Catheter for local area perfusion system

Abstract

Disclosed herein is a catheter (100) designed to improve the performance of a local area perfusion system, including a perfusion catheter for a supply line and a recovery catheter for a return line. In certain embodiments, the catheter includes an occlusion structure (110). In certain embodiments, the conduit is configured to support a liquid flow rate of about 400 mL / min or greater.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 312,029, filed on February 20, 2022, the disclosure of which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present invention relates to catheters, and more particularly to catheters designed to improve the performance of local regional perfusion systems. Background Art

[0004] Gene therapy and cell therapy technologies are receiving increasing attention in treatment because of their unique targeting and potential to effectively address the underlying pathogenesis of various diseases. However, delivery-related issues, including carrier efficiency, dosage, specificity, and safety, remain. Therefore, further research is needed to achieve more targeted and uniform delivery of drugs suitable for treating various diseases. In addition, there is a need for improved devices to facilitate local delivery of gene therapy drugs into the body to treat target organs, such as by isolating the target organ from the systemic circulation. Summary of the invention

[0005] The following content presents a simplified overview of various aspects of the present disclosure in order to provide a basic understanding of such aspects. This overview is not a comprehensive review of the present disclosure. It is neither intended to identify the key or important elements of the present disclosure, nor to delimit any scope of the specific embodiments of the present disclosure or any scope of the claims. Its only purpose is to present some concepts of the present disclosure in a simplified form as a preface to a more detailed description presented later.

[0006] One aspect of the present disclosure relates to a retrieval catheter comprising: a luminal shaft having a proximal end and a distal end; an expandable balloon structure disposed near the distal end of the luminal shaft; and a tip portion located between the balloon structure and the distal end of the luminal shaft. In at least one embodiment, the retrieval catheter is configured to support a liquid flow rate of about 150 mL / min or greater, or about 400 mL / min or greater.

[0007] In at least one embodiment, the tip portion comprises an elongated shaft extending from the balloon portion to the distal end of the lumen shaft. In at least one embodiment, the tip comprises a distal opening at the distal end and a plurality of perforations along the elongated shaft. In at least one embodiment, the length of the elongated shaft of the tip portion is about 2 mm to about 35 mm, about 5 mm to about 30 mm, about 10 mm to about 25 mm, or about 15 mm to 25 mm.

[0008] In at least one embodiment, the inner diameter of the lumen shaft is at least about 2 mm.

[0009] In at least one embodiment, the expanded diameter of the balloon structure is about 15 mm to about 30 mm, about 15 mm to about 20 mm, about 20 mm to about 25 mm, about 24 mm to about 28 mm, or about 25 mm to about 30 mm.

[0010] In at least one embodiment, the lumen shaft is a multi-lumen shaft comprising at least two lumen shafts.

[0011] In at least one embodiment, the multi-lumen shaft comprises an inner lumen shaft and an outer lumen shaft, the outer lumen shaft at least partially surrounding the inner lumen shaft to expose a proximal portion of the inner lumen shaft near the proximal end of the lumen shaft. In at least one embodiment, the balloon structure and the tip portion are disposed on the inner lumen shaft.

[0012] In at least one embodiment, the retrieval catheter is a multi-balloon catheter, and the multi-balloon catheter further includes at least an additional expandable balloon structure disposed adjacent to the main balloon structure. In at least one embodiment, the expanded diameter of the additional balloon structure is greater than the expanded diameter of the main balloon structure. In at least one embodiment, the portion of the luminal axis between the balloon structures includes one or more perforations.

[0013] In at least one embodiment, the retrieval catheter further comprises: a stent structure disposed on a portion of the lumen shaft between the tip portion and the balloon structure.

[0014] In at least one embodiment, the retrieval catheter further comprises: a perforation along the luminal axis between the balloon structure and the stent structure and / or between the stent structure and the distal end.

[0015] Another aspect of the present disclosure relates to a retrieval catheter, comprising: a tubular shaft having a proximal end and a distal end; a coated disc-shaped stent structure disposed near the distal end of the tubular shaft; and a tip portion located between the coated disc-shaped stent structure and the distal end of the tubular shaft. In at least one embodiment, the retrieval catheter is configured to support a liquid flow rate of about 150 mL / min or greater, or about 400 mL / min or greater.

[0016] In at least one embodiment, the tip portion includes a radio marker or a radiopaque filler composition.

[0017] Another aspect of the present disclosure relates to a retrieval catheter comprising: a luminal shaft having a proximal end and a distal end; and an expandable stent structure disposed at the distal end of the luminal shaft, the stent structure comprising a covering on a proximal portion. In at least one embodiment, the stent structure is uncovered at the distal portion when deployed. In at least one embodiment, the retrieval catheter is configured to support a liquid flow rate of about 150 mL / min or greater, or about 400 mL / min or greater.

[0018] In at least one embodiment, any of the aforementioned recovery conduits is configured to support a liquid flow rate of at least about 150 mL / min, at least about 200 mL / min, at least about 250 mL / min, at least about 300 mL / min, at least about 350 mL / min, at least about 400 mL / min, at least about 450 mL / min, at least about 500 mL / min, at least about 550 mL / min, at least about 600 mL / min, at least about 650 mL / min, at least about 700 mL / min, at least about 750 mL / min, at least about 800 mL / min, at least about 850 mL / min, at least about 900 mL / min, at least about 950 mL / min, or at least about 1000 mL / min. In at least one embodiment, any of the aforementioned recovery conduits is configured to support a liquid flow rate of about 150 mL / min to about 1000 mL / min.

[0019] Another aspect of the present disclosure relates to a perfusion catheter comprising: a tubular shaft having a proximal end and a distal end; an occlusive structure near the distal end of the tubular shaft, the occlusive structure being adapted to seal perfused blood from systemic blood circulation when inserted into a blood vessel; and a tip portion comprising an elongated shaft extending from the occlusive structure to the proximal end of the tubular shaft, the tip comprising a proximal opening at the proximal end. In at least one embodiment, the occlusive structure is selected from: a balloon; a plug configurable between a retracted state and an extended state; a wedge shaped to accommodate a blood vessel or an orifice; a releasable covered stent; and a releasable braided disc. In at least one embodiment, the perfusion catheter is configured to support a fluid flow rate of about 150 mL / min or greater, or about 400 mL / min or greater.

[0020] In at least one embodiment, the occlusive structure includes the plug configurable between a retracted state and an extended state. In at least one embodiment, when in the extended state, a portion of the plug extends distally from the tip portion.

