Treating Pulmonary Disease with Spinal Cord Stimulation

Abstract

The present invention relates to a kit for the treatment of a pulmonary disease, the kit comprising at least one lead having at least one contact and a pulse generator configured to connect to the at least one lead, the pulse generator programmed to generate electrical signals transmitted through the at least one lead and emitted by the at least one contact at a predetermined location in the epidural space to alleviate symptoms of the pulmonary disease.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application was filed as a PCT International Patent Application on March 30, 2022, and claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 168,702, filed March 31, 2021, and U.S. Provisional Patent Application No. 63 / 240,155, filed September 2, 2021, the entire disclosures of which are incorporated herein by reference.

[0002] Asthma is a long-term inflammatory disease of the airways of the lungs. There are approximately 3 million new diagnoses of asthma each year in the United States. Although there are treatments available to help manage asthma, there is no known cure.

[0003] Asthma can severely affect a person's quality of life by making breathing difficult. Asthma symptoms include shortness of breath, difficulty breathing, wheezing, coughing, and chest tightness. It is not uncommon for asthma patients to have frequent emergency department visits that often result in hospitalization.

[0004] An asthma attack is a sudden worsening of asthma symptoms caused by muscle contraction around the bronchial tubes. An asthma attack can cause respiratory failure, loss of consciousness, and even death. An asthma attack can be triggered by temperature changes, dust, dander, smoke, pollen, and chemical fumes. In some instances, mental stress, exercise, and gastric reflux can also trigger an asthma attack. Additionally, certain medications, such as beta-blockers, nonsteroidal anti-inflammatory drugs (NSAIDs), and aspirin, can also trigger an asthma attack.

[0005] Oral medications, inhalers, and injections are commonly used to relieve the bronchospasm associated with asthma. More recently, immunosuppressants known as "biologic" agents have also been used. However, none of these treatments provide consistent relief, and side effects from these drugs are common. Summary of the Invention

[0006] In general terms, the present disclosure relates to the treatment of pulmonary diseases, such as asthma and / or chronic obstructive pulmonary disease (COPD), using spinal cord stimulation. Various aspects are described in the present disclosure, including, but not limited to, the following aspects:

[0007] In one aspect, a kit for treating a pulmonary disease comprising at least one lead having at least one contact and a pulse generator configured to connect to the at least one lead, the pulse generator programmed to generate an electrical signal to alleviate a symptom of the pulmonary disease, the electrical signal being transmitted through the at least one lead and emitted by the at least one contact at a predetermined location in the epidural space.

[0008] In another aspect, a method of treating a pulmonary disease comprising: implanting at least one lead to position at least one contact at a predetermined location in the epidural space; connecting the at least one lead to a pulse generator; and programming the pulse generator to generate an electrical signal, the electrical signal being emitted by the at least one contact at the predetermined location to alleviate a symptom of the pulmonary disease.

[0009] The following drawings form part of this application and are intended to illustrate the described technology, but are not intended to limit the scope of the disclosure in any way. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 illustrates an example of a system for performing a procedure to implant one or more leads for spinal cord stimulation therapy. [Diagram 2] FIG. 2 shows an example of a kit for treating asthma using spinal cord stimulation therapy. [Diagram 3] FIG. 3 shows an anatomical diagram of the human spine. [Figure 4] FIG. 4 illustrates an example of a method for treating a pulmonary condition using spinal cord stimulation. [Diagram 5] FIG. 5 illustrates another example of a method for alleviating symptoms of pulmonary disease using spinal cord stimulation. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] 1 shows an example of a system 100 for performing a procedure to implant one or more leads for spinal cord stimulation therapy. In some examples, an epidural needle 110 is used to implant a temporary percutaneous lead for a trial of treatment with spinal cord stimulation therapy. In other examples, the epidural needle 110 is used to implant a permanent percutaneous lead. The system 100 includes a table 102 on which a patient P lies face down. The patient P's back is exposed for a physician MD to insert the epidural needle 110.

