Electro-catheter with inner lumen for drug delivery

Abstract

An electro-catheter for delivering electrical stimulation to an anatomical target (e.g., a dorsal root ganglion) includes an inner lumen for delivering a pharmacological agent to the anatomical target. The catheter includes a catheter body extending along a length from a first end to a second end about a central axis. An electrode assembly is arranged at the second end of the catheter body to deliver electrical stimulation to the anatomical target. The inner lumen extends through the catheter body to deliver the pharmacological agent to the anatomical target. A port is formed in the catheter body such that the port is in fluid communication with the inner lumen.

Description

ELECTRO-CATHETER WITH INNER LUMEN FOR DRUG DELIVERYBACKGROUND

[0001] Electrical stimulation of the dorsal root ganglion (DRG) is an established clinical approach fortreating pain. To initiate DRG stimulation, an electrode is inserted into the spinal canal by a standard interlaminar approach (e.g., as is routinely used for inserting an epidural catheter). Final placement of the electrode is guided by x-ray imaging and by the patient reporting on their sensation of the stimulation when the location adjacent to the DRG is achieved.SUMMARY OF THE DISCLOSURE

[0002] It is an aspect of the present disclosure to provide a catheter for delivering electrical stimulation. The catheter includes a catheter body extending along a length from a first end to a second end about a central axis. An electrode assembly is arranged at the second end of the catheter body to deliver electrical stimulation to an anatomical target. An inner lumen extends through the catheter body to deliver a pharmacological agent to the anatomical target. A port is formed in the catheter body such that the port is in fluid communication with the inner lumen.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] FIG. 1 illustrates an example electro-catheter with a drug delivery lumen for providing electrical stimulation and pharmacological agent delivery to an anatomical target, such as a dorsal root ganglion.

[0004] FIG. 2 shows an example configuration of an electro-catheter with a forwardfacing port for delivering a pharmacological agent in a forward direction.

[0005] FIG. 3 shows an example configuration of an electro-catheter with a side-facing port for delivering a pharmacological agent in a direction radially outward from the catheter body.

[0006] FIG. 4 shows an example configuration of an electro-catheter with an angled side-facing port for delivering a pharmacological agent in a direction radially outward along an angle from the catheter body.

[0007] FIG. 5 shows an example configuration of an electro-catheter having multiple inner lumens fluidically coupled to multiple ports for delivery of one or more pharmacological agents.

[0008] FIG. 6 shows an example configuration of an electro-catheter having a single lumen and two ports facing opposite directions.

[0009] FIG. 7 shows an example configuration of an electro-catheter having a single lumen and three ports facing the same direction.

[0010] FIG. 8 shows an example configuration of an electro-catheter having a single lumen and three ports facing alternating directions.

[0011] FIG. 9 illustrates an example electro-catheter having an implantable device components that includes a controller, a reservoir, and one or more pumps fluidically coupling the reservoir to the inner lumen(s) of the electro-catheter.

[0012] FIG. 10 is a block diagram of an example controller that can implement the methods described in the present disclosure for controlling operation of an electro-catheter with a drug delivery lumen.

[0013] FIG. 11 is a flowchart of an example method for delivering pharmacologically modulated electrical stimulation to a subject using an electro-catheter.DETAILED DESCRIPTION

[0014] Described here systems and methods for delivering electrical stimulation to the dorsal root ganglion (DRG) using an electro-catheter that is capable of delivering both electrical stimulation and pharmacological modulation of the DRG. The electro-catheter may include a stimulating electrode lead having one or more channels for delivering drugs, biological agents, or other pharmacological agents adjacent the DRG. In this way, the electrocatheter is capable of providing both electrical stimulation and pharmacological modulation of the DRG usingthe same device. Advantageously, this arrangement allows for simultaneous modulation of the DRG via a pharmacological agent and electrical stimulation.

