System catheter for local area irrigation

Abstract

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

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 312,029, filed February 20, 2022, the disclosure of which is incorporated by reference herein in its entirety.

[0002] The present invention relates to catheters, and in particular to catheters designed to improve performance in local-regional perfusion systems. [Background technology]

[0003] Gene therapy and cell therapy techniques in treatment have attracted more attention due to their potential to be uniquely tailored and effective in addressing the pathogenic mechanisms of the root causes of various pathologies. Nevertheless, issues remain regarding delivery, including vector efficiency, dosage, specificity, and safety. Therefore, further research is needed to target ways to achieve more targeted and homogenous delivery of drugs suitable for treating various pathologies. In addition, improved devices are needed to facilitate local delivery of gene therapy drugs into the body to treat target organs, for example, by isolating the target organs from the systemic circulation.

[0004] The above and other features of the present disclosure, its nature and various advantages will become apparent from a consideration of the following detailed description taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0005] [Figure 1] 1 illustrates an exemplary retrieval catheter having a lumen shaft having a proximal end and a distal end, in accordance with at least one embodiment. [Diagram 2] 1 is an image of a deployed catheter having a balloon according to at least one embodiment. [Diagram 3] 1 illustrates the insertion of an exemplary catheter into the coronary sinus via the right atrium, in accordance with at least one embodiment. [Figure 4] 1 illustrates a catheter only partially inserted into the coronary sinus so as to abut the ostium of the coronary sinus, in accordance with at least one embodiment. [Diagram 5] 1 illustrates the use of a two-catheter system, according to at least one embodiment. [Figure 6] 1 illustrates a variation of a two-catheter system according to at least one embodiment. [Figure 7] 1 illustrates the use of a single catheter including multiple balloons in accordance with at least one embodiment. [Figure 8] 1 illustrates a catheter including a partially covered, recaptureable stent structure according to at least one embodiment. [Figure 9] 1 illustrates a catheter including a deployable and contractible stent structure in accordance with at least one embodiment. [Figure 10] 1 illustrates a catheter including a disc-shaped covered stent structure according to at least one embodiment. [Figure 11A] 1 illustrates a first exemplary perfusion catheter having a deployable balloon in accordance with at least one embodiment. [Figure 11B] 1 illustrates a first exemplary perfusion catheter with a balloon in a deployed state in accordance with at least one embodiment. [Figure 11C] 1 illustrates a first exemplary perfusion catheter with a balloon in a deflated state in accordance with at least one embodiment. [Figure 11D] 1 illustrates the deployment of a first exemplary perfusion catheter in the aorta, according to at least one embodiment. [Figure 12A] 1 illustrates a second exemplary perfusion catheter having a plug in accordance with at least one embodiment. [Figure 12B] 1 illustrates a plug of a second exemplary perfusion catheter in a contracted state in accordance with at least one embodiment. [Figure 12C] 1 illustrates a plug of a second exemplary perfusion catheter in an extended state in accordance with at least one embodiment. [Figure 12D]1 illustrates the deployment of a second exemplary perfusion catheter in the aorta, according to at least one embodiment. [Figure 13A] 1 illustrates a third exemplary perfusion catheter having a wedge in accordance with at least one embodiment. [Figure 13B] 1 illustrates a third exemplary perfusion catheter wedge in accordance with at least one embodiment. [Figure 13C] FIG. 13 shows a further view of a wedge of a third exemplary perfusion catheter in accordance with at least one embodiment. [Figure 13D] 13 illustrates the deployment of a third exemplary perfusion catheter in the aorta, according to at least one embodiment. [Figure 14A] 13 illustrates a fourth exemplary perfusion catheter including a partially covered, recaptivable delivery structure according to at least one embodiment. [Figure 14B] 13 illustrates the deployment of a stent structure on a fourth exemplary perfusion catheter, according to at least one embodiment. [Figure 14C] 13 illustrates the deployment of a stent structure of a fourth exemplary perfusion catheter according to at least one embodiment. [Figure 15A] 13 illustrates a fifth exemplary perfusion catheter including a releasable coated braided disk in accordance with at least one embodiment. [Figure 15B] 13 illustrates a releasable coated braid disk of a fifth exemplary perfusion catheter in a deployed state in accordance with at least one embodiment. [Figure 16A] 1 illustrates a sixth exemplary perfusion catheter in accordance with at least one embodiment. [Figure 16B] 13 illustrates a sixth exemplary perfusion catheter placement according to at least one embodiment. [Figure 16C] 13 illustrates the deployment of a sixth exemplary perfusion catheter in the aorta, according to at least one embodiment. [Figure 16D] 13 illustrates a pre-shaped catheter lumen for a sixth exemplary perfusion catheter, according to at least one embodiment. [Figure 17]1 illustrates a preformed lumen shaft according to various embodiments. Summary of the Invention

[0006] The following presents a simplified summary of various aspects of the present disclosure to provide a basic understanding of such aspects. This summary is not an extensive overview of the disclosure. It is not intended to identify key or critical elements of the disclosure, nor to describe the scope of any particular embodiments of the disclosure or the scope of the claims. The sole purpose of this summary is to present some concepts of the disclosure in a simplified form as a prelude to the more detailed description that is presented later.

