A pericardial catheter containing a camera to guide the cutting through the pericardium.

Abstract

To provide medical probes. [Solution] The medical probe comprises a shaft, a camera, a hollow cutting tool, and an inflatable balloon. The shaft is configured to be inserted through a cutting site in the patient's body, while the shaft includes an operating vacuum channel extending through it. The camera is mounted at the distal end of the shaft and is configured to provide images of a target tissue site in the body. The hollow cutting tool is placed over a guidewire and inserted into the operating vacuum channel of the shaft, and is configured to perforate the target tissue site under the guidance of images taken by the camera. The inflatable balloon is configured to stabilize the distal end of the shaft and is positioned proximal to the camera so as not to obstruct images of the target tissue site.

Description

Technical Field

[0001] The present invention relates broadly to minimally invasive probes, and more specifically to minimally invasive cardiac probes.

Background Art

[0002] Various techniques for applying minimally invasive procedures to internal tissues have been proposed in the patent literature. For example, U.S. Patent Application Publication No. 2016 / 0249978 describes an apparatus and method for pericardial access for performing procedures therein. The apparatus includes a catheter including a tubular member having a proximal end, a distal end sized to be introduced into a patient's body, an imaging assembly on the distal end, and a substantially transparent expandable member attached to the distal end of the tubular member. The imaging assembly is disposed inside the expandable member, where the imaging assembly images tissue through the surface of the expandable member. The tubular member includes a drainage lumen that communicates with one or more drainage ports on the distal end of the tubular member proximal to the balloon for aspirating fluid from the patient's body. The catheter may be used to access the pericardial cavity, and an ablation probe may be introduced through the catheter to treat cardiac tissue while fluid is being injected and / or aspirated through the drainage ports.

[0003] As another example, U.S. Patent Application Publication 2008 / 0183080 describes an interventional medical device that incorporates an imaging system and is minimally invasive. The device is equipped with a slidable and lockable anchoring portion on an elongated body outside the human body. The device further includes deployable first and second balloons for similarly securing the device to, for example, an internal wall inside the human body. The medical device may take the form of a catheter, a sheath, or include an interventional device, particularly suitable for minimally invasive procedures in the pericardium. The double-sealing / locking balloon may include a slidably movable assembly for moving from a first position over the inflation channel to a second position over the inflation channel to inflate the distal balloon to the patient's skin surface and then the proximal balloon separately. Alternatively, the balloon assembly may be fixed from the proximal end across the first and second inflation / deflation channels. The imaging system comprises one or more ultrasonic transducers positioned near the distal end and / or on the side of an elongated body portion, and can therefore be used to guide the instrument to a target area, guide the inflation of a deployable balloon, guide the execution of a procedure, and / or provide visual access to the target area for performing the procedure through multiple lumens.

[0004] U.S. Patent No. 5,827,216 describes a device and method for pericardial puncture to access the pericardial cavity. This invention involves inserting a percutaneous tube having a perforated tip, the perforation of which is positioned on and in contact with the anterior pericardium. By introducing a vacuum into the tube, a pericardial bleb is formed within the perforation. A guide needle within the tube is advanced to puncture the pericardial bleb while avoiding contact with the epicardium. A hollow filament, electrocardiogram lead, or flexible guidewire within the needle can then be advanced into the pericardial cavity. The guidewire may be used to guide an intrapericardial catheter into the pericardial cavity to inject or inject a selected therapeutic agent into the pericardial cavity to treat various cardiovascular diseases. A controlled drug-release material may be injected through the needle to deliver the therapeutic agent slowly and / or continuously into the pericardial cavity. [Overview of the project] [Means for solving the problem]

[0005] One embodiment of the present invention provides a medical probe comprising a shaft, a camera, a hollow cutting tool, and an inflatable balloon. The shaft is configured to be inserted through a cutting site in the patient's body, while the shaft includes a working vacuum channel extending through it. The camera is mounted at the distal end of the shaft and is configured to provide images of a target tissue site within the body. The hollow cutting tool is for insertion into the working vacuum channel of the shaft, placed over a guidewire, and is configured to puncture the target tissue site under the guidance of images taken by the camera. The inflatable balloon is configured to stabilize the distal end of the shaft and is positioned proximal to the camera so as not to obstruct images of the target tissue site.

[0006] In some embodiments, the target tissue site includes a pericardial site, and the shaft is configured to be inserted through a cut in the patient's chest.

