HK40027074B - Medical occluder device - Google Patents

Description

Medical occlusion device

Technical Field

This invention generally relates to an occluder device for closing a cardiovascular defect or a gap between a medical device and adjacent body tissue. In particular, this invention relates to a paravalvular leak occluder device. The various devices of this invention are intended to be implantable via a percutaneous or minimally invasive intervention.

Background Technology

There are many types of unnecessary or even pathological pathways in the body. If located in blood vessels or the heart, such pathways can lead to a highly undesirable reduction in blood flow or a bypass of blood flow around an organ.

WO 95/32018 discloses a method and apparatus for blocking a bodily passage, the method and apparatus comprising inserting an expandable frame into the passage and expanding the frame using an expandable balloon to locally embed the frame into multiple walls of the passage. The frame may have a separate sealing membrane, or the balloon may function as the sealing membrane. If the balloon is not used as the sealing membrane, it may be removed along with an inflation tube after the expansion step, or the balloon may be detached from the inflation tube and left in place as a sealing membrane or simply to lock the frame in place. The frame can be maintained in its expanded state by plastic deformation during the expansion step. The expandable frame has a substantially cylindrical shape and is described as suitable for, for example, closing an open arterial catheter, wherein an unwanted passage or conduit connects the aorta to the main pulmonary artery near the heart.

US Patent document US 4,836,204 describes a device for closing a perforation in the diaphragm of the heart. The device comprises a double-balloon diaphragm defect closure catheter to be inserted, such that the two initially compressed balloons are positioned on opposite sides of the diaphragm. Once inflated, the balloons conform tightly to their respective diaphragm wall sections, thereby preventing leakage through the perforation.

Perivalvular leakage is a common complication, occurring in up to 30% of patients who have undergone surgical or transcatheter prosthesis implantation. Percutaneous treatment of these defects offers a safer solution for high-risk patients without exposing them to the risks associated with open cardiac reoperation. However, currently used multiple devices are suboptimal because they have not been specifically developed for this intended use. Currently, closure of perivalvular leakage is typically achieved using multiple devices originally designed to close congenital heart defects. These are usually implanted in a low-flow environment, such as patent foramen ovale or atrial septal defects, and are implanted with a simple geometry. In contrast, perivalvular leakage develops under high pressure and flow conditions, and they are characterized by complex geometries. The defects are often crescent-shaped or elliptical, and may include a tubular cross-section with multiple deformations, and the structure is at most minimally compliant. In this environment, most of the aforementioned currently available devices are limited by the poor adaptability of the devices to the aforementioned defects (lack of compliance) and by the lack of internal sealing (due to the high-flow environment).

Nevertheless, there are still some concepts and implementations of closed multiple occlusion devices specifically designed for perivalvular leakage.

US Patent document US 2014/0277426 A1 describes various devices for sealing a gap between a medical device and adjacent body tissue. These devices typically include a compliant body having a hollow interior and a fluid port designed to supply a pressurized fluid to expand the compliant body. Various shapes and compositions of the compliant body, delivery means, and fixation means are described.

US Patent document US 7,628,805 B2 generally discloses several concepts for positioning and repairing perivalvular leakage. These concepts include multiple sealing supports and multi-component systems with radiation-cured adhesives.

US Patent Document US 2012/078295 A1 discloses a occluder device for sealing a passage in a circulation system. The device includes an expandable fixing unit for securing the occluder to the passage, which can be achieved by switching between a compressed form and an expanded form.

Despite the above, there remains a need for an improved occlusion device that avoids the aforementioned disadvantages or several currently known devices.

Summary of the Invention

The above and other objectives can be achieved through this invention.

According to one aspect, an occluder device is provided for closing a cardiovascular defect or a gap between a medical device and adjacent body tissue, the occluder device comprising:

A compliant balloon defines a fluid-tight balloon cavity and has a balloon channel that forms a longitudinal passage from a proximal side to a distal side of the balloon.

