Background of the Invention

This invention relates to a suture closure device for particular use in laparoscopic surgery. aparoscopic surgery is currently a rapidly spread¬ ing innovative medical technique. In laparoscopic surgery, internal organs of the patient are operated upon through a plurality of sleeves inserted in the abdominal wall of the patient. The progress of the operation is continuously monitored by the surgeon and assisting personnel with the aid of a specialized camera device called a laparoscope. The laparoscope is itself inserted into the patient through one of the sleeves in the abdominal wall. The action of the distal ends of laparoscopic instruments on the internal tissues of the patient is observed on one or more television monitors connected to the laparoscope.

One of the drawbacks of laparoscopic surgery is the inability to effectively form sutures. This problem is solved by the present invention. Summary of the Invention

A device for locking a suture particularly during a laparoscopic surgical operation comprises, in accordance with the present invention, a body member made of biocompatible material and provided with a passageway for receiving a suture. The body member is further provided with locking com- poentry or elements for preventing a suture from passing in a first predetermined direction along the passageway. The device has dimensions sufficiently small to enable insertion of the device into a patient's body via a laparoscopic can- nula.

According to another feature of the present inven¬ tion, the locking componentry is disposed along the passageway through the body member and allows the suture to slide rela¬ tive to the body member in a second direction through the pas¬ sageway opposite to the first direction. The locking com¬ ponentry in this case may take the form of a plurality of barbs. The barbs extend at least partially radially inwardly and may be permanently angled in the second direction. Alter¬ natively, if the barbs are flexible, they bend in the second direction upon an insertion of suture strands through the pas¬ sageway in the second direction.

According to another feature of the present inven-

tion, the body member tapers down in the direction of slidability of a suture through the passageway. The pas¬ sageway itself may be tapered in that direction.

The body member may take the form of a slotted ring provided with flared extensions at the slot for facilitating a lateral insertion of a suture into the ring.

The device described above is used to close or lock a suture. Upon a passing of the suture through organic tis¬ sues of a patient so that two strands of the suture extend from the organic tissues on opposite sides of an opening in the tissues, at least one of the strands is inserted into the passageway. The other strand is either pre-inserted through the device or is threaded through the device at this juncture. Then, the locking device is slid along the two strands until the locking device is substantially juxtaposed to. the organic tissues at the opening in the organic tissues of the patient, thereby drawing the strands together and locking the strands in a tightened closure configuration. The strands are then severed on a side of the locking device opposite the organic tissues and the opening.

In one embodiment of the locking device in accord¬ ance with the present invention, the body member is provided with a pair of substantially parallel passageways or channels, each of the channels being provided with barbs or other lock¬ ing elements for preventing a suture from passing in the first predetermined direction along the respective channel while allowing the suture to slide relative to the body member in the opposite direction through the respective channel. In that event, one suture strand or end section is inserted through one channel of the locking device and the other strand or end section is inserted through the other channel. It is possible, however, to provide the locking device with one channel or passageway, both strands of the suturing device being inserted through that passageway.

A laparoscopic suturing method utilizing a suture locking device in accordance with the present invention com¬ prises the steps of (a) disposing a trocar sleeve or laparo¬ scopic cannula in an abdominal wall of a patient, (b) moving a first end section of a suture through the trocar sleeve and into an abdominal cavity of the patient so that a second end

section of the suture remains outside the patient, (c) passing the first end section of the suture through organic abdominal tissues of the patient, and (d) drawing the first end section of the suture back out through the trocar sleeve upon passing of the suture through the abdominal tissues of the patient. Upon drawing of the first end section of the suture out of the patient, the locking device described above is slid along the suture end sections and through the trocar sleeve until the locking device is substantially juxtaposed to the organic tis¬ sues at the opening. Then, the suture end sections are severed on a side of the locking device opposite the abdominal tissues and the opening.

The step of sliding may particularly include the steps of (i) providing an elongate instrument, (ii) inserting a distal end portion of the elongate instrument through the trocar sleeve, and (iii) pushing the locking device along the suture end sections by engaging the locking device with the distal end portion of the instrument.

Where the laparoscopic pushing instrument is pro¬ vided at a distal tip of the distal end portion with a cutting edge, the severing of the suture end sections includes the step of manipulating the instrument and the suture from out¬ side the patient so as to bring the suture end sections at the locking device into contact with the edge.

