WO2007098212A2 - Endoscopic suturing devices - Google Patents

Endoscopic suturing devices

Info

Publication number
WO2007098212A2
WO2007098212A2 PCT/US2007/004527 US2007004527W WO2007098212A2 WO 2007098212 A2 WO2007098212 A2 WO 2007098212A2 US 2007004527 W US2007004527 W US 2007004527W WO 2007098212 A2 WO2007098212 A2 WO 2007098212A2
Authority
WO
Grant status
Application
Patent type
Prior art keywords
suture
device
tissue
microcarabiner
thread
Prior art date
Application number
PCT/US2007/004527
Other languages
French (fr)
Other versions
WO2007098212A3 (en )
Inventor
Amir Belson
Original Assignee
Amir Belson
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0483Hand-held instruments for holding sutures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066Needles, e.g. needle tip configurations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004(bio)absorbable, (bio)resorbable, resorptive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00278Transorgan operations, e.g. transgastric
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0412Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from suture anchor body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • AHUMAN NECESSITIES
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    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417T-fasteners
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0427Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0427Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
    • A61B2017/0435Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • A61B2017/0441Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws the shaft being a rigid coil or spiral
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0454Means for attaching and blocking the suture in the suture anchor the anchor being crimped or clamped on the suture
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0461Means for attaching and blocking the suture in the suture anchor with features cooperating with special features on the suture, e.g. protrusions on the suture
    • A61B2017/0462One way system, i.e. also tensioning the suture
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0496Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066Needles, e.g. needle tip configurations
    • A61B2017/06076Needles, e.g. needle tip configurations helically or spirally coiled
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066Needles, e.g. needle tip configurations
    • A61B2017/061Needles, e.g. needle tip configurations hollow or tubular

Abstract

Endoscopic suturing devices for transgastric flexible endoscopy procedures are described. In a first aspect, the endoscopic suturing device includes a hollow helical needle carrying an elongated suture thread with a suture anchor on the distal end of the suture thread. The suture anchor has a low-profile insertion position and an expanded anchoring position. A suture lock is provided for attachment at the proximal end of the suture thread. In another aspect, the suture device includes a microcarabiner and suture lock. The suture device may take the form of a conventional suture thread or a zip-tie fastener. In an alternate configuration, the microcarabiner can be combined with a tissue anchor. One or more such tissue anchors can be used to form a running suture, purse string suture or other suture configurations. Methods of applying sutures using the endoscopic suturing devices are described.

Description

ENDOSCOPIC SUTURING DEVICES

FIELD OF THE INVENTION

The present invention relates to suturing devices, particularly to suturing devices useful in endoscopic surgery. Certain embodiments of the suturing devices are particularly well adapted for transgastric flexible endoscopy procedures.

BACKGROUND OF THE INVENTION

Endoscopic surgical techniques have reduced the invasiveness, trauma and morbidity and improved patient recovery times in a great number of surgical procedures. Transgastric flexible endoscopy is another new surgical procedure with diagnostic and therapeutic applications that has tremendous promise in further reducing the invasiveness, trauma and morbidity of surgeries and even further improving patient recovery times.

In transgastric flexible endoscopy, also known as flexible transgastric peritoneoscopy, a flexible endoscope is inserted through the patient's mouth and esophagus into the stomach. An incision is made in the stomach wall to give the endoscope surgical access to the peritoneum and the organs within the abdomen. In a variation of the procedure, retroflexion of the flexible endoscope is used to redirect the endoscope in a caudal direction and an incision is made in the superior wall of the stomach to give surgical access to the diaphragm and, by crossing through the diaphragm, to the organs within the mediastinum and thorax. Published experimental studies have shown the feasibility of using transgastric flexible endoscopy for surgical access to the intestines, liver, pancreas, gallbladder, uterus and Fallopian tubes. With improvements in instrumentation and techniques, the indications for this approach will be greatly expanded.

When a peroral, transgastric approach is used, no external incisions are needed to gain surgical access to the internal organs. This is advantageous because the gastric wall is one of the fastest healing tissues in the human body. As a consequence, pain, morbidity and patient recovery times are significantly reduced.

However, because of limited access and visualization, the endoscopic surgical approach presents many technical challenges. Sewing and tying of sutures to close an incision or to make an anastomosis between organs can be especially difficult in endoscopic procedures. Each time the needle or suture must be released and regrasped, it adds to the difficulty of the procedure. Even devices such as zip-tie fasteners, which are designed to facilitate endoscopic suturing, require the distal end of the fastener to be threaded through a locking device, then released and regrasped in order to pull the fastener tight.

