US20100211082A1 - Medical instrument to place a pursestring suture, open a hole and pass a guidewire - Google Patents
Medical instrument to place a pursestring suture, open a hole and pass a guidewire Download PDFInfo
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- US20100211082A1 US20100211082A1 US12/766,967 US76696710A US2010211082A1 US 20100211082 A1 US20100211082 A1 US 20100211082A1 US 76696710 A US76696710 A US 76696710A US 2010211082 A1 US2010211082 A1 US 2010211082A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00278—Transorgan operations, e.g. transgastric
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/00663—Type of implements the implement being a suture
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00862—Material properties elastic or resilient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1142—Purse-string sutures
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B2017/2901—Details of shaft
- A61B2017/2905—Details of shaft flexible
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
- A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
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Abstract
A therapeutic instrument for the ergonomic, effective and safe opening and closing of targeted remote tissue sites; includes a pistol grip style handle with a hand activated lever for needle deployment and, optionally, with features to control tissue cutting and guide wire installation; also incorporates a specialized elongated rigid or flexible instrument shaft, which enables vacuum assisted holding of tissue at a uniquely contoured distal tip, where placement of a suture in a purse string configures occurs along with, if desired, tissue cutting and guide wire passage.
Description
- This application is a divisional of U.S. application Ser. No. 11/411,626, filed Apr. 26, 2006.
- None.
- None.
- None.
- 1. Field of the Invention
- This invention relates generally to a medical device for placement of a purse string suture in tissue and more particularly to such a device that can also cut tissue and enable placement of a guide wire through the cut opening. More particularly, this invention relates to a method and apparatus in which living tissue is positioned using vacuum within a contoured opening located near the end of the device, which also provides for the simultaneous passage of two needles through multiple points in the held tissue. After traversing the tissue, the needles engage and pick up both ends of a segment of suture and subsequently pull the suture ends back through the targeted tissue to facilitate a reliably customized suture placement. A slidable mechanism is provided to cut the held tissue and also, when desired, to enable the passage of a guide wire through the cut opening. This invention is particularly useful for the creation of closable openings in tissue structures or for safely harvesting deeper samples from the walls of tissue structures.
- 2. Description of Related Art
- Despite all of the advances of modern medicine, many seemingly simple patient interventions still present significant challenges regarding their safe and reliable implementation. For many patients, substantial therapeutic advantage could be offered by a technology facilitating rapid and reliable cutting open and closing of a remote tissue sites.
- Efforts to improve a physician's ability to do more than just see the outer characteristics of a patient are essential to modern health care. For centuries, health care practitioners have used existing external anatomic features for gaining limited access to a patient's internal structures for diagnostic or therapeutic interventions. Without the right equipment, health care providers can only use their direct vision to view their patient's body surfaces, exposed orifices or anatomy exposed through open incisions or wounds. The use of radiographic techniques (e.g., X-ray, CT and MRI), endoscopic techniques (e.g., colonoscopy, gastroscopy, cystoscopy, bronchoscopy) and open or laparoscopic surgery, along with combinations of these modalities, now routinely provide clinically significant data and the opportunity for direct therapeutic interventions.
- An endoscopic technique for viewing internal patient body cavities was first reported in 1805. Important advancements in less invasive techniques (e.g., laparoscopic surgery in 1901, flexible fiber optic endoscopes in 1957, endoscopic retrograde cholangiopancreatography (E.R.C.P) in 1968, laparoscopic cholecystectomy in 1988, etc.) helped usher in this era of modern medicine. Improvements to endoscopic technology continue to yield significant improvements in therapeutics.
- Many patients could benefit from a physician's ability to gain access to internal body locations through an organ structure naturally communicating with an existing external orifice instead of through a painful incision in the skin and its underlying muscle and fascial structures. Interventions using this alternative approach have come to be called “Natural Orifice Translumenal Endoscopic Surgery” or its acronym, “NOTES,” procedures.
- Examples of excellent potential access points to facilitate minimally invasive NOTES procedures include: safe entry to and exit from the peritoneal cavity through a wall of the stomach (i.e., transgastric), via the mouth, through the rectum and sigmoid colon (i.e., transcolonic), via the anus, or through the posterior formix of the vagina (i.e., transvaginal) via the external vaginal opening. Generally, access to other body parts or compartments through the wall of a tissue structure is commonly referred to as “transmural” (i.e., through the wall) access; more specifically, gaining such access through the wall of a tubular tissue structure, from the inside (i.e., the lumen) to the outside, is commonly called an extralumenal (i.e., outside of the lumen) approach.
- The proper utilization of naturally existing orifices to provide initial entry for therapeutic interventions may minimize many of the risks and morbidities of more traditional open laparotomy or laparoscopic surgery. To support a paradigm shift away from surgery requiring skin incisions, it would be helpful to have a technology, like the present invention, that could appropriately hold remote tissue, reliably provide a suture to subsequently secure it closed, safely cut it and to enable the placement of a temporary guide wire to facilitate easier instrument passage.
- In the American Journal of Surgery, April 1944, Drs. Decker and Cherry published a manuscript describing a procedure they “termed culdoscopy.” They reported use of the “vaginal route” to access the peritoneal cavity for viewing internal structures and for instrument manipulations. They presented the “Decker culdoscope” and a “trochar and cannula set” for “puncturing the posterior vaginal wall.” Examples of the transmural procedures they reported include rupture of small cysts, biopsy of ovaries, testing the fallopian tubes for patency and tubal ligation for sterilization.
- A recent resurgence of interest in the transmural NOTES procedures has lead to several new reports regarding the use of this approach in mostly animal experimental models. A gastroscopic “pancreatic necrosectomy” procedure was presented the internationally renowned “Digestive Disease Week” conference in 2003. This presentation reported the use of a gastroscopic instrumentation to exit through the stomach and debride a pancreas of necrotic tissue. At the “Digestive Disease Week” conference in 2004, investigators presented their “successful peroral transgastric ligation of fallopian tubes . . . in a survivor porcine model.” Other investigators presented transgastric biliary surgery, including the removal of a gallbladder from a pig. While the use of an instrument called the Eagle Claw V (Olympus Medical Systems Corporation, Tokyo, Japan) was reported for transgastric suturing of intraperitoneal tissue structures like a splenic artery; it was not used to close the transmural access site. Other investigators suggested the use of computer-controlled robots to aid in transgastric surgery. A conclusion stated, “clearly, there is a need for better instrumentation.”
- Academic leaders in this area wrote an authoritative publication entitled, “ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery—White Paper—October 2005.” They reviewed recent porcine research and noted a report of a human transgastric appendectomy. While the paper mostly highlighted the per oral transgastric approach, they also mentioned the promise of the transcolonic and transvaginal access. These expert laparoscopic surgeons and endoscopists “(A)II agreed that Translumenal Endoscopic Surgery could offer significant benefits to patients such as less pain, faster recovery, and better cosmesis than current laparoscopic techniques.” They stated, “(I)t seems feasible that major intraperitoneal surgery may one day be performed without skin incisions. The natural orifices may provide the entry point for surgical interventions in the peritoneal cavity, thereby avoiding abdominal wall incisions.”