[0015] Using the electro-catheter described in the present disclosure allows for short acting local anesthetic to be administered through the electro-catheter as a means of confirming that the DRG being targeted is a source of pain for the patient. If the localanesthetic has no effect, then it is highly unlikely that the targeted DRG is a source of pain for the patient, and another DRG should be targeted for treatment.

[0016] Additionally or alternatively, long-term infusion of local anesthetic through the electro-catheter can be continued as a therapeutic approach, whether alone or with concurrent or otherwise complementary electrical stimulation.

[0017] Using the systems and methods described in the present disclosure, the delivery of other analgesic agents targeting the DRG, such as virus for expression of analgesic peptides, can be administered via the electro-catheter, taking advantage of its confirmed close proximity to the DRG. Thus, the electro-catheter expands the repertoire of analgesic approaches to best suit the needs of each patient, which cannot be done by an electrode without a catheter lumen. As a non-limiting example, the delivery of gene therapy (e.g., using an adeno-associated virus (AAV) vector) by delivering transgene products that are expressed within the sensory neurons can be used to enhance or supplement the analgesia provided by the electrical stimulation alone, such as by the expression of a constitutively active CaMKII.

[0018] FIG. 1 shows an example catheter 10 for delivering electrical stimulation and a pharmacological agent to an anatomical target 50 (e.g., a dorsal root ganglion) according to some examples described in the present disclosure. The catheter 10 generally includes a catheter body 12 extending from a first end 14 to a second end 16 about a central axis 18. An electrode assembly 20 is arranged at the second end 16 of the catheter body 12.

[0019] The electrode assembly 20 generally includes electrodes 22 for delivering electrical stimulation to the anatomical target 50. In some examples, the electrode assembly 20 may also include electrodes that are capable of sensing electrical activity in the anatomical target 50 (e.g., measuring electrophysiological activity in the anatomical target 50). In some examples, the electrode assembly 20 includes a single electrode 22 that may be arranged at or near the second end 16 of the catheter body 12. In some other examples, the electrode assembly 20 may include two or more electrodes 22. For instance, the electrode assembly 20 may include multiple electrodes 22 that are arranged at different positions along the length of the catheter body 12. In some examples, the electrodes 22 may form an electrode array. The electrodes 22 may be separately controllable to generate different electrical stimulation fields, or may operate in unison to generate a single electrical stimulation field.

[0020] An inner lumen 30 extends through the catheter body 12. In general, the inner lumen 30 extends from the first end 14 of the catheter body 12 to a port 32 that is formed in the catheter body 12 at or near the second end 16 of the catheter body 12. The inner lumen 30 is fluidica lly coupled to, or otherwise in fluid communication with, the port 32 such that a pharmacological agent delivered via the inner lumen 30 is made to flow through the port 32 and outside of the catheter body 12 where the pharmacological agent is able to interact with the anatomical target 50.

[0021] In one example, the port 32 is arranged at the tip of the catheter body 12, as illustrated in FIG. 2. In this configuration, the port 32 is coaxial with the central axis 18 of the catheter body 12. The port 32 is a forward-facing port, which delivers the pharmacological agent longitudinally outward from the catheter body 12 in a forward direction. In some examples, the tip of the catheter body 12 may be pointed, sharp, or otherwise shaped or configured such that the tip of the catheter body 12 may pierce the anatomical target 50. In these instances, the pharmacological agent may be administered to an inner volume of the anatomical target 50 via the port 32. As a non-limiting example, the anatomical target 50 may be a dorsal root ganglion and the tip of the catheter body 12 may be pointed and / or sharpened such that the catheter body 12 may pierce the dorsal root ganglion to directly administer the pharmacological agent into the dorsal root ganglion rather than on the external surface of the dorsal root ganglion.