[0007] One aspect of the disclosure relates to a retrieval catheter that includes a lumen shaft having a proximal end and a distal end, an expandable balloon structure disposed near the distal end of the lumen shaft, and a tip between the balloon structure and the distal end of the lumen shaft, In at least one embodiment, the retrieval catheter is designed to support a fluid flow rate of about 150 mL / min or greater, or about 400 mL / min or greater.

[0008] In at least one embodiment, the tip section includes an elongate shaft extending from the balloon portion to the distal end of the lumen shaft. In at least one embodiment, the tip section includes a distal opening at the distal end and a plurality of perforations along the elongate shaft. In at least one embodiment, the length of the elongate shaft of the tip section 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 about 25 mm.

[0009] In at least one embodiment, the inner diameter of the lumen shaft is at least about 2 mm.

[0010] In at least one embodiment, the expanded diameter of the balloon structure is from about 15 mm to about 30 mm, from about 15 mm to about 20 mm, from about 20 mm to about 25 mm, from about 24 mm to about 28 mm, or from about 25 mm to about 30 mm.

[0011] In at least one embodiment, the lumen shaft is a multi-lumen shaft comprising at least two lumen shafts.

[0012] In at least one embodiment, the multi-lumen shaft includes an inner lumen shaft and an outer lumen shaft, the outer lumen shaft at least partially enclosing the inner lumen shaft to expose a proximal portion of the inner lumen shaft near a proximal end of the lumen shaft, In at least one embodiment, the balloon structure and the tip are disposed on the inner lumen shaft.

[0013] In at least one embodiment, the retrieval catheter is a multi-balloon catheter and 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 longer than the expanded diameter of the main balloon structure. In at least one embodiment, the portion of the lumen shaft between the balloon structures includes one or more perforations.

[0014] In at least one embodiment, the retrieval catheter further comprises a stent structure disposed in a portion of the lumen shaft between the tip and the balloon structure.

[0015] In at least one embodiment, the retrieval catheter further includes perforations along the lumen shaft between the balloon structure and the stent structure and / or between the stent structure and the distal end.

[0016] Another aspect of the present disclosure relates to a retrieval catheter including a lumen shaft having a proximal end and a distal end, a disc-shaped covered stent structure disposed near the distal end of the lumen shaft, and a tip portion between the disc-shaped covered stent structure and the distal end of the lumen shaft, hi at least one embodiment, the retrieval catheter is designed to support a fluid flow rate of about 150 mL / min or greater, or about 400 mL / min or greater.

[0017] In at least one embodiment, the tip comprises a radiographic marker or a radiopaque filler composition.

[0018] Another aspect of the present disclosure relates to a retrieval catheter comprising a luminal shaft having a proximal end and a distal end, and a deployable stent structure disposed at the distal end of the luminal shaft, the stent structure comprising a covering at a proximal portion. In at least one embodiment, the stent structure is uncovered at a distal portion when deployed. In at least one embodiment, the retrieval catheter is designed to support a fluid flow rate of about 150 mL / min or greater, or about 400 mL / min or greater.

[0019] In at least one embodiment, any of the aforementioned recovery catheters are 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, at least about 1000 mL / min. In at least one embodiment, any of the aforementioned recovery catheters are configured to support a fluid flow rate of about 150 mL / min to about 1000 mL / min.

[0020] Another aspect of the disclosure relates to a perfusion catheter comprising a lumen shaft having a proximal end and a distal end, an occlusion structure near the distal end of the lumen shaft, the occlusion structure adapted to seal perfused blood from systemic blood circulation when inserted into a conduit blood vessel, and a tip section including an elongate shaft extending from the occlusion structure to the proximal end of the lumen shaft, the tip section including a proximal opening at the proximal end. In at least one embodiment, the occlusion structure is selected from a balloon, a plug configurable between a contracted state and an expanded state, a wedge shaped to fit a vessel or ostium, a releasable covered stent, and a releasable braided disk. In at least one embodiment, the perfusion catheter is designed to support a liquid flow rate of about 150 mL / min or greater, or about 400 mL / min or greater.

[0021] In at least one embodiment, the occlusion structure includes a plug configurable between a contracted state and an extended state, hi at least one embodiment, when in the extended state, a portion of the plug extends distally from the tip.

[0022] In at least one embodiment, the occlusion structure includes a releasable covered stent. In at least one embodiment, the lumen shaft includes an outer sheath that covers the releasable covered stent. In at least one embodiment, when the sheath is retracted proximally, the releasable covered stent is deployed beyond a distal end of the lumen shaft having an expanded diameter greater than a diameter of the lumen shaft.

[0023] In at least one embodiment, the occlusion structure includes a releasable braided disk. In at least one embodiment, the lumen shaft includes an outer sheath that covers the releasable braided disk. In at least one embodiment, when the sheath retracts proximally, the releasable braided disk is deployed to have an expanded diameter that is greater than the diameter of the lumen shaft. In at least one embodiment, the tip extends distally upon deployment beyond the releasable braided disk.

[0024] In at least one embodiment, any of the aforementioned perfusion catheters are 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 approximately 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.

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

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

[0027] Also, as used herein, "perfusion," "perfused," and "perfusing" have their normal and accustomed meaning in the art and refer to administration over a period of time (usually one minute or longer) that is substantially longer than the art-recognized terms "injection" or "bolus administration" (usually less than one minute). The rate of perfusion depends at least in part on the amount administered.

