Patent Publication Number: US-8535260-B2

Title: Devices, systems, and methods for localized drug delivery

Description:
PRIORITY 
     The present application is related to, and claims the priority benefit of, U.S. Provisional Patent Application Ser. No. 61/105,510, filed Oct. 15, 2008, the contents of which are incorporated herein by reference in their entirety. 
    
    
     BACKGROUND 
     Medications traditionally have been administered in various ways, including orally, subcutaneously, intramuscularly, or intravenously. Other drug delivery systems include transdermal patches, membrane-encased cells genetically engineered to secrete a desired drug (e.g., nerve growth factor or insulin), and slow-release drug systems. Traditional routes of administration require patients to actively follow dosing instructions, for example, when medication is administered orally, such as an antibiotic, hormone, or vitamin, or when repeated visits to the doctor are necessary because the route of administration is by injection. These methods of administration are especially problematic in cases where the patient is a child, elderly, or where the medication must be administered on a chronic basis. Generally, compliance with taking medication is a problem for many adults as they simply forget to take it as recommended or required. 
     Transdermal patches are used currently to administer drugs such as hormones, estrogen, nicotine, and nitroglycerin (for angina or chest pain). While such a system has been shown to be effective in certain instances, a drug must penetrate the skin barrier in order to be administered via a transdermal patch. Many drugs cannot be administered in effective amounts transdermally. Other slow-release delivery systems are useful, but they require the removal of the matrix itself after the drug has been completely absorbed. Hence, surgery is required to insert the composition and to remove the exhausted matrix from the patient. 
     Since the sustained release of biological agents was established several decades ago, the sustained release has been advanced by controlling the diffusion of drugs through polymeric matrices and/or the degradation of these polymers. Recently, drug release in proportion to internal or external stimuli has become recognized, which can be achieved by using stimuli-responsive polymeric materials. Many of these polymers achieve their functions by changes in temperature, pH, glucose concentration, and the release of ribosomal enzymes. Biodegradable polymers have great potential for applications as implantable carriers for drug delivery systems. With an auto-feed-back drug delivery system, several physiological changes in a living body can be utilized as the signal inducing polymer degradation and subsequent drug release. 
     The sustained delivery of antibiotic pharmaceutical agents is often desirable for the treatment of intractable fungal and bacterial infections. Methods of slow drug release have considerable pharmacodynamic advantages over long-term intravenous drug therapy. The former may result in shorter hospitalizations and greater degrees of compliance, and may eliminate the need for indwelling catheters. Slow drug release is usually achieved either by incorporation of a therapeutic drug into an implantable reservoir or by implantation of biodegradable materials containing the desired drug. The development of biodegradable antimicrobial compounds is particularly appealing for the treatment of postsurgical infections and of focal infections in immuno-compromised patients. Efficacies of slow drug release systems are usually determined by measurement of concentrations of the implanted drug in plasma or by assessment of the underlying disease treated (e.g., improving infection or decrease in the size of cancer, etc.). 
     For chronic heart problems, slow drug release with therapeutic factors having angiogenic, myogenic, and antiarrhythmic potential is very important. The local drug release avoids using larger concentrations or doses to avoid systemic effects. The disclosure of the present application introduces devices, systems, and methods by which implants (biological, chemical or electrical) can be delivered to a tissue and/or organ to provide long term therapeutics. 
     BRIEF SUMMARY 
     In at least one embodiment of a device for localized drug delivery of the present disclosure, the device comprises at least one drug release portion comprising at least one drug to be released over time and a binder intermixed with the at least one drug, wherein the binder is biologically degradable within a mammalian body at a first rate of degradation, and also comprises at least one resorbable anchor portion coupled to the at least one drug release portion, wherein the at least one resorbable anchor portion is biologically degradable within the mammalian body at a second rate of degradation, wherein the second rate of degradation is slower than the first rate of degradation. In an exemplary embodiment, and when the device is anchored to a tissue or organ within the mammalian body, as the binder degrades and the at least one drug is released into the mammalian body, the at least one resorbable anchor portion maintains its anchored position within the tissue or organ. In another embodiment, wherein when the device is positioned within the mammalian body, as the binder degrades at the first rate of degradation the at least one drug is released into the mammalian body. 