[0021] In at least one embodiment, the occlusive structure includes the releasable stent graft. In at least one embodiment, the luminal shaft includes an outer sheath covering the releasable stent graft. In at least one embodiment, when the sheath is retracted proximally, the releasable stent graft is deployed beyond the distal end of the luminal shaft, and the expanded diameter of the releasable stent graft is greater than the diameter of the luminal shaft.

[0022] In at least one embodiment, the occlusive structure comprises the releasable braided disc. In at least one embodiment, the luminal shaft comprises an outer sheath covering the releasable braided disc. In at least one embodiment, when the sheath is retracted proximally, the releasable braided disc is deployed with an expanded diameter greater than the diameter of the luminal shaft. In at least one embodiment, the tip portion extends distally beyond the releasable braided disc when the releasable braided disc is deployed.

[0023] In at least one embodiment, any of the aforementioned perfusion catheters is configured to support a fluid flow rate of at least about 150 mL / min, at least about 200 mL / min, at least about 250 mL / min, at least about 300 mL / min, at least about 350 mL / min, at least about 400 mL / min, at least about 450 mL / min, at least about 500 mL / min, at least about 550 mL / min, at least about 600 mL / min, at least about 650 mL / min, at least about 700 mL / min, at least about 750 mL / min, at least about 800 mL / min, at least about 850 mL / min, at least about 900 mL / min, at least about 950 mL / min, or at least about 1000 mL / min.

[0024] definition

[0025] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, "a drug" includes a single drug as well as a mixture of two or more different drugs.

[0026] Likewise, as used herein, "about" when used in conjunction with a measured amount refers to the normal variation of that measured amount as would be expected by one of ordinary skill in the art when making the measurements and exercising a level of care commensurate with the purpose of the measurement and the precision of the measuring equipment. In certain embodiments, the term "about" includes ±10% of the recited number, such that "about 10" would include 9 to 11.

[0027] Likewise, as used herein, "infusion," "infusion," and "infusion" have their ordinary and customary meanings in the art, and refer to administration over a period of time (usually one minute or more) that is much longer than the art-recognized terms "injection" or "bolus" (usually less than one minute). The flow rate of the infusion depends, at least in part, on the amount administered.

[0028] Additionally, as used herein, "isolated," "substantially isolated," "mostly isolated," and variations thereof are terms that do not require complete or absolute isolation of the renal or systemic circulation; rather, they are intended to mean that a majority, preferably a major portion, or even substantially all of a particular circulation is isolated. Likewise, as used herein, "partially isolated" means that any non-trivial portion of a specified circulation is isolated.

[0029] Likewise, as used herein, "non-natural restriction" includes any method that restricts the flow of fluid through a blood vessel, such as balloon catheters, sutures, etc., but does not include naturally occurring restrictions, such as plaque buildup (stenosis). Non-natural restrictions include substantial or complete isolation of, for example, the renal circulation.

[0030] Likewise, as used herein, "minimally invasive" is intended to include any procedure that does not require open surgical access to the kidney or blood vessels closely associated with the kidney. These procedures include using endoscopic approaches to access the kidney, as well as relying on catheter-based means of access via the aorta and vein.

[0031] Likewise, as used herein, the term "patient" refers to a subject, particularly a human (but may include non-humans), who has exhibited clinical manifestations of one or more specific symptoms suggesting a need for treatment, has been treated prophylactically for a condition, or has been diagnosed with a condition to be treated.

[0032] Likewise, as used herein, "subject" encompasses the definition of the term "patient" and does not exclude otherwise healthy individuals.

[0033] Likewise, as used herein, "treating" includes administering a drug to lessen the severity of a condition (eg, a kidney condition or kidney disease) or to prevent the condition.

[0034] Likewise, as used herein, "active agent" means any substance intended to produce a therapeutic, prophylactic, or other desired effect, whether or not approved for that purpose by a governmental agency.

[0035] Unless otherwise specified herein, the enumeration of value ranges herein is intended only to be used as a shorthand method for individually representing each individual value belonging to the range, and each individual value is incorporated into the specification as if it were individually described herein. Unless otherwise specified herein or clearly contradictory to the context, all methods described herein can be performed in any suitable order. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended only to illustrate certain materials and methods and is not intended to limit the scope. The language in the specification should not be considered to indicate that any unclaimed element is necessary for implementing the disclosed materials and methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The above and other features of the present disclosure, its nature and various advantages will become more apparent upon consideration of the following detailed description taken in conjunction with the accompanying drawings, in which:

[0037] Figure 1 An exemplary retrieval catheter having a lumen shaft with a proximal end and a distal end is shown according to at least one embodiment;

[0038] Figure 2 is an image of a catheter with a balloon in its deployed state according to at least one embodiment;

[0039] Figure 3 An exemplary catheter according to at least one embodiment is shown inserted into the coronary sinus via the right atrium;

[0040] Figure 4 shows a catheter only partially inserted into the coronary sinus such that it abuts the ostium of the coronary sinus in accordance with at least one embodiment;

[0041] Figure 5 illustrates the use of a dual catheter system according to at least one embodiment;

[0042] Figure 6 Variations of a dual conduit system according to at least one embodiment are shown;

[0043] Figure 7 illustrates the use of a single catheter including multiple balloons according to at least one embodiment;

[0044] Figure 8 A catheter including a partially covered and recaptureable stent structure is shown according to at least one embodiment;

[0045] Fig. 9 A catheter including an expandable and retractable stent structure is shown according to at least one embodiment;

[0046] Fig.10 A catheter including a coated disc-shaped stent structure according to at least one embodiment is shown;

[0047] Fig.11A A first exemplary irrigation catheter having an expandable balloon according to at least one embodiment is shown;

[0048] Fig. 11B A first exemplary perfusion catheter having a balloon in its deployed state is shown according to at least one embodiment;

[0049] Fig. 11C A first exemplary perfusion catheter having a balloon in its deflated state is shown according to at least one embodiment;

[0050] Fig.11D illustrates deployment of a first exemplary perfusion catheter in the aorta in accordance with at least one embodiment;

[0051] Fig. 12A A second exemplary irrigation catheter having a plug is shown according to at least one embodiment;

[0052] Fig. 12B illustrates a plug of a second exemplary irrigation catheter in a retracted state according to at least one embodiment;

[0053] Fig. 12C illustrates a plug of a second exemplary irrigation catheter in an extended state according to at least one embodiment;

[0054] Fig.12D illustrates deployment of a second exemplary perfusion catheter in the aorta in accordance with at least one embodiment;

