External anchor delivery pressure measuring handle

Abstract

The present invention discloses an external anchor delivery and pressure measurement handle, comprising: a hollow handle shell; a force transmission lock tube axially movably disposed within the handle shell, having an axial passage for movably passing a tie rod and a distal end that can be connected to the locking structure of the external anchor; a pressure sensor disposed at the proximal end of the handle shell, the distal end of the pressure sensor abutting the proximal end of the force transmission lock tube for sensing cardiac pressure transmitted from the force transmission lock tube. The external anchor delivery and pressure measurement handle of the present invention has a simple structure, requiring only a force transmission lock tube to achieve the locking and unlocking functions of the external anchor locking structure, and also has a force measurement transmission function.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to an external anchor delivery pressure measuring handle. Background Art

[0002] Left ventricular aneurysm (LVA) is a common complication of myocardial infarction. It occurs when a coronary artery blockage causes ischemia and necrosis of part of the ventricular myocardium. The necrotic ventricular myocardium loses its contractile function, and during heart contraction, this necrotic area bulges outward, forming an aneurysm, also known as scar tissue. Due to compensatory effects, the heart continues to enlarge, leading to heart failure and pulmonary congestion.

[0003] Left ventricular volume reduction is a ventricular enhancement method used to address scar tissue in patients with ischemic cardiomyopathy after myocardial infarction. Patent application number 202210410403.8 provides a medical device for left ventricular volume reduction. Through the traction of an internal anchor in the right ventricle and an external anchor outside the left ventricle, the device pulls scar tissue closer to the ventricular septum, preventing it from bulging outward during cardiac contraction and improving cardiac contraction function.

[0004] The external anchor structure of currently available left ventricular volume reduction devices requires both an external anchor release mechanism and a mechanical pressure reading device. These two devices require two separate operations, making operation complex. Furthermore, the mechanical pressure reading device can only provide a rough estimate based on the on-device indicator scale, failing to accurately read the pressure value, thus compromising the final pressure measurement results. Summary of the Invention

[0005] The present invention addresses the technical problem of the prior art requiring the use of two sets of devices, a delivery device and a pressure mechanical reading device, and aims to provide an integrated external anchor delivery pressure measuring handle for a left ventricular volume reduction device. The handle adopts a pressure sensor method, which can read accurate pressure values ​​in real time, and integrates the delivery device and the pressure measuring device into a simple handle device.

[0006] The external anchor conveying pressure measuring handle of the present invention has:

[0007] A hollow stalk shell;

[0008] a force transmission lock tube axially movably disposed within the handle shell, having an axial passage for movably passing a tie rod and a distal end for connection to the locking structure of the outer anchor; the force transmission lock tube can lock and unlock the locking structure of the outer anchor and also has the function of transmitting cardiac pressure;

[0009] A pressure sensor is arranged at the proximal end of the handle shell, and the distal end of the pressure sensor abuts against the proximal end of the force transmission lock tube, for sensing the heart pressure transmitted from the force transmission lock tube.

[0010] Preferably, the external anchor delivery pressure measuring handle has:

[0011] A pair of delivery rods for delivering the outer anchor, wherein the delivery rods have proximal ends respectively connected to both sides of the distal end of the handle shell and a distal end that can be connected to the outer anchor.

[0012] Preferably, the external anchor delivery pressure measuring handle has:

[0013] A disengagement rod has an inner end fixed on the force transmission lock tube and an outer end protruding from the handle shell.

[0014] Preferably, the handle shell has a radial rod hole penetrating the shell, and the outer end of the dissociation rod can drive the force transmission lock tube to rotate radially and pass through the radial rod hole:

[0015] Preferably, the external anchor conveying pressure measuring handle has: two radial limit rings, which are respectively fixed on the distal end and the proximal section of the handle shell; the middle section and the proximal section of the force transmission lock tube are respectively axially movable and pass through the radial limit rings of the distal end and the proximal section of the handle shell, thereby limiting the radial displacement of the force transmission lock tube.

[0016] Preferably, the radial limiting ring is a linear bearing.

[0017] Preferably, the inner wall of the handle shell is provided with a distal convex ring, a middle convex ring and a proximal convex ring from the distal end to the proximal end respectively.

[0018] Preferably, the radial limit ring at the distal end of the handle shell is located between the distal face wall and the distal convex ring, the pressure sensor is located between the proximal convex ring and the proximal face wall, and the radial limit ring at the proximal section of the handle shell is located between the middle convex ring and the proximal convex ring.

[0019] Preferably, the external anchor delivery pressure measuring handle further comprises:

[0020] A compression spring, the distal end of the compression spring is connected to the inner wall of the handle shell, and the proximal end of the compression spring is connected to the force transmission lock tube, so that the distal end of the pressure sensor and the proximal end of the force transmission lock tube are continuously in abutment.

[0021] Preferably,

[0022] A middle convex ring is fixed on the inner wall of the middle section of the handle shell, and a fixed convex ring is fixed on the outer wall of the proximal section of the force transmission lock tube;

[0023] The distal end of the compression spring is connected to the middle convex ring on the inner wall of the handle shell, and the proximal end of the compression spring is connected to the fixed convex ring on the force transmission lock tube, so that the distal end of the pressure sensor and the proximal end of the force transmission lock tube are continuously in abutment.

[0024] Preferably, the proximal end of the handle shell is further connected to a tail button for fixedly connecting the proximal end of the tie rod.

[0025] Preferably, the distal end of the delivery rod has an anchor limiting groove or an anchor limiting protrusion.

[0026] Preferably, the outer surface of the handle shell has a display screen connected to the pressure sensor sensing signal and a plurality of buttons connected to the pressure sensor signal.

[0027] Preferably, a battery is provided in the handle shell and is electrically connected to the pressure sensor.

[0028] Preferably, axial flat grooves for observing the locking state of the outer anchor are cut on opposite sides of the distal end of the force transmission locking tube, and the axial flat grooves partially expose the axial channel.

[0029] Preferably, a radial groove for clamping the locking structure of the outer anchor is dug on the distal end surface of the force transmission locking tube.

[0030] Preferably, two tube limiting protrusions or two tube limiting grooves that can engage with the rotary cover of the locking structure are provided in the radial groove.

