Patent Application
20100331862
The present invention relates to the field of tissue compression employing surgical clips.
Several methods are known in the art for joining tissue portions requiring tissue closure, particularly in the gastrointestinal (GI) tract. Methods for joining severed tissue or tissue deficiencies as a result of excisions are known. These include threads for manual suturing, staplers for mechanical suturing, tissue adhesives and compression rings and clips.
While manual suturing is a time tested, universally known and relatively inexpensive technique, the degree of success depends considerably on the skill of the surgeon. Another disadvantage of this technique is that post-operative complications are common Further, suturing an organ results in lack of smoothness of the sutured tissue. When the sutured organ is part of the gastrointestinal tract, the sutural scar tissue hampers peristalsis in the sutured area. Suturing involves a foreign body reaction while the tissue is healing which may also affect recurrence rates in cancer patients. Finally, suturing is both labor and time consuming and, when performed endoscopically, is also technically complicated.
Increasingly, stapling is being used for suturing. Staples for mechanical suturing ensure a reliable joining of tissue and reduce the time needed for surgery compared with manual suturing. However, after healing, metal staples remain in place along the perimeter of the suture, which reduces elasticity of the junction and adversely affects peristalsis when the sutured organ is part of the gastrointestinal tract. These complications often lead to strictures and inflammatory reactions to the foreign bodies left behind. Staples also often lead to undesired leakage of blood and other body liquids into the region of resected tissue which leads to a local inflammatory process and may result in severe infection. Additionally, stapling mechanisms generally are relatively large and fairly rigid, limiting the maneuverability of an endoscope used in conjunction with the stapling mechanism. This lack of maneuverability restricts an endoscopic approach to many locations within the body.
Junctions using compression devices, such as rings (or loops) and clips, ensure the best seal and allow for ideal post-operative function of organs. The compression force exerted by compression rings and clips is applied at the junction and decreases as the tissue is crushed and its thickness is reduced. Their design is cheap and they are small in size. Moreover, when used in the GI tract they are often self-evacuated.
A major disadvantage of known clips is that they permit compression of only approximately 80-85% of the junction perimeter, thus requiring additional manual sutures. This reduces the integrity of the seal of the junction during the healing period and its elasticity during the post-operative period. Furthermore, additional suturing is problematic inasmuch as it has to be carried out across a joint which includes a portion of the clip, thereby rendering difficult sealing and anastomosis of the organ portions.
The compressive force exerted by clips generally is not equal at both ends of the clip because of the clip's typically asymmetric construction. This can lead to the clip disengaging from the closure site before hemostasis is complete and before scar tissue is mature.
Typically, clips do not necessarily have a securing mechanism against slipping off the tissue. In clips that do have a securing mechanism, the compression line is collinear with the securing line, the latter formed by, and positioned between, the securing elements holding the tissue to be compressed. This can lead to compromised tissue healing and, in cases where securing elements penetrate the tissue, to leakage or bleeding. Clips, as currently designed, may also affect the maneuverability of an endoscope.
Perforations in organs may be caused by ulcers, neoplasms, infection, trauma and other pathological processes and may be iatrogenic in nature. These may occur in various systems such as the gastrointestinal tract, the urinary tract, the vaginal cavity, the peritoneal cavity and others. Surgical treatment of perforations or repair of incisions and fistulas in these systems, whether as a result of a pathology or as a result of an iatrogenic procedure, often requires the closure of large openings or excisions.
Additionally, natural orifice transluminal endoscopic surgery (NOTES) which obviates the need for cutting through the abdominal wall, is a new and promising surgical technique. In NOTES, an incision is made from within a natural orifice, for example the GI tract or other body lumen, to reach the peritoneal cavity or other organs. While methods for joining tissue portions or repairing of tissue perforations are known, they suffer from many of the drawbacks noted above. Likewise, solutions for joining tissue portions adjacent to tissue excised in a NOTES procedure that are superior to solutions currently available will be required.
Closing perforations and openings after iatrogenic procedures including NOTES or as a result of pathological processes all require wound closing instruments, systems and methods to prevent leakage into the peritoneal cavity or other body organs. In a recent meeting of a group of surgeons from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and gastroenterologists from the American Society of Gastrointestinal Endoscopists (ASGE), a framework for the initial safe application of NOTES procedures was discussed and worked out. It was agreed that further expansion of the use of NOTES procedures depends inter alia on an effective collaboration with industry. Development of effective instruments allowing traction/countertraction and stable optical platforms, as well as the means to control hemostasis, securely close the visceral wall, and perform suturing functions and gastrointestinal anastomoses were deemed critical.
