US20050085832A1

Movatterモバイル変換

Info

Publication number: US20050085832A1
Application number: US10/919,792
Authority: US
Inventors: Gregory Sancoff; Douglas Fogg; Frederic Field
Original assignee: DVL Acquisition Sub Inc
Current assignee: DVL Acquisition Sub Inc
Priority date: 1998-08-27
Filing date: 2004-08-17
Publication date: 2005-04-21
Also published as: US6786913B1

Abstract

A device is disclosed for introducing a flexible elongated element through at least two portions of a subject. In an embodiment, the device includes a proximal end and a distal end, as well as an advancement unit for longitudinally advancing the flexible elongated element toward the distal end such that a proximal end of the elongated element may pass from the distal end of said device with sufficient force to pass through the portions of the subject. The device also includes a securing unit for variably adjusting a securing force applied by the flexible elongated element to secure together the portions of the subject.

Description

REFERENCE TO EARLIER APPLICATIONS

This application is a continuation of U.S. application Ser. No. 09/496,305, filed Feb. 1, 2000, which claims the benefit of U.S. provisional application No. 60/118,039, filed Feb. 1, 1999. This application is also a continuation-in-part of U.S. application Ser. No. 10/014,991, filed Dec. 11, 2001, which is a continuation of U.S. application Ser. No. 09/368,273, filed Aug. 3, 1999 which claims the benefit of U.S. provisional application No. 60/118,039, filed Feb. 1, 1999 and U.S. provisional application No. 60/098,152, filed Aug. 27, 1998. Each of the above identified applications are hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

This invention relates to medical instruments and procedures in general, and more particularly to suturing instruments and methods for suturing.

BACKGROUND OF THE INVENTION

Suturing instruments are typically used to draw together two or more portions of a subject patient (e.g., tissue such as muscle or skin) or to attach an object to the patient (e.g., to attach a piece of surgical mesh to the abdominal wall of the patient during hernia repair surgery).

Certain suturing instruments employ a needle that precedes a length of suture material through a subject.

For example, U.S. Pat. Nos. 3,470,875; 4,027,608; 4,747,358; 5,308,353; 5,674,230; 5,690,653; 5,759,188; and 5,766,186 generally disclose suturing instruments in which a needle, with trailing suture material, is passed through a subject.

U.S. Pat. Nos. 4,890,615; 4,935,027; 5,417,700; and 5,728,112 generally disclose suturing instruments in which suture material is passed through the end of a hollow needle after that needle has passed through a subject.

With all of the foregoing devices, a needle must be passed through the subject in order to deploy the suture. This is generally undesirable, since the needle typically leaves a larger hole in the subject than is necessary to accommodate only the suture material. In this respect it should be appreciated that it is generally desirable to alter each portion of the material being sutured as little as possible.

A suturing instrument has been devised which permits the suture material itself to pierce the subject without the use of a needle. However, this device does not permit sufficient flexibility with regard to the amount of tension that may be applied to the suture and tissue.

More particularly, U.S. Pat. No. 5,499,990 discloses a suturing instrument in which a 0.25 mm stainless steel suturing wire is advanced to the distal end of a suturing instrument, whereupon the distal end of the suturing wire is caused to travel in a spiral direction so as to effect stitches joining together two portions of a subject. After the spiral is formed, the beginning and end portions of the suture may be bent toward the tissue in order to inhibit retraction of the suture wire into the tissue upon removal of the suturing instrument. The stainless steel wire is sufficiently firm to hold this locking set. In addition, after the spiral is formed, the radius of the deployed suture spiral may then be decreased by advancing an outer tube over a portion of the distal end of the instrument. Again, the stainless steel wire is sufficiently firm to hold this reducing set.

Unfortunately, however, such a system does not permit sufficient flexibility in all situations with regard to the appropriate amount of tension to be applied to the subject, since the wire is relatively firm (i.e., firm enough to hold its sets). Such a system also does not provide sufficient flexibility with regard to the appropriate type of suture stitch to be applied, since the device is specifically configured to provide only a spiral suture stitch.

In contrast to the aforementioned limitations of the suturing instrument of U.S. Pat. No. 5,499,990, it is desirable that a suturing instrument approximate the portions of the material which is to be joined in the correct physiological relationship, and to urge the portions together with an appropriate amount of force. If too much force (or tension) is applied to the suture material, then the subject portions may become necrotic or the sutures may cut through the subject. If too little tension is applied to the suture material, then the healing process may be impaired.

U.S. Pat. No. 4,453,661 discloses a surgical instrument for applying staples. The staples are formed from the distal end of a length of wire. The distal end of the wire is passed through a subject, and thereafter contacts a die that causes the wire to bend, thereby forming the staple. The wire is sufficiently firm to take the set imposed by the die. The staple portion is then cut from the wire by a knife. Again, such a system suffers from the fact that it does not permit sufficient flexibility in all situations with regard to the appropriate tension to be applied to the subject, since the attachment is made by a staple which has a predefined geometry and is formed with relatively firm wire. In addition, the system is limited as to the type of fastening which may be applied, since the surgical instrument is limited to only applying wire staples.

There is a need, therefore, for a new suturing device that permits minimally disruptive suturing and permits flexibility in the placement, application, and tensioning of the suture material.

SUMMARY OF THE INVENTION

The invention provides a device for introducing a flexible elongated element through a subject. In one embodiment, the device includes a proximal end and a distal end, as well as an advancement unit for longitudinally advancing the flexible elongated element toward the distal end of the device such that a distal end of the flexible elongated element may pass from the distal end of the device with sufficient force to pass through the subject. The device also includes a securing unit for variably adjusting a securing force applied by the flexible elongated element so as to provide the desired securement to the subject.