[0028] Also, as used herein, "isolated," "substantially isolated," "largely 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 majority or substantially all, of the designated circulation is isolated. Also, as used herein, "partially isolated" refers to any significant portion of the designated circulation being isolated.

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

[0030] Also, as used herein, "minimally invasive" is intended to include any procedure that does not require surgical open access to the kidney or blood vessels closely associated with the kidney. Such procedures include the use of endoscopic means to access the kidney, as well as catheter-based means that rely on access via the aorta and vena cava.

[0031] Also, as used herein, "patient" refers to a subject, particularly humans (but will include non-humans), who is exhibiting clinical signs of a particular condition or symptoms indicating the need for treatment, is being prophylactically treated for a condition, or has been diagnosed with a condition to be treated.

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

[0033] Also, as used herein, "treatment of" and "treating" include the administration of a drug to reduce the severity of or prevent a condition, e.g., kidney disease or renal failure.

[0034] Also, as used herein, "active drug" refers to any substance intended to produce a therapeutic, prophylactic, or other intended effect, regardless of whether it has been approved by a government agency for that purpose.

[0035] The recitation of ranges of values ​​herein is intended to serve merely as a shorthand method of individually referring to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated herein as if it were individually recited herein. All methods described herein may be performed in any suitable order, unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended merely to facilitate understanding of certain materials and methods, and does not limit the scope of the claims. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the disclosed materials and methods. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] Certain embodiments of the present disclosure are directed to catheters for use in local regional perfusion (LRP) systems that are designed for high fluid flow rates throughout the organ in which LRP is performed, improving the sealing and isolation of the LRP circuit while providing stability to the positioning of the catheter during perfusion and collection of perfusate.

[0037] LRP can be performed in various body organs, including, but not limited to, the heart, kidney, and liver. Exemplary systems for performing LRP procedures on a non-arrested, beating heart are described in International Application No. PCT / IB2020 / 000692, filed August 26, 2020, and International Application No. PCT / EP2022 / 054361, filed February 22, 2022, the disclosures of which are incorporated herein by reference in their entirety. The coronary circulation provides blood supply to the tissues of the heart, which are numerous in the form of coronary arteries. Typically, four major coronary arteries, namely the left main and right coronary arteries, the left anterior descending artery, and the left circumflex artery, supply oxygenated blood to the heart for distribution throughout the cardiac tissue. Blood depleted of oxygen flows through the coronary sinus.

[0038] An exemplary LRP procedure of the heart includes isolating the patient's coronary circulation from the patient's systemic circulation by forming a closed circuit through the coronary circulation including a first perfusion catheter connected to a supply line, a second perfusion catheter connected to a supply line, a recovery 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 recovery catheter is inserted into the coronary sinus. A perfusion solution containing a drug suitable for treating a cardiac condition may be delivered to the myocardium while substantially isolating the patient's coronary circulation from the patient's systemic circulation using the closed circuit.

[0039] An exemplary LRP procedure in the kidney includes positioning a perfusion catheter in the renal artery of the kidney and a withdrawal catheter in the renal vein of the kidney. A closed circuit is created by the perfusion catheter and withdrawal catheter in combination with a membrane oxygenation device. The perfusion fluid then flows through the closed circuit of the renal circulation, which is substantially isolated from the patient's systemic circulation. An additional withdrawal catheter can be inserted into the bladder during perfusion to measure urine output. An exemplary system for performing an LRP procedure in the kidney is described in International Application No. PCT / EP2022 / 054360, filed February 22, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0040] An exemplary LRP procedure of the liver includes positioning a first perfusion catheter in the hepatic artery, a second perfusion catheter in the portal vein, and one or more recovery catheters in the inferior vena cava proximal to the liver. A closed circuit is created by the perfusion catheter and one or more recovery catheters in combination with one or more membrane oxygenation devices. The perfusion fluid then flows through the closed circuit of the hepatic circulation, which 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 February 22, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0041] Exemplary retrieval and perfusion catheters will now be described. Although various catheter embodiments are depicted as being deployed within the heart, it should be understood that cardiac deployment is merely exemplary. The catheters can be configured for the anatomy of the target organ in which LRP must be performed, as would be understood by one of skill in the art. Additionally, it should be understood that any of the catheters described as "retrieval catheters" can also be used as "perfusion catheters" 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 the systemic circulation, for example, to reduce or prevent exposure of the target organ to drugs or other substances introduced into the systemic circulation that may have deleterious effects on the target organ. Those skilled in the art will appreciate other applications of the catheter embodiments described herein, such as, for example, in applications in which sealing of blood vessels is desired.

[0042] Retrieval Catheter Embodiments Exemplary catheter embodiments for use as recovery catheters in the LRP system will now be described. In at least one embodiment, the recovery catheter is designed to support a liquid aspiration flow rate of about 150 mL / min or more (e.g., about 700 mL / min or more). For example, in certain embodiments, the exemplary catheter can support an in vitro aspiration flow rate of about 800 mL / min at about -80 mmHg.