Improved endoscopic suturing devices are needed to facilitate endoscopic surgical procedures. Improved suturing devices would be useful in many different surgical procedures, including endoscopic surgery, arthroscopic surgery, transgastric, transcolonic or transvaginal flexible endoscopy, laparoscopy, thoracoscopy, standard open surgical procedures and for use on the surface of the body (such as closure of skin wounds and incisions).

SUMMARY OF THE INVENTION

The present invention provides endoscopic suturing devices that are particularly well suited for flexible endoscopic procedures.

In a first aspect, the invention provides an endoscopic suturing device that includes a hollow helical needle carrying an elongated suture thread. On the distal end of the suture thread is a suture anchor. Preferably, the suture anchor has a low-profile insertion position and an anchoring position. A suture lock is provided for attachment at the proximal end of the suture thread. A method of applying a suture using the endoscopic suturing device is described.

In another aspect, the invention provides a suture device having a microcarabiner and suture lock. The suture device may take the form of a conventional suture thread or a zip-tie fastener. In an alternate configuration, the microcarabiner can be combined with a tissue anchor. One or more such tissue anchors can be used to form a running suture, purse string suture or other suture configurations.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG 1 illustrates a peroral, transgastric surgical approach used in transgastric flexible endoscopy.

FIG 2 shows a distal portion of an endoscopic suturing device according to the present invention.

FIG 3 shows an endoscopic suturing device used at a right angle to the endoscope. FIGS 4A-4B show the insertion position and the anchoring position of a suture anchor for use with the present invention.

FIGS 5A-5B show the insertion position and the anchoring position of another suture anchor for use with the present invention.

FIGS 6A-6E illustrate the steps of applying a suture using the endoscopic suturing device.

FIGS 7-9 are schematic drawings showing the basic function of a microcarabiner.

FIGS 10-12 show a suture lock that can be used with the suture device and microcarabiner.

FIGS 13-14 show another embodiment of a suture lock that can be used with the suture device and microcarabiner.

FIGS 15-16 show an embodiment of a suture device incorporating a microcarabiner.

FIGS 17-18 show an embodiment of a zip-tie suture device incorporating a microcarabiner.

FIG 19 shows an interrupted suture along an incision formed using multiple suture devices of the type shown in FIGS 17-18.

FIGS 20-21 show another embodiment of a suture lock that can be used with the suture device and microcarabiner.

FIG 22 shows a tissue anchor with a barb-like distal anchoring structure and a microcarabiner at the proximal end.

FIG 23 shows a tissue anchor with a corkscrew or auger-like distal anchoring structure and a microcarabiner at the proximal end.

FIG 24 shows multiple tissue anchors used to form a running suture.

FIG 25 shows multiple tissue anchors used to form a purse string suture.

FIG 26 shows an embodiment of a microcarabiner with a double gate. FIG 27 shows the microcarabiner of FIG 26 with the double gate pivoting inward to open.

FIG 28 shows a tissue anchor with an expanding distal anchoring mechanism and a microcarabiner at the proximal end.

FIG 29 shows the tissue anchor of FIG 28 with the distal anchoring mechanism in the expanded position.

FIG 30 shows a tissue anchor with a microcarabiner having a funnel or guide to direct the suture thread into the gate of the microcarabiner.

FIG 31 shows a suture device with a microcarabiner having a funnel or guide to direct the suture thread into the gate of the microcarabiner.

FIG 32 shows the suture device of FIG 31 with the funnel guiding the suture thread into the gate of the microcarabiner.

FIG 33 shows the suture device of FIG 31 with the suture thread in the ring of the microcarabiner.

FIG 34 shows a cutaway front view of a delivery device for suture anchors.

FIG 35 shows a cutaway side view of the delivery device for suture anchors.

DESCRIPTION OF THE INVENTION

FIG 1 illustrates the peroral, transgastric surgical approach used in transgastric flexible endoscopy. In transgastric flexible endoscopy, which is also known as flexible transgastric peritoneoscopy, a flexible endoscope 102 is inserted through the patient's mouth and esophagus into the stomach. An incision 104 is made in the stomach wall to give the endoscope surgical access to the peritoneum and the organs within the abdomen. In a variation of the procedure, retroflexion of the flexible endoscope is used to redirect the endoscope in a caudal direction and an incision 106 is made in the superior wall of the stomach to give surgical access to the diaphragm and, by crossing through the diaphragm, to the organs within the mediastinum and thorax. FIG 2 shows a distal portion of an endoscopic suturing device 110 according to the present invention. The endoscopic suturing device 110 is particularly useful for closing incisions during endoscopic surgery, such as transgastric flexible endoscopy procedures.

