Basket for catheter device

Abstract

To provide a catheter basket that is designed to be deployed within the complex vascular system to provide optimal treatment of vascular and arterial disease conditions such as blood clots, thrombus, and deep vein thrombosis. The basket can include a shaft with multiple cuts along a portion of its length to form multiple prongs 115 that support multiple porous tubes to form the branches of the basket. The prongs radially expand away from the longitudinal axis of the basket as the longitudinal length of the basket shortens. The prongs can also be coupled to a drug delivery system, thus enabling the disclosed basket to use both mechanical and pharmaceutical means for thrombolysis.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 15 / 808,649, filed November 9, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present invention relates to a mechanically deployable basket configuration for a catheter device, an infusion catheter, and a method for the treatment of pulmonary embolism and deep vein thrombosis. [Background technology]

[0003] Conventional catheter-directed thrombolysis methods involve injecting clot-dissolving drugs through single-lumen infusion catheters, which are usually much smaller in diameter than the blood vessel in which they are placed. In addition, blood flow through the vessel is reduced or stopped by the clot, which reduces the dispersion of the clot-dissolving drug. Catheter-directed thrombolysis devices may additionally utilize expandable baskets to mechanically open the clot, but these expandable baskets usually work best in straight vessels and do not apply well to curved vessels. For example, in the case of pulmonary embolism and pulmonary artery anatomy, large clots often get stuck in the deeper, more curved parts of the pulmonary artery, making them difficult to treat. Simultaneous monitoring of important vital signs, such as blood pressure, in the blocked vessel is also not possible during deployment of current catheter-directed thrombolysis devices.

[0004] There is a need in the art for improved baskets and infusion catheters that address the above limitations. Summary of the Invention [Problem to be solved by the invention]

[0005] SUMMARY OF THE PRESENT EMBODIMENT The present invention addresses the above-mentioned needs by providing a deployable basket, an infusion catheter, and a method for treating a thrombus in a blood vessel. [Means for solving the problem]

[0006] In one aspect, the disclosure provides a basket for an infusion catheter, the basket comprising: a shaft defining a longitudinal axis including a wall having an inner surface and an outer surface and a lumen extending between a distal end and a proximal end, wherein a plurality of cuts between the inner and outer surfaces of the wall along at least a portion of the shaft form a plurality of tines; and a plurality of tubes, each tube including a wall having an inner and outer surface and a lumen extending between a distal end and a proximal end, wherein each of the plurality of tines of the shaft is disposed within the lumen of each of the plurality of tubes to form a plurality of limbs, wherein a distal end of each of the plurality of limbs is attached and a proximal end of each of the plurality of limbs is attached.

[0007] In some embodiments, the basket for an infusion catheter of the present application comprises a shaft defining a longitudinal axis, the shaft including a wall having an inner surface and an outer surface and a lumen extending between a distal end and a proximal end, a plurality of helical cuts between the inner and outer surfaces of the wall along at least a portion of the shaft forming a plurality of prongs, the proximal end of the shaft being uncut; a plurality of tubes, each tube including a wall having an inner and outer surface and a lumen extending between a distal end and a proximal end; and a plurality of tubes fused together and cut along the shaft. a plurality of tubes fused to an outer surface of the shaft at a proximal end thereof without a lumen; each of the plurality of prongs of the shaft being disposed within a lumen of each of the plurality of tubes to form a plurality of branches; the plurality of prongs individually support the branches between the proximal and distal ends of the prongs without interconnecting the prongs; and the distal ends of each of the plurality of branches are attached together.

[0008] In some embodiments, the branches of the basket deploy from a first position to a second position when the longitudinal length of the basket decreases.

[0009] In some embodiments, in the first position the branches of the basket are in a closed state, hi some embodiments, the branches of the basket radially expand away from the longitudinal axis as the longitudinal length of the basket shortens.

[0010] In some embodiments, the shaft comprises a shape memory material, hi some embodiments, the shape memory material is a Nitinol alloy of Nickel-Titanium.

[0011] In some embodiments, the plurality of cuts are formed by laser cutting. In some embodiments, the plurality of cuts are spiral and rotate at least 360 degrees over the length of the deployable infusion basket. In some embodiments, the plurality of spiral cuts rotate at least 450 degrees over the length of the deployable infusion basket. In some embodiments, the plurality of cuts do not extend to the proximal end of the shaft.

[0012] In some embodiments, each of the plurality of tubes is porous. In some embodiments, each of the plurality of tubes includes a plurality of injection ports extending between the inner and outer surfaces of the walls of the tube. In some embodiments, the injection ports are holes having a diameter between 0.001 and 0.006 inches.

[0013] In some embodiments, the basket is between 3 and 8 inches long. In some embodiments, the basket is about 6 inches long.

[0014] In some embodiments, the basket further includes fiber optic material disposed within the lumen of at least one of the plurality of tubes.

[0015] In another aspect, the disclosure provides a catheter including a basket, the basket including a shaft defining a longitudinal axis including a wall having an inner surface and an outer surface and a lumen extending between a distal end and a proximal end, a plurality of helical cuts between the inner and outer surfaces of the wall along at least a portion of the shaft forming a plurality of prongs, and a plurality of tubes, each tube including a wall having an inner and outer surface and a lumen extending between a distal end and a proximal end, each of the plurality of prongs of the shaft disposed within the lumen of each of the plurality of tubes forming a plurality of branches, a distal end of each of the plurality of branches being the proximal ends of each of the plurality of branches are attached, the catheter further comprising: an elongated inner shaft including a wall having an inner surface and an outer surface and a lumen extending between a distal end and a proximal end, the elongated inner shaft being coaxially disposed within the shaft lumen and attached to the distal end of the basket; and an outer shaft including a wall having an inner surface and an outer surface and a lumen extending between a distal end and a proximal end, the outer shaft being coaxially disposed around the inner shaft to form a fluid compartment between an inner surface of the outer shaft and an outer surface of the inner shaft, the proximal ends of the branches of the basket being connected to the fluid compartment.

