WO2006116019A2 - Brosse endovasculaire - Google Patents

Brosse endovasculaire Download PDF

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Publication number
WO2006116019A2
WO2006116019A2 PCT/US2006/014984 US2006014984W WO2006116019A2 WO 2006116019 A2 WO2006116019 A2 WO 2006116019A2 US 2006014984 W US2006014984 W US 2006014984W WO 2006116019 A2 WO2006116019 A2 WO 2006116019A2
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WO
WIPO (PCT)
Prior art keywords
brush
endovascular
segment
brash
vascular
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Application number
PCT/US2006/014984
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English (en)
Other versions
WO2006116019A3 (fr
Inventor
John Pile-Spellman
Feng Lei
Original Assignee
The Trustees Of Columbia University In The City Of New York
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Filing date
Publication date
Application filed by The Trustees Of Columbia University In The City Of New York filed Critical The Trustees Of Columbia University In The City Of New York
Publication of WO2006116019A2 publication Critical patent/WO2006116019A2/fr
Publication of WO2006116019A3 publication Critical patent/WO2006116019A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0216—Sampling brushes

Definitions

  • the present invention generally relates to endovascular devices. More particularly, the present invention relates to devices for use in minimally invasive endovascular procedures.
  • endothelium the cells that line the luminal surface of blood vessels, sense the micro-milieu of flowing blood and regulate important functions of blood vessels. For example, endothelial cells synthesize potent vasodilators and constrictors to alter the vascular tone in order to control blood pressure and blood flow. Endothelial cells also produce cytokines that mediate inflammatory responses in the vessel wall, which underscores the pathogenesis of many vascular diseases, such as atherosclerosis. Accordingly, a number of drugs have been developed, e.g., for treating vascular diseases, which target the endothelium. Endothelial gene expression changes in response to drug therapy long before anatomical changes or clinical symptoms occur. It is therefore possible to use endothelial gene expression patterns as a surrogate indicator of drug efficacy to greatly facilitate drug design and testing, and significantly shorten clinical trials.
  • a number of brushes have been adopted in the art for minimally invasive biopsies, such as the biopsy brushes described in United States Patent Nos. 5,474,075, entitled “Brush-tipped catheter for ultrasound imaging”, 5,201,323, entitled “Wire-guided cytology brush”, and 5,133,361, entitled “Biopsy brush”, collectively “the biopsy brush patents”, each of which is hereby incorporated herein by reference.
  • the brushes discussed in the biopsy brush patents are primarily designed for use in obtaining biopsy samples from the urinary, tracheal, bronchial, and gastrointestinal tracts, and are not suited or safe for endovascular use, particularly with respect to relatively small blood vessels. Additionally, the brushes are not very effective in obtaining biopsy samples.
  • vaso-occlusive devices discussed in United States Patent Nos. 5,582,619, entitled “Stretch resistant vaso-occlusive coils", 5,746,734, entitled, "Introducer cartridge for delivering an embolization device", 5,976,126, entitled “Endovascular electrolytically detachable wire and tip formation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas", 5,797,953, entitled “Helical embolization coil", 6,117,157, entitled “Helical embolization coil", 6,569,179, entitled “Bioactive three loop coil", 6,231,590, entitled “Bioactive coating for vaso-occlusive devices", 6,299,627, entitled “Water soluble coating for vaso-occlusive devices", 5,980,550, entitled “Water soluble coating for vaso- occlusive devices", 6,139,
  • Patent Application Pub. No. 2002/0128671 entitled “Polymer covered vaso- occlusive devices and methods of producing such devices", and PCT International Publication Nos. WO 95/25480, entitled “Helical embolization coil”, and WO 93/16650, entitled “Electrovascular electrolytically detachable wire for thrombus formation”, collectively “the vaso-occlusive device references”, each of which is hereby incorporated herein by reference.
  • the devices discussed in the vaso-occlusive device references are sufficiently soft to allow the devices to be inserted and packed into an aneurism, malformation, or fistula, and designed to occlude the aneurism, malformation, or fistula beginning with the formation a thrombus or blood clot. Thrombus formation is enhanced with relatively long hairs extending from the vaso occlusive devises that accelerate thrombi formation. These devices are therefore not suited for endovascular uses where thrombus formation is not desired.
