WO2022047653A1

WO2022047653A1 - Handle mechanism, delivery system, and operating method

Info

Publication number: WO2022047653A1
Application number: PCT/CN2020/112985
Authority: WO
Inventors: 宾莫勒·肯尼斯; 金鸿雁; 李常青; 马小军; 沈正华; 唐志
Original assignee: 南微医学科技股份有限公司; 宾莫勒·肯尼斯
Priority date: 2020-09-02
Filing date: 2020-09-02
Publication date: 2022-03-10

Abstract

A handle mechanism, a delivery system, and an operating method. The handle mechanism comprises a body, a first anchoring component provided on the body, a second anchoring component provided on the body, a tightening device provided on the body, and a locking and cutting device provided on the body; the first anchoring component is configured to control a first tissue anchor; the second anchoring component is configured to control a second tissue anchor; and the tightening device is configured to pull a suture member.

Description

Handle mechanism, delivery system, and method of operation

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 technique

In gastrointestinal endoscopy and treatment procedures, operators often wish to repair or reconstruct tears or defects with sutures or otherwise access or immobilize tissue or other materials.

Metal gripping devices were first introduced for the primary purpose of achieving hemostasis of focal gastrointestinal bleeding. Indications of their use have expanded to include closure of perforations and fistulas, fixation of catheters and stents, and as marker devices to guide endoscopy, surgery, and radiation therapy, among others. Several endoscope holding devices are commercially available. They both consist of metallic bi- or tri- prongs connected at the proximal ends. The prongs of the clip are applied with pressure to the target tissue and are clamped closed by manually squeezing the catheter handle assembly. The gripping device is limited by a fixed distance and relationship between the forks.

The fixed distance between the prongs limits the operator's ability to close defects beyond this distance, which limits applicability to small defects. The fixed relationship between the prongs limits the operator's ability to properly position the clip relative to the area in need of treatment. For example, clips cannot close tangentially approached defects with curves or angles. Furthermore, because the proximal ends of the legs are connected, it is not possible for the operator to adjust the positioning of one clip prong without affecting the positioning of the second clip prong. Positioning may also be limited because the clips may not be properly oriented when deployed, or the clips may slide out of alignment during application. Finally, the legs of the currently used clip must be simultaneously actuated and anchored. If unequal pressure is applied to the leg during anchoring, closure may be secondary therapeutic and shearing of the leg may occur, which can lead to tissue damage. Currently used clips are only capable of capturing the mucosa and do not penetrate into the deeper parietal layers (submucosa and lamina propria).

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

The Ovesco "Over-the-Scope-Clip System" (OTSC) enables full-thickness closure of defects by aspirating tissue into a cap attachment mounted on the end of the endoscope. Similar to band ligation, the clip mounted on the cover attachment is released by turning the handwheel. The small size of the defect that can be closed is limited by the diameter of the cover attachment. Similar to Apollo Overstitch, OTSC must be pre-mounted on the endoscope before use.

Accordingly, it would be desirable to have a multi-tissue anchor and delivery system configured to facilitate repair of wall defects, folds of tissue, and treatment of lesions delivered through the working channel of an endoscope.

It would also be desirable to have a multi-tissue anchor and delivery system configured to repair wall defects, crease tissue, and treat lesions, whereby the device and method have the ability to facilitate repairing defects of any size, creasing tissue of any size, and treating tissue of any size. Injury capability, where each anchor is deployed independently of each other under direct endoscopic visualization.

It would also be desirable to have a multi-tissue anchor and delivery system to provide treatment of relatively large areas of perforations, lesions and lesions under endoscopic visualization.

It would also be desirable to have a handle mechanism, delivery system, and method of operation for medical practitioners to facilitate repair of wall defects, folds of tissue, and treatment of lesions delivered through the working channel of an endoscope.

SUMMARY OF THE INVENTION

The present disclosure includes a novel delivery system configured to deliver two or more tissue anchors through an endoscope or colonoscope to repair wall defects, fold tissue, or treat lesions. The delivery system includes a sheath tube designed to pass through the working channel of the endoscope.

Three separate tubular members are contained in the sheath tube-shaped member axially parallel; the first tubular member is designed to deploy a first tissue anchor (sometimes referred to hereinafter as the "first helical unit"), and the second tubular member is Designed to deploy a second tissue anchor (sometimes referred to hereinafter as the "second helical unit"), and a third tubular member, which contains a retraction member. The first tubular member coaxially contains a first reinforcing tubular member in which a first control wire allows rotational manipulation of a first tissue anchor designed to be embedded in the wall tissue. The first tubular member also has a lumen whereby the first control wire is coaxially enclosed therein to be configured to release the first tissue anchor. After the first tissue anchor is embedded in the wall tissue, it is released and the first tubular member is retracted proximally. The second tubular member coaxially contains a second reinforcing tubular member in which a second control wire allows rotational manipulation of a second tissue anchor designed to be embedded in the wall tissue. The second tubular member also has a lumen whereby the second control wire is coaxially enclosed therein to be configured to release the second tissue anchor. After the second tissue anchor is embedded in the wall tissue, it is released and the second tubular member is retracted proximally. Attached to the first and second tissue anchors is a strap or suture member contained within the third tubular member.

The strap or suture member is engaged to the third tubular member and, when moved distally, causes the suture member to be pulled between the first and second tissue anchors, forcing the first and second tissue anchors to be The area to be treated is closed together and partially or completely.

A novel handle assembly can be attached to the proximal end of a sheathed sleeve that surrounds a first, second, and third tubular. The handle assembly includes a plurality of rotating thumbwheels, sliding buttons and a release mechanism.

In clinical procedures, standard endoscopic techniques are first used to access and visualize the area to be treated. The clinician passes the delivery system (the delivery system including the sheath tube and all tubes therein) through the working channel of the endoscope.

To engage one side of the injury area, the clinician advances one of the thumb sliders, pushing the first tissue anchor and its delivery catheter out of the distal end of the outer catheter sheath. The first helical unit and its delivery catheter may be endoscopically visible. The clinician maneuvers the endoscope and manipulates the first tissue anchor and its delivery catheter by sliding the ratchet thumb slider forward to position the first tissue anchor against the target site, then rotate the thumbwheel to move the first helical Cells are embedded into mucosa, submucosa, or muscle tissue as desired. After the first helical unit is satisfactorily embedded in the tissue, the clinician retracts the release mechanism to release the first helical unit. This is accomplished by pulling back the release mechanism behind the ratchet thumb slider. Once the first helical unit is released, driving the center button on the thumb slide down releases the thumb slide from the ratchet, allowing it to be pulled proximally with the release mechanism. Retracting the thumb slide pulls the delivery catheter back into the sheath tube, leaving the first helical unit with the tape or suture attached in the tissue.

The clinician then engages the other side of the lesion by advancing the other thumb slide to push the second tissue anchor and its delivery catheter out of the distal end of the catheter shaft. The second tissue anchor and its delivery catheter may be endoscopically visible. The clinician manipulates the endoscope and manipulates the second helical unit and its delivery catheter to position the second tissue anchor against the target site, then rotate the thumbwheel to embed the second helical unit into the mucosa of the wall, as needed, in the submucosa or muscle layer. After the second helical unit is satisfactorily embedded in the tissue, the clinician retracts the release mechanism to release the second helical unit. This is accomplished by pulling back the release mechanism behind the ratchet thumb slider. Once the second helical unit is released, driving the center button on the second thumb slide down releases the thumb slide from the ratchet, allowing it to be pulled proximally. Retracting the thumb slide pulls the delivery catheter back into the sheath tube, leaving the second helical unit with the tape or suture attached in the tissue.

The clinician then advances the third inner tube to draw together the two helical devices and the tissue to which they are attached. A ferrell, bolero knot, locking anchor, spring clip or pre-formed knot and knot pusher lock the two tissue anchors together to partially or completely close the area to be treated.

There are two embodiments that perform the same tissue access using anchors and delivery systems, but differ in the internal delivery catheter mechanism.

The first embodiment has a single lumen sheath with three elements extending its entire length. The two tubular elements engage the connector, the anchor engagement and the anchor member. The third tubular element is configured to manipulate a band or suture held by a thread extending proximally through the handle. After the anchor is delivered, the two tubular elements of the delivery system are retracted from the sheath and the knot pusher or cuff is pushed onto the third element and the suture or band tether moves and locks the anchors together, closing Tissue openings.

