Patent Grant
7635374
The present invention relates to a method and a system and subsystems thereof for endoscopic full thickness resection surgical procedures, typically of the gastrointestinal (GI) tract.
Polyps are defined as growths or masses protruding from a mucous membrane of the body. Polyps may be classified by their morphology. A polyp may be attached to a mucous membrane by a stalk (pedunculated polyp) or the polyp may have a broad base (sessile polyp). They may occur in the mucous membrane of many different types of organs, such as the nose, mouth, stomach, intestines, rectum, urinary bladder, and uterus. Most polyps are benign and eventually stop growing, but some, may ultimately become cancerous tumors.
The probability of any single polyp becoming cancerous depends on its gross appearance, histological features, and size. Polyps greater than 1 centimeter have a greater risk of being or becoming cancerous than polyps smaller than 1 centimeter. As these tumors grow larger, they can invade the underlying tissue layers supporting the polyp. In the final stages, the cancer may metastasize to other distant organs. Particularly common, yet readily treatable, are polyps of the colon. Colorectal or gastric cancers, often beginning as benign or precancerous polyps, can essentially be avoided if detected and treated in their early stages by performing a polypectomy.
Polypectomy is the medical term for removing polyps, particularly small polyps of the colon and stomach. These can be removed by using a biopsy forceps, which removes small pieces of tissue. Larger polyps are usually removed by putting a noose, or snare, around the polyp base or stalk and burning through the tissue with an electric instrument (cauterization). Other devices employ physical or electrical scraping of the lining of an organ, such as the colon, rectum or stomach, to remove a polyp.
In almost all cases, the severed polyps are retrieved for examination by a pathologist. For decisively ruling out cancer, a sample of adequate size is required for the pathology laboratory. This includes a clean margin around the polyp as well as all the layers of the organ wall.
Complications, however, sometimes occur during polypectomies. Electrocauterization, for example, often produces desiccation and perforation of the organ wall. Other complications include non-specific tissue destruction caused by unnecessary heating in the treatment environment resulting from the presence of saline, a highly conductive electrolyte. Finally, conventional electrosurgical cutting or resecting devices tend to leave the operating field cluttered with tissue fragments that have been resected from the target tissue. These tissue fragments make observation of the surgical site extremely difficult.
An endoscopist's ability to resect large sessile polyps is limited, due to the inherent limitations of endoscopes, the lack of polyp accessibility, the lack of available accessories, and the difficulty in achieving full thickness resection. While colonoscopes/gastroscopes are widely used for diagnostic purposes their therapeutic abilities are limited. This is a result of the need to control and manipulate instruments, including the endoscope's distal end, from outside the body. Because of the limitations in current technology, large polyps that cannot be resected endoscopically, or polyps suspected to be malignant, are referred to surgery.
Prior art snare instruments used in polypectomies have several problems. First, it is difficult for the physician to precisely position the snare. Typically, it is necessary for the physician to repeatedly push, pull, and torque the sheath and the shaft of the instrument in order to position the snare around the polyp. Second, prior art instruments are not capable of efficient steering, because the shaft generally used includes a cable having low torsional stiffness. Third, while several attempts have been made at providing a snare instrument with a handle adapted to more adeptly steer the snare, most such prior art instruments do not specifically allow for rotating the snare so as to position it relative to the polyp. Rather, the physician must rotate the shaft of the instrument by tightly gripping and rotating the sheath where it enters the endoscope in an effort to try to maneuver the snare over the polyp.
Mechanical surgical clips for use in endoscopic surgery are known; however, they too have drawbacks. The typical known clip is a two legged clip that is passed through an endoscope's working channel via a flexible delivery catheter. Because the clip needs to pass through the endoscope, the clip's size is limited. Size limitations prevent the clip from being able to clamp off all of the vessels in the tissue around a wound. Additionally, the clip is unable to provide sufficient clamping force because of its structural design. An additional problem with these clips is that when delivering these clips to the wound site, good visualization of a bleeding vessel cannot be obtained. The endoscopist may be required to blindly attach the clip, resulting in an imprecisely performed procedure that requires guess work on the part of the endoscopist.
Currently, there are two endoscopic techniques used to resect large polyps. However, these are complicated, require significant experience and instrumentation, may be associated with complications and require repeated procedures to achieve complete resection. Determining the pathology of the lesion is usually limited because of the endoscopists' inability to perform a full thickness resection. In one technique, the piecemeal technique, a snare is used to remove the polyp piece by piece. In many cases this procedure needs more than one session to completely resect the polyp. The samples sent for pathology using this technique have the following drawbacks: loss of orientation of the resected tissue (polyp), inability to identify infiltration beyond the mucosa to diagnose malignant changes, inability to conclusively comment on the margins of resection, and inability to judge completeness of the resection. This leads to frequent follow-up endoscopic surveillance, adding to patient discomfort and extra costs to the health care system.
The second and more advanced technique is mucosectomy. With this technique the polyp is first elevated from the submucosa using a submucosal injection of a variety of solutions. The polyp is then excised using a variety of knives and/or snares. This procedure requires experience with advanced endoscopic techniques and may be associated with serious complications such as bleeding and perforation, complications that may result in surgery and hospitalization. A prerequisite for a safe mucosectomy is that the polyp should not invade the submucosa. Evaluation by high frequency intra-luminal endosonography is mandatory prior to performing a mucosectomy, a procedure available at only a limited number of endoscopy centers throughout the world. Although lateral margins can be commented upon in a specimen obtained through mucosectomy, evaluation of the deeper margin of the specimen may still be in adequate.
An optimal solution would involve the resection of the entire polyp together with adequate margins (i.e. surrounding normal tissue) and the various layers of the polyp's adjacent organ wall, mucosa, submucosa, muscular propria layer and serosa (Full Thickness Resection). The tissue deficit should be endoscopically closed at the same time. To date, the only full thickness resection systems, sub-systems and methods discussed in the patent literature employ surgical staples. Staples often lead to undesired complications such as leakage of blood and other body liquids into the region of the resected polyp, particularly polyps of the colon, often resulting in severe infection. Other complications include strictures and inflammatory reactions to the foreign bodies left behind.
An additional problem with staple systems and methods is that they require a stapling mechanism which generally is relatively large and fairly rigid. This limits the maneuverability of an endoscope and does not allow approach to all locations.
Therefore, there remains a need for a method, a system and elements of a system which would facilitate full thickness resection without the drawbacks discussed above.
“Proximal” relates to the side of the endoscope or devices closest to the user, while “distal” refers to the side of the endoscope or devices furthest from the user. Similarly, “proximal” refers to the side of the multi-lumen sleeve encasing the endoscope or of the working instruments associated with the endoscope or endoscopic system closest to the user and “distal” refers to the side furthest from the user.
“Polyp” as used in the specification and claims below is not intended to restrict the system, subsystems, elements and method discussed herein to polyps alone. Other types of suspect lesions may also be resected using the system, subsystems, elements and method discussed herein.
“Lesion” may be used in place of the word “polyp” without any intent at differentiating between the terms except where specifically indicated.
“Gastrointestinal tract” or its equivalents are used in the specifications and claims without the intent of being limiting. Other organ systems, and lesions found therein, are also contemplated as being treatable with the system, subsystems, elements and methods discussed in the present specification.
“Full thickness resection” and its equivalent “full transmural resection”, both abbreviated as FTR, are used in the specification and claims without any intent at differentiating between these terms except where specifically indicated.
