Extraction of medical lead from calcified binding site with lithotripsy using intravascular laser catheter and sheath

Abstract

An apparatus includes a laser atherectomy catheter configured to remove, from a patient body, a medical lead implanted in a blood vessel at a binding site comprising calcium. The laser atherectomy catheter includes a catheter lumen configured to receive the medical lead during removal of the medical lead from the patient body, and an optical fiber. The apparatus also includes a sheath configured to be positioned around the laser atherectomy catheter. At least one of the laser atherectomy catheter or the sheath define a fluid delivery lumen separate from the catheter lumen, where the fluid delivery lumen is configured to deliver a photoreactive fluid into the blood vessel. The optical fiber is configured to deliver a first laser pulse to the photoreactive fluid for lithotripsy of the calcium before or during the removal of the medical lead.

Description

EXTRACTION OF MEDICAL LEAD FROM CALCIFIED BINDING SITE WITH LITHOTRIPSY USING INTRAVASCULAR LASER CATHETER AND SHEATHTECHNICAL FIELD

[0001] The subject matter described herein relates to systems, devices, and methods for generating pressure / acoustic waves for intravascular lithotripsy and directing ablative laser light for intravascular atherectomy. The system disclosed herein has particular but not exclusive utility for removal of an implanted lead surrounded by a calcified adhesion inside of a blood vessel.BACKGROUND

[0002] Many patients with cardiac implantable electronic devices (CIED) will eventually require extraction of intravascular CIED leads, which may be surrounded by adhesions that immobilize the lead. Current extraction techniques use both laser based and mechanical tools to extract CIED leads that need removal. Mechanical tools are primarily used when the adhesion is deemed to be calcified, as laser technology is not as effective at cutting leads from calcified adhesions. Some calcium can even be so dense that several mechanical tools are required to cut through the calcified adhesion, and occasionally lead extraction fails. In general, procedures involving heavily calcified adhesions result in longer and more stressful procedures for the physicians, and often involve more extraction tools than in less calcified procedures. Successful procedural outcomes for older, more heavily calcified leads are also lower than those of newer, less calcified leads.

[0003] The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be regarded as subject matter by which the scope of the disclosure is to be bound.SUMMARY

[0004] Disclosed is an intravascular laser lithotripsy and lead removal system which has particular, but not exclusive, utility for removing a medical lead (e.g., CIED leads) implanted in a blood vessel at a calcified adhesion or binding site. The system described herein includes an intravascular laser atherectomy catheter incorporating optical fibers and a sheath positioned around the outside of the catheter. The sheath and the catheter are movable relative to one another. To perform lithotripsy for removal of the implanted medical lead, the sheath is positioned distal of the catheter, which defines a space within sheath. For example, a lumen of the catheter can deliver photoreactive fluid (e.g., mix of saline and radiopaque contrast) to the space. The catheter emits laser pulses to the photoreactive fluid, which causes a photoreaction, generating the pressure / acoustic waves (or shockwaves) that break up the calcium. The catheter and sheath can be positioned to the side of or proximal of the calcified adhesion / binding site. The pressure / acoustic waves reach the calcium from the radial direction (e.g., when the catheter and sheath are positioned to the side of the calcium) and / or the longitudinal direction (when the catheter and sheath are positioned proximal of the calcium). To perform atherectomy for removal of the implanted medical lead, the sheath is positioned proximal of the catheter.

[0005] One general aspect includes an apparatus with a laser atherectomy catheter configured to remove, from a patient body, a medical lead implanted in a blood vessel at a binding site may include calcium, where the laser atherectomy catheter may include: a catheter lumen configured to receive the medical lead during removal of the medical lead from the patient body; and an optical fiber. The apparatus also includes a sheath configured to be positioned around the laser atherectomy catheter, where at least one of the laser atherectomy catheter or the sheath define a fluid delivery lumen separate from the catheter lumen, where the fluid delivery lumen is configured to deliver a photoreactive fluid into the blood vessel. The optical fiber is configured to deliver a first laser pulse to the photoreactive fluid for lithotripsy of the calcium before or during the removal of the medical lead.

[0006] Implementations may include one or more of the following features. In some aspects, the laser atherectomy catheter may include the fluid delivery lumen. In some aspects, the fluid delivery lumen extends within the catheter lumen. In some aspects, the laser atherectomy catheter may include a catheter wall defining the catheter lumen, where the optical fiber extends within the catheter wall such that the optical fiber is positioned radially outward of the fluid delivery lumen. In some aspects, the fluid delivery lumen may includean exit aperture open to the catheter lumen. In some aspects, the exit aperture is slanted. In some aspects, the laser atherectomy catheter may include a catheter distal end, where the exit aperture is positioned proximal of the catheter distal end. In some aspects, the laser atherectomy catheter may include a catheter wall, where the optical fiber and the fluid delivery lumen extend within the catheter wall. In some aspects, the laser atherectomy catheter may include a catheter distal end, where the fluid delivery lumen may include an exit aperture, where the catheter distal end may include an end of the optical fiber and the exit aperture. In some aspects, the catheter distal end is beveled such that the catheter distal end may include a leading edge and a trailing edge, where the fluid delivery lumen is positioned at the trailing edge. In some aspects, the laser atherectomy catheter may include a plurality of optical fibers, where the plurality of optical fibers is adjacent to the fluid delivery lumen on both sides of the fluid delivery lumen. In some aspects, after the delivery of the first laser pulse, the catheter lumen is configured to receive the medical lead for the removal of the medical lead from the patient body without re-positioning the laser atherectomy catheter to be around the medical lead. In some aspects, the laser atherectomy catheter may include a flexible elongate member and a handle assembly coupled to a proximal portion of the flexible elongate member, where the handle assembly may include: an infusion lumen in fluid communication with the fluid delivery lumen, where the infusion lumen is configured to receive the photoreactive fluid; and a hemostatic valve. In some aspects, the sheath may include a flexible elongate member and a handle assembly coupled to a proximal portion of the flexible elongate member, where the handle assembly may include: an infusion lumen in fluid communication with the fluid delivery lumen, where the infusion lumen is configured to receive the photoreactive fluid; and a hemostatic valve. In some aspects, the laser atherectomy catheter may include an outer surface, where the sheath may include a sheath lumen with an inner surface, where the fluid delivery lumen may include an annular volume between outer surface and the inner surface. In some aspects, the laser atherectomy catheter may include a catheter distal end, where the sheath may include a sheath distal end, where the laser atherectomy catheter and the sheath configured to transition between a lithotripsy configuration and an atherectomy configuration, where, in the atherectomy configuration, the sheath distal end is proximal of the catheter distal end, where, in the lithotripsy configuration, the sheath distal end is distal of the catheter distal end. In some aspects, in the atherectomy configuration, the optical fiber is configured to deliver a second laser pulse for atherectomy of the binding site during the removal of the medical lead, and in the lithotripsy configuration: the sheath is configured to surround a volume within the blood vessel that isdistal of the catheter distal end, thereby defining a reaction space, the fluid delivery lumen is configured to deliver the photoreactive fluid to the reaction space, and the delivery of the first laser pulse is configured to cause the photoreactive fluid to generate a pressure wave for the lithotripsy. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0007] One general aspect includes an apparatus a laser atherectomy catheter configured to remove, from a patient body, a medical lead implanted in a blood vessel at a binding site may include calcium, where the laser atherectomy catheter may include: a catheter lumen configured to receive the medical lead during removal of the medical lead from the patient body; and an optical fiber; and a sheath, where the optical fiber is configured to perform delivery of a first laser pulse to a photoreactive fluid, where, during the delivery of the first laser pulse, the sheath is configured to surround the laser atherectomy catheter and a space within the blood vessel may include the photoreactive fluid, where the delivery of the first laser pulse is configured to cause the photoreactive fluid to generate a pressure wave fracturing the calcium for the removal of the medical lead.

[0008] Implementations may include one or more of the following features. In some aspects, the laser atherectomy catheter may include a catheter distal end, where the sheath may include a sheath distal end, where, during the delivery of the first laser pulse, the sheath distal end is configured to be positioned distal of the catheter distal end, thereby defining the space. In some aspects, the optical fiber is configured perform delivery of a second laser pulse for atherectomy of the binding site, where the laser atherectomy catheter and the sheath are configured to be movable relative to one another such that, during the delivery of the second laser pulse, the sheath distal end is positioned proximal of the catheter distal end. In some aspects, during the delivery of the first laser pulse: the laser atherectomy catheter and the sheath are configured to be positioned to a side of the medical lead and the binding site; and the catheter lumen does not receive the medical lead. In some aspects, the sheath may include a sheath wall, where the sheath is configured to allow transmission of the pressure wave radially outward from the space, through the sheath wall, to the calcium. In some aspects, the optical fiber is configured perform delivery of a second laser pulse for atherectomy of the binding site, where the delivery of the second laser pulse is configured to be performed after the delivery of the first laser pulse and after the laser atherectomy catheter has been re-positioned to be around the medical lead. In some aspects, after the delivery of the first laser pulse, the laser atherectomy catheter is configured to be re-positioned around the medical lead such that the catheter lumen receives the medical lead for the removal of themedical lead. In some aspects, during the delivery of the first laser pulse: the laser atherectomy catheter and the sheath are configured to be positioned proximal of the medical lead and the binding site; and the catheter lumen is configured to receive the medical lead. In some aspects, the sheath is configured to allow transmission of the pressure wave distally from the space to the calcium. In some aspects, the optical fiber is configured perform delivery of a second laser pulse for atherectomy of the binding site, where the delivery of second laser pulse is configured to be performed after the delivery of the first laser pulse, without re-positioning the laser atherectomy catheter to be around the medical lead. In some aspects, the catheter lumen is configured to deliver the photoreactive fluid to the space. In some aspects, the laser atherectomy catheter may include a fluid delivery lumen separate from the catheter lumen, where the fluid delivery lumen is configured to deliver the photoreactive fluid to the space. In some aspects, the laser atherectomy catheter may include an infusion port configured to provide the photoreactive fluid to the fluid delivery lumen. In some aspects, the laser atherectomy catheter may include a hemostatic valve. In some aspects, the catheter lumen is configured to receive the support catheter. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0009] A system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions. Other aspects include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0010] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive presentation of features, details, utilities, and advantages of the intravascular laser lithotripsy and lead removal system, as defined in the claims, is provided in the following written description of various aspects of the disclosure and illustrated in the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Illustrative aspects of the present disclosure will be described with reference to the accompanying drawings, of which:

[0012] Figure l is a schematic, diagrammatic representation, in block diagram form, of an example intravascular laser lithotripsy and lead removal system with intravascular laser lead removal catheter, in accordance with at least one aspect of the present disclosure.

[0013] Figure 2A is a schematic, diagrammatic side view of at least a portion of an example intravascular laser lithotripsy and lead removal containment sheath, in accordance with at least one aspect of the present disclosure.

[0014] Figure 2B is a schematic, diagrammatic cross-sectional view of at least a portion of an example intravascular laser lithotripsy and lead removal containment sheath taken along cut line 2B-2B of figure 2A, in accordance with at least one aspect of the present disclosure.

