WO2022018599A1

WO2022018599A1 - System and method for pericardial puncture

Info

Publication number: WO2022018599A1
Application number: PCT/IB2021/056465
Authority: WO
Inventors: Brock Miller; Matthew Gravett; Rund ABOU MARIE
Original assignee: Baylis Medical Company Inc.; Baylis Medical Usa Inc.
Priority date: 2020-07-24
Filing date: 2021-07-16
Publication date: 2022-01-27

Abstract

A method for pericardial puncture includes contacting a pericardium of a heart of a patient with an electrode of a medical device, delivering a stimulus signal from the electrode to the heart, using electrocardiography (ECG) to capture a response to the stimulus signal, based on the response to the stimulus signal, assessing a location of the electrode, and delivering radiofrequency energy from the electrode to puncture the pericardium.

Description

SYSTEM AND METHOD FOR PERICARDIAL PUNCTURE

FIELD:

[0001]This document relates to methods for carrying out medical procedures. More specifically, this document relates to methods for pericardial puncture, and related systems.

SUMMARY:

[0002]The following summary is intended to introduce the reader to various aspects of the detailed description, but not to define or delimit any invention.

[0003] Methods for pericardial puncture are disclosed. According to some aspects, a method for pericardial puncture includes: a. advancing an electrode of a medical device towards a target tissue of a patient; b. after step a., delivering a signal from the electrode; c. capturing a response to the signal; d. after step c., based on the response to the signal, assessing a location of the electrode; and e. after step d., delivering radiofrequency energy from the electrode to puncture the target tissue.

[0004]The target tissue can be a pericardium of a heart. Step a. can include contacting the pericardium with the electrode.

[0005]The signal can be a stimulus signal. Step c. can include using electrocardiography (ECG) to capture the response to the stimulus signal.

[0006] Step c. can include using the electrode to receive a response signal and deliver the response signal to an ECG monitoring system, and processing the response signal with the ECG monitoring system. Step c. can include displaying an indication of the location on the ECG monitoring system. Step d. can include determining whether the electrode is proximate to the ventricle of the heart, and/or determining whether the electrode is proximate to the atrium of the heart. [0007]The method can further include, after step d. and prior to step e., repositioning the electrode. After repositioning the electrode and prior to step e., the method can include repeating steps b. to d.

[0008] Step c. can include using a secondary medical device to receive a response signal and deliver the response signal to an ECG monitoring system. The secondary medical device can include a coronary sinus catheter, and step d. can include determining whether the electrode is proximate a coronary sinus of the heart. The secondary medical device can include a His catheter, and step d. can include determining whether the electrode is proximate a bundle of His of the heart. The secondary medical device can include a 12 Lead ECG.

[0009]The medical device can include an elongate shaft, and the electrode can be at a distal end of the shaft.

[0010] Step a. can include percutaneously advancing the medical device towards the heart via an introducer.

[0011]Step b. can include delivering the stimulus signal from a stimulus signal generator.

[0012] Step e. can include delivering the radiofrequency energy from a radio frequency generator.

[0013] Systems of medical devices are also disclosed. According to some aspects, a system of medical devices includes a signal generator, a monitoring system, a radiofrequency (RF) generator, and a medical device. The medical device includes an elongate shaft and an electrode at a distal end of the shaft. The electrode is electrically connected to the signal generator for receiving a signal from the signal generator and delivering the signal to a tissue. The electrode is electrically connected to the monitoring system for delivering a response signal from the tissue to the monitoring system. The electrode is electrically connected to the RF generator for receiving RF energy from the RF generator and delivering the RF energy to a tissue to puncture the tissue. [0014] In some examples, the elongate shaft includes a wire and a layer of electrical insulation on the wire, and the electrode includes an electrically exposed end of the wire.

[0015]The monitoring system can be an ECG monitoring system.

[0016]The signal generator can be a stimulus signal generator.

BRIEF DESCRIPTION OF THE DRAWINGS:

[0017] The accompanying drawings are for illustrating examples of articles, methods, and apparatuses of the present disclosure and are not intended to be limiting. In the drawings:

[0018] Figure 1 is a perspective view of a system for pericardial puncture;

[0019] Figure 2 is a cross section taken along line 2-2 in Figure 1 ;

[0020] Figure 3 shows an electrocardiograph generated in the absence of a stimulus signal;

[0021] Figure 4 shows an electrocardiograph generated in response to a stimulus signal delivered by an electrode positioned proximate an AV node;

[0022] Figure 5 shows an electrocardiograph generated in response to a stimulus signal delivered by an electrode positioned proximate a ventricle;

[0023] Figure 6 shows an electrocardiograph generated in response to a stimulus signal delivered by an electrode positioned proximate a coronary sinus, where a response signal was captured with a coronary sinus catheter; and