- This Natural Orifice Translumenal Endoscopic Surgery—White Paper identified “ten critical areas that will impact the safety of NOTES.” The first two areas listed by these authors are directly addressed by the present invention. From “Table 2. Potential Barriers to Clinical Practice,” the first and second listed areas are, respectively, “Access to peritoneal Cavity” and Gastric (intestinal) closure.” They state that while the “most important areas of initial study are . . . safe peritoneal access and secure gastric closure,” the “optimal techniques to do so . . . are unknown.”
- The long term results of recent efforts to endoscopically suture the native lining of remote tissue sites to achieve tissue thickening and/or tightening (i.e., in medical terms, a “plication”) have proved to be relatively disappointing. Clinical investigations exploring such suture-mediated changes to tissue have typically shown excellent short-term realization of the desired symptom relief. However, without any other wound closure site preparation, over time, the sutures alone tend to loose their ability to hold tissue together for thickening or tightening. Examples of encouraging short termed success, but later disappointment, are included in most of the published clinical study's of the use of the ESD™, Endoscopic Suturing Device (manufactured by LSI SOLUTIONS®, Victor, N.Y.) or the EndoCinch® (manufactured by Bard®, Bellarica, Mass.); the encouraging early relief from endoscopically placed suture alone (without site preparation) at the distal esophagus in patients with gastroesophageal reflux disease or at the dilated surgically created stomach to small bowel connections (i.e., gastrojejunal anastomoses) in gastric bypass patients usually faded completely within two years.
- Thousands of patients suffering from gastroesophageal reflux disease (GERD) have undergone endoscopic suturing using commercially available products in conjunction with gastroscopy. Despite highly encouraging initial symptom relief, most patients progressively returned to their baseline state of “heart burn” or other discomfort over weeks or months following their procedure. Without proper healing, living tissue tends to return to its prevailing state. Sutures or surgical staples alone typically can only provide a temporary mechanical arrangement to promote tissue healing. In most cases, the body has to respond and take over the functional process. Almost all patients receiving suture thickening and tightening of their esophagus adjacent to the stomach only had a few stitches placed to bulk up and narrow the native lining (called the mucosa) of the esophagus against itself. Over time, the bodies of these patients overcame the presence of the foreign material (i.e., the suture) and the walls of their distal esophagus attenuated and loosened.
- Laboratory research indicates that successful long-term plication to thicken and tighten the distal esophagus is more achievable by stimulating the tissue to actually heal into the desired configuration, instead of relying solely on sutures to hold the tissue in position. Research in our porcine laboratory indicated that methods using tissue cutting or burning to promote healing at distal esophageal wound closure sites were worthy of further study. A study, entitled, “Mucosal Apposition in Endoscopic Suturing,” published by colleagues at the Cleveland Clinic, Cleveland, Ohio, reported promising results through the use of cauterizing the esophageal mucosa prior to suturing. Excellent clinical results were also reported in pediatric GERD patients who received cautery mediated wound site preparation to take away the protective mucosal lining of the esophagus and expose the inner healing tissues in preparation prior to ESD suturing.
- For some bariatric patients with failed gastric bypass procedures, the endoscopic use of suturing to narrow the opening between the reduced stomach and its outflow into the by-passed small bowel has only produced acceptable, durable improvements in patients who have also received suturing site preparation to remove some mucosa and stimulate the underlying tissue to realize long term healing. Dr. Christopher Thompson's pioneering team in Boston report the largest series of patient amelioration by using suture to reduce the diameter of the connection between the functional stomach and small bowel. Their satisfactory results only came after improving their anastomotic tightening technique to also include suture site preparation.
- To achieve long-term tissue thickening and tightening, tissue closure site preparation is required in addition to suture fixation. A device that facilitates remote tissue site preparation for healing and reliable suture mediated site closure could offer a substantial improvement to the therapeutic options for many patients.
- Another example of the need for better technology for remote tissue cutting and closing is evident from the fact that currently many patients still often require more extensive and dangerous surgery to remove certain intestinal lesions (e.g., abnormal growths, like polyps) that extend deeper than the superficial layer lining the intestine. Many superficial intestinal lesions reached using standard intestinal endoscopy equipment and techniques can be routinely completely removed endoscopically from the intestinal wall using a wire snare. Because of the lack of effective technology and techniques, typical deeper lesions cannot yet be safely removed using this non-surgical approach.
- Patients who present with larger or deeper potentially intramural intestinal lesions usually would benefit from having part of the intestinal wall immediately adjacent to the base of the lesion also removed with the lesion. While removing some of the surrounding normal intestinal tissue can ensure that the lesion is more adequately removed, the risk of harvest site leakage or impaired wound healing substantially increases if the wound is not adequately closed. Currently available technology fails to provide a safe and reliable option for the completely endoscopic removal of deep-seated internal pathologic lesions. This second preferred embodiment holds promise for eliminating the need for some patients to have to go to the surgical operating room instead of just finishing the endoscopy in the endoscopy suite with the safe and complete removal of these deeper lesions.
- To provide better patient outcomes, improved technologies are needed to continue to reduce the invasiveness and potential morbidity of opening and closing holes remotely made inside of patients. While the ability to remotely cut or open and close the walls of tubular tissue structures along with the use of translumenal therapeutic interventions offer exciting potential improvements to patient care, excellent technology is needed to make this promising opportunity into clinical reality. This innovation represents a significantly means to help a broader population of patients.
- Briefly stated and in accordance with both presently preferred embodiments of the invention: a therapeutic instrument for the ergonomic, effective and safe opening and closing of targeted remote tissue sites; includes a pistol grip style handle with a hand activated lever for needle deployment and, optionally, with features to control tissue cutting and guide wire installation; also incorporates a specialized elongated rigid or flexible instrument shaft, which enables vacuum assisted holding of tissue at a uniquely contoured distal tip, where placement of a suture in a purse string configures occurs along with, if desired, tissue cutting and guide wire passage.
- In accordance with first preferred embodiment of this invention used for providing safe and reliable transmural access, this instrument enables creation of closeable transmural access sites by utilizing the special features disclosed herein: This innovation provides for vacuum mediated tissue manipulation and holding across multiple specially contoured gaps, which also support the simultaneous traverse of two needles that pick-up and retract back both ends of a single strand of suture configured to create a purse string suture arrangement in that tissue. The tissue is cut with a blade oriented perpendicular to the tissue held in the jaw and pulled toward the handle along the long axis of the distal tip. This incision is located appropriately between the purse string stitches. A guide wire can be passed through this incised tissue opening within the purse string suture to enable subsequent instrument passage over the guide wire through the transmural access point and into the extralumenal location. Upon completion of the intervention, after the device, guide wire and any other instruments are removed form the patient, the suture is drawn tight and secured to close the hole.
- In accordance with another aspect, this invention provides a novel approach to stimulate wound healing by cutting and closing the wall of the tubular tissue structure (without necessarily removing any tissue or using the site for access) has potential for therapeutic interventions, called “plications,” in which increasing tissue thickness or tissue tightening is advantageous. For example, a durable esophageal plication thickening and tighten tissue at the distal esophagus may reduce the risk of stomach contents from refluxing up from the stomach into the esophagus. Symptoms of gastric reflux range from mild heart burn to obstruction from esophageal cancer. Just placing stitches in the distal esophagus leads to temporary amelioration of reflux while the stitches remain in place to tip the balance towards supporting an effective anti-reflux mechanism. Without healing the stitches typically fall out within weeks or months. With healing at the site, the bulked up region of the esophagus can act as a permanent pressure valve against reflux.
