Meniscal repair tool with enhanced steering and suture deployment mechanism

Abstract

A meniscal repair tool is described for use in arthroscopic knee surgery, designed to facilitate the repair of meniscal tears with improved precision and control. The tool features an ergonomic handle connected to an elongated shaft that extends into the knee joint. The distal end of the shaft includes a working end preloaded with sutures and anchors for securing meniscal tissue. A deployment mechanism allows for the controlled release of these sutures and anchors, while an integrated steering mechanism enables directional control of the working end. The steering mechanism, operable through dials or other controls on the handle, allows the working end to bend through a significant range, providing access to difficult -to-reach areas of the meniscus. Various embodiments include mechanical, electronic, or hydraulic actuators to enhance the flexibility and responsiveness of the steering mechanism, ensuring effective and minimally invasive meniscal repairs.

Description

Meniscal Repair Tool with Enhanced Steering and SutureDeployment MechanismField of the Invention

[0001] The present specification relates to surgical instruments, and more specifically, to a meniscal repair tool designed for the arthroscopic repair of meniscal tears within the knee joint. The tool is particularly suited for use in minimally invasive procedures, providing enhanced control and precision in the deployment of sutures and anchors to secure and repair meniscal tissue.Background of the Invention

[0002] Meniscal tears are a prevalent injury, particularly among athletes and aging populations, and can lead to significant knee pain, instability, and long-term joint degeneration if left untreated. Traditionally, repairing meniscal tears often necessitated open surgery, which is invasive, involves prolonged recovery periods, and poses greater risks to the patient. To address these challenges, arthroscopic techniques have been developed, enabling the repair of meniscal tears through small incisions, thereby reducing recovery time, decreasing postoperative pain, and minimising the risk of complications.

[0003] Despite the advantages of arthroscopy, performing meniscal repairs using this method presents significant challenges due to the complexity and confined nature of the knee joint. Accessing and repairing tears, particularly in the anterior or posterior regions of the meniscus, can be difficult with standard arthroscopic tools, which may lack the necessary flexibility and precision to navigate the joint effectively. Incomplete repairs or the need for more invasive procedures can result from these limitations.

[0004] To enhance the effectiveness of arthroscopic meniscal repairs, various surgical tools have been developed, incorporating features designed to improve the surgeon's ability to access difficult-to-reach areas of the meniscus. One such device is the FAST-FIX FLEX Meniscal Repair System by Smith & Nephew. The FAST-FIX FLEX system is designed to deliver preloaded sutures into the meniscus with minimal invasiveness. It features a flexible delivery mechanism that allows sutures to bedeployed across the meniscal tear without requiring multiple needle passes through the tissue. Specifically, the mechanism comprises a bendable tip, which can be physically bent to achieve the desired angle for suture placement. This bending is achieved using a separate bending tool, which is operated by the surgeon. The surgeon holds the bendable tip in one hand and the bending tool in the other, manually adjusting the angle of the tip to access the meniscal tear site.

[0005] Although the FAST-FIX FLEX system represents a significant advancement in meniscal repair tools, the reliance on manual bending can limit the precision and ease of use, particularly in complex cases. The need for multiple adjustments to reach certain tear sites can be time-consuming and may not always allow for the fine-tuned control required to perform optimal repairs in all regions of the meniscus. Consequently, there remains a need for further advancements in meniscal repair tools that can provide enhanced flexibility, precision, and ease of use, allowing surgeons to perform more effective repairs with minimal invasiveness.Summary of the Disclosure

[0006] The present meniscal repair tool is designed for the minimally invasive repair of meniscal tears within the knee joint, particularly during arthroscopic procedures. The tool features a handle configured for user manipulation, connected to an elongated shaft that extends into the knee joint. At the distal end of the shaft, a working end is equipped with preloaded sutures and anchors, which are deployed to secure the meniscal tear. The deployment of these sutures and anchors is controlled by a mechanism operated via a trigger or button on the handle. Additionally, the tool integrates a steering mechanism within the shaft, allowing directional control of the working end to facilitate precise navigation to various sites within the knee joint, enhancing the surgeon's ability to access and repair tears in difficult-to-reach areas of the meniscus.

[0007] Optionally, the steering mechanism within the elongated shaft may be configured to bend the working end through a range of more than 90 degrees, providing enhanced manoeuvrability and allowing the surgeon to access meniscal tears in anatomically challenging locations. For even greater flexibility, the steeringmechanism may be configured to bend the working end through a range of more than 180 degrees, facilitating access to both anterior and posterior regions of the knee joint, thereby improving the effectiveness of the procedure.