[0016] In some embodiments, the connection between the proximal ends of the tines of the basket and the fluid compartment includes a seal disposed between the inner shaft and the proximal ends of the plurality of tines.

[0017] In some embodiments, the branches of the basket deploy from a first position to a second position upon proximal movement of the inner shaft. In some embodiments, the branches of the basket expand radially away from the longitudinal axis upon proximal movement of the inner shaft. In some embodiments, each of the plurality of tubes includes a plurality of injection ports extending between an inner surface and an outer surface of the wall of the elution arm. In some embodiments, the catheter further includes fiber optic material disposed within a lumen of the inner shaft or at least one of the plurality of tubes. In some embodiments, the basket further includes an illumination source.

[0018] Also provided herein is a method of thrombolysis utilizing a catheter, comprising the steps of providing a catheter, the catheter including a basket, the basket including a shaft defining a longitudinal axis including a wall having an inner surface and an outer surface and a lumen extending between a distal end and a proximal end, a plurality of helical cuts between the inner and outer surfaces of the wall along at least a portion of the shaft forming a plurality of prongs, and a plurality of tubes, each tube including a wall having an inner and outer surface and a lumen extending between a distal end and a proximal end, each of the plurality of tubes including a plurality of injection ports extending between the inner and outer surfaces of the wall of the tube, each of the plurality of prongs of the shaft disposed within the lumen of each of the plurality of tubes forming a plurality of branches, a distal end of each of the plurality of branches being affixed, a proximal end of each of the basket branches is attached, the catheter further comprising an elongated inner shaft including a wall having inner and outer surfaces and a lumen extending between a distal end and a proximal end, the elongated inner shaft being coaxially disposed within the shaft lumen and attached to the distal end of the basket, and an outer shaft including a wall having inner and outer surfaces and a lumen extending between a distal end and a proximal end, the outer shaft being coaxially disposed around the inner shaft to form a fluid compartment between the inner surface of the outer shaft and the outer surface of the inner shaft, the proximal ends of the basket branches being coupled to the fluid compartment; advancing the infusion basket at a first location at least part way into the thrombus in the blood vessel; deploying the basket to a second location; and simultaneously infusing a therapeutic fluid through an infusion port in the branch of the basket.

[0019] In some embodiments, the tines of the basket are closed in a first position and radially expand away from the longitudinal axis in a second position, hi some embodiments, a fluid opening is created through the thrombus when the basket is deployed to the second position.

[0020] In some embodiments, the therapeutic fluid comprises a thrombolytic agent.

[0021] In some embodiments, the method further includes delivering optical energy to the thrombus. In some embodiments, the optical energy is delivered to the thrombus through fiber optic material disposed within the inner shaft or the lumen of at least one of the plurality of tubes. In some embodiments, the optical energy is delivered to the thrombus simultaneously with the injection of the therapeutic fluid.

[0022] The details of one or more embodiments of the invention are set forth in the description that follows. Other features, objects, and advantages of the invention will become apparent from the description, and from the claims.

[0023] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate presently preferred embodiments of the invention and, together with the general description above and the detailed description below, serve to explain features of the invention. [Brief description of the drawings]

[0024] [Figure 1] 1A-1C illustrate an exemplary basket frame in a first position (A) and a second position (B), as well as an assembled basket (C), according to an embodiment of the present disclosure. [Diagram 2] 1 is a photograph of a frame prior to assembly into a basket according to an embodiment of the present disclosure. [Diagram 3] 13A-13C illustrate a method for creating uniform flow along the length of an exemplary tine of a basket according to an embodiment of the present disclosure. [Figure 4] 1A-1C show exemplary internal frames in an expanded state within (A) a straight vessel, (B) a curved vessel, and (C) a vessel mimicking a more curved portion of the pulmonary artery. [Diagram 5] 1A-1C are diagrams illustrating exemplary frames with different helical pitches. [Figure 6] 1 illustrates an exemplary basket having a fiber optic component according to an embodiment of the present disclosure. [Figure 7]1A-1C show an exemplary infusion catheter device in an open or extended position (A) and a closed position (B) from a side view, and in an open or extended position (C) from an axial view, according to an embodiment of the present disclosure. [Figure 8] FIG. 1 illustrates a sealant assembly of an exemplary infusion catheter device according to an embodiment of the present disclosure. [Figure 9] FIG. 1 illustrates an exemplary infusion catheter device according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] The present invention is described more fully below, however, many modifications and other embodiments of the invention described herein will come to mind to one skilled in the art to which this invention pertains having the benefit of the teachings presented in the foregoing description. It is to be understood, therefore, that the invention is not limited to the specific embodiments disclosed, and that modifications and other embodiments are intended to be included within the scope of the appended claims.

[0026] References to features, advantages, or similar language throughout this specification do not imply that all of the features and advantages that may be realized by the present disclosure should or are present in any single embodiment of the present disclosure. Rather, language referring to features and advantages is understood to mean that the specific feature, advantage, or characteristic described in connection with an embodiment is included in at least one embodiment of the present disclosure. Thus, discussions of features and advantages and similar language may, but do not necessarily, refer to the same embodiment throughout this specification.

[0027] Furthermore, the features, advantages, and characteristics of the present disclosure described may be combined in any suitable manner in one or more embodiments. In light of the description herein, a person skilled in the relevant art will recognize that the present disclosure can be practiced without one or more of the specific features or advantages of a particular embodiment. In addition, additional features and advantages may be recognized in certain embodiments in some cases, but may not be present in all embodiments of the present disclosure.