In further embodiments, the device includes a guide tube for guiding the flexible elongated element through the device, toward the distal end of the device, as well as a rotation unit for rotating the distal end of the device so as to cause the flexible elongated element to wrap around itself, whereby to adjustably apply the securing force to the flexible elongated element.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiment of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein:

FIG. 1 is a side view of a suturing instrument formed in accordance with the present invention;

FIG. 2 is a partial side view, partially in section, of the suturing instrument shown inFIG. 1;

FIG. 3 is a partial top view, partially in section, of the suturing instrument shown inFIG. 1;

FIG. 4 is a schematic partial side view showing some of the internal components of the suturing instrument shown inFIG. 1;

FIG. 4A is a perspective view of a drive barrel assembly incorporated in the suturing instrument shown inFIG. 1;

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

FIG. 6 is a perspective view of the suturing instrument's wire supply cartridge, which includes the wire guide support unit shown inFIG. 5;

FIG. 7 is a perspective view, partially in section, of the wire supply cartridge shown inFIG. 6;

FIG. 8 is a perspective rear view of the drive barrel assembly incorporated in the suturing instrument shown inFIG. 1, with the drive barrel assembly's release lever being shown in its closed position;

FIG. 9 is a perspective view of the proximal (i.e., rear) end of the drive barrel assembly shown inFIG. 8, with the release lever being shown in its open position;

FIG. 10 is a perspective view of the proximal (i.e., rear) end of the same drive barrel assembly, with the release lever being shown in its closed position, and with the wire guide and wire guide support unit being advanced relative to the drive barrel assembly (but with the remainder of the wire supply cartridge being removed from view);

FIG. 11 is a schematic view taken along the line11-11 ofFIG. 4;

FIG. 12 is a side view of a shaft and an end effector portion of the suturing instrument shown inFIG. 1;

FIG. 13 is a side view of the end effector portion of the suturing instrument shown inFIG. 1;

FIG. 14 is a side view, partially in section, of the end effector portion shown inFIG. 13, with the end effector portion being shown with its cutting bar in its forward (i.e., non-cutting) position;

FIG. 15 is a side view, partially in section, of the end effector portion shown inFIG. 14, but with the end effector portion being shown with its cutting bar in its retracted (i.e., cutting) position;

FIG. 16 is a perspective view of the end effector portion of the suturing instrument shown inFIG. 1;

FIGS. 17A-17J show various steps in a suturing operation conducted with the suturing instrument shown inFIG. 1;

FIG. 18 is a sectional view showing one possible construction for the suturing instrument's fixed jaw portion and its associated cutting bar;

FIG. 19 is a side view showing a piece of wire cut with the apparatus shown inFIG. 18;

FIG. 20 is a sectional view showing another possible fixed construction for the suturing instrument's fixed jaw portion and its associated cutting bar;

FIG. 21 is a side view showing a piece of wire cut with the apparatus shown inFIG. 20;

FIG. 22 is a side view, partially in section, of the end effector portion of the device, wherein the end effector portion includes a piezoelectric element to aid in wire penetration;

FIG. 23A is a schematic diagram of the device's fixed jaw portion, illustrating how the suture wire may sometimes curve as it exits the fixed jaw portion;

FIG. 23B is a schematic diagram of a modified form of the device's fixed jaw portion, illustrating how the profile of the device can be modified so as to counteract the aforementioned wire curvature;

FIG. 23C is a schematic diagram of a modified form of the device's movable jaw portion, illustrating how the mouth of the movable jaw portion's opening may be enlarged so as to facilitate suture capture;

FIG. 24 is a schematic diagram of a modified form of the device, wherein one or more legs have been provided to help stabilize the tissue during suturing; and

FIG. 25 is a schematic diagram of another modified form of the device, wherein a second set of jaws have been added to the device to help stabilize the tissue during suturing.

FIGS. 26A-45F show additional constructions of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTOverview

Looking first atFIG. 1, there is shown asuturing instrument10 which comprises a preferred embodiment of the present invention. Suturinginstrument10 includes ahousing12, ahandle14, ashaft16 and anend effector18. Suturinginstrument10 includes ahousing12, ahandle14, ashaft16 and anend effector18. Suturinginstrument10 also includes awire advance button20, ajaw closing actuator22, awire cutting actuator24, a left-thumb-actuatedrotation button26, and a right-thumb actuated rotation button28 (FIG. 3). Suturinginstrument10 also includes awire supply cartridge30, as well as ashaft retaining nut32.Shaft retaining nut32 allowsshaft16 to be dismounted from the remainder of the device for cleaning purposes.

As will be discussed in further detail below, generally during use, suture wire (comprising wire formed of metal or any other suitable material having the required flexibility and stiffness) is drawn from a winding inwire supply cartridge30 and is pushed throughhousing12 andshaft16 to endeffector18, which includes a pair of opposing jaw portions. The jaw portions may be brought together around the material which is to be sutured by actuatingjaw closing actuator22 when the jaw portions are positioned at an appropriate surgical location. The suture wire is driven throughhousing12 andshaft16 to endeffector18 by actuatingwire advance button20. The suture wire is driven from one jaw portion to the other jaw portion with sufficient force to penetrate the tissue placed between the jaw portions, and the suture wire is permitted to pass through the second jaw portion. The jaw portions are then permitted to separate and move away from the tissue, leaving the suture wire extending from the subject tissue to each of the two jaw portions.Shaft16 and end effector18 (together with wire supply cartridge30) may then be rotated with respect tohousing12 and handle14 by actuating either left-thumb-actuatedrotation button26 or right-thumb-actuatedrotation button28. This causes the portions of the suture wire that extend from the tissue to be twisted about one another so as to form a closed loop extending through the tissue. It will be appreciated that the size of this closed loop may be adjustably reduced by increasing the degree of twisting in the wire. The twisted loop of suture wire may then be cut off, atend effector18, from the remaining portion of the suture wire that extends back through the suturing instrument. Such cutting may be effected by actuatingwire cutting actuator24.

As will be discussed in further detail below,wire supply cartridge30 may be supplied separately from suturinginstrument10, with thewire supply cartridge30 being loaded intosuturing instrument10 prior to commencing a suturing operation. As will also be discussed in further detail below,wire supply cartridge30 may be disposable, such that the cartridge may be discarded after all of its wire has been used up.

Construction Details

As shown inFIGS. 2 and 4, handle14 provides a cavity that may receivebatteries34. In other embodiments, the unit may be powered remotely via a power transmission cord or any other source of suitable power.

Batteries

34 supply a ground (or negative) potential to a ground connector post36 (FIG. 2), which in turn communicates with arotary ground communicator38.Rotary ground communicator38 permits electrical contact to be maintained withground connector post36 whenrotary ground communicator38 is rotated with respect toground connector post36, as occurs whenshaft16 andend effector18 are rotated so as to twist closed suture wire extending through the tissue.

Batteries

34 supply a positive potential to wireadvance button20, and to afirst connector post40, which in turn communicates with a first rotaryelectrical communicator42. First rotaryelectrical communicator42 permits electrical contact to be maintained withfirst connector post40 when first rotaryelectrical communicator42 is rotated with respect tofirst connector post40. The positive potential frombatteries34 is also supplied (in parallel) to each thumb-activatedrotation button26,28 (FIG. 3), and to a second connector post44 (FIG. 2), which in turn communicates with a second rotaryelectrical communicator46. Again, second rotaryelectrical communicator46 permits electrical contact to be maintained withsecond connector post44 when second rotaryelectrical communicator46 is rotated with respect tosecond connector post44. Each of the connector posts36,40 and44 may be spring-biased so as to remain in contact with its respective rotary communicator. In view of the foregoing construction, the positive potentials may be switched on by depressing the

respective actuator button

20,26,28.Handle14 also includes acap48 which may be removed so as to permit insertion ofbatteries34.