[0031] Preferably, the outer anchor conveying pressure measuring handle has an outer anchor, and the outer anchor has:

[0032] an outer anchor body, the outer anchor body having a contact surface capable of resting against the outer wall of the atrium and a non-contact surface opposite to the contact surface, the outer anchor body having a locking hole extending through the outer anchor body at a central position, and both side ends of the non-contact surface of the outer anchor body being respectively connected to the distal end of the delivery rod;

[0033] A locking structure is fixed at a locking hole position on the non-contact surface of the outer anchor body, and the distal end of the force transmission lock tube is connected to the locking structure.

[0034] Preferably,

[0035] Both side ends of the non-contact surface of the outer anchor body are respectively provided with anchor limiting protrusions or anchor limiting grooves;

[0036] The distal ends of the two delivery rods are respectively provided with anchor limiting grooves or anchor limiting protrusions;

[0037] The two side ends of the non-contact surface of the outer anchor body and the distal ends of the two delivery rods are connected together in a radially non-rotatable manner by means of the matching connection between the anchor limiting protrusion of the outer anchor body and the anchor limiting groove of the delivery rod, or by means of the matching connection between the anchor limiting groove of the outer anchor body and the anchor limiting protrusion of the delivery rod.

[0038] Preferably,

[0039] The distal end surface of the force transmission lock tube is dug with a radial groove;

[0040] The locking structure has a rotary cover, and the rotary cover is engaged in the radial groove to connect the distal end of the force transmission lock tube to the locking structure.

[0041] Preferably,

[0042] Two tube limiting protrusions or two tube limiting grooves are provided in the radial groove of the force transmission lock tube;

[0043] The cover edge of the rotary cover of the locking structure has two tube limiting grooves or two tube limiting protrusions;

[0044] The tube limiting protrusion of the radial groove is engaged with the tube limiting groove of the rotary cover, or the tube limiting groove of the radial groove is engaged with the tube limiting protrusion of the rotary cover, so that the distal end of the force transmission lock tube is connected to the locking structure in a radially non-rotatable manner.

[0045] Preferably, the locking structure has:

[0046] a locking base fixable on the outer anchor body, the locking base having an inner cavity into which the tie rod can be inserted;

[0047] A locking block is arranged in the inner cavity of the locking base, and the locking block has a branch end supported on the inner wall of the inner cavity of the locking base, a locking end that can be pressed against the tie rod, and a contact end that uses the branch end as a fulcrum to trigger the locking end to rotate closer to or away from the tie rod.

[0048] Preferably, the contact end is fixed with a pressable and releasable contact rod in the direction out of the inner cavity, and the contact rod space is perpendicular to the support axis of the support end.

[0049] Preferably, the outer anchor tie rod locking structure comprises: a rotary cover which can be arranged on the locking base, and the rotary cover has:

[0050] a fan-shaped hole corresponding to the inner cavity position of the locking base for the tie rod to pass through, the edge of the fan-shaped hole having an arc edge against which the tie rod abuts, and the arc edge having a corresponding center;

[0051] A waist-shaped hole is disposed opposite the fan-shaped hole. The waist-shaped hole has a proximal end closer to the center of the fan-shaped hole and a distal end farther from the center of the fan-shaped hole. The proximal and distal ends of the waist-shaped hole rotate back and forth to allow the sensing rod to pass through. When the rotary cover is rotated until the sensing rod is located at the distal end of the waist-shaped hole, the locking end of the locking block is farther away from the tie rod, thereby unlocking the lock. When the rotary cover is rotated until the sensing rod is located at the proximal end of the waist-shaped hole, the locking end of the locking block is pressed against the tie rod, and the locking structure is locked.

[0052] Preferably, the branch end of the locking block further has a support shaft, the middle portion of the support shaft is arranged in the branch end, and both ends of the support shaft are arranged on both side walls of the inner cavity of the locking base.

[0053] Preferably,

[0054] The locking base is a cylindrical base with a circle of cover limiting grooves on the outer surface;

[0055] The rotary cover is also a cylindrical cover with a hollow interior. The side wall of the cover is provided with a plurality of cover limiting pins passing through. The cover limiting pins are inserted into the cover limiting grooves to prevent the rotary cover from falling off the locking base.

[0056] Preferably, the locking block is in the shape of a right-angled trapezoid, the branch end is located at the short bottom end of the right-angled trapezoid, the locking end is located at the acute angle of the long bottom end of the right-angled trapezoid, and the contact end is located at the right angle of the long bottom end of the right-angled trapezoid.

[0057] Another object of the present invention is to provide a device for reducing left ventricular volume, comprising:

[0058] The external anchor conveying pressure measuring handle of the present invention;

[0059] A tie rod, the middle part of which is passed through the inner cavity of the locking structure of the outer anchor of the outer anchor delivery pressure measuring handle, the proximal section of which is movably passed through the force transmission lock tube of the outer anchor delivery pressure measuring handle, and the proximal end is fixed to the proximal end of the handle shell of the outer anchor delivery pressure measuring handle.

[0060] An inner anchor is hingedly connected to the distal end of the tie rod.

[0061] Preferably, the inner anchor has:

[0062] a contact surface adapted to abut the right ventricular septum; and

[0063] A non-contact surface opposite to the contact surface, characterized in that at least one side of the non-contact surface extends toward the middle of the non-contact surface with a barb substantially parallel to the non-contact surface, and the space between the barb and the non-contact surface forms a guide cavity that can provide guidance for the snare.

[0064] Preferably, the barbs substantially parallel to the non-contact surface are extended from two opposite side edges of the non-contact surface respectively toward the middle of the non-contact surface.

[0065] Preferably, there is a certain distance between the two barbs on two opposite sides of the non-contact surface, and the distance forms a barb opening for the snare to enter the guide cavity.

[0066] Preferably, the end point of the guide cavity ends at the center of the lateral end of the inner anchor.

[0067] Preferably, the barb has a guide protrusion protruding from the guide cavity near the end point of the guide cavity for indicating the guide end point.

[0068] Preferably, the barb is U-shaped.

[0069] Preferably, the main body of the inner anchor is in the shape of a cuboid.

