INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

FIELD

The present application is related to methods, devices and systems useful for suturing tissue, particularly in difficult to access regions.

BACKGROUND

Suturing of tissue during surgical procedures is time consuming and can be particularly challenging in difficult to access body regions and regions that have limited clearance, such as regions partially surrounded or covered by bone. For many surgical procedures, it is necessary to make a large opening in the human body to expose the area requiring surgical repair. However, in many cases, accessing the tissue in this manner is undesirable, increasing recovery time, and exposing the patient to greater risk of infection.

Suturing instruments (“suture passers” or “suturing devices”) have been developed to assist in accessing and treating internal body regions, and to generally assist a physician in repairing tissue. Although many such devices are available for endoscopic and/or percutaneous use, these devices suffer from a variety of problems, including limited ability to navigate and be operated within the tight confines of the body, risk of injury to adjacent structures, problems controlling the position and/or condition of the tissue before, during, and after passing the suture, as well as problems with the reliable functioning of the suture passer.

For example, some surgical instruments used in endoscopic procedures are limited by the manner in which they access the areas of the human body in need of repair. In particular, the instruments may not be able to access tissue or organs located deep within the body or that are in some way obstructed. In addition, many of the instruments are limited by the way they grasp tissue, apply a suture, or recapture the needle and suture. Furthermore, many of the instruments are complicated and expensive to use due to the numerous parts and/or subassemblies required to make them function properly. Suturing remains a delicate and time-consuming aspect of most surgeries, including those performed endoscopically.

There is a need for new methods and devices for suturing tissue, particularly tissue in difficult to access regions of the body including the joints (shoulder, knee, etc.). The methods and devices described herein address this need.

SUMMARY OF THE DISCLOSURE

The present invention relates to suture passer devices and methods of using the devices.

In one aspect, the present disclosure describes a suture passer device, wherein suture is prevented from being passed without clamping the first and second jaw members. This has the advantage of avoiding a failed stitch due to the suture missing the suture trap. The device includes an elongated body having a proximal end region and a distal end region; a first jaw member extending from the distal end region of the elongated body and configured for angular movement relative to the elongated body; a second jaw member configured to form an opening with the first jaw member when the second jaw member is axially extended; a clamp trigger configured to actuate clamping of the first and second jaw members; a tissue penetrator trigger configured to extend a tissue penetrator between the first and second jaw members when actuated; and a lock between the clamp trigger and the tissue penetrator trigger configured to interact with the clamp trigger and the tissue penetrator trigger to prevent the tissue penetrator from extending until the first jaw member is closed relative to the second jaw member by a predetermined amount.

In another aspect, the present disclosure discloses a method for passing a suture. The method includes at least partially closing a first jaw member of a suture passer, wherein the first jaw member is extended from the distal end region of an elongated body and is configured for angular movement relative to the elongated body; wherein the second jaw is configured to form an opening with the first jaw member; and passing a tissue penetrator between the first and second jaw members when the first jaw member is at least partially clamped with the second jaw member, whereby the tissue penetrator is prevented from being extended without clamping the jaws.

In yet another aspect, the present disclosure includes a suture passer device, wherein the device uses thumb triggers to extend the second jaw member. The device includes an elongated body having a proximal end region and a distal end region; a first jaw member extending from the distal end region of the elongated body and configured for angular movement relative to the elongated body; a second jaw member configured to extend axially relative to the elongated body, wherein the second jaw is configured to form an opening with the first jaw member when the second jaw member is axially extended; a clamp trigger configured to actuate clamping of the first and second jaw members; a tissue penetrator trigger configured to extend a tissue penetrator between the first and second jaw members when actuated; and a thumb trigger configured to extend or retract the second jaw member, wherein the thumb trigger has a first surface and a second surface. The suture passer device also includes a handle, housing a sleeve member, a carriage member and a detent member; and wherein the first surface of the thumb trigger is connected to an outer surface of the sleeve member, wherein an inner surface of the sleeve member is connected with the carriage member and wherein the sleeve member and carriage member both interact with the detent member to maintain a position of an extended second jaw member.

In still another aspect, the present disclosure provides a method for controlling a suture passer having a first jaw member extending from the distal end region of an elongated body and configured for angular movement relative to the elongated body, a second jaw member configured to form an opening with the first jaw member when the second jaw member is axially extended, and a thumb trigger actuated to retract or extend the second jaw member, the method includes: extending the second jaw by pushing the thumb trigger in a first direction; and retracting the second jaw by pushing the thumb trigger in the same direction.