[0055] Fig.13A illustrates a third exemplary irrigation catheter having a wedge according to at least one embodiment;

[0056] Fig. 13B illustrates a wedge of a third exemplary irrigation catheter according to at least one embodiment;

[0057] Fig. 13C showing additional views of a wedge of a third exemplary irrigation catheter according to at least one embodiment;

[0058] Fig.13D shows deployment of a third exemplary perfusion catheter in the aorta according to at least one embodiment;

[0059] Fig.14A A fourth exemplary perfusion catheter including a partially covered and recaptureable stent structure is shown according to at least one embodiment;

[0060] Fig. 14Billustrates placement of a stent structure of a fourth exemplary perfusion catheter according to at least one embodiment;

[0061] Fig. 14C illustrates deployment of a stent structure of a fourth exemplary perfusion catheter according to at least one embodiment;

[0062] Fig.15A A fifth exemplary irrigation catheter including a releasable coated braided disc is shown according to at least one embodiment;

[0063] Fig. 15B illustrates a releasable coated braided disc of a fifth exemplary irrigation catheter in a deployed state according to at least one embodiment;

[0064] Fig.16A illustrates a sixth exemplary irrigation catheter according to at least one embodiment;

[0065] Fig. 16B illustrates placement of a sixth exemplary irrigation catheter in accordance with at least one embodiment;

[0066] Fig. 16C shows deployment of a sixth exemplary perfusion catheter in the aorta in accordance with at least one embodiment;

[0067] Fig.16D illustrates a preformed catheter lumen of a sixth exemplary irrigation catheter according to at least one embodiment; and

[0068] Fig.17 A preformed lumen shaft is shown according to various embodiments. DETAILED DESCRIPTION

[0069] Certain embodiments of the present disclosure are directed to catheters for locoregional perfusion (LRP) systems. The catheters are designed to achieve high fluid flow rates in an organ undergoing LRP while providing improved sealing and isolation of the LRP circuit and stability of catheter positioning during perfusion and perfusate recovery.

[0070] LRP can be performed in various body organs, including but not limited to the heart, kidneys, and liver. Exemplary systems for performing LRP procedures in a non-stop heart are described in International Application Nos. PCT / IB2020 / 000692, filed on August 26, 2020, and PCT / EP2022 / 054361, filed on February 22, 2022, the disclosures of which are hereby incorporated by reference in their entirety. The coronary circulation provides blood supply to cardiac tissue, of which there are many coronary arteries. Normally, four main coronary arteries supply the heart with oxygenated blood for distribution throughout the cardiac tissue: the left main and right coronary arteries, the left anterior descending artery, and the left circumflex artery. Deoxygenated blood flows through the coronary sinus.

[0071] An exemplary LRP procedure of the heart involves isolating the patient's coronary circulation from the patient's systemic circulation by forming a closed circuit through the coronary circulation, the closed circuit comprising a first perfusion catheter connected to a supply line, a second perfusion catheter connected to a supply line, a retrieval catheter connected to a return line, and an external membrane oxygenation device. In an exemplary system, each perfusion catheter is inserted into a coronary artery, and the retrieval catheter is inserted into the coronary sinus. A perfusion fluid containing a drug suitable for treating a heart condition can be delivered to the myocardium while substantially isolating the patient's coronary circulation from the patient's systemic circulation through the closed circuit.

[0072] An exemplary LRP procedure of the kidney involves positioning an infusion catheter in the renal artery of the kidney and positioning a retrieval catheter in the renal vein of the kidney. The infusion catheter and the retrieval catheter are combined with a membrane oxygenation device to form a closed circuit. The perfusion fluid then flows through a closed circuit in the renal circulation, which is substantially isolated from the patient's systemic circulation. An additional retrieval catheter may be inserted into the bladder to measure urine excretion during perfusion. An exemplary system for performing an LRP procedure in the kidney is described in International Application No. PCT / EP2022 / 054360, filed on February 22, 2022, the disclosure of which is hereby incorporated by reference herein in its entirety.

[0073] An exemplary LRP procedure of the liver involves positioning a first perfusion catheter in the hepatic artery, a second perfusion catheter in the portal vein, and one or more retrieval catheters in the inferior vena cava near the liver. The perfusion catheter and the one or more retrieval catheters are combined with one or more membrane oxygenation devices to form a closed circuit. The perfusion fluid then flows through a closed circuit in the liver circulation that is substantially isolated from the patient's systemic circulation. An exemplary system for performing an LRP procedure in the liver is described in International Application No. PCT / EP2022 / 054356, filed on February 22, 2022, the disclosure of which is hereby incorporated by reference herein in its entirety.

[0074] Exemplary retrieval catheters and perfusion catheters are now described. Although various catheter embodiments are depicted as being deployed within the heart, it should be understood that deployment within the heart is merely illustrative. One of ordinary skill in the art will appreciate that the catheter can be configured according to the anatomical structure of the target organ to be subjected to LRP. In addition, it should be understood that any catheter described as a "retrieval catheter" may also be used as a "perfusion catheter" and vice versa. The embodiments described herein are not limited to LRP of a target organ, but may also be used to isolate the circulation of a target organ from systemic circulation, for example, to reduce or prevent exposure of the target organ to drugs or other agents introduced into the systemic circulation that may have a deleterious effect on the target organ. One of ordinary skill in the art will appreciate other uses of the catheter embodiments described herein, such as in applications where blood vessels need to be sealed.

[0075] Retrieval catheter implementation plan

[0076] Embodiments of exemplary catheters for use as retrieval catheters in LRP systems are now described. In at least one embodiment, the retrieval catheter is designed to support a liquid aspiration flow rate of about 150 mL / min or greater (e.g., about 700 mL / min or greater). For example, in certain embodiments, the exemplary catheter can support an extracorporeal aspiration flow rate of about 800 mL / min at about -80 mmHg.

[0077] Certain embodiments of the retrieval catheter have advantages in the return line for the LRP system, which is used to form a closed circuit in a heart that is not stopped when inserted into the coronary sinus. The catheter described herein can be designed to meet the following criteria: capable of entering the coronary sinus via the right internal jugular vein; compatible with an introducer sheath with an inner diameter of 24 Fr or less; compatible with a guidewire of 0.035 inches or less; capable of entering, sealing and occluding the coronary sinus with an inner diameter of 6 to 20 mm in human subjects or up to 30 mm in a porcine animal model; capable of avoiding occlusion of prominent lateral veins (e.g., the central cardiac vein); and capable of maintaining a stable position for at least 60 minutes during the LRP procedure.

