JP2009525137A - Porous material used in aneurysms - Google Patents

Abstract

The present invention relates to a device for occluding a body space. In particular, the device comprises an elastomeric porous material, preferably having a pore size greater than about 30 microns. The elastomeric porous material can optionally be expanded from its uncompressed form. The device may further comprise a metallic structural element, and the elastomeric porous material is attached to the structural element. The device can be placed at a desired site in the mammalian body and is useful for inhibiting the formation of scar tissue. The device is particularly useful for the treatment of active aneurysms.

Description

  Disclosed are compositions and methods for repair of aneurysms. In particular, porous materials that enhance healing within an aneurysm are disclosed along with methods for making and using these devices.

  An aneurysm is an enlargement of a blood vessel that poses a health risk due to the possibility of rupture, coagulation, or dissection. An aneurysm rupture in the brain causes a stroke, and an aneurysm rupture in the abdomen causes a shock condition. Cerebral aneurysms are usually detected in patients as a result of stroke or bleeding and can result in significant morbidity or mortality.

  A variety of materials and devices have been used to treat aneurysms, including platinum and stainless steel microcoils, polyvinyl alcohol sponges (Ivalone), and other mechanical devices. For example, a vaso-occlusive device is a surgical instrument, i.e., typically placed through the catheter into the vasculature of the human body, blocking the blood flow through the blood vessels that form that portion of the vasculature by the formation of an embolus Or an implant to form an embolus within an aneurysm originating from a blood vessel. One widely used vaso-occlusive device is a helical wire coil with windings that can be dimensioned to engage a vessel wall (see, for example, US Pat. ). Other more flexible helical coiled devices have been disclosed along with those that include woven braids. See, for example, US Pat.

  Both U.S. Pat. Nos. 5,099,086 to Guglielmi et al. And its parent patent U.S. Pat. Also disclosed are vaso-occlusive coils that have little or no inherent secondary shape. For example, commonly owned US Pat. Nos. 5,099,086 and 6,037,689 by Berenstein et al. Disclose a coil that has little or no shape after introduction into the vascular gap. Patent document 8 is disclosing the non-expanding braid which covers a primary coil structure.

  A vaso-occlusive device comprising one or more coatings is also disclosed. U.S. Patent No. 6,099,077 discloses a vaso-occlusive device that includes a biodegradable coating. U.S. Patent No. 6,099,077 discloses a vaso-occlusive device comprising an elongate flexible carrier and a hydrogel material having pores less than 25 microns. U.S. Patent No. 6,057,031 discloses a vaso-occlusive device comprising a foam polymer material having pores of less than 250 microns in an open cell structure and comprising a radiopaque material. U.S. Patent No. 6,099,077 discloses a vaso-occlusive device comprising a collagen plug having pores greater than 50 microns.

Thus, any of the documents described above includes an implantable device as described herein that includes one or more porous materials that limit the formation of scar tissue and prevent long-term recanalization of an aneurysm. Is not shown.
US Pat. No. 4,994,069 US Pat. No. 6,299,627 US Pat. No. 5,354,295 US Pat. No. 5,122,136 US Pat. No. 5,690,666 US Pat. No. 5,826,587 US Pat. No. 6,458,119 US Pat. No. 5,382,259 US Pat. No. 6,280,457 US Pat. No. 6,602,261 US Pat. No. 6,245,090 US Pat. No. 5,456,693

  Accordingly, the present invention includes novel occlusive compositions and methods of using and making these compositions.

  In one aspect, the present invention is a vascular occlusion device (for occluding a target vessel) comprising an elastomeric porous material having a first compressed volume and a second uncompressed volume, wherein the porous material is disposed A device is provided that later expands from a second uncompressed volume.

  In any of the devices described herein, the porous material can comprise one or more polymers, such as silicon, polytetrafluoroethylene, polyester, polyurethane, protein, hydrogel material, and / or combinations thereof.