[0015] Figure 3A is a schematic, diagrammatic side view of at least a portion of an example intravascular laser lithotripsy and lead removal catheter, in accordance with at least one aspect of the present disclosure.

[0016] Figure 3B is a schematic, diagrammatic cross-sectional view of at least a portion of an example intravascular laser lithotripsy and lead removal catheter taken along cut line 3B-3B of Figure 3 A, in accordance with at least one aspect of the present disclosure.

[0017] Figure 4 is a schematic, diagrammatic representation, in flow diagram form, of an example intravascular laser lithotripsy and lead removal method, in accordance with at least one aspect of the present disclosure.

[0018] Figure 5 is a schematic, diagrammatic representation, in flow diagram form, of an example intravascular laser lithotripsy and lead removal method, in accordance with at least one aspect of the present disclosure.

[0019] Figures 6A, 6B, 6C, 6D, 6E, 6F, 6G, 6H, 61, 6J, 6K, and 6L are schematic, diagrammatic, side cross-sectional views of different steps in removal of an implanted lead from a calcified binding site, with intravascular laser lithotripsy performed from the side of the binding site, in accordance with at least one aspect of the present disclosure.

[0001] Figure 7 is a schematic, diagrammatic representation, in flow diagram form, of an example intravascular laser lithotripsy and lead removal method, in accordance with at least one aspect of the present disclosure.

[0002] Figures 8A, 8B, 8C, 8D, 8E, 8F, 8G, 8H, 81, and 8J are schematic, diagrammatic, side-cross sectional views of different steps in removal of an implanted leadfrom a calcified binding site, with intravascular laser lithotripsy performed from proximal of the binding site, in accordance with at least one aspect of the present disclosure.

[0020] Figure 9A, 9B, and 9C are schematic, diagrammatic end cross-sectional views of at least a portion of an example intravascular laser lithotripsy and lead removal system, in accordance with at least one aspect of the present disclosure.

[0021] Figure 10 is an end perspective view of at least a portion of an example intravascular laser lithotripsy and lead removal system 1000, in accordance with at least one aspect of the present disclosure.

[0022] Figure 11 is a side perspective cross-sectional view of the laser lithotripsy and lead removal system 1000 of Figure 10, in accordance with at least one aspect of the present disclosure.

[0023] Figure 12A is a side perspective view of at least a portion of an example intravascular laser lithotripsy and lead removal system 1200, in accordance with at least one aspect of the present disclosure.

[0024] Figure 12B is a side perspective view of at least a portion of an example intravascular laser lithotripsy and lead removal system 1250, in accordance with at least one aspect of the present disclosure.

[0025] Figure 13 is a is a side perspective cross-sectional view of the laser lithotripsy and lead removal system 1200 of Figure 12, in accordance with at least one aspect of the present disclosure.

[0026] Figure 14 is a side cross-sectional view of a handle assembly 1400 of an example laser lithotripsy and lead removal system, in accordance with at least one aspect of the present disclosure.

[0027] Figure 15 is a side cross-sectional view of a handle assembly 1500 of an example laser lithotripsy and lead removal system, in accordance with at least one aspect of the present disclosure.

[0028] Figure 16 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intravascular laser lithotripsy and lead removal system, in accordance with at least one aspect of the present disclosure.

[0029] Figure 17 is a schematic diagram of a processor circuit, in accordance with at least one aspect of the present disclosure.DETAILED DESCRIPTION

[0030] Pressure / acoustic waves (shockwaves) can be used to modify calcified implanted CIED leads adhesions prior to lead extraction. Using acoustic shockwaves prior to extraction can help to crack the calcium in the adhesion, resulting in a quicker and / or safer extraction, since the lead will be easier to remove. A combined intravascular laser atherectomy and intravascular lithotripsy apparatus can be used for calcium modification prior to extraction of the implanted lead. This can facilitate removal of the implanted lead with fewer extraction tools, thus improving procedural efficiency and safety.

[0031] The present disclosure describes a laser-based lithotripsy and lead extraction device that delivers a photoreactive fluid to a reaction chamber in the distal portion of a sheath, and uses optical fibers to deliver laser energy to the fluid in the reaction chamber, thus producing an exothermic reaction that creates acoustic shockwaves. Depending on the implementation, the shockwaves may be delivered to the adhesion either radially or longitudinally from the sheath.

[0032] Existing intravascular lithotripsy devices have several limitations. The distance over which the shockwaves are applied are limited to the length of the balloon on the device. For vessels with long stretches of calcium, the balloon would need to be repositioned and redeployed a multitude of times to cover the desired therapy area. Repositioning of devices within the vasculature increases procedure time, as well as increased risk of damage to vasculature. For example, the superior vena cava (SVC) in particular is a very thin vessel that can easily rupture if it is diseased, which is one reason repeated inflation / deflation cycles are not an ideal way to generate pressure waves for lithotripsy. Also, due to the balloon catheter configuration of the device, bulk / rigidity / profile of certain areas of the catheter, and other design elements (potentially also being an over-the-wire design), the device deliverability (i.e. the ability to navigate the balloon through the vasculature and position it where needed) is limited.

[0033] No single apparatus exists currently that performs both intravascular lithotripsy and laser atherectomy for lead removal.

[0034] The present disclosure provides an intravascular laser lithotripsy and lead removal system for an intravascular treatment system. The intravascular laser lithotripsy and lead removal system is configured to subject vascular calcifications to fatigue fracture, and thus help to enable removal of the lead from the adhesion. Calcifications tend to be well rooted into soft tissue, or even completely encapsulated by soft tissue, such that fracturing thecalcification does not generally release the calcified material into the bloodstream, and does not, by itself, free the lead from the adhesion. The fracturing process may for example be analogous to breaking up a bag of frozen-together ice cubes, without opening the bag.

[0035] The laser can be used to initiate an exothermic reaction in the photoreactive fluid that generates shockwaves (also known as pressure waves, acoustic waves, acoustic shock, or hydraulic shock). These shockwaves can fracture the calcified tissue embedded in the vessel wall, without damaging the soft tissue of the vessel wall itself.

[0036] The present disclosure provides a device that has a highly localized shockwave functionality for cracking the calcium in radial and / or longitudinal directions, which can facilitate freeing a medical lead from the binding site in the blood vessel.

[0037] Examples of laser-based lithotripsy and shockwave generation can also be found in U.S. Application No. 18 / 755,936, filed June 27, 2024, titled “Combined Laser Atherectomy And Pressure Wave Device”, U.S. Provisional Application No. 63 / 527,881, filed July 20, 2023, titled “Intravascular Laser Lithotripsy Catheter”, U.S. Patent No.11,058,492, titled “Laser-Induced Pressure Wave Emitting Catheter Sheath”, and U.S. Patent No. 11,246,659, titled “Liquid Laser-Induced Pressure Wave Emitting Catheter Sheath”, each of which is incorporated by reference as though fully set forth herein.

[0038] In some aspects, the intravascular laser lithotripsy and lead removal system includes a space or reaction chamber, in acoustical communication with the blood volume inside the vessel. The space or reaction chamber can be defined when the sheath distal end is distal of the catheter distal end. For example, the space or reaction chamber can be a portion inside of the sheath lumen that is distal of the catheter distal end. The photoreaction can take place while being surrounded by the sheath, thus protecting the blood vessel wall and / or surrounding anatomy from direct exposure to the pressure / acoustic waves. Depending on the implementation, the intravascular laser lithotripsy and lead removal system may produce a sudden pressure wave (e.g., a shockwave) in the blood vessel, or may produce repeated shocks, or may produce a time-varying (e.g., sinusoidal) pressure. A shockwave may for example occur when the expansion of a fluid, or motion of an object through the fluid, exceeds the fluid’s local speed of sound, resulting in a sudden pressure change or series of sudden pressure changes.

[0039] The present disclosure provides a system including an intravascular laser atherectomy catheter with one or multiple optical fibers and / or a fluid-bearing lumen for photoreactive fluid and a sheath around the intravascular laser atherectomy catheter. A reaction space / chamber is defined as the volume, within the blood vessel, that is between thecatheter distal end and the sheath distal end (the sheath being distal of the catheter). The fluid-bearing lumen is in fluid communication with the reaction space / chamber. The liquid in the reaction space / chamber can be an opaque, photoreactive liquid (e.g., mixture of saline and X-ray contrast liquid) that is able to generate acoustic / pressure waves (e.g., shockwaves) as part of the reaction with laser light. The system can produce acoustic / pressure waves that can pass radially outward through the sheath wall and / or longitudinally forward through the distal opening of the sheath.

[0040] The intravascular laser lithotripsy and lead removal system includes a laser extraction catheter (e.g., similar to the Philips GlideLight lead removal catheter) and lasing material (e.g., X-ray contrast material) introduce-able into a reaction chamber housed within a sheath. The sheath has an inner diameter large enough to fit the laser catheter and a material composition that allows the transmission of acoustic pulses to surrounding materials.

[0041] The new device can include two subassemblies: (1) The laser extraction catheter or extraction sheath. The extraction catheter may contain a lumen specific to delivering saline / contrast along the regular lumen for extracting the lead. The extraction sheath may also utilize a hemostatic valve and infusion port so that contrast / saline can be directly injected. (2) A containment sheath that goes on the outside of the laser extraction catheter and can be slid forward to shroud the tip of the laser extraction catheter.

[0042] In some aspects, the containment sheath may use an acoustically transparent wall construction, such that acoustic waves can be adequately transmitted through the sheath wall, while still providing strength for the sheath wall to withstand the acoustic waves. In other aspects, the containment sheath may be acoustically opaque, such that acoustic waves can be emitted from the open distal end of the sheath. The containment sheath prevents direct contact of the vasculature with the exothermic contrast / laser pulse reaction.

[0043] Performing lithotripsy of the calcified binding site may make lead extraction easier, by breaking up the calcium that is contributing to holding the medical lead fixed inside of the patient body. Examples of the present disclosure include:

[0044] Treatment adjacent to a lead. Prior to extraction of the lead, the device is inserted alongside (not over) the lead, into the subclavian and up to the point of adhesion. The containment sheath is advanced so it is shrouding the tip of the laser extraction catheter, thus forming a reaction chamber between the distal end of the laser catheter and the distal end of the sheath. The correct positioning of the sheath can be done via fluoroscopic guidance or markings on the working length of the laser sheath, or a mechanical method to lock the containment sheath in the correct position. An injection of contrast / saline mix is depositednear the distal end of the laser extraction sheath, using either the existing lumen, a support catheter such as Philips Quick Cross, or a lumen integrated into the extraction catheter. A smaller lumen than the extraction sheath is desired, in order to minimize the amount of contrast delivered into to the patient. The laser is then activated as the saline / contrast media is delivered, producing acoustic waves, which transmit radially through the wall of the containment sheath to disrupt the calcified binding site. The entire device is removed from the body once calcium disruption has been completed. The containment sheath can be removed at the physician’s discretion or used as a typical outer sheath for the duration of the procedure. The laser extraction sheath is then placed over the lead and used to ablate the adhesion holding the lead in place, after the calcified binding site has been broken up by the acoustic pretreatment.