     In at least one embodiment of a device for localized drug delivery of the present disclosure, the device comprises a configuration selected from the group consisting of a pin configuration, a hook-pin configuration, and a chip configuration. In an additional embodiment, the at least one resorbable anchor portion comprises at least one barb and at least one point-tip. In yet another embodiment, the at least one resorbable anchor portion comprises at least one coil. In at least one embodiment, the tissue or organ within the mammalian body comprises a mammalian heart. 
     In at least one embodiment of a system for localized drug delivery of the present disclosure, the system comprises a tube having a proximal end and a distal end, the tube defining a first opening at the proximal end and a second opening at the distal end, the tube sized and shaped to facilitate placement of a resorbable device within a mammalian body by delivering the resorbable device from the second opening of the tube to a location within the mammalian body, and the resorbable device comprising at least one drug release portion and at least one resorbable anchor portion intermixed with the at least one drug release portion. In another embodiment, the system further comprises a shaft positioned within the tube, the shaft having a longitudinal axis, a proximal end, and a distal end, wherein the shaft is operable to facilitate placement of the resorbable device within the mammalian body. In yet another embodiment, the system further comprises an embolus positioned at or near the distal end of the shaft, wherein the embolus is sized and shaped to facilitate placement of the resorbable device within the mammalian body. In an additional embodiment, the shaft is rotatable about its longitudinal axis, and wherein the rotation of the shaft is operable to facilitate placement of the resorbable device within the mammalian body. 
     In at least one embodiment of a system for localized drug delivery of the present disclosure, the system further comprises a spring positioned at or near the distal end of the shaft between the shaft and the embolus, the spring capable to facilitate placement of the resorbable device within the mammalian body. In another embodiment, the system further comprises an embolus positioned at or near the distal end of the shaft, wherein the embolus is sized and shaped to facilitate placement of the resorbable device within the mammalian body. In an additional embodiment, the introduction of a gas at or near the proximal end of the tube facilitates placement of the resorbable device within the mammalian body. 
     In at least one embodiment of a system for localized drug delivery of the present disclosure, the tube comprises an engagement catheter. In at least one embodiment, the engagement catheter comprises a suction engagement steering catheter. In another embodiment, the suction engagement steering catheter comprises a skirt positioned at the distal end of the suction engagement steering catheter, the skirt operable to reversibly engage a tissue or organ within the mammalian body to facilitate placement of the resorbable device within the mammalian body. In at least one embodiment, the at least one drug release portion comprises at least one drug to be released over time and a binder intermixed with the at least one drug, the binder biologically degradable within a mammalian body at a first rate of degradation, and wherein the at least one resorbable anchor portion is biologically degradable within the mammalian body at a second rate of degradation, the second rate of degradation being slower than the first rate of degradation. 
     In at least one embodiment of a method for localized drug delivery of the present disclosure, the method comprises the step of positioning a resorbable device of the present disclosure within a mammalian body, wherein the resorbable device comprises at least one drug release portion comprising at least one drug to be released over time and a binder intermixed with the at least one drug, and further comprising at least one resorbable anchor portion coupled to the at least one drug release portion. In at least one embodiment, the step of positioning the resorbable device within the mammalian body comprises the steps of placing the resorbable device within a tube, introducing the tube within the mammalian body at or near a tissue or organ within the mammalian body, and anchoring the resorbable device to the tissue or organ. In another embodiment, the step of anchoring the resorbable device to the tissue or organ is performed using a shaft positioned within the tube. In yet another embodiment, the step of anchoring the resorbable device to the tissue or organ is performed using a gas from a gas source introduced into the tube to facilitate placement of the resorbable device. In an additional embodiment, the tissue or organ within the mammalian body comprises a mammalian heart. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  shows a block diagram of an exemplary composition of at least one embodiment of a resorbable device according to the present application; 
         FIG. 1B  shows a block diagram of another exemplary composition of a resorbable device according to the present application; 
