Treatment methods for lung diseases using spinal cord stimulation therapy

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 and priority of U.S. Provisional Patent Application No. 63 / 168702, filed on March 31, 2021, and U.S. Provisional Patent Application No. 63 / 240155, filed on September 2, 2021. The entire disclosures of these are incorporated herein by reference.

[0002] Asthma is a chronic inflammatory disease of the airways of the lungs. In the United States, approximately 3 million new asthma diagnoses are made annually. Although there are treatments to help manage asthma, there is no known cure.

[0003] Asthma can significantly affect a person's quality of life by making breathing difficult. The symptoms of asthma include shortness of breath, dyspnea, wheezing, coughing, and chest tightness. It is not uncommon for asthma patients to frequently visit the emergency department and as a result often be hospitalized.

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

[0005] Oral medications, inhalers, and injections are commonly used to relieve the bronchospasm associated with asthma. More recently, immunosuppressive agents known as "biological" agents have also been used. However, none of these treatments can provide consistent relief, and the side effects of these medications are common. [Overview of the project]

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

[0007] In one embodiment, a kit for the treatment of a lung disease, comprising at least one lead having at least one contactor, and a pulse generator configured to be connected to at least one lead, wherein the pulse generator is programmed to generate an electrical signal to alleviate the symptoms of a lung disease, the electrical signal being transmitted through at least one lead and emitted by at least one contactor located at a predetermined position in the epidural space.

[0008] In another embodiment, a method for treating a lung disease, the method comprising: implanting at least one lead such that at least one contactor is positioned at a predetermined location in the epidural space; connecting at least one lead to a pulse generator; and programming the pulse generator to generate an electrical signal which is emitted by at least one contactor at the predetermined location to alleviate symptoms of the lung disease.

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

[0010] [Figure 1] Figure 1 shows an example of a system for performing a procedure involving the implantation of one or more leads for spinal cord stimulation therapy. [Figure 2] Figure 2 shows an example of a kit for treating asthma using spinal cord stimulation therapy. [Figure 3] Figure 3 shows an anatomical diagram of the human spine. [Figure 4] Figure 4 shows an example of a method for treating symptoms of lung disease using spinal cord stimulation therapy. [Figure 5] Figure 5 shows another example of using spinal cord stimulation therapy to alleviate symptoms of lung disease. [Modes for carrying out the invention]

[0011] Figure 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 a procedure using 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 patient P lies face down. Patient P's back is exposed for physician MD to insert the epidural needle 110.

[0012] The epidural needle 110 is inserted into the skin and travels through the paravertebral muscles to reach the lamina adjacent to the spinous process, located just below a selected target position within the epidural space of the patient's spine. The epidural needle 110 then travels through the ligamentum flavum and enters the epidural space. The epidural space is located between the dura mater and the wall of the spinal canal. The epidural space contains fat, veins, arteries, spinal nerve roots, and lymphatic vessels. As will be described in further detail below, the distal end of at least one lead having at least one contactor is embedded in the epidural space and emits electrical signals for the treatment of asthma by spinal cord stimulation therapy. The electrical signals emitted by at least one contactor can also relieve pain in addition to treating asthma.

[0013] System 100 includes a fluoroscopy system 104, which has at least one imaging device 106 for capturing a fluoroscopic image (i.e., an X-ray image) of the patient P's spine, and a display device 108 for displaying the fluoroscopic image as seen by the physician (MD). When inserting the epidural needle 110 into the epidural space of patient P, and when implanting the lead into the epidural space of patient P, the physician (MD) can view the fluorescence image for guidance.

[0014] As an exemplary example, physician MD inserts an epidural needle 110 into the epidural space of patient P's spine, and then passes one or more insulated wire leads through the epidural needle 110, embedding the distal ends of the leads in the epidural space. For example, the distal end of at least one lead is embedded in the posterior epidural space between the thoracic vertebrae T1-T5 (see Figure 3) to ensure that the lead is effective in performing the desired treatment. The epidural space between the thoracic vertebrae T1-T5 is a location where the electrical signals emitted from at least one contactor are effective in treating asthma.

[0015] In the example shown in Figure 1, the marking 112 pattern is drawn on the back of patient P. The marking 112 pattern may be used by physician MD as a pathway to guide the insertion of the epidural needle 110 into patient P's spine at the correct angle. The marking 112 pattern can be drawn using the device described in U.S. Patent Application No. 17 / 113232, filed December 7, 2020, which is incorporated herein by reference in its entirety.

[0016] Figure 2 shows a kit 200 for the treatment of asthma using spinal cord stimulation therapy. Kit 200 includes at least one lead 202 connected to a pulse generator 220. In the illustrated example, 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 alleviate asthma symptoms, which are transmitted through at least one lead 202 and emitted by at least one contactor 208 of the lead, located at a predetermined location in the epidural space. In addition to treating asthma, kit 200 may also be used to perform spinal cord stimulation therapy to alleviate pain in the back, abdomen, chest, and other parts of the body.

