Patent Publication Number: US-2023149067-A1

Title: System of medical devices and method for pericardial puncture

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application is a continuation application of International Application No. PCT/IB2021/056017, filed Jul. 5, 2021, titled “SYSTEM OF MEDICAL DEVICES AND METHOD FOR PERICARDIAL PUNCTURE,” which claims priority to U.S. Provisional Application No. 63/049,182, filed Jul. 8, 2020, titled “SYSTEM OF MEDICAL DEVICES AND METHOD FOR PERICARDIAL PUNCTURE,” the entire disclosures of which are incorporated herein by reference. 
    
    
     FIELD 
     This document relates to medical devices. More specifically, this document relates to systems of medical devices that can be used in pericardial puncture, and related methods. 
     SUMMARY 
     The following summary is intended to introduce the reader to various aspects of the detailed description, but not to define or delimit any invention. 
     Systems of medical devices are disclosed. According to some aspects, a system of medical devices includes an introducer extending between an introducer proximal end and an introducer distal end. The introducer has a lumen extending therethrough from the introducer proximal end to the introducer distal end. The introducer includes a first indicator electrode that faces radially inwardly toward the lumen. The system further includes a puncture device extending from a puncture device proximal end to a puncture device distal end. The puncture device includes a radiofrequency puncture electrode at the puncture device distal end and a second indicator electrode that is positioned proximal of the radiofrequency puncture electrode and that faces radially outwardly. The puncture device is advanceable through the lumen from the introducer proximal end towards the introducer distal end to position the puncture device in a puncture position in which the radiofrequency puncture electrode is proud of the introducer distal end and in which the second indicator electrode is longitudinally aligned with the first indicator electrode. The system further includes an indicator system that is electrically connectable to the first indicator electrode and the second indicator electrode. The indicator system includes an indicator that is activated when the second indicator electrode is longitudinally aligned with the first indicator electrode. 
     In some examples, the indicator includes a light, and activation of the indicator includes the illumination of the light. 
     In some examples, when the second indicator electrode is longitudinally aligned with the first indicator electrode, the second indicator electrode is in electrical contact with the first indicator electrode. Electrical contact of the first indicator electrode and the second indicator electrode can complete an electrical circuit of the indicator system and thereby activate the indicator. 
     In some examples, the indicator system includes a first impedance sensor for sensing an impedance of the first indicator electrode and a second impedance sensor for sensing an impedance of the second indicator electrode. When the second indicator electrode is in contact with the first indicator electrode, the impedance of the first impedance sensor can approximate the impedance of the second impedance sensor. The indicator can be activated when the impedance of the first impedance sensor approximates the impedance of the second impedance sensor. 
     The indicator system can be built into the puncture device or the introducer. The puncture device can include a hub at the proximal end, and the indicator can be provided on the hub. 
     In some examples, the system includes a radiofrequency generator electrically connectable to the radiofrequency puncture electrode. The indicator system and radiofrequency generator can be an all-in-one unit. 
     Methods for pericardial puncture are also disclosed. According to some aspects, a method for pericardial puncture includes: a. advancing an introducer towards a pericardium; b. advancing a puncture device through the introducer towards the pericardium; c. activating an indicator when an indicator electrode of the introducer is longitudinally aligned with an indicator electrode of the puncture device, to indicate that the puncture device is in a puncture position; and d. after step c., puncturing the pericardium with the puncture device. 
     In some examples, in the puncture position, a radiofrequency puncture electrode of the puncture device is proud of a distal end of the introducer. Step c. can include delivering radiofrequency energy from a radiofrequency generator to the radiofrequency puncture electrode. The indicator can be part of an all-in-one unit with the radiofrequency generator, or can be built into the puncture device. 
     In some examples, the indicator includes a light that is illuminated when activated. 
     In some examples, when the indicator electrode of the introducer is longitudinally aligned with the indicator electrode of the puncture device, the indicator electrode of the introducer is in electrical contact with the indicator electrode of the puncture device. Electrical contact of the indicator electrode of the introducer and the indicator electrode of the puncture device can complete an electrical circuit to activate the indicator. 