         FIGS. 2A and 2B  show exemplary embodiments of resorbable devices according to the present application having a pin configuration; 
         FIG. 2C  shows an exemplary embodiment of a resorbable device according to the present application having a hook-pin configuration; 
         FIG. 2D  shows an exemplary embodiment of a resorbable device according to the present application having a chip configuration; 
         FIG. 2E  shows an exemplary embodiment of a resorbable device according to the present application having a coiled resorbable anchor portion; 
         FIGS. 3A and 3B  show cross-sectional views of an exemplary embodiment of a delivery system according to the present application having a tube, a shaft, a spring, and an embolus, wherein the delivery system is used to position a resorbable device at a tissue and/or organ; 
         FIG. 3C  shows a cross-sectional views of an exemplary embodiment of a delivery system according to the present application having a tube, a shaft, a spring, and an embolus, wherein the delivery system has a notable curvature useful to facilitate positioning a resorbable device at a tissue and/or organ; 
         FIGS. 4A and 4B  show cross-sectional views of an exemplary embodiment of a delivery system according to the present application having a tube, a shaft, and an embolus, wherein the delivery system is used to position a resorbable device at a tissue and/or organ; 
         FIGS. 5A and 5B  show cross-sectional views of an exemplary embodiment of a delivery system according to the present application having a tube and an embolus, wherein the delivery system is used to position a resorbable device at a tissue and/or organ using a gas; 
         FIGS. 6A and 6B  show cross-sectional views of an exemplary embodiment of a delivery system according to the present application having a tube, a shaft, and an embolus, wherein the delivery system is used to position a resorbable device at a tissue and/or organ by rotating the shaft about its longitudinal axis; 
         FIG. 7  shows a cross-sectional view of an exemplary embodiment of a delivery system according to the present application having an engagement catheter with an optional skirt, a shaft, and an embolus, wherein the delivery system is used to position a resorbable device at a tissue and/or organ; 
         FIG. 8A  shows an exemplary embodiment of a resorbable device of the present application having a hook-pin configuration positioned at a tissue and/or organ; 
         FIGS. 8B and 8C  show cross-sectional views of an exemplary embodiment of a delivery system according to the present application having a tube, a shaft, and an embolus, wherein the delivery system is used to position a resorbable device having a hook-pin configuration at a tissue and/or organ; 
         FIG. 9A  shows an exemplary embodiment of a resorbable device according to the present application having a chip configuration; 
         FIG. 9B  shows an exemplary embodiment of a resorbable device according to the present application having a chip configuration positioned at a tissue and/or organ; 
         FIG. 9C  shows a cross-sectional view of an exemplary embodiment of a delivery system according to the present application having a tube, a shaft, and an embolus, wherein the delivery system is used to position a resorbable device having a chip configuration at a tissue and/or organ; 
         FIG. 10A  shows an exemplary embodiment of a resorbable device according to the present application positioned at a tissue and/or organ; 
         FIG. 10B  shows an exemplary embodiment of a resorbable device according to the present application positioned at a tissue and/or organ wherein the drug release portion of the resorbable device has start to biologically degrade allowing the release of drug; 
         FIG. 10C  shows an exemplary embodiment of a resorbable device according to the present application positioned at a tissue and/or organ wherein the drug release portion has completely biologically degraded; 
         FIG. 10D  shows an exemplary embodiment of a resorbable device according to the present application positioned at a tissue and/or organ wherein the resorbable anchor portion of the resorbable device has start to biologically degrade; 
         FIG. 10E  shows an exemplary embodiment of a resorbable device according to the present application positioned at a tissue and/or organ wherein the drug release portion and the resorbable anchor portion have both completely biologically degraded; 
         FIG. 11A  shows an exemplary embodiment of a delivery system according to the present application used to position a resorbable device within a heart; 
         FIG. 11B  shows an exemplary embodiment of a resorbable device according to the present application positioned at a heart septum; and 
         FIG. 12  shows a block diagram of an exemplary method of positioning a resorbable device within a body according to the present application. 
     
    
    
     DETAILED DESCRIPTION 
     The disclosure of the present application provides various devices and systems for localized drug delivery and methods for using the same. For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of this disclosure is thereby intended. 
