Methods and devices for tissue defect closure - Patents.com
Patent Information
- Application Number
- JP2023566774
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-05-07
- Filing Date
- 2022-05-06
- Publication Date
- 2025-03-19
- Estimated Expiration
- 2042-05-06
AI Technical Summary
Existing methods for closing tissue defects, such as those caused by hernias or surgical incisions, face challenges in atraumatic closure and determining the required force, especially for defects wider than 8 cm to 20 cm, and lack visual indicators of tension during robotic surgeries.
A tissue closure device with grippers and a spring mechanism that biases the grippers to close the defect, providing a visual force indicator to determine the retraction force applied, and includes a lock for maintaining the extended configuration.
Facilitates atraumatic closure of tissue defects by ensuring sufficient retraction force without slipping, allowing for precise closure and reducing tissue damage, while providing visual feedback for optimal closure techniques.
Smart Images

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Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Application No. 63 / 185,685, filed May 7, 2021, the disclosure of which is incorporated by reference in its entirety into this specification.
[0002] FIELD OF THE DISCLOSURE
[0002] The disclosed embodiments relate to methods and devices for tissue defect closure. [Background technology]
[0003]
[0003] Closure of openings in tissue, such as defects in fascial tissue, is a common surgical procedure. Such openings may be created during surgery, for example by making an incision. In some cases, such openings occur naturally, such as in the case of a hernia. Suture and patch closures are often used to close and repair openings in tissue. Summary of the Invention
[0004]
[0004] In one aspect, a tissue closure device includes a first tissue gripper, a second tissue gripper, a spring operably coupled to the first and second tissue grippers, and a lock configured to hold the first and second tissue grippers in an extended configuration in a locked configuration, the spring configured to bias the first and second tissue grippers toward a retracted configuration when the lock is in an unlocked configuration.
[0005] Another aspect is directed to a method for closing an opening in tissue. In some embodiments, the method includes holding a first tissue gripper engaged with a first tissue portion and a second tissue gripper engaged with a second tissue portion in an extended configuration, changing a lock from a locked configuration to an unlocked configuration to release the first tissue gripper and the second tissue gripper from the extended configuration, and biasing the first tissue gripper toward the second tissue gripper to move the first tissue gripper and the first tissue portion toward the second tissue gripper and the second tissue portion.
[0006] In another aspect, a tissue closure device is provided. According to some embodiments, the tissue closure device includes a first tissue gripper, a second tissue gripper, a spring operably coupled to the first and second tissue grippers, a housing including a first and second housing portion, where the first tissue gripper is operably coupled to the first housing portion and the second gripper is operably coupled to the second housing portion, the spring configured to bias the first and second tissue grippers from an extended configuration toward a retracted configuration, and a force indicator configured to visually indicate a retraction force applied by the first and second tissue grippers to the first and second tissue portions.
[0007] In yet another aspect, a method for closing an opening in tissue is provided. In some embodiments, the method includes holding a first tissue gripper engaged with a first tissue portion and a second tissue gripper engaged with a second tissue portion in an extended configuration, biasing the first tissue gripper toward the second tissue gripper to move the first tissue gripper and the first tissue portion toward the second tissue gripper and the second tissue portion, and visually indicating a contraction force applied by the first and second tissue grippers to the first and second tissue portions using a force indicator.
[0008]
[0008] It should be understood that the foregoing concepts, and additional concepts discussed below, may be arranged in any suitable combination, as the disclosure is not limited in this respect. Moreover, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying drawings.
[0009]
[0009] The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown in various figures may be represented by a similar numeral. For clarity, not every component may be labeled in every figure. [Brief description of the drawings]
[0010] [Figure 1A] 1 shows a cross-sectional schematic view of a device for tissue closure, according to certain embodiments. [Figure 1B] 1 shows a cross-sectional schematic view of a device for tissue closure, according to certain embodiments. [Figure 1C] 1 shows a cross-sectional schematic view of a device for tissue closure, according to certain embodiments. [Figure 2A]
[0011] 1 illustrates a perspective view of a device for tissue closure, according to certain embodiments. [Figure 2B]
[0011] FIG. 1 illustrates a perspective view of a device for tissue closure, in accordance with certain embodiments. [Diagram 3]
[0012] 1 illustrates an exploded perspective view of a device for tissue closure with a lock, according to certain embodiments. [Figure 4A]
[0013] 1 illustrates a device for tissue closure, according to certain embodiments. [Figure 4B] 1 illustrates a device for tissue closure, in accordance with certain embodiments. [Figure 5A]
[0014] FIG. 1 illustrates a housing with a cantilever lock, according to certain embodiments. [Figure 5B] FIG. 1 illustrates a housing with a cantilever lock, according to certain embodiments. [Figure 5C] FIG. 1 illustrates a housing with a cantilever lock, according to certain embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0011]
[0015] Generally, devices and methods are provided for the closure of an opening in tissue (a defect in fascial tissue). Closure of an opening in tissue, for example using sutures and patch closure, is generally a surgical procedure. However, in the context of the present disclosure, it has been recognized that there is a need for improved methods and devices for atraumatically closing a tissue opening and for determining the force required to completely close the opening and / or to maintain the opening closed. In some embodiments, methods and devices are generally provided for using a tissue gripper to engage tissue portions and then biasing the tissue gripper and tissue portions toward each other to assist in closing an opening formed in the tissue.
[0012]
[0016] The inventors have realized that defects in fascial tissue, such as defects created during hernias or defects created intentionally during other surgical procedures, can be difficult to close and repair without risking further damage to the fascial tissue. For example, sutures used to close the fascial defect can pierce the fascial tissue when the sutures are tightened, causing the defect to reopen and cause additional damage. The difficulty of repairing the tissue in these cases can increase with the width of the fascial defect, and in some cases with the width of the fascial defect. Specifically, fascial defects with widths between or equal to 8 cm and 20 cm can be difficult to close using standard closure procedures.
[0013]
[0017] Difficulties with fascial defect closure may also be exacerbated by the lack of a visual indicator of the tension exerted on the fascial tissue during a typical procedure. For example, many fascial tissue repairs are performed robotically. When performing such fascial tissue repairs, the primary visual indicator of undue stress on the fascial tissue is tearing of the sutures and / or tissue due to the lack of tactile feedback. Thus, the inventors have realized that it may be desirable to provide a visual indication of the tension applied during repair of a fascial defect.
[0014]
[0018] In view of the above, the inventors have realized benefits associated with a device that is attachable to opposing portions of a fascial defect and capable of transitioning between extended and contracted configurations to apply a force to assist in closing the fascial defect. In addition to tensioning the fascial tissue surrounding the fascial defect, in some embodiments described herein, the device may also provide a visual indication of the force being applied to the tissue by the device.