[0022] In another example, the port 32 is formed in a side wall 34 of the catheter body 12, as illustrated in FIG. 3. In this configuration, the port 32 is a side-facing port that is oriented along a direction that is nonparallel with the central axis 18 of the catheter body 12; that is, the port 32 is oriented in a radial direction such that the pharmacological agent is delivered radially outward from the catheter body 12. The port 32 may be perpendicular to the central axis 18 of the catheter body 12 (i.e., normal to the surface of the catheter body 12 at the side wall 34) as illustrated in FIG. 3, or may be oriented at another angle relative to the surface of the catheter body 12 at the side wall, as illustrated in FIG. 4.

[0023] Although FIGS. 1-4 show the catheter 10 as having a single inner lumen 30, in some other examples there may be more than one inner lumens 30 formed in the catheter body 12, as illustrated in FIG. 5. In these instances, the inner lumens 30 may be fluidically coupled to the same port 32, or the catheter 10 may include multiple ports 32 formed in thecatheter body 12, with each inner lumen 30 being fluidically coupled to a different one of the multiple ports 32. In the illustrated example, the catheter body 12 includes two inner lumens 30a, 30b fluidically coupled to two ports 32a, 32b. The electrode assembly 20 is arranged at the second end 16 of the catheter body 12 at a position that is distal to the ports 32a, 32b. In other configurations, the electrode assembly 20 may be arranged proximal to the ports 32a, 32b (i.e., where the first end 14 is a proximal end of the catheter body 12 and the second end 16 is a distal end of the catheter body 12).

[0024] Additionally or alternatively, the catheter body 12 may have multiple ports 32 formed therein. These ports 32 may be fluidically coupled to different inner lumens 30 (e.g., to deliver different pharmacological agents via the different paired inner lumens 30 and ports 32) as illustrated in FIG. 5, or may be fluidically coupled to a single inner lumen 30. In the example shown in FIG. 6, the catheter 10 includes one inner lumen 30 and two ports 32 that are each configured as side-facing ports. Moreso, the ports 32 shown in FIG. 6 are arranged on different sides of the catheter body 12, such as opposite sides of the catheter body 12. In a different configuration, such as the one shown in FIG. 7, the ports 32 may be arranged on the same side of the catheter body 12. In the example shown in FIG. 7, the catheter 10 includes one inner lumen that is fluidically coupled to three different ports 32 that are all arranged on the same side of the catheter body 12.

[0025] The inner lumen 30 (or one or more of multiple such inner lumens) may additionally or alternatively be sized to receive a medical instrument, or the like. In this way, the inner lumen 30, in addition to serving as a fluid passage for deliveringthe pharmacological agent, may provide a pathway for passing another device to the anatomical target. As one non-limiting example, a user may want to send a needle-tipped injection system through the catheter 10 for injecting a pharmacological agent (e.g., AAV, or the like) in order to waste less product in the residual volume of the long catheter and to have a sharp-tipped end that allows penetration into the anatomical target (e.g., a DRG) for direct internal injection of the pharmacological agent into the anatomical target. For instance, direct internal injection of a pharmacological agent into the DRG can improve effectiveness compared to injecting outside the capsule of the DRG.

[0026] Additionally or alternatively, the inner lumen 30 could be used to send a metallic-tipped electrode or other medical instrument or device down to the anatomicaltarget, and in some instances directed into the anatomical target. As a non-limiting example, an electrode can be introduced through the inner lumen 30 to provide recording of spontaneous electrical activity in the anatomical target, which may be indicative of neuropathology. Additionally or alternatively, such an electrode could be used to record activity induced by touch or movement of distal body parts, which may then be judged as normal or excessive, thereby guiding diagnosis. As still another example, an electrode can be used to provide simulation of a DRG to confirm that the correct segment is being treated, which can also be done with the electrodes 22 coupled to the catheter body 12.

[0027] As described above, in some examples the electrode assembly 20 may include electrodes 22. The electrodes 22 may be arranged at different positions along the length of the catheter body 12. Additionally, the catheter body 12 may have multiple inner lumens 30 and ports 32, such that the ports 32 are interleaved with, or otherwise interspersed between, the electrodes 22, as illustrated in FIG. 8.