     The devices, systems, and methods of the disclosure of the present application allow patients to receive medications in a slow-release, self-absorbing/resorbable form at various time intervals, for example, from days to weeks to months. In at least one embodiment, one or more drugs may be released at intervals of about one month, depending on the rate of absorption of the associated matrix. Exemplary devices of the present disclosure may be used as an implantable, slow-release, self-absorbing pharmaceutical composition containing one or more active agents in combination with a biologically-compatible, self-absorbing matrix useful to deliver the pharmaceutical composition to the bloodstream and/or directly to a bodily tissue and/or organ. Such devices may also be a pacemaker-type device or similar electronics to transmit electrical therapy (pacing, resynchronization or defibrillation) chronically and as needed. As referenced herein, the terms “self-absorbing” and “resorbable” refer to properties of various devices which are biologically absorbable within a mammalian body as described in further detail herein. 
     The disclosure of the present application discloses devices providing an implantable pharmaceutical composition containing the active substance in a biologically-compatible, self-absorbing matrix. Further, the disclosure of the present application provides an implantation device for implanting such pharmaceutical compositions in various bodily tissues including, for example, myocardial muscle. In at least some embodiments of a device of the disclosure of the present application, the device comprises a slow-release, self-absorbing, pharmaceutical composition containing one or more active agents in combination with a biologically-compatible, self-absorbing matrix to treat patients with congestive heart failure (using, for example, various beta blockers, anticalcic agents, and/or cardiotonic drugs), coronary vasodilators in patients with refractory angina, anti-arrhythmic drugs, pulmonary vasodilators (PG1) to treat primary pulmonary hypertension, anticoagulation therapy (using, for example, fibrinolitics and/or antiadhesive platelets treatment), antibiotics for chronic fungal or bacterial cardiac infections or pulmonary infections (e.g., cystic fibrosis lung disease), and anti-rejection drugs (heart transplants), for example. 
     In addition to the foregoing, there are particular sites within the myocardium which may benefit from local drug release therapy. Examples include ischemic sites and arrhythmogenic sites for localized use of fibrinolitic or anticoagulation therapy or vasodilators. The local delivery of agents within such tissues will minimize the dilution of agents and decrease the possibility of the agents being delivered to inappropriate sites. This localized delivery is important, for example, for antiarrhythmic agents whose pro-arrhythmia systemic effects have been well recognized. 
     In at least one embodiment of a system and/or device of the present application, the system and/or device comprises an engagement-suction catheter that can deliver drugs to specific and precise “target” within the heart or other organ(s) and/or tissue(s). The disclosure of the present application is intended for minimally invasive delivery of agents for the treatment of medical conditions, for example, those conditions in the heart or adjacent veins and arteries where precision injection of genes or other agents is required in the treatment of the patient. Available epidemiologic, pharmacologic, and clinico-therapeutic evidence demonstrates how the chronobiologic approach to ischemic heart disease can contribute new insight and opportunities to improve drug design and drug delivery to enhance therapeutic outcomes. In at least one embodiment of a device, system, or method of the present disclosure, an objective is to make drug delivery to the endocardial surface of the heart very specific and precise. 
     At least one embodiment of a device of the present application is shown in the block diagram of  FIG. 1A . As shown in  FIG. 1A , an exemplary device (generally referred to herein as a resorbable device  100 ) comprises at least two components, namely a drug release portion  102  and a resorbable anchor portion  104 . Drug release portion  102 , in order to facilitate the delivery of a drug over time as described herein, is configured so that a drug is capable of at least localized delivery within a patient&#39;s body after resorbable device  100  has been implanted therein. For purposes of the present disclosure, a “drug” shall mean at least one of any number of therapeutics, pharmaceuticals, vitamins, antibiotics, hormones, and the like. The disclosure of the present application does not intend for the term “drug” to be limited to, for example, a prescription medication. 
     Drug release portion  102  may comprise any number of configurations for the release of a drug over time. For example, drug release portion  102  may comprise a drug combined with a binder/filler, whereby as the binder/filler breaks down over time within the body, the drug is released over time. Drug release portion  102  may comprise, for example, a biologically-compatible, resorbable matrix that biodegrades over time once positioned within a patient&#39;s body. Drug release portion  102  may also comprise a drug positioned within a biodegradable shell, wherein the drug may be released within a body as the biodegradable shell degrades, is absorbed, or is digested within a body. 