  If the elastomeric material cannot expand further (eg, due to hydration), its pore size is typically measured when the material is in an uncompressed shape. Similarly, if the elastomeric material can be further expanded, the pore size is preferably measured when the material is in its final expanded shape. In certain embodiments, the elastomeric material comprises a porous material having a nominal pore size greater than about 30 microns in a fully expanded shape, with at least 50 percent of the pores interconnected with adjacent pores. . In certain embodiments, the pore size (in a fully expanded shape) is between about 40 microns and about 400 microns. In other embodiments, at least 80% of the pores are interconnected with adjacent pores.

  In the devices described herein where the porous material is expandable, the porous material can expand immediately after deployment. As an alternative, in other embodiments, the porous expandable material does not expand immediately after deployment.

  In another aspect, any vaso-occlusive device described herein may further comprise one or more structural elements. In certain embodiments, the elastomeric porous material at least partially surrounds the structural element. In other embodiments, the elastomeric material is at least partially surrounded by structural elements. In a further embodiment, the porous material at least partially surrounds the structural element and is at least partially surrounded by the structural element. In any device described herein comprising one or more structural elements, the structural elements may comprise a coil, a tubular braid, or a combination thereof.

  In other aspects, any device described herein may further comprise two or more additional members (eg, structural elements such as coiled or braided members). In certain embodiments, the additional member is itself a vaso-occlusive device. The porous material may surround and / or be surrounded by this additional structural element. In certain embodiments, the porous material is attached to the structural member at one or more locations. In any of the devices described herein, the additional member can comprise a metal (eg, nickel, titanium, platinum, gold, tungsten, iridium, and alloys or combinations thereof), stainless steel, or a superelastic alloy. The structural element can be formed into a helical coil, for example. In any of the devices described herein, the structural element can further comprise a biodegradable material and / or a bioactive component.

  Any of the devices described herein may further comprise a detachable joint that can be coupled to the pusher element. The separable junction can be placed at any location on the device, for example, at one or both ends of the device. In some embodiments, the separable joint is an electrolytically separable assembly configured to segregate upon application of a current, a mechanically separable assembly configured to segregate by motion or pressure, a junction A thermally separable assembly configured to be separated by a local supply of heat to the part, a radiation separable assembly configured to be separated by electromagnetic radiation to the joint, or a combination thereof It is. The separable joint can be attached to a porous material or one or more additional vaso-occlusive members.

  In another aspect, a method for occluding a body cavity is described that includes introducing any implantable device described herein into the body cavity. In certain embodiments, the body cavity is an aneurysm.

  These and other embodiments of the invention will be readily apparent to those skilled in the art in light of the disclosure herein.

  It should be understood that the drawings show only exemplary embodiments and are not to be considered as limiting the scope of the invention.

  An occlusive (eg, embolic) composition is described. The implantable porous biomaterial described herein has a suitable structure to promote new blood vessel formation and maintain healthy living tissue in and around the implant. The methods of making and using these vasoocclusive elements also form an aspect of the present invention.

  All documents (gazettes, patents, patent applications) cited herein are hereby incorporated by reference in their entirety, regardless of what is mentioned above or what will be discussed.

  As used herein in the specification and in the claims, the singular forms “a”, “an”, and “the” include plural unless the context clearly dictates otherwise. Should. Thus, for example, an implant comprising a “channel” includes an implant comprising two or more such elements.

  The implantable devices described herein are primarily composed of void (pore) biocompatible materials that fill the space within the aneurysm and promote a long lasting foreign body response to materials that do not become scar tissue. Elastomer compressible material. “Elastomer” means a material that can recover its size and shape after deformation (eg, compression). Thus, the materials described herein can be significantly compressed, eg, for delivery through the lumen of a catheter, and can self-expand to an uncompressed volume when deployed.

  The voids (pores) allow the material to be significantly compressed (eg in thickness) and the nature of the elastomer is that the material returns to an uncompressed shape when the pores are not compressed. Enable. Thus, the advantage of the porous material described herein is that air can be forced out of the pores (the material can be compressed) until the material is delivered, and then The material is able to return to a convenient (original) state. This provides the advantage of delivering the material through a smaller diameter catheter than the final uncompressed material.

