a stylet guide catheter (as shown in FIG. 3A-3B) is inserted into the reservoir through a port opening at the proximal end of the reservoir (as shown in FIG. 2A and FIG. 2B). The catheter is then secured inside the reservoir to prevent the patient from accidentally removing the catheter. FIG. 4A-4B illustrate several techniques that can be used to secure the catheter in place. For example, an inflatable balloon can be used to secure the catheter inside the reservoir. The balloon, its size being larger than the reservoir port, will prevent the catheter from being accidentally removed. In addition to the mechanism for fixing the catheter inside the reservoir, the catheter also has a drug port for administering fluids and medications. As shown in Figures 5 and 6, the drug port of the catheter is connected to an infusion system. After administering fluids or medications through the catheter, the small balloon will deflate and the catheter can be safely removed. Removing the catheter when not in use significantly reduces the risk of infection since there is no exposure to the outside world. If further medication is required, the disposable catheter can be safely replaced.

[0039] FIG 1A illustrates a collapsed reservoir with a balloon inflation device. The collapsed reservoir 11 includes a stylet 14. The collapsed reservoir 11 may be constructed of a mesh 13. A syringe 12 or other device is connected to the collapsed reservoir 11 to provide inflation, as shown in FIG 1B, which illustrates the expanded reservoir 11.

[0040] 2A and 2B illustrate the mesh in a collapsed and expanded configuration. A port 21 is positioned within the reservoir to allow a catheter to be inserted therein for administration of fluids and medications.

[0041] FIG 3A illustrates a catheter and stylet with a hub having two ports in addition to an inflatable balloon port and a port for administration of fluids or drugs. A needle 31 communicates with a balloon inflation port 32 and a hub 33 for administration of drugs and / or fluids. FIG 3B illustrates a catheter (needle) 31 with a hub 33 for administration of fluids or drugs with an inflated balloon 34. FIG 3C illustrates a catheter (needle) 31 with an inflated balloon 34 inside an expanded reservoir 35.

[0042] Figure 4A illustrates an expanded reservoir 11 with a catheter 31 attached to an infusion system 41. Figure 4B illustrates an expanded reservoir 11 with a catheter 31 attached to an infusion system 41 attached to the body.

[0043] FIG. 5 illustrates an expanded reservoir 11 catheter 31 attached to a patient-controlled anesthesia (PCA) pump 53 having a control unit 54 that includes an IV fluid delivery system 55 in communication therewith.

[0044] Figures 6A-6C illustrate an implantable drug pump 61 and attached mesh 62. Figure 6B illustrates an implantable drug pump 61 having mesh 62 and a second port 63 for recharging drug via a drug recharge infusion system 64.

[0045] FIG. 7 illustrates an abdominal under-skin drug pump having a drug replacement infusion system 64 and a drug pump 65 positioned under the abdominal skin.

[0046] Reservoir Material The choice of material used for the reservoir should depend on the application and duration of treatment. Another important consideration would be the need to remove the expandable reservoir at the end of treatment. For example, if the reservoir is used in a hospice environment with PCA, removal of the reservoir is not necessary. The reservoir can be made of other suitable materials, including biodegradable polymers, synthetic or natural materials, or metals, depending on the application. A biodegradable material or polymer is defined as one that is capable of being broken down into harmless products by the action of the human body. The reservoir can elute a drug, if necessary. The material selected for the reservoir should not cause side effects in humans. Similarly, the drug-eluting reservoir is designed to inhibit the formation of collagen and fibrotic tissue around the reservoir. The drug-eluting reservoir releases the drug over time.

[0047] For diseases requiring a relatively short treatment period, the biodegradable reservoir from the biodegradable material would preferably be drug-free or have a drug eluted from it. One example of a short-term use of the reservoir is the treatment of dehydration caused by diarrhea or hypovolemic shock. Other applications may require a much longer treatment period, for example using antibiotics or long-term parenteral nutrition that may use non-degradable materials.

[0048] If metal wire is the most convenient material for the reservoir for the application, the metal should be selected from metals already used in other medical devices, for example, cardiovascular stents. The advantage of using metals already used in other Class 3 medical devices is their proven safety record. These metals include, but are not limited to, L-605 cobalt chrome, cobalt alloy, F-562 cobalt chrome, 316L stainless steel, platinum chrome, 316L stainless steel (iron, chromium, nickel, molybdenum).