Where the instrument is provided at a distal tip of the distal end portion with an aperture smaller than the lock¬ ing device, the method further comprises the step of passing the first end section and the second end section through the aperture prior to insertion of the distal end portion of the instrument through the trocar sleeve.

According to another feature of the present inven¬ tion, the locking componentry on the body member of the suture locking device includes an element for wedging the suture in the passageway. The wedging element may be a conically tapered plug attached to the body member via a flexible link or strap. The plug is inserted into the passageway of the body member upon an insertion of suture strands through the passageway and a juxtaposition of the body member to the tis¬ sues being sutured.

In another specific embodiment of a suture locking

device in accordance with the present invention the locking componentry includes a plurality of tapered slots provided on the body member for receiving the suture in a friction lock. In this case, the body member may be X-shaped with a pair of opposite tapered suture-receiving slots or W-shaped with a pair of substantially parallel suture-receiving slots. During a suturing operation, suture strands may be inserted into the slots at the tissues being sutured. Alternatively, the suture strands may be inserted into the slots outside of the patient, with the locking device being subsequently slid down the sutures through a laparoscopic cannula to the tissues inside the patient.

A surgical instrument for use in applying a locking device as described above to suture strands comprises an elongate instrument shaft insertable through a laparoscopic cannula, a holder or support at a distal end of the shaft for releasably holding the body member, and a closure component for engaging a locking part (cap, insert, conical section) of the suture locking device and moving the locking part to lock the suture device upon insertion of suture strands through the passageway in the body member. The closure means may include a pivoting or translating pusher member for wedging the lock¬ ing element in the passageway.

Another laparoscopic instrument comprises, in accordance with the present invention, an elongate shaft, means at a distal end of the shaft defining an aperture, and a cutting edge attached to the instrument at the distal end along the aperture.

The present invention provides a device for use in quickly locking a suture. The device is especially useful in laparoscopic operations. Brief Description of the Drawing

Fig. 1 is a schematic longitudinal cross-sectional view, on an enlarged scale, of a suture locking device in accordance with the present invention.

Figs. 2A-2C are schematic cross-sectional views of a patient's abdomen, showing successive steps in a laparoscopic suturing procedure utilizing the device of Fig. 1.

Fig. 2D is a schematic perspective view of an organ and an incision or wound closed by a suture which is locked by

the device of Fig. 1, in accordance with the present inven¬ tion.

Fig. 3 is a side elevational view of a laparoscopic instrument shown in use in Fig. 2C, for applying the locking device of Fig. 1.

Fig. 4 is a schematic cross-sectional view similar to Figs. 2A-2C, showing a step performable between the step of Fig. 2C and the step of Fig. 2D.

Fig. 5 is a partial schematic perspective view of the laparoscopic instrument of Figs. 2C and 3, showing a cut¬ ting edge in accordance with the present invention.

Fig. 6 is a partial schematic perspective view, showing a modification of the instrument of Figs. 2C, 3, and 5.

Fig. 7 is a schematic perspective view, on an enlarged scale, of another locking device in accordance with the present invention, showing two strands of a suture inserted through the locking device.

Fig. 8 is a schematic perspective view, on a sub¬ stantially enlarged scale, of a further locking device in accordance with the present invention.

Fig. 9A is a schematic exploded perspective view of a suture locking device, suture strands and a suture threading device in accordance with the present invention.

Fig. 9B is a schematic perspective view of the suture locking device, suture strands and the suture threading device of Fig. 9B, showing the suture strands inserted through the threading device which in turn is inserted through the locking device.

Fig. 9C shows a step in a suture insertion operation subsequent to a step shown in Fig. 9B.

Fig. 9D shows another succeeding step in a suture insertion operation subsequent to the step shown in Fig. 9C.

Fig. 10 is a schematic perspective view of another suture locking device in accordance with the present inven¬ tion.

Fig. 11 is a schematic perspective view of a further suture locking device in accordance with the present inven¬ tion.

Fig. 12A is a schematic perspective view of yet

another suture locking device in accordance with the present invention, showing the device in an opened, pre-use configura¬ tion.

Fig. 12B is a schematic perspective view of the suture locking device of Fig. 12B, showing the device in a closed, use configuration.

Fig. 13 is a schematic side elevational view of a laparoscopic instrument for applying the locking device of Figs. 12A and 12B.

