Intracardiac delivery catheter and methods of use thereof

Abstract

An intracardiac delivery catheter or assembly is disclosed. The delivery catheter includes a delivery lumen and a flow-assisted balloon that can be inflated through the inflatable lumen. In the illustrated embodiment, the delivery lumen has a diameter of at least 8F, 9F, 10F, or between 8F and 14F for inserting an intracardiac echocardiography (ICE) catheter for placement at an intracardiac imaging site. In the described embodiment, an asymmetric balloon with an asymmetric profile and portions is used to place the ICE catheter in the pulmonary artery or other treatment sites to guide the delivery catheter, for example, into the right ventricle and pulmonary artery.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Patent No. 62 / 861906, filed June 14, 2019, entitled "INTRACARDIAC IMAGING ASSEMBLY AND METHOD OF USE," and U.S. Patent No. 63 / 007792, filed April 9, 2020, entitled "INTRACARDIAC DELIVERY CATHETER AND METHOD OF USE," the entire contents of which are incorporated herein by reference. Background Technology

[0003] Various cardiac treatment procedures require the use of imaging equipment during the treatment. Inserting imaging equipment or other treatment devices into the pulmonary artery or other intracardiac treatment sites can be difficult, and the devices may dislodge during use, making the treatment process even more challenging and cumbersome. Summary of the Invention

[0004] This application relates to an intracardiac delivery catheter for placing an imaging or therapeutic device for use within the heart. In the illustrated embodiment, the delivery catheter includes a flow assist balloon for intracardiac placement of the catheter and a delivery lumen passing through the balloon. In the illustrated embodiment, the delivery lumen has a diameter of 8F, 9F, or 10F for inserting an intracardiac echocardiography catheter or intracardiac echocardiography (ICE) catheter and guidewire. For example, in the disclosed embodiments, the diameter of the delivery lumen is between 8F and 14F or 9F and 14F. The delivery lumen extends from an inlet proximal to the distal end of the catheter shaft. In the illustrated embodiment, the outlet of the delivery lumen is located away from the flow assist balloon of the delivery catheter and is formed distal to the opening of the catheter shaft and the delivery lumen. Embodiments of the delivery catheter include a guidewire lumen and an inflation lumen, in addition to the delivery lumen, for expanding the flow assist balloon for intracardiac placement of the delivery catheter. In the illustrated embodiment, the guidewire lumen is a shortened guidewire lumen.

[0005] Embodiments of intracardiac delivery catheters include an asymmetrically shaped flow-assisted balloon that has an asymmetrical shape in its inflation or expansion profile. As disclosed, the asymmetrical shape provides a moment arm or asymmetrical portion relative to the longitudinal axis of the catheter axis, allowing the catheter axis to rotate about an acute angle, for example, when placed in the pulmonary artery via the tricuspid and pulmonary valves. As disclosed, in the illustrated embodiments, the delivery lumen is used for intracardiac delivery of materials, imaging catheters, or other therapeutic devices.

[0006] Embodiments of multi-lumen delivery catheters include an internal balloon within the delivery lumen to engage an imaging or echocardiographic catheter inserted into the delivery lumen. As disclosed, in the illustrated embodiments, the length of the delivery catheter is sized to accommodate intracardiac placement in the pulmonary artery or other intracardiac locations. The delivery catheter can be inserted into the right atrium via the femoral vein through the inferior vena cava or via the jugular vein through the superior vena cava. In the illustrated embodiments, the elongated length of the catheter shaft has varying stiffness or flexibility, including a relatively flexible distal portion.

[0007] This application provides a kit for intracardiac imaging, including a multi-lumen delivery catheter and an intracardiac echocardiography catheter for cardiac imaging and treatment. In the illustrated embodiment, the multiple lumens include a delivery lumen, a guidewire lumen, and an inflation lumen to allow a flow-assisted balloon to inflate. In the disclosed embodiments, the diameter of the delivery lumen is at least 8F, 9F, or 10F, or between 8F and 14F or 9F and 14F, for inserting the intracardiac echocardiography catheter. In use, the delivery catheter is inserted into the right atrium and right ventricle to reach the pulmonary artery. The delivery catheter is traced to the right atrium via the inferior vena cava or superior vena cava.

[0008] In alternative embodiments, the delivery catheter is used to place an imaging catheter in the superior vena cava, pulmonary artery, or alternative intracardiac imaging sites. In the illustrated embodiment, the catheter shaft includes a guidewire lumen for intracardiac placement, a flow-assisted balloon, and a delivery lumen for insertion of the intracardiac echocardiography catheter. In another embodiment, the delivery catheter includes a flow-assisted balloon and a delivery lumen of a smaller size for use with medications or other therapeutic or imaging devices, or an asymmetric balloon and delivery lumen. Details of the invention are described in the following figures and description. Attached Figure Description

[0009] Figure 1A illustrates an embodiment of the components of this application;

[0010] Figure 1B is a cross-sectional view of a flow-assisted delivery catheter without guidewire and imaging catheter inserted, shown along line 1B-1B of Figure 1A.

[0011] Figure 1C shows the hemostatic connector attached to the delivery chamber;

[0012] Figure 1D is a detailed cross-sectional view of a portion of the conduit in Figure 1A, showing the flow assist balloon in the deflated state;

[0013] Figure 1E is a detailed illustration of the distal end of the component in Figure 1A, showing the flow assist airbag inflated for use.

[0014] Figure 1F schematically illustrates an embodiment of the intracardiac imaging catheter (ICE) of this application;

[0015] Figure 1G shows the components and the proximal end of the imaging catheter;

[0016] Figures 2A-2E illustrate step-by-step the process of using the components of this application for intracardiac imaging;

[0017] Figures 3A-3B illustrate another embodiment of the components of this application;

[0018] Figure 4A illustrates another embodiment of the components of this application;

[0019] Figure 4B is a cross-sectional view taken along line 4B-4B in Figure 4A;

[0020] Figure 4C is a cross-sectional view of a portion of the delivery conduit, showing the imaging conduit and the inflated inner balloon in the delivery cavity;

[0021] Figure 5A illustrates another embodiment of the components of this application;

[0022] Figure 5B is a cross-sectional view taken along line 5B-5B of Figure 5A;

[0023] Figure 5C is a cross-sectional view of the distal end of the delivery catheter, showing the guidewire extending through the guidewire lumen formed along the distal end of the delivery cavity;

[0024] Figure 5D is a cross-sectional view taken along line 5D-5D in Figure 5C;

[0025] Figure 5E is a cross-sectional view of the delivery conduit, which has an ICE conduit inserted into the delivery chamber and an inner air bladder inflated to adjoin the ICE conduit.