In a second embodiment, the sheath has a multi-lumen configuration comprising three or four separate lumens designed to each contain one of the three elements and one configured to Suture or tape. The two lumens of the sheath are configured to operate the helical device. The third and fourth lumens contain a suture or strap assembly and a locking mechanism. The third and fourth lumens can be combined to further reduce the catheter profile. The delivery procedure is similar between the two embodiments, whereby advancement of the second embodiment of the third element is achieved by advancing the sheath itself. The second embodiment of having a separate lumen in the sheath configured as a suture or band element reduces the possibility of twisting the delivery element around the helical device. The third element with its locking mechanism is similar in both embodiments, whereby they similarly pull the suture or band closing the tissue opening. After the catheter tip is placed to bring the tissue together, the handle element is pulled to first clamp and lock the suture or band element, and then cut the suture or band element. The delivery system is then removed through the endoscope.

Embodiments of the present disclosure provide a handle mechanism, wherein the handle mechanism includes:

main body;

a first anchoring assembly disposed on the main body, the first anchoring assembly being configured to control the first tissue anchor to anchor the first tissue anchor into the tissue and release it;

a second anchoring assembly disposed on the body, the second anchoring assembly being configured to control the second tissue anchor to anchor and release the second tissue anchor into the tissue;

a tightening device disposed on the body, the tightening device configured to pull the suture member to tighten the first tissue anchor and the second tissue anchor connected to the suture member;

A locking cutting device is provided to the body, the locking cutting device is configured to lock the suture member and the tubular member, cut the suture member, and fully release the tubular member and a portion of the suture member connected to the tubular member.

Embodiments of the present disclosure also provide a delivery system that includes the handle mechanism described above.

The embodiments of the present disclosure also provide an operation method, which is realized by using the above-mentioned handle mechanism, and the operation method includes:

Use an endoscope to access and visualize the area to be treated;

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

operating the first anchor delivery assembly to anchor the first tissue anchor into the first target tissue, and release the first tissue anchor;

operating the second anchoring assembly to anchor the second tissue anchor into the second target tissue and release the second tissue anchor;

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

The locking cutting device is operated to lock the suture member to the tubular member and to cut the suture member and fully release the tubular member and a portion of the suture member connected to the tubular member.

Description of drawings

1 is a perspective view of a distal end of a catheter system showing a multi-lumen catheter, showing first and second tubular members and a third tubular member corresponding to first and second tissue anchors, showing The tightening device and fourth tubular member are shown with the suture strap mechanism engaged to the proximal end of the long shaft.

2 is a perspective view of the distal end of the tissue anchor delivery system showing the first tissue anchor assembly projecting distally outward from the multitubular catheter shaft.

3 is an interior perspective view of the distal end of the tissue anchor delivery system showing the first and second anchor assemblies and the suture tightening and resection tubular with the multitubular catheter shaft removed.

4 is a perspective view of a suture take-up and resection tubular member having a distal portion coaxially engaged to a third tubular member whereby both the distal portion and the third tubular member are Both are coaxially coupled to the elongated shaft member.

Figure 5 is a perspective view of the suture tightening and cutting out the tubular member and the third tubular member, whereby the distal cover is retracted, causing the suture to be tightened between the distal cover and the distal portion.

Figure 6 is a perspective view of a suture tightening and resection tubular and a third tubular, whereby the distal and proximal portions have been separated from each other by retracting the distal bulb mechanism, and wherein retraction of the proximal portion cuts Suture or tape.

7 is a top perspective view of the proximal handle mechanism showing the general design and configuration of the channel.

Figure 8 is an interior perspective view of the proximal handle mechanism with the top body member removed showing the interaction of the components with the tubular.

9 is a skeletal perspective view of the components of the proximal handle mechanism with the top and bottom body members removed, and also showing the interaction of the components with the tubular.

Figure 10 is a perspective view of a tissue anchor and suture delivery component in a clinical setting whereby a defect in the tissue has been closed by manipulating the delivery handle controls and retracting the sutures attached to the two tissue anchors, said Two tissue anchors are embedded within the lateral area of the tissue defect.

FIG. 11 shows a schematic diagram from a first perspective of another conveying system provided by an embodiment of the present disclosure.

FIG. 12 shows a schematic diagram of another conveying system provided by an embodiment of the present disclosure from a second perspective.

FIG. 13 shows a schematic view of the handle mechanism of FIG. 11 .

FIG. 14 shows a schematic view of the distal portion of the delivery system of FIG. 11 .

Corresponding reference characters indicate corresponding parts throughout the several views. The examples set forth herein illustrate exemplary embodiments of the present disclosure, and these examples should not be construed to limit the scope of the present disclosure in any way.

detailed description

Referring now to the drawings and in particular to FIG. 1 , which is a perspective view of the present disclosure 10 including a distal end of a catheter system showing a multi-lumen catheter 11 , a first lumen 13 and a first Two lumens 15 corresponding to the first and second tissue anchors and associated shaft members and third and

fourth lumens

19 and 27 in which the suture strap and tightening mechanism are engaged to the proximal end of the long shaft, The long shaft extends the entire length of the multi-lumen catheter and terminates at the connection to the handle mechanism 70 .

Multi-lumen catheters can be made from a variety of polymeric materials such as polytetrafluoroethylene (PTFE), FEP, ETFE, polyvinyl chloride (PVC), polyethylene, polypropylene, PEEK, polybutene, vinyl cyanide-butanediol Ethylene-styrene (ABS), rubber modified styrene, polyoxymethylene, polyethylene, graphite or nylon, or a combination of metal coils or braids encapsulated in a polymeric material, or any combination thereof. The diameter of the first lumen 13 and the second lumen 15 is in the range of 0.25mm to 1.2mm, with a preferred diameter of 0.5mm. Depending on the clinical application, the multi-lumen catheter 11 may have a length in the range of 100 to 500 cm.

Referring now to FIGS. 2 and 8 , coaxially aligned within the first lumen 13 is a first long axis 114 (see FIG. 8 ) that extends the entire length of the multi-lumen catheter and terminates with the Connection of handle mechanism 70 . The first elongated shaft 114 has a series of components designed to have the first removable anchor engagement component 14 at the distal end thereof. At the distal end of the first elongated shaft 114 is a fixed first connector 12 that coaxially and removably engages the first removable anchor connector 14 . Not shown is a prong configuration mechanism extending from the distal end of the first connector 12 for coaxial insertion into the first removable anchor connector 14 . On the surface of each prong construction member are tabs that are inserted into holes in the first removable anchor link 14 . The first connection tabs with corresponding hole/tab assemblies 17 are configured to removably secure the first connector 12 to the first removable anchor connector 14 .

The first tissue anchor 26 is attached to the distal end of the first removable anchor connector 14 . The first tissue anchor 26 has two different wraps or pitches, with the coil in a tight configuration 36 at the proximal end and an opposing loose configuration 40 at its distal end. The opposing loose configuration 40 is designed to use rotational force to embed the first tissue anchor 26 into the mucosa, submucosa, or muscle tissue. Applicants anticipate that the length of the compact formation 46 may be shortened appropriately to minimize the compact formation from protruding from the treated tissue area. Also, when the first tissue anchor is embedded, the depth of tissue anchor capture can be adjusted to enable full thickness tissue closure and full thickness folds. Located between the first tissue anchor 26 and the first removable anchor connector 14 is the suture attachment region 21 , whereby the suture strap mechanism 22 is secured by a series of rotations about the suture attachment region 21 . The suture strap mechanism 22 is designed to allow rotation of the proximal portion of the first long shaft 114, the first connector 12, the first removable anchor connector 14, and the first tissue anchor 26, while the suture strap mechanism does not rotate. The diameter of the first connector 12 and the first removable anchor connector 14 is in the range of 0.25mm to 1.2mm, preferably 0.5mm in diameter. The first connector 12 and the first removable anchor connector 14 may be made of metallic materials such as brass, brass alloys, stainless steel, cobalt chromium alloys, nickel titanium, copper alloys, or both resorbable and non-resorbable Polymer suture materials such as nylon, polypropylene, polyethylene, Kevlar, polyurethane, lactic acid, polycaprolactone, or metallic materials such as brass, brass alloys, stainless steel, cobalt chrome, nickel titanium, copper alloys, or Any combination thereof, or polymeric materials such as polyvinyl chloride (PVC), polyethylene, polypropylene, PEEK, Ultem, polybutene, vinyl cyanide-butadiene-styrene (ABS), rubber-modified styrene, Polybutene, polyethylene, graphite, polyurethane or nylon, or any combination thereof.

Suture strap mechanism 22 may be of single-strand or multi-strand construction and may be made from a variety of polymeric suture materials, both resorbable and non-resorbable, such as nylon, polypropylene, polyethylene, Kevlar, polyurethane, lactic acid , polycaprolactone, or from metallic materials such as brass, brass alloys, stainless steel, cobalt-chromium alloys, nickel-titanium, copper alloys or any combination thereof, or from polymeric materials such as polyvinyl chloride (PVC), polyethylene , polypropylene, PEEK, polybutene, vinyl cyanide-butadiene-styrene (ABS), rubber-modified styrene, polyacetal, polyethylene, graphite, polyurethane, or nylon, or any combination thereof.