[0078] Figures 1 to 10 Various catheter embodiments suitable for use in fluid recovery in an LRP system are depicted. Figures 1 to 10Any of the catheters depicted in can be configured to support a liquid flow rate (aspiration or infusion) of at least about 150 mL / min, at least about 200 mL / min, at least about 250 mL / min, at least about 300 mL / min, at least about 350 mL / min, at least about 400 mL / min, at least about 450 mL / min, at least about 500 mL / min, at least about 550 mL / min, at least about 600 mL / min, at least about 650 mL / min, at least about 700 mL / min, at least about 750 mL / min, at least about 800 mL / min, at least about 850 mL / min, at least about 900 mL / min, at least about 950 mL / min, at least about 1000 mL / min, or within any range defined by any of the foregoing lower limits (e.g., from about 150 mL / min to about 1000 mL / min, about 400 mL / min to about 800 mL / min, etc.). Each catheter is compatible with a steerable guide sheath that provides stability and guides the distal end of the catheter and allows the catheter to generate directional thrust. Each catheter can also have a pull wire integrated into its shaft assembly, allowing the section proximal to the occlusive structure to bend at angles up to 120° and achieve better occlusive structure tracking and centering.

[0079] In certain embodiments, one or more conduits can be multi-lumen conduits, such as double-lumen conduits. In certain embodiments, multi-lumen conduits allow liquid to flow (e.g., perfusate) and can expand one or more balloons. In certain embodiments, one or more of the conduits can be multi-balloon conduits with two or more balloons. In certain embodiments, one or more of the balloons can be independently deployed or deflated.

[0080] Figure 1 An exemplary catheter 100 having a lumen axis 104 / 106 is shown, the lumen axis having a proximal end 101 and a distal end 102. Lumen axis 104 / 106 can be formed by an outer lumen axis 104, the outer lumen axis at least partially surrounding an inner lumen axis 106 to expose the distal portion of the inner lumen axis 106 near the distal end 102. Proximal end 101 includes an outlet structure that can be fluidically coupled to an LRP system. One or more of the outer lumen axis 104 or the inner lumen axis 106 can be formed by a durable polymer material, such as a polyether block amide (PEBA) material (e.g., commercially available PEBAX®). In at least one embodiment, the innermost diameter ("inner diameter") of the inner lumen axis 106 is at least about 4 mm to provide a fluid flow path. In at least one embodiment, catheter 100 can be designed to include an additional lumen axis.

[0081] The catheter 100 includes a tip portion 108 at the distal end 102 and an expandable balloon structure 110 disposed along a portion 112 of the inner lumen axis 106. In at least one embodiment, the tip portion 108 includes an elongated shaft extending from the balloon structure 110 to the distal end 102. In at least one embodiment, the length of the elongated shaft of the tip portion is about 2 mm to about 35 mm, about 5 mm to about 30 mm, about 10 mm to about 25 mm, about 15 mm to 25 mm, or any sub-range defined therein (e.g., about 2 mm to about 5 mm). In at least one embodiment, the tip portion 108 includes an opening at the distal end 102 and one or more perforations along the elongated shaft. In at least one embodiment, the tip portion is formed of a compliant material that is more flexible than the material of the inner lumen axis 106.

[0082] In at least one embodiment, the inner lumen shaft 106 includes a concentric inner flow path surrounding the liquid flow path. The concentric inner flow path provides a gas flow path from the balloon structure 110 to the port 114, which can be used to inflate or deflate the balloon according to the pressure applied at the port 114. In at least one embodiment, the outermost surface of the inner lumen shaft 106 at the portion 112 is removed so that the portion 112 is sealed by the balloon structure 110 to isolate the gas flow from the concentric inner flow path to the balloon structure 110. In at least one embodiment, the expanded diameter of the balloon structure is about 15 mm to about 30 mm, about 15 mm to about 20 mm, about 20 mm to about 25 mm, about 24 mm to about 28 mm, or about 25 mm to about 30 mm.

[0083] Figure 2 is an image of a catheter having a structure similar to catheter 100, with the balloon in its expanded state. The dimensions of the catheter include: 19 Fr (6.3 mm) through profile; 12 Fr (4.0 mm) innermost diameter; 80 cm usable length; 25 mm balloon diameter (when expanded); and 20 mm tip portion length. The lumen shaft may be formed of a polymer material such as PEBAX® 63 supported by a strong stainless steel braid. The balloon may be formed of a compliant thermoplastic / elastomeric material such as ChronoPrene TM 25A). The tip portion may be formed of a polymer material (such as PEBAX® 35) and may be loaded with a radio-tagged marker or a radiopaque filler composition such as BaSO 4 .

[0084] Figure 3An exemplary catheter 300 is shown inserted into the coronary sinus 352 via the right atrium 350 according to at least one embodiment; the catheter 300 can be the same or similar to the catheter 100, having a proximal end 301, a distal end 302, an inner lumen shaft 304, an outer lumen shaft 306, a tip portion 308, and a balloon structure 310 disposed on a portion 312 of the inner lumen shaft 304. The balloon structure 310 is sufficiently compliant when deployed to conform to the anatomy of the coronary sinus 352 and occlude blood flow through the coronary sinus 352 into the right atrium 350 without exerting excessive force on the tissue. Figure 3 As shown, the catheter 300 is inserted beyond the middle cardiac vein (MCV) 354 to avoid obstructing blood flow from the MCV 354 to the atrium 350 .

[0085] Figures 4 to 10 Other occlusion techniques according to various embodiments of the present disclosure are shown. Figures 4 to 10 The catheter depicted in FIG. 1 may be similar in some respects to the catheter depicted in FIG. Figures 1 to 3 The catheters depicted in are similar, for example, in size, material, or structure.

[0086] Figure 4 A catheter 400 is shown that is only partially inserted into the coronary sinus 352 so that it is adjacent to the ostium of the coronary sinus 352 according to at least one embodiment. The catheter 400 includes a proximal end 401, a distal end 402, an inner lumen shaft 404, an outer lumen shaft 406, a tip portion 408, and a balloon structure 410 disposed on a portion 412 of the inner lumen shaft 404. In at least one embodiment, when deployed, the diameter of the balloon structure 410 is greater than about 15 mm, greater than about 20 mm, greater than about 25 mm, or greater than about 30 mm. In addition to the opening at the distal end 402, the tip portion 408 can also include one or more perforations to facilitate blood flow from the coronary sinus 352 and the MCV 354 into the catheter 400.