Hemorrhoids, when surgically removed by procedures other than heat, laser or infrared instruments, employ suturing, stapling and rubber ligation bands. Challenges outlined above for suturing and stapling also apply to suturing and/or stapling in hemorrhoidectomies. Additionally, rubber ligation bands purse tissue which often leads to bleeding and/or rugged scar formation. In addition, in most cases band ligation does not deal with the root cause of the hemorrhoid, i.e. the feeding blood vessel.
A new compression clip and a system and method for its use would therefore answer long standing problems in several surgical areas where compression is the best way to accelerate wound healing.
“Proximal” relates to the side of a clip or device closest to the user, while “distal” refers to the side of a clip or device furthest from the user.
“Lesion” may be used in place of the word “polyp” “perforation”, hemorrhoids, tissue adjacent to a resected site, or openings within tissue generated by any surgical procedure or occurring naturally, without any intent at differentiating between these different types of lesions, except where specifically indicated or otherwise obvious from the context of the relevant discussion in the text. Ulcerous lesions may also be subsumed under the term “lesion” discussed herein when the context of the discussion admits of that possibility.
“Gastrointestinal tract” or its equivalents are used in the specification and claims without any intent at being limiting. Other organ systems, and lesions found therein, are also contemplated as being treatable with the compression clips, devices and methods described in the present specification.
“Hinge spring” is one type of 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 is based on, their being formed from and possessing the force applying properties of shape-memory materials. Hinge springs may be described herein as “hinge members”, “force means” and “force members”, again, without any attempt at differentiating between these terms except where specifically indicated.
The present invention seeks to provide an improved surgical compression clip, as well as a system and method for its use, having force appliers/force means formed of a shape memory alloy material. These clips may be used for joining tissue portions at the site of a tissue opening or excision, as well as in a method for closing various other types of organ perforations. These clips may be used inter alia in gastrectomies, polypectomies, surgical treatment of intestinal and gastric perforations, natural orifice transmural endoscopic surgery (NOTES) procedures, and gastroplastic procedures. The systems and methods here may even be applied to surgeries that generally are not thought of in purely tissue closure terms, such as hemorrhoidectomies. In general, they can be used in all cases where compression is needed.
It is an object of the present invention to provide a surgical compression clip which exerts a constant compressive force irrespective of the thickness of the tissue being compressed, and its changes in thickness during the wound healing process. Such a clip thereby reduces the chances of liquid leakage during compression and ensures necrosis in an aseptic environment, and faster healing and closure of the tissue around an opening or other type of lesion.
It is a further object to provide a clip which is not left within the body after tissue closure is complete.
Another object of the present invention is to provide a non-unitary surgical clip which exerts a substantially slowly changing compressive force along a line between its linear compressing elements which provides a compressive force over large elongations. Since the compression is effected along a continuous line, undesired post-surgery fluid leakage and bleeding is prevented. Such a continuous line is difficult to attain when using surgical staples.
Another object of the present invention is to use compression clips for compressing that exert pressure along a compression line that is closer to the base of the lesion than is the clip's securing line. This assists in reducing leakage of bodily fluids.
It is a further object of the present invention to provide a surgical compression clip, and a system for applying the clip, that reduces the risk of tissue perforation by a clip.
The surgical clips described herein may find particular use in various types of 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 use with a surgical compression clip for compressing tissue thereby inducing necrosis in the compressed tissue and subsequent healing of the tissue adjacent to the compression site. The clip comprises a pair of compression elements and one or more force applier element formed of a shape memory material, the clip having an open position and a closed position and configured to receive tissue to be compressed therethrough when in its open position. The force applier element is operative for providing a force to the compressing elements, and the compressing elements are operative to apply a compression force to the tissue to be compressed when the clip is closed thereabout, so as to cause first tissue necrosis, closure and then healing of the tissue around the compression site. The system includes: an endoscope having an insertion shaft having one or more channel; a multi-lumen sleeve having a primary lumen encasing the endoscope insertion shaft, and one or more secondary lumen; a clip applier for advancing the clip through a working conduit and for positioning the clip near the tissue to be compressed, wherein the working conduit is a preselected one of (i) the one or more channel of the insertion shaft and (ii) the one or more secondary lumen of the multi-lumen sleeve; and a grasper assembly selectably extendible through the working conduit, for engaging and pulling the tissue to be compressed through the clip when the clip is in its open position.
