US20090043317A1 - Method and apparatus for delivery of a ligating suture - Google Patents
Method and apparatus for delivery of a ligating suture Download PDFInfo
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- US20090043317A1 US20090043317A1 US12/187,486 US18748608A US2009043317A1 US 20090043317 A1 US20090043317 A1 US 20090043317A1 US 18748608 A US18748608 A US 18748608A US 2009043317 A1 US2009043317 A1 US 2009043317A1
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- suture
- armature
- protrusion
- medical
- distal end
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0467—Instruments for cutting sutures
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
- A61B2017/0448—Additional elements on or within the anchor
- A61B2017/0451—Cams or wedges holding the suture by friction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B17/2909—Handles
- A61B2017/2912—Handles transmission of forces to actuating rod or piston
- A61B2017/2923—Toothed members, e.g. rack and pinion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B2017/2926—Details of heads or jaws
- A61B2017/2932—Transmission of forces to jaw members
- A61B2017/2939—Details of linkages or pivot points
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B90/361—Image-producing devices, e.g. surgical cameras
Abstract
An apparatus for ligating a medical protrusion comprises a ligating suture having a proximal end and a distal end configured to circumscribe the medical protrusion, and a one-way lock positioned there between. The apparatus further comprises an endoscope, a cutter blade configured to cut the suture, and a device for ligating a medical protrusion. The device comprises a tubular body having a proximal end and a distal end, a handle positioned at the proximal end, an endoscope controller operably connectable to the endoscope, a cutting controller operably connectable to the cutter blade, a suture controller configured to be operatively coupled with the suture, a curved bridge positioned at the distal end, the bridge having a proximal end and a distal end, and an armature, having a proximal end and a distal end, configured to releaseably retain at least a portion of the suture.
Description
- This application claims benefit of U.S. provisional patent application Ser. No. 60/963,958, filed Aug. 8, 2007, which is herein incorporated by reference.
- The invention relates to a device or apparatus, systems and methods for medical tissue protrusion removals, and more specifically, to methods for ligating medical tissue protrusions.
- Nasal polyps are an outgrowth of sinus linings that protrude into the nasal cavities, and are the result of nasal allergy infection and other causes of nasal obstruction, which interrupts the normal function of the sinuses. The nasal blockage caused by polyps further impairs the passage of air through the nasal passages leading to infection, snoring, loss of taste, and disorders of sleep. Furthermore, the nose and sinuses are vital anatomical parts to breathing: they allow incoming air to be warmed, cleaned, and moisturized for transport into the lungs. Therefore, removal of nasal polyps by surgical intervention eliminates obstruction and restores nasal and sinus function. This is critical to respiratory health.
- Because removal of polyps, most of which originate in the deep recesses of the nose, demands utilization of a surgical operating team and appropriate anesthesia in a surgical suite, the procedure is costly, inconvenient and associated with the usual post-operative problems such as bleeding, infection, pain, slow recovery and anesthetic side effects.
- The present surgical procedure for nasal polyp removal in a blind area is to identify the size and origin of the polyp using an endoscope (light source and lens viewing) and, after stabilizing the tissue to be removed, use a cutting device, ligature and/or cautery to free the protruding lesion from its base, stop bleeding, and extract the polyp from the cavity with a surgical snare. The tissue removal requires several surgical procedures: endoscopy, tissue removal and hemostasis with different instruments prior to extraction of the tissue. Each of these procedures involves time and tissue manipulation utilizing instruments that are single-purpose tools. They cannot be used jointly and, because of the size of the operative field, they need to be used one after another for the planned surgery. In fact, during the tissue removal process, each instrument must be available simultaneously for quick, effective, trouble-free extraction. The presence of post operative bleeding which demands nasal packing is the most troublesome complication for patient and surgeon.
- Systems currently in practice almost exclusively remove the nasal polyp by cutting and cauterizing the base which demands use of a surgical suite and anesthesia. No workable substitute system including the use of a non-surgical technique such as ligature application for compression of the polyp base exists.
- Since the origin of most nasal polyps is within the sinus cavity, not the nose, the base of the polyp tissue is difficult to identify and encircle. Tying a surgical knot in the small recesses of the nose where most polyps originate is cumbersome and ineffective leading to complications. Instruments that rely on a circular surgical loop for delivery of a ligature at the mouth or ostium of the sinus cannot reach the base of the polyp tissue for removal. For these reasons previously designed instruments for nasal polyp removal by ligature compression of the base of the polyp have not been successful and are not in general use.
- Accordingly, there is a need for methods and instruments that address the above mentioned problems and can provide a simple, convenient and rapid approach to this medical procedure. This approach would allow, in most situations, the physician, not necessarily a surgeon, the use of a private medical office rather than a hospital operating suite. It would eliminate the use of an anesthetic and thus eliminate many of the complications of the current procedure providing safety and patient comfort at a fraction of the cost.
