Description:TECHNICAL FIELD
[1] The present disclosure relates to medical devices for cardiovascular surgery. More particularly the present disclosure relates to a device for repairing a leaflet of a heart valve.
BACKGROUND
[2] Mitral regurgitation is a prevalent condition wherein the chordae tendineae that hold the mitral valve leaflets in place become damaged or elongated, preventing the valve from sealing effectively. This malfunction leads to blood leaking backwards into the left atrium when the left ventricle contracts. Proper mitral valve function is crucial for maintaining efficient blood flow and heart function.
[3] Current medical technologies for correcting mitral regurgitation due to posterior leaflet prolapse involve deploying artificial chordae to replace damaged natural chords. However, existing systems are limited in that only one suture knot can be deployed at a time, requiring surgical procedures to be repeated multiple times for adequate repair. Repeating the surgical procedure multiple times to deploy the suture knots not only extends the surgical procedure but also increases the risk of blood loss and postoperative complications. Given the need to deploy multiple sutures (at least three) to balance mechanical tension and ensure valve competence, such existing systems are inadequate for optimal treatment outcomes.
[4] Therefore, in light of the foregoing discussion, there exists a need to overcome the aforementioned drawbacks.
SUMMARY
[5] The present disclosure provides a device for repairing a leaflet of a heart valve. The present disclosure provides a solution to the technical problem of how to efficiently deploy multiple sutures in a single procedure without the need for repetition, thereby reducing surgical time and minimizing the risk of blood loss and complications. An aim of the present disclosure is to provide a solution that overcomes at least partially the problems encountered in the prior art and provides an improved device capable of deploying multiple sutures simultaneously or sequentially, ensuring optimal mechanical tension and valve competence with reduced procedural complexity.
[6] One or more objectives of the present disclosure are achieved by the solutions provided in the enclosed independent claims. Advantageous implementations of the present disclosure are further defined in the dependent claims.
[7] In one aspect, the present disclosure provides a device for repairing a leaflet of a heart valve, including a handle; an elongated shaft extending from the handle; a clamping assembly at a distal end of the elongated shaft, the clamping assembly comprising an upper jaw member and a lower jaw member configured to cooperate with the upper jaw member to grasp the leaflet of the heart valve; a plurality of needle tools, each needle tool movably disposed within the elongated shaft and configured to puncture the leaflet when grasped by the clamping assembly; a multi-lumen tubular assembly including a plurality of separate lumens extending through the elongated shaft, each lumen configured to accommodate a suture; and a plurality of ribs disposed at the lower jaw member of the clamping assembly in a staircase-like configuration. Each rib of the plurality of ribs is associated with one of the plurality of separate lumens and configured to guide the suture. The device is configured to sequentially deploy a plurality of sutures to the leaflet through the plurality of separate lumens of the multi-lumen tubular assembly in a single-use.
[8] The device of the present disclosure offers several technical advantages for repairing a heart valve leaflet. The integration of the handle with the elongated shaft and the clamping assembly allows for precise control and stability during the procedure, enabling the surgeon to effectively grasp the leaflet. The inclusion of the plurality of needle tools, each capable of puncturing the leaflet, enhances the versatility of the device in handling different suture requirements. The multi-lumen tubular assembly, with its separate lumens designed to accommodate sutures, ensures that multiple sutures may be deployed in a controlled and organized manner. The staircase-like configuration of the ribs at the lower jaw member further aids in guiding the sutures accurately to their intended locations, reducing the likelihood of suture tangling or misplacement. By enabling the sequential deployment of multiple sutures in a single-use, the device minimizes the need for repeated procedures, thus reducing overall surgical time, the risk of blood loss, and potential complications. The device ultimately improves the efficiency and effectiveness of mitral valve repair surgeries, providing better patient outcomes.
[9] It is to be appreciated that all the aforementioned implementation forms can be combined. All steps that are performed by the various entities described in the present application, as well as the functionalities described to be performed by the various entities, are intended to mean that the respective entity is adapted to or configured to perform the respective steps and functionalities. It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing from the scope of the present disclosure as defined by the appended claims.
[10] Additional aspects, advantages, features, and objects of the present disclosure would be made apparent from the drawings and the detailed description of the illustrative implementations construed in conjunction with the appended claims that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[11] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the present disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale. Wherever possible, like elements have been indicated by identical numbers.