First rotaryelectrical communicator42 is in electrical communication with awire advance motor50 shown inFIGS. 2 and 4. The output shaft ofwire advance motor50 is coupled to amiter drive gear52, which is in turn coupled to amiter follower gear54.Miter follower gear54 is coupled to adrive wheel56 which contacts thesuture wire58, as will be described in further detail below with reference toFIGS. 5-10.

Second rotaryelectrical communicator46 is in electrical communication with a shaft rotation motor60 (FIGS. 3 and 4), the output of which is coupled to a pinion gear62 (FIGS. 4, 4A and11) that rotates along an internal gear64 (FIGS. 4 and 11). As shown inFIG. 3, left-thumb-actuatedrotation button26 and right-thumb-activatedrotation button28 may be provided to permit the user to use the thumb of either their left hand or their right hand, respectively, so as to actuateshaft rotation motor60. In this respect it will be appreciated that, inasmuch as left-thumb-actuatedrotation button26 and right-thumb-actuatedrotation button28 are wired in parallel,shaft rotation motor60 will rotate in the same direction regardless of which button (i.e.,button26 or button28) may be actuated.

Jaw closing actuator22 (FIGS. 2 and 4) is coupled to ajaw linkage coupler66, which in turn contacts a jaw linkage68 (FIGS. 2 and 14). Whenjaw closing actuator22 is pulled toward handle14 (FIG. 2),jaw closing actuator22 pivots on its pivot pin67 (FIG. 4) so as to drivejaw linkage coupler66 distally, against the force of biasingspring69, and so as to cause thejaw linkage68 to move forward toward the distal end of suturinginstrument10. This action will in turn causemovable jaw portion98 to close on fixed jaw portion96 (FIG. 17A), as will hereinafter be discussed in further detail. Whenjaw closing actuator22 is subsequently released, biasing spring69 (FIG. 4) drivesjaw linkage coupler66 proximally, so as to causejaw linkage68 to move proximally. This action will causemovable jaw portion98 to open relative to fixed jaw portion96 (FIG. 14), as will hereinafter be discussed in further detail. The action ofjaw linkage68 at the distal end of the device is discussed further below with reference toFIGS. 13 and 14.

Wire cutting actuator

24 is coupled to a wire cutting linkage coupler70 (FIGS. 2 and 4), which in turn contacts a wire cutting linkage72 (FIGS. 2, 14 and15). Whenwire cutting actuator24 is pulled toward handle14 (FIG. 2),wire cutting actuator24 pivots on its pivot pin73 (FIG. 4) so as to drive wire cuttinglinkage coupler70 proximally, against the force of biasingspring69, and so as to causewire cutting linkage72 to move proximally, away from the distal end of suturinginstrument10. This action will in turn cause cutting bar104 (FIG. 14) to move proximally (FIG. 15) so as to effect wire cutting, as will hereinafter be discussed in further detail. Whenwire cutting actuator24 is subsequently released, biasingspring69 drives wire cuttinglinkage coupler70 distally, so as to causewire cutting linkage72 to move distally. This action causes cuttingbar104 to move distally, so as to assume the position shown inFIG. 14.Wire cutting linkage72 moves adjacent to, and independent of,jaw linkage68 discussed above. The action ofwire cutting linkage72 at the distal end of the device is discussed further below with reference toFIGS. 14 and 15.

Thewire supply cartridge30 shown inFIG. 1 includes a wireguide support unit74, as shown inFIGS. 5-7. A supply coil of suture wire58 (comprising wire formed of metal or any other suitable material having the required flexibility and stiffness) may be supplied in the base ofcartridge30 and is fed into thesupport unit74 as shown inFIG. 7. Awire guide76 surroundssuture wire58, fromsupport unit74 to the distal end of suturinginstrument10, adjacent to end effector18 (FIGS. 5-7,14 and15).Wire guide76 ensures thatsuture wire58 does not bend or buckle as the suture wire is pushed throughhousing12 andshaft16. More particularly, wire guide76 preferably forms a sufficiently close sliding fit withsuture wire58 such thatsuture wire58 cannot bend or buckle as the suture wire is advanced throughsuturing instrument10. At the same time,wire guide76 is also formed so as to present a minimum of friction tosuture wire58 as the suture wire is advanced through the instrument. The foregoing characteristics are important, inasmuch assuture wire58 is extremely thin and flexible and highly susceptible to bending or buckling in the absence of some sort of lateral support.

By way of example but not limitation, wheresuture wire58 is formed out of stainless steel and has a diameter of 0.005 inch,wire guide76 might have an inside diameter of 0.008 inch and an outside diameter of 0.016 inch. In addition,wire guide76 is preferably formed out of polytetrafluoroethylene (PTFE) or some other relatively lubricious material. Alternatively, the interior ofwire guide76 may be coated with a lubricant so as to facilitate closely-supported, low-friction passage of the suture wire through the wire guide.

Further by way of example but not limitation, in one preferred form of the invention,suture wire58 may comprise 316 LVM stainless steel having a tensile strength of 170 kpsi.

Althoughwire guide76 extends through support unit74 (FIG. 7),wire guide76 has two openings78 (one on either side ofwire guide76, only one of which is shown inFIG. 5) in the center ofsupport unit74.Openings78 expose a portion ofsuture wire58 so that wire drive wheel56 (FIG. 8) may contactsuture wire58 and urge the suture wire forward toward the distal end of suturinginstrument10, as will be discussed in detail below with reference toFIGS. 8-10.

As shown inFIGS. 2, 3,4A and8,housing12 receives adrive barrel assembly80 that contains the

aforementioned motors

50 and60, and provides a distally-extending barrel shaft81 (FIGS. 4A and 8), on the outside of which are located the

rotary communicators

38,42 and46′. A recess82 (FIG. 4A) is provided on the distal end ofbarrel shaft81 for receiving a coupling pin84 (FIGS. 2 and 4) which is located on the proximal end ofshaft16, such that rotation ofdrive barrel assembly80 causes rotation ofcoupling pin84 and henceshaft16. Drivebarrel assembly80 is rotationally held withinhousing12 bybearings86, as shown inFIGS. 2 and 3.

