MEDICAL OCCLUDER DEVICE

Abstract

An occluder device (20) for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue comprises:a compliant balloon (5) defining a fluid-tight balloon chamber and provided with a balloon channel (7) forming a longitudinal passage from a proximal side (B2) to a distal side (B1) of the balloon; a tip element (10) disposed at the distal side of the balloon, a base element (4) disposed at the proximal side of the balloon, and connecting means comprising at least one connecting stmt (9) attached to the tip element and to the base element, the tip element and the base element each having a guide opening (105a, 105b) substantially coaxial to the balloon channel (7) for slidingly receiving therein a guidewire (106) for the device; elongated actuating means disposed longitudinally slidable in the balloon channel (7), releasably connectable to the tip element (10), and longitudinally slidable with respect to the base element (4); locking means (2, 13) for maintaining a predetermined distance between the tip element (10) and the base element (4); proximal connector means (1) for releasably connecting the occluder device (20) to correspondingly configured distal connector means of a catheter device (107); the balloon (5) comprising a fluid port (19) for filling and unfilling a fluid into and from the balloon chamber. An occluder system comprises an occluder device (20) and a catheter device (107) cooperating therewith.

Claims

1. An occluder device (20) for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue, the occluder device comprising: a compliant balloon (5) defining a fluid-tight balloon chamber and provided with a balloon channel (7) forming a longitudinal passage from a proximal side (B2) to a distal side (B1) of the balloon; a tip element (10) disposed at the distal side of the balloon, a base element (4) disposed at the proximal side of the balloon, and connecting means comprising at least one connecting strut (9, 11, 12) attached to the tip element and to the base element, the tip element and the base element each having a guide opening (105a, 105b) substantially coaxial to the balloon channel (7) for slidingly receiving therein a guidewire (106) for the device; elongated actuating means disposed longitudinally slidable in the balloon channel (7), releasably connectable to the tip element (10), and longitudinally slidable with respect to the base element (4); locking means (2, 13) for maintaining a predetermined distance between the tip element (10) and the base element (4); proximal connector means (1) for releasably connecting the occluder device (20) to correspondingly configured distal connector means of a catheter device (107); the balloon (5) comprising a fluid port (19) for filling and unfilling a fluid into and from the balloon chamber.

2. The occluder device according to claim 1, wherein the compliant balloon (5) is made of a compliant material selected from polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA) and polydioxanone (PDO or PDS).

3. The occluder device according to claim 1 or 2, wherein the connecting means comprise a single connecting strut (9) disposed within the balloon channel (7).

4. The occluder device according to claim 1 or 2, wherein the connecting means comprise a single connecting strut (12) disposed outside the balloon (5).

5. The occluder device according to claim 1 or 2, wherein the connecting means comprise multiple connecting struts (11) disposed in cage-like manner outside the balloon (5).

6. The occluder device according to one of the preceding claims, wherein the locking means are configured as a ratchet mechanism (13) whereby said predetermined distance between the tip element (10) and the base element (4) is selectable from a range of distances.

7. The occluder device according to one of the preceding claims, wherein the elongated actuating means are configured as actuating wire.

8. The occluder device according to one of the preceding claims, wherein the fluid port (19) is configured as a self-closing valve when it is not connected to a corresponding fluid transfer system (19).

9. An occluder system, comprising an occluder device (20) according to one of the preceding claims and a catheter device (107) cooperating therewith, the catheter device comprising an implant catheter tube (14) connected to an operating handle, the implant catheter tube (14) comprising a longitudinal passageway for a guidewire (106), distal connector means for releasably connecting the catheter device (107) to the correspondingly configured proximal connector means (1) of the occluder device (20), and a fluid transfer system (19) releasably connectable to the corresponding fluid port (19) of the occluder device (20).

