An artificial chordae tendineae includes a chordae tendineae main body with at least one end connected to a fixing member. A side of the fixing member facing away from the chordae tendineae main body is provided with a puncturing connection member. An artificial chordae tendineae implantion system includes a clamping device, a puncturing device including a puncture needle, the artificial chordae tendineae, and a pushing device including a pushing shaft. The puncturing device and the clamping device are received in the pushing shaft. A proximal clamp of the clamping device is provided at a distal end of the pushing shaft. A distal clamp of the clamping device is provided at a distal end of the clamping push rod. A distal end of the puncture needle is provided with a tapped straight tip. The artificial chordae tendineae is received in the clamping device. The fixing member corresponds to the puncture needle.

FIELD OF THE INVENTION

The present disclosure relates to the field of medical devices, relates to devices for repairing heart valve defeats, and in particular to an artificial chordae tendineae and an artificial chordae tendineae implantation system.

BACKGROUND OF THE INVENTION

The mitral valve is a one-way “valve” between the left atrium (LA) and the left ventricle (LV), which ensures blood flow from the left atrium to the left ventricle. As illustrated inFIG.1, a normal healthy mitral valve has multiple chordae tendineae (CT). The mitral valve includes an anterior leaflet and a posterior leaflet. When the left ventricle is in a diastolic state, the anterior leaflet and the posterior leaflet are in an open state, and blood flows from the left atrium to the left ventricle. When the left ventricle is in a contracted state, the chordae tendineae are stretched, such that the leaflets will not be rushed into the left atrium by the blood flow. At this time, the anterior leaflet and the posterior leaflet both are well closed, thereby ensuring that blood flows from the left ventricle to the aorta via the aortic valve (AV). If there is a lesion in the chordae tendineae or papillary muscles, such as a rupture of the chordae tendineae of the posterior leaflet as illustrated inFIG.2, when the left ventricle is in the contracted state, the mitral valve cannot return to a closed state as normal, and the impulse of the blood flow will further cause the leaflet to be rushed into the left atrium, causing blood reflux.

At present, lesions in the chordae tendineae are generally treated by surgically implanting artificial chordae tendineae. However, this requires adopting invasive open thoracotomy approaches, under general anesthesia, and moderate hypothermia cardiopulmonary bypass as an auxiliary support. Such surgical operations have the disadvantages of complicated surgical procedures, high surgical cost, high surgical costs, high degrees of patient trauma, high risks of complications, long hospitalization, and painful recovery processes.

Another treatment is to implant an artificial chordae tendineae in a minimally invasive manner. In prior art, medical devices for implanting the artificial chordae tendineae include a handle assembly, a capture assembly, and a needle. After leaflets are captured by the capture assembly, a needle with a hook-shaped end is used to pass through the leaflet to pick a suture as the artificial chordate as. The needle is then retracted to drive the artificial chordae tendineae to pass through the leaflet, and one end of the artificial chordae tendineae is fixed to a ventricular wall. However, the above medical device has the disadvantages of low probability of the needle picking the artificial chordae tendineae, a low success rate of surgery, and a long surgery time.

SUMMARY OF THE INVENTION

In response to the disadvantages of the prior art, a technical problem to be solved by the present disclosure is to provide an artificial chordae tendineae capable of forming a stable connection with a puncture needle.

A further technical problem to be solved by the present disclosure is to provide an artificial chordae tendineae implantation system capable of reliably connecting an artificial chordae tendineae.

The technical solutions adopted by the present disclosure to solve the above technical problems are the following.

An artificial chordae tendineae includes a flexible chordae tendineae main body and a fixing member. The fixing member is connected to at least one end of the chordae tendineae main body. The fixing member is configured to be connected with a puncture needle. The fixing member includes a puncture connection member disposed at a side of the fixing member facing away from the chordae tendineae main body.

In an illustrative embodiment, the fixing member is provided with an accommodation cavity for accommodating the puncture needle. The puncture connection member is selected from a group consisting of threads, an adhesive layer, a rough surface, and at least one groove or hole disposed on a sidewall of the accommodation cavity. The at least one groove or hole is configured to engage with the puncture needle in an interference fit connection, a snap connection, and a key connection.

In an illustrative embodiment, the chordae tendineae main body is sleeved with an anti-slip member. The anti-slip member slides along an axis of the chordae tendineae main body.

In an illustrative embodiment, the anti-slip member is provided with a through hole, and the chordae tendineae main body extends through the through hole; or the anti-slip member defines a pair of through holes, and two ends of the chordae tendineae main body respectively extend through the through holes; or the anti-slip member defines at least two through holes, and at least two chordae tendineae bodies respectively extend through the at least two through holes.

In an illustrative embodiment, the anti-slip member is blocked by the fixing member.

In an illustrative embodiment, the anti-slip member includes a fitting surface configured to be fitted on a leaflet.

An artificial chordae tendineaeate implantation system includes an artificial chordae tendineae, a pushing device, a clamping device, and a puncturing device. The pushing device includes a pushing shaft. The pushing shaft defines a number of lumens along an axis thereof. The clamping device and the puncturing device are movably received in different lumens of the pushing shaft. The clamping device includes a clamping push rod, a distal clamp, and a proximal clamp. The distal clamp and the proximal clamp cooperatively clamp a leaflet. The proximal clamp is disposed at a proximal end of the pushing shaft. The distal clamp is disposed at a distal end of the clamping push rod. The puncturing device includes a puncture needle. A distal end of the puncture needle is provided with a straight tapered tip. The artificial chordae tendineae is received in the clamping device. The artificial chordae tendineae includes a flexible chordae tendineae main body. At least one end of the chordae tendineae main body is connected with a fixing member which is configured to connect with the puncture needle.

In an illustrative embodiment, the fixing member includes a puncture connection member disposed at a side thereof facing away from the chordae tendineae main body. The puncture needle further includes chordae tendineae connection member configured to be connected with the puncture connection member.