Looking next atFIGS. 7-10,wire supply cartridge30 may be attached to drivebarrel assembly80 by rotating arelease lever87 away from the center of drive barrel assembly80 (FIGS. 8 and 9), so as to move acarriage88 relative to drivebarrel assembly80. Most particularly,release lever87 rides on apin90, and rotation ofrelease lever87 from the position shown inFIG. 8 to the position shown inFIG. 9 drawscarriage88, as well as awire follower wheel92, away from the center ofdrive barrel assembly80. Oncewire follower wheel92 is separated fromwire drive wheel56 by a sufficient distance to expose the drive barrel assembly's central passageway93 (FIG. 9), wire guide76 (overlying suture wire58) may be inserted into passageway93 (FIG. 10), and wire guide support unit74 (FIGS. 6, 7 and10) may be inserted betweenwheels56 and92 (FIG. 10), such that

wheels

56 and92 contact either side ofsuture wire58 throughopenings78 formed in either side ofwire guide76. A biasing spring94 (FIGS. 8-10) is provided oncarriage88 to urgewire follower wheel92 into close contact withsuture wire58. In other embodiments,wire follower wheel92 may also be driven indirectly bywire drive wheel56 in order to provide additional forces to movesuture wire58 distally (i.e., forward, toward the tool's end effector18).

Pinion gear62 (FIGS. 4, 4A and0.11) extends distally fromdrive barrel assembly80 and engages the housing'sinternal gear64, as shown inFIGS. 4 and 11. As a result of this construction, whenshaft rotation motor60 is actuated,pinion gear62 rotates aroundinternal gear64, bringing with it the entiredrive barrel assembly80. This in turn causesshaft16 to rotate, sinceshaft16 is coupled to drivebarrel assembly80. More particularly, the rotation ofdrive barrel assembly80 is transferred toshaft16 through the shaft's coupling pin84 (FIGS. 2, 4 and12), which is seated in recess82 (FIG. 8) ofdrive barrel assembly80.

End effector18 (FIGS. 1 and 13-16) includes a fixedjaw portion96 and amovable jaw portion98.Movable jaw portion98 is coupled to the aforementioned jaw linkage68 (FIG. 14) via ajaw linkage pin100, such that whenjaw linkage68 is moved distally (i.e., by pullingjaw closing actuator22 toward handle14),jaw portion98 is rotated about a pivot pin102 (FIG. 13) and closes onto fixedjaw portion96. Conversely, whenjaw linkage68 is moved proximally (i.e., by the power of biasingspring69 acting onjaw linkage coupler66 and hence jaw linkage68),movable jaw portion98 will open away from fixedjaw portion96. It will be appreciated that the force of biasingspring69 will normally keepmovable jaw portion98 open relative fixed jaw portion98 (FIGS. 1, 13 and14), unless and untiljaw closing actuator22 is activated so as to overcome the bias ofspring69.

Wire cutting linkage72 (FIGS. 2, 3,14 and15) is coupled to a cutting bar104 (FIGS. 14 and 15) that includes asmall opening106 through whichsuture wire58 may pass, as will hereinafter be discussed in further detail. Preferably cuttingbar104 is slidably received in a passageway107 (FIGS. 14, 15,16 and17H) formed in fixedjaw portion96. In one position (FIG. 14), cuttingbar104 is positioned in fixedjaw portion96 such that the cutting bar'sopening106 is aligned with achannel108 formed in fixedjaw portion96, whereby suture wire may be passed from the distal end ofwire guide76, throughchannel108 formed in fixed jaw portion96 (where it undergoes an approximately 90 degree change of direction), throughopening106 in cuttingbar104, through achannel extension108A formed in fixedjaw portion96, and across tomovable jaw portion98, as will hereinafter be discussed in further detail. However, whenwire cutting linkage72 is moved proximally by pullingwire cutting actuator24 towardhandle14, cuttingbar104 is also moved proximally (FIG. 15) so as to cut any suture wire extending from channel108 (in fixed portion96) into opening106 (in cutting bar104). In this respect it will be appreciated that it is desirable to formchannel extension108A with a length greater than channel108 (seeFIGS. 14 and 15) so as to prevent the suture wire from being cut in two places (i.e., atchannel108 and again atchannel extension108A) when cuttingbar104 is moved proximally by pulling onwire cutting actuator24. At the same time, however, it should also be appreciated that the fixed jaw portion'schannel108 andchannel extension108A, and the cutting bar'sopening106, are all sized, relative tosuture wire58, so as to provide as much support as possible to the suture wire as it passes through, and out of, fixedjaw portion96.

It will be appreciated that the force of biasingspring69 will normally keep cuttingbar104 in its distal position (i.e., with the cutting bar'sopening106 aligned with the fixed jaw portion's channel108), unless and untilwire cutting actuator24 is activated so as to overcome the bias ofspring69.

In view of the foregoing construction, it will be seen that: (1) release lever87 (FIGS. 8-10) may be activated so as to movewire follower wheel92 away from, and toward,wire drive wheel56 so as to permit a full wire supply cartridge30 (FIGS. 1 and 5-7) to be loaded intosuturing instrument10; (2) activatingjaw closing actuator22 will causemovable jaw portion98 to close on fixedjaw portion96; (3) activatingwire advance button20 will causewire drive wheel56 to advancesuture wire58 throughhousing12 andshaft16; (4) activatingrotation button26 and/orrotation button28 will causeshaft16 to rotate relative tohousing12; and (5) activatingwire cutting actuator24 will cause cuttingbar104 to move proximally so as to sever any suture wire extending from fixedjaw portion96.

Operation

Suturinginstrument10 may be used to applywire suture58 to a subject so as to effect a desired suturing operation.

By way of example but not limitation, and looking now atFIGS. 17A-17J, suturinginstrument10 may be used to suture together two

portions

110,112 of a subject which is to be sutured. In a typical case,

portions

110,112 might comprise two sections of severed tissue which need to be reattached to one another, or two pieces of previously unattached tissue which need to be attached to one another. However, one or the other of the

portions

110,112 might also comprise artificial mesh or some other object being attached to tissue, etc. In addition, in a typical case,

portions

110,112 might be located relatively deep within a patient, and might be accessed during a so-called “minimally invasive”, or a so-called “closed surgery”, procedure; however, in other circumstances,

portions

110,112 might be accessed during a conventional, or so-called “open surgery”, procedure. This later situation might include procedures done at the outer surface of the patient's body, i.e., where

portions

110,112 comprise surface subjects.