[0028] References to "one embodiment," "an embodiment," or similar language found throughout this specification mean that a particular feature, structure, or characteristic described in connection with the indicated embodiment is included in at least one embodiment of the disclosure. Thus, the phrases "in one embodiment," "in an embodiment," and similar language found throughout this specification may, but do not necessarily, all refer to the same embodiment.

[0029] In one aspect, the present disclosure relates to a mechanically deployable basket for an infusion catheter. The basket of the present disclosure is specifically designed to be deployed within a complex vasculature for optimal treatment of vascular and arterial disease conditions such as blood clots, thrombi, and deep vein thrombosis. The basket has multiple cuts along a portion of its length to form multiple prongs. The basket may include a shaft, the prongs supporting a plurality of porous tubes to form the branches of the basket. The ends of the branches may be attached such that as the longitudinal length of the basket decreases, the branches of the basket expand radially away from the longitudinal axis of the basket. The branches may also be coupled to a drug delivery system, such that the basket of the present disclosure allows for both mechanical and pharmaceutical means of thrombolysis. Also provided herein is an infusion catheter including the basket of the present disclosure. In another aspect, the present disclosure relates to methods of treatment and methods of thrombolysis utilizing a catheter.

[0030] As used herein, the singular forms "a," "an," and "the" include plural referents unless otherwise clearly indicated by context. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0031] As used herein, the terms "about" and "approximately" can be used interchangeably and are intended to encompass variations of ±20%, ±10%, ±5%, ±1%, and ±0.1% from the specified value, where such variations are reasonable.

[0032] As used herein, the terms "communicate" and "communication" include, but are not limited to, either a direct connection or a remote connection between two or more fluid system elements that allows fluid contact between the elements.

[0033] As used herein, the term "connectable" or "connected" refers to capable of being joined together, including but not limited to, to allow fluid flow. The term "connectable" can refer to being capable of being joined together temporarily or permanently.

[0034] As used herein, the term "drug delivery system" refers to devices that allow for the controlled introduction of a therapeutic substance into a patient. These may include, for example, an infusion pump and other necessary components.

[0035] As used herein, the term "helical" refers to a helix or other three-dimensional curve disposed along the circumference of a cylinder, cone, or similar structure. The "pitch" of a helix or helical curve refers to the longitudinal distance over which the helix or helical curve completes one revolution (360°). For example, a 3 inch pitch means that the helix completes one revolution every 3 inches, while a 6 inch pitch means that the helix completes one revolution every 6 inches. A helix or helical curve can also be described by the number of degrees of revolution that the helix or helical curve completes from its starting point to its end point. For example, a 360° helix or helical curve completes a single revolution along the circumference over its length, while a 450° helix completes one and a quarter revolution and a 540° helix completes one and a half revolutions over its length.

[0036] As used herein, the terms "Luer connector" and "Luer adapter" refer to an adapter or connector that conforms to International Organization for Standardization (ISO) standard 594-2.

[0037] As used herein, a "patient" or "subject" refers to any animal species, preferably a mammalian species, and optionally a human. A subject may be an apparently healthy individual, an individual suffering from a disease, or an individual being treated for a disease.

[0038] As used herein, the term "shape memory material" refers to a shape memory alloy or a shape memory polymer. These materials are characterized by pseudoelasticity or superelasticity, a reversible elastic response to an applied stress that allows the material to return from a temporarily deformed state to a permanent original shape after the applied stress or force is removed. Exemplary shape memory alloys include copper-aluminum-nickel alloys and nickel-titanium (nitinol) alloys.

[0039] As used herein, a "therapeutic fluid" is a fluid that may be administered to a patient through the basket or catheter of the present disclosure. These "therapeutic fluids" may be inert and administered in conjunction with other therapeutic techniques and methods disclosed herein, or may contain one or more therapeutic agents. A "therapeutic agent" (or "pharmaceutical agent," "pharmaceutical active agent," "drug," or other related terms that may be used interchangeably herein) refers to an agent that can be used to treat a disease or condition (i.e., to prevent a disease or condition, or to reduce or eliminate symptoms associated with a disease or condition, or to substantially or completely eliminate a disease or condition). These agents may include thrombolytic agents used to dissolve blood clots, including, but not limited to, fibrinolytic agents such as streptokinase, urokinase, anistreplase, recombinant tissue plasminogen activator, or staphylokinase, or other thrombolytic agents as known to those skilled in the art.

[0040] As used herein, the terms "treating" and "treatment" refer to the management and care of a patient with a disease state or condition by the administration of one or more therapeutic methods contemplated by the present disclosure. Treating also includes administering one or more methods of the present disclosure or using any of the systems, devices, or compositions of the present disclosure in treating a patient. As used herein, "treatment" or "treatment" refers to therapeutic treatment and prophylactic or preventative measures. "Treating" or "treatment" includes protocols that do not necessarily require complete relief of signs or symptoms, do not necessarily require a cure, and have only a minor or incomplete effect on the patient.

[0041] As used herein, the term "vessel" refers to a bodily passageway or duct within which a basket of the present disclosure may be disposed, which may include, for example, the circulatory system, the digestive tract, the urinary tract, the biliary duct, or other passageways within the body.

[0042] Referring now to FIG. 1, an embodiment of a basket of the present disclosure is provided. As shown in FIG. 1A, the deployable basket includes a frame 110. The frame 110 includes a hollow tube or shaft including a wall having an inner surface and an outer surface and a lumen extending between its proximal end 101 and its distal end 102, defining a longitudinal axis. The wall of the shaft has a number of cuts extending longitudinally from an end of the shaft, e.g., the distal end, along a portion of its length, from the outer surface of the wall to the inner surface of the wall, thereby providing a number of prongs 115, the ends of which are free and unattached to one another. The cuts do not extend the entire length of the shaft, but rather, the other end, e.g., the proximal end, is uncut to maintain a secure attachment point between each of the prongs 115. A photograph of the frame 110 with the prongs 115 is shown in FIG. 2. As can be seen, the cuts extend from the left end of the shaft to form the prongs 115, while the right end of the shaft remains intact. The free ends of the tines 115 can be permanently or temporarily attached together to prevent movement of the free ends, particularly radially away from the longitudinal axis. For example, a cap 116 can be placed over the free ends of the tines 115, as shown in FIG. 1A. With the ends of the tines joined together, the basket frame 110 can be deployed from a closed state to an expanded state by shortening the longitudinal length L of the frame 110, i.e., by moving the proximal and distal ends closer together along the longitudinal axis, as shown in FIG. 1B. In some embodiments, the tines 115 of the frame 110 can be extended from the longitudinal length L of the frame to the expanded state. As it shortens in length it expands radially away from the longitudinal axis.