  • the present invention generally provides endovascular brushes and methods for their use, which allow for safe and efficient endovascular use for a wide variety of blood vessels.
  • the present invention may be described by way of example in relation to endothelial biopsy, the present invention is equally applicable for use in obtaining other types endovascular cells, such as fibroblasts or smooth muscle cells, malignant, benign neoplastic cells, or hyperplastic, from blood vessels, lymphatics, biliary tract, pancreatic ducts, urinary tract and other types of small tubular structures, and for use in other types of endovascular procedures, such as thrombectomies, arthroscopies, atherectomies, etc., and is therefore not limited thereto.
  • an endovascular brush has a brush segment at the distal end of the endovascular brush and a mandrel segment extending from the brush segment to the proximal end of the endovascular brush.
  • the brush segment includes at least one brush element that is configured to provide at least one space for retaining target cell biopsied with the brush and to reduce the thrombogenicity of the endovascular brush, which allows the endovascular brush to be used to obtain endovascular tissue from a target vascular segment in-vivo.
  • Various types of brush element or abrasive elements may be used to provide the functionality described below, including fibers, bristles, loops, ridges, and corrugations.
  • the endovascular brush includes a plurality of brush elements that are dimensioned accordingly to provide space to retain the biopsied endothelial cells or other intended cell types, and to reduce the thrombogenicity of the brush by minimizing vascular wall damage in connection with the use of the endovascular brush. This may be accomplished by limiting the height or depth of the brush elements to less than about 0.5 mm, or more preferably to less than about 0.1 mm. In one embodiment, the brush elements have a height or depth between about 10 microns to about 80 microns.
  • the spacing between the brush elements may be controlled to provide at least one space for retaining cells and to reduce thrombogenicity, such as by limiting the spacing from about 10 microns to about 100 microns.
  • reduced thrombogenicity may be achieved by configuring or controlling the size, shape, number, spacing, surface texture, stiffness, exposure of the brush elements, or a combination thereof. Reduced thrombogenicity may also be achieved by charging the brush elements to repel blood components, forming the brush elements from non- thrombogenic material, or coating the brush element with non-thrombogenic substances.
  • the endovascular brush includes a flexible and elastic brush segment that is capable of being deformed from an original shape and is also capable of recovering the original shape from a deformed shape.
  • a brush segment that includes a helically wound primary coil which has a lumen, and a stretch resistant filament contained within the lumen of the primary coil and firmly attached to both ends of the primary coil.
  • the primary coil is generally sufficiently stiff that when inserted into a vascular segment allows a user to apply or applies the pressure necessary to remove tissue from a vascular segment with the brush element.
  • the primary coil may have a diameter of about 0.25 mm to about 0.35 mm, or a diameter of about 0.9 mm.
  • the brush segment may have a variety of different types of original shapes, hi one embodiment, the original shape is a cylindrical shaped secondary coil, which may have a coil diameter of about 1 mm to about 2 mm, a secondary coil length of about 2 mm to about 1 cm, and a pitch of about 1 mm to about 2 mm. In another embodiment, the original shape is a conical shaped secondary coil, which may have a distal diameter of about 1 mm to about 3 mm, a proximal diameter of about 2.5 mm to about 5 mm, a coil length of about 0.5 cm to about 2 cm, and a pitch of about 0.5 mm to about 3 mm.
  • the brush segment is connected to the mandrel segment with a detachment segment, which delineates the brush segment and the mandrel segment for detaching the brush segment from the mandrel segment.
  • the detachment segment is preferably made of a relatively soft material, e.g., malleable material, that is sufficiently strong so that the brush segment and the mandrel segment will not separate from each other during endo vascular uses and is however easily severed with an appropriate cutter.
  • the endovascular brush includes or comes with a sheath for enclosing at least a portion of the brush segment.
  • the sheath maintains the brush segment in a straightened shape as opposed to the brush segment's original shape.
  • an endovascular brush is provided that has a brush segment at the distal end and a mandrel segment extending from the brush segment to the proximal end of the endovascular brush.
  • the brush segment includes at least one brush element having a height or depth of less than 0.1 mm thereby providing at least one space for retaining cells biopsied therewith and reducing the thrombogenicity of the endovascular brush by minimizing vascular wall damage in connection with use of the endovascular brush, which allows the endovascular brush to be used to obtain endovascular tissue from a target vascular segment in-vivo.