[0043] Certain embodiments of retrieval catheters are advantageous for use in the return line of an LRP system used to form a closed circuit in a non-arrested beating heart when inserted into the coronary sinus. The catheters described herein can be designed to meet the following criteria: ability to access the coronary sinus via the right internal jugular vein, compatibility with introducer sheaths having an inner diameter of 24 Fr or less, compatibility with guidewires of 0.035 inches or less, ability to access, seal, and occlude coronary sinuses having vessel inner diameters of 6-20 mm in human subjects or up to 30 mm in porcine animal models, ability to avoid occlusion of prominent side veins (e.g., central cardiac veins), and ability to maintain a stable position for at least 60 minutes during the LRP procedure.

[0044] 1-10 show various catheter embodiments suitable for fluid withdrawal in an LRP system. Any of the catheters shown in Figures 1-10 may be configured to support a fluid flow rate (aspiration or irrigation) 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 any range defined by any of the foregoing lower limits (e.g., about 150 mL / min to about 1000 mL / min, about 400 mL / min to about 800 mL / min). Each catheter may be compatible with a steerable introducer sheath that provides stability, guides the distal end of the catheter, and allows the catheter to exert a directional pushing force. Each catheter may also have a pull wire integrated into its shaft assembly, allowing the portion proximal to the occluding structure to bend at angles of up to 120° to achieve better tracking and centering of the occluding structure.

[0045] In certain embodiments, one or more of the catheters may be a multi-lumen catheter, such as a double lumen catheter. In certain embodiments, the multi-lumen catheter allows for the flow of fluid (e.g., perfusion fluid) and allows for the inflation of one or more balloons. In certain embodiments, one or more of the catheters may be a multi-balloon catheter having two or more balloons. In certain embodiments, one or more of the balloons may be independently deployable or deflated.

[0046] FIG. 1 illustrates an exemplary catheter 100 having a lumen shaft 104 / 106 having a proximal end 101 and a distal end 102. The lumen shaft 104 / 106 can be formed from an outer lumen shaft 104 that at least partially surrounds the inner lumen shaft 106 and exposes a distal portion of the inner lumen shaft 106 near the distal end 102. The proximal end 101 includes an outlet structure that can be fluidly coupled to an LRP system. One or more of the outer lumen shaft 104 or the inner lumen shaft 106 can be formed from a durable polymeric material, such as a polyether block amide (PEBA) material (e.g., commercially available as PEBAX®). In at least one embodiment, the innermost diameter ("inner diameter") of the inner lumen shaft 106 is at least about 4 mm to provide a liquid flow path. In at least one embodiment, the catheter 100 can be designed to include additional lumen shafts.

[0047] The catheter 100 includes a tip section 108 at the distal end 102 and an expandable balloon structure 110 disposed along a portion 112 of the inner lumen shaft 106. In at least one embodiment, the tip section 108 includes an elongate shaft extending from the balloon structure 110 to the distal end 102. In at least one embodiment, the length of the elongate shaft of the tip section is between about 2 mm and about 35 mm, about 5 mm and about 30 mm, about 10 mm and about 25 mm, about 15 mm and about 25 mm, or any subrange defined therebetween (e.g., about 2 mm and about 5 mm). In at least one embodiment, the tip section 108 includes an opening at the distal end 102 and one or more perforations along the elongate shaft. In at least one embodiment, the tip section is formed from a pliable material that is more flexible than the material of the inner lumen shaft 106.

[0048] In at least one embodiment, the inner lumen shaft 106 includes a concentric inner flow passage surrounding the liquid flow passage. The concentric inner flow passage provides a path for gas flow from the balloon structure 110 to a port 114, which can be used to inflate or deflate the balloon depending on pressure applied at the port 114. In at least one embodiment, the outermost surface of the inner lumen shaft 106 at section 112 is removed such that section 112 is sealed by the balloon structure 110, isolating gas flow from the concentric inner flow passage 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.

[0049] FIG. 2 is an image of a catheter with a similar structure to catheter 100 with the balloon in a deployed state. The catheter dimensions include a cross profile of 19 Fr (6.3 mm), a maximum inner diameter of 12 Fr (4.0 mm), a usable length of 80 cm, a balloon diameter (deployed) of 25 mm, and a tip length of 20 mm. The lumen shaft may be formed from a polymeric material such as PEBAX® 63 supported by a strong stainless steel braid. The balloon may be formed from a flexible thermoplastic / elastomeric material such as ChronoPrene™ 25A. The tip may be formed from a polymeric material such as PEBAX® 35 and may be filled with a radiopaque filler composition such as a radiomarker or BaSO4.

[0050] 3 illustrates the insertion of an exemplary catheter 300 into the coronary sinus 352 via the right atrium 350, according to at least one embodiment. The catheter 300 may be the same as or similar to the catheter 100, and has a proximal end 301, a distal end 302, an inner lumen shaft 304, an outer lumen shaft 306, a tip 308, and a balloon structure 310 disposed on a portion 312 of the inner lumen shaft 304. The balloon structure 310, upon deployment, is flexible enough 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 creating excessive force on the tissue. As shown in FIG. 3, the catheter 300 is inserted beyond the central vein (MCV) 354 to avoid occluding flow from the MCV 354 into the atrium 350.

[0051] Figures 4-10 illustrate other occlusion techniques according to various embodiments of the present disclosure. The catheters illustrated in Figures 4-10 may, in certain aspects, be similar to the catheters illustrated in Figures 1-3 in terms of, for example, dimensions, materials, or construction.