[0043] FIG. 1C shows the basket 100 fully assembled, further including a plurality of tubes 120 disposed around each of the prongs 115. The tubes may include a wall having an inner surface and an outer surface and a lumen extending between a distal end and a proximal end. In some embodiments, the tubes may be slid over the free ends of the prongs 115 before the ends of the prongs are joined. The prongs 115 of the frame 110 and the tubes 120 together form the prongs of the basket 100 of the present disclosure. The free ends of the prongs may be permanently or temporarily attached to one another by joining or bonding the free ends of the prongs 115, the tubes 120, or both together. In some embodiments, the free ends of the prongs are bonded by fusing or gluing the ends of the tubes 120 together. A cap 140 may be placed over the free ends of the prongs. It should be understood that when the prongs 115 are disposed within the lumen of the tube 120, the free ends of the prongs 115 are similarly secured together by fastening the free ends of the tube 120 together to prevent radial movement away from the longitudinal axis of the basket 100. As described above, once the free ends of the prongs 115 are joined, either directly or by fastening the ends of the tube 120, the basket 100 can be deployed to an expanded state by shortening its longitudinal length. In this manner, the frame 110 provides support for the tube 120, and the structure dictates how the basket 100 is. In some embodiments, the prongs of the basket 100 radially expand away from the longitudinal axis as their longitudinal length shortens. In this manner, the basket of the present disclosure can mechanically open a passageway through an occluded blood vessel by expanding the prongs of the basket 100 when the basket 100 is disposed within a thrombus.

[0044] Each of the tubes 120 may be porous and may include multiple ports 121 between the inner and outer surfaces of the wall of the tube 120, fluidly connecting the inner lumen of the tube 120 to the outside. One, multiple, or all ends of the tube 120 may be fluidly connected to a drug delivery system, for example, through a catheter shaft, and the porosity of the tube 120 allows for the delivery of a therapeutic substance through the basket 100. The number, size, and orientation of the ports 121 may be adjusted to obtain a desired infusion rate and to ensure uniform distribution of the therapeutic fluid along the entire length of the basket 100. The ports may be evenly distributed or non-uniform along the length of the tube 120. The ports may also be placed to achieve directional infusion. For example, the ports may be placed on the wall of the tube 120 further away from the central longitudinal axis of the basket 100, i.e., in the portion of the wall of the tube 120 that will come into contact with the blood clot when deployed. In this manner, the basket 100 of the present disclosure may therapeutically dissolve blood clots via infusion. In some embodiments, the ports 121 can be laser drilled holes having a diameter between 0.001 and 0.010 inches, with 5 to 100 ports 121 per tube 120. In some embodiments, the tube 120 can include 48 ports 121 sized between 0.001 and 0.006 inches. The design of the ports 121 can be matched to the input flow rate requirements of a drug delivery system coupled to one, more than one, or all of the lumens of the tube 120. Matching the flow rate can create an optimal back pressure in the tube 120 for uniform release of the treatment fluid along its entire length.

[0045] In some embodiments, the basket may include an additional set of outer tubes 125 including walls having inner and outer surfaces and lumens extending between distal and proximal ends disposed around each of the tubes 120, as shown in FIG. 3, which depicts a single branch of the basket 100. The outer tubes 125 may be sized such that a fluid compartment is formed between the inner surface of the wall of the outer tubes 125 and the outer surface of the wall of the tubes 120. The proximal and distal ends of the outer tube 125 can be sealed to the proximal and distal ends of the tube 120 such that the fluid compartments formed are sealed at the proximal and distal ends. The outer tube 125 can be porous and can include a number of ports 126 between the inner and outer surfaces of the wall of the outer tube, similar to the number of ports 121 on the tube 120, except that the ports 126 can be sized and spatially configured such that the flow rate of treatment fluid through the ports 126 is less than the flow rate of treatment fluid through the ports 121, e.g., the cross-sectional surface area of ​​the ports 126 is less than the surface area of ​​the ports 121. In this way, fluid flowing through the lumen of the tube 120 and expelled from the ports 121 accumulates in the fluid compartments formed and is dispersed along the longitudinal length of the branch as it is expelled through the ports 126. Thus, fluid dispersion along the entire length of the branch is ensured. In some embodiments, the ports 126 can be laser drilled holes having a diameter between 0.001 and 0.010 inches, with between 5 and 100 ports 126 per outer tube 125 .

[0046] The length of the basket 100 can be adjusted to provide the desired therapeutic benefit at the desired target location. In some embodiments, the basket 100 can be between 2 inches and 8 inches in the closed state. In some embodiments, the basket 100 is about 5 inches long in the closed state. However, as the length of the basket 100 increases, its structural properties may be affected to the detriment of its thrombolytic performance. In cases where a longer basket length is desired, one or more baskets 100 may be disposed next to each other along the same longitudinal axis. In some embodiments, an optional port 122 may be provided at the distal end 101 of the basket 100 to create a longer injection length.

