Coated Endovascular Intrasaccular Occlusion Device Method of Use

Abstract

A method to close bodily outpouchings using a novel endovascular treatment mesh device that affixes at least one amorphous hydrogel layer expandable in vivo to any or all surfaces of an expandable body comprising at least one material adapted to close said outpouching in the body. The treatment mesh further includes a telescoping center-support bar disposed therein, the center-support bar having at least two telescoping elements that act as reinforcing extension elements to minimize the risk of collapse. Hydrogel is affixed to the surface of the telescoping elements to inhibit retraction. The method includes use of an embodiment of the novel device wherein the treatment mesh device is a stent.

Claims

1. A method, comprising: positioning an intrasaccular occlusion device relative to a target site within a vascular lumen, the occlusion device including: an expandable body; an amorphous hydrogel on one or more surface portions of the expandable body; and expandable in vivo; and a reinforcing extension element configured to minimizes risk of collapse of the expandable body, the reinforcing extension element being a telescoping center-support bar having at least two telescoping elements and the hydrogel disposed with respect to telescoping center-support bar, and wherein the hydrogel minimizes relative movement of the at least two telescopic elements subsequent to at least partial deployment to facilitate retention of the expandable body relative to the target area.

2. The method according to claim 1, further comprising: coupling an insertion tool to the occlusion device, the insertion tool having a first end and a second end, wherein the second end is a proximal end terminating outside of a patient, and the first end is a distal end configured to couple with the occlusion device, the occlusion device having a first end and a second end, wherein the second end of the occlusion device is configured to communicate with the first end of the insertion tool, the second end of the intrasaccular occlusion device being configured to deploy relative to the target area, the occlusion device having an outer surface and an inner surface, the outer surface being coated with the hydrogel, the occlusion device being moveable between a retracted condition and a deployed condition; inserting the occlusion device into the patient via one or more vascular pathways in communication with the vascular lumen, with the occlusion device in the retracted condition; moving the occlusion device toward the target area; enabling the expandable body of the occlusion device to expand to provide a seal relative to the target area and the vascular lumen; securing the outer surface of the occlusion device against a wall of the vascular lumen; reinforcing the occlusion device by extending the telescoping center-support bar; leaving the occlusion device relative to the target area to permit release of pharmaceutical compounds within one of the occlusion device and the hydrogel; detaching the insertion rod from the occlusion device; and removing the insertion rod from the patient.

3. The method according to claim 2, wherein the hydrogel is disposed on the inner surface of the expandable body.

4. The method according to claim 2, wherein the hydrogel is impregnated with at least one pharmaceutical compound.

5. The method according to claim 2, wherein the at least one pharmaceutical compound is configured to be released into the vascular lumen at a prescribed dose over a prescribed time.

6. The method according to claim 2, wherein the hydrogel is coated upon any surface that is configured to be exposed to blood or a lumen wall of the occlusion device.

7. The method according to claim 2, wherein the hydrogel is deployed upon the expandable body, and expands in vivo to occlude interstices of the expandable body.

8. The method according to claim 2, wherein the hydrogel is biodegradable or non-biodegradable.

9. (canceled)

10. The method according to claim 2, wherein the hydrogel is disposed on the expandable body, wherein the expandable body includes a mesh configured for use as a cardiac prosthesis.

11. (canceled)

12. The method according to claim 2, wherein the hydrogel is disposed on the expandable body, wherein the expandable body includes a mesh configured to be a stent having the reinforcing extension element.

13. A method, comprising: advancing a delivery tool having an occlusion device coupled thereto within a body lumen of a subject to position the occlusion device relative to a target site within the body lumen; deploying a treatment body of the occlusion device adjacent the target area; securing the treatment body relative to the body lumen; and supporting the occlusion device in the body lumen with a reinforcement member mounted to the treatment body.

14. The method according to claim 13, wherein the treatment body comprises one or more amorphous hydrogel layers expandable in vivo; and wherein securing the treatment body relative to the body lumen is effected, at least in part, through engagement of the one or more amorphous hydrogel layers with inner lumen surfaces of the body lumen.