In an illustrative embodiment, the chordae tendineae connection member is disposed at a distal end of the puncture. The chordae tendineae connection member is at least one protruding tooth or a circle of protruding flanges connected with the puncture connection member in an interference fit connection, a snap connection, or a key connection; or the chordae tendineae connection member is threads, an adhesive layer, or a rough surface is disposed on an external surface of the puncture needle.

In an illustrative embodiment, the distal clamp includes a clamping surface dispose at a proximal end of the distal clamp. The puncturing device includes a puncturing push rod connected to the puncture needle. The puncturing push rod is received in the lumens of the pushing shaft. The clamping push rod is provided with an artificial chordae tendineae channel along an axial direction. The distal clamp is provided with an artificial chordate tendineae accommodation chamber which is connected through with the clamping surface of the distal clamp. The artificial chordae tendineae accommodation chamberis connected with the artificial chordae tendineae channel. The artificial chordae tendineae is received in the artificial chordae tendineae channel and the artificial chordae tendineae accommodation chamber.

In an illustrative embodiment, the chordae tendineae main body is sleeved with an anti-slip member sliding along an axial of the chordae tendineae main body. The clamping surface of the distal clamp defines an accommodation slot for accommodating the anti-slip member. The accommodation slot is radially in communication with the artificial chordae tendineae accommodation chamber.

In an illustrative embodiment, the fixing member is received in the distal clamp and the fixing member corresponds to the puncture needle.

In an illustrative embodiment, the clamping surface of the distal clamp defines a fixing cavity for receiving the fixing member. The fixing cavity is axially in communication with the artificial chordae tendineae accommodation chamber. The fixing cavity is radially in communication with the accommodation slot.

In an illustrative embodiment, a shape of the fixing cavity corresponds to a shape of the fixing member. A diameter of an inscribed circle of the fixing cavity is larger than a diameter of a circumscribed circle of the artificial chordae tendineae accommodation chamber.

In an illustrative embodiment, the proximal clamp includes a clamping surface disposed at a distal end of the proximal clamp. The clamping surface of the proximal clamp and the clamping surface of the distal clamp are capable of being fitted together. At least one of the clamping surfaces includes a reinforcing member for increasing clamping forces.

In an illustrative embodiment, the reinforcing member is selected from a group consisting of a protrusion, a ridge, a groove, and a recess provided on the clamping surfaces.

In an illustrative embodiment, the distal clamp includes a clamping surface disposed at a proximal end of the distal clamp. The puncturing device includes a pair of puncture needles and a pair of puncturing push rods connected to the puncture needles respectively. The puncturing push rods are received in the lumens of the pushing shaft. The artificial chordae tendineae is provided with a pair of fixing members respectively disposed at the two ends of the artificial chordae tendineae main body. The two fixing members are received in the distal clamp. The two puncture needles respectively correspond to the two fixing members.

In an illustrative embodiment, the clamping push rod is provided with an artificial chordae tendineae channel along an axial direction. The distal clamp is provided with a pair of artificial chordae tendineae accommodation chambers which are connected through with the clamping surface of the distal clamp. The pair of artificial chordae tendineae accommodation chambers is connected with the artificial chordae tendineae channel. The pair of artificial chordae tendineae accommodation chambers are radially connected with each other. The two ends of the chordae tendineae main body extend through the artificial chordae tendinea channel and the two artificial chordae tendinea accommodation chambers to be connected with the two fixing members, respectively.

In an illustrative embodiment, the clamping surface of the distal clamp defines a pair of fixing cavities for respectively receiving the fixing members. Each of the fixing cavities is axially in communication with the pair of artificial chordae tendineae accommodation chambers. The pair of the fixing cavities are radially in communication with each other.

In an illustrative embodiment, the chordae tendineae main body of the artificial chordae tendineae is sleeved with an anti-slip member. The anti-slip member defines a pair of through holes for two ends of the chordae tendineae main body extending therethrough respectively.

In an illustrative embodiment, the clamping surface of the distal clamp defines a pair of fixing cavities for receiving the pair of fixing members and an accommodation slot for accommodating the anti-slip member. Each of the fixing cavities is radially in communication with the accommodation slot. The accommodation slot is radially in communication with the artificial chordae tendineae accommodation chamber.

In an illustrative embodiment, the proximal end of the pushing shaft is provided with a first handle, and a proximal end of the clamping push rod is provided with a second handle. A proximal end of the puncturing device is provided with a third handle. The second handle drives the clamping device to move along an axis of the pushing shaft. The third handle drives the puncture needle to move along the axis of the pushing shaft.

Compared with the prior art, the present disclosure at least has the following advantages.

At least one end of the chordae tendineae main body of the artificial chordae tendineae of the present disclosure is provided with the fixing member configured to be connected with the puncture needle. In this way, although the puncture needle and the artificial chordae tendineae are not directly connected, the artificial chordae tendineae is connected with the puncture needle via the fixing member. Therefore, reliability of the connection between the artificial chordae tendineae and the puncture needle is improved. During retracing of the puncture needle, the artificial chordae tendineae can be prevented from falling off from the puncture needle.

In the artificial chordae tendineae implantation system of the present disclosure, the puncture needle is provided with the straight tapered tip. Compared with a hook-shaped puncture needle in prior art, the puncture needle of the present disclosure has a smaller puncturing point formed on the leaflet. The diameter of the puncturing point is controlled to range from 0.3 mm to 1.5 mm. Thus, damage to the leaflet is reduced and postoperative healing process is accelerated.

The fixing member of the artificial chordae tendineae and the puncture needle are positioned via the clamping device. In this way, the probability of successful connection between the puncture needle and the fixing member is effectively increased, and accordingly the surgery time is reduced. In addition, the stable and reliable indirect connection between the puncture needle and the artificial chordae tendineae is formed. In this way, the artificial chordae tendineae is not easily released from the puncture needle, and the artificial chordae tendineae can be easily pulled to fixed positions.

