Patent ID: 12193653

DESCRIPTION OF THE REFERENCE NUMERALS IN THE DRAWINGS

14: supporting wire16: blocking balloon17: balloon tube18: balloon-adjusting hub19: ring-shaped wire20: connecting tube22: guidewire-guiding lumen30: fixing member for the pulmonary artery32: fixture for the pulmonary artery34: fixing member body for the pulmonary artery36: fixing-member-connecting wire40: sheath tube50: guidewire60: fixing member for the inferior vena cava62: fixture for the inferior vena cava64: fixing member body for the inferior vena cava66: protruding hook for the inferior vena cava100: device for performing tricuspid regurgitation operationS10: step of moving guidewireS20: step of moving device for performing tricuspid regurgitation operationS30: step of fixing device for performing tricuspid regurgitation operation

BEST MODE

Benefits and features of the present invention, and methods of accomplishing the same may be understood more readily by reference to the following detailed description of exemplary embodiments and the accompanying drawings. However, the present disclosure may be embodied in many different forms, and should not be construed as being limited to the exemplary embodiments set forth herein. Rather, these exemplary embodiments are provided so that this disclosure will be thorough and complete and will fully convey the concept of the invention to those skilled in the art, and the present disclosure will only be defined by the appended claims.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings. Regardless of the drawings, the same reference numbers refer to the same components, and “and/or” includes each and every combination of one or more of the items mentioned.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In this description, the singular also includes the plural unless specifically stated otherwise in the phrase. As used herein, “comprises” and/or “comprising” does not exclude the presence or addition of one or more other components in addition to the mentioned components.

Unless otherwise defined, all terms (including technical and scientific terms) used in the present description may be used in a sense that can be commonly understood by those skilled in the art. In addition, the terms defined in the commonly used dictionaries are not comprehensively or excessively interpreted unless they are specifically defined clearly.

Hereinafter, preferred exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings.

FIG.1is a perspective view of a device for performing tricuspid regurgitation operation according to a preferred exemplary embodiment of the present invention.

Referring toFIG.1, the device for performing tricuspid regurgitation operation100according to the present invention fundamentally includes a fixing member for the pulmonary artery30, a fixing member for the inferior vena cava60, a connecting tube20, and a blocking part10.

The fixing member for the pulmonary artery30is fixed to the pulmonary artery and includes: at the lower part thereof, a fixing member body for the pulmonary artery34; and a plurality of fixtures for the pulmonary artery32radially coupled on the upper surface of the fixing member body for the pulmonary artery34.

The fixing member for the inferior vena cava60is fixed to the inferior vena cava and includes: at the lower part thereof, a fixing member body for the inferior vena cava64; a plurality of fixtures for the inferior vena cava62radially coupled to the upper surface of the fixing member body for the inferior vena cava64; and a protruding hook for the inferior vena cava66provided at a position on the lower surface of the fixing member body for the inferior vena cava64.

The fixture for the pulmonary artery32and the fixture for the inferior vena cava62may be made of a metal wire (i.e., stainless steel, nylon coating on metal, etc.), and is composed of a shape memory alloy, an elastic body, or a self-expandable stent.

The fixing member body for the pulmonary artery34and the fixing member body for the inferior vena cava64are configured in a cylindrical shape having a hole formed on a central axis thereof and have an inner circumferential surface closely coupled to an outer circumferential surface of the connecting tube20.

The connecting tube20is provided with a guidewire-guiding lumen22formed therein to be movable along a guidewire50.

The connecting tube20may be composed of synthetic resin such as rubber, soft plastic, and the like having softness and high ductility and made of a material having excellent flexibility and resilience to be movable according to the heartbeat.

The fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60are installed in the same direction. One end of the connecting tube20is fitted to the lower side of the fixing member body for the pulmonary artery34, and the other end of the connecting tube20is fitted to the upper side of the fixing member body for the inferior vena cava64.

