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EP-4312849-B1 - SAFETY SENSOR FOR LASER INDUCED PRESSURE WAVE IN CONTRAST MEDIA WITHIN A CONTAINMENT CATHETER DURING VASCULAR THERAPY

EP4312849B1EP 4312849 B1EP4312849 B1EP 4312849B1EP-4312849-B1

Inventors

  • CRONE, Tyler West

Dates

Publication Date
20260506
Application Date
20220325

Claims (7)

  1. A vascular therapy device ( 10 ), comprising: a catheter ( 12 ) including at least one optical fiber ( 18 ) with a light output aperture ( 20 ); a containment sheath ( 14 ) having a sheath opening ( 18 ) disposed at an end thereof, the catheter disposed inside the containment sheath and movable relative to the containment sheath to extend the light output aperture beyond the sheath opening such that the light output aperture is outside of the containment sheath; wherein the device is configured to operate in a saline mode in which saline flows through the containment sheath ( 14 ) and in a contrast mode in which contrast medium flows through the containment sheath; and characterized in that the device further comprises: a safety sensor ( 22 ) configured to detect whether the light output aperture is in a safe zone inside the containment sheath; and a device controller ( 42 ) configured to automatically turn off a laser operating to inject light into the at least one optical fiber ( 18 ) of the catheter ( 12 ) in response to a safety interlock condition in which the device is operating in contrast mode and the safety sensor ( 22 ) detects that the light output aperture ( 20 ) is not in the safe zone inside the containment sheath.
  2. The device ( 10 ) of claim 1, wherein the safety sensor ( 22 ) includes: a proximity sensor ( 22 ) configured to detect passage events in which the light output aperture ( 20 ) passes through the sheath opening ( 18 ); and an electronic processor ( 36 ) configured to detect whether the light output aperture is in the safe zone based at least on the passage events detected by the proximity sensor.
  3. The device ( 10 ) of claim 2, wherein the proximity sensor ( 22 ) includes: an aperture marker ( 24 ) disposed on the catheter ( 12 ); and a sheath opening marker ( 26 ) disposed on the containment sheath ( 14 ); wherein one of the aperture marker and the sheath opening marker is a passive marker and the other of the aperture marker and the sheath opening marker is an active marker configured to detect proximity of the passive marker.
  4. The device ( 10 ) of any one of claims 1 to 3, wherein the safety sensor ( 22 ) further includes: a backside proximity sensor ( 28 ) configured to detect passage events in which the light output aperture ( 20 ) passes through an interior boundary of the safe zone wherein the interior boundary is located inside the containment sheath ( 14 ); wherein the electronic processor ( 36 ) is configured to detect whether the light output aperture is in the safe zone further based on the passage events detected by the backside proximity sensor.
  5. The device ( 10 ) of claim 1, wherein the safety sensor ( 22 ) includes: a radiopaque aperture marker ( 24 ) disposed on the catheter ( 12 ); a radiopaque sheath opening marker ( 26 ) disposed on the containment sheath ( 14 ); and an electronic processor ( 36 ) configured to: receive images from an interventional radiology imaging device ( 38 ) that depict the radiopaque aperture marker and the radiopaque sheath opening marker; and detect whether the light output aperture is in the safe zone based on the received images.
  6. The device ( 10 ) of anyone one of claims 1-5, wherein the electronic processor ( 36 ) is programmed to implement a state machine ( 40 ) by: determining an inside state of the light output aperture ( 20 ) indicative of whether the light output aperture is inside of the containment sheath ( 14 ); update the state machine from the inside state to an outside state after determining that the light output aperture is outside of the containment sheath; determine whether the catheter ( 12 ) is in the saline mode or the contrast mode; and cease supplying optical energy to the at least one optical fiber ( 18 ) when (i) the catheter is in the contrast mode and (ii) the state of the light output aperture is in the outside state.
  7. The device ( 10 ) of claim 6, wherein the electronic processor ( 36 ) is further programmed to: update the state machine ( 40 ) of the light output aperture ( 20 ) from the outside state to the inside state by determining whether the aperture marker ( 24 ) no longer extends past the sheath opening marker ( 26 ).