In one embodiment of the system 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 pins 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 of the present invention the compression clip includes a threaded bolt inside a compression element, 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 still another embodiment of the system, the at least one force applier element is two force applier elements and the compression clip includes a compression element and one or more connector elements on each of the two force applier elements, and wherein 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 moves to its closed position from its open position when the wires are released.
In another embodiment of the system the grasper assembly 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 tissue to be compressed; and a wire in mechanical connection with and for controlling and maneuvering the forceps arms and for bringing the forcep arms from their closed position to their open position and vice versa; and a grasper transporting element for transporting the grasper in its closed position to a location near the portion of the tissue to be compressed whereat the grasper is ejected from the transporting element allowing the forcep arms to open to their open position. In some instances of this embodiment the one or more of the wire and the forceps arms includes a bend, the bend facilitating grasping and pulling the tissue to be compressed through the clip. In some instances of this embodiment the one or more of the wire and the forceps arms is formed at least partially of a shape memory material.
In another embodiment of the system the grasper assembly includes: 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 site of the tissue to be compressed where the vacuum cup is ejected from the transporting element allowing the vacuum cup to open to its open position; and articulation means for bringing the vacuum cup to the site of the tissue to be compressed 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 system for compressing tissue to induce necrosis and subsequent healing of the tissue around the compression site. The system comprising: an endoscope having an insertion shaft having one or more channel; a multi-lumen sleeve having a primary lumen encasing the endoscope insertion shaft, and one or more secondary lumen; a compression clip having an open position and a closed position, the clip configured to receive tissue to be compressed therethrough when in its open position, and operative to apply a compression force thereto when closed thereabout; a clip applier for advancing the clip through a working conduit and for positioning the clip near the tissue to be compressed, wherein the working conduit is a preselected one of (i) the one or more channel of the insertion shaft and (ii) the one or more secondary lumen of the multi-lumen sleeve; and a grasper assembly selectably extendible through the working conduit, for engaging and pulling the tissue to be compressed, the engaged tissue being positioned in the clip when the clip is in its open position, wherein the compression clip is operable to compress the tissue extending therethrough, thereby inducing necrosis and subsequent healing of the tissue around the compression site.
In one embodiment in this second system of the present embodiment, the compression clip further includes a pair of generally elongated compressing elements for compressing the tissue to be compressed, the compressing elements formed and configured for being disengageably joined to the clip applier. In some instances of this embodiment, the compression clip includes one or more shape memory force applier elements formed of shape memory material, the one or more force applier element operative for providing a force to the pair of compressing elements for compressing tissue held therebetween. In some embodiments the compressing elements and the one or more shape memory force applier element form a planar configuration in both the clip's open and closed positions and the compressing elements of the surgical clip apply a compressive force to the tissue to be compressed, the compressive force acting in the plane of the clip and in a line between the compressing elements. In some instances of this embodiment, the system further includes a pair of generally elongated securing elements and wherein the one or more shape memory force applier element is positioned between, and in mechanical connection with, the operatively associated securing and compressing elements, and wherein the one or more shape memory force applier element 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 and wherein an axis of securing for holding the tissue to be compressed is formed by, and is tangential to, the securing elements and an axis of compression for compressing tissue to be compressed is formed by, and tangent to, the compression elements, the lines of securing and of compression not being collinear lines. In some of this cases of this last embodiment the securing and compressing elements are substantially linear elements.
In another embodiment of the second system, 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 therebetween the tissue to be compressed, the securing elements operationally associated with the compressing elements, the securing elements 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 the last embodiment of the system the securing and compressing elements are substantially linear elements.
In yet another embodiment of the herein above mentioned second system of the present invention, the grasper assembly includes a grasper having a closed and an open position, the grasper including: forceps arms for grasping and pulling the tissue to be compressed; 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 a grasper transporting element for transporting the grasper in its closed position to a location near the tissue to be compressed 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 the one or more of the wires and the forceps arms includes a bend, the bend facilitating grasping and pulling the tissue to be compressed through the clip. In some instances of this embodiment the one or more of the wires and the forceps arms is formed at least partially of a shape memory material.
In yet anther embodiment of the second system of the present invention, the grasper assembly includes: 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 tissue to be compressed where the vacuum cup is ejected from the transporting element allowing the vacuum cup to open to its open position; and articulation means for bringing the vacuum cup, when in its open position, to the tissue to be compressed for engaging the tissue under a suction force, and for subsequently pulling the tissue through the surgical clip.