[0007] In some embodiments, the medical probe further comprises a second probe configured to be inserted through a working vacuum channel to treat a target tissue location, and a camera further configured to provide images of the treatment by the second probe.

[0008] In one embodiment, the second probe is also configured to act as a deflectable guidewire for a medical probe.

[0009] In another embodiment, the second probe includes an ablation catheter.

[0010] In some embodiments, the inflatable balloon is configured to stabilize both the medical probe and the second probe.

[0011] In some embodiments, the target tissue location includes a myocardial location.

[0012] Furthermore, according to one embodiment of the present invention, a method is provided comprising inserting a medical probe through a cut site in a patient's body, the probe comprising a shaft having a working vacuum channel extending through the shaft, a camera mounted at the distal end of the shaft, and an inflatable balloon positioned proximal to the camera. To puncture a target tissue site under the guidance of images taken by the camera, the hollow cutting tool is inserted through the working vacuum channel, over a guidewire. The guidewire is retracted. A second probe is inserted through the working vacuum channel. The balloon is inflated to stabilize the medical probe and the second probe. Under the guidance of images taken by the camera, the target tissue location is treated using the second probe.

[0013] This invention will be more fully understood by considering the following "Modes for Carrying Out the Invention" in conjunction with the drawings. [Brief explanation of the drawing]

[0014] [Figure 1] This is a schematic diagram of a system for minimally invasive pericardial treatment equipped with a pericardial catheter, according to an embodiment of the present invention. [Figure 2] This is a schematic diagram of the pericardial catheter shown in Figure 1, according to an embodiment of the present invention. [Figure 3] This is a schematic diagram of the distal end of the pericardial catheter shown in Figure 2, according to an embodiment of the present invention. [Figure 4] This flowchart schematically illustrates a method for manufacturing the distal end shown in Figure 3 according to an embodiment of the present invention. [Figure 5] This is a flowchart illustrating a method for minimally invasive pericardial treatment according to an embodiment of the present invention. [Modes for carrying out the invention]

[0015] Overview Pericardial therapies, such as radiofrequency (RF) ablation, may be used to alleviate certain types of ventricular arrhythmias and some forms of atrial fibrillation. However, pericardial ablation, applied to the outer surface of the myocardium, has been somewhat limited in success due to the presence of epicardial fat. The fat layer can interfere with proper RF energy delivery, for example, by causing improper contact between the ablation catheter and muscle tissue. In addition, due to the presence of a significant amount of epicardial fat, any ablation energy intended for the myocardium may rather be absorbed by the fat, which has considerably lower conductivity compared to the myocardium. Pericardial ablation can also be limited by an increased likelihood of other complications, such as those that can occur due to energy delivery in close proximity to the coronary arteries.

[0016] Embodiments of the present invention described and illustrated below provide a camera-guided medical probe (e.g., a catheter, also referred to herein as the “first probe”) to enable controlled access to and treatment of target tissues within the body, such as myocardium. Embodiments described herein provide a camera-guided pericardial catheter with a second probe capable of accessing and treating the outer surface of the myocardium. The disclosed pericardial catheter is inserted into the patient through a small incision in the chest and navigated to the pericardium using a camera. Once the catheter is positioned just outside the pericardium, the treating physician, guided by images captured by the camera, inserts a hollow cutting tool into the catheter's working channel via a guidewire to perforate the pericardium, including perforating its fatty subepidermal layer. The camera helps the physician avoid incidental damage in the process, such as accidentally perforating the myocardium itself with the hollow cutting tool.

[0017] In the context of the disclosed description, the term “hollow cutting tool” refers to any tool, such as a needle, blade, or cutting laser, that is inserted through the working channel of a pericardial catheter and used to perform cutting within the pericardium.

[0018] In some embodiments, the working channel additionally serves as a vacuum channel configured to lift the pericardium in order to minimize the risk to the underlying myocardium and facilitate incision by a hollow cutting tool.

[0019] The guide wire is then advanced through the incision within the pericardium, the hollow cutting tool is withdrawn, and the catheter is advanced over the guide wire through the incision within the pericardium. When the catheter is positioned inside the pericardium, the guide wire is retracted, and a second probe, typically an RF ablation catheter, is inserted into the working channel and again navigated, using the camera, to a desired region such as the location of the target tissue (i.e., the myocardium).