In any case, suturinginstrument10 is initially prepared for use by installingbatteries34 intohandle14, ifbatteries34 are not already installed, and by installingwire supply cartridge30 into the suturing instrument, if acartridge30 is not yet installed. As noted above,wire supply cartridge30 is installed in suturinginstrument10 by (1) moving the drive barrel assembly'srelease lever87 to its open position (FIG. 9), so as to movewire follower wheel92 away fromwire drive wheel56 and thereby expose the barrel assembly'scentral passageway93; (2) passing the distal end of the cartridge (i.e., the distal end of wire guide76) throughdrive barrel assembly80 andshaft16 until the distal end ofwire guide76 is in communication with thechannel108 formed in fixed jaw portion96 (FIG.14), at which point the cartridge's wireguide support unit74 will be positioned intermediatewire drive wheel56 and wire follower wheel92 (FIG. 2); and (3) moving the drive barrel assembly'srelease lever87 back to its closed position (FIG. 8), so as to causewire drive wheel56 andwire follower wheel92 to extend through the wire guide'sopenings78 and engagesuture wire58.

At thispoint suturing instrument10 will be ready for use, with itsmovable jaw portion98 being opened away from its fixedjaw portion96, and with its cuttingbar104 being in its forward (FIG. 14) position.

Next, suturinginstrument10 has itsmovable jaw portion98 moved into engagement with its fixed jaw portion96 (i.e., the

jaws

96,98 are placed in their “closed” position) by pullingjaw closing actuator22 towardhandle14, and then the distal end of suturinginstrument10 is moved adjacent tosubject portions110,112 (FIG. 17A).

In the case of a so-called closed surgical procedure, such positioning will generally involve moving the distal end of the suturing instrument through a cannula and into an interior body cavity; however, it is also envisioned that one might move the distal end of the suturing instrument directly into an otherwise-accessible body cavity, e.g., directly into the colon or esophagus, etc. In the case of a so-called open surgical procedure, such positioning might involve positioning the distal end of the suturing instrument adjacent to more readily accessible

subject portions

110,112.

In any case, once the distal end of suturinginstrument10 has been placed adjacent to

subject portions

110,112,jaw closing actuator22 is released, such that biasing spring69 (FIG. 4) will causemovable jaw portion98 to open away from fixed jaw portion96 (FIG. 17B). Then the distal end of suturinginstrument10 is moved so that its

jaws

96,98 straddle

subject portions

110,112, and thenjaw closing actuator22 is actuated again, by pullingjaw closing actuator22 towardhandle14, so as to closemovable jaw portion98 against fixedjaw portion96, whereby to capturesubject portions110,112 (FIG. 17C).

Next,wire advance button20 is activated so as to causesuture wire58 to be driven forward, out of the distal end ofwire guide76, through the fixed jaw portion'schannel108, throughopening106 in cuttingbar104, through the fixed jaw portion'schannel extension108A, through

subject portions

110,112, and finally through an opening113 (FIGS. 14, 15 and17C) formed inmovable jaw portion98.Suture wire58 is preferably advanced-so that alength58A ofwire58 extends approximately 1 centimeter out of the bottom end of movable jaw portion98 (FIG. 17C). In this respect it will be appreciated that, assuture wire58 leaves fixedjaw portion96 and engages

subject portions

110,112, the fixed jaw portion'schannel108, the cutting bar'sopening106 and the fixed jaw portion'schannel extension108A will support the thin suture wire so as to enable the suture wire to penetrate

subject portions

110,112.

Once this has been done,jaw closing actuator22 is released so as to permitmovable jaw portion98 to return to its “open” position relative to fixedjaw portion96, and then wireadvance button20 is used to pay outadditional suture wire58 as the distal end of suturinginstrument10 is stepped back (e.g., by about a centimeter or so) fromsubject portions110,112 (FIG. 17D).

Thenjaw closing actuator22 is used to movejaw portion98 back into engagement with fixedjaw portion96 once more (FIG. 17E).

Next, left-thumb-actuatedrotation button26, or right-thumb-actuatedrotation button28, is used to rotateshaft16 and hence endeffector18. This causessuture wire58 to twist on itself, initially creating a relatively large loop116 (FIG. 17F) ofsuture wire58 extending from

subject portions

110,112 toward suturinginstrument10. However, asrotation button26 and/orrotation button28 is used to rotate shaft16 (and hence end effector18) more and more, theloop116 of suture material will progressively close down (FIG. 17G) so as to form a tight binder for

subject portions

110,112. In this respect it will be appreciated that the longer the period of time that endeffector18 is rotated, the greater the amount of twisting ofsuture wire58, and the greater the force holding

subject portions

110,112. In this respect it will also be appreciated thatsuture wire58 is preferably carefully selected with respect to its flexibility relative to the strength of

subject portions

110,112. In particular,suture wire58 is chosen so as to have a flexibility such that the suture wire will twist, andloop116 will close down, before

subject portions

110,112 will undergo substantial deformation and/or tearing. By way of example but not limitation, in practice, it has been found that 0.005 inch diameter stainless steel wire can be used with most types of mammalian tissue such that the suture wire can be twisted closed without causing substantial deformation and/or tearing of the tissue.

Oncesuture wire58 has been tightened to the desired degree, rotation ofshaft16 andend effector18 is stopped, i.e., by releasingbutton26 orbutton28. Then wire cuttingactuator24 is depressed (e.g., it is pulled back toward handle14) so as to pull cuttingbar104 proximally and thereby sever thesuture wire58 as the suture wire emerges from the fixed jaw portion'schannel108 and enters the cutting bar's opening106 (FIG. 17H andFIG. 16). This action separates the deployed suture wire extending through

subject portions

110,112 from the suture wire remaining inwire supply cartridge30,wire guide76 and the fixed jaw portion'schannel108.

Then wire cuttingactuator24 is released, allowing biasingspring69 to return cuttingbar104 to return to its distal position, and thenjaw closing actuator22 is released, allowingmovable jaw portion98 to move away from fixedjaw portion96. Suturinginstrument10 may then be removed from

subject portions

110,112, which action will pullwire length58A from movable jaw portion98 (FIG. 17I).

The deployedsuture wire58 may then be pressed down flat against

subject portions

110,112, or rounded into a ball, or otherwise operated upon, so as to reduce the profile of, or reduce the tendency to snag on, the deployed suture wire (FIG. 17J).

It will be appreciated that suturinginstrument10 will have application in a broad range of different suturing operations. More particularly, it will be appreciated that suturinginstrument10 will have application in both “open” and “closed” surgical procedures, with the former including, but not limited to, large entry procedures, relatively shallow procedures, and surface procedures; and with the latter including, but not limited to, surgical procedures where access is gained to an interior structure through the use of a cannula, and surgical procedures where access is gained directly to an internal body cavity without the use of a cannula, e.g., such as a procedure conducted within the colon or the esophagus.