[0070] Preferably, the inner anchor has a guidewire lumen at its axial center for allowing a guidewire to pass through.

[0071] Preferably, the side end of the inner anchor is a spherical end surface.

[0072] Preferably, the contact surface of the inner anchor has a tie rod groove along the axial direction for accommodating and limiting the tie rod.

[0073] Preferably, the middle portion of the contact surface of the inner anchor has hinges located on both sides of the tie rod groove and a tie rod shaft spanning the tie rod groove for passing the tie rod, and both ends of the tie rod shaft are respectively fixed to the middle portion of the hinge.

[0074] Preferably, the cross section of the inner anchor is I-shaped.

[0075] Preferably, the tie rod has a square connecting section, a guide section and a needle section which are connected in sequence, and the inner anchor is hinged to the distal end of the square connecting section of the tie rod.

[0076] Preferably, the distal end of the square connecting segment has a twisting hole, and the twisting hole can be passed through the tie rod shaft on the inner anchor.

[0077] Preferably, the guide section and the needle section have mutually communicating guide wire channels at their axial centers.

[0078] Preferably, the guide section has a guide hole at a head end close to the square connecting section for the guide wire to pass through the guide wire channel.

[0079] Another object of the present invention is to provide a tie rod locking structure for an external anchor, by means of which the purpose of locking and unlocking can be easily achieved by the external anchor delivery pressure measuring handle of the present invention.

[0080] The tie rod locking structure for an external anchor of the present invention has the following features:

[0081] a locking base fixable on the outer anchor body, the locking base having an inner cavity into which the tie rod can be inserted;

[0082] A locking block is arranged in the inner cavity of the locking base, and the locking block has a branch end supported on the inner wall of the inner cavity of the locking base, a locking end that can be pressed against the tie rod, and a contact end that uses the branch end as a fulcrum to trigger the locking end to rotate closer to or away from the tie rod.

[0083] Preferably, the contact end is fixed with a pressable and releasable contact rod in the direction out of the inner cavity, and the contact rod space is perpendicular to the support axis of the support end.

[0084] Preferably, the outer anchor tie rod locking structure comprises: a rotary cover which can be arranged on the locking base, and the rotary cover has:

[0085] a fan-shaped hole corresponding to the inner cavity position of the locking base for the tie rod to pass through, the edge of the fan-shaped hole having an arc edge against which the tie rod abuts, and the arc edge having a corresponding center;

[0086] A waist-shaped hole is disposed opposite the fan-shaped hole. The waist-shaped hole has a proximal end closer to the center of the fan-shaped hole and a distal end farther from the center of the fan-shaped hole. The proximal and distal ends of the waist-shaped hole rotate back and forth to allow the sensing rod to pass through. When the rotary cover is rotated until the sensing rod is located at the distal end of the waist-shaped hole, the locking end of the locking block is farther away from the tie rod, thereby unlocking the lock. When the rotary cover is rotated until the sensing rod is located at the proximal end of the waist-shaped hole, the locking end of the locking block is pressed against the tie rod, and the locking structure is locked.

[0087] Preferably, the branch end of the locking block further has a support shaft, the middle portion of the support shaft is arranged in the branch end, and both ends of the support shaft are arranged on both side walls of the inner cavity of the locking base.

[0088] Preferably,

[0089] The locking base is a cylindrical base with a circle of cover limiting grooves on the outer surface;

[0090] The rotary cover is also a cylindrical cover with a hollow interior. The side wall of the cover is provided with a plurality of cover limiting pins passing through. The cover limiting pins are inserted into the cover limiting grooves to prevent the rotary cover from falling off the locking base.

[0091] Preferably,

[0092] The locking block is in the shape of a right-angled trapezoid, the branch end is located at the short bottom end of the right-angled trapezoid, the locking end is located at the acute angle of the long bottom end of the right-angled trapezoid, and the contact end is located at the right angle of the long bottom end of the right-angled trapezoid.

[0093] Preferably, the cover edge of the screw cap has two tube limiting grooves or two tube limiting protrusions.

[0094] Another object of the present invention is to provide an external anchor for a left ventricular volume reduction device, comprising:

[0095] an outer anchor body, the outer anchor body having a contact surface capable of resting against the outer wall of the atrium and a non-contact surface opposite to the contact surface, the outer anchor body having a locking hole penetrating the outer anchor body at a central position;

[0096] A locking structure is fixed at the locking hole position of the non-contact surface of the outer anchor body, characterized in that the locking structure is the locking structure described in the present invention.

[0097] Preferably, both side ends of the non-contact surface of the outer anchor body are provided with anchor limiting protrusions or anchor limiting grooves respectively.

[0098] The positive progress effect of the present invention is:

[0099] 1) The locking structure of the external anchor of the present invention has a locking block. By rotating the rotary cover of the locking structure, the locking block can be locked and unlocked, providing a new locking structure.

[0100] 2) The external anchor conveying and pressure measuring handle of the present invention has a simple structure and only requires one force transmission lock tube to realize the locking and unlocking functions of the external anchor locking structure, and also has a force measurement transmission function.

[0101] 3) The present invention uses a pressure sensor for force measurement, which is more accurate, and uses a compression spring to ensure that the force transmission lock tube is in continuous contact with the pressure sensor in real time, thereby achieving true pressure measurement.

[0102] 4) The present invention is provided with a zero button to eliminate the influence of the force of the external anchor conveying pressure measuring handle structure itself. BRIEF DESCRIPTION OF THE DRAWINGS

[0103] Figure 1 is a schematic diagram of the three-dimensional structure of the left ventricular volume reduction device of the present invention;

[0104] Figure 2 Schematic diagram of the structure of the tie rod 10 of the present invention;

[0105] Figures 3A to 3DThis is a schematic structural diagram of the recyclable inner anchor of the present invention;

[0106] Figure 3E Schematic diagram of the recovery process of the recyclable inner anchor of the present invention;

[0107] Figures 4A and 4B It is a structural schematic diagram of the outer anchor 30 and the locking structure of the present invention;

[0108] Figures 5A to 5G It is a structural schematic diagram of the locking structure of the present invention;

[0109] Figures 6A and 6B This is a structural diagram of the external anchor conveying pressure measuring handle of the present invention;

[0110] Figure 6C Schematic diagram of the structure of the force transmission lock tube 50 of the present invention;

[0111] Figures 7A-7D This is a structural schematic diagram of the implantation process of the left ventricular volume reduction device of the present invention. DETAILED DESCRIPTION

[0112] In order to make the technical means, creative features, objectives and effects achieved by the present invention easier to understand, the present invention is further described below with reference to specific illustrations.