[0045] Treatment over a targeted lead. In this case, the device is loaded onto the lead and advanced to the binding site. The containment sheath is advanced so it is shrouding the tip of the laser extraction catheter, thus forming a reaction chamber between the distal end of the laser catheter and the distal end of the containment sheath. The correct positioning of the sheath can be done via fluoroscopic guidance or markings on the working length of the laser sheath, or a mechanical method to lock the containment sheath in the correct position. An injection of contrast / saline mix is deposited near the distal end of the laser extraction catheter, either using the existing lumen, a support catheter such as Philips Quick Cross, or a lumen integrated into the extraction catheter. A smaller lumen than the extraction catheter is desired, in order to minimize the amount of contrast delivered to the patient. The laser is activated as the saline / contrast media is delivered, producing acoustic waves, which transmit longitudinally out of the open distal end of the containment sheath to disrupt the calcified binding site. The containment sheath is retracted so the laser extraction catheter tip is exposed. The user utilizes the laser extraction catheter to complete the extraction.

[0046] The present disclosure aids substantially in the treatment (e.g., removal) of calcified CIED leads, by improving a clinician’s ability to deliver high pressures to the calcification. In acoustic communication with blood in the vessel, the intravascular laser lithotripsy and lead removal system disclosed herein provides a practical ability to deliver pressure waves, shockwaves, or vibrations to a calcified lead adhesion. This improved intravascular therapy technique transforms a solid calcification into a number of tissue-bound fragments, without the normally routine need to cut the calcification with mechanical tools. This unconventional approach improves the functioning of the intravascular treatment system, by permitting leads with calcified adhesions to be removed with a single tool.

[0047] The intravascular laser lithotripsy and lead removal system may be controlled manually, or through an automated process at least partially viewable on a display and executing on a processor that accepts user inputs from a keyboard, mouse, touchscreen interface, or other user interface. In that regard, the control process performs certain specific operations in response to different inputs or selections made at different times. Certain structures, functions, and operations of the processor, display, sensors, and user input systems are known in the art, while others are recited herein to enable novel features or aspects of the present disclosure with particularity.

[0048] These descriptions are provided for exemplary purposes only and should not be considered to limit the scope of the intravascular laser lithotripsy and lead removal system. Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter.

[0049] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the aspects illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and / or steps described with respect to one aspect may be combined with the features, components, and / or steps described with respect to other aspects of the present disclosure. For the sake of brevity, however, the numerous iterations of these combinations will not be described separately.

[0050] Figure l is a schematic, diagrammatic representation, in block diagram form, of an example intravascular laser lithotripsy and lead removal system 100 with intravascular laser lead removal catheter 102, in accordance with at least one aspect of the present disclosure. The intravascular laser lithotripsy and lead removal system 100 includes a console or workstation 130 and an intravascular laser lead extraction catheter 102.

[0051] The console 130 of a laser-induced pressure wave emitting catheter and sheath is described for example in US Patent No. 11,058,492 and US Patent No. 11,246,659, each of which is incorporated by reference as though fully set forth herein, along with background information relating to the problems addressed by the present disclosure. In the example shown in Figure 1, the console 130 includes a housing 135, a display 108 (e.g., a touchscreen display), a user interface 137 (which may for example include virtual controls on thetouchscreen display and / or physical knobs, buttons, etc.), a processor circuit 106, and a light source 140, such as a UV laser light source emitting within the range of 100-400 nm.

[0052] Components shown as being inside the console 130 may be in separate housings (e.g., different consoles). For example, there could be a separate light source console. The light source console can be a housing with the light source, a processor circuit, display, user interface for control of the light source. The console 130 interfaces with an intravascular laser lithotripsy and lead removal catheter 102. In the example shown in Figure 1, the intravascular laser lithotripsy and lead removal catheter 102 includes a flexible elongate member 115 comprising a lead extraction lumen 236, optical fibers 105, and an outer sheath 103. In some aspects, the flexible elongate member 115 is guided through a blood vessel 120 of the patient by a guidewire 118 or medical lead 128. In an example, the guidewire 118 or medical lead 128 is stationary within the blood vessel 120, and the flexible elongate member 115 is slid over the guidewire 118 or medical lead 128 via the catheter lumen or lead removal lumen 236 until the distal end of the flexible elongate member has reached the binding site 136 within the vessel of interest 120. It is noted that the binding site 136 may contain both calcified and non-calcified tissue.

[0053] The composition and structure of the optical fiber 105 and sheath 103 may for example be similar to those described in US Patent No. 11,058,492 and US Patent No. 11,246,659, which are incorporated by reference herein in their entireties.

[0054] In the example shown in Figure 1, the light source 140 is in optical communication with the optical fibers 105 by an optical communication line 145, such as an optical fiber or bundle of optical fibers. Similarly, a photoreactive fluid source (or pressure wave fluid source) 170 is in fluid communication with the reaction space / chamber 190. Depending on the implementation, the photoreactive pressure wave fluid may be a liquid, a gas, or combinations thereof. For example, the photoreactive pressure wave fluid may be a mix of saline and radiopaque contrast, can also be referred to as pressure wave fluid or photoreactive fluid. In a non-limiting example, some X-ray contrast fluids such as loversol, loxilan, or other commercially available iodine-containing injectable X-ray contrasts produce an exothermic reaction when struck by ultraviolet light, and can thus serve as a photoreactive fluid.

[0055] In some aspects, a clinician (e.g., a physician or other medical professional) uses a syringe 150 to provide to the photoreactive fluid from the source 170 to the reaction chamber 190 via a fluid channel 180. The fluid channel 180 can be inside or outside of the patient body. In some aspects, the fluid channel 180 is a separate conduit that can carry thephotoreactive fluid. The fluid line 180 can be a part of the syringe 150, the catheter 102, and / or the sheath 103 (e.g., a lumen or volume within the syringe 150, the catheter 102, and / or the sheath 103). For example, the fluid line 180 can be a lumen or volume at a distal end of the syringe. For example, the fluid channel 180 is a fluid delivery lumen (distinct from the catheter lumen 236 and the sheath lumen 106) defined by the catheter 102 and / or the sheath 103.

[0056] In some aspects, the system 100 includes a pump 155 in fluid communication with the photoreactive fluid source 170 and in signal communication with the processor circuit 106 and / or other processor circuit. The processor circuit 106 and / or other processor circuit can control (e.g., activate / deactivate, change flow volume, change flow rate, etc.) the pump 155 and / or photoreactive fluid source 170 to deliver the photoreactive fluid to the reaction chamber / space 190.

[0057] In order to provide the benefits pressure wave generation, without the need for precise repositioning of the sheath and without introducing the pressure wave fluid or photoreactive fluid into the bloodstream of the patient, the intravascular laser lithotripsy and lead removal system 100 provides a laser atherectomy and lead removal catheter 102 and sheath 103 that are movable relative to one another. Furthermore, the space between the distal end of the laser catheter 102 and the distal end of the sheath 103 forms a reaction chamber 190, such that the exothermic photoreaction remains inside the distal end of the sheath. The intravascular laser lithotripsy and lead removal catheter 102 may be inserted and pulled back or advanced manually by a clinician.

[0058] It is understood that block diagrams are provided herein for exemplary purposes; a person of ordinary skill in the art will recognize myriad variations that nonetheless fall within the scope of the present disclosure. For example, block diagrams may show a particular arrangement of components, modules, services, steps, processes, or layers, resulting in a particular flow of data, light, fluids, etc. It is understood that some embodiments of the systems disclosed herein may include additional components, that some components shown may be absent from some aspects, and that the arrangement of components may be different than shown, resulting in different flows while still performing the methods described herein.

[0059] Before continuing, it should be noted that the examples described above are provided for purposes of illustration and are not intended to be limiting. Other devices and / or device configurations may be utilized to carry out the operations described herein.

[0060] Depending on the implementation, the structure of the sheath may be strong enough to withstand pressure waves or shockwaves, but also compliant enough to allow themto be transmitted through sheath wall / body, or stiff enough to allow them to reflect internally to the sheath and be transmitted longitudinally through the distal opening of the sheath. Example sheath materials include a polymer (such as Teflon, PTFE, Pebax, etc.), combinations of polymers, a combination of polymer and a metal, etc.

[0061] Figure 2A is a schematic, diagrammatic side view of at least a portion of an example intravascular laser lithotripsy and lead removal containment sheath 103, in accordance with at least one aspect of the present disclosure. The sheath 103 includes a hollow, flexible elongate member 104, with a central lumen and a sheath wall / body 204 whose structure (e.g., polymer, combination of polymers, combination of polymer and / or metal, etc.) allows acoustic / pressure waves to pass through in a radial direction or be internally reflected such that the exit from the open distal end 210 of the sheath 103. The sheath wall / body 204 is a flexible elongate member. The distal portion (terminating at a distal end) can be positioned within the patient body (e.g., blood vessel(s)). The proximal portion (e.g., terminating a proximal end) can be positioned outside of the patient body. An example of a proximal portion / end of the sheath is shown in Fig. 15. The sheath 103 also includes a proximal end 220 and an angled / beveled / slanted tip 230 at its distal end. Depending on the implementation, the sheath can also include radiopaque markers 240 to facilitate placement of the sheath 103 relative to the laser atherectomy and lead removal catheter. The sheath 103 has an outer diameter Dsheath and an inner diameter Diumen that are both larger than the outer diameter of the laser atherectomy and lead removal catheter.

[0062] Figure 2B is a schematic, diagrammatic cross-sectional view of at least a portion of an example intravascular laser lithotripsy and lead removal containment sheath 103 taken along cut line 2B-2B of Figure 2A, in accordance with at least one aspect of the present disclosure. The sheath 103 includes a sheath wall / body 204 whose structure and composition (e.g., polymer, combination of polymers, combination of polymer and / or metal, etc.) allows acoustic / pressure waves to pass through, or to be internally reflected out the distal end of the sheath. The sheath wall / body 204 defines an interior lumen 106 that is sized and shaped to receive, e.g., the laser atherectomy and lead removal catheter, such that the sheath wall / body 204 can surround the laser atherectomy catheter. The inner diameter Diumen (e.g. the diameter of lumen 106) of the sheath 103 is larger than the outer diameter Dcatheter of the laser atherectomy and lead removal catheter 102.

[0063] Figure 3A is a schematic, diagrammatic side view of at least a portion of an example intravascular laser lithotripsy and lead removal catheter 102, in accordance with at least one aspect of the present disclosure. The catheter 102 includes a hollow, flexibleelongate member 104, with a central lumen and a wall / body 215 carrying the optical fibers 105 (see Figs. 1 and 3B). The distal portion (terminating at a distal end) can be positioned within the patient body (e.g., blood vessel(s)). The proximal portion (e.g., terminating a proximal end) can be positioned outside of the patient body. An example of a proximal portion / end of the catheter 102 is shown in Fig. 14. The catheter 102 also includes an angled / beveled / sl anted tip 242 at its distal end, which may for example be made of a stiff, radiopaque material such as metal, to facilitate pushing the catheter 102 through the adhesion in order to separate the lead from the adhesion. Depending on the implementation, the catheter 102 can also include radiopaque markers 240 to facilitate placement of the catheter 102 relative to the sheath 103. The catheter 102 has an outer diameter Dcatheter that is smaller than the inner diameter Diumen of the sheath 103, such that the catheter 102 fits readily within the sheath 103 and is capable of longitudinal movement within the sheath 103.