15. The method according to claim 14, wherein the one or more amorphous hydrogel layers comprises one or more pharmaceutical compounds, and further including releasing the pharmaceutical compounds into the body lumen.

16. The method according to claim 15, wherein the treatment body includes a stent.

17. The method according to claim 15, wherein the occlusion device is configured for positioning relative to an aneurysm.

18. The method according to claim 13, wherein the reinforcement member comprises an amorphous hydrogel layer expandable in vivo.

19. The method according to claim 18, wherein the amorphous hydrogel layer is configured to stabilize the reinforcement member within the treatment body.

20. The method according to claim 13, wherein the delivery tool comprises an amorphous hydrogel layer expandable in vivo.

21. The method according to claim 13, wherein deploying includes transitioning the treatment body from a first unexpanded condition to a second expanded condition.

22. The method according to claim 21 wherein the reinforcement member includes a telescoping center-support bar having at least two telescoping elements, and further including moving the at least two telescoping elements relative to each other to stabilize the occlusion device in the body lumen.

23. The method of claim 13 wherein the treatment body comprises a sac configured to fill at least a portion of a luminal outpouching.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0066] The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detail description thereof. Such description makes reference to the annexed drawings wherein:

[0067] FIG. 1 showing at distal end of wire (12) deployed device (10) designed to implement an endovascular treatment mesh (20) at treatment site with hydrogel coating (22).

[0068] FIG. 2 showing at distal end of wire (12) showing un-deployed device designed to implement an endovascular treatment mesh (20) with hydrogel coating (22).

[0069] FIG. 3 showing at distal end of wire (12) deployed device designed to implement an endovascular treatment mesh (20) with hydrogel coating (22), further including radial stiff bars (40) in vertical orientation.

[0070] FIG. 4 showing at distal end of wire (12) deployed device designed to implement an endovascular treatment mesh (20) with hydrogel coating (22), further including vertically oriented elements (50) of reinforced mesh.

[0071] FIG. 5 showing at distal end of wire (12) deployed device designed to implement an endovascular treatment mesh (20) with hydrogel coating (22), further including a simple center-support bar or stick (60).

[0072] FIGS. 6A and 6B showing at distal end of wire (12) deployed device designed to implement an endovascular treatment mesh (20) with hydrogel coating (22), further including a telescoping center-support bar (70).

[0073] FIG. 7 showing at distal end of wire (12) deployed device designed to implement an endovascular treatment mesh (20) with hydrogel coating (22), further including a bar (60) with umbrella-like radial support struts (80).

[0074] FIG. 8 showing at distal end of wire (12) deployed device designed to implement an endovascular treatment mesh (20) with hydrogel coating (22), further including a spring (90) of preset coil length that straightens in delivery-sheath catheter.

[0075] FIG. 9 shows the elements of FIG. 1 wherein the entire structure is coated with hydrogel (22).

[0076] FIG. 10A and FIG. 10B are planar views showing a stent covered in hydrogel depicted as mis-formed circles or beads; a reinforcement member is not shown.

[0077] FIG. 11 depicts a cross-section of the embodiment of the present invention shown in FIGS. 10A-B, situated within in a mammalian vessel, without showing the delivery system.

[0078] Note that hydrogel coating is depicted in the foregoing Figures as mis-formed circles or beads as being representative only, and said circles or beads shown are not drawn to scale.

DETAILED DESCRIPTION OF THE INVENTION

[0079] The first (the coated endovascular component) element of the current invention teaches the placement of hydrogel within or coating surfaces of intravascular devices and stents, which are often delivered proximally to target area using a stent allowing for the implementation of a therapeutic endovascular treatment.

[0080] Referring now to FIGS. 10A and 10B, a stent 910 disposed upon a delivery device 920. Stent 910 is shown deployed within vessel wall 9100. A reinforcement member (not shown), at least one support bar is configured to attach to opposing sides within stent 910 oriented perpendicularly to the longitudinal axis of the lumen. Said support element may be a spring, a piston, a telescoping element, an umbrella-like element, without limitation.