[0015]
[0019] In one embodiment, the tissue closure device may include a first tissue gripper configured to be engaged with a first tissue portion and a second tissue gripper configured to be engaged with a second tissue portion, and the grippers may be maintained in a first extended configuration. In some embodiments, the device includes a lock that may be transitioned from a locked configuration to an unlocked configuration to release the first and second tissue grippers from the extended configuration. When the grippers are released from the extended configuration by the lock, the first tissue gripper may be biased toward the second tissue gripper to move the first tissue gripper and the first tissue portion toward the second tissue gripper and the second tissue portion. In some embodiments, including a lock may allow a user to attach the first and second tissue grippers to the tissue prior to applying a closure force to an opening formed in the tissue.
[0016]
[0020] In another aspect, the tissue closure device can be configured to indicate a force applied to the tissue. The device can include a first tissue gripper configured to be engaged with a first tissue portion and a second tissue gripper configured to be engaged with a second tissue portion in a first extended configuration. The first tissue gripper can be biased toward the second tissue gripper to move the first tissue gripper and the first tissue portion toward the second tissue gripper and the second tissue portion. In some embodiments, the tissue closure device can include a force indicator configured to provide an indication of a retraction force applied by the first and second tissue grippers to the first and second tissue portions described herein. Such a measurement of the retraction force can help inform the surgeon of a force that may be required to close the opening. For example, this can help the surgeon determine how best to close the opening, including application of sutures, tissue patches, component separation, and / or additional devices for tissue closure.
[0017]
[0021] Depending on the embodiment, the above concepts of using locks and / or force indicators may be used individually and / or together. For example, a device described herein in one embodiment may be used to close an opening in tissue in some embodiments. As a specific non-limiting example, in certain embodiments, a device described herein may be inserted into a tissue opening (fascial defect) locked in an extended configuration so that a first tissue gripper can engage a first portion of tissue (e.g., fascial tissue). Next, a second tissue gripper is manipulated to engage a second portion of tissue (e.g., fascial tissue) according to some embodiments. Following these steps, the device may be switched (e.g., using a robotic surgical system) from a locked configuration to an unlocked configuration. If the device is capable of providing sufficient contraction force without slippage, the spring of the device in the unlocked configuration will bias the first tissue gripper toward the second tissue gripper to move the first tissue gripper and first tissue portion toward the second tissue gripper and second tissue portion. If necessary, additional devices may be introduced until the tissue opening is sufficiently closed to allow for surgical repair. In some embodiments, if the initial device is unable to fully retract on its own, the need for additional devices may be indicated by a force indicator on the initial device. Once the opening is fully closed, in some embodiments, the tissue may be sutured together and the device may be removed. As an alternative or addition to sutures, a tissue patch may be used to close the opening. In some embodiments, once the tissue opening is at least partially sutured or patched, the device for tissue closure may be separated from the tissue portions and / or removed from the tissue opening.
[0018]
[0022] As mentioned above, in some embodiments, the device may include a force indicator configured to visually indicate the contraction force applied by the first and second tissue grippers to the first and second tissue portions (e.g., may be used to determine the contraction force applied by the first and second tissue grippers). Any suitable type of force indicator may be used. For example, in some embodiments, the force indicator includes a plurality of markings on an exterior surface of the first and / or second housing portions and a marker configured to move relative to the plurality of markings to indicate the force applied as the device transitions between the extended and retracted configurations to indicate the contraction force. Of course, other types of force indicators may be used, including a force dial, a digital readout display, and / or any other suitable type of force indicator capable of visually indicating the force applied to an associated tissue, as the disclosure is not so limited.
[0019]
[0023] According to certain embodiments, the device comprises a housing. The housing may include a first housing portion and a second housing portion. In some embodiments, a first tissue gripper is operably coupled to the first housing portion and a second tissue gripper is operably coupled to the second housing portion. A spring may be operably coupled to the first housing portion and the second housing portion for biasing the first housing portion toward the second housing portion. In some embodiments, at least a portion of the second housing portion is configured to slide within the interior volume of the first housing portion. In certain embodiments, the spring is disposed at least partially within the interior volume of the first housing portion and / or at least partially within the interior volume of the second housing portion.
[0020]
[0024] In some embodiments, the device may include a longitudinal axis (e.g., an axis extending along a pulling direction of the tissue closure device including the housing). According to certain embodiments, the device includes a maximum longitudinal dimension (e.g., a length). Any suitable maximum longitudinal dimension may be used depending on the desired application. However, according to certain embodiments, an advantageous maximum longitudinal dimension of the device in the extended configuration may correspond approximately to the maximum width of the opening in the tissue (e.g., fascial defect) that the device is to close. Thus, in some embodiments, the device in the extended configuration may include a maximum longitudinal dimension of greater than or equal to 5 cm, greater than or equal to 8 cm, greater than or equal to 10 cm, greater than or equal to 12 cm, greater than or equal to 15 cm, or any other suitable dimension. In some embodiments, the device in the extended configuration includes a maximum longitudinal dimension of less than or equal to 20 cm, less than or equal to 18 cm, less than or equal to 15 cm, less than or equal to 12 cm, less than or equal to 10 cm, less than or equal to 8 cm, or any other suitable dimension. These ranges may be combined. For example, in some embodiments, the device in the extended configuration may have a maximum vertical dimension that is greater than or equal to 5 cm and less than or equal to 20 cm. Of course, maximum vertical dimensions in the extended configuration both greater than and less than the aforementioned dimensions are also contemplated, as the disclosure is not so limited.
[0021]
[0025] In the retracted configuration, in some embodiments, the device has a maximum vertical dimension greater than or equal to 1 cm, greater than or equal to 1.2 cm, greater than or equal to 1.5 cm, greater than or equal to 2 cm, greater than or equal to 3 cm, greater than or equal to 5 cm, greater than or equal to 8 cm, or any other suitable dimension. In the retracted configuration, in some embodiments, the device has a maximum vertical dimension less than or equal to 10 cm, less than or equal to 8 cm, less than or equal to 5 cm, less than or equal to 3 cm, less than or equal to 2.5 cm, less than or equal to 2 cm, less than or equal to 1.5 cm, or any other suitable dimension. Combinations of these ranges are possible. For example, in some embodiments, in the retracted configuration, the device has a maximum vertical dimension greater than or equal to 1 cm and less than or equal to 10 cm. Of course, maximum vertical dimensions in the retracted configuration both greater than and less than the aforementioned dimensions are also contemplated, as the disclosure is not so limited.