It will also be appreciated that suturinginstrument10 will have application where two portions of tissue must be attached to one another (e.g., where two severed pieces of tissue must be re-attached to one another, or where two separate pieces of tissue must be attached to one another, or where two sections of a single piece of tissue must be approximated to one another), and where an object must be attached to the patient (e.g., where surgical mesh must be attached to the patient's abdominal wall during hernia repair surgery, etc.).

Among other things, it is believed that suturinginstrument10 will have particular application in the areas of general laparoscopic surgery, general thoracic surgery, cardiac surgery, general intestinal surgery, vascular surgery, skin surgery and plastic surgery.

Looking next atFIGS. 18 and 19, it will be seen that where the fixed jaw portion'schannel108 is disposed so as to be substantially aligned with the center of cutting bar104 (FIG. 18),suture wire58 will be cut with a relatively flatleading end58B (FIG. 19). However, it has sometimes been found helpful to providesuture wire58 with a relatively sharp leading point. Such a leading point can help open the subject for the following portion of the suture wire. In addition, such a leading point can help the suture wire penetrate the subject with a substantially straight path, so that the suture wire will reliably enter the movable jaw portion'sopening113. To this end, it has been found that moving the fixed jaw portion'schannel108 off-center relative to cutting bar104 (FIG. 20) will cause theleading end58B ofsuture wire58 to be formed with a relativelysharp tip58C (FIG. 21).

It is also possible to usesuturing instrument10 to ligate a subject rather than to pass a suture through the subject. For example, suturinginstrument10 might be used to ligate a blood vessel withsuture wire58. In this case, suturinginstrument10 is deployed so thatsuture wire58 will pass around the far side of the subject, rather than through the subject as in the case of the suturing operation of the type described above.

By way of example but not limitation, in a typical ligating operation,movable jaw portion98 is first opened relative to fixedjaw portion96. Then suturinginstrument10 is positioned about the subject so that whenmovable jaw portion98 is thereafter closed toward fixedjaw portion96, the fixed jaw portion'schannel108 and the movable jaw portion'sopening113 will both lie on the far side of the subject. Themovable jaw portion98 is then closed against the fixedjaw portion96, andsuture wire58 is passed from fixedjaw portion96 tomovable jaw portion98, i.e., around the far side of the subject. Themovable jaw portion98 is then opened, andsuture wire58 is payed out as the instrument is stepped back from the subject. Then themovable jaw portion98 is again closed against the fixedjaw portion96. The shaft of the instrument is then rotated so as to form, and then close down, the ligating loop. Then cuttingbar104 is activated so as to cut the ligating loop from the remainder of the suture wire still in the tool, themovable jaw member98 is opened, and the instrument is withdrawn from the surgical site. The deployedsuture wire58 may then be pressed down flat against the subject, or rounded into a ball, or otherwise operated upon, so as to reduce the profile of, or reduce the tendency to snag on, the deployed suture wire. As will be appreciated by a person skilled in the art, whereinstrument10 is to be used for ligating purposes, fixedjaw portion96 andmovable jaw portion98 might be formed with a greater longitudinal length so as to facilitate passing the suture wire around the far side of the subject. Furthermore,movable jaw member98 might be formed with a recess, intermediate its jaw linkage pin100 (FIG. 15) and itsopening113, for accommodating the subject, whereby to prevent compressing the subject whenmovable jaw member98 is moved into engagement with fixedjaw member96.

Suture wire

58 may comprise a wire formed out of a metal or any other suitable material having the required flexibility and stiffness. By way of example but not limitation,suture wire58 may comprise stainless steel, titanium, tantalum, etc.

If desired,suture wire58 may also be coated with various active agents. For example,suture wire58 may be coated with an anti-inflammatory agent, or an anti-coagulant agent, or an antibiotic, or a radioactive agent, etc.

Looking next atFIG. 22, it is also possible to impart ultrasound energy to the wire in order to make tissue penetration easier. More particularly, because of the small cross-sectional area of the wire and the propensity for the wire to buckle when axially loaded, it is beneficial to be able to advance the wire into tissue with a minimum of load. This can be achieved by appropriately applying ultrasound energy to the wire.

Apiezoelectric element200 is placed at the outside radius of thewire guide path108 at the right angle bend in the fixedjaw portion96 just before where the wire enters the tissue. Thepiezoelectric element200 vibrates at a position along this bend such that it supports the wire in completing the turn but also imparts a component of displacement in the direction of the tissue. Displacement of this kind at ultrasonic frequencies, in addition to the existing wire driving means, would cause the tip of the wire to penetrate the tissue using less force. In addition to reducing the tendency for outright wire buckling, lowering the wire loads will also allow the wire penetration to proceed in a straighter path.

Looking next atFIG. 23A, it will be seen that, in some circumstances, thesuture wire58 may exit fixedjaw portion96 with a curvature, due to the fact thatsuture wire58 follows acurved channel108 in fixedjaw portion96. In some cases this curvature in thesuture wire58 may be quite modest, so that it may be effectively ignored. However, in other circumstances, this curvature might be large enough to cause the suture wire advancing out of fixedjaw portion96 to miss thetarget opening113 inmovable jaw portion98. In this case the curvature insuture wire58 can present a significant problem. However, and looking now atFIG. 23B, it has been found that the profile of the cutting bar'sopening106 may be modified so as to provide a deflecting die which will counteract undesirable curvature in the suture wire and return the suture wire to a straight path as the suture wire exits fixedjaw portion96. Alternatively, the profile of the fixed jaw portion'schannel108 may be modified, adjacent to cuttingbar104, so as to provide a similar deflecting die which will counteract undesirable curvature in the suture wire and return the suture wire to a straight path as the suture wire exits fixedjaw portion96. Futhermore, and looking now atFIG. 23C, the mouth of the movable jaw portion'sopening113 may be enlarged to help capture a suture wire deviating from a straight path.

Looking next atFIG. 24, it will be seen that one oremore legs300 may be provided on suturinginstrument10, whereinlegs300 help stabilize the tissue during suturing.

And looking next atFIG. 25, it will be seen that agrasper400, comprising

jaws

405 and410, may be added to suturinginstrument10 to help stabilize the tissue during suturing.

If desired, theend effector18 of suturinginstrument10 may be constructed so as to have two movable, opposing jaws, rather than one fixed jaw and one movable jaw as described above.

