JP2003531652A - Surgical suturing instrument and method of use - Google Patents

Abstract

(57) Summary An apparatus for introducing an elongated flexible element into at least two target portions has been disclosed. In one embodiment, the device includes a proximal end and a distal end, such that the proximal end of the elongate flexible element can be passed from the distal end of the device with sufficient force to penetrate a subject. And an advancement unit for longitudinally advancing the elongated flexible element toward the distal end in an effective manner. The apparatus further includes a fixation unit that variably adjusts the fixation force applied by the elongated flexible element to provide a desired fixation to the subject.

Description

Detailed Description of the Invention

REFERENCE TO PENDING PATENT APPLICATION This application is made by Gregory E. Sancoff et al.
SURGICAL SUTURING INSTR filed on August 3, 1999
It is a continuation-in-part application of pending US patent application Ser. No. 09 / 386,273 named UMENT AND METHOD OF USE.

[0002] This patent application is filed on March 27, 2000 by SURGICAL SUTURING IN by Gregory E. Sancoff et al.
US Provisional Patent Application No. 60/192487 (Attorney Docket No. ONUX-15) entitled STRUMENT AND METHOD OF USE
PROV) benefits are claimed. This patent application is incorporated herein by reference.

FIELD OF THE INVENTION The present invention relates to medical suturing instruments and, more particularly, to drive means therein for threading sutures through tissue and the like.

BACKGROUND OF THE INVENTION Suture devices generally pull two or more parts (eg, muscle, tissue such as skin) of a subject together to pull them together or attach an object to the patient (eg, during hernia repair surgery). It is used to attach a piece of surgical mesh to the abdominal wall of a patient).

One type of suturing instrument uses a needle with a piece of suture material behind it in the subject. For example, U.S. Pat. .

US Pat. Nos. 4,890,615, 4935027, 5417700 and 5
No. 728112 discloses a suturing instrument that passes a hollow needle through the subject and then passes suture material through the end of the needle.

In all of the above devices, a needle must be passed through the subject to place the suture material. This is generally undesirable because needles generally leave larger holes in the subject than are necessary to accommodate only suture material. In this regard, it should be appreciated that it is generally desirable to have as little variation in each portion of the material to be sutured.

A suturing instrument has been devised that punctures an object with the suture material itself without the use of a needle.
However, this device does not provide sufficient flexibility to accommodate the amount of tension that may be applied to the suture material and tissue.

Specifically, US Pat. No. 5,499,990 discloses a 0.25 mm diameter stainless steel suture wire that is advanced to the distal end of a suturing instrument and then the distal end of the suture wire is moved in a helical direction. Thus, a suturing instrument for performing suturing to join two parts of a subject is disclosed. To prevent the suture wire from retracting into the tissue after removing the suturing device, the leading and ending portions of the suture wire are folded towards the tissue after forming the helix. The stainless steel wire is stiff enough to hold this lock set. Further, after forming the helix, the outer tube can be advanced over a portion of the distal end of the instrument to reduce the radius of the helix of the deployed suture wire. The stainless steel wire is stiff enough to hold this radius reduction set.

Unfortunately, however, because the wire is relatively stiff (ie, stiff enough to hold the set), in all situations such a system is associated with an appropriate amount of tension applied to the subject. After all, it does not give enough flexibility. Moreover, such a system does not provide sufficient flexibility with respect to the appropriate type of suture applied, as the device is specifically configured only to provide helical sutures.

In contrast to the above-mentioned limitations of the suturing device described in US Pat. No. 5,499,990, the suturing device approaches the material parts and joins them together in the correct physiological relationship, and a suitable amount of It is desirable to press these parts with force. If the force (or tension) applied to the suture material is too great, the target area may be necrotic or the suture material may sever the target. If the tension applied to the suture material is too low, the healing process may be impaired.

US Pat. No. 4,453,661 discloses a surgical instrument for applying staples. The staple is formed from the distal end of a single wire. The distal end of the wire is threaded through the subject and then contacts the die. The die bends the wire, thereby forming staples. The wire is sufficiently stiff to hold the bend imposed by the die. The staple portion is then cut from the wire with a knife. Since this attachment is accomplished by staples formed from relatively stiff wires and having a predetermined geometry, such systems are also sufficiently flexible in all situations with respect to the appropriate tension applied to the subject. There is a problem that it does not give sex. Since the surgical instrument is limited to applying wire staples, the system is also limited as to the type of fixation that can be applied.

Therefore, there is a need for new suturing devices that provide sutures with minimal damage and provide flexibility in placement, application and tensioning of suture material. SUMMARY OF THE INVENTION The present invention provides an apparatus for introducing an elongated flexible element into an object. In one embodiment, the device includes a proximal end and a distal end, further allowing the distal end of the elongated flexible element to be threaded from the distal end of the device with sufficient force to penetrate a subject. In various ways, it includes an advancing unit for advancing the elongated flexible element longitudinally toward the distal end of the device. The device further includes a fixation unit that variably adjusts the fixation force applied by the elongated flexible element to provide the desired fixation to the subject.

In another embodiment, the device rotates the guide tube that guides the elongate flexible element through the device toward the distal end of the device and the distal end of the device to rotate the elongate flexible element into the element itself. It includes a rotating unit that is wound around and thereby adjustably applies a fixing force to the elongated flexible element.

In another embodiment, the device comprises an elongate flexible element allowing the element to loop or coil through tissue to attach one tissue portion to another or select a portion of the element. And includes means for guiding the elongate, flexible element out of the distal end of the device in such a manner as to adhere to the tissue being affixed.

In another embodiment, the invention provides a tool for joining a first material layer to a second material layer. The tool comprises a handle and an end effector (an element acting at an end) attached to the handle, the end effector having a first channel for holding a wire guide and a first channel. A second channel extending from the wire guide for supporting the suture wire, a passage for holding the cutting bar, and a distal recess. The second channel is curved to impart a loop shape to the portion of the suture wire passing therethrough. The end recess has a curved surface at the bottom of the end recess such that the end recess receives the looped suture wire emerging from the second channel. The tool further includes a wire advance actuator attached to the handle for moving a suture wire through the second channel and first and second material layers, and a wire cut attached to the handle. An actuator, a wire cutting actuator for moving the cutting bar for cutting engagement with the suture wire.

In another embodiment, the invention provides a tool for joining a first material layer to a second material layer. The tool comprises a handle and an end effector attached to the handle, the end effector having a first groove defining a portion of a first channel holding a wire guide. A portion, a second channel extending from the first channel to support the suture wire extending from the wire guide, a portion of the passage holding the cutting bar, and a distal end of the end effector. A wall structure defining a portion of the end recess in the first, a second securing portion having a first groove defining a remaining portion of the first channel, and a second groove defining a remaining portion of the passage. , A wall portion defining a remaining portion of the second channel and a sidewall defining a remaining portion of an end recess, the second channel looped to a suture wire portion therethrough. And a distal recess is partially defined by a curved surface of the end effector defining a bottom of the distal recess, thereby forming a loop shape out of the second channel. Of the suture wire is received in a distal recess, the tool further being a wire advance actuator mounted on the handle to move the suture wire through the second channel and the first and second material layers. And a wire cutting actuator attached to the handle for moving the cutting bar to cut and engage the suture wire.

