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WO2025169220A1 - Filtre vasculaire - Google Patents

Filtre vasculaire

Info

Publication number
WO2025169220A1
WO2025169220A1 PCT/IN2025/050118 IN2025050118W WO2025169220A1 WO 2025169220 A1 WO2025169220 A1 WO 2025169220A1 IN 2025050118 W IN2025050118 W IN 2025050118W WO 2025169220 A1 WO2025169220 A1 WO 2025169220A1
Authority
WO
WIPO (PCT)
Prior art keywords
struts
filter
shaped
elongate member
distal end
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/IN2025/050118
Other languages
English (en)
Inventor
Deveshkumar Mahendralal KOTHWALA
Arpit Pradipkumar DAVE
Mahesh Laxman Pawar
Ramkumar Kushwaha
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Meril Life Sciences Pvt Ltd
Original Assignee
Meril Life Sciences Pvt Ltd
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 Meril Life Sciences Pvt Ltd filed Critical Meril Life Sciences Pvt Ltd
Publication of WO2025169220A1 publication Critical patent/WO2025169220A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61F2/011—Instruments for their placement or removal
    • 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
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/005—Rosette-shaped, e.g. star-shaped
    • 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 present disclosure relates to a medical device. More particularly, the present disclosure relates to a vascular filter.
  • IVC Inferior vena cava
  • Vena cava filters are one of the treatment options available to prevent pulmonary embolism for patients having thromboembolism, absolute contraindication to anticoagulation, etc. They also provide distal protection during vascular procedures.
  • the conventional vena cava filters are generally difficult to retrieve after their implantation.
  • the elongate member is disposed at a proximal end of the filter.
  • the plurality of first struts extends away from the elongate member and towards a distal end of the filter.
  • the plurality of first struts are radially collapsible and expandable.
  • the plurality of second struts extends away from the elongate member and towards the distal end of the filter.
  • the plurality of second struts are radially collapsible and expandable.
  • the plurality of first struts are relatively smaller in length than the plurality of the second struts.
  • the plurality of first struts and the plurality of second struts are arranged alternatingly.
  • the at least one V-shaped struts coupling at least one of the first struts to an adjacently disposed one of the second struts.
  • FIG. 1 depicts a filter 100 according to an embodiment of the present disclosure.
  • Fig. lb depicts a proximal view of the filter 100 according to an embodiment of the present disclosure.
  • Fig. 2 depicts a method to deploy the filter 100 according to an embodiment of the present disclosure.
  • Fig. 3 depicts a method to retrieve the filter 100 according to an embodiment of the present disclosure.
  • Fig. 3b depicts the filter 100 constrained within the retrieval sheath 10 according to an embodiment of the present disclosure.
  • the present invention discloses a vascular filter (or filter) used to filter blood flow and trap blood clots (or thrombus or emboli).
  • the filter is used for various therapeutic purposes, such as thrombus capture in vena cava, distal protection during vascular procedures, etc.
  • the filter is implanted inside a blood vessel of the patient, for example, with the patient's inferior vena cava.
  • the filter of the present disclosure is provided with a plurality of struts having a plurality of barbs and a hook.
  • the filter may be temporarily implanted within the vasculature tissue and then easily retrieved from therein, even after long term implantation.
  • the filter is also suitable for permanent implantation at the discretion of the physician.
  • the clots in the blood stream are trapped inside the filter until the body's own lytic system dissolves it into smaller fragments.
  • the filter can also be used during implantation of other medical devices/implants or at the time of surgeries thereby preventing the risk of clots entering the heart.
  • the filter of the present disclosure is self-expandable from a radially collapsed state to a radially expandable state.
  • the filter allows the physician to deploy the filter in an easy and controlled manner.
  • Fig. 1 depicts an exemplary filter 100, according to an embodiment of the present disclosure.
  • the filter 100 has a proximal end 100a and a distal end 100b.
  • the filter 100 includes an elongate member 101, a plurality of first struts 103, a plurality of second struts 105 and a plurality of V-shaped struts 107.
  • At least a portion of the filter 100 is selfexpandable, for example, the plurality of first struts 103, the plurality of second struts 105, and the plurality of V-shaped struts 107 are radially collapsible and expandable.
  • the filter 100 of the present disclosure is described with an example of an integrated structure, the filter 100 may have components either removably or fixedly coupled to each other and the same is within the scope of the teachings of the present disclosure.
