Potting of distal optical systems for medical devices
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- CANON USA INC
- Filing Date
- 2023-09-13
- Publication Date
- 2026-08-03
Smart Images
Figure 0007899146000001 
Figure 0007899146000002 
Figure 0007899146000003
Abstract
Description
Technical Field
[0001] The present disclosure generally relates to medical devices, and more particularly to the fixation / potting of components of catheter-based medical devices using potting.
[0002] Potting generally involves filling voids in an assembly with a material to support components, shield them from exposure, and strengthen parts of the device.
Background Art
[0003] Medical devices, including catheters, endoscopes, bronchoscopes, laparoscopes, ablation devices, and other devices, perform medical procedures that involve inserting a flexible medical tool or hollow tube into a patient's body and inspecting or treating internal sites through the tool.
[0004] Disposable medical devices in the form of MMOCT fiber optic imaging catheters can reliably function multiple times (e.g., six or more times) for a single patient.
[0005] Fiber optic-based catheters often employ a distal optics at the usable distal end, where the fiber buffer layer is often stripped to enable fusion or other connection operations. MMOCT catheters may break in the stripped fiber region near the distal end, resulting in the need to replace the catheter. If the catheter breaks and fails to function properly, medical treatment may be delayed and the patient's risk may increase. The process of replacing a catheter inserted into a delicate and vulnerable artery poses significant and undue risks to the patient. This is particularly problematic in very tortuous anatomical structures and is presumed to be due to bending stress on the fiber optic in the stripped region near the distal optics.
[0006] It would be beneficial to extend the life of the device and avoid such failures.
Summary of the Invention
[0007] A benefit of this disclosure is that it helps prevent damage, breakage, replacement, etc., and promotes and extends the service life and / or lifespan of medical devices, optical fibers, catheters, or other components or combinations thereof.
[0008] According to some embodiments, the medical device includes a flexible member having a cavity extending between a proximal and distal end, an optical fiber extending through the cavity, and a potting material for fixing / potting the optical fiber and distal optical system to the distal end to prevent damage to the distal end. The potting material may be an adhesive, which may be a UV-curable adhesive, a dual-cure adhesive, or another adhesive.
[0009] According to some embodiments, the medical device may be a strip optical fiber or a buffered optical fiber, may include a spacer, and the optical fiber may be fused to the spacer and potted at the distal end. The medical device may have a rebuffer heat shrink tubing surrounding a portion of the optical fiber, and a potting material is filled in the gap between the optical fiber and the heat shrink tubing. The potting material may be a dual-cure adhesive present only inside the rebuffer heat shrink tubing. The optical fiber with the rebuffer heat shrink tubing may be on a guidewire. The medical device may have a distal optical system at its distal end, including at least a spacer, a lens, and a reflector. The medical device may be a disposable catheter or an MMOCT catheter. The medical device may functionally interact with a display to show images, data, or other information.
[0010] Further features of this disclosure will become apparent from the following description of exemplary embodiments with reference to the accompanying drawings. Similar structures are indicated by similar reference numerals. [Brief explanation of the drawing]
[0011] [Figure 1]Figure 1 illustrates the strip optical fiber region of a catheter according to one embodiment. [Figure 2] Figure 2 illustrates the strip optical fiber region of a catheter according to one embodiment. [Figure 3] Figure 3 illustrates a catheter according to one embodiment. [Figure 4] Figure 4 illustrates a medical configuration according to one embodiment. [Modes for carrying out the invention]
[0012] Various exemplary embodiments, features, and aspects of this disclosure will be described with reference to the drawings.
[0013] The following embodiments describe configurations of medical devices and apparatus, including catheters, endoscopes, bronchoscopes, ablation devices, other devices, and combinations thereof, which may have different performance, operating characteristics, parameters, advantages, disadvantages, etc. This disclosure is not limited to any particular configuration.
