• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
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    • 专利摘要:
    an organ can be cooled to minimize damage to ischemic tissue from a vascular occlusion by a thrombus or dissection. a catheter including a thermal member can be used to introduce cold fluid downstream of an arterial occlusion to cool the tissue affected by the occlusion. this is particularly useful for minimizing neurological damage caused by a thrombotic stroke.
    公开号:BR112019020986A2
    申请号:R112019020986
    申请日:2018-04-06
    公开日:2020-05-05
    发明作者:Berez Aaron；Lim Elaine；Ting Ye Tina
    申请人:Palmera Medical Inc；
    IPC主号:
    专利说明:

    THERAPEUTIC ORGAN COOLING
    BACKGROUND OF THE INVENTION [001] Hypothermia is a promising therapeutic option for patients suffering from a lack of oxygen supply to an organ, for example, due to reduced blood flow. Cerebral ischemia during acute thromboembolic stroke is an example.
    SUMMARY OF THE INVENTION [002] Certain embodiments of the invention provide fabric cooling devices comprising: an elongated member having a fluid release lumen that extends through it to a distal port and being sized and configured to extend into a vessel blood; a thermal member extending over at least a portion of the elongated member and having a fluid chamber through which a first circulating fluid flows when in use, thereby cooling a second fluid which flows through the fluid release lumen and exits through the distal door; and a cooling unit comprising (i) a cooling element that cools the first fluid and (ii) a pump for circulating the first fluid through the fluid chamber.
    [003] Certain embodiments of the invention provide methods of protecting tissues, comprising: introducing a fluid into a lumen site of an artery, the site being located downstream of an occlusion in the artery, the fluid being colder than blood in the artery.
    BRIEF DESCRIPTION OF THE DRAWINGS [004] Figures 1A-1D show a modality of the methods disclosed in this invention, introducing a cooler fluid in a location in the lumen of an artery 101 that is downstream 107 of an occlusion 103 in artery 101, in which around occlusion 103 passes a distal end of a guide wire 105
    Petition 870190121187, of 11/21/2019, p. 10/31
    2/18 first, then passing through occlusion 103 of a distal end of a catheter 106 to introduce the cooler fluid into the location in the lumen of artery 101 which is downstream 107 of occlusion 103.
    [005] Figure 1A shows the distal end of the guide wire 105 approaching occlusion 103 at a location upstream 104 of occlusion 103 and close to where occlusion 103 comes into contact with the internal wall of vessel 102 of artery 101.
    [006] Figure IB shows the distal end of the guidewire that passes around occlusion 103 between occlusion 103 and the inner wall of vessel 102 of artery 101 and reaching a location downstream 107 of occlusion 103 in artery 101.
    [007] Figure 1C shows a catheter 106 covering the guide wire 105 from an end close to the guide wire 105 to close the distal end of the guide wire 105, passing around occlusion 103 between occlusion 103 and the inner wall of the vessel 102 of artery 101, and arrive at a location downstream 107 of occlusion 103 in artery 101.
    [008] Figure 1D shows the guide wire 105 pulled out of the lumen of catheter 106 and a cooler liquid being introduced through catheter 106 to a location downstream 107 of occlusion 103 in artery 101.
    [009] Figure 2 shows examples of catheters with various configurations with one or more lumens.
    [010] Figure 3 shows a modality of a cooling catheter 300, having a heat transfer medium injected into the internal lumen 311 and returned through the external lumen 310.
    [011] Figure 4 shows a mode of a cooling catheter, having a heat transfer medium injected into the external lumen 310 and returned through the internal lumen 311.
    DETAILED DESCRIPTION
    Petition 870190121187, of 11/21/2019, p. 11/31
    3/18 [012] Cooling the entire body is often used to achieve hypothermia. However, this produces adverse side effects that affect almost all body systems, potentially leading to cardiovascular dysfunction, immunosuppression, impaired coagulation, electrolyte imbalances and acid / base disorders. In addition, cooling the entire body requires more time and thermal energy to reach a target temperature at a target site than localized body cooling.
