Surgical system with position detection

Abstract

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

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 512,413, filed July 7, 2023, the entire disclosure of which is hereby incorporated by reference in its entirety. TECHNICAL FIELD

[0003] The present disclosure relates to medical devices, systems, and methods for use in surgical procedures. More particularly, the present disclosure relates to surgical devices, systems, and methods for cutting and accessing body tissue and providing information about the vicinity of the heart. BACKGROUND

[0004] The epicardium or outer layer of the heart is accessed for a variety of cardiac procedures. Traditionally, the epicardium or epicardial space has been accessed for procedures such as catheter ablation of ventricular arrhythmias and accessory pathways. The epicardium or epicardial space is also accessed for treatment of 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. However, accessing the epicardial space is a challenge and typically involves in-depth knowledge of cardiac anatomy, extensive training, and expertise to avoid problems such as inadvertent right ventricular perforation. A number of technical advances have led to a significant increase in the success rate of epicardial access. Examples of advances include carbon dioxide insufflation through the coronary sinus or right atrial appendage, pressure sensors on needles, computed tomography, cardiac magnetic resonance, and electroanatomic mapping to guide access. SUMMARY

[0005] In Example 1, a system for accessing the epicardium of a heart, the system comprising: a stimulation probe configured to be advanced toward the pericardium and configured to provide an electrical stimulation signal of a selected amplitude and frequency; and a controller coupled to the stimulation probe, the controller configured to provide the electrical stimulation signal of the selected amplitude and frequency to the stimulation probe and to adjust at least one of the selected amplitude or the frequency of the electrical stimulation signal based on a detected stimulation of the heart in response to the electrical stimulation signal.

[0006] In Example 2, the system of Example 1, wherein adjusting at least one of the selected amplitude and frequency comprises reducing the amplitude.

[0007] In Example 3, the system of any of Examples 1-2, wherein the stimulation probe comprises a needle configured to pierce the pericardium.

[0008] In Example 4, the system of Example 3, wherein the needle is a Tuohy needle.

[0009] In Example 5, the system of Example 3, wherein the needle is included in a micropuncture needle set.

[0010] In Example 6, the system of any of Examples 1-2, wherein the stimulation probe comprises a delivery sheath.

[0011] In Example 7, the system of Example 6, wherein the delivery sheath comprises an electrode.

[0012] In Example 8, the system of any of Examples 1-7, wherein the stimulation probe comprises an electrode configured in a monopolar mode.

[0013] In Example 9, the system of any of Examples 1, 2, and 8, wherein the stimulation probe is a radiofrequency (RF) crossing device.

[0014] In Example 10, the system of any of Examples 1-9, wherein the controller is configured to detect stimulation of the heart in response to the electrical stimulation signal.

[0015] 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.

[0016] In Example 12, the system of any of Examples 1-10, wherein the detected stimulation of the heart is based on a change in an electrogram signal.

[0017] In Example 13, the system of any of Examples 1-10, wherein the detected stimulation of the heart is based on fluoroscopy.

[0018] 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.

[0019] In Example 15, the system of any of Examples 1-14, wherein the controller is configured to provide a visualization.

[0020] In Example 16, a method of epicardial access to a heart, the method comprising: providing a puncture device comprising a shaft having a proximal portion and a distal portion, the distal portion comprising an electrode; providing a first stimulation signal to the electrode having a first amplitude and a first frequency, having a first stimulation energy; 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 to the electrode having a second stimulation signal having a second amplitude and a second frequency, having a second stimulation energy; and detecting a second stimulation of the heart in response to the second stimulation signal based on the electrode contacting an epicardium of the heart; wherein the first stimulation energy is greater than the second stimulation energy.

[0021] In Example 17, the method of Example 16, wherein upon detecting stimulation of the heart in response to the electrical stimulation signal, determining whether the stimulation probe is touching the pericardium.

[0022] In Example 18, the method of Example 17, wherein if the stimulation probe is touching the pericardium, puncturing the pericardium.

[0023] In Example 19, the method of Example 17, wherein if the stimulation probe is not touching the pericardium, further advancing the stimulation probe toward the pericardium, the stimulation probe providing at least one of an adjusted amplitude and frequency of the electrical stimulation signal.