[0113] In the field of interventional medical devices, "distal" and "proximal" are defined as the end away from the operator during surgery, and "proximal" and "distal" are defined as the end close to the operator during surgery.

[0114] In the present invention, unless otherwise specified or limited, the terms "installed," "connected," "connected," "fixed," etc. should be understood in a broad sense. For example, they can refer to fixed connection, detachable connection, or integration; direct connection or indirect connection through an intermediate medium; internal communication between two elements or interaction between two elements, unless otherwise specified. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0115] like Figure 1As shown, the device for left ventricular volume reduction of the present invention comprises a tie rod 10, an internal anchor 20, and an external anchor delivery and pressure measurement handle. The external anchor delivery and pressure measurement handle comprises an external anchor 30, a delivery rod 40, a force-transmitting locking tube 50, a handle housing 60, and a pressure sensor 70. The internal anchor 20 can be hinged to the distal end of the tie rod 10; the external anchor 30 is threaded through the tie rod 10. The external anchor 30 is delivered by the delivery rod 40 of the external anchor delivery and pressure measurement handle. The locking structure on the external anchor 30 is connected to the force-transmitting locking tube 50, which is used to lock and unlock the device. Through contact between the external anchor 30 and the outer wall of the cardiac scar, pressure from the cardiac scar is transmitted to the locking structure on the external anchor, which then acts on the force-transmitting locking tube 50. The force-transmitting locking tube 50, in turn, abuts against a proximal pressure sensor 70, which measures cardiac pressure. The left ventricular volume reduction device provided by the present invention embeds the internal and external anchors 30 into the ventricular wall, suturing excess scar tissue to help the heart restore its previous shape and function.

[0116] The tie rod of the present invention can be a common tie rod in the prior art; it can also be a three-section type, such as Figure 2 As described above, the tie rod 10 has a square connecting section 11, a guide section 12 and a needle section 13 from the distal end to the proximal end. The square connecting section 11, the guide section 12 and the needle section 13 are integrally formed in the order from the distal end to the proximal end. The needle section 13 at the proximal end is made of a high-hardness metal such as stainless steel or a polymer material. The distal end of the connecting section 11 has a twisting hole 111. The axial centers of the guide section 12 and the needle section 13 respectively have guide wire channels that are interconnected. The guide section 12 has a guide hole 121 near the head end of the connecting section 11 for the guide wire to pass through the guide wire channel. The tie rod 10 can be made of polymer materials such as stainless steel, platinum-iridium alloy, PEEK, etc.

[0117] The inner anchor of the present invention can be any structure in the prior art, as long as it can be set on the right ventricular septum of the heart. However, in order to reduce the risk of chest surgery after the implantation of the heart volume reduction device fails or the patient needs to remove the left ventricular volume reduction device later, the present invention Figures 3A to 3EAn exemplary retrievable inner anchor 20 is provided. The main body of the retrievable inner anchor 20 is roughly rectangular in shape and has two surfaces: a contact surface 21 and a non-contact surface 22. The contact surface 21 refers to the surface that adheres to the right ventricular septum of the heart after implantation; the non-contact surface 22 refers to the surface that does not adhere to the heart after implantation, that is, the surface opposite to the contact surface 21. The inner anchor 20 has a guidewire lumen 23 at its axial center for the guidewire to pass through during surgical delivery of the inner anchor. The cross-section of the guidewire lumen 23 can be square, circular, or any other hollow lumen shape, as long as it allows the guidewire to pass through. Preferably, it is a circular through-hole. The side end of the inner anchor 20 can have any smooth curved surface shape, preferably a spherical end surface. The spherical end surface facilitates the smooth entry of the inner anchor 20 into the delivery sheath and reduces delivery resistance. The contact surface 21 can rest against the right ventricular septum. Contact surface 21 may not have a tie rod groove, as in the prior art. During delivery of the internal anchor, tie rod 10 is in close contact with contact surface 21. To reduce the size of the delivery sheath, a preferred approach is to provide contact surface 21 with a tie rod groove 211 along the axial direction. During delivery of the internal anchor, tie rod 10 is accommodated within tie rod groove 211, reducing the volume of the internal anchor and tie rod during delivery. Tie rod groove 211 also limits the position of tie rod 10, constraining it within tie rod groove 211 and regulating its movement to prevent damage to cardiac tissue. The tie rod 10 can be pivoted at the middle of the contact surface 21. A better way is a non-detachable way. For example, there is a hinge part 212 located on both sides of the tie rod groove 211 in the middle of the contact surface 21 and a tie rod shaft 213 spanning the tie rod groove 211 for passing the tie rod 10. The two ends of the tie rod shaft 213 are respectively fixed at the middle of the hinge part 212. The hinge part 212 serves as the support points at both ends of the tie rod shaft 213. The tie rod shaft 213 cannot be removed from the hinge part 212. The hinge hole 111 of the tie rod 10 is passed through the tie rod shaft 213 on the inner anchor 20.