  Another advantage of the elastomeric nature of the porous materials described herein is that the material can be easily drawn into a delivery mechanism (eg, a catheter) by compressing the voids. This allows the operator to easily retrieve and / or reposition the device.

  Optionally, the porous materials described herein may be able to expand (expand) from an uncompressed state, for example, when exposed to a sufficient amount of moisture. The amount of hydration sufficient to cause expansion may be such that expansion occurs immediately after placement (immediately after contact with moisture). As an alternative, it may take time to reach a sufficient amount of hydration to cause expansion, thereby delaying expansion from the uncompressed volume so that the physician can move to the desired location. Devices can be placed.

  The length of time to delay the inflation can be as little as 30 seconds or 1 hour or more, and any time in between (eg, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, Minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes or more )including. Hydrogel materials are known in the art and are described herein. US Pat. Nos. 6,979,344, 6,960,617, 6,913,765, 6,855,743, 6,818,018, 6,676,971 No. 6,616,617, 6,463,317, 6,152,943, 6,113,629, 5,510,418, 5,328,955, and See 5,258,042.

  Further, the time required for the uncompressed material to become fully expanded (eg, through water diffusion) can be determined by any suitable means, including, but not limited to, Selection of materials with inherent hydrophobicity that provide the desired delay in expansion; selection of materials with inherent expansion properties that delay expansion (e.g., diffusion of ions from blood into the material and / or changes in pH) If required, see, for example, US Patent Publication Nos. 2005/0004660 and 2003/0014075); in order to delay the diffusion of water into the elastomeric intumescent material, the intumescent material in the soluble material Coating or encapsulating (containing) part or all of the material; an insoluble material that acts as a barrier to the diffusion of water into the underlying material Coating or coating part or all of the swellable material with; selection of materials that are highly lipophilic and swell in response to absorption of blood soluble lipids (eg, free lipids are at low concentrations in the blood, so A soluble binder (e.g., one or more water-soluble polymers and / or one or more water-soluble) that keeps the compressed material in a collapsed state until the rate of expansion is slow and / or the binder is sufficiently dissolved Part or all of the pores with a protein).

  The porous material described herein, when expanded, has at least 200% (or without limitation, 250%, 300%, 350% of its original, uncompressed (original) volume, It is preferred to expand to any amount over 200%, including 400%, 450%, 500%, 600%, 700%, 800%, 1000%, or more. Obviously, when the material is expandable, the pores are sized to properly accommodate expansion (eg, during hydration).

  Thus, the elastomeric material described herein will have a “fully expanded state”. For certain materials (ie, materials that do not expand further from their uncompressed state), the fully expanded state is the uncompressed state. With respect to materials that expand further from the uncompressed state, the fully expanded state occurs when the material acquires a fully expanded form, i.e., in an uncompressed state and when expanded from this uncompressed state.

  In certain embodiments, the porous material is a macroporous material when fully expanded. “Macroporosity” means a material having pores greater than 40 microns, generally between about 40 microns and about 400 microns (or any value therebetween), for example, It is from about 40 microns to about 100 microns (or any value in between), from about 100 microns to about 200 microns (or any value in between), from about 200 microns to about 300 microns (or in between) Any value), or from about 300 microns to about 400 microns (or any value in between). In general, the pores of the macroporous material are amorphous.

  The pores of the vaso-occlusive porous material described herein can be distinct. As an alternative, some or all of the pores are interconnected. For example, in some embodiments, between about 10% and about 80% (or 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, Pores of any value in between (including 60%, 65%, 70%, 75%, or 80%) are interconnected. In certain preferred embodiments, at least about 50% to about 80% (or any value therebetween) of the pores are interconnected.

  A “biocompatible material” is a synthetic that can be used for any period of time as a whole or part of a system that treats, augments, or replaces any tissue, organ, or function of a subject (eg, a mammal) Or any naturally occurring substance or combination thereof.