FIG. 2 also shows the third tubular take-up mechanism 34 and the retraction ball mechanism 36 engaged to the third connecting shaft 54 .

Referring now to Figures 3 and 8, interior perspective views of the distal end of the tissue anchor delivery system showing the first and second tissue anchors and the suture tightening and resection tubular are shown. The first tissue anchor is described in the paragraph above, this paragraph will focus primarily on the second tissue anchor. Coaxially aligned within the second lumen 15 is a second long axis 116 that extends the entire length of the multi-lumen catheter and terminates at the connection to the handle mechanism 70 . The second long shaft 116 has a series of components designed to have the second removable anchor link 16 at its distal end. On the distal end of the second elongated shaft 116 is a second fixed link that coaxially and removably engages the second removable anchor link 16 . Not shown is a prong configuration mechanism extending from the distal end of the second connector 29 for coaxial insertion into the first removable anchor connector 16 . On the surface of each prong construction member is a tab that inserts into a hole in the second removable anchor link 16 . The second connection tabs with corresponding hole/tab assemblies 18 are configured to removably secure the second connector 29 to the second removable anchor connector 16 .

The second tissue anchor 42 is attached to the distal end of the second removable anchor connector 16 . The second tissue anchor 42 has two different wraps or pitches with the coil in a tight configuration 46 at the proximal end and an opposing loose configuration 44 at its distal end. The opposing loose configuration 44 is designed to use rotational force to embed the second tissue anchor 42 in the mucosa, submucosa, or muscle tissue. Applicants anticipate that the length of the compact formation 46 may be shortened appropriately to minimize the compact formation from protruding from the treated tissue area. Furthermore, when the second tissue anchor is embedded, the depth of tissue capture can be adjusted to enable full thickness tissue closure and full thickness folds. Located between the second tissue anchor 42 and the second removable anchor connector 16 is the second suture attachment region 23 , whereby the suture strap mechanism 22 is secured by a series of rotations about the second suture attachment region 23 . The suture strap mechanism 22 is designed to allow rotation of the proximal portion of the second long shaft 116, the second connector 29, the second removable anchor connector 16, and the second tissue anchor 42 without the suture strap mechanism rotating. The second connector 29 and the second removable anchor connector 16 may be made of metallic materials such as brass, brass alloys, stainless steel, cobalt chromium alloys, nickel titanium, copper alloys, or both resorbable and non-resorbable Polymer suture materials such as nylon, polypropylene, polyethylene, Kevlar, polyurethane, lactic acid, polycaprolactone, or metallic materials such as brass, brass alloys, stainless steel, cobalt chrome, nickel titanium, copper alloys, or Any combination thereof, or polymeric materials such as polyvinyl chloride (PVC), polyethylene, polypropylene, PEEK, polybutene, vinyl cyanide-butadiene-styrene (ABS), rubber-modified styrene, polycondensate Aldehyde, polyethylene, graphite, polyurethane or nylon, or any combination thereof.

Figures 3 and 8 also show the third suture tightening and resection tubular 30 of the proximally located single suture band mechanism 118 in an extended configuration with the third inner tubular tightening mechanism extending out of the suture tightening and the distal end of the resecting tubular member 30 , and this third suture tightening and resecting tubular member 30 has a retraction ball mechanism 36 . The pair of suture strap mechanisms 32 extend out of the third suture take-up and resection tubular member 30 and are attached to the first and second suture connection regions as described above. The other end of the pair of suture strap mechanisms passes through a window 50 in the distal end that extends proximally toward the handle and forms a loop at a proximal location (not shown) that engages proximally The single suture strap mechanism 118 extends proximally along the catheter lumen to the handle 70. Also shown is an interference capture mechanism 28 designed to engage the retraction ball mechanism 36 and retract the suture tightening and resection tubular 30 proximally. As the third suture tightening and resection tubular 30 is retracted further proximally, the pair of suture strap mechanisms 32 are captured by the sharpened distal ends of the windows 50 in the third suture tightening and resection tubular 30 Partial cut.

Referring now to FIG. 4 , which shows a perspective view of a suture take-up and resection tubular member 30 having a distal portion coaxially engaged to a proximal third tubular member 20, Thereby both the distal end portion and the third tubular member are coaxially joined to the distal end portion of the elongated shaft member 54 . The distal end 54 is connected to the long shaft 118 and extends the catheter lumen to the handle assembly 70 . On the proximal end is a third tubular member 20 that includes a pair of prongs 56 at the distal end. The fork is designed to guide the interference catch mechanism 28 . The window 50 in the third distal tubular member 30 is clearly shown with the pair of suture strap mechanisms 32 traveling through the window 50, out of the distal end 60, which continues to the first suture strap mechanism connection area 21 and the second suture band mechanism connection area 23.

The perspective view of FIG. 5 shows suture take-up and cut-away tubular member 30 and third tubular member 20, whereby distal cover 34 is retracted, causing the pair of suture strap mechanisms 62 to retract between distal cover 34 and suture. Tightening and resection between the distal end of the tubular member 30.

A perspective view of the suture tightening and cutting tubular member 30 and the third tubular member 20 is shown in FIG. 6, whereby the distal and proximal portions have been separated from each other by retracting the distal cap ball mechanism 36, and wherein The retraction of the proximal portion cuts the suture. Resection of the suture band mechanism typically occurs when the first tissue anchor 26 and the second tissue anchor 42 have been embedded in the mucosal tissue layer and the defects in the wall have been biased towards each other by the first tissue anchor 26 and the second tissue anchor 42 after being closed.

FIG. 7 is a perspective view of a handle mechanism 70 having a body 78 that includes a clamshell design. The clamshell design has a top portion and a bottom portion that facilitates manufacture and placement of handle components within handle mechanism 70 . The handle mechanism 70 has a pair of

thumb wheels

96, 94 configured to generate rotational force on the

tubular members

114, 116, respectively, while having distally mounted tissue anchors 26, 42. The handle mechanism 70 includes a first slide button 88 configured to advance and retract the first tubular member 114 and a first release button 84 configured to disengage the first tissue anchor 26 . The handle mechanism 70 also includes a second slide button 90 configured to advance and retract the second tubular member 116 and a second release button 86 configured to disengage the second tissue anchor 42 . The proximal end of the outer sheath 102 with the strain relief mechanism 100 is attached and engaged to the distal end of the handle body 78 .

The first tubular member 114 enters the handle body 78 from its starting distal end at the sheath strain relief 100, whereby the outer surface of the first tubular member 114 engages the first thumb wheel 96, allowing the first tissue anchor 26 Rotational Movements and Embedding. The first tubular member 114 is further engaged to the first sliding mechanism 88 configured to advance and retract the first tubular member 114 within the sheath and configured to maneuver its proximal end together with the first tissue anchor 26 toward the desired treatment site. The first release button 84 is also engaged to the stylus of the first tubular member, configured to release the first tissue anchor 26 after being embedded in tissue.

The second tubular member 116 enters the handle body 78 from its distal end at the sheath strain relief 100, whereby the outer surface of the second tubular member 116 engages the second thumbwheel 94, allowing configuration to embed a second tissue Rotational movement of anchor 42 . The second tubular member 116 is further engaged to the second sliding mechanism 90 configured to advance and retract the second tubular member 116 within the sheath and configured to maneuver its proximal end together with the second tissue anchor 42 toward the desired treatment site. The second release button 86 is also engaged to the stylus of the second tubular member for releasing the second tissue anchor 42 after being embedded in tissue.

The handle body 78, the pair of

thumb wheels

94, 96, the pair of

slide buttons

86, 88 and the pair of

release buttons

84, 86 can all be made of a variety of polymeric materials such as polyvinyl chloride (PVC), polyethylene, polypropylene , PEEK, polybutene, vinyl cyanide-butadiene-styrene (ABS), rubber-modified styrene, polyacetal, polyethylene, polyurethane, or nylon, or any combination thereof.