[0081] Stent 910 includes a distal end 911. Delivery device 920 has a distal end 921.

[0082] Stent 910 is coated with hydrogel 22 or 915 or 916. Hydrogel 22 or 915 or 916 is typically amorphous. It is adhered to all or select surfaces of stent 910 or another intravascular device. For purposed of clarity, 915 refers to hydrogel on the outer surfaces of a structure, 916 refers to hydrogel on the outer surfaces of a structure and 22 refers to hydrogel on the outer surfaces of a structure and the inner surface of a structure.

[0083] In a preferred embodiment, stent 910 is covered with a one (1) nanometer to one (1) millimeter layer of hydrogel 915 or 916 to prevent thrombosis and tissue reactions. Another embodiment includes impregnating medications into hydrogel 915 or 916 on stent 910. This alternate embodiment may have multiple subgroups including chemotherapy and vasodilator agents, among others. This embodiment could also have multiple applications for treatment of cancer, vasospasm, and other diseases, with varying the medications and the location of the stent.

[0084] Referring now to FIG. 11, a cross-section of deployed covered stent 910 within vessel wall 9100, showing hydrogel coating on the outer surface 915 and the inner surface 916.

[0085] When said coated device 910 is employed in an endovascular treatment, the exposure of the adhered added hydrogel 915 or 916 with the device 910 to the blood and temperature in the body causes it to expand further, decreasing the permeability of device 910 to blood and which decreases the risk of the aneurysm rupturing or clots forming and embolizing.

[0086] The present invention uses a device designed to facilitate endovascular treatment by coating hydrogel along delivery device 920 to prevent episodes of distal migration due to addition of hydrogel 915 and 916.

[0087] In one embodiment of the current invention a thin coating of hydrogel 915 and 916 is placed on all surfaces, including the surface pressing on the vessel wall to reduce the rate of intimal hyperplasia caused by the vessel reacting to the foreign body. This results in a non-obvious benefit of the use of hydrogel 915 and 916 because vasospasms tum cause sub-optimal outcomes, including in some cases the death of the patent.

[0088] The thickness of the hydrogel 915 and 916 coating on the stent 910 would be from the minimum possible thickness of approximately one nanometer or less, up to one centimeter in 14 thickness. However, for most carotid and vertebral artery applications the preferred thickness is one millimeter or less.

[0089] In general dosage depends on the specific medication and the intended task. For example, Verapamil 2 mg/hr. and Cardene 100 mcg/hr. are non-limiting examples of medication doses that are released to the blood for cases of vasospasm. Various possible vasodilators, including and not limited to the ones listed herein may be infused for treating vasospasms; any chemotherapy agent may be employed for treatment of cancer.

[0090] In alternate embodiments (not shown), hydrogel 915 and 916 is lined onto nonvascular stents 910, such as biliary and ureter stents, to reduce rates of in-stent stenosis; and may help anchor the stent 910 in place and prevent stent migration.

[0091] In another alternate embodiment (not shown), hydrogel 915 and 916 does not fill the interstices between metal areas of stent 910.

[0092] In alternate embodiments, hydrogel may be coated on such devices as a delivery mechanism of medications, which can be immediate release or controlled sustained slow release. Slow, local release of adhered medications is also useful in treating certain cancers.

[0093] In some embodiments, a bio-degradable hydrogel is employed. In another embodiment, a non-biodegradable hydrogel, that will be permanent, may be employed.

[0094] In some embodiments said additional coating includes chemotherapy compounds in said thin coating of hydrogel. As examples, said chemotherapy compounds embedded in a device may be used in the carotid artery for a brain tumor in that vascular distribution, or in right renal artery for a right kidney tumor, or in right pulmonary artery for a right lung mass. This could allow sustained delivery locally, while minimizing the systemic dose and associated side effects.