In a further embodiment of the system the clip further includes a pair of compressing elements and at least two shape memory force applier elements formed of shape memory material where 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 exerting a force on the tissue to be compressed when the tissue is held between the compressing elements. In some instances of this last embodiment, the clip further includes a wire snare.
In a still further embodiment of the second system the compression clip comprises a pair of generally linear compression elements for securing tissue therebetween and for applying to the secured tissue a compression force, wherein the compression clip has an initial, open position in which the linear compression elements may be positioned about the tissue to be secured therebetween, and a final, closed position whereat the compression elements are substantially parallel to each other, thereby to apply a compressive force to the secured tissue; and force means formed from a shape memory material and disposed between the pair of compression elements and operative to transmit operational forces therebetween. In some instances of this embodiment, the force means includes one or more one active hinge members disposed between the linear compression elements.
In yet another embodiment of the system the endoscope is selected from a group of instruments consisting of a rigid instrument or a flexible instrument.
In another embodiment of the system the endoscope is selected from a group of instruments consisting of: a gastroscope, a laparoscope, a colonoscope, a rectoscope, a bronchoscope, a urethroscope, and a hysteroscope.
In still another embodiment of the system, the tissue to be compressed is selected from a group consisting of: tissue adjacent to a disease-induced perforation of an organ wall; tissue adjacent to a perforation in the stomach wall resulting from a gastrectomy procedure; tissue adjacent to a perforation in an organ wall resulting from a natural orifice transmural endoscopic surgical (NOTES) procedure; stomach tissue, the compression of which is required to reduce stomach volume in a gastroplastic procedure; gastric tissue adjacent to an ulcerous lesion; duodenal tissue adjacent to an ulcerous lesion; esophageal tissue adjacent to an ulcerous legion; other tissue adjacent to an ulcerous lesion; rectal tissue adjacent to hemorrhoids that are ligated by the clip; and other tissue compressed and ligated by the clip.
In another embodiment of the system of the present invention, when the compression clip is in its open position the clip is positioned around the tissue grasped and pulled by the grasper assembly.
In yet another embodiment of the system of the present invention the grasped and pulled tissue to be compressed is brought by the grasper assembly into the clip when the clip is in its open position.
In a further aspect of the present invention there is provided a method for compressing tissue thereby inducing necrosis in the compressed tissue and subsequent healing of the tissue surrounding the compression site. The method includes the steps of: placing an endoscope in a body cavity and advancing the endoscope to and positioning it near the site of the tissue to be compressed; positioning a compression clip near the site of the tissue to be compressed; and extending a grasping instrument for grasping and pulling the tissue to be compressed, the grasped tissue being positioned in the compression clip when the clip is in its open position and compressed when the clip is in its closed position thereby producing necrosis in the compressed tissue and then healing of the tissue surrounding the compression site.
In an embodiment of the method, the method further includes the step of opening the compression clip prior to the step of extending and also further including the step of closing the compression clip after the tissue to be compressed has been positioned within the open clip by the grasping instrument thereby to compress the tissue. In some instances of this embodiment the step of positioning includes positioning the clip around a perforation in the tissue to be compressed and then in the step of closing compressing the tissue around the perforation thereby causing closure of the perforation.
In yet 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 site of the tissue to be compressed.
In still another embodiment of the method, claim 30, the step of extending the grasping instrument is advanced and brought to the site of the tissue to be compressed 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 the tissue to be compressed 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 site of the tissue to be compressed.
In another embodiment of the method, 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 the tissue to be compressed 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 site of the tissue to be compressed.
In still another embodiment of the method, in the step of extending the grasping instrument is advanced and brought to the site of the tissue to be compressed through a working channel of the endoscope and in the step of positioning the compression clip is advanced and brought to the site of the tissue to be compressed 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 site of the tissue to be compressed.
In another embodiment of the method of the present invention, 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 step of extending precedes the step of positioning and in the step of positioning the clip is positioned around the grasped and pulled tissue to be compressed.
In still another embodiment of the method, the tissue to be compressed is selected from a group consisting of: tissue adjacent to a disease-induced perforation of an organ wall; tissue adjacent to a perforation in the stomach wall resulting from a gastrectomy procedure; tissue adjacent to a perforation in an organ wall resulting from a natural orifice transmural endoscopic surgical (NOTES) procedure; stomach tissue, the compression of which is required to reduce stomach volume in a gastroplastic procedure; gastric tissue adjacent to an ulcerous lesion; duodenal tissue adjacent to an ulcerous lesion; esophageal tissue adjacent to an ulcerous legion; other tissue adjacent to an ulcerous lesion; rectal tissue adjacent to hemorrhoids that are ligated by the clip; and other tissue compressed and ligated by the clip.