     In some examples, step c. includes sensing an impedance of the indicator electrode of the introducer and sensing an impedance of the indicator electrode of the puncture device. Step c. can include activating the indicator when the impedance of the indicator electrode of the introducer approximates the impedance of the indicator electrode of the puncture device. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       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: 
         FIG.  1    is a perspective view of an example system of medical devices; 
         FIG.  2    is a perspective view of the introducer of the system of  FIG.  1   ; 
         FIG.  3    is a cross-section taken along line  3 - 3  in  FIG.  2   ; 
         FIG.  4    is a perspective view of the puncture device of the system of  FIG.  1   ; 
         FIG.  5    is a cross-section taken along line  5 - 5  in  FIG.  4   ; and 
         FIG.  6    is a cross-section taken along line  6 - 6  in  FIG.  1     
     
    
    
     DETAILED DESCRIPTION 
     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. 
     Generally disclosed herein is a system of medical devices that includes an introducer and a puncture device. The system is configured to provide the user with an indication of the relative position of a radiofrequency puncture electrode of the puncture device and the distal end of the introducer, even if the radio frequency puncture electrode and the distal end of the introducer are not visible with the naked eye. For example, the system can provide the user with an indication that the puncture device is in a puncture position—i.e. positioned with the radiofrequency puncture electrode just proud of the distal end of the introducer, so that radiofrequency energy can be delivered from the radiofrequency puncture electrode to puncture tissue. As will be described in detail below, in order to provide an indication that the puncture device is in the puncture position, the puncture device and introducer can each include a respective indicator electrode, and the indicator electrodes can be longitudinally aligned with each other when the puncture device is in the puncture position. The indicator electrodes can be in communication with an indicator system that, based on signals received from the indicator electrodes, activates an indicator (e.g. a light) when the indicator electrodes are longitudinally aligned. 
     Referring now to  FIG.  1   , an example system  100  of medical devices is shown. The system  100  generally includes an introducer  102  and a puncture device  104 , both of which are connected to an indicator system  106 . The puncture device  104  is further connected to a radiofrequency (RF) generator  108  (which may in turn be connected to one or more grounding pads, not shown). The puncture device  104  is receivable in and advanceable through the introducer  102 . The introducer  102  can serve to atraumatically guide the puncture device  104  towards a target location in a patient&#39;s body (e.g. the heart), and the puncture device  104  can then puncture the target location (e.g. puncture the pericardium) using RF energy delivered from the RF generator  108 . As will be described in further detail below, the indicator system  106  provides an indication of the position of the puncture device  104  with respect to the introducer  102 , in order to facilitate proper positioning of the puncture device  104 , enhance ease of use, and enhance patient safety. 
     Referring to  FIG.  2   , the introducer  102  extends along a longitudinal axis  110  and has a proximal portion  112  (also referred to herein as an ‘introducer proximal portion’), which defines a proximal end  114  (also referred to herein as an ‘introducer proximal end’), and a distal portion  116  (also referred to herein as an ‘introducer distal portion’), which defines a distal end  118  (also referred to herein as an ‘introducer distal end). The introducer  102  has a length (also referred to herein as an ‘introducer length’) between the proximal end  114  and the distal end  118 . A lumen  120  (shown in  FIG.  3   ) extends through the introducer  102  from the proximal end  114  to the distal end  118 , for receiving the puncture device  104 . 
     Referring still to  FIG.  2   , in the example shown, the introducer  102  includes a shaft  122  (also referred to herein as an ‘introducer shaft’) and a hub  124  (also referred to herein as an ‘introducer hub’). The hub  124  defines the proximal end  114  of the introducer  102 , while the shaft  122  defines the distal end  118  of the introducer  102 . The hub  124  may include various features, such as fluid ports and hemostatic valves, etc. (not shown). In use, the hub  124  may be grasped and manipulated by the user, while the distal portion  116  is directed to a target site within a patient&#39;s body (e.g. the heart). The distal end  118  is blunt, to avoid damaging tissue in contact with the distal end  118 . 
     Referring to  FIG.  3   , the shaft  122  includes a metallic tube  126  (e.g. a stainless steel hypotube), and a polymeric sheathing  128  (e.g. a high-density polyethylene sheathing) on the tube  126 . The introducer  102  further includes an indicator electrode  130  (also referred to herein as a ‘first indicator electrode’). The indicator electrode  130  faces radially inwardly towards the lumen  120  and is electrically exposed to the lumen  120 . In the example shown, the indicator electrode  130  is in the form of a metallic ring that is partially embedded in the polymeric sheathing  128 . The metallic tube  126  is electrically connected to the indicator electrode  130 , and serves both to provide physical reinforcement for the introducer  102  and as an electrical conductor that electrically connects the indicator electrode  130  to the indicator system  106  (shown in  FIG.  1   ). For example, the hub  124  can include electrical connectors (not shown) that allow for the electrical connection of the metallic tube  126  to a cable  132  (shown in  FIG.  2   ) that is in turn electrically connected to the indicator system  106 . The polymeric sheathing  128  serves to electrically insulate the metallic tube  126 . 