The endoscopic suturing device 110 includes a hollow helical needle 112 carrying an elongated suture thread 114. The helical needle 112 may be tubular or it may be shaped like a channel or trough. A lumen 116 extends though the helical needle 112 for holding the elongated suture thread 114. Alternatively, the helical needle 112 may be solid, in which case the suture thread 114 would be carried external to the needle. Preferably, the helical needle 112 is configured with multiple turns of the helix for applying multiple running stitches with the suture thread 114. The helical needle 112 may be formed from tubing made of stainless steel, high-strength cobalt alloys, titanium or nickel-titanium alloys or other suitable metals. Optionally, the helical needle 112 may be made of a superelastic or shape-memory nickel-titanium alloy, in which case the needle can be straightened for passage through the endoscope working channel and will resume its helical shape only after it leaves the endoscope working channel. The helical needle 112 is continuous with or attached to a proximal shaft 118. The proximal shaft 118 may be solid, tubular or shaped like a channel or trough. The proximal shaft 118 has enough torsional rigidity to transmit rotation from the proximal end outside of the patient to the helical needle 112. In a particularly preferred embodiment shown in FIG 2, the proximal shaft 118 is a tubular member that is attached at its distal end to the proximal end of the tubular helical needle 112. Alternatively, the proximal shaft 118 may be a straight extension of the tubular helical needle 112. Optionally, all or a portion of the proximal shaft 118 may be constructed of a flexible multifilar, counter-wound torque-transmitting shaft attached to the helical needle 112. As another alternative, a straight tubular proximal shaft 118 can be attached to a flexible torque-transmitting intermediate shaft 144, which is in turn attached to the helical needle 112, as shown in FIG 3. During use, the flexible intermediate shaft 144 would be located at the flexible portion of the endoscope.

The suture thread 114 used with the device may be monofilament, braided or expanded polymer (e.g. ePTFE) suture thread, wire or any other material that can be used for suturing. Optionally, the suture thread 114 may be bioabsorbable. On the distal end of the suture thread 114 is a suture anchor 120. Preferably, the suture anchor 120 has a low-profile insertion position and an anchoring position. In one embodiment shown in FIGS 4A and 4B, the suture anchor 120 is configured with one or more resilient barbs 122 attached to the suture thread 114 near its distal end. The resilient barbs lie 122 along the body of the suture 114 during insertion, as shown in FIG 4A, and then expand to grasp the tissue when tension is applied to the suture 144, as shown in FIG 4B. Alternatively, the suture anchor 120 may be configured with wings 124 that bend, pivot or spring into the anchoring position in the manner of an expanding toggle bolt, an example of which is shown in FIGS 5A-5B. As another alternative, the suture anchor 120 may be configured as a bar pivotally attached at its middle to the suture thread 114 so that it lies along the body of the suture during insertion and then pivots to grasp the tissue when tension is applied to the suture.

Optionally, the distal end 126 of the helical needle 112 may be sharpened for penetrating the tissue, as shown in FIG 4 A. In addition, the distal end of the helical needle 112 may include a notch 128 or recess for holding the suture thread 114 and/or the suture anchor 120 away from the sharpened tip 126 of the needle. Alternatively, the distal end of the helical needle 112 may be blunt and the suture anchor 120 may be configured to include a piercing element 130, as shown in FIG 5 A. Optionally, the endoscopic suturing device 110 may include a mechanism to hold the suture anchor 120 onto the distal end of the helical needle 112 and to selectively or automatically release the suture anchor 120 during withdrawal of the needle. Preferably, the suture anchor 120 is configured so that the piercing element 130 is exposed only when the suture anchor 120 is in the insertion position and covered when the suture anchor 120 is in the anchoring position to prevent inadvertent damage to surrounding tissues, as shown in FIG 5B. The suture anchor 120 may be made of metal, plastic and/or a bioabsorbable material.