[0087] In at least one embodiment, during deployment, the outer lumen axis 406 can move distally to abut against the deployed balloon structure 410, thereby causing the balloon structure 410 to generate additional pressure against the ostium of the coronary sinus 352 to further stabilize the position of the catheter 400. In at least another embodiment, a wire structure can be used to apply pressure to the balloon structure 410. For example, the wire structure can have a sinusoidal shape that can be deployed into an expanded flower-like structure extending radially from the outer lumen axis 406 or the inner lumen axis 404. When in contact with the balloon structure 410, the wire structure can create a more uniform pressure distribution on the surface of the balloon structure 410. Prior to deployment, the wire structure can be covered by the outer lumen 406, or can be covered by an additional lumen outside the outer lumen 406.

[0088] Figure 5The use of a first catheter 500 and a second catheter 550 to individually occlude and drain the coronary sinus 352 and the MCV 354, respectively, is shown in accordance with at least one embodiment. The first catheter 500 includes a proximal end 501, a distal end 502, a lumen axis 504, a tip portion 508, and a balloon structure 510 disposed on a portion 512 of the lumen axis 504. Similarly, the second catheter 550 includes a proximal end 551, a distal end 552, a lumen axis 554, a tip portion 558, and a balloon structure 560 disposed on a portion 562 of the lumen axis 554. In this configuration, the first catheter 500 is inserted into the coronary sinus 352 such that the balloon structure 510 does not occlude the MCV 354, while the second catheter 550 is inserted directly into the MCV 354. The sizes of the first catheter 500 and the second catheter 550 can be selected to provide safe and effective occlusion of the coronary sinus 352 and the MCV 354, respectively.

[0089] Figure 6 According to at least one embodiment, Figure 5 A variation of the invention is shown in which two catheters are used, only one of which has a balloon structure. The first catheter 600 includes a proximal end 601, a distal end 602, a lumen axis 604, a tip portion 608, and a balloon structure 610 disposed on a portion 612 of the lumen axis 604. The second catheter 650 includes a proximal end 651, a distal end 652, a lumen axis 654, and a tip portion 658, and does not include a balloon structure. The first catheter 600 is inserted into the coronary sinus 352 such that a portion of the balloon 610 occludes the MCV 354 and is partially located within the atrium 350 and the coronary sinus 352. The catheter 650 is directly inserted into the MCV 354 and disposed between the vessel wall and the balloon 610, which at least partially occludes the MCV 354.

[0090] Figure 7The use of a single catheter 700 including multiple balloons is shown according to at least one embodiment. The catheter 700 includes a proximal end 701, a distal end 702, a lumen shaft 704, a tip portion 708, a first balloon structure 710 disposed on a first portion 712 of the lumen shaft 704, and a second balloon structure 720 disposed on a second portion 722 of the lumen shaft 704. In at least one embodiment, the catheter 700 is designed for insertion into the coronary sinus 352 such that the first balloon structure 710 occludes the coronary sinus 352 and the second balloon structure 720 abuts the ostium of the coronary sinus 352 to occlude the MCV 354 (and further occlude the coronary sinus 352). The intermediate portion 724 of the lumen shaft 704 between the first balloon structure 710 and the second balloon structure 720 includes one or more perforations to allow drainage of the MCV 354. In at least one embodiment, the expanded diameter of the second balloon structure 720 is greater than the expanded diameter of the first balloon structure 710. In at least one embodiment, catheter 700 is a multi-lumen catheter designed to allow each balloon to be deployed and deflated independently of the others.

[0091] Figure 8 A catheter 800 including a partially coated and recaptureable stent structure 810 is shown according to at least one embodiment. The catheter 800 includes a proximal end 801 and a distal end 802, an inner lumen shaft 804 coupled to the stent structure 810, and an outer lumen shaft 806. A portion of the outer lumen shaft 806 is depicted as a cross-sectional view to show the inner lumen shaft 804 therein. The stent structure 810 is depicted in its deployed state, but can be housed within the outer lumen shaft 806 prior to deployment. The stent structure 810 is further depicted as having a proximal coated portion 810A, which can be formed of a flexible and durable polymer material, and a distal uncovered portion 810B. When inserted into the coronary sinus 352, as shown, the coated portion 810A blocks blood flow from the coronary sinus 354, while the uncovered portion 810A provides structural support within the coronary sinus 354 while allowing blood to flow directly from the coronary sinus 352 and MCV 354 into the catheter 800. In at least one embodiment, the catheter 800 can be used as an irrigation catheter connected to a supply line.

[0092] Fig. 9A catheter 900 is shown including an expandable and retractable stent structure 920 according to at least one embodiment. The catheter 900 also includes a proximal end 901, a distal end 902, a lumen shaft 906, a tip portion 908, and a balloon structure 910 disposed on a portion 912 of the lumen shaft 906. The catheter 900 may also include an outer lumen shaft (not shown) that substantially encapsulates the stent structure 920 and the balloon structure 910 before they are expanded. The expansion of the stent structure 920 may be performed by moving the outer lumen shaft in a proximal direction, and the retraction of the stent structure 920 may be performed by moving the outer lumen shaft in a distal direction. The stent structure 920 may be formed of, for example, stainless steel and disposed between the balloon structure 910 and the tip portion 908. In at least one embodiment, the lumen shaft 906 includes at least one perforation along a portion 922 between the balloon structure 910 and the stent structure 920 to allow the MCV 354 to drain into the catheter 900. When inserted into the coronary sinus 352 , the balloon structure 910 abuts the ostium of the coronary sinus 352 .

[0093] Fig.10 A catheter 1000 including a coated disc-shaped stent structure 1010 according to at least one embodiment is shown. The catheter 1000 also includes a proximal end 1001, a distal end 1002, an outer luminal shaft 1006, an inner luminal shaft 1004, and a tip portion 1008. The stent structure 1010 can be formed by, for example, a stainless steel stent with a durable polymer covering. The outer luminal shaft 1006 can cover the stent structure 1010 before it is deployed. Once the catheter 1000 is correctly positioned, the outer luminal shaft 1006 can be moved in a proximal direction to enable the stent structure 1010 to be deployed. In at least one embodiment, the stent structure 1010 is coupled to a tip portion 1008, which can be partially contained within the inner luminal shaft 1004 and can be actuatable (using a wire) to deploy the stent structure 1010 when moving in a proximal direction and retract the stent structure 1010 when moving in a distal direction. In at least one embodiment, the stent structure 1010, when deployed, is large enough to occlude the coronary sinus 352 and the MCV 354 when abutting the ostium of the coronary sinus 352. In at least one embodiment, the diameter of the stent structure 1010 is about 10 mm to about 30 mm.