- The present invention provides an apparatus for ligating a tissue protrusion, thereby restricting blood flow to the protrusion and thus allowing the tissue to drop off and be eliminated naturally. The device comprises a tubular body having a proximal end and a distal end, a handle positioned at the proximal end, and an endoscope controller operably connected to a cutter blade. The device also has a suture controller that is configured to be operatively coupled with a ligating suture, a curved bridge positioned at the distal end of the instrument with the bridge having a proximal end and a distal end, and an armature, having a proximal end and a distal end, that is configured to releasably retain at least a portion of the ligating suture. The armature is configured to place at least a portion of the ligating suture around the medical protrusion. The suture controller is configured to allow the ligating suture to ligate the medical protrusion while the cutting controller is configured to separate at least a portion of the suture from the ligated medical protrusion.
- This invention also provides a new method for ligating a medical protrusion with a suture. The suture is mounted on the apparatus and the device is inserted into the body to reach the site of the medical protrusion. The distal end of the device containing the suture material has a balloon-shaped curved armature of which the larger distal end allows ease of capture of the bulbous shaped polyp and the narrow “V” shaped proximal end of which is configured to guide the constricting suture loop tight to the narrow base of the polyp. In another embodiment, the present invention provides for a ligating device that places an elastized band about the medical protrusion.
- Other aspects and advantages of the present invention will become apparent from the following detailed description of the proposed surgical instrument.
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FIG. 1 illustrates an apparatus incorporating a flexible endoscope for ligating a medical protrusion according to an embodiment of the present invention. -
FIG. 2 illustrates a ligating suture according to another aspect of the present invention. -
FIG. 3 illustrates a cutter blade according to yet another aspect of the present invention. -
FIG. 4 is a top view of the distal end of thedevice 100 ofFIG. 1 . -
FIG. 5 is a bottom view of the distal end of thedevice 100 ofFIG. 1 . -
FIG. 6 is a side view of the distal end of thedevice 100 ofFIG. 1 . -
FIG. 7 is a cross section view of the armature according to various aspects of the present invention. -
FIG. 8 illustrates an apparatus incorporating an operable and removable armature, and camera for ligating a medical protrusion according to another embodiment of the present invention. -
FIG. 9 illustrates further detail of the operable and removable armature shown in the distal end of the apparatus shown inFIG. 8 . -
FIG. 10 illustrates further detail of a possible one-way lock which could be incorporated into the ligating loop of the present invention. -
FIG. 11 illustrates an apparatus with a straight handle, and removable and operable armature, for ligation a medical protrusion according to another embodiment of the present invention. -
FIGS. 12-14 illustrates each step of a possible procedure for ligating a polyp in the nasal cavity of a patient using the apparatus of the present invention. -
FIGS. 15-17 illustrates the step of a possible procedure for loading the ligating loop into the apparatus of the present invention. -
FIG. 18 illustrates another embodiment of the ligating loop of the present invention. - As used herein, the term “a” refers to “one or more” unless otherwise mentioned. As used herein, the term “include” refers to “includes without limitation”. As used herein, the term “circumscribe” refers to creating a loop around an object or encircling an object. As used herein, the terms “cut” or “cutting” refers to cutting, shearing or disuniting an object.
- While various conventional techniques may benefit from the apparatuses and methods discussed herein, another aspect of the present invention is a technique for treating the condition of medical protrusions itself. According to this technique, a ligation is made around the protrusion, and no incision is made. The ligation is intended to be tight such that the blood flow to the protrusion is substantially restricted. Due to the lack of blood supply, the protrusion tissue dies, and eventually the protrusion falls off the patient's body by itself, without requiring any cutting or cauterizing as required by conventional techniques.
