System for deploying an embolization device through an elongated tube

Abstract

An embolization device, a loading tool, an accessory access tool, an accessory deployment tool, a system for introducing the embolization device into a vessel, and a kit for introducing the embolization device into a vessel. The embolization device includes an elongate body, the elongate body being a single continuous piece of a polymer material. The elongate body forms a plurality of segments and a plurality of elongate partitions. The plurality of segments and the plurality of elongate partitions being alternatingly arranged. Each of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment.

Description

SYSTEM FOR DEPLOYING AN EMBOLIZATION DEVICE THROUGH AN ELONGATED TUBECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of U.S. Provisional Application No. 63 / 662,658, filed June 21, 2024, the subject matter of which is incorporated herein by reference.FIELD

[0002] The present disclosure relates to medical devices and particularly to an embolization device and to a system and method for deploying a porous material through an elongated tube.BACKGROUND

[0003] The portal venous system carries blood from various organs including the gastrointestinal tract, gall bladder, pancreas, and spleen to the liver. Portal hypertension develops in patients with conditions such as cirrhosis of the liver or extrahepatic portal vein obstruction. Portal hypertension causes the pressure in the portal venous system to increase due to restrictions in the blood flow, which may lead to various complications such as gastric varices, esophageal varices, and exacerbate rectal varices. Gastric varices are dilations of veins in the lining of the upper gastrointestinal tract including submucosal veins in the lining of the stomach. Esophageal varices are dilated veins in the esophagus. Rupture of gastric and esophageal varices leads to bleeding in the upper gastrointestinal tract evidenced by, for example, bloody vomiting and rectal bleeding, black tarry stools, lightheadedness, and is fatal in some instances. Ruptured gastric varices have been treated by injecting cyanoacrylate glue or coils into the varix endoscopically, commonly referred to as gastric variceal obliteration. While accepted as a strategy for controlling bleeding in ruptured gastric varices, these treatments are off-label and rebleeding may occur. Esophageal varices have been treated by using elastic bands to tie off bleeding veins as well as injecting cyanoacrylate glue or coils into the varix. Clinical evidence indicates that prophylactic treatment may result in better patient outcomes when gastric varices, esophageal varices, and rectal varices are encountered.

[0004] Thus, while present systems and treatments for varices achieve their intended purpose, there is a need for new and improved systems and treatments for gastric and esophageal varices, preferably those that are prophylactic and also applicable to ruptured varices.SUMMARY

[0005] Aspects of the present disclosure relate to a method of inserting an embolization device into a vessel. The method includes inserting a distal end of an elongate tube through a wall of a vessel. The elongate tube defines a lumen extending through the elongate tube and the lumen includes an embolization device. The embolization device includes an elongate body, the elongate body being a single continuous piece of a polymer material. The elongate body forms a plurality of segments and a plurality of elongate partitions. The plurality of segments and the plurality of elongate partitions being alternatingly arranged and each of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment. The method also includes applying hydraulic pressure against the embolization device in the lumen, and delivering the embolization device from the elongate tube into the vessel, wherein the embolization device expands upon delivery into the vessel.

[0006] Aspects of the present disclosure also relate to an embolization device for insertion into a vascular abnormality. The embolization device includes an elongate body, the elongate body being a single continuous piece of a compressible polymer material, the elongate body forming a plurality of segments and a plurality of elongate partitions, wherein the plurality of segments and the plurality of elongate partitions being alternatingly arranged, and wherein each of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment.

[0007] Aspects of the present disclosure further relate to a loading tool for delivering an embolization device. The loading tool includes a housing, a first opening defined in a proximal end of the housing, a second opening defined in a distal end of the housing, a first passageway extending between the first opening and the second opening, wherein in the first passageway defines a wall, a mechanical fastener defined in the wall, an elongate tube connected to the first passageway, wherein the elongate tube defines a lumen, a first seal separating the first passageway into an upper portion and a lower portion, a port extending form a side of the housing, and a second passageway defined in the port and the housing, wherein the second passageway connects to the lower portion of the first passageway.

[0008] Aspects of the present disclosure also relate to an accessory access tool for use with a loading tool, such as the above mentioned loading tool, for delivering an embolization device. The accessory tool includes a knob including a mechanical fastener mate-able to a loading tool, an extension shaft extending from a distal end of the knob, and a needle connected to a distal end of the extension shaft.

[0009] Aspects of the present disclosure also relate to an accessory deployment tool for use with a loading tool, such as the above mentioned loading tool, for delivering an embolization device. The accessory deployment tool includes a knob including a mechanical fastener mate-able to a loading tool, an extension shaft extending form a distal end of the knob, and a delivery passageway defined through the knob and the extension shaft, wherein the delivery passageway is at least one of connected and connected to a delivery device of an embolization device.

[0010] Aspects of the present disclosure also relate to a system for introducing an embolization device into a vessel including a delivery device and an embolization device. The delivery device includes an elongate tube, the elongate tube defining a lumen extending through the elongate tube, and a hydraulic pump connected to an end of the lumen, configured to introduce fluid into the lumen. The embolization device is movably disposed in the lumen. The embolization device including an elongate body, the elongate body being a single continuous piece of a compressible polymer material, the elongate body forming a plurality of segments and a plurality of elongate partitions, the plurality of segments and the plurality of elongate partitions being alternatingly arranged, each of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment.

[0011] Aspects of the present disclosure also relate to a system for delivering an embolization device. The system includes a loading tool, an accessory access tool mate-able to the loading tool, and an accessory deployment tool mate-able to the loading tool. The loading tool includes a housing, a first opening defined in a proximal end of the housing, a second opening defined in a distal end of the housing, a first passageway extending between the first opening and the second opening, wherein in the first passageway defines a wall, a first mechanical fastener defined in the wall, an elongate tube connected to the first passageway, wherein the elongate tube defines a lumen, a first seal separating the first passageway into an upper portion and a lower portion, a port extending form a side of the housing, and a second passageway definedin the port and the housing, wherein the second passageway connects to the lower portion of the first passageway. The accessory access tool includes a first knob including a second mechanical fastener mate-able with the first mechanical fastener, a first extension shaft extending from a distal end of the first knob, wherein the first extension shaft extends through the first passageway and the seal in the first passageway, and a needle connected to a distal end of the extension shaft. The accessory deployment tool includes a second knob including a mechanical fastener mate-able with the first mechanical fastener, a second extension shaft extending form a distal end of the second knob, wherein the second extension shaft extends through the first passageway and the seal in the first passageway, and a delivery passageway defined through the second knob and the second extension shaft, wherein the delivery passageway is either connected to or connectable to a second end of the delivery device of the embolization device. In aspects, the system further includes the embolization device and delivery device described above.

[0012] Aspects of the present disclosure also relate to a kit for delivering an embolization device. The kit includes a delivery device and an embolization device. The delivery device includes an elongate tube, the elongate tube defining a lumen extending through the elongate tube, and a hydraulic pump connected to an end of the lumen, configured to introduce fluid into the lumen. The embolization device is movably disposed in the lumen and includes an elongate body, the elongate body being a single continuous piece of a compressible polymer material, the elongate body forming a plurality of segments and a plurality of elongate partitions, the plurality of segments and the plurality of elongate partitions being altematingly arranged, each of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment.

[0013] Aspects of the present disclosure also relate to a kit for delivering an embolization device. The kit includes a loading tool, an accessory access tool mate-able to the loading tool, and an accessory deployment tool mate-able to the loading tool. The loading tool includes a housing, a first opening defined in a proximal end of the housing, a second opening defined in a distal end of the housing, a first passageway extending between the first opening and the second opening, wherein in the first passageway defines a wall, a first mechanical fastener defined in the wall, an elongate tube connected to the first passageway, wherein the elongate tube defines a lumen, a first seal separating the first passageway into an upper portion and a lower portion,a port extending form a side of the housing, and a second passageway defined in the port and the housing, wherein the second passageway connects to the lower portion of the first passageway. The accessory access tool includes a first knob including a second mechanical fastener mate-able with the first mechanical fastener, a first extension shaft extending from a distal end of the first knob, wherein the first extension shaft extends through the first passageway and the seal in the first passageway, and a needle connected to a distal end of the extension shaft. The accessory deployment tool includes a second knob including a mechanical fastener mate-able with the first mechanical fastener, a second extension shaft extending form a distal end of the second knob, wherein the second extension shaft extends through the first passageway and the seal in the first passageway, and a delivery passageway defined through the second knob and the second extension shaft, wherein the delivery passageway is either connected to or connectable to a second end of the delivery device of the embolization device. In aspects, the kit also includes the above described delivery device and embolization device.BRIEF DESCRIPTION OF DRAWINGS

[0014] The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way.

[0015] FIG. 1A illustrates an embolization device according to embodiments of the present disclosure.

[0016] FIG. IB illustrates a portion of an embolization device according to embodiments of the present disclosure.

[0017] FIG. 1C illustrates a cross-section of a segment and an elongate partition, illustrated in FIG. IB, according to embodiments of the present disclosure.