    [013] Skin surface cooling methods, such as cold rubbing, ice packs, helmets and cooling coils, have been used to reduce the temperature locally, but it can take at least 2 hours to reach target temperatures below the surface of the skin, without the necessary temperature reduction in an ischemic tissue, for example, deep in the brain.
    [014] It is necessary to develop a method of localized body cooling to result in rapid and selective hypothermia in an ischemic tissue, for example, affected by vascular occlusion, with reduced effect at central body temperature and to avoid systemic side effects of generalized hypothermia.
    [015] Some neuroprotective effects of hypothermia can be attributed to a reduction in oxygen demand. A decrease in brain temperature by 1 ° C reduces brain oxygen consumption by ~ 5%, thereby increasing tolerance to ischemic conditions. In addition, cooling the brain can stop or decrease some of the inflammatory and other changes initiated by ischemia. Likewise, hypothermia can be beneficial for other ischemic tissues affected by vascular occlusion, for example, softened tissue damage and improved patient recovery. The methods and devices provided here can be used for cooling
    Petition 870190121187, of 11/21/2019, p. 12/31
    4/18 located in the body, resulting in rapid and selective hypothermia in the target ischemic tissue to protect and / or improve the recovery of ischemic tissue.
    [016] Here methods are provided which comprise the introduction of a fluid into a location in the lumen of an artery in an individual (eg, humans, mammals), the site being downstream of an occlusion (eg, a thrombus or clot) ) in the artery and the liquid being colder than the blood temperature in the artery. In certain embodiments, the method further comprises: prior to introduction, passing into the lumen of the artery a distal end of an elongated member from a location upstream of the occlusion to a location downstream of the occlusion in the artery lumen. In certain embodiments, the damage to the ischemic tissue downstream of the occlusion is reduced or slowed down due to hypothermia resulting from the introduction of fluid cooler than the blood temperature in the artery.
    [017] Methods are also provided here which include introducing a fluid into a location in a lumen of a vein in an individual (eg, humans, mammals), the location being upstream of an occlusion in the vein and the fluid being colder than the temperature of the blood in the vein. In certain embodiments, the method further comprises: before introduction, passing into the lumen of the vein a distal end of an elongated member from a location downstream of the occlusion to the location upstream of the occlusion in the vein lumen. In certain embodiments, the damage to the ischemic tissue upstream of the occlusion is reduced or slowed down due to hypothermia resulting from the introduction of the fluid cooler than the blood temperature in the vein.
    [018] As used in the present invention, an occlusion is a partial or total obstruction, for example, of a blood vessel, such as an artery or vein.
    Petition 870190121187, of 11/21/2019, p. 13/31
    5/18 [019] As used in the present invention, hypothermia means that the temperature of a tissue or organ (for example, of ischemic tissue) in an individual is at least 1 ° C lower than the core temperature or blood temperature in a vein or artery of the individual. Localized hypothermia can be beneficial for protecting tissues. For example, a woman survived without brain damage after being trapped in the ice for more than an hour, when her core temperature dropped to approximately 13.7 ° C.
    [020] A person skilled in the art, such as a doctor, would be able to obtain local hypothermia beneficial to an individual treated by adjusting or selecting the temperature of the cold fluid introduced into the individual's blood vessel based on one or more of several factors, for example , the flow of the cold fluid introduced; the composition of the cold fluid introduced; the size, location and metabolic rate of any ischemic tissue that may benefit from hypothermia; the location and anatomy of the occluded vessel; the speed of induction of hypothermia; the patient's physical condition; and other comorbidities.