In addition to that shown inFIG.1, it is apparent that the fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60may be fitted to the connecting tube20, regardless of distinguishing the upper side or the lower side thereof.

The protruding hook for the inferior vena cava66can easily remove the device for performing tricuspid regurgitation operation100in the case when the device is needed to be removed from a patient's body. More particularly, in order to remove the device for performing tricuspid regurgitation operation100, by inserting a wire (not shown) having a hook shape at the upper end thereof to hook and pull the protruding hook for the inferior vena cava66, the device for performing tricuspid regurgitation operation100may be easily removed from the patient's body.

The device for performing tricuspid regurgitation operation100further includes a sheath tube40having a lumen formed therein to move into the patient's body. Each of the fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60is inserted into the sheath tube40in a folded state when moved into the patient's body, is returned to its original state and unfolded in a radial manner when the sheath tube40is removed, and is respectively fixed to the pulmonary artery and the inferior vena cava. The device for performing tricuspid regurgitation operation100will be described in detail with reference toFIGS.10and11.

The blocking part10is a part that blocks an orifice formed due to incomplete closing of the tricuspid valve, is coupled to one side of the connecting tube20, and is inserted obliquely into the tricuspid valve.

The blocking part10is made of a blocking membrane12or a blocking balloon16, and the like. InFIG.1, the blocking membrane12is illustrated. The blocking membrane12has softness, but is not easily torn, and is made of a material suitable for human body such as medical polyurethane, polyolefin, silicone, e-PTFE, PTFE, and the like.

The blocking part10includes a supporting wire14for holding the shape of the blocking membrane12. InFIG.1, both ends of the supporting wire14are fixed to the connecting tube20, but are not necessarily limited thereto, and it is apparent that neither both sides nor one side of the supporting wire14may not be fixed to the connecting tube20.

As shown inFIG.1, the blocking membrane12may have a circular shape as well as a semi-circular shape, and a plurality of connecting tubes20may also be installed to adjust the position or to fix the shape of the blocking membrane12having the circular shape.

In addition, the material of the supporting wire14may be a synthetic resin wire such as nylon or a metal wire (i.e., stainless steel, nylon coating on metal), and the like. The supporting wire14may be a single wire, and may also be a form of wire made by twisting a plurality of thin wires.

The blocking membrane12may connect the connecting tube20and the supporting wire14to each other in one layer, but the blocking membrane12may be in two layers and configured to be a form where the supporting wire14is inserted into the blocking membrane12.

FIG.2is a perspective cross-sectional view for describing a state after the treatment using the device for performing tricuspid regurgitation operation ofFIG.1.

Referring toFIG.2, a state is illustrated, wherein the device for performing tricuspid regurgitation operation100according to the preferred exemplary embodiment of the present invention is inserted into the heart of the patient. To fix the device for performing tricuspid regurgitation operation100, the fixing member for the pulmonary artery30is installed in the pulmonary artery, and the fixing member for the inferior vena cava60is installed in the inferior vena cava. The blocking part10passes obliquely through the orifice of the tricuspid valve to block the orifice to treat the tricuspid regurgitation.

Therefore, the device for performing tricuspid regurgitation operation100according to the present invention may be moved through the inferior vena cava, the tricuspid valve, and the pulmonary artery in sequence to position the blocking part10in the orifice of the tricuspid valve. Also, the blocking part10may be passed obliquely through the orifice of the tricuspid valve so as to stably block the orifice of the tricuspid valve. In addition, the fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60are respectively fixed to the pulmonary artery and the inferior vena cava. Accordingly, the blocking part is not affected by the movement of the diaphragm during breathing, so the positional change of the blocking part is less likely to happen even as time passes.

FIG.3is a perspective view showing another exemplary embodiment of a fixing member for the pulmonary artery and a fixing member for the inferior vena cava in a device for performing tricuspid regurgitation operation ofFIG.1.