[0024] In Example 20, the method of Example 16, wherein adjusting at least one of the selected amplitude and frequency includes decreasing the amplitude.

[0025] In Example 21, the method of Example 16, wherein the stimulation probe includes a needle configured to puncture the pericardium.

[0026] In Example 22, the method of Example 21, wherein the needle is a Tuohy needle.

[0027] In Example 23, the method of Example 21, wherein the needle is included in a micropuncture needle set.

[0028] In Example 24, the method of Example 16, wherein the stimulation probe includes a delivery sheath.

[0029] In Example 25, the method of Example 24, wherein the delivery sheath includes an electrode.

[0030] In Example 26, the method of Example 16, wherein the stimulation probe includes an electrode configured in a monopolar mode.

[0031] In Example 27, the method of Example 16, wherein detecting stimulation includes detecting stimulation via a QRS wave of the heart.

[0032] In Example 28, the method of Example 16, wherein detecting stimulation includes detecting stimulation via determining a change in an electrogram signal.

[0033] In Example 29, the method of Example 16, wherein the puncture device is a radiofrequency (RF) crossing device.

[0034] In Example 30, a system for accessing the epicardium of the heart includes: a stimulation probe configured to advance toward the pericardium and configured to provide an electrical stimulation signal of selected amplitude and frequency; and a controller coupled to the stimulation probe, the controller being configured to provide the electrical stimulation signal of selected amplitude and frequency to the stimulation probe and to adjust at least one of the selected amplitude or frequency of the electrical stimulation signal based on detected stimulation of the heart in response to the electrical stimulation signal.

[0035] In Example 31, the system of Example 30, wherein adjusting at least one of the selected amplitude and frequency includes reducing the amplitude.

[0036] In Example 32, a system for accessing the epicardium of the heart includes: a puncture device comprising an axis having a proximal portion and a distal portion, the distal portion including an electrode, the puncture device being configured to advance toward the pericardium of the heart by manipulating the proximal portion of the puncture device; and a controller coupled to the puncture device, the controller being configured to provide the electrode with a first stimulation signal having a first amplitude and a first frequency and having a first stimulation energy, detect a first stimulation of the heart in response to the first stimulation signal, provide the electrode with a second stimulation signal having a second amplitude and a second frequency and having a second stimulation energy, and detect a second stimulation of the heart in response to the second stimulation signal based on electrode contact with the epicardium of the heart; wherein the first stimulation energy is greater than the second stimulation energy.

[0037] In Example 33, the system of Example 32, wherein the puncture device is one of a radio frequency (RF) piercing device and a needle configured to puncture the pericardium.

[0038] In Example 34, the system of Example 33 is used, where the needle is one of a set of Tuohy needles and micropuncture needles.

[0039] In Example 35, the system of Example 32 is further configured to generate visualizations on a display.

[0040] While several embodiments have been disclosed, other embodiments of the invention will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of the invention. Therefore, the drawings and detailed description should be considered illustrative in nature, rather than restrictive. Attached Figure Description

[0041] Figure 1 This is a diagram illustrating an exemplary clinical setting for treating a patient, which includes an example system comprising an example diagnostic controller coupled with a stimulation probe.

[0042] Figure 2A It is shown that...Figure 1 schematic diagram of a first example stimulation probe for use with the example system of

[0043] Figure 2B schematic diagram of a second example stimulation probe for use with the example system of Figure 1

[0044] Figure 3 schematic diagram of a second example stimulation probe for use with the example system of Figure 1

[0045] Figure 4 schematic diagram of a second example stimulation probe for use with the example system of Figure 3 Figure 1

[0046] While the application is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail below. It should be understood, however, that the intention is not to limit the application to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the application as defined by the appended claims. DETAILED DESCRIPTION

[0047] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the examples illustrated in the drawings, which are described below. The illustrated examples disclosed herein are not meant to be exhaustive or limit the present disclosure to the precise forms disclosed in the following detailed description. Rather, the example embodiments are chosen and described so that others of ordinary skill can use them as teaching tools for their own inventive work. The use of multiple (e.g., all) features in one example does not exceed the scope of the present disclosure in all examples. Therefore, no single figure is to be construed as having any dependency or requirement relating to any single component or combination of components shown therein. Moreover, in examples, various components depicted in the figures can be integrated with various ones of the other components depicted therein (or components not shown), all within the scope of the present disclosure.