DETAILED DESCRIPTION OF THE INVENTION

The present disclosure will be described in details in combination with the accompanying drawings and embodiments such that the purpose, technical solution and advantages of the present disclosure will be more apparent.

For the sake of facilitation of illustrating, in the field of invasive medical device technology, a position near the operator is defined as a proximal end, and a position away from the operator is defined as a distal end.

As illustrated inFIG.3, an artificial chordae tendineae100of the present disclosure includes a flexible chordae tendineae main body110. The chordae tendineae main body110has a certain axial length. The chordae tendineae main body110is configured to be implanted into a heart to replace a diseased natural chordate tendineae. The chordae tendineae main body110has two opposite ends, that is, a first end and a second end opposite the first end. The first end of the chordae tendineae main body110is connected with a fixing member120. A side of the fixing member120facing away from the chordae tendineae main body110is provided with a puncture connection member which is configured for a detachable or non-detachable connection with a puncture needle.

One end of the chordae tendineae main body110may be fixed on a leaflet, and the other end of the chordae tendineae main body110may be fixed on a ventricular wall or papillary muscle. The chordae tendineae main body110is configured to replace the diseased nature chordate tendineae, thereby maintaining the tension between the leaflet and the ventricular wall or the papillary muscle. A flexible chordae tendineae main body110means that it can be bent freely in the axial direction thereof without stretching. Generally, the chordae tendineae main body110is in the form of a flexible wire. The material of the chordae tendineae main body110may be a polymer materials compatible with a human body or relatively soft metal materials, particularly a polymer material.

The first end and the second end of the chordae tendineae main body110have no difference in direction, importance, and the like.

As illustrated inFIG.3, the fixing member120may be disposed at either end of the chordae tendineae main body110.

As illustrated inFIG.4, each end of the chordae tendineae main body110may be provided with a fixing member120.

The chordae tendineae main body110may be connected with the fixing member120by tying, winding, welding, bonding, snap fitting, or the like. For example, one end of the chordae tendineae main body110may pass through the fixing member120and then tied to form a larger diameter coil, or the end may be welded to form a large diameter ball, or the end may be provided with a positioning rod. In a natural state, the positioning rod has a different axis from the chordae tendineae main body110and the fixing member120. After the positioning rod and the corresponding end of the chordae tendineae main body110pass through the fixing member120, the positioning rod returns to the natural state and snappingly blocks a back side of the fixing member120, thereby fixing the corresponding end of the chordae tendineae main body110to the fixing member120.

As illustrated inFIG.5, when one end of the chordae tendineae main body110is provided with the fixing member120, and other end of the chordae tendineae main body110is not provided with the fixing member120, the other end of the chordae tendineae main body110may, by way of tying, winding, or providing a spherical end, a disc-shaped end, or the like, have a cross-sectional dimension greater than a cross-sectional dimension of the chordae tendineae main body110, thereby blocking the other end of the chordae tendineae main body110on an upper surface of the leaflet.

As illustrated inFIGS.6to9, a detachable or a non-detachable connection may be formed between the fixing member120and the puncture needle. The fixing member120has a shape corresponding to the corresponding connection. Since a distal end of the puncture needle is generally provided with a sharp tapped straight tip, a contact area between the puncture needle and an external surface of the fixing member120should be as large as possible, thereby forming a stable connection between the fixing member120and the puncture needle. The side of the fixing member120facing away from the chordae tendineae main body110is provided with an accommodation cavity121for accommodating the puncture needle. A shape of the accommodation cavity121corresponds to a shape of the distal end of the puncture needle. The accommodation cavity121is generally tapered or cylindrical, and the fixing member120is generally cylindrical. The fixing member120may has a cross section in a round, elliptical, polygonal shape. In an illustrated embodiment, the fixing member120has a cross section in a round or elliptical shape.

The artificial chordae tendineae accommodation chamber121is provided with a puncture connection member125configured to be connected with the puncture needle. The puncture connection member125is embodied in a number of implementations as the following.

As illustrated inFIG.6, the puncture connection member125according to a first implementation of the present disclosure is internal threads defined in a sidewall of the accommodation cavity121and configured to engage with the puncture needle. Accordingly, an external surface of the puncture needle defines external threads to engage with the internal threads of the fixing member120.

As illustrated inFIG.7, the puncture connection member125according to a second implementation of the present disclosure is an adhesive layer provided on the sidewall of the accommodation cavity121and configured to be adhered to the puncture needle. For example, the sidewall of the accommodation cavity121is provided with biocompatible adhesives to form the adhesive layer. The external surface of the puncture needle is adhered to the fixing member120via the adhesive layer, and thus a non-detachable connection between the puncture needle and the fixing member120is formed.

As illustrated inFIG.8, the puncture connection member125according to a third embodiment of the present disclosure is a rough surface provided on the sidewall of the accommodation cavity121and configured to be frictionally connected with the puncture needle. In an illustrated embodiment, the external surface of the puncture needle is provided with a rough surface to engage the rough surface of the sidewall of the accommodation cavity121. Thus, a detachable connection between the puncture needle and the fixing member120is formed by friction. The rough surfaces may be obtained by providing a number of tiny protrusions or ridges on the sidewall of the accommodation cavity121and/or the external surface of the puncture needle. Or, the rough surfaces may be obtained by directly roughening the sidewall of the accommodation cavity121and/or the external surface of the puncture needle. Or, the sidewall of the accommodation cavity121and/or the external surface of the puncture needle may be made of materials with a certain coefficient of friction to obtain the rough surfaces.

As illustrated inFIG.9, the puncture connection member125according to a fourth implementation of the present disclosure is at least one groove or hole defined in the sidewall of the accommodation cavity121and configured to engage with the puncture needle in an interference fit connection, a snap connection, or a key connection.

The interference fit connection refers to a shape of the groove or the hole provided in the sidewall of the accommodation cavity121corresponding to a shape of the puncture needle and the groove or the hole provided in the sidewall of the accommodation cavity121engaging with the puncture needle under an interference fit. Thus, a detachable connection between the fixing member120and the puncture needle is formed.