[0020] In some embodiments, the medical probe includes an inflatable balloon, which is typically used during a subsequent ablation procedure and is kept in a compressed state during the incision. The balloon is typically positioned proximal to the camera so as not to obscure the field of view, including the forward line of sight (e.g., the visual field), between the camera and the target tissue site of the incision (i.e., the pericardium). Subsequently, when inflated, the balloon stabilizes the pericardial catheter and the second probe by pressing against the epicardial layer from one end of the balloon and against the myocardium from the other end.

[0021] In one embodiment, the second probe can be deflected, but the pericardial catheter is constructed to be more flexible than the second probe, so that the second probe acts as a deflectable guide wire in addition to performing a treatment function (e.g., RF ablation).

[0022] The disclosed camera-guided pericardial catheter can not only reduce the risk of minimally invasive pericardial treatment, but can also improve the clinical outcomes of myocardial treatments such as ablation in some cases.

[0023] Description of the System Figure 1 is a schematic pictorial view of a system 20 for minimally invasive pericardial treatment with a pericardial catheter 28, according to an embodiment of the present invention. Physician 26 is inserting the shaft 29 of pericardial catheter 28 through sheath 47 into the chest incision of patient 22 near heart 24. Next, physician 26 manipulates the pericardial catheter so that the distal end 30 of catheter shaft 29 approaches pericardial sac 55 and cuts it to access myocardium 51, as shown in insertion view 25. This cutting is done for the purpose of later inserting a second treatment probe, such as an ablation catheter, to ablate an area below myocardium 51.

[0024] To gain access to myocardium 51, a hollow cutting tool 32 is attached to distal end 30 and advanced distally through a working channel within pericardial catheter 28. However, as described above, by cutting pericardial sac 55, particularly the fatty epicardial sublayer 57 of pericardial sac 55, incidental damage can occur, such as the hollow cutting tool 32 puncturing myocardium 51 and even penetrating into heart cavity 50.

[0025] To carefully and accurately guide hollow cutting tool 32, physician 26 uses a camera 35 disposed at distal end 30, which is for providing an image 37 (e.g., a video image) of pericardium 55 during the cutting procedure. The video image of pericardium 55 is presented on display 27 for physician 26. From the field of view of camera 35, a perfusion pump 48 supplies a fluid, such as saline, to wash the lens of camera 35, for example, to remove blood. The cleaning fluid flows through the lumen within catheter 28 to distal end 30 and exits through tube 40.

[0026] As described below, as an additional means to avoid incidental damage, such as puncturing myocardium 51, physician 26 operates a vacuum channel 34 to lift the epicardium away from the myocardium. Channel 34 is connected via cable tube 36 to a vacuum pump 46 within console 24.

[0027] After performing a cut in the pericardium 55, the hollow cutting tool 32 is retracted, and a second probe, such as an ablation catheter (shown in Figure 3), is advanced through the same or a different working channel of the pericardial catheter 28 to treat the myocardium 51, as described below.

[0028] In one embodiment, the ablation catheter is inserted under the guidance of a camera 35 through a pericardial segment near the myocardial site for ablation. After confirming that the tip of the ablation catheter is in contact with the myocardium at the target myocardial site, the physician 26 performs the RF ablation using the image captured by the camera 35.

[0029] To perform RF ablation, physician 26 activates an RF energy generator 44 in the control console 42 to supply RF energy to the distal end 30 via cable 38. A temperature sensor (not shown) in the distal end 30 may provide feedback to the console 42 for use in controlling the amount of RF energy supplied and / or the flow rate of the cooling irrigation.

[0030] A pericardial catheter containing a camera to guide the cutting through the pericardium. Figure 2 is a schematic illustration of the pericardial catheter 28 of Figure 1 according to an embodiment of the present invention. As shown, the hollow cutting tool 32 is confirmed to protrude beyond the distal edge of the distal end 30 and to be in close proximity to the pericardial sac 55 and the epicardial layer 57 below it. The hollow cutting tool 32 is inserted through a vacuum channel 34 which also serves as a working channel (confirmed in the cross section 128 of the catheter 28). The vacuum channel 34 is configured to lift both layers 55 and 57, facilitating incision by the hollow cutting tool 32 with minimal risk to the underlying myocardium 51. The entire incision process is guided using a camera 35 having a field of view 350 to provide an image of the hollow cutting tool 32 relative to the target pericardial tissue. Illumination to the camera 35 is provided by one or more light sources 39, such as a bundle of optical fibers, or by LEDs covered with diffusive optical components.

[0031] The inflatable balloon 45, which appears compressed, is mounted distal to the camera 35 so as not to obstruct the field of view 350. The balloon is then inflated and compressed using the fluid channel 145.