8 is a top perspective view of the bottom portion 106 of the handle mechanism 70 showing the general design and configuration of the channel. In this figure, the upper clamshell components have been removed and a better view of all internal components is shown. The handle mechanism 70 is a clam shell design that facilitates the assembly process for placing and positioning the various components. The upper and lower portions of the clamshell design can be attached to each other using common adhesive, snap fit or screw techniques. At the proximal end of the handle mechanism 70 is a proximal retraction member 72 having a proximal member shaft 74 and a proximal retraction finger grasper. Positioned at specific locations are first, second, third and

fourth clamshell connections

104a, 104b, 104c, 104d. Also positioned at key locations are first and second

clamshell alignment tabs

110a and 110b. The third slide button 80 is engaged to the spring mechanism and the upper half of the handle 78 to apply tension to the suture strap mechanism. A single suture strap mechanism 118 enters from strain relief 100 and is positioned by alignment bridge 98 and is closed by spring mechanism 108 near its connection to third slide button 80 . The proximal portion of the first tubular member 114 enters from the strain relief 100 and is positioned by the alignment bridge 98 to the first tissue anchor thumbwheel 96. The outer surface of the first tubular member 114 is bonded or press-fitted to the lumen of the first tissue anchor thumbwheel 96, such that rotation of the first tissue anchor thumbwheel imparts the same rotational force onto the first tubular member 114 and toward the lumen of the first tissue anchor thumbwheel 96. The first tissue anchor 26 is previously imparted. The first tubular member 114 terminates in engagement with the first slide button 88 . The proximal portion of the second tubular member 116 enters from the strain relief 100 and is positioned by the alignment bridge 98 to the second tissue anchor thumbwheel 94 . The outer surface of the second tubular member 116 is bonded or press-fitted to the lumen of the first tissue anchor thumbwheel 94 such that rotation of the first tissue anchor thumbwheel 94 applies the same rotational force to the second tubular member 116 and applied forward to the second tissue anchor 42 . The second tubular member 116 terminates in engagement with the second slide button 96 .

Figure 9 is a skeletal perspective view of the components of the proximal handle mechanism with the top and bottom body members removed, and also showing the main components and interaction with the tubular. Exiting the strain relief 100 are the first tubular member 114 , the second tubular member 116 , the tightening member 55 and the single suture strap mechanism 118 . Also shown are a first tubular member 114 passing through and attached to the lumen of the first thumbwheel 96 and a second tubular member 116 passing through and attached to the lumen of the second thumbwheel 94 . The terminal end of the first tubular member 114 is attached to the first slide 88 and the second tubular member 116 is attached to the second slide 90 . The single suture strap mechanism 118 passes through the spring mechanism 108 and terminates at the third slide mechanism 80 , and the tightening member 55 is attached to the proximal retraction handle 76 .

Figure 10 is a perspective view of a pair of tissue anchors 128, 126 and suture delivery component 30 in a clinical setting whereby the sutures attached to the two tissue anchors, intestinal mucosa, mucosal membrane, are retracted by manipulating the delivery handle controls and retracting The defect 124 in the underlying or muscle tissue has been closed, and the two tissue anchors are embedded in the lateral area of the mucosal or muscle tissue defect.

Applicants contemplate that further developments and embodiments for tissue anchors and delivery devices with multiple tissue anchors in series within a catheter include specially designed equipment to deploy a series of anchors (details not shown in the figures). In this additional embodiment, the tissue anchor(s) are deployed within the catheter in an extended or flattened form and then immediately crimp into a circular or helical configuration as they are pushed out of the confinement tube. Other modifications or embodiments of the tissue anchor device have at least two tissue anchors arranged in series within the catheter, with a suture or suture-like material secured to the first or distal anchor and then passed through each subsequent anchor (one or multiple anchors) eyelets. The suture is allowed to slide freely through the subsequent anchor and then extends through the catheter and out of the proximal end of the catheter so that the operator can grasp the end of the suture. A sliding crimp knot is positioned between each two anchors in series along the catheter. Once the first anchor is fired and secured to the tissue, it exits the catheter and the suture is attached, moving the second anchor while sliding but attaching the suture to the leading or distal end of the catheter. Once the second anchor is secured to the tissue, the suture material connects the two secured anchors, and the sliding crimp knot also exits the catheter after the second anchor. The operator grasps the proximal suture end, and pulls it, with the crimped knot supported by the distal end of the catheter, and slides the knot so that the anchors come close to each other and are secured in this configuration, whereby the defect will be removed. closure. Two, three, four or any number of anchors can be deployed in the same manner as described above to close complex tissue defects.

operate

The operational steps for repairing wall defects and damage of the first embodiment are presented below.

Access and visualize the area to be treated using standard endoscopy.

Advance the tissue anchor device through the working channel of the endoscope.

To engage one side of the treatment site, one of the plurality of thumb slides is advanced so that the first helical unit and its delivery catheter are pushed out of the distal end of the catheter shaft by the desired length and locked. The first helical unit and its delivery catheter can be visualized by the endoscope.

The endoscope and the first tissue anchor and its delivery catheter are manipulated to position the first helical unit against the first attachment target site.

Rotate the first thumbwheel to embed the first helical unit into the mucosa, submucosa, or muscle tissue as desired.

Pull back the first release mechanism to release the first helical unit.

Push the center button on the first thumb slide to release the thumb slide, allowing it to be pulled proximally.

The thumb slider is retracted and the delivery catheter is pulled back into the sheath tube so that the first helical unit is attached to the suture band mechanism embedded in the tissue.

To engage the other side of the lesion, the second thumb slide is advanced and locked so that the second tissue anchor and its delivery catheter are pushed out the desired length from the distal end of the catheter shaft. The second helical tissue device and its delivery catheter can be visualized endoscopically.

The endoscope and the second tissue anchor and its delivery catheter are manipulated to position the second helical unit against the second attachment target site.

Rotate the other thumbwheel to embed the second helical unit into the mucosa, submucosa, or muscle tissue as desired.

Pull back the second release mechanism to release the second helical unit.

Push down on the center button on the second thumb slide to release the thumb slide, allowing it to be pulled proximally.

The thumb slider is retracted and the delivery catheter is pulled back into the sheath tube so that the second helical unit is attached to the suture band mechanism embedded in the tissue.

The entire device is advanced forward, allowing the tensioned suture strap mechanism to draw the suture strap into the outer sheath until the two anchors and the tissue defect wall are drawn together, partially or completely closing the tissue defect.

The proximal retraction finger grabber is pulled back to initially lock the suture strip to the tightening and resecting tubular.

Continue to pull the retracting finger gripper to cut the suture strip and release the suture from the tightening member to tighten and cut the tubular.

The device can then be removed from the endoscope such that the tissue defect is partially or completely closed by the tightened anchor.

In another embodiment of the device, the tightening mechanism may be a separate catheter. In this embodiment, once the anchor is placed, the device is removed from the endoscope, leaving the suture strap mechanism in the endoscope channel.

By keeping the central mandrel stationary and sliding the separate tightening device forward, the tightening member, hoop, bolero knot or spring or knot pushed with the knot pusher is pushed distally, thereby moving the two tissue anchors and Lock together to partially or completely close the area to be treated.

Please refer to FIG. 11-FIG. 14, the embodiment of the present disclosure also provides another conveying system 10, the structure, working principle, technical problems solved and technical effects that can be brought, etc. are shown in FIG. 1-FIG. 10. Most of the delivery systems 10 are the same, and the delivery system 10 shown in FIGS. 11-14 will be described below. It should be noted that the biggest difference between the delivery system 10 shown in FIGS. 11-14 and the delivery system 10 shown in FIGS. 1-10 is that the specific structure of the handle mechanism 70 is different, and the rest of the parts are roughly the same , except for the handle mechanism 70, the rest of the components can be described with reference to FIGS. 1-10 and their related texts. Therefore, the detailed description of the handle mechanism 70 will be focused on below.

11 and 12 illustrate the delivery system 10 from different perspectives, including the handle mechanism 70 and the multi-lumen catheter 11 and the like. FIG. 13 shows details of handle mechanism 70 and FIG. 14 shows details of the distal end portion of delivery system 10 .

Throughout the text, the terms "distal end", "proximal end", etc. need to be explained, and the explanations here are only for a better understanding of the present disclosure, and should not be construed as a limitation of the present disclosure. Generally, when the delivery system 10 is in use, the front end portion of the delivery system 10 (in the relative position in FIG. 11 , refers to the left end of the delivery system 10 ) will protrude into the human body, and the rear end portion of the delivery system 10 ( In the relative position in Figure 11, referring to the right end of the delivery system 10), it will remain outside the body for medical personnel to operate. Thus, "distal" can be understood as the front end portion of the part or component relatively close to the body, and "proximal" can be understood as the rear end part of the part or component relatively close to the body. Of course, when the "proximal end" and "distal end" of which part or component is not clearly indicated, the default refers to the proximal end and the distal end of the entire delivery system 10 .