[0018] FIG. 2A illustrates a delivery device for an embolization device according to embodiments of the present disclosure.

[0019] FIG. 2B illustrates a cross-section of an elongate conduit according to embodiments of the present disclosure.

[0020] FIG. 3 illustrates a cross-sectional view of a loading tool, according to embodiments of the present disclosure.

[0021] FIG. 4A illustrates an accessory access tool located in a first position, engaging a fraction of the threads in the loading tool, according to embodiments of the present disclosure.

[0022] FIG. 4B illustrates the accessory access tool of FIG. 4 A located in a second position in the loading tool, engaging additional threads, according to embodiments of the present disclosure.

[0023] FIG. 5 illustrates an accessory embolization delivery tool positioned in the loading tool, according to embodiments of the present disclosure.

[0024] FIG. 6 illustrates a method of delivering an embolization device, according to embodiments of the present disclosure.

[0025] FIG. 7 illustrates a further method of delivering an embolization device, according to embodiments of the present disclosure.

[0026] FIG. 8A illustrates a blood vessel including an abnormality, according to embodiments of the present disclosure.

[0027] FIG. 8B illustrates the vessel of FIG. 8A with an embolization device placed in the varix, according to embodiments of the present disclosure.

[0028] FIG. 9 illustrates a system and a kit for deploying an embolization device, according to embodiments of the present disclosure.DETAILED DESCRIPTION

[0029] The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding introduction, summary, or the following detailed description. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features.

[0030] Reference will now be made in detail to several examples of the disclosure that are illustrated in accompanying drawings. Whenever possible, the same or similar reference numerals are used in the drawings and the description to refer to the same or like parts or steps. The drawings are in simplified form and are not to precise scale.

[0031] The present disclosure relates to an embolization device for treating abnormalities in the vascular system such as varices. The present disclosure also relates to a system and method of delivering the embolization device to the vascular abnormality. While the devices, systems and methods herein are described in connection with gastric varices, the embolization device, systems, and methods described herein may be applied to other vascular abnormalities including, but not limited to, other dilated or ruptured veins or arteries, such as esophagealvarices, duodenal varices, renal vein varices, ovarian varices, varicocele, cerebral aneurysms, thoracic aortic aneurysms, and abdominal aortic aneurysms.

[0032] FIG. 1 A illustrates an embodiment of an embolization device 100. The embolization device 100 includes an elongate body 102. The elongate body 102 includes a plurality of segments 104 and a plurality of elongate partitions 106 between the segments 104, arranged in an alternating manner such that the elongate partitions 106 separate each of the segments 104. In embodiments, the elongate body 102, including the plurality of segments 104 and the plurality of elongate partitions 106, is formed from a single continuous piece of polymer material. The embolization device 100 generally assumes the shape of a flexible strand, where flexible is understood herein as capable of bending and strand is understood as a threadlike piece of a natural or synthetic material.

[0033] The plurality of segments 104 each exhibit a segment length 112, also measured along a first axis Al, in the range of 5 millimeters to 50 millimeters, including all values and ranges therein. The plurality of elongate partitions 106 between the segments 104 each exhibit a partition length 114 in the range of 1 millimeter to 10 millimeters, including all values and ranges therein. In embodiments, the ratio of the elongate partition length 114 to an adjacent segment length 112 is in the range of 1 : 0.5 to 1 :50.

[0034] With reference to FIGS. IB and 1C, the segments 104 each exhibit a segment cross-section 122 and the elongate partitions 106 each exhibit a partition cross-section 124. In embodiments, the segment cross-section 122 and the partition cross-section 124 exhibit the same shape, although their size differs. As illustrated, the cross-sections 122, 124 each exhibit a circular geometry. Alternatively, the cross-sections 122, 124 may assume a polygonal or oval geometry. Further, in alternative or additional embodiments, the cross-sections 122, 124 may assume different geometries. Polygonal geometries may include three or more line segments, including all values and ranges from 3 to 12 line segments, and may be for example, square, rectangular, trapezoidal, pentagonal, hexagonal, heptagonal, octagonal, etc. The cross-section 122, 124 is understood as a plane figure obtained by the intersection of the embolization device 100 with a plane at a 90 degree angle orthogonal to the first axis Al that is generally parallel to the length 108 of the embolization device 100. The cross-section 122, 124 defines a cross- sectional length 110, 120, which is understood as the longest linear length spanning the crosssection 122, 124. In the case of a circular cross-section 122, 124, as illustrated in FIG. 1C, thecross-sectional length 1 10, 120 is the diameter of the cross-section 122, 124. In the case of a non-circular cross-section, such as a rectangular, square or other polygonal shape, the cross- sectional length is the longest length spanning the cross-section, such as a diagonal. The cross- sectional length 110 of each segment 104 is in the range of 0.8 millimeters to 12 millimeters, including all values and ranges therein. The cross-sectional length 120 of each partition is in the range of 0.1 millimeters to 0.6 millimeters, including all values and ranges therein. The ratio of the cross-sectional length of each elongate partition to the cross-sectional length of an adjacent segment is in the range of 1 : 1.3 to 1:20. In embodiments, the cross-sectional length 120 of each elongate partition 106 is consistent, varying less than 20 percent of the total cross- sectional length 120, along the length 114 of each partition 106.

[0035] Referring again to FIG. 1A, the embolization device 100 exhibits an overall length 108 greater than the longest cross-sectional length 110 of the segments 104 of the embolization device 100. In embodiments, the embolization device 100 exhibits an overall length 108 in the range of 10 centimeters to 100 centimeters, including all values and ranges therein. The overall length 108 is measured when the embolization device 100 is fully extended along, or parallel to, a first axis Al. In embodiments, the ratio of the overall length 108 to the cross-sectional length 110 of the largest of the plurality of segments 104 is in the range of 125: 1 to 10,000: 1.

[0036] The elongate body 102 is formed from a polymer material, including either a thermoplastic material, a thermoset material, a biopolymer, or a combination of at least two of a thermoplastic material, a thermoset material, and a biopolymer such as in a block copolymer. In embodiments, the polymer is a polyurethane. Alternatively or additionally, polyvinyl alcohol, cellulose, silicone, neoprene, polyethylene, ethylene-vinyl acetate, polyacrylate, sodiumpolyacrylate and combinations thereof may be used as the polymer material. Further, bioabsorbable polymer materials, such as those including polylactic acid, polylactic acid polymers including magnesium bioactive ions, poly(lactic-co-glycolic acid), and block copolymers of s-caprolactone, lactide, glycolide, and trimethylene carbonate, or blends of anionic polymers with cationic polymers, may be used as additional or alternative polymer materials. In yet further additional or alternative embodiments, the polymer material includes a polysaccharide such as at least one of chitin, chitosan, carboxymethyl chitosan, glucomannan, gelatin, carboxymethyl cellulose, and cellulose. In yet further embodiments, the polymer material absorbs blood, or components in blood to swell in size.

[0037] In embodiments, the polymer material is an open cell foam. It should be appreciated that the porosity exhibited by open cell foam allows for ingrowth of tissue. In alternative embodiments, a closed cell foam may be used. Prior to being formed into the elongate body, the polymer material exhibits a density in the in the range of 1.6 kilograms per cubic meter (0.1 pounds per cubic foot) to 96.1 kilograms per cubic meter (6.0 pounds per cubic foot). Further, in embodiments, the polymer material can be compressed down to 6.7 percent of the polymer material’s initial size upon the application of a compression force and rebounds, expanding, upon release of the compressive force. In alternative or additional embodiments, the polymer material expands upon the introduction of components in the blood, such as water.

[0038] Further, in embodiments, the polymer material includes a radiopaque fdler, such as barium sulfate and bismuth subcarbonate, bismuth trioxide, and bismuth oxychloride. The radiopaque filler may assist in locating the embolization device 100 within the patient using fluoroscopy. In additional embodiments, in addition or as an alternative to using radiopaque fillers, fluoroscopically visible markers, such as a cannula, may be affixed to the embolization device 100. For example, a cannula may be added to at least one of 1) one or more of the plurality of segments 104, and 2) one or more of the plurality of partitions 106. Other additives may be included such as, but not limited to, growth factors including, but not limited to, one or more of vascular endothelial growth factors and fibroblast growth factor 1 (FGF-1); clotting factors including, but not limited to, thrombin; sclerosing agents including but not limited to ethanolamine oleate iopamidol (EOI), sodium tetradecyl sulfate, and polidocanol; antimicrobials; and colorants. Growth factors promote the ingrowth of tissue into the embolization device 100.