These and other objects and features of the present invention will be more fully disclosed or made apparent by considering the following detailed description of the preferred embodiments of the invention in conjunction with the accompanying drawings. . In the drawings, like reference numbers refer to like parts.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Overview Referring initially to FIG. 1, a suturing instrument 10 including a preferred embodiment of the present invention is shown. The suturing instrument 10 includes a housing 12, a handle 14, a shaft 16 and an end effector 18. The suturing instrument 10 further includes a wire advance button 20, a jaw closing actuator 22, and a wire cutting actuator 2.
4, including a left thumb actuation rotation button 26 and a right thumb actuation rotation button 28 (FIG. 3). The suturing instrument 10 further includes a wire supply cartridge 30 and a shaft retaining nut 32. The shaft retaining nut 32 allows the shaft 16 to be removed from the rest of the device and cleaned.

As will be discussed in greater detail below, suture wires, including wires formed of metal or other suitable material that has the necessary flexibility and rigidity, are generally wound into wire winding cartridge 30 during use. Pulled out of the wire and pushed through housing 12 and shaft 16 to end effector 18. The end effector 18 includes a pair of opposing jaw portions. The jaw portions can be brought together in the vicinity of the material to be sutured by actuating the jaw closure actuator 22 when the jaw portions are in the proper surgical position. Suture wire
Actuation of the wire advance button 20 passes through the housing 12 and shaft 16 to the end effector 18. The suture wire is driven from one jaw section to the other jaw section with sufficient force to penetrate tissue placed between the jaw sections. The suture wire can pass through the second jaw portion. The jaws are then separated from each other, away from the tissue and 2 away from the target tissue.
Leave a suture wire that extends to each respective jaw portion. The shaft 16 and end effector 18 (along with the wire feed cartridge 30) are then rotated relative to the housing 12 and handle 14 by actuating the left thumb actuation rotary button 26 or the right thumb actuation rotary button 28. This causes the portions of the suture wire that extend from the tissue to be twisted together, resulting in the formation of a closed loop that extends through the tissue. It should be appreciated that the size of this closed loop can be adjustably reduced by increasing the degree to which the wires are twisted together. The twisted loop of suture wire is then cut at the end effector 18 from the remainder of the suture wire that extends posteriorly through the suturing instrument. Such cutting can be accomplished by actuating the wire cutting actuator 24.

The wire supply cartridge 30 may be supplied separately from the suturing instrument 10, as discussed in detail below. That is, the wire supply cartridge 30 can be loaded into the suturing instrument 10 before the suturing operation is started. As will also be discussed in more detail below, the wire supply cartridge 30 can be a disposable cartridge so that it can be used up and then discarded.

Structural Details As shown in FIGS. 2 and 4, the handle 14 has a cavity that can receive a battery 34. In other embodiments, the unit is powered remotely via a power cord or other suitable power source.

The battery 34 has a ground (or negative) potential at the ground connector post 36 (FIG. 2).
) And ground connector post 36 is a rotating ground communicator 38.
To contact. The rotating ground communicator 38 can maintain electrical contact with the ground connector post 36 when the rotating ground communicator 38 is rotated relative to the ground connector post 36. This rotation occurs when the shaft 16 and end effector 18 are rotated to twist the closed suture wire extending through the tissue.

The battery 34 supplies a positive potential to the wire advance button 20 and the first connector post 40, the first connector post 40 having a first rotating electrical communicator 42.
To contact. The first rotating electrical communicator 42 maintains electrical contact with the first connector post 40 when the first rotating electrical communicator 42 is rotated relative to the first connector post 40. be able to. The positive potential from the battery 34 is applied to the thumb actuated rotary buttons 26, 28 (FIG. 3) and the second connector post 4.
4 (FIG. 2) (in parallel), the second connector post 44 communicates with a second rotating electrical communicator 46. The second rotating electrical communicator 46 also maintains electrical contact with the second connector post 44 when the second rotating electrical communicator 46 is rotated with respect to the second connector post 44. be able to. Each connector post 36, 40 and 44 may be spring biased to maintain contact with its respective rotating communicator. As can be seen from the above structure, each actuator
The positive potential can be turned on by depressing the buttons 20, 26, 28. The handle 14 further includes a cap 48, which can be removed to insert the battery 34.

The first rotary electric communicator 42 is in electrical communication with the wire advance motor 50 shown in FIGS. 2 and 4. The output shaft of the wire advance motor 50 is connected to a miter drive gear 52, which is in turn connected to a miter driven gear 54. The miter driven gear 54 is coupled to the drive wheel 56 in contact with the suture wire 58. This will be described in detail later with reference to FIGS.

The second rotary electric communicator 46 is in electrical communication with a shaft rotary motor 60 (FIGS. 3 and 4), the output of the shaft rotary motor 60 being the internal gear 64 (
4 and 11) rotating pinion gear 62 (FIGS. 4, 4A and 11)
Is bound to. As shown in FIG. 3, a left thumb actuation rotary button 26 and a right thumb actuation rotary button 28 are provided to allow the user to activate the shaft rotary motor 60 using his or her left or right thumb. Can be
In this regard, since the left thumb actuating rotary button 26 and the right thumb actuating rotary button 28 are wired in parallel, whichever button (button 26 or button 28) is actuated, the shaft rotary motor 60 is in the same direction. It should be understood that it rotates.

The jaw closure actuator 22 (FIGS. 2 and 4) is coupled to a jaw linkage coupler (coupling member) 66 which contacts the jaw linkage 68 (FIGS. 2 and 14). ing. When the jaw closure actuator 22 is pulled toward the handle 14 (FIG. 2), the jaw closure actuator 22
Rotates about its pivot pin 67 (FIG. 4) to drive the jaw linkage coupler 66 distally against the force of the biasing spring 69, causing the jaw linkage 68 to move distally of the suturing instrument 10. Move forward toward the end. This action causes the movable jaw portion 98 to close relative to the fixed jaw portion 96 (FIG. 17A). This will be discussed in detail later. Subsequent release of jaw closure actuator 22 causes bias spring 69 (FIG. 4) to drive jaw linkage coupler 66 in a proximal direction, causing jaw linkage 68 to move in a proximal direction. This action causes the movable jaw portion 98 to open relative to the fixed jaw portion 96 (FIG. 14). This will be discussed in detail later. The operation of the jaw linkage 68 at the distal end of the device will be discussed further below with reference to FIGS.

The wire cutting actuator 24 includes a wire cutting linkage coupler 70 (FIG. 2).
And 4), the wire breakage linkage coupler 70 is in contact with the wire breakage linkage 72 (FIGS. 2, 14 and 15). When the wire cutting actuator 24 is pulled toward the handle 14 (FIG. 2), the wire cutting actuator 2
4 rotates about its pivot pin 73 (Fig. 4) to provide a wire cutting linkage.
The coupler 70 is driven proximally against the force of the biasing spring 69 to move the wire cutting linkage 72 proximally away from the distal end of the suturing instrument 10. This action causes the cutting bar 104 (FIG. 14) to move proximally (FIG. 15) to cut the wire. This will be discussed in detail later. When the wire cut actuator 24 is subsequently released, the bias spring 69 causes the wire cut linkage coupler 7 to move.
Drive 0 distally to move the wire cutting linkage 72 distally.
This action causes the cutting bar 104 to move distally and assume the position shown in FIG. The wire cutting linkage 72 is adjacent to the jaw linkage 68 discussed above and moves independently of the jaw linkage 68. The operation of the wire cutting linkage 72 at the distal end of the device is discussed further below with reference to FIGS. 14 and 15.

