|Publication number||US20050165419 A1|
|Application number||US 11/085,703|
|Publication date||Jul 28, 2005|
|Filing date||Mar 21, 2005|
|Priority date||Feb 2, 2001|
|Also published as||EP1408809A2, EP1408809A4, US6997931, US20020107530, US20100331623, WO2002062200A2, WO2002062200A3, WO2002062200B1|
|Publication number||085703, 11085703, US 2005/0165419 A1, US 2005/165419 A1, US 20050165419 A1, US 20050165419A1, US 2005165419 A1, US 2005165419A1, US-A1-20050165419, US-A1-2005165419, US2005/0165419A1, US2005/165419A1, US20050165419 A1, US20050165419A1, US2005165419 A1, US2005165419A1|
|Inventors||Jude Sauer, Michael Fitzsimmons, Mark Bovard|
|Original Assignee||Sauer Jude S., Fitzsimmons Michael W., Bovard Mark A.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (28), Referenced by (151), Classifications (13)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present invention relates to a system (and method) for endoscopic suturing, and in particular to a system for suturing through an accessory tube coupled to a flexible endoscope, which may be placed in the stomach through mouth and the esophagus of a patient utilizing a tissue suturing instrument and a suture securing instrument. The invention is suitable, for example, for applying at least one suture in the soft tissue lining of the stomach for different procedures such as gastroplasty, fundoplication, anterior gastropexy, or other procedures requiring suturing in the stomach, without the need for laparotomy or laparoscopy.
Application of sutures in the gastrointestinal tract is required for several different types of medical procedures, for example, transoral endoscopic valvuloplasty for gastroesophageal reflux disease, gastroplasty, fundoplication, anterior gastropexy, suturing esophageal perforations, or closure of esophageal side of tracheo-esophageal fistula. Traditionally, these procedures were performed by physicians, such as gastroenterologist or surgeons, either by laparoscopy or open surgical techniques. Such procedures are invasive, as laparoscopy requires small access incision(s) made in the body of the patient through which a laparoscope and other surgical enabling tools are provided, while open surgical techniques are traditionally invasive and can have complications and long patient recovery periods.
The solution to these problems is to perform these medical procedures through the gastroesophageal tract via the mouth or other naturally occurring orifices. Already available flexible endoscopes, commonly called gastroscopes, can be provided through the gastroesophageal tract and enable illumination and visualization of tissue along the gastroesophageal tract on a video display for diagnostic purposes. Although gastroscopes often have a working channel to a port at the distal end of the gastroscope through which a biopsy tool may be provided to obtain tissue samples, they are not currently designed or typically large enough to be capable of applying sutures in tissue.
U.S. Pat. No. 5,792,153 describes a sewing device coupled to the distal end of an endoscope, which enables suturing in the gastroesophageal tract of a patient. The sewing device has a single hollow needle mounted in the biopsy channel of the endoscope, and a wire extending through the needle to a T-shaped tag having one end of a suture thread which extends outside of the patient. To apply a suture, suction is applied to a U-shaped opening of the sewing device via another channel of the endoscope to suck a layer (or fold) of tissue into the U-shaped opening, the needle in the biopsy channel is then pushed through the tissue, and then the wire is pushed and rotated to position the tag in a chamber along one side of the U-shaped opening. This rotates the tag into a position which captures the tag and the suture end in this chamber, and the needle and wire are retracted to the other side of the U-shaped opening. The endoscope and its coupled sewing device are removed from the patient, leaving a loop of suture through the tissue which must then be secured and closed. The patent also provides another sewing device at the end of an endoscope which enables multiple stitches in tissue with the same needle and suture thread. The sewing device of U.S. Pat. No. 5,792,153 to apply a single stitch is manufactured by Laboratories BARD S.A. of Voisinsle Bretonneux, France, and described in Kadirkamanathan et al., Gastrointestinal Endoscopy, August 1996, Vol. 44, No. 2, pp. 144-162.