[0022]
[0026] In some embodiments, the device may exhibit a longitudinal distance between a first tissue gripper of the device and a second tissue gripper of the device that may vary as the device transitions between the extended and retracted configurations. In the extended configuration, in some embodiments, the longitudinal distance between the first tissue gripper and the second tissue gripper is greater than or equal to 1 cm, greater than or equal to 4 cm, greater than or equal to 6 cm, greater than or equal to 8 cm, greater than or equal to 10 cm, or any other suitable dimension. In the extended configuration, in some embodiments, the longitudinal distance between the first tissue gripper and the second tissue gripper is less than or equal to 18 cm, less than or equal to 15 cm, less than or equal to 12 cm, less than or equal to 10 cm, greater than or equal to 8 cm, or any other suitable dimension. Combinations of these ranges are possible. For example, in some embodiments, in the extended configuration, the longitudinal distance between the first tissue gripper and the second tissue gripper is greater than or equal to 1 cm and less than or equal to 18 cm. Of course, distances both greater than and less than the aforementioned distances are contemplated.
[0023]
[0027] In the retracted configuration, in some embodiments, the longitudinal distance between the first and second tissue grippers of the device is greater than or equal to 0 cm, greater than or equal to 0.2 cm, greater than or equal to 0.5 cm, greater than or equal to 0.8 cm, greater than or equal to 1 cm, greater than or equal to 1.2 cm, greater than or equal to 1.5, or any other suitable dimension. In the retracted configuration, in some embodiments, the longitudinal distance between the first and second tissue grippers is less than or equal to 2 cm, less than or equal to 1.5 cm, less than or equal to 1.2 cm, less than or equal to 1 cm, greater than or equal to 0.8 cm, greater than or equal to 0.5 cm, or any other suitable dimension. Combinations of these ranges are possible. For example, in some embodiments, in the retracted configuration, the longitudinal distance between the first and second tissue grippers is greater than or equal to 0 cm and less than or equal to 2 cm. As a more specific example, in some embodiments, in the retracted configuration, the minimum distance between the first and second tissue grippers is greater than or equal to 1 cm and less than or equal to 2 cm. Of course, ranges different from the foregoing are contemplated as the disclosure is not so limited.
[0024]
[0028] According to certain embodiments, the device has a maximum transverse dimension, such as a width or diameter, that may be perpendicular to the maximum longitudinal dimension of the device. Any suitable maximum transverse dimension may be selected. However, it may be advantageous to allow the device to be inserted through a surgical trocar according to certain embodiments for selecting the maximum transverse dimension. In some embodiments, the device has a maximum transverse dimension greater than or equal to 3 mm, greater than or equal to 4 mm, greater than or equal to 5 mm, greater than or equal to 6 mm, greater than or equal to 7 mm, or any other suitable dimension. In some embodiments, the housing has a maximum transverse dimension less than or equal to 8 mm, less than or equal to 7 mm, less than or equal to 6 mm, less than or equal to 5 mm, less than or equal to 4 mm, or any other suitable dimension. These ranges may be combined. For example, in some embodiments, the housing has a maximum transverse dimension greater than or equal to 3 mm and less than or equal to 8 mm. In some embodiments, for example, when the device does not need to be inserted through a surgical trocar, the device may have a maximum transverse dimension greater than or equal to 8 mm. Additionally, any other suitable ranges of maximum lateral dimensions, both greater than the aforementioned dimensions and less than the aforementioned dimensions, may also be used, as the disclosure is not so limited.
[0025]
[0029] Various embodiments disclosed herein may use a spring. It should be understood that in these embodiments, any suitable spring capable of applying a force to bias the tissue grippers of the device toward one another may be used. In some embodiments, it may be advantageous to use a tension spring. According to certain embodiments, the spring is a coil spring (e.g., a spring comprising a coil of material, such as a metal) configured to act as a tension spring. For example, the spring may be operably connected to a first tissue gripper and another tissue gripper such that increasing the distance between the first tissue gripper and the second tissue gripper will cause tension on the spring. According to certain embodiments, the spring is a coil spring (e.g., a spring comprising a coil of material, such as a metal) configured to act as a compression spring. For example, the spring may be disposed between a first portion of the housing and a second portion of the housing such that when the first housing portion slides away from the second housing portion, the coil spring will be compressed between the two housing portions. The spring can also be an elastic component, such as an elastic band, an elastic tube, and / or any other elastic structure capable of being used as a spring (e.g., comprising a polymeric material that can be elastically deformed by greater than or equal to 20%, greater than or equal to 30%, greater than or equal to 50%, greater than or equal to 100%, or more of its undeformed length under an applied load). Other suitable types of springs include, but are not limited to, drawbar springs, gas springs, torsion springs, rotational springs, and / or any other suitable type of spring, as the disclosure is not so limited.
[0026]
[0030] According to certain embodiments, it may be advantageous for the spring to be approximately linearly elastic. Generally, a change in force applied to a linearly elastic spring will result in a proportional change in the length of the linearly elastic spring. According to certain embodiments, this may be advantageous for determining the contractile force applied by the first and second tissue grippers operatively coupled to the spring, since the contractile force is proportional to the displacement, allowing the contractile force to be determined using regularly spaced markers to indicate the displacement. However, a linearly elastic spring is not a requirement, and in some embodiments, irregularly spaced markers or other methods may be used to indicate the contractile force, as described in more detail below.
[0027]
[0031] Turning now to the tissue gripper, in some embodiments, the tissue gripper is configured to engage the tissue portion (e.g., to apply a contraction force to the tissue portion). In general, the tissue gripper may have any suitable dimension. However, it may be advantageous for the tissue gripper to distribute the force (e.g., the contraction force) over a relatively wide area to reduce the possibility of damage to the tissue portion. For example, according to certain embodiments, the tissue gripper has a length that may extend in a direction parallel to a longitudinal axis of the gripper and / or the entire device. Additionally, the gripper length may extend in a direction configured perpendicular to an edge of the portion of tissue engaged by the gripper. In some embodiments, the tissue gripper has a length greater than or equal to 1 cm, greater than or equal to 1.2 cm, greater than or equal to 1.4 cm, greater than or equal to 1.6 cm, greater than or equal to 1.8 cm, or any other suitable dimension. In some embodiments, the tissue gripper has a length less than or equal to 2 cm, less than or equal to 1.8 cm, less than or equal to 1.6 cm, less than or equal to 1.4 cm, less than or equal to 1.2 cm, or any other suitable dimension. Combinations of these ranges are possible. For example, in some embodiments, the tissue gripper has a length greater than or equal to 1 cm and less than or equal to 2 cm, although both greater and lesser ranges are contemplated as the disclosure is not so limited.
[0028]
[0032] In some embodiments, the tissue gripper has a width that may extend in a direction transverse to the longitudinal axis of the gripper and / or the entire device. Additionally, the gripper width may extend in a direction configured to be parallel to the edge of the portion of tissue engaged by the gripper. The tissue gripper may have any suitable width. However, as previously mentioned, it may be advantageous to select a width that allows the device to be inserted through a surgical trocar. In some embodiments, the tissue gripper has a width greater than or equal to 3 mm, greater than or equal to 4 mm, greater than or equal to 5 mm, greater than or equal to 6 mm, greater than or equal to 7 mm. In some embodiments, the tissue gripper has a width less than or equal to 8 mm, less than or equal to 7 mm, less than or equal to 6 mm, less than or equal to 5 mm, less than or equal to 4 mm. These ranges may be combined. For example, in some embodiments, the tissue gripper has a width greater than or equal to 3 mm and less than or equal to 8 mm. In some embodiments, for example, when the device does not need to be inserted through a surgical trocar or through the use of a flexible or collapsible tissue gripper, the tissue gripper can have a width of greater than 8 mm as the disclosure is not so limited.