    [021] In certain embodiments of the methods disclosed in the present invention, the fluid introduced has a temperature of approximately 2 ° C to approximately 35 ° C, approximately 2 ° C to approximately 30 ° C, approximately 4 ° C to approximately 17 ° C , approximately 5 ° C to approximately 30 ° C, approximately 5 ° C to approximately 25 ° C, approximately 10 ° C to approximately 33.9 ° C, approximately 10 ° C to approximately 20 ° C, approximately 10 ° C to approximately 15 ° C, approximately 32 ° C to approximately 34 ° C, approximately 33 ° C to approximately 35 ° C, or approximately 14 ° C. In certain embodiments, the fluid temperature is approximately 1 ° C to approximately 2 ° C, approximately 1 ° C to approximately 10 ° C, approximately 1 ° C to
    Petition 870190121187, of 11/21/2019, p. 14/31
    6/18 approximately 15 ° C, approximately 1 ° C to approximately 28 ° C from the blood temperature of the artery or vein. In certain embodiments, the fluid is introduced until the completion of a thrombectomy or other appropriate procedure to remove the occlusion. In some embodiments, the fluid is introduced for an additional 30-60 minutes, 1-3 hours, 6-12 hours, 12-24 hours, 1-3 days or other period, depending on the patient's response or other factors. In certain embodiments, the fluid is introduced as quickly as possible after the occurrence of symptoms or signs of occlusion, for example, in about 1, 2 or 4 hours, in about 6 to 12 hours, in about 12 to 24 hours , in about 1-3 days, or within 7 days after the occurrence of symptoms or signs of the occurrence of occlusion.
    [022] As used in the present invention, the catheter has its common meaning and can include any elongated structure, such as a tubular member, configured to transmit fluid or objects through a conduit that extends over at least a portion of the length of the catheter . A catheter can have any of several cross-sectional shapes, such as round or polygonal, and can look like a tube, tape, etc. As used in the present invention, guide wire (or guidewire) has its common meaning and can include any elongated structure, such as a metallic and / or polymeric member, configured to extend into a viscous body or vessel to facilitate access to a location in the body by a catheter or other device. A guide wire can have any of several cross-sectional shapes, such as round or polygonal, and can look like a wire, ribbon, rope or other object.
    [023] In certain modalities of the methods disclosed in the present invention, the introduction of the fluid is made through a catheter, an elongated member that passes through the occlusion. In certain modalities, the introduction of the fluid is through a second elongated member (catheter), different from the
    Petition 870190121187, of 11/21/2019, p. 15/31
    7/18 first elongated limb that passes through the occlusion (a guidewire). In certain embodiments, the catheter may comprise a plurality of lumens (see, for example, examples shown in figure 2) for introducing different fluids and / or introducing other accessories as desired, for example, guide wire, an expandable element (for example, balloon, also referred to in the present invention as an expandable member), stent, perforation element (for example, by ultrasound), imaging element, recovery element, cooling element (also known in the present invention as a thermal member), insulation element thermal element, sensor element and any combinations as described in this invention.
    [024] The cooling catheter of the invention is, in some modalities, placed intra-arterially with its distal tip in the internal carotid artery (ICA). This provides a thermally insulated conduit for the ICA. The cooling catheter can be washed with a cold wash solution during the procedure.
    [025] Figures 1A-1D show an embodiment of the methods disclosed in the present invention. Figure 1A shows an occlusion 103 in a lumen of an artery 101 having a vessel wall 102, a distal end of a guide wire 105 approaches occlusion 103 in lumen 104 of artery 101 upstream 104 of occlusion 103, in which the occlusion 103 comes into contact with the inner wall of vessel 102. Figure 1B shows the distal end of the guide wire 105 passing around occlusion 103 to a location downstream 107 of occlusion 103 through the passage between occlusion 103 and the inner wall of vessel 102. A catheter 106 is applied to the guide wire 105 from a location near an end close to the guide wire 105 (figure 1B), until catheter 106 passes around occlusion 103 between occlusion 103 and the wall internal vessel 102 to reach a location downstream 107 of occlusion 103 in lumen 104 of the artery
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    8/18
    101 (figure 1C). The guide wire 105 is pulled out of catheter 106, and a cooler liquid that has a lower temperature than the artery blood temperature is introduced into the site downstream 107 of occlusion 103 (figure 1D).
