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WO2025183945A2 - Ensemble cathéter comprenant un émetteur radiofréquence - Google Patents

Ensemble cathéter comprenant un émetteur radiofréquence

Info

Publication number
WO2025183945A2
WO2025183945A2 PCT/US2025/016297 US2025016297W WO2025183945A2 WO 2025183945 A2 WO2025183945 A2 WO 2025183945A2 US 2025016297 W US2025016297 W US 2025016297W WO 2025183945 A2 WO2025183945 A2 WO 2025183945A2
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
lumen
balloon
fluid
outer catheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/016297
Other languages
English (en)
Other versions
WO2025183945A3 (fr
Inventor
Pasquale SANTANGELI
Samir Kapadia
Paresh VASANDANI
James P. HOPE
Tanner HARGENS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cleveland Clinic Foundation
Original Assignee
Cleveland Clinic Foundation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cleveland Clinic Foundation filed Critical Cleveland Clinic Foundation
Publication of WO2025183945A2 publication Critical patent/WO2025183945A2/fr
Publication of WO2025183945A3 publication Critical patent/WO2025183945A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3937—Visible markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image

Definitions

  • the present disclosure generally relates to catheters for performing cardiovascular procedures, and more particularly but not exclusively relates to catheter assemblies for performing cannulation and/or perforation procedures.
  • Cannulation and perforation of cardiac or vascular tissue can be required to obtain intravascular, intracardiac or epicardial access for a variety of cardiac procedures.
  • surgeries for treating atrial or ventricular arrhythmias can require access to the epicardium.
  • Catheters for cardiac ablation procedures or other epicardial electrophysiologic procedures are ubiquitous in treatment processes.
  • percutaneous pericardial access for ablation procedures is often desired, such procedures are limited by a high rate of periprocedural complications related to bleeding and/or inadvertent cardiac perforation.
  • percutaneous procedures to recanalize occluded vessels may require the creation of small channels through the obstruction to allow for percutaneous recanalization with balloon angioplasty and/or stenting.
  • one current treatment option for epicardial mapping and ablation of cardiac arrhythmias involves percutaneous pericardial access via an incision made just below the xiphoid process 82, which projects from the sternum 81.
  • a needle or catheter 70 is inserted through the subxiphoid incision to access the pericardial space 93 while avoiding contacting and/or damaging the liver 83.
  • This approach is minimally invasive and provides direct access to the pericardial space 93 and epicardium.
  • Such direct access via the subxiphoid access route 84 typically results in a cost-effective procedure and a fast recovery for the patient.
  • this approach has relatively high complication rates due to a lack of
  • the catheter assembly generally includes an outer catheter, an inner catheter, and a balloon.
  • the outer catheter includes a first lumen and a second lumen, and an aperture in a wall of the outer catheter is in fluid communication with the second lumen.
  • the inner catheter is operable to be received and translated within the first lumen of the outer catheter, and the inner catheter comprises a radiofrequency emitter tip adapted to emit radiofrequency energy.
  • the balloon is sealed to an external surface of the outer catheter, and an interior of the balloon is in fluid communication with the second lumen via the aperture such that the balloon is operable to be inflated via the second lumen.
  • FIG. 1 illustrates insertion of a catheter or needle for percutaneous pericardial access via a subxiphoid access route.
  • Fig. 2 is a sagittal image of a chest cavity that further illustrates the subxiphoid access route.
  • FIG. 3 is a perspective illustration of a catheter assembly according to certain embodiments.
  • Fig. 4 is a partially exploded view of the catheter assembly illustrated in Fig. 3.
  • Fig. 5 is a partially exploded view of an introducer according to certain embodiments.
  • Fig. 6 is a partially exploded view of an outer catheter assembly according to certain embodiments.
  • Fig. 7 is a cross-sectional view of an outer catheter, taken along the line VII- VII in Fig. 6.
  • Fig. 8A is a plan view of a distal end portion of an outer catheter according to certain embodiments.
  • Fig. 8B is a cutaway view of the distal end portion of the outer catheter.
  • Fig. 8C is a perspective view of the distal portion of the outer catheter.
  • Fig. 8D is a plan view of a distal portion of the catheter assembly.
  • FIG. 9 is a perspective illustration of an inner catheter assembly according to certain embodiments.
  • Fig. 10A is a cutaway view of a radiofrequency (RF) catheter tip according to certain embodiments.