[0048] Figure 1 ​​​​An example of a clinical environment 10 for treating a patient 20, such as the heart 30 of the patient 20, is shown. In one example, the clinical environment is configured to access the epicardium of the patient's heart in order to perform one or more of several procedures, such as catheter ablation of ventricular arrhythmias and accessory pathways. The clinical environment 10 includes a system 100 having a diagnostic controller 102 coupled with a stimulation probe 104. In one example, the diagnostic controller 102 is configured to generate an adjustable electrical stimulation signal of a selected amplitude and frequency. The stimulation probe 104 is electrically coupled to the diagnostic controller 102 and is configured to receive the electrical stimulation signal, such as via a cable 106, and to apply the electrical stimulation signal to the patient 20, such as via electrodes 110 disposed on the stimulation probe 104, such as on a distal end region of the stimulation probe. The stimulation probe 104 is also configured to access the patient 20, such as via a skin incision 40, and to be advanced through tissue toward the pericardium of the patient 20. In one embodiment, the stimulation probe 104 is configured with the electrodes 110 and is also configured to cut or puncture tissue of the patient, such as the pericardium.

[0049] Epicardial access is achieved via puncturing the layers of the pericardium while avoiding the myocardium of the heart. The pericardium is a tough, double-walled, fibroelastic sac that surrounds the root of the heart and great vessels. The pericardium includes two layers, an outer layer made of strong connective tissue, commonly referred to as the fibrous pericardium, and an inner layer made of serous membrane, commonly referred to as the serous pericardium. The mesothelium or mesothelial cells that make up the serous pericardium also line the myocardium of the heart as epicardium, resulting in a continuous serous membrane inwardly invaginated as two opposing surfaces, such as on the fibrous pericardium and on the heart. This creates a bag-like virtual or potential space around the heart enclosed between the two opposing serous surfaces, commonly referred to as the pericardial space or pericardial cavity. The pericardial cavity is filled with a small amount of serous fluid and defines the mediastinum. During ventricular contraction, the depolarization wave moves from the endocardium of the heart to the epicardial surface of the heart. The pericardium serves to separate the heart from interference by other structures, and the serous fluid protects the heart from infection and blunt trauma, and lubricates the movement of the heart.

[0050] The system 100 also includes a recording system 112 including a controller 114 operably coupled to the patient 20 via a patient interface 116. In this example, the recording controller 114 is configured to monitor activity of the heart 30 and detect stimulation of the heart 30 in response to the electrical stimulation signal provided via the stimulation probe 104. In the illustrated recording system 112 of the system 100, the recording controller 114 is operably coupled to a graphical display 118 to provide visualization of the heart activity and stimulation of the heart 30 in response to the electrical stimulation signal. In one embodiment, the recording controller 114 is an electrocardiogram (ECG) recorder that is operably coupled to the patient via ECG electrodes as the patient interface 116. The ECG recorder can monitor and generate a visualization of the patient's cardiac rhythm or electrical activity on the display 118. Stimulation of the heart 30 in response to the stimulation signal can be detected in the electrical activity, such as in the QRS wave representing ventricular depolarization, as a change to the normal cardiac rhythm or electrical activity in response to the presence of the electrical stimulation signal. The electrocardiogram signal acquired by the patient interface 116 can be amplified, clipped, filtered, and otherwise processed with the recording controller 114 before being presented in visualization to the display 118.

[0051] In another embodiment of the recording system 112, the recording controller 114 is an echocardiogram recorder that is operably coupled to the patient via ultrasound transducers as the patient interface 116. The echocardiogram recorder can monitor and generate a visualization of the patient's cardiac motion or activity on the display 118. Stimulation of the heart 30 in response to the stimulation signal can be detected in the cardiac motion or activity as a change to the normal cardiac motion or activity in response to the presence of the electrical stimulation signal.