A tip element disposed at the distal side of the balloon; a base element disposed at the proximal side of the balloon; and a connecting tool including at least one connecting post attached to the tip element and the base element, the tip element and the base element each having a guide opening substantially coaxial with the balloon channel for slidably receiving a guidewire for the device in the balloon channel;

A slender actuating tool is configured to slide longitudinally within the balloon channel and is releasably connected to the tip element, and is also longitudinally slidable relative to the base element;

Multiple locking tools are used to maintain a predetermined distance between the tip element and the base element;

A proximal connector tool for releasably connecting the occluder device to a corresponding distal connector tool of a catheter device;

The balloon includes a fluid port for filling the balloon cavity with fluid and draining the fluid from the balloon cavity.

According to another aspect, an occluder system is provided, comprising: an occluder device as defined above, and a catheter device cooperating with the occluder device; the catheter device comprising: an implanted catheter fitting connected to an operating handle, the implanted catheter fitting including a longitudinal passage for a guidewire; a distal connector tool for releasably connecting the catheter device to a correspondingly configured proximal connector tool of the occluder device; and a fluid transfer system releasably connected to a corresponding fluid port of the occluder device. The distal and proximal connector tools are typically configured as a plurality of cooperating members respectively located at the distal end of the catheter device and the proximal end of the occluder device. Examples of such cooperating members include cooperating threads, bayonet, or snap-fit connections.

Multiple clinical indications include, but are not limited to, perivalvular leakage (PVL), patent foramen ovale (PFO), atrial septal defect (ASD), ventricular septal defect (VSD), intravalvular leakage (IVL), intralobular leakage, interlobular perforation, type I intravascular leakage after vascular transplantation, and left atrial appendage occlusion.

The device is designed to be delivered to the area to be treated in a compressed, i.e., longitudinally extended manner. The device then utilizes two mechanisms to adapt to the anatomy of the landing area: the inflation of the balloon and the shortening of the longitudinal dimension of the frame formed between the base element and the tip element. Under internal pressure, the balloon will exhibit a certain volume, which, for a specific longitudinal frame size, implies a certain lateral or radial dimension. Changing the longitudinal frame size by selecting a different distance between the tip element and the base element will result in a corresponding change in radial extension. In other words, under otherwise constant conditions, shortening the distance between the tip element and the base element will result in a corresponding increase in radial extension.

In the context of this disclosure, the terms “distal” and “proximal” are used accordingly in their standard meanings in the field of percutaneous cardiovascular devices. The term “proximal” refers to those components of the device assembly closer to the distal end of a delivery catheter during percutaneous delivery, the catheter being configured for manipulation by a user (e.g., by a catheter handle manipulated by a surgeon). The term “distal” is used to refer to those components of the device assembly further away from the distal end of the catheter, the catheter being configured for manipulation by a user and/or further insertion into a patient's body. Thus, in a device used in a gap between a medical device and adjacent body tissue, such as pervalvular mitral valve leakage, when the device is placed in the defect using a transseptal approach, the proximal end may face the left atrium, while the distal end may face the left ventricle.

The term "compliance" used in relation to multiple balloons or multiple structural components should be understood to imply a deformability that substantially follows an applied force. Therefore, a "compliant balloon" should be understood as a balloon that gradually expands under increasing radial pressure, provided that a certain burst pressure is not exceeded.

The connecting tool includes at least one connecting post attached to the tip element and the base element. The term "post" should be understood as an elongated structural element that can be formed, for example, as a thin wire, rod, or back-walled tube, and does not necessarily have a circular cross-section.

According to a further aspect, a method for closing a cardiovascular defect or a gap between a medical device and adjacent body tissue using an occluder system as defined above includes the following steps:

Provides the occluder system having the occluder device, the occluder device being connected to the conduit device;

The occluder device is positioned in a compressed and longitudinally extended form in an area to be sealed off;

The balloon is inflated by filling it with a fluid.

The balloon is expanded in a radial or lateral direction by shortening the distance between the tip element and the base element to the predetermined distance, and the distance is locked.

Release the occluder device from the catheter device.

Several advantageous embodiments of the invention are defined in the dependent claims and/or described below.

The plurality of compliant balloons of the present invention do not require pre-forming. However, a plurality of pre-formed balloons can be used to establish a predetermined and non-uniform local elasticity against an applied radial pressure. Preferably, the balloons are made of a compliant material selected from polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), and polydioxanone (PDO or PDS). Most preferably, the compliant material is polycaprolactone.

Depending on the specific application, various configurations of the connection tool may be considered. According to one embodiment, the connection tool includes a single connection strut disposed within or outside the balloon channel.