Also, if desired,shaft rotation motor60 and

thumb buttons

26,28 may be configured so that depressing one button (e.g., button26) will causeend effector18 to rotate in one direction (e.g., clockwise), and depressing the other button (e.g., button28) will causeend effector18 to rotate in the opposite direction (e.g., counterclockwise).

Further Constructions for the Wire Suturing Device

Other Suture Materials

It is possible to use other suture wire materials provided they are stiff enough to penetrate the tissue. Other medical grade metals such as ASTM 1341 titanium and ASTM F 1091 cobalt-chromium alloy. Plastic materials that are sufficiently stiff could also be used such as polymide thermoplastics, Nylon, and polypropylene.

Collet Wire Drive Mechanism

Pushing the wire forward could also be done using a collet system such as sometimes used to drive lead in a mechanical pencil. The collet system could be smaller than the drive wheel mechanism and would allow it to be placed near the end of the instrument shaft. The collet would hold the wire and a mechanism would then push the collet and wire forward. An example of a colletwire drive mechanism500 is shown inFIGS. 26A-26E. Aspring505 presses acollet collar510 ontocollet515 which causescollet515 to squeeze and holdwire520. The taper ofcollet515 is such thatcollet collar510 is now stuck on the collar and no longer needs spring force bias to maintain the hold onwire520. As thecollet assembly500 is moved forward by a force against thepush collar510,wire520 is also moved forward until thecollet collar510 hits acollet collar stop525 at the end of the advance stroke. At thispoint collet collar510 is pushed off thecollet515 thereby releasing the hold onwire520 so that as thecollet assembly500 moves backwardswire520 remains in its advanced position. As thecollet assembly505 moves all the way back,collet collar510 encounters thecollet collar backstop530 which pushescollar510 back onto thecollet515 with the force ofspring505 so thatwire520 is held again and ready for another thrust forward. Various methods can be used to advancepush collar535 such as a pivotingmanual lever mechanism540 and amotorized cam system545, both shown inFIGS. 26A-26E.

As thecollet515 advances,wire520 in front ofcollet515 needs to be supported to preventwire515 from buckling, yet the support must shrink and expand with the motion of the collet movement. As shown inFIGS. 27A-27D, methods for providing this support are to placewire520 inside a small coil spring550, atube555 of an elastomeric material, or atelescoping tubes560.

Because collets for very small wires can be difficult to manufacture, small pieces ofplastic tubing565 with a small internal diameter sufficient to accommodate the wire with some clearance, can be placed incollet515 as an interface betweencollet515 and the wire. The deformability of the plastic tubing will allowcollet515 to collapseplastic tube565 enough to press and hold the wire (seeFIGS. 28A and 28B). The plastic can be chosen such that the coefficient of friction between the plastic and wire is very high, thereby reducing the forces required to hold the wire. Whencollet515 is released the plastic tube has sufficient resilience to open the internal diameter and provide clearance between the wire and the inside of the plastic tube. Ascollet515 moves backwards after advancing the wire, the wire will remain in the incrementally forwarded position.

Wire Cutting

It is advantageous to cutwire520 with a minimum of force since the mechanism for cuttingwire520 has to be at the end of a small shaft. Providing the cutting surfaces with

stress concentrators

570,575 can substantially reduce the load required to cut the wire (seeFIGS. 29-29D,30).

It is also advantageous to providewire520 with asharp tip580 after cutting so that when it is pushed through tissue during the next suture placement it can be done with a minimum of force. Forcing a symmetric wedge-shapedcutting surface570 intowire520 from both sides will causewire520 to have atip585 with sloped sides making it sharper for tissue penetration (seeFIGS. 29-29D). A cuttingbar590 that shears thewire520 at an angle to the length ofwire520 will create a correspondinglyangled tip595. This could be done for example if thewire path600 traversed a circular cutting bar nearer one side of the bar rather than the middle (seeFIGS. 31 and 31A).

Wire Feed Stop

The moveable side of the jaw that accommodates the distal end ofwire520 as it passes throughtissue605 may include a stop to prevent excess wire advancement into surrounding tissues in surgical settings where it is difficult to see. The stop can be as simple as aphysical end610 to the hole in the jaw that the wire moves into after it has passed through the tissue. Alternatively, the wire end could be sensed as it passes into the moveable side of the jaw with devices such as anoptical interrupter615,pressure switch620, or the like that would be used to provide an audible, tactile, or visual feedback to the surgeon indicating that they should stop advancing wire (seeFIGS. 32A-32H).

Jaw Surfaces that Enhance Tissue Grasping

A large function of the jaw is to bring together the two pieces of tissue that are to be sutured. To facilitate this, the jaw surface may haveundulations625,abrasive surfaces630, orconcave areas635 that create a ridge at the tip of the jaw. The jaw may also be tapered to apointed tip640 to increase its ability to pinch or isolate smaller sections of tissue. During hernia repairs, it is often necessary to attach a tightly woven mesh to the inside of the abdominal wall. The mesh can be anchored by using sutures placed through the mesh and into the tissue on the other side. In order for this to be feasible with the present device, the jaws must be able to grab a substantially flat section of mesh overlying tissue and pinch them in order to position them in the jaw. Once the mesh and tissue is properly positioned in the jaw, the wire can be passed through the tissue and twisted as is normally done (seeFIGS. 33A-33G).

Jaw Feature that Facilitates Wire Penetration

A raisedportion645 on the jaw surface wherewire520 exists and also on the opposite jaw surface through whichwire520 passes after penetratingtissue605, can reduce the travel distance of the wire. This reduces the chances that the wire will deviate from the intended path through the tissue (seeFIGS. 34A and 34B).

Tubular Ligation

It is often necessary to surgically occlude atubular structure650 by tying asuture655 tightly around the circumference so that the lumen is collapsed and closed. By placing aspace660 in the jaw proximal to wherewire520 emanates, atubular structure650 can be held in the closed jaw while wire is passed around the distal side of the structure. The jaw is then opened and pulled back while wire is being advanced. When wire is completely around it, the jaws are closed and the wire is twisted until the structure is occluded (seeFIGS. 35A-35D).

Wire Coloring

The wire may be colored to make it easier to see in the video monitors used for minimally invasive surgery. The colorings may also be striped so that wire advance can more easily be seen. The wire may also be made with a matte finish to reduce the glare and enhance visibility.

Wire Coatings

The wire can be coated with anti-coagulant materials so that when it is used in vascular procedures it will not promote the formation of clots. To decrease the chances of infection, the wire can be coated with antibiotics. In order to reduce damage and inflammation to the vessel wall due to the presence of the wire, the wire can be coated with an anti-inflammatory agent. The wire may also be coated with a lubricant to facilitate its penetration through tissue.