Referring toFIG.3, at each of the lower parts, the fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60includes: a fixing member body for the pulmonary artery34and a fixing member body for the inferior vena cava64; and a plurality of fixtures for the pulmonary artery32and a plurality of fixtures for the inferior vena cava62, respectively coupled in a radial shape to the fixing member body for the pulmonary artery34and the fixing member body for the inferior vena cava64. In addition, the fixing member for the pulmonary artery30includes the fixing-member-connecting wire36for connecting the fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60to each other. The connecting tube20and the blocking part10are the same as those inFIG.1.

The fixing member body for the pulmonary artery34and the fixing member body for the inferior vena cava64are formed in a ring shape. One end of the fixing-member-connecting wire36is coupled to the fixing member body for the pulmonary artery34and inserted into the connecting tube20, and the other end thereof is coupled to the fixing member body for the inferior vena cava64. The fixing-member-connecting wire18may be made of the same material as the supporting wire42.

Each of the fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60is inserted in a folded state when inserted into the sheath tube40in order to be moved into the patient's body, and is returned to its original state and unfolded in a radial manner when the sheath tube40is removed, and then, is respectively fixed to the pulmonary artery and the inferior vena cava.

In this case, the fixture for the pulmonary artery32and the fixture for the inferior vena cava62may not be inserted into the sheath tube40, but may be inserted into the connecting tube20.

FIG.4is a perspective view showing yet another exemplary embodiment of a fixing member for the pulmonary artery and a fixing member for the inferior vena cava in a device for performing tricuspid regurgitation operation ofFIG.1.

Referring toFIG.4, yet another fixing member for the pulmonary artery30and fixing member for the inferior vena cava60includes: a fixture for the pulmonary artery32and a fixture for the inferior vena cava62, respectively formed of a wire having a ribbon shape with a convex central part; and the fixing member body for the pulmonary artery34and the fixing member body for the inferior vena cava64, respectively coupled to one end of the fixture for the pulmonary artery32and the fixture for the inferior vena cava62. The connecting tube20and the blocking part10are the same as those inFIG.1.

The fixing member body for the pulmonary artery34and the fixing member body for the inferior vena cava64are configured in a cylindrical shape having a hole in a central axis thereof, and each have an inner circumferential surface closely coupled to the outer circumferential surface of the connecting tube20.

The fixture for the pulmonary artery32and the fixture for the inferior vena cava62, respectively formed of a wire having a convex ribbon shape, may be made of a shape memory alloy, an elastic body, or a self-expanding stent. The fixing member body for the pulmonary artery34is fitted to one end of the connecting tube20, and the fixing member body for the inferior vena cava64is fitted to the other end of the connecting tube20.

The device for performing tricuspid regurgitation operation100ofFIG.4is inserted into the sheath tube40when moved into the patient's body. Also, the fixture for the pulmonary artery32and the fixture for the inferior vena cava62are inserted with the convex center pressed in so as to be inserted into the sheath tube40, and when the sheath tube40is removed, each fixture is returned to the ribbon shape having the convex central part and respectively fixed to the pulmonary artery and the inferior vena cava.

FIG.5is a perspective view showing the yet another exemplary embodiment of the fixing member for the pulmonary artery and the fixing member for the inferior vena cava in the device for performing tricuspid regurgitation operation ofFIG.1.

Referring toFIG.5, the fixing member for the pulmonary artery30and fixing member for the inferior vena cava60includes: a fixture for the pulmonary artery32and an fixture for the inferior vena cava62, respectively formed of a wire having a ribbon shape with a convex central part; and a fixing member body for the pulmonary artery34and a fixing member body for the inferior vena cava64, respectively having a ring shape and respectively coupled to one end of the fixture for the pulmonary artery32and one end of the fixture for the inferior vena cava62. In addition, the fixing member for the pulmonary artery30includes the fixing-member-connecting wire36for connecting the fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60to each other.