     In the exemplary embodiment of a resorbable device  100  shown in the block diagram of  FIG. 1B , resorbable device  100  comprises a drug release portion  102 , wherein drug release portion  102  comprises a drug portion  106  and a binder  108  either bound to and/or around drug portion  106 , whereby the use of the binder  108  allows the drug within drug portion  106  to be released, for example, within the blood stream, as binder  108  breaks down within the body. In such an exemplary embodiment, drug portion  106  and binder  108  are intermixed with one another to facilitate the time-release of drug portion  106  as referenced herein. 
     To facilitate the “anchoring” of resorbable device  100  within the body, resorbable device  100  comprises a resorbable anchor portion  104 . Exemplary embodiments of resorbable devices  100  of the disclosure of the present application are shown  FIGS. 2A-2E . In the exemplary embodiment of a resorbable device  100  shown in  FIG. 2A , resorbable device  100  has a “pin” configuration, whereby the pin  200  is sized and shaped for placement within the body in, for example, cardiac tissue or one or more other bodily organs, such as digestive, respiratory, and/or urinary tracts. In such an embodiment, and as with additional embodiments referenced herein, the pin  200  (or other form of a resorbable device  100 ) may be anchored within the body for a period of time to allow for at least some drug delivery over time from the drug release portion  102 . In the exemplary embodiment shown in  FIG. 2A , resorbable device  100  comprises a partially-round drug release portion  102  and a resorbable anchor portion  104  having barbs  202  to facilitate anchoring within a body as described herein.  FIG. 2B  shows another exemplary embodiment of a resorbable device  100  in having a pin  200  configuration, wherein the drug release portion  102  is substantially round and wherein the pin  200  has a point tip  204  allowing resorbable device to be positioned within a body. As referenced herein, various additional embodiments and/or configurations of pins  200  may comprise any number of shapes, components and/or features, including, but not limited to, barbs  202  and/or point tip  204 . 
     Additional exemplary embodiments of a resorbable device  100  of the disclosure of the present application are shown in  FIGS. 2C-2E .  FIG. 2C  shows an embodiment of a resorbable device  100  with a natively curved configuration, whereby resorbable device  100  may be anchored within a body using two resorbable anchor portions  104  to allow drug release portion  102  to release drug over time. Anchor portion  104  may comprise any number of attributes as referenced herein in connection with other anchor portions  104 , including, but not limited to, barbs  202  and/or point tip  204 . Placement of such an embodiment within a body is shown in  FIGS. 8B and 8C . 
       FIG. 2D  shows an embodiment of a resorbable device  100  in “chip” form, wherein the drug release portion  102  comprises a chip  206 , and wherein one or more resorbable anchor portions  104  facilitate the anchoring of resorbable device  100  within a body. Chip  206  may also comprise, for example, a microchip and/or one or more other mechanisms to facilitate a programmed delivery of drug over time. In addition, a resorbable device  100  having a chip  206  configuration, or another configuration of a resorbable device  100  of the present disclosure sized and shaped to allow for the positioning of a microchip thereon, may be or function similar to various electrical stimulating pacemakers or other types of electronics to transmit electrical therapy chronically and/or as needed. For example, and in at least one embodiment of a resorbable device  100  of the present disclosure, resorbable device  100  comprises a chip  206  configuration as shown in  FIG. 2D , wherein the chip  206  comprises a microchip. 
       FIG. 2E  shows an exemplary embodiment of a resorbable device  100  whereby the resorbable anchor portion  104  comprises a screw-like configuration (a coil screw  208  with a single or double helix, for example), whereby the resorbable device  100  may be screwed into position as described in  FIGS. 6A and 6B . Additional embodiments and configurations of resorbable device  100  comprising a drug release portion  102  and a resorbable anchor portion  104  as referenced herein are contemplated to be within the scope of the present application. 