10. A method of occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue by means of an occluder system as defined above comprises the following steps: providing the occluder system with the occluder device connected to the catheter device; positioning the occluder device in a compressed, longitudinally extended form thereof in a region to be occluded; inflating the balloon by filling a fluid into the balloon chamber; expanding the balloon in radial or lateral direction by shortening the distance between the tip element and the base element to said predetermined distance and locking said distance; releasing the occluder device from the catheter device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The above mentioned and other features and objects of this invention and the manner of achieving them will become more apparent and this invention itself will be better understood by reference to the following description of various embodiments of this invention taken in conjunction with the accompanying drawings, wherein:

[0040] FIG. 1 (a) shows a cross-sectional view of an expanded occlusion device according to an embodiment of the invention comprising one connecting component within the balloon embodiment;

[0041] (b) and (c) show side elevational views of the device illustrated in FIG. 1a;

[0042] FIG. 2 (a) shows a cross-sectional view of an expanded occlusion device according to an embodiment of the invention comprising multiple connecting components outside the balloon embodiment;

[0043] (b) and (c) show side elevational views of the device illustrated in FIG. 2a;

[0044] FIG. 3 (a) shows a cross-sectional view of an expanded occlusion device according to an embodiment of the invention comprising one connecting component outside the balloon embodiment;

[0045] (b) and (c) show side elevational views of the device illustrated in FIG. 3a;

[0046] FIG. 4 (a) shows a cross-sectional view of an expanded occlusion device according to an embodiment of the invention when deployed within a cardiovascular defect comprising a ratchet longitudinal adjustment component within the balloon embodiment;

[0047] (b) and (c) show side elevational views of the device illustrated in FIG. 4a;

[0048] FIG. 5 (a) shows a cross-sectional view of the device illustrated in FIG. 4a after the ratchet component actuation and longitudinal shortening; [0049] (b) and (c) show side elevational views of the device illustrated in FIG. 5a;

[0050] FIG. 6 shows a side view of the device illustrated in FIG. 2a when connected with the implant delivery system comprising a steerable catheter and a multiple knobs delivery handle;

[0051] FIG. 7 shows a side view of the device illustrated in FIG. 2a when expanded within a congenital defect;

[0052] FIG. 8 shows a side view of the device illustrated in FIG. 2a when expanded within a cardiovascular defect intended as cavity or discontinuity of the body tissue; and

[0053] FIG. 9 shows a side view of the device illustrated in FIG. 2a when expanded within a gap between a medical device and the adjacent body tissue.

[0054] It will be understood that the figures are not necessarily drawn to scale. In some in-stances, relative dimensions may be substantially distorted for ease of visualization.

DETAILED DESCRIPTION OF THE INVENTION

[0055] FIG. 1a shows a cross-sectional view of an expanded occlusion device 20 according to an embodiment of the invention comprising one connecting component within the balloon embodiment. As shown, the device 20 comprises a compliant balloon 5 as well as a central lumen 6 and a frame formed of two plastic or metallic deformable disks, placed at the distal end 10 and proximal end 4 of the implant and connected by one strut 9 passing within the balloon 5 central lumen 6. The frame allows structural support to the balloon. The frame may be formed from a cut structure so that each component of the frame is integrally connected with each other. The strut may have a linear or nonlinear section and may have plastic or metallic deformable characteristics. The occluder forms a closed three-dimensional device. The embodiment comprises a connection element 1 of the device 20 to attach and release it from the implant catheter 14. An inflation port 3 entering into the balloon along the central axis or in the close vicinity of it is connected to the implant catheter 14 and allows inflation and deflation of the balloon 5 while connected before the device 20 release. Within the central lumen 6 of the balloon may be the guidewire lumen 7 allowing a guidewire to freely move axially through the device 20.

[0056] According to an embodiment of the present invention, the compliant balloon 5 can be inflated by means of any fluid component, including but not limited to saline solution, blood, foam, liquid polymer that can change its proprieties becoming rigid. This fluid will act as the long-term shape setting, sealing and occluding component of the chronic device 20. The balloon 5 act as acute shape setting, sealing, and as occluding component of the chronic device 20. The implant catheter 14 and the inflation port 3 may contain specific channels, valves and membranes designed to be compatible with the fluid con-sidered, including filter membranes that can be permeable to blood in the case blood is used as filling fluid of the balloon 5.