  • RF radiofrequency
  • Fig. 10B is a cross-sectional illustration of a wall of the RF catheter tip illustrated in Fig. 10A.
  • Fig. 11 A is a cutaway view of a radiofrequency (RF) catheter tip according to certain embodiments.
  • Fig. 1 IB is a cross-sectional illustration of a wall of the RF catheter tip illustrated in Fig.
  • Fig. 12 is a perspective illustration of a distal portion of an inner catheter having a guidewire extending therethrough.
  • Fig. 13 is a cross-sectional illustration of the catheter assembly in an assembled state.
  • Fig. 14 illustrates the inner catheter extending into the pericardial space between the parietal pericardium and the visceral pericardium.
  • Fig. 15 is a medical image illustrating separation of the pericardial layers following introduction of a fluid via the inner catheter.
  • Fig. 16 is a plan view of a catheter assembly according to certain embodiments.
  • Fig. 17 is a cross-sectional view of the catheter assembly illustrated in Fig. 16.
  • Fig. 18 is a longitudinal cross-sectional view of a distal end portion of the catheter assembly illustrated in Fig. 16.
  • Fig. 19 is a transverse cross-sectional view of the distal end portion of the catheter assembly illustrated in Fig. 16.
  • Fig. 20 is a plan view of a catheter assembly according to certain embodiments.
  • Fig. 21 illustrates a patient’s heart during introduction of the catheter assembly illustrated in Fig. 20.
  • Fig. 22 illustrates inflation of a balloon and perforation of a cardiac wall with the catheter assembly illustrated in Fig. 20.
  • Fig. 23 illustrates introduction of an inner catheter to the pericardial space and insufflation of the pericardial space.
  • Fig. 24 illustrates access to the pericardial space via the subxiphoid approach.
  • references in the specification to “one embodiment,” “an embodiment,” “an illustrative embodiment,” etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may or may not necessarily include that particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. It should further be appreciated that although reference to a “preferred” component or feature may indicate the desirability of a particular component or feature with respect to an embodiment, the disclosure is not so limiting with respect to other embodiments, which may omit such a component or feature. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to implement such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.
  • items included in a list in the form of “at least one of A, B, and C” can mean (A); (B); (C); (A and B); (B and C); (A and C); or (A, B, and C).
  • items listed in the form of “at least one of A, B, or C” can mean (A); (B); (C); (A and B); (B and C); (A and C); or (A, B, and C).
  • Items listed in the form of “A, B, and/or C” can also mean (A); (B); (C); (A and B); (B and C); (A and C); or (A, B, and C).
  • CCF06-GN009/TSH 170230087 arrangements and/or orderings may not necessarily be required. Rather, in some embodiments, such features may be arranged in a different manner and/or order than shown in the illustrative figures unless indicated to the contrary. Additionally, the inclusion of a structural or method feature in a particular figure is not meant to imply that such feature is required in all embodiments and, in some embodiments, may be omitted or may be combined with other features.
  • the catheter assembly 100 can be used to augment the separation between the parietal and visceral pericardium (via insufflation/inj ection) to greatly enhance visibility during the aforementioned xiphoid process approach.
  • the catheter assembly 100 is a nested assembly of catheters, including an inner assembly 102 selectively receivable in an outer assembly 104.
  • the inner and outer assemblies 102, 104 have inner and outer catheters 106, 108, respectively, wherein the inner catheter 106 is insertable into an introducer 110 of the outer assembly 104 for translating within the outer catheter 108.
  • the inner catheter 106 has a maximum outer diameter smaller than that of the outer catheter 108 to permit smooth translation of the inner catheter 106 within the outer catheter 108.
  • the inner catheter 106 may have an outer diameter of 1.8 French gauge (Fr), of 1.5 Fr, or of 1 Fr, while the outer catheter 108 may have an outer diameter of about 4 Fr.
  • each of the catheters 106, 108 is flexible and can have an outer surface with a low coefficient of friction and/or a hydrophilic coating. Additionally, the inner catheter 106 is longer than the outer catheter 108 such that a distal end portion 107 of the inner catheter 106 can project beyond a tip 148 of a distal end portion 109 of the outer catheter 108.
  • the outer catheter 108 may have a length between 130 cm and 180 cm, while the inner catheter 106 may have an overall length that is greater (e.g., by 10 cm to 20 cm) than that of the outer catheter 108.