     A cross-sectional view of an exemplary system for positioning a resorbable device within a body is shown in  FIGS. 3A and 3B . As shown in  FIG. 3A , exemplary delivery system  300  comprises a delivery tube  302  and a shaft  304  slidingly engaged within delivery tube  302 . Shaft  304 , when moved in a direction as shown by arrow  314  in  FIG. 3B , exerts pressure on a spring  306  which, in turn, exerts a pressure on an embolus  308  to facilitate delivery of resorbable device  100  (shown having a pin  200  configuration in  FIGS. 3A and 3B ). As shown in  FIG. 3B , when shaft  304  moves in the direction shown by arrow  314 , resorbable device  100  may be implanted into tissue and/or organ  310 , with the surface of tissue and/or organ  310  shown in  FIGS. 3A and 3B . In an embodiment of a resorbable device  100  wherein resorbable device  100  comprises barbs  202  and/or a point tip  204  (as shown in  FIGS. 2A ,  2 C, and  2 D), point tip  204  may puncture tissue and/or organ  310  to facilitate anchoring of resorbable device  100  therein, and/or barbs  202  may physically engage tissue and/or organ  310  to prohibit removal of resorbable device  100  after it is anchored. 
     As shaft  304  slides within tube  302 , embolus  308  facilitates the delivery of resorbable device  100  as shown in  FIG. 3B . Embolus  308  may be prevented from exiting tube  302  by, for example, the use of one or more embolus stop bars  312  as shown in  FIGS. 3A and 3B . Furthermore, embolus  308  (and/or portions of shaft  304  as described below) may be sized and shaped so that a resorbable device  100  may be removably engaged thereto and subsequently delivered to a target area within a body as described herein. 
     Exemplary resorbable devices  100  of the disclosure of the present application may be positioned in or onto any number of tissues and/or organs  310 , including, but not limited to, heart tissue, muscle, the brain, and the lungs. Such resorbable devices  100 , when positioned within a tissue and/or organ  310 , should not be positioned so deeply as to cause potential hemorrhage and/or filtration of a vascular bed. In at least one embodiment, resorbable devices  100  may be delivered to a target tissue and/or organs using any number of delivery systems  300  of the present disclosure, with the various delivery systems  300  configured for a particular application. For example, an exemplary delivery system  300 , such as delivery system  300  shown in  FIGS. 3A and 3B , may be used to deliver resorbable devices  100  to a tissue or organ having a surface relatively perpendicular to the direction of entry of the delivery system  300 . As shown in  FIG. 3A , for example, the distal end  316  of delivery system  300  is relatively perpendicular to tissue and/or organ  310 , whereby such a configuration of delivery system  300  is suitable to deliver a resorbable device  100  of the present disclosure. In at least another embodiment, and as shown in the cross-sectional view of an exemplary system for positioning a resorbable device within a body shown in  FIG. 3C , delivery system  300  has a notable curvature to facilitate delivery of resorbable device  100  to a tissue and/or organ  310  relatively parallel to the direction of entry of delivery system  300  into the body. 
     Additional cross-sectional views of exemplary embodiments of delivery systems  300  of the disclosure of the present application are shown in  FIGS. 4A and 4B . As shown in the embodiment shown in  FIG. 4A , delivery system  300  comprises tube  302 , shaft  304 , and embolus  308 . In this exemplary embodiment, delivery system  300  does not comprise a spring  306 , and use of the system (by sliding shaft  304  in the direction of arrow  400  shown in  FIG. 4B  towards the distal end of tube  302 ) delivers a resorbable device  100  as previously described herein. In the exemplary embodiment shown in  FIG. 4B , delivery system  300  comprises a tube  302  and a shaft  304 , whereby resorbable device  100  may be positioned using only shaft  304 . The embodiments of delivery system  300  as shown in  FIGS. 3A-4B  are exemplary in nature, and other mechanical embodiments of delivery systems  300  operable to deliver resorbable devices  100  as referenced herein are considered to be within the scope of the present application. 
     An cross-sectional view of an exemplary embodiment of a delivery system  300  of the disclosure of the present application utilizing pressurized gas is shown in  FIGS. 5A and 5B . As shown in  FIGS. 5A and 5B , delivery system  300  comprises a tube  302 , an embolus  308 , and a resorbable device  100 . The delivery of a gas from a gas source (not shown) may, as shown in  FIG. 5B , cause embolus  308  and resorbable device  100  to move in the direction shown by arrows  500 ,  502  so that resorbable device  100  may be positioned within a tissue and/or organ  310 . Carbon dioxide (CO 2 ) is shown as being the gas in this exemplary embodiment, but any number of various gases may be used to accomplish the same. Additionally, one or more fluids (water, saline, etc.) may be used either in place of, or in addition to, one or more gases to facilitate delivery of resorbable device  100 . 