Fig. 14 is a schematic perspective view of another laparoscopic instrument in accordance with the present inven¬ tion for applying yet another suture locking device shown in Fig. 14. Detailed Description

As illustrated in Fig. 1, a device 8 for locking a suture comprises a body member 10 made of biocompatible material and provided with two substantially parallel pas¬ sageways or channels 12 and 14. Each passageway or channel 12 and 14 is lined with barb-like protuberances 16 pointed generally towards one end of the respective passageway 12 and 14. During use of locking device 8, a suture end (not shown in Fig. 1) is passed through a passageway 12 or 14 from one side 18 of device 8 towards an opposite side 20 thereof. Barb-like protuberances 16 serve to prevent the suture from moving in the opposite direction from side 20 to side 18, while allowing suture insertion in the opposite direction along the respective passageway. It is to be noted that device 8 may also work if just one passageway is provided (see Figs. 7-9D).

As further illustrated in Fig. 1, body member 10 is tapered in a direction from side 18 to side 20. Likewise, passageways 12 and 14 each taper down in the same direction to facilitate insertion of a suture thread in the proper direc¬ tion through the passageways.

As depicted in Figs. 2A-2D, in a laparoscopic sutur¬ ing procedure, a trocar sleeve 22 is disposed in an abdominal wall AW of the patient. A first end section or strand 24 of a suture 26 is moved through trocar sleeve 22 and into an abdominal cavity AC of the patient while a second end section or strand 28 of the suture remains outside the patient. As

illustrated in Fig. 2A, first end section 24 of suture 26 is passed through tissues of an abdominal organ AO of the patient, for example, through the use of an arcuate needle as disclosed in U.S. Patent No. 5,281,234, the disclosure of which is hereby incorporated by reference. More particularly, first end section 24 of suture 26 is passed through an inci¬ sion INC in abdominal organ AO. Subsequently, first end sec¬ tion 24 is brought back out through trocar sleeve 22 (Fig. 2B) and passed through one passageway 12 or 14 of locking device 8.

Second end section 28 of suture 26 is inserted through the other passageway 14 or 12 of device 8, either before or after the passing of end section 28 therethrough. Alternatively, locking device 8 may be pre-attached to suture 26 along end section 28. In that case, only the first end section 24 need be threaded through device 8 during a laparo¬ scopic operation.

As illustrated in Fig. 2B, both suture end sections or strands 24 and 28 are inserted through locking device 8 outside of the patient. Then, as depicted in Fig. 2C, an elongate laparoscopic instrument 30, provided at a distal end with a transversely extending ring 32 (see Fig. 3), is used to push locking device 8 along suture end sections 24 and 28 and through trocar sleeve 22 into abdominal cavity AC until the locking device is substantially juxtaposed to organ AO at incision or opening INC. Then, suture end sections 24 and 28 are severed on a proximal side of locking device 8, opposite abdominal organ AO and incision INC (Fig. 2D) .

In sliding locking device 8 along suture end sec¬ tions 24 and 28, distal ring 32 of instrument 30 is inserted through trocar sleeve 22 and engages locking device 8 along the proximal side 20 thereof. As illustrated in Figs. 3 and 5, pushing instrument 30 may be provided at a distal tip with a pair of scissors 34 or other movable cutting element which is operatively connected to an actuator button 36 on a handle 38 of the instrument. Upon a sliding of locking device 8 to the abdominal organ AO, button 36 is pressed to close the scissors or cutting element 34 to sever suture end sections 24 and 28. Fig. 5 shows scissors in a closed, cutting configura¬ tion. During a sliding of locking device 8 along suture end

sections 24 and 28, scissors 34 are opened and spaced from the end sections 24 and 28.

In a modification of the above-described procedure, shown in Fig. 4, a pushing instrument 40 is used which has an elongate shaft 42 provided at a distal end with a slotted ring 44. Upon a juxtaposition of the locking device 8 with the abdominal organ AO under repair, instrument 40 is manipulated from outside the patient to remove suture end sections 24 and 28 from the ring (see Fig. 4). A laparoscopic scalpel or scissors 46 inserted into the abdomen through another trocar sleeve 48 is then operated to sever the suture end sections 24 and 28 at the proximal side of the locking device 8.

As illustrated in Fig. 6, a guide ring 50 extending in a substantially transverse plane at the distal end of a laparoscopic instrument shaft 52 may be provided with a fixed cutting edge 54 which is reached by a suture only upon manipulating the suture and the instrument to pass the suture from a main guide aperture 56 and through a labyrinthine type slot 58. The labyrinthine slot 58 prevents inadvertant sever¬ ing of a suture during an insertion of locking device 8.

