WO2018073663A1 - Piège intravasculaire - Google Patents

Piège intravasculaire Download PDF

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Publication number
WO2018073663A1
WO2018073663A1 PCT/IB2017/055291 IB2017055291W WO2018073663A1 WO 2018073663 A1 WO2018073663 A1 WO 2018073663A1 IB 2017055291 W IB2017055291 W IB 2017055291W WO 2018073663 A1 WO2018073663 A1 WO 2018073663A1
Authority
WO
WIPO (PCT)
Prior art keywords
trap
aperture
trap according
filter
intravascular
Prior art date
Application number
PCT/IB2017/055291
Other languages
English (en)
Inventor
Ram NOZYK
Original Assignee
Nozyk Ram
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nozyk Ram filed Critical Nozyk Ram
Publication of WO2018073663A1 publication Critical patent/WO2018073663A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/0105—Open ended, i.e. legs gathered only at one side
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0023—Angular shapes triangular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical

Definitions

  • the various described embodiments are in the field of intravascular filtration.
  • Intracardiac and intravascular procedures/operations can liberate particulate debris in blood vessels.
  • Particulate debris in the vascular system contributes to complications including vascular occlusion, end-organ ischemia, stroke, and heart attack.
  • Various ways to filter this debris from the vascular system before it arrives at distal organs have been proposed.
  • Filters deployed in the arterial system capture particulate debris in the blood. In many cases, captured particles escape the filter during diastole and/or during filter removal.
  • intravascular filters examples are described in, for example, US 7,758,606 and US 7,537,600.
  • a broad aspect of the invention relates to intravascular filtration.
  • proximal indicates a portion of the trap through which blood enters during systole and the term “distal” indicates a portion of the trap through which blood enters during diastole.
  • distal indicates a portion of the trap through which blood enters during diastole.
  • Moving parts refers to hinges, flaps, doors, valves and other active mechanisms.
  • portions of the trap are constructed of materials which are sufficiently flexible that they bend or flex in response to changes in blood pressure and/or flow direction.
  • a body of the trap is constructed primarily of polymeric membrane or mesh.
  • the body of the trap is supported by struts and/or rings.
  • cords restrict changes in orientation between various parts of the trap.
  • a trap including a proximal funnel with a wide aperture on the proximal side and a narrow aperture on the distal side.
  • walls of the funnel are constructed primarily of polymeric membrane or mesh.
  • walls of the funnel guide particle to the narrow aperture while allowing liquid to flow though the wall.
  • the apertures of the funnel are defined by rigid rings.
  • the diameter of the narrow aperture is narrower than the diameter the wide aperture by a factor of 2, 3, 4, 5, 5.5 or 6 or intermediate or greater ratios. In some embodiments, increasing this ratio contributes to an increase inefficiency of the trap.
  • a trap including a distal particle filter adapted to guide particles radially outward from the center of the filter during systole.
  • the particle filter includes a center region which is convex towards the proximal side.
  • the center region of the particle trap is aligned with a center of the narrow aperture of the funnel.
  • the center region of the particle trap and the centers of the two apertures of the funnel are positioned along a linear axis of a blood vessel in which the trap is installed.
  • Another aspect of some embodiments of the invention relates to a trap including a proximal funnel joined to a distal trap by a common ring.
  • an intravascular trap including: (a) a proximal funnel with a wide aperture on the proximal side and a narrow aperture on the distal side; and (b) a particle filter adapted to guide particles radially outward from the center of the filter during systole.
  • the trap includes outer walls connecting the funnel and the filter.
  • the trap includes a ring which defines the wide aperture.
  • the ring engages the walls.
  • the trap includes a ring which defines the narrow aperture.
  • a diameter of the narrow aperture is narrower than a diameter of the wide aperture by a factor of at least 2.
  • a distance between the narrow aperture and the wide aperture is at least 0.3 mm.
  • a distance between the narrow aperture and the wide aperture is less than 30 mm.
  • the filter includes a center region which is convex towards its proximal side.
  • a distance between the narrow aperture and the center region is at least 0 mm during systole.
  • a distance between the narrow aperture and the center region is less than zero during systole.
  • the trap includes struts adapted to support a portion of the trap.
  • the trap includes cords adapted to restrict changes in orientation between various parts of the trap.
  • the terms “comprising” and “including” or grammatical variants thereof are to be taken as specifying inclusion of the stated features, integers, actions or components without precluding the addition of one or more additional features, integers, actions, components or groups thereof.
  • This term is broader than, and includes the terms “consisting of and “consisting essentially of as defined by the Manual of Patent Examination Procedure of the United States Patent and Trademark Office.