Once the suture thread is placed through the tissue with the sewing device of U.S. Pat. No. 5,792,153, the suture thread must be secured and then cut close to the tissue. One device also manufactured by Laboratories BARD S.A., and described in U.S. Pat. No. 5,755,730, provides for securing and cutting suture using an endoscope. The device passes through the biopsy channel of the endoscope is order to push a knot made by a physician or surgeon, which ties the ends of a loop of suture thread together, down to the tissue, and then a cutting member cut the ends of the suture. Since the sewing device of U.S. Pat. No. 5,792,153 does not allow normal use of its biopsy channel of the endoscope upon which the sewing device is mounted, a second endoscope must be used to secure and cut the suture through its biopsy channel using the device described in U.S. Pat. No. 5,755,730. This results in multiple passes of endoscopes back and forth through the gastroesophageal tract, especially if single sutures are each applied and secured at multiple locations in tissue. To reduce possible damage to the esophageal tract and to facilitate multiple instrument insertions, an overtube is first placed in the esophageal tract and each endoscope is inserted and removed through the overtube. However, the overtube may be uncomfortable to patients, and can cause complications, such as mucosal tears in the esophagus. Accordingly, it would be desirable to provide a system for suturing which does not require different endoscopes for suture placement and suture securing, and moreover can apply and secure multiple single sutures in tissue with the single insertion of a flexible endoscope, i.e., gastroscope without requiring an overtube.
Other sewing devices or machines mounted on the end of an endoscope are described in U.S. Pat. Nos. 5,037,021 and 4,841,888. These sewing devices similarly utilize two channels of the endoscope, one to suction tissue into a slot of the device and the other to advance and retract a wire coupled to needle through the tissue. The needle has a suture loop at its tip such that when the needle is advanced through the slot it extends into a chamber where a hook or U-shaped member pivots to retain the suture loop when the needle retracts. A wire is coupled to the hook and extends through the same channel where suction is provided, such that movement of this wire pivot the hook to capture the suture thread. Removal of the sewing device then leaves a loop of suture through the tissue.
A further sewing device is described in U.S. Pat. No. 5,080,663 and also utilizes an operating device having tubes in a tubular sheath, such as endoscopic means, to provide suction to a slot in the device to capture a double fold of tissue and two wires extending through such tubes. One wire advances and retracts a needle having a tag with suture at its tip through tissue and the other wire controls capture of a tag at the other side of the opening. The patent provides for applying a sensor or transmitter in the body of a patient, such as the stomach. This sewing device is also described in Swaine et al., An endoscopically deliverable tissue-transfixing device for securing biosensors in the gastrointestinal tract, Gastrointestinal Endoscopy, November/December 1994, Vol. 40, No. 6, pp. 730-737.
Like the sewing devices of U.S. Pat. No. 5,792,153, those described in U.S. Pat. Nos. 5,037,021 4,841,888, and 5,080,663 have the same drawbacks as these devices are also mounted on an endoscope. Moreover, mounting on an endoscope limits the use of the endoscope for full visualization of tissue, as the sewing device partially obstructs the viewing area at the distal end of the endoscope. Further the use of the biopsy or working channel of an endoscope for needle placement does not allow use of the channel for other purposes, such as obtaining a biopsy. Accordingly, it would further be desirable to provide for suturing with a flexible endoscope which allows for more complete traditional use of the endoscope.
Accordingly, it is the principal object of the present invention to provide an improved system for endoscopic suturing that overcomes the drawbacks of the prior art.
It is another object of the present invention to provide an improved system for endoscopic suturing which allows single insertion of an endoscope and accessory tube assembly in the gastrointestinal tract of a patient through which multiple instruments for suturing and securing sutures can be used without removal of the endoscope between suturing and suture securing operations.
It is a further object of the present invention to provide an improved system for endoscopic suturing which provides a channel to sew through independent of an endoscope.
Yet a further object of the present invention is to provide an improved system for endoscopic suturing in which a suturing instrument separate from an endoscope can utilize suction to capture tissue to be sutured.
A still further object of the present invention is to provide an improved system for remote suturing in which can readily adapted to different types of flexible endoscopes to provide an external accessory tube through which medical or surgical instruments can pass.
A still further object of the present invention is to provide an improved system for endoscopic suturing which utilizes one or more instruments which each have a sufficient flexible shaft to pass through an external flexible accessory tube attached to a flexible endoscope.