In another aspect, the present disclosure includes a suture passer device, wherein the device is designed to prevent retraction of the second jaw member when the tissue penetrator is extending or extended. The device includes an elongated body having a proximal end region and a distal end region; a first jaw member extending from the distal end region of the elongated body; a second jaw member configured to extend axially relative to the elongated body, wherein the second jaw is configured to form an opening with the first jaw member when the second jaw member is axially extended. The device also includes a tissue penetrator trigger configured to extend a tissue penetrator between the first and second jaw members when actuated; and a thumb trigger configured to retract or extend the second jaw member when actuated, wherein when the tissue penetrator is extended, the second jaw member is blocked from retracting.

In yet another aspect, the present disclosure describes a method for preventing damage to a tissue when using a suture passer device. The suture passer device has a first jaw member extending from the distal end region of an elongated body, a second jaw member configured to extend axially relative to the elongated body, wherein the second jaw is configured to form an opening with the first jaw member when the second jaw member is axially extended. The suture passer device also includes a tissue penetrator trigger configured to extend a tissue penetrator between the first and second jaw members when actuated, and a thumb trigger configured to retract or extend the second jaw member when actuated, the method including: blocking the thumb trigger from actuating to retract the second jaw member when a tissue penetrator is extended.

In yet another aspect, the present disclosure discloses a suture passer device including an elongated body having a proximal end and distal end, the proximal end coupled to a device handle. A first jaw member is coupled to the distal end and may is moved angularly relative to a longitudinal axis of the elongated body. A second jaw member is also coupled to the distal end and may retract in and out of the elongate body and form an opening with the first jaw member. The handle may include a clamp trigger that is operatively coupled to the first jaw member so that actuation of the clamp trigger may move the first jaw member between and open and a clamped configuration relative to the second jaw member. The first and second jaw members are relatively closer to each other in the clamped configuration than the open configuration. The handle may also include a tissue penetrator trigger, operatively coupled to a tissue penetrator disposed at the distal end so as to selectively extend the tissue penetrator between the first and second jaw members. The handle also includes a lock member disposed between the clamp trigger and the tissue penetrator trigger. The lock member may interact with the clamp trigger and the tissue penetrator trigger so as to prevent the tissue penetrator from extending until the first jaw member is in the clamped configuration. The second jaw member may extend and retract axially relative to the elongated body. The lock member may have a first surface configured to interact with the clamp trigger and a second surface configured to interact with the tissue penetrator trigger. The first and second surface may be at opposing ends to each other of the lock member. The lock member may interact with the clamp trigger and tissue penetrator trigger such that when the first jaw member is in the open configuration, the second surface is engaged with the tissue penetrator trigger to block the tissue penetrator from extending. The clamp trigger may include a surface that engages the first surface of the lock while moving the first jaw member towards the clamped configuration, so as to rotate the lock member and disengage the second surface from the tissue penetrator trigger. When in the clamped configuration, the first and second jaw members defines a predetermined opening, which may be an angular opening between 5 degrees and 85 degrees. The first jaw member comprises a tissue penetrator receiving region seen best inFIG.6Afor receiving the tissue penetrator and capturing the suture, and wherein the predetermined opening defines a maximum opening such that the tissue penetrator extends reliably from the second jaw member and through the tissue penetrator receiving region. Should the predetermined opening or angular opening be any wider tissue penetrator may extend away from receiving region and suture transfer from the second jaw member to the first may fail.

In yet another aspect, the present disclosure includes a method for passing a suture, including moving a first jaw member of a suture passer from a first open orientation towards a second jaw member and thereby towards a second clamped orientation, wherein the first and second jaw member extend from a distal end region of an elongate body of a suture passer. A tissue penetrator is then passed between the first and second jaw members when the first jaw member is in the second clamped configuration, whereby the tissue penetrator is prevented from being extended when the first jaw member is in the first open orientation. The step of moving the first jaw member may include actuating a clamp trigger coupled to a proximal end of the elongate body. The step of passing a tissue penetrator may include actuating a tissue penetrator trigger coupled to the proximal end of the elongate body. The suture passer may also include a lock member disposed between the clamp trigger and the tissue penetrator trigger and wherein the lock comprises a lock arm that engages with and thereby inhibits actuation of the tissue penetrator trigger when the first jaw is in the first open orientation. Moving the first jaw to the second clamped configuration may include engaging the clamp trigger with a first portion of the lock member so as to move the lock arm and allow actuation of the tissue penetrator trigger. The lock may be pivotally coupled to the suture passer and the lock arm may extend in a first direction from a center of rotation of the lock member and a second arm may extend in a different direction towards the first portion of the lock, and wherein the lock may rotate to disengage the lock arm from the tissue penetrator trigger. The second jaw may axially extend from within an elongate body of the suture passer before the step of moving the first jaw member.

