Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
EMBOLIZATION DEVICE
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

 
FIELD OF INVENTION
[001] The present invention relates to a medical device. More specifically, the present invention relates to an embolization device.
BACKGROUND OF INVENTION
[002] Conditions such as, uncontrollable bleeding, tumors and/or vascular malformations, require immediate blocking of blood flow to avoid further losses. Severe injuries can cause significant blood loss, which can be life threatening. Alternately, for example, continuous blood flow to a vascular malformation, for example, a tumor, in a patient provides it with essential resources for growth and survival. Moreover, increased blood flow to such vascular malformations, can damage surrounding tissues and can rupture the blood vessel.
[003] Traditional method to stop the blood flow at a vascular access site includes manual compression and/or suture-based closure. However, manual compression involves applying continuous pressure to the site to stop blood flow. In such a case, prolonged pressure can cause discomfort to a patient and also lead to potential tissue damage.
[004] To overcome these drawbacks including embolizing blood vessels, embolization devices were designed. Embolization is a procedure to block the blood flow through a blood vessel. In embolization, a surgeon makes an incision in a patient’s body to access the target site through a guidewire. The guidewire guides the catheter to gain access to the target site inside a blood vessel. The catheter introduces an embolization device to the target site, which promotes thrombus formation and closure of the vascular access site.
[005] However, conventional devices heavily suffer from risks including damage to the blood vessel, bleeding at the puncture site, and infection. In some cases, the embolic devices may migrate from its intended target site, causing unintended blockages in other vessels.
[006] Thus, there arises a need for a device that overcomes the problems associated with the conventional solutions.
SUMMARY OF INVENTION
[007] The present invention relates to an embolization device including, a braided structure, a membrane, a frame and a cover. The braided structure includes a first section and a second section. Each of the first section and the second section of the membrane defines an outer surface. The frame includes a substantially tubular structure with a proximal end and a distal end. The frame includes a plurality of slots. The frame is coupled to the outer surface of the first section of the membrane. The braided structure is coupled to the outer surface of the second section of the membrane and towards the proximal end of the frame. The braided structure woven using one or more strands. Each strand includes a first end and a second end. The first end of a strand is coupled to a respective slot of the plurality of slots of the frame. The cover is coupled to the connecting ribs of the frame.
[008] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[009] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0010] Fig. 1 depicts an embolization device 100, according to an embodiment of the present disclosure.
[0011] Figs. 2a-2b depict a braided structure 200 of the embolization device 100, according to an embodiment of the present disclosure.
[0012] Fig. 3a depicts the membrane 250 of the embolization device 100, according to an embodiment of the present disclosure.
[0013] Fig. 3b depicts a frame 300 of the embolization device 100, according to an embodiment of the present disclosure.
[0014] Fig. 3c depicts a cover 350 of the embolization device 100, according to an embodiment of the present disclosure.
[0015] Fig. 3d depicts an assembly of the membrane 250, the frame 300 and the cover 350 of the device 100, according to an embodiment of the present disclosure.
[0016] Fig. 4a depicts the device 100 in a collapsed state in a catheter 400, according to an embodiment of the present invention.
[0017] Fig. 4b depicts the detachment of the braided structure 200 of the device 100 from the catheter 400, according to an embodiment of the present disclosure.
[0018] Fig. 4c depicts the device 100 in a deployed state, in the blood vessel, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0019] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like; Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[0020] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[0021] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[0022] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[0023] In accordance with the present disclosure, an embolization device is disclosed (hereinafter a device). The device is used in various embolization procedures. The device is used to block blood flow to a vascular site of a patient via for example, a peripheral vascular intervention. In the peripheral vascular intervention procedure, the device is used for closing a vascular access site following a medical procedure like angioplasty, stenting, atherectomy, or thrombectomy. The device may be deployed at the vascular site using a minimally invasive device like a catheter. The device is capable of self-expansion or being collapsed when constraint.
