GB1561996A - Surgical ligatinginstrument and method - Google Patents

Description

(54) SURGICAL LIGATING INSTRUMENT AND METHOD (71) We, KLI, INC, a corporation organised and existing under the laws of the State of Pennsylvania, United States of America, of 65 Industrial Drive, Ivyland, Pennsylvania 18974, United States of America, do hereby declare the invention for which we pray that a patent may be granted to us, and the method by which it is to be performed, to be particularly described in and by the following statement:- This invention relates to surgical ligating instrument or applicator for tubal ligation within the human and/or animal body, by the application of at least one elastic ring to an anatomical structure. Although this invention relates particularly to female sterilization procedures involving the Fallopian tubes, the instrument and method of this invention may be applied to one or a plurality of vas in the human male, and to any other anatomical structural member.

The surgical ligating instrument in accordance with this invention may be used ideally in minilaparotomy in alternative with single and dual incision laparoscopy. It can be used in combination with a laparoscopy system of the type described in the issued U.S. Patent to Lampman and Knepshield No.3,834,392. In the alternative, it may be used in a two-incision oper ation, or in minilaparotomy in a supra pubic type of operation. The instrument in accordance with this invention is relatively simple and inexpensive in construction, and requires a minimum of maintenance. Of greater importance, however, is the fact that it is extremely convenient and effective for the surgeon to handle, particularly in allowing the surgeon to perform the most delicate and critical steps of the procedure smoothly and continuously and, if desired, for applying successive rings without removing the instrument from the body cavity. It operates smoothly and continu ously and eliminates possible misjudgment on the part of the physician as to size of loop and tension on the Fallopian or other tube-which factors are set by the applicator and the ring.

As will further become apparent hereinafter, the instrument and method in accordance with this invention are of particular advantage in that heretofore the surgeon, after performing one step of the method by applying one ring to one of the Fallopian tubes, has been required to remove the applicator from the body cavity and apply another elastic ring to the applicator before he could perform the further step of the procedure in which the applicator is reinserted into the body cavity and the other ring is stretched over the other Fallopian tube.

Surgical ligating instruments have heretofore been used for a wide variety of purposes.

In the prior U.S. Patent to Lampman and Knepshield No.3,834,392 granted September 10, 1974, a laparoscopy system is disclosed for female sterilization, whereby a single unit contains a power source to provide illumination, oscillatory electrical power and CO2 for a laparoscopy. CO2 gas, under pressure, is first passed into the body through a needle into the peritoneal cavity. A trocar and cannula are inserted into the gas-filled abdominal cavity. A laparoscope connected to a source of illumination is inserted into the body cavity through the cannula. The Fallopian tubes are then identified through the laparoscope.

A flexible forceps is, thereafter, inserted through the laparoscope into the body cavity. The forceps is manipulated to successively close the passage through each Fallopian tube either by means of sending electrical oscillations through the forceps to simultaneously cut, seal and cauterize each tube in turn, or by means of a specific clamp which clamps the passage shut.

A typical clamp for that purpose is described in the U.S. Patent to Davis No.

3,856,016, granted December 24, 1974.

Still another clamping means utilized in tubal ligation, having the form of an elastic cord or ring, is shown and described in the U.S. Patent to Van Hoorn No.3,760,810, granted September 25, 1973. The Van Hoorn patent shows a surgical instrument for ligating internal structures of a cavity in the human body, by means of at least one elastic cord. Two tubes are mounted for relative sliding movement one inside the other, the inner tube protruding at the front of the outer tube. An elastic cord or band is stretched upon the outer surface of the protruding portion of the inner tube, and after the tube to be ligated is drawn into the inner tube of the surgical ligating instrument, relative displacement of the outer tube forwardly relative to the inner tube ejects the elastic band and tightens it about the tube to be ligated. Thus, a stretchable or elastic cord or ring is used in the manner of the clamp of the Davis patent, for tubal ligation of blood vessels in the treatment of rectosigmoidal lesions, and in the treatment of internal structures of the human body.

The use of an elastic band or ring in tubal ligation of the Fallopian tubes in the human female, or the vas in the human male, using the system of the aforesaid U.S.

Patent No.3,834,392 is shown in the U.S.

Patent to Yoon No.3,870,048, granted March 11, 1975. In the Yoon device, as well as in the aforesaid patent, the procedure is preferably used in conjunction with a viewing device such as an endoscope or laparoscope for example. The placement of the elastic ring on the tubes eliminates the rieed for time-consuming procedures which are discomforting to the patient and the use of bulky and expensive equipment. Moreover, depending upon the size and elastic power of the rings, the sterilization can be made permanently or reversibly, as desired.