    [026] In certain embodiments of the methods disclosed in the present invention, the passage includes passage through or around a portion of the occlusion. In certain embodiments, the elongated member comprises a penetrating element (for example, an element with a blunt or sharp distal end and / or with a piercing element at the distal end) passing through or around the occlusion portion. The penetrating element can be pulled out of the catheter after the passage step, so that fluid can be introduced through the elongated member. For catheters with a plurality of lumens, the penetrating element may not need to be pulled out prior to the introduction of the fluid, as the fluid may be introduced through a different lumen.
    [027] In certain embodiments of the methods disclosed in the present invention, the method further comprises the use of one or more catheter lumens and / or one or more accessories for one or more tasks in which those lumens and / or accessories can be used. For example, the method can also comprise one or more stages of recovery of the occlusion through the recovery element, providing an image of the location downstream of the occlusion of an artery or upstream of the occlusion of a vein, detecting one or more parameters of the location a downstream of occlusion of an artery or upstream of occlusion of a vein by one or more sensor elements and cooling the fluid until it is introduced in the desired location.
    [028] In certain embodiments of the methods disclosed in the present invention, the passage includes the passage around the occlusion, for example,
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    9/18 between the occlusion and the vessel wall of the artery or vein. In certain embodiments, the elongated member comprises a guidewire that passes between the occlusion and the vessel wall of the artery or vein. The elongated member can be a catheter comprising one or more lumens. The guidewire can be pulled out of the catheter so that fluid can be introduced through the catheter. For catheters with a plurality of lumens, the guide wire may not need to be pulled prior to the introduction of the fluid, as the fluid may be introduced through a different lumen.
    [029] In certain embodiments of the methods disclosed in the present invention, a catheter can be configured to comprise an expandable element (e.g., balloon) near the distal end of the catheter, and the method further comprises expanding the expandable element after the distal end of the elongated member and the expandable element are positioned in the desired location. The expandable element can block the blood vessel to stop the flow while introducing the cooler fluid.
    [030] In certain embodiments of the methods disclosed in the present invention, the occlusion can be removed by a recovery element with which the catheter is configured, immediately or after the first cooling of the ischemic tissue to the desired therapeutic hypothermic temperature. For example, the recovery element can be positioned adjacent to an occlusive thrombus and recover the thrombus. Examples of recovery elements include, without limitation, a thrombectomy device (eg, Solitaire® revascularization device), basket, wire, or atherectomy device.
    [031] In certain embodiments of the methods disclosed in the present invention, the fluid is cooled extracorporeally. In certain embodiments, the fluid is cooled or kept at a temperature below the temperature of the
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    10/18 blood of the treated individual when a catheter that introduces the fluid comprises a cooling mechanism and / or a thermal insulator.
    [032] In certain embodiments of the methods disclosed in the present invention, the fluid comprises an intravenous solution. Examples of intravenous solutions include, without limitation, colloidal solutions, crystalloids and blood products, such as serum or plasma. Other examples of colloid solutions include, without limitation, albumin (e.g., 5% or 25%), hetastarch (hespan), dextran. Examples of crystalloid solutions include, without limitation, normal saline, semi-normal saline, lactate ringers and 5% dextrose, semi-normal D5 saline. In certain embodiments, the fluid may further comprise additional oxygen dissolved therein.
    [033] In certain embodiments of the methods disclosed in the present invention, the fluid further comprises one or more active ingredients (Al) for therapeutic and / or diagnostic purposes. Examples of Al may include thrombolytic agents, such as tissue plasminogen activator (tPA), streptokinase or urokinase. AI can slow apoptosis and / or ischemic tissue metabolism, downstream of occlusion in an artery or upstream of occlusion in a vein. For example, kinase inhibitors (for example, tyrosine kinase inhibitors, GSK-3 inhibitors, PI3 kinase gamma inhibitors), monocarboxylate transport inhibitors (MCT) can be used. It may also include osmotic agents, such as mannitol (for example, 20% mannitol) to reduce intracranial pressure and any combinations of agents or classes of agents.