     A cross-sectional view of an additional embodiment of a delivery system  300  of the disclosure of the present application is shown in  FIGS. 6A and 6B . As shown in  FIGS. 6A and 6B , delivery system  300  comprises a tube  302  and a shaft  304  where shaft  304  is capable of rotation about its longitudinal axis as shown in  FIG. 6B . Shaft  304  is either permanently or removably coupled to embolus  308  and is sized and shaped to facilitate delivery of resorbable device  100 . Resorbable device  100  may be positioned at or near a tissue and/or organ  310  by moving shaft  304  in a direction of arrow  600  shown in  FIG. 6A . When resorbable device is positioned at or near tissue and/or organ  310 , shaft  304  may be rotated about its longitudinal axis as shown by arrow  602  in  FIG. 6B , causing resorbable device  100  (having a resorbable anchor portion  104  comprising a screw-like configuration as shown, for example, in  FIG. 2E ) to be screwed into position within tissue and/or organ  310 . 
       FIG. 7  shows a cross-sectional view of an embodiment of a delivery system  300  of the disclosure of the present application wherein suction facilitates the delivery of resorbable device  100 . As shown in the exemplary embodiment shown in  FIG. 7 , delivery system  300  comprises an engagement catheter  700  and shaft  304  positioned therein, wherein the movement of shaft  304  within engagement catheter  700 , similar to the movement of shaft  304  within tube  302  in other embodiments referenced herein, facilitates the positioning of resorbable device  100  within a target tissue and/or organ  310 . Engagement catheter  700  may comprise any number of engagement catheters capable of reversibly attaching to a target tissue and/or organ  310  as shown in  FIG. 7 . In at least one preferred embodiment, engagement catheter  700  comprises a suction engagement steering catheter, wherein said catheter may be inserted into a body to a particular target site for delivery of resorbable device  100 . In such an embodiment, engagement catheter  700  may be referred to generally as a delivery catheter if it facilitates the placement, or delivery, of a resorbable device  100 . 
     In the exemplary embodiment shown in  FIG. 7 , delivery system  300  further comprises an embolus  308  sized and shaped to facilitate the delivery of resorbable device  100 . In addition, and as shown in this exemplary embodiment, engagement catheter  700  may optionally comprise a skirt  702  coupled to the distal end of engagement catheter  700 , allowing engagement catheter  700  to engage a larger surface area of a tissue and/or organ  310  as would otherwise be possible without such a skirt  702 . Engagement catheter  700  may reversibly attach to a tissue and/or organ  310  using suction from a suction source (not shown) operably coupled to the engagement catheter  700  at or near the proximal end of the engagement catheter  700 . 
     Another cross-sectional view of an embodiment of a delivery system  300  of the disclosure of the present application is shown in  FIGS. 8B and 8C . As shown in  FIGS. 8B and 8C , delivery system  300  comprises an engagement catheter  700  (shown with an optional skirt  702 ), a shaft  304 , and an embolus  308 , whereby delivery system  300  is operable to deliver resorbable device  100  to a target tissue and/or organ  310  in the direction of arrows  800 ,  802 . In the exemplary embodiment shown in  FIGS. 8A-8C , resorbable device  100  has a hook-pin configuration (similar to the configuration shown in  FIG. 2C ), and in this particular embodiment, resorbable device  100  comprises a “memory” whereby its natural/native configuration is a hook configuration (as shown in  FIG. 8A ), which can be temporarily bent into a relatively open position for implantation as shown in  FIGS. 8B and 8C ). Materials having such a memory suitable for various resorbable devices of the present disclosure include, but are not limited to, polymers derived from polylactic-co-glycolic acid) (PLGA) including various copolymers, graft copolymers, interpenetrating networks (IPNS), dipalmitylphosphatidylcholine, chondroitin sulfate A, polylactic acid) (PLA), and PLGA itself. In practice, such an embodiment of resorbable device  100  may be bent open to fit within engagement catheter  700 , and pushed into position using shaft  304  and/or embolus  308 . After resorbable device  100  has engaged tissue and/or organ  310  as shown in  FIG. 8C  (by way of a resorbable anchor portion  104 ), removal of delivery system  300  away from resorbable device  100  may allow resorbable device  100 , as shown in the embodiment shown in  FIG. 8A , to bend back into its natural/native configuration, allowing a second resorbable anchor portion  104  to engage tissue and/or organ  310 . Such a delivery may then allow drug release portion  102  to deliver a drug over time as described herein. 