[0039] The elongate body 102 is formed into the embolization device 100 by forming the plurality of elongate partitions 106 between the plurality of segments 104. In embodiments, the elongate partitions 106 are formed by twisting the elongate body 102 in discrete locations along the length of the elongate body 102, thereby forming a plurality of twists that define each of the elongate partitions 106. In alternative embodiments, the elongate partitions 106 are formed by compressing or crimping the elongate body 102 in the regions along the length of the elongate body 102. In embodiments, the twisted or compressed elongate partitions 106 may be secured in the compressed state by applying at least one of an adhesive, mechanical fasteners, and heat. Non-limiting examples of an adhesive includes one or more of an epoxy adhesive, acyanoacrylate adhesive, an acrylic adhesive, and a hot melt adhesive. Mechanical fasteners include, for example, elongate sleeves, natural or synthetic thread, polymer filament, mesh sleeves, metal tubes, polymer tubes, and heat shrink tubes. In addition, or alternatively, the elongate partitions 106 are cut out of the elongate body 102 and material is removed from the elongate body 102 to form the elongate partitions 106. In yet further, or alternative embodiments, the elongate body 102 is drawn down in the areas forming the elongate partitions 106 while the elongate body 102 is being formed, reducing the cross-sectional length of the elongate partitions 106.

[0040] In embodiments, the plurality of elongate partitions 106 exhibit a first density and the plurality of segments 104 exhibit a second density. The second density is equal to the density of the polymer material forming the elongate body 102. In addition, the first density is higher than the second density. In alternative embodiments, the first density and second density are equal. In additional or alternative embodiments, the plurality of elongate partitions 106 exhibit a first porosity and the plurality of segments 104 exhibit a second porosity. The second porosity is equal to the porosity of the polymer material forming the elongate body 102. In addition, the first porosity is lower than the second porosity. In alternative embodiments, the first porosity is the same as the second porosity.

[0041] In alternative embodiments, rather than forming the plurality of segments 104 from a single elongate body 102, the segments 104 are individually formed from any of the above referenced polymer materials and are attached to a flexible strand. The strand includes one or more of the following: a synthetic filament, a metal wire, a metal alloy wire, a natural fiber, a synthetic fiber, and bundles thereof. The overall shape and dimensions of the embolization device 100 remain the same with the exception of the flexible strand, which may exhibit a cross-sectional length in the range of 0.1 millimeters to 1 millimeters, including all values and ranges therein.

[0042] The embolization device 100 is deployed into a vascular abnormality, such as a varix, using a deployment device 200, an embodiment of which is illustrated in FIGS. 2A and 2B. The deployment device 200 includes an elongate conduit 202 and a hydraulic pump 204 connected to the proximal end 206 of the elongate conduit 202. In embodiments, the elongate conduit 202 is in the range of 10 centimeters to 230 centimeters in length, including all values and ranges therein, such as 130 centimeters to 230 centimeters. In addition, the elongate conduit 202 defines a lumen 210 in the elongate conduit 202 that extends the length of the elongate conduit202 having openings at the proximal end 206 of the elongate conduit 202 and at the distal end 208 of the elongate conduit 202. The inner diameter 212 of the lumen 210 is in the range of 0.8 millimeters to 4.0 millimeters, including all values and ranges therein. The embolization device 100 is placed in the lumen 210. In embodiments, the embolization device 100 is compressed prior to placement in the lumen 210 and expands upon release from the lumen 210. In alternative embodiments, the embolization device 100 is placed in the lumen 210 without compression. In embodiments, the distal end 208 of the elongate conduit 202 is connected to a loading tool accessory, such as an accessory deployment tool 500, described further herein.

[0043] The hydraulic pump 204 is connected to the proximal end 206 of the elongate conduit 202 and is used to inject fluid into the lumen 210 of the elongate conduit 202 to dispense the embolization device 100. In embodiments, the connection is made using a connector 214, such as a Luer connection. Alternatively, a syringe needle or adaptor connected to or integrated with the hydraulic pump 204 and may be inserted into the lumen 210 of the elongate conduit 202. The needle or adapter exhibits an outer diameter that is larger than the inner diameter 212 of the lumen forming an interference fit with the inner diameter 212 of the lumen 210. In further alternative embodiments, the elongated conduit 202 is integrated into the hydraulic pump 204. In the illustrated embodiment, the hydraulic pump 204 is a manually operated syringe. Alternatively, or additionally, the hydraulic pump 204 is at least one of a peristaltic pump, a piston pump, a gear pump, and a screw pump. Fluid injected into the elongate conduit 202 by the hydraulic pump 204 includes, for example, normal saline, half normal saline, heparinized saline solution, and lactated Ringer solution.

[0044] As alluded to above, a loading tool 300 is also provided in embodiments of the present disclosure. The loading tool 300 delivers the embolization device 100 to the vascular abnormality. In embodiments, the loading tool 300 is a part of a system that also includes at least one of the embolization device 100 and the deployment device 200. In further or additional embodiments, the loading tool 300 is part of a kit including at least one of the embolization device 100 and the deployment device 200.

[0045] An embodiment of a loading tool 300 is illustrated in FIG. 3. The loading tool 300 includes a housing 302. In the illustrated embodiment, the housing 302 is formed from an upper portion 304 and a lower portion 306. Alternatively, the housing 302 is formed from a single unitarypiece. A first passageway 310 extends between a first opening 312 defined at a first end 314, such as a proximal end, and a second opening 316 defined at a second end 318 of the housing 302, such as a distal end. In embodiments, the first opening 312 is defined in the upper portion 304 of the housing 302 and the second opening 316 is defined in the lower portion 306 of the housing 302.

[0046] When present, the upper portion 304 of the housing 302 and the lower portion of the housing 302 are fastened together. In embodiments, upper portion 304 and lower portion 306 are welded or fastened together with an adhesive. In alternative embodiments, the upper portion 304 and lower portion 306 are mechanically retained against each other using mating threads or an interference fit between the housing pieces. For example, as illustrated, the upper portion 304 includes a collar 320 extending from the distal end 321 of the upper portion 304 into which is received a hollow cylinder 322 extending from the proximal end 323 of the lower portion 306. In embodiments, the collar 320 and the hollow cylinder 322 may be dimensioned to form an interference fit between the collar 320 and the hollow cylinder 322.

[0047] Mating threads 324, for accommodating one or more removable accessory tools described further herein, are defined in the wall of the first passageway 310. In embodiments, the mating threads 324 extend from the first end 314 of the first passageway 310 five percent to 30 percent of the total length 326 of the first passageway 310. Alternatively, other mating mechanical fastener receptacles may be provided, such as receptacles for quarter turn clamp cams, ball locking pin receptacles, and shaft coupling clamp cam receptacles.

[0048] An elongate tube 328 is connected to the first passageway 310 and defines a lumen 327 therein. In embodiments, the elongate tube 328 is a catheter, such as a balloon catheter, a braided catheter, or a braided catheter with a balloon. In the illustrated embodiment, the elongate tube 328 is connected to the first passageway 310 within the body of the housing 302 and extends from the second end 318 of the housing 302 through the second opening 316. In embodiments, the elongate tube 328 is secured in place in the first passageway 310 by an adhesive or by a welding process. In alternative, or additional embodiments, the elongate tube 328 is secured by an interference fit in the first passageway 310. In embodiments, the elongate tube 328 is in the range of 15 centimeters to 230 centimeters in length, including all values and ranges therein. In embodiments, such as in applications using direct percutaneous access, the elongate tube 328 may be in the range of 15 centimeters to 65 centimeters. In alternativeembodiments, such as in peripheral percutaneous access, the elongate tube 328 may be in the range of 50 centimeters to 80 centimeters. In embodiments where endoscopic access is utilized, the elongate tube 328 may be in the range of 130 centimeters to 230 centimeters.

[0049] As illustrated, the first passageway 310 includes a reduced portion 308 that exhibits a reduced diameter 307, forming a buttress 305 within the first passageway 310 providing a stop for the elongate tube 328, preventing over-insertion of the elongate tube 328 into the first passageway 310. The ratio of the reduced diameter 307 and the diameter 311 of the first passageway 310 is in the range of 0.1 : 1 to 0.9: 1, including all ranges and increments therein, such as 0.3: 1, 0.5: 1, 0.7: 1, etc.

[0050] In any of the above embodiments, a first seal 334 is provided in the first passageway 310, dividing the first passageway 310 into an upper passageway 336 and a lower passageway 338. The first seal 334 remains normally closed. In embodiments where an upper portion 304 of the housing 302 and a lower portion 306 of the housing 302 is present, the first seal 334 extends between and is secured between the upper portion 304 and the lower portion 306 of the housing 302. In embodiments, the first seal 334 is captured between the hollow cylinder 322 projecting from the proximal end 323 of the lower portion 306 of the housing 302, the collar 320 of the upper portion 304 of the housing 302, and a surface 332 generally orthogonal to and surrounding the first passageway 310, bordered by the collar 320. In further embodiments, the seal 334 is adhered in place with an adhesive or welded in place. Raised features may, in embodiments, be provided projecting from either or both the surfaces of the surface 332 and the hollow cylinder 322 that contact the seal 334 to retain the seal 334 in place mechanically. In yet further embodiments, the seal 334 is a hemostatic valve and seals the upper passageway 336 from the lower passageway 338 and prevents the flow of fluid from the lower passageway 338 into the upper passageway 336.