[0024] In an exemplary embodiment, the embolization device of the present invention includes without limitation a laser cut frame and, a braided structure mounted at least partially on the laser cut frame. The device further includes a membrane extending from one end to the other end of the device and coupled to the inner surfaces of the braided structure and the laser cut frame. The braided structure of the device provides flexibility and conformability to the vessel at the vascular site. While, the laser cut frame provides desired shape and size to the device according to the specific needs of the patient, improving overall device performance.
[0025] The combination of the laser-cut frame and the braided structure reduces the risk of device migration, restenosis, and/or other complications associated with a traditional device. The combination of the laser-cut frame and the braided structure also facilitates accurate and precise placement of the device in a body vasculature. The use of a laser cut frame with a braided structure allows for delivery of the device via a minimally invasive procedure, and reduced recovery time. Further, due to the combination, the device is durable and long-lasting, providing patients with a more reliable treatment option for vascular diseases. Further, the device achieves better occlusion in peripheral vascular procedures by combining the benefits of a member for example, a PET fabric, with a laser-cut and braided stent design. The device helps in efficiently and effectively closing off the treated area post-procedure.
[0026] The device of the present disclosure can be manufactured in various sizes to accommodate different anatomies and configurations of blood vessels, making it versatile and suitable for a wide range of applications.
[0027] Now specifically referring to figures, Fig. 1 depicts a device 100. The device 100 is deployed at a vascular access site in a patient. The device 100 includes a proximal end 100a and a distal end 100b. The device 100 includes a braided structure 200, a membrane 250, a frame 300 and a cover 350. Further details of the braided structure 200 are explained in context of Figs. 2a-2b while details of the membrane 250, the frame 300 and the cover 350 are explained in context of Figs. 3a-3d respectively.
[0028] The braided structure 200 includes an inner surface, a proximal end 200a and a distal end 200b. The braided structure 200 may be a substantially tubular structure. In an embodiment, the braided structure 200 is tapered at the proximal end 200a. The braided structure 200 is capable of self-expansion or being collapsed when constrained. The braided structure 200 provides flexibility and conformability to the device 100 at the vascular site. The braided structure 200 is coupled to an outer surface of the second section 254 of the membrane 250 and towards the proximal end 300a of the frame 300 (as explained later). Further, the braided structure 200 reinforces the second section 254 of the membrane 250 and supports the blood vessel.
[0029] The braided structure 200 is woven using one or more strands 220 of a biocompatible material. The biocompatible material may without limitation include, polytetrafluoroethylene (PTFE), polyethylene, polypropylene, polyester, nylon, silicone, polyurethane, or bioresorbable materials etc, or a combination thereof. In an embodiment, the one or more strands 220 is made of polytetrafluoroethylene (PTFE). The strands 220 may have a suitable cross-section such as without limitation circular, oval, square, etc. In an embodiment, the strand 220 has a circular cross-section, with a predefined diameter. In an embodiment, the predefined diameter of the strands 220 ranges from 0.025cm to 0.045cm. The strands 220 may be braided using a braiding technique including without limitation, three-dimensional braiding, flat braiding, or tubular braiding.
[0030] Each strand 220 of the braided structure 200 includes two ends - a first end and a second end. At the distal end 200b of the braided structure 200, the first end of the strand 220 is coupled to the slot 308 of the frame 300 (as explained later). The coupling of the first end of the strand 220 to a slot 308 of the frame 300 may be done via for example, welding. The second end of the strand 220 is coupled to a coupling element 210 provided at the tapered proximal end 200a, of the braided structure 200. The coupling of the second end of the strand 220 to a coupling element 210 may be done via for example, welding.
[0031] In an embodiment, the coupling element 210 is made of stainless steel. Further, the coupling element 210 at the proximal end 200a of the braided structure 200, may include a cavity 212 (as shown in Fig. 2b). In an embodiment, the cavity 212 is circular having a predefined diameter. In an embodiment, the diameter of the cavity 212 ranges from 0.007cm to 0.02cm. Alternately, the cavity 212 may be oval, spherical. In an embodiment, the cavity 212 of the coupling element 210 is provided with threads to attach to a catheter 400.