The wire supply cartridge 30 shown in FIG.
A guide support unit 74 is included. A supply coil of suture wire 58 (including a wire formed of metal or other suitable material having the required flexibility and rigidity);
It can be fed into the base of the cartridge 30 and the suture wire 58 is shown in FIG.
Is supplied to the support unit 74 as shown in FIG. The wire guide 76 surrounds the suture wire 58 from the support unit 74 to the distal end of the suturing instrument 10 adjacent the end effector 18 (FIGS. 5-7, 14 and 15). The wire guide 76 ensures that the suture wire 58 does not bend when the suture wire is pushed in the housing 12 and shaft 16. Specifically, it is preferred that the wire guide 76 form a sufficiently tight interference fit with the suture wire 58 so that the suture wire 58 does not bend as the suture wire is advanced through the suturing instrument 10. At the same time, the wire guide 76 is formed to minimize friction with the suture wire 58 as it is advanced through the instrument. The above properties are important because the suture wire 58 is very thin and flexible and is very flexible without some lateral support.

For example, if the suture wire 58 is made of stainless steel and has a diameter of 0.005 inch, the guide 76 may have an inner diameter of 0.008 inch and an outer diameter of 0.016. However, it is not limited to these values. Further, the wire guide 76 is preferably formed from polytetrafluoroethylene (PTFE) or other relatively smooth material. Alternatively, the inside of the wire guide 76 may be coated with a lubricant so that the suture wire is closely supported within the wire guide and the wire passes through the wire guide with low friction.

For example, in one preferred form of the invention, the suture wire 58 has a tensile strength of 170 kp.
Includes si 316LVM stainless steel. However, it is not limited to this.

Although the wire guide 76 extends through the support unit 74 (FIG. 7), the wire guide 76 has two openings 78 in the center of the support unit 74 (one on each side of the wire guide 76). (Fig. 5 shows only one of them). Opening 78
Exposes a portion of the suture wire 58 so that the wire drive wheel 56 (FIG. 8) can contact the suture wire 58 and advance the suture wire toward the distal end of the suturing instrument 10. This will be discussed in detail later with reference to FIGS.

The housing 12 receives a drive barrel assembly 80, as shown in FIGS. Drive barrel assembly 80 includes motors 50 and 6 described above.
A barrel shaft 81 (FIGS. 4A and 8) that includes a zero and extends distally is provided. Outside the barrel shaft 81 are rotating communicators 38, 42 and 46.
Is located. The distal end of the barrel shaft 81 has a recess 82 (FIG. 4A) for receiving a coupling pin 84 (FIGS. 2 and 4) located at the proximal end of the shaft 16, which causes the drive barrel assembly 80 to rotate. Then, the coupling pin 84 rotates and thus the shaft 16 also rotates. Drive barrel assembly 80 is shown in FIGS.
As shown in, the bearing 86 rotatably holds the inside of the housing 12.

Next, please refer to FIGS. The wire feed cartridge 30 drives the drive barrel assembly 80 by rotating the release lever 87 away from the center of the drive barrel assembly 80 (FIGS. 8 and 9) and moving the carriage 88 relative to the drive barrel assembly 80. 80 can be attached. Specifically, the release lever 87 rotates about the pin 90, and when the release lever 87 is rotated from the position shown in FIG. 8 to the position shown in FIG. 9, the carriage 88 moves away from the center of the drive barrel assembly 80. And the wire driven wheel 92 is pulled. Once the wire follower wheel 92 is far enough from the wire drive wheel 56 to expose the central passage 93 (FIG. 9) of the drive barrel assembly, pass the wire guide 76 (covering the suture wire 58). 93 (FIG. 10) and wire guide support unit 74 (FIGS. 6, 7 and 10) between wheels 56 and 92 (FIG. 10) to provide openings formed on either side of wire guide 76. Wheels 56 and 92 are in contact with both sides of suture wire 58 through 78. A biasing spring 94 (FIGS. 8-10) is mounted on the carriage 88 for securely contacting the wire follower wheel 92 with the suture wire 58. In other embodiments,
The wire follower wheel 92 is indirectly driven by the wire drive wheel 56 to provide additional force to move the suture wire 58 distally (ie, forward toward the tool end effector 18). .

Extending distally from the drive barrel assembly 80 is a pinion gear 62 (FIGS. 4, 4A and 11) which engages an internal gear 64 of the housing as shown in FIGS. 4 and 11. As a result of this construction, actuation of the shaft rotary motor 60 causes the pinion gear 62 to rotate along the internal gear 64, which in turn rotates the entire drive barrel assembly 80. Since the shaft 16 is coupled to the drive barrel assembly 80, this rotation also rotates the shaft 16. Specifically, rotation of the drive barrel assembly 80 causes the recess 82 (
8) is transmitted to the shaft 16 via the connecting pin 84 (FIGS. 2, 4 and 12) of the shaft seated in FIG. 8).

The end effector 18 (FIGS. 1 and 13-16) includes a fixed jaw portion 96 and a movable jaw portion 98. The movable jaw portion 98 is a jaw linkage
It is coupled to the aforementioned jaw linkage 68 (FIG. 14) via pin 100, so that when the jaw linkage 68 is moved distally (by pulling the jaw closure actuator 22 towards the handle 14), Movable jaw portion 98 rotates about pivot pin 102 (FIG. 13) and closes with respect to fixed jaw portion 96. Conversely, when the jaw linkage 68 moves proximally (due to the force of the biasing spring 69 acting on the jaw linkage coupler 66, and thus the jaw linkage 68), the movable jaw portion 98 moves away from the fixed jaw portion 96 and opens. .
Unless the jaw closure actuator 22 is actuated to counteract the bias of the spring 69, the movable jaw portion 98 will normally remain open (FIGS. 1, 13 and 14) relative to the fixed jaw portion 98 by the force of the bias spring 69. Please understand that it is done.

The wire cutting linkage 72 (FIGS. 2, 3, 14 and 15) includes a cutting bar 104 (
14 and 15). The cutting bar 104, as will be discussed in detail below.
Includes a small opening 106 through which the suture wire 58 can pass. Cutting bar 10
4 is preferably slidably received in a passageway 107 (FIGS. 14, 15, 16 and 17H) formed in the fixed jaw portion 96. In one position (FIG. 14), the cutting bar 104 is positioned within the fixed jaw portion 96 such that the opening 106 of the cutting bar 104 is aligned with the channel 108 formed in the fixed jaw portion 96, thereby allowing the suture wire to , From the distal end of the wire guide 76 to the fixed jaw portion 96.
Formed in the channel 108 (where the wire turns about 90 degrees), the opening 106 in the cutting bar 104, the channel extension 10 formed in the fixed jaw portion 96.
The movable jaw portion 98 can be reached through 8A. This will be discussed in detail later. However, when the wire cutting linkage 72 is moved proximally by pulling the wire cutting actuator 24 toward the handle 14, the cutting bar 104 also moves proximally (FIG. 15), (of the securing portion 96). Cut the suture wire extending from the channel 108 into the opening 106 (of the cutting bar 104). In this regard, by pulling the wire cutting actuator 24, the cutting bar 10
4 in the proximal direction when the suture wire is moved to two positions (ie, the channel 108).
It should be appreciated that it may be desirable to form a channel extension 108A that is longer than the channel 108 (see FIGS. 14 and 15) in order to prevent breakage at the channel extension 108A). At the same time, however, the size of the fixed jaw portion channel 108 and channel extension portion 108A, and the cutting bar opening 106 are all relative to the suture wire 58 as they pass through the fixed jaw portion 96 and out of the fixed jaw portion 96. It should also be appreciated that the suture wire is determined to provide as much support as possible.