[0052] In another embodiment of the recording system 112, the recording controller 114 is a fluoroscopy recorder that is operably coupled to the patient via a C-arm or real-time X-ray device as the patient interface 116. The fluoroscopy recorder can monitor and generate a visualization of the patient's cardiac motion or activity on the display 118. Stimulation of the heart 30 in response to the stimulation signal can be detected in the cardiac motion or activity as a change to the normal cardiac motion or activity in response to the presence of the electrical stimulation signal.

[0053] The diagnostic controller 102 can provide monopolar or monopolar and bipolar stimulation signal output to a designated instrument, such as the stimulation probe 104 or a plurality or set of instruments applied in the clinical environment 10. In one example, the diagnostic controller 102 is capable of powering both designated monopolar and bipolar instruments simultaneously, but can include a lockout function to prevent the monopolar and bipolar outputs from being activated at the same time.

[0054] During monopolar operation of the stimulation probe 104, a first electrode, often referred to as the active electrode 110, is provided with the stimulation probe 104, while a second electrode 120, often referred to as the indifferent or neutral electrode, is provided in the form of a ground pad dispersed electrode located on the patient 20. In one embodiment, the active electrode 110 is a conductive component on the instrument or stimulation probe 104, such as a ring conductor, blade, or needle attached to the distal tip of the stimulation probe, or a plurality of conductors attached to the stimulation probe, configured to receive the electrical stimulation signal. In another embodiment, the entire conductive instrument is configured to receive the stimulation signal. During the procedure, the ground pad dispersed electrode 120 is typically placed on the back, buttocks, thigh, or other suitable anatomical location. In this configuration, the ground pad dispersed electrode 120 is often referred to as the patient return electrode. In this configuration, an electrical circuit of stimulation energy is formed through the patient 20 between the active electrode 110 and the ground pad dispersed electrode 120 via the stimulation signal provided to the stimulation probe 104.

[0055] As the stimulation probe 104 is advanced toward the pericardium, the intensity of the stimulation signal in the electrical circuit in the patient 20 relative to the heart increases and stimulates the heart. The stimulation of the heart in response to the electrical signal is detected via the recording system 112. The stimulation signal can be adjusted, such as reducing one or both of the power and frequency of the stimulation signal, and the stimulation probe 104 is further advanced toward the pericardium. As the stimulation probe is further advanced toward the pericardium, the intensity of the stimulation signal in the electrical circuit in the patient 20 relative to the heart again increases, and the stimulation signal will again stimulate the heart. The stimulation of the heart in response to the electrical signal is detected via the recording system 112. The stimulation signal can be adjusted, such as reducing one or both of the power and frequency of the stimulation signal. This process can continue to be repeated until it is determined that the probe 104 is touching the pericardium. Once it is determined that the probe 104 is touching the pericardium, the probe 104 can be applied to pierce the outer layer of the pericardium to access the epicardial space.

[0056] Cable 106 is included to mechanically and electrically couple stimulation probe 104 to diagnostic controller 102. Cable 106 includes a plug 132 that connects to a receptacle 134 on diagnostic controller 102. In one embodiment, cable 106 is a single pin cable configured to receive stimulation energy from diagnostic controller 102 and provide it to stimulation probe 104. In another embodiment, cable 106 can include multiple conductors and associated plugs, and the receptacles can correspond to active electrode receptacles, and one or more receptacles can correspond to controls on stimulation probe 104. In one embodiment, both ends of cable 106 include releasable locking mechanisms to ensure mechanical and electrical connection with diagnostic controller 102 and stimulation probe 104. If cable 106 is configured with multiple lead conductors, the cable can include labeled coupling plugs to indicate proper mating with electrical connectors on stimulation probe 104, or be designed to mate with electrical connectors on the stimulation probe in a particular manner. An additional cable 140 connects ground pad electrode 120 with plug 142 to a ground pad receptacle 144 of diagnostic controller 102.