[0029]
[0033] According to some embodiments, the tissue gripper is configured to apply a combination of forces to the tissue portions used during engagement. In some embodiments, these forces may include a first component corresponding to a compressive force applied to the tissue disposed between the opposing jaws of the gripper, as well as a second component that may correspond to a shear force applied to the tissue as it draws the opposing portions of the tissue opening toward one another. In some cases, this shear force may be referred to as a retaining force that holds the tissue within the tissue gripper when a tension force is applied to the gripper.
[0030]
[0034] In some embodiments, the clamping force applied by the tissue gripper to the tissue engaged with the tissue may be applied uniformly across the area of the gripper. However, embodiments in which a non-uniform force distribution is applied by the tissue gripper to the tissue are also contemplated. According to certain embodiments, the total clamping force applied by the gripper to the engaged tissue is greater than or equal to 0.5N, greater than or equal to 1N, greater than or equal to 1.5N, greater than or equal to 2N, greater than or equal to 3N, greater than or equal to 5N, greater than or equal to 8N, greater than or equal to 10N, greater than or equal to 15N, or any other suitable clamping force. In some embodiments, the total clamping force is less than or equal to 20N, less than or equal to 15N, less than or equal to 10N, less than or equal to 8N, less than or equal to 5N, less than or equal to 3N, less than or equal to 2N, less than or equal to 1.5N, or any other suitable clamping force. These ranges can be combined. For example, in some embodiments, the total clamping force is greater than or equal to 0.5 N and less than or equal to 20 N. In some cases, the clamping force applied by the tissue gripper can be measured using a load cell and / or calculated based on known design parameters of the gripper.
[0031]
[0035] In some embodiments, the tissue gripper may be configured to apply a maximum holding force to tissue held within the tissue gripper prior to sliding of the tissue within the gripper. In some embodiments, the maximum holding force of the tissue gripper is designed to accommodate the maximum breaking force of an existing absorbable suture. The maximum holding force may be greater than or equal to 2.5N, greater than or equal to 3N, greater than or equal to 3.5N, greater than or equal to 4N, greater than or equal to 4.5N, greater than or equal to 5N, or any other suitable holding force. In some embodiments, the maximum holding force of the tissue gripper is less than or equal to 6N, less than or equal to 5.5N, less than or equal to 5N, less than or equal to 4.5N, less than or equal to 4N, less than or equal to 3.5N, or any other suitable holding force. These ranges may be combined. For example, in some embodiments, the maximum holding force of the tissue gripper is greater than or equal to 2.5N and less than or equal to 6N. The maximum holding force of the tissue gripper can be measured, according to certain embodiments, by measuring the maximum shear force that can be applied in a tensile tester when the gripper is engaged with tissue that resembles human tissue (e.g., fascia tissue collected from a pig with the appropriate thickness to be gripped in the tissue gripper for testing).
[0032]
[0036] In some embodiments, when the tissue gripper is configured to apply a retaining force to an engaged tissue portion, the retraction force applied by the tissue gripper to the opposing tissue portion of the tissue opening can be equal to the retaining force that the tissue gripper applies to the engaged tissue. Thus, the maximum retaining force noted above can also correspond to the maximum retraction force that can be applied by a given tissue gripper in some embodiments. Of course, retraction and / or retaining forces greater than or less than the aforementioned forces are also contemplated, as the disclosure is not so limited.
[0033]
[0037] Any suitable type of tissue gripper capable of transitioning between a closed configuration for engaging tissue and an open configuration for releasing tissue may be used with the various embodiments described herein. For example, in some embodiments, the tissue gripper may be single action (e.g., may transition between an open and closed configuration via a single jaw movement relative to the device). The tissue gripper may also be dual action (e.g., may transition between an open and closed configuration via a two jaw movement relative to the device). The tissue gripper may be fenestrated (e.g., may incorporate an open area or window in one or both jaws to provide a more secure grip). The tissue gripper may be non-fenestrated (e.g., may include solid jaws that rely on friction to hold tissue). Additionally, in some embodiments, the first tissue gripper and / or the second tissue gripper may be biased toward a closed configuration. For example, the tissue gripper may include a spring clip that may be biased by a spring, such as a torsion spring (e.g., a rotational spring), a compression spring (e.g., a coil spring configured to operate under pressure), or an expansion spring as previously described. However, in other embodiments, the first tissue gripper and / or the second tissue gripper are biased toward an open configuration. As one non-limiting example, in some embodiments, the overtube is configured to close the tissue gripper biased toward the open configuration when the overtube is slid toward an end of the tissue gripper, causing the jaws of the gripper to close. In view of the above, it should be understood that these embodiments are non-limiting and that any method and / or structure for providing a tissue gripper capable of releasably engaging tissue may be used as the disclosure is not limited in this manner.
[0034]
[0038] In some embodiments, it may be desirable to avoid damaging tissue engaged by the tissue gripper. Thus, the tissue gripper (e.g., first tissue gripper, second tissue gripper) may be configured in certain embodiments to non-traumatically apply force to the tissue portion (e.g., without puncturing, tearing, squeezing, or otherwise damaging the tissue portion). In general, the non-traumatically applied force may be provided in a variety of manners. For example, the first tissue-engaging surface and / or the second tissue-engaging surface of the tissue gripper may comprise one or more types of texture features, such as ridges, ridges, grooves, and / or teeth, configured to provide frictional engagement with the tissue without damaging the tissue. In some embodiments, the inclusion of texture features on the tissue-engaging surface of the tissue gripper may increase the maximum holding force of the tissue gripper without risking additional traumatic damage to the engaged tissue portion. In some embodiments, the tissue gripper of the device may be configured to non-traumatically release the associated engaged tissue portion if the contraction force would otherwise exceed a threshold value. In some embodiments, this threshold force is less than the maximum holding force of the tissue gripper static friction as described above and may result in release of the tissue portions. An advantage of such an embodiment is that it reduces the risk of tissue damage when a contraction force is applied to the tissue that may otherwise cause the tissue to slip within the tissue gripper.