[0008] In a preferred embodiment, the steering mechanism may include an indicator that displays the bend angle of the working end, allowing the surgeon to make precise adjustments and maintain optimal control throughout the procedure. The steering mechanism may incorporate a steering dial on the handle, where the rotational position of the dial corresponds to the bend angle of the working end. This feature ensures intuitive and accurate control over the direction of the working end, reducing the risk of damage to surrounding tissues.

[0009] The deployment mechanism may include a flexible internal push rod that contacts the anchors, allowing the tool to function effectively even when the working end is bent. This flexibility ensures consistent and reliable deployment of the sutures and anchors, regardless of the orientation of the working end. Furthermore, the working end may define an open-sided channel, within which the push rod is retained. This configuration allows the push rod to engage the anchors through the channel’s opening, ensuring precise and controlled deployment.

[0010] Optionally, the steering mechanism may utilise a tension cable running through the elongated shaft, which connects to the working end and responds to the operation of the steering dial. This configuration enables selective bending of the working end in a desired direction, providing the surgeon with the ability to finely tune the position of the tool within the joint. In certain embodiments, the working end may be biased to bend in one direction, with the tension cable configured to bend it in the opposite direction, allowing for efficient and simplified control using only one cable.

[0011] Alternatively, the steering mechanism may include a pair of opposing tension cables that allow for precise control of the working end’s movement in a single plane, enhancing the tool's versatility and enabling it to adapt to a wide range of surgical scenarios.

[0012] In other embodiments, the steering mechanism may be actuated by an electronic system, such as a piezoelectric material, shape memory alloy (SMA),bimetallic strip, or electroactive polymer (EAP), which responds to the application of electrical current by bending the working end. These advanced materials provide rapid and precise control, offering additional flexibility in the tool's design and application.

[0013] Alternatively, the steering mechanism may employ a hydraulic actuator, wherein pressurisation of a hydraulic chamber within the working end causes it to bend. This hydraulic actuation provides smooth and controlled movement of the working end, enhancing the surgeon’s ability to perform delicate repairs with minimal force.

[0014] The elongated shaft of the tool may include a rigid portion, while the working end remains flexible, ensuring both stability during insertion and flexibility during the repair procedure.

[0015] Other aspects of the invention are also disclosed.Description of Embodiments

[0016] The meniscal repair tool described herein is specifically designed to address the challenges associated with accessing meniscal repair sites within the knee joint during arthroscopic surgery. This tool is particularly beneficial in keyhole surgery, where maintaining minimally invasive techniques is crucial to avoid the need for open surgery. The tool is designed to enhance the surgeon's ability to effectively reach and repair both anterior and posterior sites of the meniscus, thereby improving surgical outcomes and reducing patient recovery time.

[0017] The meniscal repair tool comprises a handle that is ergonomically designed to facilitate comfortable manipulation by the surgeon. This handle serves as the control hub for the tool, housing the mechanisms necessary for both deployment and steering operations. Attached to the handle is an elongated shaft, which extends distally and is dimensioned for insertion into the knee joint through a small incision.

[0018] At the distal end of the elongated shaft is the working end, which is equipped with preloaded sutures and anchors. These sutures and anchors are specifically configured for deployment into the meniscal tissue to secure and repair a meniscal tear. The preloading of these components simplifies the surgical procedure byreducing preparation time and ensuring that the sutures and anchors are correctly positioned within the tool, ready for immediate deployment.

[0019] The tool includes a deployment mechanism, which is operable via a trigger or button activator located on the handle. This mechanism is responsible for releasing the preloaded sutures and anchors from the working end, allowing the surgeon to secure the meniscal tear efficiently. The deployment mechanism typically includes an internal push rod that interacts with the anchors.

[0020] The tool comprises a steering mechanism operative within the elongated shaft. This mechanism is designed to provide directional control of the working end, significantly enhancing the surgeon's ability to access both anterior and posterior sites of the meniscus. The steering mechanism preferably allows the working end to bend through a range of more than 90° making it particularly effective for navigating to difficult-to-access areas within the knee joint and further preferably through a range of more than 180° to allow access of the anterior repair sites.

[0021] The steering mechanism may be controlled via one or more steering dials located on the handle. Each dial is operable to control the movement of the working end in a specific plane, with the dials preferably being configured to control movement in orthogonal planes. This arrangement provides multi-directional control, enabling the surgeon to precisely position the working end for optimal suture and anchor placement. In some embodiments, the steering mechanism comprises a steering slider, which provides additional directional control by allowing positional offsets that adjust the working end’s orientation in a single plane.