[0118] The non-contact surface 22 of the retrievable inner anchor 20 faces away from the contact surface 21. A barb 221 extends from at least one side of the non-contact surface 22, generally parallel to the non-contact surface 22, toward the center of the non-contact surface 22. This facilitates the snare 91's capture of the inner anchor 20. Preferably, two opposing sides of the non-contact surface 22 each extend a barb 221 generally parallel to the non-contact surface 22, toward the center of the non-contact surface 22. Having barbs on both sides further facilitates the snare 91's capture of the inner anchor 20. The barbs 221 extending from both sides of the non-contact surface 22 create an I-shaped cross-section of the inner anchor. This I-shaped cross-section facilitates the snare wire to accumulate within the I-shaped cross-section of the inner anchor when the snare 91 withdraws the inner anchor 20, reducing resistance to the withdrawal of the inner anchor 20. The barbs 221 can be elongated, but can be U-shaped to reduce endothelial growth of the inner anchor 20 within the body, facilitating subsequent retrieval. The space between the barbs 221 and the non-contact surface 22 forms a guide cavity 222 that provides guidance for the snare 91. The retrievable inner anchor 20 is provided with barbs 221 on one side of the inner anchor that can be hooked and pulled by the snare 91, thereby retrieving the inner anchor 20 by pulling it out of the delivery sheath, eliminating the need for additional open-heart surgery to remove the inner anchor. When barbs 221 extend from both opposing sides of the non-contact surface 22, the two barbs 221 on the opposing sides of the non-contact surface 22 are spaced apart by a certain distance, meaning that the two barbs 221 are not aligned. This distance creates a barb opening 223 that allows the snare 91 to enter the guide cavity 222. At this time, the guide lumen 222 extends from the barb opening 223 along a straight line parallel to the non-contact surface 22 of the inner anchor. When it reaches the lateral end of the inner anchor 20 but not yet, the guide lumen 222 begins to bend and extend toward the axial center of the inner anchor 20. Ultimately, the guide lumen 222 terminates at the axial center of the lateral end of the inner anchor 20, that is, the guide lumen 222 terminates at the axial center of the guidewire lumen 23. This arrangement ensures that when the inner anchor is retrieved, the snare 91 mounted in the guide lumen 222 is positioned at the center of the inner anchor 20 when it captures the inner anchor 20, facilitating the movement of the snare 91. The snare's position at the center of the inner anchor 20 facilitates the entry of the inner anchor 20 into the delivery sheath. Furthermore, the barb 221 has a guide protrusion 224 protruding from the guide lumen 222 at the end point of the guide lumen 222 to indicate the end point of the guide. When the snare 91 moves to this position, the snare captures the internal anchor 20 in conjunction with an external imaging device, and the snare 91 can be removed. The internal anchor 20 in this example can be integrally formed. The internal anchor material can be made of one or more biocompatible and tough metal materials, such as stainless steel, titanium, and nickel-titanium alloy. The contact surface of the internal anchor or the entire internal anchor can also be coated with a polyester coating or surface coating. This coating can cushion the contact between the internal anchor and cardiac tissue, increase the rate of endothelialization, and reduce the corresponding inflammatory response.

[0119] The external anchor of the present invention can be any external anchor of the prior art, and is used to exclude the scar structure of the left ventricle. Figures 4A and 4B As shown, one structural form of an external anchor, such as external anchor 30, is generally flat and rectangular in shape, comprising an external anchor body 30a. The external anchor body also has two surfaces: a contact surface and a non-contact surface. The contact surface can abut against the wall of the left ventricle, while the non-contact surface faces away from the contact surface. A through-hole is provided in the center of external anchor body 30a, through which a tie rod 10 is inserted. Anchor retaining projections 30c or anchor retaining grooves are provided on either side of the non-contact surface of external anchor body 30a. The external anchor can be made of one or a combination of biocompatible and tough metal materials such as stainless steel, titanium, nickel-titanium alloy, cobalt-chromium alloy, and platinum-iridium alloy. The contact surface or the entire external anchor body can also be coated with a polyester coating or surface treatment. The coating structure can cushion the contact between the external anchor and cardiac tissue, increase the rate of endothelialization, and reduce the corresponding inflammatory response.

[0120] In order to strengthen the locking strength of the outer anchor 30 on the tie rod 10, a locking structure is provided on the non-contact surface of the lock hole of the outer anchor body 30a. The locking structure of the present invention can be any structure that can tightly lock the outer anchor 30 and the tie rod 10 to each other.

[0121] Continue as Figures 4A and 4B as well as Figures 5A to 5G As shown, in this example, the locking structure comprises a locking base 31, a locking block 32, and a screw cap 33 that can be fixed to the outer anchor body 30a. The locking base 31 is generally cylindrical in shape, with a hollow, square inner cavity 311 extending from one circular bottom surface of the cylindrical locking base 31 to the other. The locking base 31 is fixed to the non-contact surface of the outer anchor body 30a using one of the circular bottom surfaces as a connection surface. The square connecting section 11 of the tie rod 10 can be inserted into the inner cavity 311 of the locking base 31 and passed through the locking hole of the outer anchor body 30a. The outer surface of the cylindrical locking base 31 has a circle of cap retaining grooves 312 near the proximal end. A pair of axial holes 313 are also formed on the distal inner wall of the inner cavity 311 of the locking base 31, extending through the base wall of the locking base 31.

[0122] In this example, the locking block 32 is disposed within the inner cavity 311 of the locking base 31. The side surface of the locking block 32 is in the shape of a right-angled trapezoid, with a short base (i.e., the upper base of the trapezoid) and a long base (i.e., the lower base of the trapezoid). The locking block 32 has a branch end 321 and a support shaft 324. The branch end 321 is located at the short base of the right-angled trapezoid, and the middle portion of the support shaft 324 passes through the branch end 321. The ends of the support shaft 324 pass through the shaft holes 313 on the side walls of the inner cavity 311 of the locking base 31, or they can protrude from the shaft holes 313 to the outer wall of the locking base 31. Therefore, the locking block 32 can rotate about the support shaft 324, and the branch end 321 can be supported on the base wall of the inner cavity 311 of the locking base 31 via the support shaft 324. The locking block 32 also has a locking end 322, located at the acute angle of the long bottom end of the right-angled trapezoid. This end can press against the tie rod 10, thereby locking the tie rod 10 to the locking structure. The locking block 32 also has a contact end 323, located at a right angle to the long bottom end of the right-angled trapezoid. Pressing this contact end 323 causes the locking end 322 to rotate about the pivot 324 of the branch end 321, toward the tie rod 10, or away from the tie rod 10. Specifically, the contact end 323 triggers the locking end 322 to move toward or away from the tie rod 10 by fixing a contact rod 325 in the direction away from the inner cavity 311. The contact rod 325 is perpendicular to the pivot 324 of the branch end 321. Pressing this contact rod 325 causes the locking end 322 to move toward and away from the tie rod 10, thereby achieving the locking function. To unlock the lock, simply release the contact rod 325.

