Assembly-type device for treatment of tricuspid regurgitation
11564796 · 2023-01-31
Assignee
Inventors
Cpc classification
A61F2220/0008
HUMAN NECESSITIES
A61F2/246
HUMAN NECESSITIES
A61F2250/0003
HUMAN NECESSITIES
A61F2210/0014
HUMAN NECESSITIES
International classification
Abstract
An assembly-type device for the treatment of tricuspid regurgitation is proposed. The assembly-type device includes: a fixing member for the pulmonary artery, the fixing member installed in the pulmonary artery; a connecting tube provided with a connecting tube lumen formed therein to be movable along a connecting wire; an assembly part provided with a first assembly coupled to a lower end of the fixing member for the pulmonary artery and a second assembly coupled to an upper end of the connecting tube, wherein the fixing member for the pulmonary artery and the connecting tube are assembled together; a fixing member for inferior vena cava, the fixing member coupled to a lower end of the connecting tube and installed in the inferior vena cava; and a blocking part coupled to one side of the connecting tube and obliquely passing through a tricuspid valve to block an orifice of the tricuspid valve.
Claims
1. A catheter device comprising: a distal fixing member configured for anchoring within the pulmonary artery; a connecting tube provided with a connecting tube lumen formed therein to be movable along a connecting wire; an assembly part provided with a first assembly coupled to a lower end of the distal fixing member and a second assembly coupled to an upper end of the connecting tube, whereby the distal fixing member and the connecting tube are coupled together; a proximal fixing member configured for anchoring within the inferior vena cava, the proximal fixing member being coupled to a lower end of the connecting tube; and a blocking part coupled to one side of the connecting tube; wherein the connecting tube has a distal bend with a first predetermined curvature at a location distal to the blocking part, wherein the first predetermined curvature is oriented in a first direction; wherein the connecting tube further has a proximal bend with a second predetermined curvature at a location proximal to the blocking part, wherein the second predetermined curvature is oriented in a second direction.
2. The device of claim 1, wherein a first screw thread is formed on an inner circumferential surface of the first assembly, and a second screw thread is formed on an outer circumferential surface of the second assembly, wherein the second screw thread corresponds with the first screw thread so that the first assembly and the second assembly are engaged with each other.
3. The device of claim 1, wherein the first assembly is spherical in shape, and the second assembly is an elastic tongs having elasticity, and in a shape of the tongs surrounding the first assembly, and wherein the second assembly is unfolded along an outer surface of the first assembly when the second assembly is pushed toward the first assembly, and then, is returned to an original state by the elasticity.
4. The device of claim 1, wherein the first assembly is provided with a fastening groove formed on a side surface thereof, and the second assembly is provided with a fastening protrusion formed on a side surface thereof, and wherein the fastening protrusion is inserted into the fastening groove when the second assembly is pushed toward the first assembly so that the first assembly and the second assembly is assembled together.
5. The device of claim 1, further comprising: a connecting wire assembly part comprising a first connecting wire assembly coupled to one side of the first assembly and provided with a screw thread formed on an inner circumferential surface thereof; and a second connecting wire assembly coupled to an upper end of the connecting wire and provided with a screw thread corresponding to the screw thread formed in the first connecting wire assembly on an outer circumference thereof, wherein the connecting wire assembly part is assembled in a screw-type engagement, and is disassembled by rotating the connecting wire.
6. The device of claim 1, wherein the distal fixing member and the proximal fixing member have a radial structure.
7. The device of claim 1, wherein the distal fixing member and the proximal fixing member are configured as a ribbon shape.
8. The device of claim 1, wherein the blocking part comprises: a supporting wire having both ends thereof coupled to the connecting tube; and a blocking membrane having one side thereof fixed to the connecting tube and supported by the supporting wire.
9. The device of claim 1, wherein the blocking part is a blocking balloon in a form of a balloon that may be expanded or contracted, and wherein the blocking part further comprises: a balloon tube having an upper end thereof connected to and communicated with the blocking balloon; and a balloon-adjusting hub connected to another end of the balloon tube and operable for expanding or contracting the blocking balloon.
10. The device of claim 1, wherein the blocking part comprises: a ring-shaped wire installed for the connecting tube to be passed through and provided with a central axis formed obliquely to the connecting tube, and a blocking membrane connecting the connecting tube and the ring-shaped wire to each other.
11. The device of claim 1, further comprising a sheath tube having a sheath lumen; wherein the catheter device is inserted through the sheath lumen; wherein the distal fixing member is in a folded configuration inside the sheath lumen; wherein the distal fixing member unfolds when exiting out of the sheath lumen.