- A second embodiment of this invention can be used to safely and efficiently remove part of the wall of a hollow tissue structure along with an abnormal tissue growth attached to that part of the wall. Limitations in currently available intestinal endoscopy equipment force the need to have deep-seated lesions, which may extend into the adjacent wall (i.e., intramural), removed by a subsequent surgical procedure in the operating room instead of at the time of their evaluation in the endoscopy suite.
- 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:
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FIG. 1 is a perspective view of the tissue suturing instrument in accordance with the first embodiment of the present invention; -
FIG. 2 is a perspective view of the tissue suturing instrument ofFIG. 1 in which the right cover of the housing of the instrument is removed and sections of the shaft are removed to illustrate internal components; -
FIG. 3 is a partially exploded perspective view of the tissue suturing instrument ofFIG. 1 in which the handle halves are separated highlighting the functional components for vacuum augmented tissue manipulation, purse string suture placement, tissue cutting and guide wire installation; -
FIG. 4 is an exploded perspective view of the tissue suturing instrument ofFIG. 1 ; -
FIG. 5 is a perspective view of the tissue suturing instrument ofFIG. 1 showing a curved or flexible shaft; -
FIGS. 6A and 6B are perspective views of the vacuum assisted tissue manipulation components ofFIG. 3 ; -
FIGS. 7A and 7B show an end view and a cross sectional view, respectively, of the distal vacuum tip ofFIG. 3 ; -
FIG. 8A is an perspective view highlighting the needle drive components ofFIG. 3 ; -
FIGS. 8B and 8C are perspective views of the proximal and distal ends, respectively, of the needle ofFIG. 3 ; -
FIG. 9A is an perspective view showing the suture storage features ofFIG. 3 ; -
FIG. 9B shows the ferrules at each end of a single strand of suture ofFIG. 3 ; -
FIGS. 9C and 9D show a perspective views of a needle next to a cross sectional view of a ferrule and another perspective view of a needle engaged within a cross sectional view of a ferrule, respectively; -
FIG. 10A is a perspective view of the tell-tale suture loops held in the suture storage indicator and of the relative of the location of the ferrules held in the ferrule compartments at the distal side of the distal tip ofFIG. 1 ; -
FIG. 10B is a perspective view of the tell-tale suture loops now partially straightened out in the suture storage indicator and of the relative location of the ferrules now brought back to the proximal side of the distal tip ofFIG. 1 ; -
FIG. 11A is a perspective view of the tissue cutting components instrument ofFIG. 1 showing the tissue cutter knob fully forward; -
FIG. 11B is a perspective view of the tissue cutting blade and shuttle components on the blade tube of the instrument ofFIG. 11A ; -
FIG. 11C is a perspective view of the tissue cutting components instrument ofFIG. 1 showing the tissue cutter knob about half way pulled back and the cutting blade near the middle of the tissue manifold; -
FIG. 11D is a perspective view of the tissue cutting blade and shuttle components on the blade tube of the instrument ofFIG. 11A highlighting the shuttle's location relative to the distal end of the device; -
FIG. 11E is a perspective view of the tissue cutting and guide wire placement components instrument ofFIG. 1 showing the tissue cutter knob fully back and a guide wire partially inserted through the shuttle tube; -
FIG. 11F is a perspective view of the tissue cutting blade and shuttle components on the blade tube of the instrument ofFIG. 11A showing the blade shuttle fully retracted and the guide wire protruding through the curved distal portion of the shuttle tube; -
FIG. 12A-12E show end views and cross section views of various blade shuttle components of the instrument ofFIG. 3 ; -
FIG. 13A is a perspective view of the instrument ofFIG. 1 with the right handle housing removed and the distal tip magnified to show the lever fully forward and the needle tips not extending into the jaw; -
FIG. 13B is a perspective view of the instrument ofFIG. 1 with the right handle housing removed and the distal tip magnified to show the lever partially rotated back and the needle tips now extending into the jaws; -
FIG. 13C is a perspective view of the instrument ofFIG. 1 with the right handle housing removed and the distal tip magnified to show the lever fully rotated back and the needles fully forward through the jaw; -
FIG. 13D is a perspective view of the instrument ofFIG. 1 with the right handle housing removed and the distal tip magnified to show the lever partially released and the needles along with the attached suture ends traversing back through the jaw; -
FIG. 13E is a perspective view of the instrument ofFIG. 1 with the right handle housing removed and the distal tip magnified to show the lever fully forward back into its initial position and the needles and suture ends fully back to the proximal side of the jaw; -
FIG. 13F is a perspective view of the instrument ofFIG. 1 with the right handle housing removed and the distal tip magnified highlighting the blade knob and blade partially pulled back; -
FIG. 13G is a perspective view of the instrument ofFIG. 1 with the right handle housing removed and the distal tip magnified highlighting the blade knob and blade fully pulled back and a guide wire partially in place; -
FIG. 14 is a schematic perspective view of the tissue suturing instrument ofFIG. 1 shown in a transanal application; -
FIG. 15A is a perspective view of the distal end of the instrument ofFIG. 1 and a schematic representation of a tubular tissue; -
FIG. 15B is a perspective view of the distal end of the instrument ofFIG. 1 shown inserted into the lumen of the tubular tissue structure; -
FIG. 15C is a perspective view of the distal end of the instrument ofFIG. 1 with a segment of the tissue sucked into the jaws of the distal tip; -
FIG. 15D is a perspective view of the distal end of the instrument ofFIG. 1 with a segment of the tissue sucked into the jaws of the distal tip and the needles partially advanced through the tissue over the proximal manifold; -
FIG. 15E is a perspective view of the distal end of the instrument ofFIG. 1 with the needles fully advanced above the tissue proximal and distal jaws, but under the tissue between the jaws; -
FIG. 15F is a perspective view of the distal end of the instrument ofFIG. 1 showing the suture coming back over the tissue in the proximal and distal jaws but under the tissue in area between the jaws; -
FIG. 15G is a perspective view of the distal end of the instrument ofFIG. 1 showing a purse string suture placed around a segment of the tissue sucked into the jaws and the tissue cutting blade pulled back partially cutting the tissue held against the manifold; -
FIG. 15H is a perspective view of the distal end of the instrument ofFIG. 1 showing a purse string suture placed around a segment of the tissue sucked into the jaws and the tissue cutting blade pulled fully back into the instrument shaft to provide an incision in the tissue held in the manifold; -
FIG. 15J is a perspective view of the distal end of the instrument ofFIG. 1 inside of a tubular tissue structure showing a guide wire advancing through the incision in the tissue held in the manifold; -
FIG. 15K is a perspective view of the distal end of the instrument ofFIG. 1 pulled out of the tubular tissue structure leaving a purse string suture in place around an incision with a guide wire passed through it; -
FIG. 15L is a perspective view of the tubular tissue structure with an incision circumscribed with a purse string suture and containing a guide wire over which a endoscope is passed; -
FIG. 15M is a perspective view of the tubular tissue structure with an incision circumscribed with a purse string suture after the guide wire and instruments are removed; -
FIG. 15N is a perspective view of the tubular tissue structure with an incision now drawn closed by placing tension on the ends of the purse string suture; -
FIG. 15P is a perspective view of the tubular tissue structure with an incision now drawn closed by the tightened purse string suture over which a suture fastener and cutting device is passed; -