[0057] The features of diagnostic controller 102 described are for illustration only, and a diagnostic controller for stimulation probe 104, such as a generator or electrosurgical unit, can include some, all, or other features in addition to those described below. In one example, diagnostic controller 102 is capable of operating in monopolar mode and bipolar mode, and multiple functions in one mode, such as monopolar stimulation function, monopolar cutting function, and monopolar coagulation function. In some examples, a monopolar device can perform a monopolar hemostasis or tissue sealing function. In monopolar stimulation function, an electrical stimulation signal is provided at a selected amplitude, such as power, and frequency, such as a selected stimulation setting. The stimulation setting can be selected from a range of suitable stimulation settings having an associated amplitude, such as power, from an amplitude or power range, and a frequency from a frequency range. For example, electrical energy for stimulation function can be provided to active electrode 110 at a relatively low voltage and continuous current in a range of nominal impedances. In one example, the energy can be applied in the form of bursts. Each burst typically has a selected duration when the stimulation signal is provided to the active electrode. The pulses can be sinusoidal or square waves, and are biphasic, i.e., positive and negative amplitudes alternate.

[0058] Diagnostic controller 102 includes a power switch for turning the unit on and off, and a settings display for displaying information about the stimulation signal supplied to stimulation probe 104. The settings display can display the amplitude setting numerically in selected units, such as watts, and the frequency setting numerically in selected units, such as hertz. The settings display can also include additional information, such as the form of the pulses and the range of settings.

[0059] The diagnostic controller 102 includes a stimulation signal selector that includes amplitude and frequency setting switches for selecting or adjusting the power and frequency settings. The user can press a power setting switch to increase the power setting and press another power setting switch to decrease the power setting. The user can press a frequency setting switch to increase the frequency setting and press another frequency setting switch to decrease the frequency setting. The diagnostic controller 102 can also include a set of preprogrammed stimulation signal switches to select the stimulation signal from a set of preprogrammed frequency settings. In one embodiment, the setting switches are membrane switches, soft keys, or part of a touch screen.

[0060] In one embodiment, the diagnostic controller 102 provides the stimulation signal to the stimulation probe 104, but the power and frequency levels delivered to the stimulation probe 104 can be selected via controls on the stimulation probe 104 rather than controls on the diagnostic controller 102. In another embodiment, the diagnostic controller 102 is programmed to provide power and frequency levels within a selected power range and frequency range, and the stimulation probe 104 is used to select the output power level and frequency within the preprogrammed range. For example, the diagnostic controller 102 is programmed to provide a monopolar stimulation signal within a power setting range and a frequency range. Using controls on the stimulation probe 104 or at another location, such as using a foot pedal or voice control, rather than using controls on the diagnostic controller 102, the power setting can be adjusted within the power range or the frequency range. Other embodiments are contemplated in which the power setting and frequency are controlled using controls on the stimulation probe 104 rather than controls on the diagnostic controller 102.

[0061] Figure 2A and Figure 2B Stimulation probes 200, 250, which show many embodiments of stimulation probes, are used as the stimulation probe 104 in the system 100. As Figure 2AAs shown, the stimulation probe 200 is configured as a Tuohy needle, or an elongated hypodermic needle with a slight curve at the distal end. In this embodiment, the stimulation probe 200 includes an elongated tubular needle 210 having an open, sharp distal end portion 212 with an open, sharp distal tip 214 configured to puncture tissue and advance toward the pericardium. A proximal end 216 includes a wing 218 and a hub 220. A distal electrode 222 is disposed on the distal end and is operably coupled to an elongated conductor 224 that extends along the axis of the needle to the proximal end 216. The elongated conductor 224 is operably coupled to an electrical connector 226, such as disposed on the hub 220. The electrical connector 226 can be coupled to the electrical cable 106 to receive the electrical stimulation signal from the diagnostic controller 102 and deliver the electrical stimulation signal to the distal electrode 222 configured as the active electrode 110. The distal electrode 222 and the elongated conductor 224 are formed as electrically conductive arms, wires, traces, other electrically conductive elements, and other electrical paths formed of electrically conductive materials, such as metals, and can include stainless steel, titanium, gold, silver, platinum, or any other suitable material. The distal electrode 222 is formed as an electrically conductive element approximately 1 to 2 millimeters in size. In one example, the elongated conductor 224 is insulated or covered with an electrically insulating material.

