CN-122003213-A - Systems and methods for neurostimulation lead placement

Abstract

A system and method for locating and guiding peripheral nerve assessment (PNE) leads. The system includes an X-ray system for capturing an image of a patient. The images are processed by the system and provided to the user for insertion of a needle with the measurement device for placement of a lead for the PNE procedure.

Inventors

• WAN YUQING
• Faizal Abdin
• HUANG XUECHEN
• LI HENRY
• David Malvishin
• JIANG GUANGQIANG

Assignees

• 爱颂尼科公司

Dates

Publication Date

20260508

Application Date

20241011

Priority Date

20231013

Claims (20)

1. 1. A device for guiding needle insertion into a patient receiving sacral nerve stimulation therapy, the device comprising: an elongated base having a first set of indicia configured to extend longitudinally along a back of the patient, wherein the base is configured to rest adjacent to and press against a coccyx of the patient; a cross member slidably attached to the elongated base, wherein the cross member includes a second set of indicia, and An element guide mounted to the cross member configured to facilitate insertion of the needle into the patient at a predetermined angle at the target location.
2. 2. The device of claim 1, further comprising an adjustable needle guide attached to the element guide.
3. 3. The device of claim 1, wherein the first set of indicia corresponds to a distance along the elongate base from the coccyx end toward the rostral side.
4. 4. The device of claim 3, wherein the second set of indicia corresponds to a distance laterally away from the patient's spine.
5. 5. The apparatus of claim 1, further comprising a radiopaque positioning element configured to be selectively attached to the elongate base.
6. 6. The apparatus of claim 5, wherein the first set of indicia corresponds to a distance relative to the positioning element.
7. 7. A device for guiding insertion of a needle for sacral nerve stimulation therapy into a patient, the device comprising: an elongated base having a first set of indicia configured to extend longitudinally along a back of the patient, and wherein the base is configured to rest adjacent to and press against a coccyx of the patient; A cross member having a second set of indicia; wherein the cross member is slidably attached to the elongate base; A guide body slidably attached to the cross member, wherein the guide body is configured to move in a direction perpendicular to the elongated base, and Wherein the guide body comprises an inclined guide configured to guide the needle at a predetermined angle to a target location on the patient.
8. 8. The device of claim 7, the guide body comprising a plurality of grooves configured to guide the needle.
9. 9. The apparatus of claim 8, wherein the plurality of grooves are arranged in a fan-shaped pattern.
10. 10. The device of claim 7, wherein the guide body further comprises an aperture on the base of the guide body and a third set of indicia disposed along a length of a slot on a top surface of the guide body.
11. 11. The apparatus of claim 7, further comprising a radiopaque positioning element configured to be selectively attached to the elongate base.
12. 12. The apparatus of claim 11, wherein the first set of measurement identities corresponds to distances relative to the positioning element.
13. 13. The apparatus of claim 7, wherein the first set of markings corresponds to a distance along the elongate base toward the rostral side relative to a vertical reference line drawn from an end of the tailbone to the elongate base.
14. 14. The device of claim 13, wherein the predetermined angle is measured relative to a line tangential to an arcuate length of the device.
15. 15. A method for identifying a location on a patient for inserting a needle to place a lead for neurostimulation therapy, the method comprising the steps of: obtaining a scaled image of the patient; Selecting a tip of a patient's coccyx shown in the image; applying a first line over the image, wherein the first line extends from the tip of the coccyx to the patient's skin surface; Applying a second line on the image, wherein the second line extends from a target location perpendicular to the patient's sacrum to the patient's skin surface; Calculating a measurement value corresponding to a location on the patient; Retrieving the measurement value, and The patient is identified based on the measurements using a measurement device.
16. 16. The method of claim 15, wherein the method is used to identify an insertion location for a needle for placement near an S3 hole of the patient.
17. 17. The method of claim 15, wherein the measurement comprises a calculated distance from the first line toward the head side on the measurement device.
18. 18. The method of claim 17, further comprising inserting the needle into the patient at the location of the patient aperture.
19. 19. The method of claim 15, wherein the measurement comprises a needle entry angle, wherein the calculation of the needle entry angle is derived from the second line and a line tangent to an arcuate length of the device.
20. 20. The method of claim 15, wherein the measurement device comprises an elongated base having a first set of indicia configured to extend longitudinally on the back of the patient and rest near the coccyx of the patient, and a cross member having a second set of indicia slidably attached to the elongated base.