The device and method are also applicable to the sterilization of the human male by ligature of the vas. Further, the device of the Yoon patent includes an outer tube having an expandable end portion which permits the device to be "loaded" with two or more rings at the same time, and to discharge separate rings at different times and in succession to one another, so that both Fallopian tubes may be successfully ligated without removing the ring applicator device from the peritoneal cavity of the patient.

The devices of the prior art, as discussed herein, tend to be rather complicated for the surgeon to operate. The ejection of multiple rings in succession, for example, as in the Yoon patent, requires a considerable number of successive manipulations in order to grasp the Fallopian tube, draw it into the inner tube of the instrument, and discharge each elastic ring to its desired position surrounding each Fallopian tube.

Also, substantial gas pressure losses are encountered, requiring monitoring and replacement of gas escaping from the peritoneal or other cavity.

In a copending application 16100/77, Serial No.l 560 282, a special applicator is provided having a novel means for providing minimum resistance to the movement of the surgeon's hand while the Fallopian tube is being drawn into the tubular member of the surgical instrument, and for providing increased resistance after the foregoing step has been completed and prior to the step of releasing the elastic ring. Also, the aforesaid application discloses a plurality of elongated cylindrical or tubular members, slidable axially with respect to each other to perform the tubal ligation operation, and which cylindrical or tubular members may easily be disassembled for effective cleaning and sterilization. However, an instrument of the type disclosed in the aforesaid pending application is adapted for the discharging of a single ring upon a single Fallopian tube, and must be removed from the body cavity of the patient for the purpose of stretching another ring over the cylindrical applicator tube, in order to prepare the instrument for reinsertion into the body cavity and for discharging the added elastic ring into a position in which it is stretched around the other Fallopian tube within the body of the patient.

According to the present invention we provide a surgical ligating instrument for applying a plurality of elastic rings to an anatomical element to be ligated, the combination which comprises; (a) a support member having a portion adapted for supporting a plurality of elastic rings mounted thereon.

(b) actuating means movable relative to said support member for displacing said rings toward said end of said support member.

(c) shiftable control means for limiting the relative movement of (a) and (b) said control means in a first position limiting said movement of (a) and (b) in a manner to limit to a predetermined number the number of elastic rings displaced off of said support member and, concurrently to displace a predetermined number of elastic rings remaining on said support member along said support member to a position for subsequent displacement off said support member, said control means in a subsequently shifted position permitting movement of (a) and (b) beyond the movement allowed by the first position, said subsequent shifted position adapted for permitting the displacement of one or more re maining elastic rings off of said support member.

Reference is now made to the accompanying drawings, in which: Figure 1 is a perspective view of a ligating instrument embodying features of the present invention; Figure 2 is a side elevational view of the instrument indicated in Figure 1, with certain parts shown in section in order to illustrate important details, taken along the lines and arrows 2 - 2 which appear in Figure 1; Figure 3 is a sectional view taken along the lines and arrows 3 - 3 as indicated in Figure 2; Figure 4 is a side view of the same embodiment as Figure 2, illustrating the manner in which the grasping means may be manipulated to grasp the anatomical tube to be ligated; Figure 5 is a similar side view, showing a subsequent operational step involving the rearward movement of the grasping means into the inner tube member; Figure 6 is a detailed sectional view of the forward end of the instrument of Figure 1, showing an anatomical tube being drawn into the forward end portion of the inner tube member; Figure 7 is a side view similar to Figure 5, illustrating commencement of the rearward movement of the inner tubular member; Figure 8 is a side view similar to Figure 7, illustrating a subsequent step involving the ejection of one occluding ring from its position around the inner tube member as the stop member abuts the pistol grip; Figure 9 is a detailed view, partially in section, of a portion of the instrument of Figure 1, showing one form of an adjusting means used to adjust the effective position of the stop member; Figure 10 is a sectional view taken along the lines and arrows 10 - 10, which are indicated in Figure 9; Figure 11 is a side view similar to Figure 8, illustrating a further manipulative step involving the forward displacement of the trigger to move the grasping means forwardly from the elongated inner member so as to grasp another anatomical tube to be ligated; Figure 12 is a side view similar to Figure 11, illustrating another step of the method, involving the rearward movement of the grasping means toward the inner tube member; Figure 13 is a detailed sectional view of the forward end portion of the applicator, showing the anatomical tube being drawn within the inner tube member; Figure 14 is a side view similar to Figure Il, showing a further step of the method involving maximum rearward withdrawal of the inner tubular member in relation to the outer tube, so that a second occlusion ring will be ejected over the same or another anatomical tubular structure; Figure 15 is a detailed sectional view of the forward end portion of the applicator after the inner tube member has been rearwardly drawn into the outer tube so as to place the occlusion ring about the desired anatomical tube; and Figure 16 is an exploded view of the applicator of Figure 1, and Figure 17 is a view in perspective of an alternative embodiment of the invention (rings not shown).