In one preferred embodiment, the endoscopic suturing device 110 includes a suction tube 132 with a closed distal end 134 and a suction lumen 136 connecting to side ports 138 on a distal portion of the suction tube 132 for approximating the tissue on both sides of the incision. A connector, such as a luer fitting, is attached at the proximal end of the suction tube 132 for connecting to a syringe or other suction source. Preferably, the suction tube 132 is inserted through the lumen 140 of the tubular proximal shaft 118 so that it is positioned coaxially with the helical needle 112 and is movable independently of the helical needle 112. Optionally, the distal portion of the suction tube 132 where the side ports 138 are located may be flattened somewhat to allow for closer approximation of the tissue.

The endoscopic suturing device 110 is configured to fit through the working channel of a flexible endoscope. Optionally, the endoscopic suturing device 110 includes an outer tube or sheath enclosing the suction tube 132 and the helical needle 112 to facilitate inserting and removing these components through the working channel of the endoscope as a single unit. Often it is necessary to place sutures at an angle to the longitudinal axis of the endoscope, which is difficult with many existing endoscopic suturing devices. FIG 3 shows an endoscopic suturing device being used to place a suture at a right angle to the endoscope. For this application, the endoscopic suturing device will include an elbow or angled tube 142 at the distal end of the outer tube. The angled tube 142 may be rigid or it may be a cable-controlled, flexible articulated tube so that the angle of the endoscopic suturing device can be changed as desired. Preferably, the proximal shaft 118 of the endoscopic suturing device will have a flexible portion 144 where it passes through the angled tube 142 so that rotation can be smoothly transmitted around the angle. In a preferred embodiment, the outer tube and the angled tube 142 will have sufficient torsional rigidity so that the endoscopic suturing device can be rotated in the desired direction from the proximal end, which is outside of the patient's body. For example, the outer tube can be constructed of braid-reinforced polymer tubing to provide the desired combination of flexibility and torsional stiffness.

FIGS 6A-6E illustrate the steps of applying a suture using the endoscopic suturing device. When it is time in a surgical procedure to close an incision or wound, the endoscopic suturing device, which has previously been loaded with a suture thread 114, is inserted through the working channel of the endoscope. Alternatively, an endoscopic suturing device can be built in or integrated into the distal end of an endoscope. The optional suction tube 132 may be advanced beyond the helical needle 112 and placed between the two sides of the incision, as shown in FIG 6 A. Using suction applied through the lumen of the suction tube 132, and/or with the help of endoscopic grasping instruments if necessary, the sides of the incision are approximated. The helical needle 112 is advanced to contact the tissue and rotated in the direction of helix to penetrate the tissue, as shown in FIG 6B. As the helical needle 112 rotates through the tissue in a helical path, it carries the suture thread 114 with it. The helical path may be entirely within the tissue or the helical needle 112 may pass in and out of the tissue with each rotation.

When the helical needle 112 has advanced as far as desired, the direction of rotation is reversed causing the helical needle 112 to back out along the same helical path, as shown in FIG 6C. The suture anchor 120 deploys to the anchoring position to anchor the distal end of the suture 114 to the tissue. Generally, the suction should be turned off and the suction tube 132 withdrawn from the incision at the time the direction of needle rotation is reversed. Optionally, the suction tube 132 may be withdrawn synchronously with the withdrawal of the helical needle 112. The suture thread 114 is allowed to play out from the distal end of the helical needle 112 along the helical path as the needle backs out. Optionally, a controlled amount of tension may be applied to the suture thread 114 to more closely approximate the tissue as the helical needle 112 backs out. Once the helical needle 112 has been entirely backed out of the tissue, a suture lock 146 is deployed on the suture thread 114 to hold the stitch in place, as shown in FIG 6D. Preferably, the suture lock 146 is prepositioned on a proximal portion of the suture thread 114 so that it is ready to be deployed when needed. Similar to the suture anchor 120, the suture lock 146 will preferably have a low-profile insertion position for passing through the endoscope and an expanded locking position for holding the suture thread 114 and distributing pressure over the surface area of the tissue. The suture lock 146 may be made of metal, plastic and/or a bioabsorbable material.

The suture lock 146 is snugged up against the tissue by applying tension on the suture thread 114 from the proximal end while pushing on the suture lock 146 with the distal end of the outer tube or with a separate suture lock pusher tube 148 slidably received within the outer tube. The stitch is completed by cutting the suture thread 114 proximal to the suture lock 146, as shown in FIG 6E. A suture cutting mechanism may be incorporated into the distal end of the pusher tube. Alternatively, a separate endoscopic suture cutting instrument may be used. If necessary, additional sutures may be placed by repeating these steps.