[0028] In some configurations, the catheter 10 can include an implantable device 90 for housing control electronics and / or a reservoir containing the pharmacological agent to be delivered to the subject. As illustrated in FIG. 9, the catheter body 12 can be coupled at the first end 14 to a housing 92 of the implantable device 90. The housing 92 can house a controller 94, a reservoir 96, and / or one or more pumps 98 (e.g., one or more micropumps, or the like). As described below in more detail, the controller 94 can control operations of the catheter 10, including controlling operation of the electrode assembly 20 and / or delivery of the pharmacological agent via the inner lumen(s) 30. For instance, the controller 94 can control the operation of one or more pumps 98 to pump the pharmacological agent from the reservoir 96 into the inner lumen 30 and out of the port 32 such that the pharmacological agent is made to exit the catheter 10 where it may come into contact with the anatomical target 50 or otherwise modulate the anatomical target 50.

[0029] The pharmacological agent may be a local anesthetic, as described above. Additionally or alternatively, the pharmacological agent may include other drugs or agents, such as an adenovirus containing solution, a transgene containing solution, or the like.

[0030] Referring now to FIG. 10, an example of a controller 94 that can implement the methods described in the present disclosure to control an electro-catheter device is illustrated. In general, the controller 94 includes a processor 912, a memory 914, an input916, and an output 918. The controller 94 can be implemented as part of an implanted medical device coupled to an electro-catheter, or as a separate controller that is in communication with the electro-catheter via the output 918. As one example, the controller 94 can be implemented in an implantable medical device (e.g., an implanted nerve stimulation system), or the like. In other examples, the controller 94 can be implemented in a remote computer that communicates with the electro-catheter. In still other example, the controller 94 can be implemented in a smartphone that is paired with the electro-catheter, such as via Bluetooth or another wireless or wired communication.

[0031] In some embodiments, the input 916 is capable of sensing feedback data from the user. As one example, the feedback data can be electrophysiological activity, and the input 916 can be one or more electrodes. As another example, the feedback data can be chemical signal data, such as measured levels of chemicals. In such instances, the input 916 can include a suitable sensor for measuring the chemical signal data. Such a sensor could be a part of the electro-catheter, or could be a separate sensor that is in communication with the controller 94 via the input 916, whether through a wired or wireless connection. Such chemical data could also be measured through other means, such as via a blood sample taken from the user, and transmitted to the controller 94 via the input 916. The input 916 can thus more generally include a wired or wireless connector for receiving feedback data, which as noted above may also include user feedback data (e.g., a user describing whether electrical stimulation is alleviating their symptoms or not).

[0032] The processor 912 includes at least one hardware processor to execute instructions embedded in or otherwise stored on the memory 914 to implement the methods described in the present disclosure. The memory can also store measured feedback data for processing, as well as settings to be provided to the processor 912 for generating control signals to be provided to the electro-catheter via the output 918.

[0033] The output 918 communicates control signal to the electro-catheter. As one example, the control signals provided to the output 918 can control one or more electrodes to operate under control of the controller 94 to sense electrophysiological activity in a subject and to deliver electrical stimulations to the subject. In some examples, sensing circuitry in the controller 94 can detect and processes electrophysiological activity sensed by the one or more one electrodes via the input 916. As another example, the control signals provided tothe output 918 can control one or mor pumps under control of the controller 94 to deliver a pharmacological agent to a subject via an inner lumen of the electro-catheter.

[0034] The controller 94 can also include a transceiver 920 and associated circuitry for communicating with a programmer or other external or internal device. As one example, the transceiver 920 can include a telemetry coil. In some embodiments, the transceiver 920 can be a part of the input 916.