[0094] Irrigation catheter implementation

[0095] Embodiments of exemplary catheters for use as perfusion catheters in LRP systems are now described. In at least one embodiment, the perfusion catheter is designed to support a liquid perfusion flow rate of about 150 mL / min or greater (e.g., about 700 mL / min or greater). In embodiments where multiple perfusion catheters are used (e.g., a first catheter is inserted into the right coronary artery and a second catheter is inserted into the left coronary artery), a combined flow capacity of 700 mL / min or greater may be supported.

[0096] Certain embodiments of the retrieval catheter have advantages in the supply line for the LRP system, which is used to form a closed circuit in the heart that is not stopped when inserted into the coronary artery. The catheter described herein can be designed to meet the following criteria: ability to enter the coronary artery through the femoral artery; an outer diameter of 8 Fr or less for entering the coronary artery; an outer diameter of about 6 mm to about 8 mm for occlusion; compatibility with a 0.018-inch guidewire and a 0.014-inch pressure wire; and the ability to maintain a stable position for at least 60 minutes during the LRP procedure.

[0097] 11-16 depict various catheter embodiments suitable for use in fluid perfusion in an LRP system. Any of the catheters depicted in Figures 11 to 16 can be configured to support a liquid flow rate (aspiration or irrigation) of at least about 150 mL / min, at least about 200 mL / min, at least about 200 mL / min, at least about 250 mL / min, at least about 300 mL / min, at least about 350 mL / min, at least about 400 mL / min, at least about 450 mL / min, at least about 500 mL / min, at least about 550 mL / min, at least about 600 mL / min, at least about 650 mL / min, at least about 700 mL / min, at least about 750 mL / min, at least about 800 mL / min, at least about 850 mL / min, at least about 900 mL / min, at least about 950 mL / min, at least about 1000 mL / min, or within any range defined by any of the foregoing lower limits (e.g., from about 150 mL / min to about 1000 mL / min, about 400 mL / min to about 800 mL / min, etc.). Each catheter can be designed to have a smooth profile from the proximal catheter body to a low distal profile, for example, using one or more concentric lumen axes. In addition, the catheter can be designed to have a lumen axis pre-shaped according to the anatomical structure of the LRP procedure to be performed, which can improve the overall stability during use. Fig.17 An example of a preformed catheter lumen is shown.

[0098] In certain embodiments, one or more conduits can be multi-lumen conduits, such as double-lumen conduits. In certain embodiments, multi-lumen conduits allow liquid to flow (e.g., perfusate) and can expand one or more balloons. In certain embodiments, one or more of the conduits can be multi-balloon conduits with two or more balloons. In certain embodiments, one or more of the balloons can be independently deployed or deflated.

[0099] FIG. 11A to FIG. 11C An exemplary catheter 1100 is shown having a lumen shaft 1104 / 1106 having a proximal end 1101 and a distal end 1102 having an opening from which perfusion fluid can flow. Lumen shaft 1104 / 1106 can be formed by an outer lumen shaft 1104 that at least partially surrounds an inner lumen shaft 1106 to expose a distal portion of the inner lumen shaft 1106 near the distal end 1102. Proximal end 1101 includes an outlet structure that can be fluidically coupled to an LRP system. One or more of the outer lumen shaft 1104 or the inner lumen shaft 1106 can be formed by a durable polymer material, such as a polyether block amide (PEBA) material (e.g., commercially available PEBAX®). In at least one embodiment, the innermost diameter of the inner lumen shaft 1106 is at least about 2 mm, at least about 2.5 mm, at least about 3 mm, at least about 3.5 mm, at least about 4 mm, at least about 4.5 mm, or at least about 5 mm to provide a fluid flow path.

[0100] The catheter 1100 includes an expandable balloon structure 1110, which is arranged along a portion 1112 corresponding to the inner lumen axis 1106 and a tip portion formed by an additional lumen. In at least one embodiment, the inner lumen axis 1106 includes a concentric inner flow path surrounding a liquid flow path. The concentric inner flow path provides a gas flow path from the balloon structure 1110 to the port 1114, which can be used to inflate or deflate the balloon according to the pressure applied at the port 1114. In at least one embodiment, the outermost surface of the inner lumen axis 1106 at the portion 1112 is removed so that the portion 1112 is sealed by the balloon structure 1110 to isolate the gas flow from the concentric inner flow path to the balloon structure 1110. In at least one embodiment, the expanded diameter of the balloon structure is about 15 mm to about 30 mm, about 15 mm to about 20 mm, about 20 mm to about 25 mm, about 24 mm to about 28 mm, about 25 mm to about 30 mm, or any subrange defined therebetween (e.g., about 20 mm to about 28 mm). Fig. 11B and Fig. 11C The balloon is shown in its expanded and deflated states, respectively.

[0101] Fig.11DThe deployment of the catheter 1100 in the aorta 1150 according to at least one embodiment is shown. As shown, the catheter 1100 is pre-shaped for insertion into the aorta 1150 to facilitate navigation. In addition, the shape can take advantage of the support force of the aortic wall to further enhance stability during coronary artery occlusion and perfusion.

[0102] Figures 12 and 13 respectively show a catheter including a plug and a wedge-shaped occlusion structure, which is advantageous in adapting its shape to a blood vessel or an orifice, is made of a highly compressible and atraumatic material for safe introduction and deployment, is shorter in length than a balloon structure, and does not require an additional lumen for inflation as does a balloon structure.

[0103] FIG. 12A to FIG. 12C An exemplary catheter 1200 is shown having a lumen shaft 1204 / 1206 having a proximal end 1201 and a distal end 1202 having an opening from which perfusion fluid can flow. The lumen shaft 1204 / 1206 can be formed by an outer lumen shaft 1204 that at least partially surrounds an inner lumen shaft 1206 to expose a distal portion of the inner lumen shaft 1206 near the distal end 1202. The proximal end 1201 includes an outlet structure that can be fluidly coupled to an LRP system. One or more of the outer lumen shaft 1204 or the inner lumen shaft 1206 can be formed of a durable polymer material, such as a polyether block amide (PEBA) material (e.g., commercially available PEBAX®). In at least one embodiment, the innermost diameter of the inner lumen shaft 1206 is at least about 2 mm, at least about 2.5 mm, at least about 3 mm, at least about 3.5 mm, at least about 4 mm, at least about 4.5 mm, or at least about 5 mm to provide a fluid flow path.