In conjunction with FIG. 13 , the handle mechanism 70 shown in FIG. 13 includes:

main body 78;

a first anchoring assembly 710 disposed on the body 78, the first anchoring assembly 710 being configured to control the first tissue anchor 26 to anchor and release the first tissue anchor 26 into tissue;

a second anchoring assembly 720 disposed on the body 78, the second anchoring assembly 720 being configured to control the second tissue anchor 42 to anchor and release the second tissue anchor 42 into the tissue;

a tightening device 730 disposed on the main body 78, the tightening device 730 is configured to pull the suture member 32 to tighten the first tissue anchor 26 and the second tissue anchor 42 connected to the suture member 32;

A locking cutting device 740 disposed on the body 78 configured to lock the suture member 32 and the tubular member 30, cut the suture member 32, and fully release the tubular member 30 and a portion of the suture member connected to the tubular member 30 32.

It should be noted that the components mentioned here: "first tissue anchor 26", "second tissue anchor 42", "suture member 32" and "tubular member 30" can be combined with reference to the components shown in Figs. 1-10. out structure. The "handle mechanism 70" mentioned herein may be referred to in conjunction with FIGS. 7 and 13 . The first anchoring assembly 710, the second anchoring assembly 720, the tightening device 730, and the locking cutting device 740 of the handle mechanism 70 can be operated independently, eg, the first anchoring assembly 710 can be operated to attach the first tissue anchor 26 Anchoring into tissue and releasing, operation of second anchoring assembly 720 to anchor and release second tissue anchor 42 into tissue, operation of tightening device 730 to tighten suture member 32, and operation of locking cutting device 740 to tighten the suture member 32 and the tubular member 30 are locked and released by cutting the suture member 32. Referring to FIG. 10 here, the relative positions in FIG. 10 are introduced. The first tissue anchor 26 (126) is anchored into the first target tissue on the right, and the second tissue anchor 42 (128) is anchored into the second target tissue on the left. Target tissue, wherein the first target tissue and the second target tissue are separated by defect 124 . By anchoring the two tissue anchors into the two separated target tissues, the two tissue anchors can be pulled taut by tensioning the suture member 32, thereby achieving the close proximity of the two target tissues so that the defect 124 is closed. Then by cutting the suture member 32, the first tissue anchor 26, the second tissue anchor 42 and part of the suture member 32 are released, so that the two target tissues are firmly tensioned, and the defect 124 is always in a closed state .

In this embodiment, a total of two anchoring assemblies of the first anchoring assembly 710 and the second anchoring assembly 720 are disclosed. In other embodiments, the number of anchoring assemblies is not limited, that is, the number of the anchoring assemblies may be for three or more. The specific structure of the first anchoring assembly 710 will be described in detail below. In this embodiment, the structures of the two anchoring assemblies are basically the same, so the second anchoring assembly 720 will not be described in detail. Of course, other embodiments , the structures of the two anchoring assemblies may also be different.

In the first example, referring to FIG. 13 , the first anchoring assembly 710 includes a first sliding member 88 and a first release button 84 , the first sliding member 88 is configured to be connected with the first long shaft 114 and the first tubular member 130 , The first sliding member 88 is slidably connected to the main body 78 to drive the first long shaft 114 and the first tubular member 130 to move; the first release button 84 is configured to be connected with the first long shaft 114, and the first release button 84 is slidably connected to the main body 78 to drive the first long shaft 114 to move;

The first long shaft 114 movably shuttles through the first tubular member 130, the first connecting member 12 is connected to the distal end of the first tubular member 130, the first tissue anchor 26 is connected to the distal end of the first long shaft 114, A tissue anchor 26 is removably connected to the first connector 12; when the first tissue anchor 26 is engaged with the first connector 12 and the first slide 88 is moved distally, the first tissue anchor 26 is connected to the first The member 12 moves distally, and the first tissue anchor 26 can contact and anchor into the tissue under the action of the first long axis 114; Upon proximal movement, the first connector 12 is disengaged from the first tissue anchor 26 and the first tissue anchor 26 is released.

It should be noted that this "first tissue anchor 26" may be a piercing-type tissue anchor (similar to a hooked anchor). During the operation of the first sliding member 88 to move toward the distal end, the first tissue anchor 26 Moves distally, and the first tissue anchor 26 can contact and penetrate into the tissue under the action of the first long shaft 114, keeping the position of the first slider 88 unchanged, and the first release button 84 moves proximally When the first connector 12 is disengaged from the first tissue anchor 26, and the first tissue anchor 26 is released, at this time, the first tissue anchor 26 is retained on the tissue because it is hooked on the tissue.

In the second example, based on the first example, the first sliding member 88 is rotatably connected to the main body 78 to drive the first long shaft 114 to rotate; wherein, when the first sliding member 88 rotates relative to the main body 78 , the first tissue anchor 26 can contact and rotate anchored into the tissue under the action of the first long axis 114 .

It should be noted that this "first tissue anchor 26" may be a rotational anchoring type tissue anchor.

In the third example, referring to FIG. 13 , the first anchoring assembly 710 includes a first sliding member 88 , a first thumb wheel 96 and a first release button 84 , and the first sliding member 88 is configured to be connected with the first long axis 114 and the first release button 84 . A tubular member 130 is connected, and the first sliding member 88 is slidably connected to the main body 78 to drive the first long shaft 114 and the first tubular member 130 to move; the first thumb wheel 96 is configured to be connected to the first long shaft 114, the first The thumb wheel 96 is rotatably connected to the main body 78 to drive the first long shaft 114 to rotate; the first release button 84 is configured to be connected to the first long shaft 114, and the first release button 84 is slidably connected to the main body 78 to drive the first long shaft 114. The long axis 114 moves;

The first long shaft 114 movably shuttles through the first tubular member 130, the first connecting member 12 is connected to the distal end of the first tubular member 130, the first tissue anchor 26 is connected to the distal end of the first long shaft 114, A tissue anchor 26 is removably connected to the first connector 12; when the first tissue anchor 26 is engaged with the first connector 12 and the first slide 88 is moved distally, the first tissue anchor 26 is connected to the first The member 12 moves distally; when the first thumb wheel 96 rotates relative to the main body 78, the first tissue anchor 26 can contact and rotate anchored into the tissue under the action of the first long shaft 114; When the position of the body 78 remains unchanged and the first release button 84 is moved proximally, the first connector 12 is disengaged from the first tissue anchor 26 and the first tissue anchor 26 is released.

It should be noted that the "first tissue anchor 26" may be a rotary anchor type tissue anchor, the first long axis 114 movably shuttles through the first tubular member 130, and the first tubular member 130 movably shuttles through the multiple tubes In the lumen catheter 11. The medical staff operates the first sliding member 88, the first thumb wheel 96 and the first release button 84, these components drive the first long shaft 114 and the first tubular member 130 to move, and finally realize the rotation and anchoring of the first tissue anchor 26 into the tissue, And the first tissue anchor 26 is released.

In combination with the above, it can be understood that the structure of the rotary anchor type tissue anchor is similar to the spring structure, and its distal end is sharp, penetrates into the tissue when it contacts and moves toward the tissue, and is screwed into the tissue during the rotation process. , the number of rotations can to a certain extent determine the depth of insertion of the distal end of the tissue anchor into the tissue. When the tissue anchor is released, it is retained on the tissue as it is screwed into the tissue. Whereas a penetrating tissue anchor penetrates the tissue as it contacts and moves toward the tissue, the depth of penetration is determined in part by the distance the first slider 88 moves distally. When the tissue anchor is released, the hook portion of the tissue anchor is retained on the tissue as it is hooked to the tissue.

Specifically, the first thumb wheel 96 is secured to the proximal end of the first slider 88 . This facilitates the operation of the first thumb wheel 96, and at the same time, because it is located at the proximal end of the first sliding member 88, when the first release button 84 is operated to move toward the proximal end, the first thumb wheel 96 can abut against the palm of the medical staff, play a supporting role. In other embodiments, the first thumb wheel 96 can also be installed at the middle or the distal end of the first sliding member 88. When installed at the proximal end of the first sliding member 88 according to this embodiment, the entire first anchoring assembly 710 structure is more compact. In other embodiments, the first thumb wheel 96 and the first sliding member 88 may be integrally formed, that is, the two components are integral, or the outer wall of the first sliding member 88 is provided with an uneven surface to facilitate the operation of medical staff. , the uneven part is called the first thumb wheel 96 . Therefore, the setting form of the first thumb wheel 96 is not limited, and the first sliding member 88 can also be directly rotated to realize the rotation of the first long axis 114, and the above technical effect can be achieved regardless of whether the first thumb wheel 96 is provided or not. .