[0012] The epidural needle 110 is inserted into the skin and through the paraspinal muscles to the lamina next to the spinous process located just below the selected target location in the epidural space of the patient's spine. The epidural needle 110 then passes through the ligamentum flavum into the epidural space. The epidural space is located between the dura mater and the wall of the spinal canal. The epidural space includes fat, veins, arteries, spinal nerve roots, and lymphatic vessels. As described in more detail below, the distal end of at least one lead having at least one contact is implanted into the epidural space and emits electrical signals for the treatment of asthma by spinal cord stimulation. In addition to treating asthma, the electrical signals emitted by the at least one contact can also provide pain relief.

[0013] System 100 includes a fluoroscopy system 104 having at least one imaging device 106 that captures a fluoroscopic image (i.e., an x-ray image) of the spine of patient P, and a display device 108 that displays the fluoroscopic image for viewing by physician MD. Physician MD can view the fluoroscopic image for guidance when inserting epidural needle 110 into the epidural space of patient P and when implanting leads into the epidural space of patient P.

[0014] As an illustrative example, the physician MD inserts the epidural needle 110 into the epidural space of the patient P's spine, and thereafter threads one or more insulated wire leads through the epidural needle 110 and implants the distal ends of the leads into the epidural space. As an example, the distal end of at least one lead is implanted into the posterior epidural space between the thoracic vertebrae T1-T5 (see FIG. 3) to ensure that the lead is effective to perform the desired treatment. The epidural space between the thoracic vertebrae T1-T5 is a location where the electrical signal emitted from the at least one contact is effective for treating asthma.

[0015] In the example shown in FIG. 1, a pattern of markings 112 is drawn on the back of a patient P. The pattern of markings 112 can be used by a physician MD as a path to guide the insertion of an epidural needle 110 at the correct angle into the spine of a patient P. The pattern of markings 112 can be drawn using a device described in U.S. Patent Application No. 17 / 113,232, filed December 7, 2020, the entirety of which is incorporated herein by reference.

[0016] 2 shows a kit 200 for treating asthma using spinal cord stimulation therapy. The kit 200 includes at least one lead 202 connected to a pulse generator 220. In the illustrated example, the kit 200 includes a pair of percutaneous leads connected to the pulse generator 220. As will be described in more detail, the pulse generator 220 is programmed to generate electrical signals to relieve asthma symptoms, the electrical signals being transmitted through the at least one lead 202 and emitted by at least one contact 208 of the lead at a predetermined location in the epidural space. In addition to treating asthma, the kit 200 may also be used to perform spinal cord stimulation therapy to relieve pain in the back, abdomen, chest, and other parts of the body.

[0017] In some examples, the at least one lead 202 is a temporary percutaneous lead that is implanted during a temporary trial. Alternatively, the at least one lead 202 may be a permanent lead that is implanted after completion of a successful temporary trial. In such alternative examples, the at least one lead 202 may be a permanent percutaneous lead or a permanent paddle lead.

[0018] Each of the at least one lead 202 has a body portion extending between a distal end 204 and a proximal end 206. The body portion has a tubular shape of uniform diameter and circumference that allows the at least one lead 202 to easily slide in and out of the epidural needle 110. The distal end 204 of the at least one lead 202 is configured to be placed at a predetermined location in the epidural space to emit an electrical signal for relief of asthma symptoms and / or treatment of chronic pain. The proximal end 206 is configured to connect to a pulse generator 220.

[0019] Each of the at least one lead 202 includes one or more contacts 208 positioned toward the distal end 204. Each contact 208 is configured to receive electrical signals from the pulse generator 220 and emit electrical signals to interact with one or more nerves at a predetermined location in the epidural space to alleviate asthma symptoms. In some examples, the contacts 208 are evenly spaced apart. The number of contacts 208 included in each of the at least one lead 202 may vary. For example, the at least one lead 202 may include at least one contact or may include multiple contacts. The multiple contacts may range from 5 to 20 contacts or may be more than 20 contacts. In one example, each of the at least one lead 202 has 16 contacts.

[0020] In some examples, the proximal end 206 of each of the at least one lead 202 is configured to extend outside the body of the patient P for connection to a pulse generator 220. In such examples, the pulse generator 220 is an external device carried or worn by the patient P, such as during a temporary trial for spinal cord stimulation therapy.

[0021] Alternatively, the pulse generator 220 may be an implantable pulse generator that is permanently implanted beneath the surface of the skin of the patient P. In such an example, the proximal end 206 of each of the at least one lead 202 remains within the body of the patient P.