[0024] Figure 7 shows an electrocardiograph generated in response to a stimulus signal delivered by an electrode positioned proximate a bundle of His, where a response signal was captured with a His catheter;

DETAILED DESCRIPTION:

[0025] Various apparatuses or processes or compositions will be described below to provide an example of an embodiment of the claimed subject matter. No example described below limits any claim and any claim may cover processes or apparatuses or compositions that differ from those described below. The claims are not limited to apparatuses or processes or compositions having all of the features of any one apparatus or process or composition described below or to features common to multiple or all of the apparatuses or processes or compositions described below. It is possible that an apparatus or process or composition described below is not an embodiment of any exclusive right granted by issuance of this patent application. Any subject matter described below and for which an exclusive right is not granted by issuance of this patent application may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicants, inventors or owners do not intend to abandon, disclaim or dedicate to the public any such subject matter by its disclosure in this document.

[0026] Generally disclosed herein is a method for tissue puncture (e.g. pericardial puncture) in which a position of a puncturing device is assessed using a monitoring system such as an electrocardiography (ECG) monitoring system or an image monitoring system. More specifically, a radio frequency (RF) puncture device can be used to puncture the pericardium; however, prior to puncturing the pericardium, the radiofrequency puncture device can be used to deliver a signal. The signal can be a stimulus signal that is delivered to the heart, and can be delivered while monitoring the heart with ECG. Based on the effect of the signal (e.g. the effect of the stimulus signal as seen in the electrocardiogram), the position of the radiofrequency puncture device can be confirmed or determined or approximated. If the effect of the stimulus signal indicates that the RF puncture device is in the desired position, puncturing of the pericardium can proceed. If the effect of the stimulus signal indicates that the RF puncture device is not in the desired position, the RF puncture device can be repositioned, and the position can again be assessed (e.g. using ECG). Accordingly, the methods disclosed herein can enhance patient safety.

[0027] Referring now to Figure 1 , an example system 100 of medical devices is shown. The system 100 generally includes a medical device 102 that can be used for RF puncture, stimulus signal delivery, and response signal capture. More specifically, the medical device 102 includes an elongate shaft 104 having a proximal end 106 and a distal end 108. An electrode 110 is at the distal end 108. Referring to Figure 2, in the example shown, the shaft 104 includes a wire 112 and a layer of electrical insulation 114 on the wire 112, and the electrode 110 is in the form of an electrically exposed end of the wire 112. The electrode 110 can deliver a stimulus signal to a tissue, capture a response signal from the tissue, and deliver RF energy to puncture the tissue. Such medical devices are sold by Baylis Medical Company Inc. (Montreal, Canada) under the brand name NRG®.

[0028] Referring back to Figure 1 , the system further includes a stimulus signal generator 116, an ECG monitoring system 118, and an RF generator 120. The electrode 110 of the medical device 102 is electrically connectable to the stimulus signal generator 116, the ECG monitoring system 118, and the RF generator 120 via the wire 112, an electrical connector 120, and a set of cables 122, 124, 126.

[0029]The stimulus signal generator 116 can generate a stimulus signal, and the electrode 110 can receive the stimulus signal and deliver the stimulus signal to a tissue with which the electrode 110 is in contact or a tissue to which the electrode 110 is proximate. The stimulus signal generator 116 can be, for example, one sold by GE Flealthcare under the brand name Micropace.

[0030] The electrode 110 can further capture a response signal from the tissue and deliver the response signal to the ECG monitoring system 118, which can in turn process the response signal in order to assess the location of the electrode 110 (as will be described in detail below).

[0031 ] The RF generator 120 can generate RF energy and the electrode 110 can receive the RF energy from the RF generator 120 and deliver the RF energy to the tissue with which the electrode 110 is in contact, to puncture the tissue. The RF generator 120 can be, for example, one sold by Baylis Medical Company Inc. (Montreal, Canada).

[0032] In use, the medical device 102 can be advanced towards a target tissue at a target location. The target tissue can be, for example, the pericardium. The target location can be, for example, the pericardium proximate an AV node, or proximate a ventricle, or proximate a coronary sinus, or proximate a His bundle. The medical device 102 can optionally be advanced towards the pericardium via an introducer (not shown). For example, the introducer can be percutaneously advanced towards the target location via the subxiphoid approach, with a stylet (not shown) received in the introducer. The stylet can then be removed, and the medical device 102 can be advanced through the introducer towards the target location, optionally to contact the pericardium with the electrode 110.

[0033]0nce the electrode 110 is in contact with the pericardium or proximate the pericardium, a stimulus signal can be delivered from the electrode 110 to the heart. The stimulus signal can be delivered from the stimulus signal generator 116 to the electrode 110 via the wire 112 of the medical device 102.