“Hinge spring” is a force applier and this latter term may be used herein interchangeably with hinge spring without any intent at differentiating between these terms, except where specifically indicated. Accordingly, the latch described herein, as well as elements having other shapes, may also be considered force appliers if they are used for, and their operation are based on, their possessing the properties of shape-memory materials with which to apply force in a compression clip. “Force means” may sometimes be used as a synonym for “force applier” without any attempt at differentiating between them unless specifically indicated. Similarly, hinge member may be used as a synonym for hinge spring without any attempt at differentiating between them unless specifically indicated.
“Working conduit”, when used in the specification and claims, may refer to a working channel of the endoscope or a secondary lumen of the sleeve whose primary lumen encases an endoscope's insertion shaft.
“Endoscope”, as used herein, should be construed as including all types of invasive instruments, flexible or rigid, having scope features. These include, but are not limited to, colonoscopes, gastroscopes, laparoscopes, and rectoscopes. Similarly, the use of “endoscopic” is to be construed as referring to all types of invasive scopes.
It is an object of the present invention to provide a system and method for full thickness resection of a lesion, typically but without being limiting, a gastrointestinal lesion such as a polyp.
An additional object is to provide a system and method that can allow for complete full thickness resection in a single procedure rather than the more typical piecemeal procedures currently in use.
It is a further object to provide a system and method where no foreign bodies are left behind in the body cavity after healing of the tissue at the resected site is completed.
It is another object of the present invention to provide a system and method for full thickness resection using compression clips. The clips exert continuous compression on the resected site along a continuous line thereby preventing undesired post-surgery fluid leakage. Such a continuous line is impossible to attain when using surgical staples.
It is an object of the present invention to provide a system and method which ensures that complete closure of a resected site is indifferent to variations in tissue thickness typical of a specific organ.
It is a further object of the present invention to provide a method and system to reduce the risk of tissue perforation when all tissue layers proximate to a lesion are resected.
It is another object of the present invention to provide a grasper assembly which allows for full transmural, i.e. full thickness, resection of a lesion, typically but without being limiting, a gastrointestinal lesion, such as a polyp.
A further object of the present invention is to provide a grasper assembly at least part of which is made of a material having shape-memory properties, allowing large reversible deformations, which enable grasping a sufficient amount of tissue for a full thickness resection.
It is an object of the present invention to provide a system and method for full thickness resection that employs instruments of relatively smaller dimensions than the large bulky instruments currently used with resections employing staples. Smaller instruments permit easier advance of the instrument to the lesion site.
The endoscopic system, its sub-systems and elements, and the method described herein may find particular use in full thickness resections of a suspect lesion, such lesion arising in for example, but without intending to be limiting, the bowel, rectum, appendix, gallbladder, uterus, stomach esophagus, etc.
In one aspect of the present invention there is provided a system for performing a full thickness resection of a portion of an organ wall for use with a surgical compression clip. The clip comprises a pair of compression elements and one or more force applier elements, the latter formed of shape memory material. The clip has an open position and a closed position and is configured to receive a full thickness of an organ wall portion when in its open position. The one or more force applier element is operative to provide a force to the compression elements, the compressive elements are operative to apply a compression force to the organ wall portion when the clip is closed around the tissue so as to cause organ wall closure after resection of a portion of the organ wall. The system for performing a full thickness resection of a portion of an organ wall with a surgical compression clip comprises: an endoscope having an insertion shaft having one or more channels; a multi-lumen sleeve having a primary lumen encasing the endoscope insertion shaft, and one or more secondary lumens; a clip applier for advancing the clip through a working conduit and for positioning the clip near the tissue to be resected, wherein the working conduit is a preselected one of (i) the one or more channels of the insertion shaft and (ii) the one or more secondary lumens of the multi-lumen sleeve; a severing element for resecting tissue, selectably extendable through the working conduit so as to be brought into a position of operational proximity to tissue extending through the compression clip; and a grasper assembly selectably extendable through the working conduit, for engaging and pulling the full thickness of an organ wall portion through the clip when the clip is in its open position. The severing element is operable to resect the full thickness of the portion of the organ wall extending through the clip.
In one embodiment of the system for performing a full thickness resection of a portion of an organ wall, the clip applier includes: two arm elements selectably engageable with the compression clip each arm element having a slot and a pin hole; a position controlling element in mechanical communication with the arm elements, the position controlling element including a first and second pin, where the first pin passes through the position controlling element and the pin hole on each of the two arm elements and the second pin passes through the position controlling element and the slot on each of the arm elements; and an activating element in mechanical communication with and operable to move the second pin in the position controlling element, thereby to produce substantially scissor-like motion of the arm elements bringing them from their closed adjacent position to their open spaced apart position and vice versa; and thereby to cause the compression clip to move from its open position to its closed position and vice versa in tandem with the motion of the arm elements of the clip applier.
In another embodiment of the system for use with a compression clip, the clip includes a threaded bolt inside a compression element of the clip, the threaded bolt having a receiving aperture, and the clip applier includes: a head element mateably insertable into the receiving aperture on the threaded bolt inside the compression element of the compression clip; and an activator for rotating the head element, thereby to cause the threaded bolt to rotate and the clip to move from its open position to its closed position and vice versa depending on the direction of rotation.
In yet another embodiment of the system for use with a compression clip, the clip includes a compression element and one or more connector elements on each of two force applier elements, and the clip applier includes: two wires each connected to a connector element on a different one of the two force applier elements; and a pin passing through an anchor positioned in the compression element, one of the wires being wound around the pin, whereby the compression clip moves from its closed position to its open position when the wires are pulled and said clip moves from its closed position to its open position when the wires are released.
In an embodiment of the system for use with a compression clip the grasper assembly is comprised of: a grasper having a closed position and an open position where the grasper is comprised of: forceps arms for grasping and pulling the portion of the organ wall to be resected; and a wire in mechanical connection with and for controlling and maneuvering the forceps arms and for bringing the forceps arms from their closed position to their open position and vice versa; and the grasper assembly also includes a grasper transporting element for transporting the grasper in its closed position to a location near the portion of the organ wall to be resected whereat the grasper is ejected from the transporting element allowing the forceps arms to open to their open position. In cases of this embodiment one or both of the wire and the forceps arms includes a bend, the bend facilitating grasping and pulling the organ wall to be resected through the clip. In some instances of this embodiment one or both of the wire and the forceps arms is formed at least partially of a shape memory material.
In a further embodiment of the system for use with a compression clip, the grasper assembly is comprised of: a flexible resilient vacuum cup having a closed and an open position; a suction source for generating negative pressure; a conduit joining the vacuum cup to the suction source; a grasper transporting element for transporting the vacuum cup in its closed position to a location near the portion of the organ wall to be resected where the vacuum cup is ejected from the transporting element allowing the vacuum cup to open to its open position and an articulation means for bringing the vacuum cup, when in its open position, to the portion of the organ wall to be resected, for engaging the tissue under a suction force, and for subsequently pulling the tissue through the surgical clip.
In another aspect of the present invention, there is provided a second system for performing a full thickness resection of a portion of an organ wall, which comprises: an endoscope having an insertion shaft having one or more channels; a multi-lumen sleeve having a primary lumen encasing the endoscope insertion shaft, and one or more secondary lumens; a compression clip having an open position and a closed position, the clip configured to receive a full thickness of an organ wall portion therethrough when in the open position, and operative to apply a compression force thereto when closed thereabout, so as to cause organ wall closure after resection of a portion of the organ wall; a clip applier for advancing the clip through a working conduit and for positioning the clip near the tissue to be resected, wherein the working conduit is a preselected one of (i) the one or more channels of the insertion shaft and (ii) the one or more secondary lumens of the multi-lumen sleeve; a severing element for resecting tissue, selectably extendable through the working conduit so as to be brought into a position of operational proximity to tissue extending through the compression clip; and a grasper assembly selectably extendable through the working conduit, for engaging and pulling the full thickness of an organ wall portion through the clip when the clip is in its open position. The severing element is operable to resect the full thickness of the portion of the organ wall extending through the clip.