  • the elongate member 101 is disposed at the proximal end 100a of the filter 100.
  • the elongate member 101 may have pre-defined shape including, but not limited to, star shaped, tubular shaped, delta shaped, oval shaped, etc.
  • the elongate member 101 may be solid or hollow. In an embodiment, the elongate member 101 has a hollow tubular shape.
  • the elongate member 101 may have a pre-defined diameter ranging from 0.9 mm to 2.2 mm. In an embodiment, the diameter of the elongate member 101 is 1.8 mm.
  • the elongate member 101 is flared outwardly as a plurality of wings 101a.
  • the elongate member 101 is provided with two outwardly flaring wings 101a.
  • the wings 101a may be coupled to the elongate member 101 towards the proximal end 100a of the filter 100.
  • the wings 101a may form a first angle with an axially extending axis (not shown) of the filter 100.
  • the first angle ranges from 190° to 320°. In an embodiment, the first angle is 225°.
  • the wings 101a help to easily grab (or snare) the filter 100 for easy retrieval from within the vasculature tissue (explained later). Due to the presence of more than one wings 101a, the filter 100 can be securely grabbed from one of the wings 101a if the other wing(s) 101a is compromised due to tilting of the filter 100.
  • the elongate member 101 is provided with a jacket 101b (as shown in Fig. la).
  • the jacket 101b is disposed within the elongate member 101 towards the proximal end 100a of the filter 100.
  • the jacket 101b is provided with a plurality of internal threads lOlbl configured to receive a delivery wire (not shown).
  • the internal threads lOlbl are used to screw the delivery wire to the elongate member 101 (explained later).
  • the first struts 103 extend away from the elongate member 101 and towards the distal end 100b of the filter 100.
  • the filter 100 is provided with three first struts 103.
  • the first struts 103 may have a pre-defined shape including, but not limited to, ramp shaped, straight shaped, sine shaped, zig-zag shaped, etc.
  • the first struts 103 have a slight sine shape.
  • the first struts 103 may have a pre-defined length ranging from 20 mm to 50 mm.
  • the first struts 103 may have a pre-defined width ranging from 0.2 mm to 1.0 mm.
  • the first struts 103 may have a pre-defined thickness ranging from 0.1 mm to 0.4 mm. In an exemplary embodiment, the length, width, and thickness of the first struts 103 are 40 mm, 0.4 mm, and 0.2 mm, respectively.
  • the first struts 103 provide stability to the filter 100 by preventing the filter 100 from tilting.
  • the first struts 103 provide strength to the filter 100 and help to entrap the blood clots.
  • Each of the first struts 103 may be provided with at least one first barb 103a.
  • the first barbs 103a may be disposed towards the distal end 100b of the filter 100.
  • the first barbs 103a may have any pre-defined shape including, but not limited to, hook shaped, L-shaped, V-shaped, N-shaped, etc.
  • each of the first struts 103 is provided with one V-shaped first barb 103a.
  • the second struts 105 extends away from the elongate member 101 and towards the distal end 100b of the filter 100.
  • the filter 100 is provided with three second struts 105.
  • the second struts 105 may have a pre-defined shape including, but not limited to, J-shaped, flare shaped, Arabic six shaped (3), sine shaped, waning crescent shaped, etc. In an embodiment, as shown in Fig. 1, the second struts 105 have a slight sine shape.
  • the second struts 105 may have a pre-defined length ranging from 38 mm to 58 mm.
  • the second struts 105 may have a pre-defined width ranging from 0.2 mm to 1.2 mm.
  • the second struts 105 may have a pre-defined thickness ranging from 0.1 mm to 0.4 mm. In an exemplary embodiment, the length, width and thickness of the second struts 105 are 46 mm, 0.6 mm and 0.2 mm, respectively.
  • the second struts 105 provide strength and stability to the filter 100 to grasp the surrounding wall of the blood vessel after the filter 100 is deployed. The second struts 105 help in uniform deployment of the filter 100 and help to entrap the blood clots.
  • Each of the second struts 105 may be provided with at least one second barb 105a.
  • the second barbs 105a may be disposed towards the distal end 100b of the filter 100.
  • the plurality of second barbs 107' may have a pre-defined shape including, but not limited to, Latin gamma shaped (y), r-shaped, J-shaped, square root shaped (V), psi shaped (UJ), etc.
  • each of the second struts 105 is provided with a J-shaped second barb 105a.
  • the first and second barbs 103a, 105a help to hold and secure the filter 100 within the vasculature after the filter 100 is deployed, i.e., once the filter 100 is deployed within a blood vessel the first and second barbs 103a, 105a provide resistance to migration and tilting of the filter 100.
  • the first and second barbs 103a, 105a also prevent transverse rotation of the filter 100 within the blood vessel.
  • the pre-defined shape of the first and second barbs 103a, 105a minimizes the risk of puncture and trauma to the blood vessels and provides good holding ability to the filter 100 in severe circumstances such as high blood pressure.