[12] Embodiments of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:
FIG. 1 is a schematic perspective view of a device for repairing a leaflet of a heart valve, in accordance with an embodiment of the present disclosure;
FIGs. 2A, 2B, and 2C are enlarged perspective views of a clamping assembly of the device of FIG. 1, in accordance with an embodiment of the present disclosure;
FIG. 3A is an enlarged perspective view of a multi-lumen tubular assembly of the device of FIG. 1, in accordance with an embodiment of the present disclosure;
FIG. 3B is an enlarged perspective view of a plurality of sutures preloaded and positioned into the multi-lumen tubular assembly of the device of FIG. 1, in accordance with an embodiment of the present disclosure;
FIGs. 4A, 4B, and 4C are enlarged schematic views of a portion of a plurality of needle tools to be used in the device of FIG. 1, in accordance with an embodiment of the present disclosure;
FIG. 5 is an enlarged perspective view of a first needle tool of the device deploying a first suture, in accordance with an embodiment of the present disclosure;
FIG. 6A is a cross-sectional view of the first needle tool extending outwards through an elongated shaft of the device, in accordance with an embodiment of the present disclosure;
FIG. 6B is a cross-sectional view of the first needle tool retracting inwards through the elongated shaft of the device while catching the first suture for deployment, in accordance with an embodiment of the present disclosure;
FIG. 7 is an enlarged perspective view of a second needle tool of the device deploying a second suture, in accordance with an embodiment of the present disclosure;
FIG. 8A is a cross-sectional view of the second needle tool extending outwards through the elongated shaft of the device, in accordance with an embodiment of the present disclosure;
FIG. 8B is a cross-sectional view of the second needle tool retracting inwards through the elongated shaft of the device while catching the second suture for deployment, in accordance with an embodiment of the present disclosure;
FIG. 9 is an enlarged perspective view of a third needle tool of the device deploying a third suture, in accordance with an embodiment of the present disclosure;
FIG. 10A is a cross-sectional view of the third needle tool extending outwards through the elongated shaft of the device, in accordance with an embodiment of the present disclosure;
FIG. 10B is a cross-sectional view of the third needle tool retracting inwards through the elongated shaft of the device while catching the third suture for deployment, in accordance with an embodiment of the present disclosure;
FIG. 11 is a cross-sectional view of a rear portion of the device illustrating a plurality of suture openings in a handle of the device, in accordance with an embodiment of the present disclosure;
FIG. 12 is an enlarged perspective view of the rear portion of the device illustrating a needle guiding port located on the handle, in accordance with an embodiment of the present disclosure;
FIG. 13A is a cross-sectional view of a middle portion of the device illustrating a holder member, in accordance with an embodiment of the present disclosure; and
FIG. 13B is an enlarged perspective view of the middle portion of the device illustrating the holder member, in accordance with an embodiment of the present disclosure.
[13] In the accompanying drawings, an underlined number is employed to represent an item over which the underlined number is positioned or an item to which the underlined number is adjacent. A non-underlined number relates to an item identified by a line linking the non-underlined number to the item. When a number is non-underlined and accompanied by an associated arrow, the non-underlined number is used to identify a general item at which the arrow is pointing.
DETAILED DESCRIPTION OF EMBODIMENTS
[14] The following detailed description illustrates embodiments of the present disclosure and ways in which they can be implemented. Although some modes of carrying out the present disclosure have been disclosed, those skilled in the art would recognize that other embodiments for carrying out or practicing the present disclosure are also possible.
[15] FIG. 1 is a schematic perspective view of a device 100 for repairing a leaflet of a heart valve, in accordance with an embodiment of the present disclosure. With reference to FIG. 1, there is shown a device 100 for repairing the leaflet of the heart valve. The device 100 includes a handle 102 and an elongated shaft 104 extending from the handle 102. The elongated shaft 104 includes a proximal end 106 and a distal end 108 opposite the proximal end 106. The device 100 further includes a holder member 110 partially inserted into the elongated shaft 104. The device 100 further includes a clamping assembly 112 at the distal end 108 of the elongated shaft 104. The device 100 further includes a plurality of sutures 114 preloaded into the device 100. In the illustrated embodiment of FIG. 1, the plurality of sutures 114 includes a first suture 114A, a second suture 114B, and a third suture 114C. However, in some other embodiments, the plurality of sutures 114 may include any number of sutures that may be preloaded into the device 100.
[16] The device 100 further includes a plurality of needle tools, such as a needle tool 116. In some implementations, the plurality of needle tools includes needles of different sizes corresponding to the plurality of sutures 114. In some implementations, each needle tool of the plurality of needle tools (for example, the needle tool 116) is movably disposed within the elongated shaft 104. In the illustrated embodiment of FIG. 1, the needle tool 116 is inserted into the elongated shaft 104 via a needle guiding port 118 located at the handle 102. In some embodiments, the elongated shaft 104 may have a channel to guide the needle tool 116 inserted into the channel through the needle guiding port 118. In some implementations, a needle tool 116 having a size different than the needle tool 116 may also be inserted into the elongated shaft 104 via the needle guiding port 118, as per application requirements. In some implementations, the needle tool 116 has a flexible body, a hook-like feature at one end of the flexible body for catching a suture, and a flat disc at another end of the flexible body for manual manipulation. In some implementations, the plurality of needle tools is configured to create a plurality of punctures in the leaflet at a set of predefined different locations.
[17] In some implementations, the handle 102 of the device 100 includes a spring-loaded plunger 120 for actuation of the clamping assembly 112. Pressing the spring-loaded plunger 120 actuates the clamping assembly 112 to grasp the leaflet. The handle 102 further includes at least two finger rests 122 extending radially outwards from the handle 102. The at least two finger rests 122 are configured to provide ergonomic support for fingers of a user pressing the spring-loaded plunger 120 for the actuation of the clamping assembly 112.
[18] In some implementations, the handle 102 further includes a plurality of suture openings 124. Each suture opening is configured to accommodate a suture from the plurality of sutures 114. In the illustrated embodiment of FIG. 1, the plurality of suture openings 124 includes a first suture opening 124A for the first suture 114A, a second suture opening 124B for the second suture 114B, and a third suture opening 124C for the third suture 114C. Each suture opening of the plurality of suture openings 124 is provided with a cap of the plurality of caps 126 to secure and close each suture opening when the device 100 is not in operation, and to selectively loosen the plurality of sutures 114 for deployment during operation. Specifically, the first suture opening 124A is provided with a first cap 126A, the second suture opening 124B is provided with a second cap 126B, and the third suture opening 124C is provided with a third cap 126C.