[0022] The kit 200 further includes a remote control 230 that wirelessly communicates with the pulse generator 220 to condition the electrical signals generated by the pulse generator 220 and emitted by the one or more contacts 208. As shown in FIG. 2, the remote control 230 includes one or more input buttons 232 and a display screen 234.

[0023] As an illustrative example, one or more of the input buttons 232 can be selected by the patient P to increase the frequency and / or intensity of the electrical signal. For example, one or more of the input buttons 232 can be selected to provide greater relief from asthma or pain. Additionally, one or more of the input buttons 232 can be selected by the patient P to decrease the frequency and / or intensity of the electrical signal to provide less relief from asthma or pain. One or more of the input buttons 232 can also be selected to change the pulse strength, pulse width, and pulse frequency from the pulse generator 220 to optimize the electrical signal to provide relief from asthma symptoms.

[0024] Figure 3 shows a diagram of a spinal column 300. As shown in Figure 3, the spinal column 300 includes cervical vertebrae C1-C7, thoracic vertebrae T1-T12, and lumbar vertebrae L1-L5. The cervical vertebrae C1-C7 are the vertebrae in the neck and are located just below the skull. The thoracic vertebrae T1-T12 are located at the caudal portion (i.e., toward the tail) of the cervical spine and make up the central portion of the spinal column 300. The lumbar vertebrae L1-L5 are the bones that form the lower back portion of the spinal column 300 and are located above the pelvis.

[0025] 4 illustrates a method 400 of treating a pulmonary condition using spinal cord stimulation therapy. For example, method 400 can be implemented to relieve shortness of breath, difficulty in breathing, wheezing, coughing, chest tightness, and the like. In addition to treating a pulmonary condition, method 400 can also be implemented to relieve pain in the back, abdomen, chest, and other parts of the body using spinal cord stimulation therapy.

[0026] 4, the method 400 may include an initial step 402 of receiving a diagnosis of a pulmonary disorder. For example, the diagnosis of a pulmonary disorder may be for asthma, chronic obstructive pulmonary disease (COPD), and / or other similar types of pulmonary disorders. The diagnosis of a pulmonary disorder may be received from a pulmonologist or other qualified medical professional.

[0027] Next, the method 400 includes step 404 of implanting at least one lead 202, step 406 of connecting the at least one lead 202 to a pulse generator 220, and step 408 of programming the pulse generator 220 to generate an electrical signal to alleviate the symptoms of the diagnosed pulmonary disorder. The order of steps 404-408 shown in the example of Figure 4 may be varied. For example, step 408 of programming the pulse generator 220 may be performed before step 404 of implanting at least one lead 202.

[0028] The step 404 of implanting the at least one lead 202 includes positioning the at least one contact 208 adjacent to spinal nerve tissue of the spinal cord at a predetermined location in the epidural space. In some examples, the predetermined location of the epidural space is between vertebrae C7 and T5. In some examples, the predetermined location of the epidural space is between vertebrae T1 and T5. In some further examples, the predetermined location of the epidural space is between vertebrae T1 and T4. In some further examples, the predetermined location of the epidural space is between vertebrae T2 and T5. These locations allow electrical signals emitted from the at least one contact 208 to stimulate a posterior portion of the thoracic spinal cord to help relieve asthma symptoms while simultaneously reducing chest pain.

[0029] In addition to dorsal spinal stimulation therapy, the electrical signal emitted from at least one contact 208 may also be used to stimulate the dorsal root ganglion between vertebrae T1 to T5 to help relieve asthma symptoms while simultaneously reducing chest pain.

[0030] By stimulating the dorsal spinal cord and / or dorsal root ganglion between the T1-T5 vertebrae with electrical signals emitted from at least one contact 208, sympathetic pathways serving the chest, heart, and lungs are stimulated. Bronchial smooth muscle is controlled by sympathetically mediated beta fibers, which are relaxed by stimulation emitted from at least one contact 208 of the lead. Relaxation of bronchial smooth muscle can reduce symptoms of an asthma attack. Implanting at least one contact 208 in the epidural space between the T1-T5 vertebrae can also relieve chest pain in addition to treating asthma.