  • the first struts 103 and the second struts 105 may have different lengths.
  • the first struts 103 have a relatively smaller length than the second struts 105.
  • the difference in length of the first and second struts 103, 105 provides easy and controlled expansion of the filter 100 while the filter 100 is being deployed within the blood vessel (explained later).
  • the first struts 103 and the second struts 105 are arranged alternatingly in a circular manner such that at least one of the first struts 103 is coupled to an adjacently disposed one of the second struts 105 via at least one V-shaped strut 107.
  • the filter 100 is provided with three first struts 103 and three second struts 105 arranged alternatively such that each first strut 103 is coupled to the adjacently disposed second strut 105 via one V-shaped strut 107.
  • the V-shaped struts 107 may be disposed between the adjacent first and second struts 103,105.
  • the V-shaped struts 107 may point towards the proximal end 100a or the distal end 100b of the filter 100.
  • the V-shaped struts 107, pointing towards the distal end 100b are disposed adjacent to the elongate member 101.
  • the V- shaped struts 107 along with the first and the second struts 103, 105 help to form a mesh-like structure (as shown in Fig. lb) of the filter 100.
  • the mesh-like structure of the filter 100 helps to filter the blood flow and entraps blood clots.
  • Fig. 2 depicts an exemplary method 200 to deploy the filter 100 within a vasculature.
  • the method 200 commences at step 201 by radially collapsing the first and second struts 103, 105 and constraining the filter 100 within a delivery sheath (not shown).
  • the delivery sheath prevents the filter 100 from radially expanding such that the filter 100 can be safely advanced to an implantation site within the vasculature.
  • the delivery wire is coupled to the filter 100.
  • an end of the delivery wire (not shown) is screwed to the internal threads lOlbl of the jacket 101b.
  • the filter 100 is advanced to and positioned at the implantation site within the vasculature.
  • the filter 100 is gradually pushed out of the delivery sheath thereby enabling the filter 100 to gradually self-expand.
  • the filter 100 is pushed out of the delivery sheath by pushing the delivery wire while the delivery sheath is kept stationary.
  • the filter 100 is pushed out of the delivery sheath by retracting the delivery sheath while the delivery wire is kept stationary.
  • the filter 100 is gradually pushed out of the delivery sheath by simultaneously retracting the delivery sheath and pushing the delivery wire.
  • the filter 100 Due to the difference in length of the first and second struts 103, 105, while the filter 100 is gradually pushed out from the delivery sheath, the filter 100 is deployed in a controller and step-wise manner.
  • the second struts 105 self-expand prior to the first struts 103. Accordingly, the second struts 105 grasp the surrounding wall of the vasculature before the first struts 103.
  • the physician may optionally reposition the filter 100 within the vasculature.
  • the first struts 103 self-expand after the second struts 105 has grasped the surrounding wall of the vasculature.
  • the delivery sheath is completely retracted from over the filter 100 before the first struts 103 are able to grasp the surrounding wall of the vasculature.
  • the complete retraction of the delivery sheath from over the filter 100 induces a sudden jolt in the filter 100. Since the second struts 105 have already grasped the surrounding wall of the vasculature, the sudden jolt is safely absorbed within the vasculature without the filter 100 getting disoriented at the implantation site.
  • the delivery wire is unscrewed from the internal threads lOlbl of the jacket 101b.
  • Fig. 3 depicts an exemplary method 300 to retrieve the filter 100 after the filter 100 has been deployed at the implantation site.
  • the method 300 commences at step 301 by determining the location of the deployed filter 100 within the vasculature. In an exemplary embodiment, the location of the filter 100 is confirmed by X-ray imaging with contrast.
  • a retrieval sheath 10 (as shown in Fig. 3a) along with a snare loop 11 (as shown in Fig. 3a) is advanced to the location of the deployed filter 100 within the vasculature.
  • the snare loop 11 includes a retrieval wire with one or more loops 11a at an end.
  • the snare loop 11 is disposed within a lumen of the retrieval sheath 10.
  • the snare loop 11 is advanced out of the retrieval sheath 10 such that at least one loop 11a of the one or more loops 11a of the snare loop 11 encircles at least one of the wings 101a of the filter 100 (as shown in Fig. 3a).
  • the snare loop 11 is retracted within the retrieval sheath 10 to snag the loop(s) 11a of the snare loop 11 with the wing(s) 101a of the filter 100.
  • the retrieval sheath 10 is gradually advanced to constrain the filter 100 within the lumen of the retrieval sheath 10 (as shown in Fig. 3b). While the retrieval sheath 10 is gradually advanced over the filter 100, the filter 100 radially collapses.
  • step 311 the retrieval sheath 10 constraining the filter 100 is withdrawn from within the vasculature.

