DESC:TECHNICAL FIELD
The present invention relates to suture passers, suturing techniques, devices and methods and material of suture passers for surgical use and methods of repairing tissue. More particularly, described herein are suture passers that may be used for performing arthroscopic (including minimally invasive, e.g., endoscopic) procedures.
BACKGROUND
The subject matter discussed in the background section should not be assumed to be prior art merely because of its mention in the background section. Similarly, a problem mentioned in the background section or associated with the subject matter of the background section should not be assumed to have been previously recognized in the prior art. The subject matter in the background section merely represents different approaches, which in and of themselves may also correspond to implementations of the claimed medical device.
In the process of repair surgery, suture anchors are implanted into the bone to secure damaged tendon or other tissue to the bone with sutures. This process is performed either with the help of pre-drilling holes in the bones, hammering the anchors directly into the bone using an inserter or inserting a self-drilling suture anchor into the bone by way of drilling. For this purpose, the suture needs to be pulled to make the suture anchor entering the bone canal knotted. All the processes entail potential damage or shock to the bones.
Also, passing a suture through tissue is a necessary but challenging procedure in an arthroscopic surgery because of limited visualization. It also requires mending a tear or connecting the pieces of soft tissue. The difficulty further increases in case of severe tissue damages when suturing the labrum needs to be sutured. There is thus a need of a mechanism which facilitates easy passing and retrieving of suture in an arthroscopic atmosphere, or a device that easily passes suture through tissue with the suture fixed to the mechanism or where the suture is captured by the mechanism and allowed to slide.
The position and configuration of sutures on the cuff repair has an important biomechanical effect on the tendon suture interface which is why we require precision in the suture passing devices.
Among the suture passing devices, antegrade suture passers represent one type of device to place sutures in tendon, and are widely used due to their convenience and effectiveness in use.
An antegrade suture passer penetrates the tendon using a flexible, small caliber needle loaded in the passer and the needle is made of nitinol which is known for excellent biocompatibility.
The suture threads that are hung in the groove of the needle, which is located at the end of the needle, can be passed through the tendon along with the needle passage.
Antegrade suture passers are one of the most widely used devices in arthroscopic targeted tissue or tendons or bone repair. These devices combine tendon grasping, suture passage, and suture retrieval in one convenient step. They also use flexible, small-caliber needles that help to minimize damage to the tendon during surgery. This is important because the tendon-suture interface is the weakest point and accounts for the highest rates of fixation failure.
The different shapes and sizes of suture passing devices affect the tensile strength of repair, superior biomechanics are achieved when the caliber of tendon penetration is small, making antegrade suture passage an effective and convenient method.
An antegrade suture passer can be used without complication in the majority of cases. However, clinically there are difficulties such as oblique passage of the needle, failure of the needle to completely penetrate the tendon, and needlepoint breakage. This is particularly evident when attempting to pass through the thick torn end of the targeted tissue or tendons or bone in bursal side partial tears and acute tears.
There is not much information on how the thickness of the tendon affects antegrade suture passer performance, or at what thickness limit these devices no longer reliably succeed. There is also not much information on tendon thickness of the targeted tissue or tendons or bone during surgery. In anatomical studies of the supraspinatus, the medial to the lateral width at the mid-point measures from 9.6 mm to 16 mm. Tendon thickness itself is probably smaller, nevertheless, in clinical experience the tendon can be up to approximately 10 mm thick.
However, the needle of the antegrade suture passer is not strong because the needle should be flexible enough to be bent by almost 90 to go up to the tendon from the suture passer device, and the groove site of the needle is especially weak. Thus, if the tendon is too thick or stiff, the needle of the antegrade suture passer may be broken while penetrating the tendon, especially at the groove site. Following needle breakage, the broken needle tip is usually stuck inside the tendon, and may become difficult to find. In addition, even if it can be found, the removal of the embedded broken needle from the tendon may inflict considerable damage to the tendon. When the broken needle cannot be found easily, clinicians may leave the broken needle tip in the tendon, because either they cannot find it or out of fear of damaging the tendon while searching for the embedded broken needle tip in the tendon.