[0032] Fig. 3a depicts the membrane 250 according to an embodiment of the present disclosure. The membrane 250 may be made of any suitable biocompatible material. The materials may without limitation include, collagen, or a synthetic fabric. The synthetic fabric may include without limitation, Polyethylene Terephthalate (PET), Nylon, Polyvinyl Alcohol (PVA), Polytetrafluoroethylene (PTFE), etc. In an embodiment, the membrane 250 is made of a PET fabric. The use of PET fabric provides reduced risk of inflammatory reactions, improved structural integrity, compatibility with imaging techniques, enhanced biocompatibility, improved occlusion and durability to the device 100. Further, the PET fabric provides a tight seal around the blood vessel, reducing the risk of bleeding and improving the overall effectiveness of the device 100.
[0033] The membrane 250 includes an outer surface, a proximal end 250a and a distal end 250b. The proximal end 250a of the membrane 250 includes a first section 252. The distal end 250b of the membrane 250 includes a second section 254. The first section 252 and the second section 254 define the outer surface of the membrane 250. The membrane 250 is configured to cover the inner surface of the frame 300, providing a barrier to the blood flow in the blood vessel, where the device 100 is deployed. The membrane 250 is capable of self-expansion or being collapsed when constrained.
[0034] The first section 252 may be a substantially tubular structure including a taper. In an embodiment, the first section 252 is tapered towards the distal end 250b of the membrane 250. The second section 254 may extend away from the first section 252. In an embodiment, the second section 254 extends away from the tapered end of the first section 252. The second section 254 may be a substantially tubular structure without a taper. The first section 252 and the second section 254 of the membrane 250 may be cut from a fabric. Alternately, these may be separate components and thereafter stitched or sewn etc.
[0035] Fig. 3b depicts the frame 300 of the device 100. The frame 300 may be configured to couple to the membrane 250. Specifically, the inner surface of the frame 300 is coupled to the outer surface of the first section 252 of the membrane 250. The frame 300 may be made of any biocompatible material such as without limitation nitinol, titanium, etc, or a combination thereof. In an embodiment, the frame 300 is made of nitinol.
[0036] The frame 300 may be a substantially tubular structure having an inner surface. The frame 300 includes a proximal end 300a and a distal end 300b. The frame 300 includes one or more of axial ribs 304, one or more connecting ribs 306 and one or more slots 308. The frame 300 includes a rim 302 at the proximal end 300a connecting the one or more of axial ribs 304. The rim 302 may be coupled at the proximal end of the axial ribs 304 or at a predefined distance from the proximal end. The frame 300 is coupled to the outer surface of the first section 252 of the membrane 250. The frame 300 enables precise and targeted positioning of the device 100 in the target site due to its fluorescent properties. The frame 300 is capable of self-expansion or being collapsed when constrained.
[0037] The one or more axial ribs 304 of the frame 300 may extend from the proximal end 300a to the distal end 300b. At the proximal end 300a, the one or more axial ribs 304 may be coupled to the rim 302 of the frame 300. Each of the of axial ribs 304, may be placed apart defining a gap between two consecutive axial ribs 304 (shown in Fig. 3b). In an embodiment, the gap between each of the consecutive axial ribs 304 is uniform. In another embodiment, the gap between each consecutive rib is non-uniform. The one or more axial ribs 304 may have a suitable cross-section such as, rectangular, circular, oval, etc. In an embodiment, the axial ribs 304 have rectangular cross-section. The axial ribs 304 of the frame 300 are used to provide structural support to the device 100. Further, the axial ribs 304 enhance the stability of the device 100, facilitating optimal placement of the device 100.