[0064] Figure 3B is a schematic, diagrammatic cross-sectional view of at least a portion of an example intravascular laser lithotripsy and lead removal catheter 102 taken along cut line 3B-3B of Figure 3 A, in accordance with at least one aspect of the present disclosure. The catheter 102 includes a catheter wall / body 215 with embedded optical fibers 105 that carry laser light from the light source. The catheter wall / body 215 defines a central lumen 236 which is sized and shaped to receive the medical lead and / or a guidewire. The outer diameter Dcatheter of the catheter 102 is smaller than the diameter Diumen of the sheath lumen. The inner diameter Dcathiumen of the catheter lumen is smaller than the outer diameter of the medical lead and / or of the guidewire, as shown below in Figs. 6C, 61, and 8B.

[0065] Figure 4 is a schematic, diagrammatic representation, in flow diagram form, of an example intravascular laser lithotripsy and lead removal method 400, in accordance with at least one aspect of the present disclosure. It is understood that the steps of method 400 may be performed in a different order than shown in Figure 4, additional steps can be provided before, during, and after the steps, and / or some of the steps described can be replaced or eliminated in other embodiments. One or more of steps of the method 400 can be carried by one or more devices and / or systems described herein, such as components of the system 100, processor circuit 1750, etc.

[0066] The method 400 of Figure 4 includes various lithotripsy methods, including treatment adjacent to an implanted medical lead (e.g., from the side of the binding site) and treatment over an implanted medical lead (e.g., from proximal of the binding site).

[0067] In step 410, the method 400 includes inserting the laser atherectomy and lead removal catheter into a blood vessel and moving it proximate to a binding site. Execution then proceeds to step 415.

[0068] In step 415, the method 400 includes inserting the sheath into the blood vessel over the laser atherectomy catheter and moving the distal end of the sheath distal of the distal end of the catheter to define a space or reaction chamber within the sheath. Execution then proceeds to step 420.

[0069] In step 420, the method 400 includes providing photoreactive fluid into the space or reaction chamber (e.g., by injecting with a syringe or pump). Execution then proceeds to step 425.

[0070] In step 425, the method 400 includes controlling the light source to provide light (e.g., laser light) to the optical fibers of the laser atherectomy and lead removal catheter, such that the optical fibers deliver a first light pulse to the photoreactive fluid in the space or reaction chamber. Execution then proceeds to step 430.

[0071] In step 430, the method 400 includes the photoreactive fluid generating pressure waves that fracture calcium in the binding site or adhesion, to facilitate removal of the medical lead. Execution then proceeds to step 435.

[0072] In step 435, the method 400 includes controlling the light source to provide light (e.g., laser light) to the optical fibers of the laser atherectomy and lead removal catheter, such that the optical fibers deliver a second light pulse to the binding site for laser atherectomy (e.g., laser ablation of the adhesion). Execution then proceeds to step 440.

[0073] In step 440, the method 400 includes removing the medical lead from the body. Execution then proceeds to step 445.

[0074] In step 445, the method 400 includes removing the laser atherectomy and lead removal catheter and sheath from the patient’s body. The method 400 is now complete.

[0075] Flow diagrams and block diagrams are provided herein for exemplary purposes; a person of ordinary skill in the art will recognize myriad variations that nonetheless fall within the scope of the present disclosure. For example, any of the steps described herein may optionally include an output to a user of information relevant to the step, and may thus represent an improvement in the user interface over existing art by providing information (whether static or dynamically updated) that is not otherwise available.

[0076] Similarly, the logic of flow diagrams may be shown as sequential. However, similar logic could be parallel, massively parallel, object oriented, real-time, event-driven, cellular automaton, or otherwise, while accomplishing the same or similar functions. In orderto perform the methods described herein, a processor may divide each of the steps described herein into a plurality of machine instructions, and may execute these instructions at the rate of several hundred, several thousand, several million, or several billion per second, in a single processor or across a plurality of processors. Such rapid execution may be necessary in order to execute the method in real time or near-real time as described herein.

[0077] Figure 5 is a schematic, diagrammatic representation, in flow diagram form, of an example intravascular laser lithotripsy and lead removal method 500, in accordance with at least one aspect of the present disclosure. The method 500 of Figure 5 is a more detailed example of the method 400 of Figure 4. In particular, Figure 5 is specific to lead removal with lithotripsy performed adjacent to the implanted lead (e.g., pressure / acoustic waves delivered from the side of the binding site). It is understood that the steps of method 500 may be performed in a different order than shown in Figure 5, additional steps can be provided before, during, and after the steps, and / or some of the steps described can be replaced or eliminated in other embodiments. One or more of steps of the method 500 can be carried by one or more devices and / or systems described herein, such as components of the system 100, processor circuit 1750, etc.

[0078] In step 510, the method 500 includes inserting a guidewire into the blood vessel and advancing it to the side of the binding site with the overgrown medical lead. Execution then proceeds to step 515.

[0079] In step 515, the method 500 includes inserting the laser atherectomy and lead removal catheter into the blood vessel over the guidewire and advancing it until it is positioned to the side of the binding site or adhesion. Execution then proceeds to step 520.

[0080] In step 520, the method 500 includes removing the guidewire from the blood vessel. Execution then proceeds to step 525.

[0081] In step 525, the method 500 includes inserting the sheath into the blood vessel over the laser atherectomy catheter and moving the distal end of the sheath distal of the distal end of the catheter, to the side of the binding site, to define a space or reaction chamber within the sheath. Execution then proceeds to step 530.

[0082] In step 530, the method 500 providing photoreactive fluid into the space or reaction chamber (e.g., by injecting with a syringe or activating a pump). Execution then proceeds to step 535.

[0083] In step 535, the method 500 includes controlling the light source to provide light (e.g., laser light) to the optical fibers of the laser atherectomy and lead removal catheter, suchthat the optical fibers deliver a first light pulse to the photoreactive fluid. Execution then proceeds to step 540.

[0084] In step 540, the method 500 includes the photoreactive fluid generating pressure waves, at least some of which propagate outward through the sheath wall to fracture calcium in the binding site or adhesion, to facilitate removal of the medical lead. Execution then proceeds to step 545.

[0085] In step 545, the method 500 includes removing the laser atherectomy and lead removal catheter and sheath from the patient’s body. Execution then proceeds to step 550.

[0086] In step 550, the method 500 includes re-inserting the laser catheter and sheath into the blood vessel over the medical lead, such that the distal end of the sheath is proximal of the distal end of the laser catheter, thus exposing the distal end of the laser catheter. Execution then proceeds to step 555.

[0087] In step 555, the method 500 includes controlling the light source to provide light (e.g., laser light) to the optical fibers of the laser atherectomy and lead removal catheter, such that the optical fibers deliver a second light pulse to the binding site for laser atherectomy (e.g., laser ablation of the adhesion). Execution then proceeds to step 560.

[0088] In step 560, the method 500 includes removing the medical lead from the patient’s body. Execution then proceeds to step 565.

[0089] In step 565, the method 500 includes removing the laser atherectomy and lead removal catheter and the sheath from the patient’s body. The method 500 is now complete.

[0090] Figures 6A, 6B, 6C, 6D, 6E, 6F, 6G, 6H, 61, 6J, 6K, and 6L are schematic, diagrammatic, side cross-sectional views of different steps in removal of an implanted lead from a calcified binding site, with intravascular laser lithotripsy performed from the side of the binding site, in accordance with at least one aspect of the present disclosure. Figures 6A- 6L illustrate various steps described in the method 500 of Figure 5. Lead removal with lithotripsy from adjacent to the implanted lead (from the side of the binding site) can collectively include aspects described in Figure 5 and Figures 6A-6L. It is understood that Figures 6A-6L may illustrate aspects that are not included in method 500 of Figure 5 and / or omit aspects that are included in method 500. Similarly, method 500 of Figure 5 may describe aspects that are not included in Figures 6A-6L and / or omit aspects that are included in Figures 6A-6L.

[0091] Figure 6A is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. The blood vessel 120 includes a vessel wall (the top and bottom ofFigs. 6A-6L). The blood vessel 120 contains an implanted medical lead, which is partially trapped by an adhesion 610 at a binding site 136. The adhesion 610 includes both calcified tissue 620 and non-calcified tissue 630, which bind to the medical lead 128 and prevent removal of the medical lead 128 from the blood vessel 120. Blood 645 flows inside a lumen of the blood vessel 120.

[0092] Figure 6B is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a first step in the lead removal process (analogous to step 510 of Figure 5), a guidewire 118 is inserted into the blood vessel, and advanced until it is proximate to the binding site 136, to one side of the binding site 136.

[0003] Figure 6C is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a second step in the lead removal process (analogous to step 515 of Figure 5), the laser catheter 102 is inserted into the blood vessel, over the guidewire 118, and advanced until it is proximate to the binding site 136, to one side of the binding site 136.

[0093] Figure 6D is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a third step in the lead removal process (analogous to step 520 of Figure 5), the guidewire is removed from the blood vessel, while the laser atherectomy catheter 102 is held stationary, leaving it proximate to the adhesion 610, to one side of the adhesion 610 or binding site 136.

[0094] Figure 6E is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a fourth step in the lead removal process (analogous to step 525 of Figure 5), the sheath 103 is inserted into blood vessel over the laser atherectomy catheter 102, and is advanced (e.g., moved in the distal direction) until the sheath 103 is positioned proximate to the adhesion 610, on one side of the adhesion 610. The sheath 103 is positioned relative to the catheter 102 such that the sheath’s distal end is distal of the catheter’s distal end. This defines a space or reaction chamber 190 within the blood vessel that is distal of the laser atherectomy catheter (e.g., the catheter’s distal end), within the sheath lumen, to the side of the adhesion 610 (and / or the calcium portion 620 the adhesion 610) within the binding site 136. In some aspects, the reaction space or reaction chamber 190 is not a closed off volume. Rather, because the distal end of the catheter 102 and the sheath 103 are open at their distal ends, the reaction space or reaction chamber 190 can be open to the blood within the bloodvessel 120, and thus the photoreactive fluid that occupies the reaction space or reaction chamber 190 can flow into the blood vessel 120.

[0095] Figure 6F is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a fifth step in the lead removal process (analogous to steps 530-540 of Figure 5), the clinician uses a syringe, or activates a pump and / or the photoreactive fluid source to provide the photoreactive fluid 690. The photoreactive fluid 690 can be provided through the catheter lumen 236 (e.g., injected from the proximal end of the catheter at an opening where the medical lead would exit, as shown for example in Figure 29A). In other aspects, the photoreactive fluid 690 can be provided through a dedicated fluid delivery lumen of the laser atherectomy catheter 102 (e.g., injected through an infusion port at the proximal end of the laser atherectomy catheter 102), can be provided through the sheath lumen 106 (e.g., through the space within the sheath lumen 106 surrounding the catheter 102), and / or through a support catheter positioned inside the laser atherectomy catheter 102 (as shown for example in Figure 29B).