Many prior disclosures, such as U.S. Patent No. 919,138, employ a hollow needle driven through the tissue with the suture material passing through the hollow center lumen. The needle is withdrawn, leaving the suture material in place, and the suture is tied, completing the approximation. A limitation of these types of devices is that they are particularly adapted for use in open surgical procedures where there is ample room for the surgeon to manipulate the instrument.
Others have attempted to devise suturing instruments that resemble traditional forceps, such as U.S. Patent No. 3,946,740. These devices pinch tissue between opposing jaws and pass a needle from one jaw through the tissue to the other jaw. Graspers then pull the needle and suture material through the tissue. A limitation of these designs is that they also are adapted primarily for open surgery, in that they require exposure of the tissues to be sutured in order that the tissue may be grasped or pinched between the jaws of the instrument. This is a severe limitation in the case of endoscopic surgery.
The subject invention overcomes the limitations of the prior art by proposing a manual suture passer device intended to pass a tape or a suture material through tissues in arthroscopic procedures. The device consists of a cannulated shaft attached to a handle containing the device controls. The shaft contains jaws at the distal end for grasping and manipulating tissue and a suture capture mechanism. The device can be passed through the tissue without the need for a needle, reducing the risk of damage to the tendon and eliminating the possibility of needle breakage.
Objects of the Invention:
The main object of the invention is to provide a reusable suture passing instrument made of high-quality Acrylonitrile Butadiene Styrene (ABS) plastic, which is intended to pass tape or suture material through soft tissue in arthroscopic procedures. The instrument is of simple configuration and has wide opening jaws to accommodate a range of tissue thickness. The instrument is designed to be used with a 5.5 mm or larger cannula. The controls of the instrument consist of two levers, one to actuate the jaws and the other one to control needle deployment and activate the suture retrieval mechanism. There is a consistent control locking in ratchet mechanism. The jaws of the instrument are marked with a range of 1.5 mm to 5.5 mm on the gripping surface, indicating the maximum thickness of tissue that can be grasped by the instrument, and are formed with a holder for supporting a suture. The instrument also includes a needle slidably disposed within the first jaw, with a hook on a side for releasably capturing a portion of a suture, a channel for receiving the needle, and a ramp for deflecting the needle transversely of the shaft when advanced to an extended position. The instrument further includes a locking mechanism for locking the jaws in a closed position. The instrument is sold non-sterile for reuse.
Another object of the invention is to use high-quality Acrylonitrile Butadiene Styrene (ABS) plastic as the material for the suture passing instrument. ABS plastic is a strong and durable material that allows for the instrument to be reused multiple times. The non-sterile nature of the instrument makes it a cost-effective option for medical professionals who need to perform multiple procedures without having to dispose of the device after each use.
In summary, the invention aims to provide a cost-effective, efficient, and reusable suture passing instrument that is easy to use and suitable for a range of soft tissue thicknesses during arthroscopic procedures. The use of high-quality ABS plastic as the material ensures durability and strength for multiple uses.
SUMMARY
This summary provides an overview of the system and method related to a suture passing instrument. The instrument is designed to be simple to use for loading sutures and is described in detail below. The purpose of this summary is not to limit the scope of the claimed subject matter, nor is it intended to identify essential features of the claimed subject matter. Its purpose is only to provide a brief introduction to the concepts related to the invention.
With respect to some of the features or characteristics of the invention, it is contemplated that the invention may include the following features. It however should be understood that these features are not the only ones that can be adopted in the preferred embodiments, and further, these features can be adopted alone or in combination with one another in one or more preferred embodiments. These features are intended to provide a more detailed description of the invention and the possible variations that may be included in the preferred embodiments.
In one embodiment of the invention, the suture passer device has a marked jaw configuration that allows for grasping tissue up to 18mm deep.
This embodiment of the invention comprises a pair of jaws designed to grip and hold tissue during the suturing process. Each jaw is equipped with a gripping surface that has a marking indicating a range of 1.5 mm to 5.5 mm, which helps to ensure that the suture is placed at the correct depth within the tissue. Additionally, each jaw also includes a holder for supporting the suture, which keeps the suture in place while it is being passed through the tissue. This feature helps to prevent the suture from slipping or moving out of position during the suturing process, which can lead to a less secure closure of the wound or incision.