  Aneurysms treated with known vaso-occlusive devices can result in the formation of scar tissue over time. Since scar tissue is an avascular, cell-free mass composed primarily of extracellular matrix proteins, the interface between scar tissue and healthy tissue is more fragile than the surrounding tissue, resulting in long-term Resistant to general recanalization. The vaso-occlusive device described herein comprises a material (also referred to as a microstructure-driven cardiovascular material) that can inhibit wound healing in the state of a degenerative foreign body reaction, resulting in The resulting tissue response does not develop into a scar and is therefore adjacent (continuous) to healthy tissue and is more resistant to shear, flow, and recanalization. It should be noted that there is no boundary between the response to foreign material and the response to natural tissue, they are co-continuous.

  Through a typical process of wound healing, neutrophils are the dominant cell type at the wound site within the first 24-48 hours, killing and phagocytosing bacteria and / or cell debris. After about 48 hours, macrophages become the dominant cell type, further removing cells and extraneous debris from the wound site. Within 3-4 days, fibroblasts migrate from the surrounding connective tissue (eg, intima) to the wound area and begin to synthesize collagen, which quickly fills the wound space, and cells and extracellular matrix A composite tertiary structure consisting of both is formed. At this time, new blood vessel growth also begins in that area, supplying the oxygen and nutrients required by metabolically active fibroblasts and macrophages. However, in a typical process of wound healing, the formation of new blood vessels begins to regress at the second week, resulting in the formation of avascular and acellular scars.

  The porous biomaterial described herein provides tissue biomaterial anchoring and promotes ingrowth across the pores. The resulting “hallway” or “channel” pattern of cell growth is a healthy space-filling mass, which persists throughout the implantation period, the aneurysm wall and the implant and aneurysm space. Promotes host cell integration with the whole.

  For example, in embodiments where most or all of the pores of the biocompatible material described herein are suitably interconnected (co-continuous), the co-continuous pore structure of the biocompatible material is: Promotes space-filling ingrowth of cells between the aneurysm wall and the implanted material. Accordingly, the porous implants described herein promote proper wound healing action within the aneurysm environment and throughout the porous material. It is preferred that at least 50% of the pores interconnect with adjacent pores. It is further preferred that the interconnectivity exceeds at least about 80%.

  In addition, the porous materials described herein having interconnected pores consist mostly of voids and cells in which cells grow in and around. There may be other examples in which a porous material is used within an aneurysm, but that material will allow the host cells to grow ingrowth and become co-continuous with other host cell filled pores. , Not particularly needed. See International Patent Publications WO 04/078023, WO 04/103208, WO 04/062531, and WO 04/037318. Other techniques may allow protein adsorption or absorption, but also do not promote cell ingrowth throughout the interconnected porous structure. Thus, unlike other disclosed porous biomaterials, the co-continuous pore structure of certain materials described herein promotes host cell ingrowth with concomitant neovascularization. In addition, it increases the persistence of cells and blood vessels in the pores.

  FIG. 1 shows an exemplary embodiment of the inventive porous implant described herein. The entire device is generally indicated by reference numeral (10) and is indicated by a three-dimensional block. FIG. 1 shows an embodiment in which all of the pores (5) are interconnected.

  The porous implants described herein suitably comprise one or more materials that favor a suppressed foreign body reaction, which is essentially granular as described above and has new blood vessel formation. .

  Non-limiting examples of suitable porous materials include natural and synthetic materials such as acrylates, silicon, ePTFE, urethane (eg, polyurethane), collagen, and / or hydrogel. Copolymers of these materials that incorporate hydrophilic segments, such as polyethylene oxide, polyvinyl alcohol, polyacrylamide, polysaccharides, and other polymers known to form gels can also be used.