[0038] The axial ribs 304 may include one or more slots 308. In an embodiment, each axial rib 304 includes the one or more slots 308 towards the proximal end 300a of the frame 300. The slots 308 may have without limitation, a circular, square, rectangular, oval etc. cross-section. In an embodiment, the slots 308 have a circular shape. The slots 308 help in coupling the frame 300 to the braided structure 200 (as explained later). Mechanisms of such coupling include without limitation, adhesive bonding, interlocking engagement, welding etc.
[0039] The one or more connecting ribs 306 are included at the distal end 300b of the frame 300. The connecting ribs 306 are configured to join two or more axial ribs 304. In an embodiment, one connecting rib 306 is configured to join two consecutive axial ribs 304 of the frame 300. The one or more connecting ribs 306 may have a suitable cross-section such as, rectangular, circular, oval, triangular, etc. In an embodiment, the connecting ribs 306 have a circular cross-section. In an embodiment, the connecting ribs 306 have a smooth surface to prevent trauma to surrounding body vasculature.
[0040] The axial ribs 304, the connecting ribs 306 and the slots 308 of the frame 300 may be laser cut from a tube. Alternately, these may be separate components and thereafter, welded, soldered, brazed etc. together.
[0041] The cover 350 (as shown in Fig. 3c) of the device 100 includes a base 352 and a wall 354. In an embodiment, the base 352 is circular. The wall 354 extends away from the base 352. The wall 354 surrounds the base 352 of the cover 350. The cover 350 may be configured to couple with the distal end 300b of the frame 300. More specifically, the cover 350 is coupled to the connecting ribs 306 of the frame 300. The diameter of the cover 350 corresponds to the diameter of the distal end 300b of the frame 300. The cover 350 of the device 100 is used to block the blood flow in the blood vessel, where the device 100 is deployed. Further, the cover 350 provides enhanced bio-compatibility and durability. Also, the cover 350 acts as a protective barrier, minimizing the exposure of frame 300 to corrosive bodily fluids, thereby preserving its structural integrity and prolonging its lifespan.
[0042] The cover 350 may be made of any biocompatible material such as without limitation polyethylene, polytetrafluoroethylene (PTFE), polypropylene, polyester, nylon, silicone, polyurethane, or bioresorbable materials etc., or a combination thereof. In an embodiment, the cover 350 is made of polytetrafluoroethylene (PTFE). The cover 350 is capable of self-expansion or being collapsed when constrained.
[0043] Now the coupling of the braided structure 200, the membrane 250, the frame 300 and the cover 350 is explained. The frame 300 may be coupled to the membrane 250. In an embodiment, the frame 300 is coupled along the length of the first section 252 of the membrane 250 (as shown in Fig. 3d) barring a predefined length towards the distal end. More specifically, the frame 300 encompasses the first section 252 of the membrane 250 barring the predefined length towards the distal end. The frame 300 may be coupled to the membrane 250 using at least one of, suturing, sewing, etc. In an embodiment, the frame 300 is coupled to the membrane 250 using suturing.
[0044] The predefined length towards the distal end allows seating of the cover 350 in the distal end of the frame 300 (as shown in Fig. 3d). In an embodiment, the cover 350 is coupled to the frame 300 at the distal end 300b along the predefined length. In an embodiment, the connecting ribs 306 of the frame 300 are coupled to the wall 354 of the cover 350. The cover 350 may be coupled to the frame 300 using at least one of, suturing, lacing, etc. In an embodiment, the frame 300 is coupled to the membrane 250 using suturing.
[0045] Thereafter, the braided structure 200 with the coupling element 210, is coupled to the frame 300. In an embodiment, the braided structure 200 is coupled to the frame 300 at the proximal end 300a (shown in Fig. 1). In an embodiment, the first ends of the one or more strands 220 at the distal end 200b, are coupled to the one or more slots 308. The one or more strands 220 of the braided structure 200, may be coupled to the one or more slots 308 using, without limitation, welding, bonding, brazing etc. In an embodiment, the strands 220 are coupled to the slots 308 of the frame 300, using a laser welding technique.