[0062] Figure 2A A single distal electrode 222 is shown disposed on or near the distal tip 214 of the stimulation probe 200. Other configurations are possible. In one embodiment, multiple electrodes can be included on the stimulation probe, such as an electrode on the distal tip and electrodes spaced apart along the elongated portion of the needle. Each electrode can be associated with an insulated elongated conductor and electrically coupled to an electrical connector on the base.

[0063] As Figure 2BAs shown, the stimulation probe 250 is configured as a microneedle set or needle-in-needle set, including a micropuncture needle 252 configured to be inserted into a tubular guide needle 254 or Cook needle 254. The guide needle 254 is advanced through the patient 20 toward the pericardium with the micropuncture needle 252 included therein. At the pericardium, the micropuncture needle 252 is applied to puncture the fibrous pericardium. Larger gauge needles can penetrate the tough fibrous pericardium with greater force than smaller gauge needles, which can push the needle into contact with the epicardial surface in the presence of respiration and heart motion. A 21 gauge microneedle has 58% less surface area than an 18 gauge Tuohy needle and exerts less shear force. In this embodiment, the guide needle 254 is configured as an elongated tubular needle 260 having an open, sharp distal end portion 262 with an open and sharp distal tip 264 configured to puncture and advance through tissue toward the pericardium. A proximal end 266 includes a hub 268. In this example, a distal electrode 270 is disposed on the distal end and is operably coupled to an elongated conductor 272 that extends along the axis of the needle to the proximal end 266. The elongated conductor 272 is operably coupled to an electrical connector 274, such as disposed on the hub 268. The electrical connector 274 is coupled to the electrical cable 106 to receive the electrical stimulation signal from the diagnostic controller 102 and deliver the electrical stimulation signal to the distal electrode 270 configured as the active electrode 110. The distal electrode 270 and elongated conductor 272 are formed as electrically conductive arms, wires, traces, other electrically conductive elements, and other electrical paths formed of electrically conductive materials, such as metals, and can include stainless steel, titanium, gold, silver, platinum, or any other suitable material. The distal electrode 270 is formed as an electrically conductive element approximately 1 to 2 millimeters in size. In one example, the elongated conductor 272 is insulated or covered with an electrically insulating material. In other embodiments, the electrode 270 is disposed on the micropuncture needle 252, or multiple electrodes can be spaced along the guide needle 254 or on the micropuncture needle 252. The guide needle 254 is operable as a guide sheath for the micropuncture needle 252. In other embodiments, the stimulation probe 104 is configured as a guide sheath with the active electrode 110 disposed on the distal end or along the sheath.

[0064] In some embodiments, the stimulation probes 200, 250 are equipped with switches or controls disposed on the base 220, 268 to apply the electrical stimulation signal to the electrodes, or adjust or control the electrical stimulation signal applied to the electrodes. For example, the base is equipped with a binary switch to selectively activate or deactivate the electrodes when the electrical stimulation signal is provided to the stimulation probe 200, 250. In other embodiments, the base is equipped with a variable control, such as a variable position or output switch or touch control, to adjust the amplitude or frequency of the electrical stimulation signal, or adjust the amplitude or frequency of the electrical stimulation signal within a range of amplitudes or frequencies provided by the diagnostic controller 102.