[19] In operation, when the user presses the spring-loaded plunger 120 on the handle 102, actuating the clamping assembly 112 at the distal end 108 of the elongated shaft 104. Upon releasing the spring-loaded plunger 120, the clamping assembly 112 grasps the leaflet 212 of the heart valve. The needle tool 116 is then inserted into the elongated shaft 104 through the needle guiding port 118 on the handle 102 and guided to puncture the grasped leaflet 212 at the predefined location. To prepare for suture deployment, a cap on a suture opening from the plurality of suture openings 124 is loosened, releasing the corresponding suture from the plurality of sutures 114. The corresponding suture is then deployed through the puncture created by the needle tool 116. After deployment, the corresponding suture is pulled out from the needle guiding port 118. At last, the holder member 110 is pulled out from the elongated shaft 104 to remove the corresponding suture from the device 100. Such process of suture deployment may be repeated for each of the plurality of sutures 114 using different sized needle tools of the plurality of needle tools as required, without removing the device 100 from the surgical site. Mechanism of the device 100 allows for the sequential deployment of the plurality of sutures 114 to repair the leaflet of the heart valve in a single procedure, thereby improving efficiency and reducing trauma to the patient.
[20] For example, in a typical procedure using the device 100, the user or a surgeon begins by pressing the spring-loaded plunger 120 to actuate the clamping assembly 112, which then grasps a target heart valve leaflet 212 upon release. The surgeon then inserts a needle tool (for example, the needle tool 116) through the needle guiding port 118 into the elongated shaft 104. The needle tool 116 punctures the leaflet at a predetermined location. The surgeon then loosens the first cap 126A on the first suture opening 124A, releasing the first suture 114A. The first suture 114A is deployed through the puncture created by the needle tool 116. After deployment, the first suture 114A is pulled out from the needle guiding port 118, and the holder member 110 is used to extract the first suture 114A from the device 100. The process is then repeated for the second suture 114B. A potentially different-sized needle tool 116 is inserted through the same needle guiding port 118, creating a second puncture in the leaflet. The second cap 126B on the second suture opening 124B is loosened, and the second suture 114B is deployed and extracted in the same manner as the first suture 114A. Finally, the procedure is repeated a third time for the third suture 114C, using the third suture opening 124C. Mechanism of the device 100 allows for the placement of three sutures at different locations on the leaflet, all without removing the device 100 from the surgical site. The staggered arrangement of the suture openings 124A, 124B, and 124C, along with the ability to use different-sized needle tools, enables precise placement of each suture according to the specific needs of the repair.
[21] FIGs. 2A, 2B, and 2C are enlarged perspective views of a clamping assembly of the device of FIG. 1, in accordance with an embodiment of the present disclosure. FIGs. 2A, 2B, and 2C are described in conjunction with the elements of FIG. 1. With reference to FIG. 2A, there is shown an enlarged diagram of the clamping assembly 112 of the device 100. With reference to FIG. 2B, there is shown an enlarged diagram of the clamping assembly 112 of the device 100 in a non-actuated state and a leaflet 212 of the heart valve in positioned in the clamping assembly 112. With reference to FIG. 2C, there is shown an enlarged diagram of the clamping assembly 112 of the device 100 in an actuated state and the leaflet 212 of the heart valve grasped by the clamping assembly 112. Referring to FIGs. 2A, 2B, and 2C, the clamping assembly 112 includes an upper jaw member 202 and a lower jaw member 204 configured to cooperate with the upper jaw member 202 to grasp the leaflet 212 of the heart valve. In the illustrated embodiment of FIG. 2A, the upper jaw member 202 has a two part integral structure including a distal part having a frustum shape and a proximal part having a circular shape. However, in some other embodiments, the upper jaw member 202 may have any other shape as per application requirements. The upper jaw member 202 further includes a rectangular through-hole 202A along a height of the frustum shape of the distal part of the upper jaw member 202. As illustrated, the rectangular through-hole 202A has two openings, i.e., one from the base of the frustum shape and another from the curved surface area, forming a rectangular shape along a slant height of the frustum shape of the distal part of the upper jaw member 202. Moreover, the rectangular through-hole 202A may be radially offset from a central axis of the frustum shape of the distal part of the upper jaw member 202. The rectangular through-hole 202A is configured to accommodate each of the plurality of needle tools and allow each of the plurality of needle tools to move longitudinally and freely through the rectangular through-hole 202A. In other embodiments, the rectangular through-hole 202A may have a different shape according to a shape and size of the plurality of needle tools, as per application requirements.
[22] Further, the proximal part of the upper jaw member 202 has a rectangular groove 204A complementing the rectangular through-hole 202A. Both, the rectangular through-hole 202A and the rectangular groove 204A align with one another to guide the plurality of needle tools through the rectangular through-hole 202A and the rectangular groove 204A.
[23] The lower jaw member 204 of the clamping assembly 112 has a cylindrical shape with a flat end. The flat end of the lower jaw member 204 is configured to press with the upper jaw member 202, allowing the leaflet 212 of the heart valve to be securely grasped between the upper jaw member 202 and the lower jaw member 204 when the spring-loaded plunger 120 is released. In some implementations, the lower jaw member 204 is integral with the elongated shaft 104 (shown in FIG. 1), as shown in FIG. 2A. In other implementations, the lower jaw member 204 is a separate component that is coupled to the elongated shaft 104, allowing for flexibility in design and assembly.
[24] The clamping assembly 112 further includes an elongated member 206 connected with the upper jaw member 202 and the spring-loaded plunger 120 (of FIG. 1). The spring-loaded plunger 120 is configured to push the elongated member 206 of the clamping assembly 112. In some implementations, the elongated member 206 is fixedly coupled with the lower jaw member 204.