Adjunctive incision closure techniques may be used in combination with the endoscopic suturing device. For example, tissue adhesive may be applied to the incision prior to applying sutures. A separate catheter may be used to inject the tissue adhesive into the incision or a second lumen can be provided in the suction catheter for injecting the tissue adhesive. As another example, a durable or bioabsorbable seal plug (for example collagen foam) may be inserted into the incision prior to applying sutures to provide a better seal and/or to promote healing of the incision.

hi another aspect, the present invention provides a suture device having a microcarabiner 150 and an optional suture lock 152, as illustrated in FIGS 7-33. The suture device may take the form of a conventional suture thread or a zip-tie fastener. In an alternate configuration, the microcarabiner can be combined with a tissue anchor. One or more such tissue anchors can be used to form a running suture, purse string suture or other suture configurations.

A microcarabiner is a miniature gated ring component that is attached to the suture device and functions similar to a carabiner used in mountaineering. A carabiner is a gated connector: a metal ring with a usually sprung swinging gate designed as a connector that can quickly and reversibly join together components in safety-critical systems; for example, a common use is to attach a rope to a fixed anchor. Carabiners are widely used in sports requiring ropework, such as climbing, caving, canyoning, and sailing, and in industrial rope access work, such as construction or window cleaning. Some carabiners used in industry do not have a sprung swinging gate but have a screw shut gate that generally can only be opened and closed using a special tool.

Similar to a mountaineer's carabiner, the microcarabiner has a ring with a sprung gate that allows the ring to be fastened around an elongated body such as a suture device. Preferably, the microcarabiner is permanently attached to a proximal end of the suture device such that a loop can be formed by passing the body of the suture device through the sprung gate into the ring. The loop can be pulled tight and fastened in place with the suture lock. The suture lock can be a separate component or it can be incorporated into the microcarabiner and/or the suture device.

FIGS 7, 8 and 9 are schematic drawings showing the basic function of the microcarabiner 150. FIG 7 shows the microcarabiner 150 by itself; the ring 154 can be seen with the sprung gate 156 in the closed position. The ring 154 and the gate 156 can be formed from a polymer and/or a metal. The gate 156 is hinged to the ring 154 so that it can pivot inward. A spring member urges the gate into the closed position. For simplicity of construction, the functions of the hinge and the spring member may be performed by a living hinge 160 that connects the gate 156 to the ring 154 adjacent to the opening 162. FIG 8 shows the microcarabiner with the sprung gate 156 swinging open to allow a suture 164 to enter the ring 154 through the opening 162. FIG 9 shows the microcarabiner 150 with the sprung gate 156 closed to capture the suture 164 inside of the ring 154. The microcarabiner 150 allows a loop to be formed in a suture without having to thread the distal end of the suture through it.

FIG 10 shows a suture lock 152 that can be used with the suture device and microcarabiner 150. The suture lock 152 is in the form of a hollow cone 166 with a lumen 168 extending through it just large enough to accommodate the suture body 164. The cone has a slit 170 along one side. The slit 170 performs two functions. First, it allows the suture body 164 to be inserted into the lumen 168 through the side of the cone 166 without having to thread the distal end of the suture through it, as shown in FIG 11. Second, it allows the cone 166 to be compressed to lock the suture q64 in place when the cone 166 is pushed or pulled into the ring 154 of the microcarabiner 150, as shown in FIG 12.

FIG 13 shows another embodiment of a suture lock 152 that can be used with the suture device and microcarabiner 150. Similar to the embodiment of FIG 10, the suture lock 152 is in the form of a hollow cone 166 with a slit 170 along one side and a lumen 168 extending through it just large enough to accommodate the suture body 164. In addition, the cone 166 has ridges, barbs or steps 172 on the outside that act like ratchet teeth to lock the suture 164 in place when the cone 166 is pushed or pulled into the ring 154 of the raicrocarabiner 150, as shown in FIG 14.

FIGS 20-21 shows another embodiment of a suture lock 152 that can be used with the suture device and microcarabiner 150. This suture lock 152 has a two-part locking body 174, 176 that is hinged 178 at the middle. The two-part locking body 174, 176 hinges open to allow it to be placed around the suture body 164, as shown in FIG 20. The two-part locking body 174, 176 is closed around the suture body 164 and locks in place, as shown in FIG 21. Optionally, the two- part locking body 174, 176 may have a conically tapered distal portion 180 that interacts with the ring of the microcarabiner, similar to the embodiments of FIGS 10-12, so that tension on the suture loop tends to tighten the suture lock 152 even more securely.