[0035]
[0039] According to certain embodiments, the device further comprises a lock configured such that when the lock is in a locked configuration, the device is held in an extended configuration. In the locked configuration, the first and second tissue grippers are held at a fixed distance from one another, while in the unlocked configuration, the first and second tissue grippers may move relative to one another in response to external and biasing forces applied to the tissue grippers from a spring or other structure. The inclusion of a lock may be advantageous for several reasons. For example, the lock may be used to maintain the device in an extended configuration prior to engagement of the tissue grippers of the device with a tissue portion, reducing the need for external manipulation of the device and / or tissue prior to unlocking the device.
[0036]
[0040] Any suitable locking mechanism may be used. For example, in some embodiments, the lock is a slot and key lock, comprising a slot located in a first portion of the housing of the device and a key located in a second portion of the housing of the device. In such embodiments, the device may be locked or unlocked via a rotational movement of one housing portion relative to the other such that the key may slide into or out of a correspondingly sized and shaped slot configured to receive and hold the key in the locked configuration. In some embodiments, the lock is a spring detent, in which the spring is configured to trap a ball, or other correspondingly sized and shaped structure, in the locked configuration, against a hole, recess, or other type of detent to lock the device in a desired configuration. In some embodiments, the lock is a cantilever lock, for example, the second housing portion comprises a cantilever connected to the key and the first housing portion comprises a catch, such as a hole, recess, or other structure configured to receive the key. In some such embodiments, depressing the key elastically deforms the cantilever, releasing the key from the catch to allow the first housing portion to slide relative to the second housing portion. In such embodiments, the second housing portion may include multiple catches, detents, or keyway mechanisms to allow the first housing portion to be unilaterally indexed to a specified extension length prior to use to address various defect sizes. Other locking mechanisms are possible, and thus the disclosure is not limited. For certain applications, including surgeries performed using a robotic surgical system, a cantilever lock and / or a push button lock, such as a slot and key lock, may be advantageous as they may be more easily operated by the robotic surgical system.
[0037]
[0041] In some embodiments, the devices described herein may be non-toxic and sterile prior to use. The devices may comprise any suitable materials. For example, the devices described herein may comprise any suitable combination of biocompatible metals, polymers, ceramics, combinations thereof, and / or any other suitable types of materials. In some embodiments, the devices are configured for reuse. However, in some embodiments, the devices are intended to be disposable and single use.
[0038]
[0042] In some embodiments, the materials used to construct the devices described herein may be easily sterilizable. Various techniques exist for sterilizing materials, including sterilization using UV irradiation, ethylene oxide (ETO) sterilization, gamma irradiation, autoclaving, or dry heat. In some embodiments, polymeric materials are selected because they are more easily sterilized for a single use (e.g., using ETO or gamma irradiation). However, in some embodiments, metals may be selected because they are more easily sterilized for multiple uses. For example, in some embodiments, metals are autocleavable and less prone to degradation during autocleavage and / or sterilization using dry heat.
[0039]
[0043] In some embodiments, a material may instead be selected for its mechanical properties. For example, in some embodiments, metal may be the preferred material for the spring because it is less prone to fracture than polymer springs, or because it may have a more linear elastic behavior than polymer springs. However, in other embodiments, polymer may be preferred for the spring (e.g., elastic band) because it is less expensive or has a preferred elastic deformation profile. Similar advantages and disadvantages for each material exist for each component described herein. Thus, depending on the application, in some embodiments, a device may include both plastic and metal components, and the disclosure is not so limited.
[0040]
[0044] The devices and methods described herein may be used to close any type of opening in tissue. For example, the opening may be a defect in fascial tissue in some embodiments. Such fascial defects may occur naturally, for example, due to the formation of a hernia. Tissue openings and openings in fascial tissue may also form as a result of cuts made during surgery, and closing these openings may be difficult using conventional methods, especially for larger cuts. Fascial defects may also occur as a result of traumatic injury. The applications and methods described herein may be used to close tissue openings regardless of origin, and the disclosure is not so limited.
[0041]
[0045] In some embodiments, the devices and methods described herein may be used in laparoscopic surgery. In some such embodiments, the devices may be inserted into a patient via a trocar that is inserted into an incision less than 2 cm in diameter. In certain embodiments, the devices and methods described herein may be performed using a robotic surgery system. For example, the devices and methods herein may be performed laparoscopically using a robotic surgery system. The robotic surgery system may include components configured to operate the locks of the device and / or provide visual feedback to an operator of the robotic surgery system, according to certain embodiments. In some embodiments, the robotic surgery system may be used to engage or disengage the tissue gripper from the tissue portion. In certain embodiments, the locks and tissue grippers described herein may be selected to be operable by the robotic surgery system.
[0042]
[0046] Turning now to the figures, certain non-limiting embodiments will be described in further detail. It will be understood that the various systems, components, mechanisms, and methods described in connection with these embodiments are not limited to only the specific embodiments described herein, and can be used individually and / or in any desired combination.
[0043]
[0047] 1A-1C show an exemplary embodiment of a tissue closure device, according to certain embodiments. As shown in FIG. 1A, the tissue closure device 101 may include a first tissue gripper 102 and a second tissue gripper 103. Each tissue gripper may include two opposing jaws with two tissue engaging surfaces 119 oriented toward each other. In FIG. 1A, the first tissue gripper 102 is engaged with a first tissue portion 105, one tissue engaging surface pressing against each side of the first tissue portion 105, such that the first tissue portion is compressed between the opposing tissue engaging surfaces of the opposing jaws of the first tissue gripper. The second tissue gripper 103 is shown in an open configuration such that only one of the tissue engaging surfaces 119 presses against the second tissue portion 107, such that the second tissue gripper is not engaged with the second tissue portion 107. The second tissue gripper is shown in a closed configuration in FIG. 1B. Each tissue engaging surface may include one or more types of texture features, such as ridges, ridges, grooves, and / or teeth (not shown). The tissue grippers may each include a hinge 160, or other connecting structure, that movably connects the jaws of the associated gripper to one another and enables the tissue gripper to transition between an open configuration and a closed configuration. In some embodiments, the hinge 160 is associated with a torsion spring (not shown) that is configured to bias the associated tissue gripper toward the closed configuration. However, as detailed above, other types of tissue grippers may also be used.
[0044]
[0048] Each of the tissue grippers 102 and 103 may, in some embodiments, be connected to the housing 170 of the device using any suitable type of connection. In the embodiment shown, a hinge 160 connects the jaws of the tissue gripper to the housing, the associated portion of the housing. However, other types of connections may be used as the disclosure is not so limited. In the embodiment shown, the housing comprises a first housing portion 111 and a second housing portion 113. In some embodiments, as shown in FIGS. 1A-1C, the first housing portion 111 and the second housing portion 113 are coaxially aligned tubes with open ends oriented toward one another. The tubes are sized and shaped such that the open ends allow the second housing portion 113 to slide at least partially within the interior volume of the first housing portion 111. However, the first and second housing portions may have any suitable shape and / or overall structure such that the housing portions may move relative to one another to transition between an extended configuration and a retracted configuration.