  • an endovascular brush has a flexible and elastic brush segment at the distal end and a mandrel segment extending from the brush segment to the proximal end of the endovascular brush, the brush segment comprising at least one brush element configured to reduce the thrombogenicity of the brush by minimizing vascular wall damage in connection with use of the endovascular brush, the brush segment capable of being deformed from an original shape and capable of recovering the original shape from a deformed shape.
  • an endovascular method includes the steps of introducing an endovascular brush into a subject's vasculature through one of a guiding catheter, needle, and angiocath, advancing the endovascular brush to a vascular site of interest, exposing the brush segment from one of the guiding catheter, needle, and angiocath, rubbing the brush segment against an intravascular surface at the site of interest to remove endovascular tissue from the intravascular surface, and retracting the endovascular brush from the subject.
  • the short exposure of the endovascular brush to the blood stream further minimizes the risk of thrombosis.
  • the endovascular brush includes a brush segment at a distal end and a mandrel segment extending from the brush segment to a proximal end of the endovascular brush.
  • the brush segment includes at least one brush element configured to provide at least one space for retaining cells biopsied therewith and to reduce thrombogenicity by minimizing vascular wall damage in connection with use of the endovascular brush, which allows the endovascular brush to be used to obtain endovascular tissue from a target vascular segment in-vivo.
  • the endovascular brush includes a flexible and elastic brush segment having an original shape restrained with one of the guiding catheter, needle, and angiocath, and the brush segment resumes the original shape as the brush segment is extruded from on of the guiding catheter, needle, and angiocath.
  • the brush segment expands in the vascular site of interest and provides pressure against the vascular segment that is necessary to remove tissue there from as the endovascular brush is retracted from the target vessel.
  • the present invention may, for example, be used to obtain a small number of endovascular tissue or cells, such as endothelial cells, from a selective vascular segment of a subject's artery or vein, for example, with minimally invasive procedures, which are described in greater detail below.
  • the subject may be any animal, including amphibians, birds, fish, mammals, and marsupials, but is preferably a mammal ⁇ e.g., a human; a domestic animal, such as a cat, dog, monkey, mouse, and rat; or a commercial animal, such as a cow or pig)- Endovascular cells may be sampled from a variety of blood vessels and for a variety of purposes.
  • Endovascular cells may be sampled from a vascular site having lesion, from a vascular site or sites without a lesion, or a combination thereof. Endovascular cells from such sites may also be obtained periodically, for example, to gauge the efficacy of drug treatment or the effects of drug treatments on normal cells. Alternatively, or in addition, endovascular cells can also be obtained from peripheral veins, e.g., by general physicians, as described below, with little discomfort to the subject, thereby further providing means for safely and repetitively obtaining endovascular cells. The endovascular cells gene expressions may then be determined with immunocytochemisty (IC) and reverse transcription polymerase chain reaction (rtPCR), and analyzed, for example, to diagnose vascular diseases, to determine the efficacy of drug treatments, etc.
  • IC immunocytochemisty
  • rtPCR reverse transcription polymerase chain reaction
  • FIGs. 1 A-ID are partial side view of an endovascular brush according to a plurality embodiment of the invention.
  • FIG. 2 is a side view of an endovascular brush having a cylindrical secondary coil shape according to one embodiment of the invention.
  • FIG. 3 is a side view of an endovascular brush having a conical secondary coil shape according to one embodiment of the invention.
  • FIG. 4 is a side view of an endovascular brush according to one embodiment of the invention disposed in a sheath.
  • FIGs. 5A-5D are various partial side and sectional views that illustrate an endovascular biopsy technique using an endovascular brush according to one embodiment of the invention.
  • FIGs. 6A-6B are various sectional side views that illustrate an endovascular biopsy technique using an endovascular brush according to one embodiment of the invention for a peripheral blood vessel.
  • FIG. 7A-7B are various views that illustrate a technique for removing biopsy tissue obtained with an endovascular brush according to one embodiment of the invention.
  • a slender endovascular brush includes a brush segment 101 at the distal end of the endovascular brush and a mandrel segment 105 extending from the brush segment to the proximal end of the endovascular brush.
  • the brash segment 101 includes at least one brush element 106, configured to retain biopsied cells on the brash, reduce the thrombogenicity of the endovascular brash, or a combination thereof, connected or otherwise incorporated thereto.