[0014] In some embodiments, medical devices involve inserting a flexible medical tool or hollow tube into a patient's body and performing medical procedures that involve passing an instrument through the tool to examine or treat a part of the body. These medical devices and procedures allow for minimally invasive examination of hollow viscous cavities or body cavities and can provide information from optical coherence tomography (OCT), multimodal or multimodality OCT (MMOCT), in vivo imaging, intravascular imaging, percutaneous coronary intervention (PCI), coronary angiography, intravascular ultrasound (IVUS), radiology, ultrasound, other imaging modalities, and combinations thereof. These medical devices may have an adjustable tip that can be remotely controlled to change the field of view without moving other parts of the device.
[0015] Multimodal optical imaging combines the strengths of different imaging modalities across various physical contrast mechanisms, providing comprehensive structural, functional, and molecular information about biological tissues. Some embodiments of medical devices can be used in cardiology, ophthalmology, coronary angioplasty, urethral insertion, laparoscopic surgery, intravascular injection, angioplasty, angiography, atherosclerosis, venous thrombosis, arterial thrombosis, vascular diseases, vascular injury, and other medical procedures and combinations thereof.
[0016] These medical devices are disposable and can be single-use devices to reduce costs and environmental waste. Furthermore, certain devices can be safely reused as multi-use devices, reusable devices, or reusable devices if thoroughly cleaned, disinfected, and sterilized.
[0017] Some embodiments functionally interact with a continuum robot, robotic or snake-type catheter assembly having a rotational drive assembly or other actuators to impart rotational motion to the imaging core of a medical device or instrument (including optical catheters, maneuverable catheters, endoscopes, and other flexible medical devices or surgical instruments).
[0018] A fiber optic catheter is an example of an optical catheter that includes a flexible sheath and a coil, optical probe, and / or imaging core housed within the sheath, and may also include other components. Catheterization procedures may incorporate a 'guide catheter' that functions to help guide a guidewire or other catheter-based device to the atrioventricular orifice (opening to the coronary artery). The drive assembly, called the patient interface unit (PIU), can be detachably connected to the catheter. A detachment mechanism may be used to detach the drive assembly from the catheter in response to a detachment force.
[0019] Disposable MMOCT fiber optic imaging catheters can reliably function multiple times (e.g., more than 6 times) for a single patient.
[0020] If the catheter is damaged and fails to function properly, there is a risk that medical treatment will be delayed and the patient's risk will increase. The process of replacing a catheter inserted into a delicate and easily damaged artery poses a significant risk to the patient.
[0021] Advantageous features, characteristics, and other qualities according to some embodiments prevent damage, breakage, replacement, etc., and promote and extend the service life and / or lifespan of medical devices, optical fibers, catheters, other components, or combinations thereof.
[0022] Medical devices according to some embodiments include various configurations of catheters having an elongated flexible tubular member extending between a proximal end and a distal end configured to be disposed intravascularly within a lumen.
[0023] Figures 1 and 2 illustrate a catheter 100 according to some embodiments, the catheter 100 including, at the distal end, an optical fiber, an optical fiber buffer, a dual-cure adhesive, a re-buffer, and a distal optics. The stripped optical fiber region of the catheter 100 111 is illustrated, Catheter 100 is, including a buffer optical fiber region 110, a stripped optical fiber region 111, a spacer 112, an adhesive 113, a re-buffer heat shrink tube 114, a drive cable 115, and other components may be included.
[0024] The buffer optical fiber region 110 is a portion of the optical fiber where the buffer layer has been stripped strip to protect the optical fiber region 111. The adhesive 113 strip can fix / pot the stripped optical fiber region 111 and the spacer 112 to prevent damage to the optical fiber region 111. The re-buffer heat shrink tube 114 covers the stripped optical fiber region 111. The re-buffer heat shrink tube 114 strip is shaped such that a gap occurs between the optical fiber region 111 and the re-buffer heat shrink tube 114 stripIt can surround the strip portion of the optical fiber region 111 and can also be filled with a potting material. gap The buffer tube can be used in the strip region or its periphery after fusion to allow a dual-cure adhesive to penetrate into the buffer tube to form a seal and surround the exposed glass of the fiber in the strip region. Preferably, a tight buffer layer is formed or reformed, and the dual-cure adhesive is present only inside the buffer tube to maintain the integrity of the optical fiber glass near the fused or adhered joint.