[0051] A port 344 extends from a side 342 of the housing 302. The port 344 and the housing 302 define a second passageway 346 therein. In embodiments, a first end 348 of the port 344, at the first end 348 of the second passageway 346, includes a fitting 352, such as a Luer lock, or an adapter for connecting the port 344 and the second passageway 346 to a fluid source for flushing the first passageway 310. The second end 350 of the second passageway 346 connects to the first passageway 310 within the housing 302. The second passageway 346 is illustrated as generally perpendicular to the first passageway 310. Alternatively, the second passageway346 may intersect the first passageway 310 at any given angle. In embodiments, the port 344 is connected to the lower portion 306 of the housing 302 and the second passageway 346 connects to the lower passageway 338. Thus, the first seal 334, when in the normal, closed position, prevents the introduction of fluid into the second passageway 346 from being introduced into the upper passageway 336 of the first passageway 310. An additional seal 340 is also provided in the first passageway 310 between the second end 350 of the second passageway 346 and the reduced portion 308 of the first passageway 310 exhibiting the reduced diameter 309, in any of the above embodiments, to seal, retain or both seal and retain the loading accessory tools, described further herein.

[0052] Turning now to FIGS. 4A and 4B, FIG. 4A illustrates an embodiment of an accessory access tool 400 positioned in a first position in the loading tool 300 and FIG. 4B illustrates the accessory access tool 400 of FIG. 4B positioned in a second position in the loading tool 300. The accessory access tool 400 forms a part of a loading tool system, which also includes the loading tool 300. Further, the accessory access tool 400, in embodiments, is packaged in a kit with the loading tool 300. The accessory access tool 400 includes a first end 402 and a second end 405. In addition, the accessory access tool 400 includes a knob 404 for grasping and turning the accessory access tool 400, mating threads 408 formed on the outer surface 409 of the knob 404 that mate with the loading tool 300, and an extension shaft 410 that extends from the distal end 426 of the knob 404 and mating threads 408. Connected to the distal end 405 of the extension shaft 410 is a needle 412. In embodiments, the needle 412 is an endoscopic needle. The needle 412 includes a dilator 416 positioned on the distal end 420 of the needle 412 proximal to the needle tip 422 and a sheath 424.

[0053] The knob 404, located proximal to the first end 402 of the accessory access tool 400, is illustrated as being generally cylindrical in shape when viewed from the first end 402. In embodiments, the knob 404 may alternatively assume another configuration such as oval, elliptical, or polygonal including three or more segments. Formed on the surface 409 of the knob 404 at a distal end 426 of the knob 404 are mating threads 408, that mate with the threads 324 of the loading tool 300. Alternatively, other mating mechanical fasteners may be provided and integrated into the knob 404, such as quarter turn clamp cams, ball locking pins, and shaft coupling clamp cams.

[0054] The extension shaft 410 is configured to extend through the first passageway 310 of the loading tool 300 and through the first seal 334. In embodiments, the first passageway 310 includes a stop surface 430 and the extension shaft 410 is configured to bottom out at the stop surface 430 when the accessory access tool 400 is in a second position as illustrated in FIG. 4B.

[0055] The needle 412, connected to or extending from the distal end 405 of the extension shaft 410, extends through the elongate tube 328, but remains recessed within the elongate tube 328 when the accessory access tool 400 is mated to the loading tool 300 in the first position. When the accessory access tool 400 is in the second position the needle 412 extends out from the distal end 432 of the elongate tube 328. The gauge of the needle 412 is in the range of 14 gauge to 25 gauge, including all values and ranges therein, such as 19 gauge.

[0056] The needle 412 includes a dilator 416 adjacent to the needle tip 422. The dilator 416 assists in widening the opening of the vessel for insertion of the elongate tube 328 into the vessel. In addition, the needle 412 includes a needle sheath 424 adjacent to the dilator 416. In embodiments, the needle sheath 424 may support or increase the rigidity of the needle 412. The needle sheath 424 extends over at least a portion of the needle 412 from the proximal end 440 of the dilator 416 up to the second end 405 of the accessory access tool 400 including all values and ranges therein, such as from a 10 millimeters from the proximal end 440 of the dilator to the second end 405 of the accessory access tool 400. The needle sheath 424 may be formed of a polymer material, such as polyether ether ketone (PEEK), ultrahigh molecular weight polyethylene, nylon, polyether imide (PEI), fluorinatedethylenepropylene (FEP), polytetrafluoroethylene (PTFE), and acetal. When the accessory access tool 400, including mating threads 408 is rotated relative to the mating threads 324 in the loading tool 300 and placed in a second position, as illustrated in FIG. 4B, the needle 412 extends out from the end 432 of the elongate tube 328, exposing the needle 412 and the dilator 416.

[0057] Referring now to FIG. 5, FIG 5 illustrates an embodiment of an accessory deployment tool 500. The accessory deployment tool 500 forms a part of a loading tool system, which also includes the loading tool 300 and may further include the accessory access tool 400. Further, the accessory deployment tool 500, in embodiments, is packaged in a kit with the loading tool 300 and may further include the accessory access tool 400. The accessory deployment tool 500 includes a first end 502 and a second end 505. In addition, the accessory deployment tool 500includes a knob 504 for grasping and turning the accessory tool, mating threads 508 formed on the outer surface 509 of the knob 504 that mate with the loading tool 300, and an extension shaft 510 that extends from the distal end of the knob 504 and mating threads 508.

[0058] The knob 504, located proximal to the first end 502 of the accessory deployment tool 500, is illustrated as being generally cylindrical in shape when viewed from the first end 502. In embodiments, the knob 504 may alternatively assume another configuration such as oval, elliptical, or polygonal including three or more segments. Formed on the surface 509 of the knob 504 at a distal end 526 of the knob 504 are mating threads 508, that mate with the threads 324 of the loading tool 300. Alternatively, other mating mechanical fasteners may be provided and integrated into the knob 504, such as quarter turn clamp cams, ball locking pins, and shaft coupling clamp cams.

[0059] The extension shaft 510 is configured to extend through the first passageway 310 of the loading tool 300, through the first seal 334. In embodiments, the first passageway 310 includes a stop surface 530 and the second end 505 of the extension shaft 510 is configured to bottom out at the stop surface 530 when the accessory deployment tool 500 is mated to the loading tool 300. In embodiments, the stop surface 530 and the second end 505 of the extension shaft 510 contacting the stop surface 530 exhibit complimentary surfaces to prevent gaps from forming between the stop surface 530 and the second end 505. For example, if the stop surface 530 is flat, the surface 532 at the second end 505 of the extension shaft 510 is flat, or if the stop surface 530 is concave, the surface 532 at the second end 505 of the extension shaft 510 is convex.

[0060] In embodiments, the first end 502 of the accessory deployment tool 500 is connected to the distal end 208 of the elongate conduit 202 of the delivery device 200. A delivery passageway 514 is defined between the first end 502 of the accessory deployment tool 500 and the second end 505 of the accessory deployment tool 500 having an opening 516 at the first end 502 to receive the contents of the elongate conduit 202 and an opening 518 at the second end 505 to pass the contents of the elongate conduit 202 into the elongate tube 328. The elongate conduit 202 is connected to the accessory deployment tool 500 by welding or by an adhesive. Alternatively, the distal end 208 of the elongate conduit 202 and first end 502 of the accessory deployment tool 500 are provided with mechanical mating fasteners, such as adapters that exhibit an interference fit, threads, etc.

[0061] FIG. 6, with further references to FIGS. 1 through 5, 8A and 8B, illustrates a general method 600 of delivering the embolization device 100 to the vessel 804. At block 602, the embolization device 100 is placed into the lumen 210 of the elongate conduit 202. In embodiments, the embolization device 100 is compressed before or as it is placed into the lumen 210. The embolization device 100 may be inserted into the lumen 210 prior to delivery of the embolization device 100 to the patient or caregiver. In further embodiments, the embolization device 100 is inserted into the lumen 210 by the caregiver during a procedure.

[0062] At block 604, a distal end 432 of the elongate tube 328 is inserted through the wall 810 of a vessel 804. In embodiments, the elongate tube 328 is inserted through the wall 810 at the vascular abnormality or near to the vascular abnormality. In additional or alternative embodiments, the elongate tube 328 is inserted through the wall 810 of the vessel 804 and navigated to the vascular abnormality. For example, the elongate tube 328 is inserted into the wall 810 of the vessel 804 in the neck, groin, or transabdominally, which may be upstream or downstream from the vascular abnormality. In further embodiments, where the abnormality has already burst, the elongate tube 328 is inserted into the opening at the burst location. Depending on the modality of insertion, an aseptic field around the insertion point of the elongate tube is created prior to inserting the elongate tube 328 into the wall 810. For example, an aseptic zone on the skin or tissues of the intestinal tract may be created through the application of at least one of povidone-iodine, chlorhexidine, ortho-phthalaldehyde, peracetic acid, hydrogen peroxide, electrolyzed water, and gluteraldehyde at the insertion site. The aseptic agent may be delivered through the elongate tube 328, delivered through the elongate conduit 202 of the delivery device 200, or applied onto the skin in delivering percutaneously or tissue in delivering through the upper gastrointestinal tract. In addition or alternatively, a sclerosing agent, such as those described above, may be similarly delivered.