  • the outer catheter 108 has a preformed bend 181 at a distal portion thereof.
  • the bend 181 may be of about 45° degrees relative to a longitudinal axis of the outer catheter 108.
  • this preconfigured bend 181 is likewise flexible, which may facilitate navigation of the outer catheter 108 in more tortuous vascular anatomy.
  • the illustrated inner catheter 106 likewise includes a bend 182 at a distal portion thereof, this bend 182 is not necessarily preformed, and the inner catheter 106 is
  • CCF06-GN009/TSH 170230087 instead flexible so as to conform to the shape of the outer catheter 108.
  • at least a portion of one or both of the catheters 106, 108 may be radiopaque.
  • an entirety of the inner catheter 106 and/or an entirety of the outer catheter 108 may be radiopaque.
  • the introducer 110 includes a branched manifold 112 having three branch inlets 120, which are respectively connectable to a catheter access port 114, a first fluid assembly 116, and a second fluid assembly 118.
  • the access port 114 provides a guide for inserting the inner catheter 106 into the outer assembly 104 via the manifold 112.
  • the first and second fluid assemblies 116, 118 are connectable to fluid sources 117, 119 for injecting fluid into the outer catheter 108, also via the manifold 112.
  • Each of the access port 114 and the first and second fluid assemblies 116, 118 is connectable to a corresponding branch inlet 120 of the manifold 112 via conventional connectors (e.g., male-female connections, Luer fittings, etc.).
  • each of the first and second fluid assemblies 116, 118 includes a tube 122 extending between a valve 124 and a fitting 126.
  • the first fluid assembly 116 is directly connected to its corresponding branch inlet 120 of the manifold 112
  • the second fluid assembly 118 is connected to its corresponding branch inlet 120 via an intermediate three-way (Y-) connector 128.
  • the three- way connector 128 includes a convergent sensor inlet port 130 for receiving a sensor tip 141 (Fig. 13) of a pressure sensor 140 to be translated within the outer catheter 108, as will be further discussed below.
  • an exit port 132 of the manifold 112 is connectable to and configured to be provided in fluid communication with a proximal end portion 182 of the outer catheter 108.
  • proximal refers to an end adjacent to or in the direction toward the operator, whereas the term “distal” refers to the opposite end, or in a direction away from the operator.
  • Fluid communication between the exit port 132 and the outer catheter proximal end portion 182 may be established, for example, by a winged, female, Luer- type connector 134.
  • a Luer-lock 136 may be provided to enhance the connection between the winged connector 134 and the manifold exit port 132.
  • an inflatable balloon 138 is provided to the distal end portion 109 of the outer catheter 108.
  • the balloon 138 is inflatable via fluid supplied from the second fluid assembly 118, as will be discussed further below. When fully inflated (as
  • an outer diameter of the balloon 138 may be at least 9 Fr, or in a range of 9 Fr to 15 Fr.
  • the outer catheter 108 defines a first lumen 142 and a second lumen 144 that is fluidically isolated from the first lumen.
  • the first lumen 142 is provided for receiving the inner catheter 106 in order to deliver it to a targeted location within the heart 90.
  • the first lumen 142 can be used as a conduit for delivering or evacuating fluids to/from the vicinity of the distal end portion 109 of the outer catheter 108.
  • the second lumen 144 is provided to supply inflation fluid for inflating the balloon 138, and may further receive therein a pressure sensor 140 (Fig. 13).
  • the first lumen 142 is circular in cross-section and is radially offset from a centerline of the outer catheter 108 such that the first lumen 142 is not coaxial with the outer catheter 108.
  • the second lumen 144 of the illustrated embodiment is crescent-shaped in cross-section and is disposed radially adjacent to the first lumen 142. It is to be understood that the cross-sectional shapes of the first and second lumens 142, 144 are not limited to the aforementioned, and that other cross- sectional shapes are contemplated.
  • the first lumen 142 extends the entire length of the outer catheter 108 (i.e., from its proximal end portion 182 to its distal tip 148).
  • the second lumen 144 does not extend the entire length of the outer catheter 108. Rather, as described in further detail below, the second lumen 144 extends from the proximal end portion 182 of the outer catheter 108 and terminates prior to reaching the distal tip 148 of the outer catheter 108.