[0025] The drive cable 115 is strip wound around the optical fiber region 111 and drives the catheter 100 to fiber optic rotate during the imaging procedure.
[0026] According to some embodiments, potting is used to fill the voids in the optical fiber region and other parts of the catheter with material to support the components, shield them from exposure, and strengthen parts of the medical device.
[0027] The coating material for covering and buffering the optical fiber region 110 is selected based on parameters including modulus or Young's modulus, refractive index, temperature range, viscosity and cure rate, adhesion and peel resistance, stripability, microbending performance, abrasion resistance, other parameters, or combinations thereof. The coating material generally does not peel off during use, but the ability to remove a short length of the coating when not in use is useful for splicing, connector attachment, creating fused connections, etc., where very high temperatures that melt or fuse the glass are used.
[0028] Suitable coating materials include various types of glass, acrylic, acrylate, polymers, polymer coating compositions, polyimides, carbon, metals, nitrides, sapphire, silicone, dyes, fluorescent materials, detection reagents, nanomaterials, other materials, or combinations thereof. The coating material protects the silica or glass core and cladding surface of the optical fiber from air, moisture, chemical contaminants, scratches, impacts, abrasion, sharp bending, microcracks, and other hazards that can cause cracks in the glass surface.
[0029] UV-curable acrylic polymer coating materials protect optical fibers from the harmful effects of radiation, strip The outer diameter of the optical fiber region 111 is increased. The UV-curable coating may be a two-layer coating including a primary coating and a secondary coating. The primary coating may be a soft inner layer, and the secondary coating may be a hard outer layer. These coatings may have different optical and mechanical properties.
[0030] strip The optical fiber region 111 may have multiple layers, including a core, at least one cladding layer, at least one coating layer, a buffer layer, an outer jacket, other layers, components, performance characteristic attributes, hybrids or combinations thereof. The core is a cylinder made of quartz, silica, glass, plastic or other material, providing an optical transmission medium that guides light. The cladding surrounds the core to confine the light to it, and the optical fiber is protected by a buffer layer, coating layer, outer jacket, other layers, or a combination thereof surrounding the cladding. Laser light or optical energy travels through the core between the proximal and distal ends to the target as a result of internal refraction between the core and the glass layers of the cladding. Light energy leaking from the core is bent back into the core due to the low refractive index of the cladding layer. The buffer layer may be a polymer layer that tightly surrounds the optical fiber glass. The buffer strengthens and makes the optical fiber robust.
[0031] The buffer layer is removed from the distal end of the optical fiber to form a strip optical fiber 111, which is then fused to a coreless fiber that functions as a spacer 112. Since the coreless fiber has no core, the optical beam dissipates rather than is guided through a core.
[0032] The strip optical fiber region 111 is the portion of the optical fiber from which the buffer layer has been removed. The outer diameter of the strip optical fiber region 111 is smaller than or smaller than the outer diameter of the buffer region 110. When the outer buffer layer is removed, the glass fiber is supported by the jacket during bending and curving, but this creates weakly unsupported areas in the fiber. Furthermore, the glass fiber is exposed to ambient humidity, which may cause microcracks to form on the outer surface of the fiber in the exposed areas.
[0033] The strip optical fiber region 111 is located at the distal end and may include a spacer 112. The adhesive 113 acts as a potting agent and is used to fix or pot the strip optical fiber region and the fused spacer 112. If high sensitivity is not required, the adhesive can be used to... Strip optical fiber area It can be bonded to 111, but in this case, undesirable back reflection may occur due to a mismatch in refractive index. Additional optical components may include lenses and reflectors, which can be potted within catheter 100. All potted components must have a longer fatigue life than those that are not potted. Since the optical fiber contributes to the majority of the core's tensile strength, potting also serves as a strong attachment to the distal end to prevent damage to the distal end and to increase the final tensile strength.
[0034] According to some embodiments, potting is used to fill gaps in the optical fiber region or other parts of a catheter with material in order to support the component, shield it from exposure, prevent damage, and reinforce parts of the medical device.