12. The device of claim 1, wherein the second direction is different from the first direction.
13. The device of claim 12, wherein the second direction is opposite from the first direction.
14. The device of claim 13, the proximal bend is mirror symmetrical to the distal bend.
15. The device of claim 1, wherein the connecting tube consists of only a single bend proximal to the blocking part, wherein said single bend is the proximal bend.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1)
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(3)
(4)
(5)
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DETAILED DESCRIPTION OF THE INVENTION
(9) 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.
(10) Hereinafter, the preferred exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings.
(11) An assembly-type device for a treatment of tricuspid regurgitation according to the present invention is a device in which components are assembled in a patient's body, and the position of a blocking part is easily adjusted according to the patient, thereby treating tricuspid regurgitation by blocking an orifice formed by incomplete closing of the tricuspid valve.
(12)
(13) Referring to
(14) First, referring to the fixing member for the pulmonary artery 30 according to the preferred exemplary embodiment of the present invention, the fixing member for the pulmonary artery 30 is installed in the pulmonary artery, is provided with a lower end thereof coupled to the assembly part 70, and has a radial structure.
(15) The fixing member for the pulmonary artery 30 may 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.
(16) The self-expandable stent refers to a stent capable of self-expansion with a frame made of Nitinol alloy.
(17) The lower end of the fixing member for the pulmonary artery 30 is coupled to the assembly part 70, and the upper end thereof unfolds radially upward and is inserted in a folded state when inserted into a sheath tube 40 for insertion into the patients' body. When reaching a target position of the pulmonary artery and protruding out of the sheath tube 40, the fixing member for the pulmonary artery 30 is unfolded and returned to its original state, and is installed in the pulmonary artery.
(18) The sheath tube 40 has the same shape as a general purpose catheter and is provided with a lumen into which the assembly-type device for the treatment of tricuspid regurgitation is inserted.
(19) The sheath tube 40 is formed long enough to be operated at a position of the patient's thigh by an operator. The material of the sheath tube 40 may be synthetic resin material such as rubber, soft plastic, etc., and is made of a material having high flexibility and excellent resilience to be movable according the heartbeat.
(20) The assembly part 70 coupled to the lower end of the fixing member for the pulmonary artery 30 may have a polygonal column shape such as a triangular column shape, a square column shape, or the like, but preferably has a cylindrical shape.
(21) Detailed description of the assembly part 70 will be described with reference to
(22)
(23) The first assembly 72 has a shape (II) recessed upwardly from the bottom surface thereof, the top surface thereof is closed and the bottom surface thereof is open. A screw thread is famed on the inner circumferential surface of the first assembly 72.
(24) In addition, the connecting wire assembly part 90 is coupled to the inner upper surface of the recessed space of the first assembly 72. One end of the connecting wire 80 is coupled to the bottom surface of the connecting wire assembly part 90, and a detailed description of the connecting wire assembly part 90 will be described in more detail with reference to
(25) The second assembly 74 is coupled to the upper end of the connecting tube 20, wherein, on the outer circumferential surface of the second assembly, a screw thread corresponding to the screw thread formed on the first assembly 72 is formed, and the inside thereof has a cavity so that the connecting wire assembly part 90 and the connecting wire 80 are inserted.
(26) The diameter of the second assembly 74 is preferably smaller than the diameter of the first assembly 72. Thus, the second assembly 74 is inserted into the recessed space of the first assembly 72 and engaged with each other. First, the diameter of the first assembly 72 inserted into the patient's body is to be greater than the diameter of the second assembly 74, so that the treatment is more convenient.
(27) The first assembly 72 and the second assembly 74 is made of a rigid metal (i.e., stainless steel, nylon coating on the metal) or plastics to facilitate to be engaged with each other.
(28) In the case when the first assembly 72 and the second assembly 74 are engaged with each other more than half, the assembly part 70 has a binding power with such a degree that disassembly thereof by the movement of the heart is prevented.
(29) Therefore, the second assembly 74 is further rotatable after being coupled with the first assembly 72. At this time, it is desirable that the direction of rotation of the second assembly 74 is in the direction that may be better coupled to the assembly part 70. As the operator moves the connecting tube 20 to the left and right, the second assembly 74 is rotated and the blocking part 10 coupled to the connecting tube 20 is moved to the left and right, so that the position of the blocking part 10 is adjusted.