[0065] Figure 3 A method 300 that can be used with the example system 100 is shown. In one embodiment, the method 300 can be used with a system having a piercing device, such as the stimulation probe 104. The piercing device includes a shaft having a proximal portion and a distal portion, the distal portion including an electrode. In one embodiment, the electrode is configured in a monopolar mode. At 302, an electrical stimulation signal is provided at the stimulation probe. In one embodiment, a first stimulation signal having a first amplitude and a first frequency and having a first stimulation energy is provided to the electrode. At 304, the electrode of the piercing device is advanced toward the pericardium of the heart by manipulating the proximal portion of the piercing device. At 306, stimulation of the heart in response to the stimulation signal is detected. In one embodiment, a first stimulation of the heart in response to the first stimulation signal. If the probe does not have mechanical contact with the heart, such as abutting the heart, at 308, the stimulation signal is adjusted at 310. In one embodiment, a second stimulation signal having a second amplitude and a second frequency and having a second stimulation energy is provided to the electrode. The signal is adjusted so that the first stimulation energy is greater than the second stimulation energy. For example, the first stimulation signal includes a greater amplitude than the second stimulation signal. The stimulation probe provides the adjusted or second electrical stimulation signal. At 304, when the probe is again advanced toward the heart, the stimulation energy used to stimulate the heart becomes less. If the process of reducing the stimulation energy while stimulating the heart is repeated enough, the heart will be stimulated by a small amount of stimulation energy applied when the probe is near the pericardium. Once the probe is determined to be in contact with the pericardium at 308, the pericardium can be punctured with the probe at 312. In some embodiments, the pericardium can be mechanically punctured with a needle or sharp tip. In other embodiments, the piercing device is a radio frequency (RF) piercing device. For example, the probe can include an electrode to apply an RF signal supplied by a generator to pierce the pericardium. In this embodiment, the RF signal is much greater than the stimulation signal applied to the probe.

[0066] Figure 4An embodiment of a controller 400 that can be used with the system 100 is shown that includes features of the diagnostic controller 102 and the recording controller 112. The controller 400 can be implemented to provide an electrical stimulation signal of a selected amplitude and frequency to a stimulation probe, detect stimulation of the heart in response to the electrical stimulation signal, and adjust at least one of the selected amplitude or frequency of the electrical stimulation signal. The controller 400 can include a processor 402 and a memory 404. The memory 404 stores processor-executable instructions 406. In one embodiment, the processor-executable instructions 406 can be in the form of a program, such as a computer program or an application program. The processor 402 can execute instructions that can be included in the instructions 406 that configure the controller 400. In one example, the controller 400 can be implemented as a generator or a professional medical device, or include a general-purpose computing device, such as a laptop, workstation, desktop computer, tablet, or smartphone. The controller 400 can include additional components, such as a display, touchscreen, speaker or other output device, buttons, switches, other controls, a keyboard or other input device, or communication circuitry, such as a computer network adapter. The controller 400 can be implemented in various architectures and components, such as the processor 402 and the memory 404, which can be distributed in different locations.

[0067] In one embodiment, the processor 402 includes multiple main processing cores to run an operating system and perform general-purpose tasks on an integrated circuit. The processor 402 can also include built-in logic or programmable functional units also on the same integrated circuit. In addition to multiple general-purpose main processing cores and application processing units, the controller 400 can include other devices or circuitry, such as a graphics processing unit or a neural network processing unit.

[0068] The memory 404 is an example of computer storage media. Computer storage media includes RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, USB flash drives, flash cards, or other flash memory devices, or any other storage medium that can be used to store the desired information and that can be accessed by the processor 402. Any such computer storage media can be part of the controller 400 and be implemented as the memory 404. The memory 404 is a non-transitory, processor-readable memory device. Thus, a propagating signal per se does not qualify as memory or the memory 404.

[0069] The controller 400 is configured to provide outputs and receive inputs or information from the system. For example, the controller 400 provides a selected stimulation signal 410 continuously or at selected times based on a selected or controller determined amplitude and frequency of the electrical signal. The controller 400 includes or is connected to circuitry to generate and provide the selected stimulation electrical circuitry to the sockets, such as the socket 134 and the ground pad socket 144. The controller 400 is also configured to receive cardiac activity information 412, which can be used to determine whether the heart was stimulated in response to the stimulation signal. For example, the cardiac activity information 412 can be received in the form of electrode signals from an ECG interface, transducer signals from an echocardiogram interface, signals representative of X-rays such as from a C-arm, a cardiac map, or other information. Other inputs can include parameters regarding the stimulation probe, the number of electrodes on the stimulation probe, and patient information. The controller 400 can be configured to generate a visualization 420, which can be based on the selected stimulation signal 410 or the cardiac activity information 412, a determination of whether the heart was stimulated, and other features. In some examples, the visualization 420 can correspond to other information, such as an audio alert or other sound, such as an alarm if the controller detects that the heart was stimulated and another alarm if the controller determines that the stimulation probe is touching the pericardium.