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now in detail to the Figures of the drawings, wherein similar reference numerals refer to similar parts, and turning to Figure 1, there is shown one form of applicator of the present invention. The number 12 designates a ligating instrument in acordance with this invention. Instrument 12 includes tubular portion 16, fiber optic connector 32, and a source of light 20 which can be wired with wires 22 to deliver light through a fiber optics outer tube 30 as is known per se.

As shown in Figure 1, elastic ligating or occlusion rings 34, 36 are stretched over the forward end portion of inner tube member 28 in a side-by-side fashion so that the rings may be sequentially ejected therefrom. This is an important feature of this invention since both rings are subjected to substantially exactly the same degree of stretch, the outside diameter of the end of inner tube 28 being substantially uniform.

The ligating instrument of the present invention may be utilized with or without an endoscope operatively connected therewith. Indeed, it may be desirable for the surgeon to perform a single incision operation wherein applicator and endoscope are operatively combined. Such an operation and apparatus therefor are shown in U.S. Patent 3,834,392.

Moreover, the applicator, subject of the present invention, may be utilized in a twoincision operation wherein the applicator and endoscope, as separate instruments, enter the body cavity through different incisions. Also, the applicator may be utilized with a light source but no optics, in a supra-pubic operation.

Turning next to Figure 16 of the drawings, wherein the components are shown separately in the interest of clarity, the applicator includes an elongated rod member 24 that has grasping means, such as forceps 26, located at the forward end portion of rod 24. Forceps 26 are designed to grasp an anatomical tube, such as a Fallopian tube in a female, or the vas in the male, to be ligated. Inner tube member 28, having an inside diameter only slightly larger than the outside diameter of rod 24, fits slidably over rod 24 in such a manner that rod 24 may be slidably drawn inside of inner tube member 28 while gas cannot escape in significant amounts between these two elongated members.

In turn, elongated fiber optic outer tube member 30, in like manner, snugly but slidably fits over inner tube member 28 so that significant amounts of gas may not escape between the inner and outer tubes.

As will further become apparent hereinafter, when the applicator is assembled, the forward edge portion of fiber optic outer tube 30 is spaced rearwardly in relation to the forward edge portion of inner tube member 28, providing a protruding portion upon which one or more elastic occlusion rings may be loaded.

An extension 32 is provided, and contains a bundle of fiber optic strands which bend forwardly in tubular portion 16 and extend to forward end 30, which parts are themselves well known, and are accordingly not shown, wherein the extension is adapted to be connected to a light source or a light transmitting cable which also comprises a bundle of fiber optic strands encased in a flexible sheathing, for example, adapted to be connected to an illuminator in the manner fully shown and described in aforementioned U.S. Patent No.3,834,392. In this construction the fiber optic strands have a bore whose inner diameter forms a close fit over the outer diameter of the outer tube.

Light transmitting means, such as fiber optic strands, may be placed within a bore located in rod 24, or in inner tube 28. Also, rod 24, or tube 28 can be used as an optical viewing tube, reference being made to the aforesaid U.S. Patent No.3,834,392.

Push-pull trigger housing 38, having oppositely faced concave trigger surfaces 40, 40 depending therefrom, is mounted for back and forth reciprocation on outer tube 30. Connector rod 42 extends through and is threaded to an aperture (not visible in Figure 1, but indicated as 100 in Figure 16) formed in a side wall of housing 38, and fits through aligned slots 76, 74 (see Figure 16) which will be described in further detail hereinafter, but which are formed in outer tube 30 and inner tube 28, respectively. The rod 42 accordingly projects into bore 44 (Figure 16) formed in the rearward end portion of rod 24 and has a non-threaded end 42(a) extending therein. In this manner, housing 38 is reciprocably drivingly connected directly to rod 24, through contact between non-threaded end 42(a) and the inner wall of bore 44. Bore 44 and slots 76, 74 are aligned.

As is seen in Figure 16, a guide rod 48, adapted to be spaced parallel to outer tube 30, is adapted to be slidably disposed through bore 38' of trigger housing 38 and to be threadedly anchored at its rearward end in threaded opening 46' in pistol grip member 46. The pistol grip member 46 may be a solid, unitary assembly, or it may include a hole 46" shown in dotted lines bored therethrough and adapted to accommodate the surgeon's thumb. As shown in Figure 16, the pistol grip has a substantially flat rearward surface 47' so that the surgeon's palm may bear against this surface area.

As best seen in Figure 16, the rearward end portion of outer tube 30 carries a threaded adaptor 50 which is threaded into a corresponding threaded aperture 50' formed in the pistol grip member 46 (Figure 16). A collar 52 is formed at the rearward end portion of inner tube member 28, and is arranged to abut forwardly against the rear surface of threaded adaptor 50. Projecting from the rear end portion of inner tube -collar 52 is a helical compression spring 54 that is secured to a slug 56 which in turn is arranged to abut against a dead end 58' in bore 58 of pistol grip member 46.