Description

FIELD The following relates generally to the catheter arts, thrombectomy arts, atherectomy arts, catheter safety arts, and related arts. BACKGROUND Vascular therapy (e.g., thrombectomy, atherectomy, and so forth) devices are medical devices designed to remove or modify tissue or material from inside a diseased vessel (e.g., an artery, a vein, etc.). Intravascular devices attempt to remove this material without surgically opening the vessel. The mechanisms of intravascular removal can include simple suction, mechanical cutting, chemical dissolution, ablation through heat or light, maceration by mechanical or sonic energy, and so forth. The mechanism of action in, for example, some types of laser atherectomy utilizing a laser for material removal, is referred to as ultraviolet (UV) photoablation. However, this approach is less effective for calcified deposits, due to lower absorption of the laser light (e.g., in the near ultraviolet, such as at 308 nm in some specific systems). The photoablation can be enhanced for the purposes of debulking tissues at the target sites, especially but not limited to calcified deposits. The use of contrast media in combination with a UV laser produces a Laser Induced Pressure Wave (LIPW). This involves laser energy absorption at a molecular level in the contrast media, release of that energy producing a vapor bubble which expands, followed by a rapid collapse. This mechanism is effective for the purpose of debulking plaque and/or calcified lesions within the blood vessel. In order to do this safely, the lasing in contrast protocol is performed with the laser and proximate absorbing contrast medium located within a containment catheter. US2020/0046429A1 discloses an example vascular therapy device able to provide a LIPW mode treatment using light emitters located within a cavity to transmit pulses of light energy into a liquid medium within the cavity. The following discloses certain improvements. SUMMARY The invention is defined in the appended claims. In some embodiments disclosed herein, a vascular therapy device includes a catheter including at least one optical fiber with a light output aperture. A containment sheath has a sheath opening disposed at an end thereof. The catheter is disposed inside the containment sheath and movable relative to the containment sheath to extend the light output aperture beyond the sheath opening such that the light output aperture is outside of the containment sheath. A safety sensor is configured to detect whether the light output aperture is in a safe zone inside the containment sheath. The device is configured to operate in a saline mode in which saline flows through the containment sheath and in a contrast mode in which contrast medium flows through the containment sheath. The device further includes a device controller configured to automatically turn off a laser operating to inject light into the at least one optical fiber of the catheter in response to a safety interlock condition in which the device is operating in contrast mode and the safety sensor detects that the light output aperture is not in the safe zone inside the containment sheath. One advantage resides in providing an intravascular device with a safeguard feature to prevent blood vessel damage. Another advantage resides in providing an intravascular device with a safety sensor to prevent blood vessel damage. Another advantage resides in providing an intravascular device with one or more sensors to determine when an ablating instrument operating under conditions that generate LIPW is within a containment sheath. Another advantage resides in providing an intravascular device with one or more sensors to determine when an ablating instrument is within a containment sheath and a controller to cease supply of energy to an ablating instrument when the ablating instrument is outside of the containment sheath and is operating under conditions that generate LIPW. A given embodiment may provide none, one, two, more, or all of the foregoing advantages, and/or may provide other advantages as will become apparent to one of ordinary skill in the art upon reading and understanding the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS The disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the disclosure. FIGURE 1 diagrammatically illustrates a vascular therapy device in accordance with the present disclosure.FIGURE 2 diagrammatically illustrates another view of the device of FIGURE 1.FIGURE 3 diagrammatically illustrates another view of the device of FIGURE 1.FIGURE 4 diagrammatically illustrates another view of the device of FIGURE 1.FIGURE 5 diagrammatically illustrates another embodiment of the device of FIGURE 1.FIGURE 6 diagrammatically illustrates a method of performing a vascular therapy me