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 invention describes a system for the use of non-unitary surgical compression clips, in various tissue compressing surgical procedures. These procedures include full or partial excisions and partial resections or tissue closure. These situations all require good compression for tissue necrosis and healing. The compression is critical for the initiation of a necrotic process at the compression site yielding tissue closure. Healing is dependent on continuously compressing the tissue at the resection, perforation, or lesion site, and is independent of the variation of tissue thickness. Compression lessens the likelihood of internal leakage of bodily fluids, or bleeding, which often occurs when staple suturing is used.
These clips, when used with the system of the present invention, also lessen the likelihood of bleeding and assist in rapid healing in surgical procedures were there are dilated blood vessels, such as in hemorrhoidectomies and non-full thickness resections of, for example, pedunculated GI polyps. Preventing leakage is also critical in gastrectomies and gastroplastic procedures as well as surgical treatment of intestinal and gastric perforations. The system and clips used therewith may also be used to induce necrosis and subsequent healing with naturally occurring lesions such as ulcers.
The non-unitary, i.e. compound, surgical compression clip described herein, typically has one or more elements, generally two or more elements, made of a shape-memory material, such as a nickel-titanium (Ni—Ti) alloy. The clip includes two compressing elements connected operationally by at least one of the shape-memory elements. Typically, the clip also includes securing elements with which to hold the tissue being compressed. Also typically, the compressing elements are linear as are the securing elements. When tissue to be joined is held between the two compressing elements, a constant compressive force acts between the two elements, these latter being connected at both of their ends by the shape-memory elements. The slowly changing force is a result of the well-documented long plateau region of the shape-memory material's stress-strain hysteresis curve. The force is slowly changing constant irrespective of deformation in the deformation range of the plateau. 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.
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 shape-memory elements, which act as a force applier, are typically made of nickel-titanium (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 compression clips described herein are attached to an applier and brought to tissue adjacent to a resection site, or to tissue adjacent to a perforation to be joined, or to tissue having an opening requiring closure, or to any tissue requiring compression.
No foreign bodies are left behind in the body cavity after healing as the clip is typically self-evacuating.
The surgical clips described herein may be used with standard commercially available endoscopes. Dedicated or specially designed endoscopes may be used but are not required.
Current clips which are delivered to a treatment site using an endoscope or other medical instrument are typically limited in size. Accordingly, all currently contemplated solutions for NOTES are sutures-based. However, endoscopic suturing is not commonly used and is very complicated technically. It is envisioned that the larger size of the clips discussed in the present invention will allow the closure of larger tissue openings. Similarly, the clips of the present invention should be able to close tissue openings in organs with thicker tissue such as the stomach. Additionally, perforations that may require multiple smaller clips should be able to be closed with a single clip.
Additionally, grasper assemblies for bringing sufficient tissue to ensure adequate compression resulting in closure of surgically produced or naturally occurring openings or perforations in a body lumen, or compression of tissue at a resection site or compression of a lesion, e.g. hemorrhoid and ulcers, are also described. The grasper assemblies describe herein can be used to grasp many different types of lesions contemplated as treatable with the clips of the present invention. These include, but are not limited to polyps, perforations—naturally occurring and surgically induced—and hemorrhoids. These also include excisions performed by NOTES procedures or stomach volume reduction resulting from a gastroplastic procedure. In general, larger tissue openings can be closed with the grasper assemblies and the compression clips taught herein below than can be closed with prior art systems and clips.
Additionally, using the compression clips of the present invention is not limited to any particular direction or shape of resection incision; both radial and longitudinal incisions are contemplated by the present invention.
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 14B 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
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.
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 or closed, a vacuum-based tissue grasper assembly is contemplated. Like the mechanical grasper assembly, the vacuum-based grasper assembly is also capable of grasping and pulling a large section of a, generally slippery, polyp extending from an organ wall, or other type of lesion, sufficient for resection and/or closure. Also like the mechanical grasper, the vacuum grasper can be employed in general tissue closing surgical procedures.
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 are not intended to be limiting.