  • an aperture 146 is provided in the outer catheter 108 and is proximally offset from the distal tip 148 of the outer catheter 108. More specifically, the aperture 146 is formed in a sidewall 174 that defines an outer surface 175 of the outer catheter 108.
  • the aperture 146 provides fluid communication with the second lumen 144 (as shown in FIG. 8B) through a wall of the outer catheter 108.
  • the tip 148 of the outer catheter 108 is formed of a material that is radiopaque and includes an opening defining an open end 143 of the first lumen 142. In contrast, as mentioned above, no opening is provided at the tip 148 for accessing the second lumen 144. Rather, the second lumen 144 terminates at or optionally just distal of the aperture 146, which is proximally spaced from the tip 148.
  • the balloon 138 is shown in a fully inflated configuration.
  • the balloon 138 includes distal and proximal mouths 150, 152 that are attached (e.g., sealed) to an outer surface 108' of the outer catheter 108 such that the inflated balloon 138
  • CCF06-GN009/TSH 170230087 is essentially in the form of a toroid.
  • the distal mouth 150 is located distally from the aperture 146 along the length of the outer catheter 108, and the proximal mouth 152 is located proximally from the aperture 146. Accordingly, with the mouths 150, 152 being circumferentially sealed to the outer surface 108' of the outer catheter 108, the interior of the balloon 138 is provided in fluid communication with the second lumen 144 (via the aperture 146), and thus the balloon 138 is inflatable via injection of inflation fluid from the second fluid assembly 118.
  • the outer catheter 108 may include one or more radiopaque markers 172, for example at or near one or both of the mouths 150, 152.
  • the radiopaque marker(s) 172 may be viewed with conventional imaging techniques to indicate the position of the balloon 138.
  • the outer catheter 108 may include radiopaque markers at other locations, for example to indicate the position of the tip of the outer catheter 108.
  • the inner assembly 102 includes the inner catheter 106 and a handle 156 at the proximal end 183 of the inner catheter 106.
  • the inner catheter 106 has a lumen 158 extending between its proximal and distal ends, and the lumen 158 is in fluid communication with an interior of the handle 156.
  • the lumen 158 is configured to receive fluid (e.g., CO2, contrast agent, therapeutics, saline, etc.) from an external source 161, for example via the handle 156.
  • the external source 161 can be selectively provided in fluid communication with the interior of the handle 156 (and thus with the lumen 158) via an entry port 160 of the handle 156.
  • the lumen 158 is also configured to receive a coronary guidewire 162, which can be introduced via the entry port 160.
  • the inner catheter 106 can include a mechanical reinforcement to enhance its structural rigidity.
  • the inner catheter 106 can include at least one braid, coil, or other such mechanical insert provided at desired locations within the lumen 158 (e.g., at spaced intervals). If so, the inner catheter 106 can also have an inner liner (e.g., a hollow tube) provided within the lumen 158 to entrap said reinforcement between an inner circumferential surface that defines the lumen 158 and an external surface of the liner.
  • an inner liner e.g., a hollow tube
  • the inner catheter 106 has a radio frequency (RF) emitter tip 164 at its distal end.
  • the RF emitter tip 164 is configured to emit radiofrequency energy, such as 5- 50W. It is also contemplated that the RF energy may be in a range of 10-25W, or in a range of
  • the RF emitter tip 164 may emit short bursts of RF energy, for example burst of less than one second at a power of 20W to 30W.
  • the RF energy may be provided at a power and/or frequency selected to ensure that the size of the perforation corresponds to the diameter of the RF emitter tip 164.
  • the RF emitter tip 164 is preferably radiopaque.
  • the RF emitter tip 164 includes electrical connections that can be connected to an external RF generator via wiring extending out of a wiring sheath 166 of the handle 156.
  • the RF emitter tip 164 has a hollow substantially cylindrical configuration, and the thickness of the wall defining the tip 164 tapers radially inward towards a distal surface 168, which in the illustrated form is circular and concentric with the cylindrical tip 164. It should be appreciated, however, that the taper may be omitted.
  • the RF tip 164 may be closed at its distal end (e.g., provided with a dome or planar surface that defines the distal surface 168). In these forms and others, the lumen 158 of the inner catheter 106 may be omitted.