FIG 15 shows an embodiment of a suture device 148 incorporating a microcarabiner. The suture device 148 has an elongated suture body 182, which may be a conventional suture material, such as monofilament, braided or expanded polymer (e.g. ePTFE) suture thread, or wire. Optionally, a needle 184 may be attached to the distal end 186 of the suture body. The microcarabiner 150 is attached at the proximal end 188 of the suture body 182.

In use, the distal end 186 of the suture body is threaded through or around the tissue to be sutured using a needle or the like. The body of the suture 182 is passed through the sprung gate into the ring of the microcarabiner 150 as shown in FIG 16, which can be conveniently done without releasing and regrasping the distal end of the suture. Next the loop 190 formed in the suture is pulled tight and a suture lock 152, such as those shown in FIGS 10-14 and 20-21, is applied to lock the suture device 148 in place. This step can also be conveniently done without releasing and regrasping the distal end of the suture. If desired, the excess length of the suture body 182 can be cut off.

FIG 17 shows another embodiment of a suture device 148 incorporating 'a microcarabiner. The suture device 148 is in the form of a zip-tie, which has an elongated suture body 192 having ridges, barbs or steps 194 on an outside surface that function as ratchet teeth. Optionally, a needle 184 may be attached to the distal end of the suture body 192. The microcarabiner 150 is attached at the proximal end 188 of the suture body 192. Preferably, the ring of the microcarabiner 150 is sized to act as an integrally formed suture lock by interacting with the ratchet teeth 194 on the suture body 192. In use, the distal end of the suture body 186 is threaded through or around the tissue to be sutured using a needle or the like. The body of the suture 192 is passed through the sprung gate into the ring of the microcarabiner 150 as shown in FIG 18, which can be conveniently done without releasing and regrasping the distal end of the suture. Next the loop 190 formed in the suture body 192 is pulled tight and the ring of the microcarabiner 150 interacts with the ratchet teeth 194 on the suture body 192 to lock the suture device in place. If desired, the excess length of the suture 192 body can be cut off.

FIG 19 shows an interrupted suture along an incision formed using multiple suture devices 148 of the type shown in FIGS 17-18.

In an alternate configuration, a microcarabiner can be combined with a tissue anchor. One or more such tissue anchors can be used to form a running suture, purse string suture or other suture configurations.

FIG 22 shows a simple tissue anchor 200 with a barb-like distal anchoring structure 196 and a microcarabiner 150 attached or integrally formed at the proximal end. The microcarabiner 150 may be fixed or it may swivel with respect to the tissue anchor 200. The tissue anchor 200 can be inserted into the tissue with a mechanical or pneumatic device.

FIG 23 shows a tissue anchor 200 with a corkscrew or auger-like distal anchoring structure 198 and a microcarabiner 150 attached or integrally formed at the proximal end. The microcarabiner 150 may be fixed or it may swivel with respect to the tissue anchor 200. The tissue anchor 200 can be screwed into the tissue manually or with a motorized insertion device.

FIG 24 shows how multiple tissue anchors 200 can be placed along the two sides of an incision and joined together with a running suture 164 through the rings of the microcarabiners 150. A suture lock 152 may be used after the last tissue anchor to secure the running suture.

FIG 25 shows how multiple tissue anchors 200 can be placed around an incision or other opening and joined together with a suture 164 through the rings of the microcarabiners to form a purse string suture 164. A suture lock 152 may be used after the last tissue anchor to secure the purse string suture. Optionally, a purse string suture can be placed before making the incision in the tissue. The suture devices of FIGS 24 and 25 may optionally be configured to use only one tissue anchor 200 with a microcarabiner 150 in the first or last position. The remainder of the tissue anchors 200 may have solid, non-gated rings that are prethreaded onto the suture thread 164. The prethreaded tissue anchors can be stacked in a catheter or in the working channel of an endoscope and a device that uses mechanical or pneumatic force or a rotation mechanism can be used to drive the anchors into the tissue wall.

FIG 26 shows an embodiment of a microcarabiner 150 with a double gate 156, 156. FIG 27 shows the microcarabiner of FIG 26 with the double gate 156, 156 beginning to pivot inward to open. The double gate provides a wider opening for the suture thread to enter the ring of the microcarabiner. It also serves as a guide to center the suture thread so that it passes more easily through the opening of the microcarabiner.