In yet another aspect, the present disclosure includes a suture passer device with an elongated body having a proximal end region and a distal end region. A first jaw member may be coupled to the distal end region of the elongated body and configured for angular movement relative to the elongated body. A second jaw member may extend axially relative to the elongated body and form an opening with the first jaw member when the second jaw member is axially extended. The suture passer device may also include a thumb trigger that is operatively coupled to the second jaw member so as to extend or retract the second jaw member, wherein the thumb trigger has a first surface and a second surface. The suture passer device may also include a housing with a sleeve member and a carriage member therein. The first surface of the thumb trigger may be communicably coupled to the sleeve member and carriage member, such that activating the thumb trigger axially moves the sleeve member, carriage member and thereby second jaw member. The housing may also include a detent member that engages with an opening of the carriage member to hold the second jaw in an extended configuration. The detent member may be selectively coupled to the carriage member so as to be disengaged from a carriage member opening during retraction of the second jaw member. The detent member may also include proximal tip or end-tip at an end of an arm of the detent member that interacts with a curved rib and ramp disposed on a top surface of the sleeve such that actuation of the thumb trigger to extend the second jaw member slides the sleeve so that the proximal tip moves from a first side of the curved rib and ramp, axially to a second side of the curved rib and ramp and wherein releasing of the thumb trigger to an intermediate position maintains the extended position of the second jaw member with the proximal tip remaining on the second side of the curved rib and ramp.

In yet another aspect, the present disclosure includes a method for controlling a suture passer. Suture passer may have a first jaw member extending from a distal end region of an elongate body, the first jaw may be coupled to the body so as to angularly move relative to the elongated body. A second jaw member may be coupled to the elongate body and may form an opening with the first jaw member when the second jaw member is axially extended. A thumb trigger of the suture passer may be actuated to retract or extend the second jaw member. The method may include extending the second jaw by pushing the thumb trigger in a first direction along an arced path and retracting the second jaw by pushing the thumb trigger in the first direction, followed by releasing the thumb trigger. Extending the second jaw may comprise pushing the thumb trigger to slide a sleeve member and carriage member axially in a distal direction to extend the second jaw member. Retracting may comprise pushing the thumb trigger to slide the sleeve member axially in a distal direction and the step of releasing the thumb trigger may release the sleeve member and carriage member so that they restract in a proximal direction. The sleeve member may be connected to a proximally disposed biasing member configured to draw the sleeve proximally during the step of releasing. The carriage member may be engaged with a detent member when the second jaw member is extended. The carriage member may be disengaged from a detent member during the step of retracting.

In yet another aspect, the present disclosure includes a method for preventing damage to a tissue when using a suture passer device. Suture passer device includes a first jaw member extending from the distal end region of an elongated body, a second jaw member configured to extend axially relative to the elongated body. The second jaw is configured to form an opening with the first jaw member when the second jaw member is axially extended. The suture passer device also includes a tissue penetrator trigger configured to extend a tissue penetrator between the first and second jaw members when actuated, and a thumb trigger configured to retract or extend the second jaw member when actuated. The method may include blocking the thumb trigger from actuating to retract the second jaw member when a tissue penetrator is extended. Blocking may comprise pushing the thumb trigger to extend the second jaw and pressing the tissue penetrator trigger to extend the tissue penetrator, whereby the thumb trigger is blocked from retracting the second jaw member. Blocking may comprise restricting the actuation of the thumb trigger by engaging the tissue penetrator trigger with a protrusion member extended above a first surface of the thumb trigger, whereby the actuation of the thumb trigger to retract a second jaw member is blocked. The tissue penetrator trigger may comprise an outer surface adjacent to the first surface of the thumb trigger, said outer surface interacting with the protrusion member to block the actuation of the thumb trigger to retract a second jaw member.

In yet another aspect, the present disclosure includes a suture passer device with an elongated body having a proximal end region and a distal end region. A first jaw member extends from the distal end region and a second jaw member may extend axially relative to the elongated body. The second jaw is configured to form an opening with the first jaw member when the second jaw member is axially extended. The suture passer device may also include a tissue penetrator trigger configured to extend a tissue penetrator between the first and second jaw members when actuated and a thumb trigger configured to retract or extend the second jaw member when actuated. When the tissue penetrator is extended, the second jaw member is blocked from retracting. The thumb trigger may include a protrusion member extended above a first surface of the thumb trigger and when engaged with the actuated tissue penetrator trigger, the protrusion member may be restricted from movement and thereby actuation of the thumb trigger to retract the second jaw member may be inhibited. The suture passer device may also include a clamp trigger that actuates clamping of the first and second jaw members.