The snap connection refers to the groove or the hole provided in the sidewall of the accommodation cavity121engaging with the protrusions or the ridges provided on the puncture needle to form a non-detachable or detachable connection. In this embodiment, as illustrated inFIG.9, at least one groove125is radially defined in the sidewall of the accommodation cavity121of the fixing member120to engage with the protrusions provided on the puncture needle. It can be understood that, the hole or the groove may be a blind hole or a through hole as long as a shape of the hole or the groove may substantially corresponds to a shape of the protrusion or the ridges provided on the puncture needle to form the snap connection. In this embodiment, three recesses125are defined in the fixing member120, such that stability of the connection between the fixing member120and the puncture needle is improved, and shaking amplitude of the puncture needle connected with the fixing member120is reduced.

The key connection may be a flat key connection, a spline key connection, and the like. The key connection may form a tight key connection, and accordingly force may also be transmitted along an axial direction of the puncture needle. The key connection structure is well known in art, and details are not described herein.

As illustrated inFIGS.4,5,10, a contact between the artificial chordae tendineae100and the leaflet is changed from point contact to face contact to increase contact area, so as to effectively reduce the risk of tearing the artificial chordae tendineae100. In an illustrated embodiment, the chordae tendineae main body110is sleeved with an anti-slip member130. The anti-slip member130may slide along the chordae tendineae main body110and be blocked by the fixing member120. After the anti-slip member130is disposed on the artificial chordae tendineae100, the puncture needle punctures the leaflet and is connected with the artificial chordae tendineae100. The anti-slip member130can be driven to a puncturing point. The anti-slip member130together with the artificial chordae tendineae100is fixed on the leaflet. The anti-slip member130is attached to the artificial chordae tendineae100as follows. A through hole131is provided in the anti-slip member130for the chordae tendineae main body110passing through. When the first end of the chordae tendineae main body110is provided with the fixing member120and the second end of the chordae tendineae main body110is not provided with the fixing member120, the second end is knotted, wound, or provided with a spherical end, a disc-shaped end, or the like, such that the second end has a cross section larger than that of the through hole131defined in the anti-slip member130.

As illustrated inFIG.10, the anti-slip member130defines at least two through holes131therein for the first end and the second end of the chordae tendineae main body110respectively to pass through.

In other implementations, the anti-slip member130defines at least two through holes131therein respectively for at least two chordae tendineae bodies110of two artificial chordae tendineaes100to pass through, that is, at least two artificial chordae tendineaes100share one anti-slip member130.

To prevent the anti-slip member130from falling off from the artificial chordae tendineae100, the through hole131has a cross section smaller than that of the fixing member120. For example, when the through hole131of the anti-slip member130is a round hole and the fixing member120is cylindrical, a diameter of the through hole131of the anti-slip member130is less than that of the fixing member120. The end of the chordae tendineae main body110without the fixing member120should be knotted, or provided with a spherical end, a disc-shaped end, or the like, such that a diameter of this end is larger than that of the through hole131of the anti-slip member130, as illustrated inFIG.5.

In order to spread force applied to the leaflet by the chordae tendineae main body110on a contact area between the anti-slip member130and the leaflet, and accordingly the anti-slip member130needs to be in contact with the leaflet as much as possible. Thus, the anti-slip member130is provided with a fitting surface132that fits the leaflet. Except for the fitting surface132, the specific structure of the anti-slip member130may be not limited, may be a sheet shape, a disk shape or a spherical shape, or even an irregular shape having a certain area, and is preferably a sheet shape. The anti-slip member130may have a non-porous structure, a mesh structure, a bar-like structure, or the like. The anti-slip member130can be made of biocompatible materials, either of elastic materials or non-elastic materials. The anti-slip member130may be selected from a group consisting of an elastic pledget, a heart patch, a felt sheet, a mesh structure, a disc-like structure, or a double disc-like structure. The structure of the anti-slip member130having the disk-like structure or the double-disc structure is similar to an occluder in prior art, and will not be described herein. To reduce an overall size of the artificial chordate tendineae, the anti-slip member130having a disc-like structure or a double disc-like may be made of shape memory materials.

Compared with the related art, the artificial chordae tendineae of the present disclosure has advantages as follows.

At least one end of the chordae tendineae main body is provided with the fixing member configured to be connected with the puncture needle, such that a detachable connection or a non-detachable connection between the chordae tendineae main body and the puncture needle is formed. In this way, although there is no direct contact between the puncture needle and the artificial chordae tendineae, the artificial chordae tendineae, the fixing member, and the puncture needle are sequentially connected via the connection between the puncture needle and the fixing member. Thus, reliability of the connection between the artificial chordae tendineae and the puncture needle is improved and the artificial chordae tendineaeate may be prevented from falling off from the puncture needle.

As illustrated inFIGS.11to23, an artificial chordae tendineae implantation system according to a first embodiment of the present disclosure is configured to implant the artificial chordae tendineae100into a heart to replace a diseased natural chordae tendineae. The artificial chordae tendineae implantation system according to the first embodiment of the present disclosure includes the artificial chordae tendineae100, a clamping device300, a puncturing device400a, and a pushing device200. The pushing device200includes a pushing shaft210. The pushing shaft210is provided with a number of lumens211in an axial direction of the pushing shaft210. The puncturing device400aand the clamping device300are movably received in different lumens211of the pushing shaft210, respectively. The clamping device300includes a clamping push rod330, a distal clamp310, and a proximal clamp320. The lumens211extends through the proximal clamp320, as illustrated inFIG.11. The distal clamp310and proximal clamp320cooperate to clamp the leaflet therebetween. The proximal clamp320is disposed at a distal end of the pushing shaft210. The distal clamp310is disposed at a distal end of the clamping push rod330. The puncturing device400aincludes a puncture needle410and a puncturing push rod420coupled to a proximal end of the puncture needle410. A distal end of the puncture needle410has a straight tapered tip. The artificial chordae tendineae100is received in the clamping device300. The fixing member120of the artificial chordae tendineae100corresponds to the puncture needle410of the puncturing device400a.