In another embodiment of invention, the suture passer device has a handle that is designed for grasping and locking tissue in place during the suture passing process. The handle features a ratchet mechanism that allows for secure closure of the jaws around the tissue. This feature ensures that the tissue remains firmly grasped during the procedure, preventing it from slipping or moving out of place. The ratchet mechanism can be easily released once the suture material has been passed through the tissue and secured in place, allowing for efficient and effective closure of the wound. Overall, the handle with ratchet mechanism is a critical feature of the suture passer device that enables precise and secure tissue grasping and closure during soft tissue repair procedures.
In another embodiment of invention, the suture passer device features include a pivot point that connects the handles to the jaws. The pivot point allows the jaws to move from a first position where they are spaced apart to a second position where they are parallel and in contact with each other. This allows for the jaws to grasp and hold tissue securely while the suture is passed through the tissue with a needle. The pivot point also allows for greater control and precision during the suture passing process.
In yet another embodiment of invention, the suture passer device features a vertical needle deployment mechanism that enables the user to advance the needle through the central or thickest portion of the targeted tissue. This mechanism allows for precise control over the placement of the suture material, ensuring that it passes through the desired area of tissue.
By deploying the needle vertically, the user can avoid damaging surrounding tissue and reduce the risk of complications during the procedure. Additionally, the needle deployment mechanism enables the user to advance the needle to the desired depth with the marked jaws, ensuring that the suture material is passed through the targeted tissue at the appropriate depth.
In another embodiment of invention, the suture passer device is equipped with a needle that is designed to advance suture material through the central portion of the tissue. The needle is slidably disposed within the first jaw of the instrument and is advanced through the targeted tissue using the vertical needle deployment mechanism. The needle has a hook on its side that captures a portion of the suture material, enabling it to be advanced through the tissue as the needle is pulled through. By passing the suture material through the central portion of the tissue, the device ensures that the suture is securely placed and provides optimal tissue closure. This feature is critical for achieving successful soft tissue repair and promoting efficient healing.
A locking mechanism is an important component of the suture passer device, as it ensures that the jaws are held securely in the second position, providing a secure closure of the tissue around the suture. This prevents the suture from slipping or becoming dislodged during the suturing process, which can lead to complications and affect the outcome of the surgery.
In another embodiment of invention, the suture passer device is locking mechanism may be operated by a trigger or lever that is connected to the shaft of the device. When the handles are squeezed together, the jaws move into the second position and the locking mechanism is engaged to hold them in place. This allows the surgeon to focus on passing the suture through the tissue without having to worry about the jaws moving or the tissue slipping out of place.
The design of the locking mechanism have a ratcheting mechanism that allows the surgeon to incrementally adjust the tension on the jaws. The ratcheting mechanism ensures that the tension on the jaws can be adjusted precisely to meet the needs of the tissue being worked on. This helps to reduce the risk of damage to the tissue and ensures that the suture is securely held in place. The locking mechanism also prevents the jaws from accidentally opening during the procedure, providing added safety and control to the surgeon.
The locking mechanism in the suture passer device is a critical feature that ensures that the tissue is held securely in place during the suture passing process. This feature is particularly important when dealing with delicate or complex soft tissue structures, such as tendons, ligaments, and meniscus, where precise suture placement is critical for optimal healing and recovery.When the jaws of the device are closed around the tissue, the locking mechanism engages, preventing any movement or slippage of the tissue during the suture passing process. This ensures that the suture is placed exactly where it is intended, without any unintended movement or distortion of the tissue.
Another embodiment of the suture passer device invention includes a suture that is designed to provide resistance when tensioned in the opposite direction. This feature is achieved by incorporating a locking mechanism into the suture that engages when the suture is tensioned in the opposite direction. This locking mechanism enables the suture to resist movement or slipping once it has been tensioned, providing enhanced stability and security for soft tissue repair. By providing resistance in the opposite direction, the suture ensures that the tissue remains securely closed, reducing the risk of complications and promoting faster healing.