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FIG. 1 illustrates anapparatus 140 for ligating a medical protrusion in accordance with certain aspects of the present invention. Theapparatus 140 comprises adevice 100 for ligating a medical protrusion, anendoscope 112, a ligating suture 200 (FIG. 2 ), and a cutter blade 300 (FIG. 3 ). Theendoscope 112 has one or more lighting means, such as means that either generate or transport light, for example, fiber optic cables, miniature LEDs, among various others, and one or more image capturing means, such as, digital cameras and analog cameras (still or motion medium), among others. Power and image data transfer for electronics are either contained in the removable section of thehandle 100 or are transferred via a power/data cord 126 or via any type of wireless protocol. It is understood that this apparatus could incorporate a replaceable and operable armature as illustrated in 808 (FIG. 8 ), and a possible handle as illustrated in 1102 (FIG. 11 ). -
FIG. 2 illustrates thesuture 200 which is a ligating suture, according to certain aspects of the present invention According to various embodiments, thesuture 200 comprises a biodegradable material in a thread-like structure. Thesuture 200 includes a sutureproximal end 204 and a suturedistal end 202 connected by aninterstitial cord 212. A one-way lock 208 is positioned between the suturedistal end 202 and the sutureproximal end 204. In certain embodiments the suturedistal end 202 has a shape of a loop (shown). Only the suturedistal end 202, which is used for ligating the protrusion may be made of a biodegradable material, and the rest of thesuture 200 may be made of another material. In the embodiment illustrated byFIG. 2 , the suturedistal end 202 is a balloon shaped loop. Thesuture 200 is configured such that pulling the sutureproximal end 204 away from the suturedistal end 202 constricts the suturedistal end 202 loop. According to one embodiment, this constriction is enabled by the one-way lock 208 (a possible one-way lock configuration is illustrated inFIG. 10 ) which is a preformed ball having aprojection 210 embedded at an angle with respect to the suture thread passing through the preformedball 208. Theprojection 210 is configured to allow slidable movement of the suture thread in one direction through the one-way lock 208. As illustrated inFIG. 2 , this configuration is achieved by having theprojection 210 project such that if thecord 212 were to be pulled away from the suturedistal loop 202, theprojection 210 does not offer any resistance. However, in case of reverse movement, theprojection 210 offers resistance to the portion of the engaging suture material. For example, as shown inFIG. 2 , theprojection 210 prevents movement in the reverse direction by obstructing the sliding motion of the suture material. - According to certain aspects, the
projection 210 is made of a biodegradable material, identical to that of thesuture 200. However, the material, in one embodiment, in theprojection 210 is compressed higher than in the rest of thesuture 200, and accordingly theprojection 210 has the suture material with a higher density, thereby causing the projection to bite into and restrain the softer suture thread. Those skilled in the art will appreciate that multiple such equivalent configurations can provide a one-way lock in a manner similar to that described ofFIG. 2 , and all such obvious mechanisms are included within the scope of the present claims. - Further, conventional tied knots need an amount of end length so that they are not untied at an inopportune time, thereby leaving a stub of suture material out of the ligation, which is a cause for potential irritation to the patient and highly undesirable. The one-
lock 208 as disclosed herein is not a tied knot. Nor does it require an end length stubbing out. Thepresent suture 200 thus provides for a ligation of a medical protrusion without leaving undesirable knots. - The suture
proximal end 204 is usable for constricting the suturedistal end 202 loop. The pulling action of the sutureproximal end 204 enables in constricting theloop 202. As will be apparent to those in the art, the pulling functionality of the sutureproximal loop 204 may be implemented in multiple ways. According to one embodiment, the sutureproximal end 204 is a preformed ball 903 (FIG. 9 ) configured to be operably coupled to a cupping means 904 (FIG. 9 ). The cupping means grips by “cupping” around the sutureproximal end 204 preformed ball, and the cupping means are pulled to actuate the pulling of the sutureproximal end 204. According to another embodiment, as also illustrated inFIG. 2 , the sutureproximal end 204 is a loop, configured to be operably coupled to a hooking means (not shown inFIG. 2 , but shown in 404 (FIG. 4 andFIG. 6 ). The hooking means when pulled, pull the sutureproximal end 204 thereby constricting the suturedistal end 202 loop. -
FIG. 3 illustrates thecutter blade 300 according to various aspects of the present invention. According to an aspect, thecutter blade 300 includes asafety blade edge 302 and a cutterblade coupling device 304 to couple to thecutter controller 124. In the embodiment ofFIG. 3 , thesafety blade edge 302 has a “V” shape, which advantageously shears off thecord 212 from the suturedistal end 202 more easily than a flat blade, and eliminates the need for an anvil (a base required as support for the flat blade to operate) that may get worn and become less effective with use. Further, thesafety blade edge 302 advantageously slices thecord 212 off the suturedistal end 202 very near to the one-lock 208, leaving substantially negligible or no thread material extending out from the one-lock 208. This results in a neat cut eliminating potential patient irritation. Further, thecutter blade 300 is a replaceable blade, configured to mate with theapparatus 140 releasably, and may be easily replaced after use. This aspect is particularly advantageous in light of communicable infections, such as for example, HIV, Hepatitis, and other serious transferable diseases among various others. The speed at which things can be handled in dangerous situation is important, and thecutter blade 300 as illustrated above is quickly and easily replaceable with minimal safety concerns because thesafety blade edge 302 is concealed to the inside, as illustrated. This advantageously allows for the users to handle the cutter blade without the danger of getting infected unduly, because the sharp edge of the blade is not exposed. - The