In addition, as one end of the fixing-member-connecting wire36is coupled to the fixture for the pulmonary artery32and inserted into the connecting tube20by passing through the central axis of the fixing member body for the pulmonary artery34, the other end thereof passes through the central axis of the fixing member body for the inferior vena cava64and is coupled to the fixture for the inferior vena cava62. The connecting tube20and the blocking part10are the same as those inFIG.1.

The fixture for the pulmonary artery32and the fixture for the inferior vena cava62are inserted in a flat ribbon shape into the sheath tube40in order to be moved into the patient's body. When the sheath tube40is removed, the fixing member body for the pulmonary artery34and the fixing member body for the inferior vena cava64, or the fixture for the pulmonary artery32and the fixture for the inferior vena cava62are pushed forward by the sheath tube40. Accordingly, the fixture for the pulmonary artery32and the fixture for the inferior vena cava62become a ribbon shape having a convex central part, and are respectively fixed to the pulmonary artery and the inferior vena cava.

In this case, the fixture for the pulmonary artery32and the fixture for the inferior vena cava62may not be inserted into the sheath tube40, but may be inserted into the connecting tube20.

Different forms other than the fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60of the above-described form are also possible.

FIG.6is a perspective view of a device for performing tricuspid regurgitation operation according to another preferred exemplary embodiment of the present invention, andFIG.7is a perspective cross-sectional view for describing a state after the treatment using the device for performing tricuspid regurgitation operation ofFIG.6.

Referring toFIGS.6and7, the device for performing tricuspid regurgitation operation100according to the another preferred exemplary embodiment of the present invention includes: the fixing member for the pulmonary artery30fixed to the pulmonary artery; the fixing member for the inferior vena cava60fixed to the inferior vena cava; the connecting tube20connecting the fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60to each other; and the blocking part10coupled to one side of the connecting tube20.

The blocking part10includes: a blocking balloon16having a balloon shape capable of expanding or contracting; a balloon tube17having one end thereof coupled to and communicated with the blocking balloon16; and a balloon-adjusting hub18having the other end thereof coupled to the balloon tube17and supplying air, oxygen, foam, and the like to the blocking balloon16.

The balloon-adjusting hub18is installed outside the patient's body, and the blocking balloon16may be expanded or contracted by air, oxygen, foam, and the like supplied from the balloon-adjusting hub18.

The blocking balloon16is expanded by receiving air, oxygen, form, and the like from the balloon-adjusting hub18so as to block the orifice of the tricuspid valve, and the size of the blocking balloon16is adjustable according to the size of the orifice.

The fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60may be of the form described above with reference toFIGS.3to5as well as the form shown inFIGS.6and7.

FIG.8is a perspective view of a device for performing tricuspid regurgitation operation according to yet another preferred exemplary embodiment of the present invention, andFIG.9is a perspective cross-sectional view for describing a state after the treatment using the device for performing tricuspid regurgitation operation ofFIG.8.

Referring toFIGS.8and9, the device for performing tricuspid regurgitation operation100according to the yet another preferred exemplary embodiment of the present invention includes: the fixing member for the pulmonary artery30fixed to the pulmonary artery; the fixing member for the inferior vena cava60fixed to the inferior vena cava; the connecting tube20connecting the fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60to each other; and the blocking part10coupled to an outer circumferential surface of the connecting tube20.

The fixing member for the pulmonary artery30and the fixing member for the inferior vena cava60may be of the form described above with reference toFIGS.3to5as well as the form shown inFIGS.8and9.

The blocking part10is installed so that the connecting tube20passes through thereof, and includes a ring-shaped wire19having a central axis obliquely formed on the connecting tube20, and a blocking membrane41connecting the connecting tube20and the ring-shaped wire19to each other.

The ring-shaped wire19is positioned in parallel to the tricuspid valve inclined at a certain angle, due to a central axis obliquely formed to the connecting tube20. Thus, the orifice of the tricuspid valve may be effectively blocked.

Hereinafter, a process of treating tricuspid regurgitation using the device for performing tricuspid regurgitation operation100will be described.