[0052] 4 shows a catheter 400 according to at least one embodiment only partially inserted into the coronary sinus 352 such that it abuts the ostium of the coronary sinus 352. 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, the diameter of the balloon structure 410 when deployed is greater than about 15 mm, greater than about 20 mm, greater than about 25 mm, or greater than about 30 mm. The tip portion 408 may include one or more perforations in addition to the openings at the distal end 402 to facilitate blood flow from the coronary sinus 352 and the MCV 354 into the catheter 400.

[0053] In at least one embodiment, during deployment, the outer lumen shaft 406 can move distally to abut the deployed balloon structure 410, resulting in additional pressure by the balloon structure 410 against the ostium of the coronary sinus 352, further stabilizing the position of the catheter 400. In at least another embodiment, a wire structure may be utilized to apply pressure to the balloon structure 410. The wire structure may have, for example, a sinusoidal shape that is deployable into an expanded flower-like structure that extends radially from the outer lumen shaft 406 or the inner lumen shaft 404. When the wire structure contacts the balloon structure 410, it may create a more uniform pressure profile across the surface of the balloon structure 410. Before deployment, the wire structure may be covered by the outer lumen 406 or may be covered by an additional lumen outside the outer lumen 406.

[0054] 5 illustrates the use of a first catheter 500 and a second catheter 550 to separately occlude and drain the coronary sinus 352 and the MCV 354, respectively, in accordance with at least one embodiment. The first catheter 500 includes a proximal end 501, a distal end 502, a lumen shaft 504, a tip portion 508, and a balloon structure 510 disposed on a portion 512 of the lumen shaft 504. Similarly, the second catheter 550 includes a proximal end 551, a distal end 552, a lumen shaft 554, a tip portion 558, and a balloon structure 560 disposed on a portion 562 of the lumen shaft 554. In this configuration, the first catheter 500 is inserted into the coronary sinus 352, while the second catheter 550 is inserted directly into the MCV 354, such that the balloon structure 510 does not occlude the MCV 354. The dimensions of the first catheter 500 and the second catheter 550 may be selected to provide safe and effective occlusion of the coronary sinus 352 and the MCV 354, respectively.

[0055] FIG. 6 illustrates a variation of FIG. 5 using two catheters, only one of which has a balloon structure according to at least one embodiment. A first catheter 600 includes a proximal end 601, a distal end 602, a lumen shaft 604, a tip 608, and a balloon structure 610 disposed on a portion 612 of the lumen shaft 604. A second catheter 650 includes a proximal end 651, a distal end 652, a lumen shaft 654, a tip 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 inside the atrium 350 and the coronary sinus 352. The catheter 650 is inserted directly into the MCV 354 and disposed between the vessel wall and the balloon 610, thereby at least partially occluding the MCV 354.

[0056] 7 illustrates the use of a single catheter 700 including multiple balloons according to at least one embodiment. The catheter 700 includes a proximal end 701, a distal end 702, a lumen shaft 704, a tip 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). An 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, the catheter 700 is a multi-lumen catheter designed to allow each balloon to be deployed and deflated independently of each other.

[0057] 8 illustrates a catheter 800 including a partially covered, recaptureable stent structure 810 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 cutaway to show the inner lumen shaft 804 within. The stent structure 810 is shown in a deployed state, but may be contained within the outer lumen shaft 806 prior to deployment. The stent structure 810 is further depicted as having a proximal covered portion 810A, which may be formed from a flexible and durable polymeric material, and a distal uncovered portion 810B. When inserted into the coronary sinus 352, as shown, the covered portion 810A occludes blood flow out of the coronary sinus 354, while the uncovered portion 810A provides structural support within the coronary sinus 354 while allowing blood flow into the catheter 800 directly from both the coronary sinus 352 and the MCV 354. In at least one embodiment, the catheter 800 can be used as a perfusion catheter connected to a supply line.

[0058] 9 illustrates a catheter 900 including a deployable and contractable stent structure 920 according to at least one embodiment. The catheter 900 further includes a proximal end 901, a distal end 902, a lumen shaft 906, a tip portion 908, and a balloon structure 910 disposed at a portion 912 of the lumen shaft 906. The catheter 900 may further include an outer lumen shaft (not shown) that substantially encapsulates the stent structure 920 and the balloon structure 910 prior to deployment. Deployment of the stent structure 920 may be performed by moving the outer lumen shaft in a proximal direction, and contraction 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, for example, from stainless steel, and is 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 drainage of the MCV 354 into the catheter 900. When inserted into the coronary sinus 352, the balloon structure 910 abuts the ostium of the coronary sinus 352.

[0059] FIG. 10 illustrates a catheter 1000 including a disk-shaped covered stent structure 1010 according to at least one embodiment. The catheter 1000 further includes a proximal end 1001, a distal end 1002, an outer lumen shaft 1006, an inner lumen shaft 1004, and a tip section 1008. The stent structure 1010 may be formed, for example, from a stainless steel stent with a durable polymeric coating. The outer lumen shaft 1006 may cover the stent structure 1010 prior to deployment. Once the catheter 1000 is properly positioned, the outer lumen shaft 1006 may be moved proximally to allow for deployment of the stent structure 1010. In at least one embodiment, the stent structure 1010 may be partially contained within the inner lumen shaft 1004 and coupled to a tip section 1008 that is actuable (using a wire) to deploy the stent structure 1010 when moved proximally and to contract the stent structure 1010 when moved distally. In at least one embodiment, the stent structure 1010 is large enough that, when deployed, it will 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 between about 10 mm and about 30 mm.