device 100 for ligating a medical protrusion includes atubular body 116 having aproximal end 120 and adistal end 108. Ahandle 102 is positioned at theproximal end 120. It is understood that this apparatus could incorporate a possible straight handle as illustrated in 1102 (FIG. 11 ) which is in line with thetubular body 116. Afinger brace 104 is used to help guide the suture loop over the polyp without accidentally advancing the suture controller. The device further includes anendoscope controller 122 operably connectable to theendoscope 112, a cuttingcontroller 124 operably connected to thecutter blade 300, and asuture controller 106 operatively coupled with thesuture 200. Acurved bridge 108 is positioned at thedistal end 128. The bridge has a bridgeproximal end 128 and a bridgedistal end 130. Thedevice 100 further includes anarmature 110. Thearmature 110 is positioned in proximity of thebridge 108 and towards the bridgedistal end 130. Thearmature 110 has an armatureproximal end 132 and an armaturedistal end 134. Thearmature 110 is configured to releaseably retain at least a portion of thesuture 200. Thearmature 110 is configured to place at least a portion of thesuture 200 about the medical protrusion. Thesuture controller 106 is configured to ligate thesuture 200 about the medical protrusion, and the cuttingcontroller 124 is configured to operate thecutter blade 300 so as to detach the portion of thesuture 200 ligating the medical protrusion from theapparatus 140. -
FIG. 4 is a partial top view of thearmature 110 loaded with thesuture 200. The dotted lines indicate the structure beneath the top covering wall ofendoscope 112. Thehook 404 is coupled with the suture proximal end 204 (loop) by tilting thesuture controller 106 clockwise and moving it forward to thesuture load position 127. As will be apparent to those in the art, the coupling functionality of thesuture controller 106 as illustrated inFIG. 4 andFIG. 6 may be implemented in multiple ways. Thesuture controller 106 is configured to pull the suture proximal end 204 (loop) on actuation of thesuture controller 106 towards the proximal end of thedevice 100 whereby theratchet 105 controls the tension of thesuture 200 allowing the user to “feel” the amount of the pressure necessary to keep thecord 212 tight and to facilitate the cutting with thesafety blade edge 302. The one-lock 208 is positioned substantially towards the armatureproximal end 132.FIG. 5 illustrates a bottom view of thearmature 110 along the section 5-5 ofFIG. 1 . The armatureproximal end 132 has a cup 502 (see also 502 ofFIG. 6 ) that holds the one-lock 208 in position and aslot 504 that passes only thesuture cord 212. According to certain embodiments, when viewed from the top or bottom, thearmature 110 has a balloon shape with the armaturedistal end 134 having a substantially rounded shape and the armatureproximal end 132 having a substantial “V” shape, also referred to as thearmature opening 402. In certain embodiments, when viewed from the side (FIG. 6 ), thearmature 110 is curved, such as, for example, convave upwards, convex downwards, among others. In certain embodiments, the curve of thearmature 110 is offset towards the armaturedistal end 134. According to the embodiment illustrated byFIG. 6 , the curve is concave upwards and offset 608 towards the armaturedistal end 134 or thetip 134 of the armature. Further, thearmature 110 is positioned at an offset 608 with respect to thetubular body 116 axis A-A′. For example, in the illustrated embodiment, thearmature 110 is positioned below thetubular body 116 axis A-A′ when viewed from the side. In certain other embodiments, thearmature 110 may be positioned above thetubular body 116 axis A-A′ when viewed from the side. Thearmature 110 may be coupled to thedevice 100 at or around theproximal end 128, such as, for example, to thecurved bridge 108 at the bridgedistal end 130, in the embodiment illustrated byFIG. 6 andFIG. 9 . According to certain aspects, thearmature 110 is configured to be releasably coupled to thedevice 100. That is, armatures of varied shapes or sizes may be mounted on thedevice 100 in a simple attach and release configuration, as already known in the art, and as also shown in one embodiment inFIG. 8 andFIG. 9 . - According to certain embodiments, as also illustrated by
FIGS. 4-7 , thearmature opening 402 is advantageously configured to be parallel to normal tissue around the medical protrusion. Further, the armaturedistal end 134 is curved upwards (FIG. 6 ). Also, as illustrated inFIG. 7 , thearmature 110 has a “C” shapedcross section 700.Edges 702 of the “C” shape provide a narrower opening than thesuture 200 thread diameter, while hollow 704 of the “C” section is larger than thesuture 200 thread diameter. - According to one embodiment, the armature is configured to receive the
removable suture 200 manually. For example, thesuture 200 is finger loadable by hooking the one-lock 208 of thesuture 200 intocup 502, hookingcord 212 underhook 506, movinghook 404 forward to its load position, hookingloop 204 overhook 404 and finally pressingdistal loop 202 into theopening 704 at the inside of the armature with the finger or a thin shaft. Even for armatures having relatively smaller size, this design provides a convenient way to load thesuture 200 manually and conveniently, as most human fingers will be able to load the suture conveniently for armatures configured for even small medical protrusions, such as, for example, nasal polyps among others. Further, thesuture 200 is easily loadable in its entirety, in a few seconds, and does not require the person loading the suture to be extensively trained. Furthermore, only thesuture 200 is required, and no suture cartridges or additional material is needed. In this fashion, thesuture 200 can be advantageously loaded quickly in to thesame device 100 for subsequent protrusion removal while the patient is still under the influence of relevant medicines, such as, for example, local anesthesia. -