    [034] In certain embodiments of the methods disclosed in the present invention, occlusion in the artery or vein may include thrombus, dissection, atheromatous plaque, embolism (by air, fat, foreign body, thrombus) or any combination thereof. The organs that occlusion in the artery or vein
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    11/18 may affect include, without limitation, brain (eg, thrombotic or thromboembolic stroke, certain cases of hemorrhagic stroke, traumatic brain injury and iatrogenic injury during intervention procedures), heart, lung, limbs, liver, pancreas , spleen and kidney.
    [035] There is a limitation in the release of cold fluid to the injury site. The cold fluid injected into the central point of a regular catheter that is placed in the circulating warm blood is heated the moment it reaches the tip of the catheter. Catheters comprising a lumen for introducing the coldest fluid into a desired location are provided in the present invention, as described in the methods of the present invention.
    [036] In certain embodiments, the catheter comprises a release lumen through which the cooler fluid travels until it is introduced into a desired location, as described in the present invention. In certain embodiments, the release lumen is thermally insulated (a thermally insulated lumen), which reduces the temperature change of the fluid that circulates there. Thus, the cooler fluid exiting the distal end of the release lumen can cool at least a portion of the tissue that the cooler fluid comes into contact with. In certain embodiments, the tissue is in a brain, heart, lung, limb or kidney, and such a release of colder fluid, as disclosed in the present invention, can lower the organ temperature and induce therapeutic hypothermia to the ischemic tissue affected by the artery with occlusion.
    [037] In certain embodiments, the catheter comprises a cooling element not only reducing the temperature gain of a cooler fluid that circulates there, but also lowering the fluid temperature even further. The cooling element can comprise a system of
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    12/18 circulation of heat transfer medium, in which a heat transfer medium is circulated to generate heat exchange through the internal wall of the catheter, through which the fluid circulates. The cooling element can comprise a compressed air cooling system or any other cooling system that can implement the desired heat exchange with the fluid.
    [038] For example, the cooling element may involve a substantial portion of the catheter release lumen that is close to the distal end of the catheter and is in contact with blood in the blood vessel through which the catheter circulates. The cooling element comprises a plurality of ports for a plurality of lumens in fluid communication desired for circulation with a chiller unit that provides cooler heat transfer means, a suitable cooling means for heat transfer can be introduced into the cooling element. cooling from one or more doors, then travels through the corresponding lumens until it leaves the cooling element of one or more doors. The fluid flowing through the release lumen is cooled or kept cool when in heat transfer with the cooler heat transfer medium circulated in the plurality of lumens of the cooling element.
    [039] In certain embodiments, the catheter further comprises an expandable element near its distal end, so that, once the expandable element passes through the occlusion as described in the present invention, it has a larger diameter than the predominant section of the catheter from its proximal end. The larger diameter of the expandable element prevents the fluid introduced through the catheter from being refluxed. For example, the largest diameter of the expandable element can be about 2 to about 10 times larger, about 2 to about 15 times, or about 2 to about 20 times larger
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    13/18 than the diameter of the catheter section immediately after the expandable element.
    [040] In certain embodiments, the expandable element expands after undergoing occlusion, as described in the present invention. Examples of expandable elements include, without limitation, balloons.