Advantageously, the connecting tool comprises a plurality of connecting struts arranged in a cage-like manner outside the balloon. Applying internal pressure to the balloon results in an elastic force resisting the material of the compliant balloon, as well as resistance to the expansion of the balloon by the structural constraints provided by the plurality of external connecting struts. In particular, this configuration provides the advantage of improved stability of the compliant balloon against unwanted local deformation. Typically, this will result in an improved adaptability of the occluder device to the geometry of the leak to be sealed.

The plurality of locking elements for maintaining a predetermined distance between the tip element and the base element can be configured in various ways. For example, they may include a rotatable actuating line having a threaded portion formed to cooperate with a corresponding block formed in the distal disk. According to an advantageous embodiment, the plurality of locking tools are configured as a ratchet mechanism, thereby allowing the predetermined distance between the tip element and the base element to be selected from a range of distances. This allows for an accurate and reliable definition of the radial extension of the occluder device, and thus improves the reliability of the device.

The elongated actuation tool is configured to slide longitudinally within the balloon channel and is releasably connected to the tip element, and also slide longitudinally relative to the base element. For this purpose, the actuation tool is formed as an elongated, elastic member with a smooth surface. According to an advantageous embodiment, the elongated actuation tool is configured as a coherent actuation line. The use of multiple actuation lines is well established in the field of cardiovascular intervention. Herein, a single wire used with multiple suitable proximal counterpieces allows for simple, precise, and reproducible selection of the distance between the tip element and the base element.

In the field of cardiovascular intervention, various tools are well known for inflating and deflating multiple balloons and other inflatable devices. According to an advantageous embodiment, the balloon has a fluid port that is configured as an automatically shut-off valve when not connected to a corresponding fluid transfer system. Specifically, this allows the balloon to be inflated via a longitudinal fluid line, which can then be disconnected and retracted, and if further inflation or deflation of the balloon is required, the longitudinal fluid line only needs to be reinserted and reconnected.

The aforementioned elements, as well as those described and claimed below and those used in accordance with the invention, should be generally understood as having the meaning established in the medical field.

Attached Figure Description

The foregoing content, as well as other features and objectives of the invention and the ways in which they are achieved, will become apparent, and the invention itself will be better understood by reference to the following description of various embodiments of the invention in conjunction with the accompanying drawings.

Figure 1a shows a cross-sectional view of an extended occlusion device according to an embodiment of the present invention, the occlusion device including a connecting assembly within the balloon embodiment;

Figures 1b and 1c show multiple side front views of the device illustrated in Figure 1a;

Figure 2a shows a cross-sectional view of an extended occlusion device according to an embodiment of the present invention, the occlusion device including a plurality of connecting components outside the balloon embodiment;

Figures 2b and 2c show multiple side front views of the device illustrated in Figure 2a;

Figure 3a shows a cross-sectional view of an extended occlusion device according to an embodiment of the present invention, the occlusion device including a connecting assembly outside the balloon embodiment;

Figures 3b and 3c show multiple side front views of the device illustrated in Figure 3a;

Figure 4a shows a cross-sectional view of an extended occlusion device according to an embodiment of the present invention, which, when deployed in a cardiovascular defect, includes a ratchet longitudinal adjustment assembly within the balloon embodiment;

Figures 4b and 4c show multiple side front views of the device illustrated in Figure 4a;

Figure 5a shows a cross-sectional view of the device illustrated in Figure 4a after actuation and longitudinal shortening of the ratchet assembly;

Figures 5b and 5c show multiple side front views of the device illustrated in Figure 5a;

Figure 6 shows a side view of the device illustrated in Figure 2a when connected to an implanted delivery system, which includes a steerable catheter and a multi-knob delivery handle.

Figure 7 shows a side view of the device illustrated in Figure 2a when it expands in a congenital defect;

Figure 8 shows a side view of the device illustrated in Figure 2a when it expands in a cardiovascular defect, which refers to a cavity or discontinuity in body tissue; and

Figure 9 shows a side view of the device illustrated in Figure 2a when extended in a gap between a medical device and adjacent body tissue.

It will be understood that the accompanying drawings are not necessarily drawn to scale. In some cases, multiple relative dimensions may be substantially distorted for ease of observation.