FIG. 8 illustrates anotherapparatus 800 for ligating a medical protrusion in accordance with certain aspects of the present invention. In thisembodiment apparatus 800, with further detail inFIG. 9 , illustrates thearmature 808 as movable abouthinge 806, to allow rotational movement ofarmature 808 about a rotational axis perpendicular totubular body 116, along axis A-A′,distal end 134 of which followsark 905 whenarmature controller 804 is manipulated. The feature in this aspect of this pivot readily allows for the capture of a polyp by allowing for a change in the angle of the opening of the armature in relation to the angle of the polyp. This aspect also has a replaceable head that disassembles at joint 814 to allow alternate heads of different sizes and shapes to be used as needed based on the size and location of polyp and the limitations of the nose and sinus cavity. Thecontroller wire 812 disengages the replaceable heads at thewire pivot lug 810. Further illustrated in this embodiment is ahandle 802 which contains apparatus for self contained rechargeable power, and Bluetooth capability or other if desired to project an image to a user adjustable flat screen suspended from a user adjustable boom. It is understood that this embodiment of the apparatus of the present invention could incorporate a flexible endoscope. -
FIG. 10 illustrates a possible one-way lock configuration that may be used in the present invention. In an embodiment not shown, the free end of the loop could snap into the body of the one-way lock 208 when necessary to capture a protrusion or entity where there is no access to an open end, such as to act like an instant tourniquet . Further, in an embodiment not shown, this one-way lock configuration with the ability to snap into the body of the one-way lock 208 the proximal end is either grip-able or could be couple to a device. -
FIG. 11 illustrates anotherapparatus 1100 for ligating a medical protrusion in accordance with certain aspects of the present invention. In this embodiment theapparatus 1100 illustrates thehandle 1102 in line with thetubular body 116, to allow for greater ease in capturing a polyp located on the head side of the nasal or sinus cavities without the handle interfering with the patient's face. In this aspect, the tilting of the armature is achieved with use of thearmature controller wheel 1122. To operate the finger depression is dialed on thearmature controller wheel 1122 up towards the distal end of the apparatus or back towards the proximal end. Thecutter controller 1124 operates by pressing the finger button on it towards the distal end of the tool. This cutter controller 1224 is spring loaded to return to position and retract the blade. It is understood that this embodiment of the apparatus of the present invention could incorporate thearmature 110 as well. - According to another embodiment of the present invention, a method for ligating a medical protrusion using a suture, such as the ligating
suture 200 is provided. Ligating the medical protrusion using theligating suture 200 comprises mounting of thesuture 200 to thedevice 100, negotiating thedevice 100 to the site of the medical protrusion inside a patient's body, delivering the suture's ligating portion, such as the suturedistal end 202 loop over the protrusion to capture at least a portion of the protrusion, constricting theloop 202 about the base of the protrusion, and cutting the loop around the medical protrusion from the rest of thesuture 200.FIGS. 12 to 14 illustrate the basic steps involved in ligating a medical protrusion after the mounting of thesuture 200 to thedevice 100 has been performed. - The
suture 200 is mounted on a device for ligating a medical protrusion, such as thedevice 100 in the fashion as described above. Loading the suture is further illustrated inFIGS. 15 to 17 . Thesuture 200 loadeddevice 100 is then negotiated into a patient's body to the relevant area where the protrusion to be ligated exists. This is effected by inserting thearmature 110 orarmature 808 of thedevice 100 into the relevant patient's body part. An endoscope, such as theendoscope 112, provides a view of the path to the remote body part where the protrusion exists, enabling the user of thedevice 100 to direct thearmature 110 orarmature 808 to the proximity of the protrusion. - Once the
device 100 is in proximity of the desired destination, thedevice 100 is manipulated by the user over the bulbous of the protrusion deliver the ligatingsuture 200 to the base of the protrusion. Thesuture 200 needs to be delivered by thedevice 100 on the protrusion such that thesuture 200 may form a clean, precise and deep ligation around the protrusion. Many features of thedevice 100, as disclosed herein by various embodiments, are instrumental in providing these features. For example, thesuture 200 advantageously comprises of a ligating portion, such as the loop 202 (or “the suture loop”), which has a balloon shape. Thearmature 110 that holds theloop 202 stiff for ease of delivery to the protrusion site is similarly balloon shaped—the opening of thearmature 110 near the armatureproximal end 132 is “V” shaped while the armaturedistal end 134 is approximately semi-circular. Further, thearmature 110 is curved when viewed from the side, for example, it is curved concave upwards, and the tip of the armaturedistal end 134 may be further bent upwards. This bent shape allows the armaturedistal end 134 to negotiate over difficult to reach protrusions easily. At the same time the “V” shaped armatureproximal end 132 opening combined with the concave