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

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

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

[0020] In some examples, the proximal end 206 of at least one lead 202 is configured to extend outside the patient P's body to connect to a pulse generator 220. In such examples, the pulse generator 220 is an external device carried or worn by the patient P, for example, 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 skin surface of patient P. In such an example, the proximal end 206 of at least one lead 202 remains in the patient P's body.

[0022] Kit 200 further includes a remote control unit 230, which wirelessly communicates with the pulse generator 220 to adjust electrical signals generated from the pulse generator 220 and emitted by one or more contacts 208. As shown in Figure 2, the remote control unit 230 includes one or more input buttons 232 and a display screen 234.

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

[0024] Figure 3 shows a diagram of the 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 of the neck and are located immediately below the skull. The thoracic vertebrae T1-T12 are located at the tail of the cervical vertebrae (i.e., towards the tail) and form the central portion of the spinal column 300. The lumbar vertebrae L1-L5 are the bones that form the lumbar region of the spinal column 300 and are located above the pelvis.

[0025] Figure 4 shows a method 400 for treating symptoms of lung diseases using spinal cord stimulation therapy. For example, method 400 can be implemented to relieve shortness of breath, dyspnea, wheezing, cough, chest tightness, and similar symptoms. 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 in addition to treating symptoms of lung diseases.

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

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

[0028] Step 404, implanting at least one lead 202, includes positioning at least one contactor 208 adjacent to the 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 at least one contactor 208 to stimulate the posterior portion of the thoracic spinal cord, helping to alleviate asthma symptoms while simultaneously reducing chest pain.

[0029] In addition to dorsal spinal stimulation therapy, electrical signals emitted from at least one contactor 208 can also be used to stimulate the dorsal root ganglia between vertebrae T1 to T5, helping to alleviate asthma symptoms while simultaneously reducing chest pain.

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

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

[0032] As another example, step 404 may include, in addition to stimulating the chest by positioning at least one contactor 208 between vertebrae C7 to T5 to provide relief from lumbar pain and to provide relief from asthma, positioning at least one additional contactor of 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 into a predetermined location in the epidural space and then passing at least one lead 202 through the epidural needle 110 to position at least one contactor 208 in a 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 contactor 208 in a location between vertebrae C7 and T5.

[0034] At least one lead 202 may be inserted into the patient's body in an anterograde (i.e., higher or upward) or retrograde (i.e., lower or downward) direction. How at least one lead 202 is inserted into the epidural space (i.e., anterograde vs. retrograde) affects how the spinal cord and dorsal root ganglia are stimulated by the contactor of the lead.

[0035] In some cases, at least one lead 202 is inserted retrogradely (i.e., lower or downward) into the patient's body to better position at least one contactor 208 in contact with the dorsal root ganglion. For example, at least one lead 202 may be inserted into the epidural space starting from vertebra C7 and pushed downward toward vertebra T5. When at least one lead 202 is inserted retrogradely, it can naturally deliver the nerve root sleeve posteriorly to where the dorsal root ganglion is located, so that at least one contactor 208 is positioned in contact with the dorsal root ganglion. This allows stimulation of the sensory portion of any given nerve root between vertebrae T1 and T5. In this way, at least one contactor 208 may also be used to stimulate the posterior portion of a somatic nerve emerging from the spinal cord, helping to alleviate chest pain while simultaneously relieving asthma symptoms.

[0036] In step 406, the proximal end 206 of at least one lead 202 may extend outside the patient P's body to connect to the pulse generator 220, as in the case where the pulse generator is an external trial simulator. Alternatively, the proximal end 206 of at least one lead 202 may remain inside the patient P's body when connected to the pulse generator 220, as in the example where the pulse generator 220 is an implantable pulse generator.

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

[0038] In a particular case, steps 404–408 are performed as part of a trial procedure to determine the effectiveness of spinal cord stimulation therapy in treating the asthma symptoms of patient P. After the completion of the temporary trial, and upon determination that spinal cord stimulation therapy has effectively relieved the asthma symptoms of patient P, method 400 may further include step 410, in which a permanent spinal cord stimulation therapy procedure is performed.

[0039] For example, step 410 may include replacing at least one lead 202 with a permanent lead, the permanent lead being implanted to have at least one contactor positioned 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 under 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] Figure 5 shows an example of a method 500 for alleviating symptoms of lung disease using spinal cord stimulation therapy. Method 500 may include step 502, in which the patient experiences one or more symptoms, the one or more symptoms being shortness of breath, difficulty breathing, wheezing, cough, chest tightness, and similar symptoms. Such symptoms may be due to asthma, chronic obstructive pulmonary disease (COPD), and / or other similar types of lung disease, etc.

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

[0042] As another example, step 504 may include selecting one or more input buttons 232 to increase the frequency and / or intensity of an electrical signal in order to more strongly alleviate the symptoms of the lung disease. Additionally, step 504 may include selecting one or more input buttons 232 to decrease the frequency and / or intensity of an electrical signal.

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

[0044] Next, method 500 includes 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 of symptoms of the lung disease. Advantageously, method 500 can be implemented to deliver the minimum effective dose for relief of symptoms of the lung disease.