The artificial chordae tendineae100is further provided with the anti-slip member130. Contact between the artificial chordae tendineae100and the leaflet is changed from point contact to face contact. The chordae tendineae main body110is provided with at least one anti-slip member130. The anti-slip member130can smoothly slide along the chordae tendineae main body110and cannot slip off from the chordae tendineae main body110due to being blocked by the fixing member120. Due to the anti-slip member130, contact between the artificial chordae tendineae100and the leaflet is face contact rather than point contact. In this way, risk of the artificial chordae tendineae100tearing the leaflet is effectively reduced.

As illustrated inFIG.12, the pushing device200includes the pushing shaft210. The pushing shaft210is a tube having a certain length. The lumens211in the pushing shaft210are separated from each other. The pushing shaft210can be an integrally formed. The pushing shaft210may be formed via a number of internal tubes each with a small size being mounted in an external tube with a larger size. The pushing shaft210can be made of biocompatible polymer materials, metal materials, or metal-polymer composite materials. The polymer materials may be polyoxymethylene (POM), polyethylene (PE), nylon (PA), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene copolymer (ABS), elastomer pebax, or polyurethane (PU), or the like. The metal materials may be stainless steel or nickel-titanium alloy. The proximal end of the pushing shaft210is provided with a first handle201for manipulating the pushing shaft210to move toward the distal end or withdraw toward the proximal end.

The puncture needle410is configured to puncture the leaflet. The puncture needle410is connected to the fixing member120of the artificial chordae tendineae100to facilitate driving the chordae tendineae main body110toward the proximal end. The distal end of the puncture needle410is provided with the straight tapered tip, which facilitates puncture of the leaflet and reduces a size of a puncturing point formed on the leaflet. Compared with the hook-shaped needle in the related art, the puncture needle410with the straight tapered tip forms a smaller puncturing point on the leaflet, thereby facilitating postoperative healing of the patient. In this embodiment, the puncturing point formed on the leaflet has a diameter ranging from 0.3 mm to 1.5 mm. Furthermore, by setting a suitable shape and a diameter of the puncture needle410, the diameter of the puncturing point may controlled to be about 0.7 mm.

The puncture needle410is further provided with a chordae tendineae connection member411corresponding to the puncture connection member125of the artificial chordae tendineae100to form a stable and reliable connection between the artificial chordae tendineae100and the puncture needle410. The chordae tendineae connection member411is configured to increase the reliability of the connection between the puncture needle410and the artificial chordae tendineae100. The chordae tendineae connection member411is embodied as the following implementations.

As illustrated inFIGS.14to15, the chordae tendineae connection member411according to a first implementation of the present disclosure is a protruding tooth or a circle of protruding flanges disposed at the distal end of the puncture needle410and configured to engage with the fixing member120in an interference fit connection, a snap connection, or a key connection.

After puncturing, the accommodation cavity121provided at the side of the fixing member120faces away from the chordae tendineae main body110, which allows the puncture needle410to be inserted accommodation cavity121to tightly engage with the fixing member120, that is, an interference fit connection is formed between the fixing member120of the puncture needle410. In an illustrative embodiment, the chordae tendineae connection member411is a protruding tooth or a circle of protruding flanges disposed next to the tapped straight end of the puncture needle410.

It can be understood that, in other embodiments, an external surface of the puncture needle410next to the tapped straight tip is provided with at least one protruding tooth or a circle of protruding flanges as the puncture connection member125, corresponding to the hole or groove defined in the sidewall of the accommodation cavity121of the fixing member120. The at least one protruding tooth or circle of protruding flanges is slightly larger than the groove or the hole. As such, an interference fit connection between the puncture needle410and the fixing member120is formed.

As illustrated inFIG.15, a snap connection between the puncture needle410and the fixing member120may be formed. A portion of the puncture needle410next to the tapped straight tip or a circle of the puncture needle410next to the tapped straight tip is removed, such that the tapped straight tip forms the at least one protruding tooth or the circle of protruding flanges as the chordae tendineae connection member411. Accordingly, the fixing member120of the artificial chordae tendineae100is provided with the groove or the hole as the puncture connection member125. After puncturing, the at least one protruding tooth or the circle of protruding flanges of the puncture needle410engage with the groove or the hole of the fixing member120, and accordingly detachable connection between the puncture needle410and the fixing member120is formed.

The at least one protruding tooth or the circle of protruding flanges as the chordae tendineae connection member411engage with the puncturing connection member125of the artificial chordae tendineae100, and thus a tight key connection between the puncture needle410and the fixing member120is formed.

As illustrated inFIGS.16to17, the chordae tendineae connection member411according to a second implementation of the present disclosure is external threads provided on the external surface of the puncture needle410to threadedly engage with the fixing member120. For example, at least part of the puncture needle410is provided with external threads. In an illustrative embodiment, the puncture needle410is provided with the external threads next to the tapped straight end. After puncturing, the puncture needle410threadedly engages with the fixing member120of the artificial chordae tendineae100, and thus a detachable connection between the puncture needle410and the fixing member120is formed, as illustrated inFIG.17.

As illustrated inFIGS.18to19, the chordae tendineae connection member411according to a third implementation of the present disclosure is an adhesive layer provided on the external surface of the puncture needle410. For example, biocompatible adhesives are applied to at least part of the external surface of the puncture needle410to form the adhesive layer. After puncturing, the fixing member120is adhered to the adhesive layer of the puncture needle410. Thus, a non-detachable connection between the puncture needle410and the fixing member120is formed, as illustrated inFIG.19.