[0031] In certain instances, additional contacts of at least one lead 202 are positioned at additional locations in the epidural space to provide further pain relief. For example, step 404 may further include positioning an additional contact of at least one lead 202 in the epidural space between vertebrae T5 and T6 to stimulate the abdomen, thereby providing abdominal pain relief. In some instances, contacts of at least one lead 202 are positioned between vertebrae T4 and T6 to treat asthma and reduce both chest and abdominal pain.

[0032] As another example, step 404 may include positioning at least one contact 208 between vertebrae C7 to T5 to stimulate the thorax and provide asthma relief, and positioning additional contacts of at least one lead 202 between vertebrae T7 and T8, between vertebrae T8 and T9, between vertebrae T9 and T10, between vertebrae T11 and T12, or between vertebrae T12 and L1.

[0033] Step 404 may be performed by inserting the epidural needle 110 at a predetermined location in the epidural space and then threading at least one lead 202 through the epidural needle 110 to position at least one contact 208 at the predetermined location. For example, the epidural needle 110 may be inserted between vertebrae C7 and T1, between vertebrae T1 and T2, between vertebrae T2 and T3, between vertebrae T3 and T4, or between vertebrae T4 and T5 to implant at least one contact 208 at a location between vertebrae C7 and T5.

[0034] The at least one lead 202 may be inserted into the patient antegrade (i.e., higher or upward) or retrograde (i.e., lower or downward). How the at least one lead 202 is inserted into the epidural space (i.e., antegrade vs. retrograde) affects how the spinal cord and dorsal root ganglion are stimulated by the contacts of the lead.

[0035] In some instances, the at least one lead 202 is inserted retrogradely (i.e., lower or downward) into the patient's body to better position the at least one contact 208 adjacent to the dorsal root ganglion. For example, the at least one lead 202 can be inserted into the epidural space starting at vertebra C7 and pushed down toward vertebra T5. When the at least one lead 202 is inserted retrogradely, the at least one lead 202 can naturally send out a nerve root sleeve posteriorly where the dorsal root ganglion is located so that the at least one contact 208 is positioned adjacent to the dorsal root ganglion. This can stimulate the sensory portion of any given nerve root between vertebrae T1 and T5. In this manner, the at least one contact 208 can be used to stimulate the posterior portion of the somatic nerves exiting the spinal cord to help relieve asthma symptoms while also reducing chest pain.

[0036] In step 406, the proximal end 206 of at least one lead 202 may extend outside the body of the patient P for connection to the pulse generator 220, such as when the pulse generator is an external trial simulator, or the proximal end 206 of the at least one lead 202 may remain within the body of the patient P when connected to the pulse generator 220, such as in instances where the pulse generator 220 is an implantable pulse generator.

[0037] In step 408, the pulse generator 220 may be programmed to generate electrical signals continuously to provide relief from asthma symptoms over an extended period of time without requiring any input from the patient P. Alternatively, the pulse generator 220, controlled by the remote control device 230, may be programmed to generate electrical signals on demand to provide relief upon the sudden onset of symptoms, such as during an asthma attack.

[0038] In certain examples, steps 404-408 are performed as part of a trial procedure to determine the effectiveness of spinal cord stimulation in treating the asthma symptoms of patient P. After completion of the temporary trial, and upon a determination that the spinal cord stimulation has effectively alleviated the asthma symptoms of patient P, method 400 may further include step 410 of performing a permanent spinal cord stimulation procedure.

[0039] For example, step 410 may include replacing at least one lead 202 with a permanent lead, the permanent lead being implanted having at least one contact located in a predetermined location in the epidural space (e.g., between vertebrae C7 and T5), connecting the permanent lead to an implantable pulse generator, and permanently implanting the implantable pulse generator below the skin surface. In a permanent spinal cord stimulation procedure, the permanent lead may be a permanent percutaneous lead or a permanent paddle lead.

[0040] 5 illustrates an example method 500 for alleviating symptoms of a pulmonary disorder using spinal cord stimulation therapy. The method 500 may include step 502, in which a patient experiences one or more symptoms, the one or more symptoms being shortness of breath, difficulty breathing, wheezing, coughing, chest tightness, and the like. Such symptoms may be due to asthma, chronic obstructive pulmonary disease (COPD), and / or other similar types of pulmonary disorders, etc.