[0026] Figure 5F is a cross-sectional view taken along line 5F-5F in Figure 5E;

[0027] Figures 6A-6D illustrate step-by-step the process steps for using the components of this application;

[0028] Figure 6E is a flowchart illustrating the steps of performing cardiac imaging using the delivery catheter of this application;

[0029] Figure 7A illustrates another embodiment of the intracardiac delivery catheter of this application;

[0030] Figure 7B shows an end view of the flow assist balloon of an embodiment of the intracardiac delivery catheter;

[0031] Figure 7C is a longitudinal cross-sectional view of the intracardiac delivery catheter of Figure 7A, including the rigid proximal length and the relatively flexible distal length;

[0032] Figure 7D is a cross-sectional view taken along line DD in Figure 7C;

[0033] Figure 7E is a cross-sectional view taken along line EE in Figure 7C;

[0034] Figure 7F is a cross-sectional view taken along line FF in Figure 7C;

[0035] Figure 7G is a cross-sectional view taken along line GG in Figure 7C;

[0036] Figure 7H is a detailed view of the distal portion of the shaft of the intracardiac delivery catheter of an illustrative embodiment;

[0037] Figure 7I shows an embodiment of an asymmetric balloon located at the distal end of the catheter shaft of an intracardiac delivery catheter;

[0038] Figure 7J schematically shows the distal end of the catheter shaft of the embodiment shown in Figures 7A-7I, with the central imaging catheter (ICE) extending through the distal opening of the catheter shaft.

[0039] Figure 7K shows the proximal end of the intracardiac delivery catheter and components;

[0040] Figure 8A schematic diagram illustrates the forces and moments interacting with the asymmetric airbag;

[0041] Figure 8B schematically illustrates an embodiment of intracardiac navigation using an asymmetric balloon;

[0042] Figure 9A schematically illustrates another embodiment of the intracardiac delivery catheter of this application;

[0043] Figure 9B shows an end view of the asymmetric flow assist airbag;

[0044] Figure 9C is a cross-sectional view taken along line CC in Figure 9A;

[0045] Figure 9D is a cross-sectional view taken along line DD in Figure 9A;

[0046] Figure 10A illustrates another embodiment of the intracardiac delivery catheter of this application with a shortened guidewire lumen;

[0047] Figure 10B is an end view of the flow assist balloon of the intracardiac delivery catheter in Figure 10A;

[0048] Figure 10C is a cross-sectional view of the delivery catheter in Figure 10A, showing the shortened guidewire lumen;

[0049] Figure 10D is a cross-sectional view taken along line DD in Figure 10C;

[0050] Figure 10E is a cross-sectional view taken along line EE in Figure 10C;

[0051] Figure 11A illustrates another embodiment of an intracardiac delivery catheter with a short imaging catheter (ICE) lumen;

[0052] Figure 11B is a cross-sectional view of the delivery catheter of Figure 11A, showing the imaging catheter lumen;

[0053] Figure 11C is a cross-sectional view taken along line CC in Figure 11B;

[0054] Figure 11D is a cross-sectional view taken along line DD in Figure 11B;

[0055] Figure 12A illustrates the manufacturing steps of an embodiment of this application;

[0056] Figure 12B is a flowchart illustrating a manufacturing embodiment of the multi-chamber intracardiac delivery catheter of this application;

[0057] Figure 13 schematically illustrates an embodiment of a steerable distal end for use in an embodiment of the delivery catheter of this application;

[0058] In the reference figures above, similar numbers are used to identify similar parts. It should be noted that the features in the figures are not necessarily drawn to scale. Detailed Implementation

[0059] This application relates to components and methods for intracardiac imaging. Illustrative embodiments of the component utilize an echocardiographic catheter to provide intracardiac images for medical purposes. Placing an imaging catheter at the imaging site can be difficult due to cardiac anatomy or the desired image. Embodiments of this application provide a component and method for placing an imaging catheter in the pulmonary artery, superior vena cava, or other intracardiac locations to provide feedback images for treatment.

[0060] An illustrative embodiment of this component includes an intracardiac delivery catheter (IDC) 100 for placing an imaging catheter (e.g., for use with an intracardiac echocardiography catheter (ICE catheter) 102). The intracardiac delivery catheter 100 is formed of an elongated shaft 104 having an elongated length extending between a proximal end 106 and a distal end 108. In the illustrated embodiment, the shaft 104 is formed of a flexible material of sufficient length to pass through the patient's right atrium and right ventricle into the pulmonary artery, or other treatments as described herein, from the insertion site. In the illustrated embodiment, the insertion site is the femoral vein or jugular vein.

[0061] The shaft 104 of catheter 102 is flexible and has sufficient rigidity and torsional capacity to navigate a circuitous path from the insertion location for intracardiac placement at the imaging location. The length of catheter body 104 can have varying degrees of flexibility to navigate through the patient's body to the intracardiac treatment site. In the illustrated embodiment, the approximate length of the delivery catheter is between 60 cm and 90 cm; however, in other embodiments, the length is between 50 cm and 120 cm. As shown, catheter 102 includes a flow assist balloon 110, which is connected to the catheter shaft 104 near its distal end 108. Inflation fluid is injected into the flow assist balloon 110 via an inflation injector 112 or other inflation device connected to the proximal end 106 of shaft 104. The proximal end 106 of shaft 104 also includes a hemostatic connector 116 for ICE catheter 102 and a connector 118 providing a port for guidewire 120. In the illustrated embodiment, hemostatic connector 116 includes a flushing port 122. As shown in the figure, sleeve 124 encloses the proximal connectors 116, 118 and the syringe 112 to form the proximal hub of delivery conduit 100.

[0062] As shown in the cross-sectional view of Figure 1B, the shaft 104 of the flow-assisted delivery catheter 100 includes a plurality of lumens along the length of the shaft 104. The plurality of lumens includes a delivery lumen 130, a guidewire lumen 132, and an inflation lumen 134. The diameter of the delivery lumen 130 is adapted to insert an ICE catheter 102 therein. The lumen 130 of the delivery catheter has an elongated length extending from a proximal end 106 of the shaft 104 to approximately a distal end 108. The ICE catheter 102 is inserted via a hemostatic connector 116 coupled to the proximal end of the lumen 130 and slidably passes through the lumen 130 for use. In the illustrated embodiment, the lumen 130 has an open distal end. In the illustrated embodiment, the diameter of the delivery lumen 130 is at least between 8F, 9F, or 10F, or 8F-14F, or 9F-14F (French catheter diameter scale) to accommodate the 3D intracardiac echocardiography catheter 102.