Landscapes

  • 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

La présente divulgation concerne un filtre (100) comprenant un élément allongé (101), une pluralité de premières entretoises (103), une pluralité de deuxièmes entretoises (105) et au moins une entretoise en forme de V (107). L'élément allongé (101) est disposé au niveau d'une extrémité proximale (100a) du filtre (100). La pluralité de premières entretoises (103) s'étend à l'opposé de l'élément allongé (101) et vers une extrémité distale (100b) du filtre (100). La pluralité de premières entretoises (103) et la pluralité de deuxièmes entretoises (105) sont radialement pliables et extensibles. La pluralité de deuxièmes entretoises (105) s'étend à l'opposé de l'élément allongé (101) et vers l'extrémité distale (100b) du filtre (100). Ladite entretoise en forme de V au moins (107) couple au moins l'une des premières entretoises (103) à une entretoise disposée adjacente parmi les deuxièmes entretoises (105).
PCT/IN2025/050118 2024-02-07 2025-01-31 Filtre vasculaire Pending WO2025169220A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202421008384 2024-02-07
IN202421008384 2024-02-07

Publications (1)

Publication Number Publication Date
WO2025169220A1 true WO2025169220A1 (fr) 2025-08-14

Family

ID=96699436

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2025/050118 Pending WO2025169220A1 (fr) 2024-02-07 2025-01-31 Filtre vasculaire

Country Status (1)

Country Link
WO (1) WO2025169220A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060178695A1 (en) * 2005-02-04 2006-08-10 Decant Leonard J Jr Vascular filter with sensing capability
US20100121373A1 (en) * 2008-11-10 2010-05-13 Cook Incorporated Removable vena cava filter with improved leg

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060178695A1 (en) * 2005-02-04 2006-08-10 Decant Leonard J Jr Vascular filter with sensing capability
US20100121373A1 (en) * 2008-11-10 2010-05-13 Cook Incorporated Removable vena cava filter with improved leg

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