[25] In the non-actuated state, the upper jaw member 202 and the lower jaw member 204 are configured to provide a space 208 to position the leaflet 212 of the heart valve into the space 208, as shown in FIG. 2B. In the actuated state, the upper jaw member 202 is pulled towards the lower jaw member 204 by the spring-loaded plunger 120 when released, as shown in FIG. 2C. Specifically, the upper jaw member 202 is pulled towards a surface of the proximal part of the lower jaw member 204. Pulling the upper jaw member 202 towards the lower jaw member 204 facilitate grasping the leaflet 212 positioned between the lower jaw member 204 and the upper jaw member 202, as shown in FIG. 2C. In both the non-actuated state and the actuated state, the lower jaw member 204 retain its original position and the upper jaw member 202 move in a longitudinal direction D1 when the spring-loaded plunger 120 is pressed as shown in FIG. 2B, upon releasing the spring-loaded plunger 120 the upper jaw member 202 move in a longitudinal direction D2 as shown in FIG. 2C, relative to the lower jaw member 204.
[26] In the illustrated embodiment of FIGs. 2A, 2B, and 2C, the device 100 further includes a plurality of ribs 210 disposed at the upper jaw member 202 of the clamping assembly 112 in a staircase-like configuration. In some implementations, the plurality of ribs 210 is configured to guide the suture of the plurality of sutures 114. As illustrated, the plurality of ribs 210 includes a first rib 210A associated with the first suture 114A, a second rib 210B associated with the second suture 114B, and a third rib 210C associated with the third suture 114C. Specifically, the plurality of sutures 114 are positioned on the plurality of ribs 210. It should be noted that while the illustrated embodiment depicts three sutures and corresponding ribs, the number of sutures and ribs may vary in other implementations depending on the requirements of the application. In such implementations, positioning the plurality of sutures 114 on a corresponding rib of the plurality of ribs 210 prevents entanglement of the plurality of sutures 114 with one another. In some implementations, the staircase-like configuration of the plurality of ribs 210 is configured to distribute tension across the plurality of sutures 114 when deployed. By utilizing the plurality of ribs 210, the device 100 may separately deploy each of the plurality of sutures 114 without any hassle or entanglement of the plurality of sutures 114.
[27] In some implementations, each of the plurality of sutures 114 has a different length corresponding to its position in the staircase-like configuration of the plurality of ribs 210. For example, a length of the first suture 114A is greater than lengths of the second suture 114B and the third suture 114C as the first suture 114A is positioned on the first rib 210A of the plurality of ribs 210. Similarly, the length of the second suture 114B is greater than the length of the third suture 114C but smaller than the length of the first suture 114A as the second suture 114B is positioned on the second rib 210B. Lastly, in a similar way, the length of the third suture 114C is smaller than the length of the first suture 114A and the length of the second suture 114B as the third suture 114C is positioned on the third rib 210C.
[28] FIG. 3A is an enlarged perspective view of a multi-lumen tubular assembly of the device of FIG. 1, in accordance with an embodiment of the present disclosure. FIG. 3A is described in conjunction with the elements of FIGs. 1, 2A, 2B, and 2C. With reference to FIG. 3A, there is shown a front end of the device 100 including a multi-lumen tubular assembly 300.
[29] The multi-lumen tubular assembly 300 includes a plurality of separate lumens 304 extending through the elongated shaft 104. In the illustrated embodiment of FIG. 3A, the multi-lumen tubular assembly 300 includes a tubular structure 302 including the plurality of separate lumens 304. As illustrated, the elongated member 206 has a groove underneath. The groove of the elongated member 206 has a shape similar to an inverted English letter “U”. Specifically, the tubular structure 302 is disposed within the groove of the elongated member 206.
[30] The plurality of separate lumens 304 of the multi-lumen tubular assembly 300 includes at least three lumens, for example, a first lumen 304A, a second lumen 304B, and a third lumen 304C. However, in some other embodiments, the plurality of separate lumens 304 may include any number of lumens as per application requirements. In such embodiment, the tubular structure 302 may include any number of lumens such as two lumens, four lumens, five lumens and the like, without limiting the scope of the present disclosure. In some embodiments, the multi-lumen tubular assembly 300 may include more than one tubular structure (similar to the tubular structure 302) having the plurality of separate lumens 304. Further, each lumen of the plurality of separate lumens 304 is configured to accommodate the suture of the plurality of sutures 114 as explained in detail below with reference to FIG. 3B.
[31] FIG. 3B is an enlarged perspective view of a plurality of sutures preloaded and positioned into the multi-lumen tubular assembly 300 of the device of FIG. 1, in accordance with an embodiment of the present disclosure. FIG. 3B is described in conjunction with the elements of FIGs. 1, 2A, 2B, 2C, and 3A. With reference to FIG. 3B, there is shown a front end of the device 100 including the multi-lumen tubular assembly 300 that is preloaded with the plurality of sutures 114.
[32] In some implementations, each suture of the plurality of sutures 114 is preloaded within one of the plurality of separate lumens 304. For example, in the illustrated embodiment of FIG. 3B, the first lumen 304A of the plurality of separate lumens 304 is preloaded within the first lumen 304A. Similarly, the second lumen 304B of the plurality of separate lumens 304 is preloaded within the second lumen 304B. Further, the third lumen 304C of the plurality of separate lumens 304 is preloaded within the third lumen 304C.
[33] It should be noted that the plurality of sutures 114 are preloaded into the plurality of separate lumens 304 within the device 100 using a long needle, similar to a sewing needle. The process involves inserting the suture of the plurality of sutures 114 into a hole of the sewing needle and then guiding the suture through an opening at the distal end 108 of a corresponding lumen from the plurality of separate lumens 304. The suture is passed through the corresponding lumen from the distal end 108 to the proximal end 106, where the suture exits through a corresponding suture opening of the plurality of suture openings 124 located on the handle 102. After the suture is passed through the corresponding suture opening, a cap is configured to engage with the corresponding suture opening to secure and tighten the corresponding suture opening. For example, the first suture 114A is inserted into the first lumen 304A through its opening at the distal end 108, passed through the lumen 304A to the proximal end 106, and then through the first suture opening 124A on the handle 102. The first cap 126A is then engaged to secure the first suture opening 124A. Similarly, the second suture 114B and the third suture 114C are loaded into their respective lumens 304B and 304C and secured in the same manner.