  • any recitation that an embodiment "includes” or “comprises” a feature is a specific statement that sub embodiments “consist essentially of and/or “consist of the recited feature.
  • method refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of architecture and/or computer science.
  • Fig. la is a perspective view of an intravascular trap according to some exemplary embodiments of the invention.
  • Fig. lb is an exploded view of the intravascular trap depicted in Fig. la;
  • Fig.2a is a schematic side view of an intravascular trap according to some exemplary embodiments of the invention deployed in a blood vessel during systole;
  • Fig. 2b is a schematic side view of an intravascular trap as in Fig. 2a deployed in a blood vessel during diastole;
  • Fig. 3 is a schematic side view of an exemplary assembly including an intravascular trap according to an embodiment of the invention installed on a catheter.
  • Embodiments of the invention relate to intravascular traps and methods of installation and use thereof.
  • some embodiments of the invention can be used to trap particles freed into the bloodstream as a result of a cardiac procedure (e.g. angioplasty, TAVI, intravascular operation, heart operation or stent placement).
  • a cardiac procedure e.g. angioplasty, TAVI, intravascular operation, heart operation or stent placement.
  • Fig. la is a perspective view of an intravascular trap according to some exemplary embodiments of the invention indicated generally as 100.
  • Depicted exemplary trap 100 includes a proximal funnel 40 with a wide aperture 42 (ring 50) on the proximal side and a narrow aperture (46; Fig. lb) on the distal side and a particle filter 30 adapted to guide particles radially outward from the center of the filter during systole.
  • insertion cannula70 and struts 80 and 82 are also visible in Fig. la.
  • insertion cannula 70 is used to place trap 100 into a blood vessel through the wall of the vessel.
  • struts 80 and/or 82 support flexible parts of trap 100.
  • Fig. lb is an exploded view of the intravascular trap depicted in Fig. la which illustrates outer walls 34 of filter 30, connecting funnel 40 and filter 30 by means of a common ring at wide aperture 50.
  • ring 50 defines a shape and/or size of hole 42.
  • the ring which defines wide aperture 42 (ring 50) is constructed of a shape memory material (e.g. Nitinol).
  • the ring 50 at wide aperture 42 applies force to an interior wall of a blood vessel to hold trap 100 in place.
  • the ring 50 at wide aperture 42 engages walls 34.
  • narrow aperture 46 is also defined by a ring.
  • the ring which defines narrow aperture 46 is constructed of a shape memory material (e.g. Nitinol).
  • a diameter of narrow aperture 46 is narrower than a diameter wide aperture 42 (ring 50) by a factor of at least 2, at least 3, at least 4, at least 5 at least 6 or intermediate or larger factors.
  • a distance between narrow aperture 46 and wide aperture 50(as measured along a line connecting their centers) is at least 0.3 mm, at least 3 mm, at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, at least 30 mm or intermediate or greater distances.
  • the distance between narrow aperture 46 and wide aperture 42 (ring 50) is less than 30 mm, lessthan25 mm, less than 20 mm, less than 15 mm, less than 10 mm, less than 7.5 mm, less than 5 mm, less than 3 mm, less than 0.3 mm or intermediate or lesser distances.
  • filter 30 of trap 100 includes a center region 36 which is convex towards its proximal side.
  • the convex nature of center region 36 creates a circumferential trough 38 at the distal end of trap 30 in which trapped particles tend to collect during systole.
  • a distance "D" (Fig. 2a) between narrow aperture 46 and center region 36 is at least 0 mm, at least 1 mm at least 2 mm, at least 5 mm, at least 7.5 mm, at least 10 mm, at least 12.5 mm, at least 15 mm or intermediate or greater distances during systole.
  • a distance "D" (Fig. 2a) between narrow aperture 46 and center region 36 is less than zero during systole, less than 1mm, less than 2 mm, less than 5 mm, less than 7.5 mm, less than 10 mm, less than 12.5 mm, less than 15 mm or intermediate or lesser distances.
  • center region 36 protrudes through narrow aperture 46 into funnel 40.
  • trap 100 includes struts 85 (Fig. lb) adapted to support a portion of the trap.
  • wide aperture 42 and/or narrow aperture 46 are supported by rings.
  • struts 82 are attached to walls 44 of funnel 40. In those embodiments which employ struts 82, they reduce a tendency of the funnel to invert during diastole. According to various exemplary embodiments of the invention attachment of struts 82 to walls 44 of funnel 40 is on an inner surface of walls 44 and/or on an outer surface of walls 44. Alternatively or additionally, attachment of struts 82 to walls 44 of funnel 40 is by gluing, sewing, heat welding, riveting or other methods.
  • struts 80 are attached to walls 34 of filter 30. In those embodiments which employ struts 80, they reduce a tendency of the filter to move towards funnel 40 during diastole. According to various exemplary embodiments of the invention attachment of struts 80 to walls 34 of filter 30 is on an inner surface of walls 34 and/or on an outer surface of walls 34. Alternatively or additionally, attachment of struts 80 to walls 34 of filter 30 is by gluing, sewing, heat welding, riveting or other methods. Alternatively or additionally, in some embodiments the struts 85 apply force to an interior wall of a blood vessel to hold trap 100 in place.
  • trap 100 includes cords 65 adapted to restrict changes in orientation between various parts of the trap.