upward shape allows theopening 132 to get very close to the base of the protrusion, allowing the suture to capture a fuller portion of the protrusion and form a tighter ligation of the protrusion. Thearmature 110 having a bent tip at the armaturedistal end 134 advantageously circumscribes the protrusion by peeling out first of the armaturedistal end 134 and continuing to peel out of thearmature 110 successively close to the “V” shaped armatureproximal end 132 guiding theloop 202 as close to the base of the polyp as allowed. It is appreciated that this bent tip shape of thearmature 110 enables it to circumscribe protrusions having a greater height, or in otherwise difficult to access positions. In certain embodiments where thearmature 110 has a balloon shape with the armaturedistal end 134 having a substantially rounded shape and the armatureproximal end 132 having a substantial “V” shape, the armaturedistal end 134 will allow for capture of a bulbous outer end of the protrusion while the “V” shaped armatureproximal end 132 will allow for positioning in close at the thinner base of the protrusion. These features allow for a larger portion of the polyp to be extracted as these features allow for circumscribing protrusions conveniently in comparison with circular type armatured suture loops. In this way, a user may conveniently mount thesuture loop 202 on the protrusion, such that the opening of thearmature 110 is substantially parallel to the normal tissue lining and generally perpendicular to the protrusion growth. The concave upward shape of thearmature 110 allows for the armature to get particularly close to the base of the protrusion circumscribing and therefore capturing a fuller portion of the protrusion. - Constricting the
suture loop 202 around the protrusion includes actuating thesuture controller 106 to pull the sutureproximal end 204. The movement of theproximal end 204 away from the suture loop 202 (suture distal end 202) causes thecord 212 to pull away through the one-way lock 208, reducing the circumference of thesuture loop 202 and thereby constricting thesuture loop 202 around the protrusion. The user of thedevice 100 can determine using theendoscope 112, or otherwise, the amount of constriction of thesuture loop 202 required to ligate the protrusion. - Cutting the
suture loop 202 includes actuating the cuttingcontroller 124 that causes the cutter blade 300 (FIG. 1 ) to be incident on thesuture 200 on thecord 212 very close to the one-lock 208. The incidence of thesafety blade edge 302 on thesuture 200 causes thecord 212 to cut thesuture loop 202. It is intended that thecutter blade 300 is incident on thesuture 200 as close to the one-lock 208 as possible, thereby making a clean cut and leaving no or minimal stub. The clean cut made possible by the blade according to various aspects of the present invention eliminates or minimizes potential irritation by such a stub to the patient. - It is believed that the suture with the one-way one-lock discussed above could be replaced with an elastized band. The elastized band would be loaded into the armature in a fashion that would cause the band to be stretched outward in all directions over a convex channel located to the outside of the
armature 110. Actuating the elasticized band controller would roll an edge off the armature causing it to snap in place to the bottom side of thearmature 110 causing it to contract about the base of the medical protrusion. Suitable elastized bands include those made of rubber and other biological compatible materials. - In an alternate configuration the one way device can capture lengths of tissue where the ends of the tissue are not available say in clamping off a vein prior to cutting it or temporarily shutting off a sperm duct for a reversible vasectomy. The
device end 1808 shown onFIG. 18 can be looped over a continuous length of tissue and then snapped into adepression 1806 prior toactuating 903. Thechannel 1802 to 1804 is only wide enough to accept the cord of the suture loop. Removal of the ligation device is as easy as cutting the cord near 1804 with a scalpel. In a further configuration of the above snap-able device the size can be altered to a much larger scale and with an added handle at 903 the device can have EMS and military uses as an instant tourniquet to stop bleeding in emergencies. - The present invention, in its various aspects, provides multiple advantages over conventional apparatuses or methods. For example, the suture as disclosed in accordance with various embodiments advantageously eliminates the tied knot and the associated requirement to have a stub of an extended thread, which is potential source of irritation. The suture further has a balloon shaped armature for holding the suture loop rigid while passing over the ligating protrusion. This balloon shaped suture in conjunction with the device for delivering the suture advantageously helps in capturing a fuller portion of the protrusion, and in capturing protrusions larger in size or in relatively inaccessible configuration. The device as provided in accordance with various aspects, provides for a simpler movement of endoscope, especially for applications, such as, for example, nasal protruding removal. Further, the present invention provides for a cutter blade with enhanced safety features that address the concerns of dangerous infectious conditions such as, for example, HIV, Hepatitis and the like, in the environments that need quick replacements of the cutter blade. Further, the technique of substantially constricting the blood supply to kill the protrusion tissue, eventually causing protrusion removal without requiring any incisions or cauterizing advantageously eliminates the problems associated with managing the wounds, and also provides patient comfort in the long run. Finally, the method to removal nasal polyp with the present invention described herein is minimally invasive, requires no surgery, allows for ambulatory care, and anesthesia is not required though topical anesthesia may used.