The manner in which the individual components of Figure 16 are connected to each other will now become apparent. The rod 24, with forceps 26, is slid rearwardly into inner tube 28 until the forceps 26 are closed and positioned completely within the inner tube 28. (The forceps 26 and their leg portions 26' are preferably staggered slightly with respect to one another, and pass closely adjacent to each other when they are closed.) The bore 44 is, of course, aligned with slot 74 of inner tube 28.

The resulting sub-assembly is then inserted forwardly through the rearward end (50) of outer tube 30, taking care that bore 44 and both slots 74 and 76 are aligned. Forward movement is continued until flange 52 of inner tube 28 contacts the rearward surface 50(a) of threaded adapter 50. Threaded bore 100 of housing 38 is then aligned with bore 44 of rod 24, by suitable rotation and positioning of housing 38, and the threaded driving connector 42 is threaded securely into bore 100, with its unthreaded end 42(a) extending into bore 44.

The pistol grip 46 is then threaded directly to the outer tube 30 by inserting slug 56, spring 54 and collar 52 of the inner tube 28 into the threaded opening 50' of pistol grip 46, with threaded connector 50 of outer tube 30 threadedly engaged in threads 50' of pistol grip 46. By relative rotation of the outer tube 30 and pistol grip 46, this threaded connection is secured and tightened, thus bringing the end of slug 56 into contact with the blank end wall 58' of threaded opening 50'. The bore 46' of pistol grip 46 is then lined up with the bore 38' of housing 38, and the guide rod 48 is inserted forwardly through both bores, and threaded portion 48' is screwed into threaded opening 46' with the use of knurled head 48" of guide rod 48.

With particular reference to Figure 2, a stop means is shown in detail, and comprises an important feature of this invention. A portion of trigger housing 38 is hollowed around the outer circumference of outer tube 30 to form an adjustment channel 60. Inserted about outer tube 30, and within adjustment channel 60, is a stop sleeve 62. Stop sleeve 62 is urged toward the forward end of ligating instrument 12 by the action of a coiled compression spring 64 that surrounds the middle portion of sleeve 62. Stop adjustment handle 66 (see Figure 1) is firmly secured to, or is an integral part of, stop sleeve 62. By manually engaging handle 66 and moving it to the lower and forwardmost position in slot 68 (as shown in Figure 11), stop sleeve 62 is drawn entirely within trigger housing 38. By placing the stop adjustment handle in its upper and forward position as shown in Figure 1, the rear end of sleeve 62 protrudes from the rearward end portion of the trigger housing (Figure 2). Normally, the stop sleeve and adjustment apparatus are aligned in such manner that the stop sleeve can be made to halt the rearward movement of the trigger by being adjusted to different incremental positions. These different incremental stop positions may desirably be spaced apart from each other at a distance that is approximately equal to the width of an occlusion ring.

As has been previously stated, connector 42 is carried by the reciprocating motion of trigger housing 38 along outer tube 30 and guide 48. As appears in Figures 3 and 10, connector member 42 contains a threaded portion 70 that securely anchors the connector to the trigger housing. Stud portion 42(a) fits through aligned channels 74, 76 (Figure 16) formed in the inner and outer tubes respectively and is threaded through aperture 44 drilled in the rear end of rod member 24.

OPERA TION In order better to describe the operation of ligating instrument 12, reference will be made to its use in the occlusion of the Fallopian tubes of a female patient. It should be remembered that such reference is for illustrative purposes only, as the novel apparatus of the present invention may be utilized to ligate any anatomical tubular structures. Therefore, the description of the operational aspects of the invention should be construed as being descriptive only, and not limiting in any manner whatsoever. In referring to the sequence of steps performed, Figures 1, 2, 4, 5, 7, 8, 11, 12 and 14 may be considered as illustrative of typical steps as performed by the surgeon in performing ligation procedures on two Fallopian tubes without removing the instrument from the incision.

As may be seen in Figure 1, occlusion rings 34, 36 are loaded onto the forward edge portion of inner tube member 28 in a side-by-side fashion. Accordingly, it will be seen that the length of the surface of the forward end portion of inner tube 28 that protrudes from outer tube 30 must equal at least N x W (wherein N is equal to the number of occlusion rings to be loaded about the inner tube and W is equal to the width of an occlusion ring).

Before starting, the surgeon should make sure that adjustment handle 66 is at its top uppermost position in adjustment slot 68 as may be seen in Figure 1, so that the rear end portion of stop sleeve 62 protrudes a predetermined distance (as shown in Figure 2, approximately equal to the width of one occlusion ring) from the rear of trigger housing 38. After suitable incision, insufflation of the abdominal cavity (if applicable) and insertion of the instrument, the surgeon displaces the concave trigger face forwardly with the front portion of his index finger, shifting the forceps 26 from the Figure 2 to the Figure 4 position. Rod 24 is caused to move forwardly as in Figure 4 with respect to both the inner and outer tubular members, due to the threaded engagement of screw 42, carried by housing 38, in aperture 44 bored in the rear end portion of rod 24, as previously described in connection with Figure 16.