[0063] As shown in Figure 1C, the hemostatic connector 116 comprises a connector body 140 having a channel 142 extending between opposite ends of the connector body 140. The connector body 140 includes (illustrated) a flexible hemostatic valve structure (e.g., a gasket) 144 along the channel 142. A flushing port 122 is connected to the channel 142 of the connector 116 via a branch structure 146 having a branch channel 148. Fluid flow through the branch channel 148 is controlled by a flushing port valve 150, which is operable between an open and closed position to open and close the flushing port 122. Applications are not limited to a specific hemostatic valve structure 144, and various designs will be understood by those skilled in the art.

[0064] The guidewire lumen 120 has an elongated length extending from the proximal end 106 of the catheter shaft 104 to the distal end of the catheter shaft 104. The guidewire 120 is inserted through the connector 118 and slidably passes through the lumen 132 for placement through the open distal end of the guidewire lumen 132. An inflation lumen 134 extends along the elongated shaft 104 to connect to the interior of the flow assist balloon 110 via an inflation port 154, into which inflatable fluid is injected, as shown in FIG1D. The balloon 110 is formed of an elastomer or other balloon material and has a proximal collar 156 connected around the cylindrical body 104 behind the inflation portion 154, and a distal collar 158 connected around the cylindrical body 104 in front of the inflation port 154. As shown in Figure 1E, inflatable fluid is injected into cavity 134 via syringe 112 to inflate flow-assisted delivery airbag 110. As those skilled in the art will understand, the airbag is a Swan-Ganz type airbag having the construction described in U.S. Patent No. 3,634,924, the contents of which are incorporated herein by reference.

[0065] As previously described, the delivery catheter 100 is configured to place the ICE catheter 102 at the imaging site via insertion through the delivery lumen 130. Illustrative imaging catheters include two-dimensional and three-dimensional intracardiac echocardiography imaging catheters. Figure 1F is an illustrative embodiment of the ICE imaging catheter 102 placed via the delivery catheter 100. As shown, the ICE catheter 102 has an elongated tubular body or shaft 160 having an elongated length extending between a proximal end 162 and a distal end 164. The elongated length of the tubular body provides sufficient flexibility, maneuverability, and length for intracardiac placement in the pulmonary artery or other intracardiac imaging sites, starting from the insertion site. A plurality of transducer elements or transducer arrays 166 (shown schematically) are coupled to the distal end of the elongated body 160 to generate ultrasound or vibration and detect feedback vibration or excitation for imaging. As shown, the transducer elements 166 are coupled to a control unit 170 via multiple wires / leads 172 and a socket connector 180 to provide input excitation or vibration and receive feedback vibration or excitation. In the illustrated embodiment, the ICE conduit 102 includes a separate transducer 166 for transmitting and receiving ultrasonic vibrations, or the same transducer may be used as both a transmitter and a receiver.

[0066] Control unit 170 includes circuitry that generates ultrasonic or echo high-frequency vibrations in response to input control 174 and processes feedback signals from transducer element 166 to provide an output image 176 for display on GUI device 178. Control unit 170 is coupled to a power source for use and is coupled to transducer element 166 via one or more circuit elements and / or flexible circuitry. Illustrative transducer element 166 includes an array of piezoelectric elements, capacitive elements, or other electromechanical transducer elements for generating ultrasonic vibrations or disturbances and detecting feedback vibrations. In the illustrated embodiment, as shown in Figures 1E-1F, imaging catheter 102 has a circular or contoured distal end for intracardiac placement. As shown in Figure 1G, in the illustrated embodiment, plug and receptacle connector 180 includes a plug 180a connected to the distal end of ICE catheter 102, which is connected to a receptacle (not shown) connected to control unit 170.

[0067] As previously described, this delivery catheter 100 is suitable for placing an ICE catheter 102 within the heart. The heart includes the right ventricle (RV), which supplies blood flow to the pulmonary artery (PA). Blood flows into the right ventricle (RV) from the right atrium (RA) and either the superior or inferior vena cava. The pulmonary artery (PA) is located near the aorta, which receives blood flow from the right ventricle (RV). The proximity of the pulmonary artery (PA) to the aorta provides a practical location for electrophysiological and structural procedures to image the aorta or other structures of the heart. Due to the structure of the heart, it is difficult for the ICE catheter 102 to pass through the right atrium (RA) into the right ventricle (RV) and pulmonary artery (PA). In particular, to position the imaging catheter 102 from the right ventricle (RV) into the pulmonary artery (PA), the catheter must be guided and manipulated along an “S”-curve path, and due to the tortuous path, the catheter often falls back into the right ventricle. As shown in Figures 2A-2E, the use of this assembly facilitates the placement of the ICE catheter 102.

[0068] As shown in Figure 2A, the delivery catheter 100 is inserted into the right atrium (RA), for example via the femoral vein through the inferior vena cava or via the jugular vein through the superior vena cava (not shown). As shown in Figure 2B, inflation fluid is injected into the flow assist balloon 110 through the inflation chamber 134 to inflate the flow assist balloon 110. The balloon 110 is inflated to utilize the blood flow flowing from the right atrium (RA) into the right ventricle (RV) and pulmonary artery (PA). Specifically, as indicated by arrow 182, the inflation of the flow assist balloon 110 provides an expanded profile to engage with the blood flow from the right atrium (RA) into the right ventricle (RV) and pulmonary artery (PA). The interface with the blood flow provides input force or power to assist the delivery catheter 100 in moving or rotating from the right atrium (RA) into the right ventricle (RV) and pulmonary artery (PA). In the illustrative embodiment, the balloon is inflated prior to insertion of the tricuspid and pulmonary valves to protect the valves from damage.