- While particular embodiments and/or individual features of the present invention and its applications have been illustrated and described, it would be obvious to those skilled in the art that various other changes, modifications and adaptation to other procedures can be made without departing from the spirit and scope of the invention. Further, it should be apparent that all combinations of such embodiments and features are possible and can result in preferred executions of the invention. Therefore, the appended claims are intended to cover all such changes and modifications that are within the scope of the invention.
Claims (38)
1. A device for ligating a medical protrusion, the device comprising:
a) a tubular body having a proximal end and a distal end;
b) a handle positioned at the proximal end;
c) an endoscope controller operably connectable to an endoscope having at least one lighting means and at least one image capturing means positioned at the distal end;
d) a cutting controller operably connectable to a cutter blade;
e) a suture controller configured to be operatively coupled with a ligating suture;
f) a curved bridge positioned at the distal end, said bridge having a proximal end and a distal end; and
g) an armature connected to the distal end of the bridge and configured to releaseably retain at least a portion of the ligating suture, said armature having a distal and proximal end,
wherein the armature is configured to place at least a portion of the ligating suture about the medical protrusion and wherein the manipulation of the suture controller is configured to cause the ligating suture to ligate the medical protrusion and wherein manipulation of the cutting controller is configured to result in the separation of at least a portion of the ligating suture from the ligated medical protrusion.
2. The device of claim 1 , wherein the cutter blade is removable.
3. The device of claim 1 , wherein the endoscope can move with respect to the device allowing the user to visually capture the medical protrusion to be ligated.
4. The device of claim 1 , wherein the armature is balloon shaped wherein the distal end is round and the proximal end is “V” shape.
5. The device of claim 1 , wherein the endoscope is removable.
6. The device of claim 1 , wherein the armature, when viewed from the side, is curved.
7. The device of claim 1 , wherein the armature is offset with respect to the tubular body axis.
8. The device of claim 1 , wherein the armature is configured to receive the removable ligating suture manually.
9. The device of claim 1 , wherein the armature has “C” shaped cross section.
10. The device of claim 9 , wherein the edges of the “C” shape armature cross section are configured to provide a narrower opening than the suture diameter.
11. The device of claim 1 , wherein the armature is configured such that the cutter blade cuts the suture in such a way as to leave little excess suture material with the ligated medical protrusion.
12. The device of claim 1 , wherein the armature distal end is movable with respect to the curved bridge.
13. The device of claim 1 further comprising an armature movement controller operably connected to the armature, wherein the armature movement controller is configured to control movement of the armature about an axis passing through the armature proximal end and parallel to the plane of the armature.
14. The device of claim 1 further comprising a ligating loop having a distal one way locking loop and a proximal support member.
15. The device of claim 14 , wherein the ligating suture is configured such that pulling the support member in the proximal direction, causes the constriction of the distal one-way locking loop when circumscribed about a medical protrusion.
16. The device of claim 14 , wherein the one-way lock is a preformed ball having a projection at an angle with respect to its base, and wherein the projection is configured to allow slidable movement of the suture in one direction only.
17. The device of claim 14 , wherein the ligating suture is biodegradable.
18. The device of claim 14 , where the ligating suture is elastized.
19. An apparatus for ligating a medical protrusion, the apparatus comprising:
a) a ligating suture, said suture having a proximal end and a distal end configured to circumscribe the medical protrusion, and a one-way lock positioned there between;
b) an endoscope having at least one lighting means and at least one image capturing means;
c) a safety cutter blade configured to cut the suture at the proximal end of the one-way lock; and
d) a device for ligating a medical protrusion, the device comprising
i) a tubular body having a proximal end and a distal end,
ii) a handle positioned at the proximal end,
iii) an endoscope controller operably connectable to the endoscope,
iv) a cutting controller operably connectable to the cutter blade,
v) a suture controller configured to be operatively coupled with the suture,
vi) a curved bridge positioned at the distal end, said bridge having a proximal end and a distal end, and
vii) an armature configured to releaseably retain at least a portion of the suture, said armature having a proximal end and a distal end,
wherein the armature is configured to place at least a portion of the suture about the medical protrusion and wherein the manipulation of the suture controller is configured to cause the suture to ligate the medical protrusion and wherein manipulation of the cutting controller is configured to result in the separation of at least a portion of the ligating suture from the ligated medical protrusion.