Detailed Implementation

Figure 1a shows a cross-sectional view of an extended occlusion device 20 according to an embodiment of the present invention, the occlusion device including a connecting assembly within the balloon embodiment. As shown, the device 20 includes a compliant balloon 5 and a central cavity 6 and a frame formed of two deformable plastic or metal discs disposed at a distal end 10 and a proximal end 4 of the implant and connected by a strut 9 passing through the interior of the central cavity 6 of the balloon 5. The frame allows for structural support of the balloon. The frame may be formed by a cut structure such that each component of the frame is integrated and connected to each other. The strut may have a linear or non-linear segment and may have multiple deformable plastic or metal features. The occluder forms a closed three-dimensional device. The embodiment includes a connecting element 1 of the device 20 for attachment to or release from an implanted catheter 14. An inflation port 3, which enters the balloon along or near a central axis, is connected to the implanted catheter 14, and during connection prior to release of the device 20, the inflation port allows the balloon 5 to inflate and deflate. Within the central cavity 6 of the balloon may be a guidewire cavity 7, which allows a guidewire to move axially and freely through the device 20.

According to one embodiment of the invention, the compliant balloon 5 can be inflated with any fluid composition, including but not limited to saline solution, blood, foam, and liquid polymers that can be hardened by altering several of their properties. This fluid will act as a long-term shape-fixing, sealing, and closure component of the chronic device 20. The balloon 5 also acts as an acute shape-fixing, sealing, and closure component of the chronic device 20. The implanted catheter 14 and the inflation port 3 may contain multiple specific channels, valves, and membranes designed to be compatible with the considered fluids, including various filter membranes that are permeable to blood in the case where blood is used as the filling fluid for the balloon 5.

Furthermore, the frame allows for longitudinal adjustment of the balloon 5 to enhance the stability and defect closure of the device 20. A locking line passes through a locking mechanism 1 within the central cavity 6 and connects to the distal disc 20. When the actuation line is placed within the central cavity 6 and passes through the locking mechanism 1 in the proximal end of the device 20, and connects to the distal disc 10, after the device 20 undergoes a longitudinal change in size by altering the distance between the two discs 10 and 4, and after the device 20 is released from the distal disc 10, the locking mechanism is activated to secure the locking line within its structure, thereby maintaining a fixed distance between the two discs 10 and 4. The user can directly pull the actuation line; in this example, an axial movement of the actuation line pulls the distal disc 10 in the direction of the proximal disc 4. Alternatively, the actuation wire can be rotated by the user, in this example, the actuation wire engaging with a screw mechanism placed within the locking mechanism 1, thereby rotating the wire to pull the distal disk 10 in the direction of the proximal disk 4 and causing the device 20 to shorten.

The plurality of disks 4, 10 may have a circular shape, an elliptical shape, a floral shape, an asymmetrical shape, or any other shape necessary or suitable for the appropriate closure of cardiovascular defects and the stability of the device.

In some embodiments, the frame may be designed to have limited verifiability to produce a conical shape, thereby providing asymmetrical constraint on the balloon 5, for example, by gradually narrowing at the distal end. The frame may have a generally conical or truncated conical shape, a cylindrical shape, or any other necessary or suitable shape.

Figures 1b and 1c show multiple side front views of the device 20 illustrated in Figure 1a.

Figures 2a through 5c further illustrate a number of optional features that can be provided in conjunction with the apparatus 20 presented in the embodiments of Figures 1a through 1c. To avoid repetition, only those features that differ from the apparatus described above will be published. The same reference numerals denote the same or corresponding features.

As further shown in Figure 2a, the frame can be formed from two deformable discs of plastic or metal, proximal 4 and distal 10, connected by one or more struts 11 of any suitable form, extending externally and gradually narrowing the balloon 5 assembly. This embodiment allows for a cage-like structural constraint of the balloon 5 within its assembly to avoid unnecessary interference with body tissue or implanted prostheses, and provides anchoring support for the device 20 in the cardiovascular defect. In this embodiment of the invention, the frame may have 2, 4, 6, 8, 10, 12, or any suitable number of struts.