[0123] In this example, the rotary cover 33 is mounted on the locking base 31. The rotary cover 33 is roughly cylindrical in shape, with a hollow interior and a similar cylindrical cavity, allowing it to be mounted on the cylindrical locking base 31. The circular bottom surface of the rotary cover 33 has a fan-shaped hole 331, with an arc edge 3311. When the tie rod 10 passes through the inner cavity 311 of the locking base 31, it also passes through the fan-shaped hole 331. The two straight edges 3312 of the fan-shaped hole 331 are roughly perpendicular to each other. When the rotary cover 33 is rotated, the two straight edges 3312 of the fan-shaped hole 331 fold back and forth against the tie rod 10, while the arc edge 3311 of the fan-shaped hole 331 slides back and forth against the side of the tie rod 10. The arcuate edge 3311 of the fan-shaped hole has a corresponding center 3313 (i.e., the distance from any point on the arcuate edge 3311 to the center 3313 is always the same), and this center 3313 can coincide with the center of the cover 33. The circular bottom surface of the cover 33 also has a waist-shaped hole 332, which is arranged opposite the fan-shaped hole 331. The waist-shaped hole 332 has a proximal end 3321 closer to the center 3313 of the fan-shaped hole 331 and a distal end 3322 farther from the center 3313 of the fan-shaped hole 331. The proximal end 3321 and distal end 3322 of the waist-shaped hole 332 allow the contact rod 325 to pass through them during back-and-forth rotation. Because the proximal end 3321 is closer to the center 3313 of the fan-shaped hole 331, when the contact rod 325 of the contact end 323 is rotated by the screw cap 33 and positioned within the proximal end 3321, the distance between the contact end 323 and the tie rod 10 passing through the fan-shaped hole 331 is shortened, causing the locking end 322 to press against the tie rod 10, thereby locking the lock. Conversely, when the contact rod 325 of the contact end 323 is rotated by the screw cap 33 and positioned within the distal end 3322, the distance between the contact end 323 and the tie rod 10 is increased, causing the locking end 322 to move away from the tie rod 10 and disengage. This is how the locking and disengaging process of the locking structure is achieved. To prevent the cover 33 from falling off the locking base 31 during rotation, several cover retaining pins 333 are provided on the sidewalls of the cover 33. These pins 333 are inserted into the cover retaining grooves 312 on the outer surface of the locking base 31. Even if the cover 33 rotates, the retaining pins 333 remain locked within the retaining grooves 312 and cannot slide out. The edge of the cover 33 has two retaining grooves 334 or two retaining protrusions (not shown) to prevent relative rotation between the cover 33 and the force-transmitting locking tube 50.

[0124] like Figures 6A-6CIn this example, the force-transmitting locking tube 50, as its name suggests, serves two functions: first, to transmit pressure from the cardiac scar area; second, to lock and unlock the locking mechanism. This dual function is integrated into one, thereby simplifying the structure of the pressure-transmitting handle. The force-transmitting locking tube 50 is a long tube, positioned within the handle housing 60 in a manner that allows for axial movement but not radial displacement. It contains an axially oriented, hollow passage 51. The middle and proximal sections of the tie rod 10 pass through the passage 51 and extend from its proximal end. Axial flat grooves 52 are cut into opposite sides of the distal end of the force-transmitting locking tube 50, exposing the passage 51. This allows observation of the tie rod 10 within the passage 51 to determine the locking status of the external anchor. A radial groove 53 is cut into the distal side of the force-transmitting locking tube 50, into which the screw cap 33 of the locking mechanism of the external anchor 30 is retained. When the force transmission lock tube 50 is rotated, it drives the rotary cap 33 to rotate, thereby achieving the locking and releasing process of the locking structure. Of course, two tube-limiting protrusions 531 or two tube-limiting grooves (not shown) are also required within the radial groove 53. The tube-limiting protrusions 531 within the radial groove 53 engage with the tube-limiting grooves 334 on the edge of the rotary cap 33, or the tube-limiting grooves within the radial groove 53 engage with the tube-limiting protrusions on the edge of the rotary cap 33 (not shown). With this design, when the force transmission lock tube 50 drives the rotary cap 33 to rotate, there is no relative rotation between the two, and the rotary cap 33 can only rotate with it, thus successfully achieving the locking and releasing process of the locking structure and the tie rod 10. To facilitate rotation of the force transmission lock tube 50, a release lever 54 is fixed to the outer wall of the force transmission lock tube 50. The inner end of the release lever 54 is fixed to the force transmission lock tube 50, for example, by being mounted and secured with a pin. The outer end of the release lever 54 protrudes from the handle housing 60. To facilitate gripping and rotation, a rubber sleeve can be mounted on the outer end of the release lever 54. A fixed protruding ring 55 connected to a compression spring 66 is fixed to the proximal outer wall of the force transmission lock tube 50.

[0125] In this example, the handle housing 60 is a long, hollow box with an exterior that can be rectangular, cylindrical, or any other curved shape. A distal raised ring 61, a middle raised ring 62, and a proximal raised ring 63 are fixed to the inner wall of the handle housing 60 from the distal end to the proximal end. The centers of the distal raised ring 61, middle raised ring 62, and proximal raised ring 63 are all hollow, so when the force transmission lock tube 50 is axially positioned within the handle housing 60, it can be located within the hollow portions of the distal raised ring 61, middle raised ring 62, and proximal raised ring 63. The handle housing 60 has two radial retaining rings 64, such as linear bearings. The distal radial retaining ring 64 is located between the distal wall of the handle housing 60 and the distal convex ring 61. The pressure sensor 70 is located between the proximal convex ring 63 and the proximal wall of the handle housing 60. The proximal radial retaining ring 64 is located between the middle convex ring 62 and the proximal convex ring 63. The tie rod 10 is inserted within the radial retaining rings 64 and can only move axially and linearly, without radial displacement, thus preventing wobble and improving pressure measurement accuracy. The pressure sensor 70 is located at the proximal end of the handle housing 60. The distal end of the pressure sensor 70 abuts the proximal end of the force transmission lock tube 50, thereby sensing the cardiac pressure transmitted from the force transmission lock tube 50. The handle housing 60 has a radial rod hole 65 extending through the housing. The outer end of the disengagement rod 54 on the force transmission lock tube 50 extends from the radial rod hole 65 of the handle housing 60, allowing the disengagement rod 54 to be pushed within the radial rod hole 65. To ensure that the proximal end of the force-transmitting lock tube 50 maintains constant contact with the distal end of the pressure sensor 70, a compression spring 66 is installed within the handle housing 60. The distal end of the compression spring 66 is connected to the central raised ring 62 on the inner wall of the handle housing 60, while the proximal end of the compression spring 66 is connected to the fixed raised ring 55 on the force-transmitting lock tube 50. This prevents the possibility of pressure measurement failure. The proximal end of the handle housing 60 is also threadedly connected to a tail button 67 for securing the proximal end of the tie rod 10. The proximal end of the tie rod 10 passes through the tail button 67. The outer surface of the handle housing 60 features a display screen 68 connected to the pressure sensor 70's sensing signal and several buttons 69 connected to the pressure sensor 70's signal signal. The functions of these buttons include, but are not limited to, on / off, zero reset, and pressure alarm. A battery (not shown) is installed within the handle housing 60 and is electrically connected to the pressure sensor 70 to power it.