A method for effecting resection of, for example a pedunculated polyp in the GI tract, using the compression clips of the present invention is illustrated in
The method of operation of the clips, their applier systems, and the grasper assemblies of the present invention in other situations, such as where only tissue closure is required or in a hemorrhoidectomy, is similar to the method shown in
It should also be readily understood by one skilled in the art that certain features and working instruments shown 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 (
Closed clip 10 is then brought to its 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 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 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 252A and 252B 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 252A and 252B 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
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 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. Using applier 105 to open clip 70 occurs only after clip 70 has exited the secondary lumen or working channel.
It is readily understood by one skilled in the art that 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 the present method, a specially designed grasper assembly as described herein is used. The grasper assembly is used to ensure that the entire polyp plus an adequate margin is resected.
The vacuum-based grasper assembly discussed above in conjunction with
As can be seen 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 typically 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 (
Closed clip 10 is then brought to its final position adjacent to polyp P. (
A vacuum grasper assembly, such as vacuum grasper assembly 1000 shown in
In other embodiments, the vacuum grasper assembly is introduced via a working channel 154 of the endoscope insertion shaft 300 and not through a secondary lumen 158 of 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.
Clip 10 is then opened by applier 30 (
Up to this point, vacuum cup 1022 remains inside its grasper transporting element 1020. Now vacuum cup 1022 of the grasper assembly 1000 is ejected from grasper transporting element 1020 and positioned to grasp polyp P through the open 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. Using an articulation wire to maneuver flexible cup transporter 1020, here formed having a spring construction, vacuum cup 1022 is positioned to grasp polyp P through open clip 10 (
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.
Polyp P is then pulled by vacuum cup 1022 into the separated compressing and securing elements 16A, 16B and 14A, 14B, respectively, of open clip 10 which is then closed. This is shown in
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, 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 using a vacuum-based grasper assembly 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
Reference now is made to
In another application of the system and method of the present invention there is presented in
Gastroplastic surgical procedures are used to reduce the volume of the stomach in order to encourage weight loss in obese individuals. A portion of the stomach is grasped, pulled and held within a compression clip 10 as shown in
In the discussion in conjunction with
Typical lesions which may be compressively closed according to the system and method of this invention include: tissue adjacent to a disease-induced perforation of an organ wall; tissue adjacent to a perforation in the stomach wall resulting from a gastrectomy procedure; tissue adjacent to a perforation in an organ wall resulting from a natural orifice transmural endoscopic surgical (NOTES) procedure; stomach tissue, the compression of which is required to reduce stomach volume in a gastroplastic procedure; gastric tissue adjacent to an ulcerous lesion; duodenal tissue adjacent to an ulcerous lesion; esophageal tissue adjacent to an ulcerous legion; other tissue adjacent to an ulcerous lesion; rectal tissue adjacent to hemorrhoids that are ligated by the clip; and other tissue compressed and ligated by the clip. This list is not intended to be limiting.
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.
“Endoscope”, as used herein, contemplates the use of the present invention with all different types of invasive instruments, flexible or rigid, having scope features. These include, but are not limited to, instruments referred to as endoscopes, gastroscopes, laparoscopes, colonoscopes, rectoscopes, bronchoscopes, urethroscopes, and hysteroscopes. Such instruments, as is readily known to those skilled in the art, are subsumed within the term endoscope. The present invention, while discussed in terms of general endoscopes can readily be adapted for use with each of these specific instruments with little or no modification. It should also be noted that the use of the term “endoscopic” is to be construed as referring to the many different types of invasive scopes subsumed under the term endoscopes. As known by those skilled in the art the term “invasive” denotes a medical procedure requiring insertion of an instrument or device into the body through the skin or a body orifice for diagnosis or treatment.
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.
The present application claims priority rights from “Tissue Compression Using Surgical Clips”, U.S. Provisional Application 60/897,842, filed Jan. 29, 2007; “Endoscopic Full Thickness Resection Using Surgical Compression Clips”, U.S. patent application Ser. No. 11/647,912, filed Dec. 29, 2006; and “Surgical Compression Clips”, U.S. patent application Ser. No. 11/647,913, filed Dec. 29, 2006. The present invention is a continuation-in-part of U.S. patent application Ser. No. 11/647,912, filed Dec. 29, 2006.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IL2007/001619 | 12/27/2007 | WO | 00 | 6/29/2009 |
| Number | Date | Country | |
|---|---|---|---|
| 60780446 | Mar 2006 | US | |
| 60780446 | Mar 2006 | US | |
| 60897842 | Jan 2007 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11647913 | Dec 2006 | US |
| Child | 12521597 | US | |
| Parent | 11647912 | Dec 2006 | US |
| Child | PCT/IL2007/001619 | US |