Description

Systems and methods for neurostimulation lead placement Cross Reference to Related Applications The present application claims priority and benefit from U.S. provisional application 63/544,067 filed on day 13, 10, 2023. Technical Field The present application relates to devices and methods for assisting in placement of leads used in neural stimulation. In exemplary embodiments, the devices and methods relate to placement of electrical leads used in sacral neuromodulation, and more particularly, to devices and methods for locating sacral foramina during a peripheral nerve assessment (PNE) procedure in order to place electrical leads of a PNE system in place. Sacral neuromodulation is a treatment for bladder and bowel dysfunction that involves implanting a device that provides controlled electrical stimulation to the patient' S sacral S3 spinal nerves. Prior to receiving the permanent implant, the patient receives a procedure known as peripheral nerve assessment (PNE). The procedure involves implanting a temporary lead into the patient, where the lead is connected to an external pulse generator, and then observing the results for a period of time, typically almost between 3 and 14 days. If the results meet certain clinical criteria, the patient may be a candidate for receiving an implantable pulse generator for sacral neuromodulation. Current techniques for lead placement during an assessment procedure involve identifying palpable bone or bony landmarks on a patient and inserting a hole needle into the patient based on the location of these landmarks. The purpose during this procedure is to insert a foraminous needle through the skin and into the S3 foramen so that an electrical stimulation lead can be provided along the sacral S3 spinal nerve. The procedure may be performed in an operating room environment with fluoroscopic or other image guidance to provide more accurate lead placement. However, the procedure is most often performed under local anesthesia in an office environment and without imaging. In an office environment, the placement method is essentially a "blind" insertion method, as it does not rely on pictures or fluoroscopy of the patient's anatomy. When fluoroscopy or other imaging is not used, such as in an office environment, the physician inserts the hole needle from outside the patient' S body and into the S3 hole based on experience and by referencing tactile markers. When the physician tries to place the hole needle through the S3 hole, they cannot see the S3 hole. The use of palpable bones or bony landmarks is based on normal anatomy, irrespective of anatomical or pathological changes. This may lead to improper placement of leads in an office environment and ultimately failure of the PNE. For example, it is often the case that multiple attempts are required to locate the S3 hole and successfully insert a hole needle therethrough. In some cases, due to failure of multiple attempts to properly needle placement, the patient may even discard the PNE (and thus completely discard the sacral neuromodulation) without properly placing the lead. Misplaced leads can also lead to less than ideal clinical results and prematurely forego other effective treatments. Accordingly, there remains a need and a demand for providing an improved system and method for PNE lead placement. Disclosure of Invention Embodiments disclosed herein relate to devices and methods that improve the efficacy and efficiency of positioning a sacral foramen during a sacral neuromodulation procedure. Embodiments include imaging a portion of a patient, identifying an internal point of the patient in the imaging, calculating a measurement based on the imaging and the identified point, transmitting the measurement to a device, placing the device on and outside the patient using a positioning feature, and guiding a medical element (e.g., a hole needle) into the patient using an element guide of the device. The disclosed embodiments help the physician locate the S3 hole more accurately and provide improvements over conventional techniques that locate the S3 hole less accurately during blind insertion. According to one embodiment disclosed herein, a method includes the steps of determining one or more measurements from at least one image of a patient's sacrum, applying the determined one or more measurements with a guiding device, positioning the guiding device on the back of the patient using a marker, and guiding a medical element into the patient using the guiding device while the guiding device is positioned on the back of the patient. According to another disclosed embodiment, an apparatus for guiding insertion of a medical element includes an elongated base having a positioning feature that references a landmark on a patient, a head translatable along the elongated base in a first direction, and a medical element guide translatable along the head in a second direction perpendicular to the first direction, wherein the medical eleme