[0035] strip The strip portion of the optical fiber region 111 is strip The fiber can be strengthened by annealing the fiber after the optical fiber region 111 has been fused to the spacer 112. strip The optical fiber region 111 and the spacer 112 need to be locally melted to fuse with each other. Fiber annealing strengthens the low-stress regions, resulting in higher bending strength and fatigue resistance.
[0036] Strip optical fiber area Annealing in 111 involves a process of heating the fiber to near its melting point and then slowly cooling it, which can be controlled by a fiber splicer.
[0037] The heat shrink tubing 114 is a ribuffer and is positioned to cover the strip optical fiber region 111. The adhesive 113 can penetrate the heat shrink tubing 114 and penetrate the top and periphery of the strip optical fiber portion 111. The ribuffer heat shrink tubing 114 is strip The strip portion of the optical fiber region 111 may be surrounded by strip Potting material is filled into the gap between the optical fiber region 111 and the rebuffer heat shrink tube 114.
[0038] The heat-shrinkable tubing 114 is formed from a suitable material such as FEP Teflon®, PET balloon tubing, flexible Pebax®, or other materials. The heat-shrinkable tubing is not heated or shrunk on the substrate, but remains expanded so that adhesive can penetrate between the tubing and the fiber or spacer, etc., creating a space to surround and seal the glass component. The adhesive 113 may be a UV adhesive, and once fully cured, stripThe outer buffer layer supporting the optical fiber region 111 is effectively reformed, thereby effectively increasing the resistance to bending fatigue and the working life of this portion of the optical fiber. Preferably, to form or reform a tight buffer layer and maintain the integrity of the optical fiber glass near the fused or bonded joint, the dual-cure adhesive is present only inside the rebuffer tube.
[0039] The heat shrink tubing 114 is made by the high temperature required to melt glass. strip It is used as a recoat material that mimics a buffer layer or fiber buffer coating that is removed before the fusion of the optical fiber region 111 and the spacer 112.
[0040] strip To prevent microcracks in the glass of the optical fiber region 111, ambient humidity must be kept low to avoid weakening of the optical fiber due to exposure to air (especially humid air). Moisture is known to contribute to the formation of microcracks on the surface of the optical fiber, thus negatively impacting its lifespan. Since microcracks can widen with repeated bending, premature fiber fatigue failure can be a particular problem in imaging catheters where the core and optical fiber rotate at high speeds. Because the catheter core can rotate at very high speeds, optical fiber fatigue failure is particularly problematic in curved anatomical structures where the catheter is bent. When an optical fiber rotates at high speed while the strip portion of the optical fiber is in a curved section, the optical fiber is effectively bent back and forth during each rotation. This can quickly lead to fiber fatigue problems, causing microcracks to rapidly widen, forming large stress-concentrated cracks and potentially resulting in premature fiber failure.
[0041] Since catheter failure can delay PCI procedures, it is acceptable to spend significant resources to extend the lifespan of the catheter and prevent premature failure that could harm the patient.
[0042] The drive cable 115 is Strip optical fiber area It is wrapped around 111 and connected to the PIU via a proximal connector, driving catheter 100 to rotate the optical fiber during imaging procedures.
[0043] The catheter 100 may include multiple optical fibers or fiber optic systems. Each optical fiber Ba is The optical fiber may be single-mode or multimode, and the catheter 100 may be a disposable or reusable MMOCT optical fiber imaging catheter. The catheter 100 can function reliably as a disposable catheter, or it can function reliably for multiple times (e.g., six or more times) for a patient as a reusable catheter. Certain types of disposable and reusable medical devices can be reused multiple times after disinfection with a chemical agent composition such as Cydex.
[0044] strip The optical fiber region 111 may be configured as an optical probe to provide the catheter 100 with the ability to sense the characteristics of blood vessels and blood. The catheter 100 may rotate the optical probe for circumferential scanning and may have distal optical systems or imaging components such as spacers, focusing lenses, or reflectors at its distal end. The catheter 100 may have prisms, mirrors, light sources, light-emitting diodes (LEDs), optical detectors, refractive index gradient (GRIN) lenses, guidewires, guidewire inlets, other components, or combinations thereof. The guidewire is inserted through the catheter 100 and can guide the catheter 100. Focusing lenses can be attached to spacers to focus light energy into a de facto beam, the diameter of which is related to the azimuthal resolution.