In an embodiment of the system in this second aspect of the present invention the compression clip further includes a pair of generally elongated compressing elements for compressing the site of the portion of the organ wall to be resected, the compressing elements formed and configured for being disengageably joined to the clip applier. In this embodiment, the compression clip includes one or more shape memory force applier elements formed of shape memory material, the elements operative for providing a force to the pair of compressing elements for compressing the portion of the organ wall to be resected held therebetween. In some instances of this embodiment the compressing elements and the shape memory force applier elements form a planar configuration in both the clip's open and closed positions and the compressing elements of the surgical clip apply to the portion of the organ wall to be resected a compressive force acting in the plane of the clip and in a line between the compressing elements. In other cases of this embodiment, the system further includes a pair of generally elongated securing elements and wherein the one or more shape memory force applier elements are positioned between, and in mechanical connection with the operatively associated securing and compressing elements, and wherein the one or more shape memory force applier elements and the pairs of securing and compressing elements all lie in substantially the same plane in both the first open and second closed positions of the clip. A line of securing for holding the portion of the organ wall to be resected is formed by, and tangent to, the securing elements and a line of compression for compressing the portion of the organ wall to be resected is formed by, and tangent to, the compression elements. The lines of securing and of compression are not collinear lines. In these embodiments the securing and compressing elements are generally linear elements.
In some embodiments of the system in the second aspect of the invention, the clip further includes a pair of generally elongated securing elements each having formed thereon a pair of mutually opposing gripping portions adapted to secure the portion of the organ wall to be resected between them, the securing elements operationally associated with the compressing elements. The securing elements are formed and configured for being disengageably joined to the clip applier. In some instances of this embodiment the gripping portions of the securing elements include toothed first edges which are in proximity to each other when the clip is in its closed position and wherein the toothed first edges of the securing elements are spaced apart from each other when the clip is in its open position. In some instances of this embodiment, the securing and compressing elements are substantially linear elements.
In another embodiment of the system of the second aspect of the present invention, the grasper assembly of the system is comprised of: a grasper having a closed and an open position, the grasper comprised of: forceps arms for grasping and pulling the portion of the organ wall to be resected; and a wire in mechanical connection with and for controlling and maneuvering the forceps arms and for bringing the forceps arms from their closed position to their open position and vice versa. The grasper assembly also includes a grasper transporting element for transporting the grasper in its closed position to a location near the portion of the organ wall to be resected whereat the grasper is ejected from the transporting element allowing the forceps arms to open to their open position. In some instances of this embodiment, one or both of the wire and the forceps arms includes a bend, the bend facilitating grasping and pulling the organ wall to be resected through the clip. In some instances of this embodiment, one or both of the wire and the forceps arms is formed at least partially of a shape memory material.
In another embodiment of the system of the second aspect of the present invention, the system includes a grasper assembly which comprises: a flexible resilient vacuum cup having a closed and an open position; a suction source for generating negative pressure; a conduit joining the vacuum cup to the suction source; a grasper transporting element for transporting the vacuum cup in its closed position to a location near the portion of the organ wall to be resected where the vacuum cup is ejected from the transporting element allowing the vacuum cup to its open position; and an articulation means for bringing the vacuum cup, when in its open position, to the portion of the organ wall to be resected for engaging the tissue under a suction force, and for subsequently pulling the tissue through the surgical clip.
In an embodiment of the system of the second aspect of the present invention, the clip further includes a pair of compressing elements and at least two shape memory force applier elements formed of shape memory material. One of the force applier elements is constructed as a latch which is operable to engage with an engagement means formed on one end of one of the pair of compressing elements. The latch thereby exerts a force on the portion of the organ wall to be resected when the portion of the organ wall is held between the compressing elements. In this embodiment the clip further includes a wire snare.
In another aspect of the present invention there is provided a method for performing a full thickness resection of a portion of an organ wall employing an endoscope, the method comprising the steps of: placing the endoscope in a body cavity and advancing the endoscope to and positioning it near the site of the portion of the organ wall to be resected; positioning a compression clip near the site of the portion of the organ wall to be resected; extending a grasping instrument for grasping the site of the organ wall to be resected and then operating the grasping instrument to grasp and pull all tissue layers of the organ wall portion to be resected into and through the compression clip so that full thickness resection may be effected; and severing the grasped tissue with a severing instrument while it is held by the compression clip.
In an embodiment of the method of the present invention the method further includes a step of opening the compression clip prior to the step of extending a grasping instrument and also further including a step of closing the compression clip prior to the step of severing.
In one embodiment of the method of the present invention, there is also included the step of rotating the grasped and pulled portion of the organ wall to be resected over and around a working instrument extended from the endoscope. The working instrument is configured, sized and positioned for having the tissue wrapped around it thereby ensuring that all tissue layers of the organ wall to be resected have been grasped.
In another embodiment of the method of the present invention the step of extending includes the step of grasping sufficient tissue to include large margins around the portion of the organ wall being resected.
In yet another embodiment of the method of the present invention, in the step of extending the grasping instrument is advanced and brought to the site of resection through a first secondary lumen of a multi-lumen sleeve and in the step of positioning the compression clip is advanced and brought to the site of resection through a second secondary lumen of the multi-lumen sleeve, wherein the primary lumen of the sleeve encases the endoscope and wherein the second secondary lumen is the secondary lumen closest to the portion of the organ wall to be resected.
In another embodiment of the method of the present invention, in the step of extending the grasping instrument and in the step of positioning the compression clip are both advanced and brought to the site of resection through the same secondary lumen of a multi-lumen sleeve wherein the primary lumen of the sleeve encases the endoscope and wherein the aforementioned secondary lumen is the secondary lumen closest to the portion of the organ wall to be resected.
In yet another embodiment of the method, in the step of extending the grasping instrument is advanced and brought to the site of resection through a working channel of the endoscope and in the step of positioning the compression clip is advanced and brought to the site of resection through a secondary lumen of the multi-lumen sleeve, wherein the primary lumen of the sleeve encases the endoscope and wherein the aforementioned secondary lumen is the secondary lumen closest to the portion of the organ wall to be resected.
In another embodiment of the method, the method further includes the step of activating a vacuum source so as to effect the action of grasping in the step of extending by a suction operated grasping instrument.
In yet another embodiment of the method, the severing instrument in the step of severing is advanced through the secondary lumen of a multi-lumen sleeve proximate to the secondary lumen through which the surgical clip is advanced, thereby allowing the tissue to be severed to be a few millimeters from the closed clip.
In another embodiment of the method of the present invention, the severing instrument in the step of severing is advanced through the same secondary lumen of a multi-lumen sleeve as the secondary lumen through which the clip is advanced.
In yet another embodiment of the method of the present invention, the severing instrument in the step of severing is advanced through the a working channel of the endoscope, and the clip is advanced through a secondary lumen of a multi-lumen sleeve, the secondary lumen being adjacent to the working channel through which the severing device is advanced.
The present invention will be more fully understood and its features and advantages will become apparent to those skilled in the art by reference to the ensuing description, taken in conjunction with the accompanying drawings, in which:
Similar elements in the Figures are numbered with similar reference numerals.
The present application should be read in conjunction with co-pending US application “Surgical Compression Clips”, filed by the same applicant and inventors concurrently on Dec. 29, 2006. This document is herein incorporated by reference in its entirety.
The full transmural/thickness resections (FTR) contemplated by the present invention makes use of surgical compression clips, typically non-unitary compression clips, instead of conventional staples. Such clips substantially lessen the likelihood of internal leakage of bodily fluids which often occurs when staples are used. They also lessen the likelihood of bleeding and do not leave any permanent foreign body inside the body cavity.
