EP-4739237-A1 - SURGICAL SYSTEM WITH LOCATION DETECTION

Abstract

A system to access an epicardium of a heart is disclosed. The system includes a stimulation probe and a controller. The stimulation probe is advanced toward a pericardium and provides an electrical stimulation signal of a selected amplitude and frequency. The controller is coupled to the to the stimulation probe. The controller provides the electrical stimulation signal of the selected amplitude and frequency to the stimulation probe and adjusts the selected amplitude, frequency, or both of the electrical stimulation signal based on a detected stimulation of the heart in response to the electrical stimulation signal.

Inventors

• DAVIES, GARETH
• LAU, Kaylie

Assignees

• Boston Scientific Medical Device Limited

Dates

Publication Date

20260513

Application Date

20240704

Claims (20)

1. 1 . A method of epicardial access of a heart, the method comprising: providing a puncture device including a shaft having a proximal portion and a distal portion, the distal portion including an electrode; providing a first stimulation signal having a first amplitude and frequency having a first stimulation energy to the electrode; advancing the electrode of the puncture device toward a pericardium of the heart by manipulating the proximal portion of the puncture device; detecting a first stimulation of the heart in response to the first stimulation signal; providing a second stimulation signal having a second stimulation signal having a second amplitude and frequency having a second stimulation energy to the electrode; and detecting a second stimulation of the heart in response to the second stimulation signal, based on the electrode contacting the epicardium of the heart; wherein the first stimulation energy is greater than the second stimulation energy.
2. 2. The method of claim 1 , wherein upon detecting a stimulation of the heart in response to the electrical stimulation signal, determining whether the stimulation probe is touching the pericardium.
3. 3. The method of claim 2, wherein if the stimulation probe is touching the pericardium, piercing the pericardium.
4. 4. The method of claim 2, wherein if the stimulation probe is not touching the pericardium, further advancing the stimulation probe toward the pericardium, the stimulation probe providing the adjusted at least one of the amplitude and frequency of the electrical stimulation signal.
5. 5. The method of claim 1 , wherein the adjusting at least one of the selected amplitude and frequency includes lowering the amplitude.
6. 6. The method of claim 1 , wherein the stimulation probe includes a needle configured to pierce the pericardium.
7. 7. The method of claim 6, wherein the needle is a Tuohy needle.
8. 8. The method of claim 6, wherein the needle is included in a micropuncture needle set.
9. 9. The method of claim 1 , wherein the stimulation probe includes a delivery sheath.
10. 10. The method of claim 9, wherein the delivery sheath includes an electrode.
11. 11 . The method of claim 1 , wherein the stimulation probe includes an electrode configured in a monopolar mode.
12. 12. The method of claim 1 , wherein the detecting the stimulation includes detecting the stimulation via a QRS wave of the heart.
13. 13. The method of claim 1 , wherein the detecting the stimulation includes detecting the stimulation via determining changes in an electrogram signal.
14. 14. The method of claim 1 , wherein the puncture device is a radio-frequency (RF) crossing device.
15. 15. A system to access an epicardium of a heart, the system comprising: a stimulation probe configured to advance toward a pericardium and configured to provide an electrical stimulation signal of a selected amplitude and frequency; and a controller coupled to the to the stimulation probe, the controller configured to provide the electrical stimulation signal of the selected amplitude and frequency to the stimulation probe and adjust at least one of the selected amplitude and frequency of the electrical stimulation signal based on a detected stimulation of the heart in response to the electrical stimulation signal.
16. 16. The system of claim 15, wherein the adjusting at least one of the selected amplitude and frequency includes lowering the amplitude.
17. 17. A system to access an epicardium of a heart, the system comprising: a puncture device including a shaft having a proximal portion and a distal portion, the distal portion including an electrode, the puncture device configured to advance toward a pericardium of the heart by manipulating the proximal portion of the puncture device; and a controller coupled to the puncture device, the controller configured to provide a first stimulation signal having a first amplitude and frequency having a first stimulation energy to the electrode, detect a first stimulation of the heart in response to the first stimulation signal, provide a second stimulation signal having a second stimulation signal having a second amplitude and frequency having a second stimulation energy to the electrode, and detect a second stimulation of the heart in response to the second stimulation signal, based on the electrode contacting the epicardium of the heart; wherein the first stimulation energy is greater than the second stimulation energy.
18. 18. The system of claim 17, wherein the puncture device is one of a radio-frequency (RF) crossing device and a needle configured to pierce the pericardium.
19. 19. The system of claim 18, wherein the needle is one of a T uohy needle and a micropuncture needle set.
20. 20. The system of claim 17, wherein the controller is further configured to generate a visualization on a display.