[0035] In some embodiments, any suitable computer-readable media can be used for storing instructions for performing the functions and / or processes described herein. For example, in some embodiments, computer-readable media can be transitory or non- transitory. For example, non-transitory computer-readable media can include media such as magnetic media (e.g., hard disks, floppy disks), optical media (e.g., compact discs, digital video discs, Blu-ray discs), semiconductor media (e.g., RAM, flash memory, EPROM, EEPROM), any suitable media that is not fleeting or devoid of any semblance of permanence during transmission, and / or any suitable tangible media. As another example, transitory computer- readable media can include signals on networks, in wires, conductors, optical fibers, circuits, or any suitable media that is fleeting and devoid of any semblance of permanence during transmission, and / or any suitable intangible media.

[0036] As used herein in the context of computer implementation, unless otherwise specified or limited, the terms "component," "system," "module," "framework," and the like are intended to encompass part or all of computer-related systems that include hardware, software, a combination of hardware and software, or software in execution. For example, a component may be, but is not limited to being, a processor device, a process being executed (or executable) by a processor device, an object, an executable, a thread of execution, a computer program, or a computer. By way of illustration, both an application running on a computer and the computer can be a component. One or more components (or system, module, and so on) may reside within a process or thread of execution, may be localized on one computer, may be distributed between two or more computers or other processor devices, or may be included within another component (or system, module, and so on).

[0037] In some implementations, devices or systems disclosed herein can be utilized or installed using methods embodying aspects of the disclosure. Correspondingly, description herein of particular features, capabilities, or intended purposes of a device or system isgenerally intended to inherently include disclosure of a method of using such features for the intended purposes, a method of implementing such capabilities, and a method of installing disclosed (or otherwise known) components to support these purposes or capabilities. Similarly, unless otherwise indicated or limited, discussion herein of any method of manufacturing or using a particular device or system, including installing the device or system, is intended to inherently include disclosure, as embodiments of the disclosure, of the utilized features and implemented capabilities of such device or system.

[0038] Referring now to FIG. 11, a flowchart is illustrated as setting forth an example method for providing pharmacologically modulated electrical stimulation to a subject using an electro-catheter such as those described in the present disclosure. The method includes positioning or otherwise arranging an electro-catheter adjacent, proximate, or otherwise near to an anatomical target, as indicated at step 1102. As described above, the anatomical target may be a dorsal root ganglion, another anatomical target in the central nervous system, an anatomical target in the peripheral nervous system, or the like. A pharmacological agent is then administered to the anatomical target via the port in fluid communication with the inner lumen of the electro-catheter, as indicated at step 1104. In some embodiments, the pharmacological agent is administered by controlling a pump via a controller to deliver the pharmacological agent. Additionally, electrical stimulation is delivered to the anatomical target using the electrode assembly of the electro-catheter, as indicated at step 1106. In some embodiments, the electrical stimulation is delivered by controlling the electrode assembly via a controller. The electrical stimulation may be delivered while the pharmacological agent is being administered (i.e., simultaneously or contemporaneously), or may be delivered after the pharmacological agent has been administered to the anatomical target. In any event, the pharmacological agent modulates the anatomical target, as described above, such that the anatomical target is pharmacologically modulated while the electrical stimulation is delivered to the anatomical target via the electrode assembly.

[0039] As described above, in some embodiments the electrode assembly of the electro-catheter can include electrodes capable of delivering electrical stimulation (i.e., stimulating electrodes) in addition to electrodes that are capable of sensing electrical activity in the anatomical target (i.e., sensing electrodes). In still other embodiments, the electrode assembly may include electrodes capable of both delivering electrical stimulation and sensingelectrical activity in the anatomical target. In these instances, the method can include sensing electrical activity in the anatomical target and adjusting the administration of the pharmacological agent and / or delivery of the electrical stimulation via the controller based on the sensed electrical activity.

[0040] The present disclosure has described one or more preferred embodiments, and it should be appreciated that many equivalents, alternatives, variations, and modifications, aside from those expressly stated, are possible and within the scope of the invention.