[0060] Irfusion Catheter Embodiments Exemplary catheter embodiments for use as perfusion catheters in an LRP system will now be described. In at least one embodiment, the perfusion catheter is designed to support a liquid perfusion flow rate of about 150 mL / min or more (e.g., about 700 mL / min or more). Embodiments utilizing multiple perfusion catheters (e.g., a first catheter inserted into the right coronary artery and a second catheter inserted into the left coronary artery) can support a combined flow capacity of 700 mL / min or more.

[0061] Certain embodiments of retrieval catheters are advantageous for use in the supply line of an LRP system that is used to form a closed circuit in a non-arrested beating heart when inserted into a coronary artery. The catheters described herein can be designed to meet the following criteria: ability to femorally access the coronary arteries, outer diameter for coronary entry of 8Fr or less, outer diameter for occlusion of about 6mm to about 8mm, compatibility with 0.018 inch guidewires and 0.014 inch pressure wires, and ability to maintain a stable position for at least 60 minutes during an LRP procedure.

[0062] 11-16 show various catheter embodiments suitable for fluid perfusion in the LRP system. Any of the catheters shown in Figures 11-16 may be configured to support a fluid 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 any range defined by any of the foregoing lower limits (e.g., about 150 mL / min to about 1000 mL / min, about 400 mL / min to about 800 mL / min). Each catheter can be designed to have a smooth shape from the proximal catheter body to a low distal profile, for example, using one or more concentric lumen shafts. Additionally, the catheters can be designed to have a pre-shaped lumen shaft according to the anatomy where the LRP procedure is to be performed, which may improve overall stability during use. An example of a pre-shaped catheter lumen is shown in FIG.

[0063] In certain embodiments, one or more of the catheters may be a multi-lumen catheter, such as a double lumen catheter. In certain embodiments, the multi-lumen catheter allows for the flow of fluid (e.g., perfusion fluid) and allows for the inflation of one or more balloons. In certain embodiments, one or more of the catheters may be a multi-balloon catheter having two or more balloons. In certain embodiments, one or more of the balloons may be independently deployed or deflated.

[0064] 11A-11C show an exemplary catheter 1100 having a lumen shaft 1104 / 1106 having a proximal end 1101 and a distal end 1102 with an opening through which perfusion fluid can flow. The lumen shaft 1104 / 1106 can be formed from an outer lumen shaft 1104 that at least partially surrounds the inner lumen shaft 1106 and exposes a distal portion of the inner lumen shaft 1106 near the distal end 1102. The proximal end 1101 includes an outlet structure that can be fluidly coupled to an LRP system. One or more of the outer lumen shaft 1104 or the inner lumen shaft 1106 can be formed from a durable polymeric material, such as a polyether block amide (PEBA) material (e.g., commercially available as 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 liquid flow path.

[0065] The catheter 1100 includes an expandable balloon structure 1110 disposed along a portion 1112 corresponding to an inner lumen shaft 1106, and a distal end formed by an additional lumen. In at least one embodiment, the inner lumen shaft 1106 includes a concentric inner flow passage surrounding a liquid flow passage. The concentric inner flow passage provides a path for gas flow from the balloon structure 1110 to a port 1114, which can be used to inflate or deflate the balloon depending on pressure applied at the port 1114. In at least one embodiment, the outermost surface of the inner lumen shaft 1106 at the portion 1112 is removed such that the portion 1112 is sealed by the balloon structure 1110, isolating gas flow from the concentric inner flow passage 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, or about 25 mm to about 30 mm, or any subrange defined therebetween (e.g., about 20 mm and about 28 mm). Figures 11B and 11C show the balloon in its deployed and deflated states.

[0066] 11D illustrates the deployment of catheter 1100 within aorta 1150 in accordance with at least one embodiment. As shown, catheter 1100 is pre-shaped for insertion into aorta 1150 for ease of navigation. Additionally, the shape can utilize backup forces from the aortic wall to further enhance stability during coronary occlusion and perfusion.

[0067] 12 and 13 show catheters including plug and wedge occlusion structures, respectively, which advantageously conform their shape to a blood vessel or ostium, are formed from highly compressible and atraumatic materials for safe introduction and deployment, are short in length compared to balloon structures, and do not require an additional lumen for expansion as balloon structures require.

[0068] 12A-12C show an exemplary catheter 1200 having a lumen shaft 1204 / 1206 having a proximal end 1201 and a distal end 1202 with an opening through which perfusion fluid can flow. The lumen shaft 1204 / 1206 can be formed from an outer lumen shaft 1204 that at least partially surrounds the inner lumen shaft 1206 and exposes 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 inner lumen shaft 1206 can be formed from a durable polymeric material, such as a polyether block amide (PEBA) material (e.g., commercially available as 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 liquid flow path.