[0057] Moreover, the frame allows longitudinal adjustment of the balloon 5 to enhance device 20 stability and defect occlusion. A locking wire is passing into a locking mechanism 1, within the central lumen 6 and is connected to the distal disk 20. When an actuating wire is placed within the central lumen 6, passing into a locking mechanism 1 in the proximal end of the device 20 and is connected to the distal disk 10, after longitudinal variation of the device 20 dimension by means of change in the distance of the two disks 10 and 4, and after its release from the distal disk 10, the locking mechanism is activated securing the locking wire within its structure, to maintain fixed the distance between the two disks 10 and 4. The actuating wire may be pulled directly by the user, in which case the axial movement of the actuating wire pulls the distal disk 10 in the proximal disk 4 direction. Alternatively, the actuating wire may be rotated by the user, in which case it engages a screw mechanism placed within the locking mechanism 1, so that rotating the wire it pulls the distal disk 10 in the direction of the proximal disk 4 and causes shortening of device 20.

[0058] The disks 4, 10 can have a round shape, an elliptical shape or a flower-like shape, an asymmetrical shape or any other shape as necessary or appropriate for proper cardiovascular defects occlusion and device stabilization.

[0059] In some embodiments, the frame may be designed to have a limited confirmability, to create a tapered shape to provide asymmetrical confinement to the balloon 5, for example, tapered at the distal end. The frame may have a generally conical, or frusto-conical shape, cylindrical shape, or any other shape as necessary or appropriate.

[0060] FIGS. 1b and 1c show side elevational views of the device 20 illustrated in FIG. 1a.

[0061] FIGS. 2a to 5c, illustrate further optional features that may be provided in conjunction with the device 20 as presented in the embodiment of FIGS. 1a to 1c. In order to avoid repetitions, only those features differing from the device described above will be ad-dressed. Like reference numbers denominate the same or corresponding features.

[0062] As further shown in FIG. 2a the frame may be formed by two proximal 4 and distal 10 plastic or metallic deformable disks, connected by more than one strut 11, which may have any suitable form, passing outside and tapering the balloon 5 component. Such embodiment may allow a cage-like structural confinement of the balloon 5 within its assembly, to avoid unnecessary interference of the device 20 with the body tissue or with implanted prostheses and to provide anchoring support of the device 20 within the cardiovascular defect. In this embodiment of the invention frame may have 2, 4, 6, 8, 10, 12 or any other suitable number of struts.

[0063] In some embodiments of the invention, the struts 11 forming the frame may differ in wall thickness and/or width along their entire length or a section thereof. As such, a strut 11 may have a first section that is wider than a second section. In other embodiments, a middle or a distal end section of a strut 11 may be provided with a larger or smaller wall thickness and/or strut width. Varying the wall thickness and/or the strut 11 width can be determined the frame radial stability.

[0064] FIGS. 2b and 2c show side elevational views of the device 20 illustrated in FIG. 2a.

[0065] As illustrated in FIG. 3a the frame may be formed the two proximal 4 and distal 10 plastic or metallic deformable disks, connected by one strut 12 passing outside and tapering the balloon 5 component.

[0066] FIGS. 3b and 3c show side elevational views of the device 20 illustrated in FIG. 3a.

[0067] As further shown in FIG. 4a, longitudinal adjustment of the device 20 may be achieved having the locking wire designed as ratchet mechanism 13 that is placed at the proximal disk 4 level and is connected to the actuating wire. This mechanism allows longitudinal adjustment of the device 20 in one way, inhibiting movement in the other direction, so the distal and proximal plates can only come closer, before device 20 release form the implant catheter 14, as shown in FIG. 5a.

[0068] FIGS. 4b and 4c show side elevational views of the device 20 illustrated in FIG. 4a.

[0069] FIGS. 5b and 5c show side elevational views of the device 20 illustrated in FIG. 5a, equivalent to the FIG. 4a after the ratchet component actuation and longitudinal shortening.

[0070] FIG. 6 depicts a perspective view of the device 20 illustrated in FIG. 2a, and of its main components, when connected with the implant catheter 14 comprising a multiple knobs delivery system handle 18.

