The present disclosure relates generally to medical devices and, more particularly, to systems, devices and methods related to catheters used to perform ablation functions.
Cardiac ablation is a procedure by which cardiac tissue is treated to inactivate the tissue. The tissue targeted for ablation may be associated with improper electrical activity, for example. Cardiac ablation can lesion the tissue and prevent the tissue from improperly generating or conducting electrical signals.
In Example 1, a catheter system includes a catheter and a control system. The catheter includes an elongate catheter body and a catheter tip coupled to a distal end of the elongate catheter body. The catheter tip includes a plurality of openings corresponding to a plurality of lumens extending through the elongate catheter body. The control system is configured to initiate a source of vacuum pressure to at least one of the plurality of lumens, receive an indication of a vacuum seal, and in response to the indication of the vacuum seal, initiate a source of ablation energy.
In Example 2, the catheter system of Example 1, wherein the control system is configured to initiate the source of ablation in response to calculating that the vacuum seal is maintained for a predetermined period of time.
In Example 3, the catheter system of any of Examples 1-2, wherein the control system is further configured to receive an indication of contact of the catheter tip, and in response to receiving the indication of contact, initiate the source of vacuum pressure.
In Example 4, the catheter system of any of Examples 1-3, wherein the control system is further configured to receive an indication of a loss of a vacuum seal, and in response to receiving the indication of a loss of a vacuum seal, turn off the source of ablation energy.
In Example 5, the catheter system of any of Examples 1-3, wherein the control system is further configured to receive an indication of a loss of a vacuum seal, and in response to receiving the indication of a loss of a vacuum seal, initiate an alert.
In Example 6, the catheter system of any of claims 1-5, wherein the control system is configured to control a valve coupled to a first lumen and a second lumen, the control system further configured to cause the valve to fluidly couple the first lumen to the source of vacuum pressure, and cause the valve to fluidly couple the second lumen to a source of irrigation fluid.
In Example 7, the catheter system of any of Examples 1-6, wherein the control system is configured to control a valve coupled to a plurality of lumens, the control system further configured to cause the valve to fluidly couple only one of the plurality of lumens to the source of vacuum pressure.
In Example 8, the catheter system of any of the Examples 1-7, further comprising a sensor configured to detect a vacuum seal.
In Example 9, the catheter system of Example 8, wherein the vacuum seal is detected by one of a pressure change and a change in blood flow.
In Example 10, the catheter system of any of Examples 8-9, wherein the sensor is one of an optical sensor, a flow sensor, a pressure sensor, and an oxygen sensor.
In Example 11, the catheter system of Example 1, further comprising the vacuum source coupled to each of the plurality of lumens; and a valve configured to selectively fluidly couple the plurality lumens to the vacuum source.
In Example 12, the catheter system of Example 11, wherein the catheter includes a plurality of ablation electrodes.
In Example 13, the catheter system of Example 11, wherein the catheter includes a single ablation electrode.
In Example 14, a catheter system includes a catheter and a valve. The catheter includes an elongated catheter body, a first lumen and a second lumen extending through the elongated catheter body, and a catheter tip coupled to the elongated body. The catheter tip includes a first opening coupled to the first lumen and a second opening coupled to the second lumen. The valve is configured to fluidly couple the first lumen and the second lumen to a vacuum source.
In Example 15, the catheter system of Example 14, wherein the valve is further configured to fluidly couple the first lumen and the second lumen to an irrigation source.
In Example 16, a catheter system includes a catheter with an elongated catheter body, a first lumen extending through the elongated catheter body and configured to provide a vacuum, a second lumen extending through the elongated catheter body and configured to provide a vacuum, and a catheter tip coupled to the elongated body. The catheter tip includes a first opening coupled to the first lumen and configured to provide a vacuum seal and a second opening coupled to the second lumen and configured to provide a vacuum seal.