FIG. 15R is a close-up perspective view of the tubular tissue structure with an incision now secured closed by purse string suture held in place with a mechanical fastener and the extra suture material trimmed away after the suture fastener instrument and trimmed suture ends are removed; -
FIG. 16 is a perspective view of the second preferred embodiment of this invention; -
FIG. 17A is a partial section view of the distal end of the instrument ofFIG. 16 showing the needle and ferrule with suture along with the horizontal cutting blade.FIG. 17B is a section view through A-A ofFIG. 17A . -
FIG. 17C is a section view through B-B ofFIG. 17A showing the horizontal cutting blade along with its attached pulling members from the instrument ofFIG. 16 . -
FIGS. 18A , 18B and 18C show the distal end of the instrument ofFIG. 16 with the needles partially advanced, the needles fully advanced with the horizontal blade partially pulled back and the needles fully advanced with the horizontal blade almost entering under the proximal vertical perforated wall, respectively. -
FIG. 19 shows perspective view of the distal end of the instrument ofFIG. 16 with a partial cut-away to illustrate how this instrument engages a lesion attached to the wall of a tubular tissue structure; -
FIG. 20A shows the distal end of the instrument ofFIG. 16 inside of a tubular tissue structure containing a lesion; -
FIG. 20B shows the distal end of the instrument ofFIG. 16 inside of a tubular tissue structure now engaging the lesion within the opening in the distal end of the instrument; -
FIG. 20C shows the distal end of the instrument ofFIG. 16 inside of a tubular tissue structure, engaging the polyp with the needles fully advanced; -
FIG. 20D shows the distal end of the instrument ofFIG. 16 inside of a tubular tissue structure, engaging the polyp and the needles and ferrules with suture fully retracted; -
FIG. 20E shows the distal end of the instrument ofFIG. 16 inside of a tubular tissue structure, engaging the lesion with the needles fully retracted and the purse string suture in place around the base of the polyp and the horizontal blade fully excising the lesion's base from the wall of the tubular tissue structure; -
FIG. 20F shows the distal end of the instrument ofFIG. 16 now released from the inside of a tubular tissue structure with the purse string suture in place and the lesion secured within the distal opening. - In accordance with the presently preferred embodiments of the invention, medical therapeutic instruments are provided for the ergonomic, effective and safe creation of transmural access sites, effective tissue plication and harvesting deep-seated remote tissue samples. Each instrument includes a pistol grip style handle with a hand activated lever, a specialized vacuum tissue manipulation feature at the end of the instrument shaft and a double needle mechanism for engaging ferrules attached to the ends of a single strand of suture to stitch a purse string suture configuration. These embodiments vary regarding the availability of specific customized features for tissue incisions and guide wire passage. First, the first preferred embodiment is covered in this detailed description for use in providing transmural access. Next, the use of this first preferred embodiment for creating tissue plication is addressed. Last, the second preferred embodiment is presented for use in harvesting deep-seated remote lesions. For clarity, these novel design features will be presented here in the sequence that they are typically encountered in these example procedures.
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FIG. 1 is a perspective view of a tissue suturing instrument in accordance with the first embodiment of thepresent invention instrument 10. A handle assembly is constructed from aright handle portion 22 and aleft handle portion 24 which are constructed of an injection molded plastic or the like and to which subsequent components are attached. Anelongated body 34 extends from the handle to a distal end at which atip 32 is located. A suction fitting 36 is disposed on the proximal end ofbody 34 and is preferably rotatable with respect to the body. Aremovable cap 42 is attached to a neck of thesuction fitting 36. - Preferably the
handle 24 has awindow 62 described in more detail below. Acutter control knob 74 is attached to acutter shaft tube 72 extending rearwardly from the handle. - The first preferred embodiment of this invention, suturing
instrument 10, is represented inFIGS. 1-15P . Now referring toFIGS. 1-4 , the illustrated suturing technique using needles and suture attached to ferrules ofinstrument 10 may be similar to that shown in U.S. Pat. Nos. 5,431,666, 5,766,183, 6,997,931 B2, European Patent No. EP 0669101, filed Feb. 23, 1995 and granted Oct. 14, 1998, which are incorporated by reference in the SEW-RIGHT® SR5® and Running Device® and ESD™ products manufactured by LSI SOLUTIONS, Inc. (formerly LaserSurge, Inc.) of Victor, N.Y. - The innovation of the present invention is the unique combination of simultaneously firing two needles through a tissue gap in a pleat formed in the tissue by the instrument incorporating customized contours in the
distal tip 32 to enable the needles to create a purse string suture configuration by parallel needles entering and exiting the tissue multiple times in a single traverse. This surgical purse string suture configuration resembles the purse string or draw string at the top of a soft sided purse and offers a similar function. It is a single suture sewn into and out of the tissue circumscribing the selected site. The final stitch exits the tissue near the entry point of the first stitch so that the surrounded site is drawn closed when tension is placed on both ends of the suture. This technology further utilizes vacuum conveyed through ahousing 36 to hold the tissue and a specialized blade shuttle connected to afunnel knob 74 to reliably cut the tissue and, when desired, permit the installation of a guide wire. As used herein, pleat is intended to refer to any configuration of tissue that permits the above described stitch to be placed. -
FIG. 2 is a perspective view of the tissue suturing instrument ofFIG. 1 in which the right cover of the housing of the instrument and sections of the shaft are removed to illustrate internal components. -
FIG. 3 is a partially exploded perspective view of the tissue suturing instrument ofFIG. 1 in which the handle halves are separated highlighting the functional components for vacuum augmented tissue manipulation, pleat formation, purse string suture placement, tissue cutting, and guide wire installation.FIG. 4 is an exploded perspective view of the tissue suturing instrument ofFIG. 1 . - A
lever 64 configured to be operated by the fingers of a user while graspinghandle 20 provides for the extension and retraction ofneedles 56 of theinstrument 10. Distally, atube shaft 34, shown here as rigid, but which may also be flexible, protrudes from thehandle assembly 20. The housing of thehandle assembly 20 has a body shaped like a pistol having a handle portion made of a two-piece construction of moldedplastic components elongated needles 56 extends fromhousing 20 through theshaft 34 into the tissue-engagingtip 32. Eachneedle 56 has a non-tissue engaging end in the housing having aspherical member 58, such as a ball or bearing, attached thereto. Both needles 56 andspherical members 58 may be a made of metal, such as surgical stainless steel. Thespherical member 58 may have a bore 58B into which the non-tissue engaging ends of theneedles 56 extend and are joined thereto, such as by welding or brazing. - The
suturing instrument 10 includes anactuator member 64 preferably in the form of alever 64 having twopins 64A extending intoholes 22A and 24A in the sides ofhousing Actuator member 64 extends through anopening 22D and 24D (FIGS. 3 and 4 ) inhousing 20 to enable pivotal movement aboutpins 64A. Anextension spring 66 is provided which hooks at one end in anotch 64E ofactuator member 64 and is connected at the other end around ahandle spring post 24E, which extends into a handle post receiving pocket located in the side ofhousings actuator member 64 is spring biased to retainactuator member 64 normally in a forward position, as shown for example inFIG. 1 . -
Ball sockets 64B are provided in theactuator member 64 which is shaped to received both of the non-engaging ends ofneedles 56, i.e.,spherical members 58, to be driven forward by an operator pullingactuator member 64 to pivotactuator member 64 withinlever openings 22D and 24D. Twoslots 64C (FIG. 3 ) are provided forneedle shafts 56D near thespherical members 58. An additionalcentral slot 64D is also provided to allow free passage ofsuture tube 54 andcutter tube 72. - With its