[0063] At block 606, hydraulic pressure is applied against the embolization device 100 in the lumen 210 of the elongate conduit 202, which is connected to the elongate tube 328. In embodiments, the hydraulic pressure is applied at the proximal end 206 of the elongate conduit 202. Hydraulic pressure is applied at a pressure in the range of 1 millimeter-mercury (mmHg) to 5000 mmHg, including all values and ranges therein. In further embodiments, 60 cubic centimeters of fluid or less, including all values and increments from 0.1 cubic centimeters to 60 cubic centimeters, of fluid is used to force the embolization device 100 to exit the distal end208 of the elongate conduit 202 and deliver the embolization device 100 into the vessel 804. In embodiments where the embolization device 100 is made from open cell foam, the fluid is introduced into the pores of the embolization device 100 and hydraulic pressure is applied in the pores. This allows hydraulic pressure to be applied along and within the embolization device 100, assisting in the removal of the device 100 from the elongate conduit 202 and elongate tube 328. In alternative embodiments, a rod may be used to displace the embolization device 100 through the elongate conduit 202 and the elongate tube 328. Upon exiting the end 423 of the elongate tube 328, the embolization device 100, particularly the plurality of segments 104, expands. In embodiments the plurality of segments 104 rebound if compressed in the elongate conduit 202 , swell with components from the blood in the vessel 804, or both rebounds and swells. The expansion of the plurality of segments 104 occludes the vessel 804 as well as, in embodiments, the abnormality 806. In embodiments, the plurality of segments 104 exhibit a diameter 110 in the compressed state within the lumen 210 of 6 percent to 80 percent of the diameter 110 of the plurality of segments 104 in the vessel 804.

[0064] A further embodiment of a method 700 of deploying the embolization device 100 into a vessel 804 is illustrated in FIG. 7. Reference is further made to FIGS. 1 through 5, 8A and 8B. At step 702 the loading tool 300 is loaded into the accessory port of an endoscope 802. The accessory access tool 400, if not already positioned in the loading tool 300 before the loading tool 300 is placed in the accessory port of the endoscope 802, may be positioned in the first position in the loading tool 300, engaging a fraction of the mating threads 324. With the accessory access tool 400 in the first position, the needle 412 is sheathed within the elongate tube 328. In embodiments, an aseptic agent may be flushed through the elongate tube 328 prior to or after the accessory access tool 400 is positioned in the loading tool 300 by flushing it with an aseptic agent, including at least one of povidone-iodine, chlorhexidine, orthophthalaldehyde, peracetic acid, hydrogen peroxide, electrolyzed water, and glutaraldehyde forming an aseptic field.

[0065] At block 704, the knob 404 is placed in the second position in the loading tool 300, such as by turning the knob 404 to engage additional mating threads 324, 408. This inserts the needle 412 further into the elongate tube 328 until the needle 412 and dilator 416 extend out from the end 432 of the elongate tube 328. The needle 412 is visible in a camera present in the endoscope 802. The needle 412 is used to puncture the vessel 804, such as a gastric or esophageal varix,if the abnormality 806 had not already burst. Puncturing the vessel 804 forms an opening 808 in the vessel 804 and at block 706, the dilator 416 may be used to increase the size of the opening 808, if necessary.

[0066] At block 708, the distal end 432 of the elongate tube 328 is placed into the vessel 804. If the elongate tube 328 is a balloon catheter, the method also includes at block 708 expanding the balloon 816 within the vessel 804 to secure the elongate tube 328 in place within the vessel 804 and to close off the opening 808 of the vessel wall 810. At block 710 the accessory access tool 400, including the needle 412, is withdrawn from the elongate tube 328 and loading tool 300.

[0067] At block 712, the elongate tube 328 is flushed by introducing fluid through the port 344 into the second passageway 346 and the first passageway 310. The first seal 334 prevents the fluid from entering the upper passageway 336 and out of the first opening 312 at the first end 314. The fluid used to flush the elongate tube 328 may include normal saline, half normal saline, heparinized saline solution, and lactated Ringer solution. The fluid may be delivered through a bottle, pump including those discussed above, or bag connected to the port 344 by way of the fitting 352. In embodiments, a sclerosing agent may be introduced at this time.

[0068] At block 714, the accessory deployment tool 500 is inserted into the loading tool 300. The delivery device 200, if not already connected, is connected to the accessory deployment tool 500 prior to or after inserting the accessory deployment tool 500 into the loading tool 300. At block 716, the hydraulic pump 204 is used to deliver a fluid, as described above, into the lumen 210 of the elongate conduit 202. The fluid applies hydraulic pressure against the embolization device 100 located within the lumen 210 of the elongate conduit 202 and forces the embolization device 100 out of the lumen 210, through the elongate tube 328, and into the vessel 804. As previously noted, a hydraulic pressure in the range of 1 millimeter-mercury (mmHg) to 5000 mmHg, including all values and ranges therein is applied to embolization device 100. In further embodiments, 60 cubic centimeters of fluid or less, including all values and increments from 0.1 cubic centimeters to 60 cubic centimeters, of fluid is used to force the embolization device 100 to exit the distal end 208 of the elongate conduit 202 and deliver the embolization device 100 into the vessel 804.

[0069] Upon leaving the end 432 of the elongate tube 328 and entering the vessel 804, the embolization device 100 expands in the vessel 804. In embodiments, when compressive forceson the embolization device 100 is released, the embolization device 100 rebounds. Additionally, or alternatively the embolization device 100 swells from absorption of components within the blood. As alluded to above, in embodiments where a compressive force is applied to the embolization device 100 by the lumen 210, the plurality of segments 104 exhibit a diameter 110 in the compressed state within the lumen 210 of 6 percent to 80 percent of the diameter 110 of the plurality of segments 104 in the vessel 804. At block 718, the accessory deployment tool 500 may be removed from the loading tool 300. The loading tool 300 may also be removed from the accessory port of the endoscope 802 with the elongate tube 328 if no further embolization devices 100 need to be deployed. If additional embolization devices 100 need to be deployed, such as where multiple or larger abnormalities are present, an additional embolization device 100 may be loaded into the elongate conduit 202 or a new preloaded elongate conduit 202 may be connected to the loading tool 300.

[0070] FIG. 9 illustrates an embodiment of a system 900 and a kit 1000 for deploying an embolization device 100 in a vessel 804 exhibiting an abnormality. The system 900 and kit 1000 include the embolization device 100 and deployment device 200. In embodiments, the embolization device 100 is positioned within the elongate conduit 202 of the deployment device 200. In further embodiments, the system 900 and kit 1000 also include the loading tool 300, the accessory access tool 400, and the accessory deployment tool 500. Further, in additional embodiments, the kit 1000 includes a set of instructions 1002 for utilizing the embolization device 100 and the deployment device 200 as well as the loading tool 300, accessory access tool 400, and the accessory deployment tool 500, when the loading tool 300, accessory access tool 400, and the accessory deployment tool 500 are present in the kit 1000. The kit 1000 may also include a tray 1004, with recessed areas 1006, 1008, 1010, 1012, 1014 for accommodating the embolization device 100 and the deployment device 200 as well as the loading tool 300, accessory access tool 400, and the accessory deployment tool 500, when present.

[0071] Accordingly, the present disclosure pertains, in part, to an embolization device for insertion into a vascular abnormality. The embolization device includes an elongate body, the elongate body being a single continuous piece of a compressible polymer material, the elongate body forming a plurality of segments and a plurality of elongate partitions, wherein the plurality of segments and the plurality of elongate partitions being alternatingly arranged, and whereineach of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment.

[0072] In embodiments, each segment exhibits a first length and each elongate partition adjacent to each segment exhibits a second length and a ratio of the first length to the second length is in the range of 0.5 to 1 to 10 to 1.

[0073] In any of the above embodiments, the plurality of segments exhibit a first density and the plurality of elongate partitions exhibit a second density, wherein the second density is relatively higher than the first density.

[0074] In any of the above embodiments, the plurality of segments exhibit a first porosity and the plurality of elongate partitions exhibit a second porosity, wherein the second porosity is relatively lower than the first porosity.

[0075] In any of the above embodiments, the plurality of segments exhibit a first density and a first porosity, and the plurality of elongate partitions exhibit a second density and a second porosity, wherein the second density is equal to the first density and the second porosity is equal to the first porosity.

[0076] In any of the above embodiments, the compressible polymer material is an open cell foam. In further embodiments, the open cell foam is formed one or more of the following polymers: polyurethane, polyvinyl alcohol, cellulose, silicone, neoprene, polyethylene, ethylene-vinyl acetate, chitin, chitosan, carboxymethyl chitosan, glucomannan, gelatin, carboxymethyl cellulose, and cellulose. In further embodiments, the compressible polymer material includes a radiopaque fdler.