In Example 17, the catheter system of Example 16, further comprising a valve coupled to the first and second lumens, wherein the valve is configured to couple the first and second lumens to a vacuum source.
In Example 18, the catheter system of Example 17, wherein the valve is further configured to couple the first and second lumens to an irrigation fluid source.
In Example 19, the catheter system of Example 16, further comprising a third lumen extending through the elongated catheter body and configured to provide a vacuum, and wherein the catheter tip includes a third opening coupled to the third lumen and configured to provide a vacuum seal.
In Example 20, the catheter system of Example 16, wherein the catheter tip includes a plurality of ablation electrodes, and wherein the first opening is positioned between a pair of the plurality of ablation electrodes.
In Example 21, the catheter system of Example 16, wherein the catheter tip further includes a temperature sensor.
In Example 22, the catheter system of Example 21, wherein the catheter tip further includes at least one mapping sensor.
In Example 23, the catheter system of Example 16, wherein the first opening and the second opening have a surface area of 1-7.5 mm2.
In Example 24, a catheter system includes control circuitry configured to: initiate a source of vacuum pressure to one or more lumens, receive an indication of a vacuum seal, and in response to the indication of the vacuum seal, initiate a source of ablation energy.
In Example 25, the catheter system of Example 24, wherein the control circuitry is configured to initiate the source of ablation in response to calculating that the vacuum seal is maintained for a predetermined period of time.
In Example 26, the catheter system of Example 24, wherein the control circuitry is further configured to receive an indication of contact of an ablation tip, and in response to receiving the indication of contact, initiate the source of vacuum pressure.
In Example 27, the catheter system of Example 24, wherein the control circuitry is further configured to receive an indication of a loss of a vacuum seal, and in response to receiving the indication of a loss of a vacuum seal, turn off the source of ablation energy.
In Example 28, the catheter system of Example 24, wherein the control circuitry is further configured to receive an indication of a loss of a vacuum seal, and in response to receiving the indication of a loss of a vacuum seal, initiate an alert.
In Example 29, the catheter system of Example 24, wherein the control circuitry is configured to control a valve coupled to a first lumen and a second lumen, the control system further configured to cause the valve to fluidly couple the first lumen to the source of vacuum pressure, and cause the valve to fluidly couple the second lumen to a source of irrigation fluid.
In Example 30, the catheter system of Example 24, wherein the control circuitry is configured to control a valve coupled to a plurality of lumens, the control system further configured to cause the valve to fluidly couple only one of the plurality of lumens to the source of vacuum pressure.
In Example 31, the catheter system of Example 24, further comprising a sensor configured to detect a vacuum seal.
In Example 32, the catheter system of Example 31, wherein the vacuum seal is detected by one of a pressure change and a change in blood flow.
In Example 33, the catheter system of Example 32, wherein the sensor is one of an optical sensor, a flow sensor, a pressure sensor, and an oxygen sensor.
In Example 34, the catheter system of Example 24, wherein the source of vacuum pressure is configured to provide at least 5 grams of force.
In Example 35, the catheter system of Example 24, wherein the control circuitry is configured to maintain the vacuum seal while ablation energy is applied.
While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.
Various cardiac abnormalities can be attributed to improper electrical activity of cardiac tissue. Such improper electrical activity can include, but is not limited to, generation of electrical signals, conduction of electrical signals, and/or compression of the tissue in a manner that does not support efficient and/or effective cardiac function. For example, an area of cardiac tissue may become electrically active prematurely or otherwise out of synchrony during the cardiac cycle, causing the cardiac cells of the area and/or adjacent areas to contract out of rhythm. The result is an abnormal cardiac contraction that is not timed for optimal cardiac output. In some cases, an area of cardiac tissue may provide a faulty electrical pathway (e.g., a short circuit) that causes an arrhythmia, such as atrial fibrillation or supraventricular tachycardia. In some cases, inactive tissue (e.g., scar tissue) may be preferable to malfunctioning cardiac tissue.