[0049] Preferably, the drug in the drug-eluting reservoir may be selected from drugs that already have a proven record of inhibiting the growth of scar tissue, such as sirolimus, everolimus, umirolimus, novolimus, and paclitaxel. These drugs have been successfully used in cardiac drug-eluting stents for the same reasons. However, other drugs that inhibit scar formation may be used as well. For example, the drug-eluting reservoir may also use the enzyme hyaluronidase. Hyaluronidase "decomplexes" hyaluronic acid, an essential component of the extracellular matrix (ECM). Hyaluronidase enhances the diffusion capacity and bioavailability of the injected drug.

[0050] Examples of biodegradable materials that can be used for the biodegradable reservoir are polygalactin 910 or antibacterial (polyglactin 910), monocryl or monocryl antibacterial, or made of organic materials, such as chromic gut.

[0051] Subcutaneous Fluid Administration vs. Fluid Administration via a Reservoir Subcutaneous (SC) routes of fluid and drug administration can be used in the management of unhealthy elderly patients who have inadequate venous access or are unable to tolerate intravenous cannulation, presenting a common and difficult challenge to clinicians (Barton et al 2004). In some cases, subcutaneous infusion SC (subcutaneous drip) is used in palliative care when IV access is difficult. However, the volume of fluid that can be administered SC is significantly lower compared to IV fluid administration. The rate of fluid administration via subcutaneous drip is usually 50-60 ml / h (Barton et al 2004, Caccialanza et al 2018). The skin of elderly patients is also much less elastic, making the administration of fluids much easier, which is not the case for younger patients. SC fluid administration also requires significant nursing supervision, as needles can easily become dislodged. In many cases, administration of fluids via an expandable reservoir would be a better option.

[0052] Absorption of fluids, total parenteral nutrition (TPN), and drugs after IM, SC, or expandable reservoirs is based on passive and active diffusion. Active diffusion is drug specific. However, passive diffusivity follows Fick's law of diffusion. The rate of diffusion is directly proportional to the difference between surface area and concentration. Diffusion rate = surface area * concentration gradient / membrane thickness.

[0053] A significant increase in surface area for absorption dramatically increases the rate at which fluids, TPN or drugs can be delivered over a period of time.

[0054] In S / C injection, the absorption surface area is approximately equal to the end of the needle. However, a small bubble forms around the needle, and it can be assumed that the bubble radius has a surface area of ​​0.5 cm. The volume of fluid that S / C can be administered is 1 cc / min or 62 cc / hr (Caccialanza et al. 2018), and the surface area of ​​the sphere at the end of the needle is A=4πr 2 , A=A=4π1 2 =4πcm 2 And its volume is V=4 / 3πr3 , V=4 / 3*3.14*1 3 It is.

[0055] The surface area of ​​the reservoir is significantly larger and depends on its size. The surface area of ​​a cylinder 1 cm wide and 4 cm long is: A=2πr 2 , A=2πl 2 =2πcm 2 , Surface area without top and bottom S=4cm*2π=8πcm 2 , adding the upper and lower parts, A=2π*2=4πcm 2 , so the total surface area is 4π+8π=12πcm 2 It is. The cylinder volume is A=2πl 2 *h, where A=2πcm 2 *4cm=8πcm 3 It is.

[0056] The surface area increases as the cylinder size increases. [Table 1]

[0057] Absorption is further enhanced if the fluid is administered under physiological positive pressure. The amount of fluid administered via the expandable reservoir should be sufficient to treat moderate to severe dehydration in children in developing countries. In cases of more severe dehydration, when large volumes of fluid are required over a relatively short period of time, two reservoirs at two different sites or a larger size reservoir can be used. The advantage of using the reservoir approach for IV fluids is that the reservoir can be placed very quickly and does not require nursing staff to maintain it.

[0058] Dehydration reduces the fluid content of blood, which in turn increases oncotic pressure in the capillaries, and since oncotic pressure plays an important role in the reabsorption of fluid from tissues back into the vascular system, dehydration will further improve absorption.