[0069] As shown in Figure 2C, guidewire 120 is inserted through guidewire lumen 132 of delivery catheter 100. Guidewire 120 has sufficient stiffness and rigidity to straighten the curve from the right atrium (RA) to the pulmonary artery (PA) in preparation for insertion of intracardiac imaging catheter 102, as shown in Figure 2D. Specifically, guidewire 120 reduces the “S” curve configuration to provide a straighter path for placement of ICE catheter 102. As shown in Figure 2D, intracardiac imaging catheter 102 is inserted through lumen 130 of delivery catheter 100 for placement in the pulmonary artery (PA) for imaging. In illustrative embodiments, guidewire 120 is inserted together with delivery catheter 100 or after intracardiac placement of delivery catheter 100. Specifically, guidewire 120 can be inserted into delivery catheter 100 for support.

[0070] As shown in Figure 2E, once the imaging catheter 102 is in place, the delivery catheter 100 and guidewire 120 are withdrawn. In an illustrative embodiment, guidewire 120 is used to advance delivery catheter 100 or other catheters from the right ventricle (RV) into the pulmonary artery or from the right atrium into the superior vena cava for treatment or imaging, and remains in guidewire lumen 132. In an alternative embodiment, guidewire 120 is withdrawn as shown in Figure 2E, but delivery catheter 100 remains in place in the pulmonary artery (PA) during imaging, or both delivery catheter 100 and guidewire 120 remain in place.

[0071] Specifically, in the illustrated embodiment, as described in the embodiments shown herein, during imaging, the imaging catheter 102 and transducer element 166 are arranged in the delivery cavity 130. A transport fluid is inserted into the delivery cavity through port 122 to provide the transport medium for imaging. In an alternative embodiment, the length of the delivery catheter 100 should be sized to ensure that the ICE or imaging catheter 102 extends beyond the delivery catheter cavity 130 during imaging. In the illustrative embodiment, the delivery catheter 100 is held in place to prevent dislodgement of the ICE catheter 102 and to facilitate the torsion of the ICE catheter 102. The delivery catheter 100 prevents the imaging ICE catheter 102 from dislodging from the PA into the RV and from the SVC into the RA.

[0072] Therefore, as described above, the delivery catheter 100 facilitates intracardiac placement of the ICE catheter 102. In one embodiment, the ICE catheter 102 is located in the right atrium (RA), and the sensor array 166 or more sensors are oriented toward the tricuspid valve to image the right ventricle, a portion of the right atrium, and the tricuspid valve. In another embodiment, the ICE catheter 102 is oriented to provide images of the aortic valve, coronary sinus, and interatrial septum for transseptal procedures. The ICE catheter 102 may be placed in the right ventricle and oriented toward left ventricular imaging to screen for exudates or thrombi or mitral valve anatomy. Using the delivery catheter 100 in conjunction with the ICE catheter 102 enhances the torsion capability of the ICE catheter 102 within the delivery catheter 100. The delivery catheter may also pass through the interatrial septum into the pulmonary veins to support the ICE probe for examination of the mitral valve or left atrial appendage.

[0073] Figures 3A-3B illustrate alternative embodiments of the component of this application, which includes a flow-assisted delivery catheter 100 for use in conjunction with an imaging or ICE catheter 102, wherein the same reference numerals are used to refer to the same components in the previous figures. As shown in Figures 3A-3B, shaft 104 includes a delivery chamber 130, which is sized to accommodate insertion of the ICE or imaging catheter 102 and a guidewire 120 passing through it. For use, the guidewire 120 and the ICE catheter 102 are inserted into the delivery chamber 130 via connector 116 for placement of the guidewire 120 and the ICE catheter 102 for treatment, as previously described and shown in Figures 2A-2E. As described in the previous embodiment, a flow-assisted balloon 110 is inflated by injecting fluid into the inflation chamber 134 via an inflation port 154 through a syringe 112. In an alternative embodiment not shown, the delivery chamber 130 is sized to accommodate separate insertion of the ICE catheter 102 and the guidewire 120, and the guidewire 120 is withdrawn prior to insertion of the ICE catheter 102, as described in the exemplary embodiments.

[0074] Figures 4A-4B illustrate another embodiment of the delivery conduit 100, which includes a flow assist balloon 110 coupled to the distal end of the delivery conduit 100 and a plurality of cavities along the body 104 as shown in Figure 4B. The plurality of cavities include a delivery cavity 130 and an inflation cavity 134. The delivery cavity 130 is sized to accommodate a guidewire 120 and an ICE conduit, as shown in Figure 4A, and the inflation cavity 134 inflates the flow assist delivery balloon 110. As shown in Figure 4A, the flow assist balloon 110 is inflated by injecting inflation fluid into the inflation cavity 134 via a syringe 112A. The delivery conduit 100, as shown in Figure 4B, also includes an inflation cavity 190 for inflating an inner balloon 192 located distal to the delivery cavity 130, as shown in Figure 4C. Inflation fluid is injected into the balloon 192 through the cavity 190 via an inlet 194.

[0075] As shown in Figure 4C, the inner balloon 192 is inflated to retain the ICE catheter for use and to provide ultrasound transmission fluid or medium. Specifically, the inner balloon 192 includes a proximal collar 196 and a distal collar 198, the proximal collar 196 being coupled to the inner surface of the delivery chamber 130 downstream of the inlet 194, and the distal collar 198 being coupled to the delivery chamber 130 upstream of the inlet 194. Inflation fluid is injected into the chamber 190 via syringe 112B to inflate the inner balloon 192 to engage the ICE catheter disposed in the delivery chamber 130. In an alternative embodiment not shown, the embodiment shown in Figures 4A-4B includes an inner balloon 192 that includes a separate guidewire lumen 132.

[0076] Figures 5A-5F illustrate another embodiment of the component of this application. As shown, the component includes a delivery catheter 100 having an elongated shaft 104 and an elongated guidewire 120. As previously described, the delivery catheter 100 includes a flow assist balloon 110 connected to the distal end of the elongated shaft 104 for intracardiac placement. The elongated shaft 104 includes multiple cavities, including a delivery cavity 130 for an ICE catheter, an inflation cavity 134 for inflating the flow assist balloon 110, and an internal inflation cavity 190 for inflating an internal balloon 192. Fluid is supplied to the inflation cavity 134 via syringe 112A and to the inflation cavity 190 via syringe 112B.