The non-unitary, i.e. compound, surgical compression clip typically has one or more, often two, force applier elements, made of a shape-memory material, such as a nickel-titanium (Ni—Ti) alloy. The clip includes two compressing elements and two securing elements connected operationally by at least one of the shape-memory force applier elements. Typically, the compressing elements are linear as are the securing elements.
When closed on tissue, a constant compressive force acts between the two compressing elements and along their entire lengths. The compressing elements are connected at least one of their ends by the shape-memory force applier elements. The constant force which is independent of variation and tissue thickness typical of the particular organ being resected is a result of the well-documented long plateau region of the shape-memory material's stress-strain hysteresis curve. This is a consequence of properties exhibited by shape-memory materials. Additionally, stress-induced strain is recoverable in these materials; in the case of Ni—Ti alloys, 6-8% of the strain can be recovered. The shape-memory alloys have the ability to reverse large deformations (plateau part of the stress-strain hysteresis curve of the material) which results in a large clip opening. The ability to generate a constant force within a wide range of deformations ensures that the clip is equally effective irrespective of the thickness of the compressed tissue. The clip, being sutureless, promotes hemostasis and a liquid tight seal which is required for aseptic healing.
Discussions on the stress strain curves and stress-induced strain of shape memory materials can be found in many publications. See for example “Shape Memory Materials”, edited by K. Otsuka and C. M. Wayman, Cambridge University Press 1998, p. 62 and; H. Tobushi et al in “Deformation Behaviour of Ni—Ti Superelastic Alloy Subjected to Strain Variation” in SMST-94: The Proceeding of the International Conference on Shape Memory and Superelastic Technology, edited by A. Pelton, D. Hodson and T. Duerig, 1995, pp. 389-391.
It should also be noted that the line of compressive force produced by the compression elements of the clips of the present invention is not collinear with the line exerted by the securing elements on the tissue to be resected. These are two different lines of action, separated by a distance. Were they to be co-linear the healing of the tissue at the compression site may be compromised. Additionally the arrangement of non-collinearity allows for more homogeneous tissue compression by the compression elements. Any penetration of the teeth for securing the tissue is compensated for by the continuous compression line more proximate to the body cavity wall.
The present invention provides an endoscopic resection system and elements thereof for use in full transmural/thickness resections (FTR). The endoscope body is positioned in the primary lumen of a multi-lumen sleeve. The secondary lumens of the sleeve are typically collapsed and rest substantially adjacent to the primary lumen while the endoscope body is advanced through the gastrointestinal (GI) tract. After the endoscope is positioned adjacent to a lesion in the gastrointestinal tract, the one or more secondary lumens are expanded by introducing and advancing the required working instruments to the distal end of the lumen(s).
A compression clip attached to an applier is brought to the lesion through one of the secondary lumens of the sleeve while the clip and its associated applier are in their closed positions. The applier and compression clip then exit the open distal end of the secondary lumen near the suspect lesion and the clip is opened by the applier.
A grasper assembly is advanced and positioned near the suspect lesion. The assembly may be advanced through another secondary lumen of the multi-lumen sleeve, or alternatively through the same secondary lumen in which the clip and its applier are advanced, or alternatively through a working channel of the endoscope. While advancing the grasper assembly in a direction from the proximal to the distal end of the endoscope, the grasper and its forceps arms are held inside a small profile grasper transporting element. After the grasper transporting element exits the secondary lumen or working channel at its distal end, the grasper exits the grasper transporting element from an open window in its side and the forceps arms of the grasper open.
The grasper then is brought to the lesion through the open clip, grasping the lesion, pulling it, and extending it further by rotating it over, and wrapping it around, the grasper transporting element. Rotation is effected by rotating the entire grasper assembly, i.e. the grasper, the grasper transporting element, and the cable or shaft. The latter is in mechanical communication with an actuator at the proximal end of the endoscope shaft. This rotation step allows for a sufficient amount of tissue to be brought to and through the open surgical clip and to be positioned for a full transmural/thickness resection. It also allows for sufficient tissue around the base of the lesion, i.e. the margin, to be resected, ensuring that no portion of a pre-cancerous or cancerous lesion escapes resection.
In order for the grasper to reach and grasp sufficient suspect tissue, parts of the grasper assembly typically, but without intending to be limiting, have a bent configuration. Additionally, the bent portion of the assembly should typically possess sufficient elasticity to perform its function. Accordingly, parts of the grasper assembly may typically, but without intending to be limiting, be formed from a shape-memory material having the property of large reversible deformation.
A second type of grasper assembly that may be used is a vacuum-based grasper assembly. In this grasper assembly a flexible vacuum cup may be transported while in its closed position in a grasper transporting element to a lesion site. The vacuum cup is connected by one or more tubes to a suction producing source. The vacuum cup is brought adjacent to the lesion to be resected where it opens and uses suction to grasp the polyp and sufficient lateral margins. It then brings the tissue towards and through an open compression clip. Typically, the vacuum-based grasper assembly includes a means for articulation of the vacuum cup.
Once all the suspected tissue and tissue margins are brought through the open clip, i.e. past the clip's securing elements, the clip is closed. A severing device then severs the suspect tissue, and all tissue layers of the organ wall adjacent to it, while the clip compresses the resection site, producing tissue closure, necrosis and healing. As the compression clip closes over the pulled tissue, the teeth of the securing element ensure that the clip will not slip off the tissue during or after the resection.
The applier may be detached from the clip prior to resection. However, it is preferable that the applier be detached from the clip and withdrawn through the lumen or working channel through which it entered after resection. In such a case the applier acts to support the clip and resection site during resection. Similarly, after the clip is returned to its closed position and the suspect tissue is severed, the grasper or vacuum cup holding the severed tissue and the grasper transporting element are withdrawn together with the endoscope from the body.
In some embodiments of the vacuum-based grasper, the polyp or other suspect tissue may be withdrawn from the body, cavity through the sleeve. Alternatively, the vacuum may be turned off, and the vacuum-based grasper assembly withdrawn outside the body while leaving the resected polyp in the lumen. The polyp can then be retrieved using commercially available retraction devices or graspers to pull the resected polyp until it emerges from the body cavity.
The grasper assemblies and the clips and their appliers of the present invention may be used with standard commercially available endoscopes. Dedicated or specially designed endoscopes are not required.
It should be further noted that the instruments taught herein, including all the compression clips, can be used in resecting large pedunculated polyps as well as sessile polyps.
Additionally, the invention is not limited to any particular direction or shape of the resection incision; both radial and longitudinal incisions are contemplated by the present invention.
The shape-memory force applier elements contemplated in the present invention are typically made of Ni—Ti alloys but other shape memory materials may also be used. The other elements of the clip, i.e. the compressing elements and the securing elements (and possibly separate toothed elements for attachment to the securing elements when there is no integrally formed toothed edge on the securing elements), may also be made of a shape-memory material such as a Ni—Ti alloy, but that is not essential. Other metals or alloys, such as stainless steel or other titanium alloys, and even certain plastic materials may also be used.
The system and method described herein have certain advantages which inter alia include:
Before explaining embodiments of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
Details of the instruments used, the multi-lumen sleeve and other specific aspects of the system of the present invention are further discussed below.
Reference is now made to
Clip 10 is constructed of two shape-memory hinge springs 12A and 12B; also herein often denoted as force appliers. Typically, but without intending to be limiting, the shape-memory material is a Ni—Ti alloy. The operation of the clip relies on shape-memory effects exhibited by these materials. Springs 12A and 12B may be made of a single wire or flattened wire or strip or it may be constructed of two or more wires, flattened wires or strips connected together at their ends. Furthermore, in some embodiments, the springs may be constructed to have a coiled shape.