[0104] The catheter 1200 also includes a plug 1210 near the distal end 1202. In at least one embodiment, the plug 1210 is formed of a flexible material such as silicone or a foam material. In at least one embodiment, the plug 1210 includes an inner portion 1210A that fits onto the inner lumen shaft 1206; and a flexible outer portion 1210B that is shaped to be retractable in a retracted state ( Fig. 12A ) and the extended state ( Fig. 12C ) are configured between the distal ends, and in the extended state, the outer portion 1210B extends distally from the distal end 1202. Fig. 12A The plug 1210 in FIG. 1 is shown as tapering in the distal direction. In at least one embodiment, the plug 1210 can be reversed so that it tapers in the proximal direction. In at least one embodiment, the outer lumen 1204 can be configured to cover the plug 1210 before it is deployed.

[0105] Fig.12DThe deployment of the catheter 1200 in the aorta 1150 is shown according to at least one embodiment. The pressure of arterial blood flowing into the hollow space between the inner portion 1210A and the outer portion 1210B of the plug 1210 can help improve the seal of the catheter 1200 within the coronary artery. As shown, the catheter 1200 is pre-shaped for insertion into the aorta 1150 to facilitate navigation. In addition, the shape can take advantage of the support force of the aortic wall to further enhance the stability during coronary artery occlusion and perfusion.

[0106] FIG. 13A to FIG. 13C An exemplary catheter 1300 is shown having a lumen shaft 1304 / 1306 having a proximal end 1301 and a distal end 1302 having an opening from which perfusion fluid can flow. Lumen shaft 1304 / 1306 can be formed by an outer lumen shaft 1304 that at least partially surrounds an inner lumen shaft 1306 to expose a distal portion of the inner lumen shaft 1306 near the distal end 1302. Proximal end 1301 includes an outlet structure that can be fluidically coupled to an LRP system. One or more of the outer lumen shaft 1304 or the inner lumen shaft 1306 can be formed of a durable polymer material, such as a polyether block amide (PEBA) material (e.g., commercially available PEBAX®). In at least one embodiment, the innermost diameter of the inner lumen shaft 1306 is at least about 2 mm, at least about 2.5 mm, at least about 3 mm, at least about 3.5 mm, at least about 4 mm, at least about 4.5 mm, or at least about 5 mm to provide a fluid flow path.

[0107] The catheter 1300 also includes a wedge 1310 near the distal end 1302, which is shaped to fit a blood vessel or an orifice. In at least one embodiment, the wedge 1310 is formed of a flexible material, such as silicone or a foam material. In at least one embodiment, the outer lumen shaft 1304 can be configured to cover the wedge 1310 before it is deployed.

[0108] Fig.13D The deployment of the catheter 1300 in the aorta 1150 according to at least one embodiment is shown. As shown, the catheter 1300 is pre-shaped for insertion into the aorta 1150 to facilitate navigation. In addition, the shape can take advantage of the support force of the aortic wall to further enhance stability during coronary artery occlusion and perfusion.

[0109] FIG. 14A to FIG. 14C An exemplary catheter 1400 including a partially covered and recaptured stent structure 1406 is shown, similar to the embodiment of the present invention. Figure 814. The catheter 1400 is shown inserted into a coronary artery 1452 via an aorta 1450. In certain embodiments, the catheter 1400 includes an outer lumen shaft 1402 and an inner lumen shaft 1404 coupled to a stent structure 1406. The stent structure 1406 is further depicted as having a proximal coated portion, which may be formed of a flexible and durable polymer material, and a distal uncovered portion. Fig. 14B and Fig. 14C The placement and deployment of the stent structure 1406 are shown respectively when inserted into the coronary artery 1452. Deployment of the stent structure 1406 is performed by moving the outer lumen shaft 1402 in the proximal direction.

[0110] Fig.15A and Fig. 15B An exemplary catheter 1500 including a releasable coated braided disc 1510 is shown according to at least one embodiment. The catheter 1500 includes an outer lumen shaft 1506 and an inner lumen shaft 1504. During placement of the catheter 1500, the braided disc 1510 is contained within the outer lumen shaft 1506 and can be deployed by moving the outer lumen shaft 1506 in a proximal direction. In certain embodiments, when deployed, the braided disc 1510 does not expand beyond the distal end 1502 and is used to stabilize the catheter 1500 at the ostium of the coronary artery 1452 to reduce the risk of stenosis during occlusion of the coronary artery 1452 while allowing the distal end 1502 to extend into the coronary artery 1452.

[0111] FIG. 16A to FIG. 16D An exemplary catheter 1600 is shown, which has a lumen shaft 1606 having a proximal end 1601 and a distal end 1602, the distal end having an opening from which the perfusion fluid can flow out. The proximal end 1601 includes an outlet structure that can be fluidically coupled to the LRP system. The lumen shaft 1604 can be formed of a durable polymer material, such as a polyether block amide (PEBA) material (e.g., commercially available PEBAX®). In at least one embodiment, the innermost diameter of the lumen shaft 1606 is at least about 2 mm, at least about 2.5 mm, at least about 3 mm, at least about 3.5 mm, at least about 4 mm, at least about 4.5 mm, or at least about 5 mm to provide a liquid flow path. In at least one embodiment, the proximal portion 1606A of the lumen shaft 1606 can have a larger diameter than the distal portion 1606B of the lumen shaft 1606, and can taper over the length of the lumen shaft 1606.

[0112] Fig. 16CThe deployment of catheter 1600 in aorta 1150 according to at least one embodiment is shown. As shown, catheter 1600 is pre-shaped for insertion into aorta 1150 to facilitate navigation. In addition, the shape can take advantage of the support force of the aortic wall to further enhance stability during coronary artery occlusion and perfusion.

[0113] In the foregoing description, many specific details, such as specific materials, dimensions, process parameters, etc., are set forth to provide a thorough understanding of the present invention. Specific features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments. The words "exemplary" or "exemplary" are used herein to indicate use as examples, instances, or illustrations. Any aspect or design described herein as "exemplary" or "exemplary" need not be interpreted as being more preferred or more advantageous than other aspects or designs. Rather, the use of the words "exemplary" or "exemplary" is intended only to present concepts in a specific manner. As used in this application, the term "or" is intended to represent an inclusive "or", not an exclusive "or". That is, unless otherwise specified or clear from the context, "X includes A or B" is intended to represent any natural inclusive arrangement. That is, if X includes A; X includes B; or X includes both A and B, then "X includes A or B" is satisfied in any of the foregoing cases. References to "embodiments", "certain embodiments" or "one embodiment" throughout this patent specification mean that specific features, structures, or characteristics described in conjunction with the embodiments are included in at least one embodiment. Thus, the appearances of the phrases "an embodiment," "certain embodiments," or "one embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment.