  Methods for introducing suitable pores into these materials are well known and include, but are not limited to, adding excipients during the formation of the material, followed by (for example, dissolution) A method of removing the excipients and using a blowing agent or high pressure gas to rapidly expand during formation / extrusion, or to penetrate into the material structure under high pressure, followed by rapid decompression And a method of forming a large number of microbubbles. US Pat. No. 4,076,656, US Pat. No. 5,681,572, US Pat. No. 6,602,261, and International Patent Publications WO 04/078023, WO 04/103208, WO 04/062531 No. and WO 04/037318.

  Although some foam materials have been described as being used as scaffolds to promote granular tissue ingrowth (see, eg, ASAIO in US Pat. No. 6,713,079, Seare et al. (1993)). Journal 39: M668-M674), these foams are not used as vaso-occlusive devices, presumably because of their known antithrombotic properties or due to a lack of delivery systems for vasculature .

  In addition, hydrogels and other materials have been proposed for the repair of aneurysms (see US Pat. Nos. 6,818,018 and 6,602,261), but these hydrogels are The pore size is less than 25 microns. In addition, some hydrogels have large microstructures because the gel has poor strength for placement and may not have enough strength to retain the bonds between the pores (eg, the gel breaks or splits). not compatible. Further, unlike the foam polymer devices described above (see, eg, US Pat. Nos. 6,245,090 and 5,456,693), the porous materials described herein expand ( For example, when fully hydrated, eg up to a volume of at least 200% of the uncompressed volume), or alternatively, a material in which at least 50% of the pores are interconnected. As described herein, the interconnectivity between the pores can induce persistent granular tissue, which results in a durable aneurysm treatment.

  The porous material of the devices described herein may include one or more fibers, strands, coils, spherules, cones, or rods of smooth or rough amorphous or uniform shape.

  The porous devices described herein can also optionally be used in combination with other vaso-occlusive members, such as the GDC-type vaso-occlusion coil described above (US Pat. Nos. 6,723,112, 6 No. 6,663,607, No. 6,602,269, No. 6,544,163, No. 6,287,318, No. 6,280,457, and No. 5,749,894. ).

  As noted above, the porous material can be macroporous, which can be from about 20 microns to about 400 microns (or, using conventional methods for measuring pore size (porosity) in the industry) Any value in between), more preferably from about 30 to about 300 microns (or any value in between), even more preferably from 40 microns to about 200 microns (or any value in between). It comprises one or more materials having a pore size.

  FIG. 2 shows an exemplary embodiment of the porous material described herein in combination with a GDC type vaso-occlusive coil (20). As shown in FIG. 2, the porous material may have a tubular shape that surrounds the inner vasoocclusive member. The porous material can also extend into part or all of the lumen of the coil (20). Interconnected (co-continuous) pores (5) are indicated by overlapping circles. The porous component (10) can be permanently or temporarily attached to the coil (20) at one or more locations by any suitable attachment mechanism. Also shown is a separable joint (15) and pusher wire (25) located on the proximal end of the coil (20).

  As noted above, the porous devices described herein are compressible, for example, for loading into a deployment catheter. FIG. 3 shows the exemplary embodiment of FIG. 2 when partially deployed from the deployment catheter (35). Within the catheter (35), the pores (5a) of the macroporous component (10) are compressed. When placed, the pores (5) expand to their relaxed state.

  The devices described herein may include one or more other outer members that cover the porous member. Thus, the porous member may surround and / or be surrounded by one or more structural members.

  FIG. 4 shows another exemplary embodiment in which the porous component (10) is surrounded by the outer component (40). In this embodiment, the outer component (40) comprises a tubular braid.

  FIG. 5 shows another exemplary embodiment in which the porous component (10) is surrounded by the outer component (40), in which the outer component (40) is coiled.

  Optional additional members (inside or outside) can take a variety of configurations. Thus, in addition to the coils and braids shown in the drawings, other, including but not limited to wires, knits, woven structures, tubes (eg, perforated or slotted tubes), injection molded devices, etc. Shape is conceivable. See, for example, US Pat. No. 6,533,801 and International Patent Publication WO 02/096273.