[0041] Next, the method 500 includes a step 504 of activating the pulse generator 220. For example, the patient may activate the pulse generator 220 using a remote control 230 (see FIG. 2). The remote control 230 wirelessly communicates with the pulse generator 220 to regulate the electrical signal generated by the pulse generator 220 and emitted by the one or more contacts 208. In some examples, the step 504 includes selecting a particular treatment protocol for relieving a symptom of a pulmonary disease using one or more input buttons 232 and a display screen 234. For example, a treatment protocol for relieving a symptom of asthma may be selected using one or more input buttons 232 and a display screen 234. As another example, a treatment protocol for relieving a symptom of chronic obstructive pulmonary disease (COPD) may be selected using one or more input buttons 232 and a display screen 234. These treatment protocols for pulmonary diseases may be selected separately or in addition to other treatment protocols for relieving pain.

[0042] As another example, step 504 may include selecting one or more input buttons 232 to increase the frequency and / or intensity of the electrical signal to provide greater relief from the pulmonary condition. Additionally, step 504 may include selecting one or more input buttons 232 to decrease the frequency and / or intensity of the electrical signal.

[0043] Next, method 500 may include step 506, in which the patient experiences a relief of one or more symptoms initially experienced in step 502. For example, the patient may begin to notice improvement in their breathing, such that they no longer have shortness of breath, difficulty breathing, wheezing, coughing, chest tightness, and the like.

[0044] Next, the method 500 includes the step 508 of deactivating the pulse generator 220. For example, the patient may deactivate the pulse generator 220 using the remote control device 230 after experiencing relief from the symptoms of the pulmonary disorder. Advantageously, the method 500 may be implemented to deliver a minimum effective dose for relief from the symptoms of the pulmonary disorder.

[0045] The various embodiments described above are provided by way of example only and should not be construed as limiting the invention in any manner. Various modifications can be made to the above-described embodiments without departing from the true spirit and scope of the present disclosure.

Claims

1. 1. A kit for treating a pulmonary disease, the kit comprising: at least one lead having at least one contact; a pulse generator configured to connect to the at least one lead, the pulse generator programmed to generate an electrical signal to alleviate a symptom of a pulmonary disorder, the electrical signal being transmitted through the at least one lead and emitted by the at least one contact at a predetermined location in the epidural space.

2. The kit of claim 1 , wherein the predetermined location is between vertebrae C7 and T5.

3. The kit of claim 1 , wherein the predetermined location is between vertebrae T1 to T5.

4. 10. The kit of claim 1, wherein the pulse generator is programmed to adjust a pulse amplitude, a pulse width, and a pulse frequency of the electrical signal to alleviate a symptom of the pulmonary disorder.

5. 10. The kit of claim 1, wherein the pulse generator is programmed to generate the electrical signal continuously to alleviate a symptom of the pulmonary disorder.

6. 10. The kit of claim 1, further comprising a remote control, the remote control operable to control the pulse generator to generate the electrical signal upon onset of a symptom of the pulmonary disease.

7. 10. The kit of claim 1, wherein the at least one lead is a temporary percutaneous lead and the pulse generator is an external device worn by the patient during temporary trials.

8. The kit of claim 1 , wherein the at least one lead is a permanent lead.

9. 2. The kit of claim 1, wherein the pulmonary disease is asthma or chronic obstructive pulmonary disease (COPD).

10. 1. A method of configuring a device for use in treating a pulmonary disorder, the method comprising: providing at least one lead for positioning at least one contact at a predetermined location in the epidural space; connecting the at least one lead to a pulse generator; and programming the pulse generator to generate an electrical signal, the electrical signal being emitted by the at least one contact at the predetermined location to alleviate a symptom of a pulmonary disorder.

11. The method of claim 10, wherein the predetermined location is between vertebrae C7 to T5.

12. The method of claim 10, wherein the predetermined location is between vertebrae T1 to T5.

13. 11. The method of claim 10, wherein the pulmonary disease is asthma or chronic obstructive pulmonary disease (COPD).

14. The method comprises:

11. The method of claim 10, further comprising programming the pulse generator controlled by a remote control device to generate the electrical signal upon onset of a symptom of the pulmonary disease.

15. The method comprises:

11. The method of claim 10, further comprising programming the pulse generator to generate the electrical signal to stimulate the dorsal root ganglion located between vertebrae T1 to T5 to relieve asthma symptoms.

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