[0069] The catheter 1200 further includes a plug 1210 near the distal end 1202. In at least one embodiment, the plug 1210 is formed from 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 over the inner lumen shaft 1206 and a flexible outer portion 1210B that is shaped to be configurable between a contracted state (FIG. 12A) and an expanded state (FIG. 12C) in which the outer portion 1210B extends distally from the distal end 1202. The plug 1210 in FIG. 12A is shown as tapering distally. In at least one embodiment, the plug 1210 can be inverted so that it tapers proximally. In at least one embodiment, the outer lumen 1204 can be configured to cover the plug 1210 prior to deployment.

[0070] 12D illustrates deployment of the catheter 1200 within the aorta 1150 according to at least one embodiment. The pressure of the arterial blood flow into the hollow space between the inner portion 1210A and the outer portion 1210B of the plug 1210 may help improve sealing of the catheter 1200 within the coronary artery. As shown, the catheter 1200 is pre-shaped for insertion into the aorta 1150 for ease of navigation. Additionally, the shape can utilize backup forces from the aortic wall to further enhance stability during occlusion and perfusion of the coronary artery.

[0071] 13A-13C show an exemplary catheter 1300 having a lumen shaft 1304 / 1306 having a proximal end 1301 and a distal end 1302 with an opening through which perfusion fluid can flow. The lumen shaft 1304 / 1306 can be formed from an outer lumen shaft 1304 that at least partially surrounds the inner lumen shaft 1306 and exposes a distal portion of the inner lumen shaft 1306 near the distal end 1302. The proximal end 1301 includes an outlet structure that can be fluidly coupled to an LRP system. One or more of the outer lumen shaft 1304 or inner lumen shaft 1306 can be formed from a durable polymeric material, such as a polyether block amide (PEBA) material (e.g., commercially available as 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 liquid flow path.

[0072] The catheter 1300 further includes a wedge 1310 near the distal end 1302, which may be shaped to fit a blood vessel or ostium. In at least one embodiment, the wedge 1310 is formed from a flexible material, such as a silicone or foam material. In at least one embodiment, the outer lumen shaft 1304 may be configured to cover the wedge 1310 prior to deployment.

[0073] 13D illustrates the deployment of catheter 1300 within aorta 1150 in accordance with at least one embodiment. As shown, catheter 1300 is pre-shaped for insertion into aorta 1150 for ease of navigation. Additionally, the shape can utilize backup forces from the aortic wall to further enhance stability during coronary occlusion and perfusion.

[0074] 14A-14C illustrate an exemplary catheter 1400 including a partially covered, recaptureable stent structure 1406 according to at least one embodiment, similar to the catheter 800 described with respect to FIG. 8. The catheter 1400 is shown inserted into a coronary artery 1452 via an aorta 1450. The catheter 1400 includes an outer lumen shaft 1402 and an inner lumen shaft 1404 that, in certain embodiments, is coupled to the stent structure 1406. The stent structure 1406 is further depicted as having a proximal covered portion and a distal uncovered portion, which may be formed from a flexible and durable polymeric material. FIGS. 14B and 14C illustrate the placement and deployment, respectively, of the stent structure 1406 when inserted into the coronary artery 1452. The deployment of the stent structure 1406 is performed by moving the outer lumen shaft 1402 in a proximal direction.

[0075] 15A and 15B show an exemplary catheter 1500 including a releasable covered braided disk 1510, according to at least one embodiment. The catheter 1500 includes an outer lumen shaft 1506 and an inner lumen shaft 1504. The braided disk 1510 is housed within the outer lumen shaft 1506 during placement of the catheter 1500 and can be deployed by moving the outer lumen shaft 1506 in a proximal direction. In certain embodiments, upon deployment, the braided disk 1510 does not extend beyond the distal end 1502 and is used to stabilize the catheter 1500 against the ostium of the coronary artery 1452 to reduce the risk of stenosis while the coronary artery 1452 is occluded, while allowing the distal end 1502 to extend into the coronary artery 1452.

[0076] 16A-16D show an exemplary catheter 1600 having a lumen shaft 1606 with a proximal end 1601 and a distal end 1602 with an opening through which perfusion fluid can flow. The proximal end 1601 includes an outlet structure that can be fluidly coupled to an LRP system. The lumen shaft 1604 can be formed from a durable polymeric material, such as a polyether block amide (PEBA) material (e.g., commercially available as 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 may gradually taper over the length of the lumen shaft 1606.

[0077] 16C illustrates the deployment of a catheter 1600 within the aorta 1150 in accordance with at least one embodiment. As shown, the catheter 1600 is pre-shaped for insertion into the aorta 1150 for ease of navigation. Additionally, the shape can utilize backup forces from the aortic wall to further enhance stability during coronary occlusion and perfusion.

[0078] In the above description, many specific details are set forth, such as specific materials, dimensions, process parameters, etc., to provide a thorough understanding of the invention. Particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments. The word "example" or "exemplary" is used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as "example" or "exemplary" should not necessarily be construed as preferred or advantageous over other aspects or designs. Rather, the use of the word "example" or "exemplary" is merely intended to present a concept in a concrete manner. As used in this application, "or" is intended to mean an inclusive "or" rather than an exclusive "or." That is, unless otherwise specified or clear from the context, "X includes A or B" is intended to mean all natural inclusive permutations. That is, if X includes A, if X includes B, or if X includes both A and B, then "X includes A or B" is satisfied under any of the above illustrative examples. References throughout this specification to "an embodiment," "certain embodiment," or "one embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the appearances of the phrases "embodiment," "certain embodiment," or "one embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment.