[0126] The distal end of the handle housing 60 has a pair of delivery rods 40 for delivering the outer anchor. The delivery rods 40 can be square or cylindrical, without affecting the purpose of the present invention. The proximal ends of the delivery rods 40 are fixedly connected to the two side walls of the distal end of the handle housing 60. The distal ends of the two delivery rods 40 are respectively connected to the two ends of the non-contact surface of the outer anchor body 30a. Specifically, the distal ends of the delivery rods 40 have anchor retaining grooves 41 or anchor retaining protrusions (not shown). The anchor retaining protrusions 30c of the outer anchor body 30a cooperate with the anchor retaining grooves 41 of the delivery rods 40, or the anchor retaining grooves of the outer anchor body 30a cooperate with the anchor retaining protrusions of the delivery rods 40 (not shown), thereby connecting the two ends of the non-contact surface of the outer anchor body 30a to the distal ends of the two delivery rods 40. Due to the mutual engagement of the anchor retaining grooves and the anchor retaining protrusions, the outer anchor 30 cannot rotate radially on the distal ends of the delivery rods 40.

[0127] The delivery and testing process of the external anchor delivery pressure measuring handle of the present invention is:

[0128] The delivery rod 40 of the external anchor delivery and pressure measurement handle places the external anchor 30 against the left ventricular scar, disengaging the locking mechanism. Cardiac pressure is applied to the force-transmitting locking tube 50 through the external anchor 30 and the locking mechanism. The force-transmitting locking tube 50 then transmits the transmitted cardiac pressure to the pressure sensor 70. The cardiac pressure is read on the display screen on the handle housing 60. Based on the pre-calculated desired left ventricular volume reduction, the delivery rod 40 of the external anchor delivery and pressure measurement handle continues to push the external anchor to the appropriate position. Delivery of the external anchor 30 is stopped when the pressure reading on the display screen reaches the desired set value. Rotating the disengagement rod 54 of the force-transmitting locking tube 50 rotates the locking mechanism's cap 33, locking the locking block 32 to the tie rod 10, thereby achieving the locking function. If the left ventricular volume reduction device needs to be released due to patient reasons, the disengagement rod 54 of the force-transmitting locking tube 50 can also be rotated in the opposite direction to release the tie rod 10 and retract the external anchor 30. The functions of force transmission and locking and unlocking are both realized by the force transmission lock tube 50, which is a single rod with multiple uses and simplifies the structure of the external anchor conveying pressure measuring handle.

[0129] like Figures 7A-7D As shown, the implantation process of the left ventricular volume reduction device of the present invention is as follows:

[0130] The proximal needle section 13 on the tie rod 10 or other puncture parts are used to complete the puncture of the left ventricular scar area and the ventricular septum area, enter the puncture sheath, establish a channel between the right ventricle and the epicardial area, withdraw the dilator in the puncture sheath, enter the J-type guide wire 92 along the puncture sheath, use the snare 91 that enters the delivery device to complete the capture of the J-type guide wire 92, keep the snare 91 tightly binding the J-type guide wire 92, withdraw the snare 91, and pull the J-type guide wire 92 into the inner cavity of the delivery device 90, and then out of the proximal end of the delivery device.

[0131] The puncture sheath is adjusted so that its distal end enters the distal lumen of the delivery device 90. A J-shaped guidewire 92 is inserted into the proximal needle section 13 of the tie rod 10 in vitro. The J-shaped guidewire 92 is then inserted into the tie rod 10 connected to the inner anchor. The J-shaped guidewire 92 is held stationary while the tie rod 10 is pushed forward, causing the proximal end of the tie rod to sequentially enter the inner lumen of the delivery device 90, the distal lumen of the puncture sheath, the distal end of the delivery device 90, the right ventricle, the left ventricle, and the epicardium. When the proximal end of the tie rod 10 exits the epicardium, the J-shaped guidewire 92 can be withdrawn, and the tie rod 10 can be pulled to complete the insertion of the inner anchor 20.

[0132] The position of the inner anchor 20 is confirmed by imaging fluoroscopy. When the inner anchor 20 is close to the right ventricular septum, the distal end of the puncture sheath is withdrawn to the left ventricle, and the delivery device 90 is withdrawn at the same time, so that the inner anchor 20 is released at the right ventricular septum.

[0133] Cut the square connecting segment 11 at the connection between the square connecting segment 11 and the guide segment 12, adjust the locking structure of the outer anchor 30 to make it in a released state, and enter the outer anchor 30 along the square connecting segment 11 to ensure that the contact surface of the outer anchor 30 contacts the scar tissue in the epicardial area.

[0134] Shorten the distance between the inner and outer anchors while maintaining an appropriate compression force on the heart, neither too high nor too low (optimal force is 1-6N). Operate the external lock release to lock the locking mechanism, cut off the excess square connecting segment 11, and complete the implantation of the left ventricular volume reduction device. Repeat the above steps based on the patient's cardiac anatomy and actual needs. Multiple pairs of anchors can be implanted, typically 2-4 pairs.