[0045]
[0049] As shown in the figures, in some embodiments, the second housing portion 113 is configured to allow at least a portion of the second housing portion 113 to slide within the first housing portion 111. A spring 109 is disposed within the housing 170 and is shown in the example of FIG. 1A in an extended configuration. The spring 109 is connected to the first housing portion 111 and the second housing portion 113 in some embodiments such that the device 101 is biased toward a closed configuration. The spring 109 may be coaxial with the housing 170 as shown in FIGS. 1A-1C, although cases in which the spring is not coaxial with the associated housing portion are contemplated. As shown in the figures, in some embodiments, the spring 109 is at least partially disposed within the interior volume of the first housing portion 111 and / or within the interior volume of the second housing portion 113. As shown in FIG. 1A, the device 101 may have a maximum longitudinal dimension, or length C, in the extended configuration, as described elsewhere herein. The device 101 may also have a maximum lateral dimension, or width, Z, and a minimum distance between the tissue grippers, X, as described elsewhere herein.
[0046]
[0050] The spring 109 may be connected to the housing 170 by any suitable method. For example, the spring may be operatively coupled to a device portion, such as the first tissue gripper 102, the second tissue gripper 103, the first housing portion 111, and / or the second housing portion 113, using mechanical fasteners, pins, hooks, loops, mechanical interlocking portions, welds, adhesives, combinations thereof, and / or any other suitable type of connection. Although the above describes several non-limiting types of connections for connecting the spring to an associated portion of the housing, it should be understood that any suitable type of structure and / or method may be used to connect the spring to a portion of the housing as the disclosure is not so limited.
[0047]
[0051] FIG. 1B shows the device of FIG. 1A in a retracted configuration, where the second tissue gripper is closed to engage the second tissue portion 107. The device is also released such that the spring 109 applies a force biasing the housing portions and associated tissue gripper toward one another. Correspondingly, a retraction force is applied to the first tissue portion 105 and the second tissue portion 107, which pull the opposing tissue portions toward one another as the device transitions from the initial extended configuration toward the retracted configuration. If the first housing portion 111 and the second housing portion 113 are transposed on the letter, according to certain embodiments, the tension applied by the spring 109 biasing the housing portions toward one another is reduced and the portion of the second housing portion 113 disposed within the first housing portion 111 is increased. FIG. 1C shows the device of FIG. 1A rotated 90 degrees about the longitudinal axis of the device so that the width A and length B of the jaws of the tissue gripper are visible.
[0048]
[0052] Proceeding now from Figure 2A to Figure 2B, one embodiment of a tissue closure device 201 is shown. In the illustrated embodiment of Figure 2A, the tissue closure device 201 is shown in a retracted configuration and includes first and second tissue grippers 202 and 203 with a hinge 260 and tissue engaging surface 219 formed on two opposing jaws of the tissue grippers. In an embodiment such as that of Figures 2A-2B, the first and second tissue grippers are connected to corresponding first and second housing portions 211 and 213 of a housing 270 of the tissue closure device 201. Similar to the embodiment of Figures 1A-1C, the first housing portion 211 can include an interior volume sized and configured to receive at least a portion of the second housing portion 213.
[0049]
[0053] As mentioned above, in some embodiments, the device may include a force indicator configured to visually indicate the retraction force applied by the first tissue gripper 202 and the second tissue gripper 203 to the first and second tissue portions (not shown). In the illustrated example, a groove 242 is formed and extends at least partially along the length of the first housing portion. Correspondingly, a marker 223 may be operatively coupled to the second housing portion and aligned and / or positioned with the groove. A plurality of markings 225, such as force indications, may be provided, i.e., printed, engraved, or otherwise formed, on the first housing portion 211. In some embodiments, the plurality of markings 225 are regularly spaced apart, although irregularly spaced apart markings may also be used, to determine the displacement of the marker from the retracted configuration. As the housing portions move relative to each other, the marker 223 connected to the second housing portion 213 is configured to move within an associated groove formed in the first housing portion relative to the plurality of markings. Thus, as the device transitions between the extended and retracted configurations, the markers can be aligned with various markings to indicate the applied retraction force. In this embodiment, the markers 223 are shown as rectangular prisms connected to a portion of the housing. In general, however, any suitable type of markings can be used including, for example, different shaped protrusions, indicator markings printed or formed on a portion of the housing, labels affixed to the housing, and / or any other suitable mechanism applied to, connected to, or otherwise associated with a portion of the device housing that can be used to indicate the force applied to tissue.
[0050]
[0054] Figure 2B shows the device 201 of Figure 2A in an extended configuration. In Figure 2A, the marker 223 corresponds to the zero marking 225, which indicates that the device is fully retracted, while in Figure 2B, the marker 223 corresponds to the final marking position 225, which indicates that the device 201 is in the extended configuration. For configurations in between, the relative position between the marker 225 and the plurality of markings 225 can be used to visually indicate the force currently being applied by the device 201 to tissue.
[0051]
[0055] FIG. 3 shows an exploded perspective view of another tissue closure device 301, according to one embodiment. Similar to the above embodiment, the tissue closure device 301 includes a first tissue gripper 302 and a second tissue gripper 303 connected to first and second housing portions 311 and 313. The housing portions may again be formed as tubes with at least one open end, although other configurations may be used. A groove 342 may be formed in the first housing portion and may extend along at least a portion of the length of the first housing portion. The groove may include a first locking portion 321 positioned along the length of the groove. In the embodiment shown, the first locking portion corresponds to a slot formed at a predetermined location along the length of the groove. A corresponding second locking portion 323 may be coupled to the second housing portion. In some embodiments, the second locking portion is a key, such as the protrusion shown, which may be positioned within the groove and sized and formed to slide along the groove. The key may also be sized and shaped to fit within a slot corresponding to the first locking portion when the device is in both the extended and locked configurations. In the embodiment shown, the device may be locked in the extended configuration by rotating the first and second housings relative to one another to move the key into engagement with the slot when the device 301 is in the extended configuration. The device 301 may then be moved from the locked to the unlocked configuration by rotating the second housing portion 313 in the opposite direction relative to the first housing portion 311 to move the second locking portion 323 out of alignment with the groove and out of the first locking portion 321 such that the key may move axially within the groove when the first and second housing portions are moved axially relative to one another when the device 301 is in the extended configuration.
[0052]
[0056] As mentioned above, in some embodiments, such as the embodiment of FIG. 3, the device 301 also includes a spring 309 that biases the housing portions 311 and 313 and associated tissue grippers 302 and 303 toward a contracted configuration. The spring 309 is configured to operably couple to the first housing portion 311 and the second housing portion 313 via any suitable connection between the first housing portion 311 and the second housing portion 313 (corresponding hooks for engaging the spring loop 380 are not shown). In some embodiments, the device may also include a force indicator as described above. In this particular embodiment, the second locking portion 323 may function as a marker as described above with respect to FIGS. 2A and 2B. For example, the force indicator may include a plurality of markings 325 on the first housing portion 311. When released, the second locking portion 323 connected to the second housing portion 313 moves axially within the associated groove 342 relative to the plurality of markings as the device transitions between the extended and retracted configurations to indicate the retraction force. Thus, in some embodiments, such as the embodiment shown in FIG. 3, the locking mechanism may also be used as a force indicator marker.