[0032] The example shown in Figure 2 is selected solely for the purpose of illustrating the concept. Figure 2 shows only the parts relevant to embodiments of the present invention. Other system elements, such as additional sensors mounted on the distal end 30, are omitted. The catheter 28 may also include several additional working channels.

[0033] Figure 3 is a schematic illustration of the distal end 30 of the pericardial catheter of Figure 2 according to an embodiment of the present invention. As shown, an ablation catheter 60 having an ablation electrode 66 is inserted through a vacuum / working channel 34 to ablate target tissue 68 on the myocardium 51. The ablation catheter 60 is further configured to act as a deflectable guidewire for the catheter 28. A balloon 45 is inflated to stabilize the catheters 28 and 60 during the procedure (for example, by stabilizing the distal end 30 of the shaft 29). A camera 35 provides a visual image of the electrode 66 relative to the target myocardial location 68 to guide the RF ablation treatment.

[0034] The example shown in Figure 3 is selected solely for the purpose of illustrating the concept. Other system elements, such as a second probe of a different type for drug infusion, may be inserted through the working channel. Irrigation may be applied to target the myocardial location 68 through another channel within the pericardial catheter 28 during ablation.

[0035] Figure 4 is a schematic flowchart illustrating a method for manufacturing the distal end 30 shown in Figure 3 according to an embodiment of the present invention. This process begins in the camera mounting step 70 by mounting a camera 35 to the distal end 30 in such a manner that the camera has a free line of sight distal to the distal end. Next, in the optical fiber mounting step 72, an optical light source 39 (e.g., a bundle of illumination fibers or LEDs) is mounted to the distal end 39. Finally, an expandable balloon 45 is mounted to the distal end 30 distal to the camera 35 so as not to obstruct the line of sight of the camera 35.

[0036] The exemplary flowchart shown in Figure 4 was selected solely for the purpose of illustrating the concept. Only the manufacturing process relevant to embodiments of the present invention is shown.

[0037] Figure 5 is a flowchart schematically illustrating a method for minimally invasive pericardial treatment according to an embodiment of the present invention. The process begins in a pericardial catheter insertion step 80, in which a physician 26 inserts a pericardial catheter 28 into the thoracic cavity of a patient 22, positioning the distal end 30 near the heart 24. Next, in a pericardial lifting step 82, the physician 26 applies vacuum through a channel 34 to lift the pericardial sac 55 and epicardial sublayer 57. Using images provided by a camera 35, in a pericardiotomy step 84, the physician 26 applies a hollow cutting tool 32 over a guidewire 33 to cut the lifted pericardium.

[0038] In the cutting tool retraction step 86, the physician 26 retracts the hollow cutting tool 32 that is covering the guide wire 33.

[0039] Next, in the pericardial catheter advancement step 88, the physician 26 advances the distal end 30 that covers the guidewire 33 to position the compressed balloon 45 below the epicardial sublayer 57.

[0040] Once the distal end 30 of the catheter 28 has advanced sufficiently beyond the pericardial sac, in balloon stabilization step 90, the physician 26 inflates the balloon 45 to stabilize both catheters.

[0041] In the tool change step 92, the physician 26 retracts the guidewire 33 and inserts the ablation catheter 60 through the vacuum / working channel 34. Next, in the ablation catheter navigation step 96, using the camera 35 which has a clear line of sight to the myocardium 51, the physician 26 navigates the ablation catheter 60 to bring the electrode 66 into contact with the target myocardial location 68. The physician 26 may use the catheter 60 as a deflectable guidewire to slide it further on the catheter 28 if necessary, for example, to further stabilize the catheter. Finally, in the ablation step 96, the physician 26 ablates the myocardial location 68.

[0042] The illustrative flowchart shown in Figure 5 was selected solely for the purpose of illustrating the concept. In an alternative embodiment, for example, physician 26 may additionally apply irrigation and measure tissue temperature.

[0043] While the embodiments described herein primarily address cardiac applications, the methods and systems described herein may also be used in other applications, such as minimally invasive camera-guided surgery.

[0044] Accordingly, it will be understood that the embodiments described above are cited as examples, and that the present invention is not limited to those specifically shown and described above. Rather, the scope of the present invention includes both combinations of the various features described above and combinations of some thereof, as well as variations and modifications thereof that would be conceivable to a person skilled in the art by reading the above description and that are not disclosed in the prior art. Documents incorporated by reference in this patent application shall be deemed to be part of this application, except that if any term is defined in such incorporated documents in a manner that contradicts the definitions expressed or implied herein, only the definitions herein shall be considered.