Clip 10 further includes two securing elements 14A and 14B, each of which has a series of teeth 20 for grasping tissue. Each of securing elements 14A and 14B may be formed from a single piece or welded together from several pieces, typically but without intending to be limiting, of metal. Teeth 20 may be formed integrally with elements 14A and 14B or they may be joined to the elements, for example, by welding. Generally, these securing elements are made of metal and typically are welded or otherwise joined to two metal compressing elements 16A and 16B. However, the securing elements and the compressing elements may be joined together by any method known to those skilled in the art. Securing elements 14A and 14B may also be formed integrally with compressing elements 16A and 16B, respectively.
Securing elements 14A and 14B are formed with spacings 18 configured and sized to receive the pushing elements of a clip applier (not shown). Compressing elements 16A and 16B, typically, but without intending to be limiting, are cylindrically-shaped. These include holes 19 (best seen in
The metal used for forming securing elements 14A and 14B, compressing elements 16A and 16B and teeth 20, if these latter are made from separate pieces and welded to elements 14A and 14B, should be a rigid metal such as, but without being limiting, stainless steel.
While in the above embodiment, securing elements 14A and 14B are welded to compressing elements 16A and 16B, respectively, in other embodiments this need not be the case. The securing and compressing elements may be joined to each other by mechanical means such as by U-shaped elements positioned on securing elements 14A and 14B clippably engageable to compressing elements 16A and 16B or by press connections wherein an edge on each of securing elements 14A and 14B would be pressed to enter a slit in their respective compressing elements 16A and 16B. Alternatively, securing elements 14A and 14B and compressing elements 16A and 16B can be crimped together.
In other embodiments, securing elements 14A and 14B and compressing elements 16A and 16B may be made of a single piece of plastic, for example by ejection molding. In such embodiments, only hinge springs 12A and 12B are made of metal, specifically a shape-memory metal or alloy, typically but without intending to be limiting, a Ni—Ti alloy. In such plastic embodiments, hinge springs 12A and 12B (force appliers) would typically be snapped into place between securing elements 14A and 14B and compressing elements 16A and 16B. However, it is evident to one skilled in the art that other methods of introducing the metal hinge springs 12A and 12B could also be used.
Clip 10 in its closed position appears as shown in
After tissue is brought to and positioned between the separated compressing elements 16A and 16B, the applier is operated to relax the applied force allowing securing elements 14A and 4B to move toward each other and to return to their original closed position (
While the shape-memory elements used to effect opening or closing of clip 10 are here described as hinge springs, these elements can more generally be classified as force appliers. Therefore, it should be understood that elements of any shape which can generate a force for either opening or closing a compression clip may be used and these elements can and will often be denoted herein as force appliers.
In other embodiments, pushing elements of a clip applier are inserted into special indentations in securing elements 14A and 14B. The spacing/indentation is best seen as element 718 in
Shape-memory hinge springs 12A and 12B can have distinctive connectors 17 at their ends as shown in
Connectors 17, 17′ and 717 shown in
It should be noted that as in clip 10 of
Additionally, it should be noted that in some embodiments of clip 10 in
In the compression clip embodiments shown in
Reference is now made to
As best seen in
As seen in
Each of connector elements 36A and 36B has a pair of holes 41A-41D (41C and 41D not visible), one at each end of each element.
Applier arms 34A and 34B are joined to applier base 32 by connecting pin 43 which passes through applier base projection holes 37 and applier arm holes (not shown). Pin 42 is inserted into holes (not shown) in connector elements 36A and 36B and is movable in applier base slots 45 and applier arm slots 40A and 40B. As pin 42 moves it forces applier arm slots 40A and 40B to overlap with applier base slots 45 at the point of the pin, thus creating an opening and closing effect.
The proximal ends of connector elements 36B and 36A, respectively, are attached to an operating cable (not shown) that exits the proximate end of the endoscope. The cable is activated by an actuator 306 (
To open clip applier 30, an operating cable (not visible) pulls connector elements 36A and 36B in the proximal direction. Concurrently, pin 42 moves to the proximal end of applier base slots 45 and the proximal ends of applier arm slots 40A and 40B. In that position, applier arms 34A and 34B move apart as in
To close clip applier 30, the tension in the operating cable (not visible) is released. In doing so, the force that hinge springs 12A and 12B exert is greater than that of the operating cable. A force is thus exerted on applier arms 34A and 34B through securing elements 14A and 14B. The clip's force brings applier arms 34A and 34B together, which pushes connector elements 36A and 36B in the distal direction. Concurrently, pin 42 moves to the distal end of applier base slots 45 and the distal ends of applier arm slots 40A and 40B. In that position, applier arms 34A and 34B move together as in
When applier arms 34A and 34B are pushed apart as in
Turning to
Insertion links 60A and 60B each have extensions (not shown) which are positioned on their distal end so that these extensions are insertable into cylindrical elements 58A and 58B. As shown in
Compressing elements 16A and 16B, as shown in
While in the embodiment shown in
Moving from the open to the closed position of clip applier 50 (or vice versa), and therefore to the open or closed position of clip 10 (or vice versa), can be effected using an operating cable (not shown) joined to, or in other ways in direct communication with, central bar 66 (
Spring 52, in addition to protecting the cable (not shown), serves as a stop sleeve for element 56 while pulling the cable thus enabling the separation of insertion links 60A and 60B. In addition, it allows for greater flexibility of the apparatus as it advances through a lumen of a multi-lumen sleeve (or an endoscopic working channel) from the proximal end of the endoscope toward the suspect lesion near the distal end of the endoscope. Alternatively, the cable can be covered and protected by a flexible tube. The tube may be formed of polytetrafluoroethylene (PTFE), but the choice of this material is exemplary only and it is not intended to be limiting.
To open clip applier 50, central bar 66 is pulled by the operating cable (not shown) in the proximal direction. When that occurs, interconnect links 62A and 62B and 64A and 64B and insertion links 60A and 60B move apart as in
During insertion of clip 10 into a body cavity, the clip is attached to clip applier 50 and both clip 10 and applier 50 are advanced, in their closed positions, through a secondary lumen of a multi-lumen sleeve (or through a working channel of the endoscope shaft). A tension is maintained in the operating cable (not shown) in order to keep clip 10 attached to clip applier 50 during the entire advance from the proximal end of the secondary lumen (or working channel) to its distal end. The tension in the cable or wire, acts against the force of hinge springs 12A and 12B of clip 10. This creates a force between cylindrical elements 58A and 58B of applier 50 and compressing elements 16A and 16B of clip 10 preventing detachment of clip 10 from applier 50. This force is smaller than the force required to open clip applier 50 and clip 10 attached to it.
To close clip applier 50, the tension in the wire/cable (not shown) passing through spring 52 is released. The force of hinge springs 12A and 12B is passed through compressing elements 16A and 16B to insertion links 60A and 60B. This force applies a moment on links 64A and 64B, which is opposite in direction to the moment exerted when pulling the wire/cable passing through spring 52. When that occurs interconnect links 62A and 62B and 64A and 64B and insertion links 60A and 60B move together as in
While completely releasing the tension in the pull wire allows for the applier to fully return to its original closed position, the tissue pulled and held within clip 10 prevents the clip from following the applier and fully returning to its original closed position. When this occurs, cylindrical elements 58A and 58B easily disengage from clip 10 since the hinge springs' 12A and 12B force is acting essentially on the tissue instead of on the applier.