  • a brush element 106 is generally an abrasive element or feature of the endovascular brush that allows a user therewith to remove tissue, such as cells, from a vascular segment, e.g., by rubbing or grazing an intravascular surface with the brush element 106.
  • Various types of brush elements 106 maybe used to provide such functionality, including fibers and bristles as shown in FIG. IA, loops as shown in FIG. IB, ridges as shown in FIG. 1C, corrugations as shown in FIG. ID, etc.
  • Thrombogenicity is used herein as a relative term to describe the propensity of an element to cause a blood clot or thrombus to form, either due to exposure to of the element to blood or as a result of tissue damage in connection with its use.
  • the endovascular brush may further include a rounded tip 102, such as a spherical or semispherical tip, to prevent injury to the vascular tissue during catheterization and/or biopsy, and may include at least one radio-opaque marker, preferably at the distal tip, or be made of a radio-opaque material allowing at least a portion of the brush to be imaged for intraoperative image guidance.
  • a rounded tip 102 such as a spherical or semispherical tip, to prevent injury to the vascular tissue during catheterization and/or biopsy
  • at least one radio-opaque marker preferably at the distal tip, or be made of a radio-opaque material allowing at least a portion of the brush to be imaged for intraoperative image guidance.
  • FIGs. 1A-1D show the brush elements 106 in configured about the brush segment 101 in particular arrangements, it is understood that the brush elements 106 may be configured about the brush segment in a variety of ways and still achieve the desired functionality. For
  • the bristles or loops may be disposed radially about the brush segment 101.
  • the corrugations or ridges may be aligned other than diagonally as shown, such as perpendicular or parallel with respect to the axis of the axis of the endovascular brush.
  • opposing corrugations or ridges may be disposed thereon to form a lugged pattern.
  • the brush elements 106 are configured to retain biopsied cells in the presence of the moving fluid, hi one embodiment of the present invention, the size, shape, surface texture, spacing of the brush elements, e.g., the fibers or bristles, or a combination thereof are configured to provide a space or spaces where focal blood flow is relatively slow, which reduces the likelihood of target cells from being washed away in the fluid flow and correspondingly increases the likelihood for dislodged cells to remain on the brush segment 101.
  • Thrombogenicity may be tailored or reduced in various ways.
  • the brush element 106 may be formed from a non-thrombogenic material, such as platinum, etc., or may be formed from a thrombogenic material coated or impregnated with a non- or anti- thrombogenic substance or agent, such as heparin, hirudin, etc, to reduce the material's thrombogenicity.
  • This aspect reduces thrombus formation as a results of contact between the brash elements 106 and blood.
  • Brash elements 106 made of polyurethane, polyester, polyglycolic acid, and PFTE, are typically better suited for endovascular use than metallic substances, because they are softer and less likely to cause intimal dissection, vessel perforation or other type of vascular injury. These materials, however, are thrombogenic and may be coated or impregnated with a non- or anti-thrombogenic substance or agent to reduce the thrombogenicity of the brush elements 106.
  • thrombogenicity may be reduced by configuring at least one of the size, shape, number, spacing, surface texture, stiffness, exposure, and electrical charge of the brush elements 106 and/or other elements of the endovascular brash in order to minimize contact, e.g., of the type that activates blood factors to cause thrombosis, between the elements of the brash and blood components, such as platelets, or between the elements of the brash and vascular walls.
  • the configuration of the brash elements are configured to minimize vascular wall damage in connection with the use of the endovascular brash, which correspondingly reduces the thrombogenicity of the brash elements.
  • the brash elements may preferably be made of appropriately dimensioned relatively soft materials, such as polyurethane, polyester, polyglycolic acid, and PFTE, to minimize vessel wall damage and thus reduce the chance of thrombosis in connection with use of the endovascular brash.
  • Thrombogenicity may further be reduced by shielding the brash elements 106 from the blood stream with the use of a guide catheter or introducer needle and angiocath, which is explained in greater detail below.
  • the endovascular brash includes a plurality of brash elements 106 comprising at least one of a fiber, bristle, loop, ridge, or corrugation, dimensioned to retain biopsied cells, reduce thrombogenicity, or a combination thereof.
  • This may generally be achieved with brash elements 106 that have a height or depth 112 of less than about 0.5 mm.