As seen in Figure 4, forceps 26, being made of a spring-biased metal, open automatically upon forward displacement from the confines of inner tube 28. When a Fallopian tube has been grasped, as in Figure 5, the surgeon slowly pulls the trigger toward pistol grip member 46, as indicated by the arrow in Figure 5. Due to the engagement of screw 42 in aperture 44, rod 24 with associated forceps 26 is rearwardly withdrawn inside inner tube 28, as seen clearly in Figures 5 and 6.

A portion of Figure 2 has been broken open to illustrate further details of internal construction, showing how the rearward movement of trigger housing 38 actuates the release of an occlusion ring from the forward end of inner tube 28. the rearward movement of the rearward end of rod 24 is accomplished without spring resistance while the Fallopian tube is being doubled over and drawn into the forward end of inner tube 28, until the rearward end of rod 24 contacts a semi-cylindrical stop insert 28' located in a fixed position within the rearward end of inner tube 28. Further retraction, after such contact, causes rod 24 to displace inner tube 28 rearwardly relative to outer tube 30. This displaces both rings 36, 34 forwardly of the front end of inner tube 28, ultimately ejecting the first occlusion ring 34.

The length of stop insert 28' is carefully predetermined so that rearward driving movement of inner tube 28 is caused only by contact between rod 24 and stop insert 28', and not by contact of pin 42(a) against the end of slot 74.

Accordingly, retraction of trigger 38 first causes rearward movement of rod 24 when the trigger is pulled, followed by subsequent rearward movement of inner tube member 28 as in Figure 8 after the rod 24 has been withdrawn a predetermined distance. Thus the surgeon, when pulling the trigger rearwardly, initially meets little resistance as inner rod member 24 is rearwardly withdrawn as in Figure 7. However, when the rearward pull continues, as in Figure 8, the surgeon feels an increase in resistance when rearward motion of inner tube 28 is commenced, due to the compression of the spring 54. thus the surgeon, upon feeling resistance, easily knows when an occlusion ring is about to be ejected from the forward edge portion of inner tube 28.

Stop sleeve 62, due to the plaement of stop adjustment handle 66, protrudes rearwardly from trigger housing 38. As the stop sleeve abuts pistol grip 46 (see Figure 8), one occlusion ring 34 is pushed by the second occlusion ring 36, which in turn is pushed by the front edge of outer tube 30.

In this way, ring 34 is ejected from its position about the outer circumference of inner tube 28 by the rearward withdrawal of rod 24 and inner tube 28 into outer tube 30.

Concurrently, the second ring 36 is shifted forwardly by the front edge of outer tube 30 through a distance essentially equal to the width of ring 34. The rearward limit of the surgeon's pulling action, caused by the abutment of stop sleeve 62 with the front end portion of pistol grip member 46, signals the physician that one occlusion ring has been ejected around the patient's Fallopian tube.

Without withdrawing the instrument from the body cavity, the surgeon pushes the trigger forwardly with the forwardly facing surface of his index finger, as in Figure 11, to expel the now occluded Fallopian tube from the inner tube 28, thus causing the forceps 26, 26 forwardly until they are free to spring open to release the Fallopian tube. Helical spring 54 urges inner tube 28 forwardly during the first part of this forward movement without the additional help from the surgeon's index finger.

To adjust the instrument for placement of the second ring 36, the surgeon places stop adjustment handle 66 in its lower and forwardmost position as illustrated in Figures 9, 11, 12 and 14. Thus, the stop sleeve 62 is pushed to its forwardmost position within adjustment channel 60 so that the rear end portion of the sleeve 62 is shifted forwardly through a distance essentially equal to the width of a ring. As shown, sleeve 62 is so shifted as to be totally disposed within trigger housing 38.

The surgeon, after locating the other Fallopian tube, then rearwardly pulls trigger 40 toward pistol member 46 as shown in Figures 12 and 13. During rearward withdrawal, the spring-biased forceps close in response to the confining action of inner tube 28 and gently draw the doubled Fallopian tube inside the inner tube 28.

Subsequent pulling of the trigger 38 causes the inner tube 28 to move rearwardly with respect to the outer tube 30, as in Figure 14.

Again, the surgeon feels an increase in resistance to his pull. Since the stop sleeve 62 does not protrude rearwardly from the trigger housing, due to the forward placement of the stop adjustment handle 66, the second occlusion ring 36 is ejected as in Figure 15 when, or slightly before, the trigger housing 38 abuts pistol grip 46.