As illustrated inFIGS.20to21, the chordae tendineae connection member411according to a fourth implementation of the present disclosure is a rough surface provided on the external surface of the puncture needle410and configured to frictionally engage with the fixing member120. For example, the rough surface is provided on the external surface of at least part of the puncture needle410. After puncturing, the rough surface of the puncture needle410frictionally engages with the rough surface of the fixing member120of the artificial chordae tendineae100as the puncture connection member125to fix the artificial chordae tendineae100and the puncture needle410together. The rough surface may be formed by a number of tiny protrusions or ridges provided on the external surface of the puncture needle410next to the tapped straight end. The external surface of the puncture needle410next to the tapped straight end may be directly roughened to obtain the rough surface. The sidewall of the accommodation cavity121or the external surface of the puncture needle410next to the straight end may be made of materials with a certain coefficient of friction. After puncturing, a detachable connection between the puncture needle410and the fixing member120is formed, as illustrated inFIG.21.

As illustrated inFIG.12, the puncturing push rod420is connected to the proximal end of the puncture needle410. A third handle401is provided at the proximal end of the puncturing push rod420. The puncturing push rod420is movably received in the pushing shaft210. A proximal end of the third handle401extends through the proximal end of the pushing shaft210. The puncturing push rod420can be moved along an axial direction of the pushing shaft210by operating the third handle401to move axially. The puncture needle410is driven to puncture toward the distal end or withdraw toward the proximal end. After the leaflet is clamped, the puncture needle410is driven by the third handle401to puncture the leaflet. After being connected to the fixing member120of the artificial chordae tendineae100, the puncture needle410and the artificial chordae tendineae100are connected as a whole via the fixing member120.

As illustrated inFIGS.11to13, the proximal end of the clamping push rod330extends through the proximal end of the pushing shaft210and is provided with a second handle301. The clamping push rod330is moved toward the distal end via pushing the second handle301toward the distal end, such that the distal clamp310is moved away from the proximal clamp320, that is, the clamping device300in an open state, as illustrated inFIG.13. At this time, a distal end of the artificial chordae tendineae implantation system is finely adjusted, such that the leaflet enters a clamping space defined between the distal clamp310and the proximal clamp320. The second handle301is withdrawn toward the proximal end, and the clamping push rod330is driven to move toward the proximal end. Accordingly, the distal clamp310is moved close to the proximal clamp320, that is, the clamping device300is in a clamping state, as illustrated inFIG.11. At this time, the leaflet is firmly clamped by the clamping device300. The proximal clamp320, the distal clamp310, and the pushing shaft210cooperatively form a smooth external surface, for facilitating moving the artificial chordae tendineae implantation system and reducing damage to heart tissue. It can be understood that, the distal clamp310may be moved away from the proximal clamp320via driving the first handle201toward the distal end. It also can be understood that, the distal clamp310may be moved away from the proximal clamp320via withdrawing the pushing shaft210and the first handle201toward the proximal end.

In the related art, the artificial chordae tendinea implanted by a U-shaped loop sleeve combined with a hook-shaped needle may cause an edge of leaflet to be folded and to be notched, and accordingly a matching edge may not be formed and mitral valve regurgitation may easily occur. As a result, the surgical effect is not ideal. In the artificial chordae tendineae implantation system of the present disclosure, since the chordae tendineae main body110is received in the clamping push rod330, a distance between the artificial chordae tendineae and the edge of the leaflet is consistent, that is, the distance between the artificial chordae tendineae and the edge of the leaflet is the distance between the fixing cavity and the clamping push rod, which can effectively avoid the edge of the leaflet folding or a notch of the mitral valve, to enhance the surgical effect.

As illustrate inFIGS.11to13and22to23, in order to improve the clamping effect, a clamping surface321disposed on the distal end of the proximal clamp320engages with a clamping surface311disposed on the proximal end of the distal clamp310. The clamping surfaces311,321each have a large contact area in contact with the leaflet. In an illustrative embodiment, the two clamping surfaces311,321are slantingly disposed, that is, an angle formed between the clamping surface311,321and an axis of the pushing shaft210is less than 90°. In addition, at least one of the clamping surfaces311,321is provided with a reinforcing member for increasing clamping forces. In an illustrative embodiment, the reinforcing member is selected from a group consisting of a projection, a rib, a groove, and a recess provided on the clamping surface311,321. In this embodiment, the clamping surface311of the distal clamp310is provided with a number of ribs as the reinforcing member312. The ribs are parallel to each other, and accordingly the clamping surface311is stepped.

As illustrated inFIGS.22to23, the clamping push rod330is provided with an artificial chordae tendineae channel331for receiving the artificial chordae tendineae100along an axial direction. The distal clamp310is provided with an artificial chordae tendineae accommodation chamber315which is connected with the artificial chordae tendineae channel331. The chordae tendineae main body110of the artificial chordae tendineae100is received in the artificial chordae tendineae channel331and the artificial chordae tendineae accommodation chamber315.

The clamping surface311of the distal clamp310defines an accommodation slot314for accommodating the anti-slip member130. The accommodation slot314is in communication with the artificial chordae tendineae accommodation chamber315.

The clamping surface311of the distal clamp310further defines a fixing cavity313for receiving the fixing member120of the artificial chordae tendineae100. The fixing cavity313is axially in communication with the artificial chordae tendineae accommodation chamber315. The fixing cavity313is radially in communication with the accommodation slot314. The fixing member120of the artificial chordae tendineae100is received in the distal clamp310, corresponding to the puncture needle410.

After the puncture needle410is connected to the fixing member120, the puncture needle410, the fixing member120, the chordae tendineae main body110, and the anti-slip member130are simultaneously driven out of the clamping surface311of the distal clamp310by driving the puncture needle410toward the proximal end, until the puncture needle410, the fixing member120, and the chordae tendineae main body110pass through the leaflet. The anti-slip member130is fitted on the upper surface of the leaflet.