[0096] It is noted that the contours and / or positioning of the photoreactive fluid 690 in the drawing is schematic, showing an example time step. In practice, the photoreactive fluid 690 will be flowing, along with blood 645 flowing in the blood vessel 120. The photoreactive fluid 690 will be in all or a portion of the space or reaction chamber 190 at one or multiple time steps. The photoreactive fluid 690 can also be proximal and / or distal of the position shown in the drawing. Where the photoreactive fluid 690 is can depend on how it is introduced. For example, the photoreactive fluid can fill the catheter lumen 236, the fluid delivery lumen, and / or the support catheter, in addition to the space or reaction chamber 190.

[0097] The system then controls the light source to provide light (e.g., laser light) to the optical fibers 105 of the laser atherectomy catheter 102 such that the optical fibers 105 deliver first light / laser pulse(s) 640 to the photoreactive fluid 690. This is done during the one or multiple time steps when the fluid is at least in the space or reaction chamber 190.

[0098] Interaction between the laser light 640 and the photoreactive fluid 690 causes chemical reactions 650 within the photoreactive fluid 690. The photoreactive fluid 690 then generates pressure waves 660, which radiate in multiple directions. This includes pressure waves 660 propagating radially outward (e.g., perpendicular or oblique (e.g., + / - 45 degrees) to the longitudinal axis 680 of the laser atherectomy catheter 102 and / or sheath 103) through the sheath wall 204, to fracture the calcium 620 of the adhesion 610 in the binding site, for removal of the medical lead 128. As described above, the sheath wall 204 can be structuredto be strong enough to withstand the pressure waves 660, but still allow their propagation through the sheath wall 204.

[0099] In some aspects, the laser atherectomy catheter 102 can be moved in the distal direction and / or the proximal direction within the sheath lumen 106 while the optical fibers 105 are emitting first laser pulse(s) 640 and / or the photoreactive fluid 690 is being introduced. This can also allow different reactions 650 between the laser light 640 and the photoreactive fluid 690 to occur at different locations along length of the blood vessel 120, such that the pressure waves 660 originate from different locations along the length of the blood vessel 120. This can help deliver pressure waves 660 to the entire length of the 620 calcium in the adhesion 610 within the binding site 136.

[0100] Because the distal ends of catheter 102 and the sheath 103 are open, the space inside the catheter 102 (e.g., the catheter lumen 236) and sheath 103 (e.g., the sheath lumen 106) can also include blood that is flowing within the blood vessel 120, and the photoreactive fluid 690 can flow into the blood stream, along with the blood.

[0101] Figure 6G is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a sixth step in the lead removal process (analogous to step 540 of Figure 5), the solid calcium 620 in the adhesion 610 of the binding site 136 (see Figure 6F) is fractured, becoming fractured calcium 670. The fractured calcium 670 contributes to the removal of the medical lead 128 from the binding site 136, because the medical lead 128 is no longer fixed in the adhesion 610 by solid calcium 620.

[0102] Figure 6H is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a seventh step in the lead removal process (analogous to step 545- 555 of Figure 5), the laser atherectomy catheter 102 and sheath 103 are removed from the patient’s body (e.g., moved in the proximal direction). The laser atherectomy catheter 102 and sheath 103 are then re-inserted into the blood vessel 120 (e.g., moved in the distal direction) over the medical lead 128 (e.g., with the medical lead 128 positioned inside of the catheter lumen 236) such that that the distal end of the sheath 103 is proximal of the distal end of the catheter 102, and the sheath 103 and the laser atherectomy catheter 102 are proximal of the binding site 136. The system then controls the light source to provide light (e.g., laser light) to the optical fibers 105 of the laser atherectomy catheter 102 such that the optical fibers delivers second light pulse(s) 640 to the adhesion 610 in the binding site 136 for laser atherectomy (e.g., laser ablation of the adhesion 610).

[0103] Figure 61 is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In an eighth step in the lead removal process (analogous to step 555 of Figure 5), the laser atherectomy catheter 102 is advanced (e.g., moved in the distal direction, toward the adhesion 610) while the optical fibers 105 continue to emit laser light pulses 640. In this way, laser atherectomy is performed from the proximal end of the binding site 136 to the distal end of the binding site 136, thus fully ablating the adhesion 610, including both the fracture calcium 670 and the non-calcified tissue 630 of the adhesion 610. In an example, the sheath 103 remains stationary (e.g., with the distal end of the sheath 103 proximal of the distal end of the catheter 102).

[0104] Figure 6J is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a ninth step in the lead removal process (analogous to step 555 of Figure 5), the atherectomy is complete (e.g., the adhesion has been fully ablated), such that the medical lead is no longer fixed in place by the adhesion inside the blood vessel 120.

[0105] Figure 6K is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120, in accordance with at least one aspect of the present disclosure. In a tenth step in the lead removal process (analogous to step 560 of Figure 5), the medical lead is removed from the patient’s body (e.g., moved in the proximal direction) through the catheter lumen 236, such that the medical lead is removed at the proximal end of the laser atherectomy catheter.

[0106] Figure 6L is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120, in accordance with at least one aspect of the present disclosure. In an eleventh step in the lead removal process (analogous to step 565 of Figure 5), the laser atherectomy catheter 102 and sheath 103 are removed from the patient’s body (e.g., pulled in a proximal direction out of the blood vessel 120). The lead removal process is now complete.

[0107] Figure 7 is a schematic, diagrammatic representation, in flow diagram form, of an example intravascular laser lithotripsy and lead removal method 700, in accordance with at least one aspect of the present disclosure. The method 700 of Figure 7 is a more detailed example of the method 400 of Figure 4. In particular, Figure 7 is specific to lead removal with lithotripsy performed over to the implanted lead (e.g., pressure / acoustic waves delivered from proximal of the binding site). It is understood that the steps of method 700 may be performed in a different order than shown in Figure 7, additional steps can be provided before, during, and after the steps, and / or some of the steps described can be replaced oreliminated in other embodiments. One or more of steps of the method 700 can be carried by one or more devices and / or systems described herein, such as components of the system 100, processor circuit 1250, etc.

[0108] In step 710, the method 700 includes inserting the laser atherectomy and lead removal catheter into the blood vessel, over the medical lead, and moving it proximate to a binding site. Execution then proceeds to step 715.

[0109] In step 715, the method 700 includes inserting the sheath into the blood vessel over the laser atherectomy catheter and moving the distal end of the sheath distal of the distal end of the catheter to define a space or reaction chamber within the sheath. Execution then proceeds to step 720.

[0110] In step 720, the method 700 includes providing photoreactive fluid into the space or reaction chamber (e.g., by injecting with e syringe or activating a pump). Execution then proceeds to step 725.

[0111] In step 725, the method 700 includes controlling the light source to provide light (e.g., laser light) to the optical fibers of the laser atherectomy and lead removal catheter, such that the optical fibers deliver a first light pulse to the photoreactive fluid in the space or reaction chamber. Execution then proceeds to step 730.

[0112] In step 730, the method 700 includes the photoreactive fluid generating pressure waves that propagate distally to fracture calcium in the binding site or adhesion, to facilitate removal of the medical lead. Execution then proceeds to step 735.

[0113] In step 735, the method 700 includes translating the sheath relative to the laser atherectomy catheter such that the distal end of the sheath is proximal of the distal end of the catheter.

[0114] In step 740, the method 700 includes controlling the light source to provide light (e.g., laser light) to the optical fibers of the laser atherectomy and lead removal catheter, such that the optical fibers deliver second light pulses to the binding site for laser atherectomy (e.g., laser ablation of the adhesion). Execution then proceeds to step 745.

[0115] In step 745, the method 700 includes removing the medical lead from the body. Execution then proceeds to step 750.

[0116] In step 750, the method 700 includes removing the laser atherectomy and lead removal catheter, and the sheath, from the patient’s body. The method 700 is now complete.

[0117] Figures 8A, 8B, 8C, 8D, 8E, 8F, 8G, 8H, 81, and 8 J are schematic, diagrammatic, side-cross sectional views of different steps in removal of an implanted lead from a calcified binding site, with intravascular laser lithotripsy performed from proximal ofthe binding site, in accordance with at least one aspect of the present disclosure. Figures SA- 81 illustrate various steps described in the method 700 of Figure 7. Lead removal with lithotripsy from over the implanted lead (from proximal of the binding site) can collectively include aspects described in Figure 7 and Figures 8A-8J. It is understood that Figures 8A-8J may illustrate aspects that are not included in method 700 of Figure 7 and / or omit aspects that are included in method 700. Similarly, method 700 of Figure 7 may describe aspects that are not included in Figures 8A-8J and / or omit aspects that are included in Figures 8A-8J.

[0118] Figure 8A is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. The blood vessel 120 includes a vessel wall (the top and bottom of Figs. 8A-8J). The blood vessel 120 contains an implanted medical lead, which is partially trapped by an adhesion 610 at a binding site 136. The adhesion 610 includes both calcified tissue 620 and non-calcified tissue 630, which bind to the medical lead 128 and prevent removal of the medical lead 128 from the blood vessel 120. Blood 645 flows inside a lumen of the blood vessel 120.

[0119] Figure 8B is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a first step in the lead removal process (analogous to step 710 of Figure 7), the laser atherectomy catheter 102 is inserted into the blood vessel 120 (e.g., moved in the distal direction into the blood vessel 120) over the medical lead 128 (e.g., with the medical lead 128 inside of the catheter lumen 236). The laser atherectomy catheter 102 is then advanced over the lead 128 until is it proximate to, and proximal of, the binding site 136.

[0120] Figure 8C is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a second step in the lead removal process (analogous to step 715 of Figure 7), the sheath 103 is inserted into the blood vessel 120 (e.g., moved in the distal direction) over the laser atherectomy catheter 102, and advanced until the sheath 103 is positioned proximate to, and proximal of, the binding site. The sheath 103 is positioned relative to the catheter 102 such that the distal end of the sheath 103 is distal of the distal and of the catheter 102. This defines a space or reaction chamber 190 within the blood vessel 120 that is distal of the distal end of the laser atherectomy catheter 102, within the sheath lumen 103, and proximal of the binding site 136 (and / or the calcium component 620 of the adhesion 610 within the binding site 136). In some aspects, the reaction space or chamber 190 is not a closed off volume. Rather, because the distal ends of the catheter 102 and the sheath 103 areopen, the reaction space or reaction chamber 190 can be open to blood within the blood vessel 120, and the photoreactive fluid 690 that occupies the reaction space or reaction chamber 190 can flow into the blood vessel 120.

[0121] Figure 8D is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a third step in the lead removal process (analogous to steps 720- 730 of Figure 7), the clinician may use a syringe, or the system may control a control pump and / or photoreactive fluid source to provide photoreactive fluid 690. The photoreactive fluid 690 can be provided through the catheter lumen 236 (e.g., injected from the proximal end of the catheter at the opening where the medical lead would exit, as shown for example in Figure 29A). In other aspects, the photoreactive fluid 690 can be provided through a dedicated fluid delivery lumen of the laser atherectomy catheter 102 (e.g., injected through an infusion port at the proximal end of laser atherectomy catheter 102), and / or through a support catheter positioned inside the laser atherectomy catheter 102 (as shown for example in Figure 29B).