right handle half 22 shown removed and itsleft handle half 24 shown in place,FIG. 2 best illustrates the relationship between thehandle housing 20 and thetube shaft 34. Note the slottedcapture feature 24C inhandle 24 engages the annular protrudingcapture feature 34C oftube shaft 34. The partially exploded view ofFIG. 3 . further reveals theanti-rotation feature 34D oftube shaft 34 which is constrained by thecorresponding pocket 24K ofhandle 24. At its interface withhandle assembly 20,tube shaft 34 exits throughhole - The partially exploded perspective view of
FIG. 3 highlights the major functional elements of thetissue suturing instrument 10, which include thehandle assembly 20, avacuum assembly 30, a needle drive andsuture storage assembly 40, and a tissue cuttingshuttle assembly 50, which enable tissue incision and guide wire installation. A clear plastic suture-viewingwindow 62 is shown in position relative to lever 64 and to suturetube 54. -
FIG. 4 is a fully exploded perspective view of thetissue suturing instrument 10 showing itsright handle portion 22, lefthandle portion 24,needle actuating lever 64, and itsspring 66. The disassembledtube shaft assembly 30 is comprised, from distal to proximal, of adistal tip 32,tube shaft 34, aneedle guide 40, avacuum housing 36, avacuum seal 38. Also contained therein, as shown in the breakaway inFIG. 2 , are theneedles 56,suture tube 54 with itssuture 52, along withcutter tube 72 attached at its distal end to blade shuttle orfollower 70 and itsintegrated blade 68 and, at itsproximal end 72D, to funnelknob 74 capped byguide wire seal 76. -
FIG. 5 is a perspective view of theinstrument 10 now shown having atube shaft 35 that is bent, flexible, malleable or steer able as indicated at thecurved section 35A near the middle of the shaft. A non-straight or non-rigid shaft enables access to many potentially clinically relevant sites that are not reachable by straight or rigid instruments. -
FIGS. 6A , 6B, 7A and 7B present the vacuum mediated tissue positioning function of this first preferred embodiment.FIG. 6A is a sectioned partially exploded view of the vacuum features oftube shaft 34.FIG. 6B is a slightly enlarged (relative toFIG. 6A ) perspective view ofdistal tip 32. Vacuum is applied through attaching a tube connected to a negative pressure source at thehose connector 36D of rotational housing 36 (previously first described in U.S. Pat. No. 6,997,931 B2). This housing has an additional port 36C, which is closed bycap 42. Communicatinghole 36B invacuum housing 36 facilitates transmission of vacuum between the vacuum source and thetube shaft 34 through thehole 34B. The lip seals 36A on either side ofhousing 36 prevents vacuum leakage even during rotation of thevacuum housing 36 abouttube shaft 34. Communicating hole 40G ofneedle guide 40 transmits vacuum to the vacuum channel 40A ofneedle guide 40.Vacuum seal 38 has acompressible rim 38A which seals against the inside surface ofcapture feature 34C. This seal also prevents vacuum leakage around the needles 56 (not shown) at 38D and the shuttle tube 72 (not shown) at 38C and the suture tube 54 (not shown) at 38B. - The end view drawing on the left side of
FIG. 7A shows features ofdistal tip 32 with a the continuous path for vacuum throughchannels 32N, which communicate withslots 32L located in themanifold bed 32C to ultimately draw tissue into contouredgaps 32D separated byseptum 32E and down againstmanifold bed 32C to form a pleat in the tissue to enable purse string suture placement. Note the cut away shown beneathdistal tissue gap 32D. Also note cut location features 32H, which controls cut length in tissue by setting the start and stop points of the cut. Tissue stop features 32K prevent tissue from being sucked into the proximal and distal ends oftissue gaps 32D.FIG. 7B also illustratesneedle passages 32A,blade track 32B,shuttle track 32M andferrule compartment 32F withferrule stop 32G. -
FIG. 6B is an isometric view of the features described above inFIG. 7 . In addition,FIG. 6B well illustrates the guidewire exit hole 32P and therounded end 32J ofdistal tip 32. -
FIGS. 8A , 8B and 8C show the needle drive components. Many of the features inFIG. 8A . have already been individually described. This illustration shows the relationship between the pivotinglever 64 with its twoball sockets 64B andneedle slots 64C and theneedles 56 as well as the needle track features 41D of theneedle guide 41.FIG. 8B shows an enlarged view of aneedle ball 58 with bearingsurface 58A and aneedle receiving opening 58B, which attaches to theproximal needle end 56E.FIG. 8C shows thedistal needle end 56D, which connects to the distal tip of the needle where ferrule engagement occurs. Needleferrule stop shoulder 56C is proximal to asymmetricferrule snap feature 56B, which includes opposingrelief sections 56F for engaging and releasingferrules 52A (shown inFIGS. 9B and 9C ) at the symmetricalannular ferrule snap 52B. As can be seen, the needle andsection 56D has a larger diameter than the needle tip section. The ferrule snap feature 506B located proximate to the distal end of the needle has a dimension in one direction that is larger than a diameter of the adjacent needle section and a dimension in another direction, in this case orthogonal to the first direction smaller than the needle dimension. Preferably, the surface in the enlarged dimension is the rounded surface as indicated at 56B, while the surface in the other direction is a flat surface as indicated at 56F. A sharppointed tip 56A, shown here in a conical shape, is located at the most distal end ofneedle 56. -
FIG. 9C shows the asymmetricneedle snap feature 56B engaging the symmetricalannular ferrule snap 52B to temporarily attach theneedle 56 to theferrule 52A. The opposingrelief sections 56F ofneedle snap feature 56B permit release offerrules 52A off ofneedle snap feature 56B by providing clearance for the tubular ferrule to temporarily deform into an oval shape and pass over the larger diameterneedle snap feature 56B. It will be appreciated that the ferrule is at least somewhat resilient to permit to be deformed when the needle passes through the constricted portion defined by interiorcircumferential rib 52B. As can be seen, therib 52B may be formed by deforming the sleeve inwardly at the location of the rib. -
FIGS. 9A , 9Ba and 9C highlight the suture and suture storage of this embodiment. A complete suture set 52 is comprised of a single strand ofsuture 52C attached to twoferrules 52A, one at each end. Eachferrule 52A is held in itsindividual ferrule compartment 32F (seeFIGS. 7A , 7B,10A and 10B) with the attachedsuture 52C fed through thedistal tip 32 within thesuture tube 54 underneathblade shuttle 70. Thesuture 52C continues back within thesuture tube 54 through theopening 41B in theneedle guide 41. Thesuture tube 54 passes through thevacuum seal 38, enters the cavity within handle halves 22 and 24, traverses thelever slot 64D inlever 64 and the suture tubedistal end 54B terminates into the opening described by the recesses 22G and 24G inhandle halves - The mid section of suture set 52 is arranged to indicate
suture 52C payout achieved by successful pick-up of bothferrules 52A; this tell-tale safety feature demonstrates the pulling of both ferrules was described in U.S. Pat. No. 6,641,592 B1. Tell-tale suture loops 52D are arranged immediately to the ferrule side of the mid point of the suture strand. When thesuture 52C connected to eachferrule 52A is pulled toward the handle by theneedles 56, these tell-tale loops 52D straighten out as an indicator ofsuccessful ferrule 52A pick-up. -
FIG. 10A shows the arrangement and location through theclear window 62 of both tell-tale suture loops 52D separated by a septum composed of handle features 22J and 24J with bothferrules 52A remain held in their ferrule pockets 32F in thedistal tip 32.FIG. 10B shows the appearance of the now straightened out tell-tale loops (pulled through handle channel composed of openings 22G and 24G) evident ofneedle 56 retraction of bothferrules 52A with their attachedsuture 52C. As used herein, and in the claims, clear and are transparent or exemplary and are meant to describe a window through which thesuture portions 52D can be seen, and not to suggest that the window is clear or transparent in an optical sense. -