Specifically, the first release button 84 is slidably connected to the first slider 88 . The first release button 84 has two tabs to facilitate manipulation by medical personnel. At the same time, the first release button 84 is directly installed on the first sliding member 88, so that the structure of the first anchoring assembly 710 is more compact. The manner of sliding connection here is not limited. For example, the first release button 84 is provided with a sliding block, the first sliding member 88 is provided with a sliding groove, and the sliding block is slidably fitted in the sliding groove to realize the sliding connection. Alternatively, the first release button 84 is provided with a sliding groove, the first sliding member 88 is provided with a sliding block, and the sliding block is slidably fitted in the sliding groove to realize the sliding connection.

In this embodiment, the first sliding member 88 is rod-shaped, the distal end of the first sliding member 88 is slidably and rotatably connected to the main body 78 , and the first release button 84 is sleeved with the first sliding member 88 . The first release button 84 is fitted with the first sliding member 88, so that the operation is smoother and more stable. In addition, the first sliding member 88 and the main body 78 are slidable and rotatable, that is, during the sliding process, the first tissue anchor 26 can be approached or moved away from the tissue, and during the rotating process, the first tissue anchor 26 can be anchored into the tissue .

Meanwhile, in this embodiment, the first sliding member 88 is provided with a first sliding slot 881 , and the first release button 84 is slidably matched with the first sliding slot 881 . That is, the effect of stable sliding is achieved by the cooperation of the first release button 84 with the first sliding groove 881 .

Specifically, the first thumb wheel 96 is fixed to the proximal end of the first sliding member 88 , the proximal end of the first sliding groove 881 extends to the first thumb wheel 96 , and the distal end of the first sliding groove 881 extends to the first sliding member 88 In the middle of the first release button 84, a first fastener 841 is fixedly connected, and the first fastener 841 is slidably matched with the first chute 881.

The first fastener 841 can be optionally a screw, and the first release button 84 is limitedly mounted on the first sliding member 88 through the screw, and the screw slidably shuttles in the first sliding slot 881. In this way, The sliding of the first release button 84 can be made more stable, and at the same time, the stroke of the first release button 84 can be limited to a certain extent, that is, the first release button 84 can only move within the extension range of the first chute 881 . In this embodiment, the proximal end of the first long shaft 114 is connected and fixed with the first fastener 841 . It should be noted that, in other embodiments, the proximal end of the first long shaft 114 can be directly connected and fixed with the first release button 84 .

13 , the first axis 7811 (shown by the dotted line) is shown here. In this embodiment, the sliding direction of the first sliding member 88 relative to the main body 78 is the same as the first axis 7811 , and the first sliding member 88 is relative to the first axis 7811 . The axis of rotation of the main body 78 coincides with the first axis 7811 . The sliding direction of the first release button 84 relative to the first sliding member 88 is the same as the first axis 7811 .

In this embodiment, the structure of the second anchoring assembly 720 is basically the same as that of the first anchoring assembly 710, that is, the second anchoring assembly 720 includes basically the same components as the first anchoring assembly 710, that is, it includes: Two sliding members 90 , a second thumb wheel 94 and a second release button 86 . Similarly, the second sliding member 90 is provided with a second sliding slot 901 , and the second releasing button 86 is connected to the second sliding slot through a second fastener 861 901 achieves a slip fit. Therefore, the relevant details of the second anchoring assembly 720 may refer to the above-mentioned first anchoring assembly 710 , which will not be repeated here.

After the medical staff operates the first anchoring assembly 710 and the second anchoring assembly 720 to anchor the first tissue anchor 26 and the second tissue anchor 42 into the tissue and release it, the suture member 32 needs to be pulled at this time to remove the first tissue anchor 26 and the second tissue anchor 42. The tissue anchor 26 and the second tissue anchor 42 are tightened to achieve the abutment of the first target tissue and the second target tissue to complete the closure of the defect 124 . The apparatus for manipulating the suture member 32 will be described in detail below.

12 and 13 , the tightening device 730 includes a rotating wheel 76 , the rotating wheel 76 is rotatably connected to the main body 78 , and the proximal end of the suture member 32 is wound around the rotating wheel 76 . Proximal movement of suture member 32 to tighten first tissue anchor 26 and second tissue anchor 42 may be accomplished by rotating rotary wheel 76 .

During a particular use, suture member 32 is generally not allowed to move distally. Therefore, in this embodiment, the tightening device 730 further includes a pawl 761, one end of the pawl 761 is connected to the main body 78, the other end of the pawl 761 is matched with the rotating wheel 76, and the pawl 761 and the rotating wheel 76 constitute a ratchet mechanism; When the rotating wheel 76 is rotated forward, the suture member 32 is moved toward the proximal end, and when the rotating wheel 76 is reversed, the rotating wheel 76 is locked by the pawl 761 . By arranging the pawl 761 , the rotating wheel 76 can only be allowed to rotate forward, which drives the suture member 32 to move toward the proximal end, but cannot move the suture member 32 toward the distal end.

Generally, for ease of operation, and the operation process does not interfere with the normal use of other devices, the suture member 32 will be movably shuttled in the multi-lumen catheter 11 to exit at the proximal end portion (ie, the main body 78 ) of the delivery system 10 . Therefore, in this embodiment, the proximal end of the main body 78 is provided with a shuttle hole 7841 , and the proximal end of the suture member 32 shuttles inside the main body 78 , extends out of the main body 78 through the shuttle hole 7841 and is wound around the rotating wheel 76 .

Generally, after the first tissue anchor 26 and the second tissue anchor 42 are tightened, the suture member 32 connecting the first tissue anchor 26 and the second tissue anchor 42 needs to be cut so that the remaining part after cutting The suture member 32 and the first tissue anchor 26 and the second tissue anchor 42 connected with this part of the suture member 32 are released and left in the human body as a whole, so that the first target tissue and the second target tissue can always be in a tight state , that is, the defect 124 is always in a closed state. The apparatus for manipulating the suture member 32 will be described in detail below.

13 and 14 , the locking cutting device 740 includes an intermediate sliding member 741 and a third sliding button 80 , the intermediate sliding member 741 is configured to be connected with the third connecting shaft 54 and the third tubular member 20 , and the intermediate sliding member 741 is slidable is connected to the main body 78 to drive the third connecting shaft 54 and the third tubular member 20 to move; the third sliding button 80 is configured to be connected with the third connecting shaft 54, and the third sliding button 80 is slidably connected to the main body 78 to drive the third connecting shaft 54. The three connecting shafts 54 move;

The third connecting shaft 54 movably shuttles through the third tubular member 20 , the distal end of the third tubular member 20 is removably connected to the tubular member 30 , and the tubular member 30 is slidably sheathed with a sliding tubular member 101 . The tubular member 101 has a first window 201, and the tubular member 30 has a second window 50; the distal end of the third connecting shaft 54 is connected with a retraction ball mechanism 36, which removably shuttles in the distal end cap 34 , and the distal cover 34 is located at the distal end of the tubular member 30; the two distal ends of the suture member 32 are connected to the first tissue anchor 26 and the second tissue anchor 42, respectively, and the suture member 32 passes through the distal end of the tubular member 30. and extend to the proximal end after passing through the second window 50 and the first window 201 in turn; when the middle sliding member 741 slides towards the distal end, the third tubular member 20 and the tubular member 30 move towards the distal end at the same time; in the middle sliding member When the position of 741 relative to the main body 78 remains unchanged and the third sliding button 80 moves toward the proximal end, the retracting ball mechanism 36 first drives the distal cover 34 to lock the suture member 32 and the tubular member 30, and then continues to drive the sliding tubular member 101 is moved proximally so that the first window 201 and the second window 50 cooperate to cut the suture member 32, and then fully release the tubular member 30, the distal cap 34 attached to the tubular member 30, and a portion of the suture member 32.

It should be noted that the third connecting shaft 54 movably shuttles through the third tubular member 20 , and the third tubular member 20 movably shuttles through the multi-lumen catheter 11 . The medical staff operates the middle sliding member 741 and the third sliding button 80, and these components drive the third connecting shaft 54 and the third tubular member 20 to move, and finally realize that the cut part of the suture member 32 connects the first tissue anchor 26 and the second tissue The anchor 42 is tightened while the portion of the suture member 32 is locked by the distal cap 34 and the tubular member 30 .

In order to make the structure of the entire locking and cutting device 740 more compact, in this embodiment, the third sliding button 80 is slidably connected to the middle sliding member 741 . Of course, in other embodiments, the third sliding button 80 may also be installed on the main body 78 .

In this embodiment, the middle sliding member 741 is rod-shaped, the distal end of the middle sliding member 741 is slidably connected to the main body 78 , and the third sliding button 80 is sleeved with the middle sliding member 741 . By the way of wrapping, the sliding process of the third sliding button 80 is more stable and smooth.