  • the risk of vascular injury and thus the thrombogenicity of the brash may further be reduced with a length or height/depth 112 of less that about .1 mm, or more preferably between about 10 microns (0.01 mm) to about 80 microns (0.08 mm).
  • the height or depth 112 of the brash element 106 is about 40 microns (0.04 mm).
  • the spacing 120, radially or otherwise, between the brash elements 106 may be between about 10 microns (0.01 mm) to about 100 microns (0.1 mm), or more preferable between about 20 microns (0.02 mm) to about 50 microns (0.05 mm).
  • the brash elements 106 are radially spaced between about 10 microns to about 20 microns and longitudinally spaced, i.e., in the direction of the axis of the brash, between about 20 microns to about 50 microns.
  • the brush elements 106 are charged, e.g., positively charged, to repel blood components, such as platelets and red blood cells, or to attract endothelial cells or other target cell types that are normally negatively charged.
  • endothelial cells are 20-40 micron in size. Therefore, in order to provide sufficient space or spaces to retain biopsied endothelial cells, the brush element configuration should provide a space or spaces that is about 1 to about 3 times the size of the endothelial cell or other target cells, or dimensioned so that the height or depth 112 and spacing 120, range from about 20 to about 100 microns.
  • the brush segment 101 is relatively flexible and elastic such that the brush segment 101 is capable of being flexed, bent, turned, bowed, twisted, stretched, compressed, etc., or otherwise deformed, from an original shape, without breaking, and capable of recovering the original shape from the deformed shape.
  • This aspect of the brush segment 101 may be achieved in a variety of ways, such as by forming the segment 101 from a material having suitable flexibility and elasticity so that the brush segment 101 returns to the original shape upon removal of the deforming forces.
  • the desired flexibility and elasticity may be achieved with a brush segment that comprises a helically wound primary coil 130 with a stretch resistant filament 104 contained within the lumen of the primary coil 130 and firmly attached to both ends of the primary coil 130.
  • the brush segment is sufficiently strong or stiff to supply the pressure necessary to remove tissue from a vascular segment with the brush elements 106 as described below.
  • a memory alloy such as Nitinol, may be used to achieve the desired flexibility and elasticity.
  • the primary coil 130 is made from a metal selected from the group consisting of platinum, palladium, rhodium, gold, tungsten, nickel, titanium, and their alloys.
  • the primary coil 130 may also be stress relieved, for example, by heating the primary coil 130 prior to assembly.
  • the primary coil 130 may vary to accommodate a variety of blood vessel sizes and shapes.
  • the length 107 of the brush segment 101 or primary coil 130 is about 1 cm to about 2 cm, and has a primary coil diameter 110 of about 0.25 mm to about 0.35 mm for small arteries and veins and of about 0.9 mm for large arteries and veins.
  • Standard catheters have an inner diameter of 1 mm and standard microcatheters have an inner diameter of 0.35 to 0.45 mm. Accordingly, the combined diameter of the primary coil and the brush elements may be limited to less than 1 mm for use with a standard catheter, and less than 0.45 mm or preferably 0.35 mm for use with microcatheters.
  • the mandrel segment 105 may similarly be made of various materials and in various lengths.
  • the mandrel should generally be of sufficient length to access an endovascular site of interest from a selected point of entry.
  • the length 109 of the mandrel segment 105 may therefore vary between about 10 cm and about 150 cm.
  • a lO cm mandrel length 109 would, for example, be useful for peripheral blood vessel applications, whereas a 150 cm mandrel length 109 is better suited for intracranial blood vessel applications.
  • the mandrel length 109 of the is about 10 cm to about 20 cm for peripheral veins, and about 120 cm to about 150 cm for intracranial arteries and veins.
  • mandrel may similarly vary depending on the particular vascular application of the endovascular brush and will generally match or be less than the cross sectional dimensions of the brush segment 101, e.g., the primary coil diameter 110.
  • the mandrel segment 105 is made from a stainless steel alloy.
  • the brush elements 106 may be connected to or incorporated into a brush segment 101 in various ways.
  • the brush segment 101 may be formed as a unit with the brush elements 106, such as by molding, knurling, carving, etching, etc., the surface of the brash segment 101 to produce the desired brash elements 106.
  • the brush elements 106 may be adhered, fastened, tied, crimped, or otherwise secured to the brash segment 101.