FIGS. 11A-11F are perspective views of the tissue cutting and guidewire passage components 50 ofinstrument 10 ofFIG. 1 as shown assembled inFIG. 3 . Note the reference lines located at the proximal and distal ends of these drawings to help indicate the relative travel of thefunnel knob 74 disposed on the proximal and oflongitudinal blade actuator 72 and theblade shuttle 70 located on the distal end thereof, respectively.FIG. 11A shows the funnel knob fully forward.FIG. 11B shows the position of theblade shuttle 70 relative to thedistal tip 32 ofFIG. 11A . -
FIG. 11C shows the cuttercontrol funnel knob 74 back about half way and thecutting blade 68 near the middle of thetissue manifold bed 32C.FIG. 11D shows theblade shuttle 70 relative to thedistal tip 32 ofFIG. 11C .FIG. 11E showsfunnel knob 74 in the fully back position with theguide 80 passing throughguide wire seal 76 and throughshuttle tube 72. Thedistal end 80A ofguide wire 80 exits in an upward orientation out of anupturned portion 72B of theshuttle tube 72 and a guidewire exit hole 32P at the proximal side ofdistal tip 32.FIG. 11F shows blade shuttle relative to thedistal tip 32 ofFIG. 11E and well illustrates the curvedguide wire director 72B located at the distal end of theshuttle tube 72, where theguide wire 80 is diverted in the upward directed. -
FIG. 12A-12E show end views and cross section views of the blade shuttle components of the instrument ofFIG. 3 .FIGS. 12A and 12 B show a guide wire seal having aslit 76A acts as closed valve until it receives and seals around a guide wire 80 (not shown).Guide wire seal 76 includes a recessedpocket 76B to engage and seal on raisedseal lip 74E at the proximal end offunnel knob 74,FIG. 12C . A tapered guidewire receiving aperture 74A communicates with a stepped longitudinal bore having adistal shoulder 74D for engaging theproximal end 72D ofshuttle tube 72 and an enlarged shuttletube receiving opening 74C withinfunnel knob 74, which is gripped and pulled by graspingsurface 74B.FIG. 12D shows theproximal end 72D ofshuttle tube 72, which can be attached to funneltube opening 74C by means such as gluing or welding. -
FIG. 12E shows that the distal end ofshuttle tube 72 is received in opening 70B ofblade shuttle 70, which also holdsblade 68 inslot 70A thereof.Blade 68 can be attached toblade shuttle 70 by means such pinning, gluing or welding. Theblade 68 incorporates a sharpenedtip 68A and a sharpenedcurved cutting surface 68B.Blade shuttle 70 includes bearing surfaces 70C, which ride within correspondingfeatures 32M ofdistal tip 32 as shown in the end ofFIG. 7 . -
FIGS. 13A-13G are perspective views of the instrument ofFIG. 1 with theright handle housing 22 removed and thedistal tip 32 magnified relative to the rest of the drawing. These drawings highlight the needle-suture function along with the tissue cutting and guide wire passage features.FIG. 13A shows thelever 64 fully forward with the needles 56 (not visible) fully retracted and not extending into thetissue jaw 32R.FIG. 13B shows thelever 64 partially rotated back and theneedles 56 now extending into the distaltissue receiving region 32D oftissue jaw 32R.FIG. 13C shows thelever 64 fully rotated back and theneedles 56 fully forward through thetissue jaw 32R to fully engage bothsuture ferrules 52A (not visible). -
FIG. 13D shows thelever 64 partially released and theneedles 56 along with the engaged or picked-upferrules 52A with their attachedsuture 52C traversing back through thetissue jaw 32R.FIG. 13E shows thelever 64 fully released in its forward position, and theneedles 56 andsuture 52C fully extending acrosstissue jaw 32R.FIG. 13F shows theblade knob 74 with its attachedshuttle tube 72 andblade 68 partially pulled back into tissue receiving region of thejaw 32R.FIG. 13G shows theblade knob 74 with its attachedshuttle tube 72 and blade 68 (not visible) now fully pulled back. Theproximal end 80B ofguide wire 80 is inserted into theguide wire opening 76A (not shown) through theguide wire seal 76 on the shuttle pullknob 74 attached toshuttle tube 72, through which tube theguide wire 80 passes until it exits the upturned, curvedguide wire opening 32P in thedistal tip 32. Thedistal tip 80A ofguide wire 80 advances in an upward direction because of thecurved feature 72D in the distal end of theshuttle tube 72, which are not visible in this drawing because they are internal features. -
FIG. 14 is a schematic illustration of a sagittal cross section of a human female pelvis providing a perspective view of thesurgical suturing instrument 10 shown in atransanal 160 application. The placement of theshaft 34 of theinstrument 10 determines the location of thedistal tip 32. Theright leg 150 and anteriorabdominal wall 140 are labeled at the top of the drawing. Thebladder 120 anduterus 110 are in theperitoneal cavity 130 above therectum 100.Tissue receiving gaps 32D andprojection 32E in thetissue jaw 32R ofdistal tip 32 hold the rectal wall tissue in a pleated configuration in preparation for purse string suturing, tissue incision and guide wire passage. Use of this innovation is also beneficial in other tubular tissue structures, such as the vagina, esophagus, stomach, small intestine, cecum, the entire colon and even the urinary bladder. -
FIGS. 15A-15R show a method in accordance with this invention for opening and closing a transmural access site.FIG. 15A is a perspective view of thedistal end 32 of theinstrument 10 and a schematic representation of a tubular tissue segment such as rectaltubular tissue 100. The arrow indicates the direction in which the roundeddistal end 32J of thedistal tip 32 will enter the inner space or lumen ofrectal tissue structure 100.FIG. 15B is a perspective view of the rounded mostdistal end 32J now inserted into the lumen of thetubular tissue structure 100 and a hidden line representation of the remainder of thedistal tip 32. -
FIG. 15C shows a segment of the wall tissue sucked into the tissue receiving region of thejaw 32R of thedistal tip 32 and contoured to form a pleat corresponding to the shape of thetissue gaps 32D and projectingtissue septum 32E.FIG. 15D shows bothneedles 56 partially advanced through the tissue over the manifold into theproximal tissue gap 32D; the arrow indicates the direction and length of the traverse of theneedles 56.FIG. 15E shows theneedles 56 fully advanced above the tissue held in the proximal anddistal tissue gaps 32D, but through and under the tissue at thetissue septum 32E; the arrow indicates the direction and full length of the traverse of theneedles 56.FIG. 15F showsferrules 52A at each end of the attachedsuture 52C coming back over the tissue in the proximal anddistal tissue gaps 32D but under the tissue attissue septum 32E; this suture placement creates a purse string configuration. The operator can now see throughwindow 62 that the tell-tale suture loops have straightened out (FIGS. 10A-10B ) to ensure effective suture pick-up. If either tell-tale suture loop remains looped, satisfactory suture pick-up may not have occurred. Prior to cutting any tissue, the operator can remove the device and suture from the patient, view the targeted site again and determine if another transmural attempt should be made. -
FIG. 15G shows thetissue cutting blade 68 pulled back partially cutting thetissue 100 held against the manifold bed between the a purse string suture 52 placed within the segment of the tissue sucked against themanifold bed 32C of thejaw 32R.FIG. 15H shows a completedincision 101 in the tissue held against themanifold bed 32C in thetissue jaw 32R; note the vertical incision seen at the proximalcut location feature 32H.FIG. 15J shows aguide wire 80 advancing through theincision 101 in the tissue held in thetissue jaw 32R.FIG. 15K shows theinstrument 10 pulled out of the rectaltubular tissue structure 100 leaving a purse string suture 52 in place around anincision 101 with aguide wire 80 also left in place through theincision 101.FIG. 15L shows theincision 101 circumscribed with apurse string suture 52 and containing theguide wire 80 over which anendoscope 85 is passed to complete the desired procedure. -