    [041] Figures 3 and 4 show modalities of an elongated member (a cooling catheter 300) comprising a release lumen 301 defined by a release axis 302, a cooling element 303 further comprising an expandable element, such as a 304 balloon. , a fluid release port 305 for introducing the cooler fluid into release lumen 301 and two heat transfer media ports 306 and 307 near the proximal end of the cooling element 303, allowing the heat transfer media in and out of cooling element 303. Cooling element 303 comprises an external axis 308 that surrounds the release axis 302 to a substantial portion near the distal end and an internal axis 309 spaced between the external axis 308 and the release axis 302 to divide the fluid chamber between the external axis 308 and the release axis 302 into two lumens in fluid communication: the external lumen 310 between the external axis 308 and the inner axis 309 and the inner lumen 311 between the inner axis 309 and the release axis 302. The inner axis 309 does not extend between the outer axis 308 and the release axis 302 to the distal end of the cooling element 303, thus allowing the outer lumen 310 and the inner lumen 311 to enter fluidic communication. The heat transfer means can enter the outer lumen 310 through port 306 and then exit through inner lumen 311 and port 307, as shown in figure 3. Alternatively, heat transfer means can enter inner lumen 311 through from port 307 and then exit
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    14/18 through external lumen 310 and port 306, as shown in figure 4. Ports 306 and 307 can be connected to a cooling / cooling unit 313 that can provide and circulate cooler heat transfer media. The cooling / cooling unit 313 may include a pump 315 for circulating the heat transfer medium through the fluid chamber and a cooling element 316 that cools the heat transfer medium. The outer axis 308 comprises at least two sections with different diameters, a larger diameter section (balloon axis 312) near the distal end of the cooling element 303 that defines the balloon 304 and a section with smaller diameter (s) near the proximal end of the cooling element 303. The largest diameter section (balloon axis 312) has the largest diameter of the outer axis 308. The balloon can be expandable and expands in a desired location (for example, after the near end of balloon 304 passes around or through occlusion in an embodiment of the methods disclosed in the present invention). The thermal member 303 may optionally further comprise one or more radiopaque markers 314 marking the distal end of the release lumen 301, the distal end and the proximal end of the balloon 304 to assist clinicians in positioning and tracking the release lumen 301 and the balloon 304.
    [042] The 304 balloon can be made of compatible, semi-compatible or non-compatible material. For a low profile shaft design, a compatible balloon may be preferable.
    [043] Materials suitable for release shaft 302, inner shaft 309 and outer shaft 308 include, without limitation, composite reinforced shaft, multiple rigidity polymer shafts, metal hypotube shaft jacket (laser cut) with materials polymeric.
    [044] In certain embodiments, the cooling catheter 300 shown in the
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    15/18 Figures 3 and 4 may also comprise a smaller balloon (as an additional expandable element) at the distal end of the release lumen 301 which can be expanded (for example, inflated) to occlude the blood vessel (flow stop) with port additional injection to expand and deflate the balloon.
    [045] In certain embodiments, a distal access catheter can be placed through the release lumen, for example, the distal access catheter can be essentially a large hole (for example, catheter 5 or 6F with about 0.045 to 0, 07 ID) with its tip getting more distal. If the tip of the distal access catheter can reach the occlusion (for example, thrombus), it can be used as an aspiration catheter to remove the occlusion. The distal access catheter can be flushed with the coldest fluid.
    [046] Through the release lumen of the distal access catheter, a microcatheter (for example, 0.021 or 0.027 ID) can be passed over a guidewire and the tip of the microcatheter can be advanced carefully after occlusion. Once the distal end of the distal access or release lumen is positioned at a desired location in the blood vessel, the cooling of the tissues affected by the occlusion (for example, ischemic parenchyma) can begin immediately, introducing the cooler fluid, as disclosed in the present invention, even before attempting to remove the occlusion and restore the flow. Cooling the ischemic tissue before restoring oxygenated blood flow can decrease reperfusion injury. Ischemic tissue will be cooled by infusing cooler fluid, as disclosed in the present invention, which may increase the oxygen carrying capacity (for example, by blood heme or artificial heme) and / or include Ais, as disclosed in the present invention, to decrease the extent of infarction.
    [047] In addition, a recovery device as described here can
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    16/18 be placed adjacent to the occlusion, by passing through the lumen of a microcatheter, then drawing or implanting the recovery device and recovering the occlusion.
    Examples [048] Method 1. A method for protecting tissues, comprising: introducing a fluid into a location in the lumen of an artery, the location being downstream of an occlusion in the artery, the fluid being colder than blood in the artery.