20. The apparatus of claim 18 , wherein the cutter blade is removable.
21. The apparatus of claim 18 , wherein the endoscope is movable with respect to the apparatus allowing the user to visually capture the medical protrusion to be ligated.
22. The apparatus of claim 18 , wherein the endoscope is removable.
23. The apparatus of claim 18 , wherein the armature is balloon shaped with a rounded distal end and a “V” shaped proximal end.
24. The apparatus of claim 18 , wherein the armature, when viewed from the side, is curved.
25. The apparatus of claim 18 , wherein the armature is offset with respect to the tubular body axis.
26. The apparatus of claim 18 , wherein the armature is configured to receive the removable suture manually.
27. The apparatus of claim 18 , wherein the armature has “C” shaped cross section.
28. The apparatus of claim 18 , wherein the edges of the “C” shape armature cross section are configured to provide a narrower opening than the suture diameter.
29. The apparatus of claim 18 , wherein the armature is configured such that the cutter blade cuts the suture in such a way as to leave little excess suture material with the ligated medical protrusion.
30. The apparatus of claim 18 , wherein the armature distal end is movable with respect to the curved bridge.
31. The apparatus of claim 18 further comprising an armature movement controller operably connected to the armature, wherein the armature movement controller is configured to control movement of the armature about an axis passing through the armature proximal end and parallel to the plane of the armature.
32. The apparatus of claim 18 further comprising a ligating loop having a distal one-way locking loop and a proximal support member.
33. The apparatus of claim 18 , wherein the ligating suture is configured such that pulling the support member in the proximal direction, causes the constriction of the distal one-way locking loop when circumscribed about a medical protrusion.
34. The apparatus of claim 18 wherein the suture is biodegradable.
35. A method for ligating a medical protrusion, the method comprising:
a) delivering the suture to a site of the medical protrusion, wherein said suture comprises a proximal end and a distal end having a shape of a balloon, and a one-way lock positioned there between;
b) mounting the suture distal end around the protrusion using a device having a balloon shaped, concave upwards armature by circumscribing the armature around the protrusion;
c) constricting the suture distal end to provide a ligation around the medical protrusion; and
d) cutting the suture distal end and the lock from the rest of the suture.
36. A method for loading a suture to a device for ligating a medical protrusion, the method comprising:
a) providing the suture comprising a proximal end and a distal end having a shape of a balloon, a one-way lock and a cord positioned there between;
b) providing the device comprising an armature configured to releaseably retain at least a portion of the suture, said armature having a proximal end and a distal end;
c) pressing the lock at the armature proximal end;
d) pressing an edge of the suture distal end into a side of the armature, sliding in the suture distal end into the rest of the armature around its circumference; and
e) coupling the suture proximal end with the hook.
37. A method for ligating a medical protrusion with a suture, the method comprising:
a) mounting the suture to the device;
b) negotiating the device to reach the site of the medical protrusion inside a patient's body;
c) delivering the suture to a site of the medical protrusion, wherein the suture comprises a suture proximal end and a suture distal end having a shape of a balloon, and a one-way lock positioned there between;
d) mounting the suture distal end around the protrusion using a device having a balloon shaped, concave upwards armature by circumscribing the armature around the protrusion;
e) constricting the suture distal end to provide a ligation around the medical protrusion; and
f) cutting the suture distal end and the lock from the rest of the suture.
38. The method of claim 34 , wherein negotiating the device to reach the site of the medical protrusion inside a patient's body comprises ascertaining the movement of the device using an endoscope.
Priority Applications (2)
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US13/471,141 US8540738B2 (en) | 2007-08-08 | 2012-05-14 | Method and apparatus for delivery of a ligating suture |
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US96395807P | 2007-08-08 | 2007-08-08 | |
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Also Published As
Publication number | Publication date |
---|---|
EP2182856A2 (en) | 2010-05-12 |
WO2009021104A2 (en) | 2009-02-12 |
WO2009021104A3 (en) | 2009-04-16 |
US8540738B2 (en) | 2013-09-24 |
US20120226293A1 (en) | 2012-09-06 |
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