  • the distal surface 168 is configured to directly contact tissue of the heart to perforate said tissue when radiofrequency energy is emitted. In certain forms (Figs. 10A and 10B), the distal surface 168 is planar. In other forms (Figs. 11A and 1 IB), the distal surface 168 is rounded. Additionally, the distal surface 168 may have another configuration, as desired.
  • a plurality of indicia or markings 170 may be provided on an external surface of the inner catheter 106, for example near the handle 156.
  • the markings 170 when aligned with a reference point (e.g., the access port 114), provide a visual indication to an operator as to how far the distal end of the inner catheter 106 has translated through the first lumen 142 or beyond the tip 148 of the outer catheter 108.
  • at least one of the markings 170 may provide an indication when the RF emitter tip 164 of the inner catheter 106 extends a preselected distance (e.g., 3 mm) beyond the distal tip 148 of the outer catheter 108.
  • the procedure may involve an operator making an incision to obtain peripheral vascular access, for example via the femoral vein.
  • a guidewire is introduced into the femoral vein (or other accessed peripheral vessel) and advanced therethrough to the vena cava (preferably the inferior vena cava) and from there into the right atrium. After a distal end of the guidewire
  • a sheath e.g., a sheath with a diameter greater than 5 Fr
  • the guidewire may be removed.
  • the procedure also involves preparing the catheter assembly 100 for deployment.
  • Such preparation may involve insertion of a sensor tip 141 of the pressure sensor 140 into the sensor inlet port 130 of the introducer 110, and the sensor tip 141 may be translated within the second lumen 144 of the outer catheter 108.
  • the outer catheter 108 can be manufactured such that the sensor tip 141 is embedded therein (e.g., within its wall at a location corresponding to the illustrated second lumen 144) and such that the distal end of the sensor tip 141 is positioned at or adjacent the aperture 146.
  • the distal end portion 109 of the outer catheter 108 is inserted into the proximal end of the sheath and advanced until its distal tip 148 reaches the target structure to perforate.
  • the balloon 138 is in a deflated state. Once the distal end portion 109 of the outer catheter 108 (including the balloon 138) emerges from the sheath, the balloon 138 can be inflated.
  • the valve 124 of the second fluid assembly 118 may be connected to an inflation fluid source 119. Thereafter, the valve 124 may be opened to deliver inflation fluid into the manifold 112 via its corresponding branch inlet 120, and thereafter into the second lumen 144 of the outer catheter 108. The inflation fluid flows along the length of the outer catheter 108 towards the distal end portion 109 and enters the balloon 138 via the aperture 146, thereby inflating the balloon 138.
  • the pressure sensor 140 may provide real-time feedback of the fluid pressure within the second lumen 144 and/or the balloon 138. Additionally, the pressure sensor 140 may be connected to a controller 171 that regulates the delivery of inflation fluid from the inflation fluid source 119 (e.g., by controlling the inflation valve 124) and predicts the size of the balloon 138, thereby automating the inflation fluid delivery and providing a predictable size of the balloon 138. In certain forms, the pressure sensor 140 can help prevent accidental perforation. For example, the controller 171 can monitor the sensed pressure relative to a predetermined threshold pressure and emit an alarm in response to the sensed pressure exceeding the predetermined threshold pressure. With the balloon 138 inflated, the outer catheter 108 can be repositioned if necessary to ensure that the balloon 138 makes appropriate contact with the chamber of interest (e.g., the right atrial appendage).
  • the chamber of interest e.g., the right atrial appendage
  • acceptable positioning of the inflated balloon 138 within the chamber of interest may be confirmed in a conventional manner.
  • the operator can confirm the position of the balloon 138 via intracardiac echocardiogram, fluoroscopy, contrast injection or other conventional techniques.
  • a contrast agent is employed, the same may be injected via the first lumen 142 of the outer catheter 108.
  • the valve 124 of the first fluid assembly 116 can be connected to an external fluid source 117 containing a contrast agent.
  • contrast agent flows into the manifold 112, through the outer catheter 108 via the first lumen 142, and is eluted via the tip 148 into the chamber of interest (e.g., the right atrial appendage).
  • the contrast agent increases the contrast of structures (e.g., the distal tip 148 of the outer catheter 108 and/or the balloon 138) within the chamber of interest under medical imaging (e.g., X-ray).
  • the distal end of the inner catheter 106 is inserted into the access port 114 of the introducer 110 and advanced through the first lumen 142 of the outer catheter 108.