A second embodiment of a compression clip 510 constructed according to the present invention is shown in
In clip 510, hinge springs 512A and 512B are not symmetrical, each having legs which are of different lengths. Legs 508A and 508B are longer than legs 509A and 509B. Bi-directional connectors 517 are formed at the end of legs 509A and 509B. These connectors formed substantially transversally to the body of clip 510 are sized and configured to be inserted into holes 521 on securing element 514A and holes 519 on compressing element 516A. At the end of legs 508A and 508B are hollow cylinders 532A and 532B insertable over projections 530, more fully described below.
While compressing element 516A is configured essentially as in
Over the ends of threaded bolts 536A and 536B are fitted cylindrical elements 528, the latter having complementary threads on their inner surface. Threaded bolts 536A and 536B have an attachment means 534A and 534B on their ends for insertion and joining with cylindrical elements 528. Cylindrical elements 528 are each formed with a projection 530 protruding substantially transversally to the long axis of cylindrical elements 528. Projections 530 pass through slots 538 preventing fitted cylindrical elements 528 from turning as threaded bolts 536A and 536B are turned. This forces cylinders 528 to move linearly along the long axis of compression element 516B. The threaded rod with cylinders 528 are held to compressing element 516B by plugs 526. Plug 526 on one side of the rod, the proximal side, includes a recess 524, typically, but without being limiting, a square recess, which is configured to receive a screw rotation apparatus (not shown). Projections 530 on cylindrical elements 528 are configured and sized to be inserted into hollow cylinders 532A and 532B formed on the longer legs 508A and 508B of springs 512A and 512B. The placement of legs 508A and 508B of hinge springs 512A and 512B and the relationship between plugs 526, cylindrical elements 528 and threaded bolts 536A and 536B (which when joined form the threaded rod discussed above) are best seen in
Reference is now made to
The structure and operation of clip applier 550 can best be understood by viewing
In some embodiments, tube 554 may be a spring having sufficient flexibility to advance a clip attached to applier 550 past the distal end of the endoscope.
Clip 510, for example, is inserted into a cup 556 of clip applier 550. Cup 556 typically is made of plastic or metal. Plug 526 with recess 524 (
Pushing forward releases clip 510 from applier 550. First, washer element 560 pushes clip 510 out of cup 556. Then, by pulling cable 552 towards the proximal end of the endoscope, male element 562 is released from recess 524 of clip 510, thereby fully releasing the clip from the applier.
A third embodiment of a compression clip constructed according to the present invention is shown in
From
Securing and compressing elements 614A, 614B and 616A, 616B, respectively, are essentially the same as in clip 510. Hinge springs 612A and 612B are unsymmetrical as in clip 510. Again, there is a bi-directional connector 617 on the shorter legs 609A and 609B of hinge springs 612A and 612B which are inserted into holes 621 in securing element 614A and holes 619 on compressing element 616A. Compressing element 616B is again a hollow tubular member with two slots 638. The longer legs 608A and 608B of hinge springs 612A and 612B include unidirectional connectors 624 at their ends which extend in the direction of compressing element 616B allowing for insertion into preformed holes 630 of cylindrical elements 628, to be discussed below.
Cylindrical elements 628, formed with holes 630, are insertable into and retained in hollow tubular compressing element 616B. Holes 630 of cylindrical elements 628 act as receiving recesses for connectors 624 of springs 612A and 612B. When connectors 624 are inserted into holes 630 they are movable in slots 638 and do so with the opening and closing of springs 612A and 612B. Tubular compressing element 616B is capped by plugs 626. The plug 626 distal to the user has a hole into which pin 634 is inserted.
Passing through tubular compressing member 616B are wires 639A and 639B. These wires have loops 640A and 640B at their ends configured to fit over connectors 624.
Upon viewing
After severance of the suspect tissue is effected, excess wire is cut and withdrawn from the endoscope and body.
A fourth embodiment of a surgical compression clip constructed according to the present invention is shown in
This embodiment is very similar to the embodiment shown in
The present embodiment is different from the embodiment of
The positioning of connectors 717 on the inside of arms 708 of hinge spring elements 712A and 712B effectively creates a preload that allows the clip to open wider while still applying the forces needed for the necrotic process. An alternative, or additional, technique to achieve preloading is to heat hinge spring elements 712A and 712B and shape them during manufacture.
As best seen in
Clip 710 is effectively preloaded and a gap 711 (best seen in
Gap 711, can be formed in one of many ways. Without intending to be limiting, one of these ways is by forming gap forming projections 713 (best seen in
An embodiment of a clip applier 750 that can be used with clip 710 of
Referring now to
Referring now to
In
Applier body 818 includes a first and a second guide slot 826A and 826B, respectively, and configuration controller 816 is positioned so that it rides in first guide slot 826A. Wing elements 824 of configuration controller 816 move freely in first guide slot 826A. Proximal ends 828 of applier arms 802A and 802B are positioned in and move in second guide slot 826B.
Applier arms 802A and 802B each include an attachment projection 804, a hole 806 and an arm guide slot 808. Projection 804 connects to the surgical clips in a manner similar to that shown elsewhere herein. When the proximal ends 828 of applier arms 802A and 802B are inserted in second guide slot 826B, a pin 810 is inserted through hole 829 of applier body 818 and through holes 806 in applier arms 802A and 802B. This pin acts as an axis of rotation when arms 802A and 802B are brought proximate to or spaced apart from each other. When arms 802A and 802B are inserted into guide slot 826B, projection 830 of configuration controller 816 passes through arm guide slots 808 of applier arms 802A and 802B.
Now referring additionally to
A fifth embodiment of a surgical compression clip constructed according to the present invention is shown in
Clip 70 is formed of a first arm 74 and a second arm 72 which are held apart from each other by a force exerted by a hinge spring 86 (force applier). Hinge spring 86 is made of a shape-memory material, typically, but without intending to be limiting, a Ni—Ti alloy. Arms 72 and 74 are formed having teeth 98 on their faces which lie opposite each other. The teeth are positioned so that they mesh when the arms are brought proximate to each other. The teeth can be formed as an integral part of arms 72 and 74. Alternatively, they can be formed as separate elements and connected to arms 72 and 74 by, for example, welding or by any one of many other techniques known to those skilled in the art.
Second arm 72 has a slant-shaped guide 85 attached to its distal end F. Guide 85 helps lift latch 80 so that it can snap into place as shown in
Restrictor element 94 (best seen in
A latch 80 is inserted in first arm 74 of surgical clip 70. Latch 80 has a crook-shaped end 84 and includes a straight portion 71. Crook-shaped end 84 is also described herein as an engageable end. This is intended to indicate that any construction, not necessarily a crook-shaped construction, capable of engaging with a catch as described below would also be acceptable. Latch 80 is connected to an anchor element 97 which lies inside a rectangular hole 75 (best seen in
Shown in
Attached to anchor element 97 at the non-crooked shaped end 99 of latch 80 is a cable 102 which extends through clip applier 105 past its proximal end N to the proximal end of the endoscope N (
Arms 72 and 74 may be considered to consist of both compressing elements and securing elements and in this way be subsumed into the overall rubric of the other clips discussed herein. In the Figures, each arm appears as a single piece but essentially it consists of a bar, typically but without intending to be limiting, with a rounded cross section having teeth joined to it. The toothed portion (securing element) may by welded to the round bars (compressing elements) or otherwise joined or produced as an integral part of the round bars. The round elements are typically hollow and they can be considered cylindrical. The hollow arms allow insertion therein of hinge spring 86, latch 80, and wires 90 and 102 used to operate clip 70.