[0045] The lens may be a GRIN lens, a fiber Bragg lens, a ball lens, another type of lens, or a combination thereof. The sheath is Strip optical fiber areaSupporting 111, a prism or mirror can direct the light. The proximal end has free space that allows the catheter 100 to rotate while the proximal end remains fixed. One or more motors can rotate the catheter 100 and may also be formed as a rotating joint such as a fork-and-joint (FORJ). Lenses, mirrors, and other optical focusing and aiming components may be provided at the distal end or other parts of the catheter 100.
[0046] The catheter 100, optical fiber core, cladding, buffer layer, coating layer, outer jacket, and other characteristic features are susceptible to damage or weakening over time due to degradation, deterioration, bending stress, or other reasons, or a combination thereof, which may result in premature failure or replacement.
[0047] In disposable or multi-use MMOCT fiber optic imaging catheters, the fiber may break, for example, in the strip region near the distal end, necessitating catheter replacement. If the catheter breaks and ceases to function properly, medical treatment may be delayed, potentially increasing the patient's risk. The process of replacing a catheter inserted into a delicate and easily damaged artery poses a significant and undue risk to the patient. This is particularly problematic in highly convoluted anatomical structures, likely due to bending stress on the fiber in the strip region near the distal optics or at the adhesive junction of the optical path.
[0048] When exposed glass optical fibers are subjected to ambient conditions such as high humidity (for example, in the fusion-bonded strip area), microcracks may form on or near the surface of the fiber. During use, the fiber may be bent by the winding anatomical structure, causing these microcracks to widen and enlarge, ultimately leading to fiber failure. Preventing microcracks is crucial for catheter lifespan because the distal tip of medical devices operates within winding anatomical structures while rotating at a speed or frequency of approximately 200 Hz. This effectively causes the distal end of the device (including the optical fiber) to bend 200 times per second during imaging, accelerating the growth rate of microcracks. This can lead to a significant increase in stress, potentially causing premature optical fiber failure and rendering the device inoperable.
[0049] The ribuffer tube can be used in or around the strip area after fusion to allow the dual-cure adhesive to penetrate the ribuffer tube and form a seal, surrounding the exposed glass of the fiber in the strip area. The ribuffer heat shrink tube 114 is strip The strip portion of the optical fiber region 111 may be surrounded by strip Potting material is filled into the gap between the optical fiber region 111 and the rebuffer heat shrink tube 114. Preferably, the dual-cure adhesive is present only inside the rebuffer tube to form or reform a tight buffer layer and maintain the integrity of the optical fiber glass near the fused or bonded joint.
[0050] This provides the following advantages: (1) Potting the fiber strip area protects the exposed fiberglass from being exposed to the element. (2) Reforming a buffer layer on the strip area helps support the exposed fiberglass when bending and helps avoid concentration of bending stress that could cause premature fiber fatigue failure by distributing stress over a longer area. (3) Prevents the adhesive from coming into contact with the drive cable coil (which could alter the performance of the drive cable and cause degradation). Other advantages may also be included.
[0051] The fatigue strength and fracture resistance of the catheter 100 can be improved by effectively controlling the ambient conditions of the manufacturing area, maintaining low humidity, minimizing the time the strip fibers are exposed to ambient conditions, and recoating or refuffing the strip fibers with adhesive 113 as a refuffing material that acts as a strain relief to minimize stress on the strip fibers.