[0053]
[0057] 2A-3, it should be understood that any suitable types of locks and / or force indicators may be used as described above, and the disclosed concepts may be used in combination with each other or separately, as the disclosure is not so limited.
[0054]
[0058] 4A and 4B show another embodiment of a device for tissue closure. FIG. 4A shows a tissue closure device 401 in an extended configuration, according to certain embodiments. In some embodiments, such as those in FIGS. 1A-1C, 2A-2B, and 3, the tissue grippers are oriented such that the engaged tissue portions are pulled toward the spring when the device transitions from the extended to the retracted configuration. In such embodiments, the clamping force may be symmetric, so that the retraction force is equal to the holding force of the tissue grippers. However, in some embodiments, such as the embodiment shown in FIG. 4A, the first tissue gripper 402 and the tissue gripper 403 are oriented such that the engaged tissue portions are not pulled toward the spring enclosed within the housing 470 of the device 401 when the device transitions from the extended to the retracted configuration. Rather, in some embodiments, the tissue portions engaged by the first tissue gripper 402 and the second tissue gripper 403 are pulled in an axial direction that is parallel to and offset from the housing 470 and the springs disposed therein as the device transitions from the extended configuration to the contracted configuration.
[0055]
[0059] In some embodiments, such as the embodiment shown in FIG. 4A, the first tissue gripper 402 is connected to the first housing portion 411 via a first arm 482. In some embodiments, such as the embodiment shown in FIG. 4A, the second tissue gripper 403 is connected to the second housing portion 413 via a second arm 483. The first arm 482 and / or the second arm 483 may be rigid connections attached to any suitable portion of the housing, including, for example, an end of the housing 470. In the embodiment shown, the arms extend around the end of the housing 470 to extend parallel to and adjacent to the housing 470 before bending away from the housing 470 and connecting to an associated tissue gripper. According to certain embodiments, such a configuration may be advantageous because it may allow for a minimum distance X between the first tissue gripper 402 and the second tissue gripper 403 that is less than the axial length C of the housing in the retracted configuration. In some embodiments, this means that the minimum distance X between the first tissue gripper 402 and the second tissue gripper 403 can be as short as 0. In other words, the grippers can be disposed relative to one another in a fully retracted configuration in some embodiments. For example, Figure 4B shows the device of Figure 4A in a retracted configuration, with the first and second tissue grippers close to contact.
[0056]
[0060] In some embodiments, the tissue closure device comprises a cantilever lock. In some embodiments, such as the type of embodiment shown in FIG. 5A, the device comprises a first housing portion 511 comprising a first locking portion 521, which may be a catch such as a hole as shown, or any other structure configured to receive a key in a locking configuration. The device may further comprise a second housing portion 513 comprising a cantilever 540 connected to a second locking portion 523 (shown as a key in the case of FIG. 5A) configured to be received by the first locking portion 521.
[0057]
[0061] FIG. 5B shows the assembled housing parts of FIG. 5A in a locked and extended configuration. Here, a key connected to the second locking part 523, the cantilever 540, is engaged with the first locking part 521, and the key is positioned within a hole formed in the other housing part to lock the first housing part 511 relative to the second housing part 513 in the extended configuration. To unlock the device, in some embodiments, a force can be applied to the second locking mechanism, which can depress the key to disengage from the catch shown. Specifically, a force directed radially inwardly relative to the device is applied to the key, elastically deforming the cantilever by an amount sufficient to separate the first locking part 521 from the second locking part 523, allowing the first housing part 511 to slide relative to the second housing part 513. Optionally, the first housing portion 511 may include a groove 542, recess, or other structure sized and shaped to allow axial displacement after the second locking portion, i.e., the key shown, is separated from the first locking portion. As shown in Figures 5A-5C, the use of a groove or similar axially extending structure may prevent the first housing portion 511 from rotating relative to the second housing portion 513 in the unlocked configuration. However, a groove is not required in all embodiments, since in the unlocked configuration, the first housing portion 511 is still able to slide relative to the second housing portion 513, even when the cantilever is under stress against the inner surface of the second housing portion.
[0058]
[0062] While the present teachings have been described in conjunction with various embodiments and examples, it is not intended that the present teachings be limited to such embodiments or examples. Rather, the present teachings encompass various alternatives, modifications, and equivalents, as will be appreciated by those skilled in the art. Accordingly, the foregoing description and drawings are by way of example only.
[0059]
[0063] Although several embodiments of the invention have been described and illustrated herein, those skilled in the art will readily envision a variety of other means and / or structures for performing the functions and / or obtaining one or more of the results and / or advantages described herein, and each of such variations and / or modifications will be considered to be within the scope of the present invention. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the particular application in which the teachings of the present invention are used. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation many equivalents to the specific embodiments of the invention described herein. Thus, the foregoing embodiments are presented by way of example only, and it will be understood that, within the scope of the appended claims and their equivalents, the invention may be practiced otherwise than as specifically described and claimed. The present invention is directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the scope of the invention, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent.
[0060]
[0064] The indefinite articles "a" and "an," as used in the specification and claims, unless clearly indicated to the contrary, should be understood to mean "at least one."
[0061]
[0065] The phrase "and / or" as used in the specification and claims is to be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and non-conjunctively present in other cases. Other elements, whether related or unrelated to those elements specifically identified, may optionally be present other than the elements specifically identified by the "and / or" clause, unless expressly indicated to the contrary. Thus, as a non-limiting example, a reference to "A and / or B," when used in connection with open-ended language such as "comprising," can refer in one embodiment to A without B (optionally including elements other than B), in another embodiment to B without A (optionally including elements other than A), in yet another embodiment to both A and B (optionally including other elements), and so forth.
[0062]
[0066] As used herein and in the claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" should be interpreted as inclusive, i.e., including at least one but also more than one of a number or list of elements, and optionally including additional unlisted items. Only terms clearly indicated to the contrary, such as "only one of" or "exactly one of," or "consisting of" as set forth in the claims, will refer to the inclusion of exactly one of a number or list of elements. In general, the term "or" as used herein should only be interpreted as indicating exclusive alternatives (i.e., "one or the other but not both") when preceded by a term of exclusivity, such as "either," "one of," "only one of," or "exactly one of." When used in the claims, "consisting essentially of" shall have its ordinary meaning as used in the field of patent law.