[0070] In one embodiment, the instructions 406 can include instructions to provide an electrical stimulation signal to the stimulation probe at a selected amplitude and frequency, instructions to detect stimulation of the heart in response to the electrical stimulation signal, and instructions to adjust at least one of the selected amplitude or frequency of the electrical stimulation signal. Additional instructions can include instructions to receive inputs and instructions to generate a visualization.

[0071] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present disclosure. For example, while the embodiments described above refer to particular features, the scope of this disclosure also includes embodiments that do not include, among other sub-combinations, all of the features. Accordingly, the scope of the present disclosure is intended to embrace all such alternatives, modifications and variations.

Claims

1. A method of epicardial access to a heart, the method comprising: providing a puncture device comprising a shaft having a proximal portion and a distal portion, the distal portion comprising an electrode; providing the electrode with a first stimulation signal having a first amplitude and a first frequency, having a first stimulation energy; 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 the electrode with a second stimulation signal having a second amplitude and a second frequency, having a second stimulation energy; and detecting a second stimulation of the heart in response to the second stimulation signal based on the electrode contacting an epicardium of the heart; wherein the first stimulation energy is greater than the second stimulation energy.

2. The method of claim 1, wherein, Upon detecting the stimulation of the heart in response to the electrical stimulation signal, determining whether the stimulation probe is touching the pericardium.

3. The method of claim 2, wherein, If the stimulation probe is touching the pericardium, puncturing the pericardium.

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 at least one of an adjusted amplitude and frequency of the electrical stimulation signal.

5. The method of claim 1, wherein, Adjusting at least one of the selected amplitude and frequency includes decreasing the amplitude.

6. The method of claim 1, wherein, The stimulation probe comprises a needle configured to puncture the pericardium.

7. The method of claim 6, wherein, The needle is a Tuohy needle.

8. The method of claim 6, wherein, The needle is included in a micro-puncture needle set.

9. The method of claim 1, wherein, The stimulation probe comprises a delivery sheath.

10. The method of claim 9, wherein, The delivery sheath comprises an electrode.

11. The method of claim 1, wherein, The stimulation probe comprises an electrode configured in a unipolar mode.

12. The method of claim 1, wherein, Detecting the stimulation comprises detecting the stimulation via a QRS wave of the heart.

13. The method of claim 1, wherein, Detecting the stimulation comprises detecting the stimulation via determining a change in an electrogram signal.

14. The method of claim 1, wherein, The puncture device is a radio frequency (RF) crossing device.

15. A system for epicardial access to a heart, the system comprising: a stimulation probe configured to be advanced toward a pericardium and configured to provide an electrical stimulation signal of a selected amplitude and frequency; and a controller coupled to the stimulation probe, the controller configured to provide the electrical stimulation signal of a selected amplitude and frequency to the stimulation probe and to adjust at least one of the selected amplitude or frequency of the electrical stimulation signal based on a detected stimulation of the heart in response to the electrical stimulation signal.

16. The system of claim 15, wherein, Adjusting at least one of the selected amplitude and frequency includes decreasing the amplitude.

17. A system for epicardial access to a heart, the system comprising: a puncture device comprising a shaft having a proximal portion and a distal portion, the distal portion comprising an electrode, the puncture device configured to be advanced 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 the electrode with a first stimulation signal having a first amplitude and a first frequency, having a first stimulation energy, and to provide the electrode with a second stimulation signal having a second amplitude and a second frequency, having a second stimulation energy, based on the electrode contacting an epicardium of the heart. a controller coupled to the puncture device, the controller configured to provide a first stimulation signal having a first amplitude and a first 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 to the electrode, having a second amplitude and a second frequency, having a second stimulation energy, and based on the electrode contacting the epicardium of the heart, detect a second stimulation of the heart in response to the second stimulation signal; wherein the first stimulation energy is greater than the second stimulation energy.

18. The system of claim 17, wherein, the puncture device is one of a radio frequency (RF) crossing device and a needle configured to puncture the pericardium.

19. The system of claim 18, wherein, the needle is one of a Tuohy needle and a micropuncture needle set.

20. The system of claim 17, wherein, the controller is further configured to generate a visualization on a display.

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