  In addition, additional structural members (eg, vaso-occlusive members) can be made of a variety of materials, including but not limited to metals, polymers, and combinations thereof. In certain embodiments, additional members (eg, braids, coils, etc.) are, for example, platinum group metals, particularly platinum, rhodium, palladium, rhenium, and tungsten, gold, silver, tantalum, stainless steel, and of these metals. It comprises one or more metals or alloys, such as an alloy. These elements preferably comprise a material that maintains its shape even under high stress, for example a nickel-titanium alloy (48-58 atomic% nickel, and an appropriate amount of iron depending on the situation) ), Copper-zinc alloy (38-42 wt% zinc), copper-zinc alloy containing 1-10 wt% beryllium, silicon, tin, aluminum or gallium, or nickel-aluminum alloy (36-38 atomic%) It is preferable to provide a “superelastic alloy” such as aluminum. The alloys described in US Pat. Nos. 3,174,851, 3,351,463, and 3,753,700 are particularly preferred. In particular, a titanium-nickel alloy known as “Nitinol” is preferable. Also, shape memory polymers such as those described in International Patent Publication WO 03/51444 may be used.

  In certain preferred embodiments, the structural member comprises a vaso-occlusive platinum coil. The additional vaso-occlusive member can also change shape when released from the restraining member, for example, from a constrained linear shape to a relaxed three-dimensional configuration when deployed.

  As shown in FIGS. 2-5, any device described herein may further comprise a detachable separable joint (15). The separable joint (15) can be connected to a pusher element such as a pusher wire (25). The separable joint can be placed anywhere on the device, for example, at one or both ends of the structural element.

  The detachable joint can be separated in various ways, for example, an electrolytic separation type assembly configured to separate by application of current, a mechanical separation type configured to separate by motion or pressure Assemblies, thermal isolation assemblies configured to separate by the local supply of heat to the junction, radiation isolation assemblies configured to isolate by electromagnetic radiation to the junction, or thereof Combinations can be used to separate. Further, the separation mechanism can be hydraulic, for example, a pusher wire cannulated, for example, saline can be injected through the pusher wire and the coil pushed away.

  FIGS. 6A-6C illustrate an exemplary elastomeric porous material (60) described herein that also expands to a volume that exceeds the volume of the uncompressed (native) state. FIG. 6A shows a compressed material (60) that includes compressed pores (65). FIG. 6B shows an uncompressed (original) shaped material (60) and FIG. 6C shows an expanded material (60). In certain embodiments, the volume of the fully expanded shape is at least twice the volume of the original shape.

  FIG. 7 shows a porous material as described herein partially deployed from a deployment catheter (50). A thick arrow indicates how easily the porous material described herein is deployed from the catheter, and how easily by compressing the void, for example, to reposition the implant. Indicates whether it will be collected. That is, the reversible compression and expansion of the pores allows the surgeon to place the device more flexibly. As noted above, when the porous material is expandable, it is clear that it is advantageous to delay expansion relative to implantation in order to retain recoverability.

  The devices described herein can be co-solvents, plasticizers, coalescing solvents, bioactive agents, antibacterial agents, porogens, antithrombotic agents (eg, heparin), antibiotics, dyes, contrast agents, and / or any suitable Further additional components can be provided, such as ionic conductors that can be coated using a simple method or can be incorporated into the element during manufacture. See, for example, shared US Patent Application Publication No. 2005/0149109, US Pat. No. 6,585,754, and WO 02/051460, which are incorporated herein by reference in their entirety. ) Bioactive materials (eg, anticoagulants, growth factors, extracellular matrix components, live cells, DNA fragments, coagulation stabilizers, or other materials intended to enhance or promote wound healing) Can be coated on the device and / or placed in a blood vessel prior to, simultaneously with or after placement of one or more devices described herein.