For the convenience of operation, the stroke of the third sliding button 80 is limited. In this embodiment, the proximal end of the middle sliding member 741 is connected with the middle thumb wheel 742 , the middle sliding member 741 is provided with a middle sliding groove 743 , the proximal end of the middle sliding groove 743 extends to the middle thumb wheel 742 , and the distal end of the middle sliding groove 743 extends to the middle thumb wheel 742 . The end extends to the middle of the middle sliding piece 741 , the third sliding button 80 is fixedly connected with a middle fastener 744 , and the middle fastener 744 is slidably matched with the middle sliding slot 743 .

It should be noted that the middle fastener 744 can be a screw, that is, the screw slides through the middle sliding groove 743 to limit the stroke of the third sliding button 80 .

13 , the third axis 7821 (shown by the dotted line) is shown here. In this embodiment, the sliding direction of the middle sliding member 741 relative to the main body 78 is the same as the third axis 7821 , and the third sliding button 80 is relative to the middle The sliding direction of the sliding member 741 is the same as that of the third axis 7821 .

Referring to FIG. 13 again, in this embodiment, the main body 78 includes a first sleeve 781 , an intermediate sleeve 782 , a second sleeve 783 and a confluence portion 784 , the distal end of the first sleeve 781 and the distal end of the intermediate sleeve 782 And the distal end of the second sleeve 783 is connected with the proximal end of the confluence part 784, and the distal end of the confluence part 784 is configured to be connected with the multi-lumen catheter 11; the first anchoring component 710 is assembled with the first sleeve 781, and the first The second anchoring assembly 720 is assembled with the second sleeve 783, the locking and cutting device 740 is assembled with the intermediate sleeve 782, and the tightening device 730 is assembled with the converging part 784;

The first anchoring assembly 710 is configured to control the first tissue anchor 26 through the multi-lumen catheter 11; the second anchoring assembly 720 is configured to control the second tissue anchor 42 through the multi-lumen catheter 11; the tightening device 730 is configured to Suture member 32 is pulled through multi-lumen catheter 11; locking cutting device 740 is configured to lock suture member 32 and tubular member 30 through multi-lumen catheter 11, cut suture member 32, and fully release tubular member 30 and tubular member 30 A portion of the suture member 32 to which the piece 30 is attached.

It should be noted that the above-mentioned first long axis 114 , first tubular member 130 , second long axis 116 , second tubular member 150 , third connecting shaft 54 , third tubular member 20 and suture member 32 all shuttle in the In the multi-lumen catheter 11, in this way, the multi-lumen catheter 11 can restrain these components.

In order to restrict the movement strokes of the first anchoring assembly 710 , the locking cutting device 740 and the second anchoring assembly 720 , in this embodiment, the distal end of the first anchoring assembly 710 is movably disposed on the first sleeve 781 Inside, the distal end of the locking cutting device 740 is movably disposed in the intermediate sleeve 782 , and the distal end of the second anchoring assembly 720 is movably disposed in the second sleeve 783 . It can be understood that the first anchoring assembly 710, the locking cutting device 740 and the second anchoring assembly 720 are all sheathed in the corresponding sleeves. In other embodiments, the first anchoring assembly 710, the locking cutting device can also be used. 740 and the second anchoring assembly 720 are sheathed outside the corresponding sleeve.

Referring to FIG. 13 , in order to facilitate the operation of medical staff, in this embodiment, the three sleeves are set relatively independently, that is, a three-branch design. For example, the first axis 7811 of the first sleeve 781 and the second axis 7831 of the second sleeve 783 are distributed at an acute angle, and the third axis 7821 of the intermediate sleeve 782 is located between the first axis 7811 and the second axis 7831 . The first axis 7811 and the second axis 7831 can be distributed at an angle of 30°-60°, the third axis 7821 is located in the middle of the first axis 7811 and the second axis 7831, and the overall structure has better symmetry.

In order to make the entire delivery system 10 have a certain flexibility and facilitate the overall rotation, etc., in this embodiment, the main body 78 further includes a spring tube 785, the proximal end of the spring tube 785 is connected to the distal end of the confluence portion 784, and the spring tube 785 has a The distal end is configured to interface with the multi-lumen catheter 11 .

In order to facilitate the medical staff to operate the rotating wheel 76 , in this embodiment, the rotation axis line of the rotating wheel 76 is perpendicular to the third axis 7821 of the intermediate sleeve 782 .

This embodiment also provides an operation method, which is realized by using the above-mentioned handle mechanism 70, and the operation method includes:

Use an endoscope to access and visualize the area to be treated;

delivering the distal ends of the first tissue anchor 26, the second tissue anchor 42, the tubular member 30, and the suture member 32 to the distal end of the endoscope through the working channel of the endoscope;

operating the first anchoring assembly 710 to anchor the first tissue anchor 26 into the first target tissue and release the first tissue anchor 26;

operating the second anchoring assembly 720 to anchor the second tissue anchor 42 into the second target tissue and release the second tissue anchor 42;

operating the tightening device 730 to pull on the suture member 32 to tighten the first tissue anchor 26 and the second tissue anchor 42 connected to the suture member 32 to tighten the first target tissue and the second target tissue;

The locking cutting device 740 is operated to lock the suture member 32 with the tubular member 30 and cut the suture member 32 and fully release the tubular member 30 and the portion of the suture member 32 connected to the tubular member 30 .

Specifically, in an example, after the installation of the delivery system 10 is completed, during the operation, an endoscope is generally inserted into the human body, and then the entire distal portion of the delivery system 10 is delivered through the working channel of the endoscope. to the target location.

Step 1, driving the first tissue anchor 26: push the first sliding member 88 to move towards the proximal end, thereby driving the first tubular member 130 and the first long axis 114 to move towards the proximal end, at this time, the first tissue anchor 26 contacts The first target tissue; keep the position of the first slider 88 unchanged, and rotate the first thumb wheel 96, thereby driving the first long shaft 114 to rotate, so that the distally connected first tissue anchor 26 is rotated and anchored into the first target After the tissue is anchored in place, keep the position of the first sliding member 88 unchanged, and push the first release button 84 to move to the distal end, thereby driving the first long shaft 114 to move to the distal end. A long shaft 114 is disengaged from the first tissue anchor 26 , and at the same time, the first connecting member 12 fixed at the distal end of the first tubular member 130 is disengaged from the first tissue anchor 26 to complete the release of the first tissue anchor 26 .

Step 2, inserting the second tissue anchor 42: the second tissue anchor 42 is anchored into the second target tissue and released. (For specific operations, please refer to step 1)

Step 3: Tighten suture member 32: Turn rotary wheel 76 so that suture member 32 moves proximally, tensioning first tissue anchor 26 and second tissue anchor 42 at its distal position.

Step 4, cut off the suture member 32 and release the corresponding parts: push the intermediate slider 741 to move distally, while continuing to operate the rotating wheel 76 to tighten the suture member 32 to further tighten the first tissue anchor 26 and the second tissue Anchor 42; when the position of the tubular member 30 meets the requirements, keep the position of the middle sliding member 741 unchanged, pull the third sliding button 80 to move to the proximal end, and the retracting ball mechanism 36 connected at the distal end of the third connecting shaft 54 continues to The proximal end moves. During the movement, the distal end cap 34 is first driven to move toward the proximal end, and the distal end cap 34 is snapped into the distal end of the tubular member 30. The third connecting shaft 54 continues to move towards the proximal end, the retracting ball mechanism 36 is disengaged from the distal end cap 34, and then drives the sliding tubular member 101 to move towards the proximal end. At this time, the suture member 32 passes through the second window in sequence 50 and the first window 201 extend proximally, therefore, during the proximal movement of the sliding tubular member 101, the first window 201 and the second window 50 cooperate to sever the suture member 32; the third connecting shaft 54 continues to The proximal end moves so that the tubular member 30 is disengaged from the third tubular member 20 .

Step 5: Pull the main body 78 to take out the third tubular member 20, the first tubular member 130, the second tubular member 150 and the multi-lumen catheter 11 together through the working channel of the endoscope, so that the first tissue anchor 26, the second The tissue anchor 42, the tubular member 30, the distal end cap 34, and the cut portion of the suture member 32 connecting these components together are fully released.

While this disclosure has been described as having a preferred design, this disclosure can be further modified within the spirit and scope of this disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of this disclosure using the general principles of this disclosure. Furthermore, this application is intended to cover such departures from this disclosure as come within known or conventional practice and art to which this disclosure pertains and which fall within the limits of the appended claims.