     In alternative examples, the introducer can include a rigid polymer, and the metallic tube can be omitted. A wire can be embedded in the rigid polymer to electrically connect the indicator electrode and the indicator system. 
     Referring now to  FIG.  4   , the puncture device  104  extends along a longitudinal axis  134  and has a proximal portion  136  (also referred to herein as a ‘puncture device proximal portion’), which defines a proximal end  138  (also referred to herein as a ‘puncture device proximal end’), and a distal portion  140  (also referred to herein as a ‘puncture device distal portion’), which defines a distal end  142  (also referred to herein as a ‘puncture device distal end). The puncture device  104  has a length (also referred to herein as a ‘length length’) between the proximal end  138  and the distal end  142 . 
     Referring to  FIG.  5   , the puncture device  104  is an RF puncture device, and includes a core wire  144  and an electrically insulative material  146  on the core wire  144 . An electrically exposed end of the core wire  144  forms an RF puncture electrode  148  at the distal end  142  of the puncture device  104 . 
     Referring to  FIG.  4   , the proximal portion  136  of the puncture device  104  can be used to grasp and manipulate the puncture device  104 . Optionally, a guidewire torque device (not shown) can be coupled to the proximal portion  136  to facilitate grasping and manipulation. The proximal portion  136  of the puncture device  104  can be connected to the RF generator  108  via an electrical connector  150  and a cable  152  (both shown in  FIG.  1   ) so that RF energy can be delivered from the RF generator  108  to the RF puncture electrode  148  via the core wire  144 . When the RF puncture electrode  148  is in contact with a tissue (e.g. the pericardium) and RF energy is delivered to the RF puncture electrode  148 , the RF energy causes puncture of the tissue. 
     In the example shown, the puncture device  104  is relatively flexible, and can also serve as a guidewire. 
     Referring still to  FIG.  5   , the puncture device  104  further includes its own indicator electrode  154  (also referred to herein as a ‘second indicator electrode’). The second indicator electrode  154  is positioned proximally of the RF puncture electrode  148  and faces radially outwardly. In the example shown, the second indicator electrode  154  is in the form of a metallic ring that is partially embedded in the electrically insulative material  146 . An electrical conductor  156  in the form of a wire is connected to the second indicator electrode  154 , and extends proximally from the second indicator electrode  154  to electrically connect the second indicator electrode  154  to the indicator system  106  (shown in  FIG.  1   ). For example, the electrical connector  150  (shown in  FIG.  1   ) can allow for the electrical connection of the electrical conductor  156  to the cable  152 , which is in turn electrically connected to the indicator system  106  (i.e. in the example shown, the same cable  156  connects the core wire  144  to the RF generator  108  and the electrical conductor  156  to the indicator system  106 ). 
     Referring now to  FIG.  6   , the puncture device  104  is advanceable through the lumen  120  (not labelled in  FIG.  6   ) of the introducer  102 , from the introducer proximal end  114  (not shown in  FIG.  6   ) towards the introducer distal end  118 , to position the puncture device  104  in a “puncture position”. In the puncture position, as shown in  FIG.  6   , the RF puncture electrode  148  is just proud of the introducer distal end  118 , so that it can contact and deliver RF energy to a target tissue (e.g. the pericardium), while still being supported by the introducer  102 . Furthermore, in the puncture position, the second indicator electrode  154  is longitudinally aligned with and in electrical contact with the first indicator electrode  130 . 
     Referring to  FIGS.  1  and  6   , as mentioned above, the indicator system  106  (shown in  FIG.  1   ) is electrically connectable to the first indicator electrode  130  and the second indicator electrode  154  (both shown in  FIG.  6   ). When the second indicator electrode  154  is in electrical contact with the first indicator electrode  130 —i.e. when the puncture device  104  is in the puncture position—an electrical circuit of the indicator system  106  is completed. This electrical circuit further includes an indicator. In the example shown, the indicator is in the form of a light  158  (shown in  FIG.  1   ). When the electrical circuit is completed, the indicator is activated, to indicate to the user that the puncture device  104  is in the puncture position. That is, in the example shown, when the electrical circuit is completed, the light  158  illuminates, to indicate to the user that the puncture device  104  is in the puncture position. 