It is to be noted that aperture 56 in the instrument of Fig. 6, as well as the corresponding guide apertures in other pushing instruments disclosed herein, is smaller than the proximal side 20 of locking device 8.

As illustrated in Fig. 7, another locking device utilizable with the method discussed above with reference to Figs. 2A-2D and 4 takes the form of a ring 60 provided along an inner side with barbs 62 inclined in a common axial direc¬ tion for purposes of preventing suture strands 64 from sliding relative to ring 60 in a direction opposite to the direction of inclination of barbs 62. Ring 62 is optionally provided with a slot 66 for enabling a lateral insertion of strands 64 into ring 62. Barbs or projections 62 are angularly spaced from one another and extend at least partially radially inwardly from ring 60. Barbs or projections 62 may be flexi¬ ble so as to move from a planar array (not shown) to the array angled in one direction, as shown in Fig. 7, upon the inser¬ tion of suture strands 64 through the device.

Fig. 8 shows a further locking device in the form of a ring 70 provided along an inner side with barbs 72 inclined

in a common axial direction for purposes of preventing suture strands (not shown) from sliding relative to ring 70 in a direction opposite to the direction of inclination of barbs 72. Ring 72 is also provided with a slot 76 for enabling a lateral insertion of suture strands into ring 72. To further facilitate the insertion of a suture into ring 72, the ring is provided on opposite sides of slot 76 with outwardly flared lips or extensions 78. Barbs or projections 72 are angularly spaced from one another and extend at least partially radially inwardly from ring 70. Barbs or projections 72 may be flexi¬ ble so as to move from a planar array (not shown) to the array angled in one direction, as shown in Fig. 7, upon the inser¬ tion of suture strands through the device.

As depicted in Fig. 9A, a substantially conical threading or guiding device 80 is provided for facilitating insertion of suture strands 82 through an annular suture lock¬ ing device 84. Suture strands 82 are inserted in the direc¬ tion of arrows 86 into threading device 80 upon an insertion of a tapered end of that device into locking device 84, as illustrated in Fig. 9B. Subsequently, after threading of suture strands 82 completely through device 80, the threading device is removed from locking device 84, as illustrated in Fig. 9C. The threading device 80 is provided with a slot 88, whereby that device may be opened to enable removal from suture strands 82, as shown in Fig. 9D. Locking device 84 is provided with non-illustrated barbs. Threading device 80 is made, at least along an outer surface, of a material which resists penetration by the barbs of locking device 84, thereby enabling withdrawal of the threading device 80 from locking device 84.

As shown in Fig. 10, another suture locking device comprises an X-shaped body member 90 with pairs of legs 92 and 94 defining a pair of opposing passageways 96 and 98 in the form of tapering slots which receive respective strands 100 and 102. Tapered slots 96 and 98 receive suture strands 100 and 102 in a friction lock. Suture strands 100 and 102 may be inserted, via the use of laparoscopic graspers, into slots 96 and 98 at the internal tissues being sutured. Alternatively, suture strands 100 and 102 may be inserted into slots 96 and 98 outside of the patient, with the locking device being sub-

sequently slid down suture strands through a laparoscopic can¬ nula to the tissues inside the patient. Like other suture locking devices disclosed herein, body member 90 has dimen¬ sions sufficiently small to permit the insertion of the lock¬ ing device into a patient via a laparoscopic cannula.

A similar suture locking device is illustrated in Fig. 11. A generally W-shaped body member 104 has three generally parallel leg formations 106 defining two substan¬ tially parallel tapered slots 112 acting as passageways for receiving respective suture strands 114 in a suture locking procedure during a surgical operation. Tapered slots 112 receive suture strands 114 in a friction lock. Suture strands 114 may be inserted, via the use of laparoscopic graspers, into slots 112 at the internal tissues being sutured. Alter¬ natively, suture strands 114 may be inserted into slots 112 outside of the patient, with the locking device being subse¬ quently slid down suture strands through a laparoscopic can¬ nula to the tissues inside the patient.