Industrial Applicability:

In summary, the present disclosure provides a handle mechanism, delivery system, and method of operation that can facilitate repair of wall defects, folds of tissue, and treatment of lesions delivered through the working channel of an endoscope.

Claims

A handle mechanism, characterized in that the handle mechanism comprises:

main body;

a first anchoring assembly disposed on the body, the first anchoring assembly configured to control a first tissue anchor to anchor and release the first tissue anchor into tissue;

a second anchoring assembly disposed on the body, the second anchoring assembly configured to control a second tissue anchor to anchor and release the second tissue anchor into tissue;

a tightening device disposed on the body, the tightening device configured to pull on a suture member to tighten the first tissue anchor and the second tissue anchor connected to the suture member;

a locking cutting device provided to the body, the locking cutting device configured to lock the suture member and the tubular member, cut the suture member, and fully release the tubular member and the connected to the tubular member Part of the suture component.
9. The handle mechanism of claim 1, wherein the first anchoring assembly includes a first slider and a first release button, the first slider configured to be coupled with the first long shaft and the first tubular member connected, the first sliding member is slidably connected to the main body to drive the first long shaft and the first tubular member to move; the first release button is configured to be connected to the first long shaft, the first release button is slidably connected to the main body to drive the first long shaft to move;

Wherein, the first long shaft movably shuttles through the first tubular member, the distal end of the first tubular member is connected with a first connecting member, and the distal end of the first long shaft is connected with the first a tissue anchor removably connected to the first connector; when the first tissue anchor is engaged with the first connector and the first slide is moved distally, The first tissue anchor and the first connecting member move towards the distal end, and the first tissue anchor can contact and anchor into the tissue under the action of the first long axis; when the first sliding member is opposite to When the position of the main body remains unchanged and the first release button moves toward the proximal end, the first connecting member is disengaged from the first tissue anchor, and the first tissue anchor is released.
The handle mechanism of claim 2, wherein the first sliding member is rotatably connected to the main body to drive the first long shaft to rotate;

Wherein, when the first sliding member rotates relative to the main body, the first tissue anchor can contact and rotate into the tissue under the action of the first long axis.
3. The handle mechanism of claim 2, wherein the first anchoring assembly further comprises a first thumb wheel configured to connect with the first long shaft, the first thumb wheel a wheel is rotatably connected to the main body to drive the first long shaft to rotate;

Wherein, when the first thumb wheel rotates relative to the main body, the first tissue anchor can contact and rotate into the tissue under the action of the first long axis.
The handle mechanism of claim 4, wherein the first thumbwheel is fixed to the proximal end of the first slider.
5. The handle mechanism of claim 4, wherein the first release button is slidably connected to the first slider.
The handle mechanism of claim 6, wherein the first sliding member is in the shape of a rod, the distal end of the first sliding member is slidably and rotatably connected to the main body, and the first release member is slidably and rotatably connected to the main body. The button is sleeved with the first sliding member.
The handle mechanism of claim 7, wherein the first sliding member is provided with a first sliding groove, and the first release button is slidably matched with the first sliding groove.
9. The handle mechanism of claim 1, wherein the tightening device includes a rotating wheel rotatably connected to the main body, the proximal end of the suture member disposed around the rotating wheel wheel.
The handle mechanism of claim 9, wherein the tightening device further comprises a pawl, one end of the pawl is connected to the main body, and the other end of the pawl is matched with the rotating wheel, The pawl and the rotating wheel form a ratchet mechanism; when the rotating wheel rotates forward, the suture member moves toward the proximal end, and when the rotating wheel reverses, the rotating wheel is locked by the pawl .
The handle mechanism of claim 9, wherein the proximal end of the main body is provided with a shuttle hole, the proximal end of the suture member is shuttled inside the main body, and protrudes through the shuttle hole. The main body is wound around the rotating wheel.
The handle mechanism of claim 1, wherein the locking cutting device comprises an intermediate slide and a third slide button, the intermediate slide is configured to connect with the third connecting shaft and the third tubular member, the The middle sliding member is slidably connected to the main body to drive the third connecting shaft and the third tubular member to move; the third sliding button is configured to be connected with the third connecting shaft, and the third sliding button is slidably connected to the main body to drive the third connecting shaft to move;

Wherein, the third connecting shaft movably shuttles through the third tubular member, the distal end of the third tubular member is removably connected to the tubular member, and the tubular member is slidably sheathed with a sliding tubular member , the sliding tubular member has a first window, the tubular member has a second window; the distal end of the third connecting shaft is connected with a retracting ball mechanism, and the retracting ball mechanism is removably shuttled to the distal end and the distal end cap is located at the distal end of the tubular member; the two distal ends of the suture member are connected to the first tissue anchor and the second tissue anchor, respectively, and the suture The member passes through the distal end of the tubular member, and extends to the proximal end after passing through the second window and the first window in turn; when the intermediate sliding member slides toward the distal end, the third tubular member and The tubular member moves towards the distal end at the same time; in the process that the position of the intermediate sliding member relative to the main body remains unchanged and the third sliding button moves towards the proximal end, the retracting ball mechanism first drives the The distal cover locks the suture member and the tubular member, and then continues to drive the sliding tubular member to move proximally, so that the first window and the second window cooperate to cut the suture member, and then completely release all the suture members. The tubular member, the distal cap connected to the tubular member, and a portion of the suture member.
13. The handle mechanism of claim 12, wherein the third slide button is slidably connected to the intermediate slide.
The handle mechanism according to claim 13, wherein the middle sliding member is in the shape of a rod, the distal end of the middle sliding member is slidably connected to the main body, and the third sliding button is sleeved on the Intermediate slide.
The handle mechanism of claim 13, wherein the proximal end of the intermediate sliding member is connected with an intermediate thumb wheel, the intermediate sliding member is provided with an intermediate sliding groove, and the proximal end of the intermediate sliding groove extends to all the the middle thumb wheel, the distal end of the middle chute extends to the middle of the middle sliding piece, the third sliding button is fixedly connected with a middle fastener, and the middle fastener is slidably connected to the middle Chute fit.
The handle mechanism of claim 1, wherein the main body comprises a first sleeve, an intermediate sleeve, a second sleeve and a confluence, the distal end of the first sleeve, the intermediate sleeve The distal end of the second sleeve and the distal end of the second sleeve are both connected to the proximal end of the confluence, and the distal end of the confluence is configured to be connected to a multi-lumen catheter; the first anchoring assembly is connected to the the first sleeve is assembled, the second anchoring assembly is assembled with the second sleeve, the locking cutting device is assembled with the intermediate sleeve, and the tightening device is assembled with the junction;

wherein the first anchoring assembly is configured to control a first tissue anchor through the multi-lumen catheter; the second anchoring assembly is configured to control a second tissue anchor through the multi-lumen catheter; the tightening The device is configured to pull the suture member through the multi-lumen catheter; the locking cutting device is configured to lock the suture member and the tubular member through the multi-lumen catheter, and cut the suture member, and fully release The tubular member and a portion of the suture member connected to the tubular member.
17. The handle mechanism of claim 16, wherein the distal end of the first anchoring assembly is movably disposed within the first sleeve and the distal end of the locking cutting device is movably disposed in the In the middle sleeve, the distal end of the second anchoring assembly is movably disposed in the second sleeve.
The handle mechanism of claim 16, wherein the first axis of the first sleeve and the second axis of the second sleeve are distributed at an acute angle, and the third axis of the intermediate sleeve is located at an acute angle. between the first axis and the second axis.
17. The handle mechanism of claim 16, wherein the body further comprises a spring tube, the proximal end of the spring tube is connected to the distal end of the confluence, and the distal end of the spring tube is configured to be connected to the The multi-lumen catheter is docked.
17. The handle mechanism of claim 16, wherein the tightening device includes a swivel wheel rotatably connected to the body, the proximal end of the suture member disposed around the swivel wheel; the rotation axis of the rotating wheel is perpendicular to the third axis of the intermediate sleeve.
A delivery system comprising the handle mechanism of claim 1 .
An operation method, characterized in that, it is realized by using the handle mechanism of claim 1, and the operation method comprises:

Use an endoscope to access and visualize the area to be treated;

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

operating the first anchoring assembly to anchor the first tissue anchor into a first target tissue and release the first tissue anchor;

operating the second anchoring assembly to anchor the second tissue anchor into a second target tissue and release the second tissue anchor;

operating a tightening device to pull a suture member to tighten the first tissue anchor and the second tissue anchor connected to the suture member to tighten the first target tissue and the second target tissue tension;

The locking cutting device is operated to lock the suture member with the tubular member and cut the suture member and fully release the tubular member and a portion of the suture member connected to the tubular member.