Another embodiment of the suture passer device invention includes a trigger mechanism that is connected to the shaft of the instrument. The shaft has a distal end that includes a stationary jaw and a movable jaw that can be opened and closed by manipulating the handles. Additionally, the shaft has an opening that allows for the passage of a suture passing needle and the attached suture. This designed to provide greater control and precision when passing sutures through soft tissue structures. The trigger mechanism allows for easy manipulation of the movable jaw, making it easier to grasp and hold tissue in place during the suture passing process. The opening through the shaft allows for the passage of the suture passing needle and attached suture, which can be advanced through the tissue with greater accuracy and control.
Another embodiment of the suture passer device invention includes a handle and jaw design that allows for single or multiple passes of suture. The jaws of the device are designed to hold the tissue securely in place, enabling the user to make multiple passes of suture through the targeted area if necessary. This feature is particularly useful in cases where additional reinforcement or greater tension is needed to achieve optimal tissue closure. The handle of the device is designed to provide a comfortable and secure grip for the user, enabling precise control over the instrument during the procedure. By allowing for single or multiple passes of suture, the suture passer device provides greater versatility and flexibility for soft tissue repair procedures, enabling the user to tailor the repair to the specific needs of the patient,
Another embodiment of the suture passer device invention includes a handle and jaw design that accommodates multiple channels for needles. This feature enables the user to make multiple passes of suture through the targeted tissue using multiple needles, which can help to increase the strength and stability of the repair. The handle of the device is designed to provide a comfortable and secure grip for the user, while the jaws are configured to hold the tissue securely in place during the suture passing process. The multiple channels for needles are integrated into the design of the instrument, enabling the user to easily switch between needles as needed during the procedure. By accommodating multiple channels for needles, the suture passer device provides greater flexibility and versatility for soft tissue repair procedures, enabling the user to tailor the repair to the specific needs of the patient; and
The suture passer device includes a jaw construct having markings at each interval of 5 mm for helping and judging the right place for placing suture and deep tissue customized for different soft tissue structures. This feature enables the user to accurately position the suture at the appropriate up to 18mm depth within the soft tissue structure, ensuring optimal tissue closure and reducing the risk of complications. The markings are integrated into the design of the jaws, providing a convenient reference point for the user during the procedure. The customized marking for different soft tissue structures enables the user to select the appropriate marking for the specific type of tissue being repaired, providing greater precision and accuracy during the suture passing process. By incorporating markings into the jaw construct, the suture passer device provides greater accuracy and efficiency for soft tissue repair procedures, enabling the user to achieve optimal results.
The suture passer device is made of high-quality Acrylonitrile Butadiene Styrene (ABS) plastic, which is a thermoplastic polymer known for its durability, strength, and resistance to impact and temperature changes. The device is designed to be reusable, which is not only cost-effective but also environmentally friendly. By being able to sterilize and reuse the device multiple times, it reduces the need for single-use instruments and minimizes waste.The fact that the device is sold non-sterile means that it requires sterilization before use, but this also allows for flexibility in the sterilization process, as medical professionals can choose the method that best suits their needs. It also means that the device can be stored and transported without the need for special sterile packaging, which further reduces costs.
Overall, the suture passer device is a practical and efficient solution for soft tissue repair procedures, providing strength, durability, and cost-effectiveness. This suture passer device is a highly functional and versatile instrument that can be used in a variety of soft tissue repair procedures. Its reusable nature and durable construction make it a cost-effective solution for medical professionals.
The reusable suture passing device is designed with several features that enhance its functionality and versatility. The handles are made of high-quality ABS plastic, while the jaws have a marked configuration for grasping tissue. The pivot point coupling the handle portion to the jaws ensures stability during use, and the needle deployment mechanism allows for advancing the needle through the central or thickest portion of the targeted tissue.
The device also includes a suture designed to provide resistance when tensioned in the opposite direction, and the handle and jaw design allows for single or multiple passes of suture. Multiple channels for needles are accommodated by the handle and jaw design, and the jaw construct can be customized for different soft tissue structures, such as scaling the size of the jaw for meniscal repair.