FIG. 15M shows the rectaltubular tissue structure 100 with itsincision 101 circumscribed with a purse string suture 52 after theguide wire 80 and all other instruments are removed.FIG. 15N shows thetubular tissue structure 100 with itsincision 101 now drawn closed by placing tension on the ends of thepurse string suture 52.FIG. 15P shows asuture fastener 91 installed in the tip of the suture fastening and cuttingdevice 90 being passed along this suture toward the purse string closure site.FIG. 15R is a close-up perspective view from the inside of thetubular tissue structure 100 with theincision 101 now secured closed bypurse string suture 52C held in place with amechanical fastener 91 and the extra suture material trimmed away. Thesuture fastener instrument 90 and trimmed suture ends are already removed. - The creation of durable tissue plications, an additional example application of this first preferred embodiment, can also be explained using
FIGS. 15A-15R . Similar to using this first preferred embodiment (just reviewed) for opening and closing a transmural access site, the construction of a long-lasting thickening and tightening plication can be achieved with thesame instrument 10 minus utilization of the guide wire passage features. Referring now toFIGS. 13A-13B ofinstrument 10 ofFIG. 1 , the instrumentdistal tip 32 is passed through a natural orifice and positioned at an appropriate location in a tubular tissue structure. Instead of thetubular tissue structure 100 representing the rectum as in the above example, for this example, assume the sametubular tissue structure 100 now represents the distal esophagus. Theinstrument 10 is now proportionally smaller than the previously describedinstrument 10 since the esophagus is usually smaller than the rectum. -
FIG. 15C now represents the wall of the distal esophagus oftubular tissue 100 as it is drawn by vacuum into thetissue jaw 32R.FIGS. 13D-13F show the simultaneous traverse and retraction of bothneedles 56 through the contoured tissue for placement ofsutures 52C in the purse string configuration. As described for transmural access, the verticaltissue cutting blade 68 is guided through the held tissue to create atissue incision 101. This incision, which can be cut either fully or partially through the wall of the esophageal tissue, opens the protective mucosal lining and exposes the submucosal tissue containing the tissue healing elements that can promote actual healing at the wound site. - Passage of a
guide wire 80 and utilization of the opening for manipulating other instruments (e.g., an endoscope 85) as illustrated inFIGS. 15J-15L are not required for this plication application. Note, however, thatinstrument 10 withoutguide wire 80 must still be removed as shown inFIG. 15K prior to closing the prepared wound with theincision 101 circumscribed by the purse string sutures 52C as shown inFIGS. 15M-15R . Rather, after making asuccessful incision 101 ofFIG. 15H , the instrument is removed and the wound closure steps ofFIGS. 15M-15R are promptly initiated. To bulk up and tighten the distal esophagus thereby enhancing the effect of the anti-reflux valve naturally located there, thesuture 52 is drawn tight to close the wound. A surgical knot or mechanical fastener 91 (FIG. 15P-15R ) is applied to secure thesuture 52C, which is trimmed of its redundant suture tails. Further wound site manipulation should be avoided to optimize the potential of successful plication healing. -
FIG. 16 is a perspective view of aninstrument 12 in accordance with a second preferred embodiment of this invention. This embodiment has the same features and functions as theinstrument 10 of the first preferred embodiment ofFIG. 1 , except itsdistal tip 44 is shown with a differenttissue engaging jaw 44R and it incorporates a horizontal cutting blade instead of a vertical cutting blade. -
FIG. 17A is a partial section view of the distaltissue engaging tip 44 of theinstrument 12 ofFIG. 16 showing aneedle 56 in aneedle track 44A andferrule 52A withsuture 52C both located in aferrule pocket 44F abutting against a ferrule stop 44G. The angledhorizontal cutting blade 46 is guided by ablade track 44B when it is pulled byblade wires 48. Thelonger tissue jaw 44R of this embodiment consists of three distal gaps (proximal, middle and distal) 44D and two projecting tissue septums (proximal and distal) 44E to provide for two more tissue engagement bites to form a double pleat in the tissue with both needles in this purse string suture configuration. A verticalperforated wall 44H defines the proximal boundary oftissue jaw 44R. Note arrows indicating views through A-A and through B-B. -
FIG. 17B is a section view through A-A ofFIG. 17A . This view highlightstissue chamber 44K, which is separated from the upper opening in thetissue jaw 44R by the path of thehorizontal blade 46.Vacuum channels 44N communicate throughvacuum slots 44L withtissue chamber 44K. The vacuum is also transferred through thevacuum perforations 44M in verticalperforated wall 44H. -
FIG. 17C is a section view through B-B ofFIG. 17A showing thehorizontal cutting blade 46 with its angledsharp edge 46A along with its attachedwire pulling members 48 frominstrument 12 ofFIG. 16 . Separated wireblade pulling members 48 can be attached to themselves 48B or to thehorizontal blade 46 atlocation 48A by means such as welding, brazing or gluing. The bottomtissue contact surface 44C oftissue chamber 44K represents the deepest tissue engagement surface.Vacuum openings 44M provide vacuum to the bottom of eachtissue gap 44D. -
FIGS. 18A , 18B and 18C show the distal tip of theinstrument 12. These perspective views illustrate thehorizontal blade 46 passage overtissue receiving chamber 44K.FIG. 18A shows theneedles 56 exiting the verticalperforated wall 44H and partially advanced into themiddle tissue gap 44D.FIG. 18B shows theneedles 56 fully advanced intoferrules 52A (not shown) with thehorizontal blade 46 partially pulled back towards the verticalperforated wall 44H.FIG. 18C again shows theneedles 56 fully advanced, but now the horizontal blade is shown entering under the verticalperforated wall 44H to create a shearing edge. -
FIG. 19 is a perspective section view of the left half of thedistal tip 44 ofinstrument 12 ofFIG. 16 . This partial cut-away illustrates how this instrument engages alesion 104 attached to the wall of atubular tissue structure 102 within itstissue receiving chamber 44K injaw 44R. Note how thelesion 104 is positioned between thehorizontal blade 46, the wireblade pulling members 48 and the verticalperforated wall 44H. -
FIG. 20A is a partial section view of thedistal tip 44 of theinstrument 12 inside of atubular tissue structure 102 containing alesion 104.Tissue receiving jaw 44R is positioned to receivelesion 104 and its adjacent wall tissue and to form a pleat in the tissue proximate the lesion.FIG. 20B shows the effects of the vacuum causing thedistal tip 44 inside of atubular tissue structure 102 to now draw thelesion 104 into thejaw 44R. The adjacent wall tissue is shown drawn over thetissue gaps 44D andtissue projection septums 44E and intotissue chamber 44K.Needles 56 andferrules 52A attached to suture 52C remain in their original positions.FIG. 20C appears similar toFIG. 20B , except here theneedles 56 are shown fully advanced through the contoured tissue and into theferrules 52A. -
FIG. 20D represents the next step afterFIG. 20C . Theneedles 56 are now retracted back to their original position along with theferrules 52A and attachedsuture 52C to create a purse string configuration. Note thehorizontal cutting blade 46 is in its distal starting position.FIG. 20E shows thehorizontal cutting blade 46 now in its most proximal position having amputated off thelesion 104 along with surrounding wall tissue, which is now contained withintissue chamber 44K.FIG. 20F shows thedistal tip 44 of theinstrument 12 ofFIG. 16 now released from the inside of atubular tissue structure 102 with thepurse string suture 52C in place through its undulating course within the surrounding tissue. - Recently, at a Harvard/Brigham and Woman's Hospital research facility in Boston, we conducted a series of laboratory studies of this first embodiment of this invention for use in transmural access. The new technology enabled the remote placement of a single suture in a purse string configuration (i.e., a series of bites into and out of the wall in a plane of tissue) around a transmural incision. The abstract form our first ex vivo entitled, “EVALUATING AN OPTIMAL GASTRIC CLOSURE METHOD FOR TRANS-GASTRIC SURGERY,” was selected for presentation at the SAGES conference in Dallas on Apr. 29, 2006.