[0034] ECG can then be used to capture a response to the stimulus signal. That is, the electrode 110 can receive a response signal from the heart, and deliver the response signal to the ECG monitoring system 118. The ECG monitoring system 118 can process the response signal, and based on the processed response signal, display an indication of the location of the electrode 110. For example, the ECG monitoring system can generate and display an electrocardiograph. The electrocardiograph can then be analyzed to assess a location of the electrode 110.

[0035] Example simplified electrocardiographs that may be generated and displayed according to the methods described herein are shown in Figures 3 to 5. Figure 3 shows an example electrocardiograph 300 that may be generated as a result of a response signal captured by electrode 110, in the absence of a stimulus signal. The electrocardiograph 300 includes an atrial portion 302, a ventricular portion 304, and a recovery portion 306. Figure 4 shows an example simplified electrocardiograph 400 that may be generated by the ECG monitoring system 118 in response to a stimulus signal delivered by the electrode 110, and Figure 5 shows another example simplified electrocardiograph 500 that may be generated by the ECG monitoring system 118 in response to a stimulus signal delivered by the electrode 110. Each electrocardiograph 400, 500 includes a representation of the response signal. The representation of the response signal is generally shown at 408 and 508, respectively. The representations 408 and 508 provide an indication of the position of the electrode 110. In Figure 4, the representation 408 of the response signal is closer to the atrial portion 402 of the electrocardiograph 400. This indicates that, when delivering the stimulus signal, the electrode 110 was proximate the AV node. On the other hand, in Figure 5, the representation 508 of the response signal is closer to the ventricular portion 504 of the electrocardiograph 500. This indicates that, when delivering the stimulus signal, the electrode 110 was proximate the ventricle. Accordingly, by delivering a stimulus signal to the heart with the electrode 110 of the medical device 102 and using ECG to capture a response to the stimulus signal, the location of the electrode 110 of the medical device 102 can be assessed (i.e. can be confirmed, determined, and/or approximated).

[0036] In use, if the electrocardiograph indicates that the electrode 110 is at the target location (e.g. if the target location is proximate the AV node and the electrocardiograph is similar to the electrocardiograph 400 of Figure 4), RF energy can then be delivered from the electrode 110 to puncture the pericardium. More specifically RF energy can be delivered from the RF generator 120 to the electrode 110 via the wire 112 of the medical device 102. The RF energy can then be delivered from the electrode 110 to the pericardium, to puncture the pericardium.

[0037] Alternatively if the electrocardiograph indicates that the electrode 110 is not at the target location (e.g. if the target location is proximate the AV node and the electrocardiograph is similar to the electrocardiograph 500 of Figure 5), the position of the medical device 102 can be adjusted to reposition the electrode 110 with respect to the heart. The position of the electrode can then be reassessed, by delivering a stimulus signal and using ECG to capture the response to the stimulus signal. This can optionally be repeated until the electrocardiograph indicates that the electrode 110 is at the target location. When the electrocardiograph indicates that the electrode 110 is at the target location, RF energy can then be delivered from the electrode 110 to puncture the pericardium. [0038] In alternative examples, rather than or in addition to using the electrode 110 to receive the response signal and deliver the response signal to the ECG monitoring system 118, a secondary medical device can be used to receive the response signal and deliver the response signal to the ECG monitoring system 118. The secondary medical device can be, for example, a coronary sinus (CS) catheter (not shown) positioned proximate a coronary sinus of the heart, or a His catheter (not shown) positioned proximate a bundle of His of the heart, or a 12 Lead ECG.

[0039] Figure 6 shows an example simplified electrocardiograph 600 captured according to the methods disclosed herein, using a CS catheter. Figure 7 shows an example simplified electrocardiograph 700 captured according to the methods disclosed herein, using a His catheter. In Figure 6, the representation 608 of the response signal indicates that the electrode 110 is proximate the coronary sinus. This is confirmed by Figure 7, which does not include a representation of a response signal, which in turn suggests that the electrode is not proximate the bundle of His. Accordingly, by delivering a stimulus signal to the heart with the electrode 110 of the medical device 102, and using a secondary medical device to receive a response signal and deliver the response signal to an ECG monitoring system 118, the location of the electrode 110 of the medical device 102 can be assessed.

[0040] In alternative examples, the voltage of the stimulus signal can be used to estimate the proximity of the electrode to a target tissue. For example, if a low voltage stimulus signal generates a response in a target tissue, it can indicate that the electrode is close to the target tissue.