[0079] The invention has been described with reference to specific exemplary embodiments thereof. The specification and drawings are accordingly to be regarded in an illustrative rather than a restrictive sense. Various modifications of the invention in addition to those shown and described herein will become apparent to those skilled in the art and are intended to fall within the scope of the appended claims.

Claims

1. 1. A retrieval catheter comprising: a lumen shaft having a proximal end and a distal end; an expandable balloon structure disposed near the distal end of the lumen shaft; and a tip portion between the expandable balloon structure and the distal end of the lumen shaft; The recovery catheter is configured to support a fluid flow rate of 400 mL / min or greater.

2. The retrieval catheter of claim 1 , wherein the tip section includes an elongate 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 section includes a distal opening at the distal end and a plurality of perforations along the elongate shaft.

4. 3. The retrieval catheter of claim 2, wherein the elongate shaft at the distal end has a length between 2 mm and 35 mm, between 5 mm and 30 mm, between 10 mm and 25 mm, or between 15 mm and 25 mm.

5. The retrieval catheter of claim 1 , wherein the inner diameter of the lumen shaft is at least 2 mm.

6. The retrieval catheter of claim 1 , wherein the expandable balloon structure has an expanded diameter of 15 mm to 30 mm, 15 mm to 20 mm, 20 mm to 25 mm, 24 mm to 28 mm, or 25 mm to 30 mm.

7. The retrieval catheter of claim 1 , wherein the lumen shaft is a multi-lumen shaft including at least two lumens.

8. 8. The retrieval catheter of claim 7, wherein the multi-lumen shaft includes an inner lumen shaft and an outer lumen shaft that at least partially encloses the inner lumen shaft and exposes a proximal portion of the inner lumen shaft near the proximal end of the lumen shaft, and the expandable balloon structure and the tip portion are disposed on the inner lumen shaft.

9. The retrieval catheter of claim 1 , wherein the retrieval catheter is a multi-balloon catheter further including at least an additional expandable balloon structure disposed adjacent to the expandable balloon structure.

10. The retrieval catheter of claim 9 , wherein the expanded diameter of the additional expandable balloon structure is greater than the expanded diameter of the expandable balloon structure.

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

12. The retrieval catheter of claim 1 , further comprising a stent structure disposed in a portion of the lumen shaft between the tip and the expandable balloon structure.

13. The retrieval catheter of claim 12, further comprising drilling holes along the lumen shaft between the expandable balloon structure and the stent structure and / or between the stent structure and the distal end.

14. 1. A retrieval catheter comprising: a lumen shaft having a proximal end and a distal end; a disk-shaped covered stent structure disposed near the distal end of the lumen shaft; a tip portion between the disk-shaped covered stent structure and the distal end of the lumen shaft; The recovery catheter is configured to support a fluid flow rate of 400 mL / min or greater.

15. The retrieval catheter of claim 14 , wherein the tip comprises a radioactive marker or a radiopaque filler composition.

16. 1. A retrieval catheter comprising: a lumen shaft having a proximal end and a distal end; an expandable stent structure disposed at the distal end of the lumen shaft, the stent structure comprising a covering at a proximal portion and uncovered at a distal portion when deployed; The recovery catheter is configured to support a fluid flow rate of 400 mL / min or greater.

17. 17. The retrieval catheter of claim 16, wherein the retrieval catheter is configured to support a liquid flow rate of at least 450 mL / min, at least 500 mL / min, at least 550 mL / min, at least 600 mL / min, at least 650 mL / min, at least 700 mL / min, at least 750 mL / min, at least 800 mL / min, at least 850 mL / min, at least 900 mL / min, at least 950 mL / min, or at least 1000 mL / min.

18. 1. A perfusion catheter comprising: a lumen shaft having a proximal end and a distal end; an occlusion structure near the distal end of the lumen shaft, the occlusion structure adapted to seal perfused blood from the systemic blood circulation when inserted into a conduit blood vessel, the occlusion structure comprising: balloon, a plug configurable between a contracted state and an extended state; a wedge shaped to fit the vessel or ostium; releasable covered stents; a releasable blade disk; and a tip including an elongate shaft extending from the occlusion structure to the proximal end of the lumen shaft, the tip including a proximal opening at the proximal end; The perfusion catheter is configured to support a fluid flow rate of 400 mL / min or greater.

19. 20. The perfusion catheter of claim 18, wherein the occlusion structure includes the plug configurable between a contracted state and an extended state, wherein a portion of the plug extends distally from the tip when in the extended state.

20. 19. The perfusion catheter of claim 18, wherein the occlusion structure includes the releasable covered stent, the lumen shaft includes an outer sheath covering the releasable covered stent, and when the sheath is retracted proximally, the releasable covered stent is deployed beyond the distal end of the lumen shaft having an expanded diameter greater than a diameter of the lumen shaft.

21. 19. The perfusion catheter of claim 18, wherein the occlusion structure includes the releasable braided disk, the lumen shaft includes an outer sheath covering the releasable braided disk, and when the sheath is retracted proximally, the releasable braided disk is deployed with an expanded diameter greater than the diameter of the lumen shaft, and the tip extends distally beyond the releasable braided disk upon deployment.

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

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