[0095] Said hydrogel thin coating may be impregnated with pharmaceutical compounds to ameliorate vasospasm. Said compounds may include, but are not limited to nimodipine, Verapamil, Cardene, nitroglycerin, and nitroprusside. Said compounds may be formulated for immediate release or controlled sustained slow release.

[0096] By way of non-limiting example, impregnating hydrogel adhered to a stent with Verapamil that is released over two weeks, and placing said stent in carotid artery, may be used to treat intracranial vasospasm. In addition or in the alternative, impregnating hydrogel adhered to a stent with a slow release chemotherapy agent, allowing selective delivery over a time to a single organ, with lower systemic doses, is likely to lead to fewer side-effects. It may allow higher and more effective local doses of medication as well.

[0097] To minimize the risk of severe symptomatic vasospasm in aneurysmal sub-archnoid hemorrhage (a typical bleed from a ruptured brain aneurysm) or other intracranial vasoconstriction syndrome, the said thin coating of hydrogel might include a vasodilator compound that slowly releases over two to four weeks. Said medication infused hydrogel can be embedded in a stent for placement in the common or internal carotid arteries on one or both sides, and/or the placement in one or both vertebral arteries. Non-limiting examples of vasodilators that can be embedded include nimodipine, Verapamil, Cardene, nitroglycerin, and nitroprusside. They can be implanted therapeutically after vasospasm is identified. In some cases, they can be implanted prophylactically, before the onset of vasospasm.

[0098] The objective of the present invention is to deliver pharmaceutical compound(s) downstream from the stent 910. The present invention teaches four techniques to achieve this objective in a manner which is superior to the prior art.

[0099] First, the hydrogel 915 and 916 which contains the pharmaceutical compounds is located both inside and outside the stent 910 wall. Said positioning allows blood flowing through stent 10 to leach medication from hydrogel 915 or 916. Said blood flow then delivers said pharmaceutical compounds downstream of stent 910. Hydrogel 916 (interior surface) differs from the prior art because the prior art deposits the pharmaceutical compound directly on the outer surface of a (typically) metal stent.

[0100] When the prior art devices release the pharmaceutical compounds, they expose metal surfaces either inside the prior-art stent, thus harming the blood, or outside the metal stent, thus harming the vessel tissue in contact with the vessel wall 9100. In light of the fact that it is known that exposure of blood to metal causes injury, the present invention in its preferred embodiment uses an intermediate compound such as hydrogel 915 or 916, which covers the stent 910 both inside and out, after the medication has been leached away, thus preventing injury of the metal contact with either the blood or the vessel wall 9100. Coating hydrogel 916 inside stent 910 allows superior downstream results as compared to prior-art devices.

[0101] The second technique to enhance superior downstream results, when compared to the prior art, is the present invention's asymmetrical distribution of the hydrogel 915 and 916, in some embodiments. By placing relatively more hydrogel 915 and 916 toward the downstream end of stent 910, pharmaceutical compounds are more likely to exit stent 910 and travel further from stent 910 then if the compounds were uniformly distributed on a stent 910, as disclosed by the prior art.

[0102] The third technique, in some embodiments, is to shape the inside of stent 910 to produce spiral flow. Said shaping may be achieved by either forming internal spiral ridges on the inside of stent 910, or plating the inside of stent 910 with spiral mounds of hydrogel 915 and 916. Either the spiral ridges coated with hydrogel or spiral mounds of hydrogel will result in changing the course of the blood flow through stent 910. More particularly, such spiral-coated structures or mounds will cause the blood flow through stent 910 to spiral. Such spiraling will encourage turbulent flow. Turbulent flow has a well-known characteristic of clumping particulate matter such as pharmaceutical compounds in the center of the flow. Particulate matter in the center of the flow will go further downstream than particulate matter under laminar-flow conditions.

[0103] The fourth technique, in some embodiments, is to make the downstream stent 910 opening smaller than the upstream stent 910 opening. Itis well known that constricting a fluid results in turbulent flow. Therefore, for the reasons noted above, pharmaceutical compounds will travel in the center of the flow further downstream than stents with similarly sized openings, as disclosed by the prior art.