  As mentioned above, the position of the device is preferably visible using fluoroscopy. A better and preferred method is that at least some of the elements forming the device (eg, the porous component and / or the additional vaso-occlusive member) are arranged by placing a radiopaque coating on these elements. To ensure that it has significant radiation visibility. A metal coating of a metal having better visibility than stainless steel during use of the fluoroscope is preferred. Such metals are known, but include gold and the platinum group metals described above.

  One or more elements may be secured to each other at one or more positions. For example, when the various elements are thermoplastic, these elements can be welded or fused to other elements of the device. As an alternative, these elements can be glued or secured. Further, the various elements can be secured to one another at one or more positions.

(how to use)
The devices described herein are often introduced at selected sites using the techniques outlined below. This technique can be used to treat various diseases. For example, in the treatment of an aneurysm, the aneurysm itself is filled (partially or completely) with the composition described herein.

  Conventional catheter insertion and navigation techniques with a guidewire or flow-oriented device can be used to access the site with the catheter. This mechanism can be advanced exclusively through the catheter to place the vaso-occlusion device at the target site, yet the distal end portion of the delivery mechanism protrudes sufficiently from the distal end of the catheter to A mechanism that allows separation of the vaso-occlusive device. When used for peripheral or nerve surgery, the delivery mechanism is typically about 100-200 cm long, more typically 130-180 cm long. The diameter of the delivery mechanism is usually in the range of 0.25 to about 0.90 mm. Briefly, the occlusion devices (and / or additional components) described herein are typically loaded into a carrier for introduction into a delivery catheter and selected using the techniques outlined below It is introduced at the site. This approach can be used to treat various diseases. For example, in the treatment of an aneurysm, the aneurysm itself can be filled with an embolus (eg, a vascular occlusion member and / or a liquid embolus and a bioactive material) that causes the embolus to form and at some later time be implanted It is at least partially replaced by neovascularized collagen material formed around the vaso-occlusive device.

  The selected site is reached via the vasculature using a group of specially selected catheters and / or guidewires. Obviously, if this site is a remote site, such as in the brain, the access to this site is somewhat limited. One widely accepted approach is found in US Pat. No. 4,994,069 to Ritchart et al. This approach uses a thin intravascular catheter, such as found in US Pat. No. 4,739,768 to Engelson. Initially, a large catheter is introduced into the vasculature via the entry site. Generally, this catheter goes through the groin femoral artery. Other sites of entry that are sometimes selected are in the neck, and these sites are generally well known by physicians performing this type of therapy. Once the introducer is in place, a guide catheter is then used to provide a safe passage from the entry site to the area near the site to be treated. For example, during the treatment of a site in the human brain, a guide catheter is selected, which goes upstream from the site of femoral artery penetration through a large artery that extends to the heart and through the aortic arch. It moves around and goes downstream through one of the arteries extending from the top of the aorta. A guide wire and a neurovascular catheter as described in the Engelson patent are then placed through the guide catheter. Once the distal end of the catheter is in place, the catheter is often removed by locating the distal end using radiopaque marker material and fluoroscopy. For example, if a guidewire is used to position the catheter, the guidewire is withdrawn from the catheter, and then an assembly including, for example, a vaso-occlusive device at the distal end is advanced through the catheter.

  Upon reaching the selected site, the vaso-occlusive device is pushed out, for example by loading onto a pusher wire. The vaso-occlusive device is preferably via a mechanically or electrolytically cleavable joint (eg, a GDC-type joint that can be disconnected by application of heat, electrolysis, electrodynamic actuation, or other means). , Loaded onto the pusher wire. In addition, the vaso-occlusive device can have multiple separation points as described in co-owned US Patent Nos. 6,623,493 and 6,533,801, and International Patent Publication No. WO 02/45596. Can be designed to include. These separation points are held in place by gravity, shape, size, volume, magnetic field, or combinations thereof.

  It is also clear that the operator can remove the device or reposition (distal or proximal). For example, the operator can choose to move the pusher wire to place the device in the desired location before inserting and separating the devices described herein.