  • cords 67 connect wide aperture 42 (ring 50) to center region 36 of filter 30. According to these embodiments, cords 67 restrict motion of center region 36 of filter 30 during systole.
  • cords 68 connect a circumference of aperture 46 of funnel 40 to center region 36 of filter 30. According to these embodiments, cords 68 restrict motion of center region 36 of filter 30 during systole.
  • Fig. 2a is a schematic side view, indicated generally as 200, of an intravascular trap according to some exemplary embodiments of the invention deployed in a blood vessel 201 during systole.
  • a ring 50 installed at wide aperture 42 defines the shape/size of a hole 42 which conforms to the inner walls of blood vessel 201.
  • Systolic blood flow is depicted by arrows 210, 211 and 212 for simplicity.
  • Particles following the path indicated by arrow 211 proceed through wide aperture 42 (ring 50) and narrow aperture 46 across distance "D" to center region 36 which deflects them to circumferential trough 38.
  • Particles following the path indicated by arrow 210 or 212 proceed through wide aperture 42 (ring 50) and strike an inner side of wall 44 which guides them to narrow aperture 46. The particles then proceed across distance "D” and find their way to circumferential trough 38.
  • Fig. 2b is a schematic side view, indicated generally as 202, of an intravascular trap as in Fig. 2a deployed in blood vessel 201 during diastole. Diastolic blood flow is depicted by arrows 220, 221 and 222 for simplicity.
  • Arrow 221 proceeds through center region 36, across distance "D” through narrow aperture 46 and wide aperture without carrying any particles with it.
  • Arrows 220 and 222 pass through circumferential trough 38 where they move particles accumulated there towards an outer side of wall 44. These particles are deflected back towards an inner side of wall 34. The general flow direction causes them to accumulate in proximity to wide aperture 42 (ring 50) but outside wall 44 of the funnel.
  • Fig. 3 is a schematic side view of an exemplary assembly including a deployable intravascular trap according to an embodiment of the invention installed on a catheter depicted generally as 300.
  • wide aperture 42 (ring 50) is connected to struts 320 mounted on catheter 310 and walls 34 and 44 are folded back along the catheter.
  • struts 320 are attached at one end to catheter 310 and are connected to ring 50 at the other end.
  • struts 320 are constructed of a shape memory material (e.g. Nitinol).
  • Struts 320 support the shape of the trap and are the supporting part of the trap shape.
  • outer walls 34 of filter 30 are attached on one side to catheter 310 and on the other side are connected to ring 50.
  • walls 44 of funnel 40 are attached to ring 50.
  • catheter 310 During use catheter 310, with the intravascular trap assembled thereupon, is inserted via a peripheral blood vessel and guided to the target.
  • catheter 310 also carries another device (e.g. stent or angioplasty balloon).
  • the catheter introduced to the vascular system at a location which may be remote from the point of operation the deployable trap is opened remotely from the point of operation and can be folded back to the catheter remotely from the point of operation.
  • walls 44 of funnel 40 and/or walls 34 of filter 30 and/or trough 38 of filter 30 and/or center region 36 of filter 40 are constructed of material made of polyurethane, PTFE or ePTFE with a pore size selected to allow blood flow through but restrict flow of debris or emboli floating in the body lumen or cavity. Pore size of from about 20 to about 300 microns, preferably from about 50 to about 150 microns
  • cords 67 and/or 68 are constructed of thread made of nylon, polyester, PVDF or polypropylene having diameters from about 100 to about 1000 microns (e.g. common Surgical suture thread).
  • struts 80 and/or 82 are constructed of shape memory material, such as Nitinol.
  • rings 50 and/or 46 are constructed of shape memory material, such as Nitinol
  • the trap is engineered to withstand forces typically applied during systole and diastole.
  • a typical maximal force exerted on the trap during systole is about 1.6Kg.
  • a typical maximum force exerted on the trap during diastole is about l .OKg.
  • the diameter of wide aperture/ring 50 is in the range of 2 to 30 mm; 5 to 25 mm or 7 to 22 mm.
  • a total length of the trap is in the range of 5 to 50 mm; 10 to 40 mm or 20 to 30 mm.
  • Exemplary trap 100 has no hinges so it is less prone to mechanical failure than many previously available alternatives.
  • the simplicity of the described embodiments contributes to ease of folding, Ease of folding, in turn, contribute to simplification of trap insertion within the blood vessel the trap and by that to simplify the delivery of the trap to the blood vessel .
  • the trap has a unique design (shape).
  • the invention has been described in the context of cardiac surgery/ procedures but might also be used in other surgical procedures.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Un piège intravasculaire comprend un entonnoir proximal ayant une large ouverture sur le côté proximal et une ouverture étroite sur le côté distal et un filtre à particules conçu pour guider radialement des particules vers l'extérieur à partir du centre du filtre pendant la systole.
PCT/IB2017/055291 2016-10-19 2017-09-03 Piège intravasculaire WO2018073663A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662409887P 2016-10-19 2016-10-19
US62/409,887 2016-10-19