[0022] To facilitate the bending of the working end, the steering mechanism may include one or more tension cables that run through the elongated shaft. These cables are connected to the working end and respond to the operation of the steering dials (or other mechanism of the steering mechanism, such as the slider), enabling the selective bending of the working end in the desired direction. In one embodiment, the working end is biased to bend in one direction, with a single tension cable configured to bend the working end in the opposite direction. This configuration simplifies the tool’s design while maintaining its effectiveness, as it allows bending in a single planewith only one cable. Alternatively, a pair of opposing tension cables may be employed, allowing for more precise control of the working end's movement in the plane.

[0023] In certain embodiments, the push rod is flexible, allowing it to accommodate the bending of the working end, thus ensuring consistent and reliable deployment even when the working end is maneuvererd into challenging positions. Preferably, the working end defines an open-sided channel, within which the push rod is retained. This configuration allows the push rod to contact the anchors through the opening in the channel, ensuring precise deployment.

[0024] In another embodiment, the steering mechanism is actuated by an electronic actuator that bends the working end in response to the application of electrical current. This actuator may include materials such as piezoelectric elements, which expand or contract when subjected to high voltage, or shape memory alloys (SMAs), such as Nitinol, which contract upon the application of electrical current due to the Joule heating effect. These materials provide rapid and precise control over the working end’s movement, offering an alternative to mechanical tension cables. Alternatively, the actuator could comprise a bimetallic strip that bends due to differential thermal expansion when electrical current is applied, or an electroactive polymer (EAP) that bends or flexes in response to electrical stimulation, further enhancing the tool’s versatility.

[0025] The shaft of the tool is preferably configured with a rigid portion that provides structural stability, while the working end remains flexible to allow for the necessary manoeuvrability within the knee joint. This combination of rigidity and flexibility ensures that the tool can be easily navigated through the joint while maintaining the precise control needed to perform effective meniscal repairs.

[0026] An example method of using the meniscal repair tool during an arthroscopic procedure to repair a meniscal tear in the knee is described as follows. The surgeon begins by making a small incision in the patient's knee and inserting an arthroscope to visualise the interior of the joint. Once the meniscal tear is identified, the surgeon introduces the meniscal repair tool through a secondary incision, positioning the elongated shaft within the knee joint.

[0027] Using the steering mechanism integrated within the tool, the surgeon manoeuvres the working end of the tool to the site of the meniscal tear. The steering mechanism allows the surgeon to bend the working end through a range of motion, enabling precise navigation around the complex anatomy of the knee joint, particularly to reach anterior or posterior meniscal sites that are otherwise difficult to access. The surgeon adjusts the steering dials or slider on the handle to orient the working end in the desired direction, ensuring optimal positioning for suture and anchor deployment.

[0028] Once the working end is properly positioned adjacent to the tear, the surgeon activates the deployment mechanism by pressing the trigger or button on the handle. This action causes the internal push rod to advance, engaging the preloaded sutures and anchors, and deploying them into the meniscal tissue. The push rod’s flexible nature allows it to function effectively even when the working end is bent, ensuring that the sutures and anchors are delivered accurately and securely.

[0029] After the sutures and anchors are deployed, the sutures are then tensioned to draw the torn edges of the meniscus together, promoting healing. Throughout the procedure, the surgeon can use the indicator on the steering mechanism to monitor the bend angle of the working end, ensuring precise control and minimising the risk of damaging surrounding tissues.

[0030] Upon completion of the repair, the surgeon retracts the tool from the knee joint, leaving the sutures and anchors in place to facilitate the natural healing process of the meniscus. The arthroscope and any other instruments are then removed, and the incisions are closed.

[0031] The foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the invention. However, it will be apparent to one skilled in the art that specific details are not required in order to practise the invention. Thus, the foregoing descriptions of specific embodiments of the invention are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed as obviously many modifications and variations are possible in view of the aboveteachings. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications, thereby enabling others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. It is intended that the following claims and their equivalents define the scope of the invention.

Claims

Claims1. A meniscal repair tool comprising: a handle configured for manipulation by a user; an elongated shaft extending from the handle, adapted for insertion into a knee joint; a working end disposed at the distal end of the elongated shaft, the working end comprising preloaded sutures and anchors adapted to be deployed into meniscal tissue for repairing a meniscal tear; a deployment mechanism operable to release the preloaded sutures and anchors from the working end to secure the meniscal tear; wherein the tool comprises a steering mechanism integrated within the elongated shaft, the steering mechanism configured to provide directional control of the working end.

2. The meniscal repair tool of claim 1 , wherein the steering mechanism is configured to bend the working end through a range of more than 90 degrees.

3. The meniscal repair tool of claim 2, wherein the steering mechanism is configured to bend the working end through a range of more than 180 degrees.