[34] After each of the plurality of sutures 114 is loaded into the corresponding lumen of the plurality of separate lumens 304 and passed through the corresponding suture opening on the handle 102, the suture may be manually positioned on the corresponding rib of the plurality of ribs 210. To do this, the suture is first loosened from the cap that secures the corresponding suture opening, allowing for manual adjustment. The suture is then placed onto the corresponding rib, such as the first suture 114A being placed on the first rib 210A, the second suture 114B being placed on the second rib 210B and the third suture 114C being placed on the third rib 210C.
[35] Once the suture is positioned on the corresponding rib, a portion of the suture exiting from the corresponding suture opening is stressed or pulled to create tension. This tension ensures that the suture securely takes its position on the corresponding rib, maintaining the correct alignment and readiness for deployment. The method of placing the suture on the corresponding rib ensures that the suture is properly positioned and tensioned, which is crucial for the subsequent steps in the procedure of repairing the leaflet 212 of the heart valve.
[36] Referring to FIGs. 2A, 2B, 2C, 3A and 3B, each rib of the plurality of ribs 210 (shown in FIGs. 2A, 2B, and 2C) is associated with one of the plurality of separate lumens 304. For example, the first rib 210A is associated with the first lumen 304A, the second rib 210B is associated with the second lumen 304B, and the third rib 210C is associated with the third lumen 304C. Specifically, the first rib 210A is holding the first suture 114A in place that is preloaded within the first lumen 304A. Similarly, the second rib 210B is holding the second suture 114B in place that is preloaded within the second lumen 304B. Further, in a similar manner, the third rib 210C is holding the third suture 114C in place that is preloaded within the third lumen 304C.
[37] In some implementations, each lumen of the plurality of separate lumen 304 of the device 100 houses the suture from the plurality of sutures 114 in a doubled-over configuration, enhancing the stability and control of the suture during deployment. The doubled-over configuration of each suture creates a loop at one end. The loop created by each suture is strategically secured around the corresponding rib of the plurality of ribs 210.
[38] In some implementations, the device 100 is configured to sequentially deploy the plurality of sutures 114 to the leaflet 212 through the plurality of separate lumens 304 of the multi-lumen tubular assembly 300 in a single-use. The sequential deployment allows for precise and controlled placement of the plurality of sutures 114, minimizing the need for repeated procedures. By deploying all necessary sutures in a single-use, the device 100 reduces procedure time, lowers the risk of blood loss, and enhances overall surgical efficiency, leading to improved patient outcomes. Sequential deployment of the plurality of sutures 114 are explained in detail with reference to FIGs. 5-10B.
[39] FIGs. 4A, 4B, and 4C are enlarged schematic views of a portion of a plurality of needle tools to be used in the device of FIG. 1, in accordance with an embodiment of the present disclosure. FIGs. 4A, 4B, and 4C are described in conjunction with the elements of FIGs. 1, 2A, 2B, 2C, 3A, and 3B. With reference to FIG. 4A, there is shown a first needle tool 400A of the plurality of needle tools. The first needle tool 400A is configured to deploy the first suture 114A (shown in FIGs. 2A, 2B, and 2C). The first needle tool 400A includes a curved hook-like structure 402A at an end of the first needle tool 400A. The curved hook-like structure 402A has a first depth L1. With reference to FIG. 4B, there is shown a second needle tool 400B of the plurality of needle tools. The second needle tool 400B is configured to deploy the second suture 114B (shown in FIGs. 2A, 2B, and 2C). The second needle tool 400B includes a curved hook-like structure 402B at an end of the second needle tool 400B. The curved hook-like structure 402B has a second depth L2. With reference to FIG. 4C, there is shown a third needle tool 400C of the plurality of needle tools. The third needle tool 400C is configured to deploy the third suture 114C (shown in FIGs. 2A, 2B, and 2C). The third needle tool 400C includes a curved hook-like structure 402C at an end of the third needle tool 400C. The curved hook-like structure 402C has a third depth L3.
[40] Referring to FIGs. 4A, 4B, and 4C, the first depth L1 is smaller than the second depth L2 and the third depth L3. Further, the second depth L2 is smaller than the third depth L3 but greater than the first depth L1. Furthermore, the third depth L3 is greater than the first depth L1 and the second depth L2. The depth of the curved hook-like structure 402A of the first needle tool 400A, the second needle tool 400B, and the third needle tool 400C is determined by the staircase-like configuration of the plurality of ribs 210 (as shown in FIGs. 2A, 2B, and 2C). For example, the first needle tool 400A is used for the first suture 114A, which is positioned on the first rib 210A, located above the second rib 210B and the third rib 210C. Similarly, the second needle tool 400B is used for the second suture 114B positioned on the second rib 210B, and the third needle tool 400C is used for the third suture 114C positioned on the third rib 210C, based on the respective locations of the second rib 210B and the third rib 210C.
[41] FIG. 5 is an enlarged perspective view of a first needle tool 400A of the device 100 deploying a first suture 114A, in accordance with an embodiment of the present disclosure. FIG. 5 is described in conjunction with the elements of FIGs. 1-4C. With reference to FIG. 5, there is shown the first needle tool 400A (of FIG. 4A) deploying the first suture 114A.
[42] In the illustrated embodiment of FIG. 5, the first needle tool 400A is hooked into the first suture 114A positioned on the first rib 210A. Specifically, the curved hook-like structure 402A of the first needle tool 400A is hooked into the first suture 114A. The first depth L1 of the curved hook-like structure 402A is precisely matched to a height of the first rib 210A, ensuring that the first needle tool 400A hooks only the first suture 114A without interfering with other sutures or ribs. Such precise depth of the first needle tool 400A allows for accurate and controlled suture deployment.