Publications (1)

Publication Number Publication Date
WO2018073663A1 true WO2018073663A1 (fr) 2018-04-26

Family

ID=62018289

Family Applications (1)

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PCT/IB2017/055291 WO2018073663A1 (fr) 2016-10-19 2017-09-03 Piège intravasculaire

Country Status (1)

Country Link
WO (1) WO2018073663A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110833715A (zh) * 2018-08-15 2020-02-25 曼·胡默尔有限公司 在冷却回路中用作颗粒过滤器的过滤器元件以及带有电化学的能量转换器和冷却回路的装置

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6306163B1 (en) * 1998-08-04 2001-10-23 Advanced Cardiovascular Systems, Inc. Assembly for collecting emboli and method of use
US7214237B2 (en) * 2001-03-12 2007-05-08 Don Michael T Anthony Vascular filter with improved strength and flexibility
US20100228281A1 (en) * 2009-01-16 2010-09-09 Paul Gilson Vascular filter system
US20140142609A1 (en) * 2002-03-05 2014-05-22 Salviac Limited Embolic protection system

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6306163B1 (en) * 1998-08-04 2001-10-23 Advanced Cardiovascular Systems, Inc. Assembly for collecting emboli and method of use
US7214237B2 (en) * 2001-03-12 2007-05-08 Don Michael T Anthony Vascular filter with improved strength and flexibility
US20140142609A1 (en) * 2002-03-05 2014-05-22 Salviac Limited Embolic protection system
US20100228281A1 (en) * 2009-01-16 2010-09-09 Paul Gilson Vascular filter system

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110833715A (zh) * 2018-08-15 2020-02-25 曼·胡默尔有限公司 在冷却回路中用作颗粒过滤器的过滤器元件以及带有电化学的能量转换器和冷却回路的装置

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