[0059] Pressure Difference: Pressure difference is another factor that increases absorption. The increase in pressure inside the reservoir also increases the movement of drugs and fluids into the systemic circulation. Often, when advanced equipment is not available, the gravity of the water created by an IV fluid bag suspended on a pole delivers the drug to the IV line at a safe and steady rate.

[0060] Determine water pressure. Use the formula: Pressure (P) = 0.43 x height of the water column in feet (h). We use the constant 0.43 (lbs / in^2) / ft because this is the amount of pressure a foot of water exerts on a surface below it, regardless of the volume of water.

[0061] However, to increase absorption, fluids can be administered at pressures close to the arterial end net filtration pressure to closely mimic the arterial end net filtration pressure. The pressures used to administer fluids and drugs should be close to or slightly above the filtration pressure of +10mm. Specialized pumps or other devices can be used to deliver the optimal pressure.

[0062] Treatment of dehydration and volume loss due to trauma Diarrhea is the second leading cause of death in children under the age of 5. According to the WHO, diarrhea kills approximately 525,000 children under the age of 5 each year in developing countries, with the majority of these patients dying from dehydration.

[0063] Although the IV route is a very effective way to provide hydration or nutrition to patients with severe dehydration, IV access is not always possible or feasible, for example, when dehydration causes venous collapse, the patient is agitated, or the patient has fragile veins. Qualified medical personnel are required to maintain venous access and prevent vein perforation and extravasation. In epidemics, developing countries often lack the qualified personnel to obtain and maintain IV access in multiple patients simultaneously.

[0064] In these cases, alternative means of fluid delivery would be life-saving. Currently, there are two possible alternative routes for fluid administration: subcutaneous injection and intraosseous injection (administering fluid inside the bone) R.Caccialanza et al 2017. Intraosseous fluid administration requires highly qualified personnel and, if performed incorrectly, can result in fractures and osteomyelitis. As a result, subcutaneous injection (or subcutaneous drip) has the advantage of being the most direct approach. Subcutaneous fluid administration is usually delivered by gravity or an infusion pump. Gravity injection can help prevent local edema, as the infusion rate naturally slows with increasing pressure in the subcutaneous space. The rate of infusion should remain within the limits of tissue perfusion. A typical infusion rate is 62mL / hour (or 1cc / min) R.Caccialanza et al 2017.

[0065] However, in severe dehydration, it is crucial to administer large volumes of fluid relatively quickly. As a result, fluid administration via interstitial fluid reservoirs would have advantages over s / c fluid administration. Reservoirs allow for the administration of large volumes over a shorter period of time.

[0066] In severe dehydration, an initial bolus of 20ml / kg of fluid is recommended. A bolus of fluid is not possible with s / c fluid administration or an interstitial reservoir. The only way to administer a bolus of fluid is via IV. However, placing an IV, especially in a severely dehydrated young patient, is often time consuming as the veins collapse due to dehydration. In comparison, fluid administration via a reservoir can be started within 5 minutes and does not require nursing staff to maintain it. Venous collapse due to dehydration makes it difficult to find a suitable vein for infusion. Reservoir fluid administration would allow for increased fluid administration during the first few hours of fluid administration to compensate for the bolus. In the most severe cases, two reservoirs can be used.

[0067] If the patient weighs less than 10 kg, give 100 mL / kg / day. For IV administration, a patient weighing 10 kg would receive a 200 cc bolus, followed by 42 cc / hr after the bolus (10 kg would receive 1000 mL / 24 hr, or 42 cc / hr).

[0068] The patient can receive 180cc / hr of fluid via the reservoir (Table 1), so a 200cc bolus can be administered over 1.2 hours, followed by 42cc / hr of maintenance fluid.

[0069] If the patient weighs less than 20 kg, give 1000 mL / day plus 50 mL / kg / day for each kilogram between 10 and 20 kg. For example, for a 20 kg child, give 1,500 mL / 24 hours or 62.5 cc / hour. A bolus of 400 mL can be given over 2.5 hours.

[0070] If the patient weighs over 20 kg, give 1500 mL / day plus 20 mL / kg / day for each kilogram over 20 kg. For 30 kg, the optimal fluid volume is 1700 ml / 24 hrs or 70 cc / hr. Boluses can be given over several hours or a second reservoir can be used.