  • the brush element 106 comprises a plurality of bristles or fibers made of a thermoplastic material that is connected to the brash segment 101 by heating the bristles or fibers so that the bristles or fibers adhere thereto.
  • the brash segment 101 is further connected to the mandrel segment 105 with a detachment segment 103.
  • the detachment segment 103 generally delineates the brash segment 101 and the mandrel segment 105 for detaching the brash segment 101 from the mandrel segment 105.
  • the detachment segment 103 is made of a relatively soft or malleable material, such as a soft metal, that is sufficiently strong, at the dimensions necessary for catheterization of small blood vessels as noted above, so that the brash segment 101 and the mandrel segment 105 will not separate from each other during its intended use, but is easily severed, for example, with a wire cutter, hi this instance, the length 108 of the detachment segment 103 is from about lcm to about 2 cm.
  • the detachment segment 103 may include other means for mechanically detaching the brush segment 101 from the mandrel segment 105.
  • the brush segment 101 and mandrel segment 105 may be detachably connected with a threaded interface, or other means for securely fastening the segments 101, 105.
  • the detachment segment 103 may include or be made of a radio-opaque material, so that a user may be able to determine with an intraoperative imaging device, whether the brush segment 101 has been extracted from a guiding catheter.
  • the brush segment 101 or primary coil 130 may further be formed into or have an original shape.
  • the original shape is generally a shape that improves the efficacy of the endo vascular procedures described herein, such as endo vascular biopsies, thrombectomies, arthroscopies, atherectomies, etc.
  • an original shape comprising a secondary shape or coil that resembles and is dimensionally greater than that of a targeted vascular segment so that when introduced into the targeted segment, the brush segment 101 or primary coil 130 will come into contact with the intravascular surface of the targeted vascular segment on more than a localized area or a plurality of surface areas and provide the pressure necessary to remove tissue from the targeted vascular segment, hi this instance, the brush elements 106 may be disposed on the brush segment 101 so that the brush elements 106 face outward from the original shape and toward the vascular walls to be sampled. This feature further reduces thrombogenic by eliminating unnecessary surface areas on the device that, when inserted into the vascular segment, are directly exposed to blood flow.
  • the secondary coil 210 is formed into a cylindrical shape.
  • the dimensions of the cylindrical secondary coil 210 will vary depending on the size of the targeted vascular segment. It is contemplated that the endovascular brush according to the present invention will generally be made in a variety of sizes for use in a plurality of different vascular applications. The user, such as a surgeon, may then select the appropriate size based on the particular application.
  • the secondary coil diameter 212 may range from about 1 mm to about 2 mm.
  • the secondary coil length 213 may vary between about 2 mm to about 1 cm.
  • the pitch or distance 214 between secondary coil turns may be 1 mm to about 2 mm.
  • the primary coil diameter 110 is either 0.25 mm or 0.35 mm
  • the cylindrical secondary coil has a diameter 212 of 2 mm, a length 213 of 5 mm, and the pitch between each turn 214 of 1 mm.
  • the secondary coil 310 is formed into a conical shape. The dimensions of the conical secondary coil 310 may similarly vary based on the size of the targeted vascular segment.
  • the conical secondary coil 310 may have a distal diameter 317 ranging from about 1 mm to about 3 mm, and a proximal diameter 318 from about 2.5 mm to about 5 mm, a coil length 319 of about of 0.5 cm to about 2 cm, and a pitch 320 of about .5 mm to about 3 mm.
  • the distal diameter 317 is about 1.5 mm
  • the proximal diameter 318 is about 3 mm
  • the secondary coil length 319 is 1 cm
  • a pitch between turns 320 is about 1 mm.
  • the various elements of the endovascular brush such as the brush elements 106, brush segment 101, detachment segment 103, mandrel segment 105, etc., maybe made from a variety of biocompatible materials or non-biocompatible materials with biocompatible coatings, including, without limitation, polyester, Gortex, polytetrafluoroethyline (PTFE), polyethelene, polypropylene, polyurethane, silicon, steel, stainless steel, titanium, tungsten, Nitinol or other shape memory alloys, copper, silver, gold, platinum, palladium, rhodium, Kevlar, carbon, graphite, and derivatives and alloys thereof.