The fixing cavity313is axially in communication with the artificial chordae tendineae accommodation chamber315. The fixing member120of the artificial chordae tendineae100may be fixed in the fixing cavity313and smoothly pulled out of the fixing cavity313by an external force. Therefore, a shape of the fixing cavity313corresponds to a shape of the fixing member120. A diameter of an inscribed circle of the fixing cavity313is larger than that of a circumscribed circle of the artificial chordae tendineae accommodation chamber315. In an illustrative embodiment, a ratio of the diameter of the circumscribed circle of the artificial chordae tendineae accommodation chamber315to the diameter of the inscribed circle of the fixing cavity313is (0.2˜0.4):1. When the fixing cavity313and the artificial chordae tendineae accommodation chamber315both have a cross section in a round shape, a diameter of an inscribed circle of the fixing cavity313is equal to that of a cross-section diameter of the fixing cavity313, and a diameter of a circumscribed circle of the artificial chordae tendineae accommodation chamber315is equal to a cross-sectional diameter of the artificial chordae tendineae accommodation chamber315. In this embodiment, the fixing cavity313has a cross section in a round shape, and a diameter of the fixing cavity313is D1. The artificial chordae tendineae accommodation chamber315has a cross section in a round shape, and a diameter of the artificial chordae tendineae accommodation chamber315is D2, where D2is 30% of D1. If D2is too large, when the puncture needle410is connected to the fixing member120of the artificial chordae tendineae100by pushing the puncturing push rod420, the fixing member120may be moved from the fixing cavity313to the artificial chordae tendineae accommodation chamber315due to pushing forces of the puncturing push rod420. As a result, the puncture needle410and the fixing member120of the artificial chordae tendineae100may not be successfully connected at one time, and the surgery time is prolonged. If D2is too small, the chordae tendineae main body110of the artificial chordae tendineae100may not smoothly pass through the artificial chordae tendineae accommodation chamber315. As a result, after the puncture needle410is connected to the fixing member120of the artificial chordae tendineae100, the artificial chordae tendineae100may not be smoothly pulled out of the clamping surface311of the distal clamp310.

In order to smoothly pull the chordae tendineae main body110and the anti-slip member130out of the clamping surface311of the distal clamp310, the fixing cavity313is radially in communication with the accommodation slot314. In an illustrative embodiment, a width of a communicating portion between the fixing cavity313and the accommodation slot314is D3, where D3is 20%-50% of D1. If D3is too large, the fixing member120of the artificial chordae tendineae100may not be firmly fixed in the fixing cavity313of the distal clamp310. As a result, the fixing member120may easily slip out of the fixing cavity313, and the artificial chordae tendineae implantation system fails. If D3is too small, after the fixing member120is connected to the puncture needle410, the fixing member120may not be smoothly pulled out of the fixing cavity313, and accordingly, the surgery fails. It can be understood that, in other embodiments, the fixing cavity313and the artificial chordae tendineae accommodation chamber315both have a cross section in an elliptical, triangular, quadrangular, or polygonal shape as long as a shape of the fixing cavity313corresponds to a shape of the fixing member120, and the shape of the artificial chordae tendineae accommodation chamber315does not affect that the chordae tendineae main body110smoothly slides in the fixing cavity313.

In the related art, an artificial chordae tendineae is exposed outside of a device including the artificial chordae tendineae, such that an external surface of the device is not smooth. When entering a patient body, the device damages tissue of the patient due to friction and causes leakage of blood. As a result, risk of postoperative complications is increased. In the present disclosure, the fixing cavity313of the distal clamp310is configured to receive and fix the artificial chordae tendineae100in the artificial chordae tendineae implantation system. More importantly, the chordae tendineae main body110and the anti-slip member130may be pulled to the leaflet via the fixing cavity313without driving the distal clamp310to move away from the proximal clamp320. In this way, when the distal clamp310is moved away from the proximal clamp320, that is, a state of the clamping device300changes from the clamping state to the open state, the leaflet may be released from the clamping device300and resume flapping. At the moment of flapping resuming, the anti-slip member130is fitted on the upper surface of the leaflet. As such, a vigorous movement of leaflet relative to the chordae tendineae main body110and damage to the leaflet are avoided.

Compared with the related art, the artificial chordae tendineae implantation system provided by the embodiments of the present disclosure has advantages as follows.

The straight tapered tip of the puncture needle allows the puncturing point formed on the leaflet to be smaller, and accordingly damage to the leaflet is reduced.

The puncture needle and the artificial chordae tendineae are positioned via the clamping device, and accordingly the probability of successful connection between the puncture needle and the artificial chordae tendineae is increased, thereby shortening the surgery time.

In addition, a stable and reliable indirect connection between the puncture needle and the chordae tendineae main body of the artificial chordae tendineae may be formed via the fixing member. Thus, the artificial chordae tendineae may not easily detach from the puncture needle, and the artificial chordae tendineae may be quickly pulled to a fixed position.

As illustrated inFIG.24, the artificial chordae tendineae implantation system according to a second embodiment of the present disclosure is an improvement based on the artificial chordae tendineae implantation system according to the first embodiment. The artificial chordae tendineae implantation system according to the second embodiment of the present disclosure is similar to the artificial chordae tendineae implantation system according to the first embodiment except that a puncturing device400bis provided with two puncture needles410and two puncturing push rods420are respectively connected to the proximal end of the puncture needle410. Proximal ends of the two puncturing push rods420are provided with a third handle401. The two puncturing push rods420are received in the pushing shaft210parallelly. The first end and the second end of the chordae tendineae main body110of the artificial chordae tendineae100each are provided with the fixing member120. The two fixing members120are respectively received in the distal clamp310. The two puncture needles410respectively correspond to the two fixing members120.

As illustrated inFIGS.24,25, and26, the clamping push rod330is provided with the artificial chordae tendineae channel331along the axial direction. The distal clamp310defines two artificial chordae tendineae accommodation chambers315extending through the clamping surface311of the distal clamp310. The two artificial chordae tendineae accommodation chambers315are connected through the artificial chordae tendineae channels331. The two receiving chambers315are radially in communication with each other. The clamping surface311of the distal clamp310defines two fixing cavities313for respectively receiving the two fixing members120. The two fixing cavities313are radially in communication with each other. Each of the fixing cavities313is axially in communication with the corresponding artificial chordae tendineae accommodation chamber315. The ratio of the diameter D2of the artificial chordae tendineae accommodation chamber315to the diameter D1of the fixing cavity313is (0.2 to 0.4):1. The first end and the second end of the chordae tendineae main body110respectively extend through the two artificial chordae tendineae accommodation chambers315to be connected to the two fixing members120accommodated in the two fixing cavities313.