The surgeon then, after feeling the stop action due to trigger housing contacting the pistol grip, knows that the second occlusion ring 36 has been ejected, and accordingly moves the trigger forwardly to expel the now occluded second Fallopian tube from the applicator in a manner similar to that appearing in Figure 8. As previously mentioned, spring 52 urges the inner tube forwardly during part of this step.

Upon completion of the method steps just described, both Fallopian tubes are occluded and the operation may be completed by withdrawing the instrument and closing the incision. It should be noted that the applicator of this invention can be utilized to place a plurality of occlusion rings about the same or different anatomical structure and that more than two rings may be applied if desired.

It will be appreciated that, however used, and whether used in conjunction with an endoscope or not, the operation of the ligating instrument 12 is ext

Figure 17 shows an alternative embodiment of this invention, with an integral fiber light guide 101 on outer tube 30, but without optics. Instead of a trigger a flanged finger grip 102 is provided, and may be structurally similar to trigger 38 as regards stop means adjustment for precision ejection of successive occlusion rings.

Instead of pistol grip 46 a thumb grip 103 is provided, having gently sloped walls 104, 104, which are helpful in operation since the surgeon will not hit them with his fingers while withdrawing finger grip 102 toward thumb grip 103.

Of course, a wide variety of equivalent elements may be substituted for those specifically shown and described. For example, any sort of stop means may be provided, instead of the stop means provided in a hollowed portion of the trigger housing. Further, any resistance supplying means may be substituted for the compression spring 54 that is housed in the pistol grip member.

It is important that a close sliding fit may be maintained along the rod 24, the inner tube 28 and the outer tube 30. As has been noted, the ligation procedure is frequently performed while maintaining a certain required gas pressure inside the abdominal cavity of the patient. While loss of gas pressure can be readily made up, and is indeed normally made up in the course of the usual tubal ligation procedure, it is highly preferred to maintain such close clearances that, although they do not interfere with relative sliding movement, they do very substantially reduce the escape of gas between the relative sliding surfaces.

It will now be apparent that the instrument in accordance with this invention is very easy to disassemble, clean, sterilize and reassemble. As viewed in Figure 16, the separate parts contain mostly open and easily accessible surfaces. Although it is preferred to clean and sterilize the parts separately, they can be cleaned separately, and then reassembled and sterilized.

Difficulty in sterilization has been a serious drawback in instruments of the prior art.

It is highly recommended that the applicator should be cleaned immediately after use. This is done by placing the disassembled applicator parts and a cleaning brush in warm water with a mild, not abrasive detergent. A brush may be utilized to clean the insides of the tubes, and it is preferably pushed into the tubes using a rotating motion. When cleaning the outer tube 30, a brush can be pushed through until the bristle portions project from the tube.

After cleaning, the outside of the tubes are simply wiped off with a soft cloth and the parts are rinsed thoroughly with clean water and the excess liquid is shaken off, then all parts are air-dried.

It is important in accordance with this invention that the apparatus is completely free of O-rings or washers which, with packing, tend to wear. We have found surprisingly that by providing proper clearance between the rod 24, the inner tube 28 and the outer tube 30, that only minimal amounts of gas can escape from the body cavity, because of the close sliding fit-all without interfering with the smoothness and ease of operation of the ligating instrumentl2.

The provision of compression spring 54, or any other equivalent resistance device, such as an air or gas cylinder, bellows or the like, is of considerable importance in that it assures the surgeon that the ligating instrument cannot discharge the occlusion rings 34, 36 prematurely. It is normal in the operation of the ligating instrument 12 for the surgeon to feel the increased resistance at the time that the forceps 26 have been completely withdrawn within the inner tube 28, and the surgeon must deliberately draw the manually actuated trigger 40 rearwardly against this known resistance in order to cause the release of an occlusion ring.

WHAT WE CLAIM IS: 1. A surgical ligating instrument for applying a plurality of elastic rings to an anatomical element to be ligated, the combination which comprises; (a) a support member having a portion adapted for supporting a plurality of elastic rings mounted thereon.

(b) actuating means movable relative to said support member for displacing said rings toward said end of said support member.

(c) shiftable control means for limiting the relative movement of (a) and (b) said control means in a first position limiting said movement of (a) and (b) in a manner to limit to a predetermined number the number of elastic rings displaced off of said support member and, concurrently to displace a predetermined number of elastic rings remaining on said support member along said support member to a position for subsequent displacement off said support member, said control means in a subsequently shifted position permitting movement of (a) and (b) beyond the movement allowed by the first position, said subsequent shifted position adapted for permitting the displacement of one or more remaining elastic rings off of said support member.

2. An instrument as defined in claim 1, wherein said support member and said actuating means are axially relatively slidable elongated members.