Cardiac ablation is a procedure by which cardiac tissue is treated to inactivate the tissue. The tissue targeted for ablation may be associated with improper electrical activity, as described above. Cardiac ablation can lesion the tissue and prevent the tissue from improperly generating or conducting electrical signals. For example, a line, a circle, or other formation of ablated cardiac tissue can block the propagation of errant electrical signals. In some cases, cardiac ablation is intended to cause the death of cardiac tissue and to have scar tissue reform over the lesion, where the scar tissue is not associated with the improper electrical activity. Ablation therapies include radiofrequency (RF) ablation, cyroablation, microwave ablation, laser ablation, and surgical ablation, among others.
During an ablation procedure, an ablation tool such as a catheter with one or more ablation electrodes is advanced into contact with a target area of tissue where ablation energy (e.g., RF energy) is to be directed into the target tissue to form a lesion. Effective RF ablation relies on, among other things, maintaining contact with the tissue during the ablation procedure. Maintaining contact during a typical ablation cycle (e.g., 15-20 seconds) can be difficult to achieve because of a variety of reasons, including the fact that the heart continues to beat during the ablation procedure. Intermittent or unstable tissue contact results in RF energy being driven into blood surrounding the ablation electrode instead of the tissue. Features of the present disclosure are accordingly directed to catheter tip designs that assist with maintaining contact with tissue during ablation.
The catheter tip 106 includes openings 112 (three are shown in
The lumens 214 are coupled to a vacuum source (such as vacuum source 114 shown in
The lumens 214 can also be coupled to an irrigation fluid source 118 via the one or more valves (such as valve 116 shown in
In some embodiment, when the catheter tip 204 is determine to be near a target ablation site, the vacuum source 114 can be turned on to provide a negative pressure to one or more lumens 214. In some embodiments, the vacuum source 114 can be turned on upon determining that the catheter 200 is in contact with tissue. This can be determined using the one or more sensors 122 by detecting changes in impedance, capacitance, and the like. In some embodiments, the vacuum source 114 can be turned on and coupled to a particular lumen and therefore opening upon determining that a particular part or area of the catheter 200 is in contact with tissue.
Blood pulled into the one or more lumens 214 via the openings 208 would be collected at the blood collector 120. When the one or more openings 208 develop a vacuum seal with the tissue, a number of parameters could be detected by one or more sensors 122 to confirm contact and a seal. The one or more sensors 122 can include sensors that measure pressure, impedance, optical, oxygen, flow, and/or capacitance parameters. For example, when a vacuum seal is initiated, the sensor 122 could detect that blood flow (e.g., via parameters such as impedance, optical, capacitance, oxygen content, and the like) has decreased as a result of the vacuum seal. In another example, when a vacuum seal is initiated, the one or more sensors 122 could detect a pressure rise in the one or more lumens 214. The one or more sensors 122 can be coupled to the one or more lumens 214, for example, or coupled to other features of the system 100 including features external to the catheter 102. In some embodiments, the one or more sensors 122 are positioned within the one or more lumens 214.
The system 100 includes a control system 124 including a memory 126, a processor 128, a measurement sub-unit 130, a valve controller 132, a mapping sub-unit 134, and a display controller 136. The system 100 also includes an ablation energy generator 138 and a display 140. The control system 124 can be configured to carry out various routines, which may be carried out automatically or which may receive input or intervention from an operator of the system 100 at various stages of the routine.
The vacuum source 114 can be turned on in response to input from an operator, which causes the control system 124 to initiate negative pressure from the vacuum source 114 (step 404). Likewise, the valve 116 can be opened in response to input from an operator that causes the control system 124 (e.g., valve controller 132) to initiate an open command to the valve 116. Once negative pressure is provided to the one or more lumens, blood may begin to be pulled into the lumens via the openings 112 and collected by the blood collector 120.