4. The meniscal repair tool of claim 1 , wherein the steering mechanism comprises an indicator configured to indicate the bend angle of the working end.

5. The meniscal repair tool of claim 4, wherein the steering mechanism comprises a steering dial, and wherein a rotational position of the steering dial corresponds to the bend angle of the working end.

6. The meniscal repair tool of claim 1 , wherein the deployment mechanism comprises a trigger or button activator acting on an internal push rod in contact with the anchors, and wherein the push rod is flexible.

7. The meniscal repair tool of claim 6, wherein the working end defines an open-sided channel, and wherein the push rod is retained within the channel and contacts the anchors through the opening in the channel.

8. The meniscal repair tool of claim 1 , wherein the steering mechanism comprises a steering dial, and wherein a rotational position of the steering dial provides directional control of the working end in a single plane.

9. The meniscal repair tool of claim 8, wherein the steering mechanism further comprises a steering slider, and wherein a positional offset of the steering slider provides directional control of the working end in a single plane.

10. The meniscal repair tool of claim 1 , wherein the steering mechanism comprises two steering dials located on the handle, each steering dial being independently operable to control the movement of the working end in a corresponding plane.11 . The meniscal repair tool of claim 10, wherein the corresponding planes are orthogonal.

12. The meniscal repair tool of claim 1 , wherein the steering mechanism comprises a tension cable running through the elongated shaft, connected to the working end andresponsive to operation of the steering mechanism, enabling the selective bending of the working end in a desired direction.

13. The meniscal repair tool of claim 12, wherein the working end is biased to bend in one direction, and the tension cable is configured to bend the working end in an opposite direction, thereby allowing bending of the working end in a single plane with only one tension cable.

14. The meniscal repair tool of claim 1 , wherein the steering mechanism comprises a pair of opposing tension cables running through the elongated shaft, connected to the working end and responsive to operation of the steering mechanism, enabling the selective bending of the working end in the desired direction in a single plane.

15. The meniscal repair tool of claim 1 , wherein the steering mechanism comprises an actuator configured to bend the working end in response to the application of electrical current.

16. The meniscal repair tool of claim 15, wherein the actuator comprises a piezoelectric material, and wherein the application of a high voltage causes the piezoelectric material to expand or contract, thereby bending the working end.

17. The meniscal repair tool of claim 15, wherein the actuator comprises a shape memory alloy (SMA), and wherein the application of electrical current causes the SMA to contract due to the Joule heating effect, thereby bending the working end.

18. The meniscal repair tool of claim 17, wherein the shape memory alloy is a nickeltitanium alloy (Nitinol).

19. The meniscal repair tool of claim 15, wherein the actuator comprises a bimetallic strip bonded to metals with different thermal expansion coefficients, and wherein the application of electrical current causes the strip to bend due to differential therm al expansion.

20. The meniscal repair tool of claim 15, wherein the actuator comprises an electroactive polymer (EAP), and wherein the application of voltage causes the polymer to bend or flex, thereby bending the working end.

21. The meniscal repair tool of claim 1 , wherein the steering mechanism comprises a hydraulic actuator configured to bend the working end.

22. The meniscal repair tool of claim 21 , wherein the hydraulic actuator comprises a hydraulic chamber within the working end, and wherein pressurisation of the hydraulic chamber causes the working end to bend.

23. The meniscal repair tool of claim 1 , wherein the shaft comprises a rigid portion, and wherein the working end is flexible.

24. A method of repairing a meniscal tear in a knee joint using a meniscal repair tool, the method comprising: inserting an arthroscope into the knee joint to visualise the interior of the joint;inserting the meniscal repair tool into the knee joint, the meniscal repair tool comprising a handle, an elongated shaft extending from the handle, a working end disposed at the distal end of the elongated shaft, preloaded sutures and anchors disposed at the working end, a deployment mechanism operable to release the preloaded sutures and anchors from the working end, and a steering mechanism integrated within the elongated shaft for directional control of the working end; manipulating the handle to position the working end adjacent to the meniscal tear; actuating the steering mechanism to bend the working end to an appropriate angle for accessing the meniscal tear, wherein the steering mechanism is configured to bend the working end through a range of more than 90 degrees; deploying the preloaded sutures and anchors into the meniscal tissue by actuating the deployment mechanism, wherein the deployment mechanism comprises a trigger or button activator that acts on an internal push rod in contact with the anchors; tensioning the sutures to secure the meniscal tear by drawing the torn edges of the meniscus together; retracting the meniscal repair tool from the knee joint, leaving the sutures and anchors in place to facilitate healing of the meniscus; and removing the arthroscope from the knee joint after completing the repair procedure.