A further object of the present invention is to provide an improved system for endoscopic suturing using instruments having shafts with enhanced flexibility.
And a still further object of the present invention is to provide an improved system for endoscopic suturing using flexible instruments with mechanical or hydraulic steerability.
Yet a further object of the present invention is to provide an improved system for endoscopic suturing in which remote viewing with an endoscope of suture and suture securing operations is provided in the stomach without hindering endoscope functionality.
Briefly described, a preferred embodiment of this system embodying the invention includes an endoscope, such as a gastroscope, having a distal end locatable in the body of a patient, such as in the gastrointestinal or gastroesophageal tract, and a flexible shaft extending to the distal end, a flexible accessory tube coupled to the endoscope to be movable relative to the endoscope's shaft, and an attachment tip coupled to the shaft of the endoscope having an opening through which one end of the accessory tube is received. The accessory tube is coupled to the shaft of the endoscope with multiple tube guides enabling the accessory tube to slide through the tube guides in response to bending of the endoscope's shaft. The accessory tube has a cannula through which an instrument may pass in the accessory tube. The system includes a tissue suturing instrument having a partially flexible shaft locatable through the accessory tube, and a tissue engaging end coupled to the shaft which is viewable by the endoscope at its distal end when the instrument is fully inserted through the accessory tube. The tissue engaging end has a vacuum sleeve enabling suction to be selectably applied at the tissue engaging end to capture tissue in a gap of a sew tip through an opening in the vacuum sleeve. Suction is applied via a vacuum connection assembly to a channel which extends down the shaft to the sew tip. A valve is provided to close one end of the suture carrying channel to enable such suction at the sew tip. Two needles are provided which extends through the shaft of the suturing instrument. Each needle is separately actuated into the gap of the sew tip through suctioned tissue to capture a ferrule having one end of a loop of suture. The system further includes a suture securing instrument having a partially flexible shaft locatable through the accessory tube, and a distal end coupled to the shaft which is viewable by the endoscope at its distal end when the instrument is fully inserted through the accessory tube. After removal of the suturing instrument from the accessory tube, a loop of suture extends through the tissue through the accessory tube, the suture securing instrument receives the free ends of the loop of suture at its distal end through a sleeve member, and the suture securing instrument is then inserted through the accessory tube to the location of the suture in the tissue. The suture securing instrument crimps the sleeve member and cuts the free ends of the suture to retain the suture closed. The endoscope enable an operator, such as a surgeon, gastroenterologist, or other skilled physician, to view the engaging end of the suturing instrument for selecting placement of the suture through tissue, and of the distal end of the suture securing instrument to secure the suture closed.
The suturing instrument in the system may further include a mechanism for steering the tissue engaging end of the instrument independent of steerability of the flexible endoscope.
A method embodying the present invention is also provided having the steps of: locating an endoscope, such as a gastroscope, coupled to an accessory tube through the gastrointestinal or gastroesophageal tract of a patient; inserting a suturing instrument through the accessory tube to place two ends of a loop of suture through tissue of the gastrointestinal or gastroesophageal tract; removing the suturing instrument to leave a loop of suture in the tissue having two free ends extending from the accessory tube; inserting a suture securing instrument having a distal end with a sleeve member through which the free ends of the suture loop are drawn to the suture in the tissue to crimp the sleeve member and cut the free ends of the suture; and removing the suture securing instrument from the accessory tube.
Optionally, the suturing instrument and suture securing instrument may be used without the accessory tube when an internal working of biopsy channel is provided in the endoscope that permits the passage of the shaft of the suturing instrument and suture securing instrument, respectively.
The following description referring to the endoscope as a gastroscope for purposes of illustration. Other types of endoscopes may be used in the system and method.