[0104] The foregoing four techniques, individually or in a combination of one or more of these techniques, may also be used to control the amount and distance the pharmaceutical compounds will be sent downstream in addition to allowing superior downstream range of pharmaceutical-compound delivery as compared to the prior art.

[0105] The present invention can alternatively be used by embedding or impregnating pharmaceutical compounds and/or medications in stent 910 for local delivery, short release or sustained release, using permanent non-degradable hydrogel or biodegradable hydrogel. The following are non-limiting embodiments.

[0106] Placing a stent with chemotherapy embedded into carotid artery for a brain tumor in that vascular distribution, or in right renal artery for a right kidney tumor, or in right pulmonary artery for a right lung mass. This could allow sustained delivery locally, while minimizing the systemic dose and associated side effects.

[0107] Similarly, to minimize the risk of severe symptomatic vasospasm in aneurysmal subarachnoid hemorrhage (a typical bleed from a ruptured brain aneurysm), a vasodilator that slowly releases over time can be embedded in stent 910 for placement in the common or internal carotid arteries on both sides, with optional additional placement in one or both vertebral arteries. Non-limiting examples of vasodilators that can be embedded include nimodipine, Verapamil, Cardene, nitroglycerin, and nitroprusside.

[0108] The coating an endovascular device is device independent. The location of said coting is also device independent. While one embodiment is the stent 910 and the delivery device 920, an alternated embodiment disclosed by the present invention teaches the placement of amorphous hydrogel (22) within or coating surfaces of intrasaccular occlusion devices, which are delivered proximally to target vessels using wire delivery systems (12). Said intrasaccular occlusion devices are typically housed in intrasaccular tools during the transport process.

[0109] Coating said intrasaccular occlusion devices, particularly an extension such as treatment mesh (20), allows for the implementation of a therapeutic endovascular treatment.

[0110] Said amorphous hydrogel (22) is adhered to select surfaces of said device (20) designed to implement an endovascular treatment and is contained by said device designed to implement an endovascular treatment. Alternatively, said amorphous hydrogel (22) is adhered to select surfaces of said device (20) designed to implement an endovascular treatment or is contained by said device designed to implement an endovascular treatment. These alternatives are not necessarily mutually exclusive.

[0111] When said coated device is designed to implement an endovascular treatment is proximately positioned at the treatment point, and the metal mesh device (2) such as the Sequent Web or Luna Aneurysm Embolization system or similar system is deployed in the body, the exposure of the adhered added hydrogel with the device to the blood and temperature in the body causes it to expand further, decreasing the permeability of the device to blood and promoting more immediate thrombosis of the aneurysm or other vascular outpouching, which results in more immediate decrease in the risk of the aneurysm rupturing or clots forming and embolizing.

[0112] The present invention uses a device designed to facilitate endovascular treatment by coating hydrogel along the metal struts/web of the device and uses it to prevent episodes of distal migration due to addition of hydrogel. This is achieved by providing expanded hydrogel extends outside the device on the sides of the device. Said extensions will help “grip” the aneurysm walls and minimize the incidence of migration. Additionally, said extensions help speed thrombosis and minimize risk of collapse. The center open space within the web can have added strands and/or struts and/or bars of hydrogel as well. Said extensions can be oriented vertically for added support. Said extensions can be oriented in either direction as well.

[0113] More particularly, said extensions which may be made of hydrogel coated metal, metal alloys, or plastic, or other stiff material and may be integrated into the web element of the hydrogel intrasaccular occlusion device as bars and/or struts, or segments. Said extensions may also be reinforced portions of the web itself, reinforced with stiffer metal or material, that might also minimize the potential for collapse. All said reinforced elements may be further enhanced by the addition of hydrogel to these various metal bars and struts as well, especially at the center of the “spring.” All said reinforcements may also sometimes not be further enhanced by hydrogel.

[0114] The present invention can be used with hydrogel. Each embodiment may be used to treat brain aneurysms, and heart ailments.