FIG.10is a flow chart showing the treatment steps using the device for performing tricuspid regurgitation operation of the present invention, andFIG.11is a perspective cross-sectional view for describing a principle of treating tricuspid regurgitation by using the device for performing tricuspid regurgitation operation of the present invention.

Referring toFIGS.10and11, there are steps including: a step of moving guidewire S10; a step of moving device for performing tricuspid regurgitation operation S20; and a step of fixing device for performing tricuspid regurgitation operation S30. In addition, in order to move easily inside the patient's body, the device for performing tricuspid regurgitation operation100of the present invention further includes the guidewire50and the sheath tube40.

The step of moving guidewire S10is a step of inserting the guidewire50into the inferior vena cava, the tricuspid valve, and the pulmonary artery in sequence so that the device for performing tricuspid regurgitation operation100of the present invention may easily move into the patient's body. The movements of the wire and catheter in the patient's body may be observed through X-rays. In order for the guidewire50to safely pass through the tricuspid valve, a guidewire-guiding tube (not shown) having a lumen formed therein is additionally required. The guidewire-guiding tube (not shown) has a balloon or a pigtail-shaped locking means provided at the upper end thereof to pass through the safe zone of the tricuspid valve. The safe zone refers to a space free of leaflets of the tricuspid valve, subvalvular structures such as the chordae tendineae and the papillary muscles of the tricuspid valve, and the modulator band. The balloon or the pigtail-shaped locking means prevents the guidewire-guiding tube from being moved forward by being caught in the subvalvular structures and the moderator band when moving out of the safe zone. Therefore, the guidewire-guiding tube (not shown) is moved to the inferior vena cava, the safe zone of the tricuspid valve, and the pulmonary artery in sequence and the guidewire50is inserted into the guidewire-guiding tube and moves. When one end of the guidewire50moves up to the pulmonary artery, the guidewire-guiding tube is removed out of the patient's body. At this time, the device for performing tricuspid regurgitation operation100is inserted into the sheath tube40, and is prepared to move into the patient's body. The fixture for the pulmonary artery32and the fixture for the inferior vena cava62are inserted into the sheath tube40in a folded state, and the blocking part10is inserted into the sheath tube40in a wound state on the outer circumferential surface of the connecting tube20.

The step of moving device for performing tricuspid regurgitation operation S20is a step of moving the device for performing tricuspid regurgitation operation100into the patient's body by inserting the guidewire50into the guidewire-guiding lumen formed in the sheath tube40. The device for performing tricuspid regurgitation operation100inserted into the sheath tube40along the path where the guidewire50is inserted (i.e., the inferior vena cava, the tricuspid valve, and the pulmonary artery in sequence) is inserted into the patient's body. Once being positioned in the orifice of the tricuspid valve, the movement stops.

The step of fixing device for performing tricuspid regurgitation operation S30is a step of removing the guidewire50and the sheath tube40so as to fix the device for performing tricuspid regurgitation operation100to the pulmonary artery and the inferior vena cava. When the blocking part10is positioned by passing obliquely through the orifice of the tricuspid valve, the guidewire50is removed out of the patient's body. In addition, when the sheath tube40is also removed out of the patient's body, the fixture for the pulmonary artery32and the fixture for the inferior vena cava62, respectively formed of a shape memory alloy, an elastic body, or a self-expanding stent, are returned to the radial form, and thus the fixing member for the pulmonary artery30is fixed to the pulmonary artery and the fixing member for the inferior vena cava60is fixed to the inferior vena cava. In addition, the blocking part10, which is inserted into the sheath tube40in a wound state, is also returned to its original state, thereby treating tricuspid regurgitation by blocking the orifice formed by incomplete closing of the tricuspid valve.

Although the exemplary embodiment of the present invention have been described above with reference to the accompanying drawings, it will be understood that those skilled in the art to which the present invention pertains may implement the present invention in other specific forms without departing from the technical spirit or essential features thereof. Therefore, the exemplary embodiments described above are to be understood in all respects as illustrative and not restrictive.