FIG 28 shows a tissue anchor 200 with an expanding distal anchoring mechanism 202 and a microcarabiner 150 at the proximal end. The anchoring mechanism 202 has a pair of barbs 204 that pivot or flex to allow the tissue anchor to easily penetrate the tissue wall. Once the tissue anchor 200 has penetrated the tissue wall, the barbs 204 expand outward to securely anchor the device in the tissue. FIG 29 shows the tissue anchor of FIG 28 with the distal anchoring mechanism 202 in the expanded position.

FIG 30 shows a tissue anchor 200 with a microcarabiner 150 having a funnel or guide 206 to direct the suture thread into the gates 156, 156 of the microcarabiner 150. The funnel or guide 206 facilitates the operation of the tissue anchor device by guiding the suture thread into the gates 156, 156 of the microcarabiner 150.

FIG 31 shows a suture device 148 with a microcarabiner 150 having a funnel or guide to direct the suture thread into the gates 156, 156 of the microcarabiner. Similar to the embodiment of FIG 30, the funnel or guide facilitates the operation of the tissue anchor device by guiding the suture thread into the gates 156, 156 of the microcarabiner 150. FIG 32 shows the suture device 148 of FIG 31 with the funnel 206 guiding the suture thread 164 into the gates 156, 156 of the microcarabiner 150. FIG 33 shows the suture device of FIG 31 with the suture thread 164 in the ring of the microcarabiner 150.

If desired, any of the components of the invention, including the suture device, the microcarabiner, the suture lock and/or the tissue anchors can optionally be made of a bioabsorbable material, such as a bioabsorbable polymer or metal. FIG 34 shows a cutaway front view of a delivery device for suture anchors 200, such as those shown in FIGS 22 and 23. FIG 35 shows a cutaway side view of the suture anchor delivery device. The delivery device can be configured as a small diameter tubular catheter 210 that can be delivered, for example, through the working channel of a flexible endoscope. In a preferred embodiment, several suture anchors 200 will be stacked in the tubular catheter 210. Optionally, the tubular catheter 210 may have a flattened or oval cross section to hold the suture anchors 200 aligned within the delivery device. Preferably, a suture thread 164 will be prethreaded through the rings or microcarabiners 150 of the suture anchors 200 so that insertion of the suture anchors 200 into the tissue on different sides of the incision will bring the suture thread 164 with it at the same time. Optionally, a suture lock 152 may also be prethreaded onto the suture thread 164.

Preferably, the delivery device will include a mechanism for advancing and inserting the suture anchors 200 one at a time. By way of example, FIGS 34 and 35 show a push rod 212 within the tubular catheter 210 for advancing the suture anchors 200 toward the distal end of the device. A series of notches 214 in the push rod 212 interact with a detent 216 so that the suture anchors 200 can be advanced incrementally one at a time. Depending on the configuration of the suture anchors 200 used, the tubular catheter 210 will be constructed to deliver the pushing force (for anchors that are inserted by pushing) and/or the required rotation (if the insertion is done through rotation) for insertion of the suture anchors 200 into the tissue.

Alternatively, the suture anchors 200 may be loaded into the delivery device without prethreading them onto the suture thread 164. In this case, the suture anchors 200 will be inserted into the tissue using the delivery device, and then the suture thread 164 will be laced through the microcarabiners 150 on the suture anchors 200 and pulled tight to complete the suture stitch. A suture lock 152 or a knot may be used to secure the suture thread 164.

While the present invention has been described herein with respect to the exemplary embodiments and the best mode for practicing the invention, it will be apparent to one of ordinary skill in the art that many modifications, improvements and subcombinations of the various embodiments, adaptations and variations can be made to the invention without departing from the spirit and scope thereof.