[43] FIG. 6A is a cross-sectional view of the first needle tool 400A extending outwards through an elongated shaft 104 of the device 100, in accordance with an embodiment of the present disclosure. FIG. 6A is described in conjunction with the elements of FIGs. 1-5. With reference to FIG. 6A, there is shown the first needle tool 400A (of FIG. 4A) extending outwards through the elongated shaft 104 of the device 100.
[44] FIG. 6B is a cross-sectional view of the first needle tool 400A retracting inwards through the elongated shaft 104 of the device 100 while catching the first suture 114A for deployment, in accordance with an embodiment of the present disclosure. FIG. 6B is described in conjunction with the elements of FIGs. 1-6A. With reference to FIG. 6B, there is shown the first needle tool 400A (of FIG. 4A) retracting inwards through the elongated shaft 104 of the device 100 while catching the first suture 114A for deployment.
[45] Referring to FIGs. 6A and 6B, in operation, upon releasing the spring-loaded plunger 120 (of FIG. 1), the clamping assembly 112 grasps the leaflet 212 of the heart valve at a first predefined location. The first needle tool 400A is then inserted into the elongated shaft 104 through the needle guiding port 118 (shown in FIG. 1) on the handle 102 and guided to puncture the grasped leaflet 212 at a first predefined location, as shown in FIG. 6A. To prepare for suture deployment, the first cap 126A (shown in FIG. 1) on the first suture opening 124A (shown in FIG. 1) from the plurality of suture openings 124 is loosened, releasing the first suture 114A from the plurality of sutures 114. The first suture 114A is then deployed through the puncture created by the first needle tool 400A, as shown in FIG. 6B.
[46] FIG. 7 is an enlarged perspective view of a second needle tool 400B of the device 100 deploying a second suture 114B, in accordance with an embodiment of the present disclosure. FIG. 7 is described in conjunction with the elements of FIGs. 1-6B. With reference to FIG. 7, there is shown the second needle tool 400B (of FIG. 4B) deploying the second suture 114B.
[47] In the illustrated embodiment of FIG. 7, the second needle tool 400B is hooked into the second suture 114B positioned on the second rib 210B. Specifically, the curved hook-like structure 402B of the second needle tool 400B is hooked into the second suture 114B. The second depth L2 of the curved hook-like structure 402B is precisely matched to a summation of the height of the first rib 210A and a height of the second rib 210B, ensuring that the second needle tool 400B hooks only the second suture 114B without interfering with other sutures or ribs. Such precise depth of the second needle tool 400B allows for accurate and controlled suture deployment.
[48] FIG. 8A is a cross-sectional view of the second needle tool 400B extending outwards through the elongated shaft 104 of the device 100, in accordance with an embodiment of the present disclosure. FIG. 8A is described in conjunction with the elements of FIGs. 1-7. With reference to FIG. 8A, there is shown the second needle tool 400B (of FIG. 4B) extending outwards through the elongated shaft 104 of the device 100.
[49] FIG. 8B is a cross-sectional view of the second needle tool 400B retracting inwards through the elongated shaft 104 of the device 100 while catching the second suture 114B for deployment, in accordance with an embodiment of the present disclosure. FIG. 8B is described in conjunction with the elements of FIGs. 1-8A. With reference to FIG. 8B, there is shown the second needle tool 400B (of FIG. 4B) retracting inwards through the elongated shaft 104 of the device 100 while catching the second suture 114B for deployment.
[50] Referring to FIGs. 8A and 8B, in operation, upon successful deployment of the first suture 114A (shown in FIGs. 6A and 6B), the spring-loaded plunger 120 (of FIG. 1) is again used to actuate the clamping assembly 112 for grasping the leaflet 212 of the heart valve at a second predefined location. The second needle tool 400B is then inserted into the elongated shaft 104 through the needle guiding port 118 (shown in FIG. 1) on the handle 102 and guided to puncture the grasped leaflet 212 at the second predefined location, as shown in FIG. 8A. To prepare for suture deployment, the second cap 126B (shown in FIG. 1) on the second suture opening 124B (shown in FIG. 1) from the plurality of suture openings 124 is loosened, releasing the second suture 114B from the plurality of sutures 114. The second suture 114B is then deployed through the puncture created by the second needle tool 400B, as shown in FIG. 8B.
[51] FIG. 9 is an enlarged perspective view of a third needle tool 400C of the device 100 deploying a third suture 114C, in accordance with an embodiment of the present disclosure. FIG. 9 is described in conjunction with the elements of FIGs. 1-8B. With reference to FIG. 9, there is shown the third needle tool 400C (of FIG. 4C) deploying the third suture 114C.
[52] In the illustrated embodiment of FIG. 9, the third needle tool 400C is hooked into the third suture 114C positioned on the third rib 210C. Specifically, the curved hook-like structure 402C of the third needle tool 400C is hooked into the third suture 114C. The third depth L3 of the curved hook-like structure 402C is precisely matched to a summation of the height of the first rib 210A, the height of the second rib 210B, and a height of the third rib 210C, ensuring that the third needle tool 400C hooks only the third suture 114C without interfering with other components. Such precise depth of the third needle tool 400C allows for accurate and controlled suture deployment.
[53] FIG. 10A is a cross-sectional view of the third needle tool 400C extending outwards through the elongated shaft 104 of the device 100, in accordance with an embodiment of the present disclosure. FIG. 10A is described in conjunction with the elements of FIGs. 1-9. With reference to FIG. 10A, there is shown the third needle tool 400C (of FIG. 4C) extending outwards through the elongated shaft 104 of the device 100.