[0047] In some embodiments, the basket 100 includes an optional distal catch protection basket around the distal end of the basket 110. The distal capture basket 130 may further include a distal capture basket 130 that may act as a safety net by preventing larger pieces of an embolus from embolizing elsewhere in the body. This may be a particular risk when placing the basket 100 in a large artery, such as the pulmonary artery. When the basket 100 expands, a flexible thin polymeric membrane adheres to the outer surface of the branches of the basket 100 to provide a mesh between each of the branches. When expanded, the mesh forms a parachute-shaped trap that can capture particles that may float downstream. In some embodiments, the distal capture basket 130 may include holes 131 that are sized to allow blood flow to pass through but still allow the distal capture basket 130 to capture any debris that may be generated during use of the device. In addition to capturing these clots, the ports 121 of the tubes 120 at the distal ends of the branches, i.e., within the distal capture basket 130, can be oriented inwardly toward the interior space of the distal capture basket 130, allowing any trapped fragments to be dissolved with the maximum concentration of therapeutic agent injected into the interior space. Once treatment is complete, the basket can be retracted and removed from the patient, and any remaining emboli will be captured within the distal capture basket 130, allowing them to be safely removed from the body and examined. The distal capture basket 130 can be made of any suitable material, including, but not limited to, several polymers. For example, materials such as nylon 12, polyethylene terephthalate (PET), polyether ether ketone (PEEK), polyurethane, or polyether block amide in various durometers. The exact durometer and thickness of the mesh of the distal capture basket 130 and the placement of the holes 131 can be optimized for the particular size of the basket 100 and the desired application. The mesh can be made by any standard balloon blowing method as known to those skilled in the art and then cut and attached to fit the basket, or it can be placed directly over the basket end.

[0048] As mentioned above, the frame 115 of the basket 100 is constructed from a hollow shaft with multiple cuts through the shaft wall extending from one end along a portion of the shaft's length. These cuts determine the resulting structural shape of the basket 100. In some embodiments, these cuts are made by a laser with a set of specific design patterns optimally configured to provide an open or expanded shape that conforms to the vascular anatomy when in a deployed state. These cuts may be linear, i.e., parallel to the longitudinal axis of the tube, helical, or both linear and helical. Each of the multiple cuts may be congruent, i.e., identical in configuration, and may be translated along the circumference of the shaft to be parallel to each other along the longitudinal axis. That is, each of the tines 115 formed by the multiple cuts may have a consistent width along its entire length. In other embodiments, each of the multiple cuts may not be congruent, in which case the tines 115 formed therefrom vary in width along their length.

[0049] In some embodiments, the multiple cuts are helical. In particular, it has been found that a frame 110 made with multiple helical cuts over a portion of its length creates tines 115 that provide optimal opening characteristics. As shown in FIG. 4, the resulting tines 115 from the multiple helical cuts provide uniform radial distribution of the arms and create open passage channels within the deployed geometry of the infusion basket 110 in both straight (FIG. 4A) and curved (FIG. 4B) vessels. As shown in FIG. 4C, the helically cut frame 110 is optimally designed for deployment within the pulmonary artery, expanding to a deployed state where the tines 115 push outwardly through the more curved portion of the pulmonary artery, resulting in the clot being trapped in the roof of the artery. This immediately restores blood flow to the affected area, with the added benefit of preventing the unexpected dislodging of the clot.

[0050] Additionally, uniform expansion of the internal frame 110, and therefore the tines of the basket 100, along its length ensures uniform distribution of the administered therapeutic agent, and contact between the tines and the clot ensures direct administration of the therapeutic agent to the target area of ​​the clot, improving clinical outcomes and speeding up recovery. As shown in FIG. 5, which depicts two different frames 110 with helical cuts of different pitches, the pitch of the helical cuts can be manipulated to provide desired deployment characteristics. In some embodiments, the helical cuts can have a pitch between 1 inch and 6 inches (i.e., the cuts can complete between 1 revolution per inch and 1 revolution per 6 inches about the axis of the frame 110). In some embodiments, the helical cuts can rotate between 360° and 1080° over the length of the internal frame 115. In one embodiment, the helical cuts rotate about 450° over a length of about 5 inches, i.e., have a pitch of about 4 inches. In some embodiments, the pitch of the helical cut may not be constant along the length of the frame 110, for example such that the distal end may have a larger pitch than other portions along the length of the frame.

[0051] In some embodiments, the frame 110 is constructed of a shape memory material and may be made of a nickel-titanium alloy, such as Nitinol. However, it should be understood that the frame 110 may be made of any suitable material as would be understood by one of ordinary skill in the art, including, for example, stainless steel or cobalt-chrome. The frame 110 may be electropolished and / or laser cut to form the prongs 115, followed by heat setting. Heat setting the frame 110 provides the frame 110 with its permanent shape to which it returns after deformation. In some embodiments, the frame 110 may be heat set to a closed profile with the prongs extending flat against the longitudinal axis, essentially forming the shape of the axis. The frame 110 thus heat set may then be adjusted to the longitudinal axis of the frame 110 as described above. The frame 110 can be deployed to the expanded state by applying a force to shorten the longitudinal length of the frame 110, and when the force is removed, the frame 110 will return to the closed state. In other embodiments, the frame 110 can be heat set at any stage of deployment from the fully closed state to the fully expanded state. For example, when heat set in the fully expanded state, the frame 110 can be placed in the closed state by applying a force to increase the longitudinal length of the frame, and when the force is removed, the longitudinal length will shorten and the frame 110 will return to the expanded state. An outer sheath can be placed over the heat set expanded deployable basket 110 to maintain the closed position while guiding the basket to the intended location through the vasculature. The sheath can then be removed to allow expansion at the site of the occlusion, after which the sheath can be later reinstalled to maintain the closed position and allow for removal.