  • the inner catheter 106 is advanced until the RF emitter tip 164 emerges from the tip 148 of the outer catheter 108 and contacts a desired or targeted position on the cardiac wall or vascular structure.
  • radiofrequency energy is emitted from the RF emitter tip 164 in order to perforate the cardiac wall or vascular structure at the targeted position. As shown in Fig. 14, this perforation can permit access into the pericardial space 93 between the parietal pericardium 92 and the visceral pericardium 94.
  • the inner catheter 106 can be gently advanced.
  • the catheter assembly 100 can be used in other procedures.
  • the catheter assembly 100 can be used to recanalize obstructed arteries or veins.
  • an operator may obtain arterial or venous access and advance a guidewire to a targeted obstructed vessel.
  • the inner catheter 106 may be introduced such that the RF emitter tip 164 contacts the vascular obstruction.
  • radiofrequency energy e.g., short pulses of radiofrequency
  • additional interventions can be performed (e.g., balloon dilation and/or stenting).
  • the catheter assembly 100 may be used to facilitate trans-coronary sinus chemical ablation, for example with ethanol.
  • an operator may obtain femoral vein access and advance a guidewire to the right atrium.
  • a sheath is introduced within the coronary sinus, and the operator advances the outer catheter 108 within the sheath and inflates the balloon 138 to obtain a detailed coronary sinus venogram and select a target vessel for ethanol injection.
  • This can be either an atrial venous branch (e.g., for atrial fibrillation ablation procedures) or a ventricular branch (e.g., for ventricular tachycardia or premature ventricular contraction ablation procedures).
  • the balloon 138 is deflated and the outer catheter 108 is advanced to the target vessel. Once positioned within the target vessel, the balloon 138 is inflated to occlude the vessel. Notably, the balloon 138 can increase its size progressively to facilitate occlusion of different vessel sizes. Thereafter, confirmation of effective vessel occlusion can be obtained with contrast injection from the outer catheter 108. Once the target vessel occlusion has been confirmed, a chemical ablative such as ethanol may be injected via the outer catheter 108 to achieve the desired chemical ablation.
  • a chemical ablative such as ethanol may be injected via the outer catheter 108 to achieve the desired chemical ablation.
  • advancement of the inner catheter 106 is assisted by the coronary guidewire 162 and the markings 170 provided on the external surface of the inner catheter 106. More specifically, the coronary guidewire 162 is inserted into the entry port 160 of the handle 156 and through the lumen 158 of the inner catheter 106 until a distal end of the coronary guidewire 162 reaches the target site (e.g., pericardial space, or other end of a venous or arterial obstruction). Next, the inner catheter 106 can be advanced over the coronary guidewire 162.
  • the target site e.g., pericardial space, or other end of a venous or arterial obstruction
  • At least one of the markings 170 may provide an indication when the distal end portion 107 of the inner catheter 106 extends a preselected distance, such as 3 mm, beyond the tip 148 of the outer catheter 108.
  • the operator can advance the inner catheter 106 until the corresponding marking 170 aligns with a reference point on the introducer 110 (e.g., the access port 114).
  • the operator is assured that the distal end portion 107 of the inner catheter 106 extends the preselected distance (e.g., 3 mm) beyond the tip 148 of the outer catheter 108, equating to placement of the distal end portion 107 of the inner catheter 106 within the target cardiac wall, chamber or vessel.
  • preselected distance e.g. 3 mm
  • suitable intraoperative imaging can be employed
  • an external source containing contrast agent can be connected to the entry port 160 of the handle 156 for injecting contrast agent via the inner catheter 106 (through the lumen 158 thereof) into the pericardial space 93. Proper placement of the distal end portion 107 of the inner catheter 106 can then be confirmed under medical imaging.
  • the inner catheter 106 can be locked in the operative position so as to hinder/prevent unintended advancement/withdrawal of the inner catheter 106 and/or inadvertent perforation of other structures.
  • the outer assembly 104 e.g., the outer catheter 108, the introducer 110, etc.
  • introduction of fluid e.g., contrast agent, CO2, or therapeutics
  • fluid can again be introduced via the lumen 158 of the inner catheter 106.
  • insufflating the pericardial space 93 augments the separation between the parietal pericardium 92 and the visceral pericardium 94, which enhances the operator’s visibility of the pericardial anatomy under medical imaging.