[0122] It is noted that the contours and positioning of the photoreactive fluid 690 in this drawing are schematic, showing an example time step. In practice, the photoreactive fluid will be flowing, along with blood flowing in the blood vessel. The photoreactive fluid will be in all or a portion of the space or reaction chamber 190 at one or multiple time steps. The photoreactive fluid 690 can also be proximal and / or distal of the position shown in this drawing. Where the photoreactive fluid 690 is can depend on how it is introduced. For example, the photoreactive fluid 690 can fill the catheter lumen 236, the fluid delivery lumen, and / or the support catheter, in addition to the space or reaction chamber 190.

[0123] The system then controls the light source to provide light (e.g., laser light) to the optical fibers 105 of the laser atherectomy catheter 102 such that optical fibers 105 deliver first light / laser pulse(s) 640 to the photoreactive fluid690. This is done during the one or multiple time steps when the fluid is at least in the space or reaction chamber 190.

[0124] Interaction between the laser pulses 640 and the photoreactive fluid 690 causes chemical reactions 650 within the photoreactive fluid 690. The photoreactive fluid 690 then generates pressure waves 660, which radiate in multiple directions. This includes pressure waves propagating in the distal direction of the longitudinal axis of the laser atherectomy catheter 102 and / or sheath 103, through the opening 810 at the distal end of the sheath 103, to fracture the calcium 620 of the adhesion 610 in the binding site 136, to facilitate removal of the medical lead 128.

[0125] In some aspects, the acoustic waves 660 will travel in the path of least resistance, so will preferentially travel in direction of the opening 810 at the distal end of the sheath 103. To facilitate this, the sheath wall can be structured to be strong enough to withstand the pressure waves 660. The sheath wall can similarly be structured such that acoustic waves 660 oblique to the longitudinal axis can reflect off of the inner surface of the sheath lumen 106 and be reflected in the distal direction toward the binding site 136.

[0126] In some aspects, the laser atherectomy catheter 102 can be moved in distal direction and / or proximal direction within the sheath lumen 106 while the optical fibers 105 are emitting first laser pulse(s) 640 and / or the photoreactive fluid 690 is being introduced. This can also cause different reactions 650 between the laser light 640 and the photoreactive fluid 690 to occur at different locations along the length of the blood vessel 120, such that pressure waves 660 originate from different locations along the length of the blood vessel 120. This can help deliver pressure waves 660 to the length of the calcium 620 in the binding site 136.

[0127] Because the distal ends of catheter 102 and the sheath 103 are open, the space inside the catheter 102 (e.g., the catheter lumen 236) and sheath 103 (e.g., the sheath lumen 106) can also include blood that is flowing within the blood vessel 120, and the photoreactive fluid 690 can flow into the blood stream, along with the blood.

[0128] Figure 8E is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a fourth step in the lead removal process (analogous to step 730 of Figure 7), the calcium 620 in the adhesion 610 within the binding site 136 has been converted to fractured calcium 670. This can facilitate removal of the lead 128, because the lead 128 is no longer fixed in the binding site 136 by solid calcium 620.

[0129] Figure 8F is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a fifth step in the lead removal process (analogous to steps 735-740 of Figure 7), the sheath 103 is translated relative to the laser atherectomy catheter such that the distal end of the sheath 103 is proximal of the distal end of the catheter 102. The system then controls the light source to provide light to the optical fibers 105 of the laser atherectomy catheter 102 such that the optical fibers 105 deliver second light pulse(s) 640 to the adhesion 610 within the binding site 136, for laser atherectomy (e.g., laser ablation of the non-calcified tissue 630 and fractured calcium 670.

[0130] It is noted that in some cases, it may be advantageous to perform multiple steps or stages or shockwave generation and laser atherectomy, e.g., to remove the adhesion 610 from long binding sites 136. In other cases, it may be advantageous to perform laser atherectomy prior to shockwave generation, e.g., to remove a significant volume of non-calcified tissue 630 that sits between the laser catheter 102 and the calcified tissue 620. Other combinations are possible, and fall explicitly within the scope of the present disclosure.

[0131] Figure 8G is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a sixth step in the lead removal process (analogous to step 740 of Figure 7), the laser atherectomy catheter 102 is advanced (e.g., moved in the distal direction, toward the adhesion 610) while the optical fibers 105 continue to emit laser light pulses 640. In this way, laser atherectomy is performed from the proximal end of the binding site 136 to the distal end of the binding site 136, thus fully ablating the adhesion 610, including both the fracture calcium 670 and the non-calcified tissue 630 of the adhesion 610. In an example, the sheath 103 remains stationary (e.g., with the distal end of the sheath 103 proximal of the distal end of the catheter 102).

[0132] Figure 8H is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120 containing an implanted lead 128, in accordance with at least one aspect of the present disclosure. In a seventh step in the lead removal process (analogous to step 740 of Figure 7), the atherectomy is complete (e.g., the adhesion has been fully ablated), such that the medical lead is no longer fixed in place by the adhesion inside the blood vessel 120.

[0133] Figure 81 is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120, in accordance with at least one aspect of the present disclosure. In an eighth step in the lead removal process (analogous to step 745 of Figure 7), the medical lead is removed from the patient’s body (e.g., moved in the proximal direction) through the catheter lumen 236, such that the medical lead is removed at the proximal end of the laser atherectomy catheter.

[0134] Figure 8J is a schematic, diagrammatic, side cross-sectional view of an example blood vessel 120, in accordance with at least one aspect of the present disclosure. In a ninth step in the lead removal process (analogous to step 750 of Figure 7), the laser atherectomy catheter 102 and sheath 103 are removed from the patient’s body (e.g., pulled in a proximal direction out of the blood vessel 120). The lead removal process is now complete.

[0135] Figure 9A is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intravascular laser lithotripsy and lead removal system, in accordancewith at least one aspect of the present disclosure. In the example shown in Figure 9A, the sheath 103 surrounds the laser atherectomy catheter 102, e.g., the catheter 102 is positioned within the sheath lumen 106. The photoreactive fluid 690 is introduced through the catheter lumen 236. In an example, the photoreactive fluid is introduced via a syringe through the opening in the proximal end of the catheter. This opening forms the end of the catheter lumen, which is typically used to receive and remove the medical lead during extraction. Also visible are the optical fibers 105. This configuration may for example be used when the lithotripsy is performed adjacent to the lead (e.g., to the side of the binding site). The medical is lead is not within the catheter lumen 236, so the photoreactive fluid 690 is within the entire volume of the catheter lumen 236. The catheter lumen 236 can be part of the fluid line 180 (Fig. 1).

[0136] Figure 9B is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intravascular laser lithotripsy and lead removal system, in accordance with at least one aspect of the present disclosure. In the example shown in Figure 9B, the sheath 103 surrounds the laser atherectomy catheter 102 (e.g., the catheter 102 is positioned within the sheath lumen 106) and the laser atherectomy catheter 102 surrounds the medical lead 128 (e.g., the medical lead 128 is positioned within the catheter lumen 236). Also visible are the optical fibers 105. Figure 9B is the configuration when the lithotripsy is performed over the lead (e.g., from proximal of the binding site). Because the medical is lead 128 is within the catheter lumen 236, the photoreactive fluid 690 is not within the entire volume of the catheter lumen 236. Rather, photoreactive fluid 690 is within volume between the inner surface of the catheter lumen 236 and the outer surface of the medical lead 128.

[0137] Figure 9C is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intravascular laser lithotripsy and lead removal system, in accordance with at least one aspect of the present disclosure. In the example shown in Figure 9C, the sheath 103 surrounds the laser atherectomy catheter 102, e.g., the catheter 102 is positioned within the sheath lumen 106. Also visible are the optical fibers 105. However, in this example, the photoreactive fluid 690 is introduced through the lumen 910 of a support catheter 920 positioned within the catheter lumen 236. In an example, the photoreactive fluid is introduced through the opening at the proximal end of the support catheter. In other usage, support catheters provide additional guidewire support to navigate vessels or cross occlusions. The lumen 910 of the support catheter 920 can be part of the fluid line 180 (Fig. 1).

[0138] This configuration can be used when the lithotripsy is provided adjacent to the lead (e.g., from the side of the binding site). The medical lead is not within the catheter lumen 236, so there is room for the support catheter 920 to be inside the catheter lumen 236.

[0139] Figure 10 is an end perspective view of at least a portion of an example intravascular laser lithotripsy and lead removal system 1000, in accordance with at least one aspect of the present disclosure. The intravascular laser lithotripsy and lead removal system 1000 is shown in an atherectomy configuration, with the distal end 1042 of the catheter 102 positioned distal of the distal end 1003 of the sheath 103. Visible are the distal portion of the sheath 103, the distal portion of the laser atherectomy and lead removal catheter 102, the catheter lumen 236, and the metal catheter tip 242. The distal end 1042 of the metal tip 242 (which is also the distal-most end / tip of the catheter 102) includes ends of optical fibers 105, which transmit light (e.g., laser light) distally from the laser atherectomy catheter.

[0140] In the example shown in Figure 10, the catheter 102 also includes a separate photoreactive fluid delivery lumen 1010, with an exit aperture 1020 located proximal of the metal tip 242 and distal end of the catheter 102. This configuration may be easier to manufacture, as the inner lumen 1010 could potentially be a dual lumen extrusion. However, it is certainly possible for the lumen 1010 to extend all the way to the tip, as shown below in Figures 12A and 12B. The dedicated fluid delivery lumen 1010 can be part of the fluid line 180 (Fig. 1).

[0141] In the example shown in Figure 10, the fluid delivery lumen 1010 is positioned within the catheter lumen 236 (e.g., not within the wall 215 of the catheter 102). In the example shown in Figure 10, the lumen 1010 is circular cross-section. However, the shape of the lumen wall 1015 within which the lumen 1010 extends is non-circular (e.g., gaussian shaped, or mountain shaped). The lumen wall 1015 can be formed on the inner surface of the catheter lumen 236. The fluid delivery lumen 1010 and / or the lumen wall 1015 are positioned radially inward of the wall 215 of the catheter 102 (within which the optical fibers 105 extend) and therefore also positioned radially inward of the optical fibers 105. The exit aperture 1020 and fluid delivery lumen 1010 are open to and / or in fluid communication with the catheter lumen 236.

[0142] The fluid delivery lumen 1010 is smaller than the catheter lumen 236. For example, a diameter and / or a volume of the fluid delivery lumen 1010 can be between one- tenth and one-half (and / or other suitable values both larger than smaller) of the diameter and / or the volume of the catheter lumen 236. The advantage of a dedicated lumen 1010 for the photoreactive fluid is that it allows for delivery of much smaller amounts of photoreactivefluid, thus reducing patient exposure to the photoreactive fluid, while still ensuring that enough photoreactive fluid is delivered to the reaction chamber to generate shockwaves or pressure waves.