After a negative pressure is applied to the one or more lumens, the catheter tip 106 can be advanced towards to tissue if the catheter tip 106 is not already in contact with the tissue. Because of the negative pressure, when one or more of the openings 112 contact tissue, a vacuum seals develops—causing the catheter tip 106 to “grasp” the tissue and provide stable contact between the catheter tip 106 (and therefore ablation electrode 110) and tissue. When the one or more openings 112 develop a vacuum seal with the tissue, the one or more sensors can be used to detect one or more parameters that indicate the existence of a vacuum seal. For example, the one or more sensors 122 can measure parameters such as pressure, impedance, optical, oxygen, flow, and/or capacitance parameters. Once a given parameter exceeds or dips below a threshold, a signal indicating a vacuum seal can be generated (step 406). For example, the control system 124 (e.g., measurement sub-unit 130) can be configured to generate a signal in response to determining that a vacuum seal has developed between an opening and tissue. In some embodiments, a signal indicating a vacuum seal is generated after a vacuum seal is maintained for a predetermined amount of time.
In some embodiments, a signal indicating which lumen/opening has created a vacuum seal is generated. Such a signal can be used by the control system 124 to cause the valve 116 to remove application of a vacuum pressure to certain lumens. The signal can also be used by the control system 124 to cause the irrigation fluid source 118 to turn on and/or to cause the valve 116 (via the valve controller 132) to fluidly couple certain lumens to the irrigation fluid source 118.
In response to the signal indicating a vacuum seal, the control system 124 can initiate supply of ablation energy to the ablation electrode 110 (step 410). In some embodiments, the signal indicating a vacuum seal initiates an alert, which may be an audible alert or a visual alert displayed on the display 140. As such, the control system 124 can cause the ablation energy generator 138 to turn on automatically or in response to input from an operator. The ablation electrode 110 can direct ablation energy to the tissue to form a lesion while stable contact between the catheter tip 106 and tissue is maintained via the vacuum seal.
The vacuum source 114 (along with the valve 116) can provide negative pressure for a predetermined period of time or until an operator provides input to release the catheter tip 106 from contact with the tissue. The catheter tip 106 can then be moved to an adjacent portion of tissue and various steps of the routine 400 can be repeated. If one or more of the sensors 122 detects a loss of the vacuum seal, the ablation energy can be stopped and/or an alert (e.g., audible or visual) can be initiated to let the operator know of the loss of the vacuum seal (step 412).
The control system 124 can include a computer-readable recording medium or “memory” 126 for storing processor-executable instructions, data structures and other information. The memory 126 may comprise a non-volatile memory, such as read-only memory (ROM) and/or flash memory, and a random-access memory (RAM), such as dynamic random access memory (DRAM), or synchronous dynamic random access memory (SDRAM). In some embodiments, the memory 126 may store processor-executable instructions that, when executed by a processor 128, perform routines for carrying out the functions related to maintaining stable contact between a catheter and tissue during ablation.
In addition to the memory 126, the control system 124 may include other computer-readable media storing program modules, data structures, and other data described herein for assessing and monitoring tissue ablation. It will be appreciated by those skilled in the art that computer-readable media can be any available media that may be accessed by the control system 124 or other computing system for the non-transitory storage of information. Computer-readable media includes volatile and non-volatile, removable and non-removable recording media implemented in any method or technology, including, but not limited to, RAM, ROM, erasable programmable ROM (EPROM), electrically-erasable programmable ROM (EEPROM), FLASH memory or other solid-state memory technology, compact disc ROM (CD-ROM), digital versatile disk (DVD), BLU-RAY or other optical storage, magnetic tape, magnetic disk storage or other magnetic storage devices and the like.
It will be appreciated that the structure and/or functionality of the control system 124 may be different than that illustrated in
The catheter 500 of
Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.
This application claims priority to Provisional Application No. 62/400,550, filed Sep. 27, 2017, which is herein incorporated by reference in its entirety.
Number | Date | Country | |
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62400550 | Sep 2016 | US |