These pieces include a bend 103 readily recognizable in
Pushing attachments 87 and 81 each has an applier arm slot 88 in which a pushing attachment pin 107 moves when rotating pushing attachments 81 and 87 around pin 109 (
The wire is pulled taut after the tissue has been brought completely into clip 70 in its open position; the tissue is grasped and held between arms 72 and 74 and wire 90. Continuing to pull wire 90 brings distal end F (
It should readily be understood that any other suitable catch structure can be used in place of latch hole 182. The choice of a hole here, functioning as a latch catch, should be considered as exemplary only. A protrusion with which latch 80 can engage would work equally as well. In fact, any engagement means that can engage and hold latch snout 92 of latch 80 is contemplated by the present invention.
The tissue situated between arms 72 and 74 of clip 70 prevents the clip from fully tracking clip applier 105 and returning to its completely closed position. As a result of this lack of complete tracking, applier arm projections 93 disengage from projection receptor spacings 95 by themselves and applier 105 falls away from clip 70.
As noted above, the shape-memory elements used to effect opening or closing of the compression clips described herein are typically described as hinge springs. However, these elements can more generally be classified as and called force appliers. Latch 80, because it is typically formed of shape memory materials, acts as a force applier that holds compression clip 70 closed.
Applier 105 is attached to clip 70 via applier arm projections 93 of applier arms 83 and 89 (see for example
Tissue is brought between the clip arms, the clip is closed, the lesion is severed and the site of the severed lesion is compressed between arms 72 and 74 of the clip 70 until necrosis and healing occurs. The entire process is discussed in greater detail below.
It should be noted that wire 90 is pushed forward once clip 70 approaches the suspect lesion. This relaxes wire 90 and enables the user to place it over, and/or around, the lesion. The relaxed, extended wire has a loop with an increased area through which the lesion can be pulled. With clip 70, the open arms 72 and 74 of the clip may be slid from the side of the pulled tissue after the polyp is positioned in the area between arms 72 and 74 and wire 90; this is unlike with clips 10 and 710 (
The multi-lumen sleeve element of the present invention is shown in
The distal end 152 of the insertion shaft of the endoscope includes a working channel 154, and at least one auxiliary element 157, such as optics, illumination, irrigation etc. In
When inserting the sleeve-encased endoscope into a patient, the secondary lumens 158 typically but without being limiting, are collapsed. Keeping the secondary lumens collapsed allows for a smaller profile as the endoscope is inserted into a body cavity, wending its way toward a lesion. One method of keeping the secondary lumens collapsed and substantially adjacent to the primary lumen 155 is by using bands 160, typically, but without intending to be limiting, bands made of silicone.
The multi-lumen sleeve 150 can be made of any of many different types of flexible plastics. Without intending to limit the choice of flexible plastics or elastomers, these may include polyethylene, polyurethane, polyvinyl chloride and almost any other medical grade plastic.
Secondary lumens 158 may be formed using any of several known methods for working sheet plastics; most typically the secondary lumens 158 are formed integrally with the primary lumen. The secondary lumens can be kept collapsed by directly extruding the multi-lumen sleeve with the secondary lumens in their collapsed positions. Secondary lumen(s) may also be attached to a primary lumen using one of many techniques known to those skilled in the art such as by using a suitable medical grade glue or solvent, by employing soldering, by heat treatment, or by using high frequency welding.
When using high frequency plastic welding, the secondary lumens, in their collapsed shape, are welded directly to the primary lumen. High frequency plastic welding, also known as floating welding, may be used to gently weld multiple single secondary lumens to the primary lumen producing sleeve shapes shown in
While in the embodiments described above the primary lumen is continuous, in other embodiments it need not be. In these other embodiments, the primary lumen may include holes, be net-like, etc.
Reference is now made to
Grasper 250 is made up of forceps arms 252A and 252B joined to a cable 256, the cable passing through the spring (not shown) in spring cover 266. Forceps arms 252A and 252B have at their ends forceps tips, 254A and 254B, respectively. These tips can take different shapes, e.g. tooth-shaped, ball-shaped, etc. In
Cable 256 should be made of a torsion resistant material such as, but not limited to, Ni—Ti alloys, while forceps arms 252A and 252B may also be made of Ni—Ti alloys. A superelastic and/or shape memory material is preferred because the cable and forceps need to straighten when they are pulled into the grasper transporting element prior to insertion. Similarly, they are also needed to straighten when pulling the grasped tissue into an opened surgical compression clip and rotating it over and around grasper transporting element 260. Since cable 256 must be rotated, a torsion resistant cable, such as a Ni—Ti cable is important. Ni—Ti alloys typically provide better twist resistance since they possess significant torsional stability. Additionally, Ni—Ti alloys have high elasticity which makes it easier to straighten curves with large radii of curvature. This is the situation when keeping the bent forceps or bent cable inside grasper transporting element 260.
While the above has been discussed in terms of Ni—Ti alloys, it is readily apparent to one skilled in the art that other shape-memory materials having properties similar to Ni—Ti alloys may be used as well.
Turning to
Grasper assembly 200 is activated by an actuator (not shown) situated outside the proximal end of the endoscope (see for example element 308 in
In another embodiment of grasper assembly 200, the assembly can include a plastic tube instead of a spring and spring cover 266. The tube should be flexible enough to be inserted into the GI tract through an endoscope's working channel or through one of the secondary lumens of a multi-lumen sleeve. The plastic tube needs to have relatively good resistance to torsion.
In this last embodiment, the plastic tube can be extended to include an integrally formed grasper transporting element 260 obviating the need for a separate grasper transporting element 260. A side window 262 can be formed in the plastic tube. In this embodiment, therefore, the grasper assembly includes two elements, grasper 250 and a plastic tube with a side window 262 close to its distal end.
A method for effecting full transmural resection is contemplated as part of the present invention and is illustrated in
The encased endoscope insertion shaft 300 is advanced within the body lumen until it is near the lesion, herein taken to be a polyp P in the gastrointestinal (GI) tract. (
At that point a surgical compression clip 10, and its attached applier 30, both in their closed positions, are advanced through a secondary lumen 158 of the sleeve 150 to polyp P. Clip 10 exits the secondary lumen 158 still in its closed position (
Clip 10, still in its closed position, is brought to its final position adjacent to polyp P (
A grasper assembly is then inserted into a working channel 154 of the endoscope insertion shaft 300, advanced through the shaft, and then advanced out of the distal end 152 of endoscope insertion shaft 300 to the region adjacent to polyp P (
In other embodiments, the grasper assembly, i.e. grasper (not shown) and grasper transporting element 260, is introduced via a secondary lumen 158 of the multi-lumen sleeve 150 and not through a working channel 154 of the endoscope shaft. From an operational point of view, this has no significant effect on the method described.
In yet another embodiment, the grasper assembly, clip 10 and clip applier 30 may be advanced through the same secondary lumen 158 from the proximal end of the endoscope shaft to the suspect lesion.
In yet another embodiment, the grasper assembly may be inserted into and advanced through a second working channel of the endoscopic insertion shaft.
Clip 10 is then opened by applier 30. The opened clip is positioned so as to bound polyp P so that the lesion can be pulled through the clip.
Up to this point, the grasper (not shown) remains inside its grasper transporting element 260. Now the forceps arms 252 of the grasper are ejected from grasper transporting element 260 and positioned to grasp polyp P through the open clip (
Polyp P is then pulled by forceps arms 252 into the separated compressing and securing elements 16A, 16B and 14A, 14B, respectively, of open clip 10. This is shown in a top side view in
After, or simultaneously with, pulling polyp P, the polyp is rotated over and wrapped around grasper transporting element 260. This rotation is shown in an isometric view in
Clip applier 30 then closes clip 10 around the pulled and rotated polyp P (
Polyp P wrapped around grasper transporting element 260 and compressed by clip 10 is severed by a severing device 310 shown being positioned close to polyp P (
After severance of polyp P, the severed polyp held by the forceps arms of the grasper, together with the remainder of the grasper assembly, the severing device 310 and the endoscope shaft, are retracted in the direction of the proximal end of the endoscope and withdrawn from the body. Withdrawal directly from the body organ is a straight-forward step, and therefore this step of the method is not presented in a separate Figure. Polyp P can then be biopsied or treated as needed by a physician.