     In alternative examples, the indicator can be, for example, a display, and activation of the display can include displaying a certain word or phrase or color. In further alternative examples, the indicator can be a sound-generating apparatus, and activation of the indicator can include the emission of a sound. 
     In the example shown, the indicator system  106  and radiofrequency generator  108  are part of a single all-in-one unit, and the light  158  is on this unit, as shown in  FIG.  1   . In alternative examples, the indicator system and indicator can be elsewhere, such as built into the puncture device or built into the introducer (e.g. in/on the hub the introducer). In such examples, the indicator system can optionally be battery powered. 
     In the example shown, the first indicator electrode  130  is in the distal portion  116  of the introducer  102 , and the second indicator electrode  154  is in the distal portion  140  of the puncture device  104 . In alternative examples, the indicator electrodes  130 ,  154  can be positioned elsewhere, such as in the proximal portion of the introducer and the proximal portion of the puncture device, respectively. 
     In an alternative example (not shown), the introducer can include a first indicator electrode and a second indicator electrode, which are spaced apart (e.g. are on opposite sides of the lumen) and are not in direct electrical contact with each other. Each of the indicator electrodes of the introducer can be connected to the indicator system via a respective electrical connector. The puncture device can include a third indicator electrode, and the third indicator electrode can bridge the first and second indicator electrodes when the puncture device is in puncture position, in order to put the first and second indicator electrodes in electrical contact and complete an electrical circuit of the indicator system, and thereby activate an indicator. 
     In an alternative example (not shown), rather than including an electrical circuit that is completed when the second indicator electrode  154  is in electrical contact with the first indicator electrode  130 , the indicator system can include a first impedance sensor for sensing the impedance of the first indicator electrode and a second impedance sensor for sensing the impedance of second electrode, and the indicator system can be configured to activate the indicator when the impedance of the first indicator electrode equals or is similar to (i.e. approximates) the impedance of the second indicator electrode. That is, the impedance sensors can continuously poll the first and second indicator electrodes, respectively. When the puncture device is in the puncture position and the first and second indicator electrodes are in contact, the impedance of the first indicator electrode will be equal to or similar to (i.e. will approximate) the impedance of the second indicator electrode. When the impedance of the first indicator electrode approximates the impedance of the second indicator electrode, the indicator can be activated. 
     In any of the above examples, the introducer  102  and/or puncture device  104  may include a radiopaque marker (not shown), to facilitate viewing of the introducer  102  and/or puncture device  104  under fluoroscopy. 
     In one particular example of use, the introducer  102  may be advanced towards the pericardium, to position the introducer distal end  118  proximate the pericardium, and preferably slightly spaced from the pericardium. The introducer  102  may be advanced towards the pericardium percutaneously, via the subxiphoid approach. The introducer  102  may be advanced with a stylet (not shown) received in the lumen  120 . The positioning of the introducer  102  may be confirmed using fluoroscopy. 
     The puncture device  104  may then be advanced through the introducer  102 , towards the pericardium, until the puncture device  104  is in the puncture position and in contact with the pericardium. In order to achieve this, the puncture device  104  can be advanced through the introducer  102  until the indicator is activated (i.e. until the light  158  is illuminated). Activation of the indicator indicates to the user that the puncture device  104  is in the puncture position, and occurs when the indicator electrode  130  of the introducer  102  is in electrical contact with the indicator electrode  154  of the puncture device  104 , which in turn occurs when the indicator electrode  130  of the introducer  102  is longitudinally aligned with the indicator electrode  154  of the puncture device  104 . which in turn occurs when the puncture device  104  is in the puncture position. 
     Optionally, fluoroscopy can be used to confirm that the puncture device  104  is in the puncture position. 
     Once it has been confirmed that the puncture device  104  is in the puncture position, RF energy can be delivered to the RF puncture electrode  148  from the RF generator  108 , and from the RF puncture electrode  148  to puncture the pericardium. 
     Once the target tissue has been punctured, the puncture device  104  can be advanced into the pericardial space, and can serve as a guidewire in subsequent steps of the medical procedure. 
     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. 
     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.