[0052] In some embodiments, the basket 100 may further include fiber optic material 150 disposed within one, more, or all of the lumens of the tube 120 as shown in FIG. 6. These fiber optic materials may be coupled to light emitting devices and may be used to direct light energy, e.g., laser energy, E, from the branches of the basket 100 into the thrombus to provide another mechanism by which the occlusion may be broken down or removed. Thrombi within blood vessels typically absorb light energy at specific wavelengths that may be minimally absorbed by the walls of the vessel. In some embodiments, the light energy emitted by the fiber optic material may be at a wavelength that promotes the breakup of the thrombus without damaging the surrounding blood vessel. By delivering light energy through the fiber optic material 150 to the thrombus, in addition to mechanical compaction and infusion of therapeutic agents as described above, the baskets and catheters of the present disclosure may reduce the time required to dissolve the thrombus, which may exceed 24 hours using conventional pharmacological methods alone. In other embodiments, the fiber optic material may emit light energy that may be used for measurement or diagnostic purposes, such as determining the size or density of the thrombus.

[0053] Another feature of the basket of the present disclosure is the ability to provide simultaneous fluid injection and delivery of light energy, which allows the basket of the present disclosure to provide additional cooling benefits to the treatment site. During the light transmission and delivery as described above, excessive heat can be generated at the treatment site. Excessive heat limits the available energy levels, duration of treatment, reduces the effectiveness of the laser delivery device, and increases the risk that tissue damage may occur. The design of the basket of the present disclosure allows for fluid injection simultaneously with the delivery of light energy. As shown in Figures 6 and 7A-C, the energy and focal area of ​​the light energy delivered by the fiber 150 is the same as when fluid is injected from the branches of the basket of the present disclosure. The delivery of fluid simultaneously with the light energy results in cooling of the area where the light energy is concentrated, allowing for the use of higher energy levels, longer treatment duration, and improved overall effectiveness. The cooling fluid may be the treatment fluid or may be a biologically acceptable inert fluid such as saline. The temperature of the cooling fluid may be varied to provide varying degrees of cooling effect. In some embodiments, the temperature of the cooling fluid is between 70° and 90°F.

[0054] In some embodiments, the basket 100 can also be used to deliver radioisotopes to tissue, particularly tumors or cancers. The branches of the basket 100 can be used to carry and deliver radiation sources to the tissue to be treated. The radiation source can be, for example, a seed, isotope, liquid, or a composition or material containing such a seed, isotope, or liquid, that emits beta and / or gamma particles. For example, radioactive iodine (I 131 Radioisotopes such as Cr-1, Strontium-89, Samarium-153, Phosphorus-32, Yttrium-90, Radium-226, Cesium-137, Cobalt-60, Iridium-192, Iodine-125, and Gold-198 can be used. In some embodiments, the amount of radioisotopes in healthy tissue as the basket or catheter is delivered to the desired treatment site within the body can be increased. Heavy shielding may be required to prevent radiation damage. A catheter sheath can be made from a radiopaque material such as tantalum or tungsten-filled polymer and can be used to surround the closed basket. Once the basket is deployed at the target site, the sheath can be retracted to expose the basket and radiation source, which can then be deployed to an expanded state to irradiate the site. In this manner, beta and / or gamma particles can be delivered evenly to the treatment site, e.g., a tumor or cancer.

[0055] A catheter including a basket of the present disclosure is also provided. Referring now to FIG. 7, a catheter 700 having a proximal end 701 and a distal end 702 includes a basket 710 as described above, including a plurality of branches 711 disposed at the distal end 702 of the catheter 700. The catheter 700 further includes an inner shaft 720 including a wall having an inner surface and an outer surface and a lumen extending between the distal end and the proximal end, and is disposed coaxially within the lumen of the frame of the basket 710. The inner shaft 720 can have its distal end temporarily or permanently attached to the distal end of the basket 710, for example, by gluing or fusing the inner shaft 720 to the distal end of the branches 711 of the basket 710 and / or by a distal end cap 740. The inner shaft 720 extends from the distal end of the basket 710 beyond the proximal end of the basket 710 (not shown). The inner shaft 720 is free to move longitudinally relative to the proximal end of the basket 710. The diameter of the lumen of the inner shaft 720 can be sized to be compatible with a commercially available guidewire. Thus, the catheter 700 of the present disclosure can be threaded over a guidewire through the inner lumen of the inner shaft 720 to deploy the catheter 700 to a desired location within a blood vessel. In some embodiments, the diameter of the lumen of the inner shaft 720 is sized for use with a blood monitoring system as known to those skilled in the art. The proximal end of the inner shaft 720 can include a connectable fitting, e.g., a Luer connector, that can be connected to a blood monitoring system, such as, but not limited to, a pressure transducer system common in standard hospital catheterization labs. In this manner, the catheter of the present disclosure allows for simultaneous monitoring of the patient's vital signs during device deployment and use, which can provide an immediate indication of successful removal of the occlusion. For example, an increase in blood pressure may occur when an occlusion is present in a blood vessel, and by monitoring blood pressure during deployment and use of the catheters of the present disclosure, a prompt drop in blood pressure when blood flow is restored can indicate a successful procedure. In some embodiments, the diameter of the inner lumen of the inner shaft 720 is between 0.021 and 0.028 inches.In other embodiments, a fluid connection at the proximal end of the inner shaft 720 can be used to obtain a blood sample.

[0056] In other embodiments, the inner shaft 720 can be adapted to emit light or radiation energy in a manner similar to that described above, as shown in FIG. 7A with the arrow E extending away from the inner shaft 720. For example, fiber optic material can be inserted into the lumen of the inner shaft 720. The fiber optic material can be coupled to a light emitting device and used to direct light energy from the central axis of the basket for treatment, measurement, or diagnostic purposes. The light energy can be emitted radially away from the central axis or can be emitted along the longitudinal axis through the distal end of the inner shaft 720. The inner shaft 720 can also be used to carry and deliver a radiation source to the tissue to be treated. In such an embodiment, the branches 711 of the basket 710 can serve to center the light and / or radiation energy in a blood vessel, body passageway, or duct, as shown in FIG. 7C. Here, the branches 711 extend radially away from the inner shaft 720 and press against the inner surface of the vessel V, thereby centering the inner shaft 720 within the vessel as light or radiant energy E is emitted radially away from the inner shaft 720.