After puncturing, the two puncture needles410are respectively connected to the two fixing members120, such that the chordae tendineae main body110, the two fixing members120, and the two puncture needles410form a U-shaped structure. The chordae tendineae main body110is pulled out of the clamping surface311of the distal clamp310by driving the puncturing push rod420toward the proximal end. Part of the chordae tendineae main body110is fitted on the upper surface of the leaflet, and other parts of the chordae tendineae main body110together with the fixing member120and the puncture needle410pass through the leaflet until reaching the ventricular wall. Two chordae tendineae main bodies110can be simultaneously implanted between the leaflet and the ventricular wall. The anti-slip member130and part of the chordae tendineae main body110are fitted on the upper surface of the leaflet, which can limit the movement of the leaflet relative to the chordae tendineae main body110when the leaflet is flapping. Thus, damage to the leaflet is reduced.

In the embodiment, the chordae tendineae main body110may also be provided with the anti-slip member130. As illustrated inFIG.10, the first end and the second end of the chordae tendineae main body110of the artificial chordae tendineae100respectively pass through the two through holes131of the same anti-slip member130. Thus, before puncturing, the chordae tendineae main body110and the anti-slip member130form a closed loop structure. After puncturing, the anti-slip member130, the chordae tendineae main body110, the two fixing members120, and the two puncture needles410form a U-shaped structure. The chordae tendineae main body110presses the anti-slip member130, such that the anti-slip member130abuts against the upper surface of the leaflet. The chordae tendineae main body110, the anti-slip member130, and the leaflet is substantially positioned.

As illustrated inFIGS.25and26, the clamping surface311of the distal clamp310is further provided with the accommodation slot314for accommodating the anti-slip member130. The two fixing cavities313are radially in communication with the accommodation slot314. Therefore, after puncturing, the chordae tendineae main body110together with the two fixing members120and the anti-slip member130can be pulled out of the clamping surface311of the distal clamp310. In an illustrative embodiment, the width D3of the communicating portion between the fixing cavity313and the accommodation slot314is 20%-50% of the diameter D1of the fixing cavity313.

The working procedure of the artificial chordae tendineae implantation system according to the second embodiment of the present disclosure is described with the artifical chordae tendineae being implanted to the posterior leaflet of the mitral valve as an example.

As illustrated inFIG.27, the artificial chordae tendineae implantation system is driven into the left ventricle through a transapical approach. As illustrated inFIG.28, the artificial chordae tendineae implantation system is further driven until that the distal clamp310and the proximal clamp320both are located in the left atrium. The second handle301is pushed toward the distal end to drive the clamping push rod330to move in the pushing shaft210toward the distal terminal. The distal clamp310is moved away from the proximal clamp320and is moved toward the distal end. At this time, the clamping space is formed between the proximal clamp320and the distal clamp310for clamping the leaflet. The relative positions of the first handle201and the second handle301keep unchanged, the artificial chordae tendineae implantation system is slowly moved towards the proximal end, till the leaflet enters into the clamping space formed between the proximal clamp320and the distal clamp310. As illustrated inFIG.29, the distal end of the artificial chordae tendineae implantation system is slightly moved until the edge of the leaflet is in contact with the clamping push rod330. At this time, the second handle301is driven toward the proximal end to move the distal clamp310toward the proximal clamp320until the leaflet is clamped between the distal clamp310and the proximal clamp320. The third handle401is pushed toward the distal end to drive the puncture needle410to move along the axis of the pushing shaft210toward the distal terminal, that is, the puncture needle410is moved toward the distal clamp310, until that the puncture needle410passes through the leaflet and a fixed connection between the puncture needle410and the fixing member120of the artificial chordae tendineae100is formed. As illustrated inFIG.30, the third handle401is withdrawn, such that the puncture needle410drives the fixing member120of the artificial chordae tendineae100, the chordae tendineae main body110connected to the fixing member120sequentially to pass through the leaflet. At the same time, the anti-slip member130is pulled out of the clamping surface311of the distal clamp310, the fitting surface (ie, a lower surface) of the anti-slip member130is in contact with the upper surface of a leaflet900. Part of the chordae tendineae main body110presses the upper surface of the anti-slip member130such that the anti-slip member130is fitted on the leaflet900, as illustrated inFIG.31. The face contact between the anti-slip member130and the leaflet900can effectively reduce the risk of tearing the leaflet900. As illustrated inFIG.32, the third handle401is pulled back until the fixing member120is moved out of the proximal end of the pushing shaft210. The artificial chordae tendineae implantation system is withdrawn. A length of the chordae tendineae main body110left in the heart is adjusted. The first end and the second end of the chordae tendineae main body110are respectively fixed to the ventricular wall or the papillary muscles.

Compared with the related art, the artificial chordae tendineae implantation system according to the second embodiment of the present disclosure has advantages as follows.

Multiple chordae tendineae bodies may be implanted at one time. Thus, the operation efficiency is improved. In addition, the contact between the artificial chordae tendineae and the leaflet is changed from point contact to face contact, and accordingly the artificial chordae tendineae can be effectively prevented from falling off from the anti-slip member and the leaflet. Thus, better surgery effect is ensured.

The anti-slip member is tightly fitted on the upper surface of the leaflet via the chordae tendineae main body. Reliable connections between the chordae tendineae main body, the anti-slip member, and the leaflet are formed. Thus, the leaflet is effectively prevented from being torn, the risk of the chordae tendineae main body and the anti-slip member falling off from the leaf surface is reduced, and better surgery effect is achieved.

The above description is only the exemplary embodiment of the present disclosure, and is not intended to limit the present disclosure. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present disclosure should be included in the protection scope of the present disclosure.