In some embodiments of the invention, the plurality of pillars 11 forming the frame may have different wall thicknesses and/or widths along their entire length or a segment of the length. In this way, a pillar 11 may have a first segment that is wider than a second segment. In other embodiments, a middle or distal segment of a pillar 11 may have a larger or smaller wall thickness and/or pillar width. Variations in the wall thickness and/or the pillar width can determine the radial stability of the frame.

Figures 2b and 2c show multiple side front views of the device 20 illustrated in Figure 2a.

As illustrated in Figure 3a, the frame may be formed of two deformable discs of plastic or metal, with the two deformable discs connected by a support 12 and extending outwards, causing the balloon 5 assembly to gradually narrow.

Figures 3b and 3c show multiple side front views of the device 20 illustrated in Figure 3a.

As further shown in Figure 4a, longitudinal adjustment of the device 20 is achieved by the locking line having a ratchet mechanism 13, which is positioned at the level of the proximal disc 4 and connected to the actuation line. Because this mechanism allows the device 20 to be longitudinally adjusted in a manner that inhibits movement in other directions, the distal and proximal discs can only move closer together before the device 20 is released from the implanted catheter 14, as shown in Figure 5a.

Figures 4b and 4c show multiple side front views of the device 20 illustrated in Figure 4a.

Figures 5b and 5c show multiple side front views of the device 20 illustrated in Figure 5a, which are equivalent to Figure 4a after actuation and longitudinal shortening of the ratchet assembly.

Figure 6 depicts a perspective view of the device 20 and its several main components illustrated in Figure 2a when connected to the implanted catheter 14, which includes a multi-knob delivery handle 18.

The implanted catheter 14 allows the device 20 to be introduced into a defect in a cardiovascular device via a cardiovascular system to place a chronic implant 20, thereby sealing the defect and maintaining the closure.

The implanted catheter 14 is connected to the device 20 via a connecting element 1. It includes the device 20 in its constricted rather than expanded form within its steerable catheter, as well as all components and access routes to allow for controllable exposure, expansion, constriction, longitudinal adjustment recoverability, and release of the device 20 at the end of the implantation.

The exposure of the device 20 is controlled by the implanted knob 16 in the delivery system handle 18.

It allows for the routing of the guidewire and the actuation wire within its structure and within the central cavity 6 of the device 20, the guidewire being used to guide the device 20 to the target defect, and the actuation wire being used to adjust the length of the device 20.

It includes the plurality of mechanisms for inflating and deflating the implant from the inflation port 19 of the balloon 5 in the handle 18.

It features a steerable design to achieve good positioning of the occlusion device 20 in the cardiac defect, controlled by a steering knob 15, which includes a steering limiter within the delivery system handle 18. This steerability will allow for anterograde approaches from the venous groin to the inferior vena cava, to the right atrium, and to the left atrium, or retrograde approaches from the arterial groin to the left ventricle, and will allow the device 20 to be implanted using any technique known in the art.

In another configuration, the implanted catheter 14 is elastic rather than steerable. The balloon 5 implant is a fully compliant balloon implant, wherein the balloon 5 changes its radial and longitudinal shape percentages when the pressure and/or fluid volume in the balloon increases to above the pressure and/or volume required for the balloon to achieve its minimum target shape.

The balloon 5 can be made of any suitable biocompatible material, including polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), and polydioxanone (PDO or PDS).

The frame includes the distal end 10 and proximal end 4 discs and the plurality of stents 9, 11, 12 within the balloon 5 embodiment. The frame has multiple deformable plastic or metal properties and can be made of any other suitable biocompatible material, including stainless steel, titanium, nickel-titanium alloys, tantalum, gold, platinum-iridium, tungsten, and alloys of any of the above metals, including platinum-iridium alloys, cobalt-chromium alloys, nickel-titanium alloys, and nickel-titanium-platinum alloys. Alternatively, the frame can be made of polymers, including polyesters and polycarbonate copolymers, and any metal or polymer capable of deforming soft plastics, or combinations of polymers and metals. Multiple suitable materials include multiple biodegradable materials that are also biocompatible, meaning materials that undergo degradation or decomposition into multiple non-essential compounds as part of a normal biological process. A variety of suitable biodegradable materials include polylactic acid, polyglycolic acid (PGA), collagen or other connective proteins or natural materials, polycaprolactone, hyaluronic acid, adhesive proteins, copolymers of these materials, and complexes and combinations thereof, as well as combinations of other biodegradable materials.