Unless the wire cutting actuator 24 is actuated to counteract the bias of the spring 69, the cutting bar 104 will typically be in its distal position (by the force of the bias spring 69).
That is, it should be understood that the opening 106 in the cutting bar is held in position (aligned with the channel 108 in the fixed jaw portion).

Considering the above structure, the following can be seen: (1) Release lever 87 (FIGS.
10) actuate the wire driven wheel 92 away from the wire drive wheel 56 and then towards the wire drive wheel 56 to load the wire supply cartridge 30 (FIGS. 1 and 5-7) into the suturing instrument 10. (2) actuating the jaw closing actuator 22 causes the movable jaw portion 98 to close relative to the fixed jaw portion 96, and (3) actuating the wire advance button 20 causes the wire drive wheel 56 to move. , (12) advance the suture wire 58 in the housing 12 and the shaft 16 and (4) actuate the rotary button 26 and / or the rotary button 28 to cause the shaft 16 to move to the housing 12.
And (5) actuating the wire cutting actuator 24 causes the cutting bar 104 to move proximally to cut the suture wire extending from the fixed jaw portion 96.

Manipulation The suturing instrument 10 can be used to apply a wire suture 58 to a subject, thereby performing a desired suturing operation.

As an example, refer now to FIGS. However, it is not limited to this. The suturing instrument 10 can be used to suture the two portions 110, 112 to be sutured. In the general case, portions 110, 112 include two sections of cut tissue that need to be reattached to each other or two pieces of tissue that have been previously separate and need to be attached to each other. But either part 11
0, 112 may include artificial mesh or other objects that attach to tissue or the like. Further, in the general case, the portions 110, 112 are located at a relatively deep location within the patient's body and are referred to as so-called “minimally invasive surgery”.
"sive surgery," or so-called "closed surgery."
Surgery) ”, but in other situations, portions 110, 112
Are approached during conventional so-called "open surgery". This latter situation involves procedures performed on the surface of the patient's body. That is, the portions 110 and 112 include the person on the body surface.

In any case, first, the battery 34 is inserted into the handle 14 if not already inserted into the handle 14, and the wire feeding cartridge 30 is attached to the suturing instrument if not already attached. By installing the cartridge 30,
The suturing instrument 10 is ready for use. As previously mentioned, the wire feed cartridge 30 includes (1) the release lever 87 of the drive barrel assembly in its open position (FIG. 9).
) To pull the wire follower wheel 92 away from the wire drive wheel 56, thereby exposing the central passage 93 of the barrel assembly, and (2) the distal end of the wire guide 76 is formed in the fixed jaw portion 96. Until the wire guide support unit 74 of the cartridge is positioned between the wire drive wheel 56 and the wire driven wheel 92 (FIG. 2).
The distal end of the cartridge (ie, the distal end of the wire guide 76) is threaded into the drive barrel assembly 80 and shaft 16 and (3) the drive barrel assembly release lever 87 is in its closed position (FIG. 8). And attached to the suturing instrument 10 by causing the wire drive wheel 56 and the wire follower wheel 92 to extend into the wire guide opening 78 and engage the suture wire 58.

At this point, the suturing instrument 10 is ready for use, with the movable jaw portion 98 open away from the fixed jaw portion 96 (ie, the jaws 96, 98 are in the “closed” position) and the cutting bar 104. Is in its forward position (FIG. 14).

The movable jaw portion 98 is then moved into engagement with the fixed jaw portion 96 by pulling the jaw closure actuator 22 toward the handle 14, and then the distal end of the suturing instrument 10 is moved to the target portion 110, Move closer to 112 (FIG. 17A).

In the case of so-called non-invasive surgery, such an arrangement generally involves moving the distal end of the suturing instrument through the cannula and into the internal body cavity, but It is also conceivable to move it directly into an otherwise accessible body cavity, for example directly into the colon or esophagus. In the case of so-called open surgery, such placement involves placing the distal end of the suturing instrument adjacent to the more easily accessible target portions 110, 112.

In any event, once the distal end of suturing instrument 10 is positioned adjacent target portions 110, 112, jaw closure actuator 22 is released and movable jaw portion 98 is biased against bias spring 69 (FIG. 4). It is urged to move away from the fixed jaw portion 96 and open (FIG. 17B). The distal end of the suturing instrument 10 is then moved so that the jaws 96, 98 straddle the target portions 110, 112, and then the jaw closure actuator 2
The jaw closure actuator 22 is re-actuated by pulling 2 towards the handle 14 to close the movable jaw portion 98 against the fixed jaw portion 96, thereby capturing the target portions 110, 112 (FIG. 17C).

Next, the wire advancement button 20 is operated to move the suture wire 58 to the wire guide 7.
From the distal end of 6, the channel 108 of the fixed jaw part, the opening 10 of the cutting bar 104
6, fixed jaw portion channel extension 108A, target portions 110, 112, and finally opening 113 formed in movable jaw portion 98 (FIGS. 14, 15 and 17C).
Drive forward through. The suture wire 58 is preferably advanced such that the portion 58A of the wire 58 extends about 1 centimeter out of the lower end of the moveable jaw portion 98 (FIG. 17C). In this regard, the suture wire 58 is secured to the fixed jaw portion 96.
When exiting to engage target portions 110, 112, fixed jaw portion channel 108, cutting bar opening 106 and fixed jaw portion channel extension portion 108.
It is to be appreciated that A supports a thin suture wire, allowing the suture wire to penetrate the target portion 110, 112.

Thereafter, the jaw closure actuator 22 is released to return the movable jaw portion 98 to the “open” position relative to the fixed jaw portion 96, and then the distal end of the suturing instrument 10 from the target portions 110, 112 ( While retracting (eg, about 1 centimeter), the wire advance button 20 is used to unwind the additional suture wire 58 (FIG. 17).
D).

The jaw closure actuator 22 is then used to reengage the jaw portion 98 with the stationary jaw portion 96 (FIG. 17E). The left thumb actuation rotation button 26 or the right thumb actuation rotation button 28 is then used to rotate the shaft 16, and thus the end effector 18. This causes the suture wires 58 to twist together, creating a relatively large loop 116 of suture wires 58 (FIG. 17F) that extends from the target portions 110, 112 toward the suturing instrument 10. However, as the shaft 16 (and thus the end effector 18) is further rotated using the rotation button 26 and / or the rotation button 28, the loop 116 of suture material becomes smaller (FIG. 17G) and the target portion 110, 112. A tight bond is formed to. In this regard, it should be appreciated that the longer the end effector 18 is rotated, the more the suture wire 58 is twisted together and the greater the force holding the target portions 110, 112. Further in this regard, it should be appreciated that the suture wire 58 preferably has its flexibility selected with respect to the strength of the target portions 110, 112. In particular,
Until the suture wires are twisted together and the loop 116 is made smaller, the target portion 110,
A suture wire 58 is selected that is flexible so that 112 does not significantly deform and / or tear. For example, in practice, 0.005 inch diameter stainless steel wire can be used in most types of mammalian tissue to allow suture wires to be twisted together without significant tissue deformation and / or tearing. I know I can.