[0063]
[0067] As used in this specification and claims, the phrase "at least one" in connection with a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed in the list of elements, and not excluding any combinations of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements to which the phrase "at least one" refers, whether such elements are related or unrelated to those elements specifically identified. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B" or, equivalently, "at least one of A and / or B") can refer in one embodiment to at least one, optionally two or more, A, and no B (and optionally including elements other than B); in another embodiment to at least one, optionally two or more, B, and no A (and optionally including elements other than A); in yet another embodiment to at least one, optionally two or more, A, and at least one, optionally two or more, B (and optionally including other elements); and so forth.
[0064]
[0068] Within the claims, the use of conventional terms such as "first," "second," and "third" to modify claim elements does not, in and of itself, imply any priority, precedence, or order in which one claim element over another, or the temporal order in which method operations are performed, but is merely used as a label to distinguish one claim element having a particular name from another element having the same name (but for purposes of conventional terminology) to distinguish the claim element.
[0065]
[0069] In the claims as well as in the specification above, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," and the like, are to be understood to be open-ended, i.e., meaning including but not limited to. Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.
Claims
1. a first tissue gripper; a second tissue gripper; and a spring operatively coupled to the first tissue gripper and the second tissue gripper; a lock configured to hold the first and second tissue grippers in an extended configuration in a locked configuration, the spring configured to bias the first and second tissue grippers toward a retracted configuration when the lock is in an unlocked configuration; 1. A tissue closure device comprising:
2. 1. A method for closing an opening in tissue, comprising: holding a first tissue gripper engaged with a first tissue portion and a second tissue gripper engaged with a second tissue portion in an extended configuration; changing a lock from a locked configuration to an unlocked configuration to release the first tissue gripper and the second tissue gripper from the extended configuration; biasing the first tissue gripper toward the second tissue gripper to move the first tissue gripper and the first tissue portion toward the second tissue gripper and the second tissue portion; A method comprising:
3. a first tissue gripper; a second tissue gripper; and a spring operatively coupled to the first tissue gripper and the second tissue gripper; a housing including a first housing portion and a second housing portion, the first tissue gripper being operably coupled to the first housing portion and the second gripper being operably coupled to the second housing portion, the spring configured to bias the first tissue gripper and the second tissue gripper from an extended configuration toward a retracted configuration; a force indicator configured to visually indicate the contractile forces applied to the first and second tissue portions by the first and second tissue grippers; 1. A tissue closure device comprising:
4. The tissue closure device of claim 3 , further comprising a lock configured to hold the first and second tissue grippers in the extended configuration in a locked configuration.
5. The tissue closure device of claim 1 or 4, wherein the lock is selected from the group consisting of a cantilever lock and a slot and key lock.
6. 1. A method for closing an opening in tissue, comprising: holding a first tissue gripper engaged with a first tissue portion and a second tissue gripper engaged with a second tissue portion in an extended configuration; biasing the first tissue gripper toward the second tissue gripper to move the first tissue gripper and the first tissue portion toward the second tissue gripper and the second tissue portion; visually indicating contractile forces applied to the first and second tissue portions by the first and second tissue grippers using a force indicator; A method comprising:
7. The method of claim 6 , further comprising changing a lock from a locked configuration to an unlocked configuration to release the first tissue gripper and the second tissue gripper from the first extended configuration.
8. The tissue closure device of claim 1 or 3, wherein a minimum distance between the first tissue gripper and the second tissue gripper in the retracted configuration is greater than or equal to 0 cm and less than or equal to 2 cm.
9. 4. The tissue closure device of claim 1 or 3, wherein a maximum longitudinal dimension of the device is greater than or equal to 5 cm and less than or equal to 20 cm.
10. The tissue closure device of claim 1 or 3, wherein a maximum lateral dimension of the housing is greater than or equal to 3 mm and less than or equal to 8 mm.
11. The tissue closure device of claim 1 or 3, wherein a width of the first tissue gripper and the second tissue gripper is greater than or equal to 3 mm and less than or equal to 8 mm.
12. The tissue closure device of claim 1 or 3, wherein a length of the first tissue gripper and the second tissue gripper is greater than or equal to 1 cm and greater than or equal to 2 cm.
13. a housing including a first housing portion and a second housing portion; the first tissue gripper is operably coupled to the first housing portion; the second tissue gripper is operably coupled to the second housing portion; The tissue closure device of claim 1 or 3, wherein the spring is operably coupled to the first housing portion and the second housing portion to bias the first housing portion toward the second housing portion.
14. The tissue closure device of claim 3 or 4, wherein at least a portion of the second housing portion is configured to slide within an interior volume of the first housing portion.
15. The tissue closure device of claim 14 , wherein in the contracted configuration, the portion of the second housing portion disposed within the interior volume of the first housing portion is maximized.
16. The tissue closure device of claim 3 or 4, wherein the housing and the spring are coaxial.
17. The tissue closure device of claim 3 or 4, wherein the spring is at least partially disposed within an interior volume of the first housing portion and / or the second housing portion.
18. The tissue closure device of claim 1 , further comprising a force indicator configured to visually indicate the contractile force applied by the first and second tissue grippers to the first and second tissue portions.
19. The tissue closure device of claim 3 or 18, wherein the force indicator includes a plurality of markings on an exterior surface of the first housing portion and / or the second housing portion and a marker configured to move relative to the plurality of markings as the device transitions between the extended and retracted configurations to indicate the retraction force.
20. The tissue closure device of claim 1 or 3, wherein the spring is at least one selected from the group of a coil spring, a rotational spring, a gas spring, a drawbar spring, and an elastic component.
21. The tissue closure device of claim 1 or 3, wherein the spring is configured to apply a contraction force greater than or equal to 2.5N and less than or equal to 6N.
22. the first tissue gripper and the second tissue gripper have a closed configuration and an open configuration; The tissue closure device of claim 1 or 3, wherein the first tissue gripper and the second tissue gripper are biased toward the closed configuration.
23. the first tissue gripper and the second tissue gripper have a closed configuration and an open configuration; The method of claim 2 or 6, wherein the first tissue gripper and the second tissue gripper are biased toward the closed configuration.
24. The tissue closure device of claim 1 or 3, wherein the first tissue gripper and the second tissue gripper are configured to non-traumatically apply a force to a tissue portion.
25. The method of claim 2 or 6, wherein the first tissue gripper and the second tissue gripper are configured to apply a traumatic force to a tissue portion.
26. The tissue closure device of claim 1 or 3, wherein the first tissue gripper and / or the second tissue gripper are configured to release when the contraction force is greater than a threshold contraction force.
27. The method of claim 2 or 6, wherein the first tissue gripper and / or the second tissue gripper are configured to release when the contraction force is greater than a threshold contraction force.
28. The method of claim 2 or 6, further comprising visually indicating the contractile forces applied to the first and second tissue portions by the first and second tissue grippers using force indicators.