[54] FIG. 10B is a cross-sectional view of the third needle tool 400C retracting inwards through the elongated shaft 104 of the device 100 while catching the third suture 114C for deployment, in accordance with an embodiment of the present disclosure. FIG. 10B is described in conjunction with the elements of FIGs. 1-10A. With reference to FIG. 10B, there is shown the third needle tool 400C (of FIG. 4C) retracting inwards through the elongated shaft 104 of the device 100 while catching the third suture 114C for deployment.
[55] Referring to FIGs. 10A and 10B, in operation, upon successful deployment of the first suture 114A (shown in FIGs. 6A and 6B) and the second suture 114B (shown in FIGs. 8A and 8B), the spring-loaded plunger 120 (of FIG. 1) is again used to actuate the clamping assembly 112 for grasping the leaflet 212 of the heart valve at a third predefined location. The third needle tool 400C is then inserted into the elongated shaft 104 through the needle guiding port 118 (shown in FIG. 1) on the handle 102 and guided to puncture the grasped leaflet 212 at the third predefined location, as shown in FIG. 10A. To prepare for suture deployment, the third cap 126C (shown in FIG. 1) on the third suture opening 124C (shown in FIG. 1) from the plurality of suture openings 124 is loosened, releasing the third suture 114C from the plurality of sutures 114. The third suture 114C is then deployed through the puncture created by the third needle tool 400C, as shown in FIG. 10B.
[56] FIG. 11 is a cross-sectional view of a rear portion of the device 100 illustrating a plurality of suture openings 124 in a handle 102 of the device 100, in accordance with an embodiment of the present disclosure. FIG. 11 is described in conjunction with the elements of FIGs. 1-10B. With reference to FIG. 11, there is shown a close-up cross-sectional view of the rear portion of the device 100 illustrating the plurality of suture openings 124 in the handle 102.
[57] In the illustrated embodiment of FIG. 11, the first suture opening 124A includes the first cap 126A having internal threads 1102A. The first cap 126A provided for the first suture opening 124A is configured to engage with external threads 1104A on the first suture opening 124A. In other words, the internal threads 1102A of the first cap 126A matches with the external threads 1104A on the first suture opening 124A. Similarly, the second cap 126B for the second suture opening 124B includes internal threads 1102B that matches external threads 1104B on the second suture opening 124B, and the third cap 126C for the third suture opening 124C includes internal threads 1102C that matches external threads 1104C on the third suture opening 124C.
[58] FIG. 12 is an enlarged perspective view of the rear portion of the device 100 illustrating a needle guiding port 118 located on the handle 102, in accordance with an embodiment of the present disclosure. FIG. 12 is described in conjunction with the elements of FIGs. 1-11. With reference to FIG. 12, there is shown an exemplary scenario diagram that demonstrates how the first suture 114A from the plurality of sutures 114 is extracted through the needle guiding port 118 using the first needle tool 400A.
[59] The needle guiding port 118 guides the first needle tool 400A and ensures the first suture 114A is properly aligned for deployment. The needle guiding port 118 located on the handle 102 allows for a smooth transition of the first suture 114A from within the device 100 to a target area, maintaining the necessary tension and preventing any entanglement or misalignment during the procedure. After the deployment, the first suture 114A is pulled through the needle guiding port 118, ensuring the first suture 114A is securely positioned and correctly placed, contributing to the overall effectiveness and reliability of the heart valve repair procedure.
[60] It should be noted that while FIG. 12 illustrates the first suture 114A and the first needle tool 400A, the principles and functionality described are equally applicable to other sutures, such as the second suture 114B and the third suture 114C, as well as other needle tools, including the second needle tool 400B and the third needle tool 400C. Although the additional sutures and needle tools are not explicitly illustrated due to constraints in the figure, they operate in a similar manner and are fully compatible with the device 100, ensuring versatility and effectiveness in various procedural scenarios.
[61] FIG. 13A is a cross-sectional view of a middle portion of the device illustrating a holder member 110, in accordance with an embodiment of the present disclosure. FIG. 13A is described in conjunction with the elements of FIGs. 1-12. With reference to FIG. 13A, there is shown a cross-sectional view of the holder member 110.
[62] In the illustrated embodiment of FIG. 13A, the holder member 110 is inserted into a suture extracting port 1300 located on the middle portion of the elongated shaft 104. Specifically, the holder member 110 has a square shaped ring section 1302 that is inserted into the suture extracting port 1300 located on the middle portion of the elongated shaft 104 before entering the plurality of needle tools (such as the needle tool 116, the first needle tool 400A, the second needle tool 400B, and the third needle tool 400C). In some implementations, the holder member 110 is configured to retain the suture of the plurality of sutures 114 during deployment through one of the plurality of separate lumens 304 (shown in FIGs. 3A and 3B). As illustrated, the holder member 110 is configured to hold the first suture 114A during the deployment of the first suture 114A. However, the principles and functionality of the holder member 110 are equally applicable to other sutures such as the second suture 114B and the third suture 114C.
[63] FIG. 13B is an enlarged perspective view of the middle portion of the device illustrating the holder member, in accordance with an embodiment of the present disclosure. FIG. 13B is described in conjunction with the elements of FIGs. 1-13A. With reference to FIG. 13B, there is shown a schematic perspective view of the holder member 110.
[64] In some implementations, the holder member 110 is configured to lift the suture when removed from the elongated shaft 104. In the illustrated embodiment of FIG. 13B, the holder member 110 is lifted up from the suture extracting port 1300 after the deployment of the first suture 114A. Upon lifting the holder member 110, the first suture 114A is also lifted up along with the holder member 110. Specifically, after deployment of the first suture 114A, the first needle tool 400A (shown in FIG. 4A) is retracted via the needle guiding port 118 (shown in FIG. 12). Upon retraction of the first needle tool 400A, the first suture 114A hooked onto the first needle tool 400A pass through the square shaped ring section 1302 of the holder member 110. Upon listing up the holder member 110, the first suture 114A is extracted from the device 100.