The foregoing objects, features and advantages of the invention will become more apparent from a reading of the following description in connection with the accompanying drawings, in which:
Multiple tube guides 22 couple tubing 18 to shaft 14 a of gastroscope 14. Each tube guide 22 has an opening 22 a extending through the tube guide and a curved surface 22 b along its length which abuts the outer curved surface of shaft 14 a, as shown in
At the distal end of accessory tube 12 is an attachment tip 26 having two openings 26 a and 26 b to receive one end of tubing 18, and the distal end 14 b of gastroscope 14, respectively. Attachment tip 26 is shown in more detail in
Cannula 20 may be a typical type of cannula providing a sealable passage to tubing 18. For purposes of illustration, cannula 20 is shown in
The assembly of the gastroscope 14 and accessory tube 12 when in the gastrointestinal or gastroesophageal tract of a patient provides the feature of enabling instruments, such as the suturing instrument, and the later to be described suture securing instrument, to be insertable and retractable about the distal end of the gastroscope, without requiring removal of the gastroscope. Further, normal functionality of the gastroscope in viewing is provided without any partial obstruction or loss of use of the working channel 28 d. An illustration of the system 10 in a patient's body is shown in
The housing 30 has a body shaped like a pistol having a handle portion 30 a, and may be made of a two-piece construction of molded plastic. A pair of needles 34 and 35 extends from housing 30 through the shaft 16 b into the tissue engaging end 16 a. Each needle 34 and 35 has a non-tissue engaging end in the housing having a spherical member 34 a and 35 a, such as a ball or bearing, respectively, attached thereto. Both needles 34 and 35 and spherical members 34 a and 35 a may be a made of metal, such as surgical stainless steel. The spherical member 34 a and 35 a may have a bore into which the non-tissue engaging ends of the needles 34 and 35, respectively, extend and joined thereto, such as by welding or brazing.
The suturing instrument 16 includes an actuator member 36 representing a lever having two pins 36 a extending into holes in the sides of housing 30 upon which the actuator member is pivotally mounted in the housing. Actuator member 36 has a portion which extends through an opening 30 b (
A retainer member 42 is fixed in housing 30 by two flanges 42 a above actuator member 36. As best shown in
To select which of the needles 34 and 35 is to be driven by actuator member 36, the instrument 16 has a needle selection mechanism having a selector lever (or arm) 44 which is rotationally coupled with a cam member 46. The cam member 46 and selector lever 44 is supported by an adapter 48 in housing 30. Adapter 48 is mounted in housing 30 by two flanges 48 a. The selector lever 44 is pivotally mounted by a pin 48 c extending upwards from adapter 48 at a hole 44 a through the lever. Selector lever 44 extends through an opening 30 c in housing 30 and has a downwardly protruding member 44 b which is received in a notch 46 a of cam member 46 to rotate cam member 46 in a pocket 48 b in the adapter 48 as the selector lever 44 is moved left or right. The cam member 46 may have a tapered surface 46 b to facilitate its rotation in pocket 48 b and two tapered apertures 46 c through which needles 34 and 35 respectively extend, as shown in
The needle selector 44 may further have another downwardly protruding member 44 c which rides in a slot 42 g on the upper surface of retainer member 42. The slot 42 g is contoured to have angled lower regions on either side of a raised region into which member 44 c can be located to releasably lock to retain the position of lever 44 left or right.
The adapter 48 has a bore extending there through in which a needle spreader 50 is located. Needle spreader 50 has two channels 50 b and 50 c into which needles 34 and 35 are respectively located to increase the distance between the needles 34 and 35 as they extend toward cam member 46, such that the needles are properly aligned to apertures 46 b in the cam member.