[0077] As shown in Figures 5A and 5C, the delivery catheter 100 includes a rapid-change guidewire lumen 200 at its distal end for the guidewire 120. In the illustrated embodiment, the rapid-change guidewire lumen 200 is formed along the distal length of the delivery lumen 130. The rapid-change guidewire lumen 200 includes a proximal opening 202 formed through a shaft 104 into the delivery lumen 130, and a distal opening 204 formed through the open distal end of the delivery lumen 130. The distal end of the wire 120 passes along the delivery lumen 130 (guidewire lumen 200) through the distal opening 204 and through the proximal opening 202 to track the delivery catheter 100 to the treatment site, as described in Figures 5C-5D.

[0078] As shown in Figure 5E, the delivery conduit 100 also includes an inner balloon 192 along the delivery cavity 130. As shown in Figure 5E, the inner balloon 192 is inflated to engage the ICE conduit 102 inserted through the delivery cavity 130. Fluid is injected into the inner balloon 192 through the inner inflation cavity 190 to inflate the inner balloon 192 via syringe 112B to bring it close to the ICE conduit 102. The inner balloon 192, as shown, includes a proximal collar 196 connected to the inner surface of the delivery cavity 130 at the rear of the inlet 194 and a distal collar 196 connected to the inner surface of the delivery cavity 130 spaced apart from the front of the inlet 194. The inflated inner balloon 192 stabilizes the ICE conduit 102 and provides delivery fluid around the ICE conduit, particularly around the transducer element 166 of the ICE conduit.

[0079] Although in the illustrated embodiment, the quick-exchange or shortening guidewire lumen 200 is formed along the distal length of the delivery lumen 130, the application is not limited to the illustrated embodiment, and the quick-exchange guidewire lumen 200 may be formed from a separate short guidewire lumen at the distal end of the delivery conduit 100. Furthermore, the delivery conduit 100 may include a plurality of openings 202 for guidewires 120 spaced circumferentially around the delivery conduit 100. In the illustrative embodiment, the openings 202 are spaced 1-3 cm from the distal end or tip 108 of the delivery conduit 100.

[0080] Figures 6A-6D illustrate the use of the delivery catheter 100 with a guidewire lumen 200 that allows for rapid exchange or shortening, as described. As shown in Figure 6A, in the illustrated embodiment, the guidewire 120 is percutaneously inserted into the patient and guided for intracardiac placement. Specifically, in the illustrated embodiment, the guidewire 120 is advanced intravascularly into the right atrium to facilitate the insertion of the delivery catheter 100. As shown in Figure 6B, the delivery catheter 100 is advanced along the guidewire 120 for intracardiac placement. As shown in Figure 6C, inflatable fluid is injected via syringe 112A to inflate the balloon 110, thereby providing flow assistance or force to track the delivery catheter 100 into the right ventricle and pulmonary artery to reach the treatment or imaging site. Specifically, the balloon 110 is inflated to use blood flow to track the delivery catheter 100 into the right atrium, right ventricle, and pulmonary artery.

[0081] In Figure 6D, when the delivery conduit 100 is in place, the balloon 110 deflates and inserts the ICE conduit 102. In an illustrative embodiment, the balloon 110 is deflated and the guidewire 120 is withdrawn before the ICE conduit 102 is placed, or in an illustrative embodiment, the guidewire is withdrawn before the flow assist balloon 110 is inflated. In other embodiments, the guidewire is held in place for insertion of the imaging conduit 102 and remains in place during imaging. As previously described, the delivery conduit 100 may be withdrawn or held in place during imaging.

[0082] Figure 6E illustrates the steps of the components shown in this application. As shown in step 210, a guidewire 120 is inserted and tracked intravascularly for intracardiac placement, such as inserting a delivery catheter 100 into the right atrium. In step 212, the delivery catheter 100 is inserted using the guidewire 120 for intracardiac placement. In step 214, a flow-assisted balloon 110 on the delivery catheter 110 is inflated to aid in placement of the delivery catheter 100 at an intracardiac treatment site, such as into the right atrium, right ventricle, or pulmonary artery. In step 216, the ICE or imaging catheter 102 is advanced through the delivery lumen 130 to an imaging or treatment site, such as in the pulmonary artery. In an exemplary embodiment, the flow-assisted balloon 110 is deflated prior to insertion of the ICE catheter 102. An inner balloon 190 is inflated in step 218 to abut against the ICE catheter 102 and provides a fluidized space for transmitting ultrasound imaging waves during use. Optionally, liquid is injected into the delivery lumen for imaging. In an illustrative embodiment, the guidewire is withdrawn before insertion of the ICE catheter, or in an alternative embodiment, the guidewire 120 is withdrawn before the flow assist balloon is inflated. In an illustrative embodiment, the delivery catheter 100 includes separate guidewire lumens 132, 200, and the guidewire 120 is held in place to reposition the delivery catheter 100 for use.

[0083] In an alternative embodiment of the delivery catheter 100 having an inner balloon 192 and an outer balloon 110, the delivery catheter 100 includes a delivery chamber 130, an inflation chamber 134, an inflation chamber 190, and a guidewire chamber 120 extending along the length between the proximal and distal ends of the delivery catheter.

[0084] Figure 7A illustrates another embodiment of the intracardiac echocardiography delivery catheter 100A, which has an elongated cylindrical body or shaft 104A, wherein the same numerals are used in the previous figures to identify the same components. As shown, the elongated body or shaft 104A includes a relatively rigid proximal length 220 and a relatively or ultra-flexible distal length 222. The relatively rigid proximal length 220 provides maneuverability and torsion for insertion, while the relatively flexible length 222 provides sufficient flexibility or bendability for intracardiac navigation, for example, for placing an imaging or ICE catheter 102 via the inferior vena cava into the right atrium, right ventricle, and pulmonary artery. As previously described, placement of the delivery catheter 100A is assisted by a flow-assisted balloon 110A located at the distal end (or ultra-flexible distal length 222) of the catheter shaft 104A.

[0085] In the illustrated embodiment, balloon 110A is an asymmetrical balloon as shown in Figure 7B to enhance the navigation and placement of catheter 100A, as described herein. As previously stated, balloon 110A is inflated via syringe 112 to assist in the placement of delivery catheter 100A. In one illustrative embodiment, the relative rigid proximal length 220 of the catheter has a length dimension of approximately 30-50 cm (11-20 inches), and the flexible distal length 222 of the catheter has a length dimension of approximately 30 cm (11 inches).