[0071] In the United States, the technology can be used in cases of mass casualties or military personnel injured during war. In these cases, there are a large number of individuals who need to replace the amount of blood lost, but there are not enough medical personnel to accommodate all patients. In many cases, correcting the hypovolemia would be life-saving. Shock significantly reduces blood flow to the subcutaneous tissue, which adversely affects the perfusion of the subcutaneous tissue and makes s / c fluid administration much less feasible. As a result, an expandable reservoir would be a much better option and could be used immediately in the field.

[0072] Total Parenteral Nutrition Interstitial fluid administration can be beneficial for parenteral nutrition administration (TPN). In many chronically ill patients, the veins are collapsed and these patients depend on the central vein for both TPN and administration of other medications. Zaloga et al 2016 demonstrated that TPN can be administered s / c in elderly patients. However, only a limited amount of 62 ml / h can be administered s / c. Caccialanza et al 2016. However, since the s / c line can easily become dislodged with patient movement, it can only be performed in settings where medical personnel are always available (nursing homes or hospitals, not in the patient's home). As a result, current guidelines recommend IV administration of TPN. Interstitial fluid via a reservoir with interstitial fluid would be a good alternative for TPN administration. The use of reservoir administration of TPN can also be used to treat preterm infants who cannot take oral nutrition due to premature birth. Many of these babies currently receive TPN via a central line (umbilical vein). However, umbilical vein catheterization carries a high risk of complications. As with all central venous access, complications of placement include uncontrolled bleeding, infection, injury to adjacent structures, thrombosis, and placement within an artery. Specific to umbilical venous catheters, patients are at risk of placement of the catheter within the portal venous system, which can cause hepatic necrosis. Reports have also described liver abscesses, portal vein thrombosis, and cavernoma formation. Due to the small volume of the neonatal venous system, central lines must be flushed with saline to ensure there is no air within the line to prevent air embolism. Inadvertent placement in the umbilical artery can cause catheter occlusion or thrombosis of the limb arterial supply, resulting in limb ischemia (Lewis et al., 2020). Placement within the right atrium can cause perforation and subsequent pericardial effusion. Overall, complication rates for umbilical venous catheters are similar to those for percutaneously placed central venous catheters (Lewis et al., 2020). In many cases, the use of an interstitial fluid reservoir may be a better option.

[0073] Drug administration For patients who require a central line because peripheral access is not available, using an interstitial fluid reservoir can often be a better option. A central line (or central venous catheter) is like an intravenous (IV) line. It is much longer than a normal IV and reaches into veins close to or just inside the heart. It can also be used to withdraw blood. A central line requires a highly qualified person (an interventional radiologist) for placement. It must be managed by a highly qualified person to prevent infection, formation of blood clots, and migration of the catheter to places where it can cause a lot of harm. However, for many of those who do not have peripheral access, a central line is the only option currently available. In some cases, an interstitial fluid reservoir can replace the need for central line placement. An interstitial fluid reservoir can also be used to replace IV antibiotics to treat severe infections such as sepsis that require prolonged antibiotic use for 14 days or more for patients who do not have peripheral veins. Another application of an interstitial reservoir would be the administration of chemotherapy. Chemotherapy must currently be administered in many cases at special infusion centers to ensure the sterility and integrity of central lines in immunocompromised patients. The use of interstitial reservoirs instead of central lines would reduce healthcare costs.

[0074] Managing pain outside the hospital environment One of the most important pain management options for pain is Patient-Controlled Analgesia (PCA), which gives the patient the ability to control the administration of medication and titrate the administration of the medication itself according to the individual's pain tolerance. Patient-Controlled Analgesia (PCA) is the most important application for interstitial fluid reservoirs and administration of medication for patient pain in hospice patients. Patient-Controlled Analgesia (PCA) pumps are computerized machines that release medication when the patient presses a button. PCA is self-administered on-demand analgesia. PCA is commonly used in hospitals to manage post-operative pain, and pain caused by many diseases such as sickle cell anemia or cancer. The autonomy of the patient's self-determination of the timing of analgesic administration is perhaps the fundamental advantage of PCA. Higher pain scores have previously been correlated with higher anxiety levels. Many patients experience a reduction in anxiety and therefore improved analgesia due to the autonomy of PCA use. However, PCAs require connection to an IV, and IVs are very difficult to maintain at home, which is why PCAs are only available in hospitals or skilled nursing facilities and not at home.