[0041] In the above examples, the system includes a stimulus signal generator. In alternative examples, the system can generate and deliver signals other than stimulus signals - i.e. the system can include a signal generator that is not a stimulus signal generator, and the electrode can deliver signals other than stimulus signals. For example, a signal generator can deliver a fixed-amplitude signal to the electrode, and the electrode can deliver the signal to a receiving device in the heart. The receiving device can then capture the signal and deliver the signal to a monitoring system. As the electrode gets closer to the receiving device, the amplitude of the signal will increase, and the location of the electrode can be assessed by the monitoring system based on the amplitude.

[0042] In the above examples, the system includes an ECG monitoring system to capture the response to the stimulus signal. In alternative examples, the system can include another type of monitoring system, such as a monitoring system that uses imaging.

[0043] In the above examples, the target tissue is the pericardium of the heart. In alternative examples, the target tissue can be another tissue, such as a nerve or a muscle.

[0044]While the above description provides examples of one or more processes or apparatuses or compositions, it will be appreciated that other processes or apparatuses or compositions may be within the scope of the accompanying claims.

[0045]To the extent any amendments, characterizations, or other assertions previously made (in this or in any related patent applications or patents, including any parent, sibling, or child) with respect to any art, prior or otherwise, could be construed as a disclaimer of any subject matter supported by the present disclosure of this application, Applicant hereby rescinds and retracts such disclaimer. Applicant also respectfully submits that any prior art previously considered in any related patent applications or patents, including any parent, sibling, or child, may need to be re-visited.

Claims

WE CLAIM:

1 . A method for pericardial puncture, comprising: a. advancing an electrode of a medical device towards a target tissue of a patient; b. after step a., delivering a signal from the electrode; c. capturing a response to the signal; d. after step c., based on the response to the signal, assessing a location of the electrode; and e. after step d., delivering radiofrequency energy from the electrode to puncture the target tissue.

2. The method of claim 1 , wherein the target tissue is a pericardium of a heart.

3. The method of claim 2, wherein step a. comprises contacting the pericardium with the electrode.

4. The method of claim 1 , wherein the signal is a stimulus signal delivered to the target tissue.

5. The method of claim 1 , wherein step c. comprises using electrocardiography (ECG) to capture the response to the stimulus signal.

6. The method of claim 5, wherein step c. comprises using the electrode to receive a response signal and deliver the response signal to an ECG monitoring system.

7. The method of claim 6, wherein step c. comprises processing the response signal with the ECG monitoring system.

8. The method of claim 7, wherein step c. comprises displaying an indication of the location on the ECG monitoring system.

9. The method of claim 1 , wherein step d. comprises determining whether the electrode is proximate a ventricle of the heart.

10. The method of claim 1 , wherein step d. comprises determining whether the electrode is proximate an atrium of the heart.

11 .The method of claim 1 , further comprising: after step d. and prior to step e., repositioning the electrode.

12. The method of claim 11 , further comprising: after repositioning the electrode and prior to step e., repeating steps b. to d.

13. The method of claim 1 , wherein step c. comprises using a secondary medical device to receive a response signal and deliver the response signal to an ECG monitoring system.

14. The method of claim 13, wherein the secondary medical device comprises a coronary sinus catheter.

15. The method of claim 14, wherein step d. comprises determining whether the electrode is proximate a coronary sinus of the heart.

16. The method of claim 13, wherein the secondary medical device comprises a His catheter.

17. The method of claim 16, wherein step d. comprises determining whether the electrode is proximate a bundle of His of the heart.

18. The method of claim 1 , wherein the medical device comprises an elongate shaft, and the electrode is at a distal end of the shaft.

19. The method of claim 18, wherein step a. comprises percutaneously advancing the medical device towards a heart via an introducer.

20. The method of claim 1 , wherein step b. comprises delivering the signal from a signal generator.

21. The method of claim 1 , wherein step e. comprises delivering the radiofrequency energy from a radio frequency generator.

22. A system of medical devices, comprising: a signal generator; an a monitoring system; a radiofrequency (RF) generator; and a medical device comprising an elongate shaft and an electrode at a distal end of the shaft, wherein the electrode is electrically connected to the signal generator for receiving a signal from the stimulus signal generator and delivering the signal to a tissue, wherein the electrode is electrically connected to the monitoring system for delivering a response signal from the to the monitoring system, and wherein the electrode is electrically connected to the RF generator for receiving RF energy from the RF generator and delivering the RF energy to a tissue to puncture the tissue.

23. The system of claim 22, wherein the elongate shaft comprises a wire and a layer of electrical insulation on the wire, and wherein the electrode comprises an electrically exposed end of the wire.

24. The system of claim 22, wherein the monitoring system is an ECG monitoring system.

25. The system of claim 22, wherein the signal generator is a stimulus signal generator.