As illustrated in Figs. 12A and 12B, another suture locking device includes a ring 116 which is optionally formed with a slot 118 for sideways insertion of suture strands 124 into a passageway (not designated) defined by the ring. A tapered locking component in the form of a conical section or plug 120 is attached to ring 116 via a flexible strap or tie element 122. Upon a disposition of suture strands 124 so that they traverse ring 116, as shown in Fig. 12A, conical section 120 is maneuvered, by bending strap 122, and wedged partially into ring 116, thereby crimping suture strands to ring 116, as shown in Fig. 12B.

As depicted in Fig. 13, the suture locking device of Figs. 12A and 12B may be employed, during a laparoscopic surgical operation, with the aid of an elongate instrument having a main shaft 125 provided at a distal end with a longi¬ tudinal extension 126 in turn formed at a distal end with a transversely extending foot or flange 128. Foot or flange 128 is provided with a groove 130 for seating ring 116. Groove 130 may be formed as a shoulder (not illustrated) on a proximal side of foot or flange 128 or, alternatively, as a slot accessible laterally via an opening in a side of foot or flange 128.

At the onset of a suture closure procedure, ring 116 is seated in groove 130, while conical section 120 is oriented at a 90° angle, supported by extension 126, as shown in Fig. 13. A distal end portion of the instrument is then inserted into a patient's body via a laparoscopic cannula. Suture strands (not shown in Fig. 13) are drawn through ring 116 by laparoscopic graspers (not shown). An actuator handle 132 of a plunger member 134 is then pushed in a distal direction to close the suture locking device. More specifically, a camming protuberance 136 at the distal end of plunger member 134 sepa¬ rates conical section 120 from extension 126 during a distally directed stroke of the plunger member. Continued motion of plunger member 134 in the distal direction turns conical sec¬ tion 120 from the 90° orientation shown in Fig. 13 to a 180° orientation shown in Fig. 12B and causes a pusher element 138 at the distal end of plunger member 134 to wedge conical sec¬ tion 120 into ring 116, thereby binding the suture strands.

Other equivalent designs for the locking instrument of Fig. 13 will occur to those skilled in the art. For exam¬ ple, foot or flange 128 may include a pair of substantially C- shaped jaws for temporarily clamping ring 116 during a suture closure procedure. The insertion of conical section 120 into ring 116 may be implemented by a pivoting pusher (not shown) rather than by translating pusher element 138. Essential functions of the instrument include holding ring 116 and pivoting conical section 120 to wedge it into ring 116.

As depicted in Fig. 14, another laparoscopic instru¬ ment for effectuating the closure of a suture by a locking device during a laparoscopic surgical operation comprises a main shaft 140 provided at a distal end with a longitudinal extension 142 in turn formed at a distal end with a transver¬ sely extending foot or flange 144. Foot or flange 144 may be provided with a groove, shoulder or slot (not illustrated) for seating a ring 146 of a two-piece suture locking device 148. The other piece of the suture locking device is a snap-in insert 150 including a pair of flanges 152 and 154 connected by a midsection 156 of reduced diameter. Ring 146 defines a passageway (not designated) for receiving suture strands 158 and midsection 156 of snap-in insert 150.

At the onset of a suture closure procedure, ring 146

is held in foot or flange 144. Foot or flange 144 may be resilient for facilitating insertion of ring 146 at the begin¬ ning of a suture closure procedure and for facilitating removal of ring 146 and snap-in insert 150 at the end of the procedure. A distal end portion of the instrument of Fig. 14 is then inserted into a patient's body via a laparoscopic can¬ nula. Suture stands 158 are drawn through ring 146 by laparo¬ scopic graspers (not shown). A plunger member 160 releasably bearing snap-in-insert 150 as shown in Fig. 14 is then pushed in a distal direction to close the suture locking device. More specifically, plunger member 160 forces distal flange 154 of snap-in insert 150 through ring 146, thereby capturing suture strands 158.

Other equivalent designs for the locking instrument of Fig. 14 will occur to those skilled in the art. For exam¬ ple, foot or flange 144 may include a pair of substantially C- shaped jaws 162 and 164 for temporarily clamping ring 146 dur¬ ing a suture closure procedure. The insertion of snap-in insert 150 into ring 146 may be implemented by a pivoting pusher (not shown) rather than by translating plunger member 160. Both plunger member 160 and the pivoting pusher may be provided with a knob (not shown) releasably inserted into a recess (not designated) in snap-in insert 150. Essential functions of the instrument of Fig. 14 include holding ring 146 and pushing flange 154 of snap-in insert 150 through the ring to lock the suture strands 158.

Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the draw¬ ings and descriptions herein are profferred by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.