[0045] [Implementation Method] (1) A medical probe, A shaft configured to be inserted through a section of the patient's body, comprising a working vacuum channel extending through the shaft, A camera, which is attached to the distal end of the shaft and configured to provide an image of a target tissue site within the body, A hollow cutting tool for inserting into the working vacuum channel of the shaft, which is placed over a guide wire, and is configured to perforate the target tissue site under the guidance of an image taken by the camera, A medical probe comprising: an inflatable balloon configured to stabilize the distal end of the shaft, and positioned proximal to the camera so as not to obstruct the image of the target tissue site. (2) The medical probe according to Embodiment 1, wherein the target tissue site includes a pericardial site, and the shaft is configured to be inserted through a cut in the patient's chest. (3) The medical probe according to Embodiment 1, comprising a second probe configured to be inserted through the working vacuum channel to treat a target tissue location, wherein the camera is further configured to provide images of the treatment by the second probe. (4) The medical probe according to Embodiment 3, wherein the second probe is also configured to act as a deflectable guide wire for the medical probe. (5) The medical probe according to Embodiment 3, wherein the second probe comprises an ablation catheter.

[0046] (6) The medical probe according to Embodiment 3, wherein the inflatable balloon is configured to stabilize both the medical probe and the second probe. (7) The medical probe according to Embodiment 3, wherein the target tissue location includes a myocardial location. (8) A method, A medical probe comprising a shaft having a working vacuum channel extending through it, a camera attached to the distal end of the shaft, and an inflatable balloon positioned proximal to the camera, is inserted through a section in the patient's body. The hollow cutting tool is inserted over the guide wire through the aforementioned working vacuum channel, and the target tissue area is perforated under the guidance of the image captured by the camera. Retracting the aforementioned guide wire, Inserting the second probe through the aforementioned working vacuum channel, The balloon is inflated to stabilize the medical probe and the second probe, A method comprising treating a target tissue location using the second probe under the guidance of the image taken by the camera. (9) The method according to Embodiment 8, wherein inserting the hollow cutting tool and perforating the target tissue includes inserting a shaft through the cutting site in the patient's chest and perforating the pericardial site. (10) The method according to Embodiment 8, comprising inserting a second probe through the working vacuum channel to treat a target tissue location, while using the camera to provide an image of the treatment by the second probe.

[0047] (11) The method according to Embodiment 10, comprising using the second probe as a deflectable guidewire for the medical probe. (12) The method according to Embodiment 10, wherein the treatment with the second probe includes ablation. (13) The method according to Embodiment 10, comprising stabilizing both the medical probe and the second probe by inflating the inflatable balloon. (14) The method according to Embodiment 8, wherein treating the target tissue location includes treating the myocardial location.

Claims

1. A medical probe, A shaft configured to be inserted through the amputation site inside the patient's body, A camera, positioned adjacent to the distal end of the shaft and configured to provide an image of a target tissue site within the body, A hollow cutting tool for insertion into the aforementioned shaft, An inflatable balloon configured to stabilize the distal end of the shaft, the inflatable balloon being positioned proximal to the distal end of the camera so as not to obstruct the image of the target tissue area, Equipped with, A medical probe wherein the inner surface of the inflatable balloon surrounds the entire circumferential surface of the shaft and the entire circumferential surface of the camera in a portion of the longitudinal region of the shaft, and the inflatable balloon inflates when fluid is introduced between the inner surface of the inflatable balloon and the circumferential surface of the shaft and the circumferential surface of the camera.

2. The medical probe according to claim 1, wherein the target tissue region includes a pericardial region, and the shaft is configured to be inserted through a cut in the patient's chest.

3. A medical probe according to claim 1, comprising a second probe configured to be inserted through a working vacuum channel of the shaft to treat a target tissue location, wherein the camera is further configured to provide an image of the treatment by the second probe.

4. The medical probe according to claim 3, wherein the second probe is also configured to act as a deflectable guidewire for the medical probe.

5. The medical probe according to claim 3, wherein the second probe comprises an ablation catheter.

6. The medical probe according to claim 3, wherein the inflatable balloon is configured to stabilize both the medical probe and the second probe.

7. The medical probe according to claim 3, wherein the target tissue location includes a myocardial location.

8. A medical probe according to claim 1, further comprising a sheath having a lumen, through which the shaft, the camera, and the inflatable balloon pass when the shaft is inserted into the patient's body.

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