[0071] The implant catheter 14 allow the introduction of the device 20 through the cardiovascular system to a defect in the cardiovascular apparatus, to deploy chronic implant 20 to seal the defect and maintain the occlusion.

[0072] The implant catheter 14 is connected to the device 20 through a connection element 1. It comprises within its steerable catheter the device 20, in its deflated not expanded form, and all the components and passage to allow controllable device 20 exposure, inflation, deflation, longitudinal adjustment retrievability and release at the end of the implantation.

[0073] Device 20 exposure is controlled by the implant knob 16 in the delivery system handle 18.

[0074] It allows the course of the guidewire, used to guide the device 20 to the targeted defect, and of the actuating wire, used to adjust the length of the device 20, within its structure and within the device 20 central lumen 6.

[0075] It includes the mechanisms to inflate and deflate of the implant from the balloon 5 inflation port 19 in the handle 18.

[0076] It features steerability capability to achieve good positioning of the occlusion device 20 in the cardiac defect, controlled by the steering knob 15 including steering limiter within the delivery system handle 18. The steering capability will allow either anterograde approach from the venous groin to the inferior vena cava, to the right atrium, to the left atrium, or retrograde from the arterial groin to the left ventricle, and be to have the device 20 implanted by any of the techniques known in the art.

[0077] In another configuration, the implant catheter 14 is flexible instead that steerable. The balloon 5 implant is one balloon implant fully compliant, where the percentage a balloon v changes in shape, radially and longitudinal, as the pressure and/or the volume of fluid increases in the balloon 5, above the pressure and/or volume necessary for the balloon to reach the minimum targeted shape.

[0078] The balloon 5 may be made from any suitable biocompatible material includ-ing polycaprolactone (PCL), Polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone (PDO, PDS).

[0079] The frame, comprising the distal 10 and proximal 4 disks and the plethora of struts 9, 11, 12 within the balloon 5 embodiment, has plastic or metallic deformable characteristics, and may be made from any other suitable biocompatible material including stainless steel, titanium, nitinol, tantalum, gold, platinum iridium, tungsten, alloys of any of the above-mentioned met-als, including platinum-iridium alloys, cobalt-chromium alloys, nickel-titanium alloys and nickel-titanium-platinum alloys. Alternatively, it may be made of polymer, including polyester and polycarbonate copolymers, and any metal or polymer or combination of polymer(s) and metal(s) able to soft plastic deformation. Suitable materials include biodegradable materials that are also biocompatible, intending a material that undergoes breakdown or decomposition into non-significant compounds as part of a normal biological process. Suitable biodegradable materials include polylactic acid, polyglycolic acid (PGA), collagen or other connective proteins or natural materials, polycaprolactone, hyaluronic acid, adhesive proteins, co-polymers of these materials as well as composites and combinations thereof and combinations of other biodegradable polymers.

[0080] The frame and the balloon of the device 20 according to the invention may be fabricated in different sizes, as necessary or appropriate for use in different sizes of cardiovascular defects or other suitable areas of the body.

[0081] Within the initial configuration of the device 20 and implant catheter 14, to allow the device to be introduced in the patient's body, the device 20 is premounted not expanded within the implant catheter 14, and the entire assembly is sterilized.

LIST OF REFERENCE NUMERALS

[0082] 1 connection [0083] 2 locking mechanism [0084] 3 inflation port [0085] 4 proximal disk [0086] 5 balloon [0087] 6 foldable balloon lumen [0088] 7 guidewire lumen [0089] 8 locking wire [0090] 9 single internal strut [0091] 10 distal disk [0092] 11 multiple external struts [0093] 12 single external strut [0094] 13 ratchet mechanism [0095] 14 implant catheter [0096] 15 steering knob [0097] 16 implant advancement and release knob [0098] 17 disk actuating knob [0099] 18 delivery system handle [0100] 19 balloon inflation port [0101] 20 occlusion device [0102] 105a distal guide opening [0103] 105b proximal guide opening [0104] 106 guidewire [0105] 107 catheter device