    [049] Method 2. The method according to method 1, further comprising: before introduction, passing in the lumen an end of an elongated member from a location upstream of the occlusion to a location downstream of the occlusion.
    [050] Method 3. The method according to method 2, wherein the elongated member comprises a guide wire.
    [051] Method 4. The method according to method 2 or 3, in which the introduction of the fluid is through a catheter with a distal end placed in a location downstream of the occlusion.
    [052] Method 5. The method according to method 2, 3 or 4, in which the end of the elongated limb is passed to the location downstream of the occlusion passing around the occlusion.
    [053] Method 6. The method according to any of methods 2-5, further comprising expanding an expandable element that limits the fluid introduced into the site downstream of the flow upstream of the occlusion.
    [054] Method 7. The method according to any of methods 4-5, wherein the catheter comprises a thermal insulating element to keep the fluid cooled until it is introduced into the downstream location.
    [055] Method 8. The method according to any of methods 1-7,
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    17/18 in which the occlusion comprises a thrombus and further comprises recovering at least a portion of an artery thrombus.
    [056] Method 9. The method according to any of methods 1-8, wherein the fluid has a temperature of about 2 ° C to about 35 ° C.
    [057] Method 10. The method according to any of methods 19, wherein the fluid has a temperature of about 5 ° C to about 30 ° C.
    [058] Method 11. The method according to any of the ΙΙΟ methods, wherein the fluid has a temperature of about 10 ° C to about 25 ° C.
    [059] Method 12. The method according to any of the methods 1-
    11, wherein the fluid has a temperature of about 10 ° C to about 20 ° C.
    [060] Method 13. The method according to any of the methods 1-
    12, the fluid has a temperature of about 15 ° C.
    [061] Method 14. The method according to any of the methods 1-
    13, in which the place where the fluid is being introduced is in an internal carotid artery (ICA), or in its branches (for example, MCA, ACA and its branches).
    [062] Method 15. The method of any of methods 1-14, further comprising introducing cooling fluid into the artery after removal of the thrombus.
    [063] Apparatus 1. A tissue cooling device comprising: an elongated member with a fluid-releasing lumen that extends through it to a distal port and is sized and configured to extend into a blood vessel; a thermal member extending over at least a portion of the elongated member and having a fluid chamber through which a first circulating fluid flows when in use, thereby cooling a second fluid which flows through the fluid release lumen and exits through the distal door; is
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    18/18 cooling unit comprising (i) a cooling element that cools the first fluid and (ii) a pump to circulate the first fluid through the fluid chamber.
    [064] Apparatus 2. The tissue cooling device of Apparatus 1, further comprising an expandable member coupled to a distal portion of the elongated member, the expandable member configured to expand within and at least partially occlude the blood vessel.
    [065] Apparatus 3. The tissue cooling device of Apparatus 2, in which the thermal member comprises the expandable member and the first circulating fluid expands the expandable member.
    [066] Various modalities have been shown and described. Of course, several changes and substitutions can be made without departing from the spirit and scope of the invention. The invention, therefore, should not be limited, except for the following claims and their equivalents.
    权利要求:
    Claims (22)
    [1]
    1. Method for protecting fabrics, characterized by the fact that it comprises:
    introducing a fluid into a location in the lumen of an artery, the location being downstream of an occlusion in the artery, the fluid being colder than blood in the artery; or introducing a fluid into a location in the lumen of a vein, the location being upstream of an occlusion in the vein, the fluid being colder than the blood in the vein.
    [2]
    2. Method according to claim 1, characterized by the fact that it additionally comprises:
    before introduction, pass in the lumen of the artery a distal end of an elongated member from a location upstream of the occlusion to a location downstream of the occlusion; or before introduction, pass a distal end of an elongated limb from the site downstream of the occlusion to the site upstream of the occlusion in the lumen of the vein.
    [3]
    Method according to claim 2, characterized in that the elongated member comprises a guide wire.
    [4]
    Method according to claim 2 or 3, characterized by the fact that the introduction of the fluid is through a catheter having a distal end placed in a location downstream of the artery occlusion or upstream of the vein occlusion.