- This presentation will compare “the effectiveness of various techniques for gastrotomy closure by assessing leak pressures in an ex vivo porcine stomach model.” This abstract includes: “Results: The unclosed controls demonstrated air leakage at a mean pressure of 15 mm Hg (95% CI: 14-16), representing baseline system resistance. The QuickClip closures leaked air at a mean pressure of 34.2 mm Hg (95% CI: 20.7-47.6). The prototype gastrotomy device yielded a mean air leak pressures of 98 mm Hg (95% CI: 23.9-172.0), while dramatically diminishing time for incision and hole closure to approx. 5 minutes. The hand-sewn closures leaked air at a mean pressure of 52.2 mm Hg (95% CI: 21.2-83.2) . . . . Conclusions: The prototype gastrotomy device decreases procedure time and yields leak-resistant gastrotomy closures that are superior to clips and rival hand-sewn interrupted stitches.”
- Results from the survivor studies from this research were accepted for presentation at the next Digestive Disease Week conference in May 2006. This abstract from the in vivo study, “Transcolonic Access to the Peritoneal Cavity Using a Novel Incision and Closure Device,” notes “Closure of transluminal incisions can be performed using a variety of techniques, however these are technically demanding and inconsistent. Here we report the use of a novel combined incision and closure device from LSI Solutions . . . . Results. The colonic incision was easily performed and peritoneal cavity accessed without difficulty using the LSI device. Following endosope withdrawal into the lumen, complete closure was achieved in under one minute using the device. All animals survived 14 days without apparent sequelae before elective sacrifice. At necropsy, limited pelvic adhesions were identified and the incision sites were completely closed and well healed. Conclusion. Use of this novel incision and closure device allows transcolonic access to the peritoneal cavity in addition to the rapid, complete, and reproducible closure of the colonic incision. This will likely improve the efficiency and safety of translumenal procedures.”
- While the invention has been described in connection with a number of presently preferred embodiments thereof, those skilled in the art will recognize that many modifications and changes may be made therein without departing from the true spirit and scope of the invention which accordingly is intended to be defined solely by the appended claims.
Claims (14)
1. A tissue suturing instrument comprising:
a handle having an operating lever on the handle;
an elongated body extending from the handle to a distal end;
a tip at a distal end of the elongated body;
a tissue receiving region in the tip;
first and second retractable needles coupled to the operating lever and selectively extending across the tissue receiving region and retracting;
a cutter arranged generally parallel to the tissue receiving region; and
a suture having first and second ends disposed at the distal end of the tissue receiving region, the first and second ends engaging the first and second retractable needles when the needles are extended across the tissue receiving region, and being carried proximally across the regions by the needles when the needles are retracted.
2. A method of gathering and placing a suture in tissue comprising:
attracting a section of tissue to a pleat forming surface;
placing a suture through the folds of a pleat of tissue while attracted to the surface.
3. The method of claim 2 in which the attracting step comprises attracting the tissue to the surface with suction.
4. The method of claim 3 in which the step of placing a suture through the folds comprising advancing a needle through the folds, capturing an end of a length of suture with the needle, and drawing the suture back through the folds.
5. The method of claim 2 further comprising cutting an opening in the section of tissue.
6. The method of claim 5 in which cutting the opening comprises cutting the opening adjacent to the suture.
7. The method of claim 6 comprising passing a guide wire through the opening.
8. The method of placing a suture in a section of tissue of claim 2 comprising:
positioning the pleat forming surface adjacent to the tissue;
attracting the tissue to the surface to form a pleat in the tissue;
extending a pair of needles through the pleat;
engaging first and second ends of a length of suture distally of the pleat;
retracting the pair of needles proximally through the pleat;
carrying first and second ends of a length of suture proximally through the pleat; and
securing the suture proximally of the pleat to form the pursestring suture.
9. The method of claim 8 in which the attracting step comprises attracting the tissue to the surface with suction.
10. The method of claim 8 further comprising cutting an opening in the section of tissue.
11. The method of claim 10 in which cutting the opening comprises cutting an opening between the pair of needles.
12. The method of claim 11 in which the cutting step is performed between the extending step and the retracting step.
13. The method of claim 10 comprising advancing a guide wire through the opening.
14. A method of making an incision, guiding an instrument through the incision withdrawing the instrument, and closing the incision comprising:
inserting a cutting and suturing instrument through an organ structure naturally communicating with an existing external orifice;
substantially simultaneously placing a purse string suture in a wall of the existing organ structure and cutting an opening in the wall;
placing a guide wire through the opening with the cutting and suturing instrument;
withdrawing the cutting and suturing instrument leaving the guide wire in place;
inserting a second instrument through the organ structure and the opening and performing a procedure outside the organ structure;
withdrawing the second instrument; and
closing the opening with the previously placed purse string suture
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Also Published As
Publication number | Publication date |
---|---|
US7731727B2 (en) | 2010-06-08 |
EP2010069A2 (en) | 2009-01-07 |
WO2007127774A3 (en) | 2008-11-27 |
US20170215872A1 (en) | 2017-08-03 |
US20070255296A1 (en) | 2007-11-01 |
EP2010069B1 (en) | 2014-03-12 |
EP2010069A4 (en) | 2011-02-16 |
US20100211083A1 (en) | 2010-08-19 |
WO2007127774A2 (en) | 2007-11-08 |
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