  • subxiphoid percutaneous epicardial access e.g., via standard techniques
  • the fluid inflating the pericardial space can be aspirated (if necessary) from the standard subxiphoid access point.
  • the disclosed nested catheter assembly 100 and its method of use may provide improvements to one or more areas of the standard subxiphoid percutaneous epicardial access approach for mapping and ablation procedures.
  • the catheter assembly 100 may reduce the risks of complications (e.g., bleeding and/or inadvertent cardiac perforation) by augmenting the separation between the parietal pericardium and the visceral pericardium to enhance the operator’s visibility while obtaining epicardial access via the subxiphoid approach.
  • the enhanced visibility may reduce the amount of time that medical imaging (e.g., fluoroscopy) is required, thereby reducing the overall time of the procedure.
  • a catheter assembly 200 is illustrated therein.
  • the catheter assembly 200 is substantially similar to the catheter assembly 100, and similar reference characters are used to indicate similar elements and
  • the catheter assembly 200 generally includes an inner catheter 206, an outer catheter 208, an introducer 210, and a balloon 238, which respectively correspond to the inner catheter 106, outer catheter 108, introducer 110, and balloon 138 of the above-described catheter assembly 100.
  • the following description of the catheter assembly 200 focuses primarily on features different from those described above with reference to the catheter assembly 100.
  • the inner assembly 202 of the illustrated embodiment includes the inner catheter 206, which has a handle 256 mounted at its proximal end.
  • the inner assembly 202 includes a hypodermic tube or hypotube 292 and a liner 294 (e.g., a polyimide liner) nested within the inner catheter 206.
  • the hypotube 292 electrically connects the RF emitter tip 264 to an external RF generator 296, and the liner 294 is provided as an insulator.
  • the hypotube 292 serves as an electrical conductor that transmits radiofrequency energy from the external generator 296 to the RF emitter tip 264.
  • the hypotube 292 can enhance the structural rigidity of the inner catheter 206.
  • the hypotube 292 and the liner 294 are coaxial with the inner catheter 206 and are arranged such that the hypotube 292 is disposed between (i.e., radially interposing) the liner 294 and the wall of the inner catheter 206.
  • the hypotube 292 and the liner 294 extend axially from the handle 256 at the proximal end of the inner catheter 206 to the RF emitter tip 264 at the distal end of the inner catheter 206.
  • the liner 294 defines the lumen 258 configured to receive the guidewire 262 and/or fluid (e.g., CO2, contrast agent, therapeutics, saline, etc.) from an external source.
  • fluid e.g., CO2, contrast agent, therapeutics, saline, etc.
  • the hypotube 292 can be integrally formed with the RF emitter tip 264 such that the hypotube 292 itself defines the RF emitter tip 264 at the distal end of the hypotube 292.
  • the hypotube 292 may include a helical or spiral laser cut. The dimensions of the helical gaps, the pitch of the helical cuts, and/or the material may be selected to fine-tune the rigidity/flexibility of the catheter hypotube 292 as desired.
  • a catheter assembly 300 is substantially similar to the catheter assembly 100, and similar reference characters are used to indicate similar elements and features.
  • the catheter assembly 300 generally includes an inner catheter 306, an
  • a contrast fluid source 317 is in fluid communication with the first lumen of the outer catheter 308 via a valve 324 that permits contrast fluid to flow through the introducer 310 to the outer catheter 308.
  • an inflation fluid source 319 is in fluid communication with the second lumen of the outer catheter 308 such that the balloon 338 can be inflated via the second lumen.
  • An external source 361 is configured to provide fluid (e.g., CO2, contrast agent, therapeutics, saline, etc.) to the lumen of the inner catheter 306 via the handle 356.
  • an RF source 396 is in electrical communication with the RF emitter tip 364 of the inner catheter 306 such that the emitter tip 364 is operable to emit RF energy generated by the RF source 396.
  • FIG. 21-24 illustrated therein are portions of the catheter assembly 300 during an example surgical procedure.
  • the outer catheter 308 is advanced to a selected location within the heart 90, as illustrated in Fig. 24. While other forms are contemplated, in the illustrated embodiment, the outer catheter 308 has been advanced to the right atrial appendage via the femoral artery. With the distal end portion 309 of the outer catheter 308 in the desired location, fluid is introduced from the inflation lumen source 319 to the balloon 338 via the second lumen of the outer catheter 308 to thereby inflate the balloon 338 as illustrated in Fig. 25.