Claims

CLAIMS1. A catheter for delivering electrical stimulation, comprising: a catheter body extending along a length from a first end to a second end about a central axis; an electrode assembly arranged at the second end of the catheter body to deliver electrical stimulation to an anatomical target; an inner lumen extending through the catheter body to deliver a pharmacological agent to the anatomical target; and a port formed in the catheter body such that the port is in fluid communication with the inner lumen.

2. The catheter of claim 1, wherein the port is a forward-facing port coaxial with the central axis of the catheter body and formed at the second end of the catheter body.

3. The catheter of claim 1, wherein the port is a side-facing port oriented in a direction nonparallel to the central axis of the catheter body and formed in a side wall of the catheter body.

4. The catheter of claim 3, wherein the side-facing port is arranged at the second end of the catheter body.

5. The catheter of claim 1, wherein the inner lumen comprises a plurality of inner lumens extending through the catheter body, and wherein the port comprises a plurality of ports, each of the plurality of ports being in fluid communication with a different one of the plurality of inner lumens.

6. The catheter of claim 5, wherein each of the plurality of ports is a side-facing port oriented in a direction nonparallel to the central axis of the catheter body and formed in a side wall of the catheter body.

7. The catheter of claim 6, wherein each of the plurality of ports is formed on a same side of the catheter body.

8. The catheter of claim 6, wherein at least one of the plurality of ports is formed on a different side of the catheter body than at least one other of the plurality of ports.

9. The catheter of claim 6, wherein each of the plurality of ports is oriented in the same direction.

10. The catheter of claim 6, wherein each of the plurality of ports is formed at a different position along the length of the catheter body.

11. The catheter of claim 10, wherein the electrode assembly comprises a plurality of electrodes spaced apart along the length of the catheter body.

12. The catheter of claim 11, wherein the plurality of ports is interspersed with the plurality of electrodes along the length of the catheter body.

13. The catheter of claim 1, further comprising a reservoir in fluid communication with the inner lumen, wherein the reservoir contains the pharmacological agent.

14. The catheter of claim 1, further comprising an implantable housing coupled to the catheter body at the first end of the catheter body.

15. The catheter of claim 14, further comprising a reservoir in fluid communication with the lumen and housed within the implantable housing, wherein the reservoir contains the pharmacological agent.

16. The catheter of claim 15, further comprising a controller to control delivery of electrical stimulation by the electrode assembly and administration of the pharmacological agent via the inner lumen, wherein the controller is housed within the housing.

17. The catheter of claim 16, further comprising a pump housed within the housing and in fluid communication with the reservoir and the inner lumen, wherein the controller controls operation of the pump to control administration of the pharmacological agent via the inner lumen.

18. The catheter of any one of claims 1, 13, or 15, wherein the pharmacological agent comprises an anesthetic.

19. The catheter of any one of claims 1, 13, or 15, wherein the pharmacological agent comprises an adenovirus containing solution.

20. The catheter of any one of claims 1, 13, or 15, wherein the pharmacological agent comprises a transgene containing solution.

21. A method for pharmacologically modulated electrical stimulation of a subject, the method comprising: administering a pharmacological agent to an anatomical target in a subject via a catheter comprising: a body, an inner lumen extending through the body, an electrode assembly arranged on an outer surface of the body, and a port formed in the body and in fluid communication with the inner lumen, wherein the pharmacological agent is administered to the subject via the port; controlling the electrode assembly via a controller to deliver electrical stimulation to the anatomical target in the subject; andwherein the pharmacological agent modulates the anatomical target while the electrical stimulation is delivered to the anatomical target.

22. The method of claim 21, wherein the anatomical target comprises a dorsal root ganglion (DRG).

23. The method of any one of claims 21 or 22, wherein the electrical stimulation is delivered to the anatomical target while the pharmacological agent is being administered to the anatomical target.

24. The method of claim 23, wherein the pharmacological agent comprises an anesthetic.

25. The method of claim 23, wherein the pharmacological agent comprises an adenovirus containing solution.

26. The method of claim 23, wherein the pharmacological agent comprises a transgene containing solution.

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