  • biocompatible materials or non-biocompatible materials with biocompatible coatings including, without limitation, polyester, Gortex, polytetrafluoroethyline (PTFE), polyethelene, polypropylene, polyurethane, silicon, steel, stainless steel, titanium, tungsten, Nitinol or other shape memory alloys, copper, silver, gold, platinum, pal
  • the endovascular brush may be used with a sheath 402.
  • the sheath 402 is generally a tubular object capable of enclosing at least a portion or more preferable the entire length of the brush segment 101.
  • the brush segment 101 may be inserted into the sheath in preparation for catheterization. If the brush segment 101 has a secondary shape, such as a cylindrical or conical coil shape, the sheath 402 preferably maintains the brush segment in a straightened or deformed shape.
  • the sheath 402 may vary dimensionally to accommodate various endovascular brush sizes.
  • the sheath 402 is greater than about 1 cm long in order to cover the entire length of the brush segment, and has an inner diameter of at least about 0.50 mm for 0.35 or 0.25 mm diameter primary coils, and an inner diameter of at least 1 mm for 0.9 mm diameter primary coils.
  • the sheath may further be made of a transparent or semitransparent material so that the brush segment 106 or an appropriately colored detachment segment 103 is visible through the sheath 402.
  • the endovascular brush may be introduced into a subject's vasculature to, e.g., biopsy endothelium in arteries and veins, through a guiding catheter or microcatheter 526 that has been inserted into a target vessel 527, proximal to the intended site of interest, such as at a vascular site having a lesion thereon.
  • a rotating haemostatic valve 528 may also be connected to the hub of the catheter, which includes a side arm 550 with a one-way switch 529 for flushing saline there through.
  • the brush segment 101 and the sheath 402 are inserted into the rotating haemostatic valve 528 in unison with the sheath 402 covering the brush segment 101.
  • the sheath 402 should have an outer diameter larger than the luminal diameter of the guiding catheter or microcatheter 526 which should act as a stop to prevent the sheath 402 from being inserted into the hub of the catheter 526 or microcatheter.
  • the user may hold the sheath 402 so that the proximal end of the sheath 402 remains outside of the rotating haemostatic valve 528.
  • the user may insert the endo vascular brush into the subject's vasculature by pushing the mandrel segment 105 thereby advancing the brush segment 101 into the catheter 526 toward the target vascular segment, as shown in FIG. 5B.
  • the brush segment 101 is pushed out from the sheath 402 to expose the brush segment 101.
  • the brush segment 101 has an original or secondary shape, such as a cylindrical or conical coil shape, which is restrained with the sheath 402 and subsequently with the catheter 526, the brush segment 101 resumes or returns to its original or secondary shape as the brush segment 101 is extruded from the catheter 526.
  • the brush segment expands and preferably provides the necessary pressure against the vascular segment to remove tissue there from when the endovascular brush is retracted from the target vessel.
  • the location of the brush segment 101 in relation to the target vascular segment may be confirmed by imaging the site of interest, e.g., with x-ray imaging and/or contrast injection if necessary, ensure that the brush segment 101 comes into contact or overlaps the intended vascular segment or lesion. Endothelial cells may then be sampled from the vascular segment by pulling the proximal end of the mandrel segment 105 in a swift motion, which causes the brush segment 101, particularly the brush elements 106, to rub against or scrape the vascular segment, capture endothelial cells there from, and retract into the catheter 526.
  • the brush segment 101 may need to be drawn fore and aft in a plurality of cycles in order to remove the cells from the vascular segment.
  • the rotating haemostatic valve 529 can be temporarily closed to avoid washing away endothelial cells attached to the brush elements 106.
  • the endovascular brush is retracted from the subject until the brush segment 101 has been reintroduced into in the sheath 402.
  • Endovascular access to peripheral blood vessels may be provided with a needle 602 shown in FIG. 6A or an angiocath 604 shown in FIG. 6B sufficient in size to accommodate the endovascular brush as described herein, such as a 21- gauge needle or angiocath.
  • Tissue may then be sampled from a targeted vascular segment as described above in connection with FIGs 5A-5D.
  • the sheath 402 generally temporarily protects the sampled tissue, such as the endothelial cells, attached to the brush elements 106 until the tissue is transferred to a test tube or other receptacle as shown in FIGs. 7A-7B.
  • the sampled tissue is transferred to the test tube by extruding the brush segment from the sheath 402 until the detachment segment 103 is exposed, and detaching the brush segment 101 from the mandrel segment 105, e.g., by cutting the endovascular brush as the detachment segment 103.