3. An instrument as defined in claim 1 or

**WARNING** end of DESC field may overlap start of CLMS **.

Claims (30)

**WARNING** start of CLMS field may overlap end of DESC **. Figure 17 shows an alternative embodiment of this invention, with an integral fiber light guide 101 on outer tube 30, but without optics. Instead of a trigger a flanged finger grip 102 is provided, and may be structurally similar to trigger 38 as regards stop means adjustment for precision ejection of successive occlusion rings. Instead of pistol grip 46 a thumb grip 103 is provided, having gently sloped walls 104, 104, which are helpful in operation since the surgeon will not hit them with his fingers while withdrawing finger grip 102 toward thumb grip 103. Of course, a wide variety of equivalent elements may be substituted for those specifically shown and described. For example, any sort of stop means may be provided, instead of the stop means provided in a hollowed portion of the trigger housing. Further, any resistance supplying means may be substituted for the compression spring 54 that is housed in the pistol grip member. It is important that a close sliding fit may be maintained along the rod 24, the inner tube 28 and the outer tube 30. As has been noted, the ligation procedure is frequently performed while maintaining a certain required gas pressure inside the abdominal cavity of the patient. While loss of gas pressure can be readily made up, and is indeed normally made up in the course of the usual tubal ligation procedure, it is highly preferred to maintain such close clearances that, although they do not interfere with relative sliding movement, they do very substantially reduce the escape of gas between the relative sliding surfaces. It will now be apparent that the instrument in accordance with this invention is very easy to disassemble, clean, sterilize and reassemble. As viewed in Figure 16, the separate parts contain mostly open and easily accessible surfaces. Although it is preferred to clean and sterilize the parts separately, they can be cleaned separately, and then reassembled and sterilized. Difficulty in sterilization has been a serious drawback in instruments of the prior art. It is highly recommended that the applicator should be cleaned immediately after use. This is done by placing the disassembled applicator parts and a cleaning brush in warm water with a mild, not abrasive detergent. A brush may be utilized to clean the insides of the tubes, and it is preferably pushed into the tubes using a rotating motion. When cleaning the outer tube 30, a brush can be pushed through until the bristle portions project from the tube. After cleaning, the outside of the tubes are simply wiped off with a soft cloth and the parts are rinsed thoroughly with clean water and the excess liquid is shaken off, then all parts are air-dried. It is important in accordance with this invention that the apparatus is completely free of O-rings or washers which, with packing, tend to wear. We have found surprisingly that by providing proper clearance between the rod 24, the inner tube 28 and the outer tube 30, that only minimal amounts of gas can escape from the body cavity, because of the close sliding fit-all without interfering with the smoothness and ease of operation of the ligating instrumentl2. The provision of compression spring 54, or any other equivalent resistance device, such as an air or gas cylinder, bellows or the like, is of considerable importance in that it assures the surgeon that the ligating instrument cannot discharge the occlusion rings 34, 36 prematurely. It is normal in the operation of the ligating instrument 12 for the surgeon to feel the increased resistance at the time that the forceps 26 have been completely withdrawn within the inner tube 28, and the surgeon must deliberately draw the manually actuated trigger 40 rearwardly against this known resistance in order to cause the release of an occlusion ring. WHAT WE CLAIM IS:

1. A surgical ligating instrument for applying a plurality of elastic rings to an anatomical element to be ligated, the combination which comprises; (a) a support member having a portion adapted for supporting a plurality of elastic rings mounted thereon.

(b) actuating means movable relative to said support member for displacing said rings toward said end of said support member.

(c) shiftable control means for limiting the relative movement of (a) and (b) said control means in a first position limiting said movement of (a) and (b) in a manner to limit to a predetermined number the number of elastic rings displaced off of said support member and, concurrently to displace a predetermined number of elastic rings remaining on said support member along said support member to a position for subsequent displacement off said support member, said control means in a subsequently shifted position permitting movement of (a) and (b) beyond the movement allowed by the first position, said subsequent shifted position adapted for permitting the displacement of one or more remaining elastic rings off of said support member.

2. An instrument as defined in claim 1, wherein said support member and said actuating means are axially relatively slidable elongated members.

3. An instrument as defined in claim 1 or

2 wherein said control means includes an adjustably shiftable stop member.

4. An instrument as defined in claim 2 or 3 wherein said actuating means includes a forwardly and rearwardly manually operable projection.

5. An instrument as defined in any of claims 1 to 4 in which there is provided an elongated inner member having a forward end and a rearward end having a grasping means constructed and arranged for grasping the anatomical tube to be ligated.

6. An instrument as defined in any of claims 1 to 5 in which said support member for said elastic rings comprises tube means having a surface over which elastic rings are adapted to fit in a stretched condition.

7. An instrument as defined in claim 5 and 6 in which said actuating means comprises a forwardly and rearwardly manually reciprocable push-pull trigger operatively connected to said inner member, and means operative upon rearward movement of said member relative to said tube means to actuate said grasping means to grasp the anatomical tube to be ligated and to draw it rearwardly into said tube means.