The closed surgical compression clip 10 remains around that portion of the GI wall from which the tissue was resected (
The above described method may be operative when employing most of the clips designed according to embodiments of the present invention.
However, clip embodiment five discussed in conjunction with
The method for using the clip described in conjunction with
Additional or modified steps when using clip embodiment five include:
Insertion of clip 70 in its closed position together with its applier 105;
Releasing the force exerted by applier 105 allowing hinge spring 86 to spread apart arms 72 and 74 of clip 70;
Pushing wire 90 forward and extending it to form a loop;
Placing the wire 90 loop over the polyp;
Pulling the polyp with a grasper through the loop created by the extended wire;
Positioning the arms 72 and 74 of clip 70 in their open position and bringing them around the side of the polyp rather than positioning the clip from the top of the polyp as with other clips discussed in the present invention;
Alternatively, the clip may be positioned in proximity to the polyp, after which the polyp is pulled between the open clip arms using a grasper;
Pulling wire 90 taut thereby preventing the polyp from escaping from between arms 72 and 74:
Closing arms 72 and 74 by continuing to pull wire 90 and/or using applier 105, and pulling cable 102 until latch 80 snaps over the second clip arm and latches therewith;
Detaching the anchor element 97 which anchors wire 90 to arm 74; and
Pressing applier 105 slightly to release the applier.
The above step of pulling the polyp with a grasper is optional since in most situations wire 90 loop by itself can be maneuvered to encompass, grasp and pull the polyp or its stalk.
Positioning the clip from the side as discussed above is a result of the polyp being encompassed by wire 90 when the latter is in its extended position. When made taut, the wire effectively pulls the polyp from a lateral position into the waiting open arms 72 and 74 of clip 70.
Generally, insertion of closed clip 70 is effected through a secondary lumen of a multi lumen sleeve, but it also may be advanced through a working channel of the endoscope. The step of applying applier 105 occurs only after clip 70 has exited the secondary lumen or working channel.
It is readily understood by one skilled in the art that a full thickness resection with wide lateral areas (margins) is very difficult to achieve using conventional surgical approaches and employing conventional surgical instruments. This is particularly true of large polyps and especially large sessile polyps. Grasping and pulling a large section of a generally slippery, polyp is very difficult especially given the limited space available in the body lumen for manipulation of the tissue. In order to overcome this difficulty, the step of rotating taught by the method of the present invention is useful. Additionally, a specially designed grasper assembly as described herein is used to effect and execute the step of rotating. Both the grasper assembly and step of rotating may be used to ensure that the entire polyp plus an adequate margin is resected.
In a previous embodiment of the tissue grasper a mechanically operated instrument was described. Typically, at least one portion of the grasper included a shape memory material. In a second embodiment of the tissue grasper, rather than using mechanical grasping of the tissue to be resected, a vacuum-based tissue grasper assembly is contemplated. The vacuum-based grasper assembly is also capable of grasping and pulling a large section of a generally slippery, polyp sufficient for a full transmural resection with a large margin.
The vacuum-based tissue grasper assembly is shown in
Typically, but without intending to be limiting, vacuum cup 1022 is cup-shaped as in
Typically vacuum cup 1022 is formed of a resilient plastic such as polyurethane, polyvinyl chloride, or other medical grade polymeric materials. The other parts of vacuum-based grasper assembly 1000 are formed of polymeric plastics, metals or a combination of both. Cup transporter 1020 is formed as a spring having an inner coating for reducing friction between itself and vacuum cup 1022. The spring allows for easier articulation of the vacuum cup 1022 when manipulated by articulation wire 1026. Flexible plastic tubes, specially cut metal tubes, and even tubes made from Ni—Ti alloys can be used as alternatives to a spring for allowing easier articulation. The materials noted above are exemplary only and not intended to be limiting.
As can be seen in
The encased endoscope insertion shaft 300 is advanced within the body lumen until it nears the lesion, herein taken to be a polyp P in the gastrointestinal (GI) tract (
At that point, a surgical compression clip 10, and its attached applier 30, both in their closed positions, are advanced through a secondary lumen 158 of sleeve 150 to polyp P. Clip 10 exits the secondary lumen 158 still in its closed position (
A vacuum-based grasper assembly, such as the one discussed in conjunction with
In other embodiments, the grasper assembly is introduced via a working channel 154 of the endoscope insertion shaft and not through a secondary lumen 158 of the multi-lumen sleeve 150. From an operational point of view, this has no significant effect on the method described.
In yet another embodiment, the grasper assembly, clip 10 and clip applier 30 may be advanced through the same secondary lumen 158 from the proximal end of the endoscope shaft to the suspect lesion.
In yet another embodiment, the vacuum-based grasper assembly may be inserted into and advanced through a second working channel of the endoscopic insertion shaft.
Clip 10 is then opened by applier 30 so as to allow the pulling of polyp P through the clip.
Until clip 10 is opened and positioned close to polyp P, the grasper remains within connector tube 1024 inside lumen 158. After clip 10 is opened, vacuum cup 1022 advances out of lumen 158 and opens in stages similar to those shown in
Polyp P is then pulled by vacuum cup 1022 into separated compressing and securing elements 16A, 16B and 14A, 14B, respectively, of open clip 10. This is shown in a top side view in
While what is described herein above refers to an articulation wire, any element capable of causing articulation of vacuum cup 1022 may also be used.
Unlike the mechanical grasper assembly discussed in conjunction with
Clip applier 30 then closes clip 10 around pulled polyp P (
Polyp P compressed by clip 10 is severed by a severing device 310 shown being positioned close to polyp P (
After severance of polyp P, the severed polyp held by the vacuum cup 1022 of the grasper, together with the remainder of the grasper assembly, the severing device 310 and the endoscope shaft, are retracted in the direction of the proximal end of the endoscope and withdrawn from the body. Withdrawal directly from the body organ is a straight-forward step, and therefore this step of the method is not presented in a separate Figure. Polyp P can then be biopsied or treated as needed by a physician.
The closed surgical compression clip 10 remains around that portion of the GI wall from which the tissue was resected (
In the above discussion of the present invention, the invention has been described as being used in bowel polyp resections. It should be evident to one skilled in the art that other types of lesions, in other organs in other organ systems, can also be resected using the present invention with little or no modification. Such organs include, but are not limited to, the urinary bladder and other organs of the urinary tract, the uterus, the liver, the esophagus, the gall bladder, the lungs and the rectum.
In the above discussion, the system and method of the present invention have been described as being used in endoscopic procedures which do not require a direct incision into the body cavity. The system and method as described herein above has been described as being inserted into the body cavity through one of the body's existing orifices. However, it is readily understood by those skilled in the art that the system and method described herein above can be used in open surgical procedures with little or no modification, where the point of entry of the system is an incision into the body cavity.
It should be readily apparent to one skilled in the art that the device and method of the present invention can be used to excise animal tissue as well as human tissue, particularly, but without being limiting, tissue of other mammalian species.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.
It will be appreciated by persons skilled in the art that the present invention is not limited by the drawings and description hereinabove presented. Rather, the invention is defined solely by the claims that follow.
This application claims the benefit of U.S. Provisional Application No. 60/780,446, filed Mar. 9, 2006.
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