[0045] The various embodiments described above are provided for illustrative purposes only and should not be construed as limiting the invention in any way. Various modifications can be made to the embodiments described above without departing from the true spirit and scope of this disclosure. Furthermore, this disclosure includes the following aspects: [Aspect 1] A kit for the treatment of lung disease, the kit is A lead having at least one contactor, A kit comprising: a pulse generator configured to be connected to at least one lead, wherein the pulse generator is programmed to generate an electrical signal to alleviate symptoms of a lung disease, the electrical signal being transmitted through the at least one lead and emitted by the at least one contactor located at a predetermined position in the epidural space. [Aspect 2] The kit according to embodiment 1, wherein the predetermined position is between vertebrae C7 and T5. [Aspect 3] The kit according to embodiment 1, wherein the predetermined position is between vertebral T1 and T5. [Aspect 4] The kit according to embodiment 1, wherein the pulse generator is programmed to adjust the pulse amplitude, pulse width, and pulse frequency of the electrical signal in order to alleviate the symptoms of the lung disease. [Aspect 5] The kit according to embodiment 1, wherein the pulse generator is programmed to continuously generate the electrical signal in order to alleviate the symptoms of the lung disease. [Aspect 6] The kit according to embodiment 1, further comprising a remote control device, the remote control device being operable to control the pulse generator to generate the electrical signal in response to the onset of symptoms of the lung disease. [Aspect 7] The kit according to embodiment 1, wherein at least one lead is a temporary transcutaneous lead, and the pulse generator is an external device worn by the patient during a temporary trial. [Aspect 8] The kit according to embodiment 1, wherein at least one of the leads is a permanent lead. [Aspect 9] The kit according to embodiment 1, wherein the lung disease is asthma or chronic obstructive pulmonary disease (COPD). [Aspect 10] A method for treating lung disease, wherein the method is Implanting at least one lead so that at least one contactor is positioned at a predetermined location in the epidural space, Connecting at least one of the leads to the pulse generator, A method comprising 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 symptoms of a lung disease. [Aspect 11] The method according to embodiment 10, wherein the predetermined position is between vertebrae C7 and T5. [Aspect 12] The method according to embodiment 10, wherein the predetermined position is between vertebrae T1 and T5. [Aspect 13] The aforementioned method, Inserting the epidural needle into the predetermined position, The method according to embodiment 10, further comprising passing the at least one lead through the epidural needle to position the at least one contactor at the predetermined position. [Aspect 14] The method according to embodiment 13, wherein the insertion of the epidural needle includes inserting the epidural needle 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. [Aspect 15] The method according to embodiment 10, wherein the implantation of the at least one lead includes positioning the at least one contactor adjacent to spinal nerve tissue within the epidural space so that the electrical signals stimulate the posterior portion of the spinal cord to alleviate asthma symptoms and pain. [Aspect 16] The method according to embodiment 10, wherein the lung disease is asthma or chronic obstructive pulmonary disease (COPD). [Aspect 17] The aforementioned method, The method according to embodiment 10, further comprising programming the pulse generator, which is controlled by a remote control device, to generate the electrical signal in response to the onset of symptoms of the lung disease. [Aspect 18] The aforementioned method, Replacing the at least one lead with a permanent lead, wherein the permanent lead has at least one contactor positioned in the predetermined location in the epidural space. The aforementioned permanent leads are connected to an implantable pulse generator, The method according to embodiment 10, further comprising implanting the implantable pulse generator beneath the skin surface. [Aspect 19] The method according to embodiment 10, wherein the implantation of the at least one lead includes inserting the at least one lead retrogradely, so as to position the at least one contactor in contact with the dorsal root ganglion located between vertebrae T1 to T5. [Aspect 20] The aforementioned method, The method according to embodiment 19, further comprising stimulating the dorsal root ganglion located between vertebrae T1 to T5 in order to alleviate the symptoms of asthma.

Claims

1. A kit for the treatment of asthma, chronic obstructive pulmonary disease (COPD), or cough, wherein the kit comprises: At least one lead having at least one contactor, wherein the at least one lead is positioned in the posterior epidural space between vertebrae C7-T5 to stimulate the dorsal spinal cord or dorsal root ganglia, A kit comprising: a pulse generator configured to be connected to at least one lead, wherein the pulse generator is programmed to generate an electrical signal to alleviate symptoms of asthma, COPD, or cough, the electrical signal being transmitted through the at least one lead and emitted by the at least one contactor to stimulate the dorsal spinal cord or the dorsal root ganglia.

2. The kit according to claim 1, wherein the pulse generator is programmed to adjust the pulse amplitude, pulse width, and pulse frequency of the electrical signal to alleviate asthma, chronic obstructive pulmonary disease (COPD), or cough.

3. The kit according to claim 1, wherein the pulse generator is programmed to continuously generate the electrical signals to alleviate asthma, chronic obstructive pulmonary disease (COPD), or cough.

4. The kit according to claim 1, further comprising a remote control device, the remote control device being operable to control the pulse generator to generate the electrical signal.

5. The kit according to claim 1, wherein the at least one lead is a temporary transcutaneous lead, and the pulse generator is an external device worn by the patient.

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