[0077] In any of the above embodiments, the embolization device also includes a plurality of twists in the elongate body defining each of the plurality of elongate partitions. In further embodiments, the plurality of twists are secured with at least one of the following: adhesive, mechanical fasteners, and heat.

[0078] The present disclosure also pertains, in part, to a loading tool for delivering an embolization device, such as the embolization device described above. The loading tool includes a housing, a first opening defined in a proximal end of the housing, a second opening defined in a distal end of the housing, a first passageway extending between the first opening and the second opening, wherein in the first passageway defines a wall, a mechanical fastener defined in the wall, an elongate tube connected to the first passageway, wherein the elongate tube defines alumen, a first seal separating the first passageway into an upper portion and a lower portion, a port extending form a side of the housing, and a second passageway defined in the port and the housing, wherein the second passageway connects to the lower portion of the first passageway.

[0079] In embodiments, the housing includes a first portion including the upper portion of the first passageway and a second portion including the lower portion of the first passageway, wherein the first portion and second portion are fastened together. In further embodiments, the first seal is retained between the first portion of the housing and second portion of the housing.

[0080] In any of the above embodiments, the elongate tube includes a catheter. In further embodiments, the catheter is a balloon catheter.

[0081] ]In any of the above embodiments, the first seal is a hemostatic valve.

[0082] The present disclosure further pertains, in part, to an accessory access tool for use with a loading tool, such as the loading tool described above, for delivering an embolization device. The accessory tool includes a knob including a mechanical fastener mate-able to a loading tool, an extension shaft extending from a distal end of the knob, and a needle connected to a distal end of the extension shaft.

[0083] In embodiments, the needle includes a dilator at a distal end of the needle proximal to a needle tip.

[0084] In any of the above embodiments, the accessory tool also includes a needle sheath extending over a least a portion of the needle.

[0085] The present disclosure additionally pertains, in part, to an accessory deployment tool for use with a loading tool for delivering an embolization device, such as the loading tool described above. The accessory deployment tool includes a knob including a mechanical fastener mateable to a loading tool, an extension shaft extending form a distal end of the knob, and a delivery passageway defined through the knob and the extension shaft, wherein the delivery passageway is connected to an elongate tube the elongate tube defining a lumen extending through the elongate tube, and a hydraulic pump connected to an end of the lumen, configured to introduce fluid into the lumen.

[0086] The present disclosure yet also pertains to, in part, a system for introducing an embolization device into a vessel including a delivery device and an embolization device. The delivery device includes an elongate tube, the elongate tube defining a lumen extending through the elongate tube, and a hydraulic pump connected to an end of the lumen, configured to introducefluid into the lumen. The embolization device is movably disposed in the lumen. The embolization device including an elongate body, the elongate body being a single continuous piece of a compressible polymer material, the elongate body forming a plurality of segments and a plurality of elongate partitions, the plurality of segments and the plurality of elongate partitions being alternatingly arranged, each of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment.

[0087] In embodiments of the above, the system further includes a loading tool, an accessory access tool mate-able to the loading tool, and an accessory deployment tool mate-able to the loading tool. The loading tool includes a housing, a first opening defined in a proximal end of the housing, a second opening defined in a distal end of the housing, a first passageway extending between the first opening and the second opening, wherein in the first passageway defines a wall, a first mechanical fastener for defined in the wall, an elongate tube connected to the first passageway, wherein the elongate tube defines a lumen, a first seal separating the first passageway into an upper portion and a lower portion, a port extending form a side of the housing, and a second passageway defined in the port and the housing, wherein the second passageway connects to the lower portion of the first passageway. The accessory access tool includes a first knob including a second mechanical fastener mate-able with the first mechanical fastener, a first extension shaft extending from a distal end of the first knob, wherein the first extension shaft extends through the first passageway and through the seal in the first passageway, and a needle connected to a distal end of the extension shaft. The accessory deployment tool includes a second knob including a third mechanical fastener mateable with the first mechanical fastener, a second extension shaft extending form a distal end of the second knob, wherein the second extension shaft extends through the first passageway and the seal in the first passageway, and a delivery passageway defined through the second knob and the second extension shaft, wherein the delivery passageway is connected to the elongate tube of the delivery device.

[0088] The present disclosure also pertains, in part, to a system for delivering an embolization device. The system includes a loading tool, an accessory access tool mate-able to the loading tool, and an accessory deployment tool mate-able to the loading tool. The loading tool includes a housing, a first opening defined in a proximal end of the housing, a second opening defined in a distal end of the housing, a first passageway extending between the first opening and thesecond opening, wherein in the first passageway defines a wall, a first mechanical fastener defined in the wall, an elongate tube connected to the first passageway, wherein the elongate tube defines a lumen, a first seal separating the first passageway into an upper portion and a lower portion, a port extending form a side of the housing, and a second passageway defined in the port and the housing, wherein the second passageway connects to the lower portion of the first passageway. The accessory access tool includes a first knob including a second mechanical fastener mate-able with the first mechanical fastener, a first extension shaft extending from a distal end of the first knob, wherein the first extension shaft extends through the first passageway and the seal in the first passageway, and a needle connected to a distal end of the extension shaft. The accessory deployment tool includes a second knob including a mechanical fastener mate-able with the first mechanical fastener, a second extension shaft extending form a distal end of the second knob, wherein the second extension shaft extends through the first passageway and the seal in the first passageway, and a delivery passageway defined through the second knob and the second extension shaft.

[0089] The present disclosure yet further pertains to, in part, a kit for delivering an embolization device. The kit includes a delivery device and an embolization device movably disposed in the lumen. The delivery device includes an elongate tube, the elongate tube defining a lumen extending through the elongate tube, and a hydraulic pump connected to an end of the lumen, configured to introduce fluid into the lumen. The embolization device includes an elongate body, the elongate body being a single continuous piece of a compressible polymer material, the elongate body forming a plurality of segments and a plurality of elongate partitions, the plurality of segments and the plurality of elongate partitions being altematingly arranged, each of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment.

[0090] In embodiments of the above, the kit also includes a loading tool, an accessory access tool mate-able to the loading tool, and an accessory deployment tool mate-able to the loading tool. The loading tool includes a housing, a first opening defined in a proximal end of the housing, a second opening defined in a distal end of the housing, a first passageway extending between the first opening and the second opening, wherein in the first passageway defines a wall, a first mechanical fastener defined in the wall, an elongate tube connected to the first passageway, wherein the elongate tube defines a lumen, a first seal separating the first passageway into anupper portion and a lower portion, a port extending form a side of the housing, and a second passageway defined in the port and the housing, wherein the second passageway connects to the lower portion of the first passageway. The accessory access tool includes a first knob including a second mechanical fastener mate-able with the first mechanical fastener, a first extension shaft extending from a distal end of the first knob, wherein the first extension shaft extends through the first passageway and the seal in the first passageway, and a needle connected to a distal end of the extension shaft. The accessory deployment tool includes a second knob including a mechanical fastener mate-able with the first mechanical fastener, a second extension shaft extending form a distal end of the second knob, wherein the second extension shaft extends through the first passageway and the seal in the first passageway, and a delivery passageway defined through the second knob and the second extension shaft, wherein the delivery passageway is connected to the elongate tube of the delivery device.

[0091] The present disclosure also pertains, in part, to a kit for delivering an embolization device. The kit includes a loading tool, an accessory access tool mate-able to the loading tool, and an accessory deployment tool mate-able to the loading tool. The loading tool includes a housing, a first opening defined in a proximal end of the housing, a second opening defined in a distal end of the housing, a first passageway extending between the first opening and the second opening, wherein in the first passageway defines a wall, a first mechanical fastener defined in the wall, an elongate tube connected to the first passageway, wherein the elongate tube defines a lumen, a first seal separating the first passageway into an upper portion and a lower portion, a port extending form a side of the housing, and a second passageway defined in the port and the housing, wherein the second passageway connects to the lower portion of the first passageway. The accessory access tool includes a first knob including a second mechanical fastener mate-able with the first mechanical fastener, a first extension shaft extending from a distal end of the first knob, wherein the first extension shaft extends through the first passageway and the seal in the first passageway, and a needle connected to a distal end of the extension shaft. The accessory deployment tool includes a second knob including a mechanical fastener mate-able with the first mechanical fastener, a second extension shaft extending form a distal end of the second knob, wherein the second extension shaft extends through the first passageway and the seal in the first passageway, and a delivery passageway defined through the second knob and the second extension shaft,.

[0092] The present disclosure yet further pertains, in part, to a method of inserting an embolization device into a vessel. The method includes inserting a distal end of an elongate tube through a wall of a vessel, wherein the elongate tube defines a lumen extending through the elongate tube, the lumen including an embolization device, the embolization device including an elongate body, the elongate body being a single continuous piece of a polymer material, the elongate body forming a plurality of segments and a plurality of elongate partitions, the plurality of segments and the plurality of elongate partitions being altematingly arranged, each of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment. The method also includes applying hydraulic pressure against the embolization device in the lumen. The method further includes delivering the embolization device from the elongate tube into the vessel, wherein the embolization device expands upon delivery into the vessel.