  • the distal end portion 309 of the outer catheter 308 is anchored at the selected location within the heart 90.
  • the inner catheter 306 may be advanced within the first lumen of the outer catheter 308 until the RF emitter tip 364 projects beyond the distal tip 348 of the outer catheter 308 by a desired distance.
  • the inner catheter 306 may be advanced until one of the markings 370 aligns with a corresponding landmark to thereby indicate that the inner catheter 306 projects the desired distance from the distal tip 348.
  • the RF source 396 may then be activated to cause the RF emitter tip 364 to emit RF energy that perforates the cardiac wall 95 to provide access to the pericardial space 93.
  • the inner catheter 306 may be advanced to extend through the perforation 96 and into the pericardial space 93 by a desired distance, as illustrated in Fig. 23.
  • Fluid e.g., CO2
  • a desired distance as illustrated in Fig. 23.
  • Fluid e.g., CO2
  • CCF06-GN009/TSH 170230087 user may activate the external fluid source 361 to insufflate the pericardial space 93 via the lumen of the inner catheter 306. With the pericardial space 93 insufflated, the procedure may continue with access to the pericardial space 93 via the traditional subxiphoid route, as illustrated in Fig. 24.
  • the surgeon obtains femoral vein access and advances a guidewire to the right atrium of the heart 90.
  • the surgeon then introduces a sheath to the right atrium.
  • the sheath may be a commercially available >5 Fr non-deflectable or deflectable sheath.
  • the surgeon positions the sheath at the ostium of the right atrial appendage (RAA).
  • RAA right atrial appendage
  • the surgeon advances the catheter (e.g., a 4 Fr catheter) within the sheath and inflates the distal balloon 338 at the ostium of the right atrial appendage.
  • the catheter 308 (with the balloon 338 inflated) can be advanced safely within the right atrial appendage to achieve good contact with its wall.
  • a microcatheter 306 e.g., a microcatheter with a diameter of 1 Fr to 1.5 Fr, is introduced within the sheath and locked in place once 3 mm of its distal end is exposed. With the microcatheter 306 locked in place, RF energy is delivered from the RF emitter tip 364 to achieve perforation of the wall of the right atrial appendage. When locked at the proximal end of the 4 Fr outer sheath, the microcatheter will only advance for 3 mm, thereby preventing inadvertent puncture of the parietal pericardium 92.
  • Confirmation of position within the pericardial cavity can be achieved with contrast injection from the microcatheter.
  • a coronary guidewire can be introduced within the microcatheter and positioned more distally within the pericardial cavity.
  • the microcatheter can be advanced over the guidewire within the pericardial cavity.
  • Contrast and/or CO2 can be injected/insufflated within the pericardial space 93 to augment the separation between the parietal pericardium 92 and the visceral pericardium 93 and facilitate subxiphoid percutaneous epicardial access with a standard technique.
  • the microcatheter 306 is removed from the pericardial cavity and the mapping/ablation procedure is continued with the standard approach.
  • the contrast and/or CO2 insufflated within the pericardial space can be aspirated (if needed) from the standard subxiphoid access.

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Abstract

Certains modes de réalisation de la présente demande concernent un ensemble cathéter pour augmenter la séparation entre le péricarde pariétal et viscéral du cœur d'un patient. L'ensemble cathéter comprend généralement un cathéter externe, un cathéter interne et un ballonnet. Le cathéter externe comprend une première lumière et une seconde lumière, et une ouverture dans une paroi du cathéter externe est en communication fluidique avec la seconde lumière. Le cathéter interne peut être utilisé pour être reçu et translaté à l'intérieur de la première lumière du cathéter externe, et le cathéter interne comprend une pointe d'émetteur radiofréquence conçue pour émettre de l'énergie radiofréquence. Le ballonnet est scellé à une surface externe du cathéter externe et un intérieur du ballonnet est en communication fluidique avec la seconde lumière par l'intermédiaire de l'ouverture de telle sorte que le ballonnet peut être gonflé par l'intermédiaire de la seconde lumière.
PCT/US2025/016297 2024-02-29 2025-02-18 Ensemble cathéter comprenant un émetteur radiofréquence Pending WO2025183945A2 (fr)

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US202463559463P 2024-02-29 2024-02-29
US63/559,463 2024-02-29

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