  Improvements in light of the present invention of the above-described approaches and vaso-occlusive devices, and methods of using them, will be apparent to those skilled in the mechanical and surgical arts. These variations are intended to be included within the scope of the claims.

FIG. 1 illustrates an example described herein having interconnected pores for use in promoting wound healing in an aneurysm, typically in combination with a structural element (eg, a vaso-occlusive coil). It is a perspective view of a typical porous material. FIG. 2 is a partial side view and partial cross-sectional view of an exemplary device comprising an implantable porous material as described herein surrounding a coiled vaso-occlusive device. 3 is a partial side view and partial cross-sectional view of the exemplary device described in FIG. Within the deployment catheter, the porous material is shown in a compressed shape. FIG. 4 is a partial side view and partial cross-sectional view of an exemplary device comprising an implantable porous material as described herein in combination with a tubular braided coating. FIG. 5 is a partial side view and partial cross-sectional view of an exemplary device comprising an embedded porous material as described herein in combination with a coiled outer coating. 6A-6C are schematic side views showing an exemplary porous material that expands when fully hydrated. FIG. 6A shows a compressed shaped material (eg, for delivery via a catheter). FIG. 6B shows the material when released from the catheter, and FIG. 6C shows the expansion (expansion) of the material when exposed to water. The pores are sized to accommodate expansion. FIG. 7 is a side view and partial cross-sectional view of an exemplary device comprising a porous material as described herein when deployed or retrieved into a catheter. When the material is recontained in the catheter, it is easily recovered by compression of the pores (voids).

Claims (25)

  A vaso-occlusive device comprising an elastomeric porous material having a first compressed volume and a second uncompressed volume, wherein the porous material expands from the second uncompressed volume after deployment.   The device of claim 1, wherein the porous material expands immediately after placement.   The device of claim 1, wherein the porous material does not expand immediately after placement.   4. A device according to any preceding claim, wherein the porous material comprises a polymer.   The device of claim 4, wherein the polymer is selected from the group consisting of silicon, polytetrafluoroethylene, polyester, polyurethane, protein, hydrogel material, and combinations thereof.   6. A device according to any preceding claim, further comprising a radiopaque material.   The device according to claim 1, further comprising a structural element.   The device of claim 7, wherein the porous material at least partially surrounds or is at least partially surrounded by the structural element.   The device of claim 7, wherein the porous material at least partially surrounds the structural element.   The device of claim 7, wherein the structural element at least partially surrounds the porous material.   8. The device of claim 7, comprising first and second structural elements, wherein the porous material at least partially surrounds the first structural element, the second structural element comprising: A device that at least partially surrounds a porous material.   12. A device according to any of claims 7 to 11, wherein the porous material is attached to the structural element at one or more locations.   The device according to claim 7, wherein the structural element comprises a metal.   The device of claim 13, wherein the metal is selected from the group consisting of nickel, titanium, platinum, gold, tungsten, iridium, and alloys or combinations thereof.   The device of claim 14, wherein the metal is nitinol or platinum.   16. A device according to any of claims 7 to 15, wherein the structural element comprises a coil.   The device of claim 16, wherein the coil comprises a metal selected from the group consisting of nickel, titanium, platinum, gold, tungsten, iridium, and alloys or combinations thereof.   The device of claim 17, wherein the coil comprises stainless steel or a superelastic alloy.   16. A device according to any one of claims 7 to 15, wherein the structural element comprises a tubular braid.   20. A device according to any one of claims 7 to 19, wherein the structural element comprises a biodegradable material.   21. A device according to any of claims 7 to 20, wherein the structural element further comprises a separable joint.   The device of claim 21, wherein the separable junction comprises an electrolytically separable end adapted to be separated from the pusher by applying a current to the pusher.   23. A device according to any preceding claim, further comprising a bioactive component.   24. A method for occluding a body cavity comprising the step of directing a vascular occlusion device according to any of claims 1 to 23 into the body cavity.   25. The method of claim 24, wherein the body cavity is an aneurysm.

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