[0093] In embodiments, the embolization device is inserted into a vascular abnormality in the vessel. In further embodiments, the vascular abnormality is a varix.

[0094] In any of the above embodiments, the method further includes releasing a compressive force applied to the plurality of segments in the lumen upon delivering the embolization device into the vessel. In further embodiments, the plurality of segments exhibit the second diameter in the lumen and the plurality of segments exhibit a third diameter in the vessel, wherein the second diameter is in the range of 6 percent to 80 percent of the third diameter.

[0095] In any of the above embodiments, the method further includes puncturing the vessel with a needle prior to inserting the distal end of the elongate tube through the wall of the vessel.

[0096] In any of the above embodiments, the method further includes applying hydraulic pressure against the embolization device at a pressure in the range of 1 mm Hg to 5000 mm Hg.

[0097] In any of the above embodiments, applying hydraulic pressure includes injecting a fluid into a proximal end of the lumen of the elongate tube. In further embodiments, 60 cubic centimeters or less of the fluid is injected into the lumen to deliver the embolization device into the vessel.

[0098] In any of the above embodiments, the polymer material is an open cell foam including pores and the method further comprises introducing the fluid into the pores of the open cell foam and applying the hydraulic pressure in the pores.

[0099] In any of the above embodiments, the method further includes injecting the fluid with a pump selected from the following group of pumps: a syringe, a piston pump, a peristaltic pump, a gear pump, and a screw pump.

[0100] In any of the above embodiments, the method further includes extending a needle through the distal end of the elongate tube, inserting the needle and the elongate tube together through the wall of the vessel, and withdrawing the needle from the elongate tube prior to introducing the embolization device into the elongate tube. In further embodiments, the method includes expanding a balloon connected to the distal end of the elongate tube in the vessel.

[0101] In any of the above embodiments, the plurality of elongate partitions exhibit a first density and the plurality of segments exhibit a second density, wherein the first density is higher than the second density.

[0102] In any of the above embodiments, the plurality of elongate partitions exhibit a first density and the plurality of segments exhibit a second density, wherein the first density and second density are equal.

[0103] In any of the above embodiments, the plurality of elongate partitions exhibit a first porosity and the plurality of segments exhibit a second porosity, wherein the first porosity is lower than the second porosity.

[0104] In any of the above embodiments, each elongate partition exhibits a first length and each segment adjacent to each elongate partition exhibits a second length and a ratio of the first length to the second length is in the range of 1 :0.5 to 1 :50.

[0105] In any of the above embodiments, the polymer material is a foam formed of one or more of the following polymers: polyurethane, polyvinyl alcohol, cellulose, silicone, neoprene, polyethylene, ethylene-vinyl acetate, chitin, chitosan, carboxymethyl chitosan, glucomannan, gelatin, carboxymethyl cellulose, and cellulose.

[0106] In any of the above embodiments, the polymer material includes a radiopaque fdler.

[0107] In any of the above embodiments, the elongate partition exhibits a first cross-sectional length and each segment adjacent to each segment exhibits a second cross-sectional length and a ratio of the first cross-sectional length to the second cross-sectional length is in the range of 1 :1.3 to 1 :20.

[0108] The methods, devices, systems, and kits herein offer a number of advantages. These advantages include, for example, flexibility provided by the segments and partitions to assistin conformance of the embolization device with the shape of the vessel, further assisting in occluding the vessel. These advantages also include the ability to provide prophylactic treatment, which may improve patient outcomes. The use of foam in the embolization device also provides the advantage of a relatively even application of hydraulic pressure against the embolization device pushing the embolization device out of the elongate conduit and elongate tube. The hydraulic pressure may also elongate a foam embolization device allowing for a decrease in the radial force applied against the lumen of the elongate conduit by the embolization device. Further, the advantages include the occlusion of a vessel by promoting tissue ingrowth into the material.

[0109] The description of the present disclosure is merely exemplary in nature and variations that do not depart from the gist of the present disclosure are intended to be within the scope of the present disclosure. Such variations are not to be regarded as a departure from the spirit and scope of the present disclosure.

Claims

CLAIMS1. A method of inserting an embolization device into a vessel, comprising: inserting a distal end of an elongate tube through a wall of a vessel, wherein the elongate tube defines a lumen extending through the elongate tube, the lumen including an embolization device, the embolization device including an elongate body, the elongate body being a single continuous piece of a polymer material, the elongate body forming a plurality of segments and a plurality of elongate partitions, the plurality of segments and the plurality of elongate partitions being alternatingly arranged, each of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment; applying hydraulic pressure against the embolization device in the lumen; and delivering the embolization device from the elongate tube into the vessel, wherein the embolization device expands upon delivery into the vessel.

2. The method of claim 1, wherein the embolization device is inserted into a vascular abnormality in the vessel.

3. The method of claim 2, wherein the vascular abnormality is a varix.

4. The method according to any one of claims 1 to 3, further comprising releasing a compressive force applied to the plurality of segments in the lumen upon delivering the embolization device into the vessel.

5. The method of claim 4, wherein the plurality of segments exhibit the second diameter in the lumen and the plurality of segments exhibit a third diameter in the vessel, wherein the second diameter is in the range of 6 percent to 80 percent of the third diameter.

6. The method according to any one of claims 1 to 5, further comprising puncturing the vessel with a needle prior to inserting the distal end of the elongate tube through the wall of the vessel.

7. The method according to any one of claims 1 to 6, further comprising applying hydraulic pressure against the embolization device at a pressure in the range of 1 mm Hg to 5000 mm Hg.

8. The method according to any one of claims 1 to 7, wherein applying hydraulic pressure includes injecting a fluid into a proximal end of the lumen of the elongate tube.

9. The method of claim 8, wherein 60 cubic centimeters or less of the fluid is injected into the lumen to deliver the embolization device into the vessel.

10. The method according to any one of claims 8 to 9, further comprising injecting the fluid with a pump selected from the following group of pumps: a syringe, a piston pump, a peristaltic pump, a gear pump, and a screw pump.

11. The method according to any one of claims 1 to 10, wherein the polymer material is an open cell foam including pores and the method further comprises introducing the fluid into the pores of the open cell foam and applying the hydraulic pressure in the pores.

12. The method of claim according to any one of claims 1 to 11, further comprising extending a needle through the distal end of the elongate tube, inserting the needle and the elongate tube together through the wall of the vessel, and withdrawing the needle from the elongate tube prior to introducing the embolization device into the elongate tube.

13. The method of claim 12, further comprising expanding a balloon connected to the distal end of the elongate tube in the vessel.

14. The method according to any one of claims 1 to 13, wherein the plurality of elongate partitions exhibit a first density and the plurality of segments exhibit a second density, wherein the first density is higher than the second density.

15. The method according to any one of claims 1 to 13, wherein the plurality of elongate partitions exhibit a first density and the plurality of segments exhibit a second density, wherein the first density and second density are equal.

16. The method according to any one of claims 1 to 13, wherein the plurality of elongate partitions exhibit a first porosity and the plurality of segments exhibit a second porosity, wherein the first porosity is lower than the second porosity.

17. The method according to any one of claims 1 to 16, wherein each elongate partition exhibits a first length and each segment adjacent to each elongate partition exhibits a second length and a ratio of the first length to the second length is in the range of 1 :0.5 to 1 :50.

18. The method according to any one of claims 1 to 17, wherein the polymer material is one or more of the following polymers: polyurethane, polyvinyl alcohol, cellulose, silicone, neoprene, polyethylene, ethylene-vinyl acetate, chitin, chitosan, carboxymethyl chitosan, glucomannan, gelatin, carboxymethyl cellulose, and cellulose.

19. The method according to any one of claims 1 to 18, wherein the polymer material includes a radiopaque filler.

20. The method according to any one of claims 1 to 19, wherein each elongate partition exhibits a first cross-sectional length and each segment adjacent to each segment exhibits a second cross-sectional length and a ratio of the first cross-sectional length to the second cross- sectional length is in the range of 1 : 1.3 to 1 :20.

21. An embolization device for insertion into a vascular abnormality, comprising: an elongate body, the elongate body being a single continuous piece of a compressible polymer material, the elongate body forming a plurality of segments and a plurality of elongate partitions, wherein the plurality of segments and the plurality of elongate partitions being alternatingly arranged, and wherein each of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment.

22. The embolization device of claim 21 , wherein each segment exhibits a first length and each elongate partition adjacent to each segment exhibits a second length and a ratio of the first length to the second length is in the range of 0.5 to 1 to 10 to 1.

23. The embolization device according to any one of claims 21 and 22, wherein the plurality of segments exhibit a first density and the plurality of elongate partitions exhibit a second density, wherein the second density is relatively higher than the first density.

24. The embolization device according to any one of claims 21 to 23, wherein the plurality of segments exhibit a first porosity and the plurality of elongate partitions exhibit a second porosity, wherein the second porosity is relatively lower than the first porosity.