The invention may include the integration of ultrasound during surgery to optimize repair. This feature can be particularly useful in certain types of tissue repair procedures where ultrasound can help identify the extent and location of the damage and aid in guiding the instrument for more accurate repair.
Percutaneous and Less Invasive Suture Passing Method: The suture passing method used by the instrument allows for percutaneous and less invasive targeted tissue repair. This feature can be particularly beneficial in procedures where minimizing trauma and reducing recovery time is a priority.
High-Quality ABS Plastic: The instrument is made of high-quality ABS plastic, which is a strong and durable material that can withstand repeated use. This material is also lightweight, which can help reduce fatigue and improve handling during surgical procedures.
Non-Sterile for Reuse: The instrument is sold non-sterile for reuse, which can help reduce waste and lower the overall cost of the procedure. However, proper sterilization and cleaning protocols must be followed to ensure patient safety.
Functional and Versatile: Overall, these features make the suture passer device highly functional and versatile for various tissue repair procedures. The instrument's design allows for single or multiple passes of suture, accommodating multiple channels for needles, and customized jaw constructs for different soft tissue structures. These features, combined with the integration of ultrasound and less invasive suture passing method, make the instrument a valuable tool in tissue repair procedures.
To further enhance the functionality of the invention, the integration of ultrasound technology during surgery is also included. This allows for real-time visualization of the targeted tissue and precise placement of the suture. The suture passing method is designed to be percutaneous and less invasive, allowing for faster healing and recovery time for the patient.
Overall, the device offers a highly functional and versatile solution for various tissue repair procedures, with its customizable jaw design, multiple channels for needles, and suture that provides resistance when tensioned in the opposite direction. With its integration of ultrasound technology and less invasive suture passing method, the invention provides an innovative approach to tissue repair that can potentially improve patient outcomes.
The invention also comprises a method of passing suture into targeted tissue, said method comprising: (1) providing a suture passing device, comprising: (a) a pair of handles; (b) a shaft operably connected to the handles; (c) a trigger mechanism operably connected to the shaft; (d) said shaft having a distal end including marking jaws wherein one is stationary marked jaw and a movable marked jaw controlled for movement between and open position and a closed position by manipulating said handles; (e) said shaft having an opening there through to receive a suture passing needle and attached suture; (f) said shaft extending along a longitudinal axis; (2) advancing the needle through the device by operating the trigger mechanism; and (3) wherein the needle is advanced in a direction parallel to the longitudinal axis, and through the shaft into the targeted tissue.
In yet another embodiment of the invention, it may be considered a method of deploying an anchor used with a length of suture for preparing targeted tissue, said method comprising: (1) advancing the suture and anchor through a suture passing device, wherein the suture and anchor are passed into the tissue in a direction substantially parallel to a longitudinal axis of a shaft of the suture passing device; (2) placing the suture and anchor at a desired location within the targeted tissue; (3) placing tension on the suture in a direction opposite to the direction of advancement; and (4) rotating the anchor to be disposed substantially parallel to the direction of extension of the suture.
In yet another aspect of the invention, it may be considered a method of deploying an anchor used with a length of suture for preparing targeted tissue, said method comprising: (1) advancing the suture and anchor through a suture passing device, wherein the suture and anchor are passed into the tissue in a direction substantially parallel to a longitudinal axis of a shaft of the suture passing device; (2) placing the suture and anchor at a desired location within the targeted tissue; and (3) removing the anchor from within the shaft, wherein the anchor moves from a stored position within the shaft, to a deployed position within the targeted tissue, the deployed position resulting in expanding at least one dimension of the anchor.
In yet another aspect of the invention, it may be considered a suture passing needle, comprising a vertical extending needle shaft having an opening extending through said shaft, said shaft having a sharp distal tip, and a notch formed in the distal tip. This aspect may further include said needle having a plurality of perforations extending through said needle shaft.