[0052] The refuffing material of adhesive 113 may be a UV-curing adhesive or a dual-cure adhesive. Since the outer layer of the acrylic or polyimide coating is called the buffer layer, the material is referred to as the refuffing material. According to some embodiments, potting is used to fill the gaps in the optical fiber region or other parts of a catheter with material in order to support the component, shield it from exposure, prevent damage, and reinforce parts of the medical device. According to some embodiments, the use of a dual-cure potting material is proposed to ensure that all of the adhesive is completely cured, even in parts that are not exposed to UV curing light. Preferably, the dual-cure adhesive may be present only inside the refuffing tube in order to form or reform a tight buffer layer and maintain the integrity of the optical fiber glass near the fused or bonded joint.
[0053] UV adhesives, or dual-cure adhesives, are manufactured from epoxy, acrylate, other formulations, or combinations thereof to form strong and reliable bonds when exposed to a light source after application. Dual-cure UV secondary thermosetting adhesives combine the fast UV curing properties of acrylate compositions with the high adhesive performance of thermosetting epoxy compositions, and can block UV, visible, near-infrared, and other types of light. The light-blocking properties of dual-cure UV or thermosetting adhesives do not weaken with time or heat, and on-demand curing and setting facilitate precise assembly of components. Dual-cure adhesives are used in materials that transmit visible, UV, and other types of light, in which case the curing time can be adjusted depending on the type of application. UV adhesives or dual-cure adhesives offer high strength, excellent stability, fast curing, on-demand curing, high viscosity, high transparency, high precision, secondary thermocuring in areas not exposed to UV curing light, and other characteristic properties.
[0054] Figure 3 shows a catheter 200 similar to catheter 100 according to one embodiment. Catheter 200 comprises a sheath 210, a coil 212, a protector 213, and an optical fiber 214. Catheter 200 has a buffer optical fiber area, a strip optical fiber area, a spacer, adhesive, rebuffer heat shrink tubing, and a drive cable, which are components of catheter 100, and may also include other components. Catheter 200 may include an optical fiber buffer, a dual-cure adhesive, a rebuffer, and a distal optical system at its distal end. The optical fiber 214 may be configured as an optical probe to provide catheter 200 with the ability to sense the characteristics of blood vessels and blood. Catheter 200 can rotate for circumferential scanning and may have a distal optical system at its distal end, such as a spacer, a focusing lens, or a reflector. Catheter 100 may have a prism, a mirror, a light source, an LED, an optical detector, a GRIN lens, a guidewire, a guidewire inlet, other components, or a combination thereof. The guidewire is inserted through the catheter 100 and can guide the catheter 100. A focusing lens can be attached to the spacer to focus the light energy into the de facto beam, and its diameter is related to the azimuth resolution.
[0055] The lens may be a GRIN lens, a fiber Bragg lens, a ball lens, another type of lens, or a combination thereof. The sheath is Strip optical fiber area Supporting 111, a prism or mirror can direct the light. The proximal end has free space that allows the catheter 100 to rotate while the proximal end remains fixed. One or more motors can rotate the catheter 100 and may also be formed as a rotational joint such as a FORJ. Lenses, mirrors, and other optical focusing or aiming components may be provided at the distal end or other parts of the catheter 200.
[0056] Some advantageous features, properties, and other characteristics in certain embodiments help prevent damage, breakage, replacement, etc., and promote and extend the service life and / or lifespan of optical fibers, catheters, medical devices, and / or other components.
[0057] According to some embodiments, fiber-optic-based medical devices, including MMOCT catheters, can be effective and highly accurate measuring instruments that healthcare professionals, such as cardiologists, can rely on to obtain crucial information to guide medical procedures such as PCI. In some embodiments, the medical devices can be precisely assembled in a manner that ensures the final product remains accurate and reproducible for each catheter, thus providing highly reliable information. Furthermore, each catheter can be calibrated on the system used to operate it before operation.
[0058] Furthermore, the assembly of the distal optical system ensures these desirable characteristics. By using a UV-curable adhesive that also hardens upon secondary heat exposure, components can be quickly and efficiently fixed in place, and even adhesive areas not exposed to UV curing energy will harden reliably when exposed to sufficient heat.
[0059] The use of dual-cure adhesives and a UV+ heat-based curing schedule is effective in catheter 100 for the shaded areas of the cured adhesive portion when exposed to heat, following the initial desired tacking of the components via UV and subsequent curing as an assembly.