[0086] In the illustrated embodiment shown in Figure 7A, the catheter shaft 104A of the delivery catheter 100A is a multi-lumen shaft 104A, as shown in Figures 7C-7G. As shown, the multi-lumen shaft 104A includes an ICE delivery lumen 130, a guidewire lumen 132, and a balloon inflation lumen 134 formed along proximal and distal lengths 220, 222 of the shaft 104A. In the illustrated embodiment, multiple lumens are formed along an inner core or cavity structure formed by multiple microtubes 230, for each of the multiple lumens. In the illustrated embodiment, the multiple microtubes 230 are formed of polytetrafluoroethylene (PTFE), for example, Chemours Company FC, a trademark. PTFE for sale. The microtube 230 provides a lubricated inner surface for the sliding placement and movement of the ICE catheter 102 and guidewire 120.

[0087] The rigid proximal length 220 is formed by a rigid perimeter or wall structure 232 surrounding the core or cavity structure. In the illustrated embodiment, the rigid perimeter structure 232 of the proximal length 220 is formed of a hard hardness-testing polymer material such as polyether block amide, for example, a Shore D material with a hardness range of 63, available from Arkema France Corporation of Colombes France. Alternatively, polyvinyl alcohol (PVAl) polyurethane material or a similar material with a hardness range of 25-72 Shore D may be used to form a relatively rigid proximal length 220 of the conduit shaft 104A.

[0088] The flexible distal length 222 of the catheter shaft 104A has a relatively flexible perimeter or wall structure 234, formed by a helical coil 240 embedded within a soft polymer body or layer 242 (inner and outer layers). The helical coil 240 is formed of aluminum, stainless steel, or other materials. In the illustrated embodiment, the helical coil 240 provides relatively high circumferential strength to provide structural integrity of the multiple lumens of the catheter shaft 104A and the polymer body or layer 242, and the embedded helical coil 240 provides a flexible and bendable distal length for intracardiac placement of the catheter 100A. Illustratively, the flexible polymer body or layer 242 is formed of a low-hardness or high-hardness material to provide flexibility for the distal length 222. Illustrative low-hardness materials include polyvinyl chloride layers or materials with a hardness of approximately 60 Shore A, or other materials with similar hardness or hardness.

[0089] As shown in Figure 7C, the catheter shaft 104A includes a transition structure connecting the proximal and distal lengths 220, 222 to form an extended length of the catheter shaft 104A. As shown, the transition structure includes a tubular braid 252 whose length extends along the transition region between the proximal and distal lengths 220, 222 to connect the proximal and distal lengths of the catheter shaft 104A. The tubular braid 252 surrounds the core or lumen structure, as shown in Figures 7C and 7F, and is made of nickel-titanium alloy, stainless steel, or fabric material. As shown, a relatively rigid perimeter structure 232 for the proximal length 220 and a flexible perimeter or wall structure 234 for the distal length 222 are formed along the proximal and distal ends of the transition region, respectively. In addition to the structures shown, in the illustrated embodiment, the catheter shaft 104A includes one or more reinforcing wires formed along the structure of the catheter shaft 104A for steerability.

[0090] In the illustrated embodiment, the core or cavity structure is formed by a plurality of microtubes 230 extending along the length of the catheter shaft 104A. However, in an alternative embodiment, the microtubes 230 extend along the proximal length of the catheter shaft, and the cavity along the distal length is formed or molded along the distal circumferential structure 234 or the shaft 104A. As previously described, as shown in FIG7H, the length of the inflation cavity 134 extends from the proximal end of the catheter shaft 104A to a distal port 154 leading to the interior of the balloon 110A to inflate the balloon 110A at the distal end 108 of the catheter shaft 104A, as shown in FIG7I-7J. The guidewire cavity 132 and the ICE delivery cavity 130 extend the length of the catheter shaft 104A from the proximal end 106 to the distal opening at the end of the catheter shaft 104A. FIG7K shows the syringe 112 (with control valve), the ICE catheter 102, and the lead connector 118 or the port at the proximal end of the catheter shaft 104A.

[0091] As previously described and shown in Figure 7B, in an exemplary embodiment, airbag 110A is an asymmetric airbag, wherein the center of mass c of the airbag 110A body is offset from the duct axis C.s The vertical axis is shown in Figure 8A. As shown in Figure 8A, during use, blood flow or cardiac pressure provides a distributed force along the surface of the airbag 110A. In contrast to the symmetrical airbag, the force applied to the asymmetrical airbag 110A results in a net force F through the airbag's center of mass c. r The centroid c is related to the duct axis C. s Separated by the longitudinal axis to define the torque arm r or duct shaft C s The asymmetric portion between the center of mass c and the point of mass. Resultant force F r And the torque arm r is applied relative to the duct axis C s torque M CS Its size is M CS =F r *r provided. Therefore, as described above, the asymmetrical portion of the balloon 100A is oriented to aid in guiding and positioning the delivery catheter 100 for use. For example, the asymmetrical portion is oriented to guide the catheter 100 through the tricuspid valve into the right ventricle and through the pulmonary valve into the pulmonary artery.

[0092] As shown in Figure 8B, during use and insertion, the cuff is oriented to apply a clockwise torque so that the end of the delivery catheter 100A is aligned with the tricuspid valve for insertion (RV). As shown in Figure 8B, the cuff 110A is oriented to apply a counterclockwise torque M relative to the catheter axis 104A. CS This allows the distal end of the delivery catheter 100A to be aligned with the pulmonary artery (PA) for access to the imaging or treatment site. Furthermore, the off-axis alignment of the balloon reduces the surface area, thereby minimizing the back pressure and force applied to the catheter 100A during insertion.

[0093] While exemplary embodiments show an asymmetric balloon for placement of delivery catheter 100A, the application of the asymmetric balloon 110A is not limited to delivery catheter 100A and can be used to introduce other intracardiac or delivery catheters into the body or treatment site. In illustrative embodiments, the asymmetric balloon 110A is formed of an elongated, generally tubular body having spaced first and second ends connected to the outer surface of a flexible perimeter or wall structure 234 or catheter shaft 104A. The asymmetric shape is formed by the thinner or stressed wall thickness of the tubular body, such that inflation of the balloon cavity shapes the asymmetric shape of balloon 110A.

[0094] Figures 9A-9D illustrate alternative embodiments of the delivery catheter 100A, which has a rigid proximal length 220 and a relatively flexible distal length 222, as previously described with respect to Figures 7A-7G. In the illustrated embodiment, the multi-lumen catheter shaft 104A includes an ICE delivery lumen 130 and a balloon inflation lumen 134. Similar to the embodiments shown in Figures 3A-3B, the delivery lumen 130 is sized to accommodate the ICE imaging catheter 102 and the guidewire 120 for positioning the delivery catheter 100A for use.