In yet another aspect of the invention, it may be considered, in combination, a system for deploying the marked jaws and suture into targeted tissue, said system comprising: (1) a shaft of a suture passing device having an opening extending through said shaft; (2) a deployment sleeve extending through said opening; (3) a length of suture extending through said sleeve, and having a distal end extending beyond a distal end of said sleeve; (4) and an the marked jaws attached to the distal end of said suture.
BRIEF DESCRIPTION OF DRAWINGS
The description of the preferred embodiment is meant to demonstrate the broad working principles of the invention without limitation as to possible adaptations, extensions, applications etc., which would be obvious to a person skilled in the art. This invention is illustrated in the accompanying drawings, throughout which, like reference numerals indicate corresponding parts in the various figures. In the interest of brevity and for the purposes of exemplary explanation, references have been made to a system, depicted in figure 1 herein without limitation, to describe the invention which is essentially directed towards a manual device intended to pass 1.5 mm tape or suture material through tissue in arthroscopic procedures.

Figure 1 shows the overall view of the suture passer device.
Figure 2 shows the functional schematic view of the suture passer device.
Figure 3 shows the functional view of the suture passer device with the jaws open.
Figure 4 shows the functional view of the suture passer device with the jaws closed.

System:
Accordingly, the inventors have developed a new and novel approach to pass tape or suture material through soft tissue in arthroscopic procedures. Accordingly, the present invention to provide a suture passing device that is of simple configuration so that a suture may be loaded into the device with relative ease. An suture passer device that combines the function of both grasping the tissue and passing sutures through the tissue to form a mattress stitch is described. The instrument includes a pair of grasping jaws that oppose each other along a line substantially perpendicular to the long axis of the suture passer device. The distal end of the device incorporates the fixed jaw, and proximal to that jaw is a moveable jaw that is controlled by the user via a lever on the handgrip. The devices controls consist of two levers, one to actuate the jaws and the other one to control needle deployment and activate the suture retrieval mechanism. There is a consistent control locking in ratchet mechanism. The suture passer is designed to be used with a 5.5 mm or larger cannula. The jaws of the suture passer have marking, which will facilitate the surgeon to measure the depth of the tissue that needs a bite. Where in the markings are beneficial in case of treating a larger tear which helps in determine the better anchor configuration. Since Placing anchors in a double-row configuration more accurately re-creates the tendons original insertion. Consistent bite ensures that the configuration is achieved using the suture passer. The devices controls consist of two levers, one to actuate the jaws and the other one to control needle deployment and activate the suture retrieval mechanism. There is a consistent control locking in ratchet mechanism. The suture passer is designed to be used with a 5.5 mm or larger cannula.
The suture passer needle is used with the Suture passer. It is single use, disposable and sold sterile. The needle is made of Nitinol with a plastic grip tab. Once the needle is loaded into the Suture passer, suture loaded into the suture passer is captured by the needle. During suture passing, the needle travels through the suture passer shaft, which is then deflected perpendicular to the shaft and carries suture through the grasped tissue into the Upper jaw where the suture is then captured by the suture retrieval mechanism.

INTENDED USE / INDICATIONS FOR USE
The suture passer is intended to manually pass and retrieve 1.5mm tape or #2 UHMWPE suture through soft tissue during Arthroscopic or open surgical procedure.

The suture passer needle is intended to work in conjunction with the suture passer to manually pass the 1.5mm tape or #2 mm UHMWPE suture thorough soft tissue in either Arthroscopic or open surgical procedure.

The suture passer consists of piercing needle size XX. Which is designed in such a way that it passes through the soft tissue along with the suture when the jaws of the suture passer is closed and the needle is dispensed through it.

CONTRAINDICATIONS
1. Any pathological conditions in the soft tissue to be addressed first, restored or reconstructed which would adversely affect suture fixation.
2. Physical conditions that would eliminate or tend to eliminate adequate support or retard healing.
3. The device is not being used on bone or similar hard tissue.
4. Foreign body sensitivity, known or suspected allergies to implant and/or instrument materials.
INSTRUCTIONS FOR USE
Instructions for loading the suture passer needle into the suture passer
1. Before beginning the procedure, the overall compatibility of all instruments and accessories are verified.
2. With the suture passer jaws in the closed position, the sharp end of the needle is inserted into the top of the instrument with the tab pointing up.