[65] The device 100 of the present disclosure offers several technical advantages for repairing the leaflet 212 of the heart valve. The integration of the handle 102 with the elongated shaft 104 and the clamping assembly 112 allows for precise control and stability during a procedure of repairing the leaflet 212 of the heart valve, enabling a surgeon to effectively grasp the leaflet 212 of the heart valve. The inclusion of the plurality of needle tools (such as the needle tool 116, the first needle tool 400A, the second needle tool 400B, and the third needle tool 400C), each capable of puncturing the leaflet 212 of the heart valve, enhances versatility of the device 100 in handling different suture requirements. The multi-lumen tubular assembly 300, with the plurality of separate lumens 304 designed to accommodate the plurality of sutures 114, ensures that the plurality of sutures 114 may be deployed in a controlled and organized manner. The staircase-like configuration of the plurality of ribs 210 at the upper jaw member 202 further aids in guiding the plurality of sutures 114 accurately to the predefined different locations, reducing the likelihood of suture tangling or misplacement. By enabling the sequential deployment of the plurality of sutures 114 in a single-use, the device 100 minimizes the need for repeated procedures, thus reducing overall surgical time, the risk of blood loss, and potential complications. The device 100 ultimately improves the efficiency and effectiveness of mitral valve repair surgeries, providing better patient outcomes.
[66] Modifications to embodiments of the present disclosure described in the foregoing are possible without departing from the scope of the present disclosure as defined by the accompanying claims. Expressions such as "including", "comprising", "incorporating", "have", "is" used to describe and claim the present disclosure are intended to be construed in a non-exclusive manner, namely allowing for items, components or elements not explicitly described also to be present. Reference to the singular is also to be construed to relate to the plural. The word "exemplary" is used herein to mean "serving as an example, instance or illustration". Any embodiment described as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments. The word "optionally" is used herein to mean "is provided in some embodiments and not provided in other embodiments". It is appreciated that certain features of the present disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the present disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable combination or as suitable in any other described embodiment of the disclosure.
, C , Claims:We claim:
1. A device (100) for repairing a leaflet (212) of a heart valve, comprising:
a handle (102);
an elongated shaft (104) extending from the handle (102);
a clamping assembly (112) at a distal end (108) of the elongated shaft (104), the clamping assembly (112) comprising an upper jaw member (202) and a lower jaw member (204) configured to cooperate with the upper jaw member (202) to grasp the leaflet (212) of the heart valve;
a plurality of needle tools (116, 400A, 400B, 400C), each needle tool (116) movably disposed within the elongated shaft (104) and configured to puncture the leaflet (212) when grasped by the clamping assembly (112);
a multi-lumen tubular assembly (300) comprising a plurality of separate lumens (304) extending through the elongated shaft (104), each lumen configured to accommodate a suture; and
a plurality of ribs (210) disposed at the upper jaw member (202) of the clamping assembly (112) in a staircase-like configuration, wherein each rib (210A, 210B, 210C) of the plurality of ribs (210) is associated with one of the plurality of separate lumens (304) and configured to guide the suture,
wherein the device (100) is configured to sequentially deploy a plurality of sutures (114) to the leaflet (212) through the plurality of separate lumens (304) of the multi-lumen tubular assembly (300) in a single-use.
2. The device (100) as claimed in claim 1, wherein each of the plurality of sutures (114) has a different length corresponding to its position in the staircase-like configuration of the plurality of ribs (210).
3. The device (100) as claimed in claim 1, wherein the plurality of separate lumens (304) comprises at least three lumens.
4. The device (100) as claimed in claim 1, wherein the plurality of needle tools (116, 400A, 400B, 400C) is configured to create a plurality of punctures in the leaflet (212) at a set of predefined different locations.
5. The device (100) as claimed in claim 1, wherein each suture of the plurality of sutures (114) is preloaded within one of the plurality of separate lumens (304).
6. The device (100) as claimed in claim 1, wherein the staircase-like configuration of the plurality of ribs (210) is configured to distribute tension across the plurality of sutures (114) when deployed.
7. The device (100) as claimed in claim 1, wherein the handle (102) comprises a spring-loaded plunger (120), wherein pressing the spring-loaded plunger (120) actuates the clamping assembly (112) to grasp the leaflet (212).
8. The device (100) as claimed in claim 1, wherein the handle (102) comprises a plurality of suture openings (124), each configured to accommodate the suture, wherein each suture opening (124A, 124B, 124C) of the plurality of suture openings (124) is provided with a cap of the plurality of caps (126), wherein each cap (126A, 126B, 126C) having internal threads (1102A, 1102B, 1102C), and wherein the cap (126A, 126B, 126C) of the plurality of caps (126) provided for each suture opening (124A, 124B, 124C) is configured to engage with corresponding external threads (1104A, 1104B, 1104C) on each suture opening (124A, 124B, 124C) to secure and close each suture opening (124A, 124B, 124C) when the device (100) is not in operation, and to selectively loosen the plurality of sutures (114) for deployment during operation.
9. The device (100) as claimed in claim 1, further comprising a holder member (110) configured to retain each suture (114A, 114B, 114C) of the plurality of sutures (114) during deployment through one of the plurality of separate lumens (304), wherein the holder member (110) is configured to lift the suture when removed from the elongated shaft (104).
10. The device (100) as claimed in claim 1, wherein the plurality of needle tools (116, 400A, 400B, 400C) comprises needles of different sizes corresponding to the plurality of sutures (114).