[0115] The preferred embodiment would include one or more of the following extensions and reinforcements:

radial stiff bars, oriented vertically (can be metal, plastic, any other non-compressible material); [0116] 1. vertically oriented regions of reinforced mesh; [0117] 2. simple center support bar/stick (somewhat difficult thought, since device shortens as it expands when deployed); [0118] 3. Telescoping central bar or stick, with preset final minimum bar height; [0119] 4. Bar with radial support struts, like an umbrella. Can have supports on bottom, top, or both; and [0120] 5. Spring of preset coil height. The spring straightens in delivery sheath catheter (like a Merci device).

[0121] All of the above extensions may be added with a hydrogel coating on all parts. All of the above extensions may be added with a hydrogel coating on some parts. In some embodiments all of the above extensions may be added without a hydrogel coating on some parts. In some embodiments any of the above extensions may be added without any hydrogel coating at all.

[0122] All of the above extensions may be covered in a thin coating of hydrogel on the entire surface of any endovascular device exposed to the inner surface of the blood vessel and/or blood products, by placing a thin layer of hydrogen over a portion of such a device as well.

[0123] In the preferred embodiment of the current invention endovascular devices that can be covered with such a layer of hydrogel include metal stents, covered stents, cardiac valves, left atrial appendage occlusion devices such as the Watchman, intra-saccular aneurysm devices, pressure monitors, wires/Leeds Etc. In short, all surfaces of the present invention and devices which deploy the present invention would be cover with a thin layer of hydrogel and thereby covering all metals, and/or plastics, and/or polyesters, and/or Dacron surfaces.

[0124] In the preferred embodiment of the current invention a thin coating of hydrogel is placed on all surfaces, including the surface pressing on the vessel wall, it will reduce the rate of intimal hyperplasia caused by the vessel reacting to the foreign body. This result is also a non-obvious benefit of the use of hydrogel because intimal hyperplasia causes vessel narrowing and/or occlusions, which in turn causes sub-optimal outcomes, including in some case the death of the patent.

[0125] In the preferred embodiment of the current invention a thin coating of hydrogel is placed on all surfaces of all devices which deliver the claim 1 devices (an extension element for an intrasaccular occlusion tool designed to ameliorating aneurysm recurrences by deploying an amorphous hydrogel), then said hydrogel may be use to both prevent blood metal thrombosis and as a delivery mechanism for medications, which can be immediate release or controlled sustained slow release (embedded in stents or other devices).

[0126] For example, hydrogel lining to nonvascular stents, some embodiments include biliary and ureter stents, that may also reduce rates of in stent stenosis; and may help anchor the stent in place and prevent stent migration.

[0127] In some embodiments of the current invention, coatings in addition to a thin coating of hydrogel are added to said thin coating of hydrogel. Said additional coating additives embed said thin coating of hydrogel with compounds for local delivery, short release or sustained release.

[0128] In some embodiments said additional coatings include chemotherapy compounds in said thin coating of hydrogel. Said chemotherapy compounds embedded in a device may be used in the carotid artery for a brain tumor in that vascular distribution, or in right renal artery for a right kidney tumor, or in right pulmonary artery for a right lung mass: this could allow sustained delivery locally, while minimizing the systemic dose and associated side effects.

[0129] Said hydrogel thin coating may be impregnated with pharmaceutical compounds. Said compounds may include, but are not limited to nimodipine, verapamil, Cardene, nitroglycerin, and nitroprusside. Said compounds may be formulated for immediate release or controlled sustained slow release.

[0130] Alternatively, to minimize the risk of severe symptomatic vasospasm in aneurysmal subarachnoid hemorrhage (a typical bleed from a ruptured brain aneurysm) the said thin coating of hydrogel might include a vasodilator compound that slowly releases over 3 weeks can be embedded in a stent for placement in the common or internal carotid arteries on both sides, including the placement in one or both vertebral arteries. Non-limiting examples of vasodilators that can be embedded include nimodipine, verapamil, Cardene, nitroglycerin, and nitroprusside.