3. The needle is engaged by sliding the tab forward until it snaps into place.
4. With the jaws closed, the needle deployment trigger is actuated once to ensure that the needle deploys and retracts and that the suture retrieval mechanism opens during needle deployment and closes after needle retraction.
Instructions for loading and deploying suture with the suture passer
1. With the jaws of the suture passer open, the suture is loaded into the suture slot located at the distal tip of the device and pulled completely to the proximal end of the suture slot.
2. When using the device in open surgery, the jaws of the suture passer is dampened with sterile water. Also, if being used in an open procedure, the following reference is ignored to the arthroscopic cannula.
3. With the suture loaded and the jaws of the suture passer closed, and the needle retracted, the suture passer is passed through the cannula into the surgical site under direct visualization. The suture should behold slightly tight to ensure that it does not become entangled in itself or in the suture passer as it goes through the cannula. The suture passer should be used with a 5.5mm or larger cannula.
4. Once inside the joint space, the jaws are to be opened and positioned at the desired location to pass the suture. The jaws are closed securely on the tissue with a firm grasp. If jaws are not firmly closed on the tissue, the needle may miss the window of the suture retrieval mechanism.
5. The needle deployment trigger is pulled to advance the needle and suture through the tissue. If excessive force is required to pass the needle, a smaller bite of tissue should be taken, and needle deployment should be attempted again.
6. After the suture is passed, the needle deployment trigger is released allowing the needle to fully retract. It should be made sure that the jaws are kept closed until the needle has fully retracted. If the needle does not fully retract automatically, the needle deployment trigger is to be pushed further to fully retract it.
7. The jaws are opened, tissue is released, jaws are closed without grasping tissue, and the suture passer is removed with the suture loop form the cannula. If the suture passer needle is not fully retracted, the suture passer will be difficult to remove from the tissue and the retriever mechanism will not have a proper hold on the suture.
8. To remove suture from retriever mechanism, the needle deployment trigger is pulled back slightly to open the trap door and pull the suture.

CLEANING AND STERILIZATION GUIDELINES
Cleaning
1. Universal precautions for protective apparel need to be followed when handling and cleaning contaminated equipment.
2. Instruments are recommended to be cleaned as soon as reasonable possible following usage.
Preparation for cleaning
3. The suture passer needle is removed from the handle and disposed immediately according to hospital policy and procedure.
4. The jaws of the suture passer are left in the open position prior to cleaning and sterilization.
5. Instruments are pre-cleaned at point of use to prevent drying of bioburden and organic soil: wiped with moistened towel/ sponge rinse off gross debris using cool water, devices are flushed with cool water, then soaked in water at 220C-430C/720F-1100F to prevent coagulation of blood and proteins on the device. Temperature of pre-rinse water should not exceed 450C (1130F).
Manual Cleaning
6. Cleaning is performed under running water to prevent aerosolization of micro-organisms.
7. Excess soil is rinsed from the instrument.
8. Instrument is cleaned using a neutral pH detergent solution.
9. Using soft bristle brush, detergent solutions are applied to all internal and external surfaces ensuring that all moving parts are cleaned in both open and closed positions. The cleaning process is repeated until the instrument is visibly clean. Cannulation and holes should be cleaned using an appropriate brush to ensure that full diameter and depth of the feature is reached.
10. Rinsing under running tap water (Minimum temperature 380C/100.40F) is then done for a minimum of 30 seconds using minimum of 1 litre of rinse water ensuring running water passes through all crevices and cannulation.
11. It is ensured that the instrument is visibly free of detergent or cleaning residues.
Final rinse
12. It is then rinsed under running deionized water (Minimum temperature 250C/770F) using a minimum volume of 1 litre of rinse water for a minimum of 30 seconds to remove detergent residuals or debris from the device.
Inspection
13. It is then inspected for cleanliness. It is ensured that instruments are free of visible debris and/or soil.
Drying
14. The device is then dried using a clean, lint free towel until it is visibly free of water droplets and/or condensation.