[0143] Figure 11 is a side perspective cross-sectional view of the laser lithotripsy and lead removal system 1000 of Figure 10, in accordance with at least one aspect of the present disclosure. The intravascular laser lithotripsy and lead removal system 1000 is shown in an atherectomy configuration, with the distal end 1042 of the catheter 102 positioned distal of the distal end 1003 of the sheath 103. Visible are the sheath 103, laser atherectomy and lead removal catheter 102, catheter lumen 236, and metal catheter tip 242. Also visible is the dedicated photoreactive fluid delivery lumen 1010, which includes its own lumen wall 1110 that attaches to the wall or body 215 of the catheter 102 such that the lumen wall 1015 is formed on the inner surface of the catheter lumen 236. The exit aperture 1020 of the lumen 1010 is slanted / beveled so that material (leads, biologies adhered to the lead) are less likely to get caught / hang up on the lumen 1010 (e.g., at the exit aperture 1020). The fluid delivery lumen 1010 and / or the lumen wall 1015 are positioned radially inward of the wall 215 of the catheter 102 (within which the optical fibers 105 extend) and therefore also positioned radially inward of the optical fibers 105. The exit aperture 1020 and fluid delivery lumen 1010 are open to and / or in fluid communication with the catheter lumen 236.

[0144] Figure 12A is a side perspective view of at least a portion of an example intravascular laser lithotripsy and lead removal system 1200, in accordance with at least one aspect of the present disclosure. The intravascular laser lithotripsy and lead removal system 1200 is shown in an atherectomy configuration, with the distal end 1042 of the catheter 102 positioned distal of the distal end 1003 of the sheath 103. Visible are the sheath 103, laser atherectomy and lead removal catheter 102, catheter lumen 236, and metal catheter tip 242. In the example shown in Figure 12, the catheter 102 also includes a separate photoreactive fluid delivery lumen 1210, with an exit aperture 1220 located at the distal end of the metal tip 242. The dedicated fluid delivery lumen 1210 can be part of the fluid line 180 (Fig. 1).

[0145] Lumen 1210 is positioned within wall 215 of the catheter (see Fig. 13). One advantage of this configuration is that the lumen 236 remains open (without reduced area / volume) because an additional lumen is not inside of the lumen 236 (as in Figs. 10 and 11). Material moving through the lumen 236 (e.g., medical lead, biologies adhered to the medical lead, etc.) is not obstructed by the lumen 1210 because the lumen 1210 and the lumen 236 are separated by a section of the catheter wall 215. In the example shown in Figure 12, the lumen 1210 is non-circular cross-section (e.g., arc-shaped, following thecircumferential shape of wall 215 the catheter 102), and the exit aperture 1220 is flush with the distal face 1042 of the catheter 102 (e.g., the exit aperture 1220 is slanted / beveled the same as the slant / bevel of the distal end 1042 of the catheter 102).

[0146] The distal face 1042 of the catheter 102 includes ends of optical fibers 105, which transmit light (e.g., laser light) distally. The lumen 1210 has optical fibers 105 on either side, e.g., circumferentially adjacent. Because lumen 1210 occupies part of the circumference of the catheter wall 215, the optical fibers 105 are not positioned completely around the circumference of the catheter wall 215 (as shown in Figs. 10-11, for example).

[0147] The fluid delivery lumen 1210 is smaller than the catheter lumen 236. For example, a diameter and / or a volume of the fluid delivery lumen 1010 can be between one- tenth and one-half (and / or other suitable values both larger than smaller) of the diameter and / or the volume of the catheter lumen 236. The advantage of a dedicated lumen 1210 for the photoreactive fluid is that it allows for delivery of much smaller amounts of photoreactive fluid, thus reducing patient exposure to the photoreactive fluid, while still ensuring that enough photoreactive fluid is delivered to the reaction chamber to generate shockwaves or pressure waves.

[0148] The distal face 1042 is the distal most surface of the catheter 102, but because the distal face 1042 is slanted / beveled, the distal face 1042 includes a leading edge / portion 1230 and a trailing edge / portion 1240. The leading edge 1230 is further distal than the trailing edge 1240, and the trailing edge 1240 is further proximal than the leading edge 1230. In the example shown in Figure 12A, the aperture 1220 of the fluid delivery lumen 1210 is located on the leading edge 1230 of the distal face 1042 rather than the trailing edge of the distal face 1042. The fluid delivery lumen 1210 is located on the side of the catheter 102 and / or catheter wall 215 that has the leading edge 1230.

[0149] Figure 12B is a side perspective view of at least a portion of an example intravascular laser lithotripsy and lead removal system 1250, in accordance with at least one aspect of the present disclosure. The intravascular laser lithotripsy and lead removal system 1250 is shown in an atherectomy configuration, with the distal end 1042 of the catheter 102 positioned distal of the distal end 1003 of the sheath 103. Visible are the sheath 103, laser atherectomy and lead removal catheter 102, catheter lumen 236, and metal catheter tip 242. In the example shown in Figure 12, the catheter 102 also includes a separate photoreactive fluid delivery lumen 1210, with an exit aperture 1220 located at the distal end of the metal tip 242. The dedicated fluid delivery lumen 1210 can be part of the fluid line 180 (Fig. 1).

[0150] Figure 12B is similar to Figure 12A, except that the aperture 1220 of the fluid delivery lumen 1210 is located on the trailing edge 1240 of the distal face 1042 rather than the leading edge of the distal face 1042. The fluid delivery lumen 1210 is located on the side of the catheter 102 and / or catheter wall 215 that has the trailing edge 1240. This configuration may be advantageous because the optical fibers 105 that are present in the catheter 215 can be biased away from the vessel wall in, e.g., the atherectomy configuration. For example, in some aspects, in the atherectomy configuration, the laser catheter 102 performs laser atherectomy at a bend / curve in the superior vena cava (SVC) with the trailing edge 1240 closer to the vessel wall. While locating the fluid delivery lumen 1210 within the catheter wall 215 takes up space that could have been used for optical fibers (losing fiber count and ability to deliver light / laser energy), eliminating optical fibers at the trailing edge 1240 can be advantageous. In particular, because the trailing edge 1230 is closer to the vessel wall at the SVC bend / curve, reducing the light / laser energy delivered so close to the vessel wall could prevent unintended damage to tissue (e.g., the vessel wall).

[0151] Figure 13 is a is a side perspective cross-sectional view of the laser lithotripsy and lead removal system 1200 of Figure 12 A, in accordance with at least one aspect of the present disclosure. Visible are the sheath 103, laser atherectomy and lead removal catheter 102, catheter lumen 236, and metal catheter tip 242. Also visible is the dedicated photoreactive fluid delivery lumen 1210 (including exit aperture 1220), which is formed within the wall or body 215 of the catheter 102 and within the wall or body 1330 of the metal tip. The optical fiber 105 extends through the wall 215 of catheter 102 at the top portion and side portions in Fig. 13, whereas the fluid delivery lumen 1210 extends through the wall 215 of catheter 102 at the bottom portion in Fig. 13. As described in Figure 12A, the fluid delivery lumen 1210 of Fig. 13 extends on the side of the catheter wall 215 with leading edge of the distal face 1042. As described in Figure 12B, the fluid delivery lumen 1210 can extend on the side of the catheter wall 215 with trailing edge of the distal face 1042, in some aspects.

[0152] The intravascular laser lithotripsy and lead removal system 1000 is shown in a lithotripsy configuration, with the distal end 1042 of the catheter 102 positioned proximal of the distal end 1003 of the sheath 103, e.g., inside of the sheath lumen 106. As described in, e.g., Figs. 6E and 8C, the reaction space / chamber 190 can include the volume inside the sheath lumen 106 that is distal of the catheter distal end 1042. The fluid delivery lumen 1210 delivers the photoreactive fluid to the reaction space / chamber 190.

[0153] Figure 14 is a side cross-sectional view of a handle assembly 1400 of an example laser lithotripsy and lead removal system, in accordance with at least one aspect of thepresent disclosure. The handle assembly 1400 can also be called an access assembly or a multiple / multi- channel or line assembly. The handle assembly 1400 is positioned at and coupled to the proximal end of the catheter 102, and includes a handle 1410 with a hemostatic valve 1420 and a handle lumen 1430 in fluid communication with the catheter lumen 236.

[0154] During lead removal, the medical lead 128 extends within the catheter lumen 236 and the handle lumen 1430. The medical lead 128 is removed from the patient body from the proximal end of the handle lumen. When lithotripsy is done from the side of the binding site (side of the medical lead), the photoreactive fluid is introduced through the catheter lumen 236 and the handle lumen 1430 without the medical lead inside the catheter lumen 236 and the handle lumen 1430. When lithotripsy is done over the medical lead 128 (e.g., proximal of the binding site), the photoreactive fluid is introduced through the catheter lumen 236 and the handle lumen 1430 with the medical lead 128 inside the catheter lumen 236 and the handle lumen 1430.

[0155] An optical line 145 carries optical fibers 105 from an optical connector 1440 (e.g., connected to the laser light source 140 of Figure 1) to the laser atherectomy and lead removal catheter 102. The handle assembly 1400 includes an infusion port 182, which carries photoreactive fluid 690 from a syringe 150 or pump 155 to the handle lumen 1430 and into the catheter lumen 236, as shown for example in Figure 9A. The infusion port 182 and / or the handle lumen 1430 can be part of the fluid line 180 (Fig. 1). The hemostatic valve 1420 fluidly seals and / or equalizes pressure between the blood vessel and the catheter lumen 236, so as to prevent blood loss both when the medical lead 128 is extending through the hemostatic valve 1420 and when the medical lead 128 is not extending through the hemostatic valve.

[0156] Figure 15 is a side cross-sectional view of a handle assembly 1500 of a sheath 103, as well as a laser atherectomy catheter 102, in an example laser lithotripsy and lead removal system, in accordance with at least one aspect of the present disclosure. The handle assembly 1500 includes a handle 1510 with a hemostatic valve 1520 and a handle lumen 1530 in fluid communication with the sheath lumen 106. The handle assembly 1500 is positioned and coupled to the proximal portion of the sheath 103. For example, the proximal end 1540 of the sheath 103 is received within the handle lumen 1530 such that the handle 1510 and the proximal portion of the sheath 103 are overlapping.

[0157] The medical lead 128 extends through the catheter lumen 236 of the catheter 102, whose proximal end 1550 can extend through the hemostatic valve 1520. The handleassembly 1500 includes the infusion port 182, which carries photoreactive fluid 690 from a syringe 150 or pump 155 to the handle lumen 1530 and into the sheath lumen 236, as shown for example in Figure 16, following the course shown by white arrows 1590. The photoreactive fluid 690 thus occupies the volume between the inner surface of the sheath lumen 106 and the outer surface of the catheter 102. The infusion port 182 and / or the handle lumen 1530 can be part of the fluid line 180 (Fig. 1).

[0158] The hemostatic valve 1520 fluidly seals and / or equalizes pressure between the blood vessel and the sheath lumen 106, so as to prevent blood loss both when the catheter 102 and medical lead 128 are extending through the hemostatic valve 1420 and when the catheter 102 and the medical lead 128 do not extend through the hemostatic valve 1420.