[0046] The device 100 obtained post coupling the braided structure 200, the membrane 250, the frame 300 and the cover 350, can be deployed at the vascular site. For deployment, the device 100 is coupled to a catheter 400. More specifically, the coupling element 210 of the braided structure 200 of the device 100 is coupled to the catheter 400.
[0047] The device 100 is introduced in a human body in a radially collapsed state via the catheter 400 (as shown in Fig. 4a). Once the catheter 400 is positioned at the desired location, the device of the membrane 250, the frame 300 and the cover 350 is pushed outside the catheter 400. Due to this, the device 100 immediately expands upon removal of the compressive force of the catheter 400. Upon receiving a further push force, the braided structure 200 of the device 100 is also exposed or uncovered from the catheter 400. The device 100 self-expands to the radially expanded state from the radially collapsed state. The device 100 is disengaged from the catheter 400, specifically the coupling element 210 of the braided structure 200 and the catheter 400 are disengaged (as shown in Fig. 4b). The catheter 400 is withdrawn from the body lumen. The device 100 is implanted in the vascular site, an artery or a vein to embolize the vascular site (as shown in Fig. 4c).
[0048] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. An embolization device (100) comprising:
a. a membrane (250) having a first section (252) and a second section (254), each of the first section (252) and the second section (254) defining an outer surface;
b. a frame (300) having a substantially tubular structure with a proximal end (300a) and a distal end (300b), the frame (300) including a plurality of slots (308), the frame (300) being coupled to the outer surface of the first section (252);
c. a braided structure (200) coupled to the outer surface of the second section (254) of the membrane (250) and towards the proximal end (300a) of the frame (300), the braided structure (200) woven using one or more strands (220), each strand (220) including a first end and a second end, the first end of a strand (220) coupled to a respective slot of the plurality of slots (308) of the frame (300); and
d. a cover (350) coupled to the connecting ribs (306) of the frame (300).
2. The device (100) as claimed in claim 1, wherein the braided structure (200) includes a substantially tubular structure.
3. The device (100) as claimed in claim 1, the braided structure (200) includes a taper at a proximal end (200a).
4. The device (100) as claimed in claim 1, the braided structure (200) includes a coupling element (210) coupled to the second ends of the strands (220).
5. The device (100) as claimed in claim 4, wherein the coupling element (210) includes a cavity (212) provided with threads, configured to couple with a catheter (400).
6. The device (100) as claimed in claim 1, wherein the membrane (250) is made of a Polyethylene terephthalate fabric.
7. The device (100) as claimed in claim 1, wherein at least one of the first section (252) or the second section (254) of the membrane (250), includes a substantially tubular structure provided with a taper.
8. The device (100) as claimed in claim 1, wherein the frame (300) includes a plurality of axial ribs (304) coupled to the outer surface of the first section (252) of the membrane (250), each rib including at least one slot of the plurality of slots (308).
9. The device (100) as claimed in claim 1, wherein the frame (300) includes a rim (302) at the proximal end (300a), configured to connect a plurality of axial ribs (304).
10. The device (100) as claimed in claim 1, wherein the frame (300) includes a plurality of connecting ribs (306) at the distal end (300b) of the frame (300), the plurality of connecting ribs (306) coupled to respective axial ribs (304).
11. The device (100) as claimed in claim 1, wherein the frame (300) is laser-cut.
12. The device (100) as claimed in claim 1, wherein each of the axial ribs (304), is placed apart defining a gap between two consecutive axial ribs (304).
13. The device (100) as claimed in claim 1, wherein the cover (350) includes a base (352) and a wall (354) coupled to the distal end (300b) of the frame (300).
14. The device (100) as claimed in claim 1, wherein at least one of the braided structure (200), the membrane (250), the frame (300) or the cover (350), is capable of self-expansion or being collapsed when constrained.