Depending on the necessary or appropriate use in cardiovascular defects of different sizes or other suitable areas of the body, the frame and balloon of the device 20 according to the invention can be manufactured in different sizes.

In the initial configuration of the device 20 and the implanted catheter 14, in order to allow the device to be introduced into the patient's body, the device 20 is pre-installed without expansion within the implanted catheter 14, and the entire assembly is sterilized.

List of reference numerals

1 connection

2 Locking mechanisms

3 inflation ports

4 Proximal disks

5 balloons

6 Foldable balloon cavity

7. Guidewire cavity

8 Locking Lines

9 single internal pillars

10 Distal Disks

More than 11 external pillars

12 single external pillars

13 Ratchet Mechanism

14 Implanted catheters

15. Steering knob

16. Implantable advance and release knobs

17-Disc Actuated Knob

18 Transport System Handles

19 balloon inflation ports

20 sealing devices

105a distal guide opening

105b proximal guide opening

106 guidewire

107 catheter device

Claims (10)

1. An occluder device (20) for closing a cardiovascular defect or a gap between a medical device and adjacent body tissue, characterized in that: the occluder device comprises: A compliant balloon (5) defines a fluid-tight balloon cavity and is provided with a balloon channel (7) forming a longitudinal passage from a proximal side (B2) to a distal side (B1) of the balloon (5). The balloon (5) includes a fluid port (3) for filling a fluid into the balloon cavity and draining the fluid from the balloon cavity. A tip element (10) is disposed at the distal side of the balloon (5); a base (4) is disposed at the proximal side of the balloon (5); and a connecting tool comprising a plurality of connecting struts and a single internal connecting strut (9), the plurality of connecting struts being disposed in a cage-like manner outside the balloon (5) and connected to the tip element and the base, the internal connecting strut (9) being disposed within the balloon channel (7), the tip element and the base each having a guide opening (105a, 105b) coaxial with the balloon channel (7) to slidably accommodate a guidewire (106) for the device within the balloon channel; An elongated actuator is configured to slide longitudinally within the balloon channel (7) and is releasably connected to the tip element (10), and is also longitudinally slidable relative to the base (4); Multiple locking tools (2, 13) are used to maintain a predetermined distance between the tip element (10) and the substrate (4); and A proximal connector tool (1) for releasably connecting the occluder device (20) to a corresponding distal connector tool of a catheter device (107). 2. The occluder device as claimed in claim 1, characterized in that: the compliant balloon (5) is made of a compliant material selected from polycaprolactone, polyglycolic acid, polylactic acid and polydioxanone. 3. The occluder device as claimed in claim 1 or 2, characterized in that: the plurality of locking tools are configured as a ratchet mechanism, thereby allowing the predetermined distance between the tip element (10) and the base (4) to be selected from a range of distances. 4. The occluder device as claimed in claim 1 or 2, wherein the elongated actuator is configured as a uniform movement line. 5. The plugging device as claimed in claim 1 or 2, characterized in that: when the fluid port is not connected to a corresponding fluid transfer system (19), the fluid port (3) is configured as an automatic shut-off valve. 6. The occluder device as claimed in claim 1, wherein the base (4) comprises a disk. 7. The occlusion device as claimed in claim 6, wherein the disk is deformable. 8. The occluder device as claimed in claim 1, characterized in that: the balloon (5) is shaped such that, when the balloon cavity is filled with the fluid, the distal side (B1) and the proximal side (B2) of the balloon (5) have a tapered shape. 9. The occluder device as claimed in claim 1, wherein the fluid port (3) is disposed on an outer surface of the balloon (5) for filling the balloon cavity with fluid and draining it from the balloon cavity. 10. An occluder system, characterized in that: the occluder system comprises: an occluder device (20) according to claim 1, and a catheter device (107) cooperating with the occluder device; the catheter device comprises: an implanted catheter fitting (14) connected to an operating handle, the implanted catheter fitting (14) including a longitudinal passage for a guidewire (106); a distal connector tool for releasably connecting the catheter device (107) to the correspondingly configured proximal connector tool (1) of the occluder device (20); and a fluid transfer system (19) releasably connected to the fluid port (3) of the occluder device (20).