[0159] This configuration could be used either with medical lead 128 inside the catheter lumen 236 (because the catheter lumen 236 is open), such as for lithotripsy over the lead (e.g., from proximal of the binding site), or without the medical lead 128 inside the catheter lumen 236, such as for lithotripsy adjacent to the lead (e.g., from the side of the binding site).

[0160] Figure 16 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intravascular laser lithotripsy and lead removal system, in accordance with at least one aspect of the present disclosure. In the example shown in Figure 16, the sheath 103 surrounds the laser atherectomy catheter 102, e.g., the catheter 102 is positioned within the sheath lumen 106. The photoreactive fluid 690 is introduced through the sheath lumen 106, and occupies the circumferential / annular volume between the inner surface of the sheath lumen 106 and the outer surface of the catheter 102. The volume between the inner surface of the sheath lumen 106 and the outer surface of the catheter 102 can be part of the fluid line 180 (Fig. 1). In an example, the photoreactive fluid is introduced into the sheath lumen via syringe 150 or pump 155 (e.g., through the infusion port and handle lumen, as shown in Figure 15). As described with respect to Figure 15, the medical lead 128 may or may not positioned within the catheter lumen 236 when the photoreactive fluid 690 is delivered into the reaction chamber / space.

[0161] Figure 17 is a schematic diagram of a processor circuit 1750, in accordance with at least one aspect of the present disclosure. The processor circuit 1750 may be implemented in the intravascular treatment system 100, the console 130, or other devices or workstations (e.g., third-party workstations, network routers, etc.), or on a cloud processor or other remote processing unit, as necessary to implement the method. As shown, the processor circuit 1750 may include a processor 1760, a memory 1764, and a communication module 1768. Theseelements may be in direct or indirect communication with each other, for example via one or more buses.

[0162] The processor 1760 may include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, or any combination of general-purpose computing devices, reduced instruction set computing (RISC) devices, application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or other related logic devices, including mechanical and quantum computers. The processor 1760 may also comprise another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 1760 may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0163] The memory 1764 may include a cache memory (e.g., a cache memory of the processor 1760), random access memory (RAM), magnetoresistive RAM (MRAM), readonly memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In an aspect, the memory 1764 includes a non-transitory computer-readable medium. The memory 1764 may store instructions 1766. The instructions 1766 may include instructions that, when executed by the processor 1760, cause the processor 1760 to perform the operations described herein. Instructions 1766 may also be referred to as code. The terms “instructions” and “code” should be interpreted broadly to include any type of computer-readable statement(s). For example, the terms “instructions” and “code” may refer to one or more programs, routines, sub-routines, functions, procedures, etc. “Instructions” and “code” may include a single computer-readable statement or many computer-readable statements.

[0164] The communication module 1768 can include any electronic circuitry and / or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 1750, and other processors or devices. In that regard, the communication module 1768 can be an input / output (VO) device. In some instances, the communication module 1768 facilitates direct or indirect communication between various elements of the processor circuit 1750 and / or the system 100. The communication module 1768 may communicate within the processor circuit 1750 through numerous methods or protocols. Serial communication protocols may include but are not limited to United States Serial Protocol Interface (US SPI),Inter-Integrated Circuit (I2C), Recommended Standard 232 (RS-232), RS-485, Controller Area Network (CAN), Ethernet, Aeronautical Radio, Incorporated 429 (ARINC 429), MODBUS, Military Standard 1553 (MIL-STD-1553), or any other suitable method or protocol. Parallel protocols include but are not limited to Industry Standard Architecture (ISA), Advanced Technology Attachment (ATA), Small Computer System Interface (SCSI), Peripheral Component Interconnect (PCI), Institute of Electrical and Electronics Engineers 488 (IEEE-488), IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communications may be bridged by a Universal Asynchronous Receiver Transmitter (UART), Universal Synchronous Receiver Transmitter (US ART), or other appropriate subsystem.

[0165] External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and central server, or readings from the pressure gauge) may be accomplished using any suitable wireless or wired communication technology, such as a cable interface such as a universal serial bus (USB), micro USB, Lightning, or FireWire interface, Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections such as 2G / GSM (global system for mobiles) , 3G / UMTS (universal mobile telecommunications system), 4G, long term evolution (LTE), WiMax, or 5G. For example, a Bluetooth Low Energy (BLE) radio can be used to establish connectivity with a cloud service, for transmission of data, and for receipt of software patches. The controller may be configured to communicate with a remote server, or a local device such as a laptop, tablet, or handheld device, or may include a display capable of showing status variables and other information. Information may also be transferred on physical media such as a USB flash drive or memory stick.

[0166] As will be readily appreciated by those having ordinary skill in the art after becoming familiar with the teachings herein, the intravascular laser lithotripsy and lead removal system advantageously provides a capability to perform laser atherectomy and also fracture calcified vascular stenoses (including those in peripheral and coronary veins and arteries), for removal of a medical lead, all in a single procedure with a single device. The intravascular laser lithotripsy and lead removal system can also be used in the field of cardiovascular procedures to treat calcified lesions.

[0167] A number of variations are possible on the examples and aspects described above. For example, the intravascular laser lithotripsy and lead removal system could be used not only in arteries, but also in veins and other body lumens, including without limitation those of the liver, kidneys, stomach, gall bladder, lymphatic system, or otherwise. The system mayemploy other types of light sources or fluids than those described herein, without departing from the spirit of the present disclosure. The intravascular laser lithotripsy and lead removal system could be used in other body lumens where there is clinical benefit in a shockwave, pressure wave, or vibration.

[0168] Accordingly, the logical operations making up the aspects of the technology described herein are referred to variously as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these may occur, or be performed or arranged, in any order, unless explicitly claimed otherwise or a specific order is inherently necessitated by the claim language.

[0169] All directional references e.g., upper, lower, inner, outer, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal are only used for identification purposes to aid the reader’s understanding of the claimed subject matter, and do not create limitations, particularly as to the position, orientation, or use of the intravascular laser lithotripsy and lead removal system. Connection references, e.g., attached, coupled, connected, joined, or “in communication with” are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily imply that two elements are directly connected and in fixed relation to each other. The term “or” shall be interpreted to mean “and / or” rather than “exclusive or.” The word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. Unless otherwise noted in the claims, stated values shall be interpreted as illustrative only and shall not be taken to be limiting.

[0170] The above specification, examples and data provide a complete description of the structure and use of exemplary aspects of the intravascular laser lithotripsy and lead removal system as defined in the claims. Although various aspects of the claimed subject matter have been described above with a certain degree of particularity, or with reference to one or more individual aspects, those skilled in the art could make numerous alterations to the disclosed aspects without departing from the spirit or scope of the claimed subject matter. Still other aspects are contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only of particular aspects and not limiting. Changes in detail or structure may be made without departing from the basic elements of the subject matter as defined in the following claims.

Claims

CLAIMSWhat is claimed is:

1. An apparatus, comprising: a laser atherectomy catheter configured to remove, from a patient body, a medical lead implanted in a blood vessel at a binding site comprising calcium, wherein the laser atherectomy catheter comprises: a catheter lumen configured to receive the medical lead during removal of the medical lead from the patient body; and an optical fiber; and a sheath configured to be positioned around the laser atherectomy catheter, wherein at least one of the laser atherectomy catheter or the sheath define a fluid delivery lumen separate from the catheter lumen, wherein the fluid delivery lumen is configured to deliver a photoreactive fluid into the blood vessel, wherein the optical fiber is configured to deliver a first laser pulse to the photoreactive fluid for lithotripsy of the calcium before or during the removal of the medical lead.

2. The apparatus of claim 1, wherein the laser atherectomy catheter comprises the fluid delivery lumen.

3. The apparatus of claim 2, wherein the fluid delivery lumen extends within the catheter lumen.

4. The apparatus of claim 3, wherein the laser atherectomy catheter comprises a catheter wall defining the catheter lumen, wherein the optical fiber extends within the catheter wall such that the optical fiber is positioned radially outward of the fluid delivery lumen.

5. The apparatus of claim 3, wherein the fluid delivery lumen comprises an exit aperture open to the catheter lumen.

6. The apparatus of claim 5, wherein the exit aperture is slanted.

7. The apparatus of claim 5, wherein the laser atherectomy catheter comprises a catheter distal end, wherein the exit aperture is positioned proximal of the catheter distal end.

8. The apparatus of claim 2, wherein the laser atherectomy catheter comprises a catheter wall, wherein the optical fiber and the fluid delivery lumen extend within the catheter wall.

9. The apparatus of claim 8, wherein the laser atherectomy catheter comprises a catheter distal end, wherein the fluid delivery lumen comprises an exit aperture, wherein the catheter distal end comprises an end of the optical fiber and the exit aperture.

10. The apparatus of claim 9, wherein the catheter distal end is beveled such that the catheter distal end comprises a leading edge and a trailing edge, wherein the fluid delivery lumen is positioned at the trailing edge.

11. The apparatus of claim 8, wherein the laser atherectomy catheter comprises a plurality of optical fibers, wherein the plurality of optical fibers is adjacent to the fluid delivery lumen on both sides of the fluid delivery lumen.

12. The apparatus of claim 1, wherein the laser atherectomy catheter comprises a flexible elongate member and a handle assembly coupled to a proximal portion of the flexible elongate member, wherein the handle assembly comprises: an infusion lumen in fluid communication with the fluid delivery lumen, wherein the infusion lumen is configured to receive the photoreactive fluid; and a hemostatic valve.

13. The apparatus of claim 1, wherein the sheath comprises a flexible elongate member and a handle assembly coupled to a proximal portion of the flexible elongate member, wherein the handle assembly comprises: an infusion lumen in fluid communication with the fluid delivery lumen, wherein the infusion lumen is configured to receive the photoreactive fluid; and a hemostatic valve.

14. The apparatus of claim 13, wherein the laser atherectomy catheter comprises an outer surface, wherein the sheath comprises a sheath lumen with an inner surface, wherein the fluid delivery lumen comprises an annular volume between outer surface and the inner surface.

15. The apparatus of claim 1, wherein the laser atherectomy catheter comprises a catheter distal end, wherein the sheath comprises a sheath distal end, wherein the laser atherectomy catheter and the sheath configured to transition between a lithotripsy configuration and an atherectomy configuration, wherein, in the atherectomy configuration, the sheath distal end is proximal of the catheter distal end, wherein, in the lithotripsy configuration, the sheath distal end is distal of the catheter distal end.

16. The apparatus of claim 15, wherein, in the atherectomy configuration, the optical fiber is configured to deliver a second laser pulse for atherectomy of the binding site during the removal of the medical lead, and wherein, in the lithotripsy configuration: the sheath is configured to surround a volume within the blood vessel that is distal of the catheter distal end, thereby defining a reaction space, the fluid delivery lumen is configured to deliver the photoreactive fluid to the reaction space, and the delivery of the first laser pulse is configured to cause the photoreactive fluid to generate a pressure wave for the lithotripsy.

Images