Once the suture wire 58 has been tightened to the desired degree, the button 26 or button 28
Is released to stop the rotation of shaft 16 and end effector 18. The wire cutting actuator 24 is then depressed (eg, pulled back toward the handle 14) as the suture wire exits the channel 108 in the fixed jaw portion and enters the opening 106 in the cutting bar, cutting bar 104. Is pulled proximally, thereby cutting the suture wire 58. This action disconnects the suture wire extending through the target portions 110, 112 from the wire feed cartridge 30, the wire guide 76 and the suture wire remaining in the channel 108 of the fixed jaw portion.

The wire cutting actuator 24 is then released, the cutting spring 104 is returned to its distal position by the bias spring 69, and then the jaw closing actuator 22 is released, moving the movable jaw portion 98 away from the fixed jaw portion 96. The suturing instrument 10 is then removed from the target portions 110,112. This action pulls the wire 58A from the movable jaw portion 98 (FIG. 17I).

The deployed suture wire 58 is then pressed against the target portions 110, 112 to flatten it, or to roll it into a ball or otherwise process it to reduce the profile of the deployed suture wire, or Make sure the placed suture wire is not in the way (
FIG. 17J).

It should be appreciated that the suturing instrument 10 has wide applicability in a variety of suturing procedures. In particular, it should be appreciated that the suturing instrument 10 can be applied to both "open" and "non-open" surgery. The former includes large entry procedures, relatively shallow and superficial procedures, and the latter approaches using cannula to access internal structures and direct access to internal body cavities without a cannula. Procedure to do,
Examples include procedures performed in the colon or esophagus. However, it is not limited to these.

In addition, the suturing instrument 10 may require two separate tissue pieces to be attached to each other if the two tissue sections must be attached to each other (eg, two cut tissue pieces must be reattached to each other). When it has to be attached, when two sections of a single piece of tissue have to be brought close to each other, or when an object has to be attached to the patient (eg on the patient's abdominal wall during hernia repair surgery). It should be understood that it can be applied (such as when a surgical mesh has to be attached).

The suturing instrument 10 is believed to have particular application, particularly in the fields of general laparoscopic surgery, general chest surgery, heart surgery, general intestinal surgery, vascular surgery, skin surgery and plastic surgery.

Referring now to FIGS. 18 and 19, when the channel 108 of the fixed jaw portion is positioned to be generally aligned with the center of the cutting bar 104 (FIG. 18), the cut suture wire 58 is relatively It has a flat leading edge 58B (FIG. 19). However, it is beneficial when the leading end of the suture wire 58 is relatively sharp. The sharp leading end serves to pierce the subject for subsequent suture wire sections. Moreover, such a leading end helps the suture wire enter the subject in a generally straight path, which ensures that the suture wire fits within the aperture 113 of the movable jaw portion. To do this, cut the channel 108 in the fixed jaw portion into the cutting bar 1
It was found that when displaced from the center of 04 (FIG. 20), a leading end 58B of the suture wire 58 having a relatively sharp tip 58C was formed (FIG. 21).

Rather than threading a suture wire through the subject, the suturing instrument 10 can also be used to tie the subject. For example, suturing instrument 10 can be used to tie blood vessels with suture wires 58. In this case, the suturing instrument 10 is positioned such that the suture wire 58 passes across the subject, rather than passing the suture wire 58 through the subject as in sutures of the type described above.

As a non-limiting example, in typical ligature surgery, the movable jaw portion 98 is first opened with respect to the fixed jaw portion 96. The suturing instrument 10 is then closed so that when the movable jaw portion 98 is subsequently closed towards the fixed jaw portion 96, the fixed jaw portion channel 108 and the movable jaw portion opening 113 are both on the other side of the subject. Place it between them. The movable jaw portion 98 is then replaced with the fixed jaw portion 9
6 and thread the suture wire 58 from the fixed jaw portion 96 to the movable jaw portion 98, ie across the subject. The moveable jaw portion 98 is then opened and the suture wire 58 is placed while retracting the instrument from the subject. Then the movable jaw portion 98
Is closed again to the fixed jaw portion 96. The shaft of the instrument is then rotated to form a knotting loop and then the loop is made smaller. The cutting bar 104 is then actuated to disconnect the tying loop from the suture wire remaining on the tool, open the movable jaw member 98, and remove the instrument from the surgical site. The deployed suture wire 58 is then pressed against the subject to flatten it, roll it into a ball, or otherwise process it to reduce the profile of the deployed suture wire or to prevent it from interfering. Hard to become. As one of ordinary skill in the art will appreciate, the device 10 for tying purposes
When used, a fixed jaw portion 96 and a movable jaw portion 98 having a greater longitudinal length can be formed to facilitate threading the suture wire across the subject. Further, a movable jaw member 98 having a recess for accommodating an object between the jaw linkage pin 100 (FIG. 16) and the opening 113 is formed, thereby moving the movable jaw member 98 and the fixed jaw member 96. The object may not be compressed when engaged.

The suture wire 58 may include a wire formed of metal or other suitable material having the required flexibility and rigidity. For example, suture wire 58 can include stainless steel, titanium, tantalum, or the like. However, it is not limited to these.

If desired, the suture wire 58 can be coated with a variety of active agents. For example, the suture wire 58 can be coated with an anti-inflammatory drug, an anticoagulant drug, an antibiotic, a radioactive drug, or the like.

Next, refer to FIG. Ultrasonic energy can also be applied to the wire to facilitate entry into the tissue. Specifically, since the wire has a small cross-sectional area and is prone to bending when axially loaded, it would be beneficial to be able to advance the wire into tissue with minimal load. This can be accomplished by the appropriate application of ultrasonic energy to the wire.

The piezoelectric element 200 is positioned inside the fixed jaw portion 96, at a right angle bend of the outer radius of the wire guide path 108, just before the wire enters tissue. Piezoelectric element 200 oscillates at one location along this bend, which makes it a component that carries the wire during redirection and at the same time displaces it in the direction of the tissue. By applying this type of displacement at ultrasonic frequencies to existing wire drive means, the tip of the wire penetrates the tissue with less force. In addition to reducing the tendency of the wire to buckle, the reduced load on the wire allows it to enter a more straight path.

Referring now to FIG. 23A, the curved channel 10 in the fixed jaw portion 96.
It is shown that in some circumstances the suture wire 58 may curve out of the fixed jaw portion 93 due to the suture wire 58 advancing according to 8. In some cases, this curvature of suture wire 58 is not so great that it can be virtually ignored. However, in other situations this curvature may be large enough so that the suture wire exiting the fixed jaw portion 96 may not be received in the target opening 113 of the movable jaw portion 98. In this case, the bending of the suture wire 58 causes a serious problem. However, referring to FIG. 23B, the cutting bar opening 106
It will be appreciated that the cross-sectional shape of the can be modified to prevent unwanted bending of the suture wire as it exits the fixed jaw portion 96 and to provide a deflection die that returns the suture wire to a straight path. Alternatively, the cross-sectional shape of the portion of the fixed jaw portion channel 108 adjacent the cutting bar 104 may be modified to prevent undesired bending of the suture wire as it exits the fixed jaw portion 96 and straighten the suture wire. Similar deflecting dies that return to different paths can be provided. Further, referring to FIG. 23C, the mouth of the opening 113 of the movable jaw portion can be enlarged to assist in capturing the suture wire off the straight path.