Lubrication
15. If suture passer-trigger mechanism binds, lubrication of moving parts can be performed with a “Steam penetrable medical grade” lubricant in accordance with lubricant manufacturer’s instruction before sterilization. Use of silicone oil-based lubricants may inhibit sterilization and is not recommended.
Steam sterilization
16. Suture passer is prepared such that all surfaces have direct contact with steam. It is ensured that the jaw hinge is open.
17. The device is double wrapped using FDA-cleared sterilization wrap.
18. The device is sterilized according to the following parameters:

Table-1
Sterilization parameters for the suture passer using the SRS-tray (RCR-tray) with instrument or suture passer individually wrapped
Method Cycle Minimum temperature Minimum Exposure Minimum Dry Cycle

Steam (Wrapped) Pre-vacuum 2700F (1320C) 4 Minutes 20 Minutes
Steam (Wrapped) Gravity 2500F(1210C) 30 minutes 25 minutes

Note:
1. Additional drying time may be required for complete heat and moisture dissipation.
2. Performance of the suture passer has been demonstrated up to 1340C and 2 bar for 18 minutes.
,CLAIMS:1. A reusable suture passing device comprising:
a) a pair of handles made of Acrylonitrile Butadiene Styrene (ABS) plastic;
b) a pair of jaws and a holder for supporting a suture; 5
c) a handle with a ratchet mechanism that allows for secure closure of the jaws around the tissue;
d) a pivot point coupling the handles to the jaws, allowing the jaws to pivot from a first position where they are spaced apart to a second position where they are substantially parallel and in contact with 10 each other;
e) a vertical needle deployment mechanism that enables the user to advance the needle through the central portion of the targeted tissue;
f) a needle that is slidably disposed within the first jaw of the suture passer device and has a hook on its side that captures a portion of 15 the suture material;
g) the first jaw defining a channel for receiving the needle and a ramp for deflecting the needle transversely of the shaft when advanced to an extended position;
h) a locking mechanism for locking the jaws in the second position; 20
i) a trigger mechanism connected to the shaft; and
j) an opening through the shaft to receive a suture passing needle and attached suture.
2. The device as claimed in claim 1, wherein the jaws of the suture passer have a gripping surface with markings to facilitate measuring the depth of the 25 tissue that needs a bite.
3. The device as claimed in claim 1, wherein the markings of the jaw indicates a range of 1.5 mm to 5.5 mm.
4. The device as claimed in claim 1, wherein the marking on the gripping surface of the jaws allows for grasping tissues up to 18 mm deep. 30
23
5. The device as claimed in claim 1, wherein the jaw is movable and is controlled by a lever on the handgrip.
6. The device as claimed in claim 1, wherein the vertical needle deployment mechanism allows for precise control over the placement of the suture material, ensuring that it passes through the desired area of tissue. 5
7. The device as claimed in claim 1, wherein the locking mechanism in the suture resists movement or slipping once tensioned, providing enhanced stability and security for soft tissue repair.
8. The device as claimed in claim 1, wherein the trigger mechanism controls needle deployment and activates the suture retrieval mechanism. 10
9. The device as claimed in claim 1, wherein the ratchet mechanism is easily released once the suture material has been passed through the tissue and secured in place, allowing for efficient and effective closure of the wound.
10. The device as claimed in claim 1, wherein the device is designed to be used with a 5.5 mm or larger cannula. 15
11. The device as claimed in claim 1, wherein the suture material includes a barb-type or other similar configuration to prevent the suture from being pulled back out of the soft tissue after being advanced.
12. The device as claimed in claim 1, wherein the device is used for targeted tissue or tendons or bone repair. 20
13. A method for passing a suture through tissue, comprising the steps of:
a. b. grasping the tissue to be sutured with the jaws of the suture passer device of claim 1,
b. advancing the needle through the tissue with the suture passing device;
c. capturing a portion of the suture with the hook on the side of the needle; 25
d. retracting the needle back through the tissue with the captured suture;
e. releasing the captured suture from the hook on the needle; and
f. repeating steps (b) through (e) as needed to complete the suture.