[0131] As more particularly shown in FIG. 1, delivery wire (12) with mesh device (20) disposed at the distal end of said wire (12). Treatment mesh (20) is designed to be implemented at a treatment site with a hydrogel coating (22). Deployed device (10) is distally attached to a delivery system which may be as simple as a wire (12) but may be an intravascular tool (not shown) such as a nonvascular stent. In the preferred embodiment, such delivery tools would also be coated with a thin coating of hydrogel (22), preferably having a thickness of one nanometer to one centimeter. Said thickness is determined by the internal diameter of the target area, and the outer dimension of treatment mesh (20). FIG. 2 depicts the same treatment mesh (20) prior to deployment, as well as wire (12). The coating must be sufficiently thin so that the unhydrated hydrogel (22) will allow treatment mesh (20) to proceed proximally to the target area in an undeployed state. For example, if the internal target area of the vessel has a diameter of 1.1 cm., and the largest dimension of the undeployed mesh (20) is one centimeter, then the preferred thickness of the hydrogel (22) coating for this situation is 0.1 cm. FIG. 3 shows a nonspherical embodiment of treatment mesh (20) of the current invention, also having hydrogel coating (22), and further including radial stiff bars (40) in vertical orientation. In the preferred embodiment, all elements including bars (40) and wire (12) are coated with hydrogel (22).

[0132] FIG. 4 also shows the nonspherical embodiment of treatment mesh (20) of the current invention, having hydrogel coating (22), and further including vertically oriented reinforcement members (50). In the preferred embodiment, all elements including reinforcement member (50) and wire (12) are coated with hydrogel (22).

[0133] FIG. 5 shows the nonspherical embodiment of endovascular treatment mesh (20) having a hydrogel coating (22), and further including a simple center-support bar or stick (60). In the preferred embodiment, all elements including center-support bar or stick (60) and wire (12) are coated with hydrogel (22).

[0134] FIGS. 6A and 6B show the nonspherical embodiment of treatment mesh (20) of the current invention, also having hydrogel coating (22), and further including a telescoping center-support bar or stick (60). In the preferred embodiment, all elements including telescoping center-support bar (70) and wire (12) are coated with hydrogel (22).

[0135] FIG. 7 shows the nonspherical embodiment of treatment mesh (20) of the current invention, also having hydrogel coating (22), and further including umbrella-like radial support struts (80). In the preferred embodiment, all elements including umbrella-like radial support struts (80) and wire (12) are coated with hydrogel (22).

[0136] FIG. 8 shows the nonspherical embodiment of treatment mesh (20) of the current invention, also having hydrogel coating (22), and further including further including a spring of preset coil length that straightens in delivery-sheath catheter. In the preferred embodiment, all elements including spring (90) and wire (12) are coated with hydrogel (22).

[0137] FIG. 9 shows the elements of FIG. 1 wherein the entire structure is coated with hydrogel (22).

[0138] In the foregoing embodiments, wire (12) may be included with or substituted by another endovascular delivery device (not shown) which, in the preferred embodiments, are also coated with hydrogel (22) in a thickness adapted to the size of the vasculature.

[0139] The present invention may be used according to the following method. To use the present invention to ameliorate aneurysm recurrences, amorphous hydrogel is deployed upon an intrasaccular occlusion device: intrasaccular occlusion device affixing at least one layer of said amorphous hydrogel layer expandable in vivo to any or all surfaces of an expandable body comprising at least one material adapted to close the outpouching in the body further including a reinforcing extension element to minimize the risk of collapse, preferably a telescoping center-support bar having at least two telescoping elements disposed within a treatment mesh, with hydrogel affixed to the surface of said at least two telescoping elements inhibits retraction.