To increase the outer diameter of the wire without making it more stiff, the wire can be coated with a biologically inert material such as Teflon. This would be useful when suturing tissue that is weak or thin because the larger diameter would decrease the stress that the suture places on those tissues. It would also require less torque to twist the ends together than a solid metal wire of comparable size.

Shaft that Allows Angled Orientation of Jaw

The surgical field often requires that the device access an area that is not in a straight line from the entrance point of theInstrument662. One method for doing this with the present device is to give theouter tube665 of the device shaft a permanent bend θ and allow all the inner tubes670 (e.g. those that control the jaw, wire cutting, jaw rotation, etc.) to flex through this region. The outer tube of the shaft must be rigid so that the jaw maintains its orientation when it is rotated during wire twisting (seeFIGS. 36A-36C and37A-37C). Another method would be to have the outer tube of the instrument shaft selectively and controllingly flex by additional mechanisms in the instrument such as push/pullelements675 in awall680 of the outer tube of the shaft (seeFIGS. 38A and 38B).

Wire Disposable Details

The instrument will use single-use quantities ofwire520 that are sterile and disposable. The disposable consists of aplastic container685 that contains the wire and atube690 that supportswire520.Tube690 projects from the middle ofcontainer685 and is open to the wire reservoir at the proximal end. The disposable is manufactured with wire coiled in the container and fed through the distal end of the tube (seeFIGS. 39 and 40). To install the disposable, alever695 on the instrument is moved displacing one of thedrive wheels700 so that a gap is formed for the insertion of the wire tube. The tube emanating from the container is fed into the back of the instrument so thattube690 passes between the wheels and all the way up to the jaw where it interfaces with anothertube705 that leads the wire to the jaw surface. The container snaps onto the back end of the instrument. The lever is moved back to the drive position causing the drive wheel to return to the driving position against the wire.

The wire tube has asection710 at the position of the drive wheels that is cut away on both sides to expose the wire to the drive wheel surfaces700 (seeFIGS. 40 and 41). This geometric arrangement allowswire520 to be supported laterally when it is betweendrive wheels700. It also allows the wire to be aligned as it approaches the drive wheels as it leaves. If the wire entered the mouth of the wire tube after leaving the drive wheels without this lateral support and positioning, slight misalignment between the wire and the wire tube would cause the wire to bend and to potentially buckle. Because the drive wheels hold the wire tightly, misalignment of the wire as it enters the drive wheels will also result in a misalignment between the wire and the tube as the wire is driven to the other side of the drive wheels. The present configuration prevents both of these.

Because the wire tube is weak at the cutaway section for the wire, a structure that is connected to the container supports this section of the tube (seeFIGS. 39-41).

Lubricious Wire Pathways

In order to reduce the forces needed to drive the wire and to increase the amount of force reaching the tip of the wire during tissue penetration, the frictional resistance of the wire moving against the walls of the wire tube can be reduced by using a material with a low coefficient of friction. This is especially important where the wire makes a 90 degree turn from a longitudinal direction along the instrument shaft to a direction that is perpendicular to the jaw structure. Teflon is very lubricous and it can easily be made into tubes with small internal diameters.

Wire Drive Wheels with Enhanced Frictional Force against the Wire

Because the contact area of the drive wheel to the wire is very small and a normal force is required to develop a frictional force to thrust the wire, the stresses in the wire can become large enough to permanently deform the wire. If the wire encounters a very hard material that stops its advance, the drive wheel can skid along the surface causing more stresses that can cause further permanent deformations, principally on one side of the wire. Those permanent deformations can cause the drive wheel to become stuck in a section of reduced wire diameter such that the wire cannot advance. Also, sections of wire can be created that have unilateral and bilateral radii that can promote premature buckling of the wire either within the instrument or at the site of tissue penetration. To decrease the normal force of the drive wheel against the wire, the coefficient of friction between the two can be increased by treating thesurface715 of thedrive wheel700A. Examples of such treatments are machining small scratches on the drive wheel surface perpendicular to the direction of wire travel or bead blasting a rough surface onto the drive wheel. Material coatings can also be added to the surface of the drive wheel such as deposition of diamond particles (seeFIG. 42).

Another means of increasing the frictional force is to increase the area of contact betweendrive wheel700A andwire520. This could be accomplished by placing agroove720 into the drive wheel surface thatwire520 can partially fit into so that thedrive wheel700A also contacts the sides ofwire520. Also, both

wheels

700A,700B could be driven to increase the driving force. Yet another method to increase the surface area between the drive wheel and the wire, is to havemultiple drive wheels725 in series driven by a common or separate linkage (seeFIGS. 43A-43C).

Jaw Rotational Symmetry

After the wire has been passed through the tissue and the wire ends are to be twisted together, it is important that the jaws have rotational symmetry so that while they are rotating they do not scrape or catch the surrounding tissue.

Means to Grab Separated Pieces of Tissue

Because the

tissue pieces

730A,730B to be approximated are often not near each other in the surgical field, it is beneficial for the instrument to bring them together. One or more of the jaw surfaces may have a small tooth or fang740 that catches the tissue so that the jaw can be left open and moved to the other piece of tissue and positioned such that when the jaw is closed it has grasped both pieces of tissue in an optimized approximation. Wire suturing and twisting proceeds as normal thereafter (seeFIGS. 44A-44C). It is also possible for the two sides of the jaw to close independently against acentral anvil745. Each side of the jaw would grasp a piece of tissue between it andanvil745 allowing the

pieces

730A,730B to be grabbed separately and brought together. The tip of the anvil would have aslit750 in the middle of the end, open to the distal edge that would allowwire520 to pass through

tissue

730A,730B. Afterwire520 had been thus passed, the jaws would be released and pulled away for the steps of grabbingwire520 and twisting them.Slit750 incentral anvil745 would allowwire520 to exit the front end during this step (seeFIGS. 45A-45F).

Further Modifications

It will be appreciated by those skilled in the art that numerous modifications and variations may be made to the above-disclosed embodiments without departing from the spirit and scope of the present invention.

Claims

1. A device for fixing a flexible elongated element to a portion of a subject, said device comprising:

structure for retaining the flexible elongated element;

advancement means for longitudinally advancing the flexible elongated element from a proximal end of said device toward a distal end of said device with sufficient force to pass the element through the portion of the subject; and

securing means for securing the element to the subject and for variably adjusting a securing force applied by the flexible elongated element to the portion of the subject;

wherein said advancement means comprises a collect drive system.