[0057] The outer shaft 730 includes a wall having an inner surface and an outer surface, and a lumen extending between a distal end and a proximal end that is coaxially disposed around a portion of the inner shaft that extends proximally beyond the end of the basket 710 to form a fluid compartment between the inner surface of the outer shaft and the outer surface of the inner shaft. The proximal end of the branch of the basket 710 is coupled to the fluid compartment, and a fluid seal 725 can be formed between the inner shaft 720 and the proximal end of the branch of the basket 710, whereby a therapeutic fluid can flow from the fluid compartment into the lumen of the tube of the branch of the basket 710 and through multiple ports in the tube to the site of the thrombus. The diameter of the outer shaft 730 is typically between 0.050 and 0.120 inches. The proximal end of the outer shaft 730 can terminate in a fitting, such as a luer connector, that can be coupled to a drug delivery system so that a therapeutic fluid can be delivered into the catheter.

[0058] In the first position, the tines of the basket 710 lie flat against the inner shaft 720 in a closed manner, as shown in FIG. 7B. In this state, the outer diameter of the basket 710 is substantially the same diameter as the outer shaft 730 and the distal end cap 740. The basket 710 can be expanded to a second open position, as shown in FIG. 7A, in which the tines extend radially outward from the longitudinal axis by moving the inner shaft 720 proximally. Moving the inner shaft 720 proximally shortens the longitudinal length of the basket 710, and the arching tines of the basket 710 bow outward, away from the inner shaft 720. Moving the inner shaft 720 distally can return the basket 710 to the first position. In this manner, the catheter 700 of the present disclosure can be delivered into a blood clot while in a closed first position, deployed to an open second position to both mechanically remove the blood clot and inject a medicinal agent to the site, and then removed back to the closed first position.

[0059] In some embodiments, the catheter 700 includes a sealant 725 disposed between the inner shaft and the proximal ends of the multiple branches, as shown in the cutaway view of FIG. 8. The distal and proximal ends 702 and 701 of the catheter 700 and outer shaft 730 are not shown. The assembly of the basket 710, including the frame 715 and the tube 716, as described above, is shown. As described above, the ends of the tube 716 can be joined together permanently or temporarily, with suitable means being employed to ensure that the various lumens remain open during the joining process (e.g., inserting mandrels into the various lumens). The inner shaft 720 is coaxially disposed within the inner lumen of the basket 710. Disposed between the inner shaft 720 and the inner lumen of the basket 710 is a sealant 725, including a wall having an outer surface and an inner surface and a lumen from the distal end to the proximal end. For example, the outer surface of the wall of the sealant 725 can be joined, either temporarily or permanently, to the lumen of the basket 710 via fusing or gluing the inner lumen of the basket 710 to the outer surface of the wall of the sealant 725, thereby sealing it. The outer shaft 730 (not shown) would be coaxially disposed about the inner shaft 720 as described above, with the distal end of the outer shaft 730 joined to the proximal end of the branch of the basket 710 to form a fluid seal between the branch of the basket 710 and the fluid compartment formed between the inner surface of the wall of the outer shaft 730 and the outer wall of the inner shaft 720. The inner diameter of the lumen of the sealant 725 is substantially the same diameter as the outer diameter of the inner shaft 720, such that the inner shaft 720 can slide longitudinally within the lumen of the sealant 725 while preventing leakage of fluid from the distal end of the fluid compartment through the inner lumen of the basket 710. In some embodiments, the inner diameter of the lumen of the sealing member 725 may be slightly larger than the outer diameter of the inner shaft 720 such that a small amount of fluid may be able to enter the space, effectively sealing the space to prevent additional fluid from escaping, while allowing the inner shaft 720 to move proximally and distally along the longitudinal axis.The ability of the sealing member 725 to prevent fluid leakage can also be controlled by varying the length of the sealing member 725, in which case shortening the distance the interface between the inner surface of its wall and the outer surface of the wall of the inner shaft 720 extends will increase its sealing ability. A lower or longer distance provides improved sealing capability. A typical length of sealing member 725 may be 2 to 8 inches and may extend a portion of the length of basket 710. As shown in FIG. 7A, sealing member 725 extends approximately half the length of basket 710.

[0060] In addition to blood vessels, the baskets and catheters of the present disclosure may be utilized in any other vessel or duct of the body in which a deployable basket can be placed, including other areas of the body, including, but not limited to, the digestive tract, the urinary tract, and portions of the bile duct, or other vessels or body passageways.

[0061] The various tubing, shafts, and seals of the baskets and catheters of the present disclosure may be of any suitable material as known to one of skill in the art, including, but not limited to, polyimide, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyvinylidene fluoride (PVDF), high density polyethylene (HDPE), nylon 6, Pebax, or nylon. The tubing may be, for example, stainless steel, shape memory metal, or braided polymer fibers.

[0062] 9 illustrates an infusion catheter device according to an embodiment of the present disclosure. The distal end of the infusion catheter 900 includes a basket 910, an inner shaft 920, an outer shaft 930, a sealing member 925, and a distal end cap 940, as generally described above. The proximal end of the infusion catheter 900 includes a handle 950. The handle further includes a slide 955, which is coupled to the proximal end of the inner shaft 920 of the infusion catheter 900. The slide 955 can be used to deploy the basket to an expanded state by moving the slide proximally, which moves the inner shaft 920 proximally and radially expands the basket 910, as generally described above. The proximal end of the inner shaft 920 can extend beyond the end of the handle 950 and terminate in a luer connector 921. This coupled luer can be coupled to a transducer for monitoring the patient's vital signs during use, or can be coupled to other components for obtaining a blood sample. The handle 950 may also include an infusion shaft 960 fluidly coupled to the proximal end of the outer shaft 930. The infusion shaft 960 terminates in a Luer connector 961 that can be coupled to a drug delivery system, such as an intravenous pump.