Referring now to FIG. 24, suturing instrument 10 is shown to be capable of being provided with one or several legs 300. The legs 300 help stabilize the tissue during suturing.

Referring now to FIG. 25, jaws 40 are provided to help stabilize tissue during suturing.
It has been shown that a grasper 400 with 5 and 410 can be added to the suturing device 10.

If desired, the end effector 18 of the suturing instrument 10 may have two opposing moveable jaws rather than one fixed jaw and one moveable jaw as described above. Can be built.

If desired, the shaft rotation motor 60 and thumb buttons 26, 28 may also be
Pressing one button (eg, button 26) causes end effector 18 to rotate in one direction (eg, clockwise), and pressing the other button (eg, button 28) causes end effector 18 to move in the opposite direction (eg, clockwise). It can also be configured to rotate in a counterclockwise direction.

Referring to FIG. 26, an alternative end effector embodiment 18 ′ includes a channel 502 for retaining a wire guide 76 therein and a smaller diameter channel 504 for supporting a suture wire 58. It is shown to include a first fastening portion 500 having. The end effector passage 107 houses the cutting bar 104.

As shown in FIGS. 27 and 28, the alternative embodiment 18 ′ of the end effector further includes a second fixation portion 5 that forms part of the channel 502 and passageway 107.
Including 10. The second fixed portion 510 of the end effector 18 'further includes an interior curved surface 512. The curved surface 512 includes a first sidewall 516 provided by the first portion 500 and a second sidewall 518 provided by the second fixing portion 510 (FIG. 27).
), And a bottom of a recess 514 having an opening 520 located at the flat distal end 522 (FIG. 28) of the end effector 18 ′. The flat distal end 522 is formed by the flat distal ends 524 and 526 of the first and second fixation portions 500, 510, respectively.

In operation, suture wire 58 is advanced through the instrument as previously described. In the alternative embodiment 18 'of the end effector described above, the distal portion 528 of the channel 504 is
(FIG. 29) is curved so that after exiting the channel 504 the wire 5
8 is driven circularly in the distal direction, so that it enters, for example, the tissue T and then turns in the proximal direction and penetrates the tissue T ′. This circular movement can be stopped at any time to form a partial circle of the wire as shown in Figure 33, or this can be repeated once more or repeated multiple times until the wire drive means is stopped. . Curved surface 512 receives wire 58 and serves to deflect the wire again in a circular fashion toward the tissue.

Tissues T and T'need not be adjacent to each other edge-to-edge, and in many situations tissues will be stacked on top of each other (FIGS. 30-32). FIG. 30 schematically illustrates a method of establishing a suture loop by piercing a suture wire 58 through both tissue layers T and T'and then back through layers T ', T again. The suture wire 58 can be exhaled from the device 10 by a selected length, providing discrete discrete loops, or a selected number of loops or "stitches". The free end 530 of the loop can be twisted together. A similar loop of suture wire 58 is shown in FIG. 31, but in this example wire 58 penetrates tissue layer T, then loops within tissue layer T ′ and again through layer T. And is properly cut back to leave two exposed ends 530 for twisting together. In FIG. 32, a single loop is arranged in the same manner as the loop shown in FIG. 31, but its free ends 530 remain spaced apart from each other, essentially by its free ends. ,
It provides a "reverse fastener" on the user-facing side of the T '. A tool 532 (FIG. 33) can be applied to the free end 530 of the suture wire to complete the formation of the fastener.

The diameter of the suture wire loop depends on the tensile strength or hardness of the wire, the diameter of the wire,
The curvature of the wire as it exits the instrument, the material into which it enters, the curvature of the distal path 528,
And the angle A (FIG. 29) of the distal end 522 of the end effector 18 '. The diameter of the suture wire for forming such fasteners is preferably about 0.010 inch, although wire sizes of about 0.003 to 0.015 inch have been found to be useful in certain applications. There is.

With reference to FIG. 34, a looped wire 58 can be placed in an artery 540 and is shown to act as a stent 542. The instrument 10 can also be used to expel the wire 58 and clip it to tissue or the like to move and hold the tissue away from the surgical site. Alternatively, the wire secured adjacent the deep surgical site can be used as a guide wire for inserting other instruments.

FIG. 35 shows a portion of the alternative end effector 18 ″. First fixed portion 5
00 comprises a channel 502 for the wire guide 76 and a smaller diameter channel 504 for the suture wire. There is a passageway 107 for the cutting bar 104 similar to the embodiment shown in FIG. In the embodiment shown in FIG. 35, the cutting bar 104 carries a flexible blade 550 slidably disposed within a blade channel 552 that intersects the suture wire channel 504. Wire channel 504 is configured to provide significant looping or coiling to the wire as it exits device 10. The fixed part 500 of the instrument guides the force of the driven suture wire and supports a very thin and flexible wire.
The curved surface 512 having the function of r) is provided.

In use, when the operator wants to cut the suture wire after the desired length of wire has been dispensed, the operator operates the wire cutting actuator 24 to drive the cutting bar 104 and thus the blade 550 distally. , So that the wire is cut by the blade 550 at the intersection of the suture wire channel 504 and the blade channel 552.

As mentioned above, the curvature of the wire as it exits the device is one of the parameters that determines the diameter of the suture loop. In the embodiment shown in FIG. 35, a salient curvature is selected. Given the work at hand, it is clear that such curvature is a matter of choice. Another parameter that determines the diameter of the suture loop is the angle A of the distal end 522 of the effector 18 ". In a modified embodiment (not shown) of the embodiment of Figures 28 and 35, the end effector 18 ', The 18 "is pivotally mounted to the instrument to accommodate the selected angular placement of the flat distal end 522 relative to the instrument axis.

FIG. 36 illustrates another alternative embodiment 18 ′ ″ of end effector. The cutting bar 104 'can rotate rather than move axially. In this embodiment, suture wire is advanced through channel 504 and notch 554 toward the surgical site. When the wire cutting actuator 24 is operated, the cutting bar 104 'rotates and the edge portion 556 of the notch 554 cuts the suture wire 58.

With reference to FIG. 37, in another alternative embodiment of the instrument 10, the shaft 16 includes first and second shaft portions 16 a, 16 b pivotally connected to each other, such that the end effector 18 includes: The required angle can be applied to approach areas that are difficult to reach and / or provide an optimal approach angle.

As shown in FIG. 38, a scalloped surface for guiding the side wall 516, 518 and flat distal portion 524, 526 of the end effector into the funnel-shaped recess 514 of the suture coil. It can be blocked by 560 and 562. In this way, the suture wire, which would otherwise hit flat surfaces 524, 526, engages one of the scalloped surfaces 560, 562, thereby leading it to engage the curved surface 512 of the recess 514. Will.

With reference to FIGS. 39-41, in another alternative embodiment of the end effector 18, the flat distal portions 524, 526 are shown to include rounded cutouts 570, 572. Pressing the flat distal surfaces 524, 526 against the soft tissue,
Tissue generally enters cutouts 570, 572, thereby causing recess 5
The suture wire entering 14 and exiting wire channel 504 is allowed to penetrate deep below the surface of the tissue, ie, penetrate deeper into the tissue. In this embodiment, the cutting bar 104 ′ is axially moveable from the position shown in FIG. 39 to the position shown in FIG. 40 to cut the suture wire in the immediate vicinity of the exit of the wire channel 504. .