[0135] When the operation fails or the patient needs to remove the left ventricular volume reduction device, the delivery device 90 is entered along the right jugular vein, the dilator in the delivery device 90 is withdrawn, and the snare 91 is entered along the delivery device 90. With the support of the imaging device, the snare is used to capture the hook opening 223 on the inner anchor 20, and the barb 221 of the inner anchor 20 is successfully captured. The snare 91 is tightened. When the snare 91 contacts the guide protrusion 224, the imaging device prompts the snare to complete the capture of the inner anchor. The external lock release part is used to release the lock of the outer anchor 30 on the tie rod 10, and the snare is kept tightly bound to the inner anchor 20. When the snare is withdrawn, the inner anchor 20 enters the delivery device 90. The delivery device 90 is withdrawn to complete the interventional recovery of the inner anchor 20.

[0136] The basic principles, main features, and advantages of the present invention are shown and described above. Those skilled in the art should understand that the present invention is not limited to the foregoing embodiments. The foregoing embodiments and descriptions are merely illustrative of the principles of the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Such changes and modifications are intended to fall within the scope of the present invention. The scope of protection claimed in the present invention is defined by the appended claims and their equivalents.

Claims

1. An external anchor delivery pressure measuring handle, comprising: A hollow stalk shell; a force transmission lock tube axially movably disposed in the handle housing, having an axial passage for movably passing a tie rod, and a distal end that can be connected to the locking structure of the outer anchor and control the outer anchor to be separated from or locked by the tie rod; a pressure sensor, disposed at the proximal end of the handle housing, with the distal end of the pressure sensor abutting against the proximal end of the force transmission lock tube, for sensing the thrust of the external anchor on the left ventricle; The distal end surface of the force transmission lock tube is dug with a radial groove; The locking structure comprises a locking base which can be fixed on the outer anchor body, and the locking base has an inner cavity which can be inserted into the tie rod; a locking block disposed in the inner cavity of the locking base, comprising a branch end supported on the inner wall of the inner cavity of the locking base, a locking end capable of pressing against the tie rod, and a contact end for triggering the locking end to rotate toward or away from the tie rod with the branch end as a fulcrum; A rotary cover for the tie rod to be inserted can be covered on the locking base, and the distal end of the force transmission lock tube is connected to the locking structure by the rotary cover being engaged in the radial groove. The force transmission lock tube drives the rotary cover to rotate until the locking end of the locking block is far away from the tie rod, and the locking structure is in an unlocked state; or the force transmission lock tube drives the rotary cover to rotate until the locking end of the locking block is squeezed on the tie rod, and the locking structure is in a locked state.

2. The external anchor delivery pressure measuring handle according to claim 1, characterized in that The external anchor conveying pressure measuring handle has: A pair of delivery rods for delivering the outer anchor, wherein the delivery rods have proximal ends respectively connected to both sides of the distal end of the handle shell and a distal end that can be connected to the outer anchor.

3. The external anchor delivery pressure measuring handle according to claim 1, characterized in that The external anchor conveying pressure measuring handle has: A disengagement rod has an inner end fixed on the force transmission lock tube and an outer end protruding from the handle shell.

4. The external anchor delivery pressure measuring handle according to claim 3, characterized in that The handle shell has a radial rod hole that passes through the shell, and the outer end of the dissociation rod can drive the force transmission lock tube to rotate radially and pass through the radial rod hole.

5. The external anchor delivery pressure measuring handle according to claim 1, characterized in that The external anchor conveying pressure measuring handle has: Two radial limit rings are respectively fixed on the distal end and proximal section of the handle shell. The middle section and proximal section of the force transmission lock tube are respectively axially movable and pass through the radial limit rings on the distal end and proximal section of the handle shell to limit the radial displacement of the force transmission lock tube.

6. The external anchor delivery pressure measuring handle according to claim 5, characterized in that The radial limiting ring is a linear bearing.

7. The external anchor delivery pressure measuring handle according to claim 5, characterized in that The inner wall of the handle shell is respectively provided with a distal convex ring, a middle convex ring and a proximal convex ring from the distal end to the proximal end.

8. The external anchor delivery pressure measuring handle according to claim 7, characterized in that The radial limit ring at the distal end of the handle shell is located between the distal face wall and the distal convex ring, the pressure sensor is located between the proximal convex ring and the proximal face wall, and the radial limit ring at the proximal section of the handle shell is located between the middle convex ring and the proximal convex ring.

9. The external anchor delivery pressure measuring handle according to claim 1, characterized in that The external anchor delivery pressure measuring handle also has: A compression spring, the distal end of the compression spring is connected to the inner wall of the handle shell, and the proximal end of the compression spring is connected to the force transmission lock tube, so that the distal end of the pressure sensor and the proximal end of the force transmission lock tube are continuously in abutment.

10. The external anchor delivery pressure measuring handle according to claim 9, characterized in that A middle convex ring is fixed on the inner wall of the middle section of the handle shell, and a fixed convex ring is fixed on the outer wall of the proximal section of the force transmission lock tube; The distal end of the compression spring is connected to the middle convex ring on the inner wall of the handle shell, and the proximal end of the compression spring is connected to the fixed convex ring on the force transmission lock tube, so that the distal end of the pressure sensor and the proximal end of the force transmission lock tube are continuously in abutment.

11. The external anchor delivery pressure measuring handle according to claim 1, characterized in that The outer surface of the handle shell is provided with a display screen connected to the pressure sensor sensing signal and a plurality of buttons connected to the pressure sensor signal.

12. The external anchor delivery pressure measuring handle according to claim 1, characterized in that A battery is provided in the handle shell and is electrically connected to the pressure sensor.

13. The external anchor delivery pressure measuring handle according to claim 2, characterized in that The outer anchor conveying pressure measuring handle has an outer anchor, and the outer anchor has: an outer anchor body, the outer anchor body having a contact surface capable of resting against the outer wall of the atrium and a non-contact surface opposite to the contact surface, the outer anchor body having a locking hole extending through the outer anchor body at a central position, and both side ends of the non-contact surface of the outer anchor body being respectively connected to the distal end of the delivery rod; A locking structure is fixed at a locking hole position on the non-contact surface of the outer anchor body, and the distal end of the force transmission lock tube is connected to the locking structure.

Images