[0060] The strip portion of the optical fiber near the MMOCT distal optical system is a portion that should be protected from exposure to UV curing light. According to some embodiments, an adhesive with a high durometer or Shore hardness would be suitable. A durometer or Shore durometer is a standardized method for measuring the hardness of a material. According to some embodiments, a high-durometer adhesive with a high durometer of Shore D80 or higher is suitable. This is because, if such an adhesive actually cures completely, the diameter within the unshrinkable heat-shrinkable ribuffer tube covering the strip fiber area is small, and the adhesive can provide potting, support, and reinforcement for the exposed fiber.
[0061] Dual-cure UV / secondary thermosetting adhesives combine the rapid UV curing properties of acrylate compositions with the high adhesive performance of thermosetting epoxy compositions, and can block UV, visible, near-infrared, and other types of light. The light-blocking properties of dual-cure UV or thermosetting adhesives do not weaken with time or heat, and on-demand curing and setting facilitate precise assembly of components. Dual-cure adhesives can be used with materials that transmit visible, UV, and other types of light, in which case the curing time can be adjusted according to the application type. UV adhesives or dual-cure adhesives offer high strength, excellent stability, rapid curing, on-demand curing, high viscosity, high transparency, high precision, secondary thermocuring in areas not exposed to UV curing light, and other distinctive properties.
[0062] According to some embodiments, potting is used to fill gaps in the optical fiber region or other parts of a catheter with material in order to support the component, shield it from exposure, and reinforce parts of the medical device. According to some embodiments, it is proposed to use a dual-cure adhesive as the potting material to ensure that the entire adhesive is completely cured, even in parts that are not exposed to UV curing light. Preferably, the dual-cure adhesive is present only inside the refuffing tube to form or reform a tight buffer layer and maintain the integrity of the optical fiber glass near the fused or bonded joint.
[0063] UV adhesive adheres well to both the acrylic fiber jacket and the proximal end of the spacer (a glass rod that forms a functional 'strain relief' for the distal end of the fiber strip).
[0064] Furthermore, since the optical fiber functions as a major tensile component in medical devices, excessive frictional resistance to the movement of the core can significantly increase the stress on the fiber. When the PIU pulls the core back, the tensile force is transmitted through the optical fiber to the distal tip of the core.
[0065] Figure 4 shows a medical configuration 300 that can functionally interact with the configuration of a medical device or catheter according to some embodiments.
[0066] The medical configuration 300 includes an imaging console 310, an imaging catheter 320, and a motor drive unit 330. , It has an idwire 340 and may also include other components. Imaging catheter 320 The motor drive unit 330 It is detachably connected to the imaging console 310 via an interconnection cable and connector 315. 320 It is located on the guidewire 340 and has a distal optical system that passes through the blood vessel or lumen 350 together with the guidewire 340. The guidewire 340 is Imaging catheter 320 It is inserted through, Imaging catheter 320 To induce. Imaging catheter 320 This is a motor drive unit connected to the imaging console 310. 330 Driven by imaging catheter 320 During the pullback, the system rotates around the imaging plane 360, and while extending the imaging plane 360 back and forth within the blood vessel 350, it acquires images or videos.
[0067] The imaging console 310 includes one or more of the following, or a combination thereof: a processor, a controller, a control circuit, memory, an input / output (I / O) interface, and a communication interface, and may also include other elements and components, and is configured to provide overall control of the medical configuration 300. The imaging console 310 may include a display 312 and a keyboard 314 to facilitate user interaction with the console via a graphical user interface (GUI), may be interconnected with medical instruments and other devices, and may be controlled independently, externally, or remotely by a controller. The display 312 can present a display to the user for displaying images, data, or other information, and may be configured as a liquid crystal display (LCD), LED, or other type of display.
[0068] As previously stated, the advantageous features, characteristics, and other properties of some embodiments help prevent damage, breakage, replacement, etc., and promote and extend the service life and / or lifespan of medical devices, optical fibers, catheters, other components, or combinations thereof.