[0095] Figures 10A-10E illustrate another embodiment of the delivery catheter 100A, which, as previously described, includes a rigid proximal length 220 and a flexible distal length 222. In the illustrated embodiment, shaft 104A includes an ICE delivery lumen 130 and an inflation lumen 134 along the proximal and distal lengths 220, 222. As shown in Figure 10C, the distal length includes a shortened guidewire lumen 132 (200). The quick-change or shortened guidewire lumen 132 (200) includes a proximal opening 202A and a distal opening 204A (as shown in Figure 10A), which are formed distal to the opening of lumen 132 at the distal end of the catheter shaft 104A. The distal end of a wire 120 extends through the proximal opening 202A and the distal opening 204A to track the delivery catheter to the treatment site. The proximal opening 202A is spaced from the proximal end of the catheter shaft 104A. However, in the illustrated embodiment, the length of the quick-exchange or shortened guidewire lumen 132 (200) extends along the flexible distal length 222. The application is not limited to the length of the quick-exchange guidewire lumen 132 shown, and in an exemplary embodiment, the length may extend along the entire flexible distal length 222 or along a portion of the distal length and the rigid proximal length 220 so that the proximal opening 202A is positioned along the rigid proximal length 220.

[0096] Figures 11A-11D illustrate another embodiment of the delivery catheter 100A, which, as previously described, includes a rigid proximal length 220 and a flexible distal length 222. In the illustrated embodiment, the catheter 100A includes a shortened ICE delivery cavity 130 along the relatively flexible distal length 222 of the catheter axis, as shown in Figure 11B. As shown, the flexible distal length 222 includes the ICE delivery cavity 130 having a proximal opening 202B spaced apart from the proximal end 106 of the catheter axis 104A and a distal opening 204B at the distal end 108 of the catheter axis 104A (as shown in Figure 11A).

[0097] Therefore, as shown, the ICE delivery lumen 130 is formed along the flexible distal length 222 of the catheter axis. For use, the rigid proximal length 220 provides sufficient rigidity and pushability to insert the delivery catheter 100A and the ICE catheter 102 through the patient's blood vessels into the right atrium. A guidewire 120 is inserted through the lumen 132, and a balloon 110A is inflated to float the delivery catheter into the right ventricle (RV) and pulmonary artery (PA) for imaging. In an alternative embodiment (not shown), the guidewire lumen 132 and the ICE delivery lumen 130 have a shortened length extending along the flexible distal length 222 of the catheter axis 104A. In an alternative embodiment (not shown), the shortened ICE delivery lumen 130 extends along a portion of the flexible distal length 222 and the rigid proximal length 220, such that the proximal opening 202B is arranged along the rigid proximal length 220 of the catheter axis 104A.

[0098] Figure 12A schematically illustrates the manufacture of a multi-lumen delivery catheter 100A having a rigid proximal length 220 and an ultra-flexible distal length 222 according to the illustrative embodiment. As shown step-by-step in step 300, multiple mandrels 302A, 302B, 302C with different diameters to correspond to different lumen sizes are coated with… A coating or other lubricating material. In step 302, the microtube 230 assembly is mounted on mandrels 302A-302C to form multiple cavities. As previously described, in the illustrated embodiment, the microtube 230 is formed of Teflon material to provide lubricated inner surfaces for the cavities. In step 304, the microtubes 230 are joined along their length to form a multi-cavity or core structure. For example, the microtubes 230 are joined by adhesives or other materials. The outer surface of the tubular bushing may be roughened to enhance the adhesive bonding of the microtubes 230.

[0099] As shown in step 306, tubular braid 252 is deposited on the outer circumference of the microtube to form a transition between the proximal and distal lengths 220, 222 of the conduit shaft. In step 308, a rigid polymer material is coated along the proximal length of the core or lumen structure, and the tubular braid 252 is coated along the transition length. A soft polymer material or layer 242 and a spiral coil 240 are deposited on the distal length of the core or lumen structure and the transition length of the tubular braid 252 to form the proximal and distal lengths 220, 222 of the conduit shaft 104A. As shown in step 310, a heat-shrinkable tube 311 is placed near the length of the structure, and in step 312, heat is supplied to the heat-shrinkable tube 311 to apply pressure to the polymer coating or layer. In the illustrated embodiment, the heat-shrinkable tube is a fluorinated ethylene propylene (FEP) heat-shrinkable tube. The heat and pressure applied by the shrinking diameter of the shrink tube 311 cause the polymer coating or layer to flow into the gaps of the tubular braid 252 to connect the relatively rigid proximal length 220 of the conduit and the relatively flexible distal length 222 of the conduit and coil. Subsequently, in step 314, the heat-shrink tube 311 and mandrel 302 are removed to attach the proximal hub and airbag assembly to the conduit shaft 104 to form the delivery conduit 100A.

[0100] In an alternative embodiment, the length of the microtube 230 extends along the proximal length 220 rather than the distal length 222, and the polymer coating or layer forms a cavity structure with multiple cavities along the distal length 222. In the disclosed alternative embodiment, the shortened microtube 230 is used to form a shortened distal guidewire cavity 132 or ICE delivery cavity 130.

[0101] Figure 12B is a flowchart illustrating the manufacturing process steps of the delivery conduit 100A and shaft according to an embodiment of this application. As previously described, a plurality of mandrels 302 are used to form a plurality of cavities in the multi-cavity conduit shaft. As shown in step 350, a plurality of microtubes 230 are assembled on the mandrels and adhered together to form a multi-cavity / core structure. In step 352, a tubular braid 252 is assembled onto the inner cavity or core structure to form a transition zone. In step 354, the proximal length of the structure is coated with a rigid polymer material to form a rigid proximal length 220 of the conduit. In step 356, a helical spring is assembled on the distal length between the inner and outer low-hardness polymer layers to form a flexible distal length 222. In step 358, heat is applied to a heat-shrinkable tube 311 to provide heat and pressure with respect to the outer circumference of the coating or layer to provide material flow to form the peripheral wall structure of the proximal and distal lengths 220, 222 of the conduit shaft, which is connected along the transition length passing through the braided tube 252. In step 360, the heat shrink tube 311 and the mandrel 302 are removed.