    [5]
    Method according to any one of claims 2 to 4, characterized in that the end of the elongated member is passed to the location downstream of the artery occlusion or upstream of the vein occlusion passing around the occlusion.
    [6]
    A method according to any one of claims 3 to 5,
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    2/4 characterized by the fact that it additionally comprises the expansion of an expandable element that limits the fluid introduced into the downstream site to flow upstream of the artery occlusion or that limits the fluid introduced into the site upstream to flow downstream of the occlusion of the artery vein.
    [7]
    Method according to any one of claims 4 to 6, characterized in that the catheter comprises a thermal insulation element to keep the fluid cooled until it is introduced into the downstream or upstream location.
    [8]
    Method according to any one of claims 1 to 7, characterized in that the occlusion comprises a thrombus and additionally comprises recovering at least a portion of a thrombus from the artery or vein.
    [9]
    Method according to any one of claims 1 to 8, characterized in that the fluid has a temperature of about 2 ° C to about 35 ° C.
    [10]
    Method according to any one of claims 1 to 9, characterized in that the fluid has a temperature of about 5 ° C to about 30 ° C.
    [11]
    Method according to any one of claims 1 to 10, characterized in that the fluid has a temperature of about 10 ° C to about 25 ° C.
    [12]
    Method according to any one of claims 1 to 11, characterized in that the fluid has a temperature of about 10 ° C to about 20 ° C.
    [13]
    Method according to any one of claims 1 to 12, characterized in that the fluid has a temperature of about 15 ° C.
    [14]
    14. Method according to any one of claims 1 to 13,
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    3/4 characterized by the fact that the place where the fluid is introduced is in an internal carotid artery or branches of it.
    [15]
    Method according to any one of claims 1 to 14, characterized in that it additionally comprises the introduction of cooling fluid into the artery or vein after removal of the thrombus.
    [16]
    16. Elongated member (300), characterized by the fact that it comprises:
    a release lumen (301), a cooling element (303), a fluid release port (305), and two heat transfer media ports (306 and 307).
    [17]
    17. Fabric cooling device, characterized by the fact that it comprises:
    an elongated member (300) having a fluid release lumen (301) that extends through it to a distal port and is sized and configured to extend into a blood vessel;
    a thermal member (303) extending over at least a portion of the elongated member (300) and having a fluid chamber through which a first circulating fluid flows when in use, thereby cooling a second fluid flowing through the lumen release fluid and exits through the distal port; and a cooling unit (313) comprising (i) a cooling element (316) that cools the first fluid and (ii) a pump (315) for circulating the first fluid through the fluid chamber.
    [18]
    A fabric cooling device according to claim 17, characterized in that it additionally comprises an expandable member (304) coupled to a distal portion of the elongated member (300), the expandable member (304) configured to expand within and at least
    Petition 870200048248, of 16/04/2020, p. 12/13 ¢ / 4 partially occlude the blood vessel.
    [19]
    19. A fabric cooling device according to claim 18, characterized in that the thermal member (303) comprises the expandable member (304), and the first circulating fluid expands the expandable member (304).
    [20]
    20. Fabric cooling device according to any one of claims 17 to 19, characterized in that it is for use in a method for protecting fabrics.
    [21]
    21. Use of a catheter or an elongated limb, characterized by the fact that it is for the manufacture of a tissue cooling device to protect tissues by introducing a fluid into a location in the lumen of an artery or vein, the location being downstream of an occlusion in the artery or upstream of an occlusion in the vein, the fluid being colder than the blood in the artery or vein.
    [22]
    22. Invention of a product, process, system, kit or use, characterized by the fact that it comprises one or more elements described in the present patent application.
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    法律状态:
    2021-10-19| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    优先权:
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    US201762483294P| true| 2017-04-07|2017-04-07|
    PCT/US2018/026600|WO2018187776A1|2017-04-07|2018-04-06|Therapeutic organ cooling|
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