(30) Referring back to
(31) The connecting tube 20 may be synthetic resin material such as rubber, soft plastic, etc., and is made of a material having high flexibility and excellent resilience to be movable according to the heartbeat.
(32) The second assembly 74 is coupled to the upper end of the connecting tube 20, and the fixing member for the inferior vena cava 60 is coupled to the lower end thereof.
(33) The fixing member for the inferior vena cava 60 is to be installed in the inferior vena cava, wherein the lower end thereof is coupled along the outer circumferential surface of the connecting tube 20 at the lower end of the connecting tube 20, and the upper end thereof is formed in a radial structure which is unfolded upward of the connecting tube 20.
(34) The fixing member for the inferior vena cava 60 may 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.
(35) The self-expandable stent refers to a stent capable of self-expansion with a frame made of Nitinol alloy.
(36) The fixing member for the inferior vena cava 60 is inserted in a deformed shape when inserted into the sheath tube 40 for insertion into the patient's body, is returned to its original state when the sheath tube 40 is removed, and is installed to the inferior vena cava.
(37) The blocking part 10 blocks the orifice by obliquely passing through the orifice of the tricuspid valve, and is coupled to one side of the connecting tube 20.
(38) The blocking part 10 includes a supporting wire 14 having both ends thereof coupled to the connecting tube 20, and includes a blocking membrane 12 having one side thereof fixed to the connecting tube 20 and supported by the supporting wire 14.
(39) When inserted into the sheath tube 40, the blocking part 10 is unfolded and inserted in a form surrounding the outer circumferential surface of the connecting tube 20. Various exemplary embodiments of the blocking part 10 will be described in detail with reference to
(40)
(41) The first connecting wire assembly 92 is preferably coupled to the inner upper surface of the recessed part of the first assembly part 72 as described above, but is not limited thereto.
(42) The first connecting wire assembly 92, having a shape (II) recessed upward from the lower surface thereof, has the same shape as the first assembly 72. A screw thread is formed on the inner circumferential surface of the recessed part.
(43) The second connecting wire assembly 94 is provided with a screw thread formed at a position on the outer circumferential surface thereof and corresponding to a screw thread of the first connecting wire assembly 92. The first connecting wire assembly 92 and the second connecting wire assembly 94 are engaged with each other.
(44) The connecting wire 80 has an upper end thereof bonded to the lower surface of the second connecting wire assembly 94, and a lower end thereof formed long enough to be positioned outside of the patient's body through the thigh. The connecting wire 80 is composed of the same material as a guidewire 50, and is made of synthetic resin such as nylon, or metal wire (i.e., stainless steel, nylon coating on metal, etc.), and the like.
(45) The connecting wire 80 is rotated at a position outside the patient's body to enable the connecting wire assembly part 90 to be coupled or disassembled.
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(47) Referring to the assembly part 70 according to the another preferred exemplary embodiment of the present invention, the first assembly 72 is preferably formed in a spherical shape, and is composed of a rigid material such as metal or rigid plastic.
(48) The second assembly 74 has elasticity with a shape of a rounded tong to surround the first assembly 72. When the operator pushes toward the first assembly 72, the second assembly 74 unfolds along a rounded outer surface of the first assembly 72 from the lower end thereof. Then, when reaching the upper end of the first assembly 72, the second assembly 74 is returned to its original state by elasticity. The final coupling state is that the second assembly 74 is coupled to surround the entire first assembly 72.
(49) The coupling of the first assembly 72 and the second assembly 74 according to the another preferred exemplary embodiment of the present invention is not affected by the movement of the heart, but is rotatable to the left and right by the force exerted by the operator outside the patient's body. As the operator moves the connecting tube 20 to the left and right, the second assembly 74 is rotated to the left and right and the blocking part 10 coupled to the connecting tube 20 moves along the connecting tube 20, thereby the position of the blocking part 10 is capable of being adjusted.
(50) In this case, the first connecting wire assembly 92 is coupled to the lower surface of the first assembly 72. The shapes of the connecting wire assembly part 90 and the connecting wire 80 are the same as described in detail with reference to
(51)
(52) Referring to
(53) The second assembly 74, having a cylindrical shape, is preferably provided to have a diameter smaller than the diameter of the first assembly 72, and includes a fastening protrusion 74a provided at a position on one side of an outer circumferential surface thereof. The fastening protrusion 74a is elastic and has a lower part thereof provided thicker than the upper part thereof.