As shown in FIG. 41, the cutting bar 104 ′ has at its distal end a curved surface 5 of a recess 514.
A curved surface 574 having the same shape as 12 may be provided. Thus, when the cutting bar 104 ′ is in its retracted position, the surface 574 of the cutting bar has a concave curved surface 512.
And thereby contribute to guiding the suture wire into the coiled condition.

In addition to performing cutting operations, the cutting bar 104 'can perform the functions of the tool 532 shown in FIG. 33 when axially movable. That is,
The suture wire 58 can be pressed into the desired shape, such as by bending the free end of the wire into tissue as also shown in FIG. The rotational and axial movements of the cutting bar 104 'can be used in combination to perform the wire cutting operation after the wire cutting operation.

Although the cross section of the suture wire 58 is generally circular, it should be understood that wires of other cross sectional shapes will also aid in coiling. Thus, the suture wire can have an oval or polygonal cross section.

42a-42c show another embodiment of an end effector during surgery. In the immediate vicinity of the distal portion 528 of the suture wire channel 504, the wire tip forming die 5
80 are arranged. As the cutting bar 104 is moved distally to cut the wire 58, the cutting bar pushes the cut wire end 530 into the die 580 (FIG. 42b), causing the cut wire end to move radially inward. Bend to. Even after the elastic recoil of the looped wire, the severed end (cutting end) 530 faces the inside of the loop and does not trap or tear surrounding tissue or adjacent organs.

FIG. 43 shows an alternative embodiment in which the die 580 is located proximal to the distal portion 528 of the wire channel 504. The cutting bar 104 is moved proximally to cut the suture wire 58, and then the cutting end 5 of the wire 58 is proximal to the cutting bar leg 582.
30 is placed and retracted further to engage die 580. Die 580
Bend the cut end 530 of the wire toward the inside of the formed loop. The cutting bar 104 is then moved distally far enough to release the wire portion in the die, allowing the end effector 18 to be removed from the suture wire 58.

Modifications It will be appreciated by those skilled in the art that numerous modifications and variations can be made to the embodiments described above without departing from the spirit and scope of the invention.

[Brief description of drawings]

[Figure 1]   FIG. 7 is a side view of a suturing instrument formed in accordance with the present invention.

[Fig. 2]   FIG. 2 is a side sectional view of a part of the suturing instrument shown in FIG. 1.

[Figure 3]   FIG. 3 is a top cross-sectional view of a part of the suturing instrument shown in FIG. 1.

FIG. 4 is a schematic partial side view showing some internal components of the suturing instrument shown in FIG. 1. 4A is a perspective view of a drive barrel assembly incorporated into the suturing instrument shown in FIG.

5 is a perspective view of a wire guide support unit incorporated in the suturing instrument shown in FIG. 1. FIG.

FIG. 6 is a perspective view of a wire delivery cartridge of a suturing instrument including the wire guide support unit shown in FIG.

[Figure 7]   FIG. 7 is a partially sectional perspective view of the wire supply cartridge shown in FIG. 6.

FIG. 8 is a rear perspective view of a drive barrel assembly incorporated into the suturing instrument shown in FIG. The release lever of the drive barrel assembly is in the closed position.

9 is a perspective view of the proximal end (or rear end) of the drive barrel assembly shown in FIG. The release lever is in the open position.

FIG. 10 is a perspective view of the proximal end (ie, rear end) of the same drive barrel assembly. The release lever is in the closed position and the wire guide and wire guide support unit are advanced relative to the drive barrel assembly (although the rest of the wire supply cartridge is omitted from the figure).

FIG. 11   FIG. 11 is a schematic view taken along line 11-11 of FIG. 4.

FIG. 12 is a side view of the shaft and end effector portion of the suturing instrument shown in FIG.

[Fig. 13]   FIG. 3 is a side view of an end effector portion of the suturing device shown in FIG. 1.

FIG. 14 is a side sectional view of the end effector portion shown in FIG. 13. The cutting bar of the end effector portion is in the advanced position (ie, the uncut position).

FIG. 15 is a side sectional view of the end effector portion shown in FIG. The cutting bar of the end effector portion is in the retracted (or cutting) position.

FIG. 16   FIG. 2 is a perspective view of an end effector portion of the suturing device shown in FIG. 1.

FIG. 17A is a diagram showing one stage of a suturing operation performed using the suturing instrument shown in FIG. 1. FIG. 17B is a diagram showing a stage following the stage of FIG. 17A of the suturing operation performed by using the suturing instrument shown in FIG. 1. 17C is a diagram showing a stage following the stage of FIG. 17B of the suturing operation performed by using the suturing instrument shown in FIG. 1. FIG. 17D is a diagram showing a stage following the stage of FIG. 17C of the suturing operation performed by using the suturing instrument shown in FIG. 1. FIG. 17E is a diagram showing a stage following the stage of FIG. 17D of the suturing operation performed by using the suturing instrument shown in FIG. 1. FIG. 17F is a diagram showing a stage following the stage of FIG. 17E of the suturing operation performed by using the suturing instrument shown in FIG. 1. FIG. 17G is a diagram showing a stage following the stage of FIG. 17F of the suturing operation performed by using the suturing instrument shown in FIG. 1. FIG. 17H is a diagram showing a step that follows the step of FIG. 17G of the suturing operation performed using the suturing instrument shown in FIG. 1. FIG. 17I is a diagram showing a stage following the stage of FIG. 17H of the suturing operation performed using the suturing instrument shown in FIG. 1. FIG. 17J is a diagram showing a stage following the stage in FIG. 17I of the suturing operation performed using the suturing instrument shown in FIG. 1. FIG.

FIG. 18 is a cross-sectional view of one possible construction of a fixed jaw portion of a suturing instrument and its associated cutting bar.

FIG. 19   It is a side view which shows the wire piece cut | disconnected using the apparatus shown in FIG.

FIG. 20 is a cross-sectional view showing another possible fixation structure for a fixed jaw portion of a suturing instrument and its associated cutting bar.

FIG. 21   It is a side view which shows the wire piece cut | disconnected using the apparatus shown in FIG.

FIG. 22 is a side cross-sectional view of the end effector portion of the device. The end effector portion includes a piezoelectric element that aids in wire penetration.

FIG. 23A is a schematic view of the fixed jaw portion of the device showing how the suture wire bends upon exiting the fixed jaw portion. FIG. 23B is a schematic view of a modification of the fixed jaw portion of the device showing how to modify the cross-sectional shape of the device to prevent the aforementioned wire bow. FIG. 23C is a schematic view of a modification of the moveable jaw portion of the device showing how the mouth of the moveable jaw portion opening is widened to facilitate capture of suture material.

FIG. 24 is a schematic view of a modification of the device in which one or more legs were provided to help stabilize the tissue during suturing.

FIG. 25 is a schematic view of another modification of the device with the addition of a second set of jaws to help stabilize the tissue during suturing.

FIG. 26   FIG. 7 is a perspective view of a portion of an alternative end effector portion of an instrument.

FIG. 27   FIG. 7 is a perspective view of another portion of the same alternative end effector portion.

28 is a perspective view of an alternative end effector including the portion shown in FIGS. 26 and 27. FIG.

FIG. 29   FIG. 6 is a schematic view of an alternative end effector during surgery.

30 is a schematic view of an alternative suture configuration implemented with the alternative end effector of FIG. 29. FIG.

31 is a schematic view of another alternative suture configuration implemented with the alternative end effector of FIG. 29. FIG.