  • the test tube contains an endothelial cell elution solution (ECDS) 702 composes of 0.9% NaCl 0.1 M phosphate buffer (pH 7.4), 5% bovine serum albumin, and 100 mcg/ml heparin.
  • ECDS endothelial cell elution solution
  • the severed brush segment 101 is washed thoroughly in ECDS by shaking the test tube or repeated pipeting of the solution and the washed fibered coil removed from the test tube and discarded.
  • Magnetic beads cooled with anti-endothelial cell antibodies may then be added to purify the endothelial cells.
  • White blood cells can be removed either with several washes with the ECDS or by incubation the sample with magnetic beads coated with antileukocyte antibodies. Endothelial cells may then be collected from the surface of magnetic beads for further analysis, e.g., with IC or preferably with rtPCR.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne des brosses endovasculaires qui comprennent un segment de brosse à l'extrémité distale et un segment de mandrin s'étendant du segment de brosse à l'extrémité proximale de la brosse endovasculaire. Le segment de brosse comprend au moins un élément de brosse, tel qu'une fibre, une soie, une boucle, une nervure ou une cannelure, conçu pour former un espace ou espacé afin de retenir des cellules biopsiées à l'aide de la brosse endovasculaire et afin de réduire la thrombogénicité de la brosse endovasculaire, ce qui permet à un utilisateur d'obtenir de manière sûre un tissu endovasculaire d'un segment vasculaire ciblé in vivo.
PCT/US2006/014984 2005-04-22 2006-04-21 Brosse endovasculaire WO2006116019A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11325405A 2005-04-22 2005-04-22
US11/113,254 2005-04-22

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WO2006116019A2 true WO2006116019A2 (fr) 2006-11-02
WO2006116019A3 WO2006116019A3 (fr) 2006-12-14

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015171884A1 (fr) * 2014-05-09 2015-11-12 Brigham And Women's Hospital, Inc. Brosse pour cytologie endovasculaire et procédé d'utilisation
US9314289B2 (en) 2007-07-30 2016-04-19 Covidien Lp Cleaning device and methods
US20190227079A1 (en) * 2009-12-17 2019-07-25 Cornell University Methods for detecting antibodies in mucosal samples and device for sampling mucosal material
WO2020060414A1 (fr) 2018-09-21 2020-03-26 Idris Oncology B.V. Dispositif de prélèvement d'un échantillon dans un liquide
WO2022154747A1 (fr) 2021-01-18 2022-07-21 Sandell Mikael Dispositif de biopsie et procédé de prélèvement d'échantillons de cellules ou de tissu chez des mammifères

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5653696A (en) * 1984-05-14 1997-08-05 Surgical Systems & Instruments, Inc. Stent unclogging method
US6920662B2 (en) * 1998-11-25 2005-07-26 Neosci Medical, Inc. Cleaning brush for medical devices

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5653696A (en) * 1984-05-14 1997-08-05 Surgical Systems & Instruments, Inc. Stent unclogging method
US6920662B2 (en) * 1998-11-25 2005-07-26 Neosci Medical, Inc. Cleaning brush for medical devices

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9314289B2 (en) 2007-07-30 2016-04-19 Covidien Lp Cleaning device and methods
US20190227079A1 (en) * 2009-12-17 2019-07-25 Cornell University Methods for detecting antibodies in mucosal samples and device for sampling mucosal material
US11782063B2 (en) * 2009-12-17 2023-10-10 Cornell University Methods for detecting antibodies in mucosal samples and device for sampling mucosal material
WO2015171884A1 (fr) * 2014-05-09 2015-11-12 Brigham And Women's Hospital, Inc. Brosse pour cytologie endovasculaire et procédé d'utilisation
US20170181733A1 (en) * 2014-05-09 2017-06-29 Brigham And Women's Hospital, Inc. Endovascular cytology brush and method for use
WO2020060414A1 (fr) 2018-09-21 2020-03-26 Idris Oncology B.V. Dispositif de prélèvement d'un échantillon dans un liquide
WO2022154747A1 (fr) 2021-01-18 2022-07-21 Sandell Mikael Dispositif de biopsie et procédé de prélèvement d'échantillons de cellules ou de tissu chez des mammifères

Also Published As

Publication number Publication date
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