[0140] The steps further include: [0141] (a) providing an insertion rod having a first end and a second end, and [0142] (b) said intrasaccular occlusion tool connected to the first end of the insertion rod, [0143] (c) said intrasaccular occlusion tool having an outer surface and an inner surface, [0144] (d) said outer surface coated with said amorphous hydrogel, and [0145] (e) said intrasaccular occlusion tool being moveable between a retracted position and a deployed position; [0146] (f) inserting said intrasaccular occlusion tool and a portion of the insertion rod into the brain using arterial pathways while said intrasaccular occlusion tool is in a retracted position; [0147] (g) deploying said intrasaccular occlusion tool inside an aneurism such that said intrasaccular occlusion tool is configured to provide a seal between said aneurism and said arterial pathway; and [0148] (h) securing the perimeter of said outer surface of said intrasaccular occlusion tool against a wall of said aneurism.

[0149] More particularly, the insertion rod of the method includes a first end and a second end, wherein said second end is a proximal end terminating outside of the patient, where the first end is a distal end configured to communicate with said intrasaccular occlusion device; the intrasaccular occlusion device having a first end and a second end, wherein said second end of said intrasaccular occlusion device is configured to communicate with said first end of said insertion rod; the second end of said intrasaccular occlusion device is configured to deploy said treatment mesh at a target area; the intrasaccular occlusion device having an outer surface and an inner surface; and the outer surface being coated with said amorphous hydrogel.

[0150] The intrasaccular occlusion device is moveable between a retracted position and a deployed position, with the purpose of moving the devise to the target area using the rod. The steps further include: [0151] (a) inserting the intrasaccular occlusion device into a patient via vascular pathways, [0152] wherein said intrasaccular occlusion device is in a retracted position, [0153] (b) moving said intrasaccular occlusion device to said target area, [0154] wherein said intrasaccular occlusion device is configured to expand to provide a seal between said target area and a bodily lumen; [0155] (c) securing the perimeter of said outer surface of said intrasaccular occlusion device against a wall of said bodily lumen; [0156] (d) reinforcing said treatment mesh by extending said telescoping center-support bar; and [0157] (e) leaving said treatment mesh in target area until pharmaceutical compounds are released; [0158] (f) detaching said insertion rod from said intrasaccular occlusion device; and [0159] (g) removing said insertion rod from the patient.

[0160] For example, placing an intrasaccular occlusion device (for example, one structured like a stent with a reinforcement member) chemotherapy embedded into carotid artery for a brain tumor in that vascular distribution, or in right renal artery for a right kidney tumor, or in right pulmonary artery for a right lung mass. This could allow sustained delivery locally, while minimizing the systemic dose and associated side effects.

[0161] The present invention can alternatively be used by embedding or impregnating pharmaceutical compounds medications in a stent for local delivery, short release or sustained release using permanent nondegradable hydrogel or biodegradable hydrogel.

[0162] A pharmaceutically impregnated mesh is preferably left in place for sufficient time for the pharmaceutical compound to be released by the hydrogel and impregnate the target area, In sum, leaving time is equal to the time necessary to move medications from hydrogel to target area.

[0163] Embodiments of the present invention are configured for use in genitourinary tract, biliary tract, and gastrointestinal tract procedures, by adapting the size of the treatment mesh, wherein said size is configured to fill outpouchings in the appropriate tract. While keeping the mesh screen size and hydrogel density the same, the overall size of the device is conformed to fill outpouchings in the appropriate tract.

[0164] Embodiments of the present invention are configured for use in the intravascular tract (zone).

[0165] Similarly, to minimize the risk of severe symptomatic vasospasm in aneurysmal subarachnoid hemorrhage (a typical bleed from a ruptured brain aneurysm), a vasodilator that slowly releases over time can be embedded in a stent for placement in the common or internal carotid arteries on both sides, +/− placement in one or both vertebral arteries. Nonlimiting examples of vasodilators that can be embedded include nimodipine, verapamil, Cardene, nitroglycerin, and nitroprusside.

[0166] Although the invention has been described in detail in the foregoing embodiments and methods for the purpose of illustration, it is to be understood that such detail is solely for that purpose, and that variations can be made therein by those skilled in the art without departing from the spirit and scope of the invention, except as it may be described by the following claims.