[0063] Also provided herein are methods of treatment and catheter-based thrombolysis. The methods may include providing an infusion catheter as described above in the present disclosure, advancing a deployable infusion basket at least partway into a thrombus in a blood vessel at a first position; deploying the deployable infusion basket to a second position; and simultaneously injecting a therapeutic agent through an infusion port in a branch of the deployable infusion basket. In some embodiments, the branch of the deployable infusion basket is in a closed state in the first position and radially expands away from the longitudinal axis in the second position. In this manner, the method of the present disclosure mechanically opens the blood vessel while simultaneously delivering a therapeutic agent to pharmacologically dissolve the clot. In some embodiments, light energy can be applied to the clot. The method of the present disclosure can be employed on any blood vessel affected by a thrombus, including but not limited to the inferior vena cava, superior vena cava, iliac vein, aorta, pulmonary artery, or pulmonary vein. As described above, the deployable infusion basket of the present disclosure is optimally designed to function in these large, tortuous vasculature.

[0064] It will be apparent to those skilled in the art that various combinations and / or modifications and variations can be made in the infusion catheter systems and devices of the present disclosure, as dictated by the particular needs dictated by the operational and patient treatment needs. Furthermore, features illustrated or described as part of one embodiment can be used with other embodiments to achieve still further improvements. An embodiment can be obtained.

Claims

1. 1. A catheter comprising: a basket comprising: a shaft including a wall having an inner surface and an outer surface and a lumen extending between a distal end and a proximal end and defining a longitudinal axis, a plurality of discontinuities between the inner surface and the outer surface of the wall along at least a portion of the shaft forming a plurality of prongs, and the proximal end of the shaft is undisturbed; and a plurality of tubes, each tube including a wall having an inner surface and an outer surface and a lumen extending between a distal end and a proximal end; each of the plurality of prongs of the shaft is disposed within the lumen of each of the plurality of tubes to form a plurality of branches; the plurality of prongs individually supporting the prongs between the proximal and distal ends of the prongs without interconnecting the prongs; a distal end of each of the plurality of branches being attached and a proximal end of each of the plurality of branches being fused together and to an exterior surface of the shaft; The catheter further comprises: an inner shaft including a wall having an inner surface and an outer surface and a lumen extending between a distal end and a proximal end, the inner shaft being coaxially disposed within the lumen of the shaft and attached to the distal end of the basket; an outer shaft including a wall having an inner surface and an outer surface and a lumen extending between a distal end and a proximal end, the outer shaft being coaxially disposed about the inner shaft to form a fluid compartment between the inner surface of the outer shaft and the outer surface of the inner shaft; The catheter, wherein the proximal ends of the branches of the basket are connected to the fluid compartment.

2. A catheter as described in claim 1, wherein the connection between the proximal ends of the branches of the basket and the fluid compartment includes a sealant disposed between the inner shaft and the proximal ends of the plurality of branches.

3. A catheter as described in claim 1, wherein moving the inner shaft in a proximal direction causes the branches of the basket to deploy from a first position to a second position.

4. A catheter as described in claim 1, wherein the branches of the basket expand radially away from the longitudinal axis when the inner axis is moved proximally.

5. The catheter of claim 1 , wherein each of the plurality of tubes includes a plurality of injection ports extending between the inner and outer surfaces of the wall of the tube.

6. The catheter of claim 1, further comprising fiber optic material disposed within the lumen of the inner shaft or at least one of the plurality of tubes.

7. The catheter of claim 1, wherein the basket further comprises an irradiation source configured to deliver a radioisotope to tissue.

8. 1. An infusion catheter comprising: a lumen fluidly connected to the plurality of branches; and a plurality of said branches, wherein each of the plurality of prongs includes a prong inside the tube and collectively forms a plurality of prongs inside the plurality of tubes; a plurality of said tubes are fused at a proximal end; the plurality of prongs are created from a hollow shaft having a wall with an inner surface and an outer surface by forming a longitudinal spiral cut from the outer surface to the inner surface of the hollow shaft; the proximal end of the hollow shaft is unscored; the plurality of tines are not interconnected between the proximal and distal ends of the tines; The injection catheter.

9. The infusion catheter of claim 8 , wherein each tube of the plurality of tubes is porous.

10. 10. The infusion catheter of claim 9, wherein each tube of the plurality of tubes includes a plurality of infusion ports extending between the inner and outer surfaces of the wall of the tube.

11. The injection catheter of claim 10, wherein the injection port is a hole having a diameter between 0.001 and 0.006 inches.

12. The injection catheter of claim 8, wherein the prongs include a shape memory material.

13. The injection catheter of claim 12, wherein the shape memory material is a nitinol alloy of nickel-titanium.

14. 16. The infusion catheter of claim 15, wherein the helical cut formation rotates at least 360 degrees over the length of the hollow shaft.

15. The injection catheter of claim 8, wherein the injection catheter is 3 to 8 inches in length.

16. The injection catheter of claim 15, wherein the injection catheter is 6 inches in length.

17. The method of claim 1, further comprising: providing a polymeric membrane attached to the exterior of the distal end of the branch of the infusion catheter.

9. The injection catheter of claim 8.

18. Further comprising a mesh forming a distal capture protection component between each of said prongs; 20. The infusion catheter of claim 17, wherein the polymeric membrane provides the mesh.

19. The injection catheter of claim 17, wherein the polymeric membrane is a material selected from the group consisting of nylon 12, polyethylene terephthalate (PET), polyether ether ketone (PEEK), polyurethane, and polyether block amide.

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