       FIG. 9C  shows a cross-sectional view of an embodiment of a delivery system  300  of the disclosure of the present application used to position a resorbable device  100  of the present application having a chip configuration as shown in  FIGS. 9A and 9B . As shown in the exemplary embodiment shown in  FIG. 9C , delivery system  300  comprises an engagement catheter  700  having an optional skirt  702 , a shaft  304 , and an optional embolus  308 , whereby delivery system  300  is used to position a resorbable device  100  upon a tissue and/or organ  310 . When shaft  304  has been extended toward the distal end of engagement catheter  700 , resorbable device  100  may be positioned at tissue and/or organ  310  as shown in  FIG. 9B , whereby drug from the drug release portion  102  may be delivered over time. In the embodiment of resorbable device  100  shown in  FIGS. 9A-9C , resorbable device  100  comprises several resorbable anchor portions  104 , noting that various embodiments of resorbable devices  100  of the disclosure of the present application may have one or more resorbable anchor positions  104 . 
       FIG. 10A-10E  show the resorption over time of an exemplary resorbable device  100  of the disclosure of the present application.  FIG. 10A  shows an exemplary embodiment of a resorbable device  100  having a drug release portion  102  positioned outside of a tissue and/or organ  310  and a resorbable anchor portion  104  positioned within a tissue and/or organ  310 . Over time, drug release portion  102  will begin to degrade and deliver drug present within drug release portion  102  as shown in  FIG. 10B .  FIG. 10C  shows an embodiment of resorbable device  100  whereby drug release portion  102  has completely been absorbed by the body and all drug within drug release portion  102  has been released. In at least one exemplary embodiment as shown in  FIG. 10D , after drug release portion  102  has either partially or completely delivered the drug, resorbable anchor portion  104  will begin to degrade, and as shown in  FIG. 10E , no portion of resorbable device  100  remains after drug release portion  102  and resorbable anchor portion  104  has been absorbed/degraded by the body. 
       FIGS. 11A and 11B  show how an exemplary embodiment of a delivery system  300  of the disclosure of the present application may be used to deliver a resorbable device  100  of the present application to a septal wall of a heart. As shown in  FIG. 11A  and with the exemplary method steps identified in the method block diagram shown in  FIG. 12 , delivery system  300  may be positioned within a blood vessel leading to a heart  1100  (an exemplary tissue and/or organ  310 ), further accessing heart  1100  (via the pericardial space of the heart  1100 , for example), to deliver resorbable device  100  as described herein. Prior to introducing the delivery system  300  within the body at or near a target tissue or organ (introduction step  1204 ), an exemplary method  1200  of the present application comprises the step of placing the resorbable device  100  within a delivery tube  302  of delivery system  300  (placement step  1202 ).  FIG. 11B  shows an embodiment of a resorbable device  100  positioned within a heart  1100  at the septal wall  1102  of the heart  1100 , positioned therein by, for example, performing the step of anchoring the resorbable device to the target tissue or organ (anchoring step  1206 ). The disclosure of the present application is not intended to be limited to the delivery of only a pin  200  configuration of a resorbable device  100  to the septal wall  1102  of a heart  1100 , noting that any number of configurations of a resorbable device  100  of the disclosure of the present application may be positioned within any number of tissues and/or organs  310  within a body as described herein. 
     While various embodiments of devices, systems, and methods for localized drug delivery have been described in considerable detail herein, the embodiments are merely offered by way of non-limiting examples of the disclosure described herein. It will therefore be understood that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the disclosure. Indeed, this disclosure is not intended to be exhaustive or to limit the scope of the disclosure. 
     Further, in describing representative embodiments, the disclosure may have presented a method and/or process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. Other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure. In addition, disclosure directed to a method and/or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and still remain within the scope of the present disclosure.