[0075] In most cases, PCA pumps deliver opioid pain management medications such as morphine, fentanyl, and hydromorphone, all of which can be administered IM, IV, and SC, and therefore, they can also be administered via an expandable reservoir.

[0076] Other drugs can be administered through the reservoir as well, for example chemotherapy or drugs to control seizures.

[0077] Drug implants Intrathecal pumps are implantable, reloadable drug delivery systems that deliver drugs to the spinal fluid and have been commercially available for many years. However, there are no reloadable pumps that deliver drugs outside the intrathecal space. Scar tissue, the formation of connective tissue around the implant that prevents accurate administration of drugs. Attaching a reservoir to the implantable technology would allow administration of drugs in the interstitial fluid. This implantable, reloadable drug delivery system is important because it would be able to address drug compliance.

[0078] The most important application for the use of these types of implants is the treatment of substance use disorders (SUDs), where the disease itself prevents the patient from complying with treatment. For example, this technology allows the development of disulfiram implants, which would be a highly effective and safe treatment for alcohol use disorder (AUD). However, the same technology can be used to administer other drugs for the treatment of SUDs. In many cases, like disulfiram, other forms of injectable depot formulations are not an option.

[0079] Many different embodiments have been disclosed herein in connection with the above description and drawings. It is understood that describing and illustrating every combination and subcombination of these embodiments would be overly repetitive and literally obfuscating. As such, all embodiments can be combined in any manner and / or combination, and the present specification, including the drawings, shall be construed as constituting a complete written description of all combinations and subcombinations of the embodiments described herein, and the manner and process of making and using them, and shall support all claims to any such combination or subcombination.

[0080] It will be appreciated by those skilled in the art that the present embodiments are not limited to what has been particularly shown and described above. Various modifications and variations are possible in light of the above teachings without departing from the scope of the following claims.

Claims

1. 1. A device utilized for administration of drugs, fluids, or parenteral nutrition, comprising: a mesh insertable under the skin in a folded configuration, the mesh being expanded and utilized with a stylet connected to secure the mesh to an injection system; a mechanism for fixing a position within a reservoir utilized for administration of a drug, fluid, or parenteral nutrition; device.

2. The device of claim 1 , wherein the mesh is expanded and utilized with a needle guiding catheter.

3. The device of claim 1 , wherein the reservoir is expanded via a balloon.

4. The device of claim 1 , wherein the mesh is comprised of bare metal or a metal mesh.

5. The device of claim 1 , wherein the mesh elutes a drug to reduce interstitial tissue proliferation.

6. The device of claim 1 , wherein the mesh of the reservoir is constructed from a biodegradable polymer.

7. The device of claim 6 , wherein the mesh is coated with the enzyme hyaluronidase.

8. The device of claim 1 , wherein the reservoir is used in conjunction with a patient-controlled anesthesia pump.

9. The device of claim 1 , wherein the reservoir is used to treat dehydration.

10. The device of claim 1 , wherein the reservoir is used to treat hypovolemic shock.

11. The device of claim 1 , wherein the stylet is secured by an inflatable balloon.

12. The device of claim 1 , wherein the needle guiding catheter is secured by an inflatable balloon.

13. The device of claim 1 , wherein the disposable reservoir is attached to a reloadable implantable device to create an open space around the implantable device for administering one or more drugs.

14. The device of claim 1 , wherein the non-expandable reservoir is reloadable and attached to the implantable device to create an open space around the implantable device for administering one or more drugs.

15. 14. The device of claim 13, wherein the reservoir is used to administer the one or more drugs to treat a substance use disorder.

16. The device of claim 1 , wherein the rechargeable, implantable device is used to administer naltrexone.

17. The device of claim 1 , wherein the rechargeable, implantable device is used to administer disulfiram.

18. The device of claim 1 , wherein the reservoir and the catheter comprise a single device.

19. The device of claim 1 , wherein the reservoir is constructed of expandable metallic Nitinol.

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