TECHNICAL FIELD

The present disclosure relates to the field of medical devices, and in particular to a handle mechanism, a delivery system, and an operation method.

BACKGROUND ART

During a gastrointestinal endoscopy and treatment procedure, the operator often desires to repair or reconstruct a tear or defect, or otherwise approximate or fix tissue or other material by suturing.

Metallic clipping devices were first introduced for the primary purpose of achieving hemostasis of focal gastrointestinal bleeding. Indications for their use have expanded to include closure of perforations and fistulas, securing of catheters and stents, and being a marking device to direct endoscopic, surgical, and radiological therapy, among others. Several endoscopic clipping devices are commercially available, which all consist of metallic double or triple prongs (forks) joined at the proximal end. The prongs of the clip are applied with pressure onto the target tissue and clamped and closed by manually squeezing the catheter handle assembly. Clipping devices are limited by a fixed distance and relationship between the prongs.

The fixed distance between the prongs limits the operator's ability to close defects that exceed this distance, which limits applicability to small defects. The fixed relationship between the prongs limits the operator's ability to position the clip appropriately in relation to the area in need of treatment. For instance, the clip may not be able to close a defect that is approached tangentially at a curve or angle. Further, because the proximal ends of the legs are joined, the operator may not be able to adjust the positioning of prong of one clip without affecting the positioning of the prong of the second clip. Positioning also may be limited because the clip may not be properly oriented when it is deployed or the clip may slip out of alignment during application. Finally, the legs of presently used clip must be actuated and anchored at the same time. If unequal pressure is applied to the legs during anchoring, closure may be sub-therapeutic and scissoring of the legs may occur that can result in tissue damage. Presently used clips are only capable of capturing the mucosa and do not penetrate into the deeper wall layers (submucosa and muscular propria layers).

A suturing device that addresses the limitations of clips is the Apollo Overstitch. This device provides a curved needle movable on an arm to pierce tissue and perform tissue approximation and suturing. This device is capable of full-thickness (entire bowel wall) tissue capture and the closure of larger defects, however, the device cannot be delivered through the working (operative) channel of the endoscope and must be pre-mounted on the end of the endoscope. It also involves multiple time consuming, technically demanding maneuvers and manipulations. A need remains for an endoscopic tissue closure device, which addresses the limitations of presently used clips and is capable of full-thickness tissue capture.

The Ovesco “over-the-scope-clip” (OTSC) can achieve full-thickness closure of a defect by suctioning tissue into a cap attachment mounted on the end of the endoscope. The clip, mounted on the cap attachment, is released by turning a hand wheel, similar to band ligation. The size of the defect that can be closed is small, which limited by the diameter of the cap attachment. Like the Apollo Overstitch, the OTSC must be pre-mounted onto the endoscope prior to use.

Accordingly, it would be desirable to obtain a multiple tissue anchor and delivery system for facilitating the repair of wall defects, plication of tissue, and treatment of lesions delivered through the working channel of the endoscope.

It would also be desirable to obtain a multiple tissue anchor and delivery system for repairing wall defects, achieving plication of tissue, and treating lesions, whereby the apparatus and method have the capability to facilitate repair of defects of any size, plicate tissues of any size, and treatment of lesions of any size, with deployment of each anchor independent of one another under direct endoscopic visualization.

It would also be desirable to obtain a multiple tissue anchor and delivery system, so as to provide treatment of relatively large perforations, lesions and damage areas under endoscopic visualization.

It would also be desirable to obtain a handle mechanism, a delivery system, and an operation method for facilitating operation by medical staff, thereby facilitating the repair of wall defects, plication of tissue, and treatment of lesions delivered through the working channel of the endoscope.

SUMMARY

An embodiment of the present disclosure provides a handle mechanism, comprising:

a body;

a first anchor delivery device provided to the body, wherein the first anchor delivery device is configured to control a first tissue anchor, so that the first tissue anchor is anchored into a tissue and released;

a second anchor delivery device provided to the body, wherein the second anchor delivery device is configured to control a second tissue anchor, so that the second tissue anchor is anchored into a tissue and released;

a cinching device (tightening device) provided to the body, wherein the tightening device is configured to pull a suture member to cinch (tighten) the first tissue anchor and the second tissue anchor connected to the suture member; and

a locking and cutting device provided to the body, wherein the locking and cutting device is configured to lock the suture member to an inner tubular member, cut the suture member, and completely release the inner tubular member and a portion of the suture member connected to the inner tubular member.

An embodiment of the present disclosure further provides a delivery system, comprising the handle mechanism described above.

An embodiment of the present disclosure further provides an operation method, which is implemented using the handle mechanism described above, comprising:

accessing and visualizing a treatment area using an endoscope;

delivering the distal ends of the first tissue anchor, the second tissue anchor, the inner tubular member, and the suture member to a distal end of the endoscope through a working channel of the endoscope;

operating the first anchor delivery device to anchor the first tissue anchor into a first target tissue and release the first tissue anchor;

operating the second anchor delivery device to anchor the second tissue anchor into a second target tissue and release the second tissue anchor;

operating the tightening device to pull the suture member and tighten the first tissue anchor and the second tissue anchor connected to the suture member, so as to tighten the first target tissue and the second target tissue; and

operating the locking and cutting device to lock the suture member to the inner tubular member, cut the suture member, and completely release the inner tubular member and a portion of the suture member connected to the inner tubular member.

