METHOD AND APPARATUS FOR DELIVERY OF A LIGATING SUTURE
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.
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.
FIELD OF THE INVENTIONThe 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.
BACKGROUNDNasal 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.
SUMMARYThe 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.
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.
According to certain aspects, the projection 210 is made of a biodegradable material, identical to that of the suture 200. However, the material, in one embodiment, in the projection 210 is compressed higher than in the rest of the suture 200, and accordingly the projection 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 of
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. The present 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 suture distal end 202 loop. The pulling action of the suture proximal end 204 enables in constricting the loop 202. As will be apparent to those in the art, the pulling functionality of the suture proximal loop 204 may be implemented in multiple ways. According to one embodiment, the suture proximal end 204 is a preformed ball 903 (
The device 100 for ligating a medical protrusion includes a tubular body 116 having a proximal end 120 and a distal end 108. A handle 102 is positioned at the proximal end 120. It is understood that this apparatus could incorporate a possible straight handle as illustrated in 1102 (
According to certain embodiments, as also illustrated by
According to one embodiment, the armature is configured to receive the removable suture 200 manually. For example, the suture 200 is finger loadable by hooking the one-lock 208 of the suture 200 into cup 502, hooking cord 212 under hook 506, moving hook 404 forward to its load position, hooking loop 204 over hook 404 and finally pressing distal loop 202 into the opening 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 the suture 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, the suture 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 the suture 200 is required, and no suture cartridges or additional material is needed. In this fashion, the suture 200 can be advantageously loaded quickly in to the same device 100 for subsequent protrusion removal while the patient is still under the influence of relevant medicines, such as, for example, local anesthesia.
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 the ligating suture 200 comprises mounting of the suture 200 to the device 100, negotiating the device 100 to the site of the medical protrusion inside a patient's body, delivering the suture's ligating portion, such as the suture distal end 202 loop over the protrusion to capture at least a portion of the protrusion, constricting the loop 202 about the base of the protrusion, and cutting the loop around the medical protrusion from the rest of the suture 200.
The suture 200 is mounted on a device for ligating a medical protrusion, such as the device 100 in the fashion as described above. Loading the suture is further illustrated in
Once the device 100 is in proximity of the desired destination, the device 100 is manipulated by the user over the bulbous of the protrusion deliver the ligating suture 200 to the base of the protrusion. The suture 200 needs to be delivered by the device 100 on the protrusion such that the suture 200 may form a clean, precise and deep ligation around the protrusion. Many features of the device 100, as disclosed herein by various embodiments, are instrumental in providing these features. For example, the suture 200 advantageously comprises of a ligating portion, such as the loop 202 (or “the suture loop”), which has a balloon shape. The armature 110 that holds the loop 202 stiff for ease of delivery to the protrusion site is similarly balloon shaped—the opening of the armature 110 near the armature proximal end 132 is “V” shaped while the armature distal end 134 is approximately semi-circular. Further, the armature 110 is curved when viewed from the side, for example, it is curved concave upwards, and the tip of the armature distal end 134 may be further bent upwards. This bent shape allows the armature distal end 134 to negotiate over difficult to reach protrusions easily. At the same time the “V” shaped armature proximal end 132 opening combined with the concave upward shape allows the opening 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. The armature 110 having a bent tip at the armature distal end 134 advantageously circumscribes the protrusion by peeling out first of the armature distal end 134 and continuing to peel out of the armature 110 successively close to the “V” shaped armature proximal end 132 guiding the loop 202 as close to the base of the polyp as allowed. It is appreciated that this bent tip shape of the armature 110 enables it to circumscribe protrusions having a greater height, or in otherwise difficult to access positions. In certain embodiments where the armature 110 has a balloon shape with the armature distal end 134 having a substantially rounded shape and the armature proximal end 132 having a substantial “V” shape, the armature distal end 134 will allow for capture of a bulbous outer end of the protrusion while the “V” shaped armature proximal 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 the suture loop 202 on the protrusion, such that the opening of the armature 110 is substantially parallel to the normal tissue lining and generally perpendicular to the protrusion growth. The concave upward shape of the armature 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 the suture controller 106 to pull the suture proximal end 204. The movement of the proximal end 204 away from the suture loop 202 (suture distal end 202) causes the cord 212 to pull away through the one-way lock 208, reducing the circumference of the suture loop 202 and thereby constricting the suture loop 202 around the protrusion. The user of the device 100 can determine using the endoscope 112, or otherwise, the amount of constriction of the suture loop 202 required to ligate the protrusion.
Cutting the suture loop 202 includes actuating the cutting controller 124 that causes the cutter blade 300 (
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 the armature 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 on
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
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.
Type: Application
Filed: Aug 7, 2008
Publication Date: Feb 12, 2009
Inventors: Brian J. Cavanaugh (Hingham, MA), James J.A. Cavanaugh (Osterville, MA)
Application Number: 12/187,486
International Classification: A61B 17/138 (20060101);