[0114] The present invention has been described with reference to specific exemplary embodiments of the present invention. Therefore, the description and the accompanying drawings are to be considered in an illustrative rather than a restrictive sense. Various modifications of the present invention, except those shown and described herein, will be apparent to those skilled in the art and are intended to fall within the scope of the appended claims.

Claims

1. A retrieval catheter, comprising: a luminal axis having a proximal end and a distal end; an expandable balloon structure disposed proximate the distal end of the luminal shaft; as well as a tip portion located between the expandable balloon structure and the distal end of the tubular shaft, Wherein the retrieval catheter is configured to support a fluid flow rate of approximately 400 mL / min or greater.

2. The retrieval catheter of claim 1, wherein the tip portion comprises an elongated shaft extending from the expandable balloon structure to the distal end of the lumen shaft. 3 . The retrieval catheter of claim 2 , wherein the tip portion comprises a distal opening at the distal end and a plurality of perforations along the elongated shaft.

4. The retrieval catheter of claim 2, wherein the length of the elongated shaft of the tip portion is about 2 mm to about 35 mm, about 5 mm to about 30 mm, about 10 mm to about 25 mm, or about 15 mm to 25 mm.

5. A retrieval catheter according to any of the preceding claims, wherein the inner diameter of the lumen shaft is at least about 2 mm.

6. A retrieval catheter according to any of the preceding claims, wherein the expanded diameter of the expandable balloon structure is about 15 mm to about 30 mm, about 15 mm to about 20 mm, about 20 mm to about 25 mm, about 24 mm to about 28 mm, or about 25 mm to about 30 mm.

7. A retrieval catheter according to any of the preceding claims, wherein the tubular lumen shaft is a multi-lumen shaft comprising at least two lumen shafts.

8. A retrieval catheter according to claim 7, wherein the multi-lumen shaft includes an inner lumen shaft and an outer lumen shaft, the outer lumen shaft at least partially surrounding the inner lumen shaft to expose a proximal portion of the inner lumen shaft near the proximal end of the lumen shaft, and wherein the expandable balloon structure and the tip portion are disposed on the inner lumen shaft.

9. The retrieval catheter according to any one of the preceding claims, wherein the retrieval catheter is a multi-balloon catheter further comprising at least an additional expandable balloon structure disposed adjacent to the expandable balloon structure.

10. The retrieval catheter of claim 9, wherein the additional expandable balloon structure has an expanded diameter that is larger than the expanded diameter of the expandable balloon structure.

11. The retrieval catheter of claim 9 or 10, wherein a portion of the lumen shaft between the expandable balloon structure and the additional expandable balloon structure comprises one or more perforations.

12. The retrieval catheter of claim 1, further comprising: A stent structure is disposed on a portion of the luminal shaft between the tip portion and the expandable balloon structure.

13. The retrieval catheter of claim 12, further comprising: A perforation is formed along the luminal axis between the expandable balloon structure and the stent structure and / or between the stent structure and the distal end.

14. A retrieval catheter comprising: a luminal axis having a proximal end and a distal end; a coated disc-shaped stent structure disposed near the distal end of the luminal axis; as well as a tip portion located between the coated disc-shaped stent structure and the distal end of the luminal axis, Wherein the retrieval catheter is configured to support a fluid flow rate of approximately 400 mL / min or greater.

15. The retrieval catheter of any of the preceding claims, wherein the tip portion comprises a radio-marker or a radiopaque filler composition.

16. A retrieval catheter comprising: a luminal axis having a proximal end and a distal end; as well as an expandable stent structure disposed at the distal end of the luminal shaft, the stent structure being uncovered at a distal portion when expanded, Wherein the retrieval catheter is configured to support a fluid flow rate of approximately 400 mL / min or greater.

17. A retrieval catheter according to any of the preceding claims, wherein the retrieval catheter is configured to support a liquid flow rate of at least about 450 mL / min, at least about 500 mL / min, at least about 550 mL / min, at least about 600 mL / min, at least about 650 mL / min, at least about 700 mL / min, at least about 750 mL / min, at least about 800 mL / min, at least about 850 mL / min, at least about 900 mL / min, at least about 950 mL / min, or at least about 1000 mL / min.

18. An irrigation catheter comprising: a luminal axis having a proximal end and a distal end; an occlusive structure near the distal end of the tubular shaft, the occlusive structure being adapted to seal perfused blood from systemic blood circulation when inserted into a blood vessel, the occlusive structure being selected from: Balloon; a plug configurable between a retracted state and an extended state; a wedge shaped to fit a blood vessel or an orifice; releasable covered stent; releasable braided disc; and a tip portion comprising an elongated shaft extending from the occlusive structure to the proximal end of the lumen shaft, the tip portion comprising a proximal opening at the proximal end, Wherein the perfusion catheter is configured to support a fluid flow rate of approximately 400 mL / min or greater.

19. The irrigation catheter of claim 18, wherein the occlusive structure comprises the plug configurable between a retracted state and an extended state, wherein a portion of the plug extends distally from the tip portion when in the extended state.

20. An infusion catheter according to claim 18, wherein the occlusive structure includes a releasable coated stent, wherein the tubular shaft includes an outer sheath covering the releasable coated stent, and wherein when the sheath is retracted proximally, the releasable coated stent is expanded beyond the distal end of the tubular shaft, and the expanded diameter of the releasable coated stent is greater than the diameter of the tubular shaft.

21. The perfusion catheter of claim 18, wherein the occlusive structure comprises the releasable braided disc, wherein the tubular shaft comprises an outer sheath covering the releasable braided disc, wherein when the sheath is retracted proximally, the releasable braided disc expands to an expanded diameter greater than a diameter of the tubular shaft, and wherein the tip portion extends distally beyond the releasable braided disc when the releasable braided disc is expanded.

22. The perfusion catheter of any one of claims 18 to 21, wherein the perfusion catheter is configured to support a fluid flow rate of at least about 450 mL / min, at least about 500 mL / min, at least about 550 mL / min, at least about 600 mL / min, at least about 650 mL / min, at least about 700 mL / min, at least about 750 mL / min, at least about 800 mL / min, at least about 850 mL / min, at least about 900 mL / min, at least about 950 mL / min, or at least about 1000 mL / min.

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