[0102] Figure 13 shows the distal ends of an illustrative embodiment of delivery catheters 100, 100A. As shown, an elongated control line 340 is connected to the distal end of delivery catheters 100, 100A to adjust the angle of the distal end of the delivery catheter relative to the longitudinal length of the shaft 104, 104A (as shown in the model). As schematically shown, the length of the control line 340 extends from the distal end to the proximal end of the catheter shaft 104 or hub so that the user can guide the delivery catheter 100 by adjusting the angle of the distal end via a vein, as indicated by arrow 342, by moving the control line 340 to connect 100A to a treatment or imaging site. In the illustrated embodiment, one or more control lines 340 extend along one or more control line lumens (not shown) formed along the catheter shaft 104, and the illustrated embodiment includes one or more control lines 340 and one or more control line lumens (not shown).

[0103] While exemplary embodiments are shown, the application of the invention is not limited to the illustrated embodiments and can be changed and modified as will be understood by those skilled in the art. For example, the flow-assisted delivery catheter 100 can be used to place an ICE or imaging catheter 102 at an alternative imaging site. Further applications of the invention are not limited to the specific order of the described steps. As described above, the application of the exemplary embodiments allows the imaging catheter to be placed at an intracardiac imaging site without damaging the superior vena cava, or placed at the pulmonary artery or other intracardiac treatment sites without damaging the tricuspid or pulmonary valve via the balloon-terminated delivery catheter 100. While specific combinations of elements are shown in the illustrated embodiments, it should be understood that features and elements of the illustrated embodiments can be combined to form alternative embodiments of the invention.

Claims

1. An intracardiac delivery catheter for intracardiac placement of an intracardiac echocardiography (ICE) catheter, the intracardiac delivery catheter comprising: A catheter shaft having an elongated length and radial dimension extending along the longitudinal axis of the catheter shaft between its proximal and distal ends, the elongated length and radial dimension being sized for intravascular insertion, and the catheter shaft having a flexible distal portion and a relatively rigid proximal length, the flexible distal portion being bendable for intracardiac insertion of the catheter shaft, through the right atrium and right ventricle into the pulmonary artery, and the relatively rigid proximal length being for the torsionability of the catheter shaft; A delivery lumen, formed along an elongated length of the catheter axis and sized to accommodate insertion of the intracardiac echocardiography (ICE) catheter, the delivery lumen having an elongated length extending between an inlet and an outlet at the distal end of the catheter axis; An asymmetric flow assist balloon, connected to a distal end of the conduit shaft, the balloon having an asymmetric shape along a radial axis when inflated to form a torque arm near the distal end of the conduit shaft, the radial axis being generally transverse to the longitudinal axis of the conduit shaft; and An inflation chamber, formed along the elongated length of the catheter axis, has an inlet that connects to an inflation device and an outlet that leads to the interior of the asymmetric flow assist balloon to inflate the balloon to provide an asymmetric shape, thereby guiding the catheter through the right atrium and right ventricle into the pulmonary artery using fluid flow.

2. The intracardiac delivery catheter according to claim 1, wherein the outlet of the delivery lumen is distally separated from the asymmetric flow assist balloon.

3. The intracardiac delivery catheter according to claim 1, wherein the outlet of the delivery lumen is formed through the distal end of the opening of the catheter shaft.

4. The intracardiac delivery catheter of claim 3, wherein the delivery lumen has an inner diameter of at least 8F.

5. The intracardiac delivery catheter of claim 3, wherein the delivery lumen has a diameter of at least 9F.

6. The intracardiac delivery catheter of claim 1, wherein the catheter shaft further includes a guidewire lumen for inserting a guidewire.

7. The intracardiac delivery catheter of claim 6, wherein the guidewire lumen has a shortened length formed between a proximal opening spaced from the proximal end of the catheter shaft and a distal opening spaced from the proximal opening.

8. The intracardiac delivery catheter of claim 1, which is combined with an intracardiac echocardiography (ICE) catheter including an echocardiographic transducer array.

9. The intracardiac delivery catheter of claim 1, wherein the delivery chamber has an internal balloon that can be inflated through an internal inflation chamber to retain the intracardiac echocardiography (ICE) catheter in the proper position within the delivery chamber and to provide an ultrasound transmission fluid or medium.

10. The intracardiac delivery catheter of claim 1, wherein the catheter shaft includes a transition zone between the relatively rigid proximal length and the flexible distal portion.

11. The intracardiac delivery catheter of claim 1, wherein the flexible distal portion is formed of a helical coil embedded within a soft polymer body or layer.

12. A component for intracardiac placement of an intracardiac echocardiography (ICE) catheter, comprising: An intracardiac delivery catheter includes a catheter shaft formed of an elongated body having a length extending between a proximal and a distal end of the catheter shaft, and the catheter shaft having a delivery lumen of at least 8F for slidably inserting an intracardiac echocardiography (ICE) catheter for placement at an intracardiac treatment site, and the catheter shaft having a flexible distal portion and a relatively rigid proximal length, the flexible distal portion being bendable for intracardiac insertion of the catheter shaft, through the right atrium and right ventricle into the pulmonary artery, and the relatively rigid proximal length for the torsionability of the catheter shaft; and An asymmetric flow assist balloon, located at the distal end of an intracardiac delivery catheter, the intracardiac delivery catheter including an inflation chamber extending between a proximal port connectable to an inflation device and a distal port leading into the interior of the asymmetric flow assist balloon, to inflate the balloon such that the balloon has an asymmetric shape along a radial axis when inflated to form a torque arm near the distal end of the catheter axis, for placing the intracardiac delivery catheter at an intracardiac treatment site, the radial axis being generally transverse to the longitudinal axis of the catheter axis.

13. The component of claim 12, wherein, The delivery cavity has a shortened length between a proximal opening spaced from the proximal end of the catheter shaft and an outlet opening near the distal end of the catheter shaft.

14. The assembly of claim 12, wherein the catheter shaft further includes a guidewire lumen sized to accommodate guidewire insertion therein.

15. The component of claim 14, wherein, The guidewire lumen has a shortened length between an inlet opening spaced proximally from the catheter shaft and an outlet opening near the distal end of the catheter shaft.

16. The component of claim 12, wherein, The delivery chamber includes an inner balloon near the distal end of the catheter shaft, and the inner balloon is connected to an inner inflation chamber to expand the inner balloon around an intracardiac echocardiography (ICE) catheter disposed through the delivery chamber.

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