A suture routing tube 47 is provided for suture thread in housing 30. Suture routing tube 47 has one end received in a valve assembly 19, described later below, at the bottom of handle 30 a of housing 30 and then extends through notches 30 d (
A longitudinal guide member 53 is provided multiple tracks along its length, including two needle tracks 53 a and 53 b for needles 34 and 35, respectively, and a suture track 53 c for suture thread extending from opening 51 a of gasket member 51. A cross-sectional view of shaft 16 b through guide member 53 is shown in
At the other end 52 b of rigid tube 52, a coupler member 56 is mounted in which two tabs 56 a are received in two tracks 53 d along two opposing sides of guide member 53. Coupler member 56 joins the non-flexible section 32 of the shaft 16 b provided by rigid tube 52 with the flexible section 33 of the shaft 16 b (
The connection of coupler member 56, guide member 58 and a sew tip 98 of the tissue engaging end 16 a is best illustrated in
The vacuum connection assembly 64 is placed on rigid tube 52 so that the tube extends through openings 66 a and 68 a, O-rings 70 and 71, and chamber 66 b, and an opening 52 c in the rigid tube lies in chamber 66 b and faces bore 75 of the fitting member. The diameter of apertures 66 a and 68 b are slightly larger than the outer diameter of rigid tube 52 about opening 52 c. O-rings 70 and 71 engage the outer surface of rigid tube 52 to seal chamber 66 b, but for bore 75 and opening 52 c to suture track 53 c (
A valve 19 is provided at the bottom of handle 30 a, as shown in
As shown in
Other types of valve 19 may alternatively be used, such as shown in
A vacuum sleeve 106 is provided having a tube 106 a, and a rounded cap 106 b which closes one end of tube 106. The cap 106 b has an edge 106 c which mates with the edge 106 d of tube 106 a and two extending flanges 110 which are received in tube 106 a to hold the cap in place (
The tissue engaging end of suturing instrument 16 may be as described in U.S. patent application Ser. No. 09/686,420, filed Oct. 11, 2000, which is herein incorporated by reference. This Patent Application describes the loading of a length of suture material, i.e., thread, whose ends are affixed to ferrules in the sew tip 98. Before such loading, the vacuum sleeve 106 is removed from tube tip 102 by pushing in fingers 103 to release them from openings 111 and then simultaneously pulling the vacuum sleeve 106 away from tube tip 102. After loading, the vacuum sleeve 106 is replaced and latched back (i.e., fingers 103 in openings 111) onto the tube tip 102 and the loop of suture extends from the ferrules through the suture tracks 53 a and 58 a of guide members 53 and 58 to suture routing tube 47, via track 56 b of the coupler member 56 and opening 51 a of the gasket member 51, out holes 76 and 76 a of valve 19. Proper orientation of the vacuum sleeve 106 over tube tip 102 and sew tip 98 is provided by flanges 111 of cap 106 b, as described earlier, and also by ramp 112 being angled such that it prevents upside down misalignment of the vacuum sleeve over the sew tip. The forward section 98 g of the sew tip will be stopped by ramp 112 before fingers 103 reach to the tube tip openings 111, preventing the vacuum sleeve 106 from latching. For example, the suture material may represent monofilament suture material or braided suture material.
Alternatively, the suturing instrument may operate to apply a suture without suction if the target area of tissue can be sufficiently received in gap 104 of the sew tip 98. For example, the target area may represent a raised portion of tissue to be sutured. Further, the suturing instrument operating without section, may be used with the vacuum sleeve 106 removed from the tissue engaging end 16 a, such as shown for example in
After two ends of the suture have been placed through the tissue, as illustrated in
Another adapter 156 is provided which has flanges 156 a received in the two sides of housing 132. A rigid tube 158 having an end 158 a which is D-shaped is registered into a corresponding shaped opening in adapter 156, and a threaded nut 160 having an opening which extends over mounting tube 158 and screws onto the end of the adapter 156 to secure tube 158 to adapter 156. Rigid tube 158 extends from housing 132 via an opening 130 d in the housing. The assembly of components 142, 146, 148, 150, 152, and 154 described above are received in the adapter 156 and through rigid tube 158, as shown in
The assembly of the distal end 136 is best shown in
A chamber 173 is provided in the hammer and anvil section into which a securing sleeve member 174 (
Before attachment of the distal end 136 to extension tube 164 through which drive wire 154 extends, tube 164 is passes through a flexible plastic tubing 178, such as of Tygon. This tubing 178 extends from end 158 b of rigid tube 158, until distal end 136 when mounted to extension tube 164. The diameter of tubing 178 is substantially matched to the outside diameter of tube 158 and tip tube 166. A shrink wrap layer 180 is applied on the entire length of shaft 134 of instrument 130 until distal end 136.
The entire length of the instrument 130 is such that it can extend through accessory tube 12 in which its shaft 134 has a non-flexible section 134 a defined by the extend of rigid tube 158, and a flexible section defined by the extent of extension tube 164 in tubing 178. For example, the shaft 134 may be 31.5 inches in length, where its non-flexible section 134 a is 12.0 inches in length, and the flexible section 134 b is 19.5 inches in length.