32 is a schematic view of another alternative suture configuration implemented using the alternative end effector of FIG. 29. FIG.

33 is a schematic view of another alternative suture configuration implemented with the alternative end effector of FIG. 29. FIG.

FIG. 34 is a schematic cutaway side view showing an alternative method of using a looped suture wire produced by an alternative effector portion of an instrument.

FIG. 35   FIG. 8 is a perspective view of the end of another alternative embodiment of an end effector.

FIG. 36   FIG. 8 is a perspective view of another alternative embodiment of an end effector portion of an instrument.

FIG. 37   FIG. 9 is a side view of another alternative embodiment of an instrument.

FIG. 38   FIG. 8 is a perspective view of an alternative configuration of the end effector.

FIG. 39   FIG. 8 is a perspective view of another alternative embodiment of an end effector.

FIG. 40   FIG. 40 is a perspective view of an alternative embodiment of the end effector of FIG. 39.

FIG. 41   FIG. 40 is a perspective view of an alternative embodiment of the end effector of FIG. 39.

FIG. 42a is a schematic diagram showing suturing using an alternative end effector. 42b is a schematic diagram showing suturing using the alternative end effector of FIG. 42a. 42c is a schematic diagram showing suturing using the alternative end effector of FIG. 42a.

FIG. 43   FIG. 9 is an exploded view of another alternative embodiment of an end effector.

─────────────────────────────────────────────────── ─── Continued front page    (72) Inventor Field, Frederick P.             New Hampshire, United States             03862, North Hampton, Woodrun             De Road 5 (72) Inventor Fogg, Douglas A.             Massachusetts, United States 01860,             Merrimack, South Pleasant Sutri             15 (72) Inventor Guyer, Brett             New Hampshire, United States             03038, Delhi, Frost Road 36 (72) Inventor Rice, John Tee             Massachusetts State 01773,             Lincoln, Red Rail Farm             31 F-term (reference) 4C060 BB02

Claims (26)

[Claims] 1. A tool for joining a first material layer to a second material layer comprising a handle and an end effector attached to the handle, the end effector comprising a wire. A first channel for holding a guide, a second channel extending from the first channel for supporting a suture wire extending from the wire guide, a passage for holding a cutting bar, and a distal end A recess, and the second channel is curved to impart a loop shape to the portion of the suture wire passing therethrough, the distal recess having a curved surface at a bottom thereof, The end recess is thereby adapted to receive the looped suture wire emerging from the second channel by the end recess, and the tool further comprises: A wire advance actuator attached to the handle for moving the suture wire through the second channel and the first and second material layers; and a wire cut actuator attached to the handle. And a wire cutting actuator for moving the cutting bar to cut and engage the suture wire. 2. The end effector comprises a flat distal end.
Tools described in. 3. The cutting bar includes a flexible blade portion, the end bar.
The tool of claim 1, wherein the effector is provided with a blade channel, a flexible blade disposed within the blade channel, the blade channel comprising a blade channel intersecting the second channel. 4. The tool of claim 1, wherein the end effector is pivotally mounted to at least a portion of the handle. 5. The tool of claim 1, wherein the wire cutting actuator is adapted to axially move the cutting bar into cutting engagement with the suture wire. 6. The tool of claim 1, wherein the wire cutting actuator is adapted to rotate the cutting bar about its central axis for cutting engagement with the suture wire. 7. The distal recess comprises a funnel-shaped side surface defining an opening in the flat distal end, the side surface receiving and receiving the looped suture wire. The tool according to claim 2, wherein the tool is configured to be guided toward a concave portion formed by the curved surface of the bottom portion. 8. The end effector comprises a flat distal end having a recessed cutout such that pressing the distal end against a soft material layer causes the material layer to be in the cutout. 6. The tool of claim 5, adapted to penetrate and, as a result, allow deep penetration of the suture wire. 9. The tool of claim 5, wherein the distal end of the cutting bar is concave in shape. 10. The end effector further comprises a tip forming die proximate a distal portion of the second channel, the die and the cutting bar relative to each other after the cutting bar performs a cutting operation. The tool of claim 1, adapted to engage to bend the cut end of the suture wire toward the inside of the loop formed by the suture wire. 11. The tool of claim 1, wherein the first and second material layers include first and second tissue layers. 12. The tool of claim 1, wherein the first material layer comprises a prosthesis and the second material layer comprises a tissue layer. 13. The tool of claim 12, wherein the prosthesis comprises a surgical mesh and the tissue layer comprises an abdominal wall. 14. A tool for joining a first material layer to a second material layer comprising a handle and an end effector mounted to the handle, the end effector comprising a wire. A first securing portion having a first groove defining a portion of the first channel for holding a guide, and a second channel extending from the first channel and a suture extending from the wire guide A second channel for supporting the wire; a portion of the passage for holding the cutting bar; a wall structure defining a portion of a distal recess at the distal end of the end effector; A second fixed portion having a first groove defining a remaining portion, a second groove defining a remaining portion of the passage, and a wall portion defining a remaining portion of the second channel; The above A sidewall defining the remaining portion of the end recess, the second channel being curved to impart a loop shape to the portion of the suture wire therethrough, the end recess comprising: Partially defined by a curved surface of the end effector that defines the bottom of the end recess, the end recess adapted to receive a looped suture wire emerging from the second channel. A tool further comprises a wire advance actuator attached to the handle for moving a suture wire through the second channel and the first and second material layers; and attached to the handle. Wire cutting for moving the cutting bar into cutting engagement with the suture wire as a wire cutting actuator Tools that are provided with actuators, the. 15. The first and second fixed portions are first and second, respectively.
15. The tool of claim 14, comprising a flat distal end of the first flat distal end and the second flat distal end being in the same plane. 16. The cutting bar includes a flexible blade portion, the first securing portion being a blade channel into which the flexible blade portion is disposed, and 15. The tool of claim 14, comprising a blade channel that intersects the second channel. 17. The tool of claim 14, wherein the end effector is pivotally mounted to at least a portion of the handle. 18. The wire cutting actuator is adapted to axially move the cutting bar into cutting engagement with the suture wire.
Tools described in. 19. The tool of claim 14, wherein the wire cutting actuator is adapted to rotationally move the cutting bar about its central axis for cutting engagement with the suture wire. 20. The distal recess comprises a funnel-shaped side surface defining an opening at the flat distal end, the side surface receiving and receiving the looped suture wire. 16. The tool according to claim 15, wherein the tool is adapted to guide toward a recess formed by the curved surface of the bottom. 21. The end effector comprises a flat distal end having a recessed cutout such that pressing the distal end against a soft material layer causes the material layer to be in the cutout. 19. The tool of claim 18, adapted to penetrate and thereby allow deep penetration of the suture wire. 22. The tool of claim 18, wherein the cutting bar distal end is concave in shape. 23. The first securing portion further comprises a tip forming die in the immediate vicinity of a distal portion of the second channel, the die and the cutting bar relative to each other after the cutting bar performs a cutting operation. Engaged so that the cutting end of the suture wire can be bent toward the inside of the loop formed by the suture wire.
The tool according to claim 14. 24. The tool according to claim 14, wherein the first and second material layers include first and second tissue layers. 25. The tool of claim 14, wherein the first material layer comprises a prosthesis and the second material layer comprises a tissue layer. 26. The tool of claim 25, wherein the prosthesis comprises a surgical mesh and the tissue layer comprises an abdominal wall.