[0069] Some embodiments of a medical device include a flexible member having a cavity extending between a proximal and distal end, an optical fiber extending through the cavity, and a potting material for fixing / potting the optical fiber to the distal end to prevent damage to the distal end.
[0070] The potting material may be an adhesive such as a UV-curing adhesive or a dual-cure adhesive that undergoes secondary heat curing.
[0071] The medical device may be a strip optical fiber or a buffer optical fiber, may include a spacer, and the optical fiber can be fused to the spacer and potted at the distal end. The medical device may have a rebuffer heat shrink tubing surrounding a portion of the optical fiber, and a potting material is filled in the gap between the optical fiber and the heat shrink tubing. The potting material may be a dual-cure adhesive present only inside the rebuffer heat shrink tubing. The optical fiber with the rebuffer heat shrink tubing may be on a guidewire. The medical device may have a distal optical system at its distal end, including at least a spacer, a lens, and a reflector. The medical device may be a disposable catheter or an MMOCT catheter. The medical device may functionally interact with a display to show images, data, or other information.
[0072] While this disclosure has been described with reference to exemplary embodiments, it is naturally not limited to the exemplary embodiments disclosed. The following claims should be given the broadest possible interpretation to encompass all such modifications and equivalent structures and functions.
Claims
1. A flexible member having a cavity extending between a proximal end and a distal end, and a distal optical system provided at the distal end, An optical fiber extending through the aforementioned cavity, having a buffer optical fiber region and a strip optical fiber region, A spacer included in the distal optical system, wherein the distal end of the strip optical fiber region is fused to the spacer, A rebuffer heat shrink tubing covering the strip optical fiber region, A potting material surrounding the distal end of the strip optical fiber region to fix / pot the strip optical fiber region and the spacer, Medical equipment equipped with, The potting material is a dual-cure adhesive. medical equipment.
2. The dual-cure adhesive is an ultraviolet (UV) curing adhesive. The medical device according to claim 1.
3. A gap exists between the optical fiber and the rebuffer heat shrink tubing, in which the potting material is filled. The medical device according to claim 1.
4. The dual-cure adhesive is present only inside the rebuffer heat shrink tube. The medical device according to claim 3.
5. The optical fiber equipped with the aforementioned rebuffer heat shrink tubing is located on a guide wire, The medical device according to claim 3.
6. The distal optical system comprises at least the spacer, lens and reflector, The medical device according to claim 1.
7. The medical device according to claim 1, wherein the medical device is a disposable catheter.
8. The catheter is a multimodal optical coherence tomography catheter. The medical device according to claim 7.
9. The medical device functionally interacts with a display to show images, data, or other information. The medical device according to claim 1.
10. Processor and Medical equipment and, A medical device equipped with, The aforementioned medical device is A flexible member having a cavity extending between a proximal end and a distal end, and a distal optical system provided at the distal end, An optical fiber extending through the aforementioned cavity, having a buffer optical fiber region and a strip optical fiber region, A spacer included in the distal optical system, wherein the distal end of the strip optical fiber region is fused to the spacer, A rebuffer heat shrink tubing covering the strip optical fiber region, A potting material surrounding the distal end of the strip optical fiber region to fix / pot the strip optical fiber region and the spacer, It has, The potting material is a dual-cure adhesive. medical equipment.
11. The dual-cure adhesive is an ultraviolet (UV) curing adhesive. The medical device according to claim 10.
12. A gap exists between the optical fiber and the rebuffer heat shrink tubing, in which the potting material is filled. The medical device according to claim 10.
13. The dual-cure adhesive is present only inside the rebuffer heat shrink tube. The medical device according to claim 12.
14. The optical fiber equipped with the aforementioned rebuffer heat shrink tubing is located on a guide wire, The medical device according to claim 12.
15. The distal optical system comprises at least the spacer, lens and reflector, The medical device according to claim 10.
16. The medical device according to claim 10, wherein the medical device is a disposable catheter.
17. The catheter is a multimodal optical coherence tomography catheter. The medical device according to claim 16.
18. The medical device functionally interacts with a display to show images, data, or other information. The medical device according to claim 10.