Although the suturing instrument 16 and suture securing instrument 130 are described for use with gastroscope 14, instruments 16 and 130 may be used separately from the gastroscope 14 and accessory tube 12. Further, suturing instrument 16 and suture securing instrument 130 may pass through an internal channel 28 d (
Needle assembly 203 for each of needles 34 and 35 extends through a multi-lumen tube 210 which is attached at end 210 a to coupler member 36 by tabs 56 f being received in corresponding pockets 212 at end 210 a, and is attached to sew tip 98 by tabs 100 of sew tip 98 in pocket 214 at end 210 b. For purposes of illustration, needles are not shown in
The operation of suturing instrument 16 in this embodiment is the same as described earlier, except that when actuator member 36 of instrument 16 is pulled by an operator for needle 34 or 35, forward movement is translated to needle 208 via needle driver 204 and spring 207, which compresses to assist in pushing forward needle 208 in sew tip 98. When actuator member 36 is retracted, the cable 206 and spring 207 assist in pulling needle 208 back.
Alternatively in this embodiment, the multi-lumen tube 210 may be replaced by needle carrying tubes 220 and suture supply tube 222. The needle assembly 203 for each of needles 34 and 35 extends through tubes 220, respectively, as shown in
In operation, when the tissue engaging end 16 a of the instrument 16 passes through accessory tube 12 and through the attachment tip 26, the distal end 14 a of the gastroscope 14 can view the vacuum sleeve, and partially the sew tip therein, prior to engagement of protrusion members 226 in a pair of opposing slots 228. The operator then can precisely locate the position of gap 104 of the sew tip with respect to a tissue target area 121 (
As shown in
Rod 258 has at its end 258 a a hole 258 b into which a flexure member 260 is attached, such as by welding or crimping. Flexure member 260 extends into a hole in one end of tabs 100 of sew tip 98, and is attached thereto by welding or crimping. Flexure coupler 260 allows for possible misalignment between rod 258 and tab 100 of the sew tip 98. Cylinder 256 is fixed in place in one of tracks 58 d, such as by frictionally engagement when shrink wrap tubing 62 is applied over guide member 58, or may be bonded by adhesive. For example, the components of cylinder 256 may be made of stainless steel, except piston 256 c which may be made of rubber.
To steer the sew tip, an operator of the suturing instrument 16 turns the thumb wheel 248 changing the volume of fluid 245 in chamber 240, and moving the fluid into or out of outlet 248 and tube 250. In response, the volume of fluid 245 in chamber 256 c of cylinder 256 changes, and piston 256 c and rod 258 moves in cylinder 238 causing the rod to extend or retract to flex tissue engaging end 16 a, via flexure coupler 260. For purposes of illustration, arrows 239 indicate flexure of the tissue engaging end 16 a of instrument 16. Fluid 245 may be, for example, water. This provide for a hydraulic steering mechanic which an operator of the instrument 16 can use to provide additional control in positioning the tissue engaging end during suturing, such positioning being independent of other steerability of the tissue engaging as may be provided by flexure of gastroscope's shaft 14 b.
Alternatively, cylinder 256 may be replaced by a folding piston 262, as shown in
Folding piston 262 can be manufactured with a process using thin walled transparent or white heat shrink plastic tube 270 made from a non-elastic plastic, like polyester.
In a further alternative, a wire 263 may replace tube 250, such that a mechanical steering mechanism is provided. As shown in
From the foregoing description, it will be apparent that there has been provided an improved system and method for endoscopic suturing. Variations and modifications in the herein described system and method in accordance with the invention will undoubtedly suggest themselves to those skilled in the art. For example, the entire shaft 16 b or 134 of instruments 16 or 130, respectively, maybe flexible along their length. Accordingly, the foregoing description should be taken as illustrative and not in a limiting sense.
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|International Classification||A61B17/04, A61B17/30|
|Cooperative Classification||A61B17/0467, A61B1/018, A61B2017/0496, A61B2017/00296, A61B17/0482, A61B1/0014, A61B2017/306, A61B17/0469|
|European Classification||A61B1/00H8, A61B17/04E|