Claims

What is claimed is:
1. A suturing device, comprising: a hollow helical needle having a proximal end and a distal end, and a lumen extending though at least a portion of the helical needle; a tissue piercing element located adjacent the distal end of the helical needle; a suture thread positioned within the lumen of the helical needle; and a suture anchor located adjacent a distal end of the suture thread.
2. The suturing device of claim 1 , further comprising: a suture lock positionable along a proximal portion of the suture thread.
3. The suturing device of claim 1, wherein: the tissue piercing element is attached to the distal end of the helical needle.
4. The suturing device of claim 1, wherein: the tissue piercing element is attached to the suture anchor.
5. The suturing device of claim 1, wherein: the helical needle is configured with multiple turns of a helix.
6. The suturing device of claim 1, wherein: the proximal end of the helical needle is connected to a proximal shaft configured to transfer rotary motion to the helical needle.
7. The suturing device of claim 6, wherein: at least of a portion of the proximal shaft is flexible.
8. The suturing device of claim 7, further comprising: an angled tube position around the flexible portion of the proximal shaft.
9. The suturing device of claim 1, further comprising: a hollow suction tube positionable concentrically with the helical needle, the suction tube having at least one suction port connected to a suction lumen within the suction tube.
10. The suturing device of claim 1, wherein: the suture anchor has a low-profile insertion position and an expanded anchoring position.
11. The suturing device of claim 1, wherein: the helical needle has a straight insertion configuration and a helical deployed configuration.
12. The suturing device of claim 11, wherein: the helical needle is constructed of a superelastic metal.
13. The suturing device of claim 11 , wherein: the helical needle is constructed of a shape-memory material.
14. A method of suturing tissue, comprising: providing a suturing device comprising a hollow helical needle having a proximal end and a distal end, and a lumen extending though at least a portion of the helical needle, a tissue piercing element located adjacent the distal end of the helical needle, a suture thread positioned within the lumen of the helical needle, and a suture anchor located adjacent a distal end of the suture thread; piercing the tissue with the tissue piercing element; rotating the helical needle to advance the helical needle through the tissue; reversing the rotation of the helical needle to withdraw the helical needle through the tissue, and allowing the suture anchor and the suture thread to remain in the tissue as the helical needle is withdrawn.
15. The method of suturing tissue of claim 14, further comprising: expanding the suture anchor within the tissue to anchor the suture thread to the tissue.
16. The method of suturing tissue of claim 14, further comprising: attaching a suture lock to the suture thread.
17. A microcarabiner suture device comprising: a ring structure having an opening in the ring; a gate across the opening in the ring, the gate configured to open inward toward a center of the ring to allow a suture thread to enter the ring through the opening.
18. The microcarabiner suture device of claim 17, wherein: the gate is biased toward a closed position to retain the suture thread within the ring structure.
19. The microcarabiner suture device of claim 17, further comprising: a tissue anchor attached to the ring structure.
20. The microcarabiner suture device of claim 19, wherein: the tissue anchor has a low-profile insertion position and an expanded anchoring position.
21. The microcarabiner suture device of claim 19, wherein: the tissue anchor has at least one barb for securing the microcarabiner suture device into tissue.
22. The microcarabiner suture device of claim 19, wherein: the tissue anchor includes a helical screw for securing the microcarabiner suture device into tissue.
23. The microcarabiner suture device of claim 17, further comprising: a suture thread attached to the ring structure.
24. The microcarabiner suture device of claim 23, further comprising: a suture lock positionable along a proximal portion of the suture thread.
25. The microcarabiner suture device of claim 17, further comprising: a guide for directing a suture thread into the opening in the ring structure.
26. A suturing device, comprising: a tubular delivery device; a plurality of tissue anchors positioned within the tubular delivery device, each of the tissue anchors comprising a tissue piercing element, at least one of the tissue anchors comprising a microcarabiner having a ring structure with an opening in the ring, a gate across the opening in the ring, the gate configured to open inward toward a center of the ring to allow a suture thread to enter the ring through the opening.
27. The suturing device of claim 26, further comprising: a suture thread prethreaded through a ring structure on each of the tissue anchors positioned within the tubular delivery device.
28. The suturing device of claim 27, further comprising: a suture lock positioned within the tubular delivery device and prethreaded onto the suture thread.
29. A method of suturing tissue, comprising: providing a microcarabiner suture device having a ring structure with an opening in the ring, a gate across the opening in the ring, the gate configured to open inward toward a center of the ring to allow a suture thread to enter the ring through the opening; passing a suture thread through the opening into the ring of the microcarabiner suture device.
30. The method of suturing tissue of claim 29, further comprising: anchoring the microcarabiner suture device to the tissue.
31. The method of suturing tissue of claim 29, wherein: an end of the suture thread is attached to the microcarabiner suture device and the suture thread is passed around or through the tissue prior to passing the suture thread through the opening into the ring of the microcarabiner suture device.
PCT/US2007/004527 2006-02-18 2007-02-20 Endoscopic suturing devices WO2007098212A3 (en)

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