(54) When the second assembly 74 is pushed upward to insert the second assembly 74 into the first assembly 72, the fastening protrusion 74a is pressed. Then, when the fastening protrusion 74a reaches the fastening groove 72a, the fastening protrusion 74a is returned to the unpressed state again. Thus, the assembly part 70 is assembled by engaging the fastening protrusion 74a with the fastening groove 72a.
(55) The fastening protrusion 74a is not affected by the movement of the heart, and the coupling of the assembly part 70 is not disassembled. The fastening protrusion 74a is movable in the width direction within the fastening groove 72a by a force exerted by the operator outside the patient's body. As the operator moves the connecting tube 20 to the left and right, the second assembly 74 may be rotated to the left and right to adjust the position of the blocking part 10.
(56) In addition, the second assembly 74 has a cavity therein, so that the connecting wire assembly part 90 or the connecting wire 80 is inserted. The first connecting wire assembly 92 is coupled to the upper surface of the recessed part of the first assembly 72, and the shape thereof is the same as described above in
(57)
(58) Referring to
(59) The self-expandable stent refers to a stent capable of self-expansion with a frame made of Nitinol alloy.
(60) When inserted into the sheath tube 40, the fixing member for the pulmonary artery 30 and the fixing member for the inferior vena cava 60 are deformed, and when the sheath tube 40 is removed, each of the central parts thereof is returned to a ribbon shape with a convex center, and are respectively installed in the pulmonary artery and inferior vena cava.
(61)
(62) The blocking part 10 of
(63) The material of the supporting wire 14 may be synthetic resin such as nylon or metal wire (i.e., stainless steel, nylon coating on metal), and the like. The blocking membrane 12 has softness but is not easily torn, uses a material suitable for human body, and preferably is made of medical polyurethane, polyolefin, silicone, e-PTFE, PTFE, and the like. The blocking membrane 12 is made of one, two or more layers thereof.
(64) When inserted into the sheath tube 40, the blocking part 10 of
(65) The blocking part 10 of
(66) When the operator adjusts the balloon-adjusting hub 18 outside the patient's body and supplies air to the blocking balloon 16 through the balloon tube 17, the blocking balloon 16 is inflated. Also, when the air is removed, the blocking balloon 16 is reduced in size. The balloon-adjusting hub 18 injects air, oxygen, and form, and the supply amount is adjusted by the operator outside the patient's body, and thus the size of the blocking balloon 16 is changed in size. The size of the blocking balloon 16 may be adjusted according to the size of the orifice formed due to the incomplete closing of the tricuspid valve when the heart contracts.
(67) The blocking part 10 of
(68)
(69) Referring to
(70) Thereafter, the sheath tube 40 is inserted into the patient's body along the guidewire 50.
(71) As shown in
(72) In this case, the lower end of the connecting wire 80 is positioned outside the patient's body and may be adjusted by the operator. By pushing the connecting wire 80 upwards, the fixing member for the pulmonary artery 30 is unfolded and installed in the pulmonary artery.
(73) Next, as shown in
(74) At this time, the connecting wire 80 is inserted into the connecting tube 20 and moves into the patient's body along the connecting wire 80.
(75) The blocking part 10 and the fixing member for the inferior vena cava 60 are inserted into the sheath tube 40 in a deformed state by being inserted into a general purpose catheter (not shown), and the general purpose catheter (not shown) is provided long to be operable at the thigh.
(76) At this time, the sheath tube 40 is removed, and the blocking part 10 and the fixing member for the inferior vena cava 60, which are inserted into the general purpose catheter (not shown), may be inserted along the connecting wire 80.
(77) By rotating or pushing the general purpose catheter (not shown) to assemble the second assembly 74 with the first assembly 72, the assembly-type device for the treatment of tricuspid regurgitation according to the present invention is made as one device. The general purpose catheter (not shown) is removed outside the patient's body in this stage.
(78) Thereafter, as shown in
(79) The position of the blocking part 10 is adjusted to be positioned in the orifice of tricuspid valve, which varies depending on different patients, and then, by pulling the sheath tube 40 downward, the fixing member for the inferior vena cava 60 is unfolded and fixed to the inferior vena cava.
(80) Finally, the sheath tube 40 is completely removed from the patient's body as shown in
(81) As described above, the assembly-type device for the treatment of tricuspid regurgitation according to the present invention is assembled in the patient's body, and the position of the blocking part is capable of being adjusted to be positioned precisely in the orifice of the tricuspid valve, whereby it is possible to perform customized treatment according to the patient.
(82) Although the exemplary embodiments 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.