8. An instrument according to claim 7 in which said actuating means includes an outer tube adapted to fit slidably over said tube means and having a forward edge that is spaced rearwardly of the forward edge of said tube means, said outer tube being operative upon retraction of said inner member relative to said tube means to displace an elastic ring stretched over said tube means from the surface of tube means while said anatomical tube to be ligated extends into said tube means.

9. An instrument as defined in claim 8 in which a pistol grip is attached to the rearward end of said outer tube and co-operates with said trigger for effecting relative sliding movement of the component parts back and forth along the axis of said member.

10. An instrument as defined in any of claims 7 to 9 wherein said push-pull trigger has concavely shaped forward and rearward surfaces for finger accommodation in both directions.

11. An instrument as defined in any of claims 8 to 10 wherein said push-pull trigger is mounted for reciprocation back and forth on said outer tube, and wherein a guide rod is attached to said pistol grip and extends forwardly and is slidably connected to said push-pull trigger.

12. An instrument as defined in claim 11 wherein said guide rod is parallel to and spaced below said outer tube.

13. An instrument as defined in any of claims 3 to 12 wherein said stop means is provided in a position to limit retraction of said tube means after said elastic ring has been ejected.

14. An instrument as defined in claim 13 wherein said stop means extends between said push-pull trigger and said pistol grip.

15. An instrument as defined in claim 14 wherein said stop means includes a sleeve mounted on said trigger means and slidably surrounding said outer tube.

16. An instrument as defined in claim 15 wherein said sleeve is continuously urged toward said trigger by a spring which is sub stantially helical and which is mounted within said trigger means.

17. An instrument as defined in claim 16 wherein said trigger means includes a hollowed body portion including a pair of longitudinally spaced stops, wherein said spacing sleeve is within said body and in cludes a manually adjustable handle extend ing outside said trigger body, and wherein said manually engageable handle is urged by said spring toward the forward end of said instrument.

18. A tubal ligation instrument for dispensing elastic rings onto anatomical elements comprising: (a) a support member having a portion adapted for supporting a plurality of elastic rings mounted thereon.

(b) ring displacement member coaxial with and surrounding said support member, along at least part of the length thereof, and adapted to discharge off said support member to a ligating position upon said anatomical elements one or more elastic rings; (c) displacement means for moving said supporting member relative to said ring displacement member thereby to displace said elastic rings; (d) shiftable control means for limiting the relative movement of (a) and (b) said limiting means in a first position limiting said movement of (a) and (b) in a manner to limit to a predetermined number the number of elastic rings displaced off of said support member, at least one of said plurality of elastic rings remaining on said support member after the displacement, said limiting means in a subsequent shifted position permitting movement of (a) and (b) beyond the movement allowed by the first position, said subsequent shifted position adapted for permitting the displacement of one or more remaining elastic rings off of said support member.

19. The tubal ligation instrument in accordance with claim 18, wherein said support member is an inner tubular member and said ring displacement means is an outer tubular member extending longitudinally over said inner tubular member.

20. The tubal ligation instrument in accordance with claim 19, wherein said inner tubular member has a distal end from which elastic rings are displaced off of said inner tubular member.

21. The tubal ligation instrument in accordance with claim 20, wherein said displacement means is a movable grip.

22. The tubal ligation instrument in accordance with claim 21, wherein said movable grip is slidable along said outer tubular member, and adapted for being in communication with said inner tubular member.

23. The tubal ligation instrument in accordance with claim 18, wherein said shiftable limiting means in said subsequent shifted position to a second position permits further movement of (a) and (b) beyond the movement allowed by the first position for limiting to a predetermined number the number of elastic rings displaced, during said further movement, from those remaining on said inner tubular member.

24. The tubal ligation instrument in accordance with claim 23, wherein said predetermined number of elastic rings displaced off of said inner tubular member is one, with said shiftable limiting means in said first position.

25. The tubal ligation instrument in accordance with claim 18, wherein said support member is of uniform diameter for providing said elastic rings with uniform support.

26. An instrument as defined in any of claims 6 to 17 and 19 to 25, wherein a lighting means is provided surrounding said tube means.

27. An instrument as defined in any of claims 1 to 18 including means for disassembling said support member and control means from each other for separate cleaning and sterilisation.

28.. An instrument as defined in any of claims 6 to 27 wherein said member includes a bore for connection to an optical viewing device having a viewing bore substantially parallel to and within said tube.

29.. An instrument as defined in any of claims 7 to 19 wherein said instrument is combined with and connected to an optical viewing device and wherein said optical viewing device includes a bore which has an inner diameter which forms a close sliding fit with the outer diameter of said outer tube.

30. A surgical ligating instrument substantially as herein described with reference to and as shown in the accompanying drawings.