25. The embolization device according to any one of claims 21 to 24, wherein the plurality of segments exhibit a first density and a first porosity, and the plurality of elongate partitions exhibit a second density and a second porosity, wherein the second density is equal to the first density and the second porosity is equal to the first porosity.

26. The embolization device according to any one of claims 21 to 25, wherein the compressible polymer material is an open cell foam.

27. The embolization device according to any one of claims 21 to 26, wherein the compressible polymer material is formed one or more of the following polymers: polyurethane, polyvinyl alcohol, cellulose, silicone, neoprene, polyethylene, ethylene-vinyl acetate, chitin, chitosan, carboxymethyl chitosan, glucomannan, gelatin, carboxymethyl cellulose, and cellulose.

28. The embolization device of claim according to any one of claims 21 to 27, wherein the compressible polymer material includes a radiopaque filler.

29. The embolization device of claim according to any one of claims 21 to 28, further comprising a plurality of twists in the elongate body defining each of the plurality of elongate partitions.

30. The embolization device of claim 29, wherein the plurality of twists are secured with at least one of the following: adhesive, mechanical fasteners, and heat.

31. A loading tool for delivering an embolization device according to any one of claims 21 to30, comprising: a housing; a first opening defined in a proximal end of the housing; a second opening defined in a distal end of the housing; a first passageway extending between the first opening and the second opening, wherein in the first passageway defines a wall; a mechanical fastener defined in the wall; an elongate tube connected to the first passageway, wherein the elongate tube defines a lumen; a first seal separating the first passageway into an upper portion and a lower portion; a port extending form a side of the housing; and a second passageway defined in the port and the housing, wherein the second passageway connects to the lower portion of the first passageway.

32. The loading tool of claim 31, wherein the housing includes a first portion including the upper portion of the first passageway and a second portion including the lower portion of the first passageway, wherein the first portion and second portion are fastened together.

33. The loading tool of claim 32, wherein the first seal is retained between the first portion of the housing and second portion of the housing.

34. The loading tool according to any one of claims 31 to 33 , wherein the elongate tube includes a catheter.

35. The loading tool of claim 34, wherein the catheter is a balloon catheter.

36. The loading tool according to any one of claims 31 to 35, wherein the first seal is a hemostatic valve.

37. An accessory access tool for use with the loading tool according to any one of claims 31 to 36, comprising: a knob including a mechanical fastener mate-able to a loading tool; an extension shaft extending from a distal end of the knob; and a needle connected to a distal end of the extension shaft.

38. The accessory access tool of claim 37, wherein the needle includes a dilator at a distal end of the needle proximal to a needle tip.

39. The accessory access tool of claim 38, further comprising a needle sheath extending over a least a portion of the needle.

40. An accessory deployment tool for use with the loading tool according to any one of claims 31 to 36, comprising: a knob including a mechanical fastener mate-able to a loading tool; an extension shaft extending form a distal end of the knob; and a delivery passageway defined through the knob and the extension shaft, wherein the delivery passageway is connected to an elongate tube the elongate tube defining a lumen extending through the elongate tube, and a hydraulic pump connected to an end of the lumen, configured to introduce fluid into the lumen.

41. A system for introducing an embolization device into a vessel, comprising: a delivery device including an elongate tube, the elongate tube defining a lumen extending through the elongate tube, and a hydraulic pump connected to an end of the lumen, configured to introduce fluid into the lumen; andan embolization device movably disposed in the lumen, the embolization device including an elongate body, the elongate body being a single continuous piece of a compressible polymer material, the elongate body forming a plurality of segments and a plurality of elongate partitions, the plurality of segments and the plurality of elongate partitions being alternatingly arranged, each of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment.

42. The system of claim 41, further comprising: a loading tool, the loading tool including a housing, a first opening defined in a proximal end of the housing, a second opening defined in a distal end of the housing, a first passageway extending between the first opening and the second opening, wherein in the first passageway defines a wall, a first mechanical fastener for defined in the wall, an elongate tube connected to the first passageway, wherein the elongate tube defines a lumen, a first seal separating the first passageway into an upper portion and a lower portion, a port extending form a side of the housing, and a second passageway defined in the port and the housing, wherein the second passageway connects to the lower portion of the first passageway; an accessory access tool mate-able to the loading tool, the accessory access tool including a first knob including a second mechanical fastener mate-able with the first mechanical fastener, a first extension shaft extending from a distal end of the first knob, wherein the first extension shaft extends through the first passageway and through the seal in the first passageway, and a needle connected to a distal end of the extension shaft; and an accessory deployment tool mate-able to the loading tool, the accessory deployment tool includinga second knob including a third mechanical fastener mate-able with the first mechanical fastener, a second extension shaft extending form a distal end of the second knob, wherein the second extension shaft extends through the first passageway and the seal in the first passageway, and a delivery passageway defined through the second knob and the second extension shaft, wherein the delivery passageway is connected to the elongate tube of the delivery device.

43. A system for introducing an embolization device into a vessel, comprising: a loading tool, the loading tool including a housing, a first opening defined in a proximal end of the housing, a second opening defined in a distal end of the housing, a first passageway extending between the first opening and the second opening, wherein in the first passageway defines a wall, a first mechanical fastener for defined in the wall, an elongate tube connected to the first passageway, wherein the elongate tube defines a lumen, a first seal separating the first passageway into an upper portion and a lower portion, a port extending form a side of the housing, and a second passageway defined in the port and the housing, wherein the second passageway connects to the lower portion of the first passageway; an accessory access tool mate-able to the loading tool, the accessory access tool including a first knob including a second mechanical fastener mate-able with the first mechanical fastener, a first extension shaft extending from a distal end of the first knob, wherein the first extension shaft extends through the first passageway and through the seal in the first passageway, and a needle connected to a distal end of the extension shaft; andan accessory deployment tool mate-able to the loading tool, the accessory deployment tool including a second knob including a third mechanical fastener mate-able with the first mechanical fastener, a second extension shaft extending form a distal end of the second knob, wherein the second extension shaft extends through the first passageway and the seal in the first passageway, and a delivery passageway defined through the second knob and the second extension shaft.

44. A kit for delivering an embolization device, comprising: a delivery device including an elongate tube, the elongate tube defining a lumen extending through the elongate tube, and a hydraulic pump connected to an end of the lumen, configured to introduce fluid into the lumen; and an embolization device movably disposed in the lumen, the embolization device including an elongate body, the elongate body being a single continuous piece of a compressible polymer material, the elongate body forming a plurality of segments and a plurality of elongate partitions, the plurality of segments and the plurality of elongate partitions being alternatingly arranged, each of the plurality of elongate partitions having a first diameter that is less than a second diameter of an adjacent segment.

45. The kit of claim 44, further comprising: a loading tool, the loading tool including a housing, a first opening defined in a proximal end of the housing, a second opening defined in a distal end of the housing, a first passageway extending between the first opening and the second opening, wherein in the first passageway defines a wall, a first mechanical fastener defined in the wall,an elongate tube connected to the first passageway, wherein the elongate tube defines a lumen, a first seal separating the first passageway into an upper portion and a lower portion, a port extending form a side of the housing, and a second passageway defined in the port and the housing, wherein the second passageway connects to the lower portion of the first passageway; an accessory access tool mate-able to the loading tool, the accessory access tool including a first knob including a second mechanical fastener mate-able with the first mechanical fastener, a first extension shaft extending from a distal end of the first knob, wherein the first extension shaft extends through the first passageway and the seal in the first passageway, and a needle connected to a distal end of the extension shaft; and an accessory deployment tool mate-able to the loading tool, the accessory deployment tool including a second knob including a mechanical fastener mate-able with the first mechanical fastener, a second extension shaft extending form a distal end of the second knob, wherein the second extension shaft extends through the first passageway and the seal in the first passageway, and a delivery passageway defined through the second knob and the second extension shaft, wherein the delivery passageway is connected to the elongate tube of the delivery device.

46. A kit for delivering an embolization device, comprising: a loading tool, the loading tool including a housing, a first opening defined in a proximal end of the housing, a second opening defined in a distal end of the housing, a first passageway extending between the first opening and the second opening, wherein in the first passageway defines a wall,a first mechanical fastener defined in the wall, an elongate tube connected to the first passageway, wherein the elongate tube defines a lumen, a first seal separating the first passageway into an upper portion and a lower portion, a port extending form a side of the housing, and a second passageway defined in the port and the housing, wherein the second passageway connects to the lower portion of the first passageway; an accessory access tool mate-able to the loading tool, the accessory access tool including a first knob including a second mechanical fastener mate-able with the first mechanical fastener, a first extension shaft extending from a distal end of the first knob, wherein the first extension shaft extends through the first passageway and the seal in the first passageway, and a needle connected to a distal end of the extension shaft; and an accessory deployment tool mate-able to the loading tool, the accessory deployment tool including a second knob including a mechanical fastener mate-able with the first mechanical fastener, a second extension shaft extending form a distal end of the second knob, wherein the second extension shaft extends through the first passageway and the seal in the first passageway, and a delivery passageway defined through the second knob and the second extension shaft.

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