Description

SURGICAL SYSTEM WITH LOCATION DETECTION CROSS REFERENCE TO RELATED APPLICATION [0001] The present application claims priority to U.S. Provisional Patent Application No. 63/512,413, filed July 7, 2023, the entire disclosure of which is incorporated herewith in its entirety. TECHNICAL FIELD [0002] The present disclosure relates to medical devices, systems and methods for use in surgical procedures. More specifically, this disclosure relates to surgical devices, systems and methods for cutting and access of bodily tissues and providing information regarding proximity to the heart. BACKGROUND [0003] The epicardium, or outer layer of the heart, is accessed for several cardiac procedures. Traditionally, the epicardium or epicardial space has been accessed for such procedures as catheter ablation of ventricular arrhythmias and accessory pathway. The epicardium or epicardial space is also accessed to treat left atrial appendage occlusion, esophageal protection, mapping and ablation during atrial fibrillation procedures, implantation of epicardial pacing leads, and phrenic nerve displacement to facilitate safe ablation of atrial and ventricular arrhythmias. Accessing the epicardial space, however, is a challenge and typically involves intimate knowledge of cardiac anatomy, extensive training, and expertise to avoid issues such as inadvertent right ventricular perforation. Multiple technological advances have led to significant improvements in epicardial access success. Examples of advances include carbon dioxide insufflation through the coronary sinus or the right atrial appendage, pressure sensors on needles, computed tomography, cardiac magnetic resonance, and electroanatomic mapping guided access. SUMMARY [0004] In Example 1 , a system to access an epicardium of a heart, the system comprising: a stimulation probe configured to advance toward a pericardium and configured to provide an electrical stimulation signal of a selected amplitude and frequency; and a controller coupled to the to the stimulation probe, the controller configured to provide the electrical stimulation signal of the selected amplitude and frequency to the stimulation probe and adjust at least one of the selected amplitude and frequency of the electrical stimulation signal based on a detected stimulation of the heart in response to the electrical stimulation signal. [0005] In Example 2, the system of Example 1 , wherein the adjusting at least one of the selected amplitude and frequency includes lowering the amplitude. [0006] In Example 3, the system of any of Examples 1-2, wherein the stimulation probe includes a needle configured to pierce the pericardium. [0007] In Example 4, the system of Example 3, wherein the needle is a Tuohy needle. [0008] In Example 5, the system of Example 3, wherein the needle is included in a micropuncture needle set. [0009] In Example 6, the system of any of Examples 1-2, wherein the stimulation probe includes a delivery sheath. [0010] In Example 7, the system of Example 6, wherein the delivery sheath includes an electrode. [0011] In Example 8, the system of any of Examples 1-7, wherein the stimulation probe includes an electrode configured in a monopolar mode. [0012] In Example 9, the system of any of Examples 1 , 2 and 8, wherein the stimulation probe is a radio-frequency (RF) crossing device. [0013] In Example 10, the system of any of Examples 1-9, wherein the controller is configured to detect the stimulation of the heart in response to the electrical stimulation signal. [0014] In Example 11 , the system of any of Examples 1-10, wherein the detected stimulation of the heart is based on a QRS wave of the heart. [0015] In Example 12, the system of any of Examples 1-10, wherein the detected stimulation of the heart is based on changes in an electrogram signal. [0016] In Example 13, the system of any of Examples 1-10, wherein the detected stimulation of the heart is based on fluoroscopy. [0017] In Example 14, the system of any of Examples 1-12, wherein the controller is configured to determine whether the stimulation probe is touching the pericardium. [0018] In Example 15, the system of any of Examples 1-14, wherein the controller is configured to provide a visualization. [0019] In Example 16, a method of epicardial access of a heart, the method comprising: providing a puncture device including a shaft having a proximal portion and a distal portion, the distal portion including an electrode; providing a first stimulation signal having a first amplitude and frequency having a first stimulation energy to the electrode; advancing the electrode of the puncture device toward a pericardium of the heart by manipulating the proximal portion of the puncture device; detecting a first stimulation of the heart in response to the first stimulation signal; providing a second stimulation signal having a second stimulation signal having a second amplitude and frequency having a second stimulation energy to the electrode; and det